CN103191399A

CN103191399A - Traditional Chinese medicine composition for treating bronchial asthma in acute-outbreak period

Info

Publication number: CN103191399A
Application number: CN2013101361445A
Authority: CN
Inventors: 刘冰甜
Original assignee: Individual
Current assignee: Individual
Priority date: 2013-04-18
Filing date: 2013-04-18
Publication date: 2013-07-10

Abstract

The invention provides a traditional Chinese medicine composition for treating bronchial asthma in the acute-outbreak period. The traditional Chinese medicine composition comprises the following raw materials: fructus corni, semen lepidii, white mulberry root-bark, radix scutellariae, cortex lycii radicis, corydalis tuber, wadalee-gum-tree, dried ginger, iris tectorum maxim, aristolochia, fewflower lysionotus herb, celandine, saffron, American ginseng, cinnamon, physochlaina macrophylla, rhodiola, acanthopanax, changium smyrnioide, sea-buckthorn, japanese inula herb, salvia miltiorrhiza, bamboo shavings, lumbricus, pinellia ternate, cassia twig and garden balsam. The traditional Chinese medicine composition has the advantages of being capable of inhibiting the inflammatory reaction, reducing the airway hyperresponsiveness state, improving the micro-circulation, improving the pulmonary ventilation function and adjusting the immune function in the acute-outbreak period of the bronchial asthma; and compared with western medicines, the traditional Chinese medicine composition has the advantages of being capable of better improving the life quality of asthma patients and reducing the usage amount of glucocorticoids, having little toxic and side effects without drug tolerance and being low in cost.

Description

The Chinese medicine composition that is used for the treatment of bronchial asthma in acute attack stage

Technical field

The present invention relates to technical field of Chinese medicines, relate in particular to a kind of Chinese medicine composition that is used for the treatment of bronchial asthma in acute attack stage.

Background technology

Bronchial asthma is one of modal chronic disease in the world today, and the whole world has that the people suffers from asthma more than 300,000,000, and China has ten million above patient at least.Closely during the last ten years, rise to some extent in countries in the world especially national asthma prevalence such as Britain, the U.S., Australia, New Zealand and mortality rate, the average prevalence of China's asthma is 0.5-1.0%, and with the different and difference to some extent in area, the child below 12 years old is about 2% at southern area.Many patients' the course of disease reaches the more than ten years to decades.Therefore, bronchial asthma serious harm broad masses of the people's health causes a heavy burden of patient family and society, has become serious public health problem and has caused the very big concern of various countries.Over nearly 20 years, the prevalence of the bronchial asthma of many countries and regions and case fatality rate all are ascendant trend gradually.This phenomenon has caused the attention of World Health Organization (WHO) and department of national governments.

The traditional Chinese medical science generally will be divided into stage of attack and catabasis by stages, be equivalent to acute attack stage and non-acute attack stage (or chronic duration) that doctor trained in Western medicine is divided.

Bronchial asthma in acute attack stage is clinical comparatively common, particularly in today of Chinese society aged tendency of population accelerated development, and active treatment bronchial asthma, the life quality that improves the patient has positive social meaning.The main pathomechanism of bronchial asthma be allergy, airway inflammation, airway reactivity increase and factor interaction such as nerve under, bronchial wall thickens, the congested pleat that forms of mucosa swelling, mucus thromboembolism part, the bronchus endocrine stores.If prolonged and repeated outbreak, will cause airway remodeling and on every side lung tissue to the support effect disappearance of air flue.Bronchial asthma in acute attack stage refers to that tachypnea, cough, symptom such as uncomfortable in chest take place suddenly or aggravation, often with dyspnea, is reduced to feature with expiratory gas flow, often because of due to stimulus object such as contact allergen or the malpractice.The purpose of western medical treatment is to alleviate airway obstruction as early as possible, corrects hypoxemia, recovers pulmonary function, and the prevention state of an illness further worsens or outbreak again, actively prevents and treats complication.General oxygen uptake, antibiotic prophylaxis infection, the β of adopting ₂Receptor stimulating agent, theophylline class medicine, glucocorticoid suppress airway inflammation with the outbreak symptom of control bronchial asthma.

With glucocorticoid, β ₂Receptor stimulating agent and theophylline class Drug therapy though determined curative effect is breathed heavily the factor and do not had regulating action and easily produce many serious adverse reactions and dependency causing in the blood plasma, have restricted its clinical practice to a certain extent.

Ancestral's medical science is from organic conception, think that human body is an organic whole, each several part interknits, indivisible, various functions are coordinated mutually, and simultaneously, Chinese medicine is recognized except human body self is an integral body, asking of man and nature environment, social environment influences each other, be indivisible integral body, this and modern medicine have concordance to the understanding of asthma, and the pathogenesis of asthma inducement comprises air pollution, professional dust, vehicle exhaust and even social development, economic situation etc.Under the guidance of organic conception, the prevention of bronchial asthma must be conceived to integral body with treatment, pay attention to the contact between the internal organs, Virtual then mends it, sthenia syndrome requiring purgation, strengthening vital QI to eliminate pathogenic factors, conditioning patient whole body functional status, can reach this sick purpose for the treatment of, can improve the person's of thinking whole resistance again, have the advantage that the simple western medicine treatment can't replace.

Theory of Chinese medical science thinks that the retained phlegm that occurs as of bronchial asthma lies prostrate in lung, because various inducements such as weather, diet, feelings will, fatigue etc. are brought out, and phlegm rising following QI, obstruction of QI due to retention of phlegm, the knot of fighting mutually, congested air flue causes asthma.The traditional Chinese medical science is when the treatment bronchial asthma in acute attack stage, by methods such as resolving phlegm and relieving asthma, promoting blood circulation to remove obstruction in the collateral, nourishing lung and kidneys, can reach the inflammation-inhibiting reaction, reduce the airway hyper-reaction state, improve microcirculation, improve multiple effects such as pulmonary ventilation function and adjusting immunologic function, this has demonstrated fully tcm treatment according to syndrome differentiation and integrally-regulated characteristics, with respect to western medicine, it can better improve the quality of life of asthmatic patient, reduce the consumption of glucocorticoid, toxic and side effects is little, have no drug resistance low price.

Summary of the invention

Technical problem to be solved by this invention is to be to provide a kind of Chinese medicine composition that is used for the treatment of bronchial asthma in acute attack stage, but its inflammation-inhibiting reacts, reduces the airway hyper-reaction state, improves microcirculation, improves pulmonary ventilation function, regulates immunologic function, with respect to western medicine, it can better improve the quality of life of asthmatic patient, reduce the consumption of glucocorticoid, toxic and side effects is little, has no drug resistance low price.

For solving the problems of the technologies described above, the invention provides a kind of Chinese medicinal composition granules that is used for the treatment of bronchial asthma in acute attack stage, its crude drug comprises Fructus Corni, Semen Lepidii (Semen Descurainiae), Cortex Mori, Radix Scutellariae, Cortex Lycii, Rhizoma Corydalis, catechu, Rhizoma Zingiberis, Rhizoma Belamcandae, Fructus Aristolochiae, Herba Lysionoti Pauciflori, Herba Chelidonii, Stigma Croci, Radix Panacis Quinquefolii, Cortex Cinnamomi, Radix Physochlainae, Radix Rhodiolae, Radix Et Caulis Acanthopanacis Senticosi, Radix Changii, Fructus Hippophae, Herba Inulae, Radix Salviae Miltiorrhizae, Caulis Bambusae In Taenia, Pheretima, the Rhizoma Pinelliae, Ramulus Cinnamomi, Semen Impatientis.

For solving the problems of the technologies described above, the invention provides a kind of Chinese medicine composition composition spray that is used for the treatment of bronchial asthma in acute attack stage, its crude drug comprises Fructus Corni, Semen Lepidii (Semen Descurainiae), Cortex Mori, Radix Scutellariae, Cortex Lycii, Rhizoma Corydalis, catechu, Rhizoma Zingiberis, Rhizoma Belamcandae, Fructus Aristolochiae, Herba Lysionoti Pauciflori, Herba Chelidonii, Stigma Croci, Radix Panacis Quinquefolii, Cortex Cinnamomi, Radix Physochlainae, Radix Rhodiolae, Radix Et Caulis Acanthopanacis Senticosi, Radix Changii, Fructus Hippophae, Herba Inulae, Radix Salviae Miltiorrhizae, Caulis Bambusae In Taenia, Pheretima, the Rhizoma Pinelliae, Ramulus Cinnamomi, Semen Impatientis.

Ask in order to solve above-mentioned technology, the invention provides a kind of Chinese medicine composition that is used for the treatment of bronchial asthma in acute attack stage, its crude drug comprises Fructus Corni, Semen Lepidii (Semen Descurainiae), Cortex Mori, Radix Scutellariae, Cortex Lycii, Rhizoma Corydalis, catechu, Rhizoma Zingiberis, Rhizoma Belamcandae, Fructus Aristolochiae, Herba Lysionoti Pauciflori, Herba Chelidonii, Stigma Croci, Radix Panacis Quinquefolii, Cortex Cinnamomi, Radix Physochlainae, Radix Rhodiolae, Radix Et Caulis Acanthopanacis Senticosi, Radix Changii, Fructus Hippophae, Herba Inulae, Radix Salviae Miltiorrhizae, Caulis Bambusae In Taenia, Pheretima, the Rhizoma Pinelliae, Ramulus Cinnamomi, Semen Impatientis.

Wherein, the weight portion of each crude drug is respectively in the described Chinese medicine composition:

Fructus Corni 35 weight portions～45 weight portions, Semen Lepidii (Semen Descurainiae) 25 weight portions～35 weight portions, Cortex Mori 30 weight portions～40 weight portions, Radix Scutellariae 75 weight portions～85 weight portions, Cortex Lycii 25 weight portions～35 weight portions, Rhizoma Corydalis 35 weight portions～45 weight portions, catechu 30 weight portions～40 weight portions, Rhizoma Zingiberis 20 weight portions～30 weight portions, Rhizoma Belamcandae 45 weight portions～55 weight portions, Fructus Aristolochiae 40 weight portions～50 weight portions, Herba Lysionoti Pauciflori 30 weight portions～40 weight portions, Herba Chelidonii 25 weight portions～35 weight portions, Stigma Croci 30 weight portions～40 weight portions, Radix Panacis Quinquefolii 55 weight portions～65 weight portions, Cortex Cinnamomi 30 weight portions～40 weight portions, Radix Physochlainae 50 weight portions～60 weight portions, Radix Rhodiolae 30 weight portions～40 weight portions, Radix Et Caulis Acanthopanacis Senticosi 40 weight portions～50 weight portions, Radix Changii 30 weight portions～40 weight portions, Fructus Hippophae 25 weight portions～35 weight portions, Herba Inulae 40 weight portions～50 weight portions, Radix Salviae Miltiorrhizae 40 weight portions～50 weight portions, Caulis Bambusae In Taenia 30 weight portions～40 weight portions, Pheretima 20 weight portions～30 weight portions, the Rhizoma Pinelliae 35 weight portions～45 weight portions, Ramulus Cinnamomi 20 weight portions～30 weight portions, Semen Impatientis 10 weight portions～20 weight portions.

Wherein, described Chinese medicine composition can be prepared into dosage form for oral administration and exterior-applied formulation, and described dosage form for oral administration is decoction, powder, oral liquid, syrup, soft capsule, tablet, granule, pill, and described exterior-applied formulation is patch, spray.

