CN101940704A - Compound combination medicament for treating asthma and preparation method thereof - Google Patents
Compound combination medicament for treating asthma and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a compound combination medicament for treating asthma and a preparation method thereof. The compound combination medicament comprises the following components in part by weight: 10 to 60 parts of blackberrykiky rhizome, 20 to 50 parts of prepared ephedra herb, 40 to 100 parts of snakegourd fruit, 15 to 60 parts of longstamen onion bulb (fried), 10 to 60 parts of stiff silkworm (fried), 20 to 60 parts of white paeony root (fried), 10 to 100 parts of pepperweed seed, 5 to 70 parts of prepared liquoric root, 15 to 120 parts of earthworm, 10 to 110 parts of common cnidium fruit, 10 to 150 parts of clam shell, 10 to 60 parts of bitter almond kernel, 5 to 160 parts of anisetree bark, 40 to 200 parts of kadsura pepper stem, 10 to 100 parts of peach seed and 10 to 60 parts of baical skullcap root. The compound combination medicament of the invention is used for treating chronic asthma, gurgling with sputum in throat, chest distress, breathing obstruction, shortness of breath, coughing, white phlegm asthma or phlegm-heat type asthma, and has the characteristics of good and thorough curative effect, short treatment course and no side effect and the like. The compound combination medicament can be prepared into mixtures, tablets, capsules, micropills and the like to facilitate carrying and administration.
Description
Technical field
The present invention relates to a kind of compound composite medicament, be specifically related to a kind of with the prepared slices of Chinese crude drugs be raw material make be used for the treatment of compound composite medicament of bronchial asthma and preparation method thereof.
Background technology
Asthma is universally acknowledged difficult medical problem, does not still have the radical cure method so far, is classified as one of four big pertinacious diseases in the disease by World Health Organization (WHO), and China has 2,000 ten thousand above asthmatic patients at least.It is by the various kinds of cell chronic airway inflammation that participates in of mastocyte, eosinophilic granulocyte and T lymphocyte particularly; This kind inflammation can cause repeatedly symptoms such as the panting of outbreak, tachypnea, uncomfortable in chest and cough in the susceptible person, how to take place at night or morning.Treatment of asthma is improved mobility and quality of life with controlling symptoms (comprising the symptom at night) as far as possible, and making pulmonary function is target near optimum state.
The Western medicine of treatment asthma has bronchodilatation medicine and anti-inflammatory drug at present, and the bronchodilatation medicated bag is drawn together β2Ji Dongji, theophylline class and anticholinergic agent, and anti-inflammatory drug commonly used is glucocorticoid and chromone class medicine and the leukotrienes regulator etc. that suck.The Western medicine hormone has inevitable side effect, and theophylline and β2Ji Dongji, anticholinergic agent also have side effect such as its in various degree digestive system, nervous system, and inconvenience is used for a long time.Mainly control its outbreak at this onste Chinese medicine from the treatment of aspects such as asthma of cold-type, asthma of heat type, anemophlegmatic asthma, asthma of cold-type is used belamcanda mahuangtang, the treatment of XIAOQINGLONG TANG plus-minus always, sanzi yangqin decoction, the treatment of ERCHEN TANG plus-minus are used in the treatment of asthma of heat type " a thousand pieces of gold " DINGCHUAN TANG plus-minus commonly used, anemophlegmatic asthma always.There is defective at present in Chinese medical discrimination, and asthma of cold-type, asthma of heat type are not many genus asthma witnesses, and anemophlegmatic asthma is comparatively common, but its side's correspondence and effect are relatively poor, can not promote the use.
Summary of the invention
Goal of the invention: at the deficiencies in the prior art, the purpose of this invention is to provide a kind of compound composite medicament for the treatment of asthma, to realize effectively treating asthma disease.Another object of the present invention provides a kind of preparation method of above-mentioned compound composite medicament.
