WO2013173960A1

WO2013173960A1 - Traditional chinese medicine composition for treating lower respiratory tract viral infectious diseases and preparation method therefor

Info

Publication number: WO2013173960A1
Application number: PCT/CN2012/075819
Authority: WO
Inventors: 曲敬来; 高雪; 陈生; 齐继贵
Original assignee: 深圳市齐旺投资有限公司
Priority date: 2012-05-21
Filing date: 2012-05-21
Publication date: 2013-11-28

Abstract

Provided are a traditional Chinese medicine composition for treating lower respiratory tract viral infectious diseases and the preparation method therefor. The composition comprises active pharmaceutical ingredients of the following weights: 10-40 grams of Bupleurum chinense, 5-25 grams of Zhimahuang, 5-25 grams of Rhizoma Pinelliae Preparatum, 5-25 grams of Fructus Perillae, 5-25 grams of Semen Armeniacae Amarum, 5-25 grams of Cortex Mori, and 3-15 grams of Radix Glycyrrhizae. The above-mentioned active pharmaceutical ingredients with excipients and flavoring agents can be directly or indirectly made into a number of pharmaceutically acceptable formulation products, such as capsules, oral liquid, granules, syrups, tablets, effervescent granules, pills, aerosols, sprays, gargles, etc. by conventional processes. The composition is effective in treating or preventing lower respiratory tract viral infectious diseases caused by influenza A virus, influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, ECHO virus, coxsackie virus, etc.

Description

Traditional Chinese medicine composition for treating lower respiratory tract virus infectious diseases and preparation method thereof

The invention belongs to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating lower respiratory tract virus infectious diseases and a preparation method thereof. Wherein the lower respiratory virus infectious diseases are influenza A virus, influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, echovirus, coxsackie virus, etc. Caused by lower respiratory tract infections.

Background technique

Lower respiratory tract infections include bronchitis, bronchitis, and bronchial pneumonia. The pathogens of lower respiratory tract infections are mainly viruses and bacteria. Frail, allergic, and chronic sinusitis are often predisposed to the disease, especially when climate change or air pollution occurs. In addition to the symptoms of upper respiratory tract infection, cough is dry in the early stage and becomes a wet cough in the later stage. Some patients have wheezing, increased respiratory rhythm, lethargy, poor appetite, and lower respiratory tract infection. The incidence of diseases has increased in recent years. For example, according to pathogen research, viral pneumonia accounts for about 18% of community-acquired pneumonia, and about 5% of hospital-acquired infections during the same period, especially in current infections. Among the AIDS patients with human immunodeficiency virus (HIV), the incidence rate has risen sharply and has attracted more and more attention. Therefore, how to cure the lower respiratory tract virus infectious diseases quickly and effectively is particularly important.

Common viruses that cause lower respiratory tract infections include influenza A virus, influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, echovirus, coxsackie virus, etc. Influenza A and influenza B viruses are the most common. Acute viral laryngitis is caused by rhinovirus, influenza A virus, influenza B virus, parainfluenza virus and adenovirus. The clinical features are hoarseness, difficulty in speech, pain during cough, often fever, pharyngitis or cough. Physical examination showed laryngeal edema, hyperemia, mild lymphadenopathy and tenderness of local lymph nodes, audible and wheezing; acute viral bronchitis mostly by rhinovirus, influenza A virus, influenza B virus, parainfluenza virus, respiratory syncytial cells Caused by viruses, adenoviruses, etc., clinical manifestations of cough, no sputum or sputum mucus, accompanied by fever and fatigue, other symptoms often have hoarseness, non-pleural sub-sternal pain, audible and dry or wet voice, X Line chest radiograph shows increased and increased vascular shadow, but no lung infiltration shadow; influenza A virus, influenza B virus or rhinovirus bronchitis often cause acute exacerbation of chronic bronchitis; viral bronchiolitis is mainly caused by respiratory syncytium Caused by the virus, usually occurs in infants and young children, showing cough, asthma, severe cases may appear purpura; viral pneumonia is mainly caused by type A Influenza virus, influenza B virus, parainfluenza virus, rhinovirus, adenovirus and respiratory syncytial virus are caused. It shows fever, cough, shortness of breath, and nasal fan. In severe cases, lips and nails may appear cyanosis, and chest shadows may appear in the lungs.

Since the virus utilizes the metabolic pathway of the host cell for replication, it is generally difficult to eliminate it without using a drug that is toxic to the host cell. At present, Western and Western doctors use ribavirin for the treatment of coronavirus, rhinovirus and other viral infections. Due to the large number of coronavirus and rhinovirus subtypes, it is difficult to use vaccines to prevent the occurrence of viruses. The prevention and treatment methods for influenza A and influenza B viruses use vaccines to prevent the occurrence of viruses according to the theory of antigen-antibody. However, because the antigens of viruses continue to mutate, vaccines often lose their effectiveness. The antiviral drugs, based on virus variability and drug resistance, and antibiotics are ineffective against the virus, so that the prevention and treatment of the virus is still very serious. The lower respiratory tract virus infectious disease belongs to the "cough", "hepatitis syndrome" and "snake disease" of Chinese medicine. For respiratory diseases, the theory of traditional Chinese medicine thinks that "the lung is the main gas, the company is breathing". The term "qi" as used herein refers to the breath of breath on the one hand and the function of the lungs and other organs on the one hand. "The lungs open to the nose and throat, and the fur is combined.""Su Wen. Cough Theory" said: "The fur, the lungs are also combined, the fur is first subjected to evil spirits, and the evil spirits are combined with it." It is said that the lungs communicate with the outside through the nasopharynx and skin edema, just like a barrier. , in charge of the body's defense function. The external wind, cold, heat, dampness, dryness, and fire (collectively referred to as the six evils) often cause pathogenic factors through the nasopharynx and fur, first invading the lungs, causing lung loss in the declaration or surrender. Both of them will cause cough, wheezing, cough and other symptoms on the lungs. This is a cough. Six sinister evils cause disease, mostly wind and evil, winter is more cold, spring is hot, summer is hot and humid, autumn is more windy, and the rainy season is more wet and evil. When the virus is not hurt, it is often not limited to the season, and the condition is multiple, which is easy to cause infection. Influenza, a category of warm-blooded winds, is a common cold, and its characteristics also include the characteristics of exogenous respiratory diseases: From time to time, high fever, serious illness, strong epidemics, and a wide range.

Traditional Chinese medicine not only has the advantages of low drug resistance, side effects and less adverse reactions, but also has a comprehensive effect of inhibiting viral replication, regulating immune function, improving blood circulation, antipyretic and analgesic, antibacterial and anti-inflammatory, and is unique in preventing and treating viral infections. Advantages and broad development prospects. Studies have shown that many of the traditional Chinese medicines for detoxification and detoxification have direct antiviral effects, such as honeysuckle, wild chrysanthemum, Daqingye, Guanzhong and so on.

Summary of the invention

Therefore, there is still a great demand for a traditional Chinese medicine preparation for treating lower respiratory tract virus infectious diseases with better curative effect. To date, no reports have been found regarding the pharmaceutical composition of the present invention. The present inventors have successively studied and repeatedly verified the in vitro and clinical trials, and finally found a Chinese medicine composition for treating lower respiratory tract virus infectious diseases having a better therapeutic effect, thereby completing the present invention. In order to solve the above-mentioned etiology and pathogenesis, this study was formulated with a targeted and unique herbal medicine for treating lower respiratory tract virus infectious diseases. The composition is mainly composed of Bupleurum, ramie, French Pinellia, Perilla, Almond, Mulberry, and Licorice. It has the functions of relieving heat and tonifying lung, reducing gas and removing phlegm, and can be used for treating or preventing it. Lower respiratory tract virus infectious diseases caused by influenza virus, influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, echovirus, coxsackie virus, etc.

