CN101091787A - Composition of Chinese traditional medicine for treating asthma, preparation method - Google Patents
Composition of Chinese traditional medicine for treating asthma, preparation method Download PDFInfo
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- CN101091787A CN101091787A CN 200610086866 CN200610086866A CN101091787A CN 101091787 A CN101091787 A CN 101091787A CN 200610086866 CN200610086866 CN 200610086866 CN 200610086866 A CN200610086866 A CN 200610086866A CN 101091787 A CN101091787 A CN 101091787A
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Abstract
The present invention relates to a Chinese medicine composition for effectively curing cough and asthma with obvious therapeutic effect and its preparation method. Said Chinese medicine composition is formed from 5 Chinese medicinal materials of ephedra root, corydalis tuber, white mustard seed, bitter apricot kernel and fresh ginger. Said invention also provides its preparation method and concrete steps.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition for the treatment of asthma and preparation method thereof.
Background technology
Bronchial asthma (bronchial asthma) is because anaphylaxis or other factors cause the bronchus diffuse spasm, a kind of chronic disease that ictal classical symptoms such as expiratory dyspnea with wheezing sound occur also can be considered a kind of specific type of chronic obstructive bronchitis.Asthma is the complexity disease of serious harm each age group population health, and there are nearly 2,000 ten thousand asthmatic patients in China.Therefore, the medicine of development prevention and treatment asthma is significant.
(β-AR) agonist is a principal agent of preventing and treating asthma at present, but the two has side effect clinically for non-specific anti-inflammatory agent glucocorticoid (GC) and adrenoreceptor.By comparison, Chinese medicine has a long history on treatment asthma, has also accumulated rich experience.Asthma is one of disease kind that embodies the Chinese medicine advantage.
Summary of the invention
The Chinese medicine composition of treatment cough with asthma of the present invention, this pharmaceutical composition comprises (weight ratio):
Herba Ephedrae 5-30 part Rhizoma Corydalis 5-30 part Semen Sinapis Albae 5-30 part,
Semen Armeniacae Amarum 5-30 part Rhizoma Zingiberis Recens is formed 5-30 part
Be preferably:
Herba Ephedrae 5-15 part Rhizoma Corydalis 5-15 part Semen Sinapis Albae 5-15 part
Semen Armeniacae Amarum 5-15 part Rhizoma Zingiberis Recens is formed 5-20 part.
More preferably:
10 parts of 10 parts of Semen Sinapis Albaes of 10 parts of Rhizoma Corydalis of Herba Ephedrae
10 parts in 10 portions of Rhizoma Zingiberis Recenss of Semen Armeniacae Amarum
This preparation of drug combination method is as follows:
Herba Ephedrae, Rhizoma Corydalis, Semen Sinapis Albae, Semen Armeniacae Amarum are ground into coarse powder, water or aquiferous ethanol extract, filter, concentrate, with the ethanol precipitation of 50-80%, the filtering precipitation, supernatant concentration becomes 1.2-1.5 (40-80 ℃), be preferably the clear paste of 1.2-1.3 (40-80 ℃), Rhizoma Zingiberis Recens is squeezed the juice, and mixes with clear paste, gets extractum.Gained extractum includes (weight ratio) through high effective liquid chromatography for measuring:
Ephedrine 5-200 part pseudoephedrine 2-500 part tetrahydropalmatine 1-180 part
The plain 1-200 part of Rhizoma Corydalis first sinalbin 0.01-150 part amygdaloside 10-500 part
Sinapic acid choline ester. 0.01-230 part zingiberol 0.1-100 part zingiberene 0.2-150 part.
Be preferably:
Ephedrine 50-150 part pseudoephedrine 50-350 part tetrahydropalmatine 10-80 part
The plain 10-100 part of Rhizoma Corydalis first sinalbin 5-100 part amygdaloside 50-400 part
Sinapic acid choline ester. 1-70 part zingiberol 1-50 part zingiberene 2-50 part
More preferably:
300 parts of 5 parts of amygdalosides of 100 parts of tetrahydropalmatines of ephedrine
5 parts of 5 parts of zingiberols of sinapic acid choline ester.
Gained extractum is added the pharmacy acceptable auxiliary,, make respectively by the galenic pharmacy technological requirement and make oral formulations, ejection preparation and external use plaster according to the specification requirement of galenic pharmacy.
Oral formulations is selected from tablet, capsule, granule, pill, powder, drop pill, syrup, mixture, distillate medicinal water, or the sustained-release preparation of tablet, capsule, granule, pill, powder, drop pill.