The present invention also provides the preparation method of above-mentioned Chinese medicine composition, is specially:

The first step, with Fructus Corni, Radix Scutellariae, Rhizoma Belamcandae, Radix Panacis Quinquefolii, Radix Physochlainae, Herba Inulae and Radix Et Caulis Acanthopanacis Senticosi mix according to each weight portion, obtain mixture, pulverize, adding decocts 2～4h with respect to the distilled water of 5～8 times of this mixture qualities, decoction liquor is filtered, the distilled water that filtering residue adds again with respect to 2～4 times of mixture qualities decocts 2～3h, decoction liquor is filtered, filtrate merges, and concentrating under reduced pressure is removed the water of 1/2～2/3 volume, adds determining alcohol and is 70%～80% ethanol to ethanol volume proportion and be till 60%～70%, the limit edged stirs, add and staticly settle, get the supernatant concentrating under reduced pressure and reclaim ethanol, concentrate desolventizing, obtain dried mastic, be ground into first powder;

Second step, remaining component is mixed by each weight portion, obtain mixture, pulverizing is placed in the mixing jar, and adding with respect to 3～5 times of determining alcohols of this mixture quality is 90%～95% ethanol, sealing, stir 1h～3h, soaked 25 days～30 days, between soak period, stirred 1 time every 3 days～4 days, each 1h～3h fully dissolves above-mentioned raw materials medicine composition, squeeze and filter subsequently, filtering residue is standby, and filtrate decompression concentrates desolventizing, obtain and get dry extract, be ground into second powder;

In the 3rd step, with first powder and second powder, be prepared into needed various dosage form on demand.

Wherein, when the dosage form for oral administration of described Chinese medicine composition is soft capsule, described the 3rd step is specially mixed powder of the 3rd step is added in the disperse medium, the mixed proportion of mixed-powder and disperse medium is 1:1～3, stirring is uniformly dispersed the mixture dissolving, obtain to disperse thing, gained disperses thing to cross colloid mill, is pressed into soft capsule with soft capsule forming machine on the soft capsule shell material, molding is 2～4 hours in the drum-type forming machine, condition of molding is 25～30 ℃ of temperature, relative humidity 15～25%, then, clean with determining alcohol 90～98% ethanol, putting then dries in the air in the dish that dries in the air puts dry 20～28 hours, 20～30 ℃ of drying conditions, humidity 15～25%.

Wherein, when the dosage form for oral administration of described Chinese medicine composition is granule; described the 3rd step is specially mixed powder of the 3rd step is added with respect to mixed-powder quality 20%～30% cane sugar powder (mass percent); be 75%～85% ethanol soft material processed with determining alcohol; granulate with oscillating granulator; 60 ℃ of oven dry down, granulate gets medicinal granule of the present invention.

Wherein, when the dosage form of described Chinese medicine composition is patch, described the 3rd step is specially, the pure and mild 20 weight portion gelatin of 15 weight account polyethylenes are joined in the water of 30 weight portions, under 70～90 ℃ temperature, be mixed into gelatin solution, in gelatin solution, add 2 weight portion Kaolin subsequently, 120 weight portion glycerol, 50 weight portion azones, add first powder of 100 weight portions and the mixed-powder that second powder constitutes again, under 60～70 ℃, stir, coating under this temperature on the polyester film that silicone oil is handled, the cooling back covers goes up polyethylene composite film as backing layer, is cut into the fritter of 3cm * 5cm, and every contains crude drug 0.6g.

Wherein, when the dosage form of described Chinese medicine composition was spray, described the 3rd step was specially the powder 1500g that the 3rd step was obtained, the adding determining alcohol is 90%～95% ethanol, is stirred to powder and dissolves fully, adds tween 80 again, glycerol, stearic acid sodium stirs, stir, regulating pH value is 7.0～7.5, leaves standstill precipitate with ethanol, filters, filtrate is concentrated into does not have the alcohol flavor, obtain solution, stirring and dissolving leaves standstill, filter, filtrate is settled to 1000ml, divides the bottle of packing into, sterilization, every bottle of 10ml, seal after charging into the propellant tetrafluoroethene, go on foot the powder that obtains with respect to the 3rd of 100 weight portions, the addition of described tween 80 is 5～15 weight portions, glycerol 10～20 weight portions, stearic acid sodium 1～3 weight portion.

Beneficial effect of the present invention:

Chinese medicine composition provided by the invention is aspect the treatment bronchial asthma in acute attack stage, but inflammation-inhibiting reacts, reduces the airway hyper-reaction state, improves microcirculation, improves pulmonary ventilation function, regulates immunologic function, with respect to western medicine, it can better improve the quality of life of asthmatic patient, reduce the consumption of glucocorticoid, toxic and side effects is little, has no drug resistance low price.

The specific embodiment

Clinical motherland's medical science " bronchial wheezing " category that belongs to of bronchial asthma.This old complaint is lost emptyly in lung, spleen, kidney three are dirty, and the deficiency of the lung can not spreading body fluid, insufficiency of the spleen can not transport precise and tiny, suffer from a deficiency of the kidney and can not evaporate water liquid so that the poly-expectorant that wets into, volt is hidden in lung, becomes " long-standing " of asthma morbidity.Because factors such as weather, diet, feelings will, overstrain, environment are brought out.The acute attack stage basic pathology of bronchial asthma be changed to " latent phlegm " meet sense draw tactile, phlegm rising following QI, obstruction of QI due to retention of phlegm, spiral knot mutually, the air flue that is jammed, the lung pipe is narrow, impairment of dispersing and descending function of the lung, priming stops the expectorant that amasss, and the rale that arrives is as shouting the breath dyspnea with rapid and short breath.As " card control converge mend bronchial wheezing " medium cloud: " and heavy breathing is phlegm dyspnea Chang Fazhe, because of in the gas that is jammed is arranged, the sense when non-is arranged outward, diaphragm has the solid expectorant of glue, the three is harmonious, and closes to refuse air flue, fights with soundly, is bronchial wheezing." this sick affection of cold, external beam wind and cold, expectorant are from cold transformation, and cold fluid-retention accumulates lung, stops up the choke road, impairment of purifying function of the lung, sending out is cold asthma.

At the characteristics of bronchial asthma in acute attack stage, according to the principle of " take stopgap measures when sending out, effect a permanent cure at ordinary times ", treatment should be followed " it is main not sending out to set upright gas, and it is anxious both having sent out to attack pathogen ", controls suitable warming lung for dispelling cold, eliminating phlegm to relieve asthma.

In addition, because the pathological essence of bronchial asthma is the air flue blood stasis, is the main cause that causes thick wind, its influence to asthma attack is more even more important than smooth muscle contraction, thereby should pay attention to blood circulation promoting and blood stasis dispelling simultaneously in the treatment, blood circulation promoting and blood stasis dispelling has blood vessel dilating, improves microcirculation, removes the blood vessel deposit, promote endotheli ocytosis, accelerate body metabolism, reach the internal organs reparation, the effect of blood stasis dispelling tissue regeneration promoting blood.

Based on above-mentioned Chinese traditional treatment theory, the present invention is the Therapeutic Principle with warming lung for dispelling cold, eliminating phlegm to relieve asthma, blood circulation promoting and blood stasis dispelling, a kind of Chinese medicine composition that is used for the treatment of bronchial asthma in acute attack stage is provided, its crude drug comprises Fructus Corni, Semen Lepidii (Semen Descurainiae), Cortex Mori, Radix Scutellariae, Cortex Lycii, Rhizoma Corydalis, catechu, Rhizoma Zingiberis, Rhizoma Belamcandae, Fructus Aristolochiae, Herba Lysionoti Pauciflori, Herba Chelidonii, Stigma Croci, Radix Panacis Quinquefolii, Cortex Cinnamomi, Radix Physochlainae, Radix Rhodiolae, Radix Et Caulis Acanthopanacis Senticosi, Radix Changii, Fructus Hippophae, Herba Inulae, Radix Salviae Miltiorrhizae, Caulis Bambusae In Taenia, Pheretima, the Rhizoma Pinelliae, Ramulus Cinnamomi, Semen Impatientis.

Preferably, described Chinese medicine composition preferably only is made of the above-mentioned raw materials medicine.

In the side, Fructus Corni helps kidney yang, benefiting essence-blood, tonifying the lung gas, the effect of relieving asthma and cough, the Semen Lepidii (Semen Descurainiae) eliminating pathogen from the lung for relieving asthma, inducing diuresis to remove edema, Cortex Mori eliminating heat from the lung, relieving cough and asthma, the Radix Scutellariae lung heat clearing is purged heat, and has antiinflammatory widely, anti-allergy action, the cough-relieving of Cortex Lycii removing heat from the lung and dissipating phlegm, the Rhizoma Corydalis promoting blood circulation to remove blood stasis, promoting the circulation of QI to relieve pain, catechu removing heat from the lung and dissipating phlegm, blood activating and promoting tissue regeneration, the Rhizoma Zingiberis warming the lung to resolve fluid-retention, warming spleen and stomach for dispelling cold, Rhizoma Belamcandae heat-clearing and toxic substances removing, dispelling phlegm and relieving sore-throat, Fructus Aristolochiae lung heat clearing sending down the abnormal ascending QI, relieving cough and asthma, Herba Lysionoti Pauciflori preventing phlegm from forming and stopping coughing, hard masses softening and resolving, the Herba Chelidonii relieving spasm to stop pain, relieving cough and asthma, Stigma Croci blood circulation promoting and blood stasis dispelling, removing pathogenic heat from blood and toxic substance from the body, the Radix Panacis Quinquefolii boosting qi and nourishing yin, clearing away heat and promoting production of body fluid, Cortex Cinnamomi dispersing cold for relieving pain, warming the meridian and promoting blood circulation, the Radix Physochlainae warming the lung to eliminate phlegm, antiasthmatic-antitussive, Radix Rhodiolae benefiting QI for activating blood circulation, promote blood circulation and relieving asthma, the Radix Et Caulis Acanthopanacis Senticosi replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization, Radix Changii moistening the lung and resolving phlegm, the yin nourishing stomach function regulating, Fructus Hippophae relieving cough and resolving phlegm, promoting blood circulation to remove blood stasis, the Herba Inulae lung qi dispersing that dispels the wind, promoting blood circulation and detumescence, the active spasmolytic of Radix Salviae Miltiorrhizae is relievingd asthma, the sensitization that Radix Salviae Miltiorrhizae can be by suppressing the antigen antagonist and prevent that mast cell degranulation from preventing asthma attack, the Caulis Bambusae In Taenia eliminating phlegm and lowering adverse QI, the active spasmolytic of Pheretima is relievingd asthma, have antihistaminic and antianaphylactic effect, Rhizoma Pinelliae warming the lung to resolve fluid-retention sending down the abnormal ascending QI, Ramulus Cinnamomi depressed lung-energy dispersing, sore-throat relieving reduces phlegm, Semen Impatientis blood stasis expelling sending down the abnormal ascending QI, hard masses softening and resolving, all medicines share, and play warming lung for dispelling cold altogether, eliminating phlegm to relieve asthma, the merit of blood circulation promoting and blood stasis dispelling.

The pharmacology of each crude drug is as follows:

Fructus Corni: sour in the mouth, puckery, slightly warm in nature is returned liver, kidney channel, has liver and kidney tonifying, the effect of essence astringing and desertion stemming.Be used for vertigo and tinnitus, soreness of waist and knee joint, impotence and seminal emission, enuresis frequent micturition, bleeding not during menses, profuse sweating collapse.Interior-heat card such as quench one's thirst.

