CN105106790A - Traditional Chinese medicine composition for treating bronchial asthma and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating bronchial asthma and preparation method thereof Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine composition for treating bronchial asthma. The traditional Chinese medicine composition comprises earthworm, Chinese magnoliavine fruit, tussilago farfara, platycodon grandiflorum, fagopyrum dibotrys, radix stemonae, radix ophiopogonis, white mulberry root bark, cynanchum glaucescens, radix asteris, cordate houttuynia, radix peucedani, ginkgo and ephedra. Compared with pure western medicine treatment, the traditional Chinese medicine composition has the advantages that bronchial asthma index can be well lowered, the clinical signs of a patient can be improved, further deterioration of the bronchial asthma can be prevented, and meanwhile, the traditional Chinese medicine composition is free of toxic and side effects and high in safety and comfortableness.
Description
Technical field
The present invention relates to technical field of Chinese medicine, particularly relate to a kind of Chinese medicine composition being used for the treatment of bronchial asthma and preparation method thereof.
Background technology
Bronchial asthma (be called for short asthma, asthma) is a kind of common chronic disease threatening public health in global range, and various countries' prevalence is not from 0.13% to 17% etc.And its M & M is in the trend risen gradually.Prevent and treat the statistics of agreement according to global asthma, the whole world has 1.6 hundred million people to suffer from this disease, and in many regional 10-20, the sickness rate of asthma adds 1 times.In many countries, no matter the financial burden for the treatment of asthma is in direct Medical Consumption, or Medical Consumption aspect is all quite heavy indirectly, makes the preventing and controlling of asthma be put the critical role of first developing in the Strategy for Health service Development of government.Asthma causes global concern day by day to the serious harm that the mankind cause.
Since the eighties, the research of medical science to asthma obtains very large progress.It is a kind of based on eosinophilic granulocyte (EOS) infiltration a large amount of in air flue for determining asthma, it is the auxiliary chronic alterative inflammation disease of air flue that mastocyte, lymphocyte and macrophage etc. infiltrate, with airway hyperreactivity and the airway pressure obstacle that causes thus for main clinical characteristics.In its pathogenetic adjustment, there is the participation of various lymphocyte and cytokine profiles, inflammation cell and inflammatory mediator; Think that delayed asthma reaction is the best model of laboratory research bronchial asthma.Clinical treatment establishes the primary Therapeutic Principle that anti-allergy inflammation treatment is asthma.Although the research of medical circle to asthma in recent years has made some progress, mechanism that asthma occurs and the asthmatic patient basic reason that increases and increase the weight of in recent years still can not be illustrated up to now completely.
Over nearly 20 years, actively seek the method for effectively preventing and treating asthma, be the problem of the tireless exploration of the world of medicine always, although new Therapeutic Method and medicine are constantly applied to clinical, effective means still lacked for the prognosis reducing the sickness rate of asthma, mortality rate and improve asthma.Domestic and international western medical treatment primary disease common drug has following a few class: inhaled glucocorticoids, beta 2 receptor agonist, anticholinergic agents inhalant, theophylline class, leukotriene antagonist, other inflammatory mediator antagonisies and cytokine antagonist, bone marrow eosinophilic granulocyte CFU-GM inhibitor and allergen specific immunization therapy and gene therapy.
Said medicine achieves certain effect in recent years clinically, main purpose remain alleviate bronchus outbreak time a series of inflammatory reaction and symptom.Still the minimizing seizure frequency breathing boundary personage common concern is not solved, the problem of the clinical long-term control state of an illness.Problems in asthmatic patient treatment simultaneously, as the course for the treatment of should be how long? when decrement? how decrement? when drug withdrawal? need to consider which kind of method or scheme more contribute to reaching the target of Control of asthma, more effective, safer to asthma patient, these had both annoying numerous clinicists, added difficulty also to the continued treatment of patient.Meanwhile, some toxic and side effects of Western medicine also seriously have impact on the continued treatment of patient.According to investigations, the asthma patient of China's nearly half does not obtain desirable control.In basic unit and rural area, most of asthma patient does not obtain effectively preventing.Therefore, that generally improves asthma prevents and treats level, shoulders heavy responsibilities.
Chinese medicine is to the understanding of asthma, and long history, rich connotation, and have development greatly, is gradually improved.The treatment of Chinese medicine to primary disease emphasizes identification of etiology according to differenciation of symptoms and signs, strengthening the body resistance, and the therapy of great attention to whole medical treatment, can make up with the advantage of its uniqueness the deficiency that Western medicine treats primary disease rightly.To rise year by year and modern medicine is also completely not clear to its pathogenesis in asthma prevalence, its control is also without today of ideal measure, and the Treatment study of TCM of asthma is subject to extensive concern and discussion.The compound Chinese medicinal preparation that existing market is used for Asthma in Remission Stage is the comparatively common of principle prescription mainly with strengthening spleen, tonifying kidney or nourishing lung and kidney greatly.At present from the Therapy study of asthma, main emphasis is placed on topical therapeutic, and thus still lack the effective treatment means regulated whole body, this is the direction of exploration in urgent need of strengthening and research.
Object of the present invention is exactly that existing Western medicine toxic and side effects in order to overcome for bronchial asthma is large, therapeutic effect is difficult to continue, and the deficiency that Chinese traditional treatment effect is undesirable, according to traditional Chinese medical science prescription and preparation principle, Chinese medicine composition is developed meticulously, the advantages such as one is pointed by force, good effect, the cycle is short, price is low, have no side effect are provided, patient can be made again to take like a shot, the pure Chinese medicinal preparation of the good nursing for treating bronchial asthma of energy.Each component collaborative onset mutually in side, and medicine is prepared simple, rapid-action, short treating period, is had good therapeutical effect to bronchial asthma.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of Chinese medicine composition being used for the treatment of bronchial asthma, and its more simple western medicine better can alleviate bronchial asthma, improves the clinical sign of patient, prevents bronchial asthma from worsening further.