Injection is selected from aqueous injection and intravenous injection.
External use plaster is selected from crust cloth cream, rubber cream, black plaster.
Pharmaceutical composition pharmacodynamic experiment method of the present invention and result are as follows:
Modern medicine thinks that asthma is a kind of syndrome, it is characterized by in various degree airway obstruction and air flue hyperreaction, and is the syndrome group by the breathing that airway inflammation causes.Most scholars think that it is a kind of chronic eosinophilic granulocyte's property bronchitis, be by T cell-mediated based on mastocyte and oxyphil cell, the bronchial mucosa chronic inflammatory disease that multiple-cell participates in is a kind of anaphylaxis of tardy property air flue.So the treatment of asthma emphasis has been changed into by simple controlling symptoms and has alleviated or suppresses airway inflammation, reduces airway reactivity and prevention of asthma and shows effect.Nonspecific inflammation is the important pathologic basis of bronchial asthma in a word, suppresses the activation of inflammatory cell and the release of inflammatory mediator.
It is method commonly used both at home and abroad at present that ovalbumin excites the Cavia porcellus asthma attack, and its method is simple, and it is more directly perceived to examine index.Reproducibility is strong, and Cavia porcellus is the feature animal of best demonstration airway hyper-reaction type, and its asthma attack is similar to people's performance.
The present invention adopts ovalbumin to excite Cavia porcellus and rat asthmatic model model, and to the antiasthmatic effect of described pharmaceutical composition, to influence of Pulmonary Function, and the effect of the release of the activation of inhibition inflammatory cell and inflammatory mediator is studied.
Experiment uses Cavia porcellus in the 0th day, the 7th day respectively at both sides thigh outside intramuscular injection 4% ovalbumin normal saline solution 0.1～0.2ml, while lumbar injection 4% gel aluminum hydroxide 0.2ml, sensitized animal, from sensitization second day, animal is divided into the large, medium and small dosage group of pharmaceutical composition, positive controls, model group and blank group at random.
The large, medium and small dosage group of pharmaceutical composition day dosage is respectively 4,8,16 times of Coming-of-Age Day dosage, is 3.0g/kg, 6.0g/kg, 12.0g/kg crude drug amount.Positive controls gives dexamethasone (1mg/kg/d), every 0.75mg (Tianjin Lisheng Pharmaceutical Co., Ltd.).Model group is given blank substrate, and blank group is given normal saline.Played oral administration on the 10th day.
Played administration after 1 hour on the 14th day, and placed Cavia porcellus to place in the airtight container of 4L (self-control) Cavia porcellus, excite with 1% ovalbumin normal saline constant-pressure atomization, the atomizing flow is 3ml/min; Spray 15～20s after stopping to spray, observes and writes down drawing of the interior Cavia porcellus of 6min and breathe heavily incubation period and the number of animals that tic is fallen, continuous seven days take place.(second and third time bring out before, every guinea pig intraperitoneal injection 5mg/kg diphenhydramine).
Experimental result shows (table 1), compares with model group, positive group, and there were significant differences for the MJ small dose group (P＜0.05)
*, the dosage group has utmost point significant difference (P＜0.01) among the MJ
*, the no significant difference of the heavy dose of group of MJ shows small dose group and middle dosage group obvious prolonged guinea pig asthma incubation period, and demonstrates dose-effect relationship, illustrates that pharmaceutical composition of the present invention has stronger antiasthmatic effect, and acts on and be better than positive drug.
This pharmaceutical composition of table 1 is to the preclinical influence of Cavia porcellus asthma
| Group | N | Dosage (g/kg) | Draw and breathe heavily incubation period (s) |
| The heavy dose of group of dosage group in the positive group of the blank group model group small dose group | 10 10 10 10 10 10 | - - 1 6 12 24 | 0 65.00±50.751 112.67±36.547 * 113.60±73.918 * 133.09±52.363 ** 95.50±58.614 |
The experimental rat same guinea pig model that divides into groups, in 1,2,3,4,5,8,9,10,11,12 days respectively lumbar injection antigen liquid 1ml (every ml contains 100mgOVA, 100mgAl (OH)
3) sensitization, the 12nd day large, medium and small three the dosage group gastric infusions of this pharmaceutical composition, 15d plays administration and after 1 hour rat is placed in the 4L bell jar, feeds 1% egg protein normal saline with the pressurization nebulizer and excites 30min, continuous 14 days.Positive controls: the rat modeling played the filling stomach on the 12nd day and gives dexamethasone (1mg/kg/d).Be made into the 0.1mg/ml normal saline.The asthmatic model group was irritated stomach on the 12nd day and is given normal saline.Blank group gives the normal saline lumbar injection, irritates stomach and sucks normal saline in atomizing in the 15th day.