Semen Lepidii (Semen Descurainiae): acrid in the mouth, hardship, cold in nature, return lung meridian, heart channel, Liver Channel, stomach warp, urinary bladder channel, has the eliminating the pathogens from the lung sending down the abnormal ascending QI, eliminating phlegm and relieving asthma, inducing diuresis to remove edema, let out by evil effect, cure mainly the dyspnea and cough with excessive sputum that sputum is stopped up lung, lung abscess, edema, breast abdomen hydrops, dysuria, chronic pulmonary heart disease, breathing heavily of heart failure is swollen, cards such as scrofula tuberculosis.

Cortex Mori: latin name Mori Cortex, sweet in the mouth, cold in nature, go into lung meridian, have eliminating pathogen from the lung for relieving asthma, the effect of inducing diuresis to remove edema is used for the lung-heat cough with asthma, the edema of the face, diseases such as dysuria.

Radix Scutellariae: latin name Scutellariae Radix, bitter in the mouth, cold in nature is gone into the heart, lung, stomach, gallbladder, large intestine channel, and heat clearing and damp drying is arranged, and eliminating fire and detoxication is antiabortive, and the effect of hemostasis is mainly used in diarrhoea, dysentery, jaundice, pyretic stranguria due to damp and hot; The cough due to lung-heat, thirsty pharyngalgia also can be used for excessive fetal movement due to heat in pregnancy, and the pyretic toxicity pathogenic fire is invaded the swollen card of carbuncle sore poison of excessive skin.

Cortex Lycii: latin name Lycii Cortex, cold in nature, sweet in the mouth has removing heat from blood except steaming, and the effect of lung heat clearing pathogenic fire reducing cures mainly cards such as deficiency of YIN hectic fever, hectic fever due to YIN-deficiency night sweat, cough due to lung-heat, spitting of blood, epistaxis.

Rhizoma Corydalis: bitter in the mouth, suffering, warm in nature, return liver, the heart, stomach warp, have benefaction and wander away, can rise and can fall, have promoting blood circulation to remove blood stasis, the effect of promoting the circulation of QI to relieve pain cures mainly obstruction of qi in the chest and cardialgia, side of body rib, all pains of gastral cavity abdomen, headache, lumbago, colicky, bones and muscles pain, dysmenorrhea, amenorrhea, puerperal, the stasis of blood was suffered from abdominal pain, cards such as traumatic injury.

Catechu: bitter in the mouth, puckery, cold nature is returned lung meridian, has the effect of removing dampness promoting tissue regeneration and ulcer healing, is used for ulcer being unable to heal, eczema, aphtha is fallen cards such as pouncing on the pain of injury, traumatic hemorrhage.

Rhizoma Zingiberis: acrid in the mouth, hot in nature, return spleen, stomach, the heart, lung meridian; Have warming spleen and stomach for dispelling cold, recuperating depleted YANG is promoted blood circulation, the dampness expectorant, and the effect of warming the lung to resolve fluid-retention is used for coldness and pain in the epigastrium, and vomiting is had loose bowels, and YANG-depletion is fainted contrary, and cold fluid-retention is breathed with cough, cards such as arthralgia due to cold-dampnes.

Rhizoma Belamcandae: latin name Iridis Tectori Rhizoma, bitter in the mouth, cold in nature, return lung meridian, have heat-clearing and toxic substances removing, the effect of dispelling phlegm and relieving sore-throat cures mainly the pent-up of pyretic toxicity phlegm-fire, and throat swells and ache, cards such as cough and asthma.

Fructus Aristolochiae: bitter in the mouth, cold nature is returned lung, large intestine channel, has the lung heat clearing sending down the abnormal ascending QI, relieving cough and asthma, the disappear effect of hemorrhoid of bowel relieving is used for dyspnea and cough due to lung-heat, sputum mixed with blood, the hot hemorrhoidal bleeding of intestinal, cards such as swelling and pain of hemorrhoid.

Herba Lysionoti Pauciflori: latin name Lysionoti Herba, bitter in the mouth, warm in nature, return lung meridian, have preventing phlegm from forming and stopping coughing, the effect that hard masses softening and resolving, blood stasis dispelling stimulate the menstrual flow cures mainly cough with copious phlegm, main air pain of dampness syndrome, cough with asthma abundant expectoration, menoxenia, dysmenorrhea, cards such as traumatic injury.

Herba Chelidonii: bitter in the mouth, cool in nature, attach to the lung and stomach meridians, have relieving spasm to stop pain, the effect of relieving cough and asthma cures mainly analgesia, cough-relieving, diuresis detoxifcation.Control gastrointestinal distress, jaundice, edema, the scabies skin ulcer is swollen, cards such as snake bite and insect sting.

Stigma Croci: sweet in the mouth, property is flat, has blood circulation promoting and blood stasis dispelling, dispersing stagnation and relieving accumulation of pathogens, the effect of pain relieving is used for the treatment of troubled thoughts pent-up, the chest and diaphragm painful abdominal mass is vexed, spits blood, and typhoid fever is gone mad, and is frightened fear in a trance, women's amenorrhea, the stasis menoxenia, prolonged lochia, blood stasis is had a pain, measles, cards such as traumatic injury.

Radix Panacis Quinquefolii: sweet in the mouth, little hardship, cool in nature, GUIXIN, lung, kidney channel have boosting qi and nourishing yin, the effect of clearing away heat and promoting production of body fluid, it is thanks to cloudy to cure mainly the deficiency of vital energy, interior-heat, cough with asthma expectorant blood, deficiency-heat is tired tired, quenches one's thirst cards such as dryness of the mouth and throat.

Cortex Cinnamomi: extremely hot in nature, acrid in the mouth, sweet is returned kidney, spleen, the heart, Liver Channel, and it is fiery supporing yang to have benefit, let the fire back to its origin, dispersing cold for relieving pain, the effect of promoting blood circulation to restore menstrual flow is used for warming the spleen and stomach, removing accumulated cold, promoting blood circulation.Control decline of the fire from the gate of life, the cold extremities faint pulse, the YANG-depletion collapse, stomachache is had loose bowels, the colic of cold type renal mass, chills and pain of the waist and kness, the amenorrhea lump in the abdomen, carbuncle of yin nature, multiple abscess, and empty sun is more floating, cards such as heat in the upper and cold in the lower.

Radix Physochlainae: latin name Physochlainae Radix, sweet in the mouth, little hardship, warm in nature, return lung, heart channel, have warming the lung to eliminate phlegm, antiasthmatic-antitussive, the analgesic effect of calming the nerves cures mainly cold-phlegm and breathes with cough, and the palpitation with fear insomnia waits card.

Radix Rhodiolae: sweet in the mouth, hardship, property is flat, returns lung, heart channel, has benefiting QI for activating blood circulation, and the effect of promoting blood circulation and relievining asthma is used for blood stasis due to qi deficiency, obstruction of qi in the chest and cardialgia, apoplectic hemiplegia, cards such as asthenia asthma.

Radix Et Caulis Acanthopanacis Senticosi: latin name Acanthopanacis Senticosi Radix et Rhizoma seu Caulis, acrid in the mouth, hardship, little sweet, warm in nature, go into spleen, kidney, heart channel, has replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization, the effect of expelling wind and removing dampness, be used for anemofrigid-damp arthralgia, lumbocrural pain, muscles and bones flaccidity soft, be slow in action, card such as the body weakness with emaciation is weak, traumatic injury, fracture, edema, beriberi, uncontrolled urination are itched.

Radix Changii: sweet in the mouth, little hardship, cold nature is returned lung, spleen, Liver Channel, has moistening the lung and resolving phlegm, the yin nourishing stomach function regulating, the effect of suppressing the hyperactive liver detoxifcation is used for the cough due to lung-heat, vomiting regurgitation, the lack of appetite xerostomia, conjunctival congestion is dizzy, cards such as furunculosis skin infection.

Fructus Hippophae: sour in the mouth; Puckery; Warm in nature, have relieving cough and resolving phlegm; Invigorating the stomach and promoting digestion; The effect of promoting blood circulation to remove blood stasis.Cure mainly cough with copious phlegm; Pulmonary abscess; Dyspepsia; Abdominal pain due to retention of food; Stomachache; The intestinal inflammation; Amenorrhea; Cards such as traumatic injury congestive edema.

Herba Inulae: latin name Inulae Herba, bitter in the mouth, suffering, salty, warm in nature, return lung, large intestine channel, have sending down the abnormal ascending QI, expectorant, the effect of row water cures mainly affection of exogenous wind-cold, and phlegm retention is held knot, cough with asthma abundant expectoration, cards such as chest and diaphragm feeling of fullness.

Radix Salviae Miltiorrhizae: bitter in the mouth, cold in nature, go into the heart, Liver Channel, the effect of blood circulation promoting and blood stasis dispelling, promoting tissue regeneration by removing blood stasis, removing heat from blood mind calming is arranged, be mainly used in the ambition of stagnation of QI and blood, the twinge of the breast side of body, sensation of oppression over the chest with shortness of breath, abdominal distention; The menoxenia of women's disharmony between QI and blood, the dysmenorrhoea amenorrhea; Stagnation of QI-blood, symptoms such as trusted subordinate's pain.

Caulis Bambusae In Taenia: cold nature, sweet in the mouth attaches to the lung and stomach meridians, and has removing heat-phlegm, and the effect that relieves restlessness and prevents vomiting is held cards such as expectorant, dysphoria with smothery sensation vomiting, palpitation with fear insomnia, wind-phlegm fan, aphasia with stiff tongue, gastropyretic vomiting, pregnancy reactions, frequent fetal movement under the arm for phlegm-heat cough, gallbladder fire.

Pheretima: salty in the mouth, cold in nature, return liver, spleen, urinary bladder channel, have the heat clearing away arresting convulsion, collateral dredging is relievingd asthma, and the effect of diuresis cures mainly unconsciousness due to high fever, arthralgia, numb limbs and tense tendons, hemiplegia, lung-heat cough with asthma, the effect of edema oliguria.

The Rhizoma Pinelliae: latin name Pinelliae Rhizoma, acrid in the mouth, warm in nature, go into lung, spleen, large intestine three warps have drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, the effect of dissolving lump and resolving mass is used for that abundant expectoration cough with asthma, phlegm retention vertigo and palpitation, interior expectorant are dizzy, syncope due to accumulation of phlegm headache, vomiting regurgitation, vexed, the globus hystericus disease of breast gastral cavity painful abdominal mass.

Ramulus Cinnamomi: acrid in the mouth, sweet, warm in nature, GUIXIN, lung, urinary bladder channel have the diaphoresis expelling pathogenic factors from muscles, warming the meridian and promoting blood circulation, supporing yang activating QI, the effect of dispersing cold for relieving pain, the Ramulus Cinnamomi warming the meridian and promoting blood circulation, horizontal logical podomere is used for the affection of exogenous wind-cold exterior syndrome, no matter antiperspirant is arranged, losslessly all can use, also be used for rheumatic arthralgia, cold syndrome of the stomach stomachache, amenorrhea, dysmenorrhea, rheumatic arthralgia, cards such as shoulder arm podomere cold type of pain, phlegm retention syndrome and bladder water-retention, heart deficiency of spleen-YANG, retention of water-damp in the body, fullness and distention in the chest and hypochondrium, phlegm retention syndromes such as cough with dyspnea dizziness.

Semen Impatientis: little hardship, suffering, warm in nature, return lung, Liver Channel, have the effect anticancer, that loose and become silted up and subside a swelling that relieves internal heat, cure mainly the removing blood stasis softening the hard mass, removing food stagnancy ， WEIJIA mass in the abdomen, amenorrhea, the dysphagic card that waits.

