CN102641356A

CN102641356A - Traditional Chinese medicine composition for treating respiratory tract viral infectious diseases and preparation method thereof

Info

Publication number: CN102641356A
Application number: CN2012101578359A
Authority: CN
Inventors: 曲敬来; 高雪; 陈生; 齐继贵
Original assignee: SHENZHEN QIWANG INVESTEMENT CO Ltd
Current assignee: SHENZHEN QIWANG INVESTEMENT CO Ltd
Priority date: 2012-05-21
Filing date: 2012-05-21
Publication date: 2012-08-22
Anticipated expiration: 2032-05-21
Also published as: CN102641356B

Abstract

The invention discloses a traditional Chinese medicine composition for treating respiratory tract viral infectious diseases and a preparation method thereof. The composition comprises the following active pharmaceutical ingredients in parts by weight: 5-25g of perilla leaf, 5-25g of tatarian aster root, 5-25g of Chinese thorowax root, 5-25g of schizonepeta spike, 5-25g of great burdock achene, 5-25g of apricot seed and 1-15g of liquoric root. The active pharmaceutical ingredients can be matched with excipients and a flavoring agent to be directly or indirectly prepared into pharmaceutically acceptable capsules, oral liquid, granules, syrup, tablets, effervescent particles, dropping pills, aerosol, spraying agent, gargle, mouthwash and a variety of formulations via conventional process steps. The traditional Chinese medicine composition can be clinically used for treating or preventing the respiratory tract viral infectious diseases caused by influenza A virus, influenza B virus, rhino virus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, enteric cytopathogenichuman orphan virus, Coxsackie virus and the like.

Description

A kind of Chinese medicine composition of treating respiratory viral infection disease and preparation method thereof

Technical field

The invention belongs to technical field of Chinese medicines, is a kind of about the treatment respiratory viral infection disease, and particularly the following respiratory viral infection disease of treatment is main Chinese medicine composition and preparation method thereof.Wherein, described respiratory virus infection is meant the respiratory virus infection that influenza A virus, Influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, echovirus, Coxsackie virus etc. are caused.

Background technology

Respiratory tract infection comprises upper respiratory tract infection, tracheitis, bronchitis and bronchopneumonia.The pathogen of lower respiratory infection is various viruses and antibacterial.Weak, allergy and chronic sinusitis person often are prone to suffer from primary disease, especially easy infection more when climate change, air pollution environment.During lower respiratory channel virus infection except that upper respiratory tract infection symptoms is arranged; Cough in early days more is dryness, transfers the moist cough in the later stage. and also have that part patient companion is stridulated, symptoms such as respiratory rhythm speeds, drowsiness, spiritual appetite difference, lower respiratory channel virus infection property disease sickness rate in recent years has the trend that increases; As showing according to Study on etiologic agents; Viral pneumonia accounts for 18% of community acquired pneumonia, accounts for 5% in the same period in the hospital acquired infection, especially in preceding AIDS VICTIMS because of infected person para-immunity defective virus (HIV); Its sickness rate sharply raises especially, more and more receives people's attention.Thereby how can cure respiratory viral infection disease efficiently and effectively and seem particularly important.

The common virus of respiratory tract infection has influenza A virus, Influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, echovirus, Coxsackie virus etc., and is wherein common with rhinovirus, influenza A virus, Influenza B virus.The acute viral laryngitis is many to be caused by rhinovirus, influenza A virus, Influenza B virus, parainfluenza virus and adenovirus etc.; Pain when Clinical symptoms is hoarseness, difficulty speaking, cough; Heating, pharyngitis or cough are often arranged; The visible laryngeal edema of health check-up, hyperemia, regional nodes's silght enlargement and tenderness, audible and whoop; The acute viral bronchitis is many to be caused by rhinovirus, influenza A virus, Influenza B virus, parainfluenza virus, respiratory syncytial virus, adenovirus etc., and clinical manifestation is mucus for cough, no expectorant or expectorant, with heating and weak, uncomfortable in chest.Other symptoms often have pain under hoarseness, the non-pleura property breastbone, audible and dryness or moist rales, and X line chest films showed blood vessel shade increases, strengthens, but apneumia soaks into shade; Influenza A virus, Influenza B virus or cacorhinia toxicity bronchitis often cause the acute attack of chronic bronchitis; Viral bronchiolitis is mainly caused by respiratory syncytial virus, generally occurs in infant, performance cough, asthma, and cyanosis can appear in severe patient; Viral pneumonia is mainly caused by influenza A virus, Influenza B virus, rhinovirus, parainfluenza virus, adenovirus and respiratory syncytial virus etc.Performance heating, cough, the QI rising in reverse order, tachypnea, flaring nares, weight person can lip occur and fingernail is livid purple, the visible pulmonary shadow of Chest X-rays.

Because virus utilizes the metabolic pathway of host cell to duplicate, so, in general, can the medicine of host cell toxigenicity effect be difficult to its elimination if do not use.At present, doctor trained in Western medicine adopts ribavirin to treat to viral infection such as rhinovirus, coronavirus more both at home and abroad.Because the hypotype of rhinovirus, coronavirus is more, be difficult to use vaccine to prevent the generation of virus.The method of preventing and treating to influenza A virus, Influenza B virus is exactly to prevent the generation of virus according to antigen-antibody theory utilization vaccine, but because the antigen of virus is constantly taking place to make a variation, vaccine often also just loses effectiveness.And be used for antiviral drug, based on the variability of virus and the problems such as drug resistance of medicine, and antibiotic is invalid to virus, makes the problem of preventing and treating of virus still very severe.

Respiratory viral infection disease belongs among the traditional Chinese medical science " flu ", " cough ", " the syndrome of dyspnea ", " bronchial wheezing ", and theory of Chinese medical science is thought " lung governing qi, department breathe ".Here said " gas ", one side is meant the gas of breathing, is meant that on the one hand lung and other internal organs show the function of breathing aspect." lung opening at nose and throat close fur outward "." element is asked. cough opinion " say: " fur receives pathogen earlier for fur person, the closing also of lung, and pathogen is to close also from it ", what say is that lung communicates with the external world through nasopharynx part and skin hair key, just as one barrier, is responsible for the defensive enginery of human body.External wind, cold, summer-heat, wet, dry, fiery paathogenic factors such as (being referred to as the heresy of six climate exopathogens) are often passed through nasopharynx part and fur; At first invade in lung; Causing that lung qi loses in a surname sends out or during respectful falling, all can make abnormal rising of lung-QI and cause cough, pant, symptom such as expectoration, this belongs to the exogenous cough.The heresy of six climate exopathogens is caused a disease, and is main with ailment said due to cold or exposure how, and the winter is windy cold, windy heat of spring, and many heat-damp in summers of summer, the autumn is windy dry, and plum rain season is held damp under the arm more.But not the time gas when holding under the arm row virus hurt sb.'s feelings, then often be not limited to season, and the state of an illness is multiple, be prone to cause infect popular.And influenza, the pathogenic wind-warm category of genus epidemic febrile disease, the genus influenza, its characteristics have also just been included the characteristics of diseases caused by exogenous pathogenic factor respiratory disease: seasonable, it is high to generate heat, and the state of an illness weighs, and infection is popular by force, scope is wide.

Advantages such as Chinese medicine has not only that drug resistance is low, side effect and untoward reaction are few; And suppress virus replication in addition, regulate immunologic function, improve blood circulation, comprehensive effects such as antipyretic-antalgic and anti-inflammation, it has special advantages and vast potential for future development aspect control viral infection.Research shows that antipyretic and antidotal type Chinese medicine has many direct antiviral effects that have, like Flos Lonicerae, Flos Chrysanthemi Indici, Folium Isatidis, Rhizoma Osmundae etc.

