Traditional Chinese medicine composition for treating viral influenza and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating viral influenza and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine compositions and preparation thereof.The traditional Chinese medicine composition is prepared from, by mass, 5-20 parts of fructus trichosanthis, 1-15 parts of rhizoma pinelliae preparata, 1-10 parts of rhizoma coptidis, 1-15 parts of radix bupleuri, 1-15 parts of radix scutellariae, 1-10 parts of radix sophorae flavescentis, 1-10 parts of raw liquorice and 1-10 parts of trollius chinensis bunge. The preparation method is simple, and the composition disclosed by the invention has a definite antiviral effect, is free from toxic and side effects, and also has the effects of relieving fever, easing pain, relieving cough and resisting inflammation.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine compositions and their preparation, and particularly relates to a traditional Chinese medicine composition for treating viral influenza and a preparation method thereof. Background Art

[0002] The clinical manifestations of viral influenza are fever, cough, muscle pain and general discomfort, and in severe cases, it can lead to viral pneumonia. Viral influenza can be transmitted through respiratory droplets. When a patient coughs, sneezes or talks, the virus is released, and people around may be infected by inhaling these droplets. In addition, contacting contaminated surfaces and then touching the mouth, nose or eyes can also transmit the influenza virus. Due to its characteristics of difficult-to-control transmission route and fast transmission speed, viral influenza poses a great threat to human health and safety, especially in autumn and winter, different degrees of influenza often break out.

[0003] At present, the chemical drugs commonly used for antiviral treatment clinically are mainly M2 receptor antagonists (such as amantadine, etc.) and neuraminidase inhibitors (such as oseltamivir phosphate). Although they have certain curative effects, the drug resistance generated by virus mutation greatly reduces the antiviral effect of the drugs. In addition, overuse of amantadine will cause adverse reactions such as dizziness, drowsiness, depression, loss of appetite, cyanosis of the skin of the extremities, ankle edema, and in elderly patients, hallucinations, delirium, mental disorders, etc. And there is no specific antidote for amantadine overdose poisoning. Oseltamivir phosphate can cause mental abnormal behaviors such as delirium, hallucinations and nightmares in patients. Other chemical drugs mainly for relieving the discomfort symptoms of patients are also used for viral influenza. At present, the chemical drugs used to improve the symptoms of influenza virus patients do have certain therapeutic effects. However, the adverse reactions caused by them cannot be ignored. For example, the antipyretic and analgesic drug acetaminophen has antipyretic and analgesic effects, but it will cause discomfort in the stomach and liver of patients, and overuse may even lead to life-threatening. And in many backward medical areas, both patients and doctors overuse medical antibiotics to treat viral influenza. Although it can relieve the discomfort for a while, long-term abuse of antibiotics will surely lead to a series of problems such as tolerance.

[0004] For example, the existing traditional Chinese patent medicines for treating or adjuvantly treating viral influenza include Lianhua Qingwen Capsule, Pudilan Xiaoyan Koufuye, Ganmao Qingre Keli, Jinhua Qinggan Keli, Zhengchaihu Yin Keli, Ganmao Qingre Keli and Shuanghuanglian Koufuye, etc. Most of the above are positioned to relieve symptoms such as fever, cough and asthma caused by viral influenza. A few traditional Chinese medicines (such as Lianhua Qingwen Capsule, Jinhua Qinggan Keli, Shuanghuanglian Koufuye) have been confirmed by animal and clinical trials to have relatively clear direct antiviral effects.

[0005] In addition, the existing traditional Chinese medicines for treating colds mostly contain pungent and warm or pungent and cool Chinese medicines for dispelling exterior pathogens such as ephedra, schizonepeta, mint, saposhnikovia, kudzu root and perilla leaf, combined with Chinese medicines for clearing heat and detoxifying such as honeysuckle, forsythia, dandelion, isatis root and scutellaria, with the treatment principle of dispelling wind and relieving exterior pathogens, and promoting lung function and relieving cough. Chinese patent application CN113350439A (publication date 2021-09-07) discloses the use of a traditional Chinese medicine composition in the preparation of antiviral drugs, which specifically discloses: the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 52-86 parts of ephedra, 194-324 parts of gypsum, 194-324 parts of forsythia, 78-130 parts of scutellaria, 194-324 parts of mulberry bark, 78-130 parts of bitter almond, 78-130 parts of peucedanum, 78-130 parts of pinellia, 78-130 parts of tangerine peel, 78-130 parts of fritillaria, 78-130 parts of arctium, 78-130 parts of honeysuckle, 39-65 parts of rhubarb, 46-76 parts of platycodon and 39-65 parts of licorice. The composition is composed of the traditional Chinese medicine ephedra, almond, licorice and gypsum soup and the febrile disease prescription Yinqiao powder with added ingredients. Pharmacological studies have shown that it has a clear anti-influenza virus effect.

[0006] Traditional Chinese medicine believes that viral colds are mostly caused by external evil invasion. According to the exogenous pathogenicity theory, colds are caused by external evil qi invading the human body. These evil qi can be wind, cold, heat, dampness, dryness, etc., and the main evil qi that causes colds is often wind evil. When wind evil invades the human body, it will cause poor circulation of qi and blood, causing cold symptoms. Therefore, traditional Chinese medicine treatment of viral colds generally includes methods such as clearing heat and relieving coughs, and promoting lung function and relieving coughs. Since ancient times, traditional Chinese medicine compound prescriptions have been used in large quantities by traditional Chinese medicine to treat diseases for a long time, and their safety and efficacy have withstood the test of time and clinical practice. Summary of the invention

[0007] Based on the technical problems existing in the existing inventions, the present invention provides a Chinese medicine composition for treating viral colds and a preparation method thereof; the Chinese medicine composition for treating viral colds not only has a clear antiviral effect, but also has antipyretic, analgesic, antitussive and anti-inflammatory effects.

