CN104043002A - Composition and medicament for treating cough post influenza and preparation methods thereof - Google Patents
Composition and medicament for treating cough post influenza and preparation methods thereof Download PDFInfo
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Abstract
The invention discloses a composition and a medicament for treating cough post influenza and preparation methods thereof. The composition is composed of water extract components of the following Chinese herbal medicine raw materials in parts by weight: 4-6 parts of ephedra, 2-4 parts of fructus perillae, 5-7 parts of rhizoma belamcandae, 6-10 parts of radix scutellariae, 4-6 parts of herba ardisiae japonicae, 4-6 parts of lumbricus, 5-7 parts of radix stemonae, 3-5 parts of periostracum cicada and 8-12 parts of herba houttuyniae. The composition and the medicament taking the composition as an active ingredient are more reasonable in constitution and have a better curative effect on the cough post influenza.
Description
Technical field
The present invention relates to a kind of composition and method of making the same and medical application for the treatment of postinfectious cough.
Background technology
Postinfectious cough refers to after the acute stage symptom of flu itself disappears, the still common respiratory system disease of protracted course of disease of coughing.Its pathophysiological mechanism is still not clear, and majority thinks that air flue damage, inflammation and airway hyperreactivity etc. that respiratory virus infection causes are the Etiologicals of postinfectious cough at present.Patient's clinical manifestation is zest dry cough or coughs a small amount of white mucus expectorant, and in sustainable 3-8 week, even the longer time, the rarely seen enhanced lung markings of x-ray rabat or nothing are abnormal.To this type of cough, doctor trained in Western medicine still lacks generally acknowledges effective medicine, conventional central antitussive and antihistamine H1 receptor antagonist are only symptomatic treatments, effective to some patients were, may cause drowsy, xerostomia, loss of appetite, feel sick, the side reaction such as constipation, easily recurrence of cough after drug withdrawal, and antibiotic therapy is often invalid, serious symptom person's Glucocorticoid Inhalation is outbreak repeatedly also, and side effect is larger, has limited its clinical practice.
Tcm syndrome differentiation and treatment postinfectious cough has obvious advantage.Chinese medicine is thought: the canopy that lung is the vital organs of the human body, to close in fur, and susceptible pathogen, causes abnormal rising of lung-QI, sends out as cough.Bibliographical information, postinfectious cough should be take ailment said due to cold or exposure as main pathology key element, comprises the pathogenic factor such as wind and cold, wind heat, wind-dryness, " wind being the primary exopathogen ", diseases caused by exogenous pathogenic factor six climate exopathogens are guide mainly with ailment said due to cold or exposure, wind attacking the lung, if the initial stage loses and to control, wrong treatment, ailment said due to cold or exposure love lung, stays and does not go, cause impaired depurative descending of lung QI, abnormal rising of lung-QI is for coughing, and it shows as the said wind card of the traditional Chinese medical science, as the benefaction number of outbreak becomes, when time is sent out, stop throat air flue gargalesthesia etc." itch " as wind resembles, " domination of wind is itched ", ailment said due to cold or exposure is stopped up stagnant throat, sees 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 " conforms to, and its pathogenesis is that ailment said due to cold or exposure is violated lung, impairment of dispersing and descending function of the lung.The Chinese patent of publication number CN1605349 has proposed a kind of Chinese medicine composition for the treatment of postinfectious cough and 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 "; The Chinese patent of publication number CN101317990 also discloses a kind of postinfectious cough Chinese medicine preparation and preparation method thereof for the treatment of, and Herba Ephedrae, Caulis Sinomenii, the Radix Stemonae, Radix Asteris, consists of.
Summary of the invention
The invention provides and a kind ofly can be used for treating the relative medicine that the pharmaceutical composition of postinfectious cough, the said composition of take are effective ingredient, and the preparation method of compositions.The composition of said composition of the present invention is more reasonable, thereby can have more preferably curative effect to treatment postinfectious cough.
