CN102641356B - Traditional Chinese medicine composition for treating respiratory tract viral infectious diseases and preparation method thereof - Google Patents

Traditional Chinese medicine composition for treating respiratory tract viral infectious diseases and preparation method thereof Download PDF

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CN102641356B
CN102641356B CN201210157835.9A CN201210157835A CN102641356B CN 102641356 B CN102641356 B CN 102641356B CN 201210157835 A CN201210157835 A CN 201210157835A CN 102641356 B CN102641356 B CN 102641356B
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medicine composition
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CN102641356A (en
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曲敬来
高雪
陈生
齐继贵
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SHENZHEN QIWANG INVESTEMENT CO Ltd
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SHENZHEN QIWANG INVESTEMENT CO Ltd
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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 for the treatment of respiratory viral infection disease and preparation method thereof
Technical field
The invention belongs to technical field of Chinese medicines, is a kind of about treatment respiratory viral infection disease, and particularly the following respiratory viral infection disease for the treatment of is main Chinese medicine composition and preparation method thereof.Wherein, described respiratory virus infection refers to the respiratory virus infection that influenza A virus, Influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, echovirus, Coxsackie virus etc. cause.
Background technology
Respiratory tract infection comprises upper respiratory tract infection, tracheitis, bronchitis and bronchopneumonia.The pathogen of lower respiratory infection is various virus and antibacterial.The normal primary disease of easily suffering from of weak, allergy and chronic sinusitis person, especially easy infection more in the time of climate change, air pollution environment.When lower respiratory channel virus infection apart from outside upper respiratory tract infection symptoms, cough is the dryness that are in early days more, transfer moist cough in the later stage. also have part patient companion to stridulate, respiratory rhythm speeds, drowsiness, the symptoms such as spirit appetite is poor, lower respiratory channel virus infection disease sickness rate in recent years has the trend increasing, as shown according to etiologic research, viral pneumonia accounts for 18% of community acquired pneumonia, in hospital acquired infection, account for 5% in the same period, especially in the AIDS VICTIMS when cause infection HIV (human immunodeficiency virus) (HIV), its sickness rate sharply raises especially, more and more receive people's concern.Thereby how can cure efficiently and effectively respiratory viral infection disease 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., wherein common with rhinovirus, influenza A virus, Influenza B virus.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, often there are heating, pharyngitis or cough, the visible laryngeal edema of health check-up, hyperemia, regional nodes's silght enlargement and tenderness, audible and whoop; 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 for coughing, being mucus without expectorant or expectorant, with heating and weak, uncomfortable in chest.Other symptoms often have pain under hoarseness, non-pleura breastbone, audible and dryness or moist rales, and x-ray chest films showed blood vessel shade increases, strengthens, but apneumia infiltrates 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 can there is cyanosis 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, QI rising in reverse order, tachypnea, flaring nares, severe one can occur lip and fingernail livid purple, the visible pulmonary shadow of Chest X-rays.
Because virus utilize the metabolic pathway of host cell to copy, so, in general, if do not use can to host cell produce toxic action medicine be difficult to by its elimination.At present, doctor trained in Western medicine adopts ribavirin to treat to the viral infection such as rhinovirus, coronavirus more both at home and abroad.Because the hypotype of rhinovirus, coronavirus is more, be difficult to use the generation of the pre-anti-virus of vaccine.Be exactly the generation of using the pre-anti-virus of vaccine according to antigen-antibody theory to the method for preventing and treating of influenza A virus, Influenza B virus, but because viral antigen is constantly occurring to make a variation, vaccine often also just lose effect.And for antiviral drug, the problems such as the variability based on viral and the 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 refers to the gas of breathing, refers to 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 "." Plain Questions. cough opinion " say: " fur is first subject to pathogen 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 by nasopharynx part and skin hair key, just as one barrier, and the defensive enginery of supervisor's human body.The paathogenic factors such as external wind, cold, summer-heat, wet, dry, fiery (being referred to as the heresy of six climate exopathogens) are often by nasopharynx part and fur, first invade in lung, causing that lung qi loses in a surname sends out or when respectful falling, all can make abnormal rising of lung-QI and cause cough, pant, the symptom such as expectoration, this belongs to exogenous cough.The heresy of six climate exopathogens is caused a disease, and is main mainly with ailment said due to cold or exposure, 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 time gas while holding under the arm row virus hurt sb.'s feelings, be often not limited to season, and the state of an illness is multiple, easily cause infect popular.And influenza, the pathogenic wind-warm category of genus epidemic febrile disease, belongs to influenza, and its feature has also just been included the feature of diseases caused by exogenous pathogenic factor respiratory disease: seasonable, generate heat high, state of an illness weight, infection is popular by force, scope is wide.
Chinese medicine not only has that drug resistance is low, side effect and the advantage such as untoward reaction is few, and suppress in addition virus replication, regulate immunologic function, improve blood circulation, the comprehensive effect such as antipyretic-antalgic and anti-inflammation, it has unique advantage and vast potential for future development aspect control viral infection.Research shows, antipyretic and antidotal type Chinese medicine has many direct antiviral effects that have, as Flos Lonicerae, Flos Chrysanthemi Indici, Folium Isatidis, Rhizoma Osmundae etc.
Summary of the invention
Still there is demand in the Chinese medicine preparation that therefore, people better treat respiratory viral infection disease to curative effect.Up to now, also do not find any report about pharmaceutical composition of the present invention.The inventor is through research repeatedly, and by external and checking repeatedly clinical trial, finally found the Chinese medicine composition that has the treatment of better curative effect respiratory viral infection disease, thereby completed the present invention.The present invention is directed to above-mentioned etiology and pathogenesis, adopt targetedly and there is unique prepared from traditional Chinese medicines for the treatment of respiratory virus infection effect to form.Said composition is mainly made up of Folium Perillae, Radix Asteris, Radix Bupleuri, Herba Schizonepetae, Fructus Arctii, Semen Armeniacae Amarum, Radix Glycyrrhizae, there is the merit of reducing heat and dispersing lung-QI, resolving phlegm and relieving asthma, can be used for clinically the respiratory viral infection disease that treatment or prevention are caused by influenza A virus, Influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, echovirus, Coxsackie virus etc.