[0008] According to the first aspect of the technical solution of the present invention, a Chinese medicine composition for treating viral colds is provided, wherein the Chinese medicine composition for treating viral colds is composed of extracts of the following Chinese medicine raw materials, and each Chinese medicine raw material includes the following Chinese medicine raw material components by mass: 5-20 parts of whole Trichosanthes, 1-15 parts of Pinellia, 1-10 parts of Coptis, 1-15 parts of Bupleurum, 1-15 parts of Scutellaria, 1-10 parts of Sophora flavescens, 1-10 parts of raw Licorice and 1-10 parts of Nasturtium; The preparation method of the extract of each Chinese medicine raw material comprises the following steps: Step S1: weighing Chinese medicinal raw materials according to their weight, wherein the Chinese medicinal raw materials are whole Trichosanthes, Pinellia, Coptis, Bupleurum, Scutellaria, Sophora flavescens, raw Licorice and Nasturtium; Step S2: Add distilled water or 70% ethanol in an amount 5 to 30 times that of the traditional Chinese medicine raw materials obtained in Step S1, soak, reflux, and filter to obtain a first extract and medicinal residues; Step S3: Soak the medicinal residues obtained in Step S2 in distilled water or 70% ethanol in an amount 0.5 to 10 times that of the residues, heat and reflux for extraction 1 to 3 times, and combine the filtrates to obtain a second extract and medicinal residues; Step S4: Soak the medicinal residues obtained in Step S3 in distilled water or 70% ethanol in an amount 0.5 to 10 times that of the residues, heat and reflux for extraction 1 to 3 times, and combine the filtrates to obtain a third extract; Step S5: Combine the first extract obtained in Step S2, the second extract obtained in Step S3, and the third extract obtained in Step S4 to obtain an extract of the traditional Chinese medicine composition; Step S6: Rotavaporize the extract of the traditional Chinese medicine composition in Step S5 to remove the excess solvent, thereby obtaining an extract paste of the traditional Chinese medicine.

[0009] Preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw material components in parts by mass: Trichosanthis Fructus 7 - 15 parts, Pinelliae Rhizoma 3 - 10 parts, Coptidis Rhizoma 3 - 6 parts, Bupleuri Radix 6 - 10 parts, Scutellariae Radix 6 - 10 parts, Sophorae Flavescentis Radix 6 - 10 parts, Glycyrrhizae Radix 3 - 10 parts, and Trollius Chinensis Bunge 6 - 10 parts.

[0010] More preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw material components in parts by mass: Trichosanthis Fructus 10 - 20 parts, Pinelliae Rhizoma 6 - 12 parts, Coptidis Rhizoma 3 - 6 parts, Bupleuri Radix 9 - 12 parts, Scutellariae Radix 9 - 12 parts, Sophorae Flavescentis Radix 10 - 15 parts, Glycyrrhizae Radix 6 - 10 parts, and Trollius Chinensis Bunge 6 - 10 parts.

[0011] Further, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw material components in parts by mass: Trichosanthis Fructus 20 parts, Pinelliae Rhizoma 10 parts, Coptidis Rhizoma 6 parts, Bupleuri Radix 10 parts, Scutellariae Radix 10 parts, Sophorae Flavescentis Radix 6 parts, Glycyrrhizae Radix 6 parts, and Trollius Chinensis Bunge 6 parts.

[0012] According to the second aspect of the technical solution of the present invention, there is provided a preparation method of a traditional Chinese medicine composition, which comprises the following steps: Step S1: Weigh the traditional Chinese medicine raw materials according to parts by mass. The traditional Chinese medicine raw materials are Trichosanthis Fructus 5 - 20 parts, Pinelliae Rhizoma 1 - 15 parts, Coptidis Rhizoma 1 - 10 parts, Bupleuri Radix 1 - 15 parts, Scutellariae Radix 1 - 15 parts, Sophorae Flavescentis Radix 1 - 10 parts, Glycyrrhizae Radix 1 - 10 parts, and Trollius Chinensis Bunge 1 - 10 parts; after removing the impurities in the traditional Chinese medicine raw materials, quickly wash the surfaces of the above - mentioned traditional Chinese medicine raw materials with clean room - temperature clear water or purified water; Step S2: Wash the traditional Chinese medicine raw materials obtained in Step S1 with clean water, and then place them in a cool room at a temperature of 18°C to 25°C to cool down naturally; add distilled water or 70% ethanol in an amount of 8 to 25 times the weight of the obtained traditional Chinese medicine raw materials, soak the mixed traditional Chinese medicine raw materials for 1 hour to 10 hours, and after soaking, reflux and filter to obtain the first extract and medicinal residues; Step S3: Soak the medicinal residues obtained in Step S2 with distilled water or 70% ethanol in an amount of 0.5 to 10 times the weight for 1 hour to 5 hours, heat the soaked medicinal residues of the traditional Chinese medicine raw materials with gentle fire until boiling, and keep boiling for 15 minutes to 30 minutes. After combining the filtrates obtained by heating and reflux extraction for 1 to 3 times, obtain the second extract and medicinal residues; Step S4: Soak the medicinal residues obtained in Step S3 with distilled water or 70% ethanol in an amount of 0.5 to 10 times the weight for 1 hour to 5 hours, heat the soaked medicinal residues of the traditional Chinese medicine raw materials with gentle fire until boiling, and keep boiling for 15 minutes to 30 minutes. After combining the filtrates obtained by heating and reflux extraction for 1 to 3 times, obtain the third extract; the medicinal residues obtained in Step S3 are the solid substances obtained after passing through the reflux extraction device in Step S3; Step S5: Combine the first extract obtained in Step S2, the second extract obtained in Step S3, and the third extract obtained in Step S4 to obtain the extraction solution of the traditional Chinese medicine composition; Step S6: Rotavaporize the extraction solution of the traditional Chinese medicine composition in Step S5 to remove the excess solvent to obtain the extract of the traditional Chinese medicine extract.

[0013] Preferably, the distilled water or 70% ethanol added in Step S2 is 10 times the weight of the traditional Chinese medicine raw materials obtained in Step S1, and the heating and reflux extraction is carried out for 2 hours.

[0014] Preferably, the rotary evaporation temperature in Step S6 is set to any temperature between 40°C and 60°C.

[0015] According to the third aspect of the technical solution of the present invention, there is provided a pharmaceutical preparation, which is made of the above traditional Chinese medicine composition and a pharmaceutically acceptable carrier, and the dosage form is any pharmaceutically acceptable dosage form; or, it is made of the extract of the traditional Chinese medicine extract prepared by the preparation method of the above traditional Chinese medicine composition and a pharmaceutically acceptable carrier, and the dosage form is any pharmaceutically acceptable dosage form.

[0016] Preferably, the dosage form of the pharmaceutical preparation is an oral preparation; further, the oral preparation is selected from tablets, capsules, granules, pills, powders, pills, syrups, oral solutions or oral suspensions.

[0017] According to the fourth aspect of the technical solution of the present invention, there is provided the use of the above traditional Chinese medicine composition and the above pharmaceutical preparation in the preparation of drugs for antiviral, antipyretic, analgesic and antitussive and anti-inflammatory effects.