According to the pathogenic analysis to postinfectious cough, present inventor is through long-term clinical practice, find that postinfectious cough is many because of ailment said due to cold or exposure love lung, cause impairment of dispersing and descending function of the lung, and through long-term clinical practice application and pharmacodynamics test checking, determined the treatment rule for the treatment of postinfectious cough pharmaceutical composition of the present invention, for dispelling wind and ventilating the lung, spasmolytic cough-relieving, therefore select Herba Ephedrae and the spasmolytic of dispelling wind and ventilating the lung, cough-relieving, the Fructus Perillae of antiinflammatory, Rhizoma Belamcandae, Radix Scutellariae, Herba Ardisiae Japonicae, Pheretima, the Radix Stemonae, Periostracum Cicadae, the water extract of the raw material of Chinese medicine such as Herba Houttuyniae becomes to be grouped into, wherein take corresponding raw material of Chinese medicine weight portion each water extract composition ratio as:
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, the preferred proportion of each water extract composition of described corresponding raw material of Chinese medicine weight portion meter is: 5 parts, Herba Ephedrae, 3 parts of Fructus Perillaes, 6 parts of Rhizoma Belamcandae, 8 parts of Radix Scutellariaes, 5 parts of Herba Ardisiae Japonicaes, 5 parts of Pheretimas, 6 parts of the Radixs Stemonae, 4 parts of Periostracum Cicadaes, 10 parts of Herba Houttuyniae.
Herba Ephedrae during above-mentioned composition forms, nature and flavor are pungent, bitter, temperature enters to return lung meridian, urinary bladder channel, function diaphoresis, relieving asthma, diuretic, control 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 from show loose also; Cough with dyspnea person, wind and cold is strongly fragrant in the lunar lung of hands also.The just > > Herba Ephedrae of < < book on Chinese herbal medicine, it is strongly fragrant that light clear floating is specially dredged lung, leads mechanism of qi off.< < Sheng Nong's herbal classic > > Herba Ephedrae is stopped cough with dyspnea, except cold and heat, thus Herba Ephedrae lung qi dispersing gas, expelling wind and cold pathogens, cough-relieving sore-throat relieving is relievingd asthma, and is the monarch drug in side.Wherein, described raw material Herba Ephedrae is preferably the sweet Herba Ephedrae of nourishing the lung to arrest cough better effects if.
Radix Scutellariae, bitter, cold, put down, enter lung, large intestine, gallbladder meridian.Function expectorant heat, lets out excess-fire, except damp and hot, controls cough due to lung-heat.< < the southern regions of the Yunnan Province book on Chinese herbal medicine > >: up purte the white, the descending bladder fire that rushes down.The positive > > of < < book on Chinese herbal medicine " 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 is coughed.”。Radix Scutellariae, bitter with dampness, cold to win heat, its property is respectful clearly, special eliminating the pathogens from the lung Weishang Jiao's fire, pathogenic fire reducing is descending, moves back heating excessive thirst, cures mainly contrary gas in the heart, and expectorant dyspnea of heat type is coughed.With Herba Ephedrae compatibility, cold expelling and heat clearing away use, the effect that more can give prominence to lung qi dispersing cold expelling, dispelling wind sore-throat relieving, ailment said due to cold or exposure must be declared, hot and suffocating must solution, is the ministerial drug in side.Wherein, described Radix Scutellariae is longer than part of the body cavity above the diaphragm housing the heart and lungs lung-heat, the better Radix Scutellariae (processed with wine) of cough suppressing effect clearly for being preferably.
Fructus Perillae, Xin Wen, nontoxicly enters lung, large intestine channel.The function therapeutic method to keep the adverse QI flowing downwards, expectorant, the wide intestinal of lung moistening.Control lung qi cough with dyspnea, phlegm dyspnea, the stagnation of QI, constipation.< < Japan hanako materia medica > >: the therapeutic method to keep the adverse QI flowing downwards, antitussive, profit cardiopulmonary, eliminating phlegm-retention, controls the asthma phlegmatic cough food painful abdominal mass expectorant of holding concurrently.Fructus Perillae master falls, and acrid in the mouth gas is fragrant main loose, patent stagnated phlegm, and cough with dyspnea is gas lift, and dyspnea with rapid respiration is pulmonary distension, and with this Dingchuan that declines, heat of the diaphragm expectorant is stopped up, and expectorant knot is vexed pain, by this eliminating phlegm eliminating stagnation.The loose gas of Fructus Perillae is very prompt, the upper and lower all gas of profit the most clearly, and Dingchuan expectorant, leads to two just.Wherein, described raw material Fructus Perillae is preferably the better Fructus Perillae (parched) of warming the lung sending down the abnormal ascending QI effect, and is more conducive to the stripping 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, the expectorant blood that falls apart.Control sore throat pharyngalgia, cough with dyspnea, accumulation and obstruction of sputum.The main cough with dyspnea sore throat of < < herbal classic > > pharyngalgia, must not message, eliminating stagnation gas.< < Japan hanako materia medica > > expectorant, broken crux, chest and diaphragm is full, abdominal distention, asthma.Rhizoma Belamcandae, energy pathogenic fire reducing eliminating stagnation gas, controls cough with dyspnea, and 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 haematemesiss of breathing of coughing, promoting blood circulation and stopping pain, detumescence, sharp diabetes involving the upper-JIAO swelling is put down out of breath.The eliminating the pathogens from the lung of faling apart of acrid in the mouth gas, opens the person of holding back and gas is suitable, and along person's diaphragm profit, stagnation of QI-blood is from disappearing.Hardship can be let out down kind falling, and controls cough with dyspnea and breathes heavily and cough, dyspnea with rapid respiration self-balancing.
