CN104043002B - For treating the compositions of postinfectious cough, medicine and preparation method - Google Patents

Abstract

For treating the compositions of postinfectious cough, medicine and preparation method.Described compositions is become to be grouped into by the water extract of following raw material of Chinese medicine, the ratio of each water extract composition in terms of corresponding raw material of Chinese medicine weight portion is: 46 parts of Herba Ephedrae, Fructus Perillae 24 parts, Rhizoma Belamcandae 57 parts, Radix Scutellariae 6 10 parts, Herba Ardisiae Japonicae 46 parts, Pheretima 46 parts, the Radix Stemonae 57 parts, Periostracum Cicadae 35 parts, Herba Houttuyniae 8 12 parts.The composition of said composition and the medicine with said composition as effective ingredient is more reasonable, and treatment postinfectious cough can be had more preferably curative effect.

Description

For treating the compositions of postinfectious cough, medicine and preparation method

Technical field

The present invention relates to a kind of compositions treating postinfectious cough and preparation method thereof and medical application.

Background technology

Postinfectious cough refers to after the acute stage symptom of flu itself disappears, the common breathing of the still protracted course of disease of coughing Systemic disease.Its pathophysiological mechanism is still not clear, and current majority thinks Airway damage that respiratory virus infection causes, inflammation It is the Etiological of postinfectious cough with airway hyperreactivity etc..The clinical manifestation of patient is zest dry cough or coughs a small amount of white Mucus expectorant, sustainable 3-8 week, the most for a long time, x-ray rabat rarely seen enhanced lung markings or without exception.This type of is coughed, doctor trained in Western medicine Still lacking and generally acknowledge effective medicine, conventional central antitussive and antihistamine H1 receptor antagonist are only symptomatic treatments, to portion Point patient is effective, may cause drowsy, xerostomia, loss of appetite, feel sick, the side reaction such as constipation, cough easily recurrence after drug withdrawal, and Antibiotic therapy is the most invalid, serious symptom person's Glucocorticoid Inhalation also recurrent exerbation, and side effect is relatively big, limits it and faces Bed application.

Tcm syndrome differentiation and treatment postinfectious cough has obvious advantage.Chinese medicine is thought: lung is the canopy of the vital organs of the human body, together in Fur, susceptible pathogen, cause abnormal rising of lung-QI, send out as cough.Document is reported, postinfectious cough should be that main pathology is wanted with ailment said due to cold or exposure Element, the pathogenic factor such as including wind and cold, wind heat, wind-dryness, " wind being the primary exopathogen ", diseases caused by exogenous pathogenic factor six climate exopathogens are many based on ailment said due to cold or exposure, wind attacking the lung, just If phase mistake is controlled, wrong treatment, then ailment said due to cold or exposure love lung, stays and does not goes, cause impaired depurative descending of lung QI, and abnormal rising of lung-QI is for coughing, and it shows as described in the traditional Chinese medical science Wind card, the benefaction number such as outbreak becomes, time when sending out only, throat air flue gargalesthesia etc.." itch " be wind as, " domination of wind is then itched ", ailment said due to cold or exposure is stopped up Stagnant throat, then be shown in itching throat.It is generally acknowledged postinfectious cough and ailment said due to cold or exposure " change of benefaction number ", the character of " wind being the primary exopathogen " is consistent, Its pathogenesis is wind result index, impairment of dispersing and descending function of the lung.The Chinese patent of publication number CN1605349 propose one treat postinfectious cough and The Chinese medicine composition of cough variant asthma, by Herba Ephedrae, Folium Perillae, Fructus Perillae, Pheretima, Folium Eriobotryae, Periostracum Cicadae, Radix Peucedani, Fructus Arctii and The five tastes molecular " SuHuang ZhiKe capsule "；After the Chinese patent of publication number CN101317990 also discloses that one treats flu Cough Chinese medicine preparation and preparation method thereof, is made up of Herba Ephedrae, Caulis Sinomenii, the Radix Stemonae, Radix Asteris.

Summary of the invention

The invention provides a kind of can be used for and treat the pharmaceutical composition of postinfectious cough, with said composition as effective ingredient Relative medicine, and the preparation method of compositions.The composition of said composition of the present invention is the most reasonable, thus coughs after treatment flu Cough and can have more preferably curative effect.