The object of the invention is: overcome the deficiencies in the prior art, a kind of Chinese medicine composition that can effectively treat or prevent the respiratory viral infection disease being 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 preparation method of this Chinese medicine composition is provided, has met the demand in market.
For reaching better curative effect, medicine of the present invention can combine with crude drug Rhizoma Pinelliae Preparatum, Fructus Perillae.
For reaching better curative effect, medicine of the present invention also can combine with crude drug Radix Scutellariae, Cortex Mori.
For reaching better curative effect, medicine of the present invention also can combine with crude drug Herba Ephedrae or Radix Saposhnikoviae.
The technical solution adopted for the present invention to solve the technical problems is: the Chinese medicine composition for the treatment of respiratory viral infection disease, comprises the crude drug of 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.
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 preparation method of medicine of the present invention is as follows:
Get crude drug Folium Perillae, Radix Asteris, Radix Bupleuri, Herba Schizonepetae, Fructus Arctii, Semen Armeniacae Amarum, Radix Glycyrrhizae and decoct with water merging filtrate, concentrated, cooling, add ethanol and make, containing alcohol amount 20-80%, to reclaim ethanol, make supernatant concentration become thick paste, for subsequent use.Add capsule to commonly use adjuvant the thick paste of preparation, dry, pulverizing incapsulates, and can be prepared into the capsule for the treatment of respiratory viral infection disease, or thick paste and the conventional adjuvant of granule are mixed, granulate, be dried and be distributed into bag, can be prepared into the granule for the treatment of respiratory viral infection disease, or conventional to thick paste and oral liquid adjuvant is mixed, boiling, thin up, leaves standstill, and filters, and mixes and is distributed into bottle, can be prepared into the oral liquid for the treatment of respiratory viral infection disease, or thick paste is added to sucrose, correctives, antiseptic, boil, be diluted with water to 1000ml, leave standstill, filter, mix, subpackage, must treat the syrup of respiratory viral infection disease, wherein said sucrose weight > 450g, described 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%, described antiseptic is that sorbic acid and k-na salt consumption thereof are < 0.3%, methyl hydroxybenzoate class consumption is < 0.05%, the packaging material that described subpackage uses is vial, plastic bottle, maybe conventional to thick paste and the tablet of preparation adjuvant is mixed, tabletting, can be prepared into the tablet for the treatment of respiratory viral infection disease.
If be also combined 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 and decoct with water merging filtrate, concentrated, cooling, add ethanol and make, containing alcohol amount 20-80%, to reclaim ethanol, make supernatant concentration become thick paste, for subsequent use.Add capsule to commonly use adjuvant the thick paste of preparation, dry, pulverizing incapsulates, and can be prepared into the capsule for the treatment of respiratory viral infection disease, or thick paste and the conventional adjuvant of granule are mixed, granulate, be dried and be distributed into bag, can be prepared into the granule for the treatment of respiratory viral infection disease, or conventional to thick paste and oral liquid adjuvant is mixed, boiling, thin up, leaves standstill, and filters, and mixes and is distributed into bottle, can be prepared into the oral liquid for the treatment of respiratory viral infection disease, or thick paste is added to sucrose, correctives, antiseptic, boil, be diluted with water to 1000ml, leave standstill, filter, mix, subpackage, must treat the syrup of respiratory viral infection disease, wherein said sucrose weight > 450g, described 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%, described antiseptic is that sorbic acid and k-na salt consumption thereof are < 0.3%, methyl hydroxybenzoate class consumption is < 0.05%, the packaging material that described subpackage uses is vial, plastic bottle, maybe conventional to thick paste and the tablet of preparation adjuvant is mixed, tabletting, can be prepared into the tablet for the treatment of respiratory viral infection disease.
If be also combined 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 and decoct with water merging filtrate, concentrated, cooling, adding ethanol makes containing alcohol amount 20-80%, reclaim ethanol, make supernatant concentration become thick paste, for subsequent use.Add capsule to commonly use adjuvant the thick paste of preparation, dry, pulverizing incapsulates, and can be prepared into the capsule for the treatment of respiratory viral infection disease, or thick paste and the conventional adjuvant of granule are mixed, granulate, be dried and be distributed into bag, can be prepared into the granule for the treatment of respiratory viral infection disease, or conventional to thick paste and oral liquid adjuvant is mixed, boiling, thin up, leaves standstill, and filters, and mixes and is distributed into bottle, can be prepared into the oral liquid for the treatment of respiratory viral infection disease, or thick paste is added to sucrose, correctives, antiseptic, boil, be diluted with water to 1000ml, leave standstill, filter, mix, subpackage, must treat the syrup of respiratory viral infection disease, wherein said sucrose weight > 450g, described 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%, described antiseptic is that sorbic acid and k-na salt consumption thereof are < 0.3%, methyl hydroxybenzoate class consumption is < 0.05%, the packaging material that described subpackage uses is vial, plastic bottle, maybe conventional to thick paste and the tablet of preparation adjuvant is mixed, tabletting, can be prepared into the tablet for the treatment of respiratory viral infection disease.