Fructus Perillae, Rhizoma Belamcandae, Herba Ardisiae Japonicae, with the effect with strengthening sending down the abnormal ascending QI cough-relieving, be ministerial drug altogether, with Herba Ephedrae compatibility, the numbness that lung qi dispersing is defended, fall the contrary of lung qi, jointly bring into play a surname one and fall, and declare to fall suitablely, more show the match function of lung qi dispersing cough-relieving, lowering the adverse QI to relieve asthma of the monarch and his subjects.
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, controls high fanatical hot-temperedly, acute pharyngitis due to wind-heat, has a headache, pants.Modern pharmacology shows: Pheretima has obvious bronchorelaxing activity.And can cause that trachea shrinks by antihistaminic, thereby reduce the spasm of trachea.Clinical report: treatment chronic tracheitis, bronchial asthma, have significant spasmolytic, relieving asthma, phlegm-dispelling functions.
The Radix Stemonae, sweet, bitter, tepor is nontoxic, enters lung meridian.Function: gentle lung qi, cough-relieving, controls cough due to wind and cold, pertussis, cruelly coughs, old cough with asthma, Dingchuan expectorant.Though the Radix Stemonae is said tepor, 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 chronic consumptive disease and breathes heavily and cough.Wherein, the described Radix Stemonae is preferably the better sweet Radix Stemonae of nourishing the lung to arrest cough effect.
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 floating, loose wind heat, dispelling wind, lung qi dispersing sore-throat relieving, determine the effect of convulsion, controls wind-heat cough, pharyngalgia, hoarseness, lung qi heap soil or fertilizer over and around the roots is stagnant unfavorable.Control hot and suffocating cough with asthma and have good effect.Modern pharmacology shows: Periostracum Cicadae can be removed bronchial muscular spasm.Make airway unobstructed.Periostracum Cicadae both can dispelling wind and ventilating the lung, again can spasmolytic cough-relieving, and full side's effect is greatly strengthened, be adjuvant drug in side.
Herba Houttuyniae, property is pungent cold, enters lung, liver two warps.Tool heat-clearing and toxic substances removing, anti-inflammation detumescence, the merit of diuresis, controls pneumonia, and heat-clearing and toxic substances removing, removing pus and relieving carbuncle, inducing diuresis for treating stranguria syndrome, remove congestion, controls upper respiratory tract infection.The < < detailed outline > > malicious carbuncle that dispels the heat.Modern pharmacology shows that Herba Houttuyniae has antibacterial action, and micrococcus catarrhalis, hemophilus influenza, streptococcus pneumoniae, gold-coloured staphylococci are had to obvious inhibitory action.Colleague has antivirus action, the diseases such as treatment viral pneumonia, bronchitis, flu.This medicine assists all medicines of the monarch and his subjects further to strengthen lung qi dispersing, cough-relieving sore-throat relieving, and the function of resolving phlegm and relieving asthma, is the medicine that makes in side.
The effect of above-mentioned each constituent, effect is complemented each other, bring out the best in each other, jointly play Xin Wenxuan loose, light clear a surname reaches, lung qi dispersing cold expelling, wind and heat dispersing, lowering the adverse flow of QI, relieving asthma and cough, dispelling phlegm and relieving sore-throat, pass through dispelling wind and ventilating the lung, the effect of spasmolytic cough-relieving, for ailment said due to cold or exposure, violate lung, long-term cough due to Lung Qi obstraction, itching throat, cough while itching, or choke and cough battle array and do to be difficult to restrain, breathe hard, meet cold air, the factors such as abnormal flavour happen suddenly or increase the weight of, or sleeping morning at night play paroxysmal cough play, be outbreak repeatedly more, dry cough without phlegm or a small amount of white thin expectorant, the diseases such as the postinfectious cough such as tongue fur BOHUANG and cough variant asthma, reach the object of curing postinfectious cough.
