WO2011143844A1

WO2011143844A1 - Traditional chinese medicine composition for treating infection of influenza a virus subtype and preparation method thereof

Info

Publication number: WO2011143844A1
Application number: PCT/CN2010/075411
Authority: WO
Inventors: 高雪; 曲敬来; 齐继贵; 陈生
Original assignee: 深圳市齐旺投资有限公司
Priority date: 2010-05-21
Filing date: 2010-07-22
Publication date: 2011-11-24

Abstract

A traditional Chinese medicine composition for treating or preventing infection of novel influenza A (H1N1) virus, and /or influenza A (H1N1) virus, and /or influenza A (H3N2) virus and preparation method thereof, said traditional Chinese medicine composition is prepared by using Rhizoma Cimicifugae, Herba Menthae, Radix Scutellariae, Herba Schizonepetae, Radix Glycyrrhizae, Radix Isatidis, Fructus Arctii, Lasiosphaera Seu Calvatia, Fructus Forsythiae, Radix Bupleuri and Radix Platycodi.

Description

Traditional Chinese medicine composition for treating influenza A virus subtype infection 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 influenza A virus subtype infection and a preparation method thereof. Wherein, the influenza A virus subtype is a novel type A H1N1, a type H H1N1, a type A H3N2 influenza virus. Background technique

The influenza virus is divided into three types: A, B, and C. The pathogenic strains are mainly type A and type B, and type C is basically not pathogenic. Among them, influenza A virus is the main pathogen of several world influenza epidemics, and most of the world's current epidemic is A. So far, a total of 15 different hemagglutinin and neuraminidase have been isolated and identified, and can be divided into various subtypes, such as H1N1, H1N2, H2N2, H3N2, etc., which are the most common in humans. The H1N1, H3N2 subtypes. In recent years, the new type A H1N1 influenza virus has attracted more and more attention in the clinic, and it has often caused epidemics in the population. Since the discovery of the flu virus, there have been five world pandemic records in the 20th century, which occurred in 1900, 1918, 1957, 1968, and 1977. Among them, a 1918 epidemic was the most serious, with more than 20 million deaths. In China, there were 12 epidemics of moderate or intermediate influenza from 1953 to 1976. Each epidemic was caused by influenza A virus. The outbreak of avian influenza in 2003 was also a respiratory tract caused by influenza A virus subtype. infectious disease. Influenza A (H1N1) is a respiratory disease caused by virus A (H1N1). The symptoms of human infection with influenza A (H1N1) are similar to those of ordinary human influenza, including fever, cough, sore throat, body aches, headache, chills and fatigue. Some may also have diarrhea and vomiting. In severe cases, pneumonia and breathing may occur. Depletion, even death.

At present, Western and Western medicines use influenza 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 use of antiviral drugs, based on virus variability and drug resistance, has made the prevention and treatment of viruses still serious. To date, no vaccines or specific treatments for the new H1N1, H1N1, and H3N2 influenza A have been found. Therefore, it is the focus of the medical community to find a new type of H1N1, H1N1, and H3N2 flu drugs with clear curative effects.

The motherland medicine believes that the flu is caused by the evil spirit of the epidemic, and the disease spreads rapidly. Causes, often into the heat. The disease is warm and poisonous, the pathogenesis is the evil of epidemic warming and epidemic, invading the lungs, and then quickly entering the gas, volatility, causing yang stagnation, lung and stagnation, clinical manifestations of high fever, evil Cold, cough and muscle soreness and other symptoms of qi and qi.

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 most of the traditional Chinese medicines for clearing away heat and detoxification have direct antiviral effects, such as forsythia, honeysuckle, wild chrysanthemum, berberine, astragalus, daqingye, houttuynia, Bupleurum, and burdock.

