CN104042811A - Externally applied compound medicament for treating catabasis of bronchial asthma, preparation method and application thereof - Google Patents

Externally applied compound medicament for treating catabasis of bronchial asthma, preparation method and application thereof Download PDF

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CN104042811A
CN104042811A CN201410265894.7A CN201410265894A CN104042811A CN 104042811 A CN104042811 A CN 104042811A CN 201410265894 A CN201410265894 A CN 201410265894A CN 104042811 A CN104042811 A CN 104042811A
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catabasis
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CN104042811B (en
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史锁芳
刘志辉
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Jiangsu Provincial Hospital of Chinese Medicine
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Abstract

The invention discloses an externally applied compound medicament for treating catabasis of bronchial asthma, a preparation method and application thereof. The externally applied compound medicament is prepared from the following traditional Chinese medicinal decoction pieces serving as raw materials in parts by weight: 6-12 parts of semen brassicae, 1-3 parts of asarum, 6-12 parts of arisacma consanguineum, 2-5 parts of processed euphorbia kansui, 6-12 parts of corydalis tuber, 3-6 parts of agilawood, 3-6 parts of cinnamon and 6-12 parts of fructus psoraleae. The externally applied compound medicament for treating catabasis of bronchial asthma, the preparation method and application thereof have the characteristics of good curative effect, no side effect and the like, are convenient to use. The preparation method of the compound composition medicament for treating catabasis of bronchial asthma is simple in process and easy to prepare massively, and is convenient to carry, store and use.

Description

A kind of external application compound medicine that is used for the treatment of catabasis of bronchitis asthma and its preparation method and application
Technical field
The invention belongs to Chinese medicine composition technical field, be specifically related to a kind of external application compound medicine that is used for the treatment of catabasis of bronchitis asthma and its preparation method and application.
Background technology
Bronchial asthma (abbreviation asthma) is a kind of common respiratory system chronic disease, and its M & M is rising year by year, and approximately there is the 1.5 hundred million people trouble asthma of controlling in the whole world, and China has more than 2,500 ten thousand this class patients at least.The pathologic basis of primary disease is chronic airway inflammation, follows airway hyperreactivity, causes disease repeatedly to be shown effect.Clinical taking uncomfortable in chest, asthma, dyspnea or cough as main manifestations.Primary disease usually outbreak repeatedly, touching difficulty more, all brings and has a strong impact on to patient's life, study, work.
Because airway inflammation is present in the overall process of asthma, can Control of asthma clinical symptoms and minimizing attack times so suppress airway inflammation treatment.Using inhaled as a line anti-inflammatory drug, be aided with the symptomatic treatments such as bronchial spasmolytic agent at present.Mainly comprise inhaled (ICS), long-acting beta 2 receptor stimulating agents (must with ICS use in conjunction), sustained-release theophyline, leukotrienes regulator, antihistaminic etc.Hormonal dependent asthma, needs again could control symptom with a certain amount of oral hormone.In addition, Allergen immunotherapy is also the important means of current control.Though it is few to suck ICS systemic adverse reactions, can causes hoarseness, pharyngeally not accommodate the untoward reaction such as monilial infection; And the side reaction of Long-term Oral hormone is large, be prone to adrenal cortex function inhibition, gastric ulcer, blood sugar increasing, osteoporosis etc.For a long time, single application beta 2 receptor agonist can cause the downward of cell membrane beta 2 receptor, generation drug resistance, curative effect reduction.Though leukotrienes regulator side reaction is lighter, also can there be gastrointestinal symptom, minority erythra, transaminase's rising etc.Although and Allergen immunotherapy has clear and definite curative effect and compared with extensive use, occur that in administration process systemic reaction makes it still have certain dispute.