[0018] Compared with the prior art, the traditional Chinese medicine composition for treating viral influenza, its preparation method and pharmaceutical preparation of the present invention have the following beneficial technical effects: 1. The traditional Chinese medicine composition for treating viral influenza of the present invention is based on the theory of quantitative pharmacology. At the same time, traditional Chinese medicine has the advantages of multi-pathway, multi-target and comprehensive intervention in regulating antiviral effects compared with chemical drugs, and is safer and more applicable; and taking advantage of the characteristics of flexibility in addition and subtraction and individualization in long-term medication of the present invention, the present invention enhances the exploration of antipyretic, analgesic, cough-relieving and anti-inflammatory aspects of the traditional Chinese medicine composition, which is of great significance for the treatment of influenza.

[0019] 2. In the present invention, Bupleuri Radix and Trichosanthis Fructus are used as the monarch drugs together to play the roles of clearing heat and relieving the exterior, regulating qi and resolving phlegm; Scutellariae Radix, Coptidis Rhizoma and Pinelliae Rhizoma are used as the minister drugs together. Among them, Scutellariae Radix and Bupleuri Radix are commonly used drug pairs, which can cooperate with Bupleuri Radix to clear the heat in the qi aspect; Trollius Chinensis Bunge and Sophorae Flavescentis Radix are used as the assistant drugs together to enhance the power of the monarch and minister drugs to clear heat and detoxify; Glycyrrhizae Radix et Rhizoma is used as the envoy drug to harmonize all the drugs. Using raw Glycyrrhizae Radix et Rhizoma also has the effect of clearing heat, detoxifying and resolving phlegm.

[0020] 3. The present invention mainly uses Bupleuri Radix, Scutellariae Radix, Trichosanthis Fructus and Coptidis Rhizoma, supplemented by Pinelliae Rhizoma, Trollius Chinensis Bunge, Sophorae Flavescentis Radix and Glycyrrhizae Radix et Rhizoma, and takes the treatment principles of reconciling Shaoyang, clearing heat and detoxifying, and drying dampness and resolving phlegm. The whole formula jointly exerts the effects of clearing heat and relieving the exterior, and detoxifying and resolving phlegm. And experimental studies have confirmed that the present invention has antiviral, antipyretic, analgesic, cough-relieving and anti-inflammatory effects.

[0021] 4. In the formula of the traditional Chinese medicine composition for treating viral influenza of the present invention, each single herb has the best synergistic antiviral, antipyretic, analgesic, cough-relieving and anti-inflammatory effects, and the effect is better than the extract of single herbs and the extract of some combinations of single herbs.

[0022] 5. In the traditional Chinese medicine composition of the present invention, Scutellariae Radix has the effects of clearing heat and drying dampness, purging fire and detoxifying, etc.; Coptidis Rhizoma has the effects of clearing heat and moistening dryness, purging fire and detoxifying; Pinelliae Rhizoma is pungent, bitter and warm in nature, mainly belongs to the lung meridian, and has the effect of warming the lung and dispelling cold. Trollius Chinensis Bunge is bitter in taste and cold in nature. Appropriate use can help clear the heat toxin in the body and has a certain auxiliary effect on relieving furuncles and carbuncles. Sophorae Flavescentis Radix can clear the damp-heat pathogen in the body. A variety of chemical components in Sophorae Flavescentis Radix have anti-inflammatory activity, can inhibit the production and release of a variety of inflammatory factors, and thus reduce the inflammatory response. Glycyrrhizae Radix et Rhizoma also has the effect of relieving cough and resolving phlegm, can soothe cough symptoms, and promote the discharge of phlegm, and is used to improve respiratory problems such as cough, asthma, and bronchitis. Glycyrrhizae Radix et Rhizoma is used as the envoy drug to harmonize all the drugs. Using raw Glycyrrhizae Radix et Rhizoma also has the effect of clearing heat, detoxifying and resolving phlegm.

[0023] 6. The traditional Chinese medicine composition of the present invention has a good effect on the treatment of influenza, and the characteristics of good safety of the pharmaceutical preparation support its use for the prevention of the above diseases, and has the potential value of moving the health protection checkpoint forward, chronic disease management and promoting national health. Description of the Drawings

[0024] Figure 1 It is a test data graph of the effect of the traditional Chinese medicine composition according to the present invention on the anal temperature of mice; Figure 2 It is an experimental test data graph of the effect of the traditional Chinese medicine composition according to the present invention on the analgesic effect of mice; Figure 3 It is an experimental test data graph of the effect of the traditional Chinese medicine composition according to the present invention on the anti-inflammatory effect of mice; Figure 4 It is an experimental test data graph of the HE staining of the lower right lobe of the lung of mice by the traditional Chinese medicine composition according to the present invention; Figure 5A and Figure 5B It is an experimental test data graph of the effect of the traditional Chinese medicine composition according to the present invention on the antitussive effect of mice; Figure 5A The expectorant effect of the drug according to the present invention is evaluated based on the number of coughs of mice, Figure 5B The expectorant effect of the drug according to the present invention is evaluated based on the concentration of phenol red; Figure 6A It is an experimental test data graph of the detection of the virus RNA copy number in the lung tissue under the antiviral effect of the traditional Chinese medicine composition according to the present invention on mice; Figure 6B It is an experimental test data graph of the detection of the virus RNA copy number in the nasal concha under the antiviral effect of the traditional Chinese medicine composition according to the present invention on mice; Figure 7A It is a comparative data graph of the experimental respiratory arrest time under the condition of inoculating mice with the virus according to the present invention; Figure 7B It is a comparative data graph of the lung index experiment under the condition of inoculating mice with the virus; Figure 8 It is a schematic diagram of the inhibitory activity of the traditional Chinese medicine composition according to the present invention on cells infected with influenza A virus; Figure 9 It is a schematic diagram of the inhibitory activity of the traditional Chinese medicine composition according to the present invention on cells infected with the Omicron pseudovirus of the novel coronavirus. Detailed implementation manners

[0025] In order to make the technical problems solved by the present invention, the technical solutions adopted and the beneficial effects obtained more clearly understood, the present invention will be further described in detail below with reference to specific embodiments. The specific embodiments described herein are only used to explain the present invention and do not constitute any limitation to the present invention. Unless otherwise defined, all terms used in the present invention have the same meaning as commonly used in the field to which the present invention belongs.

[0026] Specific embodiments are provided below to help understand the present invention. It should be understood that the embodiments and test examples listed in the present invention are only used to illustrate the present invention, but do not constitute any limitation. The actual protection scope of the present invention is set forth in the claims.