In the prior art, we have realized that Western medicine in the treatment of influenza A virus infection, with fever as the main disease, in most cases is mainly antipyretic, anti-inflammatory, abuse of antibiotics is not lacking in others, causing patients The effects of various injuries, especially on the immune function of the body, are particularly prominent. In the field of traditional Chinese medicine, for influenza A virus, traditional Chinese medicine is currently only used as a traditional Chinese medicine for clearing away heat, purging fire, antibacterial and anti-inflammatory. The effect is not satisfactory, and because it is too cool, it can often cause sequelae such as itching and coughing. The reason is more than dialectical. Summary of the invention

This study is based on the above-mentioned etiology and pathogenesis, using a specific Chinese herbal medicine with a unique anti-influenza A virus subtype. The composition is mainly composed of Cimicifuga, Mint, Astragalus, Nepeta, and Glycyrrhizae. It has the functions of clearing away heat and detoxifying, and relieving the symptoms of Xinliang. Because of the situation, it is easy to spread the wind and dispel the evil spirits, and the opposite is the opposite, which is beneficial to the warming and poisoning. It can also be used to treat or prevent the infection of new H1N1, and/or H1N1, and/or H3N2 influenza viruses.

The technical problem to be solved by the present invention is to overcome the deficiencies of the prior art and provide a traditional Chinese medicine combination capable of effectively treating a novel H1N1, and/or a H1N1, and/or H3N2 influenza virus infection without toxic side effects. And its preparation method 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 materials Banlangen, Arctium lappa, and Mabul.

In order to achieve a better therapeutic effect, the medicament of the present invention can also be combined with the prodrugs of Forsythia, Bupleurum, and Campanulaceae.

The technical solution adopted by the present invention to solve the technical problem thereof is: a traditional Chinese medicine composition for treating influenza A virus subtype infection, including the following raw materials of weight: 1-30 parts of cohosh, 1-30 parts of mint, 1 xanthine 1 -40 parts, 1-10 parts of Nepeta, 1-20 parts of licorice.

The preferred dosages are: 1-20 parts of cohosh, 1-20 parts of mint, 1-20 parts of astragalus, 3-10 parts of schizonepeta, and 1-20 parts of licorice.

The raw material of the medicament of the present invention may also be: 1-20 parts of Cimicifuga, 1-20 parts of mint, 1-20 parts of Astragalus, 3-10 parts of Nepeta, 1-20 parts of licorice, 1-20 parts of Radix Isatidis, and burdock. 6-15 parts, 3-10 parts of puffball. The raw material of the medicament of the present invention may also be: 1-20 parts of Cimicifuga, 1-20 parts of mint, 1-20 parts of Astragalus, 3-10 parts of Nepeta, 1-20 parts of licorice, 1-20 parts of Radix Isatidis, and burdock. 6-15 parts, 3-10 parts of puffball, 1-20 parts of forsythia, 3-10 parts of Bupleurum, 3-20 parts of Campanulaceae.

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

Take cohosh, mint (post-drug), astragalus (post-drug), schizonepeta, licorice and water to boil and combine the filtrate, concentrate, cool, add ethanol to make the alcohol content (20-80%, volume fraction), 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 to prepare capsules resistant to influenza A virus subtypes; or mixed with thick granules and granules, granulation, drying and dispensing In the bag, the granules can be prepared into the subtype of influenza A virus; or the thick paste can be mixed with the common auxiliary materials of the oral liquid, boiled, diluted with water, refined, filtered, mixed and bottled, and prepared to be resistant. An oral solution of influenza A virus subtype; or a thick paste added to 450-600 g of sucrose, flavoring agent, the flavoring agent is stevioside, sodium saccharin, acesulfame, glycyrrhizin, cyclohexane sulfamic acid , one or more mixtures of asparagine, alcohol sugar, aspartame, menthol, various flavors and various fruit flavors, in an amount of 0.1 to 10% (by volume); and preservatives, The preservative is sorbic acid and its potassium sodium salt, the amount is 0.1~0.3% (volume fraction), or the amount of methylparaben is 0.01~0.05% (volume fraction), boiled, diluted with water to 1000ml, refined, Filtered, mixed, divided The syrup which is resistant to the influenza A virus subtype can be prepared, or the prepared thick paste can be mixed with the common excipients of the tablet and compressed to prepare a tablet against the influenza A virus subtype.

