CN1634340A - Medicinal composition for preventing and treating children respiratory system diseases and preparation method thereof - Google Patents
Medicinal composition for preventing and treating children respiratory system diseases and preparation method thereof Download PDFInfo
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Abstract
The invention provides a medicinal composition for preventing and treating children respiratory system diseases and preparation method thereof, wherein the composition mainly comprises astragalus root, Chinese ephedra, lepidium seed, pummelo peel, and licorice root. The invention also discloses the process for preparing the composition.
Description
Technical field
The present invention relates to pharmaceutical composition of preventing and treating children respiratory system diseases and preparation method thereof, but be specially the pharmaceutical composition that comes from Chinese medicine of control juvenile disease of cough and asthma and the preparation method of industrializing implementation thereof.
Background technology
Asthma is the common respiratory system chronic disease of child, recurrence easily, difficult more, the treatment difficulty of delay.Its mechanism is that bronchial asthma is the particularly chronic inflammatory airway disease of mastocyte, eosinophilic granulocyte and the participation of T lymphocyte of various kinds of cell, and the high response of air flue is the feature of asthma, and still exists in the catabasis.Asthma is the common chronic disease of outbreak repeatedly of Childhood, and sickness rate is in rising trend in recent years, and age of onset younger ones in an age groupization day by day, seriously influences the growth promoter and the physical and mental health of infant.The bibliographical information that relates to respiratory system is a lot, and right general medication is various, is to make children's exogenous wind and cold medicine with Chinese herbal medicine such as Herba Ephedrae, Semen Armeniacae Amarum, Fructus Perillae, Rhizoma Pinelliae, Flos Farfarae, Radix Asteris, Semen Raphani, Exocarpium Citri Grandis, Semen Lepidii (Semen Descurainiae), Rhizoma Cynanchi Stauntoniis as CN1490027.
Summary of the invention
The technical problem to be solved in the present invention is that a kind of Chinese medicine that utilizes of research is prevented and treated pharmaceutical composition of children respiratory system diseases and preparation method thereof, be specially and prevent and treat the disease that the juvenile has the cough with asthma symptom, especially prevent and treat infantile asthma, start with from setting upright tonify deficiency, the enhancing body resistance against diseases, reinforcement and elimination in combination, treating both the principal and secondary aspects of a disease prevent recurrence.The present invention makes every effort to medication and simplifies, and is mutually collaborative, has QI invigorating set upright, the relieving asthma comprehensive therapeutic effect of detumescence, relieving cough and resolving phlegm.In addition, because main applicable object of the present invention is the child, thus toxic and side effects is comprised that the long term toxication requirement is very high, and mouthfeel also should be considered juvenile's demand.But the present invention also will research and develop the method for industrial preparation.
For addressing the above problem, the invention provides following technical scheme.
A kind of pharmaceutical composition of anti-treating respiratory system disease is mainly made by the following raw materials in part by weight medicine: Radix Astragali 1-12 part, Herba Ephedrae (processed) 1-6 part, Semen Lepidii (Semen Descurainiae) 1-10 part.The crude drug consumption is preferably: Radix Astragali 4-8 part, Herba Ephedrae (processed) 2-4 part, Semen Lepidii (Semen Descurainiae) 2-6 part.Described preparation of drug combination method comprises the following steps: to take by weighing each crude drug Radix Astragali, Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae), and is standby; The described weight ratio Radix Astragali is added the 40%-95% ethanol extraction, filter, astragalus root dregs is waited until post processing, gets ethanol extract, and density 1.00～1.30 when being concentrated into 70～80 ℃, gets (+)-Astragenol extracted extract A; Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae) and the astragalus root dregs of described weight ratio are merged, add decocting in water, get water cooking liquid and filter, density 1.00～1.30 when filtrate was concentrated into 70～80 ℃, got extractum B1; Extractum A and extractum B1 are merged, and mixing is dried to powder, gets the active component of pharmaceutical composition of the present invention.
Aforementioned pharmaceutical composition, wherein crude drug also has a kind of a kind of in Exocarpium Citri Grandis, Flos Farfarae, the Radix Asteris or two kinds of being selected from, and is 1-9 part by weight consumption.Preferred Exocarpium Citri Grandis, consumption is 2-5 part.This preparation of drug combination method comprises the following steps: to take by weighing each crude drug Radix Astragali, Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae), Exocarpium Citri Grandis, and is standby; The Radix Astragali of described weight ratio is added 4-12 doubly measure the 40%-95% ethanol extraction, filter, astragalus root dregs is waited until post processing, gets ethanol extract, and density 1.00～1.30 when being concentrated into 70～80 ℃, (+)-Astragenol extracted extract A; The Exocarpium Citri Grandis of described weight ratio is extracted volatile oil, and it is standby to collect Exocarpium Citri Grandis oil, gets Exocarpium Citri Grandis water liquid after water liquid is filtered and treats post processing; Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae) and the astragalus root dregs of described weight ratio are merged, add decocting in water, get water cooking liquid and filter, after filtrate and Exocarpium Citri Grandis water liquid merged, density 1.00～1.30 when being concentrated into 70～80 ℃, got extractum B2; Extractum A and extractum B2 are merged, and mixing is dried to powder, adds Exocarpium Citri Grandis oil, gets the active component of pharmaceutical composition of the present invention.
