CN1069832C - Medicinal composition for treating bronchial asthma and its preparing process - Google Patents

Medicinal composition for treating bronchial asthma and its preparing process Download PDF

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CN1069832C
CN1069832C CN97100014A CN97100014A CN1069832C CN 1069832 C CN1069832 C CN 1069832C CN 97100014 A CN97100014 A CN 97100014A CN 97100014 A CN97100014 A CN 97100014A CN 1069832 C CN1069832 C CN 1069832C
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张金磊
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Abstract

The present invention relates to a traditional Chinese medicine composition for treating bronchial asthma, which comprises active ingredients and/or pharmaceutically acceptable additives, wherein the active ingredients are prepared from rehmannia root, ophiopogon root, cornel, largehead atractylodes rhizome, lily bulb, human placenta, tendrilleaf fritillary bulb, radix glycyrrhiza, ginseng, Chinese magnolivine fruit, silktree albizzia bark and magnet. The composition has the functions of yin nourishing, Qi circulation promotion, constitution consolidation and asthma relief and can treat bronchial asthma by stabilizing internal environment for patients with bronchial asthma, enhancing the adaption of patients with bronchial asthma, regulating disease resistance and changing the highly sensitive state of the respiratory tract.

Description

A kind of pharmaceutical composition for the treatment of bronchial asthma and preparation method thereof
The present invention relates to a kind of pharmaceutical composition for the treatment of bronchial asthma and preparation method thereof.
Bronchial asthma is a kind of in the respiratory tract disease, because the pathogeny of this disease is not illustrated as yet fully, makes Chinese and western medicine in treatment very big limitation be arranged.The traditional Chinese medical science generally adopts the drink that reduces phlegm, cough-relieving is breathed heavily and the method for strengthening spleen, tonifying kidney, adopt ERCHEN TANG, XIAOQINGLONG TANG, JINGUI SHENQI WAN etc., but curative effect is of short duration more, low and easy recurrence of cure rate; Doctor trained in Western medicine only at sensitinogen, anaphylaxis is abnormal and the clinical symptoms that showed, the method that adopts antiinflammatory, antiallergic and spasmolytic to relieving asthma uses aminophylline, beta receptor analeptic, cholinolytic class, hormones and medium to discharge medicines such as retardance class; Can only the respite symptom, owing to can not effect a radical cure, make the patient have to take for a long time, thereby cause side effect such as hormone dependence, obesity, endocrine regulation.The inventor finds that through long term studies existing these medicines have all been ignored the repairing and treating that the respiratory tract part is dyed the inflamed ulcer focus that causes because of dislike; The treatment of the disturbance of blood circulation that respiratory tract local inflammation (inflammatory damage capillary network, lung tissue swelling compressing blood capillary, blood be sticking, coagulate, aggregation increases etc.) is caused; Cause interstitial pulmonary fibrosis to cause gas-exchange membrane to thicken and the treatment of gas dispersion merit obstacle and respiratory tract local patholoic change (airway obstruction, gas are more bad, histoorgan anoxia and function reduction) cause allomeric function to go down to respiratory repeated infection, thereby body function go down and influence not only the repairing and treating of respiratory tract local patholoic change never effectively these diseases of treatment but also the less medicine of side effect really clinically conversely.
The present invention just provides a kind ofly like this to have YIN nourishing training unit, stablize bronchial asthma patient organismic internal environment, strengthen adjusting of bronchial asthma patient organism adaptation and resistance against diseases, the effect of change air flue hypersensitive state is the less Chinese medicine composition of side effect again, is used for the treatment of bronchial asthma.
The present invention also provides the preparation method of this Chinese medicine composition simultaneously.