The object of the present invention is to overcome the deficiencies of the prior art and provide an effective treatment or prevention of influenza A virus, influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, A traditional Chinese medicine composition for a lower respiratory tract virus infectious disease caused by an echovirus, a Coxsackie virus or the like.

Another object of the present invention is to provide a method for preparing the traditional Chinese medicine composition to meet the needs of the market. In order to achieve a better therapeutic effect, the medicament of the present invention can be combined with the raw material medicine Manchurian red or Coltsfoot.

In order to achieve a better therapeutic effect, the medicament of the present invention can also be combined with the raw material medicine melon skin or xanthine.

In order to achieve a better therapeutic effect, the medicament of the present invention can also be combined with the raw material medicine white peony or burdock.

In order to achieve a better therapeutic effect, the medicament of the present invention can also be combined with the raw material medicine goose or herb or ginkgo. The technical solution adopted by the present invention to solve the technical problem thereof is: a traditional Chinese medicine composition for treating lower respiratory tract virus infectious diseases, including the following raw materials of the weight parts: Bupleurum 10-40 g, ramie yellow 5-25 g, French half 5-25 grams of summer, 5-25 grams of perilla, 5-25 grams of almonds, 5_25 grams of mulberry white, 3_15 grams of licorice.

The preferred dosages are: Bupleurum 10-30 g, ramie yellow 5-20 g, French Pinellia 5-20 g, perilla seed 5-20 g, almond 5-20 g, mulberry white 5-20 g, licorice 3-10 Gram.

The preparation method of the medicament of the present invention is as follows:

Take the raw materials Bupleurum, ricinus yellow, French pinellia, perilla, almond, mulberry white, licorice and water to boil and combine the filtrate, concentrate, cool, add ethanol to make the alcohol content 20-80% (V / V), The ethanol was recovered, and the supernatant was concentrated to a thick paste for use. The prepared thick paste is added into the capsule auxiliary equipment, dried, pulverized and filled into capsules to prepare capsules for treating lower respiratory tract virus infectious diseases; or mixed thick granules and granules commonly used auxiliary materials, granulating, drying and dispensing In a bag, it can be prepared into a granule for treating lower respiratory tract virus infectious diseases; or the thick paste can be mixed with common oral materials, boiled, diluted with water, allowed to stand, filtered, mixed and bottled, and then prepared. Oral solution for treating lower respiratory tract virus infectious diseases; or add thick cream to sucrose, flavoring agent, preservative, boil, dilute to 1000ml with water, let stand, filter, mix, and dispense, then treat lower respiratory tract virus A syrup of infectious diseases, wherein the sucrose weight is >450 g, and the flavoring agent is stevioside, sodium saccharin, acesulfame, glycyrrhizin, cyclohexane sulfamic acid, asparagine, alcohol sugar, aspartame Sweetener, menthol, various flavors and various fruit flavors, the amount is 0. Width 10%, the preservative is sorbic acid and its potassium sodium salt is <0.33%, the amount of methylparaben <0. 05%, the packaging material used for the sub-packaging is a glass bottle or a plastic bottle; or the prepared thick paste is mixed with the common auxiliary materials of the tablet and compressed to prepare a tablet for treating lower respiratory tract virus infectious diseases. Agent.

If it is also combined with the raw material medicine Manchurian or Coltsfoot, its preparation method is:

Take the raw materials to take Bupleurum, ricinus, French Pinellia, Perilla, Almond, Mulberry, Licorice, Manchurian Red or Coltsfoot with water and decoct the filtrate, concentrate, cool, add ethanol to make the alcohol content 20- 80% (V/V), recover ethanol, concentrate the supernatant into a thick paste, and set aside. The prepared thick paste is added into the capsule auxiliary equipment, dried, pulverized and filled into capsules, and then prepared into capsules for treating lower respiratory tract virus infectious diseases; or mixed thick granules and granules commonly used auxiliary materials, granulating, drying and dispensing In a bag, it can be prepared into a granule for treating lower respiratory tract virus infectious diseases; or the thick paste can be mixed with common oral materials, boiled, diluted with water, allowed to stand, filtered, mixed and bottled, and then prepared. Oral solution for treating lower respiratory tract virus infectious diseases; or add thick cream to sucrose, flavoring agent, preservative, boil, dilute to 1000ml with water, let stand, filter, mix, and dispense, then treat lower respiratory tract virus A syrup of infectious diseases, wherein the sucrose weight is >450 g, and the flavoring agent is stevioside, sodium saccharin, acesulfame, glycyrrhizin, cyclohexane sulfamic acid, asparagine, alcohol sugar, aspartame Sweetener, menthol, various flavors and various fruit flavors, the amount is 0. 广10%, the preservative is sorbic acid and its potassium sodium salt is <0.33%, the amount of methylparaben The packaging material used for the sub-packaging is a glass bottle or a plastic bottle; or the prepared thick paste is mixed with a common auxiliary material of the tablet, and compressed, thereby preparing a therapeutic method for treating lower respiratory tract virus infectious diseases. tablet.

If it is also combined with the raw material melon skin or astragalus, the preparation method is as follows:

Take the raw materials Bupleurum, Castor Yellow, French Pinellia, Perilla, Almond, Mulberry White, Licorice, Manchurian Red or Coltsfoot, Melon, or Astragalus with water and decoct the filtrate, concentrate, cool, add ethanol The alcohol content is 20-80% (V/V), the ethanol is recovered, and the supernatant is concentrated into a thick paste for use. The prepared thick paste is added to a capsule auxiliary auxiliary material, dried, pulverized and filled into capsules, thereby preparing a capsule for treating a lower respiratory tract virus infectious disease; Or mix the thick paste with the granules commonly used excipients, granulate, dry and pack into bags, then prepare granules for treating lower respiratory tract virus infectious diseases; or mix thick paste with common oral materials, boil, add water Dilute, let stand, filter, mix and pack into bottles, then prepare oral solution for treating lower respiratory tract virus infectious diseases; or add thick cream to sucrose, flavor, preservative, boil, dilute to 1000ml with water, The syrup for treating the lower respiratory tract virus infectious disease, wherein the weight of the sucrose is >450, the flavoring agent is stevioside, sodium saccharin, acesulfame, glycyrrhizin, standing, filtering, mixing, and dispensing , cyclohexane sulfamic acid, asparagine, alcohol sugar, aspartame, menthol, various flavors and various fruit flavors, the amount is 0. 10%, the preservative is sorbic acid and The amount of potassium and sodium salt is <0.3%, and the amount of methylparaben is <0.05%. The packaging materials used for the dispensing are glass bottles and plastic bottles; or the prepared thick paste and common accessories for tablets. Mix and compress, then prepare to treat lower respiratory virus Tablets infectious diseases.

