CN100579557C

CN100579557C - Cough-stopping granule with honeysuckle flower and bulbus fritilariae

Info

Publication number: CN100579557C
Application number: CN200510010077A
Authority: CN
Inventors: 房凯
Original assignee: Individual
Current assignee: Harbin Children Pharmaceutical Factory Co ltd
Priority date: 2005-06-10
Filing date: 2005-06-10
Publication date: 2010-01-13
Anticipated expiration: 2025-06-10
Also published as: CN1876099A

Abstract

The invention discloses a medicament for treating upper respiratory tract infection and trachitis, which is prepared from honeysuckle flower, capsule of weeping forsythia, peucedanum root, Sichuan fritillary bulb and Siberian cocklebur by a predetermined weight proportions. The medicament can be prepared into any of the conventional oral administration dosage forms.

Description

Cough-stopping granule with honeysuckle flower and bulbus fritilariae

Technical field

The present invention relates to a kind of treatment upper respiratory tract infection, the medicine of acute bronchitis belongs to the field of Chinese medicines.

Background technology

Respiratory tract disease is mostly because antibacterial, viral infection or cross infection cause.Antibiotic has been obtained tangible curative effect to bacterial infection, but desirable not to the utmost with virus or bacterial virus cross infection curative effect, and therefore, correct diagnosis, science medication are most important.

Respiratory tract disease diagnosis and therapeutic scheme, no matter upper respiratory tract infection, bronchitis or pneumonia are with regard to doctor's diagnostic level, to make a definite diagnosis means, make a definite diagnosis time etc. be not problem.To cause of disease because of definite method also very ripe, but it is longer to carry out the antibacterial culturing process, screening sensitive medicaments frost takes significant period of time (3-5 days), can not also just can not accurately make a definite diagnosis bacterial infection, viral infection or cross infection as commonly encountered diseases, frequently-occurring disease diagnostic method.Therefore, first-selection has antibiotic, antiviral, cough-relieving when the clinician treats, the medicine that reduces phlegm is treated the clinical effectiveness highly significant.But the heavier vein administering drug combinations of the state of an illness is except that medicines such as this oral cough-stopping granule with honeysuckle flower and bulbus fritilariae can obtain better effects.

Respiratory tract disease medication antibiotics is various in style, and new product constantly occurs, and is that antibiotic, the antiviral Chinese medicine preparation of representative is also asked the city in succession with the SHUANGHUANLIAN, and clinical application effect is apparent in view.Though cough-relieving, the medicine kind of reducing phlegm are more, its curative effect is all desirable not to the utmost.The Western medicine antitussive contains anesthesia composition (as codeine, carbetapentane citrate etc.) more and mostly is to reach the cough-relieving purpose by inhibition nerve centre, anesthesia respiration flesh, inhibition coughre flex, discharges but influence sputum.This class drug side effect is bigger, repeatedly uses to produce dependency, endangers bigger.Expectorant commonly used (as ammonia chloride etc.) though phlegm-dispelling functions is arranged, there is not antitussive action, and gastric mucosa is had stimulation, easily cause nausea, vomit.Therefore, can antibiotic, antiviral, can relieving cough and resolving phlegm, remove respiratory secretions, still there is demand (2002 the 9th phases of Chinese general family medicine " respiratory medicine general introduction ") in the Chinese medicine preparation that plays treating both the principal and secondary aspects of a disease, determined curative effect.Up to now, also do not find the report of any relevant pharmaceutical composition of the present invention.The inventor is through the checking repeatedly of animal and clinical trial, finally treatment due to illness poison or the caused upper respiratory tract infection of bacterial infection that better curative effect is arranged have been found, heating due to the acute bronchitis, cough, the yellow thick oral medicinal herb medicine that waits disease of coughing up phlegm, thus finished the present invention.

Summary of the invention

Purpose of the present invention just provides a kind of due to illness poison or caused upper respiratory tract infection of bacterial infection of more effectively treating, heating due to the acute bronchitis, cough, the yellow thick plurality of Chinese compositions that waits disease of coughing up phlegm.

In order to achieve the above object, the technical solution used in the present invention is: Flos Lonicerae 1-3 part, Fructus Forsythiae 1-3 part, Radix Peucedani 1-3 part, Bulbus Fritillariae Cirrhosae 0.5-2.5 part, Radix Scutellariae 0.5-2.5 part.

Wherein the consumption of each crude drug is: 2 parts of Flos Loniceraes, 2 parts of Fructus Forsythiaes, 2 parts of Radix Peucedanis, 1.3 parts of Bulbus Fritillariae Cirrhosaes, 1.3 parts of Radix Scutellariaes.

Wherein crude drug also has Radix Glycyrrhizae 0.5-1.5 part.

Wherein the consumption of each crude drug is: 2 parts of Flos Loniceraes, 2 parts of Fructus Forsythiaes, 2 parts of Radix Peucedanis, 1.3 parts of Bulbus Fritillariae Cirrhosaes, 1.3 parts of Radix Scutellariaes, 1 part in Radix Glycyrrhizae.

Wherein raw material also has: Folium Eriobotryae 1.5-2.5 part, Fructus Trichosanthis 1.5-2.5 part.

Wherein the consumption of each crude drug is: 2 parts of Flos Loniceraes, 2 parts of Fructus Forsythiaes, 2 parts of Radix Peucedanis, 1.3 parts of Bulbus Fritillariae Cirrhosaes, 1.3 parts of Radix Scutellariaes, 1 part in Radix Glycyrrhizae, 2 parts of Folium Eriobotryaes, 2 parts of Fructus Trichosanthis.

Medicament selection Flos Lonicerae of the present invention, Fructus Forsythiae, Radix Peucedani, Bulbus Fritillariae Cirrhosae, Radix Scutellariae make up, make each efficacy of drugs produce synergism these drug regimens, thereby can effectively treat due to illness poison or the caused upper respiratory tract infection of bacterial infection, heating due to the acute bronchitis, cough, the yellow thick disease of waiting of coughing up phlegm.The side is monarch with Flos Lonicerae, Fructus Forsythiae.The Flos Lonicerae nature and flavor are sweet, cold, go into lung meridian, and its light weight gas is walked the part of the body cavity above the diaphragm housing the heart and lungs clearly, except that the merit that heat-clearing and toxic substances removing is arranged, have more " effect of light a surname evacuation " (" Chinese materia medica "), so both can evacuate the wind heat that lung is defended, lung qi dispersing gas hot and suffocating clearly must be separated pyretic toxicity again, the duty that clear again respectful a surname of lung falls and cough self-balancing.Fructus Forsythiae nature and flavor hardship, be slightly cold, the function heat-clearing and toxic substances removing, " book on Chinese herbal medicine is through hundred kinds of records " say its " the gas virtue is strong and property is refrigerant; thus all edema caused by disorder of QI hot and suffocating all can be it, the flavor toil of holding concurrently again ", so " tool rises the diffusing power of floating a surname " again, " can induce sweat by saturating flesh, heat clearing away is by wind, again for controlling the wind heat key medicine." (" Records of Tradition Chinese and Western Medicine in Combination ") so; what Fructus Forsythiae can the removing summer-heat lung qi is hot and suffocating; the wind heat that can declare the lung that looses to defend again; have the merit (" Chinese materia medica ") of " heat-clearing and toxic substances removing expelling pathogenic factors from the exterior "; clinical normal and Flos Lonicerae mutual reinforcement between are for using; " the cool completely effect of evil heat clearing away of existing suffering, have again the merit of repelling foulness with aromatics detoxifcation " (" pharmacology of Chinese medical formulae ") is monarch so share clearing away and dispersing lung-heat with two medicines in square.Radix Peucedani nature and flavor hardship, suffering, be slightly cold, go into lung meridian, " detailed outline " Yan Qineng " clearing away lung-heat; the heat of reducing phlegm, the ailment said due to cold or exposure of loosing " is because of the merit of its tool dispelling wind-heat, evacuate the wind heat that lung is defended so can help Flos Lonicerae, Fructus Forsythiae, again because of " its merit is longer than the therapeutic method to keep the adverse QI flowing downwards, coughs so can control the expectorant dyspnea of heat type ... the next fire of gas falls, and expectorant also falls; be the key medicine of mental disorder ", the power of principal drug assistance lung heat clearing, so the double again disease of controlling expectorant heat is minister for it.Adjuvant drug in Radix Scutellariae, the Bulbus Fritillariae Cirrhosae side of being.Radix Scutellariae nature and flavor hardship, cold, its merit " is longer than clearing away lung-heat " (" Chinese materia medica "), and bitter in the mouth is can sending down the abnormal ascending QI contrary, so eliminating the pathogens from the lung is through fire flaming up due to disorder of QI clearly, and for controlling cough due to lung-heat's key medicine, " Standards of Diagnosis and Treatment " HUANGQIN SAN is promptly routine for it.Radix Scutellariae except that kind can clear eliminating the pathogens from the lung heat, the effect of the heat of expelling pathogenic factors from muscles table is also arranged, Li Dongyuan calls its " lunar dose of hands also for bitter in the mouth and approaching, the expelling pathogenic factors from muscles heat so can let out lung-fire "; " book on Chinese herbal medicine just " calls its " fire of the clear part of the body cavity above the diaphragm housing the heart and lungs, clearing away phlegm is gentle, relieving asthma and cough is only lost blood ... the heat of the flesh table of dispelling especially "; " medicine origin " also draws " curing mainly secret " cloud: " it is with having nine: eliminating the pathogens from the lung is through heat, and one also; Xia Yuexu usefulness, two also; The part of the body cavity above the diaphragm housing the heart and lungs and skin wind heat, three also; Go all heat, four also; ... profit is gas in the heart, and six also; The expectorant on the diaphragm that disappears, seven also ... ", this shows that Radix Scutellariae also has the merit of the sharp lung antitussive of expectorant simultaneously, so can help principal drug assistance, ministerial drug clearing away and dispersing lung-heat, preventing phlegm from forming and stopping coughing.Bulbus Fritillariae Cirrhosae nature and flavor hardship, sweet, be slightly cold, the merit of tool removing heat from the lung and dissipating phlegm cough-relieving, " the Changsha medicine is separated " speech " property of Bulbus Fritillariae Uninbracteatae bitter cold, the cool gold that expels the heat-evil, the turbid descending expectorant; its power is non-little; right clearing heat in the lung and here praiseworthy unbeaten gastric qi is very ", hold concurrently the again property of sweet cold of Bulbus Fritillariae Cirrhosae, so the merit of lung moistening is arranged again, control the lung-heat impairment of body fluid and cause the thick difficulty of expectorant and cough up with assistant.