Chinese medicine composition of the present invention mainly comprises the active component that the Chinese crude drug by following proportioning makes: (by weight) Radix Rehmanniae 20-100 part, Radix Ophiopogonis 10-50 part, Fructus Corni 3-20 part, Rhizoma Atractylodis Macrocephalae 3-20 part, Bulbus Lilii 3-20 part, Placenta Hominis 1-7 part, Bulbus Fritillariae Cirrhosae 18-90 part, Radix Glycyrrhizae 3-15 part, Radix Ginseng 1-7 part, Fructus Schisandrae Chinensis 10-50 part, Cortex Albiziae 13-65 part, Magnetitum 3-15 part.Wherein be preferably: (by weight) Radix Rehmanniae 30-80 part, Radix Ophiopogonis 15-50 part, Fructus Corni 5-15 part, Rhizoma Atractylodis Macrocephalae 5-15 part, Bulbus Lilii 5-15 part, Placenta Hominis 3-7 part, Bulbus Fritillariae Cirrhosae 30-70 part, Radix Glycyrrhizae 6-12 part, Radix Ginseng 3-7 part, Fructus Schisandrae Chinensis 15-40 part, Cortex Albiziae 20-55 part, Magnetitum 5-10 part.Wherein the best is: 60 parts in (by weight) Radix Rehmanniae, 45 parts of Radix Ophiopogonis, 12 parts of Fructus Corni, 10 parts of the Rhizoma Atractylodis Macrocephalaes, 12 parts of Bulbus Liliies, 6 parts of Placenta Hominiss, 55 parts of Bulbus Fritillariae Cirrhosaes, 10 parts in Radix Glycyrrhizae, 7 parts of Radix Ginsengs, 35 parts of Fructus Schisandrae Chinensis, 50 parts of Cortex Albiziaes, 7 parts of Magnetitums.
Active component in pharmaceutical composition of the present invention can be the extract of acetone, chloroform, ether, ethyl acetate, alcohol or the water of said ratio Chinese crude drug, be preferably the extract of water or alcohol, more preferably ethanol extraction, wherein concentration of ethanol is 50-99%, preferred 95% ethanol.The percolation that extracting method is carried for conventional Chinese crude drug extracting method warm macerating as usual, reflux extraction etc. have a detailed description in the 65-72 page or leaf in Cao Chunlin chief editor " pharmaceutics of Chinese drugs ".
When the active component of preparation in the pharmaceutical composition of the present invention, when extracting solvent and be water, generally adopt decocting method to extract twice, each consumption all be 3-30 a times of Chinese crude drug, and preferred 25 times, extraction time is 1-5 hour for the first time, be 0.2-5 hour for the second time, merge decocting liquid twice, concentrate.When the extraction solvent is alcohol, generally adopt reflux extraction to extract once, solvent load is 10-40 a times of Chinese crude drug weight, extraction time is 2-6 hour, extracting temperature is 50-80 ℃, reclaims solvent, and this extracting solution is condensed into the thick paste that relative density is 1-1.5 (50 ℃ of heat is surveyed).
The present composition is preferably pulverized the Placenta Hominis of whole consumptions and Radix Ginseng, the 10-60% of Bulbus Fritillariae Cirrhosae consumption, the 5-80% of Radix Rehmanniae consumption and the 5-80% of Cortex Albiziae consumption, mixing, cross 140 orders and make powder, with the water of other residue medical materials or the concentrated thick paste mixing of alcohol extract.
The present composition can also comprise pharmaceutically acceptable additives such as wetting agent, antiseptic, disintegrating agent, lubricant, diluent or excipient etc., adopts the conventional method of this area can make various dosage forms such as tablet, pill, capsule, oral liquid, syrup, electuary etc.
The present composition has enriching yin boost qi and consolidates the effect of Dingchuan, can stablize bronchial asthma patient organismic internal environment, strengthen bronchial asthma patient organism adaptation and regulate and resistance against diseases, thereby change the purpose that the air flue hypersensitive state reaches treatment bronchial asthma.Clinically, medicine of the present invention consolidates medicine for the treatment chronic obstructive disease of lung, with the palliative of treatment chronic obstructive disease of lung with face the control medicine and unite use, and the clinical observation through 18 years, effective percentage is 99.33%, cure rate is 81.33%.