If combined with the raw materials Banlangen, Burdock, and Mabul, the preparation method is as follows:

Take cohosh, mint (post-drug), astragalus (post-drug), schizonepeta, licorice, radix isatidis, burdock, bourbon water decoction and filtrate, concentrate, cool, add ethanol to make alcohol content (20-80 %, volume fraction), 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 to prepare capsules resistant to influenza A virus subtypes; or mixed with thick granules and granules, granulation, drying and dispensing In the bag, the granules can be prepared into the subtype of influenza A virus; or the thick paste can be mixed with the common auxiliary materials of the oral liquid, boiled, diluted with water, refined, filtered, mixed and bottled, and prepared to be resistant. An oral solution of influenza A virus subtype; or a thick paste added to 450-600 g of sucrose, flavoring agent, the flavoring agent is stevioside, sodium saccharin, acesulfame, glycyrrhizin, cyclohexane sulfamic acid , one or more mixtures of asparagine, alcohol sugar, aspartame, menthol, various flavors and various fruit flavors, in an amount of 0.1 to 10% (by volume); and preservatives, The preservative is sorbic acid and its potassium sodium salt, the dosage is 0.1~0.3% (volume fraction), or the amount of methylparaben is 0.01~0.05% (volume fraction), boiled, diluted with water to 1000ml, refined, Filtered, mixed, Loaded, obtain an anti-influenza A virus subtype syrup; thick paste or conventional tablet excipients prepared mixing, tabletting, can be prepared as an anti-influenza A virus subtype tablets.

If combined with the drug substance forsythia, Bupleurum, and platycodon, the preparation method is as follows: Take cohosh, mint (post-drug), astragalus (post-drug), schizonepeta, licorice, radix isatidis, burdock, puffball, forsythia, Bupleurum, platycodon grandiflorum with water and boiled, filtrate, concentrate, cool, add ethanol The alcohol content is (20-80%, volume fraction), 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 to prepare capsules resistant to influenza A virus subtypes; or mixed with thick granules and granules, granulation, drying and dispensing In the bag, the granules can be prepared into the subtype of influenza A virus; or the thick paste can be mixed with the common auxiliary materials of the oral liquid, boiled, diluted with water, refined, filtered, mixed and bottled, and prepared to be resistant. An oral solution of influenza A virus subtype; or a thick paste added to 450-600 g of sucrose, flavoring agent, the flavoring agent is stevioside, sodium saccharin, acesulfame, glycyrrhizin, cyclohexane sulfamic acid , one or more mixtures of asparagine, alcohol sugar, aspartame, menthol, various flavors and various fruit flavors, in an amount of 0.1 to 10% (by volume); and preservatives, The preservative is sorbic acid and its potassium sodium salt, the dosage is 0.1~0.3% (volume fraction), or the amount of methylparaben is 0.01~0.05% (volume fraction), boiled, diluted with water to 1000ml, refined, Filtered, mixed, dispensed, ie Anti-influenza A virus subtype syrup; or thick paste mixed with tablet excipients conventional tabletting prepared, can be prepared as an anti-influenza A virus subtype tablets.

The traditional Chinese medicine composition of the present invention is a pharmaceutical dosage form: capsule, oral liquid, syrup, tablet, orally disintegrating tablet, dropping pills, gargle, mouthwash, granules.

In the composition, asparagus, sweet, slightly cold, performance rises, to the lungs, spleen, stomach, large intestine, with heat, detoxification, Xinliang solution, with the treatment of wind and heat, Yangming headache, also Can be used to treat exogenous wind-heat clips; Mint Xin, cool, fragrant, into the lungs, liver, with evacuation of wind heat, clearing heat, phlegm and swelling, and relieving pain and pain. 3⁄4t is often used for wind and cold, Wind-heat headache, red eye pain, sore throat, etc.; Astragalus is a Chinese medicine for clearing heat and purging fire, jaundice, cold, heat and dampness, purging fire and detoxification, good lung fire and heat on the coke; schisandra, lukewarm, return Lung, liver, diarrhea, diarrhea, soreness, hemostasis, is a common medicine for the treatment of colds; licorice and moderate urgency, reconcile various medicines, is a famous medicine; five medicines combined, there are ascending and descending, inside and outside Tonghe, the human body airlifting benefits, the heat evil is removed, the Yin and Yang secret, the five organs are really smooth, people are safe, and restore health. On this basis, based on clinical symptoms, combined with Banlangen, burdock, and Mabul, the effects of clearing away heat and detoxifying and pharyngeal pharynx, forsythia, Bupleurum, and platycodon are synergistic, and evacuation and antipyretic are performed to improve clinical efficacy.

