CN1136900C - Medicine for treating pulmonary tuberculosis and its preparing process - Google Patents

Abstract

The present invention discloses a medicine for treating pulmonary tuberculosis. The present invention adopts raw materials of japanese ardisia stems and leaves, silkworms, stemona roots, gynostemma pentaphylla, salep, mulberry bark, bugle and polygonum filiforme which are prepared into capsules through pulverization, extraction, concentration, drying, drying object pulverization and mixing. The present invention has the advantages of unique formulation and preparation method and obvious therapeutic effect.

Description

Medicine of treatment pulmonary tuberculosis and preparation method thereof

Technical field

The present invention relates to a kind of medicine for the treatment of pulmonary tuberculosis, is the Chinese patent medicine of feedstock production with the Chinese herbal medicine specifically, the invention still further relates to the preparation method of this medicine.

Background technology

Pulmonary tuberculosis is the chronic respiratory infectious disease that is caused by tubercule bacillus, clinically mainly show as cough, spit blood, cough up phlegm, chest pain, fatigue and weakness, buccal flushing, low grade fever etc., with Chinese medicine " pulmonary tuberculosis " roughly the same.

Pulmonary tuberculosis is one of clinical common disease, and nineteen ninety WHO investigation shows, it is about 2,000 ten thousand that nearly 1,700,000,000 people in the whole world infect the existing ill people of tulase, has every year 2800000 people to die from pulmonary tuberculosis, accounts for 7% of a variety of causes death toll.Nineteen ninety China's tuberculosis epidemiology investigation calculates that pulmonary tuberculosis morbidity rate is 5,23/,100,000.It is estimated that China loses 13,900,000,000 on workday because of tuberculosis every year, closes 3,500,000,000 yuan of economic losses.Age of onset is based on child and teenager, serious threat numerous people healthy.

For the treatment of pulmonary tuberculosis, doctor trained in Western medicine mainly adopts chemotherapy, though curative effect is certainly, its course of treatment is long, and side effect is big, especially to the infringement of liver, with and chemical sproof continuous increase etc., its use is restricted.

The traditional Chinese medical science just has darker understanding in ancient times to primary disease.Modern Chinese medicine has also accumulated many experiences for the treatment of primary disease.Though the Chinese patent medicine of some treatment pulmonary tuberculosis is also arranged, main tonify deficiency and the parasiticidal method of anti-consumptive disease set upright that adopt of treatment, concrete method of treatment mainly contains supplementing QI and nourishing YIN, blood circulation promoting and blood stasis dispelling, heat-clearing and toxic substances removing etc.But because effect is not fairly obvious, the patient still has to depend on some Western medicine, as rifampicin, prothionamide etc.

Summary of the invention

The object of the present invention is to provide a kind ofly to have treatment, improve lunger's cardinal symptom, strengthen the anti-mycobacterium tuberculosis immunity, reduce, the tuberculosis treatment agent of the complication effect of prevention pulmonary carcinoma in early stage by the respiratory infectious disease that tubercule bacillus causes.

Another object of the present invention provides the preparation method of this pulmonary tuberculosis therapeutic agent.

Technical solution of the present invention is to sum up on the empirical basis of forefathers, by the theory of Chinese medical science prescription, use modern extraction process, skim the cream off milk, with modern pharmacology scientific research is carried out in pharmacological action of the present invention, with its main medicinal part and the compound composition Chinese medicinal capsule of effective ingredient preparation, go out in conjunction with clinical practice, have the merit that the anti-consumptive disease of tonifying the lung, clearing heat in the lung are reduced phlegm.Be mainly used in pulmonary tuberculosis deficiency of YIN expectorant heat syndrome, performance paroxysm of cough and choke, expectorant sticking or Huang, expectorant blood, chest pain, hyperhidrosis or fever of the body is arranged, diseases such as xerostomia red tongue, yellow and thin fur, thready,rolling and rapid pulse.Because of its main syndrome is pulmonary tuberculosis-" pulmonary tuberculosis ", the pulmonary tuberculosis patient is got well after using the treatment of this medicine, strengthen the drug effect characteristics such as immunity of anti-mycobacterium tuberculosis infection.

Medicine of the present invention is made by following prescription: (consumption is a weight portion)

Herba Ardisiae Japonicae 5～20 cutworms 5～20 Radixs Stemonae 5～20 Herb Gynostemmae Pentaphylli 3～15

Pseudobulbus Bletillae (Rhizoma Bletillae) 3～15 Cortex Mori 2～10 Herba ajugae ciliatae (Herba Ajugae Ajuga ciliata Bge.)s 3～15 Herba Glechomaes 2～10

Formula optimization weight (part) ratio range of preparation medicine of the present invention is:

Herba Ardisiae Japonicae 5～17 cutworms 8～20 Radixs Stemonae 5～17 Herb Gynostemmae Pentaphylli 5～15

Pseudobulbus Bletillae (Rhizoma Bletillae) 5～15 Cortex Mori 4～10 Herba ajugae ciliatae (Herba Ajugae Ajuga ciliata Bge.)s 3～12 Herba Glechomaes 5～10