Summary of the invention

Therefore, still there is demand in people's Chinese medicine preparation that curative effect is better treated respiratory viral infection disease.Up to now, also do not find the report of any relevant pharmaceutical composition of the present invention.The inventor is through research repeatedly, and through external and repeated validation clinical trial, found the Chinese medicine composition that the treatment of better curative effect respiratory viral infection disease is arranged finally, thereby accomplished the present invention.The present invention is directed to above-mentioned etiology and pathogenesis, adopt targetedly and have unique prepared from traditional Chinese medicines of treating the respiratory virus infection effect to form.Said composition mainly is made up of Folium Perillae, Radix Asteris, Radix Bupleuri, Herba Schizonepetae, Fructus Arctii, Semen Armeniacae Amarum, Radix Glycyrrhizae; Merit with reducing heat and dispersing lung-QI, resolving phlegm and relieving asthma can be used for the respiratory viral infection disease of treating or preventing to be caused by influenza A virus, Influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, echovirus, Coxsackie virus etc. clinically.

The objective of the invention is: overcome the deficiency of prior art, a kind of Chinese medicine composition of the respiratory viral infection disease that can effectively treat or prevent to be caused by influenza A virus, Influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, echovirus, Coxsackie virus etc. is provided.

Another object of the present invention is: the method for preparing of this Chinese medicine composition is provided, has satisfied the demand in market.

For reaching better therapeutic, medicine of the present invention can combine with crude drug Rhizoma Pinelliae Preparatum, Fructus Perillae.

For reaching better therapeutic, medicine of the present invention also can combine with crude drug Radix Scutellariae, Cortex Mori.

For reaching better therapeutic, medicine of the present invention also can with crude drug Herba Ephedrae or windproof combining.

The technical solution adopted for the present invention to solve the technical problems is: treat the Chinese medicine composition of respiratory viral infection disease, comprise the crude drug of following parts by weight: Folium Perillae 5-25 restrains, Radix Asteris 5-25 restrains, Radix Bupleuri 5-25 restrains, Herba Schizonepetae 5-25 restrains, Fructus Arctii 5-25 restrains, Semen Armeniacae Amarum 5-25 restrains, Radix Glycyrrhizae 1-15 restrains.

Preferable amount is: Folium Perillae 5-20 gram, Radix Asteris 5-20 gram, Radix Bupleuri 5-20 gram, Herba Schizonepetae 5-20 gram, Fructus Arctii 5-20 gram, Semen Armeniacae Amarum 5-20 gram, Radix Glycyrrhizae 3-10 gram.

The method for preparing of medicine of the present invention is following:

Get crude drug Folium Perillae, Radix Asteris, Radix Bupleuri, Herba Schizonepetae, Fructus Arctii, Semen Armeniacae Amarum, Radix Glycyrrhizae decocte with water merging filtrate, concentrate, cooling, add ethanol and make and contain alcohol amount 20-80%, reclaim ethanol, make supernatant concentration become thick paste, subsequent use.The thick paste of preparation is added capsule adjuvant commonly used, and dry, pulverizing incapsulates, and can be prepared into the capsule of treatment respiratory viral infection disease; Or thick paste and granule adjuvant commonly used mixed, granulate, dry be distributed into bag, can be prepared into the granule of treating respiratory viral infection disease; Or thick paste and oral liquid adjuvant commonly used mixed, boiling, thin up leaves standstill, and filters, and mixing is distributed into bottle, can be prepared into the oral liquid of treating respiratory viral infection disease; Or thick paste added sucrose, correctives, antiseptic, and boiling, thin up is to 1000ml; Leave standstill, filter mixing; Packing promptly gets the syrup of treating respiratory viral infection disease, wherein said sucrose weight＞450g; Said correctives is stevioside, saccharin sodium, acesulfame-K, glycyrrhizin, thiacyclohexane sulfamic acid, agedoite, alcohol sugar, radix asparagi sweet extract, Mentholum, various essence and various fruity material; Consumption is 0.1 ~ 10%, and said antiseptic is sorbic acid and k-na salt consumption thereof for＜0.3%, methyl hydroxybenzoate class consumption is＜0.05%, and the packaging material that said packing is used is vial, plastic bottle; Maybe thick paste and the tablet adjuvant commonly used with preparation mix, tabletting, can be prepared into the tablet of treating respiratory viral infection disease.

If also combine with crude drug Rhizoma Pinelliae Preparatum, Fructus Perillae, its preparation method is:

Get crude drug Folium Perillae, Radix Asteris, Radix Bupleuri, Herba Schizonepetae, Fructus Arctii, Semen Armeniacae Amarum, Radix Glycyrrhizae, Rhizoma Pinelliae Preparatum, Fructus Perillae decocte with water merging filtrate, concentrate, cooling, add ethanol and make and contain alcohol amount 20-80%, reclaim ethanol, make supernatant concentration become thick paste, subsequent use.The thick paste of preparation is added capsule adjuvant commonly used, and dry, pulverizing incapsulates, and can be prepared into the capsule of treatment respiratory viral infection disease; Or thick paste and granule adjuvant commonly used mixed, granulate, dry be distributed into bag, can be prepared into the granule of treating respiratory viral infection disease; Or thick paste and oral liquid adjuvant commonly used mixed, boiling, thin up leaves standstill, and filters, and mixing is distributed into bottle, can be prepared into the oral liquid of treating respiratory viral infection disease; Or thick paste added sucrose, correctives, antiseptic, and boiling, thin up is to 1000ml; Leave standstill, filter mixing; Packing promptly gets the syrup of treating respiratory viral infection disease, wherein said sucrose weight＞450g; Said correctives is stevioside, saccharin sodium, acesulfame-K, glycyrrhizin, thiacyclohexane sulfamic acid, agedoite, alcohol sugar, radix asparagi sweet extract, Mentholum, various essence and various fruity material; Consumption is 0.1 ~ 10%, and said antiseptic is sorbic acid and k-na salt consumption thereof for＜0.3%, methyl hydroxybenzoate class consumption is＜0.05%, and the packaging material that said packing is used is vial, plastic bottle; Maybe thick paste and the tablet adjuvant commonly used with preparation mix, tabletting, can be prepared into the tablet of treating respiratory viral infection disease.

If also combine with crude drug Radix Scutellariae, Cortex Mori, its preparation method is:

Get crude drug Folium Perillae, Radix Asteris, Radix Bupleuri, Herba Schizonepetae, Fructus Arctii, Semen Armeniacae Amarum, Radix Glycyrrhizae, Rhizoma Pinelliae Preparatum, Fructus Perillae, Radix Scutellariae, Cortex Mori decocte with water merging filtrate, concentrate, cool off; Adding ethanol makes and contains alcohol amount 20-80%; Reclaim ethanol, make supernatant concentration become thick paste, subsequent use.The thick paste of preparation is added capsule adjuvant commonly used, and dry, pulverizing incapsulates, and can be prepared into the capsule of treatment respiratory viral infection disease; Or thick paste and granule adjuvant commonly used mixed, granulate, dry be distributed into bag, can be prepared into the granule of treating respiratory viral infection disease; Or thick paste and oral liquid adjuvant commonly used mixed, boiling, thin up leaves standstill, and filters, and mixing is distributed into bottle, can be prepared into the oral liquid of treating respiratory viral infection disease; Or thick paste added sucrose, correctives, antiseptic, and boiling, thin up is to 1000ml; Leave standstill, filter mixing; Packing promptly gets the syrup of treating respiratory viral infection disease, wherein said sucrose weight＞450g; Said correctives is stevioside, saccharin sodium, acesulfame-K, glycyrrhizin, thiacyclohexane sulfamic acid, agedoite, alcohol sugar, radix asparagi sweet extract, Mentholum, various essence and various fruity material; Consumption is 0.1 ~ 10%, and said antiseptic is sorbic acid and k-na salt consumption thereof for＜0.3%, methyl hydroxybenzoate class consumption is＜0.05%, and the packaging material that said packing is used is vial, plastic bottle; Maybe thick paste and the tablet adjuvant commonly used with preparation mix, tabletting, can be prepared into the tablet of treating respiratory viral infection disease.