The Chinese medicine composition of the present invention's preparation is conducive to improve the air flue blood flow, alleviates the air flue blood stasis, protection and recovery air flue normal structure structure, and the inflammation-inhibiting reaction reduces the airway hyper-reaction state, improves pulmonary ventilation function and adjusting immunologic function.

The weight portion of each crude drug preferably is respectively in the described Chinese medicine composition:

The weight portion of each crude drug further preferably is respectively in the described Chinese medicine composition:

Fructus Corni 38 weight portions～42 weight portions, Semen Lepidii (Semen Descurainiae) 28 weight portions～32 weight portions, Cortex Mori 33 weight portions～37 weight portions, Radix Scutellariae 78 weight portions～82 weight portions, Cortex Lycii 28 weight portions～32 weight portions, Rhizoma Corydalis 38 weight portions～42 weight portions, catechu 33 weight portions～37 weight portions, Rhizoma Zingiberis 23 weight portions～27 weight portions, Rhizoma Belamcandae 48 weight portions～52 weight portions, Fructus Aristolochiae 43 weight portions～47 weight portions, Herba Lysionoti Pauciflori 33 weight portions～37 weight portions, Herba Chelidonii 28 weight portions～32 weight portions, Stigma Croci 33 weight portions～37 weight portions, Radix Panacis Quinquefolii 58 weight portions～62 weight portions, Cortex Cinnamomi 33 weight portions～37 weight portions, Radix Physochlainae 53 weight portions～57 weight portions, Radix Rhodiolae 33 weight portions～37 weight portions, Radix Et Caulis Acanthopanacis Senticosi 43 weight portions～47 weight portions, Radix Changii 33 weight portions～37 weight portions, Fructus Hippophae 28 weight portions～32 weight portions, Herba Inulae 43 weight portions～47 weight portions, Radix Salviae Miltiorrhizae 43 weight portions～47 weight portions, Caulis Bambusae In Taenia 33 weight portions～37 weight portions, Pheretima 23 weight portions～27 weight portions, the Rhizoma Pinelliae 38 weight portions～42 weight portions, Ramulus Cinnamomi 23 weight portions～27 weight portions, Semen Impatientis 13 weight portions～17 weight portions.

The weight portion of each crude drug most preferably is respectively in the described Chinese medicine composition:

Fructus Corni 40 weight portions, Semen Lepidii (Semen Descurainiae) 30 weight portions, Cortex Mori 35 weight portions, Radix Scutellariae 80 weight portions, Cortex Lycii 30 weight portions, Rhizoma Corydalis 40 weight portions, catechu 35 weight portions, Rhizoma Zingiberis 25 weight portions, Rhizoma Belamcandae 50 weight portions, Fructus Aristolochiae 45 weight portions, Herba Lysionoti Pauciflori 35 weight portions, Herba Chelidonii 30 weight portions, Stigma Croci 35 weight portions, Radix Panacis Quinquefolii 60 weight portions, Cortex Cinnamomi 35 weight portions, Radix Physochlainae 55 weight portions, Radix Rhodiolae 35 weight portions, Radix Et Caulis Acanthopanacis Senticosi 45 weight portions, Radix Changii 35 weight portions, Fructus Hippophae 30 weight portions, Herba Inulae 45 weight portions, Radix Salviae Miltiorrhizae 45 weight portions, Caulis Bambusae In Taenia 35 weight portions, Pheretima 25 weight portions, the Rhizoma Pinelliae 40 weight portions, Ramulus Cinnamomi 25 weight portions, Semen Impatientis 15 weight portions.

Described Chinese medicine composition can be prepared into dosage form for oral administration and exterior-applied formulation, and preferably dosage form for oral administration and exterior-applied formulation drug combination are realized the treatment to bronchial asthma in acute attack stage, and alleviation is ailing rapidly in a short time, improves patient's life quality.

The dosage form for oral administration of described Chinese medicine composition is preferably regular dosage forms such as decoction, powder, oral liquid, syrup, soft capsule, tablet, granule, pill, and described exterior-applied formulation is preferably patch, spray.

Preferably, the dosage form for oral administration of described Chinese medicine composition is soft capsule, when the dosage form for oral administration of described Chinese medicine composition is soft capsule, described the 3rd step is specially mixed powder of the 3rd step is added in the disperse medium, the mixed proportion of mixed-powder and disperse medium is 1:1～3, stirring is uniformly dispersed the mixture dissolving, obtain to disperse thing, gained disperses thing to cross colloid mill, be pressed into soft capsule with soft capsule forming machine on the soft capsule shell material, molding is 2～4 hours in the drum-type forming machine, and condition of molding is 25～30 ℃ of temperature, relative humidity 15～25%, then, clean with determining alcohol 90～98% ethanol, putting then dries in the air in the dish that dries in the air puts dry 20～28 hours, 20～30 ℃ of drying conditions, humidity 15～25%.

Wherein, described disperse medium is any in soybean oil, Semen Maydis oil, Oleum Gossypii semen, sunflower oil, cupu oil, Petiolus Trachycarpi oil, Oleum Arachidis hypogaeae semen, olive oil, the Oleum Camelliae.

Preferably; the dosage form for oral administration of described Chinese medicine composition is granule; when the dosage form for oral administration of described Chinese medicine composition is granule; described the 3rd step is specially mixed powder of the 3rd step is added with respect to mixed-powder quality 20%～30% cane sugar powder (mass percent); be 75%～85% ethanol soft material processed with determining alcohol, granulate with oscillating granulator, 60 ℃ of oven dry down; granulate gets medicinal granule of the present invention.

Preferably, the exterior-applied formulation of described Chinese medicine composition is patch, when the dosage form of described Chinese medicine composition is patch, described the 3rd step is specially, the pure and mild 20 weight portion gelatin of 15 weight account polyethylenes are joined in the water of 30 weight portions, under 70～90 ℃ temperature, be mixed into gelatin solution, in gelatin solution, add 2 weight portion Kaolin subsequently, 120 weight portion glycerol, 50 weight portion azones, add first powder of 100 weight portions and the mixed-powder that second powder constitutes again, under 60～70 ℃, stir, coating under this temperature on the polyester film that silicone oil is handled, the cooling back covers goes up polyethylene composite film as backing layer, be cut into the fritter of 3cm * 5cm, every contains crude drug 0.6g.

Preferably, the exterior-applied formulation of described Chinese medicine composition is spray, when the dosage form of described Chinese medicine composition is spray, described the 3rd step is specially the powder 1500g that the 3rd step was obtained, and the adding determining alcohol is 90%～95% ethanol, is stirred to powder and dissolves fully, add tween 80 again, glycerol, stearic acid sodium, stir, stir, regulating pH value is 7.0～7.5, leave standstill precipitate with ethanol, filter, filtrate is concentrated into does not have the alcohol flavor, obtains solution, stirring and dissolving, leave standstill, filter, filtrate is settled to 1000ml, divide the bottle of packing into, sterilization, every bottle of 10ml seals after charging into the propellant tetrafluoroethene, go on foot the powder that obtains with respect to the 3rd of 100 weight portions, the addition of described tween 80 is 5～15 weight portions, glycerol 10～20 weight portions, stearic acid sodium 1～3 weight portion.

Below adopt embodiment to describe embodiments of the present invention in detail, how the application technology means solve technical problem to the present invention whereby, and the implementation procedure of reaching technique effect can fully understand and implements according to this.

Embodiment 1 granule 1

With Fructus Corni 40g, Radix Scutellariae 80g, Rhizoma Belamcandae 50g, Radix Panacis Quinquefolii 60g, Radix Physochlainae 55g, Herba Inulae 45g and Radix Et Caulis Acanthopanacis Senticosi 45g mix, obtain mixture, pulverize, the distilled water that adds 2.4kg decocts 4h, decoction liquor is filtered, the distilled water that filtering residue adds 1kg again decocts 3h, and decoction liquor is filtered, and filtrate merges, concentrating under reduced pressure is removed the water of 2/3 volume, add determining alcohol and be 80% ethanol to ethanol volume proportion and be till 70%, the limit edged stirs, and adds to staticly settle, get the supernatant concentrating under reduced pressure and reclaim ethanol, concentrate desolventizing, obtain dried mastic, be ground into first powder; With Semen Lepidii (Semen Descurainiae) 30g; Cortex Mori 35g; Cortex Lycii 30g; Rhizoma Corydalis 40g; catechu 35g; Rhizoma Zingiberis 25g; Fructus Aristolochiae 45g; Herba Lysionoti Pauciflori 35g; Herba Chelidonii 30g; Stigma Croci 35g; Cortex Cinnamomi 35g; Radix Rhodiolae 35g; Radix Changii 35g; Fructus Hippophae 30g; Radix Salviae Miltiorrhizae 45g; Caulis Bambusae In Taenia 35g; Pheretima 25g; Rhizoma Pinelliae 40g; Ramulus Cinnamomi 25g; Semen Impatientis 15g mixes; obtain mixture; pulverizing is placed in the mixing jar; adding 1.8kg determining alcohol is 95% ethanol; 3h is stirred in sealing, soaks 30 days; between soak period; stirred 1 time every 3 days, each 2h fully dissolves above-mentioned raw materials medicine composition; squeeze and filter subsequently; filtering residue is standby, and filtrate decompression concentrates desolventizing, obtains to get dry extract; be ground into second powder; with first powder and second powder, get the 500g mixed-powder and add the 120g cane sugar powder, be 75% ethanol soft material processed with determining alcohol; granulate with oscillating granulator; 60 ℃ of oven dry down, granulate gets granule 1.

Embodiment 2 toxicity tests

Acute toxicity testing

Select 20 of Kunming mouses, female half and half, body weight (20+2) g is provided by Qingdao City's Experimental Animal Center, and the granule of embodiment 1 preparation is dissolved in the water, is mixed with the solution of 1g/ml, gavages mice, through preliminary experiment, fails to detect the LD of oral administration ₅₀So survey its maximum tolerated dose, administration volume with the 1.4ml/10g body weight gavages 2 times/d, at interval 6h, observe 7d after the administration, record animal dead and toxicity symptom when experiment finishes, are handled all animals, dissect, each main organs lesion tissue situation of perusal, gavage 140g crude drug/kg 2 times after, animal activity, the feed water inlet is not seen any unusual, observe the 7d animal dead, gross necropsy is not seen the obviously unusual of main organs tissue, therefore, the maximum dosage-feeding of Chinese medicine granules is〉140g crude drug/kg, this dosage is equivalent to 93.3 times of clinical adult (by 60kg) oral dose every day 1.5g crude drug/kg.

Long term toxicity test

Select 40 male SD rats, body constitution amount (180 ± 20) g, provided by Qingdao City's Experimental Animal Center, be divided into 2 groups at random, blank group and Chinese drug-treated group, every group 20, the blank group gives distilled water, and Chinese drug-treated group is dissolved in the granule of embodiment 1 preparation in the water, is mixed with solution, gavage rat, the amount of gavaging is 50g crude drug/kg, on every Mondays to gastric infusion 1 time in morning Saturday, and 180d continuously, the administration volume is the 2ml/100g body weight, and observe rat general state, sign, food ration, drinking-water and feces situation every day before the administration and during the administration.Behind last administration 24h, each group extracts 6, male and female half and half during administration 90d; Behind the last administration 24h, each group extracts 6, male and female half and half during 180d; Each group of 30d extracts 6 after the drug withdrawal, male and female half and half, anaesthetize with urethane, get blood from abdominal aortic, each group is all got animal extremely, checks hematology and blood parameters, get blood after, amass wealth by heavy taxation at once core, internal organs such as liver,kidney,spleen, lung, adrenal gland, thyroid, thymus, testis, ovary, uterus, brain, prostate weigh, according to weight calculator official weight coefficient and do the pathology inspection.

