CN103735677B - A kind of Chinese medicine composition and preparation method and application being used for the treatment of bronchial asthma - Google Patents
A kind of Chinese medicine composition and preparation method and application being used for the treatment of bronchial asthma Download PDFInfo
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- CN103735677B CN103735677B CN201410022162.5A CN201410022162A CN103735677B CN 103735677 B CN103735677 B CN 103735677B CN 201410022162 A CN201410022162 A CN 201410022162A CN 103735677 B CN103735677 B CN 103735677B
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Abstract
The invention provides a kind of Chinese medicine composition being used for the treatment of bronchial asthma, it is prepared by the raw material of following parts by weight: Herba Ephedrae 4-8 part, Semen Lepidii (Semen Descurainiae) 8-12 part, Fructus Mume 8-10 part, Ganoderma 10-14 part, Radix Sophorae Flavescentis 10-14 part, Herba Erodii 15-25 part, Radix Morindae Officinalis 8-12 part, Radix Glycyrrhizae 4-8 part, and have employed corresponding preparation method, be prepared into oral liquid, tablet, capsule or granule, all medicines share, play lung qi dispersing cold expelling altogether, resolving phlegm and relieving asthma, make that lung qi must be declared, wind and cold must be separated, hold concurrently with correction, then breathe heavily, cough, all diseases of expectorant explain by oneself, be used for the treatment of bronchial asthma.
Description
Technical field
The present invention relates to technical field of Chinese medicines, be specifically related to a kind of Chinese medicine composition and the preparation method and application that are used for the treatment of bronchial asthma.
Background technology
Bronchial asthma is a kind of chronic inflammation disease participated in various kinds of cell and cytokine, and chronic airway inflammation causes airway hyperreactivity, thus produces the symptoms such as the panting of recurrent exerbation, uncomfortable in chest, dyspnea and cough, is especially mainly in night and morning.Asthma harm is extensive, nearly 300,000,000 patients in the whole world, and sickness rate is also in continuous rising, annual world wide dies from the patient nearly 250,000 of asthma, the asthma prevalence of many countries and regions is in rising trend, and particularly over nearly 20 years, it is obvious that asthma prevalence and case fatality rate increase trend.All the time, it is believed that asthma is the disease that cannot cure, and 2006 GINA (GINA) propose and emphasize that asthma can control, lack very much one at present and treat bronchial asthma Chinese medicine preparation safely and effectively.
Summary of the invention
Goal of the invention: in order to solve the problem, the object of the present invention is to provide a kind of Chinese medicine composition and the preparation method and application that are used for the treatment of bronchial asthma.
Technical scheme: the object of the invention is by following scheme realize:
Be used for the treatment of a Chinese medicine composition for bronchial asthma, it is prepared by the raw material of following parts by weight: Herba Ephedrae 4-8 part, Semen Lepidii (Semen Descurainiae) 8-12 part, Fructus Mume 8-10 part, Ganoderma 10-14 part, Radix Sophorae Flavescentis 10-14 part, Herba Erodii 15-25 part, Radix Morindae Officinalis 8-12 part, Radix Glycyrrhizae 4-8 part.
The above-mentioned Chinese medicine composition being used for the treatment of bronchial asthma, it is prepared by the raw material of following parts by weight: 6 parts, Herba Ephedrae, Semen Lepidii (Semen Descurainiae) 10 parts, Fructus Mume 9 parts, Ganoderma 12 parts, Radix Sophorae Flavescentis 12 parts, Herba Erodii 20 parts, Radix Morindae Officinalis 10 parts, 6 parts, Radix Glycyrrhizae.
The above-mentioned Chinese medicine composition being used for the treatment of bronchial asthma, described raw material adds adjuvant and makes oral liquid, tablet, capsule or granule after extracting.
The above-mentioned Chinese medicine composition being used for the treatment of bronchial asthma, described adjuvant is one or more of dextrin, lactose, starch, sucrose, glucose, microcrystalline Cellulose, mannose, methylcellulose, hydroxypropyl cellulose, carboxymethyl cellulose and stevioside.
The above-mentioned preparation method being used for the treatment of the Chinese medicine composition of bronchial asthma, it comprises the steps: to get Herba Ephedrae, Semen Lepidii (Semen Descurainiae), Fructus Mume, Ganoderma, Radix Sophorae Flavescentis, Herba Erodii, Radix Morindae Officinalis, licorice medicinal materials merges, decoct with water twice, collecting decoction, when being evaporated to 65 DEG C, relative density is the extractum of 1.15-1.20, adding ethanol makes the percent by volume of alcohol content reach 75-85%, stir, leave standstill, filter, during filtrate reduced in volume to 65 DEG C, relative density is 1.25-1.30, and reclaim ethanol, obtain concentrated solution, concentrated solution to be added water and auxiliaries becomes oral liquid, or by concentrated solution spraying dry, add adjuvant and make capsule, tablet, granule.
The above-mentioned preparation method being used for the treatment of the Chinese medicine composition of bronchial asthma, in step, decocting condition is: first time adds water as the 8-12 times amount of medical material weight, decocts 1-2h, and second time adds water as the 6-10 times amount of medical material weight, decocts 1-2h.