If also with crude drug Herba Ephedrae or windproof the combination, its preparation method is:

Get crude drug Folium Perillae, Radix Asteris, Radix Bupleuri, Herba Schizonepetae, Fructus Arctii, Semen Armeniacae Amarum, Radix Glycyrrhizae, Rhizoma Pinelliae Preparatum, Fructus Perillae, Radix Scutellariae, Cortex Mori, Herba Ephedrae or windproof decocte with water merging filtrate, concentrate, cool off; Adding ethanol makes and contains alcohol amount 20-80%; Reclaim ethanol; Make supernatant concentration become thick paste, subsequent use.The thick paste of preparation is added capsule adjuvant commonly used, and dry, pulverizing incapsulates, and can be prepared into the capsule of treatment respiratory viral infection disease; Or thick paste and granule adjuvant commonly used mixed, granulate, dry be distributed into bag, can be prepared into the granule of treating respiratory viral infection disease; Or thick paste and oral liquid adjuvant commonly used mixed, boiling, thin up leaves standstill, and filters, and mixing is distributed into bottle, can be prepared into the oral liquid of treating respiratory viral infection disease; Or thick paste added sucrose, correctives, antiseptic, and boiling, thin up is to 1000ml; Leave standstill, filter mixing; Packing promptly gets the syrup of treating respiratory viral infection disease, wherein said sucrose weight＞450g; Said correctives is stevioside, saccharin sodium, acesulfame-K, glycyrrhizin, thiacyclohexane sulfamic acid, agedoite, alcohol sugar, radix asparagi sweet extract, Mentholum, various essence and various fruity material; Consumption is 0.1 ~ 10%, and said antiseptic is sorbic acid and k-na salt consumption thereof for＜0.3%, methyl hydroxybenzoate class consumption is＜0.05%, and the packaging material that said packing is used is vial, plastic bottle; Maybe thick paste and the tablet adjuvant commonly used with preparation mix, tabletting, can be prepared into the tablet of treating respiratory viral infection disease.

Chinese medicine composition of the present invention can be prepared into the above dosage form of any pharmaceutics: capsule, oral liquid, granule, syrup, tablet, effervescent granule, drop pill, aerosol, spray, gargarisma, collutory; Wherein said tablet is oral cavity disintegration tablet, effervescent tablet.

Medicament selection Folium Perillae of the present invention, Radix Asteris, Radix Bupleuri, Herba Schizonepetae, Fructus Arctii, Semen Armeniacae Amarum, Radix Glycyrrhizae make up.Make each efficacy of drugs produce synergism these drug regimens, thereby can effectively treat respiratory viral infection disease.Wherein hot, the tepor of Folium Perillae is nontoxic, returns spleen, lung two warps, cures mainly affection of exogenous wind-cold, fever with aversion to cold, and it is lossless to have a headache, monarch drug in the cough and asthma side of being; Selecting Radix Asteris, Radix Bupleuri, Herba Schizonepetae, Fructus Arctii, Semen Armeniacae Amarum for use, is that merit is apt to the moistening the lung and resolving phlegm cough-relieving, is used for bringing up phlegm when one coughs more because bitter, hot, sweet, the tepor of Radix Asteris is returned lung meridian; Radix Bupleuri is bitter, be slightly cold, and return Liver Channel, gallbladder meridian, function: evacuate and bring down a fever, the yang invigorating soothing liver-QI cures mainly cold, fever, alternate attack of chill and fever; Herba Schizonepetae is hot, tepor is returned lung, Liver Channel, and the effect of induce sweat diffusing wind, rash is arranged; Fructus Arctii is hot, bitter, cold in nature, attaches to the lung and stomach meridians, and dispelling wind and heat pathogens, heat-clearing and toxic substances removing rash, lung qi dispersing sore-throat relieving loose swollen; Bitter, the temperature, poisonous of Semen Armeniacae Amarum is returned lung, spleen, large intestine channel, has the effect of lung qi dispersing cough-relieving, lowering the adverse-rising QI to subdue asthma, loosening bowel to relieve constipation, the kind cough with asthma card of controlling, more than five medicines be that ministerial drug and adjuvant drug are assisted a ruler in governing a country monarch drug jointly; Radix Glycyrrhizae is as the existing heat-clearing and toxic substances removing of messenger drug, the merit of expelling phlegm for arresting cough, but coordinating the actions of various ingredients in a prescription again; All medicine compatibilities are dredged clearly and usefulness, go up and down and throw altogether, the merit of playing reducing heat and dispersing lung-QI, relieving cough and asthma altogether.

In order to reach good curative effect, medicine of the present invention also makes up with Rhizoma Pinelliae Preparatum, Fructus Perillae.This is because of the turbid retardance of expectorant, and lung-QI being unable to descend so select Rhizoma Pinelliae Preparatum hot, warm, is returned spleen, stomach, lung meridian, has both had the merit of the Folium Perillae of helping sending down the abnormal ascending QI cough-relieving, and the usefulness of drying dampness to eliminate phlegm is arranged again; Fructus Perillae is hot, warm, returns lung, spleen channel, the sending down the abnormal ascending QI expectorant is arranged, relievings asthma, the effect of intestine moistening.

In order to reach better therapeutic, medicine of the present invention also makes up with Radix Scutellariae, Cortex Mori.This is that so select famous clearing away heat-fire baikal skullcap root, its bitter in the mouth is cold in nature because of the turbid with the passing of time heat-transformation of expectorant, heat clearing and damp drying, eliminating fire and detoxication, the excess-heat of the kind lung heat clearing fire and the part of the body cavity above the diaphragm housing the heart and lungs; Cortex Mori is sweet cold, goes into lung meridian, but eliminating pathogen from the lung for relieving asthma, inducing diuresis to remove edema.

In order to obtain optimum curative effect, medicine of the present invention also with Herba Ephedrae or windproof combination.This is because the affection by exopathogenic cold-wind inhibited pulmonary QI so select Herba Ephedrae suffering, little hardship, temperature, is returned lung, urinary bladder channel, diaphoresis cold expelling, depressed lung-energy dispersing, inducing diuresis to remove edema; Windproof suffering, sweet, warm is returned bladder, liver, spleen channel, disperses and induces sweat, removing dampness to relieve pain, expelling wind to relieve convulsion.

Chinese medicine composition of the present invention be in traditional Chinese medical science preventing respiratory viruses clinical practice for many years, sum up use out through proved recipe, the experimental basis of science in addition, each component can be brought into play pharmacological action separately; Can play mutual synergism again, pharmacological action is strengthened, prescription rationally; The flavour of a drug refine, this side is used for treatment or prevention respiratory viral infection disease, determined curative effect; And have no side effect; At epidemic period, it is all effective with prevention to be used for treatment as general side, and dosage form and preparation technology are fit to industrialized mass.

The specific embodiment

The present invention treats or prevent the Chinese medicine composition of respiratory viral infection disease, comprises the crude drug of following parts by weight: Folium Perillae 5-25 restrains, Radix Asteris 5-25 restrains, Radix Bupleuri 5-25 restrains, Herba Schizonepetae 5-25 restrains, Fructus Arctii 5-25 restrains, Semen Armeniacae Amarum 5-25 restrains, Radix Glycyrrhizae 1-15 restrains.For reaching good curative effect, medicine of the present invention can combine with crude drug Rhizoma Pinelliae Preparatum, Fructus Perillae; For reaching better therapeutic, medicine of the present invention also can combine with crude drug Radix Scutellariae, Cortex Mori; In order to obtain optimum curative effect, medicine of the present invention also can with crude drug Herba Ephedrae or windproof combining;

Embodiment 1:

Weighting raw materials Folium Perillae 10 grams, Radix Asteris 10 grams, Radix Bupleuri 10 grams, Herba Schizonepetae 10 grams, Fructus Arctii 10 grams, Semen Armeniacae Amarum 10 grams, Radix Glycyrrhizae 10 grams; Above seven flavor medicine thing is totally 70 grams; The decocte with water merging filtrate, concentrate, cooling, add ethanol and make and contain the alcohol amount and be 20-80%, reclaim ethanol; Make supernatant concentration become thick paste, subsequent use.Add beta-schardinger dextrin-; 180 ℃ of heating for dissolving, stirring, filtration, spray drying hot-air EAT; 80 ℃ of leaving air temps, spray powder adds flavoring agent, mixing; Material under 40 ℃ of temperature dry granulation, granulate, be distributed into bag, promptly get the granule that the present invention treats respiratory viral infection disease.