If it is also combined with the raw material white peony or burdock, the preparation method is as follows:

Take the raw materials Bupleurum, ricinus, French Pinellia, Perilla, Almond, Mulberry White, Licorice, Manchurian Red or Coltsfoot, Melon or Astragalus, White Stork or Burdock, add water, boil, concentrate, After cooling, add ethanol to make the alcohol content 20-80% (V/V), recover the ethanol, and concentrate the supernatant into a thick paste for use. The prepared thick paste is added into the capsule auxiliary equipment, dried, pulverized and filled into capsules, and then prepared into capsules for treating lower respiratory tract virus infectious diseases; or mixed thick granules and granules commonly used auxiliary materials, granulating, drying and dispensing In the bag, it can be prepared into granules for treating lower respiratory tract virus infectious diseases; or the thick paste can be mixed with common oral materials, boiled, diluted with water, allowed to stand, filtered, mixed and bottled, and prepared. Oral solution for treating lower respiratory tract virus infectious diseases; or add thick cream to sucrose, flavoring agent, preservative, boil, dilute to 1000ml with water, let stand, filter, mix, and dispense, then treat lower respiratory tract virus A syrup of infectious diseases, wherein the sucrose weight is >450 g, and the flavoring agent is stevioside, sodium saccharin, acesulfame, glycyrrhizin, cyclohexane sulfamic acid, asparagine, alcohol sugar, aspartame The sweetener, menthol, various flavors and various fruit flavors, the amount of which is 0. guang 10%, the preservative is sorbic acid and its potassium sodium salt is <0.33%, methylparaben The amount of the packaging material is <0.05%, and the packaging material used for the sub-packaging is a glass bottle or a plastic bottle; or the prepared thick paste is mixed with the common auxiliary materials of the tablet, and the tablet is prepared to treat the lower respiratory tract virus infectious disease. Tablets.

If it is also combined with the raw material medicine goose or herb, it is prepared as follows:

Take raw materials such as Bupleurum, ramie, French Pinelli, Perilla, Almond, Mulberry, Licorice, Manchurian or Coltsfoot, Melon or Astragalus, White Stork or Burdock, Goose without Herb or Ginkgo The boiled filtrate is concentrated, cooled, and ethanol is added to make the alcohol content 20-80% (V/V). The ethanol is recovered, and the supernatant is concentrated into a thick paste for use. The prepared thick paste is added into the capsule auxiliary equipment, dried, pulverized and filled into capsules, and then prepared into capsules for treating lower respiratory tract virus infectious diseases; or mixed thick granules and granules commonly used auxiliary materials, granulating, drying and dispensing In a bag, it can be prepared into a granule for treating lower respiratory tract virus infectious diseases; or the thick paste can be mixed with common oral materials, boiled, diluted with water, allowed to stand, filtered, mixed and bottled, and then prepared. Oral solution for the treatment of lower respiratory tract virus infectious diseases; or add thick cream to sucrose, flavoring agent, preservative, boil, dilute to 1000ml with water, let stand, filter, mix, dispense, then treat lower respiratory tract virus A syrup of infectious diseases, wherein the sucrose weight is >450 g, and the flavoring agent is stevioside, sodium saccharin, acesulfame, glycyrrhizin, cyclohexane sulfamic acid, asparagine, alcohol sugar, aspartame Sweetener, menthol, various flavors and various fruit flavors, the amount is 0. Width 10%, the preservative is sorbic acid and its potassium sodium salt is <0.33%, the amount of methylparaben <0. 05 % The packaging material used for the sub-packaging is a glass bottle or a plastic bottle; or the prepared thick paste is mixed with a common excipient of the tablet and compressed to prepare a tablet for treating a lower respiratory tract virus infectious disease. The Chinese medicinal composition of the present invention can be prepared into any of the pharmaceutically acceptable dosage forms: capsules, oral liquids, granules, syrups, tablets, effervescent granules, dropping pills, aerosols, sprays, gargles, mashes. Oral water; wherein the tablet is an orally disintegrating tablet or an effervescent tablet.

The drug of the present invention is selected from the group consisting of Bupleurum, ramie, French Pinellia, Perilla, Almond, Mulberry, and Licorice. The combination of these drugs allows synergistic effects in the efficacy of each drug, thereby being effective in treating lower respiratory virus infectious diseases. Reuse of Chaihu bitterness, slightly cold, return to the liver, gallbladder, evacuation and antipyretic, Shengyang Shugan, attending cold, fever, cold and heat for Fang Zhongjun; use ricinus yellow, French pinellia, perilla, almond, mulberry White skin, is because ramie Huangxin, slightly bitter, warm, return to the lungs, bladder, sweating and dispelling cold, Xuanfei Pingchuan, diuretic swelling; Fascia, warm, spleen, stomach, lung, dampness Resolving phlegm, lowering the cough, clearing away phlegm and stasis; Perilla sinensis, warm, returning to the lungs, spleen, have the effect of reducing qi, eliminating asthma, moistening the intestines; almond bitter, warm, poisonous, to the lungs, spleen , large intestine, with Xuanfei cough, lowering asthma, relieving laxative effect, good governance cough and asthma syndrome; mulberry white skin cold, into the lung, can diarrhea and lung asthma, diuresis swelling; the above five drugs are The medicinal herbs and the adjuvants are used together to assist the medicinal herbs; licorice as a medicine has both heat-clearing and detoxifying, phlegm and cough-relieving, and can be adjusted with various medicines; various medicines are compatible, clean and use together, lifting and co-injection, playing a total of heat and venting lungs, descending The power of gasification.

In order to achieve a good therapeutic effect, the medicament of the present invention is also combined with Manchurian Red or Coltsfoot. This is because the mountains are red, bitter, warm, return to the lungs, spleen, warm lungs and drink, cough and asthma, used for external evils to attack the lungs, cough and asthma; coltsfoot, bitter, warm, return to the lungs, Runs the lungs, relieves cough and phlegm, and is used for coughing and asthma.

In order to achieve a better therapeutic effect, the medicament of the present invention is also combined with melon skin or xanthine. This is because melon skin, cold, lungs, stomach, lungs and phlegm, qi and wide chest, cure phlegm, sore throat, chest pain, vomiting blood, blood stasis, thirst, constipation, hemorrhoids Astragalus is a famous Chinese medicine for clearing away heat and purging fire. It is bitter, cold, clearing away heat and dampness, purging fire and detoxification, and clearing the lungs and the heat of the coke.

In order to obtain the best therapeutic effect, the medicament of the present invention is also combined with white peony or burdock. This is because Baiqixin, Wen, Guifei, large intestine, stomach, dispersing wind and dehumidification, relieving pain, relieving swelling and excretion; burdock, bitter, cold, returning to the lungs, stomach, evacuating wind, clearing away heat and detoxification The rash, Xuanfei, and pharyngeal swelling.

In order to obtain the best therapeutic effect, the medicament of the present invention is also combined with goose or herb or ginkgo. This is because the geese do not eat grass, warm, return to the lungs, liver, cold and cold, open nose, detoxification and withdrawal; ginkgo, bitter, phlegm, flat, toxic, return to the lungs, lungs and asthma, Stop the belt and urinate.

