CN102178799B - Chinese medicinal composition for treating infantile asthma and preparation method thereof - Google Patents
Chinese medicinal composition for treating infantile asthma and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Chinese medicinal composition for treating infantile asthma and a preparation method thereof. The Chinese medicinal composition is prepared from the following components: heterophylly falsestarwort root, gingko, glossy privet fruit, oriental waterplantain rhizome, snakegourd fruit, root of velutinous indigo and the like. The preparation method comprises the following steps of: decocting the six medicaments in water for three times, namely decocting for 2 hours at the first time, and decocting for 1 hour at the second time and at the third time respectively; merging decoction, filtering, concentrating filter liquor to form thick paste, grinding into superfine powder (the grain diameter is less than 5 micrometers), mixing the superfine powder and a proper amount of Tween 80, Arlacel 80 and laurinol sodium sulfate uniformly to form liquid for later use; subpackaging the liquid in a container, arranging a valve, rolling a seal cap tightly, and filling F12 by a pressure filling method to prepare appropriate aerosol. By long-term study and practice, the Chinese medicinal composition has a reasonable formula and an advanced process, does not have side effect, has the effects of tonifying lung and kidney, eliminating phlegm, relieving cough and depressing qi and relieving asthma, has the obvious effects on diseases such as bronchitis, cold-heat deficient asthma and the like, and is a medicament which is low in cost, high in quality, less in dosage, quick in response and high in curative effect, is convenient to carry and is satisfactory.
Description
Technical field
The present invention relates to field of medicaments is a kind of Chinese medicine composition for the treatment of asthma in children and preparation method thereof.
Background technology
Asthma is the respiratory system common disease, is a kind of very obstinate chronic disease, and patient's misery is very large.Therefore someone lost work even viability.The whole world has 1～1.5 hundred million people to suffer from asthma at present, approximately has every year 180000 people to die from this disease.Its patient and death toll are just in fast rise.World Health Organization (WHO) announces: whole world asthma prevalence rose approximately 50% in average per 12 years, and attractive especially is that Chinese children asthma prevalence is 2%～5%, and wherein 1～5 years old child morbidity rate is up to 85%.At present, doctor trained in Western medicine thinks that asthmatic patient is how relevant with gene genetic, often with family history, can fall ill when young; Some patients are subjected to the factor affecting such as body constitution, and morbidity is often relevant with season, environment.Some patient's four seasons show effect, the seasonal outbreak of some patients, and all because of frequency and the many cataclysms of autumn and winter climate flip, viral respiratory tract infection more cold season of sickness rate increases for this.In the last few years; clinical both at home and abroad adopt aminophyllines more, disappear and cough peaceful or cut sieve treatment tracheitis, asthma, the curative effect of just taking is better, and then patient body is stronger to the Western medicine Drug resistance; to this often repeatedly chronic disease of asthma; then need strengthen dosage, to reach therapeutic effect, what have also was difficult to find out effect because the Drug resistance reason has both made the increasing dosage; simultaneously; the toxic and side effects of these medicines is larger, and complication is many, makes numerous often ill weak patients be difficult to take.In addition, some Western medicine something in common is to take stopgap measures and do not effect a permanent cure, and the effect duration is short, still has the drawback of the large and effect relative mistake of dose.
Summary of the invention
Purpose of the present invention is exactly the deficiency for above-mentioned technology, aims to provide a kind ofly when treating asthma attack, and drug effect is strong, onset is very fast and the Chinese medicine composition of the treatment asthma for the treatment of both the principal and secondary aspects of a disease.The traditional Chinese medical science thinks that the wind root that asthma is shown effect repeatedly is " expectorant stasis of blood volt lung ", and adopt controlled the rule direction of medication usage that gas is elder generation more.Concerning the misery that solves vast asthmatic patient, the present invention is through long-term research and practice, scientific composition, meticulously make, technique is advanced, the performance Chinese Herbs is good, the speciality that has no side effect, be a kind of good and cheap, consumption is little, instant effect, curative effect are high, the gratifying asthma medication that is easy to carry and uses.