Technical scheme: in order to realize the foregoing invention purpose, the technical solution used in the present invention is as follows:
A kind of compound composite medicament for the treatment of asthma, it is that raw material is made by 16 kinds of prepared slices of Chinese crude drugs, is respectively: Rhizoma Belamcandae, Herba Ephedrae (processed), Fructus Trichosanthis, Bulbus Allii Macrostemonis, Bombyx Batryticatus, the Radix Paeoniae Alba, Semen Lepidii (Semen Descurainiae), Radix Glycyrrhizae Preparata, Pheretima, Fructus Cnidii, Concha Meretricis Seu Cyclinae, Semen Armeniacae Amarum, Cortex Illicii, Caulis Piperis Kadsurae, Semen Persicae and Radix Scutellariae.
Traditional Chinese compound medicine preparation method of the present invention is simple, take after can directly will the ten Six-element prepared slices of Chinese crude drugs decocting by traditional method, and in order to obtain better efficacy and to be more conducive to be prepared into the modern medicines dosage form, the preferred drug ratio of the present invention is as follows:
Rhizoma Belamcandae 10～60 weight portions, Herba Ephedrae (processed) 20～50 weight portions, Fructus Trichosanthis 40～100 weight portions, Bulbus Allii Macrostemonis (stir-fry) 15～60 weight portions, Bombyx Batryticatus (stir-fry) 10～60 weight portions, the Radix Paeoniae Alba (stir-fry) 20～60 weight portions, Semen Lepidii (Semen Descurainiae) 10～100 weight portions, Radix Glycyrrhizae Preparata 5～70 weight portions, Pheretima 15～120 weight portions, Fructus Cnidii 10～110 weight portions, Concha Meretricis Seu Cyclinae 10～150 weight portions, Semen Armeniacae Amarum 10～60 weight portions, Cortex Illicii 5～160 weight portions, Caulis Piperis Kadsurae 40～200 weight portions, Semen Persicae 10～100 weight portions, Radix Scutellariae 10～60 weight portions.
Preferred manufacturing procedure is: add doubly (being equivalent to the prescription weight ratio) water of 5-15, soaked 10～60 minutes, decoct 1～4 time, each 1～3 hour, filter merging filtrate, filtrate decompression is concentrated into relative density 1.05～1.25g/ml(60 ℃) extractum, adding ethanol to the alcohol amount of containing is 60%～90%, leaves standstill 24 hours, get supernatant, recovery ethanol adds water to an amount of to not having the alcohol flavor and being concentrated in right amount, stir evenly, packing, sterilization, promptly.
Can obtain the medicine of liquid by above-mentioned preparation method,, then can add pharmaceutic adjuvant, become solid dosage formss such as tablet, capsule, micropill as mixing such as starch, dextrin back refabrication if be prepared into solid preparation.
Traditional Chinese compound medicine of the present invention is through clinical verification for many years, has dispelling pathogenic wind and eliminating phlegm, opens lung and let out effect turbid, lowering the adverse QI to relieve asthma.Cure mainly asthma and send out for a long time, wheezing sound in the throat, chest distress, the sticking in vain turbid or phlegm-heat type asthma of expectorant that waits of asthma cough and spit, expectorant color.
Beneficial effect: the compound composite medicament of treatment asthma of the present invention, have good effect, short treating period, curative effect thoroughly, characteristics such as have no side effect.The preparation method of the compound composite medicament of treatment asthma, simple quick, efficient, easy operating.The mixture of preparing, tablet, capsule, micropill etc. are easy to carry, and conveniently take.
The specific embodiment
The present invention will be further explained below in conjunction with specific embodiment.
Embodiment 1
A kind of compound composite medicament for the treatment of asthma, each component that comprises following parts by weight: 40 parts of Rhizoma Belamcandae, 50 parts of Herba Ephedrae (processed), 90 parts of Fructus Trichosanthis, 50 parts of Bulbus Allii Macrostemonis (stir-fry), 60 parts of Bombyx Batryticatus (stir-fry), 50 parts of the Radix Paeoniae Albas (stir-fry), 90 parts of Semen Lepidii (Semen Descurainiae)s, 30 parts of Radix Glycyrrhizae Preparatas, 100 parts of Pheretimas, 90 parts of Fructus Cnidiis, 150 parts of Concha Meretricis Seu Cyclinaes, 50 parts of Semen Armeniacae Amarums, 50 parts of Cortex Illiciis, 50 parts of Caulis Piperis Kadsuraes, 100 parts in Semen Persicae, 30 parts of Radix Scutellariaes, totally ten Six-element medicines.