For solving the problems of the technologies described above, the invention provides a kind of Chinese medicine composition being used for the treatment of bronchial asthma, its raw material components comprises Pheretima, Fructus Schisandrae Chinensis, Flos Farfarae, Radix Platycodonis, Rhizoma Fagopyri Dibotryis, the Radix Stemonae, Radix Ophiopogonis, Cortex Mori, Rhizoma Cynanchi Stauntonii, Radix Asteris, Herba Houttuyniae, Radix Peucedani, Semen Ginkgo, Radix Ginseng and Herba Ephedrae.
Wherein, in described Chinese medicine composition, the weight portion of each raw material components is respectively Pheretima 10-16 weight portion, Fructus Schisandrae Chinensis 8-14 weight portion, Flos Farfarae 6-12 weight portion, Radix Platycodonis 8-15 weight portion, Rhizoma Fagopyri Dibotryis 5-10 weight portion, Radix Stemonae 10-16 weight portion, Radix Ophiopogonis 9-18 weight portion, Cortex Mori 6-14 weight portion, Rhizoma Cynanchi Stauntonii 5-10 weight portion, Radix Asteris 6-12 weight portion, Herba Houttuyniae 8-18 weight portion, Radix Peucedani 8-14 weight portion, Semen Ginkgo 10-16 weight portion, Radix Ginseng 6-12 weight portion, Herba Ephedrae 5-10 weight portion.
Preferably, in described Chinese medicine composition, the weight portion of each raw material components is respectively Pheretima 13-16 weight portion, Fructus Schisandrae Chinensis 10-14 weight portion, Flos Farfarae 8-12 weight portion, Radix Platycodonis 12-15 weight portion, Rhizoma Fagopyri Dibotryis 8-10 weight portion, Radix Stemonae 12-16 weight portion, Radix Ophiopogonis 14-18 weight portion, Cortex Mori 10-14 weight portion, Rhizoma Cynanchi Stauntonii 8-10 weight portion, Radix Asteris 10-12 weight portion, Herba Houttuyniae 14-18 weight portion, Radix Peucedani 12-14 weight portion, Semen Ginkgo 13-16 weight portion, Radix Ginseng 9-12 weight portion, Herba Ephedrae 8-10 weight portion.
Further preferably, in described Chinese medicine composition, the weight portion of each raw material components is respectively Pheretima 13 weight portion, Fructus Schisandrae Chinensis 10 weight portion, Flos Farfarae 8 weight portion, Radix Platycodonis 12 weight portion, Rhizoma Fagopyri Dibotryis 8 weight portion, the Radix Stemonae 12 weight portion, Radix Ophiopogonis 14 weight portion, Cortex Mori 10 weight portion, Rhizoma Cynanchi Stauntonii 8 weight portion, Radix Asteris 10 weight portion, Herba Houttuyniae 14 weight portion, Radix Peucedani 12 weight portion, Semen Ginkgo 13 weight portion, Radix Ginseng 9 weight portion, Herba Ephedrae 8 weight portion.
Present invention also offers the preparation method of above-mentioned Chinese medicine composition, its preparation process is:
A. each component in described raw material components is mixed in proportion, pulverizes;
B. be added to the water by the medical material after pulverizing and soak 30min, heating and refluxing extraction 3 times, amount of water is followed successively by 8,6,4 times of medical material weight, and extraction time is followed successively by 1.5h, 0.75h, 0.5h, and by extracting liquid filtering, the centrifugal 15min of 5000r/min, merges supernatant;
C. precipitate with ethanol: the alcohol settling by supernatant with concentration being 70-90%;
D. extract purification: a kind of absorption with macroporous adsorbent resin of precipitate in D101, XAD-7, LSD001, DA-201, XAD-7 and AB-8, washing decontamination, the ethanol elution of 70-90%, concentration and recovery ethanol, obtains compound extract;
E. by the volume ratio of PEG4000 and PEG6000 be 1: 7-9 Polyethylene Glycol composite interstitial substance put heat fused in water-bath;
F. compound extract and Polyethylene Glycol composite interstitial substance are pressed the weight ratio mixing of 1: 1.5-3, continuous agitating heating, controls mixed liquor in melting state by its mix homogeneously;
G. keep melting state, by mixed liquor impouring pill dripping machine hopper, start stirring;
H. regulate dripping bore 3mm, drip speed 45/min, drip apart from 5cm;
I. cool in the mixed liquor of compound extract and Polyethylene Glycol composite interstitial substance instillation condensing agent, described condensing agent is dimethicone, and the temperature of condensing agent is 2-8 DEG C;
J. the drop pill cooled is taken out, the liquid coolant on removing surface, air-dry and get final product.
The present invention also provides the application of above-mentioned raw materials component in the Chinese medicine composition for the preparation for the treatment of bronchial asthma.
Beneficial effect of the present invention:
The invention provides a kind of Chinese medicine composition being used for the treatment of bronchial asthma, its more simple Western medicine and existing treatment by Chinese herbs better can alleviate bronchial asthma, improve the clinical sign of patient, prevent bronchial asthma from worsening further, have no side effect simultaneously, have safety and the comfort of height.
Detailed description of the invention
The weight portion that the present invention mentions is a proportionate relationship between each component.