If be also combined with crude drug Herba Ephedrae or Radix Saposhnikoviae, 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 Radix Saposhnikoviae and decoct with water merging filtrate, concentrated, cooling, adding ethanol makes containing alcohol amount 20-80%, reclaim ethanol, make supernatant concentration become thick paste, for subsequent use.Add capsule to commonly use adjuvant the thick paste of preparation, dry, pulverizing incapsulates, and can be prepared into the capsule for the treatment of respiratory viral infection disease, or thick paste and the conventional adjuvant of granule are mixed, granulate, be dried and be distributed into bag, can be prepared into the granule for the treatment of respiratory viral infection disease, or conventional to thick paste and oral liquid adjuvant is mixed, boiling, thin up, leaves standstill, and filters, and mixes and is distributed into bottle, can be prepared into the oral liquid for the treatment of respiratory viral infection disease, or thick paste is added to sucrose, correctives, antiseptic, boil, be diluted with water to 1000ml, leave standstill, filter, mix, subpackage, must treat the syrup of respiratory viral infection disease, wherein said sucrose weight > 450g, described 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%, described antiseptic is that sorbic acid and k-na salt consumption thereof are < 0.3%, methyl hydroxybenzoate class consumption is < 0.05%, the packaging material that described subpackage uses is vial, plastic bottle, maybe conventional to thick paste and the tablet of preparation adjuvant is mixed, tabletting, can be prepared into the tablet for the treatment of 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 combine.Make each efficacy of drugs produce synergism these drug regimens, thereby can effectively treat respiratory viral infection disease.Wherein pungent, the tepor of Folium Perillae, nontoxic, returns spleen, lung two warps, cures mainly affection of exogenous wind-cold, and fever with aversion to cold, has a headache lossless, monarch drug in the cough and asthma side of being; Selecting Radix Asteris, Radix Bupleuri, Herba Schizonepetae, Fructus Arctii, Semen Armeniacae Amarum, is because of Radix Asteris hardship, pungent, sweet, tepor, returns lung meridian, and merit is apt to moistening the lung and resolving phlegm cough-relieving, is used for bringing up phlegm when one coughs; Radix Bupleuri hardship, be slightly cold, return Liver Channel, gallbladder meridian, function: evacuate and bring down a fever, yang invigorating soothing liver-QI, cures mainly cold, fever, alternate attack of chill and fever; Herba Schizonepetae is pungent, tepor is returned lung, Liver Channel, has effect of induce sweat loose wind, rash; Fructus Arctii is pungent, 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 fall apart swollen; Semen Armeniacae Amarum hardship, temperature, poisonous, return 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, and above five medicines are that ministerial drug and adjuvant drug are assisted a ruler in governing a country monarch drug jointly; Radix Glycyrrhizae is as making the existing heat-clearing and toxic substances removing of medicine, and the merit of expelling phlegm for arresting cough again can coordinating the actions of various ingredients in a prescription; All medicine compatibilities, dredge clearly and use, and lifting is thrown altogether, plays altogether the merit of reducing heat and dispersing lung-QI, relieving cough and asthma.
For the curative effect having reached, medicine of the present invention also combines with Rhizoma Pinelliae Preparatum, Fructus Perillae.This is that lung-QI being unable to descend, therefore select Rhizoma Pinelliae Preparatum pungent, warm, returns spleen, stomach, lung meridian, has both had the merit of the Folium Perillae of helping sending down the abnormal ascending QI cough-relieving, has again the use of drying dampness to eliminate phlegm because of the turbid retardance of expectorant; Fructus Perillae is pungent, warm, returns lung, spleen channel, has sending down the abnormal ascending QI expectorant, relievings asthma, the effect of intestine moistening.
In order to reach better curative effect, medicine of the present invention also combines with Radix Scutellariae, Cortex Mori.This is that therefore 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 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, enters lung meridian, can eliminating pathogen from the lung for relieving asthma, and inducing diuresis to remove edema.
In order to obtain optimum curative effect, medicine of the present invention also with Herba Ephedrae or Combined wind-proof.This is because affection by exopathogenic cold-wind inhibited pulmonary QI, therefore select pungent, the micro-hardship of Herba Ephedrae, temperature, is returned lung, urinary bladder channel, diaphoresis cold expelling, depressed lung-energy dispersing, inducing diuresis to remove edema; Radix Saposhnikoviae is pungent, sweet, warm, returns 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, in addition the experimental basis of science, each component can be brought into play pharmacological action separately, can play again mutual synergism, pharmacological action is strengthened, formula rationally, flavour of a drug refine, the party is used for the treatment of or prevents respiratory viral infection disease, determined curative effect, and have no side effect, at epidemic period, as general side be used for the treatment of with prevention all effective, dosage form and preparation technology are applicable to industrialized mass.
Detailed description of the invention
The Chinese medicine composition of the present invention treatment or prevention respiratory viral infection disease, comprises the crude drug of 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.For the curative effect having reached, medicine of the present invention can combine with crude drug Rhizoma Pinelliae Preparatum, Fructus Perillae; For reaching better curative effect, 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 combine with crude drug Herba Ephedrae or Radix Saposhnikoviae;
Embodiment 1:
10 grams of weighting raw materials Folium Perillaes, 10 grams of Radix Asteriss, 10 grams of Radix Bupleuri, 10 grams of Herba Schizonepetaes, 10 grams of Fructus Arctiis, 10 grams, Semen Armeniacae Amarum, 10 grams, Radix Glycyrrhizae, totally 70 grams of above seven flavor medicine things, decoct with water merging filtrate, concentrated, cooling, add ethanol make containing alcohol amount be 20-80%, reclaim ethanol, make supernatant concentration become thick paste, for subsequent use.Add beta-schardinger dextrin-, 180 DEG C of heating for dissolving, stirring, filtration, spraying heated drying air inlet temperature, 80 DEG C of leaving air temps, spray powder adds flavoring agent, mix, material at 40 DEG C of temperature dry granulation, granulate, be distributed into bag, obtain the present invention and treat the granule of respiratory viral infection disease.