According to the pathogenic analysis to postinfectious cough, present inventor, through long-term clinical practice, finds postinfectious cough How because of ailment said due to cold or exposure love lung, cause impairment of dispersing and descending function of the lung, and verify through long-term clinical practice application and pharmacodynamics test, it is determined that institute of the present invention State the therapeutic rules for the treatment of postinfectious cough pharmaceutical composition, for dispelling wind and ventilating the lung, spasmolytic cough-relieving, therefore the Herba Ephedrae of selection dispelling wind and ventilating the lung Water with raw material of Chinese medicine such as spasmolytic, cough-relieving, the Fructus Perillae of antiinflammatory, Rhizoma Belamcandae, Radix Scutellariae, Herba Ardisiae Japonicae, Pheretima, the Radix Stemonae, Periostracum Cicadae, Herba Houttuyniae Extract component forms, and wherein the ratio of each water extract composition in terms of corresponding raw material of Chinese medicine weight portion is:

Herba Ephedrae 4-6 part, Fructus Perillae 2-4 part, Rhizoma Belamcandae 5-7 part, Radix Scutellariae 6-10 part, Herba Ardisiae Japonicae 4-6 part,

Pheretima 4-6 part, Radix Stemonae 5-7 part, Periostracum Cicadae 3-5 part, Herba Houttuyniae 8-12 part.

In above-mentioned composition, being preferably in a proportion of of each water extract composition of described corresponding raw material of Chinese medicine weight portion meter: fiber crops Huang 5 parts, Fructus Perillae 3 parts, Rhizoma Belamcandae 6 parts, Radix Scutellariae 8 parts, Herba Ardisiae Japonicae 5 parts, Pheretima 5 parts, the Radix Stemonae 6 parts, Periostracum Cicadae 4 parts, Herba Houttuyniae 10 parts.

Herba Ephedrae in above-mentioned composition composition, nature and flavor are pungent, bitter, temperature, enter to return lung meridian, bladder warp, function diaphoresis, relieving asthma, profit Water, controls fever with chills, lossless, cough and asthma, fullness in the chest and shortness of breath, excessive phlegm." Bencao Jingshu ": Herba Ephedrae, expelling the excess with mild diaphoretic, make evil scattered from table Also；Cough with dyspnea person, wind and cold is strongly fragrant in the lunar lung of hands also." book on Chinese herbal medicine justice " Herba Ephedrae, it is strongly fragrant that light clear floating specially dredges lung, leads mechanism of qi off." god Agriculture book on Chinese herbal medicine warp " Herba Ephedrae stops cough with dyspnea, except cold and heat, therefore Herba Ephedrae lung qi dispersing gas, expelling wind and cold pathogens, cough-relieving sore-throat relieving is relievingd asthma, for the monarch in side Medicine.Wherein, described raw material Herba Ephedrae is preferably the more preferable Herba ephedrae of nourishing the lung to arrest cough effect.

Radix Scutellariae, bitter, cold, put down, enter lung, large intestine, gallbladder meridian.Function expectorant heat, lets out excess-fire, dehumidifying heat, controls cough due to lung-heat." Yunnan South book on Chinese herbal medicine ": up purte the white, descending rush down bladder fire." book on Chinese herbal medicine is just " " fire of the clear part of the body cavity above the diaphragm housing the heart and lungs of withered person, moistening and cleaning throat, expectorant promoting the circulation of QI, Dingchuan Cough.”.Radix Scutellariae, bitter with dampness, cold to win heat, its property is the most respectful, the fire of special eliminating the pathogens from the lung Weishang Jiao, and pathogenic fire reducing is descending, moves back heating excessive thirst, main Controlling in the heart against gas, expectorant dyspnea of heat type is coughed.With Herba Ephedrae compatibility, cold expelling and heat clearing away use, lung qi dispersing cold expelling, the merit of dispelling wind sore-throat relieving more can be highlighted Effect, makes ailment said due to cold or exposure to declare, and hot and suffocating must solve, for the ministerial drug in side.Wherein, described Radix Scutellariae is the most clear part of the body cavity above the diaphragm housing the heart and lungs lung-heat, stops Cough the more preferable Radix Scutellariae (processed with wine) of effect.

Fructus Perillae, Xin Wen, nontoxic enter lung, large intestine channel.The function therapeutic method to keep the adverse QI flowing downwards, expectorant, lung moistening width intestinal.Control lung qi cough with dyspnea, phlegm dyspnea, gas Stagnant, constipation." Japan hanako materia medica ": the therapeutic method to keep the adverse QI flowing downwards, antitussive, moistens cardiopulmonary, eliminating phlegm-retention, controls asthma phlegmatic cough food painful abdominal mass and hold concurrently expectorant.The main fall of Fructus Perillae, acrid in the mouth Gas perfume (or spice) master dissipates, patent stagnated phlegm, cough with dyspnea then gas lift, and dyspnea with rapid respiration then pulmonary distension declines Dingchuan with this, and heat of the diaphragm then expectorant is stopped up, and expectorant ties the most vexed pain, uses This eliminating phlegm eliminating stagnation.It is the most prompt that Fructus Perillae dissipates gas, can the upper and lower all gas of profit, Dingchuan expectorant clearly, logical two just.Wherein, described raw material Folium Perillae Son is preferably warming the lung sending down the abnormal ascending QI effect more preferably Fructus Perillae (parched), and is more beneficial for the dissolution of drug decocting and effective ingredient.