Pharmaceutical composition of the present invention, in the crude drug except that the aforementioned Radix Astragali, Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae) and be selected from a kind of in Exocarpium Citri Grandis, Flos Farfarae, the Radix Asteris or two kinds, also have Radix Glycyrrhizae 1-5 part by weight.Preferred pharmaceutical composition of the present invention is mainly made by the following raw materials in part by weight medicine: 6 parts of the Radixs Astragali, 3 parts of Herba Ephedrae (processed), 6 parts of Semen Lepidii (Semen Descurainiae)s, 3 parts of Exocarpium Citri Grandises, 3 parts in Radix Glycyrrhizae.Described preparation of drug combination method comprises the following steps: to take by weighing each crude drug Radix Astragali, Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae), Exocarpium Citri Grandis, Radix Glycyrrhizae, and is standby; The Radix Astragali of described weight ratio is added 4-12 doubly measure the 40%-95% ethanol extraction, filter, astragalus root dregs is waited until post processing, gets ethanol extract, and density 1.00～1.30 when being concentrated into 70～80 ℃, (+)-Astragenol extracted extract A; The Exocarpium Citri Grandis of described weight ratio is extracted volatile oil, collect volatile oil, after the filtration, get Exocarpium Citri Grandis oil, add beta-schardinger dextrin-, form Exocarpium Citri Grandis oil beta-cyclo dextrin included compound, the Exocarpium Citri Grandis water liquid after water liquid is filtered is treated post processing; Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae), Radix Glycyrrhizae and the astragalus root dregs of described weight ratio are merged, add decocting in water, get water cooking liquid and filter, after filtrate and Exocarpium Citri Grandis water liquid merged, density 1.00～1.30 when being concentrated into 70～80 ℃, got extractum B; Extractum A and extractum B are merged, and mixing is dried to powder, adds Exocarpium Citri Grandis oil beta-cyclo dextrin included compound, gets the active component of pharmaceutical composition of the present invention.
Described preparation method, wherein preferred: the Radix Astragali of getting weight proportion by weight/weight ratio adds 8 times of amount 70-85% ethanol, reflux, extract, 3 times, each 1 hour, merge ethanol liquid, filter, astragalus root dregs is waited until post processing, filtrate is concentrated into 70～80 ℃ of relative densities 1.10～1.15, gets (+)-Astragenol extracted extract A; The Exocarpium Citri Grandis of getting weight proportion by weight/weight ratio adds 14 times of water gagings, extracts volatile oil 8 hours, collects Exocarpium Citri Grandis oil, water liquid filters, Exocarpium Citri Grandis water liquid; Get Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae), Radix Glycyrrhizae and the astragalus root dregs of weight proportion, by weight/weight ratio adds water 10-12 doubly, boils 60-90 minute at every turn 2-3 time; Merge decoction liquor, filter, filtrate and Exocarpium Citri Grandis water liquid merge, high speed centrifugation (16000 rev/mins), and centrifugal liquid is concentrated into 70～80 ℃ of relative densities 1.10～1.15, gets extractum B; Extractum A and extractum B are merged, and spray drying gets dry medicated powder; By 1 part of Exocarpium Citri Grandis oil volume: 5-15 part beta-schardinger dextrin-weight, take by weighing beta-schardinger dextrin-, add by weight/water that the 8-20 of weight ratio meter doubly measures, after the beta-schardinger dextrin-dissolving, add Exocarpium Citri Grandis oil, placed 24 hours below 4 ℃, sucking filtration, a small amount of washing, 50 ℃ of dryings, get Exocarpium Citri Grandis oil beta-cyclo dextrin included compound, pulverize; With spray drying medicated powder, Exocarpium Citri Grandis oil beta-cyclo dextrin included compound and dextrin, add the ethanol liquid that contains 5% 30 POVIDONE K 30 BP/USP 30, mix, granulate drying.
Preferred manufacturing procedure more, wherein by 1 part of Exocarpium Citri Grandis oil volume: 10-12 part beta-schardinger dextrin-weight takes by weighing beta-schardinger dextrin-, the water that the 8-15 of adding beta-schardinger dextrin-weight doubly measures, heating makes the beta-schardinger dextrin-dissolving, keeps 60 ℃ again, under 500 rev/mins condition, add Exocarpium Citri Grandis oil, placed 24 hours sucking filtration, a small amount of washing below 4 ℃, 50 ℃ of dryings get Exocarpium Citri Grandis oil beta-cyclo dextrin included compound; Spray drying medicated powder, Exocarpium Citri Grandis oil beta-cyclo dextrin included compound are mixed tabletting, pack or fill capsule with the adjuvant commonly used of oral formulations.
In the pharmaceutical composition of the present invention: the Radix Astragali is a monarch drug, sets upright QI invigorating; Herba Ephedrae (processed) is a ministerial drug, relieving cough and asthma, inducing diuresis to remove edema; Semen Lepidii (Semen Descurainiae) is an adjuvant drug, eliminating the pathogens from the lung diuretic, eliminating phlegm relieving asthma.The Radix Astragali, Herba Ephedrae (processed) and Semen Lepidii (Semen Descurainiae) are the marrow of pharmaceutical composition of the present invention.As the not obvious person of exterior syndrome, with Herba Ephedrae (processed) (that is: processed with honey Herba Ephedrae), not only strengthen the merit of relieving cough and asthma, and can weaken the power of diaphoresis, in order to avoid hinder its table on foot.Can add dried tangerine peel again, dried tangerine peel is an adjuvant drug, the expectorant promoting the circulation of QI, and relieving epigastric distention and reducing the stagnation, and tangerine (that is: Exocarpium Citri Grandis) available Flos Farfarae, Radix Asteris substitute.Radix Glycyrrhizae is a messenger drug, coordinating the actions of various ingredients in a prescription.Above-mentioned all medicines are played QI invigorating set upright, the relieving asthma effect of detumescence, relieving cough and resolving phlegm altogether.
The asthma infant has congenital defect more, lacks of proper care after one's birth, body weakness, striae of the skin and muscles being loose, and failure of defensive QI to protect the body against pathogen can not adapt to extraneous climatic environment and change, and easily is the exopathogen invasion and attack, and exopathogen is attacked at first impairing the lung, if outbreak repeatedly, the cloudy all wounds of gas, can involve the spleen kidney.The imbalance of insufficiency of the spleen then fortuneization, hydrops becomes expectorant, and it is unfavorable that the stagnation of phlegm air flue is then breathed; The kidney being the origin of congenital constitution, and main improving inspiration by invigorating kidney-QI is taken the photograph and received mistake department, and then gas is not returned root, thus three dirty functional disorders, the state of an illness increases the weight of, and therefore " weakened body resistance " is the principal contradiction of primary disease, also is dialectical main foundation.Though asthma is alleviated through treatment, the void of internal organs is eradicated as yet, and according to the principle of " relieving the primary symptom in a chronic case ", start with from setting upright tonify deficiency, the enhancing body resistance against diseases can be prevented recurrence.Must be in the process of treatment infantile asthma the enhancing body resistance against diseases, as the major measure of control primary disease.