Embodiment 2:
10 grams of weighting raw materials Folium Perillaes, 10 grams of Radix Asteriss, 10 grams of Radix Bupleuri, 10 grams of Herba Schizonepetaes, 10 grams of Fructus Arctiis, 10 grams, Semen Armeniacae Amarum, 10 grams, Radix Glycyrrhizae, totally 70 grams of above seven flavor medicine things, decoct with water merging filtrate, concentrated, cooling, add ethanol make containing alcohol amount be 20-80%, reclaim ethanol, make supernatant concentration become thick paste, for subsequent use.In thick paste, add 2 times of 95% ethanol that cream is heavy, fully stir, under room temperature, leave standstill 24～48h, get supernatant, 65% washing with alcohol 1～2 time for precipitate, cleaning mixture and supernatant merge, if any alcohol extract, also merge with supernatant, filter clear and bright after, enter that concentrating under reduced pressure tank or alcohol distillation column reclaim ethanol until medicinal liquid without alcohol taste only.Medicinal liquid after dealcoholysis, after adding distil water dilution, be heated to 100 DEG C, make coacervation of colloid, adjust pH4.5～5.0, then 0～4 DEG C of cold preservation 24h of low temperature, make the colloidal precipitation of cohesion, then, filter to clear and bright, add appropriate correctives and antiseptic, after leaving standstill, filter clear and brightly, low-temp storage, does last purification filtering before fill again, filtrate put under lamp inspection instrument, detect clear and bright after, upper mechanical irrigation is encapsulated in straight tube easy-open lid nutrition bottle, and every in-built 10ml ± 4% of oral liquid bottle obtains the present invention and treat the oral liquid of respiratory viral infection disease.
Embodiment 3:
10 grams of weighting raw materials Folium Perillaes, 10 grams of Radix Asteriss, 10 grams of Radix Bupleuri, 10 grams of Herba Schizonepetaes, 10 grams of Fructus Arctiis, 10 grams, Semen Armeniacae Amarum, 10 grams, Radix Glycyrrhizae, 10 grams of Rhizoma Pinelliae Preparatum, 10 grams of Fructus Perillaes, totally 90 grams of above nine herbal medicines, then press the method granulation agent described in embodiment 1.
Embodiment 4:
10 grams of weighting raw materials Folium Perillaes, 10 grams of Radix Asteriss, 10 grams of Radix Bupleuri, 10 grams of Herba Schizonepetaes, 10 grams of Fructus Arctiis, 10 grams, Semen Armeniacae Amarum, 10 grams, Radix Glycyrrhizae, 10 grams of Rhizoma Pinelliae Preparatum, 10 grams of Fructus Perillaes, totally 90 grams of above nine herbal medicines, then make oral liquid by the method described in embodiment 2.
Embodiment 5:
10 grams of weighting raw materials Folium Perillaes, 10 grams of Radix Asteriss, 10 grams of Radix Bupleuri, 10 grams of Herba Schizonepetaes, 10 grams of Fructus Arctiis, 10 grams, Semen Armeniacae Amarum, 10 grams, Radix Glycyrrhizae, 10 grams of Rhizoma Pinelliae Preparatum, 10 grams of Fructus Perillaes, 10 grams of Radix Scutellariaes, 10 grams of Cortex Mori, above ten totally 110 grams of medicines simply, then press the method granulation agent described in embodiment 1.
Embodiment 6:
10 grams of weighting raw materials Folium Perillaes, 10 grams of Radix Asteriss, 10 grams of Radix Bupleuri, 10 grams of Herba Schizonepetaes, 10 grams of Fructus Arctiis, 10 grams, Semen Armeniacae Amarum, 10 grams, Radix Glycyrrhizae, 10 grams of Rhizoma Pinelliae Preparatum, 10 grams of Fructus Perillaes, 10 grams of Radix Scutellariaes, 10 grams of Cortex Mori, above ten totally 110 grams of medicines simply, then make oral liquid by the method described in embodiment 2.
Embodiment 7:
10 grams of weighting raw materials Folium Perillaes, 10 grams of Radix Asteriss, 10 grams of Radix Bupleuri, 10 grams of Herba Schizonepetaes, 10 grams of Fructus Arctiis, 10 grams, Semen Armeniacae Amarum, 10 grams, Radix Glycyrrhizae, 10 grams of Rhizoma Pinelliae Preparatum, 10 grams of Fructus Perillaes, 10 grams of Radix Scutellariaes, 10 grams of Cortex Mori, 10 grams, Herba Ephedrae, totally 120 grams of above 12 herbal medicines, then press the method granulation agent described in embodiment 1.
Embodiment 8:
10 grams of weighting raw materials Folium Perillaes, 10 grams of Radix Asteriss, 10 grams of Radix Bupleuri, 10 grams of Herba Schizonepetaes, 10 grams of Fructus Arctiis, 10 grams, Semen Armeniacae Amarum, 10 grams, Radix Glycyrrhizae, 10 grams of Rhizoma Pinelliae Preparatum, 10 grams of Fructus Perillaes, 10 grams of Radix Scutellariaes, 10 grams of Cortex Mori, 10 grams of Radix Saposhnikoviaes, totally 120 grams of above 12 herbal medicines, then make oral liquid by the method described in embodiment 2.
test example 1: the laboratory observation of Chinese medicine composition In Vitro Anti rhinovirus (HRV, N36)
Test philosophy: taking people embryo epithelial cell as virus host, 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 make respectively the solution bottling of 1000mg/ml for subsequent use; 3000rpm gets supernatant after centrifugal 20 minutes, and the sodium citrate with 50% is adjusted pH7.2～7.6, and in impouring sterile test tube, 121 DEG C, 15-20 minutes autoclavings, take out in rearmounted 4 DEG C of refrigerators and save backup; When experiment, solution example starts with culture fluid 1:10 dilution, does 2 times of dilutions, totally 8 dilution factors.