Rhizoma Belamcandae, nature and flavor are bitter, cold, enter lung, Liver Channel.Can pathogenic fire reducing, removing toxic substances, expectorant dissipates blood.Control sore throat pharyngalgia, cough with dyspnea, expectorant Saliva stops up Sheng." herbal classic " main cough with dyspnea sore throat pharyngalgia, must not message, eliminating stagnation gas." Japan hanako materia medica " expectorant, broken crux, chest and diaphragm Full, abdominal distention, asthma.Rhizoma Belamcandae, energy pathogenic fire reducing eliminating stagnation gas, control cough with dyspnea, in larynx, water bird sound is made in wheezing.

Herba Ardisiae Japonicae, property is flat, pungent, warm, nontoxic.Can expelling wind and removing dampness, cough-relieving coughs haematemesiss of breathing, promoting blood circulation and stopping pain, detumescence, sharp diabetes involving the upper-JIAO Swelling is put down out of breath.Acrid in the mouth gas dissipates eliminating the pathogens from the lung, makes that the person of holding back opens and gas is suitable, and along person's then diaphragm profit, stagnation of QI-blood is from disappearing.Hardship can let out down kind fall, Controlling cough with dyspnea to breathe heavily and cough, dyspnea with rapid respiration is from flat.

Fructus Perillae, Rhizoma Belamcandae, Herba Ardisiae Japonicae, with using the effect that can strengthen sending down the abnormal ascending QI cough-relieving, are ministerial drug altogether, and with Herba Ephedrae compatibility, lung qi dispersing is defended Numbness, fall lung qi inverse, common play a surname one fall, a surname's fall is suitable, more shows that the monarch and his subjects match the merit of lung qi dispersing cough-relieving, lowering the adverse QI to relieve asthma Energy.

Pheretima, property is salty-cold, enters lung, liver, spleen channel.Function: clearing heat and relieving dyspnea, relieving spasm by calming endogenous wind, Zhichuan dredging collateral, control high fanatical hot-tempered, Acute pharyngitis due to wind-heat, have a headache, pant.Modern pharmacology shows: Pheretima has obvious bronchorelaxing activity.And can cause by antihistaminic Airway constriction, thus reduce the spasm of trachea.Clinical report: treatment chronic tracheitis, bronchial asthma, has significantly solution Convulsion, relieving asthma, phlegm-dispelling functions.

The Radix Stemonae, sweet, bitter, tepor is nontoxic, enters lung meridian.Function: gentle lung qi, cough-relieving, control cough due to wind and cold, pertussis, cruelly cough, Old cough with asthma, Dingchuan expectorant.Though tepor said by the Radix Stemonae, so embellish but not dry, can using pungent drugs for dispersion and bitter drugs for purgation sending down the abnormal ascending QI.Opening lung-energy, declares in controlling lung-heat and void Consumptive disease is breathed heavily and is coughed.Wherein, the described Radix Stemonae is preferably nourishing the lung to arrest cough effect preferably honey Radix Stemonae.

Pheretima, the Radix Stemonae are also ministerial drug, and with Herba Ephedrae compatibility, a surname one only, plays the merit of lung qi dispersing spasmolytic altogether.

Periostracum Cicadae, property is sweet salty cool, enters lung, Liver Channel.There is light weight to float, dissipate wind heat, dispelling wind, lung qi dispersing sore-throat relieving, determine effect of convulsion, control Wind-heat cough, pharyngalgia, hoarseness, it is stagnant unfavorable that lung qi is stopped up.Control hot and suffocating cough with asthma and have good effect.Modern pharmacology shows: Periostracum Cicadae can solve Except bronchial muscular spasm.Make airway unobstructed.Periostracum Cicadae both can dispelling wind and ventilating the lung, again can spasmolytic cough-relieving, make full side effect greatly increase By force, for adjuvant drug in side.

Herba Houttuyniae, property is pungent cold, enters lung, liver two warp.Tool heat-clearing and toxic substances removing, anti-inflammation detumescence, the merit of diuresis, control pneumonia, heat clearing away solution Poison, removing pus and relieving carbuncle, inducing diuresis for treating stranguria syndrome, remove congestion, controls upper respiratory tract infection." detailed outline " heat radiation poison carbuncle.Modern pharmacology shows fish raw meat Grass has antibacterial action, and micrococcus catarrhalis, hemophilus influenza, streptococcus pneumoniae, gold-coloured staphylococci are had obvious inhibiting effect.Colleague's tool There are the diseases such as antivirus action, treatment viral pneumonia, bronchitis, flu.This medicine assists all medicines of the monarch and his subjects to strengthen lung qi dispersing further, Cough-relieving sore-throat relieving, the function of resolving phlegm and relieving asthma, for making medicine in side.