Compare with medicine commonly used, pharmaceutical composition of the present invention has the advantage of reinforcement and elimination in combination, treating both the principal and secondary aspects of a disease.The traditional Chinese medical science thinks that the asthma infant has congenital defect more, lacks of proper care after one's birth, body weakness, striae of the skin and muscles being loose, and failure of defensive QI to protect the body against pathogen can not adapt to extraneous climatic environment and change, and easily is the exopathogen invasion and attack, and exopathogen is attacked at first impairing the lung, if outbreak repeatedly, the cloudy all wounds of gas, can involve the spleen kidney.The imbalance of insufficiency of the spleen then fortuneization, hydrops becomes expectorant, and it is unfavorable that the stagnation of phlegm air flue is then breathed; The kidney being the origin of congenital constitution, and main improving inspiration by invigorating kidney-QI is taken the photograph and received mistake department, and then gas is not returned root, thus three dirty functional disorders, the state of an illness increases the weight of, and therefore " weakened body resistance " is the principal contradiction of primary disease, also is dialectical main foundation.Though asthma is alleviated through treatment, the void of internal organs is eradicated as yet, and according to the principle of " relieving the primary symptom in a chronic case ", start with from setting upright tonify deficiency, the enhancing body resistance against diseases can be prevented recurrence.Must be in the process of treatment infantile asthma the enhancing body resistance against diseases, as the major measure of control primary disease.Take a broad view of the present invention's prescription and have reinforcement and elimination in combination, the characteristics for the treatment of both the principal and secondary aspects of a disease.And indication of the present invention is clear and definite, and the present invention prescription has QI invigorating set upright, the relieving asthma comprehensive therapeutic effect of detumescence, relieving cough and resolving phlegm, is applicable to that the bronchial asthma asthma of cold-type demonstrate,proves, disease is seen rapid breathing, and wheezing sound is arranged in the larynx, the white or clear rare abundant expectoration foam of expectorant, and mouth is not thirsty, coldness of the body and aversion to cold, white and slippery fur, floating and tense pulse etc.31 routine patients are observed in clinical experiment, and the result shows, produce effects 24 examples, effective 5 examples, invalid 2 examples, total effective rate 93.5%.Reach clinical observation by experiment and show, the side effect of treatment childhood asthma is little, and curative effect is sure.Main pharmacodynamics studies show that pharmaceutical composition of the present invention can reach antitussive, eliminates the phlegm, antiasthmatic effect and antiinflammatory, anti-allergic effects, and tracheal smooth muscle spasm there is tangible mitigation, wherein the pharmaceutical composition of preparing with embodiment 4 ratios especially serves as preferred, and the concrete pharmacodynamics data of its part are as described below.The toxicological study result shows: the overt toxicity reaction is not seen in acute toxicity test, can't measure LD50 routinely, and long term toxication is not seen the overt toxicity reaction.In addition, main applicable object of the present invention is the child, so very high to the mouthfeel requirement, pharmaceutical composition of the present invention is a pure Chinese medicinal preparation, technology novelty, finished product are light brown to brown, little sweet, fragrant odour is easy to be accepted by infant, thereby produces good society and economic benefit.
Pharmaceutical composition main pharmacodynamics research of the present invention
One, to the influence (phenol red expelling phlegm method) of mice expectorant test
Pharmaceutical composition of the present invention adopts phenol red expelling phlegm method, with the phenol red excretion amount of spectrophotometric determination (OD value) by 14.0,7.0 and the dosage gastric infusion of 3.5g crude drug/kg.The result shows: the big or middle dosage group of pharmaceutical composition of the present invention and model control group specific energy mutually obviously increase respiratory mucosa phenol red output (P＜0.001).Results suggest: this product has significant phlegm-dispelling functions.
Two, to the influence of mice capillary permeability
Pharmaceutical composition of the present invention by 14.0,7.0 and the dosage gastric infusion of 3.5g crude drug/kg after, caused capillary permeability increase has the obvious suppression effect to each administration group to H+, with model control group relatively (P＜0.05～0.001).Results suggest: this product has significant antiinflammatory action.
Three, to 2, the influence of 4-dinitrochlorobenzene induced mice delayed hypersensitivity
Pharmaceutical composition of the present invention is by 14.0,7.0 and the dosage gastric infusion of 3.5g crude drug/kg, adopt 2, the 4-dinitrochlorobenzene causes mouse skin delayed hypersensitivity model, and each administration and model control group relatively can obviously reduce swelling value (P＜0.05～0.001).Results suggest: this product is to 2, and the caused skin delayed hypersensitivity of 4-dinitrochlorobenzene has the obvious suppression effect.
Four, to the antitussive action (strong aqua ammonia nebulization) of mice
Pharmaceutical composition of the present invention adopts the strong aqua ammonia nebulization to carry out the cough-relieving test by 14.0,7.0 and the dosage gastric infusion of 3.5g crude drug/kg.The result shows: the large, medium and small dosage group of pharmaceutical composition of the present invention is compared with model control group and all can be prolonged cough latent period (P＜0.01～0.001); The cough number of times obviously reduces (P＜0.001) in 2 minutes.Results suggest: this product oral administration has tangible antitussive action to mice.
Five, to the antitussive action (citric acid nebulization) of Cavia porcellus
Pharmaceutical composition of the present invention adopts the citric acid nebulization to carry out the cough-relieving test by 7.0,3.5 and the dosage gastric infusion of 1.75g crude drug/kg.The result shows: pharmaceutical composition of the present invention is the cough latent period of prolonged guinea pig (P＜0.05～0.01) obviously, obviously reduces the number of times (P＜0.01～0.001) of coughing in 5 minutes.Results suggest: this product has tangible antitussive effect to Cavia porcellus.