Take by weighing above ten Six-element medicines by weight, add 5 times of water logging bubbles 60 minutes, decoct 3 times, each 2 hours, filter merging filtrate, filtrate decompression is concentrated into relative density 1.05g/ml(60 ℃) extractum, adding ethanol to the alcohol amount of containing is 70%, leaves standstill 24 hours, get supernatant, recovery ethanol adds water to 5000mL to not having the alcohol flavor and being concentrated in right amount, stir evenly, packing, flowing steam sterilization 35min, promptly.
Embodiment 2
A kind of compound composite medicament for the treatment of asthma, each component that comprises following parts by weight: 20 parts of Rhizoma Belamcandae, 35 parts of Herba Ephedrae (processed), 50 parts of Fructus Trichosanthis, 20 parts of Bulbus Allii Macrostemonis (stir-fry), 50 parts of Bombyx Batryticatus (stir-fry), 40 parts of the Radix Paeoniae Albas (stir-fry), 90 parts of Semen Lepidii (Semen Descurainiae)s, 50 parts of Radix Glycyrrhizae Preparatas, 50 parts of Pheretimas, 50 parts of Fructus Cnidiis, 100 parts of Concha Meretricis Seu Cyclinaes, 60 parts of Semen Armeniacae Amarums, 60 parts of Cortex Illiciis, 100 parts of Caulis Piperis Kadsuraes, 60 parts in Semen Persicae, 50 parts of Radix Scutellariaes, totally ten Six-element medicines.
Take by weighing above ten Six-element medicines by weight, add 8 times of water logging bubbles 30 minutes, decocted 3 hours, filter, filtrate decompression is concentrated into relative density 1.15 g/ml(60 ℃) extractum, adding ethanol to the alcohol amount of containing is 80%, leaves standstill 24 hours, get supernatant, reclaim ethanol to not having the alcohol flavor and concentrating and continue to be concentrated into the about 1.20 g/ml(80 ℃ survey of relative density), vacuum drying is granulated, tabletting promptly gets tablet.
Embodiment 3
A kind of compound composite medicament for the treatment of asthma, each component that comprises following parts by weight: 50 parts of Rhizoma Belamcandae, 45 parts of Herba Ephedrae (processed), 100 parts of Fructus Trichosanthis, 50 parts of Bulbus Allii Macrostemonis (stir-fry), 50 parts of Bombyx Batryticatus (stir-fry), 60 parts of the Radix Paeoniae Albas (stir-fry), 100 parts of Semen Lepidii (Semen Descurainiae)s, 50 parts of Radix Glycyrrhizae Preparatas, 100 parts of Pheretimas, 100 parts of Fructus Cnidiis, 100 parts of Concha Meretricis Seu Cyclinaes, 50 parts of Semen Armeniacae Amarums, 150 parts of Cortex Illiciis, 150 parts of Caulis Piperis Kadsuraes, 60 parts in Semen Persicae, 50 parts of Radix Scutellariaes, totally ten Six-element medicines.
Take by weighing above ten Six-element medicines by weight, add 15 times of water gagings and soaked 45 minutes, decoct 2 times, each 1 hour, filter merging filtrate, filtrate decompression is concentrated into relative density 1.10 g/ml(60 ℃) extractum, adding ethanol to the alcohol amount of containing is 60%, leaves standstill 24 hours, get supernatant, recovery ethanol adds water to 1000mL to not having the alcohol flavor and being concentrated in right amount, stir evenly, packing, flowing steam sterilization 45min, promptly.