Chinese medicine composition of the present invention mainly is comprised of Radix Pseudostellariae, Semen Ginkgo, Radix Ligustri Lucidi, Rhizoma Alismatis, Fructus Trichosanthis, Radix Lespedezae Buergeri etc.Radix Pseudostellariae is the Qi-tonifying drug in the qi-restoratives medicine in the side, and function is mended strengthening spleen and lung, supplementing QI for promoting the production of body fluid.Cure mainly the cough due to deficiency of the lung, insufficiency of the spleen lack of appetite, cardiopalmus, palpitation with a distress feeling, edema is quenched one's thirst, and spirit is tired.The Semen Ginkgo gas of astringing the lung, relieving asthma and cough, leukorrhagia stopping is turbid, urine reducing.Cure mainly asthma, phlegmatic cough, leucorrhea, nebulousurine, seminal emission, gonorrhea, frequent micturition.Two medicines energy invigorating the lung and the kidney, lowering the adverse-rising QI to subdue asthma are monarch drug in the side; Rhizoma Alismatis function diuretic, eliminating dampness by diuresis expels the heat-evil.Cure mainly dysuria, edema distension, vomiting, dysentery, phlegm retention, beriberi, gonorrhea, hematuria.The lung moistening of Fructus Trichosanthis function is reduced phlegm, eliminating stagnation, laxation.Cure mainly phlegm-heat cough, the thoracic obstruction, blocked-up chest, the consumptive lung disease hemoptysis is quenched one's thirst, jaundice, constipation, carbuncle from the beginning of.Two medicines can eliminate the phlegm, cough-relieving, relieving asthma, and are ministerial drug in the side; The Radix Ligustri Lucidi merit is ended pain due to disorder of QI for loose QI and blood.Cure mainly the breast disease, cough, leucorrhea; The Radix Lespedezae Buergeri function is induced sweat, and reduces phlegm, and dampness removing is invigorated blood circulation, and cures mainly cold heating, headache, cough, stranguria with turbid discharge, women's abdominal pain due to blood stasis, metrorrhagia, carbuncle, erysipelas.Two medicines can be invigorated blood circulation, reduced phlegm, cough-relieving, relievining asthma is adjuvant in the side.The etiology and pathogenesis of the complete square asthma in children that links closely, scientific and reasonable compatibility, treating both the principal and secondary aspects of a disease, the merit of total invigorating the lung and the kidney, expelling phlegm for arresting cough, lowering the adverse-rising QI to subdue asthma.
Purpose of the present invention aims to provide and a kind ofly can either play fine treatment or relief of symptoms effect to infantile asthma, have the advantages such as good effect, speed is fast, price is low, have no side effect, a kind of Chinese medicine composition that can make again the patient bear, take like a shot without psychology.The present invention is according to understanding and the Therapeutic Principle of the traditional Chinese medical science to asthma, realizes by following technical scheme.
The consumption of drug component of the present invention is groped to sum up to draw through the inventor in a large number, and each amounts of components has preferably curative effect in following ranges, and medicine of the present invention contains
155～465 parts of 155～465 parts of Radix Ligustri Lucidis of 155～999 portions of Semen Ginkgoes of Radix Pseudostellariae
155～335 parts of 155～465 parts of Radix Lespedezae Buergeris of 155～465 parts of Fructus Trichosanthiss of Rhizoma Alismatis
Preferable range is;
165～496 parts of 331～499 parts of Radix Ligustri Lucidis of 498～998 portions of Semen Ginkgoes of Radix Pseudostellariae
155～285 parts of 331～465 parts of Radix Lespedezae Buergeris of 331～465 parts of Fructus Trichosanthiss of Rhizoma Alismatis
Optimum weight part is:
465 parts of 331 parts of Radix Ligustri Lucidis of 662 portions of Semen Ginkgoes of Radix Pseudostellariae
255 parts of 465 parts of Radix Lespedezae Buergeris of 465 parts of Fructus Trichosanthiss of Rhizoma Alismatis
Technical problem to be solved by this invention is to realize by following technical scheme.Be characterized in the medicine made take Radix Pseudostellariae, Semen Ginkgo, Radix Ligustri Lucidi, Rhizoma Alismatis, Fructus Trichosanthis, Radix Lespedezae Buergeri etc. as raw material, the Chinese medicine composition of this treatment asthma is characterized in that it is that component forms or makes active component and pharmaceutically acceptable additives form or make active component and pharmaceutically acceptable additives form by the alcohol extract of following main materials by the water extract of following main materials by following main materials.The present invention has invigorating the lung and the kidney, expelling phlegm for arresting cough, lowering the adverse-rising QI to subdue asthma effect by scientific combination, meticulously development, and to bronchitis, the disease effects such as children's's cold and heat dyspnea due to deficiency are significantly.