The preparation of compositions of the present invention, can carry out in the following manner:
A. Herba Ephedrae is 1 ~ 7 with pH value, and the hydrochloric acid solution that to be more preferably with pH value be 1 ~ 5 is got liquid after decocting;
B., after all the other raw material of Chinese medicine decoct with water, get liquid;
C. the medicinal liquid under above-mentioned a item is concentrated into 0.3 ~ 0.7g crude drug/ml, the medicinal liquid under b item mixes after being concentrated into 1 ~ 2g crude drug/ml, and spraying is dried and collects dried powder.
On the basis of above-mentioned preparation method, a kind of further preferred embodiment that can be for reference is: described raw material Herba Ephedrae decocts 2-3 time with the aqueous hydrochloric acid solution of 8-12 pH value 2 ~ 4 doubly, and each 1-3 hour, filters, filtrate is concentrated into 0.4 ~ 0.6g crude drug/ml, gets clear liquid after centrifugal; All the other described raw material of Chinese medicine add 10-15 times of decocting and boil 2-3 time, each 1-3 hour, filter, filtrate is concentrated into 0.4 ~ 0.6g crude drug/ml, after centrifugal, get clear liquid, it is 1.1-1.2 that reconcentration to 1 ~ 2g crude drug/ml(is approximately equivalent to relative density), after described Herba Ephedrae centrifugal clarification liquid mixes, spraying is dried and collects dried powder.
Take above-mentioned composition of the present invention as effective ingredient, with the auxiliary adding ingredient of acceptable in medicine, according to the processing method/mode of current routine, can obtain thering is accordingly dispelling wind and ventilating the lung, spasmolytic cough-relieving effect can be used for treating ailment said due to cold or exposure and violates lung, the oral formulations type medicine of postinfectious cough due to Lung Qi obstraction.
Experimental result demonstration, the composition of the medicine that the compositions that the present invention is above-mentioned and the said composition of take are effective ingredient is more reasonable, to treatment postinfectious cough, can have more preferably curative effect.Using the relative medicine of the present composition as effective ingredient, take prescription crude drug amount on the one as sweet Herba Ephedrae 5g, Fructus Perillae (parched) 3g, Rhizoma Belamcandae 6g, Radix Scutellariae (processed with wine) 8g, Herba Ardisiae Japonicae 5g, Pheretima 5g, sweet Radix Stemonae 6g, Periostracum Cicadae 4g, Herba Houttuyniae 10g, for clinical treatment ailment said due to cold or exposure, violate lung, cough due to Lung Qi obstraction after flu, can obtain significant curative effect.
The specific embodiment is by the following examples described in further detail foregoing of the present invention again.But this should be interpreted as to the scope of the above-mentioned theme of the present invention only limits to following example.Without departing from the idea case in the present invention described above, various replacements or the change according to ordinary skill knowledge and customary means, made, all should comprise within the scope of the invention.
The specific embodiment
embodiment 1
Get sweet Herba Ephedrae 100g, the aqueous hydrochloric acid solution that adds pH value 3 decocts twice, adds for the first time 12 times, adds for the second time 10 times, and each 1.5 hours, collecting decoction, filtered, and is concentrated into about 0.5g crude drug/ml, and centrifugal clarification, discards precipitation, and medicinal liquid is standby.Separately get Fructus Perillae (parched) 60g, Rhizoma Belamcandae 120g, Radix Scutellariae (processed with wine) 160g, Herba Ardisiae Japonicae 100g, Pheretima 100g, sweet Radix Stemonae 120g, Periostracum Cicadae 80g, Herba Houttuyniae 200g, decoct with water twice, add for the first time 15 times, decoct 2 hours, add for the second time 12 times, decoct 1.5 hours, collecting decoction, filters, and is concentrated into about 0.5g crude drug/ml, centrifugal clarification, discard precipitation, centrifugal rear medicinal liquid is concentrated into about 1.5g crude drug/ml, adds above-mentioned Herba Ephedrae centrifugal liquid, spraying is dry, collects dried powder.Take this dried powder as effective ingredient; add aspartame appropriate, mix homogeneously, crosses 80 mesh sieves; with 95% alcoholic solution of 3-5%PVP, make soft material; soft material is by a sieve granulation on granulation machine, dry, and dried particles is by sieve of oscillating granulator; bulky grain is ground; by No. four, screen out fine particle and fine powder again, subpackage, obtains oral type granule.