The invention provides a kind of Chinese medicine composition being used for the treatment of bronchial asthma, its raw material components comprises Pheretima, Fructus Schisandrae Chinensis, Flos Farfarae, Radix Platycodonis, Rhizoma Fagopyri Dibotryis, the Radix Stemonae, Radix Ophiopogonis, Cortex Mori, Rhizoma Cynanchi Stauntonii, Radix Asteris, Herba Houttuyniae, Radix Peucedani, Semen Ginkgo, Radix Ginseng and Herba Ephedrae.
Further preferably, described Chinese medicine composition is only made up of above-mentioned raw materials component.
Chinese medicine composition compatibility of the present invention is reasonable, and action effect is remarkable, wherein:
Pheretima: salty, cold; Heat clearing away is calmed the frightened, and dredging collateral, relievings asthma, diuresis; For unconsciousness due to high fever, infantile convulsion is twitched, arthralgia, numb limbs and tense tendons, hemiplegia, dyspnea and cough due to lung-heat, edema oliguria.
Fructus Schisandrae Chinensis: sour, sweet, temperature; Restrain astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming; For chronic cough dyspnea due to deficiency, emission, enuresis frequent micturition, incessant chronic diarrhea, spontaneous sweating, Tianjin wound is thirsty, and interior-heat is quenched one's thirst, palpitation and insomnia.
Flos Farfarae: pungent, micro-hardship, temperature; Nourishing the lung to keep the adverse QI downward, relieving cough and resolving phlegm; Cough for new chronic cough, dyspnea and cough with excessive sputum, chronic cough hemoptysis.
Radix Platycodonis: bitter, pungent is flat; Lung qi dispersing, sore-throat relieving, eliminates the phlegm, evacuation of pus; For cough with copious phlegm, uncomfortable in chest not smooth, pharyngalgia hoarseness, lung abscess vomiting pus.
Rhizoma Fagopyri Dibotryis: micro-pungent, puckery, cool; Heat-clearing and toxic substances removing, evacuation of pus blood stasis dispelling; For lung abscess vomiting pus, dyspnea and cough due to lung-heat, tonsillitis is swollen and ache.
The Radix Stemonae: sweet, bitter, tepor; Nourishing the lung to keep the adverse QI downward cough-relieving, parasite killing delousing; Cough for new chronic cough, pulmonary tuberculosis cough, pertussis; Outer for head louse, body louse, enterobiasis, pudendal pruritus.
Radix Ophiopogonis: sweet, micro-hardship, is slightly cold; YIN nourishing and the production of body fluid promoting, lung moistening clears away heart-fire; For dryness of the lung dry cough, deficiency of YIN consumptive disease is coughed, sore throat pharyngalgia, and Tianjin wound is thirsty, and interior-heat is quenched one's thirst, vexed insomnia, dryness of the intestine constipation.
Cortex Mori: sweet, cold; Eliminating pathogen from the lung for relieving asthma, inducing diuresis to remove edema; For dyspnea and cough due to lung-heat, edema distension oliguria, appearance skin edema.
Rhizoma Cynanchi Stauntonii: pungent, bitter, tepor; Sending down the abnormal ascending QI, expectorant, cough-relieving; Stop up real for lung qi, cough with copious phlegm, fullness in the chest dyspnea with rapid respiration.
Radix Asteris: pungent, bitter, temperature; Nourishing the lung to keep the adverse QI downward, stopping coughing and removing phlegm; Breath with cough for abundant expectoration, new chronic cough is coughed, chronic cough hemoptysis.
H. cordata: xin, slightly cold;Qingrejiedu, XiaoTong abscess, diuresis leaching;Used for pulmonary abscess vomit pus, phlegm heat out of gai, heat flow field, thermal spray, carbuncle swollen chuangdu.
Radix Peucedani: bitter, pungent, is slightly cold; Lowering the adverse-rising QI to resolve phlegm, loose wind heat clearing away; Full for expectorant dyspnea of heat type, cough up phlegm yellow thick, cough due to pathogenic wind-heat's abundant expectoration.
Semen Ginkgo: sweet, bitter, puckery, flat; Astringing lung QI for relieving asthma, Zhi Dai Shrink urinates; Breath with cough for abundant expectoration, leukorrhagia nebulousurine, enuresis frequent micturition.
Radix Ginseng: sweet, micro-hardship, tepor; Strongly invigorating primordial QI, multiple arteries and veins takes off admittedly, and invigorating the spleen to benefit the lung, promotes the production of body fluid and nourish blood, Fructus Alpiniae Oxyphyllae of calming the nerves; For weak body and prostration, cold extremities faint pulse, insufficiency of the spleen lack of appetite, the deficiency of the lung is breathed with cough, and Tianjin wound is thirsty, and interior-heat is quenched one's thirst, deficiency of qi and blood, prolonged illness weakness with emaciation, and palpitation with fear insomnia, sexual impotence official is cold.
Herba Ephedrae: pungent, micro-hardship, temperature; Diaphoresis cold expelling, depressed lung-energy dispersing, inducing diuresis to remove edema; For anemofrigid cold, uncomfortable in chestly to breath with cough, edema due to wind pathogen edema.
In described Chinese medicine composition, the weight portion of each raw material components is respectively Pheretima 10-16 weight portion, Fructus Schisandrae Chinensis 8-14 weight portion, Flos Farfarae 6-12 weight portion, Radix Platycodonis 8-15 weight portion, Rhizoma Fagopyri Dibotryis 5-10 weight portion, Radix Stemonae 10-16 weight portion, Radix Ophiopogonis 9-18 weight portion, Cortex Mori 6-14 weight portion, Rhizoma Cynanchi Stauntonii 5-10 weight portion, Radix Asteris 6-12 weight portion, Herba Houttuyniae 8-18 weight portion, Radix Peucedani 8-14 weight portion, Semen Ginkgo 10-16 weight portion, Radix Ginseng 6-12 weight portion, Herba Ephedrae 5-10 weight portion.