Above-mentioned each component is made medicine production method of the present invention is: 1. pulverize: all grass herb (Herba Ardisiae Japonicae, cutworm, Herba ajugae ciliatae (Herba Ajugae Ajuga ciliata Bge.), Herb Gynostemmae Pentaphylli, Herba Glechomae) is cut into chunks; All the other medical materials [Radix Stemonae (processed with honey), Pseudobulbus Bletillae (Rhizoma Bletillae), Cortex Mori (processed with honey)] are pulverized as the soybean grain size particles; 2. extract: with cutting and the medical material pulverized, place extraction pot, adds 8～15 times and measure 80% ethanol, soaked 1～2 hour, extract 2～3 times, each 2～3 hours, the extracting solution filtration, merging filtrate must extracting solution; 3. concentrate: extracting solution is put into concentrator, reclaim ethanol, get extractum; 4. dry: as extractum to be placed the drying baker inner drying 15～20 hours, get dry thing; 5. pulverize dry thing: dry thing is ground into 40 order medicated powder with pulverizer; 6. mix: 40 order medicated powder add 1%～5% magnesium stearate, mix through mixer, get the spice of hard capsule to be installed.

Clinical drug of the present invention uses the result to show that following advantage is arranged: 1. the present invention is to be raw material with the Chinese herbal medicine, and each prescription meets the pharmaceutical control law regulation.Utilize the comprehensive function treatment pulmonary tuberculosis of the Chinese medicine of respectively distinguishing the flavor of, have no adverse reaction after the medication, do not find the special side reaction of hemogram, liver function and renal function aspect.2. the present invention can make the lymph node number of the poke of Bacillus tuberculosis H37RV reference culture infection obviously reduce, the caseous necrosis incidence rate that alleviates the course of disease degree of its liver, spleen, lung and reduce liver, spleen, lung and lymph node obviously reduces, and can reduce the tubercule bacillus culture units number of liver, spleen, lung and lymph node.3. the present invention also can strengthen the immunity of anti-mycobacterium tuberculosis infection.The present invention efficient with it, have no side effect, large dose oral administration, table double controlled, treated and keep healthy for a long time, treatment and rehabilitation are laid equal stress on advantage.Being fit to patient and normal person takes for a long time.Can replace expensive anti-pulmonary tuberculosis medicine (rifampicin).

This medicine that studies show that of the present invention shows the in vitro tests result of Bacillus tuberculosis H37RV type strain, bacillus tuberculosis bovis and Mycobacterium phlei, this medicine is respectively the minimum inhibitory concentration (MBC) of three strain bacterium: 30,30,60 (mg/ml, in crude drug), the minimum concentration (MBC) of killing is respectively 120,60,120 (mg/ml).

The effect of the Tuberculosis in vitro nuclear bacillus of this medicine sees the following form:

The medicine drug level

Thing bacterial strain 480 240 120 60 30 15 7.5 3.8 1.9 1.0 MIC MBC

This H37RV-----+++++30 120

Medicine bacillus tuberculosis bovis-----+++++30 60

Thing Mycobacterium phlei----++++++ 60 120

100 50 25 12.5?6.25 3.13?1.56 0.78 0.39 0.20

Sharp H37RV-----+++++6.25 25

Good fortune bacillus tuberculosis bovis-----+++++6.25 12.5

Flat Mycobacterium phlei------++++ 3.13 12.5

Annotate: this drug level unit is: mg/ml; Rifampicin concentration unit: ug/ml

The surface is the Mycoderma shape, and the deep is the living elder of graininess and is (+); Do not give birth to elder (-)

This medicine is to the influence of the tuberculosis Cavia porcellus immunity X ± S that sees the following form, n=8

P.P.D local response after 6 weeks of administration

Group dosage

Red and swollen diameter, mm partial water bubble incidence rate, %

Model control group 10.7 ± 1.3 80

This medicine 3g/kg 5.4 ± 0.6 0

(height)

This medicine 1.5g/kg 6.5 ± 0.8 0

(in)

This medicine 0.75g/kg 7.8 ± 1.3 10

(low)

Rifampicin 31mg/kg 5.1 ± 0.7 0

For showing definite clinical treatment and the untoward reaction of medicine of the present invention to the active tuberculosis disease, once used this Drug therapy active tuberculosis 30 examples, obtained comparatively satisfied curative effect.

Selected case treatment is a clinic case all, meets phthisical diagnostic criteria.Male's 22 examples wherein, women's 8 examples, 2～April 5 example, May above 3 examples.

Observation item is with the situation of change of symptom before and after the treatment, as the situation of change of cough, expectoration, spitting of blood, night sweat etc. and laboratory checking index, as erythrocyte sedimentation rate, acid-fast bacilli inspection, chest X-ray, and the untoward reaction after the medication, comprise subjective symptoms and routine blood test, hepatic and renal function etc.Through oral medicine of the patient who meets diagnostic criteria (China Medicine University provides), each 4,3 times on the 1st, the February course of treatment.Inactive other medicine during the treatment at this class illness.