In order to obtain better curative effect, medicine of the present invention can also add Radix Glycyrrhizae on the basis of said medicine.Because the Radix Glycyrrhizae nature and flavor are sweet, flat, the function coordinating the actions of various ingredients in a prescription, so the property of Yin Qigan profit and go into lung is energy lung moistening and certain relieving cough and resolving phlegm effect (" Chinese materia medica ") is arranged." medicine justice " is cloud again: " Radix Glycyrrhizae gives birth to the pathogenic fire purging with cold, the main pathogenic factor in the exterior that looses, and subduing inflammation, the sore-throat relieving pain is separated hundred poison of drug, removes the long-pending heat of stomach, goes the urinary catheter pain, the power of this sweet cool heat extraction is also ", so Radix Glycyrrhizae also can help the power of clearing away heat-fire detoxifcation in we.

In order to reach best curative effect, medicine of the present invention also makes up with Fructus Trichosanthis, Folium Eriobotryae.This is because Fructus Trichosanthis, and is sweet in flavor and cold in property, " detailed outline " Yan Qineng " lung moistening is dry, and pathogenic fire reducing is controlled cough; the clearing away phlegm knot, and throat is only quenched one's thirst, sharp large intestine; the subduing inflammation sore ", and we are the merit of its removing heat from the lung and dissipating phlegm cough-relieving specially, to help Flos Lonicerae, Fructus Forsythiae removing summer-heat lung-heat, more can Qinghua heat-phlegm and the cough-relieving sore-throat relieving.Folium Eriobotryae, the nature and flavor hardship, be slightly cold, go into lung, stomach through and tool lung heat clearing stomach function regulating, the merit of lowering the adverse-rising QI to resolve phlegm, " detailed outline " cloud: " Folium Eriobotryae is controlled the disease of lung stomach, mostly gets the merit ear of its therapeutic method to keep the adverse QI flowing downwards; it is suitable that expectorant falls in the next inflammation of gas; and contrary person is not contrary, and the habitual vomiter does not vomit, the person of drinking is not thirsty; the person of coughing or not ", " Chongqing hall random notes " are cloud also: " Folium Eriobotryae, all pathogenic wind-warm; warm; the dry all heresies of summer-heat all can be controlled joint in order to preserve gentle gold the lung person ", we's's promptly special-purpose its " lung heat clearing gas; fall lung-fire, relieving cough and resolving phlegm " merit is with Radix Peucedani, Fructus Trichosanthis helps Flos Lonicerae altogether, the power of Fructus Forsythiae lung heat clearing, the double again disease of controlling expectorant heat.

This 8 flavor medicine is made up, make in the wind heat of table and must loose, expectorant heat must be changed clearly lung hot and suffocating, and lung qi must be declared, and the merit of reducing heat and dispersing lung-QI, preventing phlegm from forming and stopping coughing is played in the duty that clear again respectful a surname of lung falls and only coughing altogether.According to modern pharmacological research, Flos Lonicerae, Fructus Forsythiae, Radix Scutellariae, Radix Peucedani, Fructus Trichosanthis etc., wider antimicrobial spectrum is all arranged, have antiinflammatory, refrigeration function, multiple Gram-positive and negative bacterium all there are the obvious suppression effect, have the effect of tangible resisiting influenza virus or adenovirus, syncytial virus more than simultaneously; And Bulbus Fritillariae Cirrhosae, Radix Peucedani, Radix Glycyrrhizae etc. have and significantly eliminate the phlegm or antitussive effect, therefore treat due to illness the disease curative effect the bests such as Huang is thick of generate heat, cough, cough up phlegm due to poison or the caused upper respiratory tract infection of bacterial infection, the bronchitis.

The consumption of drug component of the present invention is also groped to sum up to draw through the inventor in a large number, and each amounts of components is for all to have better curative effect in the following weight parts scope:

Flos Lonicerae 1-3 part, Fructus Forsythiae 1-3 part, Radix Peucedani 1.5-2.5 part, Radix Scutellariae 0.5-2.5 part, Bulbus Fritillariae Cirrhosae 0.5-2.5 part.

Be preferably: 2 parts of Flos Loniceraes, 2 parts of Fructus Forsythiaes, 2 parts of Radix Peucedanis, 1.3 parts of Radix Scutellariaes, 1.3 parts of Bulbus Fritillariae Cirrhosaes.

Each amounts of components of medicine of the present invention can also be Flos Lonicerae 1-3 part, Fructus Forsythiae 1-3 part, Radix Peucedani 1.5-2.5 part, Radix Scutellariae 0.5-2.5 part, Bulbus Fritillariae Cirrhosae 0.5-2.5 part, Radix Glycyrrhizae 0.5-1.5 part.

Be preferably: 2 parts of Flos Loniceraes, 2 parts of Fructus Forsythiaes, 2 parts of Radix Peucedanis, 1.3 parts of Radix Scutellariaes, 1.3 parts of Bulbus Fritillariae Cirrhosaes, 1 part in Radix Glycyrrhizae.

Each amounts of components of medicine of the present invention can also be Flos Lonicerae 1-3 part, Fructus Forsythiae 1-3 part, Radix Peucedani 1.5-2.5 part, Folium Eriobotryae 1.5-2.5 part, Fructus Trichosanthis 1.5-2.5 part, Radix Scutellariae 0.5-2.5 part, Bulbus Fritillariae Cirrhosae 0.5-2.5 part, Radix Glycyrrhizae 0.5-1.5 part.

Be preferably: 2 parts of Flos Loniceraes, 2 parts of Fructus Forsythiaes, 2 parts of Radix Peucedanis, 2 parts of Folium Eriobotryaes, 2 parts of Fructus Trichosanthis, 1.3 parts of Radix Scutellariaes, 1.3 parts of Bulbus Fritillariae Cirrhosaes, 1 part in Radix Glycyrrhizae.

Medicine of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional oral preparations.For example these crude drug pulverize mix homogeneously can be made powder takes after mixing it with water; Can be with these raw materials decocting together, concentrate drying is made then; But bring into play drug effect better for each raw material that makes this medicine, preferably Radix Scutellariae in the crude drug is carried out acid-alkali refining, other raw material is carried out water extract-alcohol precipitation etc.But these can not be used to limit protection scope of the present invention.

Each conventional adjuvant of need when the active component of medicine of the present invention can add the preparation different dosage form, be prepared into any peroral dosage form commonly used as disintegrating agent, lubricant, binding agent etc. with the method for Chinese medicinal of routine, as pill, powder, tablet, capsule, oral liquid etc.

Medicine of the present invention has heat-clearing and toxic substances removing, functions such as relieving cough and resolving phlegm.Be applicable to copious thick sticky phlegm, diseases such as heating pharyngalgia or aversion to wind.Be used for the treatment of due to illness poison or the caused upper respiratory tract infection of bacterial infection, heating due to the acute bronchitis, cough, the yellow thick disease of waiting of coughing up phlegm.

The specific embodiment

Below further set forth the beneficial effect of medicine of the present invention by testing example, these are tested examples and have comprised that the pharmacodynamics test of medicine of the present invention (to call cough-stopping granule with honeysuckle flower and bulbus fritilariae in the following text) and clinical observation on the therapeutic effect test.

[test example 1] medicine bacteriostasis test of the present invention

One, test material

(1) medicine and reagent

1, be subjected to the reagent thing:

(1) source: cough-stopping granule with honeysuckle flower and bulbus fritilariae is prepared by Harbin Children Pharmaceutical Factory, provides lot number: 960810

(2) specification: every packed 2g (preparation labelled amount).

(3) content: the 2g preparation contains Chinese medical concrete powder 0.4g (quite 6.8g crude drug).

(4) usage and consumption: boiled water is taken after mixing it with water, and 3 times on the one, one-year-oldly once obey 0.5～1 bag with interior, once obeyed 1～2 bag in two years old to four years old, once obeyed 2～3 bags in five years old to seven years old, drink more than seven years old and increase or follow the doctor's advice.This test is once to obey 3 bags of meterings in five years old to seven years old.Pressing Chinese Pharmacopoeia " old young dosage commutation table " conversion adult (18～60 one full year of life, a 60kg body weight) day therapeutic dose according to child dose is 18gX2/60kg=0.6g (preparation)/kg (quite Chinese medical concrete powder 0.12g/kg or crude drug 2.04g/kg).

(5) adopt test specimen: Yin Yinbei cough-relieving new drug is a compound preparation, and excipient content is more, thus this test, not contain the preparation of excipient---the Chinese medical concrete powder is the test specimen that is subjected to the reagent thing.

Dosage: by the animal per kg body weight silver shellfish cough relief traditional Chinese medicine extract powder re-computation of growing up.

(6) test specimen compound method: take by weighing constant weight silver shellfish cough-relieving extractum, put into mortar and be ground into fine powder, the limit adds the waterside grinds, and is mixed with the silver-colored shellfish cough-relieving extractum liquid of desired concn with distilled water.

2, positive control drug: XIAOER KECHUANLING CHONGJI, many pharmaceutical factories of winning, Guangzhou produce, every packed 2g, oral, every day 3～4 times, five years old to seven years old each clothes 2g, this test was with five years old to seven years old each clothes 2g, every day 4 amounts of calculation, being converted into day for human beings therapeutic dose with Chinese Pharmacopoeia " old young dosage commutation table " is 8gX2/60kg=0.27g (preparation)/kg.

3, experimental strain: Diplococcus pneumoniae: Jia Xingrongxuexinglianqiujun; Beta hemolytic streptococcus; Golden yellow ' [color staphylococcus; Escherichia coli; Bacillus proteus; Enterococcus.

Above-mentioned bacterial strains is reference culture and bacterial strain after identifying in detail.Respectively available from microbiology teaching and research room of Harbin Medical University, Heilongjiang Traditional Chinese Medicine university microorganism teaching and research room, No.1 Hospital Attached to Harbin Medical Univ., second hospital's Bacteriology Room, Harbin City and Heilongjiang Prov. Sanitation and Antiepidemic Station.