Effect of above-mentioned each constituent, effect are complemented each other, and bring out the best in each other, and jointly play Xin Wen a surname and dissipate, and light clear a surname reaches, Lung qi dispersing cold expelling, wind and heat dispersing, lowering the adverse flow of QI, to relieving asthma and cough, dispelling phlegm and relieving sore-throat, by dispelling wind and ventilating the lung, the effect of spasmolytic cough-relieving, for ailment said due to cold or exposure Violate lung, the chronic cough caused by Lung Qi obstraction, itching throat, cough when itching, or choke and cough battle array and make to be difficult to restrain, breathe hard, meet cold air, different The factor such as taste burst or increase the weight of, or crouch that to play paroxysmal cough morning acute night, how in recurrent exerbation, dry cough without phlegm or a small amount of white thin expectorant, The diseases such as postinfectious cough and cough variant asthma such as tongue fur BOHUANG, reach to cure the purpose of postinfectious cough.

The preparation of compositions of the present invention, can be carried out in the following manner:

A. Herba Ephedrae pH value is 1 ~ 7, after preferably decocting with the hydrochloric acid solution that pH value is 1 ~ 5, takes liquid；

B., after remaining raw material of Chinese medicine boiling, liquid is taken；

C. by the concentration of liquid medicine under the concentration of liquid medicine under above-mentioned a item to 0.3 ~ 0.7g crude drug/ml, b item to 1 ~ 2g crude drug/ Mix after ml, be spray-dried and collect dried powder.

On the basis of above-mentioned preparation method, can a kind of further preferred embodiment for reference be: described raw material Herba Ephedrae Decocting 2-3 time with the aqueous hydrochloric acid solution of the pH value 2 ~ 4 of 8-12 times, each 1-3 hour, filter, it is raw that filtrate is concentrated into 0.4 ~ 0.6g Medicine/ml, takes clear liquid after being centrifuged；Remaining described raw material of Chinese medicine adds 10-15 times of soak by water 2-3 time, each 1-3 hour, filters, filter Liquid is concentrated into 0.4 ~ 0.6g crude drug/ml, centrifugal after take clear liquid, be further concentrated to 1 ~ 2g crude drug/ml(and be approximately equivalent to relative density be 1.1-1.2), after mixing with described Herba Ephedrae centrifugal clarification liquid, it is spray-dried and collects dried powder.

With above-mentioned composition of the present invention as effective ingredient, with acceptable auxiliary adding ingredient in medicine, press According at present conventional processing method/mode, be there is dispelling wind and ventilating the lung the most accordingly, spasmolytic cough-relieving effect can be used for treatment wind Heresy violates lung, the oral formulations type medicine of postinfectious cough caused by Lung Qi obstraction.

Experimental result shows, the composition of combinations of the above thing of the present invention and the medicine with said composition as effective ingredient more closes Reason, can have more preferably curative effect to treatment postinfectious cough.Using the present composition as the relative medicine of effective ingredient, with Prescription crude drug amount was on 1st: Herba ephedrae 5g, Fructus Perillae (parched) 3g, Rhizoma Belamcandae 6g, Radix Scutellariae (processed with wine) 8g, Herba Ardisiae Japonicae 5g, Pheretima 5g, the honey Radix Stemonae 6g, Periostracum Cicadae 4g, Herba Houttuyniae 10g, for clinical treatment wind result index, the cough after the caused flu of Lung Qi obstraction, can obtain notable Curative effect.

The foregoing of the present invention is described in further detail by detailed description of the invention by the following examples again.But This should not being interpreted as, the scope of the above-mentioned theme of the present invention is only limitted to Examples below.Without departing from the above-mentioned technological thought of the present invention In the case of, the various replacements made according to ordinary skill knowledge and customary means or change, the present invention all should be included in In the range of.