[0027] The present invention provides a traditional Chinese medicine composition for treating viral influenza, its preparation method and pharmaceutical preparation. Creatively, the traditional Chinese medicine materials Trichosanthes kirilowii Maxim., Pinellia ternata (Thunb.) Breit., Coptis chinensis Franch., Bupleurum chinense DC., Scutellaria baicalensis Georgi, Sophora flavescens Ait., Glycyrrhiza uralensis Fisch., and Trollius chinensis Bunge are combined into a formula, making it have the effects of clearing heat and detoxifying, relieving cough and anti-inflammatory.

[0028] It should be noted that the present invention provides a traditional Chinese medicine composition for treating viral influenza and its preparation method. Although some embodiments of the present invention only give the water extraction process or alcohol extraction process, the present invention can also organically combine the alcohol extraction process and the water extraction process for extracting the active ingredients of each traditional Chinese medicine raw material. The organic combination of the alcohol extraction process and the water extraction process is also within the protection scope of the present invention. In the present invention, the extracts of the water extraction process and the alcohol extraction process can both be used for medicines, but only the water extraction process can be used for foods; the water extraction process of the present invention makes the foods have no toxic or side effects source.

[0029] According to the technical solution of the present invention, the traditional Chinese medicine composition for treating viral influenza provided by the present invention includes the following traditional Chinese medicine raw material components in parts by mass: Trichosanthes kirilowii Maxim. 5 - 20 parts, Pinellia ternata (Thunb.) Breit. 1 - 15 parts, Coptis chinensis Franch. 1 - 10 parts, Bupleurum chinense DC. 1 - 15 parts, Scutellaria baicalensis Georgi 1 - 15 parts, Sophora flavescens Ait. 1 - 10 parts, Glycyrrhiza uralensis Fisch. 1 - 10 parts, and Trollius chinensis Bunge 1 - 10 parts. Compared with the prior art CN113350439A (publication date: September 7, 2021), the composition of the present invention is composed of Bupleurum chinense DC., Scutellaria baicalensis Georgi, Trichosanthes kirilowii Maxim., Coptis chinensis Franch., Pinellia ternata (Thunb.) Breit., Trollius chinensis Bunge, Sophora flavescens Ait., and Glycyrrhiza uralensis Fisch. in a certain proportion. Only three herbs, namely Scutellaria baicalensis Georgi, Pinellia ternata (Thunb.) Breit., and Glycyrrhiza uralensis Fisch., are the same as those in CN113350439A, and the traditional Chinese medicine treatment principles are completely different. The formula of the present invention does not contain traditional Chinese medicines such as Ephedra sinica Stapf, Gypsum fibrosum, Rheum palmatum L., and Armeniaca vulgaris Lam. that may be toxic or extremely cold and damage the healthy qi of the spleen and stomach. The formula of the present invention is safer and more stable. Pharmacological studies have confirmed that the present invention has multiple pharmacological activities such as anti-influenza virus, antipyretic and analgesic, cough-relieving and phlegm-dissolving, and anti-inflammatory.

[0030] In one embodiment, the traditional Chinese medicine composition for treating viral cold provided by the present invention comprises the following traditional Chinese medicine raw material components in parts by mass: Trichosanthes kirilowii Maxim. 7-15 parts, Pinellia ternata (Thunb.) Breit. var. typica Nakai 3-10 parts, Coptis chinensis Franch. 3-6 parts, Bupleurum chinense DC. 6-10 parts, Scutellaria baicalensis Georgi 6-10 parts, Sophora flavescens Ait. 6-10 parts, Glycyrrhiza uralensis Fisch. 3-10 parts, and Trollius chinensis Bunge 6-10 parts. The traditional Chinese medicine raw materials Trichosanthes kirilowii Maxim., Pinellia ternata (Thunb.) Breit. var. typica Nakai, Coptis chinensis Franch., Bupleurum chinense DC., Scutellaria baicalensis Georgi, Sophora flavescens Ait., Glycyrrhiza uralensis Fisch., and Trollius chinensis Bunge used in the traditional Chinese medicine composition of the present invention are all purchased from Beijing Tongrentang. The enteric-coated aspirin tablets used in the present invention are purchased from Bayer Healthcare AG, Germany; indomethacin is purchased from Tokyo Chemical Industry Co., Ltd. (Shanghai); pentoxyverine citrate tablets are purchased from Guosheng Pharmaceutical Co., Ltd., China National Pharmaceutical Corporation; dexamethasone is purchased from MedChemExpress; ammonia water is purchased from Xilong Scientific Co., Ltd.; bacterial endotoxin lipopolysaccharide (LPS) is purchased from Sigma-Aldrich; the SARS-CoV-2 / C57MA14 strain is derived from the Institute of Military Veterinary Medicine, Academy of Military Medical Sciences, Chinese Academy of Military Sciences; the mice are purchased from Beijing SPF Biotechnology Co., Ltd. and Vital River Laboratories Co., Ltd.

[0031] The traditional Chinese medicine composition of the present invention is a compound prescription composed of the traditional Chinese medicines Trichosanthes kirilowii Maxim., Pinellia ternata (Thunb.) Breit. var. typica Nakai, Coptis chinensis Franch., Bupleurum chinense DC., Scutellaria baicalensis Georgi, Sophora flavescens Ait., Glycyrrhiza uralensis Fisch., and Trollius chinensis Bunge, and has the effects of treating antiviral, antipyretic and analgesic, and antitussive and anti-inflammatory. The volatile oil and saponins in Bupleurum chinense DC. can inhibit the function of the central nervous system, thereby reducing the heat generated by the body and playing a role in relieving exterior syndrome and reducing fever; Trichosanthes kirilowii Maxim. tastes sweet, slightly bitter, and is cold in nature, and has the effects of clearing heat and resolving phlegm, widening the chest and dispersing binds, and moistening dryness and lubricating the intestines.