Six, to the antiasthmatic effect (spraying causes the method for breathing heavily) of Cavia porcellus
Pharmaceutical composition of the present invention adopts acetylcholine and histamine phosphate mixture to breathe heavily agent for drawing by 7.0,3.5 and the dosage gastric infusion of 1.75g crude drug/kg, observes the antiasthmatic effect of pharmaceutical composition of the present invention.The result shows: pharmaceutical composition of the present invention draws breathes heavily incubation period and model control group more all has significant prolongation (P＜0.05～0.01).Results suggest: this product oral administration can obviously prolong to draw to be breathed heavily incubation period, and Cavia porcellus is had obvious antiasthmatic effect.
Seven, to the antiasthmatic effect (egg protein method) of allergic asthma Cavia porcellus
Pharmaceutical composition of the present invention is in 7.0,3.5 and 1.75g crude drug/kg (being in the preparation of the ratio of embodiment 2) gastric infusion, duplicate guinea pig asthmatic model with egg protein, observe the influence of pharmaceutical composition of the present invention SOD, MDA, GSH-PX in leukocyte differential count, the serum in eosinophilic granulocyte, the lung-douching fluid in asthma incubation period, the peripheral blood.The result shows: pharmaceutical composition of the present invention can obviously prolong asthma incubation period (P＜0.05～0.01), reduce eosinophilic granulocyte's number (P＜0.05～0.001) in the model Cavia porcellus peripheral blood, reduce inflammatory cell sum in the lung-douching fluid, improve SOD activity (P＜0.05) in the serum, improve animal pattern lung tissue pathology and change.Results suggest: this product has the certain protection effect to allergic asthma model Cavia porcellus.
Eight, to the effect of guinea-pig isolated tracheal smooth muscle
Pharmaceutical composition treated in vitro of the present invention adopts the guinea pig trachea ring body that exsomatizes to test outward, observes treatment and preventive effect that this product is shunk the guinea-pig isolated tracheal smooth muscle that is caused by aminophylline.The result shows: pharmaceutical composition of the present invention can suppress the spastic contraction of isolated tracheal due to the aminophylline; With model group comparing difference remarkable (P＜0.05～0.001)
Nine, pharmaceutical composition rat long term toxicity test of the present invention
The research of 6 months long term toxicity test of the continuous gastric infusion of rat is bright, give SD rat continuous irrigation stomach 180 days with the pharmaceutical composition of the present invention that is equivalent to raw medicinal herbs 20.0,10.0 and 5.0g/kg dosage, wherein heavy dose ofly be about clinical people and intend 55.6 times with dosage, do not find that animal has phenomenons such as movable minimizing, Mao Songluan, listlessness be depressed, body weight, organ coefficient and the histopathologic examination etc. of rat be there is no tangible toxic reaction.But hematological examination shows 3 months quantity of leucocyte of big or middle dosed administration and reduces, small dose group is not then seen overt toxicity, show that (5.0g crude drug/kg) is following to be safe dose, in addition please be clinical notes the monitoring of dosage design and blood biochemical index during use for the low dose of this product rat long term toxicity test.
The specific embodiment
Used 5 flavor medical materials all are the medical materials of pharmacopeia regulation, and are commercially available.The Radix Astragali: Xuyi County's prepared slices of Chinese crude drugs factory.Herba Ephedrae: Nanjing Jiangning District Kang Yi prepared slices of Chinese crude drugs factory.Semen Lepidii (Semen Descurainiae): Nanjing prepared slices of Chinese crude drugs factory.Radix Glycyrrhizae: magnificent Long Zhongyaoyinpianchang.Exocarpium Citri Grandis: medical material head office Chinese medicine station, Haozhou, Anhui city.The processing method of Herba Ephedrae (processed) is by " the processing method of sweet Herba Ephedrae processing under 262 pages of Herba Ephedrae items of Chinese pharmacopoeia version in 2000.
Embodiment 1
Prescription: the Radix Astragali 12 gram Herba Ephedrae (processed) (that is: processed with honey Herba Ephedrae) 6 gram Semen Lepidii (Semen Descurainiae)s 10 grams.
Take by weighing medical material by formula ratio, standby.
The Radix Astragali add 4 times of amounts (ethanol weight: medical material weight) 40% ethanol, for the first time soaked reflux, extract, 2 times 15 minutes, each 0.5 hour, merge ethanol liquid, filter, decompression filtrate recycling ethanol further is concentrated into relative density 1.00 (80 ℃), gets the (+)-Astragenol extracted extract.
Get astragalus root dregs, Herba Ephedrae (processed) and the Semen Lepidii (Semen Descurainiae) of alcohol extraction, (water weight: medical material weight), soaked 15 minutes, decocted 30 minutes, second and third time adds 5 times of amounts of water at every turn and decocted 30 minutes to add 5 times of amounts of water for the first time.Merge decoction liquor, filter, filtrate high speed centrifugation (16000 rev/mins), centrifugal liquid is concentrated into relative density 1.00 (80 ℃), gets extractum.
(+)-Astragenol extracted extract and other medicine are closed the extracted extract merging, mixing, spray drying gets dry medicated powder.
Spray drying medicated powder and dextrin is an amount of, and (weight of ethanol liquid: 5% 30 POVIDONE K 30 BP/USP, 30 90% ethanol liquid mixed powder) stir evenly granulation, 50 ℃ of dryings, granulate, packing to add 0.2 times of amount.
Embodiment 2
Prescription: the Radix Astragali 4 gram Herba Ephedrae (processed) 2 gram Semen Lepidii (Semen Descurainiae)s 2 digest tangerine 1 gram Radix Glycyrrhizae, 1 gram.
Take by weighing medical material by formula ratio, standby.
The Radix Astragali add 15 times of amounts (ethanol weight: medical material weight) 60% ethanol, for the first time soaked reflux, extract, 2 times 15 minutes, each 0.5 hour, merge ethanol liquid, filter, decompression filtrate recycling ethanol further is concentrated into relative density 1.10 (80 ℃), gets the (+)-Astragenol extracted extract.