Embodiment 4
A kind of compound composite medicament for the treatment of asthma, each component that comprises following parts by weight: 60 parts of Rhizoma Belamcandae, 30 parts of Herba Ephedrae (processed), 80 parts of Fructus Trichosanthis, 30 parts of Bulbus Allii Macrostemonis (stir-fry), 40 parts of Bombyx Batryticatus (stir-fry), 50 parts of the Radix Paeoniae Albas (stir-fry), 65 parts of Semen Lepidii (Semen Descurainiae)s, 50 parts of Radix Glycyrrhizae Preparatas, 90 parts of Pheretimas, 110 parts of Fructus Cnidiis, 100 parts of Concha Meretricis Seu Cyclinaes, 50 parts of Semen Armeniacae Amarums, 100 parts of Cortex Illiciis, 100 parts of Caulis Piperis Kadsuraes, 50 parts in Semen Persicae, 50 parts of Radix Scutellariaes, totally ten Six-element medicines.
Take by weighing above ten Six-element medicines by weight, add 10 times of water gagings and soaked 25 minutes, decoct 2 times, each 1.5 hours, filter merging filtrate, filtrate decompression is concentrated into relative density 1.20 g/ml(60 ℃) extractum, adding ethanol is 90% to containing the alcohol amount, leaves standstill 24 hours, gets supernatant, reclaim ethanol to not having the alcohol flavor and continuing to be concentrated into the about 1.20 g/ml(80 ℃ survey of relative density), add an amount of dextrin, granulate, promptly get granule.
Embodiment 5
Choose the compound composite medicament of the foregoing description preparation wantonly, carry out the pharmacological evaluation of traditional Chinese compound medicine
Adopt the egg albumen sensitization method to set up guinea pig asthmatic model, do the medicine contrast with dexamethasone, luring of each group of record breathed heavily incubation period after one week of treatment, by the degree of histopathological examination and bronchoalveolar lavage fluid (BALF) inflammatory cell counting and classification understanding air flue inflammatory infiltration, the T lymphocyte adopts flow cytometer quantitative detecting method (FITC-Annexin V/PI staining and PI single stain) to measure its apoptosis rate in the separation BALF liquid.The result shows: luring that compound composite medicament of the present invention can the significant prolongation asthmatic guinea pigs breathe heavily incubation period, alleviate airway inflammation, promote the lymphocytic apoptosis of T among the BALF, and effect and dexamethasone be (P〉0.05) quite.Each is organized, and the airway tissue inflammatory reaction alleviates degree and T Lymphocyte Apoptosis rate has dependency.
Embodiment 6
The compound composite medicament of optional the foregoing description preparation carries out the clinical trial of traditional Chinese compound medicine
According to parallel, at random, controlled trial (RCT) design, matched group (routine of western medicine treatment: Pumi's gram and Bricasol are inhaled in spray) is set up in strictness, observes the clinical efficacy that adds with the compound composite medicament of the treatment asthma of embodiment 1 ~ 4 preparation.
One, case is selected:
1 diagnostic criteria
The Western medicine diagnose standard
(1) in the bronchial asthma diagnostic criteria " the clinical research guideline of Chinese medicine (new drug) treatment bronchial asthma " announced with reference to health ministry bureau of drug administration 1993 " diagnostic criteria and Chinese Medical Association's respiratory disease credit meeting asthma group--the prevention and control of bronchial asthma guide of acute bronchial asthma. the relevant criterion in the definition of bronchial asthma, diagnosis, treatment and education and the Managed Solution.
(2) relevant criterion in " Chinese medicine (new drug) the clinical research guideline " pant, cough, cough up phlegm, the state of an illness of wheezing sound symptom and sign and the degree criteria for classifying being formulated with reference to health ministry bureau of drug administration in 1993.
The tcm diagnosis standard
Wind-phlegm resistance lung card: asthma is done suddenly, and it is sound to stridulate, the dyspnea with rapid respiration fullness in the chest, and expectorating sticky sputum with difficulty in spitting, or be white foam expectorant, there is not obvious cold and heat tendency, onset is how anxious, often merges nose, pharynx, eye, ear and itches, and sneeze is had a stuffy nose watery nasal discharge, chest is suppressed plug, outbreak immediately thereupon, and tongue is dark red, and thin fur is sticky, stringy and rolling pulse.