Embodiment 1
A) take by weighing the Radix Rehmanniae 600 grams, restrain Radix Ophiopogonis 450, Fructus Corni 120 grams, and the Rhizoma Atractylodis Macrocephalae 100 grams, Bulbus Lilii 120 grams, Placenta Hominis 60 grams, Bulbus Fritillariae Cirrhosae 550 restrains, Radix Glycyrrhizae 100 grams, Radix Ginseng 70 grams, Fructus Schisandrae Chinensis 350 grams, Cortex Albiziae 500 grams, Magnetitum 70 restrains;
B) wherein 70 gram Radix Ginsengs, 60 gram Placenta Hominiss, the Bulbus Fritillariae Cirrhosae of 275 grams, the 60 gram Radix Rehmanniae, 50 gram Cortex Albiziaes are pulverized, and mixing is crossed 140 mesh sieves and made powder, and is standby;
C) will remain medical material and use 95% ethanol lixiviate twice, and add 25 times for the first time and extracted 5 hours, and add 15 times for the second time and extracted 2.5 hours, merge extractive liquid, filters, and being condensed into relative density is the thick paste of 1-1.5 (50 ℃ of heat are surveyed);
D) thick paste that makes in medicated powder that makes in the step b) and the step c) is mixed, pill promptly, the trade name of prepared compositions is called " asthma consolidates ball " again.Test example 1 medicine of the present invention is to bronchial asthma therapeutical effect method:
This test is adopted and is continued artificial ventilation, quick air flue obturation techniques, measures lung resistance (R L) and lung compliance (C L), the tonicity of understanding airway smooth muscle, the cytology who makes bronchoalveolar lavage fluid after the test measures, and the inflammatory of understanding air flue and alveolar changes.The test grouping:
Select common rabbit (2.0 ± 0.4kg) 20 of body weight for use, divide medicine group and matched group, every group 10, earlier two groups of rabbit atomizings are sucked 4 weeks of 1% acetylcholine, 2 times/day, the about 8-10um of atomizing particle, the atomization gas flow is 4.5L/min, to the medicine group, matched group is not given medicine, measures lung resistance and lung compliance the trial drug nasal feeding in 1 all backs.Animal is prepared:
Give the quiet notes 20% urethane 15-20ml of auricular vein of experimental rabbits.After animal is fully anaesthetized, lying on the back is fixed on the workbench, and the circulation of qi promoting cannula connects animal and uses the respirator artificial ventilation, tidal volume is 50ml, ventilatory frequency 30 times/minute, arterial cannulation monitoring blood pressure, but quiet kind of Luo Ning 0.1mg, make muscular flaccidity, heating cushion keeps body temperature, connects physiology of respiration instrument (U.S. produces 3400s/DASA) through pick off, measures and presses through lung.Ventilation volume, flow.Test data deposits the corresponding calculated machine in, with monitor monitoring test wave mode.Medicine:
Asthma consolidates ball (being the medicine that embodiment 1 makes) bronchoalveolar lavage fluid cytology and measures:
After the off-test, with 15ml normal saline lavation 6 times (total amount 80ml), bronchoalveolar lavage fluid is at 1000rpm, and under 4 ℃ of conditions centrifugal 5 minutes, cellular layer added in the 4ml normal saline, gets 50ul cell irrigating solution and makes cell counting and sort check.Eosinophilic granulocyte peroxidase (EPO) is measured:
With the content of the OPO method mensuration bronchoalveolar lavage fluid supernatant EPO that improves, with the Log value representation of measured value.Statistical method:
All data X ± SD represent, compare each sample average with variance analysis, and P<0.05 is considered to difference significance.The result:
1. trial drug is to bringing out the effect of shrinking air flue:
Medicine group and matched group compare, and lung resistance descends (P<0.05) and lung compliance increases (P<0.05), the results are shown in Table 1.This shows that medicine of the present invention can reduce lung resistance, improves compliance, and the air flue of contraction is brought out in diastole.
Table 1
Measurement index The medicine group Matched group
Lung resistance (R L) 71.2±7.6 85.6±8.5
Lung compliance (C L) 3.6±0.7 4.5±1.1
2. trial drug is to the effect of air flue inflammatory cell:
Medicine group and matched group compare, and total cellular score descends, and eosinophilic granulocyte descends (P<0.05), and pulmonary alveolar macrophage, medium-sized grain cell and lymphocyte there was no significant difference (P>0.05) the results are shown in Table 2.
Table 2
The medicine group Matched group
Total cellular score 8.7±1.0 10.3±0.9
Pulmonary alveolar macrophage 7.5±1.1 7.9±1.4
Eosinophilic granulocyte 0.40±0.37 2.01±0.63
Neutrophilic granulocyte 0.20±20.1 0.17±0.15
Lymphocyte 0.29±0.12 0.31±0.14
3. trial drug is to the effect of noise acid cell peroxidase (EPO)
Medicine group and matched group compare, and the content of EPO descends (P<0.05), shows that trial drug can reduce the release of airway inflammation medium, alleviate the airway epithelia damage, the results are shown in Table 3.