4, gastric Mucin: Huhehaote City's biochemical-pharmaceutical factory is produced, lot number: 960108

5, the experimental strain culture medium is selected:

(1) staphylococcus aureus; Escherichia coli; Bacillus proteus; Enterococcus is all selected common nutrient broth medium for use.

(2) Diplococcus pneumoniae, Jia Xingrongxuexinglianqiujun; Beta hemolytic streptococcus is all selected for use and contains 0.5% and exempt from erythrocyte meat extract soup.

6, bacterium liquid preparation:

Get the fresh slant culture-oese of above-mentioned bacterial strains respectively and be inoculated in the different separately culture medium of 1mI, put 37 ℃ and hatch after 18 hours again culture fluid and make 1: 1000 diluted for use.

(2) animal

Kunming kind white mice provides the quality certification by institute of oncology animal housing of Harbin Medical University; The moving word 09-2-1 medical faunae certificate of competency of black doctor, primary standard.

Two, method and result

(1) extracorporeal bacteria inhibitor test

1, be put to the test medicine preparation: be subjected to reagent thing and positive control all with behind the dissolved in distilled water, 100 ℃ of sterilizations in 30 minutes, continuous sterilization 3 days is standby.

2, test method: decide minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) with test tube diploidy number dilution method side.

Every strain bacterium is got 10 aseptic small test tubes, add 1ml sterilization broth bouillon under the aseptic condition respectively, draw again and be interpreted as 250mg/mI medicine to be measured dimly and tuck in 1ml and add in first pipe, fully draw 1ml behind the mixing and move second pipe ... so make doubling dilution to the 9 pipes, discard each pipe of 1ml then and adding 0.05ml10 respectively ^-3The fresh bacterium liquid of dilution.The 9th pipe is bacterial strain contrast (having bacterium not have medicine) for medicine contrast (having aseptic) the 10th pipe.Put 37 ℃ then and hatched 24 hours, observation has or not bacterial growth, and perusal culture clear person's the highest drug dilution degree both had been the minimum inhibitory concentration (MIC) of medicine.Hatching after 48 hours still, the highest drug dilution degree of asepsis growth both had been the minimum bactericidal concentration of medicine (MBC).Result of the test sees Table 0, table 1 and table 2.

3, experimental result

From table 0, table 1 and table 2 result as seen, silver-colored shellfish cough-relieving to staphylococcus aureus, Diplococcus pneumoniae, Jia Xingrongxuexinglianqiujun, beta hemolytic streptococcus, more intense antibacterial action is arranged, escherichia coli, Bacillus proteus are also had antibacterial action.Two medicine vitro antibacterial activities are compared in the cough-relieving of silver shellfish with XIAOER KECUANLING

(2) vivo bacteria corrosion action test

1, prepared by the reagent thing: after all dissolving before tested by reagent thing and positive control medicine with aquae destillata, 100 ℃ of 30 minutes steam sterilizations, once a day, continuous three days.

2, experimental strain: test the previous day, with Diplococcus pneumoniae, staphylococcus aureus, quantitatively be inoculated in the 2mI broth bouillon, get the 0.1mI culture after 6 hours in 37 ℃ of incubations and be inoculated in the 10mI broth bouillon, 37 ℃ of incubations 18 hours, this is the experiment original bacteria liquid.This original bacteria liquid is suitably diluted, finally make infection animal bacterium liquid with 5% gastric Mucin.

3, test method: select body weight 18-20g white mice for use, male and female half and half.To test to move and be divided into 6 groups at random by body weight, sex (male and female half and half), every group 10, every mice is measured through the bacterium of lumbar injection 1MLD/0.5MI, behind mouse infection, reach 6 hours at once, gradation in 24 hours, 30 hours, 48 hours, 54 hours is through gastric infusion, observed 7 days, record infects back dead mouse situation.

4, dosage setting: test drug is respectively established 5 various dose groups with the contrast medicine and is respectively:

Test drug: 2.64,1.32,0.66,0.33 and 0.17g/kg (quite Coming-of-Age Day therapeutic dose 1.4,2.8,5.5,11 and 22 times); Contrast medicine: 5.94,2.97,1.49,0.76 and 0.38g/kg (quite Coming-of-Age Day therapeutic dose 1.4,2.8,5.5,11 and 22 times).

5, experimental control: establish bacterium contrast and XIAOER KECUANLING as positive control drug.

6, Data Processing in Experiment: adopt the probability-weighted per unit system to calculate the ED of two kinds of medicines ₅₀And ED ₅₀95% fiducial limit, and to two median effective dose (ED ₅₀) significance of difference checks.

The protective effect of silver shellfish cough-relieving and XIAOER KECUANLING Diplococcus pneumoniae and infection of staphylococcus aureus white mice, it the results are shown in Table 3, table 4 and table 5.

7, result of the test

Experimental result shows that silver-colored shellfish cough-relieving all has vivo bacteria corrosion action to Diplococcus pneumoniae and staphylococcus aureus, and is especially more intense to the vivo bacteria corrosion action of Diplococcus pneumoniae.Silver shellfish cough-relieving both vivo bacteria corrosion actions of comparing with contrast medicine XIAOER KECUANLING are similar, learn processing, both there was no significant differences by statistics.

[test example 2] medicine antivirus action test of the present invention

One, test material

(1) medicine

1, is subjected to the reagent thing: test with bacteriostasis

2, positive control drug: test with bacteriostasis

(2) Strain

1, influenza virus (A ₃), respiratory syncytial virus (ASV), adenovirus III type (ADV ₃), all there is Nat'l Pharmaceutical ﹠ Biological Products Control Institute to introduce.

2, COxsackie group III type (CBV ₃), introduce by Ministry of Public Health viral myocarditis key lab of Shanghai Medical Univ.

(3) cell and culture medium

1, test is Vero-E6 and MDCK passage cell with cell.The former is used for ASV, AdV ₃, CBV ₃Virulence titration and anti-viral test; Mdck cell is used for influenza virus (A ₃) virulence titration and anti-viral test.

2, cell growth medium contains the synthetic culture fluid of MEM of 10%BS.

3, cell maintenance medium is the MEM of 2%BS.

(4) animal Kunming kind white mice, test with bacteriostasis in the source.

Two, test method and result

(1) anti-viral effect test

1, the processing of medicine; With cell maintenance medium with the dilution of reagent thing and positive control drug make 0.5%, 1%, 5%, 10% with 15% 5 different drug level (or claiming dilution factor).

2, the preparation of cell monolayer: Vero-E6 and MOCK cell are dispersed into individual cells with film enzyme EDTA Digestive system make 2.5x10 ⁵The cell suspension of/ml is inoculated 96 holes trace Tissue Culture Plate, and every hole 100 μ l put 37 ℃ of 5%CO ₂In the incubator, standby until growing up to monolayer.

3, the toxicity test of medicine; With the above-mentioned diluent that is diluted to five different pharmaceutical concentration, inoculation grows up to cell monolayer plate (removing cell growth medium in the hole).Each medicine is inoculated 4 holes, every hole 150 μ l.Place 37 ℃ of 5%CO ₂Cultivate observed and recorded cell growth state day by day under inverted microscope in the incubator.

4, medicine anti-viral effect test: adopt micro-cytopathy political reform (CPE).To select different virus to be diluted to 100TCID with cell maintenance medium respectively ₅₀Viral suspension is removed the growth-promoting media that grows up in the cell monolayer plate hole, and the virus inoculation that dilution is finished is in similar cell plate hole, and every hole 30 μ l establish four porocyte control wells simultaneously and (add 100 cell maintenance mediums.Cell plates with virus inoculation place 37 ℃ of 5%CO then ₂Absorption is 2 hours in the incubator.The effect treated finishes, and takes out cell plates, the dilute liquid medicine of the variable concentrations that the inoculation dilution is good in the cell hole of the cell of virus inoculation, and each concentration four hole, the cell maintenance medium of every hole 150 μ l places 37 ℃ of CO with cell ₂Cultivate in the incubator,, observed continuously seven in inverted microscopically observation of cell pathological changes (CPE) situation day by day.Its as a result example go into table 6.

As can be known from Table 6: silver-colored shellfish cough-relieving can suppress 100TCID in fact entirely when concentration is 50mg/mI ₅₀ASV, ADV ₃, CBV ₃And A ₃Due to cytopathy.And silver-colored shellfish cough-relieving under this concentration only to ADV ₃, CBV ₃CPE extremely inhibitory action is arranged.The cough-relieving of silver shellfish can suppress CBV in fact entirely when concentration is 10mg/mI ₃Institute's cytopathogenic effect, and children's Yin Bei cough-relieving does not have this effect under this concentration.

(2) physical ability resisiting influenza virus (A ₃) effect

1, to infecting the stream virus of A ₃The influence of mice dying rate

Get 120 of 18～22g healthy mices, male and female half and half are divided into four groups at random, each 15 of every group of 30 male and female.The blank group; The silver-colored shellfish cough-relieving of low, high dose is subjected to reagent thing group; XIAOER KECUANLING positive control drug group.Low, high dose is subjected to reagent thing group to give mice lavage 6.5% and 13.2% silver medal shellfish cough-relieving extractum liquid 0.4mI120g positive controls by 5.94g/kg dosage by 1.32g and 2.64g/kg dosage respectively, irritates stomach co-content XIAOER KECHUANLING CHONGJI; The blank group gavages the co-content normal saline.Be administered once every day by above-mentioned dose of capacity, continuous 8 days, give for the first time behind the medicine virus inoculation immediately, adopt nasal drip.The mice etherization of going ahead of the rest treats that anesthesia fully, steeves the animal head, becomes flat mouthful No. 23 injection needles to insert the mice nasal cavities with clipping tip ramp, and slowly, the inoculation titre is 103 influenza virus A3 0.03mI.Observed 12 days, and write down the mice dying number every day, the results are shown in Table 7.

From table 7 result as seen, silver-colored shellfish cough-relieving is compared with XIAOER KECUANLING group and blank group, all can significantly reduce influenza virus infection A ₃The mice dying rate, but two medicines are compared no significant difference.

2, to infecting the stream virus of A ₃The influence of white mice life span

Get 120 of body weight 18～22 healthy mices, male and female half and half, viral infection, administration Jie method and divide into groups the same.The main influence of observing infective virus to life span the results are shown in Table 8.