Take a broad view of current treatment present situation, doctor trained in Western medicine has some superiority in Control of asthma acute attack, but aspect outbreak repeatedly, relatively limits to preventing, and the side reaction of hormone has affected its application.Chinese medicine primary disease method uniqueness, with the obvious advantage, but also have its short slab and deficiency.Due to Chinese medicine greatly mainly with decoction, granule as main dosage form and treatment approach, promote inconvenience for asthmatic patients such as long-term medical treatment and children.At present still lack the common recognition with evidence-based medical for pathogenesis, pattern of syndrome, the method for the treatment of of Asthma in Remission Stage, various places diagnosis curative effect judgment criteria is unified not, treatment appraisement system shortcoming specification, yet there are no the specification side's of control medicine efficiently, mostly from tonification anti-asthma oral medications such as replenishing and restoring lung-QI, strong activating the spleen gas, invigorating kidney qis.Because of course for the treatment of primary disease catabasis longer, patient's Long-term Oral is difficult to adhere to, so outer treating method more and more comes into one's own.In the industry for the selection of external application side's medicine, mostly take over the square medicine in the Zhang Shi of the Qing Dynasty " Zhang Shi doctor is logical " " Semen Sinapis Albae painting method ", also with good grounds experience separately plus-minus plan side, various places, warming the lung, cold relieving for multiselect, relieve oedema or abdominal distension through diuresis or purgation, blood stasis dispelling class Chinese prescription, because preparation process differs, indication is fuzzy, and curative effect is uneven, applies curative effect undesirable.
Summary of the invention
Goal of the invention: for the deficiencies in the prior art, the object of the present invention is to provide a kind of external application compound medicine that is used for the treatment of catabasis of bronchitis asthma and its preparation method and application, the feature such as there is good effect, have no side effect.Another object of the present invention is to provide a kind of preparation method of the above-mentioned external application compound medicine that is used for the treatment of catabasis of bronchitis asthma.The present invention also has an object to be to provide the application of the above-mentioned external application compound medicine that is used for the treatment of catabasis of bronchitis asthma.
Technical scheme: in order to realize foregoing invention object, the technical solution used in the present invention is:
Being used for the treatment of an external application compound medicine for catabasis of bronchitis asthma, is that raw material is made by the prepared slices of Chinese crude drugs of following parts by weight: 6~12 parts of Semen Sinapis Albaes, 1~3 part of Herba Asari, 6~12 parts of Rhizoma Arisaematis (processed), 2~5 parts of Radix Kansui (processed), 6~12 parts of Rhizoma Corydalis, 3~6 parts of Lignum Aquilariae Resinatum, 3~6 parts of Cortex Cinnamomis, 6~12 parts of Fructus Psoraleaes.
The described external application compound medicine that is used for the treatment of catabasis of bronchitis asthma is preferably that raw material is made by the prepared slices of Chinese crude drugs of following parts by weight and ratio: 10 parts of Semen Sinapis Albaes, 2 parts of Herba Asaris, 8 parts of Rhizoma Arisaematis (processed), 4 parts of Radix Kansui (processed), 10 parts of Rhizoma Corydalis, 4 parts of Lignum Aquilariae Resinatum, 5 parts of Cortex Cinnamomis, 8 parts of Fructus Psoraleaes.
A method of preparing the described external application compound medicine that is used for the treatment of catabasis of bronchitis asthma, comprises the following steps:
1) square Chinese medicine mixes, and oven drying at low temperature is pulverized, and crosses 60 ~ 100 mesh sieves, and fine powder is for subsequent use;
2) get sodium carboxymethyl cellulose appropriate, add purified water swelling 24 hours, continue to add water that to be mixed with mass percent be 1~3% solution, for subsequent use;
3) in carboxymethylcellulose sodium solution, add glycerol, ethyl hydroxybenzoate, azone, make respectively its mass content reach 5 ~ 10%, 0.3 ~ 0.5%, 0.1 ~ 0.3%;
4) press the mass ratio of 1:1 ~ 3, step 1) fine powder is added in the carboxymethylcellulose sodium solution of step 3), fully mix, obtain medicated powder mastic;
5) medicated powder mastic is suitably heated, coat on non-woven fabrics, room temperature is dried, and covers anti-stick layer, is cut into small pieces, and to obtain final product.
In method, sodium carboxymethyl cellulose also can substitute with maltose or other macromolecule chemical material, and ethyl hydroxybenzoate also can use benzoic acid, sodium benzoate or ethyl hydroxybenzoate class antiseptic to substitute.