The traditional Chinese medicine composition of the invention is a combination of experience and practice in the clinical practice of the Chinese medicine epidemic for many years, the formula is reasonable, and the medicine taste is refined, and the prescription is used for treating or preventing the infection of the new type H1N1, the type A H1N1 and the type A H3N2 influenza virus. As long as there is fever, cough, jaundice, sore throat, headache and body pain, it can be applied, the curative effect is exact, and there are no toxic and side effects. During the epidemic period, it is effective as a prescription for both treatment and prevention. Formulation and preparation The process is suitable for industrial mass production. detailed description The traditional Chinese medicine composition for treating or preventing influenza A virus subtype infection of the present invention comprises the following weight parts of raw materials: 1-30 parts of Cimicifuga, 1-30 parts of mint, 1-40 parts of Astragalus, 1-10 Parts, licorice 1-20 parts. In order to achieve better curative effect, the medicament of the invention is combined with the raw materials Banlangen, burdock, and puffball; in order to achieve better curative effect, the medicament of the invention can also be combined with the prodrugs of Forsythia, Bupleurum and Campanulaceae.

Embodiment 1 :

Weigh 15g of raw materials, 10g of mint, 5g of astragalus, 10g of schizonepeta, 10g of licorice, 10g of licorice, 50g of the above five flavors, and then add the mint and scutellaria, add water to boil and combine the filtrate, concentrate, cool, add ethanol to make alcohol For (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, outlet air temperature 80 ° C, spray dry powder to add flavoring, mix, the material is dried at 40 ° C The granules of the anti-influenza A virus subtype of the present invention are obtained by granulating, granulating and sub-packaging into bags.

Embodiment 2:

Weigh 15g of raw materials, 10g of mint, 5g of astragalus, 10g of schizonepeta, 10g of licorice, 10g of licorice, 50g of the above five flavors, and then add the mint and scutellaria, add water to boil and combine the filtrate, concentrate, cool, add ethanol to make alcohol For (20-80%), the ethanol was recovered, and the supernatant was concentrated to a thick paste for use. Add sucrose (>450g), flavoring agent (stevioside, sodium saccharin, acesulfame, glycyrrhizin, cyclohexane sulfamic acid, asparagine, alcohol sugar, aspartame, menthol, various flavors And various fruit flavors, the dosage is 0.1~10%) and preservatives (the amount of sorbic acid and its potassium sodium salt is <0.3%, the amount of methylparaben is <0.05%), boil, dilute with water to 1000ml, refined (various clarifying agents such as 101 clarifying agent, tube centrifugation, basket filter), filtered, mixed, sub-packaged (package is glass bottle, plastic bottle), that is, anti-influenza A subtype Syrup.

Embodiment 3:

Weighing 15 g of cohosh, 15 g of peppermint, 5 g of sassafras, 10 g of schizonepeta, 10 g of licorice, 10 g of radix isatidis, 10 g of radix isatidis, 15 g of burdock, 10 g of puffball, 85 g of the above eight flavors, and then made according to the method described in the first embodiment. Granules.

Embodiment 4:

Weighing 15 g of cohosh, 15 g of mint, 5 g of sassafras, 10 g of schizonepeta, 10 g of licorice, 10 g of radix isatidis, 15 g of burdock, 15 g of burdock, and 10 g of the above eight flavors, and then made according to the method described in the second embodiment. syrup.

Embodiment 5:

Weigh 15g of raw materials, 10g of mint, 5g of astragalus, 10g of schizonepeta, 10g of licorice, 10g of radix isatidis, 10g of burdock, 10g of burdock, 10g of scutellaria, 10g of forsythia, 10g of Bupleurum, 10g of platycodon, and 115g of the above-mentioned drugs. The granules are then prepared as described in embodiment 1.