With reference to " the clinical respiratory disease of Chinese and western medicine is learned " (China Traditional Chinese Medicine Publishing House, 1998) mesobronchus asthma " wind-phlegm hinders the lung card " and middle bronchial wheezing " wind-phlegm asthma " formulation of the new century whole nation high Chinese medicine universities and colleges' planning teaching materials " Chinese Internal Medicine " (China Traditional Chinese Medicine Publishing House, 2003).
2 test case standards
Include case in
All Western medicine diagnoses meet: the adult person (age is between 18-65) that light (the II level) of acute bronchial asthma, the asthmatic patient of moderate (III level) diagnostic criteria, Chinese medical discrimination belong to wind-phlegm resistance lung, can include the test case in.The slight diagnostic criteria that continues asthma (II level): symptom 〉=1 time weekly, but＜every day 1 time; Outbreak may influence activity and sleep; Night symptoms of asthma 2 times every month; PEF aberration rate 20% ~ 30%; FEV1.0 〉=80% predicted value; Moderate continues the diagnostic criteria of asthma (III level): symptom is arranged every day; Outbreak influences activity and sleep; Night symptoms of asthma 1 time weekly; Use fugitive beta 2 receptor agonist every day; The PEF aberration rate〉30%; FEV1.0〉60% ~ 80% predicted value.
Get rid of case (incompatible card of parcel and rejecting standard)
(1) severe asthma; (2) the bronchial asthma catabasis; (3) chronic pulmonary heart disease (cardiac functional decompensatory period); (4) the non-genus wind-phlegm resistance of Chinese medical discrimination lung person; (5) confirm by the tuberculosis fungus the chronic patient that pants due to the factors such as tumor on inspection; (6) be associated with cardiovascular, liver, serious primary disease such as kidney and hemopoietic system, psychotic; (7) age below 18 one full year of life or the over-65s person, anemia of pregnant woman or women breast-feeding their children; (8) all standards of including in that do not meet, not medication in accordance with regulations can't be judged not umbra sound curative effect judgement person of curative effect or data.
Statistical method: clinical data and data are imported computer after inspection and verification, measurement data mean ± standard deviation (
± SD represents), with many prescriptions difference analysis or t check.
Two, test method
1 group technology: this research adopt (RCT method) at random, controlled trial observes, the above-mentioned test case of including in is adopted the random pair group technology, on random table, find treatment group and matched group, and guarantee two groups of cases at aspects such as severity extent and sex, age, the courses of disease substantially near (statistical procedures, two groups of P relatively〉0.05).
2 total case loads are no less than 79 examples, and 37 examples are organized in treatment, matched group 42 examples.
3 Therapeutic Method
The treatment group: the compound composite medicament of the treatment asthma of utilization optional embodiment 1 preparation, oral medication, being produced by the applicant's preparation portion provides instructions about how to take medicine: each 50 milliliters, day clothes three times.
Matched group: Pumi restrain aerosol (spray is inhaled, 2 times/day, the 1-2 spray/time) and Bricasol (spray is inhaled, 2 times/day, 1-2 sprays/time).
The course of treatment: be for 2 weeks.
Observe case 79 examples altogether, wherein 42 examples are organized in treatment, male's 10 examples, and women 32 years old, the oldest 64, minimum 22, average 43.95, the course of disease is the longest by 40, and is the shortest by 0.5, average 8.58 years; Severity extent: I level 8 examples (accounting for 19.05%), II level 20 examples (accounting for 47.62%), III level 14 examples (accounting for 33.33%); Matched group 37 examples, male's 11 examples, women's 26 examples, the oldest 63, minimum 23, the mean age 42.87, the course of disease is the longest by 41, and is the shortest by 0.6, average 7.98 years; Severity extent: I level 7 examples (accounting for 18.92%), II level 18 examples (accounting for 48.65%), III level 12 examples (accounting for 32.43%); Two groups of ages, the course of disease, severity extent no significant difference (P〉0.05).