Described pharmaceutically acceptable additives are following one or more: Pulvis Talci, Tween 80, sorbester p17, sodium laurylsulfate, glycerol, gelatin, Polyethylene Glycol, propylene glycol, dextrin, ethanol, dried starch, citric acid, sodium bicarbonate, ethyl hydroxybenzoate, tartaric acid, lecithin, sodium lauryl sulphate.
Its dosage form is said dosage form on any pharmaceutics, such as aerosol, syrup, granule, capsule, tablet etc.; Described capsule is common capsule, effervescent capsule or other various suitable capsules; Described tablet is common tablet, effervescent tablet, dispersible tablet or other various suitable tablets, uses suitable coating material coating or does not carry out coating.
Describe implementation of the present invention in detail below in conjunction with embodiment.
Embodiment 1: the preparation method of aerosol of the present invention:
Take by weighing by weight Radix Pseudostellariae 662 gram, Semen Ginkgo 331 grams, Radix Ligustri Lucidi 465 grams, Rhizoma Alismatis 465 grams, Fructus Trichosanthis 465 grams, Radix Lespedezae Buergeri 165 grams for subsequent use.Get Radix Pseudostellariae, Semen Ginkgo, Radix Ligustri Lucidi, Rhizoma Alismatis, Fructus Trichosanthis, Radix Lespedezae Buergeri water decocts and boiled 2 hours three first time, respectively boiled for the third time 1 hour for the second time,, merge decoction liquor, filter, filtrate is concentrated into the thick paste shape, and being ground into micropowder (particle diameter is less than 5um) becomes aqueous for subsequent use with an amount of Tween 80, sorbester p17, sodium laurylsulfate mixing.Aforesaid liquid is sub-packed in the container, loads onto valve, roll tight sealing cap, pour into F12 with pressure filling, namely be made for suitable aerosol.
Embodiment 2: the preparation method of capsule of the present invention:
Take by weighing by weight Radix Pseudostellariae 662 gram, Semen Ginkgo 331 grams, Radix Ligustri Lucidi 465 grams, Rhizoma Alismatis 465 grams, Fructus Trichosanthis 465 grams, Radix Lespedezae Buergeri 265 gram grams for subsequent use.Get Radix Pseudostellariae, Semen Ginkgo, Radix Ligustri Lucidi, Rhizoma Alismatis, Fructus Trichosanthis, Radix Lespedezae Buergeri water and decoct and boiled 2 hours three first time, respectively boiled 1 hour for the second time, for the third time, merge decoction liquor, filter, filtrate is concentrated into the thick paste shape, adds ethanol precipitation once, makes to contain the alcohol amount and reach 65%, standing over night, filter, decompression recycling ethanol also is concentrated into the thick paste shape, adds appropriate amount of starch, granulate dry for standby; Add an amount of Pulvis Talci, with the abundant mixing of above-mentioned granule, make capsule.
In like manner, press the method for embodiment 2, make suitable granule or tablet etc.
In above each composition, weight is calculated with crude drug, in the present invention, if weight in grams, this composition can be made into 1000 doses of pharmaceutical preparatioies, described 1000 doses of fingers, 1000 doses in the final drug preparation of making, as make 1000 of 1000 of capsule preparations, 1000 in tablet, granule 1000S, oral liquid 1000 ampullas, injection 1000 ampullas, drop pill etc., also can make large packing as granule, such as the 100--500 bag, specifically can be 100 bags, 150 bags, 200 bags, 250 bags, 500 bags, every bag can be used as dose 1 time.This weight of formulation can increase or reduce, but the raw medicinal herbs weight proportion constant rate between each composition.
For a better understanding of the present invention, below further set forth that medicine effect of the present invention is learned and the action effect of clinical experiment, but not to the restriction of effect of the present invention.
(1) experiment material:
1, Experimental agents: the present invention is the asthma capsule, and is oral, each 4, and 3 times on the one.
2, laboratory animal: Kunming mouse, Zhejiang medical courses in general institute zoopery center provides.