Table 3
The medicine group Matched group
LogEPO 1.40±0.3 1.81±0.3
The bronchitis of asthma relates generally to hypertrophy, eosinophilic granulocyte and lymphocyte, and wherein eosinophilic granulocyte is main function cells, and various inflammatory mediators such as leukotriene (LTC can be synthesized and discharge to eosinophilic granulocyte 4, LTD 4) and PAF, cause that tracheal smooth muscle shrinks, blood capillary infiltration and mucous gland secretion increase, PAF: promote the effect of gathering, activation and the release toxic protein of eosinophilic granulocyte in addition, the peroxidase of eosinophilic granulocyte (EPO) is that eosinophilic granulocyte produces and discharges a kind of in the toxic protein, its energy coup injury airway epithelia causes epithelium to peel off.The key of therefore effecting a radical cure asthma and control recurrence is the number that alleviates the air flue inflammatory cell, the release of the inflammatory mediator of reduction air flue and the reactivity of air flue, from above-mentioned test as can be seen, trial drug can reduce the lung resistance that brings out the contraction air flue and improve lung compliance, diastole central authorities and peripheral airways, reduce the quantity of alveolar and air flue eosinophilic granulocyte, reduce the eosinophilic granulocyte activation and discharge inflammatory mediator acidophil peroxidase (EPO), reduce the sensitivity of air flue.The clinical observation on the therapeutic effect materials and methods of test example 2 trial drugs of the present invention:
746 routine bronchial asthma patients, male's 410 examples wherein, women's 354 examples, minimum 2 years old of age, maximum 81 years old, 42 years old mean age.The diagnosis of all cases and therapeutic evaluation are all according to Chinese Medical Association's pneumatology meeting " diagnosis of bronchial asthma, by stages and efficacy assessment standard " (2)By randomized principle case is divided into two groups, wherein 600 examples are organized in treatment, matched group 164 examples.
Table 4 764 routine bronchial asthma mutual affection cloth situations
Type The treatment group Matched group Add up to
Slightly 108 18.0 32 19.5 140
Moderate 376 62.7 99 60.4 475
Severe 116 19.3 33 20.1 149
Add up to 600 100 164 100 764
x 2Two groups of no significance difference of state of an illness distribution are analysed in=1.554 P>0.05 credit by statistics.The shortest person of the course of disease not enough half a year, elder surpass 40 years, asthma person's 751 examples are arranged, cough person's 592 examples among the 746 routine patients, expectoration person's 615 examples, the person's of breathing hard 229 examples merge chronic bronchitis 102 examples, merge emphysema 184 examples, merge pulmonary heart disease 12 examples, merge pulmonary tuberculosis person's 20 examples.Therapeutic Method:
Treatment divides local treatment and two stages of wholistic therapy function, and 3 totally months is a course of treatment.The simple general 1-2 of property asthma course of treatment, 2-3 course of treatment of Secondary cases emphysema person.
Topical therapeutic medicine: lung qi dispersing anti-asthma pill.Usage: take 12 grams, every day four times, taking medicine after meal serve on 30 days, reaches the controlled degree of symptom at every turn.
Allomeric function is regulated medicine: asthma consolidates ball (prepared in the embodiment of the invention 1).Usage: each 30-60 grain, one day 2 times, morning and evening (medicine) being taken before meal usefulness, serveing on two months is a course of treatment.
Matched group all adopts antiinflammatory (erythromycin, SMZ penicillin etc.), antiallergic (oral hismanal etc.), relievings asthma (oral aminophylline, add when being in a bad way with isoproterenol, hormone etc.) therapy, adds carbetapentane citrate, bromhexine hydrochloride if any the expectoration symptom.The result:
Late result: treatment is organized in 600 examples, and clinical cure 488 examples account for 81.33%, and clinical cure 16 examples account for 9.76% in matched group 164 examples.Credit is analysed two groups of difference and is had the significance meaning by statistics.See Table 5.