Traditional Chinese compound medicine of the present invention is through clinical verification for many years, the effect of have warming the lung cold relieving, the eliminating phlegm that dispels the wind, blood stasis dispelling being relievingd asthma by drink, kidney tonifying.The mainly curing bronchial asthma catabasis, performance: the breath of losing heart is short, moving for very, air-breathing unfavorable, easy catching a cold usually, waist soreness, is afraid of cold, expectoration foam, deep-thready pulse, the fat grade of pale tongue deficiency of both the lung and kidney is demonstrate,proved.
Beneficial effect: compared with prior art, external application compound medicine that is used for the treatment of catabasis of bronchitis asthma of the present invention and its preparation method and application, has good effect, easy to use, the feature such as have no side effect.The preparation method of the compound composite medicament for the treatment of catabasis of bronchitis asthma, simple process, is easy to a large amount of preparations, is also easy to carry, preserves simultaneously, easy to use.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is further illustrated.
Embodiment 1
Be used for the treatment of an external application compound medicine for catabasis of bronchitis asthma, filling a prescription is: 12 parts of Semen Sinapis Albaes, 3 parts of Herba Asaris, 6 parts of Rhizoma Arisaematis (processed), 3 parts of Radix Kansui (processed), 9 parts of Rhizoma Corydalis, 6 parts of Lignum Aquilariae Resinatum, 6 parts of Cortex Cinnamomis, 12 parts of Fructus Psoraleaes.
Preparation method is:
1) take by weight above eight taste Chinese medicines, mix, oven drying at low temperature, pulverizes, and crosses 80 mesh sieves, and fine powder is for subsequent use;
2) get sodium carboxymethyl cellulose appropriate, add purified water swelling 24 hours, adding water and being mixed with dosage is 3% solution, for subsequent use;
3) in carboxymethylcellulose sodium solution, add glycerol, ethyl hydroxybenzoate, azone, make respectively dosage reach 10%, 0.5%, 0.3%;
4) press the mass ratio of 1:3, step 1) fine powder added to above-mentioned steps 3) carboxymethylcellulose sodium solution in, fully mix, obtain medicated powder mastic;
5) medicated powder mastic is suitably heated to 45 DEG C, coat on non-woven fabrics, room temperature is dried, and covers anti-stick layer, is cut into small pieces, and to obtain final product.
Embodiment 2
Be used for the treatment of an external application compound medicine for catabasis of bronchitis asthma, filling a prescription is: 6 parts of Semen Sinapis Albaes, 2 parts of Herba Asaris, 10 parts of Rhizoma Arisaematis (processed), 5 parts of Radix Kansui (processed), 9 parts of Rhizoma Corydalis, 3 parts of Lignum Aquilariae Resinatum, 3 parts of Cortex Cinnamomis, 6 parts of Fructus Psoraleaes.
Preparation method is:
1) take by weight above eight taste Chinese medicines, mix, oven drying at low temperature, pulverizes, and crosses 100 mesh sieves, and fine powder is for subsequent use;
2) get sodium carboxymethyl cellulose appropriate, add purified water swelling 24 hours, adding water and being mixed with mass percent is 2% solution, for subsequent use;
3) in carboxymethylcellulose sodium solution, add glycerol, ethyl hydroxybenzoate, azone, make respectively mass content reach 5%, 0.3%, 0.2%;
4) press the mass ratio of 1:3, step 1) fine powder added to above-mentioned steps 3) carboxymethylcellulose sodium solution in, fully mix, obtain medicated powder mastic;
5. medicated powder mastic is suitably heated to 40 DEG C, coat on non-woven fabrics, room temperature is dried, and covers anti-stick layer, is cut into small pieces, and to obtain final product.
Embodiment 3
Be used for the treatment of an external application compound medicine for catabasis of bronchitis asthma, filling a prescription is: 10 parts of Semen Sinapis Albaes, 3 parts of Herba Asaris, 9 parts of Rhizoma Arisaematis (processed), 3 parts of Radix Kansui (processed), 9 parts of Rhizoma Corydalis, 5 parts of Lignum Aquilariae Resinatum, 6 parts of Cortex Cinnamomis, 10 parts of Fructus Psoraleaes.