The traditional Chinese medicine composition of the invention is a combination of the experience and practice in the clinical practice of the Chinese medicine for lower respiratory tract virus infection for many years, and combined with the scientific experimental basis, each component can exert its own pharmacological effects and synergistic effects. The pharmacological action is enhanced, the formula is reasonable, and the medicinal taste is refined. The traditional Chinese medicine composition is used for treating or preventing lower respiratory tract virus infectious diseases, has a curative effect, and has no toxic and side effects, and is effective as a general prescription for treatment and prevention during the epidemic period. The dosage form and preparation process are suitable for industrial mass production. detailed description

The traditional Chinese medicine composition for treating or preventing lower respiratory tract virus infectious diseases of the present invention comprises the following raw materials of weight parts: Bupleurum 10-40 g, ramie yellow 5-25 g, French Pinellia 5-25 g, perilla 5_25 grams, 5-25 grams of almonds, 5-25 grams of mulberry white, 3-15 grams of licorice. In order to achieve a good therapeutic effect, the medicament of the present invention can be combined with the raw material medicine Manshanhong or Coltsfoot; in order to achieve better curative effect, the medicament of the present invention can also be combined with the raw material medicine. The combination of melon skin or scutellariae; in order to obtain the best therapeutic effect, the medicament of the invention can also be combined with the raw material medicine white peony or burdock; in order to obtain the best therapeutic effect, the medicine of the invention can also be combined with the raw material medicine geese or grass or white fruit. Combine.

Embodiment 1 :

Weigh 20 grams of Bupleurum, 10 grams of ramie, 10 grams of Pinellia, 10 grams of perilla, 10 grams of almonds, 10 grams of mulberry, 10 grams of licorice, 80 grams of the above seven flavors, boiled with water The filtrate was combined, concentrated, cooled, and ethanol was added to make the alcohol content (20-80%). The ethanol was recovered, and the supernatant was concentrated to a thick paste for use. Add 2 times the weight of 95% ethanol to the thick paste, stir well, let stand at room temperature for 24~48h, take the supernatant, and wash the precipitate with 65% ethanol for 1~2 times. The washing solution is combined with the supernatant, such as There is an alcohol extract, which is also combined with the supernatant. After filtering and clearing, the ethanol is recovered in a vacuum concentration tank or an alcohol recovery tower until the liquid has no alcohol. Dilute the drug solution with distilled water, heat to 100 ° C, so that the colloid is agglomerated, adjust the pH 4. 5~5. 0, then refrigerate for 24 h at low temperature 0~4 ° C, so that the coagulated colloid is precipitated, then filtered to clear, add appropriate amount The flavoring agent and preservative, after standing, filter through the clear, low temperature storage, do the final purification and filtration before filling, the filtrate is placed under the light detector to detect the clear, the machine is potted in the straight tube easy to pull the lid nutrition In the bottle, each oral liquid bottle contains 10 ml ± 4%, that is, the oral liquid for treating the lower respiratory tract virus infectious disease of the present invention; the flavoring agent is stevioside, sodium saccharin, acesulfame, glycyrrhizin, ring Alkyl sulfamic acid, asparagine, alcohol sugar, aspartame, menthol, various flavors and various fruit flavors, the dosage is 0. 10% wide, the preservative is sorbic acid and its potassium sodium The amount of the salt is <0.3%, and the amount of the methylparaben is <0.05%.

Embodiment 2:

Weigh 20 grams of Bupleurum, 10 grams of ramie, 10 grams of Pinellia, 10 grams of perilla, 10 grams of almonds, 10 grams of mulberry, 10 grams of licorice, 80 grams of the above seven flavors, boiled with water The filtrate was combined, concentrated, cooled, and ethanol was added to make the alcohol content 20-80%. The ethanol was recovered, and the supernatant was concentrated to a thick paste for use. Add β _ cyclodextrin, heat to dissolve, stir, filter, spray dry hot air inlet air temperature 180 ° C, air temperature 80 ° C, spray dry powder to add flavoring, mix, the material is dried at 40 ° C The granules of the present invention for treating lower respiratory tract virus infectious diseases can be obtained by granulating, granulating and sub-packaging into bags.

Embodiment 3:

Weigh 20 grams of Bupleurum, 10 grams of ramie, 10 grams of Pinellia, 10 grams of perilla, 10 grams of almonds, 10 grams of mulberry, 10 grams of licorice, 10 grams of Mangosteen, and above eight flavors A total of 90 g, and then an oral solution was prepared as described in Embodiment 1.

Embodiment 4:

Weigh 20 grams of Bupleurum, 10 grams of ramie, 10 grams of Pinellia, 10 grams of perilla, 10 grams of almonds, 10 grams of mulberry, 10 grams of licorice, 10 grams of coltsfoot, and more than eight flavors. 90 g, then granules were prepared as described in embodiment 2.

Embodiment 5:

Weigh 20 grams of Bupleurum, 10 grams of ramie, 10 grams of Pinellia, 10 grams of perilla, 10 grams of almonds, 10 grams of mulberry, 10 grams of licorice, 10 grams of Mangosteen, 10 grams of melon g, the above nine flavors of a total of 100 grams, and then made into an oral solution according to the method described in the first embodiment.

Embodiment 6: Weigh 20 grams of Bupleurum, 10 grams of ramie, 10 grams of Pinellia, 10 grams of perilla, 10 grams of almonds, 10 grams of mulberry, 10 grams of licorice, 10 grams of coltsfoot, 10 grams of astragalus, above A total of 100 g of the nine-flavored drug was then prepared into a granule according to the method described in Embodiment 2.

Embodiment 7:

Weigh 20 grams of Bupleurum, 10 grams of ramie, 10 grams of Pinellia, 10 grams of perilla, 10 grams of almonds, 10 grams of mulberry, 10 grams of licorice, 10 grams of Mangosteen, 10 grams of melon 10 grams of gram and white peony, 110 grams of the above ten flavored drugs, and then an oral solution was prepared according to the method described in the first embodiment.

Embodiment 8:

Weigh 20 grams of Bupleurum, 10 grams of ramie, 10 grams of Pinellia, 10 grams of perilla, 10 grams of almonds, 10 grams of mulberry, 10 grams of licorice, 10 grams of coltsfoot, 10 grams of astragalus, and burdock 10 g of the above, a total of 110 g of the above ten-flavored drugs, and then granules were prepared according to the method described in Embodiment 2.

Embodiment 9:

Weigh 20 grams of Bupleurum, 10 grams of ramie, 10 grams of Pinellia, 10 grams of perilla, 10 grams of almonds, 10 grams of mulberry, 10 grams of licorice, 10 grams of Mangosteen, 10 grams of melon 10 grams of grams, white peony, 10 grams of goose do not eat grass, 120 grams of the above eleven flavor drugs, and then made oral solution according to the method described in the first embodiment.

Embodiment 10:

Weigh 20 grams of Bupleurum, 10 grams of ramie, 10 grams of Pinellia, 10 grams of perilla, 10 grams of almonds, 10 grams of mulberry, 10 grams of licorice, 10 grams of coltsfoot, 10 grams of astragalus, and burdock 10 g of ginkgo, 10 g of ginkgo, 120 g of the above eleven flavor drugs, and then granules were prepared according to the method described in Embodiment 2.

Embodiment 11: 20 g of the raw material drug Bupleurum was weighed, and then granules were prepared by the method described in Embodiment 2.

Test Example 1: Experimental observation of anti-nasal virus (HRV, N36) in combination with traditional Chinese medicine Test principle: Human embryonic epithelial cells were used as viral hosts to measure the degree of inhibition of rhinovirus-induced human embryonic epithelial cells.

Test materials and methods:

1. Virus strain: Rhinovirus (HRV, N36).

2. Sample treatment: Take the thick paste prepared in Examples 2, 6, 8, 10, and 11 and dissolve in water and prepare a solution of 1000 mg/ml for bottling. After centrifugation at 3000 rpm for 20 minutes, take the supernatant and use 50%. Sodium citrate adjusted to pH 7. 2~7. 6, pour into a sterile test tube, autoclave at 121 °C for 15-20 minutes, remove and store in a refrigerator at 4 °C for use; Start with a 1:10 dilution and make a 2-fold dilution for a total of 8 dilutions.