On inspection, during successive administration, the activity of animal, body weight, food ration, stool and hair luster degree no abnormality seen, animal does not see death, naked eyes are not seen obvious pathological changes, each organizes the inspection of rat peripheral hemogram all in normal range, and blood is given birth to the tea index all in normal range, and Chinese drug-treated group Rats Organs and Tissues coefficient is compared with the blank group does not have significant difference.

From embodiment 2 as can be seen, the clinical use of Chinese medicine composition endo-medicine of the present invention is safe.

Embodiment 3 granules 2

With Fructus Corni 35g, Radix Scutellariae 75g, Rhizoma Belamcandae 45g, Radix Panacis Quinquefolii 55g, Radix Physochlainae 50g, Herba Inulae 40g and Radix Et Caulis Acanthopanacis Senticosi 40g mix, obtain mixture, pulverize, the distilled water that adds 2kg decocts 3h, decoction liquor is filtered, the distilled water that filtering residue adds 1kg again decocts 3h, and decoction liquor is filtered, and filtrate merges, concentrating under reduced pressure is removed the water of 2/3 volume, add determining alcohol and be 80% ethanol to ethanol volume proportion and be till 70%, the limit edged stirs, and adds to staticly settle, get the supernatant concentrating under reduced pressure and reclaim ethanol, concentrate desolventizing, obtain dried mastic, be ground into first powder; With Semen Lepidii (Semen Descurainiae) 25g; Cortex Mori 30g; Cortex Lycii 25g; Rhizoma Corydalis 35g; catechu 30g; Rhizoma Zingiberis 20g; Fructus Aristolochiae 40g; Herba Lysionoti Pauciflori 30g; Herba Chelidonii 25g; Stigma Croci 30g; Cortex Cinnamomi 30g; Radix Rhodiolae 30g; Radix Changii 30g; Fructus Hippophae 25g; Radix Salviae Miltiorrhizae 40g; Caulis Bambusae In Taenia 30g; Pheretima 20g; Rhizoma Pinelliae 35g; Ramulus Cinnamomi 20g; Semen Impatientis 10g mixes; obtain mixture; pulverizing is placed in the mixing jar; adding 1.5kg determining alcohol is 95% ethanol; 3h is stirred in sealing, soaks 30 days; between soak period; stirred 1 time every 3 days, each 2h fully dissolves above-mentioned raw materials medicine composition; squeeze and filter subsequently; filtering residue is standby, and filtrate decompression concentrates desolventizing, obtains to get dry extract; be ground into second powder; with first powder and second powder, get the 500g mixed-powder and add the 120g cane sugar powder, be 75% ethanol soft material processed with determining alcohol; granulate with oscillating granulator; 60 ℃ of oven dry down, granulate gets granule 2.

Embodiment 4 granules 3

With Fructus Corni 45g, Radix Scutellariae 85g, Rhizoma Belamcandae 55g, Radix Panacis Quinquefolii 65g, Radix Physochlainae 60g, Herba Inulae 50g and Radix Et Caulis Acanthopanacis Senticosi 50g mix, obtain mixture, pulverize, the distilled water that adds 3kg decocts 3h, decoction liquor is filtered, the distilled water that filtering residue adds 1.5kg again decocts 3h, and decoction liquor is filtered, and filtrate merges, concentrating under reduced pressure is removed the water of 2/3 volume, add determining alcohol and be 80% ethanol to ethanol volume proportion and be till 70%, the limit edged stirs, and adds to staticly settle, get the supernatant concentrating under reduced pressure and reclaim ethanol, concentrate desolventizing, obtain dried mastic, be ground into first powder; With Semen Lepidii (Semen Descurainiae) 35g; Cortex Mori 40g; Cortex Lycii 35g; Rhizoma Corydalis 45g; catechu 40g; Rhizoma Zingiberis 30g; Fructus Aristolochiae 50g; Herba Lysionoti Pauciflori 40g; Herba Chelidonii 35g; Stigma Croci 40g; Cortex Cinnamomi 40g; Radix Rhodiolae 40g; Radix Changii 40g; Fructus Hippophae 35g; Radix Salviae Miltiorrhizae 50g; Caulis Bambusae In Taenia 40g; Pheretima 30g; Rhizoma Pinelliae 45g; Ramulus Cinnamomi 30g; Semen Impatientis 20g mixes; obtain mixture; pulverizing is placed in the mixing jar; adding 2.2kg determining alcohol is 95% ethanol; 3h is stirred in sealing, soaks 30 days; between soak period; stirred 1 time every 3 days, each 2h fully dissolves above-mentioned raw materials medicine composition; squeeze and filter subsequently; filtering residue is standby, and filtrate decompression concentrates desolventizing, obtains to get dry extract; be ground into second powder; with first powder and second powder, get the 500g mixed-powder and add the 120g cane sugar powder, be 75% ethanol soft material processed with determining alcohol; granulate with oscillating granulator; 60 ℃ of oven dry down, granulate gets granule 3.

Embodiment 5 soft capsules 1

With Fructus Corni 40g, Radix Scutellariae 80g, Rhizoma Belamcandae 50g, Radix Panacis Quinquefolii 60g, Radix Physochlainae 55g, Herba Inulae 45g and Radix Et Caulis Acanthopanacis Senticosi 45g mix, obtain mixture, pulverize, the distilled water that adds 2.4kg decocts 4h, decoction liquor is filtered, the distilled water that filtering residue adds 1kg again decocts 3h, and decoction liquor is filtered, and filtrate merges, concentrating under reduced pressure is removed the water of 2/3 volume, add determining alcohol and be 80% ethanol to ethanol volume proportion and be till 70%, the limit edged stirs, and adds to staticly settle, get the supernatant concentrating under reduced pressure and reclaim ethanol, concentrate desolventizing, obtain dried mastic, be ground into first powder; With Semen Lepidii (Semen Descurainiae) 30g, Cortex Mori 35g, Cortex Lycii 30g, Rhizoma Corydalis 40g, catechu 35g, Rhizoma Zingiberis 25g, Fructus Aristolochiae 45g, Herba Lysionoti Pauciflori 35g, Herba Chelidonii 30g, Stigma Croci 35g, Cortex Cinnamomi 35g, Radix Rhodiolae 35g, Radix Changii 35g, Fructus Hippophae 30g, Radix Salviae Miltiorrhizae 45g, Caulis Bambusae In Taenia 35g, Pheretima 25g, Rhizoma Pinelliae 40g, Ramulus Cinnamomi 25g, Semen Impatientis 15g mixes, obtain mixture, pulverizing is placed in the mixing jar, adding 1.8kg determining alcohol is 95% ethanol, sealing, stir 3h, soaked 30 days, between soak period, stirred 1 time every 3 days, each 2h, above-mentioned raw materials medicine composition is fully dissolved, squeeze and filter subsequently, filtering residue is standby, filtrate decompression concentrates desolventizing, obtain and get dry extract, be ground into second powder, with first powder and second powder, to get the mixed powder of 500g and add in the 500g disperse medium soybean oil, stirring is uniformly dispersed the mixture dissolving, obtain to disperse thing, gained disperses thing to cross colloid mill, is pressed into soft capsule with soft capsule forming machine on the soft capsule shell material, and molding is 3 hours in the drum-type forming machine, condition of molding is 25 ℃ of temperature, relative humidity 15% then, cleans with determining alcohol 90% ethanol, putting then dries in the air in the dish that dries in the air puts dry 20 hours, 30 ℃ of drying conditions, humidity 15 obtains soft capsule 1.

Embodiment 6 sprays 1

With Fructus Corni 40g, Radix Scutellariae 80g, Rhizoma Belamcandae 50g, Radix Panacis Quinquefolii 60g, Radix Physochlainae 55g, Herba Inulae 45g and Radix Et Caulis Acanthopanacis Senticosi 45g mix, obtain mixture, pulverize, the distilled water that adds 2.4kg decocts 4h, decoction liquor is filtered, the distilled water that filtering residue adds 1kg again decocts 3h, and decoction liquor is filtered, and filtrate merges, concentrating under reduced pressure is removed the water of 2/3 volume, add determining alcohol and be 80% ethanol to ethanol volume proportion and be till 70%, the limit edged stirs, and adds to staticly settle, get the supernatant concentrating under reduced pressure and reclaim ethanol, concentrate desolventizing, obtain dried mastic, be ground into first powder; With Semen Lepidii (Semen Descurainiae) 30g, Cortex Mori 35g, Cortex Lycii 30g, Rhizoma Corydalis 40g, catechu 35g, Rhizoma Zingiberis 25g, Fructus Aristolochiae 45g, Herba Lysionoti Pauciflori 35g, Herba Chelidonii 30g, Stigma Croci 35g, Cortex Cinnamomi 35g, Radix Rhodiolae 35g, Radix Changii 35g, Fructus Hippophae 30g, Radix Salviae Miltiorrhizae 45g, Caulis Bambusae In Taenia 35g, Pheretima 25g, Rhizoma Pinelliae 40g, Ramulus Cinnamomi 25g, Semen Impatientis 15g mixes, obtain mixture, pulverizing is placed in the mixing jar, adding 1.8kg determining alcohol is 95% ethanol, sealing, stir 3h, soaked 30 days, between soak period, stirred 1 time every 3 days, each 2h fully dissolves above-mentioned raw materials medicine composition, squeeze and filter subsequently, filtering residue is standby, and filtrate decompression concentrates desolventizing, obtains to get dry extract, be ground into second powder, with first powder and second powder, get mixed-powder 500g, the adding determining alcohol is 95% ethanol, being stirred to powder dissolves fully, add the 50g tween 80 again, 75g glycerol, 10g stearic acid sodium, stir, stir, regulating pH value is 7.0, leaves standstill precipitate with ethanol, filter, filtrate is concentrated into does not have the alcohol flavor, obtains solution, stirring and dissolving, leave standstill, filter, filtrate is settled to 300ml, divides the bottle of packing into, sterilization, every bottle of 10ml charges into respect to sealing behind 2 times of volume propellant of solution tetrafluoroethene, obtains spray 1.

Embodiment 7 toxicity tests

Acute toxicity testing

Select 20 of Kunming mouses, female half and half, body weight (20+2) g, provided by Qingdao City's Experimental Animal Center, branch is irritated the spray 1 (also not charging into the preceding solution of propellant) of stomach embodiment 6 preparations for 2 times in the 12h, and each 0.7ml//20g observes 7d after the administration, record animal dead and toxicity symptom, when experiment finishes, all animals is handled, dissected, each main organs lesion tissue situation of perusal, after gavaging, animal activity, the feed water inlet is not seen any unusual, observe the 7d animal dead, gross necropsy is not seen the obviously unusual of main organs tissue.

Long term toxicity test

Select 40 male SD rats, body constitution amount (180 ± 20) g, provided by Qingdao City's Experimental Animal Center, be divided into 2 groups at random, blank group and Chinese drug-treated group, every group 20, the blank group gives distilled water, on every Mondays the spray 1 for preparing to 1 embodiment of gastric infusion in morning Saturday 6 (also not charging into the preceding solution of propellant), 180d continuously, the administration volume is the 2ml/100g body weight, and observe rat general state, sign, food ration, drinking-water and feces situation every day before the administration and during the administration.Behind last administration 24h, each group extracts 6, male and female half and half during administration 90d; Behind the last administration 24h, each group extracts 6, male and female half and half during 180d; Each group of 30d extracts 6 after the drug withdrawal, male and female half and half, anaesthetize with urethane, get blood from abdominal aortic, each group is all got animal extremely, checks hematology and blood parameters, get blood after, amass wealth by heavy taxation at once core, internal organs such as liver,kidney,spleen, lung, adrenal gland, thyroid, thymus, testis, ovary, uterus, brain, prostate weigh, according to weight calculator official weight coefficient and do the pathology inspection.