Embodiment 2:

Weighting raw materials Folium Perillae 10 grams, Radix Asteris 10 grams, Radix Bupleuri 10 grams, Herba Schizonepetae 10 grams, Fructus Arctii 10 grams, Semen Armeniacae Amarum 10 grams, Radix Glycyrrhizae 10 grams; Above seven flavor medicine thing is totally 70 grams; The decocte with water merging filtrate, concentrate, cooling, add ethanol and make and contain the alcohol amount and be 20-80%, reclaim ethanol; Make supernatant concentration become thick paste, subsequent use.Add 2 times of 95% ethanol that cream is heavy in the thick paste, fully stir, leave standstill 24～48h under the room temperature; Get supernatant, precipitate is with 65% washing with alcohol 1～2 time, and cleaning mixture and supernatant merge; If any alcohol extract; Also merge with supernatant, filters clear and bright after, go into concentrating under reduced pressure jar or alcohol distillation column and reclaim ethanol and only do not have the alcohol flavor until medicinal liquid.Medicinal liquid after the dealcoholysis after the adding distil water dilution, is heated to 100 ℃, makes coacervation of colloid; Transfer pH4.5～5.0,0～4 ℃ of cold preservation 24h of low temperature makes the colloidal precipitation of cohesion, then again; Filter to clear and bright, add an amount of correctives and antiseptic, after leaving standstill, filter clear and bright again; Low-temp storage is done last purification filtering before the fill, filtrating put the lamp inspection appearance under detection clear and bright after; Last mechanical irrigation is encapsulated in the straight tube easy-open lid nutrition bottle, and dress 10ml ± 4% promptly gets the oral liquid that the present invention treats respiratory viral infection disease in every oral liquid bottle.

Embodiment 3:

Weighting raw materials Folium Perillae 10 grams, Radix Asteris 10 grams, Radix Bupleuri 10 grams, Herba Schizonepetae 10 grams, Fructus Arctii 10 grams, Semen Armeniacae Amarum 10 grams, Radix Glycyrrhizae 10 grams, Rhizoma Pinelliae Preparatum 10 grams, Fructus Perillae 10 grams; More than nine herbal medicines totally 90 the gram, process granule by embodiment 1 described method then.

Embodiment 4:

Weighting raw materials Folium Perillae 10 grams, Radix Asteris 10 grams, Radix Bupleuri 10 grams, Herba Schizonepetae 10 grams, Fructus Arctii 10 grams, Semen Armeniacae Amarum 10 grams, Radix Glycyrrhizae 10 grams, Rhizoma Pinelliae Preparatum 10 grams, Fructus Perillae 10 grams; More than nine herbal medicines totally 90 the gram, process oral liquid by embodiment 2 described methods then.

Embodiment 5:

Weighting raw materials Folium Perillae 10 grams, Radix Asteris 10 grams, Radix Bupleuri 10 grams, Herba Schizonepetae 10 grams, Fructus Arctii 10 grams, Semen Armeniacae Amarum 10 grams, Radix Glycyrrhizae 10 grams, Rhizoma Pinelliae Preparatum 10 grams, Fructus Perillae 10 grams, Radix Scutellariae 10 grams, Cortex Mori 10 grams; More than ten simply medicine totally 110 the gram, process granule by embodiment 1 described method then.

Embodiment 6:

Weighting raw materials Folium Perillae 10 grams, Radix Asteris 10 grams, Radix Bupleuri 10 grams, Herba Schizonepetae 10 grams, Fructus Arctii 10 grams, Semen Armeniacae Amarum 10 grams, Radix Glycyrrhizae 10 grams, Rhizoma Pinelliae Preparatum 10 grams, Fructus Perillae 10 grams, Radix Scutellariae 10 grams, Cortex Mori 10 grams; More than ten simply medicine totally 110 the gram, process oral liquid by embodiment 2 described methods then.

Embodiment 7:

Weighting raw materials Folium Perillae 10 grams, Radix Asteris 10 grams, Radix Bupleuri 10 grams, Herba Schizonepetae 10 grams, Fructus Arctii 10 grams, Semen Armeniacae Amarum 10 grams, Radix Glycyrrhizae 10 grams, Rhizoma Pinelliae Preparatum 10 grams, Fructus Perillae 10 grams, Radix Scutellariae 10 grams, Cortex Mori 10 grams, Herba Ephedrae 10 grams; More than 12 herbal medicines totally 120 the gram, process granule by embodiment 1 described method then.

Embodiment 8:

Weighting raw materials Folium Perillae 10 grams, Radix Asteris 10 grams, Radix Bupleuri 10 grams, Herba Schizonepetae 10 grams, Fructus Arctii 10 grams, Semen Armeniacae Amarum 10 grams, Radix Glycyrrhizae 10 grams, Rhizoma Pinelliae Preparatum 10 grams, Fructus Perillae 10 grams, Radix Scutellariae 10 grams, Cortex Mori 10 grams, windproof 10 grams; More than 12 herbal medicines totally 120 the gram, process oral liquid by embodiment 2 described methods then.

Test Example 1: the external rhinovirus of Chinese medicine composition (HRV, laboratory observation N36)

Test philosophy: with people embryo epithelial cell is virus host, and working sample suppresses rhinovirus and causes people embryo epithelial cell lesion degree.

Test material and method: 1. Strain: rhinovirus (HRV, N36).

2. sample treatment: get that thick paste that embodiment 1,5,7,8 makes is dissolved in water and to process the solution bottling of 1000mg/ml respectively subsequent use; 3000rpm gets supernatant after centrifugal 20 minutes, and the sodium citrate with 50% is transferred pH7.2～7.6, and in the impouring sterile test tube, 121 ℃, 15-20 minutes autoclavings are preserved subsequent use in the rearmounted 4 ℃ of refrigerators of taking-up; Solution example is done 2 times of dilutions, totally 8 dilution factors with culture fluid 1:10 dilution beginning during experiment.

3. positive control drug: ribavirin (RBV) Jiangxi Huiren Pharmaceutical Co., Ltd produces.

4. method of testing:

1. with people embryo epithelial cell (2～4) * 10 ⁵0.1ml be inoculated into 96 hole micro plastics culture plates, 37 ℃ of every hole 100 μ l, 5%CO ₂Cultivated 1～2 day, and grew into cell monolayer.Cell growth medium is MEM100ml, contains hyclone 10%, 3% glutamine 1%, penicillin and each 100U/ml of streptomycin, NaHCO3 5%; When cell grows up to monolayer, abandon growth-promoting media, need before the virus inoculation to wash cell two times with the PBS or the Hanks liquid of preparatory temperature.

2. control is done, and adds 100 μ l, 10～100TCID ₅₀The viral suspension infection cell, 37 ℃ of absorption 1～2h abandon viral liquid, add again contain the variable concentrations testing compound keep liquid 100 μ l, each concentration 2 hole, 37 ℃ of 5%CO ₂Incubation continues to cultivate.If normal cell contrast, drug toxicity contrast, virus control, ribavirin (RBV) positive control and viral TCID ₅₀Titration.