High dose silver shellfish cough-relieving group compares with XIAOER KECUANLING and blank group as known from Table 8, all can significant prolongation influenza virus infection A ₃The white mice life span.

[test example 3] medicine relieving cough and resolving phlegm of the present invention, the test of relievining asthma

One, test material

(1) medicine and material

1, be subjected to the reagent thing: silver-colored shellfish cough-relieving is tested with antibacterial action.

2, positive control drug: XIAOER KECUANLING is tested with bacteriostasis.

3, instrument medicine: the acetyloxide choline, the Shanghai biochemical research is produced, lot number 860131; Hydrochloric acid histamine, the Shanghai biochemical research is produced, lot number 830645.

(2) animal hybrid Cavia porcellus at random, Kunming kind white mice provides the quality certification by the laboratory animal department of the Chinese Academy of Sciences of Harbin Medical University: test with antibacterial action.

Two, content of the test method and result

(1) antiasthmatic effect test

1, screening animal: get the Cavia porcellus of body weight 180～200g, male and female are also used.Putting into volume respectively is after the airtight bell glass of 4L is treated peace and quiet, starts air compressor, with 53KP _aAfter equivalent mixed liquor (draw and breathe heavily medicinal liquid) the 15S spraying that the constant voltage of (400mm Hg) sprays into the hydrochloric acid histamine of 2% acetylcholine and 0.1% stops, the incubation period of panting property tic appears in Cavia porcellus in the observation 6min, the drawing of Cavia porcellus breathes heavily incubation period person in 120S and selects for use for experiment, and surpassing 120S person's reject need not.

2, formal test: get 50 of the qualified Cavia porcelluss of screening, be divided into five groups at random, 10 every group, basic, normal, high three dosage are subjected to reagent thing group, positive controls and blank group.Before administration, surveyed respectively and respectively organized the number of animals (number of animals of tic promptly takes place) that drawing of every Cavia porcellus breathed heavily incubation period and suffocated and fallen by dyspnea.Be subjected to reagent thing group to gavage 9.6%, 19.2% and 28.8% silver medal shellfish cough-relieving cream liquid 1ml/200g to Cavia porcellus every day by 0.48g/kg (Coming-of-Age Day therapeutic dose x4 doubly), 0.96g/kg (Coming-of-Age Day therapeutic dose X8 doubly) and 1.44g/kg (Coming-of-Age Day therapeutic dose X12 doubly) dosage respectively.The positive control drug group gavages the co-content XIAOER KECHUANLING CHONGJI by 2.16g/kg dosage, be administered once every day by above-mentioned dose of capacity, successive administration eight days, with 60min after the last administration, the blank group gavages with the capacity normal saline, with similarity condition before the administration, measures once more that drawing of every Cavia porcellus breathed heavily incubation period and the tic number of animals (is caused the number of animals of suffocating and falling by dyspnea, in the 6min), the results are shown in Table 9.

As can be known from Table 9, after the cough-relieving of basic, normal, high three dosage silver shellfish gavaged eight days to Cavia porcellus, contrast all can obviously prolong to draw and breathe heavily incubation period before and after self administration; And can significantly reduce because of dyspnea and cause the number of animals of suffocating and falling, with blank group ratio, the cough-relieving of middle high dose silver shellfish also has same function, show that silver-colored shellfish cough-relieving has antiasthmatic effect, cut that antiasthmatic effect increases along with dosage increases, certain dose-effect dependence and positive control drug ratio are arranged, under identical clinical multiple dosage, antiasthmatic effect, the good and silver-colored shellfish cough-relieving of XIAOER KECHUANLING CHONGJI.

(2) the antitussive action test selects for use the Cavia porcellus citric acid to draw the method for coughing

1, preliminary election animal: get body weight 180～210g Cavia porcellus, the male and female dual-purpose, place in the volumetrical airtight bell glass of 4L, the pressure of 80kpa (600mmHg) sprays into 17.5% citric acid with nebulization (spraying into by the glass shower nozzle), spraying 1min, the cough number of times of Cavia porcellus in the record 5min, carry out preliminary election, the cough number of times is less than the person 10 times in the 5min, and reject need not.

2, formal test: get 50 of the qualified Cavia porcelluss of preliminary election, be divided into five groups at random, 10 every group.Be divided into blank, positive control drug and basic, normal, high three dosage and be subjected to reagent thing group.Be subjected to reagent thing group to gavage 9.6%, 19.2% and 28.8% silver medal shellfish cough-relieving extractum liquid 1ml200g to Cavia porcellus every day by 0.48g/kg0.96g/kg and 1.44g/kg dosage respectively; The positive control drug group gavages the co-content XIAOER KECHUANLING CHONGJI by 2.16g/kg, the blank group gavages with the capacity normal saline, be administered once every day by above-mentioned dose of capacity, continuous eight days, 60min after the last administration, the condition during again by preliminary election gives to cough in drawing, write down cough latent period and the interior cough of the 5min number of times of every Cavia porcellus, it the results are shown in Table 10.

As can be known from Table 10, the cough-relieving of basic, normal, high three kinds of various dose silver shellfish gavages to Cavia porcellus, compares with the blank group, and tangible antitussive action is all arranged, cough latent period is obviously prolonged, the cough number of times obviously reduces, the cough-relieving of middle high dose silver shellfish, and its antitussive action is better than XIAOER KECHUANLING CHONGJI, the cough-relieving of low dosage silver shellfish, with positive control drug than no significant difference (P＞0.05), with the dosage analysis, silver-colored shellfish cough-relieving antitussive action has certain dose-effect relationship.

(3) the phenol red expelling phlegm method of mice is adopted in the phlegm-dispelling functions test.Get 50 of body weight 20～24g healthy mices, be divided into five groups at random, 10 every group, basic, normal, high three kinds of dosage are subjected to reagent thing group, positive control drug and blank group.Be subjected to the reagent group respectively by giving 0.66g/kg1.32g/kg2.64g/kg dosage every day mice lavage 3.2%, 6.4% and 12.8% silver medal shellfish cough-relieving extractum liquid 0.4ml/20g; The positive control drug group is pressed 2.97g/kg dosage and is irritated stomach co-content XIAOER KECHUANLING CHONGJI.The blank group is irritated stomach co-content normal saline.Be administered once continuous eight days every day by above-mentioned metering.With 30min behind the last gastric infusion, put to death mice by taking off cervical vertebra half an hour after lumbar injection phenol red solution 0.5ml (0.25g/dl) injection, facing upward the position is fixed on the operation plate, cut off through center skin, separate trachea, No. 7 syringe needles that under larynx head polished insert about 0.3cml in the trachea, after fixing with the silk thread ligation, draw 5%NaHCO with the 1ml syringe ₃Solution 0.5ml by syringe needle lavation respiratory tract 3 times back and forth, injects a color comparison tube with irrigating solution, draws NaHCO again ₃Solution 0.5ml is as above lavation three times; Same for the third time again lavation, (about 1.5ml) puts in the color comparison tube with three times washing liquids, uses spectrophotometer in 546nm wavelength place's photometry density, with 5%NaHCO ₃Liquid is blank, sees Table 11.As can be known from Table 11, basic, normal, high three kinds of dosage silver shellfish cough-relieving and XIAOER KECUANLING group and blank group compare, and its phenol red eliminating amount significantly increases, and showing has certain phlegm-dispelling functions.Two medicines are compared no significant difference.

[test example 4] medicine antiinflammatory of the present invention, refrigeration function test

One, test material

(1) medicine and instrument medicine

1, is subjected to the reagent thing: all test with antibacterial action with the positive control drug source.

2, instrument medicine, dimethylbenzene, Harbinization two chemical reagent works produce; Typhoid fever, pair typhoid fever first and second triple vaccinies are produced lot number 960103-2-6 by Changchun Biological Products Institute, Ministry of Public Health;

(2) animal Kunming kind white mice, the Wistar kind is a rat, white big ear rabbit, test with antibacterial action in the source.

Two, content and method and result

(1) antiinflammatory action test

1, xylol to the influence of mice auricular concha inflammation: adopt the mice ear method, get 50 of body weight 18～22g healthy mices, male.Be divided into five groups at random, 10 every group, low middle Senior Three kind dosage is subjected to reagent thing group, positive controls and blank group.Be subjected to reagent thing group respectively by 0.66,1.32 and give 2.64g/kg dosage every day mouse stomach 3.2,6.4 and 12.8% silver medal shellfish cough-relieving extractum liquid 0.4ml/20g; The positive control drug group is pressed 2.97g/kg dosage and is irritated stomach co-content XIAOER KECHUANLING CHONGJI; The blank group is irritated stomach co-content normal saline.Be administered once every day by above-mentioned dose of capacity, continuous eight days, after 1 hour, every mice left side ear melted paraxylene 3 (about 0.31ml) was evenly coated in two sides, ear front and back, a mice left side in the last administration, and auris dextra compares.Cause scorching back 30min, the disconnected neck of mice is put to death, cut two ears along the auricle baseline, lay round auricle at same position respectively with 9mm diameter card punch, with organizing balance to weigh, the left auricle weight of every Mus deducts auris dextra sheet weight and is the swelling degree, obtain the inhibitory rate of intumesce of administration group, and do the t test, and comparable group differences significance, example is gone into table 12 as a result.As can be known from Table 12, silver-colored shellfish cough-relieving and XIAOER KECHUANLING CHONGJI xylol mice auricular concha inflammation have obvious inhibitory action, but two medicines are compared no significant difference.