Each group rats by intraperitoneal injection 12% urethane (2ml/100g) is made rat anesthesia, and air flue cuts and inserts Y type tracheal intubation.The Y-piece two ends are connected with flow velocity, pressure transducer respectively, and the corresponding end of flow sensor is connected with animal respirator.Tidal volume 10ml/kg is set, respiratory frequency 80 times/minute.Pressure, flow sensor are connected with powerlab data record analytical system respectively, measure FVC (forced vital capacity), Fev (0.2 second exhalation volume), PEF (maximum expiratory gas volume), lung function index such as Fev/FVC.
Experimental result shows, FVC (forced vital capacity), Fev (0.2 second exhalation volume), PEF (maximum expiratory gas volume), lung function index such as Fev/FVC are compared with model group, the positive is organized, there were significant differences for the big-and-middle small dose group of this pharmaceutical composition (P＜0.05), illustrates that this pharmaceutical composition of the present invention can obviously improve the pulmonary function of rat.
The present invention has also carried out other pharmacological experiments proves that this pharmaceutical composition can suppress the activation of inflammatory cell and the release of inflammatory mediator.In a word, this pharmaceutical composition energy relieving asthma symptoms is postponed or is reduced asthma and recurs, and shortens the asthma attack phase, and therefore, this pharmaceutical composition is prevented by asthma and treatment has definite curative effect.
The specific embodiment
Embodiment 1
With Semen Sinapis Albae 10g fragmentation, Herba Ephedrae 10g, Semen Armeniacae Amarum 10g, Rhizoma Corydalis powder 10g are broken into coarse powder, with 90% alcohol reflux three times, add 4 times of amounts of ethanol for the first time, extracted 2 hours, second and third time adds 8 times of amounts of 90% ethanol, and each extracted 1 hour, left standstill, filter, merging filtrate reclaims ethanol, and it is the clear paste of 1.30～1.40 (40 ℃) that concentrating under reduced pressure becomes relative density.Rhizoma Zingiberis Recens is squeezed the juice, and with the two mix homogeneously, gets extractum.Gained extractum includes 100 parts of (weight ratio) ephedrines, 5 parts of tetrahydropalmatines, 300 parts of amygdalosides, 5 parts of sinapic acid choline ester .s, 5 parts of zingiberols through high effective liquid chromatography for measuring.
Gained extractum is added the pharmacy acceptable auxiliary,, make tablet according to the specification requirement of tablet on the galenic pharmacy.Carry out zoopery by institute's pharmacodynamic experiment method, dosage is equivalent to 16g crude drug/kg.Excite the experiment of Cavia porcellus and rat animal model in asthma through ovalbumin, the result shows that institute's tablet has tangible antiasthmatic effect, and the lung function index of rat also tool is improved significantly, and also can significantly suppress the activation of inflammatory cell and the release of inflammatory mediator.
Embodiment 2
With Semen Sinapis Albae 15g fragmentation, Herba Ephedrae 20g, Semen Armeniacae Amarum 20g, Rhizoma Corydalis powder 15g are broken into coarse powder, with 70% alcohol reflux three times, add 10 times of amounts of ethanol for the first time, extracted 3 hours, second and third time adds 10 times of amounts of 70% ethanol, and each extracted 1.5 hours, left standstill, filter, merging filtrate reclaims ethanol, the clear paste that concentrating under reduced pressure becomes.Rhizoma Zingiberis Recens 20 g squeeze the juice, and with the two mix homogeneously, get extractum.Gained extractum includes 200 parts of (weight ratio) ephedrines, 10 parts of tetrahydropalmatines, 600 parts of amygdalosides, 7.5 parts of sinapic acid choline ester .s, 10 parts of zingiberols through high effective liquid chromatography for measuring.
Gained extractum is added the pharmacy acceptable auxiliary,, make capsule according to the specification requirement of tablet on the galenic pharmacy.Carry out zoopery by institute's pharmacodynamic experiment method, dosage is equivalent to 16g crude drug/kg.Excite the experiment of Cavia porcellus and rat animal model in asthma through ovalbumin, the result shows that institute's capsule has tangible antiasthmatic effect, and the lung function index of rat also tool is improved significantly, and also can significantly suppress the activation of inflammatory cell and the release of inflammatory mediator.