The above-mentioned preparation method being used for the treatment of the Chinese medicine composition of bronchial asthma, in step, spray drying condition is: inlet temperature is 80-120 DEG C, leaving air temp is 80-90 DEG C, temperature of charge is 70-90 DEG C, and atomizing pressure is 0.2-0.4 MPa, and spray velocity is 5-10ml/s.
The above-mentioned application of Chinese medicine composition in the medicine of preparation treatment bronchial asthma being used for the treatment of bronchial asthma.
Chinese medicine of the present invention is pharmacopeia kind.
Beneficial effect:
1, bronchial asthma is the chronic inflammatory airway disease participated in by inflammation cell and cytokine, in motherland's medical science, belong to the scope of " bronchial wheezing ", bronchial wheezing is due to retained phlegm volt lung, meets inducement or feels heresy and draw tactile, so that stagnation of phlegm air flue, impairment of purifying and descending function of the lung, the ictal rale that airway spasm causes and asthma illness, with whistling sound in the throat during outbreak, tachypnea and dyspnea, even asthma can not put down sleeping main manifestations.Just as " cause of disease arteries and veins card bronchial wheezing " said " bronchial wheezing because of, phlegm retention stays volt, forms stereotype; hide in interior; the even criminal having seven emotions, the wound of diet, or its flesh table of wind and cold bundle having season outward; the then disease work of asthma "; Yuan Dynasty Dan Xi initiates " asthma " name of disease, and set forth the pathogenesis of " asthma is specially main in expectorant ", its pathological change is drawn tactile for " latent phlegm " meets sense; phlegm rising following QI; gas because of expectorant block up, method of mutually fighting, be jammed air flue; lung pipe contraction is anxious narrow; unobstructed unfavorable, lung qi a surname falls not normal, and priming stops the expectorant amassed; and cause rale as shouted, dyspnea with rapid breath." card as converge mend " is said " because of in have the gas be jammed, sense when having non-outward, the expectorant that diaphragm has glue solid, three is harmonious, and closes and refuses air flue, fights with sound, is bronchial wheezing ".Due to illness therefore different, body constitution is variant, therefore has dividing of asthma of cold-type, asthma of heat type, brings out, innate deficiency of YANG in the body because of cold, and expectorant is from cold transformation, and belonging to cold-phlegm for suffering from is then asthma of cold-type; If because pathogenic heat is brought out, innate excess of YANG in the body, expectorant is from transconversion into heat, and belonging to heat-phlegm for suffering from is then asthma of heat type.The suitable dispersing the stagnated lung-QI by warm drugs of cold-phlegm in treatment, heat-phlegm works as clearing away heat and eliminating phlegm to keep the function of the lung, and " Jing Yue's complete work dyspnea with rapid and short breath " is said, and " righting gas person, must distinguish negative and positive, its moon of cloudy nourishing for deficiency, its sun of positive nourishing for deficiency.Attack pathogen person, must be point very micro-, or its wind loose, or Wen Qihan, or its phlegm-fire clearly ", the Therapeutic Principle that Dan Xi also proposes " do not send out based on righting gas, both sent out to attack pathogen for urgency ".Side's epheday intermedia lung qi dispersing is loose evil in relieving asthma for monarch; Radix Morindae Officinalis the kidney invigorating warming YANG, resolving phlegm and relieving asthma, matches with Herba Ephedrae, and can faling apart, it is trembled with fear, and its wind of dispelling again, the power that dispersing lung-QI and dissipating phlegm is relievingd asthma is stronger.Fructus Mume astringing lung QI for relieving asthma, matches with Herba Ephedrae, and one receives one falls apart, and both can strengthen the effect of relievining asthma, can prevent again Herba Ephedrae dissipation lung qi.Semen Lepidii (Semen Descurainiae) eliminating pathogen from the lung for relieving asthma, inducing diuresis to remove edema, associates with Herba Ephedrae, and it is minister altogether that a surname one rushes down the merit strengthening depressed lung-energy dispersing.Radix Sophorae Flavescentis is relievingd asthma and is eliminated the phlegm, Herba Erodii relieving cough and asthma, and Ganoderma correction relieving cough and resolving phlegm is relievingd asthma, and is adjuvant drug; Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, for making, has again invigorating the spleen and replenishing QI nourishing the lung to arrest cough, with Ganoderma with the effect having used treating both the principal and the secondary aspects of a disease at the same time.All medicines share, and play lung qi dispersing cold expelling altogether, resolving phlegm and relieving asthma, make that lung qi must be declared, wind and cold must be separated, hold concurrently with correction, then breathe heavily, cough, all diseases of expectorant explain by oneself.
2, Formulation of the present invention is reasonable, and compatibility is rigorous, through long-term clinical verification, and determined curative effect.
3, the present invention consists of Chinese crude drug, has no side effect, low price.
4, we are according to the principle of theory of Chinese medical science " symptomatic treatment in acute condition; relieving the primary symptom in a chronic case ", in conjunction with the understanding of modern medicine to asthma, based on clinical experience side, adopt the principle of warming lung for dispelling cold, resolving phlegm and relieving asthma, select active drug to be processed into granule, be developed into one with Ji and treat acute bronchial asthma good effect, be convenient to the medicine taken, thus meet the needs of extensive patients, there is significant clinical benefit and social benefit.