2, to the outgrowth influence of rat granuloma kind: select rat cotton balls implantation for use, get 50 of body weight 140-160g male rats, be divided into five groups at random, 10 every group.Lumbar injection 10% barbital sodium 30mg/kg anesthesia, in the subcutaneous sterilization of every rat both sides axillary region, each cuts the long osculum of 1cm, (the ammonia benzyl please mycin 1mg/0.4ml with the autoclaving cotton balls of 20mg with the ophthalmology tweezers, 50 ℃ of stove-dryings), subcutaneous from the incision implantation, skin suture began administration the same day from performing the operation immediately.Be subjected to reagent thing group to give rat oral gavage 6%, 12% and 18% silver medal shellfish cough-relieving extractum liquid 1ml/100g every day by 0.6g/kg, 1.2g/kg and 1.8g/kg dosage (5,10 and 15 times of difference therapeutic doses of suitable Coming-of-Age Day) respectively; Positive controls is pressed 2.7g/kg dosage and is irritated stomach co-content XIAOER KECHUANLING CHONGJI; The blank group is irritated stomach with physiology saline.Be administered once every day by above-mentioned dose of capacity, continuous 7 days, calculate and claimed the weight of animals earlier on the 8th, then with the rat sacrificed by decapitation, open otch, cotton balls is knitted taking-up together with tying on every side, reject fatty tissue, put in 60 ℃ of baking ovens after dry 1 hour and weigh, will claim to such an extent that weight deducts the raw cotton ball weight and is granuloma weight.Respectively organize granuloma weight, and calculate suppression ratio.The results are shown in Table 13.As can be known from Table 13, the middle and high dosage group of silver-colored shellfish cough-relieving can obviously suppress the chronic granuloma proliferative effect; And middle dosage group is similar to the inhibitory action of XIAOER KECHUANLING CHONGJI group.

(2) refrigeration function test

Choose 30 of healthy rabbits, the male and female dual-purpose, body weight 1.8～2.2kg, 38.0～39.6 ℃ of anus temperature are divided into five groups at random, 6 every group.One group is blank group, does not inject vaccine and gavages medicine, only gavages with physiology saline, and two groups is the vaccine matched group, and the injection typhoid fever is paid typhoid fever first and second triple vaccinies; Three groups is vaccine+positive control drug group; Four, five groups is vaccine+be subjected to reagent thing group, and laboratory temperature is at 17～21 ℃.Before the test rabbit was placed in the holder 1 hour at least, take temperature with anus temperature instrumentation then,, survey secondary altogether, with the meansigma methods of twice anus temperature normal body temperature as this rabbit every 30min survey 1 time.Record after its normal body temperature in the 15min, the 2nd～5 group of rabbit, slowly inject typhoid fever, pay the typhoid fever first and second triple vaccine pyrogenicity from ear vein by 1.5ml/kg, after injection reaches the injection vaccine behind the vaccine immediately 1 hour, four, five be subjected to reagent thing group, press 0.36g/kg (Coming-of-Age Day treatment amount X3 is doubly) respectively, and 0.72g/kg (Coming-of-Age Day treatment amount X6 doubly) dosage, gavage 18% and 36% silver medal shellfish cough-relieving extractum liquid 2ml/kg once to rabbit; Three groups gavage the co-content XIAOER KECHUANLING CHONGJI by 1.62g/kg dosage; One, two groups gavage with physiology saline.The injection vaccine was measured a rabbit anus temperature every one hour after 1 hour and after the administration second time, surveyed four times altogether and the results are shown in Table 14.As can be known from Table 14, the injection vaccine is after 1 hour, and rabbit body temperature obviously improves, and compares with the blank group, and notable difference (P＜0.01) is arranged.Silver shellfish cough-relieving and XIAOER KECHUANLING CHONGJI compare with the vaccine matched group, can obviously reduce typhoid fever, pay typhoid fever first and second triple vaccinies caused rabbit body temperature rising, but two medicines are compared no significant difference.

[test example 5] Drug therapy of the present invention is poison or the caused upper respiratory tract infection of bacterial infection due to illness, the clinical observation of acute bronchitis

Physical data

One, case source: this group case is the outpatient.

Two, the age: each is organized age distribution and sees Table 1.

Table 1 is respectively organized age distribution relatively (X ± S, year)

Treatment group and matched group compare: X ²=0.01 P＞0.05

By table 1 as seen, treatment group and matched group patient age distribute relatively, learn by statistics and handle, and difference does not have significance, has comparability.

Three, sex: each is organized the patient and relatively sees Table 2 respectively.

Table 2 is respectively organized patient's sex ratio

Treatment group and matched group compare: X ²=0.017 P＞0.05

By table 2 as seen, treatment group and matched group patient sex ratio are learned by statistics and are handled, and difference does not have significance, has comparability.Four, the course of disease: each is organized the distribution of patient's course of disease and relatively sees Table 3.

Table 3 respectively organize patient's course of disease distribute relatively (my god)

Treatment group and matched group compare: X ²=3.017 P＞0.05

By table 3 as seen, the treatment group and the matched group patient course of disease distribute relatively, learn by statistics and handle, and there was no significant difference has comparability.

Five, tcm symptom: each organizes patient's tcm symptom relatively, sees Table 4.

Table 4 is respectively organized patient's tcm symptom relatively

By table 4 as seen, the comparison of treatment group and matched group patient tcm symptom before the treatment is learned by statistics and is handled (Ridit), and there was no significant difference has comparability.

Six, picture of the tongue, pulse condition situation: each organizes patient's picture of the tongue, the pulse condition situation relatively sees Table 5.

Table 5 is respectively organized patient's body of the tongue, pulse condition changes relatively

Treatment group and matched group compare: body of the tongue: X ²=1.4 P＞0.05

Tongue fur: X ²=0.16 P＞0.05

Pulse condition or fingerprint: X ²=1.49 P＞0.05

By table 5 as seen, treatment group and matched group picture of the tongue, pulse condition (or fingerprint) are relatively learned by statistics and are handled (X ²Check), there was no significant difference has comparability.

Seven, the state of an illness distributes: each is organized the distribution of patient's traditional Chinese medical science state of an illness and relatively sees Table 6.

Table 6 is respectively organized patient's traditional Chinese medical science state of an illness and is distributed relatively

Treatment group and matched group compare: X ²=1.6 P＞0.05

By treatment group before treating and matched group patient's sex, age, the course of disease, the state of an illness, tcm symptom etc. are compared, show that two groups of cases all have comparability in every respect.

Research method

One, case is selected:

(1) diagnostic criteria

1, the Western medicine diagnose standard [with reference to " pediatrics (national higher medical universities and colleges association compile teaching material) is formulated]: bronchitis is main according to cough, rale, pulmonary have unfixedly do, diagnosis is made in moist rale etc.

(1) clinical symptoms: based on cough, rale.Upper respiratory tract infection symptoms is arranged earlier mostly, body temperature can height can be low, but mostly be low grade fever, minority can reach 38-39 ℃, can last for days or 2-3 week.Sick is monophone dry cough or a small amount of sputum crudum of expectoration just, the aggravation gradually of cough later on, and secretions increases gradually, and expectorant is the mucus purulence.Infant can not coughed up phlegm, and how to swallow from pharyngeal.Can also symptoms of digestive tract such as vomiting, diarrhoea can appear with General Symptomies such as headache, tired, inappetence.

(2) sign: breathing speeds slightly, and early stage two pulmonary respiration sounds are coarse, and the audible dry rale is later on because of secretions increase occurs slightly, medium rales.Rale is unfixing, and be everlasting Body Position Change or cough back are reduced even disappeared.

(3) auxiliary examination:

1. hemogram: the peripheral white blood cells number is normal or high slightly, has antibacterial to cause or can obviously raise when merging bacterial infection.

2. X ray examination: pulmonary's texture increases thick or hilar shadow increases deeply.

2, tcm diagnosis standard (industry standard " traditional Chinese medical science disease diagnosis criterion of therapeutical effect " according to State Administration of Traditional Chinese Medicine's issue in 1994 is formulated):

(1) cough is secondary to after the flu for cardinal symptom, often shows effect because of climate change;

(2) be mainly in the winter, spring;

(3) auscultation of lung: two pulmonary respiration sounds are coarse, or have and be dispersed in dried, moist rale on a small quantity;

(4) the X line is taken the photograph sheet or fluoroscopic examination, shows increased bronchovascular shadows.

3, differentiation of symptoms and signs for classification of syndrome standard (industry standard " traditional Chinese medical science disease diagnosis criterion of therapeutical effect " according to State Administration of Traditional Chinese Medicine 1994 issue is formulated): this clinical experimental study selects infantile acute bronchitis, and Chinese medical discrimination belongs to syndrome of phlegm-heat obstructing lung person is as observing pattern of syndrome.

Primary symptom: (1) cough; (2) the expectorant HUANGBAI(sic) is sticky, cough up tell not well; (3) thick or dried, moist rale of respiratory murmur;

Inferior disease: (1) heating; (2) thirsty; (3) pharynx is red; (4) yellow urine; (5) big dry stool;

Picture of the tongue: red tongue, yellow and greasy fur;

Pulse condition: sliding number or fingerprint purple.

Above primary symptom indispensability possesses two in the inferior disease, and has above-mentioned picture of the tongue, pulse condition (or fingerprint) shower, and is promptly diagnosable.

4, tcm symptom scoring method:

(1) cough: 0 minute: do not have cough.2 minutes: it was lighter to cough, do not influence play, living or studying.4 minutes: it was heavier to cough, and normal activity is had certain influence.6 minutes: hacking cough was more than, and very then the companion tells, influence sleep and daily routines.

(2) cough up phlegm: 0 minute: no expectorant.2 minutes: the idol amount of coughing up was few, and chromaticness is normal.4 minutes: coughed up a small amount of sticking expectorant, light yellow complexion.6 minutes: a small amount of yellow thick expectorant.

(3) heating: 0 minute: body temperature normal (≤37.2 ℃).1 minute: body temperature＞37.2 ℃,＜38 ℃.2 minutes: body temperature 〉=38 ℃,＜39 ℃.3 minutes: body temperature 〉=39 ℃.

(4) thirsty: 0 minute: no thirsty.1 minute: xerostomia.2 minutes: xerostomia was thirsty, tending to drink water.3 minutes: xerostomia, extreme thirst, drinking-water continues not understand again and again.

(5) pharynx is red: 0 minute: normal.2 minutes: swallow red.

(6) yellow urine: 0 minute: normal.2 minutes: yellow urine.

(7) big dry stool: 0 minute: normal.1 minute: big dry stool, difficult defecation.2 minutes: big dry stool, 1 time/2-3 day.3 minutes: constipation with dry stool, 1 time/more than 3 days.

(8) pulmonary's sign: 0 minute: normal.2 minutes: two pulmonary respiration sounds were coarse, audible dry rale, or thick, medium rales.

(9) conducting lung X-ray examination is levied: 0 minute: normal.2 minutes: increased bronchovascular shadows or hilar shadow increased deeply.

(10) end hemogram slightly: 0 minute: normal.2 minutes: total white blood cells increased.