Detailed description of the invention

Embodiment 1

Taking Herba ephedrae 100g, the aqueous hydrochloric acid solution adding pH value 3 decocts twice, adds 12 times for the first time, and second time adds 10 times, often Secondary 1.5 hours, collecting decoction, filter, be concentrated into about 0.5g crude drug/ml, centrifugal clarification, discard precipitation, medicinal liquid is standby.Separately take stir-fry Fructus Perillae 60g, Rhizoma Belamcandae 120g, Radix Scutellariae (processed with wine) 160g, Herba Ardisiae Japonicae 100g, Pheretima 100g, honey Radix Stemonae 120g, Periostracum Cicadae 80g, Herba Houttuyniae 200g, boiling twice, add 15 times for the first time, decoct 2 hours, second time adds 12 times, decocts 1.5 hours, collecting decoction, filter Crossing, be concentrated into about 0.5g crude drug/ml, centrifugal clarification, discard precipitation, centrifugal rear concentration of liquid medicine is to about 1.5g crude drug/ml, in addition State Herba Ephedrae centrifugal liquid, be spray-dried, collect dried powder.With this dried powder as effective ingredient, add aspartame in right amount, mixed Closing uniformly, cross 80 mesh sieves, make soft material with 95% ethanol solution of 3-5%PVP, soft material is by a sieve series one-tenth on granulation machine Grain, is dried, and is dried granule and passes through oscillating granulator one sieve, make bulky grain grind, then screens out fine particle by No. four And fine powder, subpackage, obtain oral type granule.

Embodiment 2

Taking Herba Ephedrae 80g, the hydrochloric acid solution of the pH value 1 adding 8 times amount decocts 3 times, each 1 hour, filters, merging filtrate, dense Being reduced to about 0.3g crude drug/ml, be centrifuged to clarification, discard precipitation, medicinal liquid is standby.Separately take Fructus Perillae 80g, Rhizoma Belamcandae 100g, Radix Scutellariae 200g, Herba Ardisiae Japonicae 80g, Pheretima 80g, Radix Stemonae 140g, Periostracum Cicadae 100g, Herba Houttuyniae 240g, add the soak by water 3 times of 10 times amount, every time 1.5 hours, filter, merging filtrate, be concentrated into about 0.3g crude drug/ml, be centrifuged to clarification, discard precipitation, centrifugal rear concentration of liquid medicine To about 2g crude drug/ml, add above-mentioned Herba Ephedrae centrifugal liquid, be spray-dried, collect dried powder, be combination of the present invention Thing.Add medical starch and Magnesium Stearate proper quantity, dry granulation, load capsule, obtain oral type capsule.

Embodiment 3

Taking Herba Ephedrae 120g, the aqueous hydrochloric acid solution of the pH value 5 adding 10 times amount decocts 2 times, each 3 hours, filters, merges filter Liquid, is concentrated into about 0.7g crude drug/ml, is centrifuged to clarification, discard precipitation, and medicinal liquid is standby.Separately take Fructus Perillae 40g, Rhizoma Belamcandae 140g, Huang A kind of reed mentioned in ancient books 120g, Herba Ardisiae Japonicae 120g, Pheretima 120g, Radix Stemonae 100g, Periostracum Cicadae 60g, Herba Houttuyniae 160g, add the soak by water 2 times of 14 times amount, often Secondary 2 hours, filter, merging filtrate, be concentrated into about 0.7g crude drug/ml, be centrifuged to clarification, discard precipitation, centrifugal rear concentration of liquid medicine To 1g crude drug/ml, add above-mentioned Herba Ephedrae centrifugal liquid, be spray-dried, collect dried powder, be compositions of the present invention. Adding microcrystalline Cellulose and Pulvis Talci is appropriate, dry-pressing is pelletized, and tabletting obtains oral type tablet.

Embodiment 4

Taking Herba ephedrae 100g, the aqueous hydrochloric acid solution adding pH value 3 decocts twice, adds 12 times for the first time, and second time adds 10 times, often Secondary 1.5 hours, collecting decoction, standby.Separately take Fructus Perillae (parched) 60g, Rhizoma Belamcandae 120g, Radix Scutellariae (processed with wine) 160g, Herba Ardisiae Japonicae 100g, Pheretima 100g, honey Radix Stemonae 120g, Periostracum Cicadae 80g, Herba Houttuyniae 200g, boiling twice, for the first time add 15 times, decoct 2 hours, for the second time Adding 12 times, decoct 1.5 hours, collecting decoction, add above-mentioned Herba Ephedrae decocting liquid, be centrifuged to clarification, discard precipitation, centrifugal rear medicinal liquid is dense It is reduced to about 2g crude drug/ml, is spray-dried, collect dried powder, be compositions of the present invention.Add aspartame to fit Amount, mixing, pelletize, be dried, subpackage, obtain oral type granule.

Embodiment 5

Take Herba ephedrae 100g, Fructus Perillae (parched) 60g, Rhizoma Belamcandae 120g, Radix Scutellariae (processed with wine) 160g, Herba Ardisiae Japonicae 100g, Pheretima 100g, honey hundred Portion 120g, Periostracum Cicadae 80g, Herba Houttuyniae 200g, boiling twice, add 15 times for the first time, decoct 2 hours, second time adds 12 times, decocts Boiling 1.5 hours, collecting decoction, be centrifuged to clarification, discard precipitation, centrifugal rear concentration of liquid medicine, to about 2g crude drug/ml, is spray-dried, Collect dried powder, be compositions of the present invention.Add aspartame appropriate, mixing, pelletize, be dried, subpackage, to obtain final product Oral type granule.