[0032] The traditional Chinese medicine composition of the present invention is compared with the classical prescription Xiaoxiaoxiong Decoction: Xiaoxiaoxiong Decoction comes from Treatise on Febrile and Miscellaneous Diseases and is composed of three herbs, Trichosanthes kirilowii Maxim., Coptis chinensis Franch., and Pinellia ternata (Thunb.) Breit.; the main indications of Xiaoxiaoxiong Decoction have been continuously expanded by later medical experts and can be used for treating diseases such as clearing heat and resolving phlegm, dispersing the lung qi and relieving cough, regulating qi and relieving fullness in the chest, etc.; in the formula of Xiaoxiaoxiong Decoction, Trichosanthes kirilowii Maxim. is sweet and cold, moistening the lung and resolving phlegm, regulating qi and relieving fullness in the chest, Pinellia ternata (Thunb.) Breit. is pungent and warm, drying dampness and resolving phlegm, dissipating binds and resolving masses, and Coptis chinensis Franch. is bitter and cold, purging heat and relieving binds. Medical experts regard "three herbs and three prescriptions" as therapeutic drugs for novel coronavirus infection; at the same time, modified Qianjin Weijing Decoction, Xuanbai Chengqi Decoction, and Xiaoxiaoxiong Decoction are also used in the treatment of patients with novel coronavirus infection; further, Qingfei Dayuan Granules for treating novel coronavirus infection also contain the prescription of Xiaoxiaoxiong Decoction. However, at present, the antiviral, antipyretic, anti-inflammatory and other effects of Xiaoxiaoxiong Decoction have not been confirmed by modern pharmacological research. Compared with the classical prescription Xiaoxiaoxiong Decoction: the traditional Chinese medicine composition of the present invention uses Bupleurum chinense DC. and Trichosanthes kirilowii Maxim. together as the monarch herbs, which can clear heat and relieve the exterior, regulate qi and resolve phlegm; Scutellaria baicalensis Georgi has the effects of clearing heat and drying dampness, purging fire and detoxifying, etc.; Coptis chinensis Franch. has the effects of clearing heat and moistening dryness, purging fire and detoxifying; Pinellia ternata (Thunb.) Breit. is pungent, bitter and warm, and mainly belongs to the lung meridian, having the effect of warming the lung and dispelling cold. In the present invention, Scutellaria baicalensis Georgi, Coptis chinensis Franch., and Pinellia ternata (Thunb.) Breit. are used together as the ministerial herbs, among which Scutellaria baicalensis Georgi and Bupleurum chinense DC. are commonly used herb pairs, which can assist Bupleurum chinense DC. in clearing the heat in the qi aspect; Trollius chinensis Bunge is bitter and cold, and appropriate use can help clear the heat toxin in the body, and has a certain adjuvant effect on relieving furuncles and carbuncles; Sophora flavescens Aiton can clear the damp-heat pathogen in the body, and various chemical components in Sophora flavescens Aiton have anti-inflammatory activity, which can inhibit the production and release of various inflammatory factors, thereby reducing the inflammatory response; Trollius chinensis Bunge and Sophora flavescens Aiton together are used as the assistant herbs to enhance the power of the monarch and ministerial herbs in clearing heat and detoxifying; Glycyrrhiza uralensis Fisch. usually also has the effect of relieving cough and resolving phlegm, can soothe cough symptoms, and promote the discharge of phlegm, and is used to improve respiratory problems such as cough, asthma, bronchitis, etc. Glycyrrhiza uralensis Fisch. is used as the guiding herb to harmonize all the herbs, and using raw Glycyrrhiza uralensis Fisch. also has the effect of clearing heat and detoxifying and resolving phlegm. The whole formula of the present invention jointly exerts the effects of clearing heat and relieving the exterior, detoxifying and resolving phlegm, and it has been confirmed by pharmacological experimental research that the present invention has antiviral, antipyretic, analgesic, antitussive and anti-inflammatory effects.

[0033] Furthermore, the traditional Chinese medicine composition for treating viral colds comprises the following traditional Chinese medicine raw material components in parts by mass: 10-20 parts of Trichosanthes kirilowii Maxim., 6-12 parts of Rhizoma Pinelliae Praeparatum, 3-6 parts of Coptis chinensis Franch., 9-12 parts of Bupleurum chinense DC., 9-12 parts of Scutellaria baicalensis Georgi, 10-15 parts of Sophora flavescens Aiton, 6-10 parts of raw Glycyrrhiza uralensis Fisch., and 6-10 parts of Trollius chinensis Bunge. In a preferred embodiment, the traditional Chinese medicine composition for treating viral colds comprises the following traditional Chinese medicine raw material components in parts by mass: 20 parts of Trichosanthes kirilowii Maxim., 10 parts of Rhizoma Pinelliae Praeparatum, 6 parts of Coptis chinensis Franch., 10 parts of Bupleurum chinense DC., 10 parts of Scutellaria baicalensis Georgi, 6 parts of Sophora flavescens Aiton, 6 parts of raw Glycyrrhiza uralensis Fisch., and 6 parts of Trollius chinensis Bunge.

[0034] According to the second aspect of the present invention, there is provided a method for preparing a traditional Chinese medicine composition for treating viral cold as described above. By means of processing and water extraction or alcohol extraction techniques, the active ingredients in the traditional Chinese medicine composition are extracted. The preparation method includes the following steps: Step S1: Weigh traditional Chinese medicine raw materials according to parts by mass. The traditional Chinese medicine raw materials are Trichosanthis Fruit, Pinelliae Rhizoma Praeparatum, Coptidis Rhizoma, Bupleuri Radix, Scutellariae Radix, Sophorae Flavescentis Radix, Glycyrrhizae Radix, and Trollius Chinensis Bunge. This step S1 includes removing impurities from all the traditional Chinese medicine raw materials. Preferably, a combination of manual impurity removal and mechanical impurity removal is used. After removing the impurities, the surfaces of the above traditional Chinese medicine raw materials are quickly washed with clean room-temperature water or purified water. Preferably, flowing water is used for washing, or a water spray gun with a water pressure between 0.2 MPa and 1.0 MPa is used for spray washing. Preferably, a water spray gun with a water pressure between 0.25 MPa and 0.80 MPa is used for spray washing. Through experimental verification, for Pinelliae Rhizoma Praeparatum, Coptidis Rhizoma, Bupleuri Radix, Scutellariae Radix, and Sophorae Flavescentis Radix, a water spray gun with a water pressure of 0.50 MPa is used for spray washing, and for Trichosanthis Fruit, Glycyrrhizae Radix, and Trollius Chinensis Bunge, a water spray gun with a water pressure of 0.30 MPa is used for spray washing.

[0035] Step S2: Add distilled water in an amount of 5 to 30 times the amount of the traditional Chinese medicine raw materials obtained in step S1 (in the present patent specification, the multiple of the traditional Chinese medicine raw materials to distilled water is in parts by mass). After soaking, refluxing, and filtering, a first extract and medicinal residues are obtained. An alcohol extraction method can also be used, that is, add 70% ethanol in an amount of 5 to 30 times the amount of the traditional Chinese medicine raw materials obtained in step S1, and after soaking, refluxing, and filtering, a first extract and medicinal residues are obtained. In step S2, the clean whole Trichosanthis Fruit, Pinelliae Rhizoma Praeparatum, Coptidis Rhizoma, Bupleuri Radix, Scutellariae Radix, Sophorae Flavescentis Radix, Glycyrrhizae Radix, and Trollius Chinensis Bunge of traditional Chinese medicine can be used for soaking; or the following steps can be adopted: Step S21: Wash the traditional Chinese medicine raw materials obtained in step S1 with water, and then place them in a cool room at a temperature of 18 °C to 25 °C to naturally cool down. In the cool room, ventilation and cleanliness need to be maintained.