Preparation method is:
1) square Chinese medicine mixes, and oven drying at low temperature is pulverized, and crosses 100 mesh sieves, and fine powder is for subsequent use;
2) get maltose appropriate, add respectively glycerol, benzoic acid, azone, make respectively mass content reach 5%, 0.8%, 0.2%;
3) press the mass ratio of 1:2, step 1) fine powder added to above-mentioned steps 2) maltose mixture in, fully mix, obtain medicated powder mastic;
4) medicated powder mastic is heated to 48 DEG C, coats on non-woven fabrics, room temperature is dried, and covers anti-stick layer, is cut into small pieces, and to obtain final product.
Embodiment 4
Be used for the treatment of an external application compound medicine for catabasis of bronchitis asthma, filling a prescription is: 12 parts of Semen Sinapis Albaes, 3 parts of Herba Asaris, 9 parts of Rhizoma Arisaematis (processed), 5 parts of Radix Kansui (processed), 10 parts of Rhizoma Corydalis, 5 parts of Lignum Aquilariae Resinatum, 3 parts of Cortex Cinnamomis, 10 parts of Fructus Psoraleaes.
Preparation method is:
1) square Chinese medicine mixes, and oven drying at low temperature is pulverized, and crosses 100 mesh sieves, and fine powder is for subsequent use;
2) get maltose appropriate, add respectively glycerol, benzoic acid, azone etc., make respectively mass content reach 8%, 1%, 0.3%;
3) press the mass ratio of 1:2.5, step 1) fine powder added to above-mentioned steps 2) maltose mixture in, fully mix, obtain medicated powder mastic;
4) medicated powder mastic is heated to 48 DEG C, coats on non-woven fabrics, room temperature is dried, and covers anti-stick layer, is cut into small pieces, and to obtain final product.
Embodiment 5
External treatment medicine prepared by optional above-described embodiment, carries out the clinical trial of Chinese medicine external application medicine.
According to parallel, random, controlled trial (RCT) design, strictly set up matched group [budesonide (budesonide) aerosol], observe the clinical efficacy that adds the external treatment Drug therapy Asthma in Remission Stage of preparing with embodiment 1-4.
One, case selection
1, diagnostic criteria
(1) Western medicine diagnose standard: 1. with reference to respirology branch of Chinese Medical Association asthma group " asthma guideline of prevention and treatment " in 2008 formulation.2. asthma grade scale: with reference to 4 grades of grade scales in GINA scheme in 2008.
(2) pant, cough, cough up phlegm, the state of an illness of wheezing sound symptom and sign and the relevant criterion that the degree criteria for classifying is formulated in " Chinese medicine (new drug) guideline of clinical investigations " with reference to health ministry bureau of drug administration for 1993.
(3) tcm diagnosis standard: deficiency of both the lung and kidney card.Main symptom: the breath of losing heart is short, moving for very, air-breathing unfavorable.Inferior disease: 1. easy catching a cold, waist soreness usually; 2. be afraid of cold, expectoration foams; 3. deep-thready pulse, pale tongue is fat.Meeting primary symptom+2 of inferior diseases is diagnosable assertive evidence.With reference to the dialectical standard of " deficiency of both the lung and kidney card " in " bronchial wheezing " in New Century higher institutions of Chinese medicine planning teaching material " Chinese Internal Medicine ".
2, test case standard
Include case in: (1) meets bronchial asthma (light, moderate) catabasis diagnostic criteria; (2) Chinese medical discrimination meets deficiency of both the lung and kidney card; (3) age between 18-75 year, male or female; (4) informed consent, volunteers tested.Obtain Informed Consent Form process and meet ethic principle.