embodiment 2
Get Herba Ephedrae 80g, the hydrochloric acid solution that adds the pH value 1 of 8 times of amounts decocts 3 times, and each 1 hour, filter, merging filtrate, is concentrated into about 0.3g crude drug/ml, and centrifugal extremely clarification, discards precipitation, and medicinal liquid is standby.Separately get Fructus Perillae 80g, Rhizoma Belamcandae 100g, Radix Scutellariae 200g, Herba Ardisiae Japonicae 80g, Pheretima 80g, Radix Stemonae 140g, Periostracum Cicadae 100g, Herba Houttuyniae 240g, the decocting that adds 10 times of amounts boils 3 times, each 1.5 hours, filter, merging filtrate, is concentrated into about 0.3g crude drug/ml, centrifugal to clarification, discard precipitation, centrifugal rear medicinal liquid is concentrated into about 2g crude drug/ml, adds above-mentioned Herba Ephedrae centrifugal liquid, and spraying is dry, collect dried powder, be compositions of the present invention.Add medical starch and magnesium stearate is appropriate, dry granulation, incapsulates, and obtains oral type capsule.
embodiment 3
Get Herba Ephedrae 120g, the aqueous hydrochloric acid solution that adds the pH value 5 of 10 times of amounts decocts 2 times, and each 3 hours, filter, merging filtrate, is concentrated into about 0.7g crude drug/ml, and centrifugal extremely clarification, discards precipitation, and medicinal liquid is standby.Separately get Fructus Perillae 40g, Rhizoma Belamcandae 140g, Radix Scutellariae 120g, Herba Ardisiae Japonicae 120g, Pheretima 120g, Radix Stemonae 100g, Periostracum Cicadae 60g, Herba Houttuyniae 160g, the decocting that adds 14 times of amounts boils 2 times, each 2 hours, filter, merging filtrate, is concentrated into about 0.7g crude drug/ml, centrifugal to clarification, discard precipitation, centrifugal rear medicinal liquid is concentrated into 1g crude drug/ml, adds above-mentioned Herba Ephedrae centrifugal liquid, and spraying is dry, collect dried powder, be compositions of the present invention.Add microcrystalline Cellulose and Pulvis Talci is appropriate, dry-pressing is granulated, and tabletting, obtains oral type tablet.
embodiment 4
Get sweet Herba Ephedrae 100g, the aqueous hydrochloric acid solution that adds pH value 3 decocts twice, adds for the first time 12 times, adds for the second time 10 times, and each 1.5 hours, collecting decoction, standby.Separately get Fructus Perillae (parched) 60g, Rhizoma Belamcandae 120g, Radix Scutellariae (processed with wine) 160g, Herba Ardisiae Japonicae 100g, Pheretima 100g, sweet Radix Stemonae 120g, Periostracum Cicadae 80g, Herba Houttuyniae 200g, decoct with water twice, add for the first time 15 times, decoct 2 hours, add for the second time 12 times, decoct 1.5 hours, collecting decoction, add above-mentioned Herba Ephedrae decocting liquid, centrifugal to clarification, discard precipitation, centrifugal rear medicinal liquid is concentrated into about 2g crude drug/ml, spraying is dry, collects dried powder, is compositions of the present invention.Add aspartame appropriate, mix, granulate, dry, subpackage, obtains oral type granule.
embodiment 5
Get sweet Herba Ephedrae 100g, Fructus Perillae (parched) 60g, Rhizoma Belamcandae 120g, Radix Scutellariae (processed with wine) 160g, Herba Ardisiae Japonicae 100g, Pheretima 100g, sweet Radix Stemonae 120g, Periostracum Cicadae 80g, Herba Houttuyniae 200g, decoct with water twice, add for the first time 15 times, decoct 2 hours, add for the second time 12 times, decoct collecting decoction 1.5 hours, centrifugal to clarification, discard precipitation, centrifugal rear medicinal liquid is concentrated into about 2g crude drug/ml, and spraying is dry, collect dried powder, be compositions of the present invention.Add aspartame appropriate, mix, granulate, dry, subpackage, obtains oral type granule.