Table 5 a liang group patient late result is analyzed
The treatment group Matched group
Cure 488 81.33 16 9.76
Produce effects 90 15.00 57 34.76
Effectively 18 3.00 34 20.73
Invalid 4 0.66 57 34.76
Add up to 600 100 164 100
Two groups of cure rates compare X 2=293.92 P<0.01.
Table 6 treatment group different symptoms control situation
The symptom characteristic The example number Curative effect The example number Total effective rate
Cough 464 Face control 442 95.25 100
Produce effects 16 3.45
Take a turn for the better 6 1.29
Invalid - -
Expectorant 482 Face control 442 95.95 100
Produce effects 14 2.90
Take a turn for the better 6 2.25
Invalid - -
Breathe heavily 600 Face control 490 81.67 99.33
Produce effects 96 16
Take a turn for the better 10 1.67
Invalid 4 0.67
Wheezing sound 483 Face control 396 81.99 97.10
Produce effects 36 7.45
Take a turn for the better 38 7.87
Invalid 14 2.90
E before and after table 7 treatment t-with E a-garland formation rate (%) situation of change
Pilot project The example number Average before the treatment Treatment back average Inequality before and after the treatment ± standard error The P value
E t-garland formation rate 181 54.10 64.10 10.00 ±2.81 <0.01
E a-garland formation rate 189 25.32 35.64 9.82 ±2.26 <0.01
Contrast has significant difference (P<0.01) before and after the treatment, shows that this medicine has adjusting and potentiation to immunologic function.The normal value E of 30 routine healthy persons t-garland formation rate 68.41 ± 8.26%, E a-garland formation rate is 38.14 ± 7.59%.
Urine 17-hydroxyl sterin situation of change before and after table 8 treatment
Group The example number Urine 17-OHNumd/24h The P value
Healthy person 30 19.78 <0.01
Before the treatment 251 6.81
After the treatment 251 18.90
Contrast has significant difference (P<0.01) before and after the treatment, shows that this medicine has adjusting and potentiation to endocrine function.(treatment group) X line situation of change and therapeutic effect relationship before and after the treatment:
This organizes 488 examples, and X line plain film is observed comparing result after treatment in 2 years:
Lung marking changes: lung marking increase, disorderly 394 examples before the treatment, and lung field is clear after treating, and texture alleviates 376 people, accounts for 95.43%, and 18 examples of no significant change account for 4.57%.
Emphysema sign: therapist emphysema 144 examples, treatment 134 routine diaphragm positions, back and lung printing opacity before have clear improvement, and account for 93.06%; 10 examples slightly change and account for 6.94%.
The patch shape shade of secondary infection all absorbs and takes a turn for the better.

Claims (8)

1. pharmaceutical composition for the treatment of bronchial asthma is characterized in that it comprises active component and/or the pharmaceutically acceptable additives of being made by following raw materials according: Radix Rehmanniae 20-100 weight portion, Radix Ophiopogonis the 10-50 weight portion, Fructus Corni 3-20 weight portion, Rhizoma Atractylodis Macrocephalae 3-20 weight portion, Bulbus Lilii 3-20 weight portion, Placenta Hominis 1-7 weight portion, Bulbus Fritillariae Cirrhosae 18-90 weight portion, Radix Glycyrrhizae 3-15 weight portion, Radix Ginseng 1-7 weight portion, Fructus Schisandrae Chinensis 10-50 weight portion, Cortex Albiziae 13-65 weight portion, Magnetitum 3-15 weight portion.
2. according to the pharmaceutical composition of claim 1, active component is wherein made by following raw materials according: Radix Rehmanniae 30-80 weight portion, Radix Ophiopogonis the 15-50 weight portion, Fructus Corni 5-15 weight portion, Rhizoma Atractylodis Macrocephalae 5-15 weight portion, Bulbus Lilii 5-15 weight portion, Placenta Hominis 3-7 weight portion, Bulbus Fritillariae Cirrhosae 30-70 weight portion, Radix Glycyrrhizae 6-12 weight portion, Radix Ginseng 3-7 weight portion, Fructus Schisandrae Chinensis 15-40 weight portion, Cortex Albiziae 20-55 weight portion, Magnetitum 5-10 weight portion.