5, traditional Chinese medical science state of an illness grade scale: it is as follows to formulate traditional Chinese medical science state of an illness grade scale according to (1)-(7): slight: integration 〉=8 minute≤13 minutes.Moderate: integration 〉=14 minute≤19 minutes.Severe: integration 〉=20 minute≤25 minutes.

(3) test case standard:

1, include the case standard in:

(1) meet the Western medicine diagnose standard of acute bronchitis, Chinese medical discrimination is the infantile cough case of syndrome of phlegm-heat obstructing lung simultaneously.

(2) morbidity is within 3 days.

(3) age (comprised 7 years old) between 6 months to 7 years old.

2, get rid of case standard (comprising inadaptation and rejecting standard)

(1) merges other primary disease person of pulmonary.

(2) age is more than 7 years old.

(3) severe malnutrition, or be associated with serious primary disease such as cardiovascular, liver, kidney and hemopoietic system, psychotic.

(4) to this medicine allergy sufferers.

(5) all standards of including in that do not meet, not medication in accordance with regulations can't be judged curative effect or data not umbra sound curative effect or safety judgement person.

Two, test method:

(1) EXPERIMENTAL DESIGN:

The method of stratified random, single blind, parallel control is adopted in this test, is multiple center trial.

1, at random: by NDST software (professor Sun Ruiyuan chief editor), carry out the layer and section equilibrium and design at random, (300 examples are organized in treatment with 400 routine cases, matched group 100 examples) be divided into two groups at random, every section internal therapy group 6 examples, matched group 5 examples are observed 5 research units respectively.

2, single blind: because trial drug is different with color, the abnormal smells from the patient of control drug, so adopt the single blind medicine of method preparation of dual analog, promptly manufacture two kinds of simulation medicines with cough-stopping granule with honeysuckle flower and bulbus fritilariae and XIAOER KECHUANLING CHONGJI outward appearance (color, granular size), abnormal smells from the patient basically identical, so that the treatment group is taken identical medicine (the simulation medicine of treatment group clothes cough-stopping granule with honeysuckle flower and bulbus fritilariae and XIAOER KECHUANLING CHONGJI with the experimenter of matched group, the simulation medicine of matched group clothes XIAOER KECHUANLING CHONGJI and cough-stopping granule with honeysuckle flower and bulbus fritilariae), so that single blind carrying out.

3, multiple center trial: this research is finished jointly by 5 tame observation units.

(2) test routine number:

Totally 400 examples, wherein 300 examples are organized in treatment, matched group 100 examples.

(3) administrated method:

The test group medicine: cough-stopping granule with honeysuckle flower and bulbus fritilariae (2g/ bag), in 1 years old, obey 2g at every turn; 2-4 year each clothes 4g; 5-7 year each clothes 6g.3 times on the 1st, boiled water is taken after mixing it with water.Take oral liquid for cough and asthma of children simulation medicine simultaneously, in 2 years old, obey 1g at every turn; 3-4 year each clothes 1.5g; 5-7 year each clothes 2g.3 times on the 1st, boiled water is taken after mixing it with water.

Concrete instructions about how to take medicine are as follows: 0.5-1 year: cough-stopping granule with honeysuckle flower and bulbus fritilariae 2g, oral liquid for cough and asthma of children simulation medicine 1g; 2 years old: cough-stopping granule with honeysuckle flower and bulbus fritilariae 4g, oral liquid for cough and asthma of children simulation medicine 1g; 3-4 year: cough-stopping granule with honeysuckle flower and bulbus fritilariae 4g, oral liquid for cough and asthma of children simulation medicine 1.5g; 5-7 year: cough-stopping granule with honeysuckle flower and bulbus fritilariae 6g, oral liquid for cough and asthma of children simulation medicine 2g.

The matched group medicine: oral liquid for cough and asthma of children (2g/ bag), in 2 years old, obey 1g at every turn; 3-4 year each clothes 1.5g; 5-7 year each clothes 2g.3 times on the 1st, boiled water is taken after mixing it with water.Take cough-stopping granule with honeysuckle flower and bulbus fritilariae simulation medicine simultaneously, in 1 years old, obey 2g at every turn; 2-4 year each clothes 4g; 5-7 year each clothes 6g.3 times on the 1st, boiled water is taken after mixing it with water.

Concrete instructions about how to take medicine are as follows: 0.5-1 year: oral liquid for cough and asthma of children 1g, cough-stopping granule with honeysuckle flower and bulbus fritilariae simulation medicine 2g; 2 years old: oral liquid for cough and asthma of children 1g, cough-stopping granule with honeysuckle flower and bulbus fritilariae simulation medicine 4g; 3-4 year: oral liquid for cough and asthma of children 1.5g, cough-stopping granule with honeysuckle flower and bulbus fritilariae simulation medicine 4g; 5-7 year: oral liquid for cough and asthma of children 2g, cough-stopping granule with honeysuckle flower and bulbus fritilariae simulation medicine 6g.

Cough-stopping granule with honeysuckle flower and bulbus fritilariae is produced by Harbin Children Pharmaceutical Factory.

Oral liquid for cough and asthma of children is produced by Hubei Province Suizhou City sky above Hubei and Hunan pharmaceutcal corporation, Ltd.

The simulation medicine of cough-stopping granule with honeysuckle flower and bulbus fritilariae and the simulation medicine of oral liquid for cough and asthma of children are produced by Harbin Children Pharmaceutical Factory.

Annotate: in process of the test, must not use any medicine or the therapy of treatment infantile acute bronchitis.

(4) course of treatment: 6 days is a course of treatment.

(5) observation index:

1, safety detects: (1) general health check-up project (heart rate, body temperature, blood pressure); (2) blood, urine, just routine examination; (3) heart, liver, kidney function test (GPT BUN Gr and electrocardiogram).

2, health giving quality observation: (1) symptom: cough, cough up phlegm, symptoms such as heating, thirsty, pharyngalgia, big dry stool.(2) variation of tongue, arteries and veins, fingerprint.(3) pulmonary's sign: comprise respiratory harshness or dried, moist rale.(4) tip hemogram checking (numeration of leukocyte and classification thereof).Chest X-ray (normotopia).Throat swab is cultivated.

(6) doctor of participation clinical trial must provide the details of relevant clinical trial to the experimenter, comprise test objective, test character, possible be benefited and dangerous, can be for other Therapeutic Method selected for use and the rights and duties etc. that meet the experimenter of Declaration of Helsinki regulation, agree after the experimenter is understood.

(7) should control variable factor from following several respects strictness to clinic case:

1, before clinical trial begins, the clinicist that tissue is participated in clinical trial studies hard clinical trial protocol, implements every technical specification.

2, participate in doctor's relative fixed of clinical trial.

3, patient should be by the requirement further consultation of observation plan, fails further consultation on time as patient, and the doctor should in time notify its further consultation or follow up a case by regular visits to.

4, for patient's compliance, carry out experimenter's work, make the meaning of its apprehension test, and supervise by family members and to take medicine.

Three, curative effect determinate standard:

(1) acute bronchitis curative effect:

With reference to " traditional Chinese medical science disease diagnosis criterion of therapeutical effect. department of pediatrics. the cough efficacy evaluation " and " new Chinese medicine clinical research guideline. acute episode of chronic bronchitis phase curative effect determinate standard ", according to the primary disease concrete condition, it is as follows to formulate the level Four curative effect determinate standard:

Recovery from illness: symptom such as cough, cough up phlegm all disappears, and body temperature recovered in 72 hours normally, pulmonary's sign disappearance, and unusual person of X line and the high person of hemogram recover normal.

Produce effects: symptom such as cough, cough up phlegm obviously alleviates, and body temperature recovered in 96 hours normally, and pulmonary's sign, X line reach the high person of hemogram unusually and recover substantially normally, and above-mentioned every total mark improves 〉=70%.

Effectively: sx such as cough, cough up phlegm, body temperature recovered in 6 days normally, and pulmonary's sign, X line reach the high person of hemogram unusually and make moderate progress, and above-mentioned every total mark improves 〉=30%.

Invalid: as not reach above-mentioned standard person.

(1) tcm syndrome curative effect determinate standard:

Judge therapeutic effect of syndrome according to integration method:

Recovery from illness: n=100%; Produce effects: n 〉=70%; Effectively: n 〉=30＜70%; Invalid: n＜30%.

Four, safety evaluatio standard:

1 grade: safety, there is not any untoward reaction.

2 grades: compare safety,, need not do any processing and can continue administration if any untoward reaction.

3 grades: safety issue is arranged, moderate untoward reaction is arranged, can continue administration after processing.

4 grades: because of test is ended in untoward reaction

Five, end and remove the standard of clinical trial:

(1) doctor who participates in clinical trial reason that test is ended and with the conscientious record of the relation of test, comprise the evaluation when ending.

1, can not adhere to therapist.

2, the person that the serious adverse reaction occurs.

3, other serious concurrent disease patient appears in the process of the test.

4, severity of symptoms, must the person of taking urgent measure.

(2) to clearly write down reason to the patient who proposes to withdraw from test midway voluntarily, and the index estimated when ending of itemized record.

1, the patient proposes to withdraw from test automatically.

2, inquiry reasons and investigation processes thereafter such as phone, mail are answered in patient's institute's further consultation that do not come in time.

3, other

(3) case is rejected principle

1, natural seceder in the observation.

2, it is effective to take this medicine, but the patient takes other similar medicine for quickening curative effect, can't judge curative effect.

3, the last diagnostic person that do not meet the assertive evidence.

Six, clinical trial record:

1, all case is all observed by the scheme requirement, and conscientiously fills in the case notes form.

2, the situation of taking medicine of conscientious record patient, reply all take, miss sometimes, have clothes over half and all not situation such as clothes carry out itemized record, explanation.

3, case history and medical history record form must not be changed as protocol, must not change protocol when making any corrigendum, can only adopt additional description to give reasons, by the physician's signature who participates in clinical trial and date.

4, various laboratory datas all should record in the clinical trial, and observing case should be bonded at initial report on the medical history record table.

5, also should record at the laboratory data of normal range, must be examined data significantly higher or beyond clinical tolerance interval, do necessary explanation by the doctor who participates in clinical trial.

6, clinical observation table uses pen to fill in without exception.