Chinese patent medicine (SuHuang ZhiKe capsule with the aforementioned publication number CN1605349 close with above-mentioned composition/efficacy of drugs of the present invention, for commercial goods) contrast, carry out following pharmacodynamic experiment research, can show the beneficial effect that pharmaceutical composition of the present invention has.
1, pharmacodynamics comparative experiments
Take cough-relieving, antiinflammatory, spasmolysis is main pharmacodynamics evaluation index, and pharmaceutical composition of the present invention and above-mentioned control drug SuHuang ZhiKe capsule are compared to research.Wherein, antitussive action alternative ammonia causes the cough experiment of mice, antiinflammatory action alternative rat carrageenan foot swelling experiment, and spasmolysis alternative histamine causes the panting property tic experiment of Cavia porcellus.
(1) experiment material
Tested medicine: SuHuang ZhiKe capsule (the accurate word Z20080014 of traditional Chinese medicines, 0.45g*12s*2 plate, Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd, lot number 13031111.Oral, one time 3,3 times on the one, every dress 0.45g).Medicine of the present invention (spray-dried powders of embodiment 1, crude drug amount on the one is 52g).
Animal: Km(Kunming kind) mice, SPF level, is provided by Sichuan Provincial Academy of Traditional Chinese Medicine animal center, the animal quality certification number: SCXK (river) 2008-19; SD rat, SPF level, is provided by Sichuan Provincial Academy of Traditional Chinese Medicine animal center, the animal quality certification number: SCXK (river) 2008-19
Key instrument: soniclizer: Shoutou Yuehua Medical Apparatus Factory Co., Ltd., WH-2000; Rat foot volume measuring apparatus: 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
Object: mice sucks after the aerosol of zest chemicals, stimulates respiratory tract sensor, causes to reflexive cough.All medicines that can suppress coughing centre or reduce respiratory tract sensor sensitivity, all have antitussive action.By measuring the antitussive action of mouse cough more different tested medicines incubation period.
Method: Km kind mice, 70, male and female half and half, body weight 18-22g, is divided into 7 groups at random by body weight, 10 every group.If model control group, SuHuang ZhiKe capsule group and medicine group of the present invention.That tested medicine arranges is respectively little, in, large 3 dosage groups (be equivalent to respectively clinical every day of recommended dose 5,10,20 times), adopt not isoconcentration medicinal liquid gastric infusion of isometric(al), gavage volume 0.2ml/10g body weight (matched group is to isometric(al) distilled water), gastric infusion is 5 days continuously, every day 1 time.1h after last administration, is placed in 500mL beaker by mice, draws after 0.3nl strong aqua ammonia injects 50mg cotton balls and puts into beaker, after 2min, takes out, and observes and record mice cough latent period and the rear 3min cough of cotton balls taking-up number of times after putting into cotton balls.Acquired results carries out data analysis, medicine group and matched group comparing difference significance, inspection level α=0.05 with t check.Experimental result is in Table 1.
Table 1 result shows, 3 dosage groups of medicine of the present invention all can obviously extend the mouse cough incubation period that ammonia causes, with matched group comparison, medicine small dose group of the present invention have significant difference (
p<0.05), middle dosage group and heavy dose of group have utmost point significant difference (
p<0.01); SuHuang ZhiKe capsule only heavy dose of group have significant difference (
p<0.05).Meanwhile, in medicine of the present invention dosage group and heavy dose of group can obviously reduce the mouse cough number of times that ammonia causes (
p<0.05,
p<0.01), and SuHuang ZhiKe capsule only heavy dose of group can reduce the mouse cough number of times that ammonia causes (
p<0.05).Show that, under the clinical dosage of same ratio, medicine of the present invention has better antitussive action than SuHuang ZhiKe capsule.
(3) comparison of antiinflammatory action
Object: the inflammation that topical application carrageenin causes, prostaglandin is synthetic obviously to be increased, and brings out edema with vasoactive amine together with kassinin kinin class.By measuring the antiinflammatory action of the more different tested medicines of rat paw edema rate.