Excluded cases (comprising inadaptable card and rejecting standard): other respiratory system diseases such as (1) pneumonia or pulmonary fibrosis or bronchiectasis, lung cyst etc. cause the person of panting; (2) bronchial asthma in acute attack stage patient; (3) chronic pulmonary heart disease (cardiac functional decompensatory period); (4) Chinese medical discrimination does not belong to deficiency of both the lung and kidney card person; (5) confirm on inspection by the patient that pants of the chronic cough due to the factors such as tuberculosis, fungus, tumor; (6) be associated with the serious primary disease such as cardiovascular, liver, kidney and hemopoietic system, or affect the serious disease of its existence, as tumor or acquired immune deficiency syndrome (AIDS); (7) age below 18 one full year of life or more than 75 years old person, anemia of pregnant woman or women breast-feeding their children; (8) all inclusive criterias that do not meet, not medication in accordance with regulations, cannot judge curative effect or the data judgement person that entirely do not affect the treatment; (9) this has used the Chinese and western drugs of other treatment asthma after falling ill.(10) because intelligence or behavior disorder are without consenter in the know.(11) there are ethanol and drug dependence medical history.(12) allergic constitution, as to two kinds or above medicine or food anaphylaxis history person; Or known to this medicine composition allergy sufferers.
Statistical method: clinical data and data, after inspection and verification, are inputted computer, mean ± standard deviation for measurement data (± SD represents), with many prescriptions difference analysis or t inspection.
Two, the standard of curative effect evaluation:
Judge total effects according to integration method, curative effect index (N)=(the rear integration of integration-treatment before treating)/integration × 100% before treating.Clinic control: N=90%; Effective: 70%< N <90%; Effective: 30%< N≤70%; Invalid: N≤30%.
Three, test method
1, group technology: employing (RCT method) is random, controlled trial is observed, the above-mentioned test case of including in is adopted to random pair group technology, on random table, find treatment group and matched group, and guarantee that two groups of cases approach (statistical procedures, two groups relatively P>0.05) substantially at aspects such as severity extent and sex, age, the courses of disease.
2, total case load 60 examples, treatment group 30 examples, matched group 30 examples.
3, Therapeutic Method
(1) external treatment medicine prepared by treatment group: stick medicine: embodiment 1.Stick acupuncture point: select bilateral FEIYU acupoint, XINYU acupoint, GEYU acupoint, PIYU acupoint, SHENYU acupoint, Gaomang point, totally 12 acupuncture points.Applying method: time: select and stick dog days, 1 Xiao Zhang that at every turn applies ointment or plaster (the bar cloth cream of preparing by above-mentioned example 1), sticks on above-mentioned acupuncture point.Application time: generally paste 3-6 hour/each.The course for the treatment of: playing subsides the first day of the first period of the hot season in summertime, pasted 1 time every 7 days, was only 1 course for the treatment of to the first day of the last period of the hot season, and finish 2 courses for the treatment of, follows up a case by regular visits to 1 year.
(2) matched group: budesonide (budesonide) aerosol, Wuxi Astra Pharmaceuticals Pty Ltd., authentication code (95) is defended the accurate word J-49(1 of medicine) (2) (3) number, specification has 200ug/100 spray.Slight: 200ug/d, 1 time every night; Moderate: 400ug/d, 1 time every night.The course for the treatment of: continuous use March was 1 course for the treatment of, medication finishes 2 courses for the treatment of, follows up a case by regular visits to 1 year.
Two groups during treating, except asthma in acute attack gives anti symptom treatment, viewing duration is without antibiotic, spasmolytic anti-asthmatic, the agent of Chinese medicine depressed lung-energy dispersing and treat relevant medicine to other and primary disease.
4, statistical result
Observe altogether case 60 people, wherein male 31 people, women 29 people.Wherein treatment group has male 16 people, women 14 people; Mean age is 40.97 years old, and standard deviation is 12.25; Average course of disease is 7.43, and standard deviation is 8.44.Matched group has male 15 people, women 15 people; Mean age is 40.80 years old, and standard deviation is 8.87; Average course of disease is 6.43, and standard deviation is 5.88.Ordinary circumstance (sex, age, the course of disease) before two groups of case treatments, difference not statistically significant (P>0.05).