[0036] Step S22: In a preferred embodiment, the large clean traditional Chinese medicine raw materials are crushed into small particles with a particle size less than 1 cm, preferably less than 0.5 cm. For example, Trichosanthis Fruit, Coptidis Rhizoma, Bupleuri Radix, Scutellariae Radix, Sophorae Flavescentis Radix, Pinelliae Rhizoma Praeparatum, Glycyrrhizae Radix, and Trollius Chinensis Bunge are cut into small particles. The cut and mixed traditional Chinese medicine raw materials are mixed with 5 to 30 times the amount of water, preferably distilled water or purified water, and soaked for 1 hour to 30 hours. In another embodiment, the mixed traditional Chinese medicine raw materials are soaked with 8 to 25 times the amount of water for 1 hour to 10 hours, preferably soaked for 3 hours to 5 hours. In a preferred embodiment, Pinellia is washed and soaked in alum solution until there is no dry core inside, and when tasted, there is a slightly numb feeling on the tongue. Then it is taken out, washed, cut into thick slices and dried, preferably with a thickness less than 1 cm.

[0037] Step S23, heating to boiling step: After soaking, use a gentle fire to heat the soaked traditional Chinese medicine raw material mixture to boiling, and maintain boiling for 15 to 30 minutes, preferably maintain boiling for 20 minutes; the gentle fire temperature in this embodiment is preferably controlled at any temperature between 120 °C and 260 °C, more preferably controlled at any temperature between 150 °C and 180 °C. In a preferred embodiment, a gentle fire of 160 °C is used.

[0038] Step S24, slightly boiling heating: Then reduce the heating temperature so that the soaked traditional Chinese medicine raw material mixture remains in a slightly boiling state for 15 to 30 minutes, preferably reduce the gentle fire heating temperature to any temperature between 80 °C and 100 °C; in a preferred embodiment, gentle fire heating at 90 °C, 95 °C or 98 °C is used.

[0039] Step S25, reflux extraction step: Use a reflux extraction device to separate the effective component substances to be extracted from the soaked traditional Chinese medicine raw material mixture after heating. The reflux extraction device preferably adopts a high-temperature condensation reflux device, and reflux extraction is carried out for 60 to 180 minutes, preferably 2 hours. The first extract is obtained in this step.

[0040] Further, filter the concentrated traditional Chinese medicine raw material mixture with a traditional Chinese medicine liquid filter to filter out the residue, and use a traditional Chinese medicine liquid filter with any pore diameter or sieve hole between 100 mesh and 800 mesh for residue filtration; preferably use a traditional Chinese medicine liquid filter with a pore diameter or sieve hole of 300 mesh, 400 mesh or 500 mesh for residue filtration to obtain the first extract (i.e., the filtrate) and the residue.

[0041] Step S3: After combining the filtrates obtained by heating and reflux extracting the residue obtained in Step S2 with 0.5 to 10 times the amount of distilled water for 1 to 3 times, a second extract and residue are obtained; Step S3 further includes the following steps: Step S31, which uses the residue obtained in Step S2 and soaks it with 0.5 to 10 times the amount of water, preferably distilled water or pure water. In another embodiment, soak the residue with 0.6 to 5 times the amount of water for 1 to 5 hours, preferably soak for 2 to 3 hours. In a preferred embodiment, soak the residue with 0.8 times the amount of pure water for 1 to 3 hours, preferably soak for 2 hours.

[0042] Step S32, heating to boiling step: After soaking, use a gentle fire to heat the soaked traditional Chinese medicine raw material residue to boiling, and maintain boiling for 15 to 30 minutes, preferably maintain boiling for 20 minutes; the gentle fire temperature in this embodiment is preferably controlled at any temperature between 120 °C and 260 °C, more preferably controlled at any temperature between 150 °C and 180 °C. In a preferred embodiment, a gentle fire of 160 °C is used.

[0043] Step S33, micro-boiling heating: Then reduce the heating temperature so that the soaked traditional Chinese medicine raw material mixture remains in a weak boiling state for 15 to 30 minutes. Preferably, reduce the gentle heating temperature to any temperature between 80 °C and 100 °C; in a preferred embodiment, use gentle heating at 90 °C, 95 °C or 98 °C.

[0044] Step S34, reflux extraction step: Use a reflux extraction device to separate the effective component substances to be extracted from the soaked traditional Chinese medicine raw material mixture after heating; obtain a second extract and medicinal residues. The reflux extraction device preferably uses a high-temperature condensation reflux device, and reflux extraction is carried out for 30 to 90 minutes, preferably 1 hour.

[0045] Step S3 can also adopt the method of ethanol extraction, that is, soak the medicinal residues obtained in Step S2 with 0.5 to 10 times the amount of 70% ethanol, and after heating and refluxing and extracting 1 to 3 times and combining the filtrates, obtain a second extract and medicinal residues.

[0046] Step S4: After combining the filtrates obtained by heating and refluxing the medicinal residues obtained in Step S3 with 0.5 to 10 times the amount of distilled water for 1 to 3 times, obtain a third extract; it further includes the following steps: Step S41, which uses the solid obtained after passing through the reflux extraction device in Step S34. The solid is the medicinal residue obtained in Step S3, and soak it with 0.5 to 3 times the amount of water, preferably distilled water or pure water. In another embodiment, soak the mixed traditional Chinese medicine raw materials with 0.6 to 1.5 times the amount of water for 1 to 5 hours, preferably soak for 2 to 3 hours. In a preferred embodiment, soak the mixed solid with 0.8 times the amount of pure water for 1 to 3 hours, preferably soak for 2 hours.

[0047] Step S42, heating to boiling step: After soaking, use gentle heat to heat the soaked traditional Chinese medicine raw material residue to boiling and maintain boiling for 15 to 30 minutes, preferably maintain boiling for 20 minutes; the gentle heat temperature in this embodiment is preferably controlled at any temperature between 120 °C and 260 °C, and more preferably controlled at any temperature between 150 °C and 180 °C. In a preferred embodiment, use gentle heat at 160 °C.

[0048] Step S43, micro-boiling heating: Then reduce the heating temperature so that the soaked traditional Chinese medicine raw material mixture remains in a weak boiling state for 15 to 30 minutes. Preferably, reduce the gentle heating temperature to any temperature between 80 °C and 100 °C; in a preferred embodiment, use gentle heating at 90 °C, 95 °C or 98 °C.