Detailed description of the invention
Form by the following examples, foregoing of the present invention is described in further detail again, but this should be interpreted as that the scope of the above-mentioned theme of the present invention is only limitted to following example, all technology realized based on foregoing of the present invention all belong to scope of the present invention.
1, in conjunction with detailed description of the invention, the present invention is further described as follows:
2, according to the form below, listed weight proportion takes raw material required for the present invention, unit: g
| Herba Ephedrae | Semen Lepidii (Semen Descurainiae) | Fructus Mume | Ganoderma | Radix Sophorae Flavescentis | Herba Erodii | Radix Morindae Officinalis | Radix Glycyrrhizae | |
| 1 | 4 | 12 | 8 | 14 | 10 | 25 | 8 | 8 |
| 2 | 6 | 10 | 9 | 12 | 12 | 20 | 10 | 6 |
| 3 | 8 | 8 | 10 | 10 | 14 | 15 | 12 | 4 |
3. prepare embodiment
More than showing Raw proportioning is example, comprises the following steps:
Embodiment 1: get Herba Ephedrae 4g, Semen Lepidii (Semen Descurainiae) 12g, Fructus Mume 8g, Ganoderma 14g, Radix Sophorae Flavescentis 10g, Herba Erodii 25g, Radix Morindae Officinalis 8g, Radix Glycyrrhizae 8g medical material merges, decoct with water twice, first time adds water as 10 times amount of medical material weight, decoct 1.5h, second time adds water as 8 times amount of medical material weight, decoct 1.5h, collecting decoction, 0.07MPa, when being evaporated to 65 DEG C at 60-70 DEG C, relative density is the extractum of 1.15, adding 95% (v/v) ethanol makes alcohol content reach 75% (v/v), stir, leave standstill 24 hours, filter, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.25 to relative density when 65 DEG C, and reclaim ethanol, obtain concentrated solution, by concentrated solution spraying dry, (condition is inlet temperature is 100 DEG C, leaving air temp is 85 DEG C, temperature of charge is 80 DEG C, atomizing pressure is 0.2 MPa, spray velocity is 5ml/s.), add appropriate amount of starch, dry granulation, cross 60 mesh sieves, load No. 1 capsule capsule.
Embodiment 2: get Herba Ephedrae 8g, Semen Lepidii (Semen Descurainiae) 8g, Fructus Mume 10g, Ganoderma 10g, Radix Sophorae Flavescentis 14g, Herba Erodii 15g, Radix Morindae Officinalis 12g, Radix Glycyrrhizae 4g medical material merges, decoct with water twice, first time adds water as 8 times amount of medical material weight, decoct 1h, second time adds water as 6 times amount of medical material weight, decoct 1h, collecting decoction, 0.07MPa, when being evaporated to 65 DEG C at 60-70 DEG C, relative density is 1.20, adding 95% (v/v) ethanol makes alcohol content reach 80% (v/v), stir, leave standstill 24 hours, filter, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.30 to relative density when 65 DEG C, and reclaim ethanol, obtain concentrated solution, filter, to add water and sucrose is mixed with oral liquid.
Embodiment 3: get Herba Ephedrae 6g, Semen Lepidii (Semen Descurainiae) 10g, Fructus Mume 9g, Ganoderma 12g, Radix Sophorae Flavescentis 12g, Herba Erodii 20g, Radix Morindae Officinalis 10g, Radix Glycyrrhizae 6g medical material merges, decoct with water twice, first time adds water as 12 times amount of medical material weight, decoct 2h, second time adds water as 10 times amount of medical material weight, decoct 2h, collecting decoction, 0.07MPa, when being evaporated to 65 DEG C at 60-70 DEG C, relative density is the extractum of 1.20, adding 95% (v/v) ethanol makes alcohol content reach 85% (v/v), stir, leave standstill 24 hours, filter, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.30 to relative density when 65 DEG C, and reclaim ethanol, obtain concentrated solution, by concentrated solution spraying dry, (condition is inlet temperature is 120 DEG C, leaving air temp is 90 DEG C, temperature of charge is 90 DEG C, atomizing pressure is 0.4 MPa, spray velocity is 10ml/s.), add appropriate dextrin, mix homogeneously, with appropriate 80% (v/v) ethanol wet, soft material processed, cross 30 mesh sieves and granulate, in 70 ~ 80 DEG C of dryings, with 60 mesh sieve granulate, tabletting, sugar coating, obtains tablet.