Embodiment 6:

Weigh 15g of raw materials, 10g of mint, 5g of astragalus, 10g of schizonepeta, 10g of licorice, 10g of radix isatidis, 10g of burdock, 10g of burdock, 10g of scutellaria, 10g of forsythia, 10g of Bupleurum, 10g of platycodon, and 115g of the above-mentioned drugs. Then according to the implementer The method of Formula 2 is made into a syrup.

Test Example 1: Efficacy of anti-influenza A virus subtypes in vitro of traditional Chinese medicine combination

(1) Principle: The MDCK (canine kidney) cells viral host of herbs inhibit influenza virus sample Influenza HlNl (A / Beijing anti / 262/95, ^10-3 infection, viral infection equivalent to 100 TCID ₅₀ ), H3N2 (A / Guangdong / 243 / 72, 1 / 5 10" ⁴ infection, viral infection equivalent to 100 TCID _5Q ) caused the degree of lesions of MDCK cells.

(2) Test materials and methods: The thick paste prepared in Example 1-6 was added, dissolved in water, and diluted to 1000 μ _§ / ηι1 as a starting concentration with a culture solution, and diluted with a culture solution. Positive control drug: ribavirin (RBV) produced by Hubei Qianjiang Pharmaceutical Factory. Test method: MDCK cells were cultured in 96-well culture plates. After 24 hours, the virus was infected, adsorbed for 2 hours, the virus solution was discarded, and the sample was added according to the above dilution. At the same time, the cell control wells and the virus control wells were set, and the degree of cytopathic observation was observed for 24 hours (CPE). The Reed-Muench method was used to calculate the half toxic concentration (TD _5Q ) and the half effective concentration (IC _5Q ) of the sample, respectively, and calculate the drug selection index (SI).

(3) Test results: Thick paste of Examples 1-6, IC ₅ against influenza A H1N1 influenza virus. C0.20 mg/mL~0.31 mg/mL), select index SI: 5.3~5.9; IC ₅ o (0.16 mg/mL~0.25 mg/mL) for influenza A H3N2 influenza virus, select index SI: 5.6~6.3 .

Test Example 2: Clinical efficacy of traditional Chinese medicine composition in treating influenza A new H1N1 influenza, influenza A H1N1 influenza, and influenza A H3N2

1.1 Materials and methods

1.1.1 Clinical data

This group of patients were diagnosed with A new H1N1 influenza, H1N1 influenza, and H3N2 influenza in 2009, aged 11 to 68 years, and 78 patients who met the following diagnostic criteria for Chinese and Western medicine, including RT-PCR. Twenty-six patients were diagnosed as type A new H1N1 flu, type A H1N1 flu, and type A H3N2 flu. They were randomly divided into treatment group (Chinese medicine composition) in 39 cases and control group (Tuffy) in 39 cases. The therapeutic components were 13 cases of treatment group A (new type H1N1 influenza), treatment group B (type A H1N1 flu) and treatment group C (type A H3N2 flu); the control group was further divided into control group A (new type A) HlNl flu), control group B (type A H1N1 flu) and control group C (type A H3N2 flu) were each 13 cases. There were no significant differences in gender, age, duration of disease and disease distribution between the groups (P>0.05).

1.1.2 Diagnostic criteria (1) Close contact with new H1N1, H1N1 or H3N2 patients. (2) - Clinical manifestations of influenza in the week. (3) A specific virus was isolated from a nasopharyngeal swab, and the specimen was detected by RT-PCR, and a novel H1N1, H1N1 or H3N2 virus RA was present, and the result was confirmed by sequencing.

1.2 Treatment

The treatment group was given the granules of the traditional Chinese medicine composition of Example 1, orally, twice daily, each dose corresponding to 10 g of each raw medicine; the control group was treated with Tamiflu (oseltamivir phosphate capsule) 75 mg/time, daily 2 Times, oral. Children are reduced. The course of treatment is 5 days.

1.3 Efficacy criteria

Significant effect: The body temperature was normal within 24 hours, and the clinical symptoms such as cough and cough were alleviated. The virus isolated from the nasopharyngeal swab was detected by RT-PCR, and the novel H1N1, H1N1, H3N2 virus RNA turned negative within 72 hours.