3. under inverted microscope, check every day and write down cytopathy (<25% is a plus sige, 25 _~50% is two plus siges, 50 _~75% is three plus siges, 75 _~100% is four plus siges), (do not add testing compound) up to the virus control hole and occur 3 _~Be the experiment terminal point during cytopathy of 4 plus siges.Write down each porocyte lesion degree, calculate every group of average cell lesion degree, compare with the virus control group, calculating inhibition 50% cytopathic compound concentration with Reed and Muench method is half-inhibition concentration (IC ₅₀).

4. press the toxicity of criterion calculation medicine pair cell 3. simultaneously, calculating generation 50% cytopathic compound concentration with Reed and Muench method is half toxic concentration (TD ₅₀).

5. TD ₅₀/ IC ₅₀Be selection index (SI).

5. experimental result

Test Example 2: the laboratory observation of the external resisiting influenza virus first of Chinese medicine composition type

Test philosophy: with MDCK (MDCK) is virus host, and working sample suppresses influenza virus A type and causes the mdck cell lesion degree.

Test material and method:

1. Strain :/243/72 (H3N2) prevented in influenza virus A type A/ Guangdong.

3. positive control drug: oseltamivir phosphate capsule.

4. method of testing: 1. with mdck cell (2～4) * 10 ⁵0.1ml be inoculated into 96 hole micro plastics culture plates, 37 ℃ of every hole 100 μ l, 5%CO ₂Cultivated 1～2 day, and grew into cell monolayer.Cell growth medium is MEM 100ml, contains hyclone 10%, 3% glutamine 1%, penicillin and each 100U/ml of streptomycin, NaHCO3 5%; Keep not increase serum of liquid; Suppress the non-specific inhibin that influenza virus is duplicated because of serum contains,, need before the virus inoculation to wash cell two times with the PBS or the Hanks liquid of preparatory temperature when cell grows up to monolayer; To remove the residual growth-promoting media that contains Ox blood serum; Substitute Ox blood serum with 1% albumin 10%, and add 0.25% pancreatin 0.2%, the same growth-promoting media of other compositions.

2. abandon growth-promoting media, control is done, and adds 100 μ l, 10～100TCID ₅₀The viral suspension infection cell, 37 ℃ of absorption 1～2h abandon viral liquid, add again contain the variable concentrations testing compound keep liquid 100 μ l, each concentration 2 hole, 37 ℃ of 5%CO ₂Incubation continues to cultivate.If normal cell contrast, drug toxicity contrast, virus control, ribavirin (RBV) positive control and viral TCID ₅₀Titration.

3. under inverted microscope, check every day and write down cytopathy (<25% is a plus sige, 25 _~50% is two plus siges, 50 _~75% is three plus siges, 75 _~100% is four plus siges), (do not add testing compound) up to the virus control hole and occur 3 _~Be the experiment terminal point during cytopathy of 4 plus siges.Write down each porocyte lesion degree, calculate every group of average cell lesion degree, compare with the virus control group, calculating inhibition 50% cytopathic compound concentration with Reed and Muench method is half-inhibition concentration (IC50).

5. TD ₅₀/ IC ₅₀Be selection index (SI).

5. experimental result

Figure 2012101578359100002DEST_PATH_IMAGE002

Test Example 3: the clinical observation of traditional Chinese medicine composition for treating rhinovirus upper respiratory tract infection

1.1 data and method

1.1.1 clinical data

This group case is the patient of the rhinovirus upper respiratory tract infection that in December, 2009 to 2012 makes a definite diagnosis year March; 1 ~ 61 years old age; The patient who meets following Chinese and western medicine diagnostic criteria, 120 routine patients are divided into treatment group (Chinese medicine composition) 60 examples at random, matched group (ribavirin) 60 examples.Treatment is organized 60 examples and is assigned randomly to each 15 example of 1,5,7,8 group of embodiment example (being called for short treatment group A, B, C, D); Matched group 60 examples are divided into four groups of (being called for short control group A, B, C, D) each 15 examples at random, two groups of not statistically significants on sex, age, the course of disease and the state of an illness distribute (P>0.05).

1.1.2 diagnostic criteria

1.1.2.1 Western medicine diagnose standard

(1) clinical symptoms: sure rhinovirus infection medical history is arranged, Acute onset, the course of disease≤2 day; With heating, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, dry pharynx itch, symptom such as cough, hoarseness;

(2) health check-up: pharyngeal congestion, antiadoncus, two pulmonary respiration sounds are coarse slightly or not coarse;

(3) Serological testing: it is positive to adopt the RT-PCR method to detect rhinovirus, the conventional leukocyte of peripheral blood calculate and classification all between normal range or numeration of leukocyte low;

(4) X line chest film inspection is normal basically.

1.1.2.2 tcm diagnosis standard:

Clinically with heating, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, dry pharynx itch, symptoms such as cough, hoarseness are principal character, reddish tongue, tongue be BOHUANG, slippery and rapid pulse slightly.

1.2 Therapeutic Method

The treatment group gives Chinese medicinal composition granules, and is oral, and every day twice, each consumption is equivalent to each raw medicinal herbs 10g; Matched group is with ribavirin effervescent granule 150mg/ time, and is every day 3 times, oral.The child is cut down according to the circumstance.Be 5 days the course of treatment.

1.3 criterion of therapeutical effect

Criterion of therapeutical effect:

Recovery from illness: treat clinical symptoms sign disappearances such as five days internal heat generations, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, dry pharynxs are itched, cough, hoarseness;

Produce effects: treat clinical symptoms signs such as five days internal heat generations, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, dry pharynxs are itched, cough, hoarseness and alleviate more than 2/3;

Effectively: treat clinical symptoms signs such as five days internal heat generations, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, dry pharynxs are itched, cough, hoarseness and alleviate 2/3～1/3;

Invalid: treating in five days conscious or other symptoms does not all have obvious improvement or increases the weight of.

1.4 result

Chinese medicine composition (treatment group A) the treatment rhinovirus upper respiratory tract infection of utilization embodiment of the present invention example 1; The result shows: clinical symptoms such as heating before and after two groups of patient's total effective rates of comparison and the medication, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, dry pharynx are itched, cough, hoarseness are improved situation, treatment group A clinical improvements total effective rate 76.58%; Control group A clinical improvements total effective rate 35.36%; Treatment group A and control group A comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 1 traditional Chinese medicine composition for treating rhinovirus upper respiratory tract infection satisfactory effect all is superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group B) the treatment rhinovirus upper respiratory tract infection of utilization embodiment of the present invention example 5; The result shows: clinical symptoms such as heating before and after two groups of patient's total effective rates of comparison and the medication, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, dry pharynx are itched, cough, hoarseness are improved situation, treatment group B clinical improvements total effective rate 84.39%; Matched group B clinical improvements total effective rate 40.56%; Treatment group B and matched group B comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 5 traditional Chinese medicine composition for treating rhinovirus upper respiratory tract infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group C) the treatment rhinovirus upper respiratory tract infection of utilization embodiment of the present invention example 7; The result shows: clinical symptoms such as heating before and after two groups of patient's total effective rates of comparison and the medication, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, dry pharynx are itched, cough, hoarseness are improved situation, treatment group C clinical improvements total effective rate 90.23%; Matched group C clinical improvements total effective rate 46.63%; Treatment group C and matched group C comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 7 traditional Chinese medicine composition for treating rhinovirus upper respiratory tract infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group D) the treatment rhinovirus upper respiratory tract infection of utilization embodiment of the present invention example 8; The result shows: clinical symptoms such as heating before and after two groups of patient's total effective rates of comparison and the medication, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, dry pharynx are itched, cough, hoarseness are improved situation, treatment group D clinical improvements total effective rate 87.54%; Matched group D clinical improvements total effective rate 42.76%; Treatment group D and matched group D comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 8 traditional Chinese medicine composition for treating rhinovirus upper respiratory tract infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Test Example 4: the clinical observation of traditional Chinese medicine composition for treating influenza virus A type H1N1 upper respiratory tract infection

1.1 data and method

1.1.1 clinical data

This group case is the patient of the influenza virus A type H1N1 upper respiratory tract infection that in December, 2009 to 2012 makes a definite diagnosis year March; 1 ~ 68 years old age; The patient who meets following Chinese and western medicine diagnostic criteria; 120 routine patients are divided into treatment group (Chinese medicine composition) 60 examples at random, matched group (ribavirin) 60 examples.Treatment is organized 60 examples and is assigned randomly to each 15 example of 1,5,7,8 group of embodiment example (being called for short treatment group A, B, C, D); Matched group 60 examples are divided into four groups of (being called for short control group A, B, C, D) each 15 examples at random, two groups of not statistically significants on sex, age, the course of disease and the state of an illness distribute (P>0.05).