[0049] Step S44, Reflux Extraction Step: Using a reflux extraction device, separate the effective component substances to be extracted from the soaked traditional Chinese medicine raw material mixture after heating; obtain the third extract. The reflux extraction device preferably adopts a high-temperature condensation reflux device and refluxes for 30 minutes to 90 minutes, preferably 1 hour.

[0050] Step S4 can also adopt the method of ethanol extraction, that is, soak the medicinal residues obtained in Step S3 with 0.5 - 10 times the amount of 70% ethanol, and after combining the filtrates obtained by heating and reflux extraction 1 - 3 times, obtain the third extract.

[0051] Step S5: Combine the first extract obtained in Step S2, the second extract obtained in Step S3, and the third extract obtained in Step S4 to obtain the traditional Chinese medicine composition extract; Step S6: Rotavaporize the excess solvent from the traditional Chinese medicine composition extract obtained in Step S5 to obtain the traditional Chinese medicine extract paste, and the traditional Chinese medicine extract paste is also the ethanol extract paste or the water extract paste. For the traditional Chinese medicine water extract paste, Step S6 further includes the following steps: Step S61, Prepare the traditional Chinese medicine composition water extract: Put the traditional Chinese medicine composition water extract obtained in Step S5 into the sample bottle of the rotavapor, ensuring that the amount of the traditional Chinese medicine composition water extract is appropriate, not too much or too little; preferably, the amount of the traditional Chinese medicine composition water extract is 2 / 3 of the capacity of the sample bottle.

[0052] Step S62, Install the sample bottle: Install the sample bottle on the rotating arm of the rotavapor, ensuring that the sample bottle is stable and well-sealed.

[0053] Step S63, Set parameters: Set the rotation speed to 100 rpm, the rotary evaporation temperature to 50 °C, and the evaporation time to 2 h.

[0054] Step S64, Start rotavaporization: Start the rotavapor and start rotating the sample bottle. At the same time, turn on the heating device to heat the traditional Chinese medicine composition water extract.

[0055] Step S65, Observe and monitor: During the rotavaporization process, closely observe the evaporation situation of the traditional Chinese medicine composition water extract to ensure that the evaporation rate is appropriate, and avoid splashing or excessive evaporation of the traditional Chinese medicine composition water extract.

[0056] Step S66, End rotavaporization: When it is observed that the water in the traditional Chinese medicine composition water extract is basically removed or the expected removal effect is achieved, the heating device and the rotavapor can be turned off.

[0057] Step S67, Collect and process: Collect the traditional Chinese medicine composition water extract paste after rotavaporization into an appropriate container, and perform subsequent processing or analysis as needed.

[0058] Using the obtained ethanol extract paste or water extract paste, prepare a preparation made of a pharmaceutically acceptable carrier, and the dosage form is any pharmaceutically acceptable dosage form. And prepare a pharmaceutical preparation with an oral dosage form, which is selected from tablets, capsules, granules, pills, powders, pills, syrups, oral solutions, and oral suspensions. The preparation may have antipyretic, analgesic, antitussive, anti-inflammatory, and antiviral effects. That is, the traditional Chinese medicine composition of the present invention is a compound formulated from the whole Trichosanthes kirilowii Maxim., Pinellia ternata (Thunb.) Breit., Rhizoma Coptidis, Bupleurum chinense DC., Scutellaria baicalensis Georgi, Sophora flavescens Ait., Radix Glycyrrhizae, and Trollius chinensis Bunge, and has effects such as antiviral, clearing heat and detoxifying, and relieving cough and inflammation.

[0059] The following are various embodiments to further illustrate the technical solutions of the present invention.

[0060] Example 1: Preparation of Traditional Chinese Medicine Extract (Extract I) A traditional Chinese medicine composition for treating viral colds, which is prepared from the whole Trichosanthes kirilowii Maxim., Pinellia ternata (Thunb.) Breit., Rhizoma Coptidis, Bupleurum chinense DC., Scutellaria baicalensis Georgi, Sophora flavescens Ait., Radix Glycyrrhizae, and Trollius chinensis Bunge.

[0061] The preparation method includes the following steps: Step S1: Calculate according to parts by mass and weigh the following traditional Chinese medicine raw material components: 10-20 parts of the whole Trichosanthes kirilowii Maxim., 6-12 parts of Pinellia ternata (Thunb.) Breit., 3-6 parts of Rhizoma Coptidis, 9-12 parts of Bupleurum chinense DC., 9-12 parts of Scutellaria baicalensis Georgi, 10-15 parts of Sophora flavescens Ait., 6-10 parts of Radix Glycyrrhizae, and 6-10 parts of Trollius chinensis Bunge; this step S1 includes removing impurities in all the traditional Chinese medicine raw materials, preferably a combination of manual impurity removal and mechanical impurity removal. After removing the impurities, quickly wash the surface of the above-mentioned traditional Chinese medicine raw materials with clean room temperature water or pure water, preferably wash with flowing water, or use a water spray gun with a water pressure between 0.2 MPa and 1.0 MPa for spray cleaning, preferably use a water spray gun with a water pressure between 0.25 MPa and 0.80 MPa for spray cleaning; through experimental verification, Pinellia ternata (Thunb.) Breit., Rhizoma Coptidis, Bupleurum chinense DC., Scutellaria baicalensis Georgi, and Sophora flavescens Ait. are spray-cleaned with a water spray gun with a water pressure of 0.50 MPa, and the whole Trichosanthes kirilowii Maxim., Radix Glycyrrhizae, and Trollius chinensis Bunge are spray-cleaned with a water spray gun with a water pressure of 0.30 MPa.

[0062] Step S2: Add distilled water in an amount 8-15 times the amount of the traditional Chinese medicine raw materials in step S1 (1:10, m:V), soak for 8-24 hours, and then heat under reflux for 1 h-2 h (hours), and filter to obtain the first extract and medicinal residues; Step S3: Heat and reflux extract the medicinal residues obtained in step S2 with 0.6-1.2 times the amount of distilled water for 1 hour-1.5 hours, and heat and reflux extract 2 times. After collecting and combining the filtrates, obtain the second extract and medicinal residues; Step S4: For the filter residue obtained after Step S3, heat under reflux with distilled water in an amount 0.6 to 1.2 times the amount of the filter residue for 1 to 1.5 hours, and perform heat reflux extraction twice. After collecting and combining the filtrates, a third extract is obtained. Step S5: Combine the first extract in Step S2, the second extract in Step S3, and the third extract in Step S4 to obtain the water extract of the traditional Chinese medicine composition. Step S6: Concentrate the water extract of the traditional Chinese medicine composition in Step S5 under reduced pressure to obtain the water extract paste of the traditional Chinese medicine.