From embodiment 7 as can be seen, the clinical use of Chinese medicine composition of the present invention is safe.

Embodiment 8 sprays 2

With Fructus Corni 35g, Radix Scutellariae 75g, Rhizoma Belamcandae 45g, Radix Panacis Quinquefolii 55g, Radix Physochlainae 50g, Herba Inulae 40g and Radix Et Caulis Acanthopanacis Senticosi 40g mix, obtain mixture, pulverize, the distilled water that adds 2kg decocts 3h, decoction liquor is filtered, the distilled water that filtering residue adds 1kg again decocts 3h, and decoction liquor is filtered, and filtrate merges, concentrating under reduced pressure is removed the water of 2/3 volume, add determining alcohol and be 80% ethanol to ethanol volume proportion and be till 70%, the limit edged stirs, and adds to staticly settle, get the supernatant concentrating under reduced pressure and reclaim ethanol, concentrate desolventizing, obtain dried mastic, be ground into first powder; With Semen Lepidii (Semen Descurainiae) 25g, Cortex Mori 30g, Cortex Lycii 25g, Rhizoma Corydalis 35g, catechu 30g, Rhizoma Zingiberis 20g, Fructus Aristolochiae 40g, Herba Lysionoti Pauciflori 30g, Herba Chelidonii 25g, Stigma Croci 30g, Cortex Cinnamomi 30g, Radix Rhodiolae 30g, Radix Changii 30g, Fructus Hippophae 25g, Radix Salviae Miltiorrhizae 40g, Caulis Bambusae In Taenia 30g, Pheretima 20g, Rhizoma Pinelliae 35g, Ramulus Cinnamomi 20g, Semen Impatientis 10g mixes, obtain mixture, pulverizing is placed in the mixing jar, adding 1.5kg determining alcohol is 95% ethanol, sealing, stir 3h, soaked 30 days, between soak period, stirred 1 time every 3 days, each 2h fully dissolves above-mentioned raw materials medicine composition, squeeze and filter subsequently, filtering residue is standby, and filtrate decompression concentrates desolventizing, obtains to get dry extract, be ground into second powder, with first powder and second powder, get mixed-powder 500g, the adding determining alcohol is 95% ethanol, being stirred to powder dissolves fully, add the 50g tween 80 again, 75g glycerol, 10g stearic acid sodium, stir, stir, regulating pH value is 7.0, leaves standstill precipitate with ethanol, filter, filtrate is concentrated into does not have the alcohol flavor, obtains solution, stirring and dissolving, leave standstill, filter, filtrate is settled to 300ml, divides the bottle of packing into, sterilization, every bottle of 10ml charges into respect to sealing behind 2 times of volume propellant of solution tetrafluoroethene, obtains spray 2.

Embodiment 9 sprays 3

With Fructus Corni 45g, Radix Scutellariae 85g, Rhizoma Belamcandae 55g, Radix Panacis Quinquefolii 65g, Radix Physochlainae 60g, Herba Inulae 50g and Radix Et Caulis Acanthopanacis Senticosi 50g mix, obtain mixture, pulverize, the distilled water that adds 3kg decocts 3h, decoction liquor is filtered, the distilled water that filtering residue adds 1.5kg again decocts 3h, and decoction liquor is filtered, and filtrate merges, concentrating under reduced pressure is removed the water of 2/3 volume, add determining alcohol and be 80% ethanol to ethanol volume proportion and be till 70%, the limit edged stirs, and adds to staticly settle, get the supernatant concentrating under reduced pressure and reclaim ethanol, concentrate desolventizing, obtain dried mastic, be ground into first powder; With Semen Lepidii (Semen Descurainiae) 35g, Cortex Mori 40g, Cortex Lycii 35g, Rhizoma Corydalis 45g, catechu 40g, Rhizoma Zingiberis 30g, Fructus Aristolochiae 50g, Herba Lysionoti Pauciflori 40g, Herba Chelidonii 35g, Stigma Croci 40g, Cortex Cinnamomi 40g, Radix Rhodiolae 40g, Radix Changii 40g, Fructus Hippophae 35g, Radix Salviae Miltiorrhizae 50g, Caulis Bambusae In Taenia 40g, Pheretima 30g, Rhizoma Pinelliae 45g, Ramulus Cinnamomi 30g, Semen Impatientis 20g mixes, obtain mixture, pulverizing is placed in the mixing jar, adding 2.2kg determining alcohol is 95% ethanol, sealing, stir 3h, soaked 30 days, between soak period, stirred 1 time every 3 days, each 2h fully dissolves above-mentioned raw materials medicine composition, squeeze and filter subsequently, filtering residue is standby, and filtrate decompression concentrates desolventizing, obtains to get dry extract, be ground into second powder, with first powder and second powder, get mixed-powder 500g, the adding determining alcohol is 95% ethanol, being stirred to powder dissolves fully, add the 50g tween 80 again, 75g glycerol, 10g stearic acid sodium, stir, stir, regulating pH value is 7.0, leaves standstill precipitate with ethanol, filter, filtrate is concentrated into does not have the alcohol flavor, obtains solution, stirring and dissolving, leave standstill, filter, filtrate is settled to 300ml, divides the bottle of packing into, sterilization, every bottle of 10ml charges into respect to sealing behind 2 times of volume propellant of solution tetrafluoroethene, obtains spray 3.

Embodiment 10 patches 1

With Fructus Corni 40g, Radix Scutellariae 80g, Rhizoma Belamcandae 50g, Radix Panacis Quinquefolii 60g, Radix Physochlainae 55g, Herba Inulae 45g and Radix Et Caulis Acanthopanacis Senticosi 45g mix, obtain mixture, pulverize, the distilled water that adds 2.4kg decocts 4h, decoction liquor is filtered, the distilled water that filtering residue adds 1kg again decocts 3h, and decoction liquor is filtered, and filtrate merges, concentrating under reduced pressure is removed the water of 2/3 volume, add determining alcohol and be 80% ethanol to ethanol volume proportion and be till 70%, the limit edged stirs, and adds to staticly settle, get the supernatant concentrating under reduced pressure and reclaim ethanol, concentrate desolventizing, obtain dried mastic, be ground into first powder; With Semen Lepidii (Semen Descurainiae) 30g, Cortex Mori 35g, Cortex Lycii 30g, Rhizoma Corydalis 40g, catechu 35g, Rhizoma Zingiberis 25g, Fructus Aristolochiae 45g, Herba Lysionoti Pauciflori 35g, Herba Chelidonii 30g, Stigma Croci 35g, Cortex Cinnamomi 35g, Radix Rhodiolae 35g, Radix Changii 35g, Fructus Hippophae 30g, Radix Salviae Miltiorrhizae 45g, Caulis Bambusae In Taenia 35g, Pheretima 25g, Rhizoma Pinelliae 40g, Ramulus Cinnamomi 25g, Semen Impatientis 15g mixes, obtain mixture, pulverizing is placed in the mixing jar, adding 1.8kg determining alcohol is 95% ethanol, sealing, stir 3h, soaked 30 days, between soak period, stirred 1 time every 3 days, each 2h, above-mentioned raw materials medicine composition is fully dissolved, squeeze and filter subsequently, filtering residue is standby, filtrate decompression concentrates desolventizing, obtain and get dry extract, be ground into second powder, with first powder and second powder, obtain mixed-powder, 75g polyvinyl alcohol and 100g gelatin are joined in the water of 150g, under 80 ℃ temperature, be mixed into gelatin solution, in gelatin solution, add 10g Kaolin subsequently, 600g glycerol, the 250g azone adds the mixed-powder of 500g again, stirs under 70 ℃, coating under this temperature on the polyester film that silicone oil is handled, the cooling back covers goes up polyethylene composite film as backing layer, is cut into the fritter of 3cm * 5cm, and every contains crude drug 0.6g.

Embodiment 11 zooperies

Material and medication

Laboratory animal: 40 male SD rats, body constitution amount (180 ± 20) g is provided by Qingdao City's Experimental Animal Center.

Egg protein: U.S. Sigma company product (lot number: 20091735).

Pertussis vaccine: the institute of biological products, Qingdao produces (lot number: 20090917).

Aluminium hydroxide: containing source rare metal company limited by Qingdao provides.

The granule 1 of the embodiment of the invention 1 preparation is pressed the administration of crude drug 5.36g/kg amount.

Rat IFN-γ ELISA test kit and IL-5ELISA test kit are all available from the brilliant U.S. biological engineering company limited in Shenzhen.

Eotaxin EL ISA test kit is Science and Technology Ltd. available from the sky, Shanghai.

Instrument PAR-ultrasound atomizer is German Kendro company product.

MB-III enzyme mark detector (Beijing Bin Daying creates Science and Technology Ltd.).

The experiment grouping

Experimental rat is divided into 3 groups at random, 30 every group: normal control group, asthmatic model group and treatment by Chinese herbs group.

Modeling method

Normal control group: 1d adopts normal saline 1mL to replace antigen to carry out lumbar injection sensitization to rat, excites with the normal saline atomizing behind the 15d, is exciting preceding 2h, and normal saline 2mL irritates stomach, every day 1 time, each 30min, 10d continuously; Asthmatic model group: 1d (contains OVA100mg, aluminium hydroxide dry powder 100mg and deactivation bordetella pertussis 6 * 10 with 1mL modeling liquid ⁹Individual) lumbar injection sensitization, (excite with 10g/L OVA solution ultrasonic atomizatio in 30cm * 30cm * 30cm), exciting preceding 2h, normal saline 2mL irritates stomach behind the 15d rat to be placed self-control atomizing case, 1 time/d, 30min/ time, 10d dysphoria, exaggerated respiration, quickening occur with rat altogether, the breathing of nodding, cough is heard and wheezing sound, is the animal model that asthma sample, mouthful all cyanosis, bradykinesia etc. show as success; Treatment by Chinese herbs group: exciting preceding 2h, adopt the granule Chinese medicine of the embodiment of the invention 1 preparation, be dissolved in the water, be configured to solution, take 2mL solution (5.36g crude drug/kg) irritate stomach, simultaneously, spray 1 to spray embodiment 5 preparations in the rat mouth, every day 6 times, each 2 times, all the other are with the asthmatic model group.

Index detects

The eosinophil count detection method: modeling 25d, every rats by intraperitoneal injection 0.2mL heparin sodium, the excision eyeball is got the about 3mL of blood and is given in the anticoagulant tube, with the centrifugal 5min of 2000r/min, gets blood plasma cytokine to be measured.The whole blood smear that takes a morsel with Jim Sha dyeing, is made Eos counting (eosinophilic granulocyte).

IL-5, the detection of IFN-γ and Eotaxin: undertaken by the test kit explanation, on the ELISA Plate of anti-IL-5 monoclonal antibody bag quilt, the standard substance (100 μ L/ hole) that add specimen and variable concentrations, room temperature (20～25 ℃) is hatched 120min, wash plate 4 times, add the anti-IL-5 monoclonal antibody (100 μ L/ hole) of enzyme labelling, incubated at room 60min, wash plate 4 times, add the substrate working solution, lucifuge room temperature 10～30min adds stop buffer, mixing, with microplate reader photometry density value, the drawing standard curve is found specimen concentration in the 5min.IFN-γ and Eotaxin are undertaken by the explanation of EL ISA test kit.