Effective: Within 72 hours, the body temperature is normal, and the clinical symptoms such as cough and cough are alleviated. The virus isolated from the nasopharyngeal swab is detected by RT-PCR, and the novel H1N1, H1N1, H3N2 virus RNA is negative within 72 hours.

Invalid: After 5 days of treatment, the clinical symptoms such as cough and cough were not relieved. The virus isolated from the nasopharyngeal swab was detected by RT-PCR, and the results of the novel H1N1, H1N1 and H3N2 viruses were still positive.

1.4 Results

Using the traditional Chinese medicine composition of the present invention to treat influenza A new H1N1 influenza, influenza A H1N1 influenza and influenza A H3N2 influenza, the results showed that: six groups of patients with clinical improvement of fever, cough, expectoration, 72 hours of viral nucleic acid negative rate, average Treatment such as antipyretic time. The total effective rate of clinical improvement in treatment group A was 68.10%, the negative rate of viral nucleic acid conversion was 36.57% in 72 hours, and the average fever time was 28.20 hours. The total effective rate of clinical improvement in treatment group B was 71.88%, and the negative rate of viral nucleic acid in 72 hours was 38.55%. The antipyretic time was 26.70 hours; the total effective rate of clinical improvement in treatment group C was 70.80%, the viral nucleic acid conversion rate was 35.20% in 72 hours, and the average fever time was 25.64 hours; the total effective rate of clinical improvement in control group A was 67.33%, 72 hours of viral nucleic acid transfer The negative rate was 40.00%, the average fever time was 40.95 hours; the total effective rate of clinical improvement in control group B was 69.10%, the negative rate of virus nucleic acid conversion was 41.55% in 72 hours, and the average fever time was 39.95 hours; the total effective rate of clinical improvement in control group was 69.88%. The 72-hour viral nucleic acid conversion rate was 44.20%, and the average fever time was 38.05 hours. There was no significant difference between the six groups (P>0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the traditional Chinese medicine composition of the present invention is satisfactory for treating influenza A new type H1N1 influenza, type A H1N1 influenza, and type A H3N2 influenza.

In the treatment group, the granules of the traditional Chinese medicine composition of the third embodiment were administered according to the method of the above test example 2, and the results were as follows: using the traditional Chinese medicine composition of the invention to treat the new type H1N1 influenza, the influenza A H1N1 influenza and the type A H3N2 Influenza, the results showed that: six groups of patients with fever, cough, expectoration and other clinical improvement, 72-hour viral nucleic acid negative rate, mean fever time and other treatment. The total effective rate of clinical improvement in treatment group A was 69.18%, the viral nucleic acid conversion rate was 37.50% in 72 hours, and the average fever time was 27.10 hours. The total effective rate of clinical improvement in treatment group B was 71.10%, and the negative rate of viral nucleic acid in 72 hours was 38.19%. The antipyretic time was 25.28 hours; the total effective rate of clinical improvement in treatment group C was 72.16%, the negative rate of viral nucleic acid conversion was 39.45% in 72 hours, and the average fever time was 26.10 hours; the total effective rate of clinical improvement in control group A was 67.74%, 72 hours of viral nucleic acid transfer The negative rate was 39.10%, the average fever time was 41.12 hours; the total effective rate of clinical improvement of control group B was 70.00%, the 72-hour viral nucleic acid conversion rate was 42.20%, and the average fever time was 39.78 hours; the total effective rate of clinical improvement of control group C was 69.67%. 72 hours of virus nucleic acid conversion rate was 42.20%, and the average fever time was 37.45 hours. There was no significant difference between the six groups (P>0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the traditional Chinese medicine composition of the present invention is satisfactory for treating the new type H1N1 influenza, the influenza A H1N1 influenza, and the influenza A H3N2 influenza.