(2) antitussive experiment:
30 of Kunming mouses, male and female dual-purpose, body weight 18～20g divide 3 groups at random. and 10 every group, gavage gives drug solution of the present invention respectively, high dose 20g/kg, low dose group matched group 10g/kg; The capacity water such as matched group, once a day, continuous three days.After the last administration 30 minutes, by only Mus being put into glass bell jar, put into long 10cm from bell jar is suitable for reading, wide 1.5cm is the filter paper bar still, and the above drips 0.5ml ammonia, airtight, the cough latent period of mice is whenever changed a Mus behind the observation suction ammonia, changes a filter paper bar, whenever all drip 0.5ml ammonia, experimental result sees Table 1.
The antitussive action of table 1 asthma capsule
With matched group than * P＜0.05 * * P＜0.01
T check between group: high low dose group antitussive effect all has significant, P＜0.01 and P＜0.05.
(3), the experiment of eliminating the phlegm: 30 of Kunming mouses, body weight 18～20g divide 3 groups at random.Every group 10, gavage gives the solution of asthma capsule respectively, high dose 20g/kg. low dose group matched group 10g/kg; The capacity water such as matched group, once a day, continuous three days, after the last administration 30 minutes, every Mus lumbar injection 0.5% phenol red 0.5ml was after half an hour.Take off cervical vertebra and put to death mice, face upward the position and be fixed on the operation plate, cut off neck center skin, separate trachea, under larynx injection needle is inserted trachea, ligation is fixed, and draws 5% carbonate ammonia natrium solution 0.5ml. flushing respiratory tract three times with syringe.Amount to flushing three times, totally nine times.Each flushing liquor is put into test tube, with 751 ultraviolet spectrophotometer colorimetrics.Experimental result sees Table 2.
Table 2: the phlegm-dispelling functions of asthma capsule
With matched group than * P＜0.05 * * P＜0.01
T check between group, high low dose group is eliminated the phlegm all has significant (P＜0.01 and P＜0.05)
Experiment conclusion: by the relieving cough and expelling phlegm experiment, confirm that the asthma capsule has obvious cough-suppressing phlegm-dispelling functions.
(4) clinical verification:
Clinical verification of the present invention is take Diagnosis of Children with Asthma standard (tentative program that national During Prevention of Asthma in Children cooperative groups was formulated in 1993) as foundation:
(1) infantile asthma diagnostic criteria (scoring method)
1. scoring method
All age＜3 year old, pant and repeatedly send out author's principle of scoring:
1. outbreak＞3 time (3 minutes) of panting;
2. pulmonary's sound (2 minutes) that occurs stridulating;
3. break out (1 minute) of panting;
4. other atopy medical histories (1 minute);
Asthma medical history (1 minute) is 5. arranged among the I and II relatives.
2. point system
(1) total points 〉=5 a minute person diagnoses infantile asthma.
(2) pant outbreak only 2 times or total points≤4 minute person's tentative diagnosis be suspicious asthma (asthmatic bronchitis), can do following any test such as pulmonary's sound of stridulating:
1. the each 0.01ml/kg of 1% epinephrine, subcutaneous injection, the alleviation of panting after 15～20 minutes, or stridulate sound obviously minimizing person add 2 minutes.
2. suck with salbutamol aerosol or salbutamol solution atomization, observe and pant or the sound of stridulating changes situation, as reduce obvious person and can add 2 minutes.
(2) Diagnosis of Children with Asthma standards more than 3 years old
1. pant to be and repeatedly send out author's (maybe can review relevant with certain allergen or stimulating factor).
2. pulmonary hears and the sound of stridulating when showing effect.
3. anti-asthmatic has obvious curative effects, and suspected case can be selected 1% epinephrine subcutaneous injection 0.01ml/kg, and maximum is not more than 0.3ml/ time, or sucks 15 minutes with salbutamol aerosol or solution atomization, observes to have or not obvious curative effects.
(3) cough variant asthma diagnostic criteria
1. cough continues or outbreak＞January repeatedly, and be everlasting night (or early morning) shows effect, and expectorant is few, the motion postemphasis.Clinical in infection sign, or invalid through the longer-term antibiotic therapy.
2. can make coughing fit alleviate (basic diagnosis condition) with bronchodilator.
3. a guy's allergies or family's allergies, air flue is high response, and positive grade of allergen skin test can be made auxiliary diagnosis.
(4) state of an illness calibration can be simultaneously with reference to maximum expiratory flow rate (PEF) and PEF aberration rate such as＞5 years old child.