Statistical procedures

Measurement data adopts

χ is relatively adopted in expression between group ²Check, all data all adopt the SPSS12.0 statistical software to handle.

The result

Chinese medicine composition of the present invention is to Eos counting and preclinical influence in the rat blood of bronchial asthma

Table 1 Chinese medicine composition is to Eos counting and preclinical influence in the rat blood of bronchial asthma

Group

Cell number (* 10 ⁹/L)

Incubation period (s)

The normal control group	0.34±0.06	-
			The asthmatic model group	0.74±0.05	97.3±6.3
The treatment by Chinese herbs group	0.38±0.04	147.6±5.2

As can be seen from Table 1, the eosinophilic granulocyte of model group significantly rises with respect to the normal control group, and the treatment of process oral medicinal herb medicine of the present invention and external used medicine, the eosinophilic granulocyte of rat significantly reduces, and P＜0.05 has comparability.With respect to model group, the incubation period that the treatment by Chinese herbs group can significant prolongation bronchial asthma, P＜0.05 has comparability.

Chinese medicine composition is to the influence (pg/mL) of experimental rat model of asthma IL-5, IFN-γ and Eotaxin expression

Table 2 Chinese medicine composition is to the influence of experimental rat model of asthma IL-5, IFN-γ and Eotaxin expression

Group	IL-5	IFN-γ	Eotaxin
				The normal control group	70.91±9.03	23.52±4.36	103.19±12.03
The asthmatic model group	35.17±6.28	47.29±6.13	568.39±27.15
				The treatment by Chinese herbs group	67.13±4.29	26.17±5.53	192.73±10.51

As can be seen from Table 2, IFN-γ level reduces in the asthmatic model group serum, and IL-5 and Eotaxin level raise, after oral medicinal herb medicine of the present invention and external used medicine intervention, the IFN-γ level in the experimental rat model of asthma serum that can effectively raise reduces IL-5 and Eotaxin level.

Embodiment 12 clinical datas

Diagnostic criteria: the standard of " prevention and control of bronchial asthma guide " that the respiratory disease credit meeting of Western medicine diagnose standard reference Chinese Medical Association was formulated in 2008, Chinese medical discrimination is with reference to " new Chinese medicine clinical research guideline " (Chinese Medicine science and technology publishing house, 2002) the dialectical and criterion of therapeutical effect of mesobronchus asthma, (1) cardinal symptom: pant, cough, cough up thin and whitish sputum.(2) minor symptom: chest and diaphragm is full vexed, dim complexion, aversion to cold.(3) sign: wheezing sound.(4) pale tongue, white, slippery and moist fur, floating and tense pulse.Main symptom possesses and inferior card 〉=2 person, and is diagnosable in conjunction with the tongue arteries and veins.

Include standard in

(1) meets light, the moderate person's diagnostic criteria of doctor trained in Western medicine bronchial asthma disease acute attack stage; (2) meet the diagnostic criteria of traditional Chinese medical science bronchial wheezing (cold asthma) syndrome; (3) age was at 18～65 years old; (5) the general glucocorticoid is not used in the course of disease≤3 day.

Exclusion standard

(1) chronic duration of bronchial asthma and catabasis patient.(2) the bronchial asthma acute exacerbation belongs to severe or critical person; (3) the acute attack stage course of disease surpasses 3 days, or the course of disease at 3 days with interior but used glucocorticoid hormone systemic administration person; (4) age is at under-18s, the patient of over-65s; (5) serious systemic disease history is arranged, or the laboratory data prompting suffer from serious systemic disease (as liver, renal function injury), psychological problem person; (6) anemia of pregnant woman, women breast-feeding their children, allergic constitution person; (7) known to certain flavor Chinese medicine allergy sufferers in such medicine or the test medication; (8) dialectical according to the tcm syndrome standard is the patient of non-cold asthma.

Clinical subjects: this patient of conformance with standard 153 examples are divided into treatment at random by the table of random number method and organize 90 examples, matched group 63 examples, male 53 examples are organized in treatment, women 37 examples, 20～64 years old age, mean age (45.3 ± 8.7) year, patients with mild 31 examples wherein, moderate patient's 59 examples.Matched group man 35 examples, women 28 examples, 22～63 years old age, mean age (42.9 ± 9.1) year, patients with mild 25 examples wherein, moderate patient's 28 examples.Two groups of physical data difference not statistically significants (P＜0.05) have comparability.

Medicine

Treatment group: the granule 1 of the embodiment of the invention 1 preparation, the spray 1 of the embodiment of the invention 6 preparations, matched group: salmaterol fluticasone powder vapor (trade name: Shu Li change SERETIDE), produced by Britain's GlaxoSmithKline PLC (GlaxoSmithKline) company, specification 50 μ g/250 μ g, 60 dosage/standards are received device.Salbutamol sulfate aerosol (trade name: Wan Tuolin VENTOLIN), produced specification 100 μ g * 200 time by Britain's GlaxoSmithKline PLC (GlaxoSmithKline) company.

Therapeutic Method

The granule 1 of oral embodiment 1 preparation test group patient every day is dissolved in it in water, every day oral 30g granule, each 10g, simultaneously, the spray 1 that the patient sprays embodiment 6 preparations in the oral cavity sprays 5～7 every day.

Matched group patient every day: the conventional suction salmaterol fluticasone powder vapor, each 50 μ g/250 μ g, every day 2 times; Suck the salbutamol sulfate aerosol as required.

The drug combination regulation

Duration of test, heavier or time of asthma attack degree can be used the salbutamol sulfate aerosol as required than the elder, bans use of other bronchodilators and Western medicine and similar Chinese medicines such as hormone.As duration of test, the state of an illness increases the weight of, and can use glucocorticoid to the ill, but must handle by invalid case.

Duration of test merges the bacterial infection person, can take the circumstances into consideration to add with antibiotic therapy (recommending levofloxacin, 0.1～0.2g, day 2 times), bans use of macrolide antibiotics.

The course for the treatment of

Be 7 days two groups of courses for the treatment of.

Safety indexes

(1) general health check-up project: comprise body temperature, heart rate, breathing, blood pressure, body weight, appetite etc.(2) blood, urine, just conventional.(3) liver function (ALT), renal function (BUN, Scr), electrocardiogram (automatic clinical chemistry analyzer model: BECKMAN CX production firm: U.S. Beckman Coulter Inc.).(4) untoward reaction that may occur comprises clinical manifestation, the order of severity, the removing method of untoward reaction, with its safety of objective evaluation.

The health giving quality index

(1) cardinal symptom and sign: pant, cough, amount of expectoration, uncomfortable in chest, and symptom and sign treatment such as pulmonary's wheezing sound change before and after change.(2) pulmonary function: FEV ₁(one second forced expiratory volume), FEV ₁Change before and after (one second forced expiratory volume)/FVC (forced vital capacity), PEF (peak expiratory flow) treatment.(pulmonary function instrument model: 5KC36LN19GT, production firm: the gloomy DIS of the U.S.).(3) change before and after the treatment of peripheral blood eosinophilic granulocyte absolute counting.

The diagnostic index

X line rabat.

Criterion of therapeutical effect

Formulate with reference to " new Chinese medicine clinical research guideline " (Chinese Medicine science and technology publishing house, 2002) with reference to Chinese medical discrimination: (1) clinic control: symptoms of asthma is alleviated fully, even idol has slight outbreak, does not need medication to alleviate.FEV ₁(or PEF) recruitment〉35%, or treatment back 〉=80% predicted value.PEF day and night fluctuation rate＜20%.(2) produce effects: asthma attack obviously alleviates FEV before the treatment ₁(or PEF) increase scope 25%～35%, or treatment back FEV ₁(or PEF) reaches 60%～79% of predicted value, PEF day and night fluctuation rate〉20%, still need with glucocorticoid or bronchodilator.(3) take a turn for the better: symptoms of asthma alleviates to some extent, FEV ₁(or PEF) recruitment 15%～24%, still need with glucocorticoid or (with) bronchodilator.(4) invalid: clinical symptoms and FEV ₁(or PEF) measured value does not have improvement or increases the weight of on the contrary.

The tcm syndrome curative effect determinate standard

Symptom scalar quantization standard is as follows:

(1) pants: normal: do not have (0 minute); Slightly (3 minutes): the idol of panting has outbreak, and degree is light, does not influence sleep and movable; Moderate (6 minutes): the outbreak of panting is more frequent, but does not influence sleep, and is moving then pant obvious; Severe (9 minutes): pant obviously influence sleep and movable.

(2) cough: normal: do not have (0 minute); Slightly (3 minutes): be interrupted cough daytime, and degree is slight; Moderate (6 minutes): frequent cough, but do not influence sleep; Severe (9 minutes): the frequent or apasm of coughing of cough round the clock, influence is had a rest and sleep.

(3) cough up thin and whitish sputum: normal: do not have (0 minute); Slightly (3 minutes): a small amount of, the 10～50mL that coughs up phlegm round the clock, or the 5～25mL that coughs up phlegm in night and early morning; Moderate (6 minutes): expectorant is arranged, the 51～100mL that coughs up phlegm round the clock, or the 26～50mL that coughs up phlegm in night and early morning; Severe (9 minutes): amount is many, cough up phlegm more than the 100mL round the clock, or night and early morning coughs up phlegm more than the 50mL.

(4) chest and diaphragm is full vexed: normal: do not have (0 minute); Slightly (1 minute): idol has outbreak, and degree is light, does not influence to have a rest or activity; Moderate (2 minutes): feel more frequent, but do not influence sleep; Severe (3 minutes): sensation obviously influences sleep or movable.

(5) dim complexion: normal: do not have (0 minute); Slightly (1 minute): complexion is darker; Moderate (2 minutes): dim complexion is more obvious; Severe (3 minutes): dim complexion.

(6) aversion to cold: normal: do not have (0 minute); Slightly (1 minute): slight chill; Moderate (2 minutes): aversion to cold need add thin clothing; Severe (3 minutes): aversion to cold needs thickening clothing or lid bedding.

(7) wheezing sound: normal: do not have (0 minute); Slightly (1 minute): idol is heard, or occurs in cough, the dark fast back of breathing; Moderate (2 minutes): two lungs are dispersed in wheezing sound; Severe (3 minutes): two fullness of the lung cloth wheezing sounds.

Total mark * 100% before tcm syndrome integration improvement rate (%)=(total mark before the treatment-treatment back total mark)/treatment.(1) clinic control: treatment back clinical symptoms, sign disappearance or basic the disappearance, the syndrome integration reduces 〉=95%; (2) produce effects: treatment back clinical symptoms, sign are obviously improved, and the syndrome integration reduces 〉=70%,＜95%; (3) effective: treatment back clinical symptoms, sign all take a favorable turn, and the syndrome integration reduces 〉=30%,＜70%; (4) invalid: treatment back clinical symptoms, sign do not have obvious improvement, even increase the weight of, the syndrome integration reduces＜30%.

The result

Two groups of patient's clinical efficacies relatively the results are shown in Table 3.

Table 3 liang group patient clinical efficacy relatively

Group	The example number	Clinic control	Produce effects	Effectively	Invalid	Control rate	Effective percentage
								The treatment group	90	52	21	13	4	57.8%	95.5%
Matched group	63	28	18	12	5	44.4%	92.1%

As can be seen from Table 3, the treatment group is compared with matched group having significant curative effect aspect the treatment bronchial asthma in acute attack stage, and difference is not remarkable.