In the treatment group, the granules of the traditional Chinese medicine composition of the fifth embodiment were administered according to the method of the above test example 2, and the results were as follows: The treatment of the new type H1N1 influenza, the influenza A H1N1 influenza and the influenza A H3N2 influenza using the traditional Chinese medicine composition of the present invention showed that : Compare the clinical improvement of fever, cough and expectoration in 72 groups, 72-hour viral nucleic acid conversion rate, and average fever time. The total effective rate of clinical improvement in treatment group A was 70.12%, the negative rate of viral nucleic acid conversion was 38.19% in 72 hours, and the average fever time was 25.10 hours. The total effective rate of clinical improvement in treatment group B was 72.18%, and the negative rate of viral nucleic acid in 72 hours was 39.10%. The antipyretic time was 23.28 hours; the total effective rate of clinical improvement in treatment group C was 72.00%, the viral nucleic acid conversion rate was 40.54% in 72 hours, and the average fever time was 24.21 hours; the total effective rate of clinical improvement in control group was 68.34%, 72 hours virus The negative rate of nucleic acid conversion was 39.78%, and the average time of fever was 40.82 hours. The total effective rate of clinical improvement in control group B was 70.00%, the negative rate of viral nucleic acid conversion was 43.00% in 72 hours, and the average fever time was 39.90 hours. The total effective rate of clinical improvement in control group C 71. 96%, the 72-hour viral nucleic acid conversion rate was 42.20%, and the average fever time was 38.00 hours. There was no significant difference between the six groups (P>0.05). No side effects were observed in clinical treatment observations. The clinical results suggest that the traditional Chinese medicine composition of the present invention is satisfactory for treating influenza A new type H1N1 influenza, type A H1N1 influenza, and type A H3N2 influenza.

The above is a further detailed description of the present invention in connection with the specific preferred embodiments, and the specific embodiments of the invention are not limited to the description. For those skilled in the art to which the present invention pertains, a number of simple deductions or substitutions may be made without departing from the inventive concept.

Claims

Claim

A traditional Chinese medicine composition for treating influenza A virus subtype infection, comprising: the following weight parts of raw materials: 1-30 parts of cohosh, 1-30 parts of mint, 1-40 parts of astragalus, Mustard 1-10 parts, licorice 1-20 parts.

2. The traditional Chinese medicine composition for treating influenza A virus subtype infection according to claim 1, comprising: the following parts by weight of the drug substance: 1-20 parts of cohosh, 1-20 parts of mint, 1 part of scutellaria 1 -20 parts, 3-10 parts of schizonepeta, 1-20 parts of licorice.

The traditional Chinese medicine composition for treating influenza A virus subtype infection according to claim 1 or 2, which further comprises the following parts by weight of raw materials: 1-20 parts of Radix isatidis, 6-15 parts of burdock , Mabul 3-10 copies.

The traditional Chinese medicine composition for treating influenza A virus subtype infection according to claim 3, which further comprises the following parts by weight of the drug substance: 1-20 parts of Forsythia, 3-10 parts of Bupleurum, Campanulaceae 3-20 parts.

The traditional Chinese medicine composition for treating influenza A virus subtype infection according to claim 4, wherein the amount of each raw material medicine is: 1-20 parts of Cimicifuga, 1-20 parts of mint, and 1-20 of scutellaria. Served, 3-10 parts of Nepeta, 1-20 parts of licorice, 1-20 parts of Radix isatidis, 6-15 parts of burdock, 3-10 parts of Mabul, 1-20 parts of Forsythia, 3-10 parts of Bupleurum, Campanulaceae 3-20 servings.

A method for preparing a traditional Chinese medicine composition for treating influenza A virus subtype infection according to claim 1, characterized in that: taking hemp, mint, scutellaria, schizonepeta, licorice and water, boiling and concentrating the filtrate, concentrating, cooling, Add ethanol to make the alcohol content 20-80% (volume fraction), recover the ethanol, and concentrate the supernatant into a thick paste for use.

7. A method for preparing a traditional Chinese medicine composition for treating influenza A virus subtype infection according to claim 3, characterized by: taking cohosh, mint, astragalus, schizonepeta, licorice, radix radix, burdock, and bourbon water to cook 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.

A method for preparing a traditional Chinese medicine composition for treating influenza A virus subtype infection according to claim 4 or 5, which comprises: taking hemp, mint, scutellaria, schizonepeta, licorice, radix isatidis, burdock, puffball, Forsythia, Bupleurum, and Campanulaceae are boiled with water, concentrated, cooled, and ethanol is added to make the alcohol content 20-80%. The ethanol is recovered, and the supernatant is concentrated into a thick paste for use.