Exocarpium Citri Grandis add 20 times of amounts (water weight: medical material weight) water, extracted volatile oil 10 hours in volatile oil extractor, collect volatile oil; Filtering liquid medicine, it is standby to collect medicinal liquid.
Get astragalus root dregs, Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae) and the Radix Glycyrrhizae of alcohol extraction, (water weight: medical material weight), soaked 90 minutes, decocted 120 minutes, second and third time adds 15 times of amounts of water (water weight: medical material weight) decocted 90 minutes at every turn to add 15 times of amounts of water for the first time.Merge decoction liquor, filter, filtrate and Exocarpium Citri Grandis medicinal liquid merge, high speed centrifugation (16000 rev/mins), and centrifugal liquid is concentrated into relative density 1.10 (70 ℃), gets extractum.
(+)-Astragenol extracted extract and other medicine are closed the extracted extract merging, mixing, spray drying gets dry medicated powder.
Take by weighing 15 times of amounts of Exocarpium Citri Grandis oil (β-CD the weight: (β-CD) of beta-schardinger dextrin-oil volume), the water that adds 20 times of amounts of β-CD (water weight: β-CD weight), heating makes β-CD dissolving, keep 80 ℃ again, under 500 rev/mins condition, slowly add Exocarpium Citri Grandis oil, placed 48 hours below 4 ℃.Take out sucking filtration, a small amount of washing, 70 ℃ of dryings get Exocarpium Citri Grandis oil β-CD inclusion complex, with this pulverizing.
Spray drying medicated powder, Exocarpium Citri Grandis oil β-CD inclusion complex and dextrin are mixed in right amount, get mixed powder, add 0.8 times of amount 5% 30 POVIDONE K 30 BP/USP 30 90% ethanol liquid (weight of ethanol liquid: mixed powder weight), stir evenly, granulate, 80 ℃ of dryings, granulate, packing.Each one bag (3 gram), every day 2 times.By " 2000 editions appendix requirements of Chinese pharmacopoeia are checked: the moisture inspection of pharmaceutical composition of the present invention, content uniformity inspection, melting inspection, limit test of microbe are all up to specification.The heavy metal check result is all less than 10ppm; Test agent arsenic salt check result is all less than 1ppm in three batches.Press " test requirements document of new drug stability " and examine projects such as the character of pharmaceutical composition of the present invention, discriminating, assay, inspection.The preliminarily stabilised result of the test shows, pharmaceutical composition of the present invention, and steady quality meets the requirements.
Embodiment 3
Prescription: the Radix Astragali 12 gram Herba Ephedrae (processed) 6 gram Semen Lepidii (Semen Descurainiae)s 10 digest tangerine 9 gram Radix Glycyrrhizaes, 5 grams.
Take by weighing medical material by formula ratio, standby.
The Radix Astragali add 10 times of amounts (ethanol weight: medical material weight) 70% ethanol, for the first time soaked reflux, extract, 3 times 90 minutes, each 1.0 hours, merge ethanol liquid, filter, decompression filtrate recycling ethanol further is concentrated into relative density 1.15 (80 ℃), gets the (+)-Astragenol extracted extract.
Exocarpium Citri Grandis add 12 times of amounts (water weight: medical material weight) water, extracted volatile oil 12 hours in volatile oil extractor, collect volatile oil, filtering liquid medicine, it is standby to collect medicinal liquid.
Get astragalus root dregs, Herba Ephedrae (processed), the Semen Lepidii (Semen Descurainiae) of alcohol extraction, (water weight: medical material weight), soaked 60 minutes, decocted 90 minutes, second and third time adds 8 times of amounts of water at every turn and decocted 90 minutes to add 8 times of amounts of water for the first time.Merge decoction liquor, filter, filtrate and Exocarpium Citri Grandis medicinal liquid merge, high speed centrifugation (16000 rev/mins), and centrifugal liquid is concentrated into relative density 1.20 (75 ℃), gets extractum.
(+)-Astragenol extracted extract and other medicine are closed the extracted extract merging, mixing, spray drying gets dry medicated powder.
Take by weighing 12 times of amounts of Exocarpium Citri Grandis oil (β-CD the weight: (β-CD) of beta-schardinger dextrin-oil volume), the water that adds 15 times of amounts of β-CD (water weight: β-CD weight), heating makes β-CD dissolving, keep 80 ℃ again, under 500 rev/mins condition, slowly add Exocarpium Citri Grandis oil, placed 48 hours below 4 ℃.Take out sucking filtration, a small amount of washing, 70 ℃ of dryings get Exocarpium Citri Grandis oil β-CD inclusion complex, with this pulverizing.
Spray drying medicated powder, Exocarpium Citri Grandis oil β-CD inclusion complex and dextrin are mixed in right amount, get mixed powder, (weight of ethanol liquid: mixed powder weight) 5% 30 POVIDONE K 30 BP/USP, 30 90% ethanol liquid stir evenly granulation, 80 ℃ of dryings, granulate, packing to add 0.8 times of amount.Each one bag (3 gram), every day 2 times.By " 2000 editions appendix requirements of Chinese pharmacopoeia are checked: the moisture inspection of pharmaceutical composition of the present invention, content uniformity inspection, melting inspection, limit test of microbe are all up to specification.The heavy metal check result is all less than 10ppm; Test agent arsenic salt check result is all less than 1ppm in three batches.Press " test requirements document of new drug stability " and examine projects such as the character of pharmaceutical composition of the present invention, discriminating, assay, inspection.The preliminarily stabilised result of the test shows, pharmaceutical composition of the present invention, and steady quality meets the requirements.
Embodiment 4
Prescription: the Radix Astragali 6 gram Herba Ephedrae (processed) 3 gram Semen Lepidii (Semen Descurainiae)s 6 digest tangerine 3 gram Radix Glycyrrhizaes, 3 grams.
Take by weighing medical material by formula ratio, standby.