Preferably, in described Chinese medicine composition, the weight portion of each raw material components is respectively Pheretima 13-16 weight portion, Fructus Schisandrae Chinensis 10-14 weight portion, Flos Farfarae 8-12 weight portion, Radix Platycodonis 12-15 weight portion, Rhizoma Fagopyri Dibotryis 8-10 weight portion, Radix Stemonae 12-16 weight portion, Radix Ophiopogonis 14-18 weight portion, Cortex Mori 10-14 weight portion, Rhizoma Cynanchi Stauntonii 8-10 weight portion, Radix Asteris 10-12 weight portion, Herba Houttuyniae 14-18 weight portion, Radix Peucedani 12-14 weight portion, Semen Ginkgo 13-16 weight portion, Radix Ginseng 9-12 weight portion, Herba Ephedrae 8-10 weight portion.
Further preferably, in described Chinese medicine composition, the weight portion of each raw material components is respectively Pheretima 13 weight portion, Fructus Schisandrae Chinensis 10 weight portion, Flos Farfarae 8 weight portion, Radix Platycodonis 12 weight portion, Rhizoma Fagopyri Dibotryis 8 weight portion, the Radix Stemonae 12 weight portion, Radix Ophiopogonis 14 weight portion, Cortex Mori 10 weight portion, Rhizoma Cynanchi Stauntonii 8 weight portion, Radix Asteris 10 weight portion, Herba Houttuyniae 14 weight portion, Radix Peucedani 12 weight portion, Semen Ginkgo 13 weight portion, Radix Ginseng 9 weight portion, Herba Ephedrae 8 weight portion.
The Chinese medicine composition for the treatment of bronchial asthma provided by the invention can be prepared into various peroral dosage form according to regular dosage form preparation method.
Present invention also offers the preparation method of above-mentioned Chinese medicine composition, comprising:
A. each component in described raw material components is mixed in proportion, pulverizes;
B. be added to the water by the medical material after pulverizing and soak 30min, heating and refluxing extraction 3 times, amount of water is followed successively by 8,6,4 times of medical material weight, and extraction time is followed successively by 1.5h, 0.75h, 0.5h, and by extracting liquid filtering, the centrifugal 15min of 5000r/min, merges supernatant;
C. precipitate with ethanol: the alcohol settling by supernatant with concentration being 70-90%;
D. extract purification: a kind of absorption with macroporous adsorbent resin of precipitate in D101, XAD-7, LSD001, DA-201, XAD-7 and AB-8, washing decontamination, the ethanol elution of 70-90%, concentration and recovery ethanol, obtains compound extract;
E. by the volume ratio of PEG4000 and PEG6000 be 1: 7-9 Polyethylene Glycol composite interstitial substance put heat fused in water-bath;
F. compound extract and Polyethylene Glycol composite interstitial substance are pressed the weight ratio mixing of 1: 1.5-3, continuous agitating heating, controls mixed liquor in melting state by its mix homogeneously;
G. keep melting state, by mixed liquor impouring pill dripping machine hopper, start stirring;
H. regulate dripping bore 3mm, drip speed 45/min, drip apart from 5cm;
I. cool in the mixed liquor of compound extract and Polyethylene Glycol composite interstitial substance instillation condensing agent, described condensing agent is dimethicone, and the temperature of condensing agent is 2-8 DEG C;
J. the drop pill cooled is taken out, the liquid coolant on removing surface, air-dry and get final product.
The present invention also provides the application of above-mentioned raw materials component in the Chinese medicine composition for the preparation for the treatment of bronchial asthma.
Embodiment
Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure reaching technique effect can fully understand and implement according to this.
Embodiment 1
Get Pheretima 10 weight portion, Fructus Schisandrae Chinensis 8 weight portion, Flos Farfarae 6 weight portion, Radix Platycodonis 8 weight portion, Rhizoma Fagopyri Dibotryis 5 weight portion, the Radix Stemonae 10 weight portion, Radix Ophiopogonis 9 weight portion, Cortex Mori 6 weight portion, Rhizoma Cynanchi Stauntonii 5 weight portion, Radix Asteris 6 weight portion, Herba Houttuyniae 8 weight portion, Radix Peucedani 8 weight portion, Semen Ginkgo 10 weight portion, Radix Ginseng 6 weight portion, Herba Ephedrae 5 weight portion, be mixed in proportion, pulverize; Medical material after pulverizing is added to the water immersion 30min, heating and refluxing extraction 3 times, and amount of water is followed successively by 8,6,4 times of medical material weight, and extraction time is followed successively by 1.5h, 0.75h, 0.5h, and by extracting liquid filtering, the centrifugal 15min of 5000r/min, merges supernatant; Be the alcohol settling of 70% by supernatant with concentration; Precipitate is through DA-201 absorption with macroporous adsorbent resin, and wash decontamination, the ethanol elution of 70%, concentration and recovery ethanol, obtains compound extract; By the volume ratio of PEG4000 and PEG6000 be 1: 7 Polyethylene Glycol composite interstitial substance put heat fused in water-bath; Compound extract and Polyethylene Glycol composite interstitial substance are pressed the weight ratio mixing of 1: 1.5, continuous agitating heating, control mixed liquor in melting state by its mix homogeneously; Keep melting state, by mixed liquor impouring pill dripping machine hopper, start stirring; Regulate dripping bore 3mm, drip speed 45/min, drip apart from 5cm; Cool in the mixed liquor of compound extract and Polyethylene Glycol composite interstitial substance instillation condensing agent, described condensing agent is dimethicone, and the temperature of condensing agent is 2 DEG C; Take out the drop pill that cooled, the liquid coolant on removing surface, air-dry and get final product.