3. positive control drug: ribavirin (RBV) Jiangxi Huiren Pharmaceutical Co., Ltd produces.
4. method of testing:
1. by people embryo epithelial cell (2～4) × 10 50.1ml is inoculated into 96 hole micro plastics culture plates, 37 DEG C of every hole 100 μ l, 5%CO 2cultivate 1～2 day, grow into cell monolayer.Cell growth medium is MEM100ml, containing hyclone 10%, 3% glutamine 1%, penicillin and the each 100U/ml of streptomycin, NaHCO3 5%; When cell grows up to monolayer, abandon growth-promoting media, before virus inoculation, need to wash cell two times with PBS or the Hanks liquid of pre-temperature.
2. control is dry, adds 100 μ l 10～100TCID 50viral suspension infection cell, 37 DEG C of absorption 1～2h, abandon virus liquid, then add the maintenance medium 100 μ l that contain variable concentrations testing compound, each concentration 2 holes, 37 DEG C 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 record cytopathy (<25% is a plus sige, 25 ~50% is two plus siges, 50 ~75% is three plus siges, 75 ~100% is four plus siges), until virus control hole (not adding testing compound) occurs 3 ~it when the cytopathy of 4 plus siges, is experiment terminal.Record each porocyte lesion degree, calculate every group of average cell lesion degree, with the comparison of virus control group, calculating inhibition 50% cytopathic compound concentration by Reed and Muench method is half-inhibition concentration (IC 50).
4. the toxicity to cell by criterion calculation medicine 3. simultaneously, calculating generation 50% cytopathic compound concentration by Reed and Muench method is half toxic concentration (TD 50).
5. TD 50/ IC 50for selection index (SI).
5. experimental result
test example 2: the laboratory observation of Chinese medicine composition In Vitro Anti influenza virus A type
Test philosophy: taking MDCK(Madin-Darby canine kidney(cell line) (MDCK)) be virus host, working sample suppresses influenza virus A type and causes mdck cell lesion degree.
Test material and method:
1. Strain :/243/72 (H3N2) prevented in influenza virus A type A/ Guangdong.
2. sample treatment: get that thick paste that embodiment 1,5,7,8 makes is dissolved in water and to make respectively the solution bottling of 1000mg/ml for subsequent use; 3000rpm gets supernatant after centrifugal 20 minutes, and the sodium citrate with 50% is adjusted pH7.2～7.6, and in impouring sterile test tube, 121 DEG C, 15-20 minutes autoclavings, take out in rearmounted 4 DEG C of refrigerators and save backup; When experiment, solution example starts with culture fluid 1:10 dilution, does 2 times of dilutions, totally 8 dilution factors.
3. positive control drug: oseltamivir phosphate capsule.
4. method of testing: 1. by mdck cell (2～4) × 10 50.1ml is inoculated into 96 hole micro plastics culture plates, 37 DEG C of every hole 100 μ l, 5%CO 2cultivate 1～2 day, grow into cell monolayer.Cell growth medium is MEM 100ml, containing hyclone 10%, 3% glutamine 1%, penicillin and the each 100U/ml of streptomycin, NaHCO3 5%; Maintenance medium is increase serum not, because containing, serum suppresses the nonspecific inhibitor that influenza virus is copied, when cell grows up to monolayer, before virus inoculation, need to wash cell two times with PBS or the Hanks liquid of pre-temperature, to remove the residual growth-promoting media containing 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 dry, adds 100 μ l 10～100TCID 50viral suspension infection cell, 37 DEG C of absorption 1～2h, abandon virus liquid, then add the maintenance medium 100 μ l that contain variable concentrations testing compound, each concentration 2 holes, 37 DEG C 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 record cytopathy (<25% is a plus sige, 25 ~50% is two plus siges, 50 ~75% is three plus siges, 75 ~100% is four plus siges), until virus control hole (not adding testing compound) occurs 3 ~it when the cytopathy of 4 plus siges, is experiment terminal.Record each porocyte lesion degree, calculate every group of average cell lesion degree, with the comparison of virus control group, calculating inhibition 50% cytopathic compound concentration by Reed and Muench method is half-inhibition concentration (IC50).
4. the toxicity to cell by criterion calculation medicine 3. simultaneously, calculating generation 50% cytopathic compound concentration by Reed and Muench method is half toxic concentration (TD 50).
5. TD 50/ IC 50for selection index (SI).
5. experimental result
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, meet the patient of 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 group 60 examples are assigned randomly to each 15 examples of 1,5,7,8 groups of embodiment examples (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 (P>0.05) on sex, age, the course of disease and the state of an illness distribute.
1.1.2 diagnostic criteria
1.1.2.1 Western medicine diagnose standard
(1) clinical symptoms: have sure rhinovirus infection medical history, Acute onset, the course of disease≤2 day; With heating, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, dry pharynx itch, the symptom such as cough, hoarseness;
(2) health check-up: pharyngeal congestion, antiadoncus, two pulmonary respiration sounds are slightly coarse or not coarse;
(3) Serological testing: adopt RT-PCR method to detect the rhinovirus positive, the conventional leukocyte of peripheral blood calculate and classification all between normal range or numeration of leukocyte low;
(4) x-ray chest film inspection normal.
1.1.2.2 tcm diagnosis standard:
Clinically taking heating, aversion to cold, headache, nasal obstruction, sneeze, watery nasal discharge, dry pharynx itch, the symptom such as cough, hoarseness is as principal character, slightly BOHUANG, slippery and rapid pulse of reddish tongue, tongue.