Chinese patent medicine with the aforementioned publication number CN1605349 close with above-mentioned composition/efficacy of drugs of the present invention (SuHuang ZhiKe capsule, for commercial goods) contrasts, and has carried out following pharmacodynamic experiment research, can be shown that medicine group of the present invention Compound is had the advantage that.

1, pharmacodynamics comparative experiments

With cough-relieving, antiinflammatory, spasmolysis for main pharmacodynamics evaluation index, to pharmaceutical composition of the present invention and above-mentioned comparison medicine Thing SuHuang ZhiKe capsule compares research.Wherein, antitussive action compares the cough experiment selecting ammonia to cause mice, antiinflammatory action Relatively selecting Rat Carrageenan colloidality foot swelling experiment, spasmolysis compares the asthmatic tic experiment selecting histamine to cause Cavia porcellus.

(1) experiment material

Test medicine: SuHuang ZhiKe capsule (traditional Chinese medicines quasi-word Z20080014,0.45g*12s*2 plate, Yangzijiang Pharmaceutical Group Beijing Potiria pectinifera (Mukller et Tro Sehel) pharmaceutcal corporation, Ltd, lot number 13031111.Oral, one time 3,3 times on the one, every dress 0.45g).Medicine of the present invention Thing (spray-dried powders of embodiment 1, crude drug amount on the one is 52g).

Animal: Km(Kunming kind) mice, SPF level, Sichuan Provincial Academy of Traditional Chinese Medicine animal center provide, the animal quality certification Number: SCXK (river) 2008-19；SD rat, SPF level, Sichuan Provincial Academy of Traditional Chinese Medicine animal center provide, the animal quality certification Number: SCXK (river) 2008-19

Key instrument: soniclizer: Shoutou Yuehua Medical Apparatus Factory Co., Ltd., WH-2000；Rat foot volume Analyzer: Chengdu TME Technology Co., Ltd., PV-200

Main agents: ammonia: Chengdu Ke Long chemical reagent factory, lot number: 20100706；Carrageenin: Sigma company, Lot number: SL05374

(2) comparison of antitussive action

Purpose: after mice sucks the aerosol of zest chemicals, stimulates airway sensor, causes to reflexive and cough Cough.All medicines that can suppress coughing centre or reduce airway sensor sensitivity, all have antitussive action.Cough by measuring mice Cough the antitussive action of more different test medicine incubation period.

Method: Km kind mice, 70, male and female half and half, body weight 18-22g, it is randomly divided into 7 groups by body weight, often group 10.If Model control group, SuHuang ZhiKe capsule group and medicine group of the present invention.Test medicine be respectively provided with little, in, big 3 dosage groups (point Be not equivalent to 5,10,20 times of clinic recommended dose every day), use isometric(al) not isoconcentration medicinal liquid gastric infusion, gavage volume 0.2ml/10g body weight (matched group is to isometric(al) distilled water), continuous gastric infusion 5 days, every day 1 time.1h after last administration, by little Mus is placed in 500mL beaker, draws after 0.3nl strong aqua ammonia injects 50mg cotton balls and puts into beaker, takes out, observe and remember after 2min Record mice is from putting into 3min cough number of times after cough latent period and cotton balls take out after cotton balls.Acquired results t inspection counts According to analysis, medicine group and matched group comparing difference significance, inspection level α=0.05.Experimental result is shown in Table 1.

Table 1 result shows, 3 dosage groups of medicine of the present invention all can be obviously prolonged the mouse cough incubation period that ammonia causes, Compare with matched group, medicine small dose group of the present invention have significant difference (P< 0.05), middle dosage group and heavy dose of group have pole Significant difference (P< 0.01)；The only heavy dose of group of SuHuang ZhiKe capsule have significant difference (P< 0.05).Meanwhile, in medicine of the present invention Dosage group and heavy dose of group can significantly reduce mouse cough number of times that ammonia causes (P<0.05、P< 0.01), and yellow cough-relieving glue of reviving The only heavy dose of group of capsule can reduce mouse cough number of times that ammonia causes (P< 0.05).Show under the clinical dosage of same ratio, Medicine of the present invention has more preferable antitussive action than SuHuang ZhiKe capsule.

(3) comparison of antiinflammatory action

Purpose: the inflammation that topical application carrageenin causes, prostaglandin synthesis substantially increases, and with vasoactive amine Edema is induced together with kassinin kinin class.By measuring the antiinflammatory action of the more different test medicine of rat paw edema rate.