Embodiment 3
With Semen Sinapis Albae 5g fragmentation, Herba Ephedrae 5g, Semen Armeniacae Amarum 5g, Rhizoma Corydalis powder 10g are broken into coarse powder, with 60% alcohol reflux three times, add 10 times of amounts of ethanol for the first time, extracted 1 hour, second and third time adds 10 times of amounts of 60% ethanol, and each extracted 1 hour, left standstill, filter, merging filtrate reclaims ethanol, the clear paste that concentrating under reduced pressure becomes.Rhizoma Zingiberis Recens 20g squeezes the juice, and with the two mix homogeneously, gets extractum.Gained extractum includes (weight ratio) ephedrine 50,5 parts of tetrahydropalmatines, 150 parts of amygdalosides, 2.5 parts of sinapic acid choline ester .s, 10 parts of zingiberols through high effective liquid chromatography for measuring.
Gained extractum is added the pharmacy acceptable auxiliary,, make granule according to the specification requirement of granule on the galenic pharmacy.Carry out zoopery by institute's pharmacodynamic experiment method, dosage is equivalent to 16g crude drug/kg.Excite Cavia porcellus and the experiment of rat animal model in asthma through ovalbumin, the result shows that the gained granule has tangible antiasthmatic effect, the lung function index of rat also tool is improved significantly, also can significantly suppress the activation of inflammatory cell and the release of inflammatory mediator.
Embodiment 4
With Semen Sinapis Albae 8g fragmentation, Herba Ephedrae 5g, Semen Armeniacae Amarum 10g, Rhizoma Corydalis powder 15g are broken into coarse powder, with 50% alcohol reflux three times, add 10 times of amounts of ethanol for the first time, extracted 1 hour, second and third time adds 10 times of amounts of 50% ethanol, and each extracted 2 hours, left standstill, filter, merging filtrate reclaims ethanol, the clear paste that concentrating under reduced pressure becomes.Rhizoma Zingiberis Recens 20g squeezes the juice, and with the two mix homogeneously, gets extractum.Gained extractum includes (weight ratio) ephedrine 50,7.5 parts of tetrahydropalmatines, 300 parts of amygdalosides, 4 parts of sinapic acid choline ester .s, 10 parts of zingiberols through high effective liquid chromatography for measuring.
Gained extractum is added the pharmacy acceptable auxiliary,, make emplastrum according to the specification requirement of emplastrum on the galenic pharmacy.Carry out zoopery by institute's pharmacodynamic experiment method, dosage is equivalent to 16g crude drug/kg.Excite the experiment of Cavia porcellus and rat animal model in asthma through ovalbumin, the result shows that the gained plaster has tangible antiasthmatic effect, and the lung function index of rat also tool is improved significantly, and also can significantly suppress the activation of inflammatory cell and the release of inflammatory mediator.
Embodiment 5
With Semen Sinapis Albae 7g fragmentation, Herba Ephedrae 8g, Semen Armeniacae Amarum 12g, Rhizoma Corydalis powder 5g are broken into coarse powder, with 75% alcohol reflux three times, add 12 times of amounts of ethanol for the first time, extracted 1 hour, second and third time adds 10 times of amounts of 50% ethanol, and each extracted 2 hours, left standstill, filter, merging filtrate reclaims ethanol, the clear paste that concentrating under reduced pressure becomes.Rhizoma Zingiberis Recens 20g squeezes the juice, and with the two mix homogeneously, gets extractum.Gained extractum includes 80 parts of (weight ratio) ephedrines, 50 parts of pseudoephedrinees, 5 parts of tetrahydropalmatines, plain 7 parts of Rhizoma Corydalis first, 210 parts of amygdalosides, 3.5 parts of sinapic acid choline ester .s, 10 parts of zingiberols, 10 parts of zingiberols through high effective liquid chromatography for measuring.
Gained extractum is added the pharmacy acceptable auxiliary,, make injection according to the specification requirement of injecting on the galenic pharmacy.Carry out zoopery by institute's pharmacodynamic experiment method, dosage is equivalent to 16g crude drug/kg.Excite Cavia porcellus and the experiment of rat animal model in asthma through ovalbumin, the result shows that the gained injection has tangible antiasthmatic effect, the lung function index of rat also tool is improved significantly, also can significantly suppress the activation of inflammatory cell and the release of inflammatory mediator.
Claims (10)
1, a kind of Chinese medicine composition for the treatment of asthma is characterized in that the parts by weight of ingredient are:
Herba Ephedrae 5-30 part Rhizoma Corydalis 5-30 part Semen Sinapis Albae 5-30 part Semen Armeniacae Amarum 5-30 part Rhizoma Zingiberis Recens is formed 5-30 part.