1.2 Therapeutic Method
Treatment group gives Chinese medicinal composition granules, oral, and every day twice, each consumption is equivalent to each raw medicinal herbs 10g; Matched group ribavirin effervescent granule 150mg/ time, every day 3 times, oral.Child is cut down according to the circumstance.Be 5 days the course for the treatment of.
1.3 criterion of therapeutical effect
Criterion of therapeutical effect:
Recovery from illness: treat the 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;
Effective: to treat the 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;
Effective: to treat the 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: to treat conscious in five days or other symptoms and be all not improved or increase the weight of.
1.4 result
Use Chinese medicine composition (treatment group A) the treatment rhinovirus upper respiratory tract infection of embodiment of the present invention example 1, result shows: the clinical symptoms such as heating before and after two groups of patient's total effective rates of comparison and 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.Clinical effectiveness prompting: embodiment of the present invention example 1 traditional Chinese medicine composition for treating rhinovirus upper respiratory tract infection satisfactory effect, is all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group B) the treatment rhinovirus upper respiratory tract infection of embodiment of the present invention example 5, result shows: the clinical symptoms such as heating before and after two groups of patient's total effective rates of comparison and 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.Clinical effectiveness prompting: embodiment of the present invention example 5 traditional Chinese medicine composition for treating rhinovirus upper respiratory tract infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group C) the treatment rhinovirus upper respiratory tract infection of embodiment of the present invention example 7, result shows: the clinical symptoms such as heating before and after two groups of patient's total effective rates of comparison and 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.Clinical effectiveness prompting: embodiment of the present invention example 7 traditional Chinese medicine composition for treating rhinovirus upper respiratory tract infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group D) the treatment rhinovirus upper respiratory tract infection of embodiment of the present invention example 8, result shows: the clinical symptoms such as heating before and after two groups of patient's total effective rates of comparison and 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.Clinical effectiveness prompting: embodiment of the present invention example 8 traditional Chinese medicine composition for treating rhinovirus upper respiratory tract infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and 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, meet the patient of 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 group 60 examples are assigned randomly to each 15 examples of 1,5,7,8 groups of embodiment examples (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 (P>0.05) on sex, age, the course of disease and the state of an illness distribute.
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;
(2) health check-up: pharyngeal congestion, antiadoncus, two pulmonary respiration sounds are slightly coarse or not coarse;
(3) Serological testing: adopt RT-PCR method to detect the influenza virus A type H1N1 positive, the conventional leukocyte of peripheral blood calculate and classification all between normal range or numeration of leukocyte low;
(4) x-ray chest film inspection normal.
1.1.2.2 tcm diagnosis standard:
Taking symptoms such as heating, cough, expectoration, watery nasal discharge, nasal obstruction, itching throat, dry pharynx pain, hoarseness as principal character, reddish tongue, tongue are omited BOHUANG, floating and rapid pulse clinically.
1.2 Therapeutic Method
Treatment group gives Chinese medicinal composition granules, oral, and every day twice, each consumption is equivalent to each raw medicinal herbs 10g; Matched group ribavirin effervescent granule 150mg/ time, every day 3 times, oral.Child is cut down according to the circumstance.Be 5 days the course for the treatment of.
1.3 criterion of therapeutical effect
Criterion of therapeutical effect:
Recovery from illness: treat the 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;
Effective: to treat the 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;
Effective: to treat the 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;
Invalid: to treat conscious in five days or other symptoms and be all not improved or increase the weight of.
1.4 result
Use Chinese medicine composition (treatment group A) the treatment influenza virus upper respiratory tract infection of embodiment of the present invention example 1, result shows: compare the 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.Clinical effectiveness prompting: embodiment of the present invention example 1 traditional Chinese medicine composition for treating influenza virus upper respiratory tract infection satisfactory effect, is all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group B) the treatment influenza virus upper respiratory tract infection of embodiment of the present invention example 5, result shows: compare the 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.Clinical effectiveness prompting: embodiment of the present invention example 5 traditional Chinese medicine composition for treating influenza virus upper respiratory tract infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group C) the treatment influenza virus upper respiratory tract infection of embodiment of the present invention example 7, result shows: compare the 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.Clinical effectiveness prompting: embodiment of the present invention example 7 traditional Chinese medicine composition for treating influenza virus upper respiratory tract infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group D) the treatment influenza virus upper respiratory tract infection of embodiment of the present invention example 8, result shows: compare the 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.Clinical effectiveness prompting: embodiment of the present invention example 8 traditional Chinese medicine composition for treating influenza virus upper respiratory tract infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and 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, meet the patient of 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 group 60 examples are assigned randomly to each 15 examples of 1,5,7,8 groups of embodiment examples (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 (P>0.05) on sex, age, the course of disease and the state of an illness distribute.
1.1.2 diagnostic criteria
1.1.2.1 Western medicine diagnose standard
(1) clinical symptoms: have sure rhinovirus infection medical history, Acute onset, the course of disease≤3 day; With generating heat, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, the 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: adopt RT-PCR method to detect the rhinovirus positive, the conventional numeration of leukocyte of peripheral blood and classification all between normal range or numeration of leukocyte low;
(4) the visible bronchitis of x-ray rabat or CT examination or pneumonia.
1.1.2.2 tcm diagnosis standard:
Clinical symptoms taking heating, aversion to cold, cough, cough up phlegm, nasal mucus, hoarseness, QI rising in reverse order, tachypnea, stridulate as principal character, slightly BOHUANG, rolling pulse of reddish tongue, tongue.
1.2 Therapeutic Method
Treatment group gives Chinese medicinal composition granules, oral, and every day twice, each consumption is equivalent to each raw medicinal herbs 10g; Matched group ribavirin effervescent granule 150mg/ time, every day 3 times, oral.Child is cut down according to the circumstance.Be 7 days the course for the treatment of.