Method: SD rat, 56,180-220g, all-male, it is randomly divided into 7 groups by body weight, often group 8.If model comparison Group, SuHuang ZhiKe capsule group and medicine group of the present invention, test medicine arrange little, in, big 3 dosage groups (be respectively equivalent to clinic Every day 10 times, 5 times of recommended dose), use isometric(al) not isoconcentration medicinal liquid gastric infusion, gavage volume 2ml/100g body weight (matched group is to isometric(al) distilled water), continuous gavage 5 days, every day 1 time.Last is administered latter 30 minutes, in every Rat Right toes Central authorities intradermal injection 1% carrageenin 0.1ml, causes 1,2,4,6 hours difference toes volumes of each mensuration after inflammation, records result, It is calculated as follows rat paw edema rate (%) and suppression ratio (%).

Toes volume before toes volume-cause is scorching after swelling rate %=(cause inflammation)/cause scorching front toes volume × 100%

The average swelling rate of suppression ratio %=(matched group-average swelling rate of administration group) average swelling rate × 100% of/matched group

Acquired results t checks and carries out data analysis, medicine group and matched group comparing difference significance, and inspection level α= 0.05。

The results are shown in Table 2, in medicine of the present invention, big two dosage groups all can significantly suppress carrageenin to cause at 1h ~ 6h Toes swelling (compare with matched group in dosage group when 1h-6hP< 0.05, heavy dose of group is when 1hP< 0.05, when 2-6hP < 0.01)；The middle dosage group of SuHuang ZhiKe capsule is when 6h, and heavy dose of group can significantly suppress carrageenin to draw when 1-6h (in comparing with matched group, dosage is when 6h in the toes swelling risenP< 0.05, heavy dose of group is when 1-4hP< 0.05, when 6hP< 0.01).Illustrate that, under the clinical dosage of same ratio, the antiinflammatory action of medicine of the present invention is better than SuHuang ZhiKe capsule.

(4) comparison of spasmolysis

Purpose: histamine can cause bronchial muscular spasm, causes asthma.Breathe heavily before and after Cavia porcellus by mensuration cause to pant Property twitch incubation period more different test medicine antiasthmatic effect.

Method: experiment the previous day by some for the Cavia porcellus of preliminary experiment, male and female half and half, 180-220g, put spray tank respectively In, constant voltage sprays into 0.1% histamine solution 15s, observes Cavia porcellus and the incubation period of asthmatic tic occurs, is used for testing less than 150s. By qualified Cavia porcellus 56, male and female half and half, it is randomly divided into 7 groups by body weight, often group 8.If model control group, SuHuang ZhiKe capsule Group and medicine of the present invention is little, in, big 3 dosage groups (being respectively equivalent to 2.5,5,10 times of recommended dose clinical every day), continuously Gastric infusion 7 days, every day 1 time, matched group gives the distilled water of equal volume.After last is administered 1h, with same experiment, observe In 6min, there is the incubation period of asthmatic tic in Cavia porcellus.Acquired results t inspection carries out data analysis, and each group compares with matched group The significance of difference, inspection level α=0.05.

The results are shown in Table 3, test medicine can extend the incubation period causing Cavia porcellus tic that histamine causes.Medicine the most of the present invention Small dose group and middle dosage group compare with matched group have significant difference (P< 0.05), heavy dose of group has pole significant difference (P< 0.01), and SuHuang ZhiKe capsule only heavy dose is organized to compare with matched group and is had significant difference.Show in same ratio Under clinical dosage, medicine of the present invention has more preferable spasmolysis than SuHuang ZhiKe capsule.

To sum up result of the test shows, under the clinical dosage of same ratio, compares with SuHuang ZhiKe capsule, medicine of the present invention There is more preferable cough-relieving, antiinflammatory and spasmolysis.

2, the experiment that active constituent content is affected by different preparation methoies

Raw material of Chinese medicine Herba Ephedrae (extract) is the monarch drug (principal agent) in the present composition, has diaphoresis cold expelling, and lung qi dispersing is put down Breathing heavily, effect of inducing diuresis to remove edema, ephedrine hydrochloride and pseudoephedrine hydrochloride are its principle active component, therefore, with reference to " middle traditional Chinese medicines Allusion quotation " content assaying method under 2010 years one Herba Ephedrae items of version, main in the compositions that difference preparation method of the present invention is obtained Effective ingredient carries out assay, and result of study is as follows:

Weigh Herba ephedrae 100g, Fructus Perillae (parched) 60g, Rhizoma Belamcandae 120g, Radix Scutellariae (processed with wine) 160g, Herba Ardisiae Japonicae 100g, Pheretima respectively 100g, honey Radix Stemonae 120g, Periostracum Cicadae 80g, Herba Houttuyniae 200g, totally 3 parts.Make as described in embodiment 1, embodiment 4 and embodiment 5 respectively Preparation Method decocts, concentrates, is spray-dried, and collects and obtains dried powder, measures ephedrine hydrochloride and hydrochloric acid by above-mentioned official method The content of pseudoephedrine, the results are shown in Table 4.