Embodiment 4: get Herba Ephedrae 6g, Semen Lepidii (Semen Descurainiae) 10g, Fructus Mume 9g, Ganoderma 12g, Radix Sophorae Flavescentis 12g, Herba Erodii 20g, Radix Morindae Officinalis 10g, Radix Glycyrrhizae 6g medical material merges, decoct with water twice, first time adds water as 10 times amount of medical material weight, decoct 1.5h, second time adds water as 8 times amount of medical material weight, decoct 1.5h, collecting decoction, 0.07MPa, when being evaporated to 65 DEG C at 65 DEG C, relative density is the extractum of 1.15, adding 95% (v/v) ethanol makes alcohol content reach 80% (v/v), stir, leave standstill 24 hours, decompression filtrate recycling ethanol is also concentrated, filtrate is at 0.07MPa, under 65 DEG C of conditions, concentrating under reduced pressure one-tenth is 1.25 to relative density when 65 DEG C, and reclaim ethanol, obtain concentrated solution, by concentrated solution spraying dry, (condition is inlet temperature is 110 DEG C, leaving air temp is 80 DEG C, temperature of charge is 70 DEG C, atomizing pressure is 0.3 MPa, spray velocity is 7.5ml/s.), add appropriate lactose, with appropriate 80% (v/v) ethanol wet, soft material processed, cross 14 mesh sieves and granulate, 70-80 DEG C of drying, 60 order granulate, obtain granule, and called after peace breathes heavily granule.
4. pair bronchial asthma in acute attack asthma of cold-type disease clinical research data is summed up
4.1 physical data
Case is originated: observe case and derive from Jiangsu Prov. Research Inst. Traditional Chinese Medical breathing training 2008.03-2008.11 month outpatient service branchial asthma patients.Ordinary circumstance: 1. Sex distribution: male 7 example, women 16 example.2. age distribution: 23-62 year; 45.1 years old male's mean age, 42 years old women's mean age; 42.9 years old mean age.3. course of disease distribution: 2-30, average 11.5.4. state of an illness distribution: Syndrome Differentiation of Traditional Chinese Medicine and foundation thereof: by " new Chinese medicine guideline of clinical investigations (trying) in 2002) " (in May, 2002 version) bronchial asthma asthma of cold-type card: there is wheezing sound in rapid breathing, larynx, expectorant is not sticky or clear rare many foams in vain, the thirsty or desire for hot drinks of mouth, coldness of the body and aversion to cold, white and slippery fur, floating and tense pulse.Western medicine diagnose standard is with reference to respirology branch of Chinese Medical Association asthma group: prevention and control of bronchial asthma guide in 2008.Diagnostic criteria: 1) recurrent exerbation pant, out of breath, uncomfortable in chest or cough, how with to contact allergen, cold air, physics, chemical irritation and viral upper respiratory tract infection, motion etc. relevant.2) during outbreak at two lung audible and be dispersed in or diffusivity, the wheezing sound based on expiratory phase, expiratory phase prolongation.3) above-mentioned symptom and sign can be alleviated or spontaneous remission through treatment.4) panting except caused by other diseases, out of breath, uncomfortable in chest and cough.5) its atypical clinical manifestations person's (as without obviously panting or sign), at least should possess following 1 test positive: (1) brinchial provocation test or the motion activated test positive; (2) the positive FEV1 of Bronchodilation Test increases >=12%, and FEV1 increases absolute value >=200ml; (3) (or 2 weeks) aberration rate >=20% in peak expiratory flow (PEF) day.Meet 1 ~ 4 or 4,5 persons, be diagnosed as asthma.
4.2 test case standards include case standard in: all primary disease that meets are diagnosed and CM syndrome differentiation criterion, and get rid of every person in " Excluded cases standard ", all can include test case in.
4.3 Excluded cases standards
4.3.1 asthma or dyspneic other diseases patient can be caused;
4.3.2 the age is at under-18s or over-65s, conceived or women breast-feeding their children and those who are allergic to this drug;
4.3.3 the severe primary diseases such as cardiovascular, liver, kidney and hemopoietic system are associated with, psychotic;
4.3.4 do not meet inclusive criteria, not by regulation medication, cannot judge that curative effect or data are not congruent and affect the treatment or judge curative effect person.
4.4 outpatient services control variable factor, and inform that the patient participated in the experiment is on voluntary basis, duration of test does not take other about anti-asthmatic, and user for some reason, makes Excluded cases.
4.5 observation index
4.5.1 safety observation, respectively looks into once when treatment starts and at the end of the course for the treatment of
4.5.1.1 general health check-up project: body temperature, breathing, heart rate, blood pressure etc.
4.5.1.2 blood, urine, feces routine test
4.5.1.3 electrocardiogram, liver function (ALT), renal function (BUN, Cr) check
4.5.1.4X line rabat
4.5.2 health giving quality is observed
4.5.2.1 tcm symptom somatic feature score (comprise pant, uncomfortable in chest, pulmonary's wheezing sound, cough, expectoration)
4.5.2.2 viewing duration Bronchial Asthma situation.
4.5.2.3 picture of the tongue, pulse condition etc.
4.5.2.4 lung function PEFR, FEV
1
4.5.2.5 blood eosinophil cell
4.5.2.6 blood immune indexes IgE safety is observed
4.6 test method
Take outpatient, formulate observe table, data and the untoward reaction such as itemized record medical history, the course of disease, symptom, sign, 3 days with examining once, within 10 days, be a course for the treatment of.After terminating the course for the treatment of, carry out curative effect judge by curative effect judging standard, and carry out statistical procedures.