Usage and consumption: every day three times, each 4-6 ball, one after each meal.
Taboo: (1) avoids eating anything raw or cold food; (2) diet raw meat thing; (3) internal and external haemorrhage disease, ulcerate disease tool avoid clothes first; (4) female menstrual period, the pregnancy period is not used.
Embodiment 2
Get Pheretima 16 weight portion, Fructus Schisandrae Chinensis 14 weight portion, Flos Farfarae 12 weight portion, Radix Platycodonis 15 weight portion, Rhizoma Fagopyri Dibotryis 10 weight portion, the Radix Stemonae 16 weight portion, Radix Ophiopogonis 18 weight portion, Cortex Mori 14 weight portion, Rhizoma Cynanchi Stauntonii 10 weight portion, Radix Asteris 12 weight portion, Herba Houttuyniae 18 weight portion, Radix Peucedani 14 weight portion, Semen Ginkgo 16 weight portion, Radix Ginseng 12 weight portion, Herba Ephedrae 10 weight portion, be mixed in proportion, pulverize; Medical material after pulverizing is added to the water immersion 30min, heating and refluxing extraction 3 times, and amount of water is followed successively by 8,6,4 times of medical material weight, and extraction time is followed successively by 1.5h, 0.75h, 0.5h, and by extracting liquid filtering, the centrifugal 15min of 5000r/min, merges supernatant; Be the alcohol settling of 90% by supernatant with concentration; Precipitate is through LSD001 absorption with macroporous adsorbent resin, and wash decontamination, the ethanol elution of 90%, concentration and recovery ethanol, obtains compound extract; By the volume ratio of PEG4000 and PEG6000 be 1: 9 Polyethylene Glycol composite interstitial substance put heat fused in water-bath; Compound extract and Polyethylene Glycol composite interstitial substance are pressed the weight ratio mixing of 1: 3, continuous agitating heating, control mixed liquor in melting state by its mix homogeneously; Keep melting state, by mixed liquor impouring pill dripping machine hopper, start stirring; Regulate dripping bore 3mm, drip speed 45/min, drip apart from 5cm; Cool in the mixed liquor of compound extract and Polyethylene Glycol composite interstitial substance instillation condensing agent, described condensing agent is dimethicone, and the temperature of condensing agent is 8 DEG C; Take out the drop pill that cooled, the liquid coolant on removing surface, air-dry and get final product.
Usage and consumption, avoid same embodiment 1.
Embodiment 3
Get Pheretima 13 weight portion, Fructus Schisandrae Chinensis 10 weight portion, Flos Farfarae 8 weight portion, Radix Platycodonis 12 weight portion, Rhizoma Fagopyri Dibotryis 8 weight portion, the Radix Stemonae 12 weight portion, Radix Ophiopogonis 14 weight portion, Cortex Mori 10 weight portion, Rhizoma Cynanchi Stauntonii 8 weight portion, Radix Asteris 10 weight portion, Herba Houttuyniae 14 weight portion, Radix Peucedani 12 weight portion, Semen Ginkgo 13 weight portion, Radix Ginseng 9 weight portion, Herba Ephedrae 8 weight portion, be mixed in proportion, pulverize; Medical material after pulverizing is added to the water immersion 30min, heating and refluxing extraction 3 times, and amount of water is followed successively by 8,6,4 times of medical material weight, and extraction time is followed successively by 1.5h, 0.75h, 0.5h, and by extracting liquid filtering, the centrifugal 15min of 5000r/min, merges supernatant; Be the alcohol settling of 80% by supernatant with concentration; Precipitate is through AB-8 absorption with macroporous adsorbent resin, and wash decontamination, the ethanol elution of 80%, concentration and recovery ethanol, obtains compound extract; By the volume ratio of PEG4000 and PEG6000 be 1: 8 Polyethylene Glycol composite interstitial substance put heat fused in water-bath; Compound extract and Polyethylene Glycol composite interstitial substance are pressed the weight ratio mixing of 1: 2, continuous agitating heating, control mixed liquor in melting state by its mix homogeneously; Keep melting state, by mixed liquor impouring pill dripping machine hopper, start stirring; Regulate dripping bore 3mm, drip speed 45/min, drip apart from 5cm; Cool in the mixed liquor of compound extract and Polyethylene Glycol composite interstitial substance instillation condensing agent, described condensing agent is dimethicone, and the temperature of condensing agent is 6 DEG C; Take out the drop pill that cooled, the liquid coolant on removing surface, air-dry and get final product.
Usage and consumption, avoid same embodiment 1.
Embodiment 4, toxicity are verified
Below test, without special instruction, all use the Chinese medicine composition that the embodiment of the present invention 3 is obtained.
1, acute toxicity test: mouse stomach gives Chinese medicine composition 115.33g/kg of the present invention, Continuous Observation 14 days, all survive, and growth promoter is good.Mice is 115.33g/kg to Chinese medicine composition maximum dosage-feeding of the present invention.
2, long term toxicity test: to continuous 6 weeks of SD rat respectively gavage give 61.2g/kg, 30.7g/kg, the Chinese medicine composition of the present invention of 15.3g/kg tri-dosage, laboratory animal terminates and convalescent period in administration, and hematological indices, blood parameters and matched group ratio are all without significant difference (p > 0.05).System becomes celestial and histopathologic examination has no drug-induced abnormal change and retardance toxic reaction.