Method: SD rat, 56,180-220g, entirely male, by body weight, be divided at random 7 groups, 8 every group.If model control group, SuHuang ZhiKe capsule group and medicine group of the present invention, that tested medicine arranges is little, in, large 3 dosage groups (be equivalent to respectively clinical every day of recommended dose 10 times, 5 times), adopt not isoconcentration medicinal liquid gastric infusion of isometric(al), gavage volume 2ml/100g body weight (matched group is to isometric(al) distilled water), gavage is 5 days continuously, every day 1 time.After last administration 30 minutes, in every intradermal injection 1% carrageenin 0.1ml of Rat Right toes central authorities, cause after scorching and respectively measure respectively toes volume one time in 1,2,4,6 hour, record result, be calculated as follows rat paw edema rate (%) and suppression ratio (%).
Swelling rate %=(cause scorching after toes volume-cause scorching before toes volume)/cause scorching before toes volume * 100%
The average swelling rate of the average swelling rate-administration of suppression ratio %=(matched group group) average swelling rate * 100% of/matched group
Acquired results carries out data analysis, medicine group and matched group comparing difference significance, inspection level α=0.05 with t check.
The results are shown in Table 2, in medicine of the present invention, large two dosage groups 1h ~ 6h all can suppress significantly the toes swelling that carrageenin causes (with matched group relatively in dosage group during at 1h-6h
p<0.05, heavy dose of group when 1h
p<0.05, when 2-6h
p<0.01); SuHuang ZhiKe capsule only has middle dosage group when 6h, heavy dose of group when 1-6h, can suppress significantly the toes swelling that carrageenin causes (with matched group relatively in dosage when the 6h
p<0.05, heavy dose of group when 1-4h
p<0.05, when 6h
p<0.01).Explanation is under the clinical dosage of same ratio, and the antiinflammatory action of medicine of the present invention is better than SuHuang ZhiKe capsule.
(4) comparison of spasmolysis
Object: histamine can cause bronchial muscular spasm, causes asthma.By mensuration cause breathe heavily before and after the tic of Cavia porcellus panting property incubation period more different tested medicines antiasthmatic effect.
Method: test the previous day by some of the Cavia porcelluss of preliminary experiment, male and female half and half, 180-220g, puts respectively in spray tank, and constant voltage sprays into the 0.1% solution 15s of histamine, observes the incubation period that Cavia porcellus occurs that panting property is twitched, and is less than 150s for experiment.By 56 of qualified Cavia porcelluss, male and female half and half, are divided into 7 groups at random by body weight, 8 every group.If model control group, SuHuang ZhiKe capsule group and medicine of the present invention are little, in, large 3 dosage groups (be equivalent to respectively clinical every day of recommended dose 2.5,5,10 times), gastric infusion is 7 days continuously, every day 1 time, matched group gives the distilled water of equal volume.After last administration 1h, to test equally, observe Cavia porcellus in 6min and occur the incubation period that panting property is twitched.Acquired results carries out data analysis with t check, each group and matched group comparing difference significance, inspection level α=0.05.
The results are shown in Table 3, tested medicine can extend the incubation period that causes Cavia porcellus tic that histamine causes.Wherein medicine small dose group of the present invention and middle dosage group and matched group relatively have significant difference (
p<0.05), heavy dose of group have utmost point significant difference (
pand SuHuang ZhiKe capsule only has heavy dose of group relatively to have significant difference with matched group <0.01).Show that, under the clinical dosage of same ratio, medicine of the present invention has better spasmolysis than SuHuang ZhiKe capsule.
To sum up result of the test shows, under the clinical dosage of same ratio, with SuHuang ZhiKe capsule comparison, medicine of the present invention has better cough-relieving, antiinflammatory and spasmolysis.
2, the experiment of different preparation methoies on active constituent content impact
Raw material of Chinese medicine Herba Ephedrae (extract) is the monarch drug (principal agent) in the present composition, there is diaphoresis cold expelling, depressed lung-energy dispersing, the effect of inducing diuresis to remove edema, ephedrine hydrochloride and pseudoephedrine hydrochloride are its main effective ingredient, therefore, with reference to the content assaying method under Herba Ephedrae item of < < Chinese Pharmacopoeia > > version in 2010, in the compositions that the different preparation methoies of the present invention are obtained, main effective ingredient carries out assay, and result of study is as follows:
Take respectively sweet Herba Ephedrae 100g, Fructus Perillae (parched) 60g, Rhizoma Belamcandae 120g, Radix Scutellariae (processed with wine) 160g, Herba Ardisiae Japonicae 100g, Pheretima 100g, sweet Radix Stemonae 120g, Periostracum Cicadae 80g, Herba Houttuyniae 200g, totally 3 parts.Press respectively that preparation method described in embodiment 1, embodiment 4 and embodiment 5 decocts, concentrated, spraying is dry, collect and obtain dried powder, the content by above-mentioned official method mensuration ephedrine hydrochloride and pseudoephedrine hydrochloride, the results are shown in Table 4.