3. Positive control drug: ribavirin (RBV) produced by Jiangxi Huiren Pharmaceutical Co., Ltd.

4. Test methods: 1 Inoculate human embryonic epithelial cells (2~4) X 10 ⁵ 0. lml into 96-well micro-plastic culture plates, each well ΙΟΟ μ Ι 37 ° C, 5% C0 ₂ culture for 1 to 2 days, It grows into a single layer of cells. Cell growth The long liquid is MEM lOOml, containing newborn or fetal bovine serum 10%, 3% glutamine 1%, penicillin and streptomycin 100U/ml, NaHC03 5%; when the cells grow into a single layer, discard the growth solution, inoculate the virus Wash the cells twice with pre-warmed PBS or Hanks.

2 control dry, add Ι μ Ι 10~100TCID ₅ . Infect the cells with the virus suspension, adsorb at 37 °C for 1~2h, discard the virus solution, and add 100 μl of the maintenance solution containing different concentrations of the test compound, each concentration of 2~3 wells, 37 . C 5 % C0 ₂ incubator incubation continued to culture. Normal cell control, drug toxicity control, virus control, ribavirin (RBV) positive control and virus TCID _{5 were set} . Titration.

3 Daily examination and recording of cytopathic changes under an inverted microscope (<25% for one plus, 25^50% for two plus, 505% for three plus, 75400% for four plus) until Virus control wells (no test compound) The end point of the experiment was the appearance of 34 plus cytopathic lesions. The degree of cytopathic effect in each well was recorded, and the average degree of cytopathic effect was calculated for each group. Compared with the virus control group, the concentration of the compound inhibiting 50% of cytopathic effects, that is, the half-inhibitory concentration (IC ₅ ) was calculated by Reed and Muench method.

4 At the same time, the toxicity of the drug to the cells was calculated according to the standard of 3, and the concentration of the compound having 50% cytopathic effect, that is, the half toxicity concentration (TD ₅ ) was calculated by the Reed and Muench method.

5 TD ₅ . / IC ₅ . To choose the index (SI).

5. Experimental results

Test Results

No. ic ₅₀ SI Example 2 2.03 mg/mL 2.75 Ribavirin 1.71 ug/mL 19.96 Example 6 0.18 mg/mL 9.41 Ribavirin 3.65 ug/mL 11.13 Example 8 0.46 mg/mL 8.62 Baverin 2.69 ug/mL 16.12 Example 10 0.60 mg/mL 6.91 ribavirin 4.66 ug/mL 5.26 Example 11 1.81 mg/mL 1.98 ribavirin 3.89 ug/mL 9.45

Test Example 2: Experimental observation of anti-influenza virus type A in combination with traditional Chinese medicine

Test principle: MDCK (dog kidney cells) was used as the viral host, and the samples were tested for inhibition of influenza virus gland archery.

Test materials and methods: 1. Virus strain: Influenza virus A/Guangdong/243/72 (H3N2).

3. Positive control drug: Tamiflu.

4. Test method: MDCK cells were cultured in 96-well culture plates. After 24 hours, they were infected with influenza A (A) A/Guangdong/243/72 (H3N2) (infected with 100 TCID50), adsorbed for 2 hours, and discarded virus solution. Add the sample according to the above dilution, set the cell control well and virus control well, observe the degree of cytopathic effect (CPE) for 24 hours, calculate the half effective concentration (IC ₅ ) of the sample by Reed-Muench method, and calculate the drug selection index. (SI).

5. Experimental results

Test Results

No. IC50 SI Buy Shiwan type 2 2. 03mg/ml 2. 1 Control group 0. 000897mg/mL

Example 6 0. 08 mg/mL 10. 7 Control group 0. 000099 mg/mL

Example 8 0. 32 mg/mL 8. 4 Control group 0. 000156 mg/mL

EXAMPLES Example 10 1. 68 mg/mL 3. 8 Control group 0. 000123 mg/mL

EXAMPLES Example 11 2. 71 mg/mL 1. 3 Control group 0. 000076 mg/mL Test Example 3: Clinical observation of traditional Chinese medicine composition in treating lower respiratory tract infection of rhinovirus

1 Materials and methods

1. 1 Clinical data

This group of patients were diagnosed with rhinovirus lower respiratory tract infection from December 2009 to March 2012. The patients were 60 years old and met the following diagnostic criteria for Chinese and Western medicine. 120 patients were randomly divided into treatment groups (Chinese medicine composition) 60 cases, 60 cases of control group (ribavirin). Sixty patients in the treatment group were randomly assigned to the second, sixth, eighth, and tenth groups (referred to as treatment groups A, B, C, and D), respectively. The machine was divided into four groups (referred to as control group A, B, C, D) in 15 cases. There was no significant difference in gender, age, disease duration and disease distribution between the two groups (P>0.05).

1. 1. 2 diagnostic criteria

1. 1. 2. 1 Western diagnostic criteria

(1) Clinical symptoms: a positive history of rhinovirus infection, acute onset, 2 days of disease; accompanied by symptoms such as fever, cough, sputum, nasal discharge, hoarseness, wheezing, and shortness of breath;

(2) Physical examination: elevated body temperature, hyperemia of the pharynx, mild swelling or tenderness of the local lymph nodes, and dry or wet rales in both lungs;

(3) Laboratory examination: RT-PCR is used to detect rhinovirus positive, and the routine white blood cell count and classification of peripheral blood are between the normal range or the white blood cell count is low;

(4) Bronchitis or pneumonia can be seen by X-ray or CT.

1. 1. 2. 2 Diagnostic Criteria of Traditional Chinese Medicine: Clinical symptoms include fever, aversion to cold, cough, sputum, nasal discharge, hoarseness, wheezing, and shortness of breath. The tongue is slightly red, the moss is slightly yellow, and the pulse slips.

1. The treatment group administered herbal composition granules, orally, twice daily amounts corresponding to respective green herbs 10g (Bupleurum 20 g); ribavirin control group effervescent granules, 150m _g / times 3 times a day, orally. Children are reduced. The course of treatment is 7 days.

1. 3 standard of efficacy

Efficacy criteria:

Healing: The symptoms and signs of fever, aversion to cold, cough, sputum, snoring, snoring, wheezing, qi, and qi are disappeared within 7 days of treatment;

Significant effect: The symptoms and signs of fever, aversion, sputum, snoring, snoring, snoring, wheezing, qi, and qi are all reduced by more than 2/3 within 7 days of treatment;

Effective: Within 7 days of treatment, fever, aversion to cold, cough, sputum, snoring, snoring, wheezing, qi stagnation, shortness of breath and other clinical symptoms and signs are reduced by 2/3 to 1/3; invalid: conscious or other symptoms within seven days of treatment No significant improvement or aggravation.

1. 4 results

The traditional Chinese medicine composition (treatment group A) of Example 2 of the present invention was used to treat the lower respiratory tract infection of rhinovirus, and the results showed that: the total effective rate of the two groups of patients was compared with fever, cough, sputum, snoring, hoarseness, The improvement of clinical symptoms such as wheezing, qi stagnation and shortness of breath, the total effective rate of clinical improvement in treatment group A was 78.46%; The total effective rate of clinical improvement in the control group was 35.66%. There was significant difference between the treatment group A and the control group A (P<0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the traditional Chinese medicine composition of the second embodiment of the present invention is satisfactory in treating lower respiratory tract infection of rhinovirus, and the Chinese medicine group is superior to the ribavirin group in alleviating clinical symptom time, total effective rate and cure rate.