1. slight of short duration outbreak＜1～2 time/week, night-time attack＜1～2 time/month, interictal is asymptomatic, PEF or forced expiratory volume in first second (FEV1)＞80% predicted value, PEF aberration rate＜20%.
2.＞1～2 times/week of moderate outbreak, night-time attack 〉=2 time/month, PEF or FEV1 are 60%～80% predicted value, PEF aberration rate 20%～30%, active receiving restriction.
3. severe is often shown effect and night-time attack, PEF and FEV＜60% predicted value, and PEF aberration rate＞30% has a strong impact on daily life.
The present invention take domestic aminophylline as contrast, is divided into two group to 300 routine patients through Zhejiang Province's First Hospital clinical verification, and every group is that 150 people treat observation.Its criterion: the three days clinical symptoms partial rcsponses of taking medicine are produce effects, and the three days clinical symptoms of taking medicine substantially disappearance person are recovery from illness.Its Cure sees Table 3.
Table 3. clinical test results is as follows;
With matched group than * P＜0.05
The present invention is by long-term research and practice, reasonable recipe, technique is advanced, gives full play to the speciality that Chinese Herbs is good, have no side effect, be a kind of good and cheap, consumption is little, instant effect, curative effect are high, the gratifying asthma in children medication that is easy to carry and uses.
Claims (7)
1. Chinese medicine composition for the treatment of asthma in children, it is characterized in that: it is by the water extract of following raw materials according or alcohol extract is made active component and pharmaceutically acceptable additives form, and the weight portion of each raw material is: 155～999 parts of Radix Pseudostellariaes, 155～465 parts of Semen Ginkgoes, 155～465 parts of Radix Ligustri Lucidis, 155～465 parts of Rhizoma Alismatis, 155～465 parts of Fructus Trichosanthiss, 155～335 parts of Radix Lespedezae Buergeris.
2. a kind of Chinese medicine composition for the treatment of asthma in children according to claim 1, it is characterized in that: the weight portion of described each raw material is: 662 parts of Radix Pseudostellariaes, 331 parts of Semen Ginkgoes, 365 parts of Radix Ligustri Lucidis, 365 parts of Rhizoma Alismatis, 365 parts of Fructus Trichosanthiss, 255 parts of Radix Lespedezae Buergeris.
According to claim 1 described a kind of treat asthma in children the preparation method of Chinese medicine composition, it is characterized in that: take by weighing Radix Pseudostellariae, Semen Ginkgo, Radix Ligustri Lucidi, Rhizoma Alismatis, Fructus Trichosanthis, Radix Lespedezae Buergeri by the proportioning of described weight for subsequent use; Get above medicine water and decoct three times, boiled 2 hours for the first time, respectively boiled 1 hour for the second time, for the third time, merge decoction liquor, filter, filtrate is concentrated into the thick paste shape, be ground into micropowder, its particle diameter is less than 5um, with an amount of Tween 80, sorbester p17, sodium laurylsulfate mixing be aqueous for subsequent use; Aforesaid liquid is sub-packed in the container, loads onto valve, roll tight sealing cap, pour into F with pressure filling
12,, namely be made for suitable aerosol.
4. a kind of Chinese medicine composition for the treatment of asthma in children according to claim 1 is characterized in that: described pharmaceutically acceptable additives are following more than one: F
12,, Pulvis Talci, Tween 80, sorbester p17, sodium laurylsulfate, glycerol, gelatin, Polyethylene Glycol, glycerol, propylene glycol, dextrin, dried starch, ethylparaben, citric acid, sodium bicarbonate, lecithin, sodium lauryl sulphate.
5. a kind of Chinese medicine composition for the treatment of asthma in children according to claim 1, it is characterized in that: its dosage form is granule, capsule or tablet.
6. a kind of Chinese medicine composition for the treatment of asthma in children according to claim 5, it is characterized in that: its capsule is the effervescent capsule.
7. a kind of Chinese medicine composition for the treatment of asthma in children according to claim 5 is characterized in that: described tablet is effervescent tablet or is dispersible tablet, with suitable coating material coating.
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| 任勤.小儿哮喘中医治疗进展.《首届国际中西医结合***反应学术会议暨全国中西医结合***反应第三次学术会议资料汇编,》.2007,452-454. * |
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