Seven, the record of untoward reaction and method for reporting:

To the untoward reaction that duration of test occurs, should be with its symptom, degree, time of occurrence, persistent period, treatment measures, pass through etc. are recorded in the observation table, and taking all factors into consideration complication, on the drug combination basis, estimate the dependency of itself and trial drug, and by doctor's itemized record.

In addition, when finding untoward reaction, observe the doctor and can whether end test, should carry out follow up survey to case, its result of itemized record because of the untoward reaction drug withdrawal according to state of an illness decision.

Eight, statistical requirements

1, balanced mensuration between the preceding group of treatment.

2, curative effect statistics and significance test between curative effect statistics, group before and after the group internal therapy.

3, dependency statistics

(1) relation of age and curative effect.

(2) relation of sex and curative effect.

(3) course of disease and therapeutic effect relationship.

(4) relation of the state of an illness and curative effect.

4, the statistics of toxic and side effects and untoward reaction.

Therapeutic outcome

One, clinical curative effect analysis:

1, acute bronchitis curative effect: each is organized patients acuity bronchitis curative effect and relatively sees Table 7.

Table 7 is respectively organized patients acuity bronchitis curative effect relatively

Treatment group and matched group compare: U=0.68 P＞0.05

By table 7 as seen, the acute bronchitis curative effect of treatment group and matched group is learned processing (Ridit check), there was no significant difference by statistics.

2, traditional Chinese medical science disease curative effect: each is organized patient's traditional Chinese medical science disease curative effect and relatively sees Table 8.

Table 8 is respectively organized patient's traditional Chinese medical science disease curative effect relatively

Treatment group and matched group compare: U=0.58 P＞0.05

By table 8 as seen, treatment group and matched group traditional Chinese medical science disease curative effect are learned processing (Ridit check), there was no significant difference by statistics.

Two, tcm symptom improves situation: each is organized patient's tcm symptom improvement situation and relatively sees Table 9,10.

Table 9 is respectively organized patient's tcm symptom improvement situation relatively

By table 9 as seen, the every tcm symptom of treatment group and matched group improves more by statistics and handles (t check), and group is relatively interior, P＜0.01, and difference has obvious significance, compares between group, P＞0.05, difference does not have significance.Illustrate that treatment group and matched group all have better curative effect to above-mentioned tcm syndrome, but therapeutical effect is similar.

Table 10 is respectively organized patient's tcm symptom integration and is improved relatively (X ± S)

Treatment group and matched group compare: t=0.422 P＞0.05

By table 9,10 as seen, treatment group and matched group tcm symptom improve to learn more by statistics handles (t check), in the group significant difference is arranged relatively before and after the treatment; But compare there was no significant difference between group.

Three, cough onset time: each is organized the patient and onset time of coughing relatively sees Table 15.

Table 11 respectively organize the patient cough onset time relatively (my god, * ± S)

t＝0.416 P＞0.05

By table 11 as seen, treatment group and matched group are relatively learned by statistics and are handled (t check), there was no significant difference.

Three, picture of the tongue, pulse condition improve situation: each organizes patient treatment front and back picture of the tongue, the pulse condition variation relatively sees Table 12-14.

Body of the tongue changed relatively before and after table 12 was respectively organized patient treatment

Treatment group and matched group compare: X ²=4.98 P＞0.05

Changes of tongue fur relatively before and after table 13 was respectively organized patient treatment

Treatment group and matched group compare: X ²=3.56 P＞0.05

Pulse condition changed relatively before and after table 14 was respectively organized patient treatment

Treatment group and matched group compare: X ²=0.47 P＞0.05

By table 12-14 as seen, treatment group picture of the tongue, pulse condition or fingerprint improve and matched group compares, and learn by statistics and handle (X ²Check), there was no significant difference.

Four, the tip hemogram improves situation: each is organized patient's tip hemogram improvement situation and relatively sees Table 15.

Table 15 is respectively organized patient's numeration of leukocyte (X10 ⁹/ 1) and classification improvement situation (X ± S) relatively

By table 15 as seen, processing (t check), there was no significant difference are learned in each improvement of organizing numeration of leukocyte before and after the patient treatment and classification thereof by statistics.Treatment group and matched group are relatively learned by statistics and are handled there was no significant difference.

Six, chest x-ray improves situation: each is organized patient's chest x-ray improvement situation and relatively sees Table 16.

Table 16 is respectively organized patient's chest X-ray improvement situation relatively

By table 16 as seen, each is organized before and after the patient treatment improvement of chest x-ray and learns processing (X 2 test), there was no significant difference by statistics.Treatment group and matched group are relatively learned by statistics and are handled there was no significant difference.

Seven, body temperature improves situation: each is organized patient temperature improvement situation and relatively sees Table 17.

Table 17 is respectively organized relatively (X ± S) of patient temperature improvement situation

By table 17 as seen, each is organized before and after the patient treatment improvement of body temperature and learns processing (t check), there was no significant difference by statistics.Treatment group and matched group are relatively learned by statistics and are handled there was no significant difference.

Eight, throat swab is cultivated the improvement situation:

In test, throat swab is cultivated the treatment group and is done 32 examples altogether, and wherein 2 examples are alpha streptococcus and mlicrococcus catarrhalis; Matched group is totally 9 examples, all do not turn out pathogenic bacterium.

Nine, safety detects: see Table 18.

Table 18 safety detects

During safety detected, the treatment group was treated proleukocyte and is lower than 4.0X10 ⁹/ L person 3 examples all recover normal after the treatment, treat back leukocyte＞10X10 ⁹/ L person 10 examples, wherein 3 examples recover that normal (2 examples are 10.1X10 after for unusual treatment the before treating fully ⁹/ L, 1 example is 10.3X10 ⁹/ L), 1 example is invalid case, 6 routine treatments are preceding normal, and slightly are higher than after the treatment normally, but the clinical symptoms improvement, due to consideration merging bacterial infection recovers fully; 1 example is treated thromboblast 88X10 ⁹/ L, it is normal to treat the back check.It is all no abnormal to treat the routine urinalysis, stool routine examination, hepatic and renal function, the electrocardiogram that detect the back before treating.Comprehensive above-mentioned detection case, obvious toxic-side effects does not appear in this group test case.

Safety evaluatio

This group test case is not found obvious toxic-side effects.

Reject case

This group test case deletion case 1 example, former because do not take medicine on time, reselect case and observe.

Model case

Model case one:

Week certain, the man 2 years old 3 months, goes to a doctor April 2 calendar year 2001.The main suit coughed 3 days.Cough after infant was suffered from cold before 3 days, watery nasal discharge, heating, T38.2 ℃, clothes " infantile common cold electuary, little white sugar syrup " 1 day heat is moved back certainly, increases the weight of but cough, and satisfies and comes my Pediatric Clinic prescription on individual diagnosis.Inscribe disease: cough is done frequently, abundant expectoration, and the watery nasal discharge yellow skin, inappetence, yellow urine, stool is normal.Red tongue, yellow and greasy fur, the fingerprint purple is to FENGGUAN.

Have a medical check-up: body temperature is normal, and P90 time/minute R30 time/minute mind is clear, and spirit can, grow normally, nutrition is medium, and the whole skin mucosa does not have xanthochromia, the superficial lymph knot does not touch, circle such as isocoria, light reflex sensitivity, the ear nose is no abnormal, red lip, pharyngeal hyperemia, bilateral amygdala 2 degree enlargements, no purulent secretion, it is consistent that thorax symmetry, bilateral are breathed moving degree, and two pulmonary respiration sounds are thick, audible and dry rale, heart rate 90 times/minute, rule is neat, and each auscultatory valve areas is not heard and noise, abdominal part is no abnormal, and neurologic check is no abnormal.

Lab testing: routine blood test WBC3.1X10 ⁹/ L, L67.3%, N23.4%, HGB118 gram/L, PLT88 * 10 ⁹/ L, the routine urianlysis feminine gender, stool routine examination is checked negative, rabat shows: twice lung marking is thick, fuzzy, and Electrocardioscopy is normal, and the hepatic and renal function inspection is all normal, the throat swab antibacterial culturing: no pathogenic bacterium growth.

Diagnosis: the traditional Chinese medical science: cough (phlegm-heat obstructing in the lung)

Doctor trained in Western medicine: acute bronchitis

The treatment process: cough-stopping granule with honeysuckle flower and bulbus fritilariae one and half/time, every day three times.Treat after 3 days, cough obviously alleviates, and treats after 6 days, and symptom, sign all disappear.Check routine blood test WBC4.9X10 ⁹/ L, L72.5%, N17.5%, HGB1121 gram/L, PLT158X10 ⁹/ L, the routine urianlysis feminine gender, stool routine examination is checked negative, the rabat no abnormality seen, Electrocardioscopy is normal, and the hepatic and renal function inspection is all normal.

Model case two:

Nie, the man, 7 years old, went to a doctor April 3 calendar year 2001.Main suit's cough occurred together hot 1 day.Infant before 1 day no obvious cause begin cough, expectorant sound is arranged, the heat that occurs together, about T37.6 ℃, today, my institute department of pediatrics was gone to a doctor.Inscribe disease: cough, expectorant is arranged, low grade fever, pharynx not bitterly, receive food can, stool Pian does, yellow urine, body of the tongue is light red, yellow and greasy fur, slippery and rapid pulse.

Have a medical check-up: T37.6 ℃ of P90 time/minute R28 time/minute mind is clear, spirit can, grow normally, nutrition is medium, have rosy cheeks, the whole skin mucosa does not have xanthochromia, and the superficial lymph knot does not touch, circle such as isocoria, the light reflex sensitivity, the ear nose is no abnormal, red lip, pharyngeal hyperemia, the enlargement of bilateral amygdala I degree, hyperemia, the thorax symmetry, it is consistent that bilateral is breathed moving degree, two pulmonary respiration sounds are thick, heart rate 90 times/minute, and rule is neat, each auscultatory valve areas is not heard and noise, and abdominal part is no abnormal, and neurologic check is no abnormal.

Lab testing: routine blood test WBC8.3X10 ⁹/ L, L14.5%, N82.3%, HGB144 gram/L, PLT21.6X10 ⁹/ L, the routine urianlysis feminine gender, stool routine examination is checked negative, and rabat shows and shows no obvious abnormalities that Electrocardioscopy is normal, and the hepatic and renal function inspection is all normal, the throat swab antibacterial culturing: no pathogenic bacterium grow.