Test medication: oral peace breathes heavily granule, by the preparation of above-described embodiment 4 method, each bag, a twice-daily, (being provided by medicament chamber of the academy of traditional Chinese medicine of Jiangsu Province).
4.7 curative effect judging standards and foundation disease curative effect judging standard thereof are with reference to " new Chinese medicine guideline of clinical investigations (trying) in 2002 " tcm syndrome the standard of curative effect evaluation: clinic control: clinical symptoms, the sign of bronchial asthma disappear or substantially disappear, and disease integration reduces >=95%; Effective: clinical symptoms, the sign of bronchial asthma are obviously improved, disease integration reduces >=70%; Effective: clinical symptoms, the sign of bronchial asthma all take a favorable turn, disease integration reduces >=30%; Invalid: clinical symptoms, the sign of bronchial asthma are not improved, even increase the weight of, disease integration < 30%.Note: computing formula (nimodipine method) is: [(treat front integration one and treat rear integration) ÷ treats front integration] × 100%.
4.7.2 individual event symptom and sign curative effect judging standard clinic control: pant, uncomfortable in chest, pulmonary's wheezing sound, cough, expectoration disappear or substantially disappear, disease integration reduces >=95%; Effective: pant, uncomfortable in chest, pulmonary's wheezing sound, cough, expectoration obviously improve, disease integration reduces >=70%; Effective: pant, uncomfortable in chest, pulmonary's wheezing sound, cough, expectoration all take a favorable turn, disease integration reduces >=30%; Invalid: to pant, uncomfortable in chest, pulmonary's wheezing sound, cough, expectoration be not improved, even increase the weight of, disease integration < 30%.
4.8, therapeutic outcome
4.8.1 comprehensive therapeutic effect analysis (see table 1):
The analysis of table 1 comprehensive therapeutic effect
4.8.2 individual event symptom curative effect: (see table 2)
Table 2 individual event symptoms and therapeutic effect
Brief summary
The present invention's peace breathes heavily the routine patient of granule therapy bronchial asthma in acute attack asthma of cold-type disease 23,10 days courses for the treatment of, aobvious control rate 78.3% after result treatment, and total effective rate 91.3% is evident in efficacy.To coughing, expectorant, breathe heavily, the curative effect of the individual event symptom such as uncomfortable in chest: aobvious control rate 47.8% of panting, total effective rate 82.2; Aobvious control rate 65.2% uncomfortable in chest, total effective rate 91.3%; The aobvious control rate 43.4% of cough, total effective rate 82.6%; Expectoration shows control rate 60.8%, total effective rate 86.9%; Pulmonary's wheezing sound shows control rate 52.2%, total effective rate 82.6%, and as can be seen from the table, peace is breathed heavily granule and especially improved obviously symptom uncomfortable in chest Bronchial Asthmas.Compare before and after the pulmonary function of bronchial asthma in acute attack stage patient, improvement rate is 23.1%, has no notable difference, but because number of cases is less, can expand case load from now on, changes further before and after inspection Pulmonary Function.Because funds reason, part observation index such as the inspection of blood Liver and kidney function, arterial blood gas analysis, x-ray, IgE inspection etc. fail to carry out.Take peace breathe heavily in the Bronchial Asthmas of granule, find no obvious adverse reaction.
It is pure Chinese medicinal preparation that peace breathes heavily granule, and in view of curative effect is better, taking convenience, has no adverse reaction, and is effective medicine for the treatment of bronchial asthma in acute attack cold syndrome.In order to meet client need, better play Chinese medicine advantage, suggestion is studied further and is excavated.
5. granule of the present invention is on the impact (mice expectorant test) of bronchial asthma
5.1 animals: Kunming mouse, ♀ ♂ half and half, cleaning grade, is purchased from Shanghai Slac Experimental Animal Co., Ltd., the quality certification number: SCXK (Shanghai) 2007-0005.Feeding environment is cleaning grade, the quality certification number: SYXK (Soviet Union) 2007-0026;
5.2 peaces breathe heavily granule: prepare granule of the present invention by above-described embodiment 4, containing 7.97g crude drug/g, and lot number: 20080306, Chinese medicine preparation research department, Jiangsu Prov. Research Inst. Traditional Chinese Medical provides;
5.3 phenol reds: Shanghai reagent three factory belonging to Solution on Chemical Reagents in Shanghai head factory produces, lot number: 931204;
5.4 ammonium chloride, sodium bicarbonate etc. are analytical pure;
5.5 instruments: 752s ultraviolet spectrophotometer, Prism Optical Technology Co produces.