The traditional Chinese medicine composition (treatment group B) of Example 6 of the present invention was used to treat the lower respiratory tract infection of rhinovirus. The results showed that: the total effective rate of the two groups of patients was compared with fever, aversion, sputum, snoring, snoring, snoring, The improvement of clinical symptoms such as wheezing, qi stagnation and shortness of breath, the total effective rate of clinical improvement in treatment group B was 90. 03%; the total effective rate of clinical improvement in control group B was 36. 96%; the difference between treatment group B and control group B was Statistical significance (P < 0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the Chinese medicine composition is satisfactory in treating lower respiratory tract infection of rhinovirus, and the Chinese medicine group is superior to the ribavirin group in alleviating clinical symptom time, total effective rate and cure rate.

The traditional Chinese medicine composition (treatment group C) of Example 8 of the present invention was used to treat the lower respiratory tract infection of rhinovirus. The results showed that: the total effective rate of the two groups of patients and the fever, aversion, sputum, snoring, snoring, sputum, The improvement of clinical symptoms such as wheezing, qi stagnation and shortness of breath, the total effective rate of clinical improvement of treatment group C was 89.23%; the total effective rate of clinical improvement of control group C was 40. 55%; the difference between treatment group C and control group C was different. Statistical significance (P < 0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the Chinese medicine composition is satisfactory for the treatment of rhinovirus lower respiratory tract infection, and the Chinese medicine group is superior to the ribavirin group in alleviating the clinical symptom time, the total effective rate and the cure rate.

The traditional Chinese medicine composition (treatment group D) of Example 10 of the present invention was used to treat the lower respiratory tract infection of rhinovirus, and the results showed that: the total effective rate of the two groups of patients and the fever, aversion, cough, sputum, snoring, hoarseness, The improvement of clinical symptoms such as wheezing, qi stagnation and shortness of breath, the total effective rate of clinical improvement in treatment group D was 80.33%; the total effective rate of clinical improvement in control group was 37.58%; the difference between treatment group D and control group D was Statistical significance (P < 0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the Chinese medicine composition of the present invention has satisfactory curative effect on the treatment of rhinovirus lower respiratory tract infection, and the Chinese medicine group is superior to the ribavirin group in alleviating the clinical symptom time, the total effective rate and the cure rate. Test Example 4: Clinical observation of traditional Chinese medicine composition in treating lower respiratory tract infection of influenza A (H1N1)

1. 1 Materials and Methods 1. 1. 1 Clinical data This group of patients were diagnosed with influenza A (H1N1) lower respiratory tract infection from June 2009 to March 2012. The age of 6-9 years old meets the following Chinese and Western medicine diagnosis. In the standard patients, 120 patients were randomly divided into a treatment group (Chinese medicine composition) 60 cases, and a control group (ribavirin) 60 cases. Sixty patients in the treatment group were randomly assigned to the group of the second, sixth, eighth, and tenth groups (referred to as treatment group A, B, C, D), respectively. The control group of 60 patients were randomly divided into four groups (referred to as control group A, B). There were 15 cases in each group, C, D). There was no statistically significant difference in gender, age, duration of disease and disease distribution (P>0.05).

1. 1. 2 diagnostic criteria 1. 1. 2. 1 Western diagnostic criteria

(1) Clinical symptoms: a positive history of influenza virus infection, acute onset, 2 days of disease; accompanied by symptoms such as fever, cough, sputum, nasal discharge, sore throat, qi stagnation, shortness of breath, and wheezing;

(3) Laboratory examination: The influenza virus type A H1N1 is positive by RT-PCR, and the routine white blood cell count and classification of the peripheral blood are between the normal range or the white blood cell count is low;

(4) Bronchitis or pneumonia can be seen by X-ray or CT.

1. 1. 2. 2 Diagnostic Criteria of Traditional Chinese Medicine: The clinical symptoms are characterized by fever, cough, sputum, nasal discharge, sore throat, qi stagnation, shortness of breath, and wheezing. The tongue is slightly red, the fur is thin yellow, and the pulse is floating.

1. 3 standard of efficacy

Efficacy criteria:

Healing: The symptoms and symptoms of fever, cough, sputum, nasal discharge, sore throat, qi stagnation, shortness of breath, wheezing, etc. disappeared within seven days of treatment;

Significant effect: Within 7 days of treatment, fever, cough, sputum, snoring, sore throat, qi stagnation, shortness of breath, wheezing and other clinical symptoms and signs are reduced by more than 2/3; effective: treatment within seven days of fever, cough, P, sputum, nasal discharge, Symptoms and signs such as sore throat, qi stagnation, shortness of breath, wheezing, etc. are alleviated by 2/3 to 1/3; Ineffective: No improvement or aggravation of conscious or other symptoms within seven days of treatment.

1. 4 results

The traditional Chinese medicine composition (treatment group A) of Example 2 of the present invention was used to treat influenza virus lower respiratory tract infection, and the results showed that: the total effective rate of the two groups of patients and the fever, cough, sputum, nasal discharge, sore throat, and gas reversal before and after treatment were compared. The improvement of clinical symptoms such as shortness of breath, wheezing, etc., the total effective rate of clinical improvement in treatment group A was 79.21%; the total effective rate of clinical improvement in control group was 35.59%; the difference between treatment group A and control group A was statistically significant. Meaning (P<0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the Chinese medicine composition of the second embodiment of the present invention is satisfactory for treating influenza virus lower respiratory tract infection, and the Chinese medicine group is superior to the ribavirin group in alleviating the clinical symptom time, the total effective rate and the cure rate. The traditional Chinese medicine composition of Example 6 of the present invention (treatment group B) was used to treat influenza virus lower respiratory tract infection, and the results showed that: the total effective rate of the two groups of patients and the fever, cough, sputum, nasal discharge, sore throat, and gas reversal before and after treatment were compared. The improvement of clinical symptoms such as shortness of breath, wheezing, etc., the total effective rate of clinical improvement in treatment group B was 91.98%; the total effective rate of clinical improvement in control group B was 37. 89%; the difference between treatment group B and control group B was statistically significant. Meaning (P<0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the traditional Chinese medicine composition of the sixth embodiment of the present invention is satisfactory for treating influenza virus lower respiratory tract infection, and the Chinese medicine group is superior to the ribavirin group in alleviating the clinical symptom time, the total effective rate and the cure rate.

The traditional Chinese medicine composition (treatment group C) of Example 8 of the present invention was used to treat influenza virus lower respiratory tract infection, and the results showed that: the total effective rate of the two groups of patients was compared with fever, cough, sputum, nasal discharge, sore throat, and gas reversal before and after medication. The improvement of clinical symptoms such as shortness of breath, wheezing, etc., the total effective rate of clinical improvement in treatment group C was 90.39%; the total effective rate of clinical improvement in control group was 40.99%; the difference between treatment group C and control group C was statistically significant. Meaning (P<0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the Chinese medicine composition is satisfactory for treating influenza virus lower respiratory tract infection, and the Chinese medicine group is superior to the ribavirin group in alleviating clinical symptom time, total effective rate and cure rate.