Embodiment 5, test of relievining asthma
(1) impact of phase sent out by medicine of the present invention on bronchial asthma speed
1 experiment material
1.1 animals: pure white Hartley healthy guinea pig, body weight 200 ± 25g, male and female half and half, are purchased from Nat'l Pharmaceutical & Biological Products Control Institute's Experimental Animal Center, and the quality certification is numbered SCXK (capital) 2002-0010.
1.2 medicines and reagent:
(1) by reagent: Chinese medicine composition of the present invention.The crude drug amount of every gram of finished product is 3.1g.The clinical plan consumption of people is 19g crude drug/day.Desired concn is mixed with before use with 0.5%CMC-Na.
(2) positive control drug: aminophylline tablets, black bamboo pharmaceutcal corporation, Ltd of Beijing, is applicable to bronchial asthma, obstructive emphysema.
(3) DINGCHUAN TANG: Shijiazhuang Yiling Pharmaceutical Co., Ltd provides.People's quantity is 69g crude drug/day.Desired concn is mixed with before use with 0.5%CMC-Na.
(4) egg protein: Sigma Products.
(5) acecoline: Sigma Products.
1.3 instruments: Yadu medical vaporizer, model YC-Y800B, is produced from Yadu Science and Technology Co., Ltd., Beijing.
2 methods and result
1, the grouping of animal and administration: Cavia porcellus 150 is only put into airtight plexiglass tent (4L) in batches, spray into draw with ultrasound atomizer atomization and breathe heavily medicinal liquid (2% acecoline and 0.1% histamine phosphate's equal-volume mixed liquor) 15s/ time, atomization quantity 4ml/min, atomizing particle diameter 1-5 μm.After spraying stops, observing Cavia porcellus in 6min and occur the incubation period of asthmatic tic, if it is unsuccessful to be greater than 120s person the incubation period of asthmatic tic.Select qualified Cavia porcellus 120 and be only divided into 6 groups at random by body weight, be i.e. model group, aminophylline group, DINGCHUAN TANG group, large, medium and small three the dosage groups of Chinese medicine composition of the present invention.
Model group Cavia porcellus gavage gives equal-volume solvent, aminophylline group gavage gives aminophylline 0.06g/kg (being equivalent to 6 times of clinical people's consumption), DINGCHUAN TANG group gavage gives 7.3g/kg (being equivalent to 6 times of clinical people's consumption), and the other gavage of the large, medium and small dosage component of medicine of the present invention gives medicine 4.7g/kg, 2.3g/kg and 1.1g/kg of the present invention (being equivalent to 12,6,3 times of clinical people's consumption respectively).Each group of successive administration 4 days, starts test after last administration 1h.
2, medicine of the present invention is to the antiasthmatic effect of drug-induced Experimental Asthma In Guinea-pigs: each treated animal is put into airtight plexiglass tent, draw as stated above and breathe heavily, after spraying stops, observing Cavia porcellus in 6min and occur the incubation period of asthmatic tic, if do not occur in 6min, asthmatic tic calculates with 6min.Statistics adopts SPSS10.0 software kit to carry out variance analysis and t inspection.Result shows, and the large, medium and small dosage group of medicine of the present invention all energy significant prolongation acecoline and histamine phosphate causes the incubation period (see table 1) of Experimental Asthma In Guinea-pigs.
Table 1: medicine of the present invention is to the antiasthmatic effect of drug-induced Experimental Asthma In Guinea-pigs
Note: compare with model group,
*p < 0.05,
*p < 0.01, compares with DINGCHUAN TANG group:
#p < 0.05,
##p < 0.01.
Normal guinea pig can cause asthma attack after sucking the mixed liquor of histamine and acecoline, and the time (p < 0.05 and p < 0.01) of panting and falling appears in the large, medium and small dosage of medicine of the present invention (4.7g/kg, 2.3g/kg, 1.1g/kg) equal energy significant prolongation Experimental Asthma In Guinea-pigs.Cavia porcellus is combined on mastocyte with producing anti ova IgE antibody after egg protein (Ovalbumin, OVA) sensitization, and when sucking antigen OVA, OVA causes cell degranulation after being combined with cell surface IgE, and release inflammatory mediator causes asthma attack.After the large, medium and small dosage of Chinese medicine composition of the present invention (4.7g/kg, 2.3g/kg, 1.1g/kg) administration, all there is the incubation period (p < 0.05 and p < 0.01) of asthma in energy significant prolongation Cavia porcellus, and its effect is obviously better than DINGCHUAN TANG.
(2) medicine of the present invention is on the impact of the tardy phase of bronchial asthma
1, the grouping of animal and administration: healthy pure white Hartley Cavia porcellus 90 points 6 groups at random: the large, medium and small dosage group (4.7g/kg, 2.3g/kg, 1.1g/kg) of model group, medicine of the present invention, DINGCHUAN TANG group (7.3g/kg), positive control drug aminophylline group (gavage aminophylline 0.06g/kg), model group is to the solvent of same volume.Within first 3 days, gastric infusion is started, successive administration 4 days in drawing to breathe heavily.
2, medicine of the present invention is to the antiasthmatic effect of the caused Experimental Asthma In Guinea-pigs of egg protein (OVA): each group Cavia porcellus 4% egg protein normal saline solution 0.2ml back leg intramuscular injection and 4% aluminium hydroxide latex 0.2ml lumbar injection sensitization, within the 7th day, adopts and uses the same method again sensitization once.Last administration is sprayed to draw with ultrasound atomizer after 1 hour and is breathed heavily, draw that to breathe heavily medicinal liquid be 2% egg protein normal saline, atomization quantity is no less than 4ml/min, and spraying continues 6min, observe Cavia porcellus in 6min and occur the incubation period of asthmatic tic, if do not occur in 6min, asthmatic tic calculates with 6min.Statistics adopts SPSS10.0 software to carry out variance analysis and t inspection.Result shows, and the large, medium and small dosage group of medicine of the present invention all can significant prolongation egg protein sensitized guinea pig asthmatic latent period (see table 2).