5.6 experimental techniques and result
Get mice 50, body weight 18 ~ 22g, fasting be can't help more than water 16h and is weighed, and is divided into 5 groups at random, often organizes 10, ♀ ♂ half and half, be respectively model control group (distilled water 20ml/kg), positive drug ammonium chloride matched group (1.0g/kg) and peace and breathe heavily the large, medium and small dosage group of granule (3.06,1.54,0.76g crude drug/kg), test sample is made into respective concentration with distilled water, and dosage is 20ml/kg.Successive administration 3 days.The phenol red normal saline 0.2ml of 0.5h lumbar injection 2.5% after last administration, after injection, 0.5h takes off neck execution animal, lie on the back and be fixed on operation plate, cut off neck center skin, be separated trachea, under larynx, No. 7 pin syringe needles are carefully inserted tracheal strips and be about 0.3cm, after fixing with silk thread ligation, 5%NaHCO3 solution 1ml is drawn with syringe, , by syringe needle lavation respiratory tract 3 times (not stopping) back and forth at every turn, irrigating solution is injected a test tube, again 5%NaHCO3 solution 1ml is drawn, as above lavation 2 times again, share washing liquid 3ml, take out and wash 9 times, the washing liquid of 3 times is merged and puts the centrifugal 10min of 3000r/nin in test tube, get the transparent red liquid ultraviolet spectrophotometer of supernatant and survey OD value in 546nm colorimetric, the expectoration amount of animal is acted on this.Each administration group and model control group carry out the process of t-inspection statistics.And calculate trachea expectoration increment rate by formula (3-1).The results are shown in Table 3.
Formula (3-1)
Table 3 peace breathe heavily Granules on Mouse phlegm-dispelling functions impact (
n=10)
Note: compare with model control group (t-inspection),
*p < 0.05.
Table 4 is visible, and peace breathes heavily the heavy dose of group of granule obviously can increase respiratory mucosa phenol red output (P < 0.05) compared with model control group, and expectoration increment rate reaches 41.03%, shows that this product has significant phlegm-dispelling functions.
6. granule of the present invention is on the impact (impact on the allergy of DNFB induced mice cutaneous delayed-type) of bronchial asthma
6.1 experiment material
6.1.1 animal: Kunming mouse, ♀ ♂ half and half, cleaning grade, is purchased from Shanghai Slac Experimental Animal Co., Ltd., the quality certification number: SCXK (Shanghai) 2007-0005.Feeding environment is cleaning grade, the quality certification number: SYXK (Soviet Union) 2007-0026;
6.1.2 peace breathes heavily granule: prepare granule of the present invention by above-described embodiment 4, containing 7.97g crude drug/g, and lot number: 20080306, Chinese medicine preparation research department, Jiangsu Prov. Research Inst. Traditional Chinese Medical provides;
6.1.3 prednisone acetate tablets: 5mg/ sheet, Nanjing second pharmaceutical factory produces, and lot number: 010702, the used time adds appropriate distilled water and is made into suitable concentration.
6.1.42,4-dinitrochlorobenzene (DNCB): Shanghai reagent one factory produces, lot number: 89-09-1.
6.2. experimental technique and result
Kunming mouse 60, male and female half and half, body weight 18 ~ 22g, is divided into 6 groups at random, i.e. the large, medium and small dosage group of Normal group, model group matched group, positive drug prednisolone acetate group and administration, often organizes 10, male and female half and half.Administration group respectively gavage gives peace and breathes heavily 3.06,1.54,0.76g crude drug/kg, and positive drug group gavage gives prednisolone acetate 10mg/kg, and normal control and model group gavage give the distilled water of same volume.Administration volume is 20ml/kg.Sensitization starts administration the previous day, and administration coats mouse part skin sensitization with 5%DNCB ethanol in second day.Successive administration 9 days, administration every day 1 time.Sensitization uses 1%DNCB (being dissolved in 1: 1 acetone: olive oil) to be applied to auris dextra after 7 days.Normal group is applied to abdominal part and auris dextra with solvent.Within after sensitization 24 hours, put to death mice, take off auricle with 7mm diameter card punch and weigh, the difference of left and right sides ear is delayed hypersensitivity value, respectively by following formulae discovery swelling rate and suppression ratio.The results are shown in Table 4.
Table 4 peace breathe heavily granule on the impact of DNCB induced mice skin-type allergy (
n=10)
Note: compare with normal group:
△ △p < 0.01; Compare with model group:
*p < 0.05,
*p < 0.01.
From table 5, big or middle dosage group compares with model control group, obviously can reduce swelling value (P < 0.05 ~ 0.01); Reduce swelling rate, bulge of the ear suppression ratio reaches 36.95%.Result is pointed out: this product has obvious inhibitory action to the delayed hypersensitivity caused by DNFB.
7 granules of the present invention are on the impact (antitussive action to mice) of bronchial asthma
7.1. experiment material
7.1.1 animal: Kunming mouse, ♀ ♂ half and half, cleaning grade, is purchased from Shanghai Slac Experimental Animal Co., Ltd., the quality certification number: SCXK (Shanghai) 2007-0005.Feeding environment is cleaning grade, the quality certification number: SYXK (Soviet Union) 2007-0026;
7.1.2 peace breathes heavily granule: prepare granule of the present invention by above-described embodiment 4, containing 7.97g crude drug/g, and lot number: 20080306, Chinese medicine preparation research department, Jiangsu Prov. Research Inst. Traditional Chinese Medical provides;
7.1.3 codeine phosphate: Qinghai Pharmaceutic Plant, lot number: 040112, the used time adds the suspension that appropriate distilled water is made into suitable concentration.