1.1.2 diagnostic criteria

1.1.2.1 Western medicine diagnose standard

(1) clinical symptoms: have sure influenza virus A type H1N1 to infect medical history, Acute onset, the course of disease≤2 day; With symptoms such as heating, cough, expectoration, watery nasal discharge, nasal obstruction, itching throat, dry pharynx pain, hoarseness;

(3) Serological testing: it is positive to adopt the RT-PCR method to detect influenza virus A type H1N1, the conventional leukocyte of peripheral blood calculate and classification all between normal range or numeration of leukocyte low;

(4) X line chest film inspection is normal basically.

1.1.2.2 tcm diagnosis standard:

Be principal character with symptoms such as heating, cough, expectoration, watery nasal discharge, nasal obstruction, itching throat, dry pharynx pain, hoarseness clinically, reddish tongue, tongue be BOHUANG, floating and rapid pulse slightly.

1.2 Therapeutic Method

1.3 criterion of therapeutical effect

Criterion of therapeutical effect:

Recovery from illness: treat clinical symptoms signs such as internal heat generation in five days, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, pharyngalgia, cough, hoarseness and disappear;

Produce effects: treat clinical symptoms signs such as internal heat generation in five days, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, pharyngalgia, cough, hoarseness and alleviate more than 2/3;

Effectively: treat clinical symptoms signs such as internal heat generation in five days, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, pharyngalgia, cough, hoarseness and alleviate 2/3～1/3;

1.4 result

Chinese medicine composition (treatment group A) the treatment influenza virus upper respiratory tract infection of utilization embodiment of the present invention example 1; The result shows: compare clinical symptoms such as two groups of patient's total effective rates and medication front and back heating, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, pharyngalgia, cough, hoarseness and improve situation, treatment group A clinical improvements total effective rate 75.23%; Control group A clinical improvements total effective rate 35.86%; Treatment group A and control group A comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 1 traditional Chinese medicine composition for treating influenza virus upper respiratory tract infection satisfactory effect all is superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group B) the treatment influenza virus upper respiratory tract infection of utilization embodiment of the present invention example 5; The result shows: compare clinical symptoms such as two groups of patient's total effective rates and medication front and back heating, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, pharyngalgia, cough, hoarseness and improve situation, treatment group B clinical improvements total effective rate 85.58%; Matched group B clinical improvements total effective rate 40.33%; Treatment group B and matched group B comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 5 traditional Chinese medicine composition for treating influenza virus upper respiratory tract infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group C) the treatment influenza virus upper respiratory tract infection of utilization embodiment of the present invention example 7; The result shows: compare clinical symptoms such as two groups of patient's total effective rates and medication front and back heating, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, pharyngalgia, cough, hoarseness and improve situation, treatment group C clinical improvements total effective rate 90.39%; Matched group C clinical improvements total effective rate 46.86%; Treatment group C and matched group C comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 7 traditional Chinese medicine composition for treating influenza virus upper respiratory tract infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group D) the treatment influenza virus upper respiratory tract infection of utilization embodiment of the present invention example 8; The result shows: compare clinical symptoms such as two groups of patient's total effective rates and medication front and back heating, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, pharyngalgia, cough, hoarseness and improve situation, treatment group D clinical improvements total effective rate 88.43%; Matched group D clinical improvements total effective rate 43.86%; Treatment group D and matched group D comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 8 traditional Chinese medicine composition for treating influenza virus upper respiratory tract infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Test Example 5: the clinical observation of traditional Chinese medicine composition for treating rhinovirus lower respiratory infection

1.1 data and method

1.1.1 clinical data

This group case is the patient of the rhinovirus lower respiratory infection that in December, 2009 to 2012 makes a definite diagnosis year March; 1 ~ 72 years old age; The patient who meets following Chinese and western medicine diagnostic criteria, 120 routine patients are divided into treatment group (Chinese medicine composition) 60 examples at random, matched group (ribavirin) 60 examples.Treatment is organized 60 examples and is assigned randomly to each 15 example of 1,5,7,8 group of embodiment example (being called for short treatment group A, B, C, D); Matched group 60 examples are divided into four groups of (being called for short control group A, B, C, D) each 15 examples at random, two groups of not statistically significants on sex, age, the course of disease and the state of an illness distribute (P>0.05).

1.1.2 diagnostic criteria

1.1.2.1 Western medicine diagnose standard

(1) clinical symptoms: sure rhinovirus infection medical history is arranged, Acute onset, the course of disease≤3 day; With generate heat, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, symptom such as tachypnea;

(2) health check-up: pharyngeal congestion, regional nodes's silght enlargement or tenderness, two lung audibles and dryness or moist rale;

(3) lab testing: it is positive to adopt the RT-PCR method to detect rhinovirus, conventional numeration of leukocyte of peripheral blood and classification all between normal range or numeration of leukocyte low;

(4) visible bronchitis of X line rabat or CT examination or pneumonia.

1.1.2.2 tcm diagnosis standard:

Clinical symptoms with heating, aversion to cold, cough, cough up phlegm, nasal mucus, hoarseness, the QI rising in reverse order, tachypnea, to stridulate be principal character, reddish tongue, tongue be BOHUANG, rolling pulse slightly.

1.2 Therapeutic Method

The treatment group gives Chinese medicinal composition granules, and is oral, and every day twice, each consumption is equivalent to each raw medicinal herbs 10g; Matched group is with ribavirin effervescent granule 150mg/ time, and is every day 3 times, oral.The child is cut down according to the circumstance.Be 7 days the course of treatment.

1.3 criterion of therapeutical effect

Criterion of therapeutical effect:

Recovery from illness: treat seven days internal heat generation aversion to cold, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, clinical symptoms sign disappearances such as the QI rising in reverse order, tachypnea;

Produce effects: treat seven days internal heat generation aversion to cold, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, clinical symptoms sign such as QI rising in reverse order, tachypnea alleviates more than 2/3;

Effectively: treat seven days internal heat generation aversion to cold, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, clinical symptoms sign such as QI rising in reverse order, tachypnea alleviates 2/3～1/3;

Invalid: treating in seven days conscious or other symptoms does not all have obvious improvement or increases the weight of.