The Radix Astragali add 8 times of amounts (ethanol weight: medical material weight) 85% ethanol, for the first time soaked reflux, extract, 3 times 90 minutes, each 1.0 hours, merge ethanol liquid, filter, decompression filtrate recycling ethanol further is concentrated into relative density 1.25 (72 ℃), gets the (+)-Astragenol extracted extract.
Exocarpium Citri Grandis add 14 times of amounts (water weight: medical material weight) water, extracted volatile oil 10 hours in volatile oil extractor, collect volatile oil, filtering liquid medicine, it is standby to collect medicinal liquid.
Get astragalus root dregs, Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae) and the Radix Glycyrrhizae of alcohol extraction, (water weight: medical material weight), soaked 60 minutes, decocted 90 minutes, second and third time adds 10 times of amounts of water at every turn and decocted 60 minutes to add 12 times of amounts of water for the first time.Merge decoction liquor, filter, filtrate and Exocarpium Citri Grandis medicinal liquid merge, high speed centrifugation (16000 rev/mins), and centrifugal liquid is concentrated into relative density 1.30 (70 ℃), gets extractum.
(+)-Astragenol extracted extract and other medicine are closed the extracted extract merging, mixing, spray drying gets dry medicated powder.
Take by weighing 10 times of amounts of Exocarpium Citri Grandis oil (β-CD the weight: (β-CD) of beta-schardinger dextrin-oil volume), the water that adds 8 times of amounts of β-CD (water weight: β-CD weight), heating makes β-CD dissolving, keep 60 ℃ again, under 400 rev/mins condition, slowly add Exocarpium Citri Grandis oil, stirred 1 hour, placed 24 hours below 4 ℃.Take out sucking filtration, a small amount of washing, 50 ℃ of dryings get Exocarpium Citri Grandis oil β-CD inclusion complex, with this pulverizing.
Spray drying medicated powder, Exocarpium Citri Grandis oil β-CD inclusion complex and dextrin are mixed in right amount, mixed powder, adds 0.8 times of amount (weight of ethanol liquid: mixed powder weight) 5% 30 POVIDONE K 30 BP/USP, 30 95% ethanol liquid, stir evenly, granulation, 70 ℃ of dryings, granulate, encapsulated.By " pertinent regulations under 2000 editions one appendix of Chinese pharmacopoeia " capsule " the inspection item are checked pharmaceutical composition of the present invention, wherein moisture inspection, disintegration time mensuration, content uniformity inspection, limit test of microbe is all up to specification, and test agent heavy metal check result is all less than 10ppm in three batches; Test agent arsenic salt check result is all less than 1ppm in three batches.The preparation stabilization Journal of Sex Research: with reference to National Drug Administration's former " provisions for new drugs approval " about Chinese medicine (new drug) " specification requirement of quality stability ", pharmaceutical composition of the present invention is placed clinical with under the terms of packing, keep sample and investigate 3 months, the projects such as character, discriminating, assay, inspection of sample have been examined in pharmaceutical composition quality standard draft and " test requirements document of new drug stability " according to the present invention.The preliminarily stabilised result of the test shows that pharmaceutical composition of the present invention was preserved 3 months down with terms of packing (inner packing is the polyolefin plastics bottle) in clinical, and steady quality meets the requirements.
Embodiment 5
Prescription: the Radix Astragali 8 gram Herba Ephedrae (processed) 4 gram Semen Lepidii (Semen Descurainiae)s 6 digest tangerine 2 gram Radix Glycyrrhizaes, 1 gram.
Take by weighing medical material by formula ratio, standby.
The Radix Astragali add 10 times of amounts (ethanol weight: medical material weight) 70% ethanol, for the first time soaked reflux, extract, 3 times 90 minutes, each 1.0 hours, merge ethanol liquid, filter, decompression filtrate recycling ethanol further is concentrated into relative density 1.15 (80 ℃), gets the (+)-Astragenol extracted extract.
Exocarpium Citri Grandis add 12 times of amounts (water weight: medical material weight) water, extracted volatile oil 12 hours in volatile oil extractor, collect volatile oil, filtering liquid medicine, it is standby to collect medicinal liquid.
Get astragalus root dregs, Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae), the Radix Glycyrrhizae of alcohol extraction, add 8 times of amounts of water (volume/medical material weight) for the first time, soaked 60 minutes, decocted 90 minutes, second and third time adds 8 times of amounts of water (volume/medical material weight) at every turn and decocted 60 minutes.Merge decoction liquor, filter, filtrate and Exocarpium Citri Grandis medicinal liquid merge, high speed centrifugation (16000 rev/mins), and centrifugal liquid is concentrated into relative density 1.10 (70 ℃), gets extractum.
(+)-Astragenol extracted extract and other medicine are closed the extracted extract merging, mixing, spray drying gets dry medicated powder.
Take by weighing 12 times of amounts of Exocarpium Citri Grandis oil (β-CD the weight: (β-CD) of beta-schardinger dextrin-oil volume), the water that adds 15 times of amounts of β-CD (water weight: β-CD weight), heating makes β-CD dissolving, keep 50 ℃ again, under 500 rev/mins condition, slowly add Exocarpium Citri Grandis oil, placed 24 hours below 4 ℃.Take out sucking filtration, a small amount of washing, 50 ℃ of dryings get Exocarpium Citri Grandis oil β-CD inclusion complex, with this pulverizing.
Spray drying medicated powder, Exocarpium Citri Grandis oil β-CD inclusion complex and dextrin are mixed in right amount, get mixed powder, (weight of ethanol liquid: mixed powder weight) 5% 30 POVIDONE K 30 BP/USP, 30 95% ethanol liquid stir evenly granulation, 70 ℃ of dryings, granulate, packing to add 0.4 times of amount.By " 2000 editions appendix requirements of Chinese pharmacopoeia are checked: the moisture inspection of pharmaceutical composition of the present invention, content uniformity inspection, melting inspection, limit test of microbe are all up to specification.The heavy metal check result is all less than 10ppm; Test agent arsenic salt check result is all less than 1ppm in three batches.Press " test requirements document of new drug stability " and examine projects such as the character of pharmaceutical composition of the present invention, discriminating, assay, inspection.The preliminarily stabilised result of the test shows, pharmaceutical composition of the present invention, and steady quality meets the requirements.