The Chinese medicine composition of Example 10 of the present invention (treatment group D) was used to treat influenza virus lower respiratory tract infection, and the results showed that: the total effective rate of the two groups of patients and the fever, cough, sputum, nasal discharge, sore throat, and gas reversal before and after treatment were compared. The improvement of clinical symptoms such as shortness of breath, wheezing, etc., the total effective rate of clinical improvement in treatment group D was 81.23%; the total effective rate of clinical improvement in control group D was 41.26%; the difference between treatment group D and control group D was statistically significant. Meaning (P<0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the Chinese medicine composition of the present invention is satisfactory for treating influenza virus lower respiratory tract infection, and the Chinese medicine group is superior to the ribavirin group in alleviating clinical symptom time, total effective rate and cure rate. Test Example 5: Clinical observation of traditional Chinese medicine composition in the treatment of influenza B virus infection

1. 1 Materials and Methods 1. 1. 1 Clinical data This group of patients were diagnosed with influenza B virus infection from June 2009 to April 2012, aged 69 years, patients who meet the following diagnostic criteria for Chinese and Western medicine 120 patients were randomly divided into treatment group (Chinese medicine composition) 60 cases, control group (ribavirin) 60 cases. Sixty patients in the treatment group were randomly assigned to the group of the second, sixth, eighth, and tenth groups (referred to as treatment group A, B, C, D), respectively. The control group of 60 patients were randomly divided into four groups (referred to as control group A, B). , C, D) 15 cases, the two groups were not statistically significant in gender, age, disease duration and disease distribution (P>0.05).

1. 1. 2 diagnostic criteria

1. 1. 2. 1 Western diagnostic criteria

(1) Clinical symptoms: a positive history of influenza virus infection, acute onset, 2 days of disease; accompanied by symptoms such as fever, cough, sputum, snoring, sore throat, qi stagnation, and shortness of breath; (2) Physical examination: elevated body temperature, pharyngeal congestion, mild swelling or tenderness of local lymph nodes, dry or wet rales in both lungs;

(3) Laboratory examination: The positive detection of influenza B virus by RT-PCR method, the routine white blood cell count and classification of peripheral blood are between the normal range or the white blood cell count is low;

(4) Bronchitis or pneumonia can be seen by X-ray or CT.

1. 1. 2. 2 Diagnostic Criteria of Traditional Chinese Medicine: The clinical symptoms are characterized by fever, cough, sputum, hoarseness, sore throat, qi stagnation and shortness of breath. The tongue is slightly red, the fur is thin yellow, and the pulse is floating.

1. 3 standard of efficacy

Efficacy criteria:

Healing: The clinical signs of fever, cough, sputum, hoarseness, sore throat, qi stagnation, and shortness of breath disappear within seven days of treatment;

Significant effect: The symptoms of fever, cough, sputum, hoarseness, sore throat, qi stagnation, shortness of breath, etc. within 7 days of treatment are reduced by more than 2/3;

Effective: Within 7 days of treatment, fever, cough, sputum, snoring, sore throat, qi stagnation, shortness of breath and other clinical symptoms and signs are reduced by 2/3~1/3; Invalid: No improvement in conscious or other symptoms within 7 days of treatment or Aggravated.

1. 4 results

The Chinese medicine composition of Example 2 of the present invention (treatment group A) was used to treat the lower respiratory tract infection of influenza B virus, and the results showed that: the total effective rate of the two groups of patients and the fever, cough, sputum, hoarseness, sore throat before and after medication were compared. The improvement of clinical symptoms such as qi stagnation and shortness of breath, the total effective rate of clinical improvement in treatment group A was 69. 21%; the total effective rate of clinical improvement in control group was 25.59%; the difference between treatment group A and control group A was statistically significant. Meaning (P<0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the Chinese medicine composition is satisfactory in treating lower respiratory tract infection of influenza B virus, and the Chinese medicine group is superior to the ribavirin group in alleviating clinical symptom time, total effective rate and cure rate.

The Chinese medicine composition of Example 6 of the present invention (treatment group B) was used to treat the lower respiratory tract infection of influenza B virus, and the results showed that: the total effective rate of the two groups of patients and the fever, cough, sputum, hoarseness, sore throat before and after medication were compared. The improvement of clinical symptoms such as qi stagnation and shortness of breath, the total effective rate of clinical improvement in treatment group B was 81. 98%; the total effective rate of clinical improvement in control group B was 31.26%; the difference between treatment group B and control group B was statistically significant. Meaning Righteousness (P<0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the Chinese medicine composition of the sixth embodiment of the present invention is satisfactory for treating the lower respiratory tract infection of influenza B virus, and the Chinese medicine group is superior to the ribavirin group in alleviating the clinical symptom time, the total effective rate and the cure rate.

The Chinese medicine composition of Example 8 of the present invention (treatment group C) was used to treat the lower respiratory tract infection of influenza B virus, and the results showed that: the total effective rate of the two groups of patients and the fever, cough, sputum, hoarseness, sore throat before and after medication were compared. The improvement of clinical symptoms such as qi stagnation and shortness of breath, the total effective rate of clinical improvement in treatment group C was 80. 39%; the total effective rate of clinical improvement in control group was 30. 99%; the difference between treatment group C and control group C was statistically significant. Meaning (P<0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the Chinese medicine composition is satisfactory in treating lower respiratory tract infection of influenza B virus, and the Chinese medicine group is superior to the ribavirin group in alleviating clinical symptom time, total effective rate and cure rate.

The Chinese medicine composition of Example 10 of the present invention (treatment group D) was used to treat the lower respiratory tract infection of influenza B virus, and the results showed that: the total effective rate of the two groups of patients was compared with fever, cough, sputum, hoarseness, sore throat before and after medication. The improvement of clinical symptoms such as qi stagnation and shortness of breath, the total effective rate of clinical improvement in treatment group was 71.23%; the total effective rate of clinical improvement in control group was 27. 89%; the difference between treatment group D and control group D was statistically significant. Meaning (P<0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the Chinese medicine composition of the present invention is satisfactory in treating lower respiratory tract infection of influenza B virus, and the Chinese medicine group is superior to the ribavirin group in alleviating clinical symptom time, total effective rate and cure rate.

The above is a further detailed description of the present invention in conjunction with the specific preferred embodiments. It is not intended that the specific embodiments of the invention are limited to the description. It is to be understood by those skilled in the art that the present invention may be construed as being limited to the scope of the present invention without departing from the spirit and scope of the invention.

Claims

Claim

A traditional Chinese medicine composition for treating a lower respiratory tract virus infectious disease, comprising: the following raw materials in parts by weight: Bupleurum 10-40 g, ramie yellow 5-25 g, French Pinellia 5-25 g 5-25 grams of perilla, 5-25 grams of almonds, 5-25 grams of mulberry white, 3_15 grams of licorice.

The traditional Chinese medicine composition for treating lower respiratory tract virus infectious diseases according to claim 1, wherein the amount of the raw material medicines may also be: Bupleurum 10-30 g, ramie yellow 5-20 g, and French Pinellia 5-20 Grams, 5-20 grams of perilla, 5-20 grams of almonds, 5-20 grams of mulberry, 3_10 grams of licorice.

The traditional Chinese medicine composition for treating lower respiratory tract virus infectious diseases according to claim 2, wherein the raw material medicine further comprises: 5-20 g of Manchurian Red or 5-20 g of Coltsfoot Flower.

The traditional Chinese medicine composition for treating a lower respiratory tract virus infectious disease according to claim 3, wherein the raw material medicine further comprises: 5-20 g of melon skin or 5-20 g of xanthine.