2, Chinese medicine composition according to claim 1 is characterized in that the ingredient parts by weight are:
Herba Ephedrae 5-15 part Rhizoma Corydalis 5-15 part Semen Sinapis Albae 5-15 part
Semen Armeniacae Amarum 5-15 part Rhizoma Zingiberis Recens is formed 5-20 part.
3, Chinese medicine composition according to claim 1 is characterized in that the ingredient parts by weight are:
10 parts of 10 parts of Semen Sinapis Albaes of 10 parts of Rhizoma Corydalis of Herba Ephedrae
10 parts in 10 portions of Rhizoma Zingiberis Recenss of Semen Armeniacae Amarum.
4, according to the described arbitrary Chinese medicine composition of claim 1-4, it is characterized in that active constituents of medicine be meant Herba Ephedrae, Rhizoma Corydalis,
The water of Semen Sinapis Albae, Semen Armeniacae Amarum, Rhizoma Zingiberis Recens or the extract of aquiferous ethanol.
5, according to the described arbitrary Chinese medicine composition of claim 1-5, oral formulations, ejection preparation and external use plaster that this pharmaceutical composition is made.
6, Chinese medicine composition according to claim 5, it is characterized in that oral formulations is selected from tablet, capsule, granule, pill, powder, drop pill, syrup, mixture, distillate medicinal water, or the sustained-release preparation of tablet, capsule, granule, pill, powder, drop pill.External use plaster is selected from crust cloth cream, rubber cream, black plaster.
7, a kind of method for preparing the described Chinese medicine composition of claim 1-6, comprise the steps: Herba Ephedrae, Rhizoma Corydalis, Semen Sinapis Albae, Semen Armeniacae Amarum are ground into coarse powder, water or aquiferous ethanol extract, filter, concentrate, ethanol precipitation with 50-80%, the filtering precipitation, supernatant concentration becomes 1.2-1.5 (40-80 ℃), be preferably the clear paste of 1.2-1.3 (40-80 ℃), Rhizoma Zingiberis Recens is squeezed the juice, and mixes with clear paste, gets extractum, add the pharmacy acceptable auxiliary, prepare oral formulations, ejection preparation and external use plaster preparation according to conventional formulation method.
8, method according to claim 7 is characterized in that described extractum Chinese medicine active component includes (weight ratio):
Ephedrine 5-100 part pseudoephedrine 2-500 part tetrahydropalmatine 1-180 part
The plain 1-200 part of Rhizoma Corydalis first sinalbin 0.01-150 part amygdaloside 10-500 part
Sinapic acid choline ester. 0.01-230 part zingiberol 0.1-100 part zingiberene 0.2-150 part.
9, method according to claim 7 is characterized in that described extractum Chinese medicine active component includes (weight ratio):
Ephedrine 50-150 part pseudoephedrine 50-350 part tetrahydropalmatine 10-80 part
The plain 10-100 part of Rhizoma Corydalis first sinalbin 5-100 part amygdaloside 50-400 part
Sinapic acid choline ester. 1-70 part zingiberol 1-50 part zingiberene 2-50 part.
10, method according to claim 7 is characterized in that described extractum Chinese medicine active component includes (weight ratio):
300 parts of 5 parts of amygdalosides of 100 parts of tetrahydropalmatines of ephedrine
5 parts of 5 parts of zingiberols of sinapic acid choline ester..
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| CN 200610086866 CN101091787A (en) | 2006-06-22 | 2006-06-22 | Composition of Chinese traditional medicine for treating asthma, preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105287539A (en) * | 2015-11-12 | 2016-02-03 | 江苏康缘药业股份有限公司 | Novel application of corydaline |
| CN116173170A (en) * | 2023-02-22 | 2023-05-30 | 河北一品制药股份有限公司 | A pharmaceutical composition for treating respiratory diseases, and its preparation method |
-
2006
- 2006-06-22 CN CN 200610086866 patent/CN101091787A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105287539A (en) * | 2015-11-12 | 2016-02-03 | 江苏康缘药业股份有限公司 | Novel application of corydaline |
| CN116173170A (en) * | 2023-02-22 | 2023-05-30 | 河北一品制药股份有限公司 | A pharmaceutical composition for treating respiratory diseases, and its preparation method |
| CN116173170B (en) * | 2023-02-22 | 2023-11-24 | 河北一品制药股份有限公司 | A pharmaceutical composition for treating respiratory diseases, and its preparation method |
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Open date: 20071226 |