Embodiment 6
Prescription: the Radix Astragali 10 gram Herba Ephedrae (processed) 6 gram Semen Lepidii (Semen Descurainiae)s 8 digest tangerine 6 gram Radix Glycyrrhizaes, 3 grams.
Take by weighing medical material by formula ratio, standby.
The Radix Astragali add 8 times of amounts (ethanol weight: medical material weight) 95% ethanol, for the first time soaked reflux, extract, 3 times 90 minutes, each 1.0 hours, merge ethanol liquid, filter, decompression filtrate recycling ethanol further is concentrated into relative density 1.30 (80 ℃), gets the (+)-Astragenol extracted extract.
Exocarpium Citri Grandis add 14 times of amounts (water weight: medical material weight) water, extracted volatile oil 10 hours in volatile oil extractor, collect volatile oil, filtering liquid medicine, it is standby to collect medicinal liquid.
Get astragalus root dregs, Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae), the Radix Glycyrrhizae of alcohol extraction, add 12 times of amounts of water (volume/medical material weight) for the first time, soaked 60 minutes, decocted 90 minutes, second and third time adds 10 times of amounts of water (volume/medical material weight) at every turn and decocted 60 minutes.Merge decoction liquor, filter, filtrate and Exocarpium Citri Grandis medicinal liquid merge, high speed centrifugation (16000 rev/mins), and centrifugal liquid is concentrated into relative density 1.10 (80 ℃), gets extractum.
(+)-Astragenol extracted extract and other medicine are closed the extracted extract merging, mixing, spray drying gets dry medicated powder.
Take by weighing 5 times of amounts of Exocarpium Citri Grandis oil (β-CD the weight: (β-CD) of beta-schardinger dextrin-oil volume), the water that adds 8 times of amounts of β-CD (water weight: β-CD weight), heating makes β-CD dissolving, keep 60 ℃ again, under 400 rev/mins condition, slowly add Exocarpium Citri Grandis oil, placed 24 hours below 4 ℃.Take out sucking filtration, a small amount of washing, 50 ℃ of dryings get Exocarpium Citri Grandis oil β-CD inclusion complex, with this pulverizing.
Spray drying medicated powder, Exocarpium Citri Grandis oil β-CD inclusion complex and dextrin are mixed in right amount, mixed powder, adds 0.5 times of amount (weight of ethanol liquid: mixed powder weight) 5% 30 POVIDONE K 30 BP/USP, 30 95% ethanol liquid, stir evenly, granulation, 70 ℃ of dryings, granulate, encapsulated.Finished product is light brown, and is little sweet, fragrant odour, good mouthfeel.
Claims (11)
1, a kind of pharmaceutical composition of anti-treating respiratory system disease is characterized in that mainly being made by the following raw materials in part by weight medicine: Radix Astragali 1-12 part, Herba Ephedrae (processed) 1-6 part, Semen Lepidii (Semen Descurainiae) 1-10 part.
2, the pharmaceutical composition of claim 1, wherein the consumption of crude drug is: Radix Astragali 4-8 part, Herba Ephedrae (processed) 2-4 part, Semen Lepidii (Semen Descurainiae) 2-6 part.
3, claim 1 or 2 described preparation of drug combination methods comprise the following steps:
Take by weighing each crude drug Radix Astragali, Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae), standby;
The described weight ratio Radix Astragali is added the 40%-95% ethanol extraction, filter, astragalus root dregs is waited until post processing, gets ethanol extract, and density 1.00～1.30 when being concentrated into 70～80 ℃, gets (+)-Astragenol extracted extract A;
Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae) and the astragalus root dregs of described weight ratio are merged, add decocting in water, get water cooking liquid and filter, density 1.00～1.30 when filtrate was concentrated into 70～80 ℃, got extractum B1;
Extractum A and extractum B1 are merged, and mixing is dried to powder, gets the active component of pharmaceutical composition of the present invention.
4, the pharmaceutical composition of claim 1, wherein crude drug also has a kind of a kind of in Exocarpium Citri Grandis, Flos Farfarae, the Radix Asteris or two kinds of being selected from, and is 1-9 part by weight consumption.
5, the pharmaceutical composition of claim 4, wherein to also have a kind of be tangerine to crude drug, consumption is 2-5 part.
6, the described preparation of drug combination method of claim 5 comprises the following steps:
Take by weighing each crude drug Radix Astragali, Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae), Exocarpium Citri Grandis, standby;
The Radix Astragali of described weight ratio is added 4-12 doubly measure the 40%-95% ethanol extraction, filter, astragalus root dregs is waited until post processing, gets ethanol extract, and density 1.00～1.30 when being concentrated into 70～80 ℃, (+)-Astragenol extracted extract A;
The Exocarpium Citri Grandis of described weight ratio is extracted volatile oil, and it is standby to collect Exocarpium Citri Grandis oil, gets Exocarpium Citri Grandis water liquid after water liquid is filtered and treats post processing;
Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae) and the astragalus root dregs of described weight ratio are merged, add decocting in water, get water cooking liquid and filter, after filtrate and Exocarpium Citri Grandis water liquid merged, density 1.00～1.30 when being concentrated into 70～80 ℃, got extractum B2;
Extractum A and extractum B2 are merged, and mixing is dried to powder, adds Exocarpium Citri Grandis oil, gets the active component of pharmaceutical composition of the present invention.
7, the pharmaceutical composition of claim 5, wherein crude drug also has Radix Glycyrrhizae 1-5 part by weight.
8, the pharmaceutical composition of claim 5 is mainly made by the following raw materials in part by weight medicine: 6 parts of the Radixs Astragali, 3 parts of Herba Ephedrae (processed), 6 parts of Semen Lepidii (Semen Descurainiae)s, 3 parts of Exocarpium Citri Grandises, 3 parts in Radix Glycyrrhizae.