Therapeutic outcome shows, clinical cure 1 example in 30 examples, produce effects 4 examples, effective 22 examples, invalid 6 examples.Total effective rate is 80%, and obvious effective rate is positive 10 examples of expectorant bacterium before 16.67% treatment, has 7 examples to turn out cloudy after the treatment, negative conversion rate 70%.There are 22 routine chest x-ray prompting focuses to have among the 30 routine patients and improve (obviously absorb or absorb).Erythrocyte sedimentation rate is 38.66 ± 11.59 before the treatment, and treatment back is average 21.76 ± 10.09, and significant difference (P＜0.0001) is relatively arranged before and after the treatment.Judge that from the symptom effectiveness in the case that 22 routine iconographys take a turn for the better, symptom control reaches 15 examples, effectively reaches 7 examples; And have 3 routine symptoms to take a turn for the better in invalid case 6 examples of iconography, thereby its symptom obvious effective rate 66.67%.The symptom total effective rate is 90%.Prompting the present invention has the cardinal symptom aspect of improving the lunger to have certain advantage than the improvement of its iconography.

The specific embodiment

Embodiment

Take by weighing raw material (kilogram) by following proportioning:

Herba Ardisiae Japonicae 15.5 cutworms 15.5 Radixs Stemonae 15.5 Herb Gynostemmae Pentaphylli 11

Pseudobulbus Bletillae (Rhizoma Bletillae) 11 Cortex Mori 8 Herba ajugae ciliatae (Herba Ajugae Ajuga ciliata Bge.)s 11 Herba Glechomaes 8

Production method is as follows:

Earlier all grass herb (Herba Ardisiae Japonicae, cutworm, Herba ajugae ciliatae (Herba Ajugae Ajuga ciliata Bge.), Herb Gynostemmae Pentaphylli, Herba Glechomae) is cut the long section of 1.5cm, other is pulverized and is the Semen Glycines bulky grain; Again medicine is dropped in the extraction pot, add 8 times of amount 80% ethanol, soaked 1 hour, reflux, extract, 2 hours, leaching medicinal liquid, medicinal residues added 8 times of amount 80% alcohol reflux 2 hours again, and the leaching medicinal liquid merges 2 times extracting solution; Again extracting solution is put into B-10 and is singly put concentrator, under 64 ℃, 0.07Mpa condition, reclaim ethanol, extractum, the extractum relative density is 1.3; Extractum is placed YZG1400 type vacuum drying oven again, carry out drying in 80 ℃, 0.08Mpa condition, be 18 hours drying time, dry thing; Be ground into 40 order powder through pulverizer, add 1% magnesium stearate, mixed 30 minutes, get capsular spice to be installed through Multidimensionblender.

Claims (4)

1, a kind of medicine for the treatment of pulmonary tuberculosis is characterized in that it is the medicament of being made by the following weight proportion raw material

Herba Ardisiae Japonicae 5～20 cutworms 5～20 Radixs Stemonae 5～20 Herb Gynostemmae Pentaphylli 3～15

Pseudobulbus Bletillae (Rhizoma Bletillae) 3～15 Cortex Mori 2～10 Herba ajugae ciliatae (Herba Ajugae Ajuga ciliata Bge.)s 3～15 Herba Glechomaes 2～10.

2, the medicine of treatment pulmonary tuberculosis according to claim 1, wherein the weight proportion of each raw material is

Herba Ardisiae Japonicae 5～1 7 cutworms, 8～20 Radixs Stemonae, 5～17 Herb Gynostemmae Pentaphylli 5～15

Pseudobulbus Bletillae (Rhizoma Bletillae) 5～15 Cortex Mori 4～10 Herba ajugae ciliatae (Herba Ajugae Ajuga ciliata Bge.)s 3～12 Herba Glechomaes 5～10.

3, the medicine of treatment pulmonary tuberculosis according to claim 1 and 2 is characterized in that described medicament is a capsule preparations.

4, the preparation method of the medicine of treatment pulmonary tuberculosis according to claim 3 is characterized in that: a, pulverizing; Whole grass raw material Herba Ardisiae Japonicae, cutworm, Herba ajugae ciliatae (Herba Ajugae Ajuga ciliata Bge.), Herb Gynostemmae Pentaphylli, Herba Glechomae are cut into chunks; All the other raw material Radixs Stemonae (processed with honey), Pseudobulbus Bletillae (Rhizoma Bletillae), Cortex Mori (processed with honey) are pulverized as the soybean grain size particles; B, extraction; With cutting and the raw material pulverized, place extraction pot, add 8～15 times of amount 80% ethanol, soaked 1～2 hour, extracts 2～3 times, each 2～3 hours, the extracting solution filtration, merging filtrate must extracting solution; C, concentrated: extracting solution is put into concentrator, reclaim ethanol, get extractum; D, drying: extractum was placed the drying baker inner drying 15～20 hours, get dry thing; E, pulverize dry thing: dry thing is ground into 40 order medicated powder with pulverizer; F, mixing: 40 order medicated powder add 1%～5% magnesium stearate, mix through mixer, get the spice of hard capsule to be installed.