From table 4, representative effective ingredient hydrochloric acid Herba Ephedrae in the spray-dried powders that the preparation method of embodiment 1 obtains Alkali and the content of pseudoephedrine hydrochloride and the extraction rate of transform are obviously higher than embodiment 4 and the preparation method of example 5.Research further Showing, Herba Ephedrae decocting liquid and other flavour of a drug decocting liquid are separately recovered concentration, remerge dry, can significantly reduce the damage of ephedrine Losing, Herba Ephedrae decocting liquid is concentrated into about 0.5g crude drug/ml, and ephedrine hydrochloride and pseudoephedrine hydrochloride lose about 5-10%, further Being concentrated into about 1g crude drug/ml, ephedrine hydrochloride and pseudoephedrine hydrochloride lose about 10-20%, and prompting concentrated solution reclaims when concentrating, Ephedrine hydrochloride and pseudoephedrine hydrochloride loss are bigger, therefore Herba ephedrae decocting liquid is concentrated into about 0.3-0.7g crude drug/ml, directly with The extraction concentrated solution of other medicines merges, is spray-dried, and can reduce the loss of effective ingredient ephedrine.

Claims (7)

1., for treating the compositions of postinfectious cough, it is characterized in that being become to be grouped into by the water extract of following raw material of Chinese medicine, with The ratio of each water extract composition of corresponding raw material of Chinese medicine weight portion meter is:

Herba Ephedrae 4-6 part, Fructus Perillae 2-4 part, Rhizoma Belamcandae 5-7 part, Radix Scutellariae 6-10 part, Herba Ardisiae Japonicae 4-6 part,

Pheretima 4-6 part, Radix Stemonae 5-7 part, Periostracum Cicadae 3-5 part, Herba Houttuyniae 8-12 part.

2. compositions as claimed in claim 1, is characterized in that described raw material of Chinese medicine ratio in parts by weight is: Herba Ephedrae 5 Part, Fructus Perillae 3 parts, Rhizoma Belamcandae 6 parts, Radix Scutellariae 8 parts, Herba Ardisiae Japonicae 5 parts, Pheretima 5 parts, the Radix Stemonae 6 parts, Periostracum Cicadae 4 parts, Herba Houttuyniae 10 parts.

3. compositions as claimed in claim 1 or 2, is characterized in that described Herba Ephedrae is Herba ephedrae, and described Fructus Perillae is for frying Fructus Perillae, the described Radix Stemonae is the honey Radix Stemonae, and described Radix Scutellariae is Radix Scutellariae (processed with wine).

4. the preparation method of the described compositions of one of claims 1 to 3, is characterized in that pressing each raw material of Chinese medicine of described ratio The mode of stating is carried out:

A., after Herba Ephedrae pH value is the hydrochloric acid solution decoction of 1 ~ 7, liquid is taken；

B., after remaining raw material of Chinese medicine boiling, liquid is taken；

By mixed after the concentration of liquid medicine under the concentration of liquid medicine under above-mentioned a item to 0.3 ~ 0.7g crude drug/ml, b item to 1 ~ 2g crude drug/ml Close, be spray-dried and collect dried powder.

5. preparation method as claimed in claim 4, it is characterized in that described raw material Herba Ephedrae decocts the pH value of solution is 1 ~ 5.

6. the preparation method as described in claim 4 or 5, is characterized in that the described raw material Herba Ephedrae pH value 2 ~ 4 of 8-12 times Aqueous hydrochloric acid solution decocts 2-3 time, each 1-3 hour, filters, and filtrate is concentrated into 0.4 ~ 0.6g crude drug/ml, takes clear liquid after being centrifuged； Remaining described raw material of Chinese medicine adds 10-15 times of soak by water 2-3 time, each 1-3 hour, filters, and it is raw that filtrate is concentrated into 0.4 ~ 0.6g Medicine/ml, takes clear liquid after being centrifuged, is further concentrated to 1 ~ 2g crude drug/ml, after mixing with described Herba Ephedrae centrifugal clarification liquid, is spray-dried And collect dried powder.

7. for treating the oral type medicine of postinfectious cough, it is characterized in that with the compositions one of claims 1 to 3 Suo Shu be In effective ingredient, with medicine, acceptable auxiliary adding ingredient collectively constitutes.