Table 2: medicine of the present invention is on the impact of egg protein sensitized guinea pig asthmatic latent period
Note: compare with model group,
*p < 0.05,
*p < 0.01, compares with DINGCHUAN TANG group:
#p < 0.05,
##p < 0.01.
Adopt egg protein sensitization, and with egg protein repeatedly Neulized inhalation attack Cavia porcellus, eosinophilic granulocyte (Eosinophil, EOS) infiltration can be caused to be main airway inflammation experimental model, i.e. Cavia porcellus allergic bronchial asthma model.Research finds, the large, medium and small dosage of Chinese medicine composition of the present invention (4.7g/kg, 2.3g/kg, 1.1g/kg) significant prolongation last OVA draw breathe heavily incubation period, reduce EOS number (p < 0.05 and p < 0.01) in whole blood, and the curative effect of Chinese medicine composition of the present invention to Cavia porcellus Delayed onset bronchial asthma is obviously better than DINGCHUAN TANG.
Embodiment 6, clinical experiment
One, case selection:
1, diagnostic criteria
Western medicine diagnose standard
(1) diagnostic criteria of the acute bronchial asthma in bronchial asthma diagnostic criteria " guideline of clinical investigations of bronchial asthma treated by Chinese medicine (new drug) " of announcing with reference to health ministry bureau of drug administration 1993 and respirology branch of Chinese Medical Association asthma group prevention and control of bronchial asthma guide. the relevant criterion in the definition of bronchial asthma, diagnosis, treatment and education and management scheme.
(2) pant, cough, cough up phlegm, relevant criterion in " Chinese medicine (new drug) guideline of clinical investigations " that the state of an illness of wheezing sound symptom and sign and the degree criteria for classifying are formulated with reference to health ministry bureau of drug administration for 1993.
Tcm diagnosis standard
Wind-phlegm resistance lung card: asthma is done suddenly, stridulates sound, dyspnea with rapid respiration fullness in the chest, expectorating sticky sputum with difficulty in spitting, or is white foam expectorant, is inclined to without obvious cold and heat, onset is how anxious, often merges nose, pharynx, eye, ear itch, sneeze, nasal obstruction, watery nasal discharge, chest suppresses plug, immediately shows effect thereupon, and tongue is dark red, and thin fur is sticky, stringy and rolling pulse.
With reference to " the clinical respirology of Chinese and western medicine " (China Traditional Chinese Medicine Publishing House, 1998) bronchial wheezing " wind-phlegm asthma " formulation in mesobronchus asthma " wind-phlegm resistance lung card " and New Century higher institutions of Chinese medicine programming textbook " Chinese Internal Medicine " (China Traditional Chinese Medicine Publishing House, 2003).
2, case standard is tested
Include case in
All Western medicine diagnoses meet: light (II grade) of acute bronchial asthma, the asthmatic patient of moderate (III grade) diagnostic criteria, Chinese medical discrimination belongs to the adult person (age is between 18-65) of wind-phlegm resistance lung, can include test case in.The diagnostic criteria of slight persistent asthma (II grade): symptom >=1 time weekly, but < every day 1 time; Outbreak may affect activity and sleep; Nighttime asthma symptoms > monthly 2 times; PEF aberration rate 20% ~ 30%; FEV1.0 >=80% predicted value; The diagnostic criteria of moderate persistent asthma (III grade): there is symptom every day; Outbreak affects activity and sleep; Nighttime asthma symptoms > 1 time weekly; Use fugitive beta 2 receptor agonist every day; PEF aberration rate >30%; FEV1.0>60% ~ 80% predicted value.
Excluded cases
(1) severe asthma; (2) catabasis of bronchitis asthma; (3) chronic pulmonary heart disease (cardiac functional decompensatory period); (4) Chinese medical discrimination non-genus wind-phlegm resistance lung person; (5) confirm on inspection by tuberculosis fungus, the chronic patient that pants caused by the factors such as tumor; (6) cardiovascular is associated with, liver, the severe primary such as kidney and hemopoietic system disease, psychotic; (7) age is below 18 one full year of life or over-65s person, anemia of pregnant woman or women breast-feeding their children; (8) allly do not meet inclusive criteria, not by regulation medication, cannot judge curative effect or data not umbra ring Outcome measure person.
Statistical method: clinical data and data are after inspection and verification, and input computer, measurement data mean ± standard deviation (X ± SD represents), with many prescriptions difference analysis or t inspection.
Two, test method
1, group technology: this research employing (RCT method) is random, controlled trial is observed, random pair group technology is adopted to above-mentioned test case of including in, random table is found treatment group and matched group, and guarantee two groups of cases in severity extent and sex, age, the course of disease etc. substantially close to (statistical procedures, two groups are compared P>0.05).
2, total case load 200 example, treatment group 10 example, matched group 100 example.
3, Therapeutic Method
Treatment group: use Chinese medicine composition of the present invention, oral medication, every day three times, each 4-6 ball, one after each meal.
Matched group: pulmicort repules (spray is inhaled, 2 times/day, 1-2 spray/time).
The course for the treatment of: be 3 weeks.
Experimental result is in table 1.Total effective rate=(curing number of cases+effective number of cases+improvement number of cases)/total number of cases.
Table 3: the comparison of two groups of patient clinical curative effects after treatment
| Group | Total number of cases | Cure number of cases (%) | Effective number of cases (%) | Improvement number of cases (%) | Invalid number of cases (%) | Total effective rate (%) |
| Treatment group | 100 | 31(31) | 35(35) | 26(26) | 8(8) | 92 ** |
| Matched group | 100 | 20(20) | 21(21) | 29(29) | 30(30) | 70 |
Note: compare with matched group:
*p < 0.01.