3. according to the pharmaceutical composition of claim 1, active component is wherein made by following raw materials according: the Radix Rehmanniae 60 weight portions, Radix Ophiopogonis 45 weight portion, Fructus Corni 12 weight portions, the Rhizoma Atractylodis Macrocephalae 10 weight portions, Bulbus Lilii 12 weight portions, Radix Glycyrrhizae 10 weight portions, Placenta Hominis 6 weight portions, Radix Ginseng 7 weight portions, Bulbus Fritillariae Cirrhosae 55 weight portions, Fructus Schisandrae Chinensis 35 weight portions, Cortex Albiziae 50 weight portions, Magnetitum 7 weight portions.
4. method for preparing the pharmaceutical composition for the treatment of bronchial asthma, it comprises the following steps: a) to press the row weight portion and takes by weighing: Radix Rehmanniae 20-100 part, Radix Ophiopogonis 10-50 part, Fructus Corni 3-20 part, Rhizoma Atractylodis Macrocephalae 3-20 part, Bulbus Lilii 3-20 part, Placenta Hominis 1-7 part, Radix Glycyrrhizae 3-15 part, Radix Ginseng 1-7 part, Bulbus Fritillariae Cirrhosae 18-90 part, Magnetitum 3-15 part, Fructus Schisandrae Chinensis 10-50 part, Cortex Albiziae 13-65 part is standby; B) 5-80% of the 5-80% of the 10-60% of whole consumptions of Placenta Hominis and Radix Ginseng, Bulbus Fritillariae Cirrhosae consumption, Radix Rehmanniae consumption, Cortex Albiziae consumption is pulverized, mixing is crossed 140 mesh sieves and made powder, and is standby; C) remaining Chinese crude drug being made 50 ℃ of heat through water or alcohol extraction, to survey relative densities be the water of 1-1.5 or the concentrated thick paste of alcohol extract, when wherein extracting solvent and being water, adopt decocting method to extract twice, the 3-30 that each consumption all is a Chinese crude drug doubly, extraction time is 1-5 hour for the first time, be 0.2-5 hour for the second time, merge decocting liquid twice, concentrate; When the extraction solvent is alcohol, adopt reflux extraction to extract once, solvent load is 10-40 a times of Chinese crude drug weight, and extraction time is 2-6 hour, and the extraction temperature is 50-80 ℃, reclaims solvent, concentrates; D) thick paste that makes in medicated powder that makes in the step b) and the step c) is carried out mixing.
5. preparation method according to claim 4, wherein the raw material consumption is: Radix Rehmanniae 30-80 weight portion, Radix Ophiopogonis the 15-50 weight portion, Fructus Corni 5-15 weight portion, Rhizoma Atractylodis Macrocephalae 5-15 weight portion, Bulbus Lilii 5-15 weight portion, Placenta Hominis 3-7 weight portion, Bulbus Fritillariae Cirrhosae 30-70 weight portion, Radix Glycyrrhizae 6-12 weight portion, Radix Ginseng 3-7 weight portion, Fructus Schisandrae Chinensis 15-40 weight portion, Cortex Albiziae 20-55 weight portion, Magnetitum 5-10 weight portion.
6. preparation method according to claim 4, wherein the raw material consumption is: the Radix Rehmanniae 60 weight portions, Radix Ophiopogonis 45 weight portion, Fructus Corni 12 weight portions, the Rhizoma Atractylodis Macrocephalae 10 weight portions, Bulbus Lilii 12 weight portions, Radix Glycyrrhizae 10 weight portions, Placenta Hominis 6 weight portions, Radix Ginseng 7 weight portions, Bulbus Fritillariae Cirrhosae 55 weight portions, Fructus Schisandrae Chinensis 35 weight portions, Cortex Albiziae 50 weight portions, Magnetitum 7 weight portions.
7. according to any one the described preparation method among the claim 4-6, wherein said alcohol is the ethanol of 50-99%.
8. preparation method according to claim 7, wherein said alcohol are 95% ethanol.
CN97100014A 1997-02-17 1997-02-17 Medicinal composition for treating bronchial asthma and its preparing process Expired - Fee Related CN1069832C (en)

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CN1315505C (en) * 2003-04-21 2007-05-16 罗大义 Formula of Chinese traditional medicine curing cough and asthma
CN103479920B (en) * 2013-09-26 2015-04-15 于海斌 Asthma treatment medicine

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