From table 4, the content of representative effective ingredient ephedrine hydrochloride and pseudoephedrine hydrochloride and extract the rate of transform all apparently higher than the preparation method of embodiment 4 and example 5 in the spray-dried powders that the preparation method of embodiment 1 obtains.Further research shows, Herba Ephedrae decocting liquid and other flavour of a drug decocting liquid reclaim respectively concentrated, remerge dry, can obviously reduce the loss of ephedrine, Herba Ephedrae decocting liquid is concentrated into about 0.5g crude drug/ml, ephedrine hydrochloride and pseudoephedrine hydrochloride lose about 5-10%, further be concentrated into again about 1g crude drug/ml, ephedrine hydrochloride and pseudoephedrine hydrochloride lose about 10-20%, prompting concentrated solution reclaims while concentrating, ephedrine hydrochloride and pseudoephedrine hydrochloride loss are larger, therefore sweet Herba Ephedrae decocting liquid is concentrated into about 0.3-0.7g crude drug/ml, extraction concentrated solutions direct and other medicines merge, spraying is dry, can reduce the loss of effective ingredient ephedrine.
Claims (7)
1. the compositions that is used for the treatment of postinfectious cough, is characterized in that being become to be grouped into by the water extract of following raw material of Chinese medicine, take corresponding raw material of Chinese medicine weight portion each water extract composition ratio as:
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 it is 5 parts, Herba Ephedrae, 3 parts of Fructus Perillaes, 6 parts of Rhizoma Belamcandae, 8 parts of Radix Scutellariaes, 5 parts of Herba Ardisiae Japonicaes, 5 parts of Pheretimas, 6 parts of the Radixs Stemonae, 4 parts of Periostracum Cicadaes, 10 parts of Herba Houttuyniae that described raw material of Chinese medicine be take the ratio of weight portion.
3. compositions as claimed in claim 1 or 2, is characterized in that described Herba Ephedrae is sweet Herba Ephedrae, and described Fructus Perillae is Fructus Perillae (parched), and the described Radix Stemonae is the sweet 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 each raw material of Chinese medicine of described ratio to carry out in the following manner:
A. the hydrochloric acid solution that Herba Ephedrae is 1 ~ 7 with pH value is got liquid after decocting;
B., after all the other raw material of Chinese medicine decoct with water, get liquid;
Medicinal liquid under above-mentioned a item is concentrated into 0.3 ~ 0.7g crude drug/ml, and the medicinal liquid under b item mixes after being concentrated into 1 ~ 2g crude drug/ml, and spraying is dried and collects dried powder.
5. preparation method as claimed in claim 4, is characterized in that the pH value of described raw material Herba Ephedrae decoction solution is 1 ~ 5.
6. the preparation method as described in claim 4 or 5, is characterized in that described raw material Herba Ephedrae decocts 2-3 time with the aqueous hydrochloric acid solution of 8-12 pH value 2 ~ 4 doubly, each 1-3 hour, and filtration, filtrate is concentrated into 0.4 ~ 0.6g crude drug/ml, gets clear liquid after centrifugal; All the other described raw material of Chinese medicine add 10-15 times of decocting and boil 2-3 time, and each 1-3 hour, filters, filtrate is concentrated into 0.4 ~ 0.6g crude drug/ml, gets clear liquid, reconcentration to 1 ~ 2g crude drug/ml after centrifugal, after described Herba Ephedrae centrifugal clarification liquid mixes, spraying is dried and collects dried powder.
7. the oral type medicine that is used for the treatment of postinfectious cough, is characterized in that take that the described compositions of one of claims 1 to 3 is effective ingredient, jointly forms with the auxiliary adding ingredient of acceptable in medicine.
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Effective date of registration: 20181218 Address after: 102206 No. 16 Life Garden Road, Changping District, Beijing Co-patentee after: Yangtze River Pharmaceutical Co., Ltd. Patentee after: Beijing Haiyan Pharmaceutical Industry Co., Ltd., Yangzijiang Pharmaceutical Ind Address before: 610041 No. 51, Fourth Section of Renmin South Road, Wuhou District, Chengdu City, Sichuan Province Patentee before: Sichuan Academy of Chinese Medicine Sciences |