Two groups of curative effects: treatment group: clinic control 14 examples, produce effects 21 examples, effective 5 examples, invalid 2 examples, obvious effective rate is 83.33%, total effective rate is 95.24%; Matched group: clinic control 3 examples, produce effects 18 examples, effective 13 examples, invalid 3 examples, obvious effective rate 56.76%, effective percentage are 91.89%.Two groups of relatively there were significant differences (Ridit analysis) u=2.9215, R1:0.4109, R2:0.6011, P＜0.01.
Claims (6)
1. compound composite medicament for the treatment of asthma, it is characterized in that, comprise each component of following parts by weight: 10～60 parts of Rhizoma Belamcandae, 20～50 parts of Herba Ephedrae (processed), 40～100 parts of Fructus Trichosanthis, 15～60 parts of Bulbus Allii Macrostemonis (stir-fry), 10～60 parts of Bombyx Batryticatus (stir-fry), 20～60 parts of the Radix Paeoniae Albas (stir-fry), 10～100 parts of Semen Lepidii (Semen Descurainiae)s, 5～70 parts of Radix Glycyrrhizae Preparatas, 15～120 parts of Pheretimas, 10～110 parts of Fructus Cnidiis, 10～150 parts of Concha Meretricis Seu Cyclinaes, 10～60 parts of Semen Armeniacae Amarums, 5～160 parts of Cortex Illiciis, 40～200 parts of Caulis Piperis Kadsuraes, 10～100 parts in Semen Persicae, 10～60 parts of Radix Scutellariaes.
2. the compound composite medicament of treatment asthma according to claim 1 is characterized in that, the dosage form of described compound composite medicament comprises liquid preparation and solid preparation.
3. the compound composite medicament of treatment asthma according to claim 2 is characterized in that, described solid preparation comprises tablet, capsule and micropill.
4. a method for preparing the compound composite medicament of the described treatment asthma of claim 1 is characterized in that, comprises following process:
Take by weighing ten Six-element medicines by weight, add the water of 5～15 times of weight ratios, soaked 10～60 minutes, decoct 1～4 time, each 1～3 hour, filter, merging filtrate, filtrate decompression are concentrated into relative density 1.05～1.25(60 ℃) extractum, adding ethanol is 60%～90% to containing alcohol amount, left standstill 24 hours, and got supernatant, reclaim ethanol to not having the alcohol flavor and being concentrated into an amount of, add water in right amount, stir evenly packing, sterilization makes liquid medicine.
5. the method for the compound composite medicament of the described treatment asthma of preparation claim 1 according to claim 4 is characterized in that, in the liquid medicine that makes, after the adding common medicinal supplementary material was mixed, refabrication became tablet, capsule or micropill.
6. the compound composite medicament of the described treatment asthma of claim 1 is used for the treatment of application in the turbid or phlegm-heat type asthmatic medicament of expectorant in preparation.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102813794A (en) * | 2012-09-05 | 2012-12-12 | 江苏省中医院 | Compound traditional Chinese medicine combination for treating bronchial asthma and preparation method and application thereof |
| CN104644908A (en) * | 2015-01-31 | 2015-05-27 | 吉林大学 | Traditional Chinese medicine spray for treating asthma |
-
2010
- 2010-10-15 CN CN201010508810XA patent/CN101940704A/en active Pending
Non-Patent Citations (1)
| Title |
|---|
| 《中国博士学位论文全文数据库 医药卫生科技辑》 20040315 郝月琴 平哮合剂治疗支气管哮喘的临床及实验研究 E056-27 1-6 , 第1期 2 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102813794A (en) * | 2012-09-05 | 2012-12-12 | 江苏省中医院 | Compound traditional Chinese medicine combination for treating bronchial asthma and preparation method and application thereof |
| CN104644908A (en) * | 2015-01-31 | 2015-05-27 | 吉林大学 | Traditional Chinese medicine spray for treating asthma |
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Open date: 20110112 |