The traditional Chinese medicine composition for treating lower respiratory tract virus infectious diseases according to claim 4, wherein the raw material medicines are: 5-20 g of white peony or 5-20 g of burdock.

The traditional Chinese medicine composition for treating lower respiratory tract virus infectious diseases according to claim 5, wherein the raw material medicines are: 3-20 g of goose or 3-20 g of ginkgo.

7. A method of preparing a traditional Chinese medicine composition according to claim 1 or 2, which comprises the steps of:

1 Take Bupleurum, ramie yellow, French pinellia, perilla, almond, mulberry white, licorice and water to boil and combine the filtrate, concentrate, cool, add ethanol to make alcohol content 20-80% (V / V), recycling Ethanol, concentrate the supernatant into a thick paste, and set aside;

2 The prepared thick paste is added to the capsules as a commonly used auxiliary material, dried and pulverized into capsules, and then prepared into capsules for treating lower respiratory tract virus infectious diseases; or mixed thick granules and granules commonly used auxiliary materials, granulating, drying and separating Packed into bags, can be prepared into granules for the treatment of lower respiratory tract virus infectious diseases; or mixed with thick paste and oral supplements, boiled, diluted with water, allowed to stand, filtered, mixed into bottles, ready to prepare Oral solution for treating lower respiratory tract virus infectious diseases; or add thick cream to sucrose, flavoring agent, preservative, boil, dilute to 1000ml with water, let stand, filter, mix, and dispense, then treat lower respiratory tract A syrup of a viral infectious disease, wherein the sucrose weight is >450 g, and the flavoring agent is stevioside, sodium saccharin, acesulfame, glycyrrhizin, cyclohexane sulfamic acid, asparagine, alcohol sugar, day The bismuth, the menthol, the menthol, the various flavors, and the various flavorings, the amount of which is 0. guang 10%, the preservative is sorbic acid and its potassium sodium salt is <0.33%, methylparaben use The packaging material used for the sub-packaging is a glass bottle or a plastic bottle; or the prepared thick paste is mixed with a common auxiliary material of the tablet and compressed, thereby preparing a therapeutic method for treating lower respiratory tract virus infectious diseases. tablet.

8. A method of preparing a traditional Chinese medicine composition according to claim 3, which comprises the steps of:

1 Take Bupleurum, ricinus, French Pinellia, Perilla, Almond, Mulberry, Licorice, Manchurian Red or Coltsfoot with water and decoct the filtrate, concentrate, cool, add ethanol to make the alcohol content 20-80% (V/V), recovering ethanol, concentrating the supernatant into a thick paste, and standby;

2 The prepared thick paste is added into the capsule auxiliary materials, dried, pulverized and filled into capsules, and then prepared into capsules for treating lower respiratory tract virus infectious diseases; or mixed thick granules and granules commonly used auxiliary materials, granulation, and drying Dry and subpackage into bags, which can be prepared into granules for treating lower respiratory tract virus infectious diseases; or mix thick paste with common oral materials, boil, dilute with water, let stand, filter, mix and pack into bottles, It can be prepared into an oral solution for treating lower respiratory tract virus infectious diseases; or add thick cream to sucrose, flavoring agent, preservative, boil, dilute to 1000ml with water, let stand, filter, mix, and dispense, that is, A syrup for treating a lower respiratory tract virus infectious disease, wherein the sucrose has a weight of >450 g, and the flavoring agent is stevioside, sodium saccharin, acesulfame, glycyrrhizin, cyclohexane sulfamic acid, asparagine, alcohol The 3%, hydroxybenzene, the amount of the sorbic acid and the potassium salt thereof is <0.33%, the hydroxybenzene is used. The amount of the methyl ester used is <0.05%, and the packaging material used for the sub-packaging is a glass bottle or a plastic bottle; or the prepared thick paste is mixed with the common auxiliary materials of the tablet and compressed, thereby preparing a lower respiratory tract virus. Tablets for infectious diseases.

9. A method of preparing a traditional Chinese medicine composition according to claim 4, which comprises the steps of:

1 Take Bupleurum, ricinus, French Pinellia, Perilla, Almond, Mulberry, Licorice, Manchurian Red or Coltsfoot, Melon, or Astragalus with water and decoct the filtrate, concentrate, cool, add ethanol to contain The amount of alcohol is 20-80% (V/V), the ethanol is recovered, and the supernatant is concentrated into a thick paste for use;

10. A method of preparing a traditional Chinese medicine composition according to claim 5, which comprises the steps of:

1 Take Bupleurum, ramie, French Pinellia, Perilla, Almond, Mulberry, Licorice, Manchurian or Coltsfoot, Melon or Astragalus, White Stork or Burdock, add water, decoct, filtrate, concentrate, and cool Add ethanol to make alcohol content 20-80% (V / V), recover ethanol, concentrate the supernatant into a thick paste, and set aside;

2 The prepared thick paste is added to the capsules as a commonly used auxiliary material, dried and pulverized into capsules, and then prepared into capsules for treating lower respiratory tract virus infectious diseases; or mixed thick granules and granules commonly used auxiliary materials, granulating, drying and separating Packed into bags, can be prepared into granules for the treatment of lower respiratory tract virus infectious diseases; or mixed with thick paste and oral supplements, boiled, diluted with water, allowed to stand, filtered, mixed into bottles, ready to prepare Oral solution for treating lower respiratory tract virus infectious diseases; or add thick cream to sucrose, flavoring agent, preservative, boil, dilute to 1000ml with water, let stand, filter, mix, and dispense, then treat lower respiratory tract A syrup of a viral infectious disease, wherein the sucrose weight is >450 g, and the flavoring agent is stevioside, sodium saccharin, acesulfame, glycyrrhizin, cyclohexane sulfamic acid, asparagine, alcohol sugar, day The bismuth, the menthol, the menthol, the various flavors, and the various flavorings, the amount of which is 0. guang 10%, the preservative is sorbic acid and its potassium sodium salt is <0.33%, methylparaben The dosage is <0. 05 %, the packaging materials used for the dispensing are glass bottles and plastic bottles; Alternatively, the prepared thick paste may be mixed with a tablet excipient and tableted to prepare a tablet for treating a lower respiratory tract virus infectious disease.

11. A method of preparing a traditional Chinese medicine composition according to claim 6, comprising the steps of:

1 Take Bupleurum, ramie, French Pinelli, Perilla, Almond, Mulberry, Licorice, Manchurian or Coltsfoot, Melon or Astragalus, White Stork or Burdock, Goose without Herb or Ginkgo The filtrate is boiled, concentrated, cooled, and ethanol is added to make the alcohol content 20-80% (V/V), and the ethanol is recovered, and the supernatant is concentrated into a thick paste, and used;

The traditional Chinese medicine composition for treating a lower respiratory tract virus infectious disease according to any one of claims 1 to 6, wherein the composition is in the form of a capsule, an oral liquid, a granule, a syrup, a tablet, and a foam. Teng granules, dropping pills, aerosols, sprays, gargles, mouthwashes; wherein the tablets are orally disintegrating tablets, effervescent tablets.

The traditional Chinese medicine composition for treating a lower respiratory tract virus infectious disease according to any one of claims 1 to 6, which is clinically useful for treating or preventing influenza A virus, influenza B virus, rhinovirus, coronavirus Lower respiratory tract virus infectious diseases caused by respiratory syncytial virus, adenovirus, parainfluenza virus, echovirus, coxsackie virus, etc.