Doctor trained in Western medicine: acute bronchitis

Treatment process: 3 bags/time of cough-stopping granule with honeysuckle flower and bulbus fritilariae, every day three times.Treat after 2 days body temperature and reduce to normally, cough obviously alleviates, and the auscultation of lung respiratory murmur is thick, treats after 6 days, and symptom, sign all disappear.Check routine blood test WBC7.0X10 ⁹/ L, N56.1%, L39.6%, HGB139 gram/L, PLT217X10 ⁹/ L, the routine urianlysis feminine gender, stool routine examination is checked negative, and Electrocardioscopy is normal, and the hepatic and renal function inspection is all normal.

Compliance

In the observed case, an example is wherein arranged after head of a family's signature, follow up a case by regular visits to and find that patient does not take this trial drug on time,, reselect case and observe so reject this case.All the other cases all can be taken medicine on request.

Discuss

This result of the test shows, cough-stopping granule with honeysuckle flower and bulbus fritilariae treatment infantile acute bronchitis (syndrome of phlegm-heat obstructing lung) determined curative effect.

Cough-stopping granule with honeysuckle flower and bulbus fritilariae treatment group example, 22 examples of wherein fully recovering (36.67%), produce effects 21 examples (35%), cure-remarkable-effectiveness rate 71.67%, total effective rate 95%.Matched group (oral liquid for cough and asthma of children) 20 examples are cured 6 examples (30%), produce effects 7 examples (35%), cure-remarkable-effectiveness rate 65%, total effective rate 90%.Two groups of total cure-remarkable-effectiveness rates relatively have significant difference, and the treatment group is better than matched group.Two groups of total effective rates compare, U=0.68, and P＞0.05, difference does not have significance.

Aspect the effect of bringing down a fever, treatment group and matched group compare, P＞0.05, and difference does not have significance, and two groups of effects of bringing down a fever are similar.

Treatment group and matched group tcm symptom (comprise cough, cough up phlegm, heating, picture of the tongue, pulse condition) improve aspect relatively, in the group relatively, P＜0.01, difference has obvious significance, between group relatively, P＞0.05, difference does not have significance.Illustrate that treatment group and matched group all have better curative effect to above-mentioned tcm syndrome, but therapeutical effect is similar.

During safety detects, the treatment group is treated proleukocyte and is lower than 4.0X109/L person's 3 examples, all recover normal after the treatment, treat back leukocyte＞10X109/L person's 10 examples, wherein 3 examples recover that normal (2 examples are 10.1X109/L after for unusual treatment the before treating fully, 1 example is 10.3X109/L), 1 example is invalid case, and is normal before 6 examples are treated, and slightly is higher than normal after the treatment, but clinical symptoms takes a turn for the better, due to consideration merging bacterial infection recovers fully; 1 example is treated thromboblast 88X109/L, and it is normal to treat the back check.It is all no abnormal to treat the routine urinalysis, stool routine examination, hepatic and renal function, the electrocardiogram that detect the back before treating.Comprehensive above-mentioned detection case, obvious toxic-side effects does not appear in this group test case.

Children's's defensive function of the body surface being insufficient, the lung being usually insufficient, weakened defensive QI, susceptible exopathogen, exopathogen are violated lung, impaired depurative descending of lung QI is strongly fragrant and give birth to heat, the heat body fluid that burns is expectorant, combination of phlegm and heat is stopped up the choke road, thus heating is arranged, the thickness of coughing, cough up phlegm, thirsty, pharynx is red, yellow urine, cards such as dry stool greatly.And cough-stopping granule with honeysuckle flower and bulbus fritilariae is made up of Flos Lonicerae, Fructus Forsythiae, Radix Scutellariae, Folium Eriobotryae, Radix Peucedani, Fructus Trichosanthis, Bulbus Fritillariae Cirrhosae, Radix Glycyrrhizae etc., has reducing heat and dispersing lung-QI, the effect of preventing phlegm from forming and stopping coughing.Flos Lonicerae, Fructus Forsythiae heat-clearing and toxic substances removing, clearing away and dispersing lung-heat in the side, the Radix Scutellariae bitter cold, lung heat clearing heat drop stomach-fire, the sharp lung of expectorant, Radix Peucedani energy clearing away lung-heat reduces phlegm turbid, Folium Eriobotryae preventing phlegm from forming and stopping coughing, the cough-relieving of Fructus Trichosanthis removing heat from the lung and dissipating phlegm, Bulbus Fritillariae Cirrhosae removing heat from the lung and dissipating phlegm, the cough-relieving of Radix Glycyrrhizae moistening the lung and resolving phlegm, coordinating the actions of various ingredients in a prescription.All medicines share and gather the merit of reducing heat and dispersing lung-QI preventing phlegm from forming and stopping coughing altogether, and the cough that is applied to phlegm-heat obstructing in the lung obtains good efficacy.

Brief summary

This group is observed case 80 examples altogether, and wherein 60 examples are organized in the cough-stopping granule with honeysuckle flower and bulbus fritilariae treatment, cures 22 examples (36.67%), produce effects 21 examples (35%), total effective rate 95%, cure-remarkable-effectiveness rate 71.67%.Oral liquid for cough and asthma of children matched group 20 examples are cured 6 examples (30%), produce effects 7 examples (35%), total effective rate 90%, cure-remarkable-effectiveness rate 65%.Two groups relatively, learns processing cure-remarkable-effectiveness rate treatment group by statistics and be better than matched group, two groups of there was no significant differences of total effective rate.Do not find obvious adverse reaction.

Below be further elaborated with regard to embodiments of the invention.

The capsule preparation of [embodiment 1] medicine of the present invention:

A) Flos Lonicerae 500g, Fructus Forsythiae 500g, Radix Peucedani 500g, Bulbus Fritillariae Cirrhosae 325g are decocted with water twice, each amount of water was not advisable to have powder, filtered, and was condensed into relative density and is 1.10 clear paste, add 90%-95% ethanol and carry out precipitate with ethanol, reclaiming ethanol and being concentrated into relative density is 1.12 clear paste 1;

B) Radix Scutellariae 325g is given as one thinks fit cataclasm, decoct twice, gradation is filtered, merging filtrate is transferred PH to 1.0-2.0 with hydrochloric acid, fully stirs, be incubated 30 minutes, cold preservation 24 hours, abandoning supernatant, precipitation adds water 3-6 and doubly measures, fully stir and make suspendible, transfer PH to 7.0, make dissolving with sodium hydroxide solution, filter, it is 1.10 clear paste 2 that filtrate is condensed into relative density.

C) merge clear paste 1 and 2, mix homogeneously is concentrated into relative density and is 1.14 clear paste, spraying drying powder-forming, the snap fit capsule of packing into.

The preparation of [embodiment 2] medicinal tablet of the present invention:

A) Flos Lonicerae 500g, Fructus Forsythiae 500g, Radix Peucedani 500g, Bulbus Fritillariae Cirrhosae 325g, Radix Glycyrrhizae 250g are decocted with water twice, each amount of water was not advisable to have powder, filter, be condensed into relative density and be 1.10 clear paste, add 90%-95% ethanol and carry out precipitate with ethanol, reclaiming ethanol and being concentrated into relative density is 1.12 clear paste 1;

C) merge clear paste 1 and 2, mix homogeneously is concentrated into relative density and is 1.14 clear paste, and spraying drying powder-forming adds that adjuvant is granulated and dry, and compacting in flakes.

[embodiment 3]

A) Flos Lonicerae 500g, Fructus Forsythiae 500g, Radix Peucedani 500g, Bulbus Fritillariae Cirrhosae 325g, Radix Glycyrrhizae 250g, Folium Eriobotryae 500g, Fructus Trichosanthis 500g are decocted with water twice, each amount of water was not advisable to have powder, filter, be condensed into relative density and be 1.10 clear paste, add 90%-95% ethanol and carry out precipitate with ethanol, reclaiming ethanol and being concentrated into relative density is 1.12 clear paste 1;

C) merge clear paste 1 and 2, mix homogeneously is concentrated into relative density and is 1.14 clear paste, and spraying drying powder-forming adds adjuvant and makes granule.

Claims

1. a cough-stopping granule with honeysuckle flower and bulbus fritilariae is characterized in that it mainly is to be made by following bulk drugs: Flos Lonicerae 1-3 part, Fructus Forsythiae 1-3 part, Radix Peucedani 1-3 part, Bulbus Fritillariae Cirrhosae 0.5-2.5 part, Radix Scutellariae 0.5-2.5 part.

2. cough-stopping granule with honeysuckle flower and bulbus fritilariae according to claim 1 is characterized in that: wherein the consumption of each crude drug is: 2 parts of Flos Loniceraes, 2 parts of Fructus Forsythiaes, 2 parts of Radix Peucedanis, 1.3 parts of Bulbus Fritillariae Cirrhosaes, 1.3 parts of Radix Scutellariaes.

3. cough-stopping granule with honeysuckle flower and bulbus fritilariae according to claim 1 is characterized in that: wherein crude drug also has Radix Glycyrrhizae 0.5-1.5 part.

4. cough-stopping granule with honeysuckle flower and bulbus fritilariae according to claim 3 is characterized in that: wherein the consumption of each crude drug is: 2 parts of Flos Loniceraes, 2 parts of Fructus Forsythiaes, 2 parts of Radix Peucedanis, 1.3 parts of Bulbus Fritillariae Cirrhosaes, 1.3 parts of Radix Scutellariaes, 1 part in Radix Glycyrrhizae.

5. according to the described cough-stopping granule with honeysuckle flower and bulbus fritilariae of claim 3, it is characterized in that: wherein raw material also has: Folium Eriobotryae 1.5-2.5 part, Fructus Trichosanthis 1.5-2.5 part.

6. described cough-stopping granule with honeysuckle flower and bulbus fritilariae according to claim 5 is characterized in that: wherein the consumption of each crude drug is: 2 parts of Flos Loniceraes, 2 parts of Fructus Forsythiaes, 2 parts of Radix Peucedanis, 1.3 parts of Bulbus Fritillariae Cirrhosaes, 1.3 parts of Radix Scutellariaes, 1 part in Radix Glycyrrhizae, 2 parts of Folium Eriobotryaes, 2 parts of Fructus Trichosanthis.