9, the described preparation of drug combination method of claim 7 comprises the following steps:
Take by weighing each crude drug Radix Astragali, Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae), Exocarpium Citri Grandis, Radix Glycyrrhizae, standby;
The Radix Astragali of described weight ratio is added 4-12 doubly measure the 40%-95% ethanol extraction, filter, astragalus root dregs is waited until post processing, gets ethanol extract, and density 1.00～1.30 when being concentrated into 70～80 ℃, (+)-Astragenol extracted extract A;
The Exocarpium Citri Grandis of described weight ratio is extracted volatile oil, collect volatile oil, after the filtration, get Exocarpium Citri Grandis oil, add beta-schardinger dextrin-, form Exocarpium Citri Grandis oil beta-cyclo dextrin included compound, the Exocarpium Citri Grandis water liquid after water liquid is filtered is treated post processing;
Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae), Radix Glycyrrhizae and the astragalus root dregs of described weight ratio are merged, add decocting in water, get water cooking liquid and filter, after filtrate and Exocarpium Citri Grandis water liquid merged, density 1.00～1.30 when being concentrated into 70～80 ℃, got extractum B;
Extractum A and extractum B are merged, and mixing is dried to powder, adds Exocarpium Citri Grandis oil beta-cyclo dextrin included compound, gets the active component of pharmaceutical composition of the present invention.
10, the preparation method of claim 9, wherein
The Radix Astragali of getting weight proportion by weight/weight ratio adds 8 times of amount 70-85% ethanol, reflux, extract, 3 times, each 1 hour, merge ethanol liquid, filter, astragalus root dregs is waited until post processing, filtrate is concentrated into 70～80 ℃ of relative densities 1.10～1.15, (+)-Astragenol extracted extract A;
The Exocarpium Citri Grandis of getting weight proportion by weight/weight ratio adds 14 times of water gagings, extracts volatile oil 8 hours, collects Exocarpium Citri Grandis oil, water liquid filters, Exocarpium Citri Grandis water liquid;
Get Herba Ephedrae (processed), Semen Lepidii (Semen Descurainiae), Radix Glycyrrhizae and the astragalus root dregs of weight proportion, by weight/weight ratio adds water 10-12 doubly, boils 60-90 minute at every turn 2-3 time; Merge decoction liquor, filter, filtrate and Exocarpium Citri Grandis water liquid merge, high speed centrifugation (16000 rev/mins), and centrifugal liquid is concentrated into 70～80 ℃ of relative densities 1.10～1.15, gets extractum B;
Extractum A and extractum B are merged, and spray drying gets dry medicated powder;
By 1 part of Exocarpium Citri Grandis oil volume: 5-15 part beta-schardinger dextrin-weight, take by weighing beta-schardinger dextrin-, add by weight/water that the 8-20 of weight ratio meter doubly measures, after the beta-schardinger dextrin-dissolving, add Exocarpium Citri Grandis oil, placed 24 hours below 4 ℃, sucking filtration, a small amount of washing, 50 ℃ of dryings, get Exocarpium Citri Grandis oil beta-cyclo dextrin included compound, pulverize;
With spray drying medicated powder, Exocarpium Citri Grandis oil beta-cyclo dextrin included compound and dextrin, add the ethanol liquid that contains 5% 30 POVIDONE K 30 BP/USP 30, mix, granulate drying.
11, the preparation method of claim 10, wherein by 1 part of Exocarpium Citri Grandis oil volume: 10-12 part beta-schardinger dextrin-weight takes by weighing beta-schardinger dextrin-, the water that the 8-15 of adding beta-schardinger dextrin-weight doubly measures, heating makes the beta-schardinger dextrin-dissolving, keeps 60 ℃ again, under 500 rev/mins condition, add Exocarpium Citri Grandis oil, placed 24 hours sucking filtration, a small amount of washing below 4 ℃, 50 ℃ of dryings get Exocarpium Citri Grandis oil beta-cyclo dextrin included compound; Spray drying medicated powder, Exocarpium Citri Grandis oil beta-cyclo dextrin included compound are mixed tabletting, pack or fill capsule with the adjuvant commonly used of oral formulations.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101007058B (en) * | 2006-01-23 | 2010-05-12 | 王忆俭 | Medicinal composition for treating bronchial asthma, chronic bronchitis and emphysema |
| CN103285128A (en) * | 2013-06-17 | 2013-09-11 | 贵州鸿德中药开发有限公司 | Traditional Chinese medicine for treating bronchial asthma and preparation method thereof |
| CN105412826A (en) * | 2015-12-10 | 2016-03-23 | 青岛麦瑞特医药技术有限公司 | Pharmaceutical composition for treating bronchialasthma and application thereof |
| CN108653509A (en) * | 2018-06-15 | 2018-10-16 | 耿广信 | Resolving sputum Chinese medicine composition and its preparation method and application |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1049597C (en) * | 1996-06-11 | 2000-02-23 | 王来运 | Liquid medicine for treatment of tracheitis and preparing method thereof |
-
2004
- 2004-11-16 CN CNB2004100657503A patent/CN100369615C/en not_active Expired - Lifetime
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101007058B (en) * | 2006-01-23 | 2010-05-12 | 王忆俭 | Medicinal composition for treating bronchial asthma, chronic bronchitis and emphysema |
| CN103285128A (en) * | 2013-06-17 | 2013-09-11 | 贵州鸿德中药开发有限公司 | Traditional Chinese medicine for treating bronchial asthma and preparation method thereof |
| CN103285128B (en) * | 2013-06-17 | 2015-01-07 | 贵州鸿德中药开发有限公司 | Traditional Chinese medicine for treating bronchial asthma and preparation method thereof |
| CN105412826A (en) * | 2015-12-10 | 2016-03-23 | 青岛麦瑞特医药技术有限公司 | Pharmaceutical composition for treating bronchialasthma and application thereof |
| CN108653509A (en) * | 2018-06-15 | 2018-10-16 | 耿广信 | Resolving sputum Chinese medicine composition and its preparation method and application |
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