7.1.4 ammonia: Nanjing chemical reagent one factory produces, lot number: 02053244
7.1.5 instrument: S-888 type soniclizer: Chinese-foreign joint Dao Fen Electronics Co., Ltd..
7.2. experimental technique and result
Get mice 50,18 ~ 22g, weigh, be divided into 5 groups at random, often organize 10, ♀ ♂ half and half, is respectively model group (distilled water 20ml/kg), positive drug codeine phosphate group (5mg/kg) and peace and breathes heavily the large, medium and small dosage group (3.06 of granule, 1.54,0.76g crude drug/kg).After respective concentration being made into for reagent product, the administration of each treated animal gavage (ig), dosage is 20ml/kg, after administration 1h, each Mus has been placed in lid active box respectively, spray in active box after strong aqua ammonia being atomized with same intensity with soniclizer, spray after 15 seconds, observe animal cough latent period (after suction ammonia aerosol, cough required time extremely occurring is incubation period) immediately, and the cough number of times recorded in 6 minutes, t-test statistics process between each administration group and model control group group.By following formulae discovery cough-relieving rate.The results are shown in Table 5.
Table 5 peace breathe heavily Granules on Mouse antitussive action impact (
n=10)
Note: with model group ratio (t checks),
*p < 0.05,
*p < 0.01.
From table 5, peace breathes heavily the heavy dose of group of granule obviously can reduce cough number of times (P < 0.01) in 6 minutes compared with model control group, and cough-relieving rate reaches 74.90%; But cough latent period is not affected.Result is pointed out: this product oral administration has certain antitussive action to mice.
8 granules of the present invention are on the impact (impact on guinea-pig isolated tracheal smooth muscle shrinks) of bronchial asthma
8.1 experiment material
8.1.1 animal: Cavia porcellus, ♀
half and half, be purchased from Qinglongshan animal reproduction field, Jiangning, the quality certification number: SCXK (Soviet Union) 2002-0027;
8.1.2 peace breathes heavily granule: prepare granule of the present invention by above-described embodiment 4, containing 7.97g crude drug/g, and lot number: 20080306, Chinese medicine preparation research department, Jiangsu Prov. Research Inst. Traditional Chinese Medical provides;
8.1.3 aminophylline injection: every 2ml includes aminophylline 0.25g, No. 258202nd, the accurate word (1982) of Su Wei medicine, Changzhou Lanling Pharmaceutical Co., Ltd., lot number 010710;
8.1.4 histamine phosphate: Chinese Academy of Sciences Shanghai east wind Biochem Technology, INC. of biochemical institute produces, and lot number: 9509151, is made into 1g/L concentration with Krebs liquid before use;
8.1.5Krebs-Henseleit liquid (g/L): NaCl5.54g, KCl0.35g, CaCl0.28g, KH2PO40.16g, MgSO47H2O0.29g, NaHCO32.1g, Glu2.1g, be mixed with 1L;
8.1.6 instrument: MP-100 multi-path physiology Signal Analysis System, Tis3209 type is in body muscle specimen system, and the U.S. produces.
8.2. experimental technique
8.2.1 the preparation of annulus trachealis
Get the male guinea pig of about body weight 300g, knock the back side of head and cause dizzy fan, outside of belly medisection skin of neck and subcutaneous tissue immediately, trachea is isolated in carefulness, under thyroid cartilage, the whole trachea of clip, puts into the plate filling oxygen-saturated 37 DEG C of Krebs liquid, rejects trachea surrounding connective tissue, trachea is cut into strip by one end to other end spiral type, and every 2 ~ 3 cartilaginous rings are cut into a spiral.Specimen hung in the thermostatic bath filling oxygen-saturated 37 DEG C of Krebs liquid, specimen one end is fixed on bottom bath, and the other end is connected with muscular tension transducer.Baseline is adjusted in fixing horizontal.Specimen fixes 1 hour in bath, changes liquid once every 20min minute.
8.2.2 histamine is caused to the impact of isolated trachea chain smooth muscle contraction
After baseline is steady, records one section of tracheal smooth muscle normal activity curve (about 4min), add 30 μ l histamine in Krebs solution (final concentration is 1.5 μ g/ml).When airway constriction peaks, (contact about 6min with histamine), in bath, add positive control drug aminophylline injection 20 μ l (final concentration is 125 μ g/ml) or pacify and breathe heavily large, medium and small three dosage of granule (final concentration is respectively 22.6mg crude drug/ml, 11.3mg crude drug/ml, 5.65mg crude drug/ml).Model group tracheal strip adds normal saline and replaces by reagent.Observe tracheal strip contraction, relaxation cases, record activity curve (contacting about 8min with medicine).Before medicine, add histamine after 6min, after dosing 4,6min two time points totally four points measure tracheal smooth muscle shrinkage amplitude respectively, and by following formulae discovery spasmolytic rate.