Therapeutic outcome: treatment group clinic control 4 examples, effective 11 examples, effective 12 examples, invalid 3 examples, total effective rate is 90%; Matched group clinic control 2 examples, effective 6 examples, effective 16 examples, invalid 6 examples, total effective rate 80%.Two groups of total effective rates are relatively without significant (P > 0.05); The rear two groups of times of common cold for the treatment of, the comparison of asthma attack number of times: treat in January, relatively no significant difference (P > 0.05) of patient's times of common cold, asthma attack number of times and the matched group for the treatment of group, treat 3 months, 6 months and after 12 months, treatment group patient's times of common cold, asthma attack number of times are compared obvious minimizing compared with matched group, have statistical significance (P < 0.05); Treatment group pulmonary function (FEV1), peripheral blood EOS, blood ECP and total IgE before and after treatment have significant difference (P < 0.05) compared with matched group.

Claims (5)

1. one kind is used for the treatment of the external application compound medicine of catabasis of bronchitis asthma, it is characterized in that, be that raw material is made by the prepared slices of Chinese crude drugs of following parts by weight: 6~12 parts of Semen Sinapis Albaes, 1~3 part of Herba Asari, 6~12 parts of Rhizoma Arisaematis (processed), 2~5 parts of Radix Kansui (processed), 6~12 parts of Rhizoma Corydalis, 3~6 parts of Lignum Aquilariae Resinatum, 3~6 parts of Cortex Cinnamomis, 6~12 parts of Fructus Psoraleaes.
2. the external application compound medicine that is used for the treatment of catabasis of bronchitis asthma according to claim 1, it is characterized in that, be that raw material is made by the prepared slices of Chinese crude drugs of following parts by weight: 10 parts of Semen Sinapis Albaes, 2 parts of Herba Asaris, 8 parts of Rhizoma Arisaematis (processed), 4 parts of Radix Kansui (processed), 10 parts of Rhizoma Corydalis, 4 parts of Lignum Aquilariae Resinatum, 5 parts of Cortex Cinnamomis, 8 parts of Fructus Psoraleaes.
3. a method of preparing the external application compound medicine that is used for the treatment of catabasis of bronchitis asthma described in claim 1 or 2, is characterized in that, comprises the following steps:
1) square Chinese medicine mixes, and oven drying at low temperature is pulverized, and crosses 60 ~ 100 mesh sieves, and fine powder is for subsequent use;
2) get sodium carboxymethyl cellulose appropriate, add purified water swelling 24 hours, continue to add water that to be mixed with mass percent be 1~3% solution, for subsequent use;
3) in carboxymethylcellulose sodium solution, add glycerol, ethyl hydroxybenzoate, azone, make respectively its mass content reach 5 ~ 10%, 0.3 ~ 0.5%, 0.1 ~ 0.3%;
4) press the mass ratio of 1:1 ~ 3, step 1) fine powder is added in the carboxymethylcellulose sodium solution of step 3), fully mix, obtain medicated powder mastic;
5) medicated powder mastic is suitably heated, coat on non-woven fabrics, room temperature is dried, and covers anti-stick layer, is cut into small pieces, and to obtain final product.
4. the method for the external application compound medicine for the preparation for the treatment of catabasis of bronchitis asthma according to claim 3, is characterized in that: the maltose of the sodium carboxymethyl cellulose in method substitutes.
5. the method for the external application compound medicine for the preparation for the treatment of catabasis of bronchitis asthma according to claim 3, is characterized in that: the benzoic acid of the ethyl hydroxybenzoate in method or sodium benzoate substitute.
CN201410265894.7A 2014-06-16 2014-06-16 Externally applied compound medicament for treating catabasis of bronchial asthma, preparation method and application thereof Active CN104042811B (en)

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CN109172644A (en) * 2018-08-30 2019-01-11 成都中医药大学附属医院 A kind of point application therapy for treating bronchial asthma

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CN105362479A (en) * 2015-11-30 2016-03-02 武汉精英聚园科技有限公司 Preparation method of plaster capable of relieving bronchial asthma
CN109172644A (en) * 2018-08-30 2019-01-11 成都中医药大学附属医院 A kind of point application therapy for treating bronchial asthma

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