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, the clinical symptoms sign disappearance such as QI rising in reverse order, tachypnea;
Effective: treat seven days internal heat generation aversion to cold, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, the clinical symptoms sign such as QI rising in reverse order, tachypnea alleviates more than 2/3;
Effective: treat seven days internal heat generation aversion to cold, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, the clinical symptoms sign such as QI rising in reverse order, tachypnea alleviates 2/3～1/3;
Invalid: to treat conscious in seven days or other symptoms and be all not improved or increase the weight of.
1.4 result
Use Chinese medicine composition (treatment group A) the treatment rhinovirus lower respiratory infection of embodiment of the present invention example 1, result shows: relatively fever with chills before and after two groups of patient's total effective rates and medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, the clinical symptoms such as QI rising in reverse order, tachypnea improves 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.Clinical effectiveness prompting: embodiment of the present invention example 1 traditional Chinese medicine composition for treating rhinovirus lower respiratory infection satisfactory effect, is all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group B) the treatment rhinovirus lower respiratory infection of embodiment of the present invention example 5, result shows: relatively fever with chills before and after two groups of patient's total effective rates and medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, the clinical symptoms such as QI rising in reverse order, tachypnea improves 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.Clinical effectiveness prompting: embodiment of the present invention example 5 traditional Chinese medicine composition for treating rhinovirus lower respiratory infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group C) the treatment rhinovirus lower respiratory infection of embodiment of the present invention example 7, result shows: relatively fever with chills before and after two groups of patient's total effective rates and medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, the clinical symptoms such as QI rising in reverse order, tachypnea improves 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.Clinical effectiveness prompting: embodiment of the present invention example 7 traditional Chinese medicine composition for treating rhinovirus lower respiratory infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group D) the treatment rhinovirus lower respiratory infection of embodiment of the present invention example 8, result shows: relatively fever with chills before and after two groups of patient's total effective rates and medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, the clinical symptoms such as QI rising in reverse order, tachypnea improves 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.Clinical effectiveness prompting: embodiment of the present invention example 8 traditional Chinese medicine composition for treating rhinovirus lower respiratory infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and 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, meet the patient of 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 group 60 examples are assigned randomly to each 15 examples of 1,5,7,8 groups of embodiment examples (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 (P>0.05) on sex, age, the course of disease and the state of an illness distribute.
1.1.2 diagnostic criteria
1.1.2.1 Western medicine diagnose standard
(1) clinical symptoms: have sure influenza infection medical history, Acute onset, the course of disease≤3 day; With generating heat, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, the 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: adopt RT-PCR method to detect the influenza virus A type H1N1 positive, the conventional numeration of leukocyte of peripheral blood and classification all between normal range or numeration of leukocyte low;
(4) the visible bronchitis of x-ray rabat or CT examination or pneumonia.
1.1.2.2 tcm diagnosis standard:
Clinical symptoms taking heating, aversion to cold, cough, cough up phlegm, nasal mucus, hoarseness, QI rising in reverse order, tachypnea, stridulate as principal character, reddish tongue, yellow and thin fur, slippery and rapid pulse.
1.2 Therapeutic Method
Treatment group gives Chinese medicinal composition granules, oral, and every day twice, each consumption is equivalent to each raw medicinal herbs 10g; Matched group ribavirin effervescent granule 150mg/ time, every day 3 times, oral.Child is cut down according to the circumstance.Be 7 days the course for the treatment of.
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, the clinical symptoms sign disappearance such as QI rising in reverse order, tachypnea;
Effective: treat seven days internal heat generation aversion to cold, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, the clinical symptoms sign such as QI rising in reverse order, tachypnea alleviates more than 2/3;
Effective: treat seven days internal heat generation aversion to cold, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, the clinical symptoms sign such as QI rising in reverse order, tachypnea alleviates 2/3～1/3;
Invalid: to treat conscious in seven days or other symptoms and be all not improved or increase the weight of.
1.4 result
Use Chinese medicine composition (treatment group A) the treatment influenza virus lower respiratory infection of embodiment of the present invention example 1, result shows: relatively fever with chills before and after two groups of patient's total effective rates and medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, the clinical symptoms such as QI rising in reverse order, tachypnea improves 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.Clinical effectiveness prompting: embodiment of the present invention example 1 traditional Chinese medicine composition for treating influenza virus lower respiratory infection satisfactory effect, is all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group B) the treatment influenza virus lower respiratory infection of embodiment of the present invention example 5, result shows: relatively fever with chills before and after two groups of patient's total effective rates and medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, the clinical symptoms such as QI rising in reverse order, tachypnea improves 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.Clinical effectiveness prompting: embodiment of the present invention example 5 traditional Chinese medicine composition for treating influenza virus lower respiratory infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group C) the treatment influenza virus lower respiratory infection of embodiment of the present invention example 7, result shows: relatively fever with chills before and after two groups of patient's total effective rates and medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, the clinical symptoms such as QI rising in reverse order, tachypnea improves 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.Clinical effectiveness prompting: embodiment of the present invention example 7 traditional Chinese medicine composition for treating influenza virus lower respiratory infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group D) the treatment influenza virus lower respiratory infection of embodiment of the present invention example 8, result shows: relatively fever with chills before and after two groups of patient's total effective rates and medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, the clinical symptoms such as QI rising in reverse order, tachypnea improves 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.Clinical effectiveness prompting: embodiment of the present invention example 8 traditional Chinese medicine composition for treating influenza virus lower respiratory infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
test example 7: the clinical observation that 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, meet the patient of 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 group 60 examples are assigned randomly to each 15 examples of 1,5,7,8 groups of embodiment examples (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 (P>0.05) on sex, age, the course of disease and the state of an illness distribute.