1.4 result

Chinese medicine composition (treatment group A) the treatment rhinovirus lower respiratory infection of utilization embodiment of the present invention example 1; The result shows: relatively fever with chills before and after two groups of patient's total effective rates and the medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, clinical symptoms such as the QI rising in reverse order, tachypnea improve situation, treatment group A clinical improvements total effective rate 76.67%; Control group A clinical improvements total effective rate 35.31%; Treatment group A and control group A comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 1 traditional Chinese medicine composition for treating rhinovirus lower respiratory infection satisfactory effect all is superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group B) the treatment rhinovirus lower respiratory infection of utilization embodiment of the present invention example 5; The result shows: relatively fever with chills before and after two groups of patient's total effective rates and the medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, clinical symptoms such as the QI rising in reverse order, tachypnea improve situation, treatment group B clinical improvements total effective rate 83.35%; Matched group B clinical improvements total effective rate 39.99%; Treatment group B and matched group B comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 5 traditional Chinese medicine composition for treating rhinovirus lower respiratory infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group C) the treatment rhinovirus lower respiratory infection of utilization embodiment of the present invention example 7; The result shows: relatively fever with chills before and after two groups of patient's total effective rates and the medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, clinical symptoms such as the QI rising in reverse order, tachypnea improve situation, treatment group C clinical improvements total effective rate 91.73%; Matched group C clinical improvements total effective rate 46.61%; Treatment group C and matched group C comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 7 traditional Chinese medicine composition for treating rhinovirus lower respiratory infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group D) the treatment rhinovirus lower respiratory infection of utilization embodiment of the present invention example 8; The result shows: relatively fever with chills before and after two groups of patient's total effective rates and the medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, clinical symptoms such as the QI rising in reverse order, tachypnea improve situation, treatment group D clinical improvements total effective rate 87.84%; Matched group D clinical improvements total effective rate 43.33%; Treatment group D and matched group D comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 8 traditional Chinese medicine composition for treating rhinovirus lower respiratory infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Test Example 6: the clinical observation of traditional Chinese medicine composition for treating influenza virus A type H1N1 lower respiratory infection

1.1 data and method

1.1.1 clinical data

This group case is the patient of the influenza virus A type H1N1 lower respiratory infection of making a definite diagnosis year March in June, 2009 to 2012; 6 ~ 69 years old age; The patient who meets following Chinese and western medicine diagnostic criteria, 120 routine patients are divided into treatment group (Chinese medicine composition) 60 examples at random, matched group (ribavirin) 60 examples.Treatment is organized 60 examples and is assigned randomly to each 15 example of 1,5,7,8 group of embodiment example (being called for short treatment group A, B, C, D); Matched group 60 examples are divided into four groups of (being called for short control group A, B, C, D) each 15 examples at random, two groups of not statistically significants on sex, age, the course of disease and the state of an illness distribute (P>0.05).

1.1.2 diagnostic criteria

1.1.2.1 Western medicine diagnose standard

(1) clinical symptoms: sure influenza infection medical history is arranged, Acute onset, the course of disease≤3 day; With generate heat, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, symptom such as tachypnea;

(3) lab testing: it is positive to adopt the RT-PCR method to detect influenza virus A type H1N1, conventional numeration of leukocyte of peripheral blood and classification all between normal range or numeration of leukocyte low;

(4) visible bronchitis of X line rabat or CT examination or pneumonia.

1.1.2.2 tcm diagnosis standard:

Clinical symptoms with heating, aversion to cold, cough, cough up phlegm, nasal mucus, hoarseness, the QI rising in reverse order, tachypnea, to stridulate be principal character, reddish tongue, yellow and thin fur, slippery and rapid pulse.

1.2 Therapeutic Method

1.3 criterion of therapeutical effect

Criterion of therapeutical effect:

1.4 result

Chinese medicine composition (treatment group A) the treatment influenza virus lower respiratory infection of utilization embodiment of the present invention example 1; The result shows: relatively fever with chills before and after two groups of patient's total effective rates and the medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, clinical symptoms such as the QI rising in reverse order, tachypnea improve situation, treatment group A clinical improvements total effective rate 78.31%; Control group A clinical improvements total effective rate 36.01%; Treatment group A and control group A comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 1 traditional Chinese medicine composition for treating influenza virus lower respiratory infection satisfactory effect all is superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group B) the treatment influenza virus lower respiratory infection of utilization embodiment of the present invention example 5; The result shows: relatively fever with chills before and after two groups of patient's total effective rates and the medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, clinical symptoms such as the QI rising in reverse order, tachypnea improve situation, treatment group B clinical improvements total effective rate 81.82%; Matched group B clinical improvements total effective rate 34.72%; Treatment group B and matched group B comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 5 traditional Chinese medicine composition for treating influenza virus lower respiratory infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group C) the treatment influenza virus lower respiratory infection of utilization embodiment of the present invention example 7; The result shows: relatively fever with chills before and after two groups of patient's total effective rates and the medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, clinical symptoms such as the QI rising in reverse order, tachypnea improve situation, treatment group C clinical improvements total effective rate 90.98%; Matched group C clinical improvements total effective rate 46.19%; Treatment group C and matched group C comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 7 traditional Chinese medicine composition for treating influenza virus lower respiratory infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group D) the treatment influenza virus lower respiratory infection of utilization embodiment of the present invention example 8; The result shows: relatively fever with chills before and after two groups of patient's total effective rates and the medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, clinical symptoms such as the QI rising in reverse order, tachypnea improve situation, treatment group D clinical improvements total effective rate 81.01%; Matched group D clinical improvements total effective rate 42.36%; Treatment group D and matched group D comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 8 traditional Chinese medicine composition for treating influenza virus lower respiratory infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Test Example 7: the clinical observation that the traditional Chinese medicine composition for treating Influenza B virus infects

1.1 data and method

1.1.1 clinical data

This group case is the patient of the Influenza B virus infection of making a definite diagnosis year April in June, 2009 to 2012; 6 ~ 69 years old age; The patient who meets following Chinese and western medicine diagnostic criteria, 120 routine patients are divided into treatment group (Chinese medicine composition) 60 examples at random, matched group (ribavirin) 60 examples.Treatment is organized 60 examples and is assigned randomly to each 15 example of 1,5,7,8 group of embodiment example (being called for short treatment group A, B, C, D); Matched group 60 examples are divided into four groups of (being called for short control group A, B, C, D) each 15 examples at random, two groups of not statistically significants on sex, age, the course of disease and the state of an illness distribute (P>0.05).

1.1.2 diagnostic criteria

1.1.2.1 Western medicine diagnose standard

(1) clinical symptoms: sure influenza infection medical history is arranged, Acute onset, the course of disease≤2 day; With generate heat, cough, cough up phlegm, hoarseness, pharyngalgia, the QI rising in reverse order, tachypnea are symptom such as main;

(2) health check-up: fervescence, pharyngeal congestion, regional nodes's silght enlargement or tenderness, two lung audibles and dryness or moist rale;

(3) lab testing: it is positive to adopt the RT-PCR method to detect Influenza B virus, conventional numeration of leukocyte of peripheral blood and classification all between normal range or numeration of leukocyte low;

(4) visible bronchitis of X line rabat or CT examination or pneumonia.

1.1.2.2 tcm diagnosis standard:

Clinical symptoms with generate heat, cough, cough up phlegm, hoarseness, pharyngalgia, the QI rising in reverse order, tachypnea be principal character, reddish tongue, yellow and thin fur, floating and rapid pulse.

1.2 Therapeutic Method

1.3 criterion of therapeutical effect

Criterion of therapeutical effect:

Recovery from illness: treat internal heat generation in seven days, cough, cough up phlegm, clinical symptoms sign disappearances such as hoarseness, pharyngalgia, the QI rising in reverse order, tachypnea;

Produce effects: treat internal heat generation in seven days, cough, cough up phlegm, clinical symptoms sign such as hoarseness, pharyngalgia, the QI rising in reverse order, tachypnea alleviates more than 2/3;

Effectively: treat internal heat generation in seven days, cough, cough up phlegm, clinical symptoms sign such as hoarseness, pharyngalgia, the QI rising in reverse order, tachypnea alleviates 2/3～1/3;