8.2.3 histamine is caused to the preventive effect of isolated trachea chain smooth muscle contraction after baseline is steady; record one section of tracheal smooth muscle normal activity curve (about 4min), in bath, add positive control drug aminophylline injection 20 μ l (final concentration is 125 μ g/ml) or pacify and breathe heavily large, medium and small three dosage of granule (final concentration is respectively 22.6mg crude drug/ml, 11.3mg crude drug/ml, 5.65mg crude drug/ml) (contacting about 2min with medicine).Model group tracheal strip adds normal saline and replaces adding bath by reagent.Observe tracheal strip contraction, relaxation cases, after tracheal strip fully contacts with medicine, add 30 μ l histamine-Krebs solution (1.5 μ g/ml) (contacting about 8min with histamine).Record activity curve.Before dosing, after dosing 2min, add histamine after 4,8min two time points totally four points measure tracheal smooth muscle shrinkage amplitude respectively, and by following formulae discovery spasmolytic rate.
8.3. peace breathes heavily the guinea-pig isolated tracheal smooth muscle contraction that the obvious antagonism of granule energy is caused by histamine, with model group comparing difference remarkable (P < 0.05 ~ 0.01).Prompting peace breathes heavily granule has obvious mitigation to isolated tracheal smooth muscle spasm.The results are shown in Table 6.
Table 6 peace breathe heavily granule to histamine cause isolated trachea chain smooth contraction therapeutical effect (
n=10)
Note: with self compare before medicine (t-checks),
△ △ △p < 0.001; Compare with model group (t-inspection),
*p < 0.05,
*p < 0.01,
* *p < 0.001.
8.3.2 the preventive effect peace causing isolated trachea chain smooth muscle contraction to histamine is breathed heavily guinea-pig isolated tracheal smooth muscle that granule causes histamine and is shunk and have obvious mitigation, with model group comparing difference significantly (P < 0.05 ~ 0.01).Prompting peace breathes heavily granule has significantly prevention and mitigation to isolated tracheal smooth muscle spasm.The results are shown in Table 7.
Table 7 peace breathe heavily granule to histamine cause isolated trachea chain smooth contraction preventive effect (
n=10)
Note: compare with model group (t-inspection),
*p < 0.05,
*p < 0.01.
Conclusion: no matter from clinical observation or pharmacological evaluation, granule of the present invention has good therapeutic effect to bronchial asthma.
Claims (6)
1. one kind is used for the treatment of the Chinese medicine composition of bronchial asthma, it is characterized in that, it is prepared by the raw material of following parts by weight: Herba Ephedrae 4-8 part, Semen Lepidii (Semen Descurainiae) 8-12 part, Fructus Mume 8-10 part, Ganoderma 10-14 part, Radix Sophorae Flavescentis 10-14 part, Herba Erodii 15-25 part, Radix Morindae Officinalis 8-12 part, Radix Glycyrrhizae 4-8 part, preparation method comprises the steps: to get Herba Ephedrae, Semen Lepidii (Semen Descurainiae), Fructus Mume, Ganoderma, Radix Sophorae Flavescentis, Herba Erodii, Radix Morindae Officinalis, licorice medicinal materials merges, decoct with water twice, collecting decoction, when being evaporated to 65 DEG C, relative density is the extractum of 1.15-1.20, adding ethanol makes the percent by volume of alcohol content reach 75-85%, stir, leave standstill, filter, during filtrate reduced in volume to 65 DEG C, relative density is 1.25-1.30, and reclaim ethanol, obtain concentrated solution, concentrated solution to be added water and auxiliaries becomes oral liquid, or by concentrated solution spraying dry, add adjuvant and make capsule, tablet, granule.
2. the Chinese medicine composition being used for the treatment of bronchial asthma according to claim 1, it is characterized in that, it is prepared by the raw material of following parts by weight: 6 parts, Herba Ephedrae, Semen Lepidii (Semen Descurainiae) 10 parts, Fructus Mume 9 parts, Ganoderma 12 parts, Radix Sophorae Flavescentis 12 parts, Herba Erodii 20 parts, Radix Morindae Officinalis 10 parts, 6 parts, Radix Glycyrrhizae.
3. the Chinese medicine composition being used for the treatment of bronchial asthma according to claim 1, it is characterized in that, described adjuvant is one or more of dextrin, lactose, starch, sucrose, glucose, microcrystalline Cellulose, mannose, methylcellulose, hydroxypropyl cellulose, carboxymethyl cellulose and stevioside.
4. the Chinese medicine composition being used for the treatment of bronchial asthma according to claim 1, is characterized in that, in preparation method step, decocting condition is: first time adds water as the 8-12 times amount of medical material weight, decoct 1-2h, second time adds water as the 6-10 times amount of medical material weight, decocts 1-2h.
5. the Chinese medicine composition being used for the treatment of bronchial asthma according to claim 1, it is characterized in that, in preparation method step, spray drying condition is: inlet temperature is 80-120 DEG C, leaving air temp is 80-90 DEG C, temperature of charge is 70-90 DEG C, and atomizing pressure is 0.2-0.4 MPa, and spray velocity is 5-10ml/s.
6. described in claim 1, be used for the treatment of the application of Chinese medicine composition in the medicine of preparation treatment bronchial asthma of bronchial asthma.
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| 安喘颗粒提取工艺研究;陈斌等;《中国中医药信息杂志》;20081130;第15卷(第11期);第52-54页，尤其是第52页摘要，左栏第1段 * |
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