The traditional Chinese medicine composition for treating influenza A virus subtype infection according to any one of claims 1 to 5, which is clinically useful for treating or preventing a new type H1N1, and/or a type H1N1, and/or a Infection of the H3N2 influenza virus.

10. The traditional Chinese medicine composition for treating influenza A virus subtype infection according to claim 9, wherein: the composition is in the form of capsules, oral liquid, syrup, tablets, orally disintegrating tablets, and drops. Pills, gargle, mouthwash, granules.

The method for preparing a medicament according to claim 6, wherein the prepared thick cream is added to a capsule auxiliary preparation, dried, pulverized and filled into capsules, thereby preparing a capsule resistant to influenza A virus subtype; or Thick paste and The granules are usually mixed with auxiliaries, granulated, dried and packaged into bags to prepare granules of influenza A virus subtypes; or mixed with thickeners and oral supplements, boiled, diluted with water, refined, filtered The mixture can be prepared into an oral liquid of the influenza A virus subtype by mixing and mixing into a bottle; or 450~600g of sucrose and flavoring agent can be added to the thick paste, and the flavoring agent is stevioside, sodium saccharin, ampule One or more mixtures of sesame, glycyrrhizin, cyclohexane sulfamic acid, asparagine, alcohol sugar, aspartame, menthol, various flavors and various fruit flavors, in an amount of 0.1 ~10% (volume fraction); and preservative, the preservative is sorbic acid and its potassium sodium salt, the amount is 0.1~0.3% (volume fraction), or the amount of methylparaben is 0.01~0.05% ( Volume fraction), boil, dilute to 1000ml with water, refine, filter, mix, sub-package, that is, get the syrup against the influenza A virus subtype; or mix the prepared thick paste with the commonly used auxiliary materials for tablets, tableting, Tablets that can be prepared as anti-influenza A virus subtypes

12. The method according to claim 7, wherein the prepared thick cream is added to a capsule auxiliary preparation, dried, pulverized and filled into capsules to prepare a capsule resistant to influenza A virus subtype; or Thick paste and granules are usually mixed with auxiliaries, granulated, dried and packaged into bags, which can be prepared into granules of anti-influenza A virus subtype; or mixed with thick paste and oral supplements, boiled, diluted with water, Refined, filtered, mixed into a bottle, can be prepared into an oral liquid against the influenza A virus subtype; or add a thick paste 450~600g sucrose, flavoring, the flavoring agent is stevioside, saccharin One or a mixture of sodium, acesulfame, glycyrrhizin, cyclohexane sulfamic acid, asparagine, alcohol sugar, aspartame, menthol, various flavors, and various fruit flavors, The dosage is 0.1~10%

(volume fraction); and a preservative, the preservative is sorbic acid and its potassium sodium salt, the amount is 0.1~0.3% (volume fraction), or the amount of methylparaben is 0.01~0.05% (volume fraction) , boil, add water to dilute to 1000ml, refine, filter, mix, sub-package, that is, get the syrup against the influenza A virus subtype; or prepare the thick paste and the common auxiliary materials for tablets, tablet, then prepare A tablet that forms an anti-influenza A virus subtype.

The method for preparing a medicament according to claim 8, wherein the prepared thick cream is added to a capsule auxiliary preparation, dried, pulverized and filled into capsules, thereby preparing a capsule resistant to influenza A virus subtype; or Thick paste and granules are usually mixed with auxiliaries, granulated, dried and packaged into bags, which can be prepared into granules of anti-influenza A virus subtype; or mixed with thick paste and oral supplements, boiled, diluted with water, Refined, filtered, mixed into a bottle, can be prepared into an oral liquid against the influenza A virus subtype; or add a thick paste 450~600g sucrose, flavoring, the flavoring agent is stevioside, saccharin One or a mixture of sodium, acesulfame, glycyrrhizin, cyclohexane sulfamic acid, asparagine, alcohol sugar, aspartame, menthol, various flavors, and various fruit flavors, The dosage is 0.1~10%