1.4 result

Chinese medicine composition (treatment group A) the treatment Influenza B virus lower respiratory infection of utilization embodiment of the present invention example 1; The result shows: relatively generate heat before and after two groups of patient's total effective rates and the medication, cough, cough up phlegm, clinical symptoms improvement situation such as hoarseness, pharyngalgia, the QI rising in reverse order, tachypnea, treatment group A clinical improvements total effective rate 66.09%; Control group A clinical improvements total effective rate 25.56%; Treatment group A has statistical significance (P＜0.05) with contrast A group comparing difference.In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 1 traditional Chinese medicine composition for treating Influenza B virus lower respiratory infection satisfactory effect all is superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group B) the treatment Influenza B virus lower respiratory infection of utilization embodiment of the present invention example 5; The result shows: relatively generate heat before and after two groups of patient's total effective rates and the medication, cough, cough up phlegm, clinical symptoms improvement situation such as hoarseness, pharyngalgia, the QI rising in reverse order, tachypnea, treatment group B clinical improvements total effective rate 72.66%; Matched group B clinical improvements total effective rate 33.06%; Treatment group B and matched group B comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 5 traditional Chinese medicine composition for treating Influenza B virus lower respiratory infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group C) the treatment Influenza B virus lower respiratory infection of utilization embodiment of the present invention example 7; The result shows: relatively generate heat before and after two groups of patient's total effective rates and the medication, cough, cough up phlegm, clinical symptoms improvement situation such as hoarseness, pharyngalgia, the QI rising in reverse order, tachypnea, treatment group C clinical improvements total effective rate 76.33%; Matched group C clinical improvements total effective rate 34.65%; Treatment group C and matched group C comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 7 traditional Chinese medicine composition for treating Influenza B virus lower respiratory infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Chinese medicine composition (treatment group D) the treatment Influenza B virus lower respiratory infection of utilization embodiment of the present invention example 8; The result shows: relatively generate heat before and after two groups of patient's total effective rates and the medication, cough, cough up phlegm, clinical symptoms improvement situation such as hoarseness, pharyngalgia, the QI rising in reverse order, tachypnea, treatment group D clinical improvements total effective rate 73.23%; Matched group D clinical improvements total effective rate 29.99%; Treatment group D and matched group D comparing difference have statistical significance (P＜0.05).In clinical treatment observation, do not find toxic and side effects.The clinical effectiveness prompting: embodiment of the present invention example 8 traditional Chinese medicine composition for treating Influenza B virus lower respiratory infection satisfactory effects all are superior to the ribavirin group in Chinese drug-treated group aspect relieve clinical symptoms time and total effective rate and the cure rate.

Above content is to combine concrete preferred implementation to the further explain that the present invention did, and can not assert that practical implementation of the present invention is confined to these explanations.For the those of ordinary skill of technical field under the present invention, under the prerequisite that does not break away from the present invention's design, can also make some simple deduction or replace, all should be regarded as belonging to protection scope of the present invention.

Claims

1. a Chinese medicine composition of treating respiratory viral infection disease is characterized in that: the crude drug that comprises following parts by weight: Folium Perillae 5-25 gram, Radix Asteris 5-25 gram, Radix Bupleuri 5-25 gram, Herba Schizonepetae 5-25 gram, Fructus Arctii 5-25 gram, Semen Armeniacae Amarum 5-25 gram, Radix Glycyrrhizae 1-15 gram.

2. the Chinese medicine composition of treatment respiratory viral infection disease according to claim 1, wherein the consumption of crude drug can also be: Folium Perillae 5-20 gram, Radix Asteris 5-20 gram, Radix Bupleuri 5-20 gram, Herba Schizonepetae 5-20 gram, Fructus Arctii 5-20 gram, Semen Armeniacae Amarum 5-20 gram, Radix Glycyrrhizae 3-10 gram.

3. the Chinese medicine composition of treatment respiratory viral infection disease according to claim 2, wherein crude drug also has: Rhizoma Pinelliae Preparatum 5-20 gram, Fructus Perillae 5-20 gram.

4. the Chinese medicine composition of treatment respiratory viral infection disease according to claim 3, wherein crude drug also has: Radix Scutellariae 5-20 gram, Cortex Mori 5-20 gram.

5. the Chinese medicine composition of treatment respiratory viral infection disease according to claim 4, wherein crude drug also has: Herba Ephedrae 5-20 gram or windproof 5-20 gram.

6. the method for preparing of claim 1 or 2 said Chinese medicine compositions, it comprises the following steps:

gets Folium Perillae, Radix Asteris, Radix Bupleuri, Herba Schizonepetae, Fructus Arctii, Semen Armeniacae Amarum, Radix Glycyrrhizae decocte with water merging filtrate, concentrates, cools off; Adding ethanol makes and contains alcohol amount 20-80%; Reclaim ethanol; Make supernatant concentration become thick paste, subsequent use;

adds capsule adjuvant commonly used with the thick paste of preparation; Dry, pulverizing incapsulates, and can be prepared into the capsule of treatment respiratory viral infection disease; Or thick paste and granule adjuvant commonly used mixed, granulate, dry be distributed into bag, can be prepared into the granule of treating respiratory viral infection disease; Or thick paste and oral liquid adjuvant commonly used mixed, boiling, thin up leaves standstill, and filters, and mixing is distributed into bottle, can be prepared into the oral liquid of treating respiratory viral infection disease; Or thick paste added sucrose, correctives, antiseptic, and boiling, thin up is to 1000ml; Leave standstill, filter mixing; Packing promptly gets the syrup of treating respiratory viral infection disease, wherein said sucrose weight＞450g; Said correctives is stevioside, saccharin sodium, acesulfame-K, glycyrrhizin, thiacyclohexane sulfamic acid, agedoite, alcohol sugar, radix asparagi sweet extract, Mentholum, various essence and various fruity material; Consumption is 0.1 ~ 10%, and said antiseptic is sorbic acid and k-na salt consumption thereof for＜0.3%, methyl hydroxybenzoate class consumption is＜0.05%, and the packaging material that said packing is used is vial, plastic bottle; Maybe thick paste and the tablet adjuvant commonly used with preparation mix, tabletting, can be prepared into the tablet of treating respiratory viral infection disease.

7. the method for preparing of the said Chinese medicine composition of claim 3, it comprises the following steps:

gets Folium Perillae, Radix Asteris, Radix Bupleuri, Herba Schizonepetae, Fructus Arctii, Semen Armeniacae Amarum, Radix Glycyrrhizae, Rhizoma Pinelliae Preparatum, Fructus Perillae decocte with water merging filtrate, concentrates, cools off; Adding ethanol makes and contains alcohol amount 20-80%; Reclaim ethanol; Make supernatant concentration become thick paste, subsequent use;

8. the method for preparing of the said Chinese medicine composition of claim 4, it comprises the following steps:

gets Folium Perillae, Radix Asteris, Radix Bupleuri, Herba Schizonepetae, Fructus Arctii, Semen Armeniacae Amarum, Radix Glycyrrhizae, Rhizoma Pinelliae Preparatum, Fructus Perillae, Radix Scutellariae, Cortex Mori decocte with water merging filtrate, concentrates, cools off; Adding ethanol makes and contains alcohol amount 20-80%; Reclaim ethanol; Make supernatant concentration become thick paste, subsequent use;

9. the method for preparing of the said Chinese medicine composition of claim 5, it comprises the following steps:

gets Folium Perillae, Radix Asteris, Radix Bupleuri, Herba Schizonepetae, Fructus Arctii, Semen Armeniacae Amarum, Radix Glycyrrhizae, Rhizoma Pinelliae Preparatum, Fructus Perillae, Radix Scutellariae, Cortex Mori, Herba Ephedrae or windproof decocte with water merging filtrate, concentrates, cools off; Adding ethanol makes and contains alcohol amount 20-80%; Reclaim ethanol; Make supernatant concentration become thick paste, subsequent use;

10. according to the Chinese medicine composition of the described treatment respiratory viral infection disease of claim 1～5, it is characterized in that: the dosage form of described compositions is: capsule, oral liquid, granule, syrup, tablet, effervescent granule, drop pill, aerosol, spray, gargarisma, collutory; Wherein said tablet is oral cavity disintegration tablet, effervescent tablet.

11. the Chinese medicine composition according to the described treatment respiratory viral infection disease of claim 1～5 is characterized in that: can be used for the respiratory viral infection disease of treating or preventing to be caused clinically by influenza A virus, Influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, echovirus, Coxsackie virus etc.