Result shows, Chinese medicine composition of the present invention has extremely significant effect to treatment Bronchial Asthmas.
The above is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.
Claims (6)
1. be used for the treatment of a Chinese medicine composition for bronchial asthma, it is characterized in that: raw material components comprises Pheretima, Fructus Schisandrae Chinensis, Flos Farfarae, Radix Platycodonis, Rhizoma Fagopyri Dibotryis, the Radix Stemonae, Radix Ophiopogonis, Cortex Mori, Rhizoma Cynanchi Stauntonii, Radix Asteris, Herba Houttuyniae, Radix Peucedani, Semen Ginkgo, Radix Ginseng and Herba Ephedrae.
2. Chinese medicine composition as claimed in claim 1, it is characterized in that: the weight portion of each raw material components is respectively Pheretima 10-16 weight portion, Fructus Schisandrae Chinensis 8-14 weight portion, Flos Farfarae 6-12 weight portion, Radix Platycodonis 8-15 weight portion, Rhizoma Fagopyri Dibotryis 5-10 weight portion, Radix Stemonae 10-16 weight portion, Radix Ophiopogonis 9-18 weight portion, Cortex Mori 6-14 weight portion, Rhizoma Cynanchi Stauntonii 5-10 weight portion, Radix Asteris 6-12 weight portion, Herba Houttuyniae 8-18 weight portion, Radix Peucedani 8-14 weight portion, Semen Ginkgo 10-16 weight portion, Radix Ginseng 6-12 weight portion, Herba Ephedrae 5-10 weight portion.
3. Chinese medicine composition as claimed in claim 1 or 2, it is characterized in that: the weight portion of each raw material components is respectively Pheretima 13-16 weight portion, Fructus Schisandrae Chinensis 10-14 weight portion, Flos Farfarae 8-12 weight portion, Radix Platycodonis 12-15 weight portion, Rhizoma Fagopyri Dibotryis 8-10 weight portion, Radix Stemonae 12-16 weight portion, Radix Ophiopogonis 14-18 weight portion, Cortex Mori 10-14 weight portion, Rhizoma Cynanchi Stauntonii 8-10 weight portion, Radix Asteris 10-12 weight portion, Herba Houttuyniae 14-18 weight portion, Radix Peucedani 12-14 weight portion, Semen Ginkgo 13-16 weight portion, Radix Ginseng 9-12 weight portion, Herba Ephedrae 8-10 weight portion.
4. the Chinese medicine composition as described in claims 1 to 3, is characterized in that: the weight portion of each raw material components is respectively Pheretima 13 weight portion, Fructus Schisandrae Chinensis 10 weight portion, Flos Farfarae 8 weight portion, Radix Platycodonis 12 weight portion, Rhizoma Fagopyri Dibotryis 8 weight portion, the Radix Stemonae 12 weight portion, Radix Ophiopogonis 14 weight portion, Cortex Mori 10 weight portion, Rhizoma Cynanchi Stauntonii 8 weight portion, Radix Asteris 10 weight portion, Herba Houttuyniae 14 weight portion, Radix Peucedani 12 weight portion, Semen Ginkgo 13 weight portion, Radix Ginseng 9 weight portion, Herba Ephedrae 8 weight portion.
5. the preparation method of Chinese medicine composition described in Claims 1-4, is characterized in that, preparation process is:
A. each component in described raw material components is mixed in proportion, pulverizes;
B. be added to the water by the medical material after pulverizing and soak 30min, heating and refluxing extraction 3 times, amount of water is followed successively by 8,6,4 times of medical material weight, and extraction time is followed successively by 1.5h, 0.75h, 0.5h, and by extracting liquid filtering, the centrifugal 15min of 5000r/min, merges supernatant;
C. precipitate with ethanol: the alcohol settling by supernatant with concentration being 70-90%;
D. extract purification: a kind of absorption with macroporous adsorbent resin of precipitate in D101, XAD-7, LSD001, DA-201, XAD-7 and AB-8, washing decontamination, the ethanol elution of 70-90%, concentration and recovery ethanol, obtains compound extract;
E. by the volume ratio of PEG4000 and PEG6000 be 1: 7-9 Polyethylene Glycol composite interstitial substance put heat fused in water-bath;
F. compound extract and Polyethylene Glycol composite interstitial substance are pressed the weight ratio mixing of 1: 1.5-3, continuous agitating heating, controls mixed liquor in melting state by its mix homogeneously;
G. keep melting state, by mixed liquor impouring pill dripping machine hopper, start stirring;
H. regulate dripping bore 3mm, drip speed 45/min, drip apart from 5cm;
I. cool in the mixed liquor of compound extract and Polyethylene Glycol composite interstitial substance instillation condensing agent, described condensing agent is dimethicone, and the temperature of condensing agent is 2-8 DEG C;
J. the drop pill cooled is taken out, the liquid coolant on removing surface, air-dry and get final product.
6. the application of the raw material components any one of claim 1-4 in the Chinese medicine composition for the preparation for the treatment of bronchial asthma.
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| CN112138084A (en) * | 2020-10-19 | 2020-12-29 | 河南中医药大学 | Traditional Chinese medicine formula for treating bronchiectasis syndrome of qi-yin deficiency and phlegm-heat obstructing lung and application thereof |
| CN112138084B (en) * | 2020-10-19 | 2022-05-13 | 河南中医药大学 | Traditional Chinese medicine composition for treating bronchiectasis qi-yin deficiency and phlegm-heat obstructing lung and application thereof |
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