1.1.2 diagnostic criteria
1.1.2.1 Western medicine diagnose standard
(1) clinical symptoms: have sure influenza infection medical history, Acute onset, the course of disease≤2 day; With generating heat, cough, cough up phlegm, hoarseness, pharyngalgia, QI rising in reverse order, tachypnea be the 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: adopt RT-PCR method to detect the Influenza B virus positive, the conventional numeration of leukocyte of peripheral blood and classification all between normal range or numeration of leukocyte low;
(4) the visible bronchitis of x-ray rabat or CT examination or pneumonia.
1.1.2.2 tcm diagnosis standard:
Clinical symptoms generating heat, to cough, to cough up phlegm, hoarseness, pharyngalgia, QI rising in reverse order, tachypnea be as principal character, reddish tongue, yellow and thin fur, floating and rapid pulse.
1.2 Therapeutic Method
Treatment group gives Chinese medicinal composition granules, oral, and every day twice, each consumption is equivalent to each raw medicinal herbs 10g; Matched group ribavirin effervescent granule 150mg/ time, every day 3 times, oral.Child is cut down according to the circumstance.Be 7 days the course for the treatment of.
1.3 criterion of therapeutical effect
Criterion of therapeutical effect:
Recovery from illness: treat internal heat generation in seven days, cough, cough up phlegm, the clinical symptoms sign disappearance such as hoarseness, pharyngalgia, QI rising in reverse order, tachypnea;
Effective: to treat internal heat generation in seven days, cough, cough up phlegm, the clinical symptoms sign such as hoarseness, pharyngalgia, QI rising in reverse order, tachypnea alleviates more than 2/3;
Effective: to treat internal heat generation in seven days, cough, cough up phlegm, the clinical symptoms sign such as hoarseness, pharyngalgia, QI rising in reverse order, tachypnea alleviates 2/3～1/3;
Invalid: to treat conscious in seven days or other symptoms and be all not improved or increase the weight of.
1.4 result
Use Chinese medicine composition (treatment group A) the treatment Influenza B virus lower respiratory infection of embodiment of the present invention example 1, result shows: relatively before and after two groups of patient's total effective rates and medication, generate heat, cough, cough up phlegm, the clinical symptoms improvement situation such as hoarseness, pharyngalgia, 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 with contrast A group comparing difference and have statistical significance (P < 0.05).In clinical treatment observation, do not find toxic and side effects.Clinical effectiveness prompting: embodiment of the present invention example 1 traditional Chinese medicine composition for treating Influenza B virus lower respiratory infection satisfactory effect, is all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group B) the treatment Influenza B virus lower respiratory infection of embodiment of the present invention example 5, result shows: relatively before and after two groups of patient's total effective rates and medication, generate heat, cough, cough up phlegm, the clinical symptoms improvement situation such as hoarseness, pharyngalgia, 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.Clinical effectiveness prompting: embodiment of the present invention example 5 traditional Chinese medicine composition for treating Influenza B virus lower respiratory infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group C) the treatment Influenza B virus lower respiratory infection of embodiment of the present invention example 7, result shows: relatively before and after two groups of patient's total effective rates and medication, generate heat, cough, cough up phlegm, the clinical symptoms improvement situation such as hoarseness, pharyngalgia, 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.Clinical effectiveness prompting: embodiment of the present invention example 7 traditional Chinese medicine composition for treating Influenza B virus lower respiratory infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Use Chinese medicine composition (treatment group D) the treatment Influenza B virus lower respiratory infection of embodiment of the present invention example 8, result shows: relatively before and after two groups of patient's total effective rates and medication, generate heat, cough, cough up phlegm, the clinical symptoms improvement situation such as hoarseness, pharyngalgia, 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.Clinical effectiveness prompting: embodiment of the present invention example 8 traditional Chinese medicine composition for treating Influenza B virus lower respiratory infection satisfactory effects, are all better than ribavirin group in Chinese drug-treated group aspect alleviation clinical symptoms time and total effective rate and cure rate.
Above content is in conjunction with concrete preferred implementation further description made for the present invention, can not assert that specific embodiment of the invention is confined to these explanations.For general technical staff of the technical field of the invention, without departing from the inventive concept of the premise, can also make some simple deduction or replace, all should be considered as belonging to protection scope of the present invention.

Claims (7)

1. a Chinese medicine composition for the treatment of respiratory viral infection disease, is characterized in that: the crude drug by following parts by weight is made: 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 for the treatment of 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 for the treatment of 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 for the treatment of 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 for the treatment of respiratory viral infection disease according to claim 4, wherein crude drug also has: Herba Ephedrae 5-20 gram or Radix Saposhnikoviae 5-20 gram.
6. according to the Chinese medicine composition of the treatment respiratory viral infection disease described in claim 1～5 any one, it is characterized in that: the dosage form of described compositions is: capsule, oral liquid, granule, tablet, effervescent granule, drop pill, aerosol, spray, gargarism; Wherein said tablet is oral cavity disintegration tablet, effervescent tablet.
7. according to the Chinese medicine composition of the treatment respiratory viral infection disease described in claim 1～5 any one, it is characterized in that: can be used for clinically the respiratory viral infection disease that treatment or prevention are caused by influenza A virus, Influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, echovirus, Coxsackie virus.
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CN106421314A (en) * 2016-04-29 2017-02-22 曲敬来 Traditional Chinese medicinal composition for treating viral respiratory infection and preparation method of traditional Chinese medicinal composition
CN105998599A (en) * 2016-04-29 2016-10-12 深圳市中医院 Traditional Chinese medicine composition for treating viral respiratory tract infection and preparation method thereof
CN105998481A (en) * 2016-06-20 2016-10-12 昆明理工大学 Chinese herbal medicine compound preparation for relieving cough and eliminating phlegm and preparation method thereof
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