The tcm syndrome integration relatively the results are shown in Table 4.

Table 4 a liang group patient syndrome compares somewhat

Group	The example number	Before the treatment	After the treatment
				The treatment group	90	19.72±5.68	3.74±4.21
Matched group	63	20.11±6.13	5.98±2.73

As can be seen from Table 4, the syndrome integration relatively has significant difference (P＜0.05) before and after two groups of patient treatments; Syndrome integration comparing difference has significance (P＜0.05) between two groups of patient's groups, and treatment group syndrome is better than matched group.

Pulmonary function relatively the results are shown in Table 5 before and after the treatment.

Pulmonary function relatively before and after the table 5 liang group treatment

Group	?	The example number	FEV ₁(L)	FEV ₁/FVC(%)	PEF(L/S)
						The treatment group	Before the treatment	90	2.21±0.47	70.74±6.44	4.03±0.68
?	After the treatment	90	2.83±0.39	85.91±5.28	6.17±0.71
						Matched group	Before the treatment	63	2.19±0.42	71.38±3.92	4.11±0.69
?	After the treatment	63	2.51±0.62	77.29±4.63	5.46±0.81

As can be seen from Table 5, compare FEV before and after the treatment for the treatment of group with before and after the treatment of control group ₁, FEV ₁/ FVC and PEF are significantly increased, and P＜0.05 has comparability.

Peripheral blood eosinophilic granulocyte absolute counting relatively the results are shown in Table 6 before and after two groups of treatments.

Peripheral blood eosinophilic granulocyte absolute counting relatively before and after the table 6 liang group treatment

Group	?	The example number	Peripheral blood eosinophilic granulocyte absolute counting (* 10 ⁹/L)
				The treatment group	Before the treatment	90	0.802±0.135
?	After the treatment	90	0.396±0.304
				Matched group	Before the treatment	63	0.788±0.152
?	After the treatment	63	0.403±0.311

As can be seen from Table 6, adopt Chinese medicine composition of the present invention can significantly reduce peripheral blood eosinophilic granulocyte number.

Embodiment 13 model cases

Model, man, 31 years old.First visit on April 5 in 2008.Examine and see: cough with asthma increases the weight of 2d, the dyspnea with rapid respiration QI rising in reverse order, and wheezing due to retention of sputum in the throat, fullness and oppression over the chest like some thing filled, the color of coughing up phlegm is white, and is thin and foam arranged, with aversion to cold, headache is lossless, aching of the whole body, thin white fur of tongue, there is petechia on the dimly red tongue limit, floating and tense pulse.Have a medical check-up: expiratory dyspnea, can not put down for sleeping in, the slight cyanosis of lip, two lungs are covered with wheezing sound.X ray examination prompting: two increased bronchovascular shadows.Diagnosis: bronchial asthma, the sick acute attack stage that belongs to.Granule 1 by 1 preparation of the oral embodiment of the invention is dissolved in granule 1 in the water, and is oral, every day oral 30g granule, each 10g, simultaneously, the spray 1 that the patient sprays embodiment 6 preparations in the oral cavity sprays 5～7 every day.After taking medicine 3, cough with asthma is flat, and aversion to cold headache is alleviated, discomfort uncomfortable in chest still, and it is not well to cough up phlegm.After taking medicine 6, uncomfortable in chestly remove, expectorant goes out brisk and neat, and cough with asthma and clinical symptoms, sign disappear substantially.

This intellectual property of primary enforcement that all are above-mentioned is not set restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.

The above only is preferred embodiment of the present invention, is not to be the restriction of the present invention being made other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not break away to any simple modification, equivalent variations and remodeling that above embodiment does, still belongs to the protection domain of technical solution of the present invention according to technical spirit of the present invention.

Claims

1. Chinese medicinal composition granules that is used for the treatment of bronchial asthma in acute attack stage, it is characterized in that: the crude drug of described granule comprises Fructus Corni, Semen Lepidii (Semen Descurainiae), Cortex Mori, Radix Scutellariae, Cortex Lycii, Rhizoma Corydalis, catechu, Rhizoma Zingiberis, Rhizoma Belamcandae, Fructus Aristolochiae, Herba Lysionoti Pauciflori, Herba Chelidonii, Stigma Croci, Radix Panacis Quinquefolii, Cortex Cinnamomi, Radix Physochlainae, Radix Rhodiolae, Radix Et Caulis Acanthopanacis Senticosi, Radix Changii, Fructus Hippophae, Herba Inulae, Radix Salviae Miltiorrhizae, Caulis Bambusae In Taenia, Pheretima, the Rhizoma Pinelliae, Ramulus Cinnamomi, Semen Impatientis.

2. Chinese medicine composition composition spray that is used for the treatment of bronchial asthma in acute attack stage, it is characterized in that: the crude drug of described spray comprises Fructus Corni, Semen Lepidii (Semen Descurainiae), Cortex Mori, Radix Scutellariae, Cortex Lycii, Rhizoma Corydalis, catechu, Rhizoma Zingiberis, Rhizoma Belamcandae, Fructus Aristolochiae, Herba Lysionoti Pauciflori, Herba Chelidonii, Stigma Croci, Radix Panacis Quinquefolii, Cortex Cinnamomi, Radix Physochlainae, Radix Rhodiolae, Radix Et Caulis Acanthopanacis Senticosi, Radix Changii, Fructus Hippophae, Herba Inulae, Radix Salviae Miltiorrhizae, Caulis Bambusae In Taenia, Pheretima, the Rhizoma Pinelliae, Ramulus Cinnamomi, Semen Impatientis.

3. Chinese medicine composition that is used for the treatment of bronchial asthma in acute attack stage, it is characterized in that: the crude drug of described Chinese medicine composition comprises Fructus Corni, Semen Lepidii (Semen Descurainiae), Cortex Mori, Radix Scutellariae, Cortex Lycii, Rhizoma Corydalis, catechu, Rhizoma Zingiberis, Rhizoma Belamcandae, Fructus Aristolochiae, Herba Lysionoti Pauciflori, Herba Chelidonii, Stigma Croci, Radix Panacis Quinquefolii, Cortex Cinnamomi, Radix Physochlainae, Radix Rhodiolae, Radix Et Caulis Acanthopanacis Senticosi, Radix Changii, Fructus Hippophae, Herba Inulae, Radix Salviae Miltiorrhizae, Caulis Bambusae In Taenia, Pheretima, the Rhizoma Pinelliae, Ramulus Cinnamomi, Semen Impatientis.

4. Chinese medicine composition as claimed in claim 3, it is characterized in that: the weight portion of each crude drug is respectively in the described Chinese medicine composition: Fructus Corni 35 weight portions～45 weight portions, Semen Lepidii (Semen Descurainiae) 25 weight portions～35 weight portions, Cortex Mori 30 weight portions～40 weight portions, Radix Scutellariae 75 weight portions～85 weight portions, Cortex Lycii 25 weight portions～35 weight portions, Rhizoma Corydalis 35 weight portions～45 weight portions, catechu 30 weight portions～40 weight portions, Rhizoma Zingiberis 20 weight portions～30 weight portions, Rhizoma Belamcandae 45 weight portions～55 weight portions, Fructus Aristolochiae 40 weight portions～50 weight portions, Herba Lysionoti Pauciflori 30 weight portions～40 weight portions, Herba Chelidonii 25 weight portions～35 weight portions, Stigma Croci 30 weight portions～40 weight portions, Radix Panacis Quinquefolii 55 weight portions～65 weight portions, Cortex Cinnamomi 30 weight portions～40 weight portions, Radix Physochlainae 50 weight portions～60 weight portions, Radix Rhodiolae 30 weight portions～40 weight portions, Radix Et Caulis Acanthopanacis Senticosi 40 weight portions～50 weight portions, Radix Changii 30 weight portions～40 weight portions, Fructus Hippophae 25 weight portions～35 weight portions, Herba Inulae 40 weight portions～50 weight portions, Radix Salviae Miltiorrhizae 40 weight portions～50 weight portions, Caulis Bambusae In Taenia 30 weight portions～40 weight portions, Pheretima 20 weight portions～30 weight portions, the Rhizoma Pinelliae 35 weight portions～45 weight portions, Ramulus Cinnamomi 20 weight portions～30 weight portions, Semen Impatientis 10 weight portions～20 weight portions.

5. as claim 3 or 4 described Chinese medicine compositions, it is characterized in that: described Chinese medicine composition can be prepared into dosage form for oral administration and exterior-applied formulation, described dosage form for oral administration is decoction, powder, oral liquid, syrup, soft capsule, tablet, granule, pill, and described exterior-applied formulation is patch, spray.

6. the preparation method of the described Chinese medicine composition of claim 3 to 5, it is characterized in that: the step of described method is specially,

7. preparation method as claimed in claim 6, it is characterized in that: when the dosage form for oral administration of described Chinese medicine composition is soft capsule, described the 3rd step is specially mixed powder of the 3rd step is added in the disperse medium, the mixed proportion of mixed-powder and disperse medium is 1:1～3, stirring is uniformly dispersed the mixture dissolving, obtain to disperse thing, gained disperses thing to cross colloid mill, be pressed into soft capsule with soft capsule forming machine on the soft capsule shell material, molding is 2～4 hours in the drum-type forming machine, condition of molding is 25～30 ℃ of temperature, relative humidity 15～25%, then, clean with determining alcohol 90～98% ethanol, putting then dries in the air in the dish that dries in the air puts dry 20～28 hours, 20～30 ℃ of drying conditions, humidity 15～25%.

8. preparation method as claimed in claim 6; it is characterized in that: when the dosage form for oral administration of described Chinese medicine composition is granule; described the 3rd step is specially mixed powder of the 3rd step is added with respect to mixed-powder quality 20%～30% cane sugar powder (mass percent); be 75%～85% ethanol soft material processed with determining alcohol; granulate with oscillating granulator; 60 ℃ of oven dry down, granulate gets medicinal granule of the present invention.

9. preparation method as claimed in claim 6, it is characterized in that: when the dosage form of described Chinese medicine composition is patch, described the 3rd step is specially, the pure and mild 20 weight portion gelatin of 15 weight account polyethylenes are joined in the water of 30 weight portions, under 70～90 ℃ temperature, be mixed into gelatin solution, in gelatin solution, add 2 weight portion Kaolin subsequently, 120 weight portion glycerol, 50 weight portion azones, add first powder of 100 weight portions and the mixed-powder that second powder constitutes again, under 60～70 ℃, stir, coating under this temperature on the polyester film that silicone oil is handled, the cooling back covers goes up polyethylene composite film as backing layer, be cut into the fritter of 3cm * 5cm, every contains crude drug 0.6g.

10. preparation method as claimed in claim 6 is characterized in that: when the dosage form of described Chinese medicine composition was spray, described the 3rd step was specially the powder 1500g that the 3rd step was obtained, the adding determining alcohol is 90%～95% ethanol, is stirred to powder and dissolves fully, adds tween 80 again, glycerol, stearic acid sodium stirs, stir, regulating pH value is 7.0～7.5, leaves standstill precipitate with ethanol, filters, filtrate is concentrated into does not have the alcohol flavor, obtain solution, stirring and dissolving leaves standstill, filter, filtrate is settled to 1000ml, divides the bottle of packing into, sterilization, every bottle of 10ml, seal after charging into the propellant tetrafluoroethene, go on foot the powder that obtains with respect to the 3rd of 100 weight portions, the addition of described tween 80 is 5～15 weight portions, glycerol 10～20 weight portions, stearic acid sodium 1～3 weight portion.