[0063] Example 2: Preparation of Traditional Chinese Medicine Extract (Extract I) A traditional Chinese medicine composition for treating viral cold of the present invention is prepared from Trichosanthis Fructus, Pinelliae Rhizoma, Coptidis Rhizoma, Bupleuri Radix, Scutellariae Radix, Sophorae Flavescentis Radix, Glycyrrhizae Radix Preparata, and Trollius Chinensis Bunge.

[0064] The preparation method includes the following steps: Step S1: Weigh 20 g of Trichosanthis Fructus, 10 g of Pinelliae Rhizoma, 6 g of Coptidis Rhizoma, 10 g of Bupleuri Radix, 10 g of Scutellariae Radix, 6 g of Sophorae Flavescentis Radix, 6 g of Glycyrrhizae Radix Preparata, and 6 g of Trollius Chinensis Bunge according to parts by mass to form the traditional Chinese medicine raw materials. Step S2: Add distilled water in an amount 10 times that of the traditional Chinese medicine raw materials in Step S1 (1:10, m:V), soak for 12 h, then heat under reflux for 2 h, and filter to obtain the first extract and the medicinal residues. Step S3: Heat the medicinal residues obtained in Step S2 under reflux with distilled water in an amount 0.8 times that of the residues for 1 hour, and perform heat reflux extraction twice. After collecting and combining the filtrates, a second extract and the medicinal residues are obtained. Step S4: For the filter residue obtained after Step S3, heat under reflux with distilled water in an amount 0.8 times that of the filter residue for 1 hour, and perform heat reflux extraction twice. After collecting and combining the filtrates, a third extract is obtained. Step S5: Combine the first extract in Step S2, the second extract in Step S3, and the third extract in Step S4 to obtain the water extract of the traditional Chinese medicine composition. Step S6: Concentrate the water extract of the traditional Chinese medicine composition in Step S5 under reduced pressure to obtain 30 g of the water extract paste, and the extraction rate = 30 g / 74 g = 40.5%.

[0065] Example 3: Preparation of Traditional Chinese Medicine Extract (Extract II) Take three flavors of Bupleuri Radix, Trollius chinensis Bunge, and Glycyrrhizae Radix, with a material-liquid ratio of 1:8, and reflux extract with 70% ethanol for 1 hour to collect the extract; then use the above medicinal residues with a material-liquid ratio of 1:6 and reflux extract with 70% ethanol for 1 hour to collect the extract; combine the above medicinal residues with other medicinal flavors, with a material-liquid ratio of 1:8 and reflux extract with distilled water for 2 hours to collect the extract; reflux extract the medicinal residues again with a material-liquid ratio of 1:6 for 1 hour to collect the extract; combine the above extracts, concentrate, and obtain the extraction extract II, with an extract yield of 42.1%.

[0066] In addition to the three-flavor extraction extract II of Bupleuri Radix, Trollius chinensis Bunge, and Glycyrrhizae Radix obtained in this example, the other five-flavor traditional Chinese medicines such as Trichosanthis Fructus, Pinelliae Rhizoma Praeparatum, Coptidis Rhizoma, Scutellariae Radix, and Sophorae Flavescentis Radix can also be extracted with a similar or identical extraction process to that in the above Example 1 and Example 2 to obtain the extract, and the obtained extract is mixed with extract II to obtain the traditional Chinese medicine extract of the present invention with antiviral, antipyretic, analgesic, and antitussive and anti-inflammatory effects.

[0067] Example 4: Preparation of Traditional Chinese Medicine Extract (Extract III) Take three flavors of Bupleuri Radix, Trollius chinensis Bunge, and Trichosanthis Fructus, with a material-liquid ratio of 1:8, and reflux extract with 70% ethanol for 1 hour to collect the extract; then use the above medicinal residues with a material-liquid ratio of 1:6 and reflux extract with 70% ethanol for 1 hour to collect the extract; combine the above medicinal residues with other medicinal flavors, with a material-liquid ratio of 1:8 and reflux extract with distilled water for 2 hours to collect the extract; reflux extract the medicinal residues again with a material-liquid ratio of 1:6 for 1 hour to collect the extract; combine the above extracts, concentrate, and obtain the extraction extract III, with an extract yield of 41.7%.

[0068] In addition to the three-flavor extraction extract III of Bupleuri Radix, Trollius chinensis Bunge, and Glycyrrhizae Radix obtained in this example, the other five-flavor traditional Chinese medicines such as Trichosanthis Fructus, Pinelliae Rhizoma Praeparatum, Coptidis Rhizoma, Scutellariae Radix, and Sophorae Flavescentis Radix can also be extracted with a similar or identical extraction process to that in the above Example 1 and Example 2 to obtain the extract, and the obtained extract is mixed with extract III to obtain the traditional Chinese medicine extract of the present invention with antiviral, antipyretic, analgesic, and antitussive and anti-inflammatory effects.

[0069] Example 5: Preparation of Traditional Chinese Medicine Extract (Extract IV) Take two flavors of Bupleuri Radix and Trollius chinensis Bunge, with a material-liquid ratio of 1:8, and reflux extract with 70% ethanol for 1 hour to collect the extract; then use the above medicinal residues with a material-liquid ratio of 1:6 and reflux extract with 70% ethanol for 1 hour to collect the extract; combine the above medicinal residues with other medicinal flavors, with a material-liquid ratio of 1:8 and reflux extract with distilled water for 2 hours to collect the extract; reflux extract the medicinal residues again with a material-liquid ratio of 1:6 for 1 hour to collect the extract; combine the above extracts, concentrate, and obtain the extraction extract IV, with an extract yield of 41.5%.

[0070] In addition to the two kinds of extractive extracts of Bupleuri Radix and Trollius chinensis Bunge obtained in this embodiment, other five kinds of traditional Chinese medicines such as Trichosanthis Fructus, Pinelliae Rhizoma, Coptidis Rhizoma, Scutellariae Radix, Sophorae Flavescentis Radix, and Glycyrrhizae Radix can also be extracted into extracts by using an extraction process similar to or the same as that in the above-mentioned Embodiment 1 and Embodiment 2. The obtained extracts are mixed with Extract IV to obtain the traditional Chinese medicine extract of the present invention having antiviral, antipyretic, analgesic, and anti-inflammatory and antitussive effects.

[0071] Example 6: Preparation of Traditional Chinese Medicine Extract (Extract V) The above eight kinds of medicinal materials, such as Trichosanthis Fructus, Pinelliae Rhizoma, Coptidis Rhizoma, Bupleuri Radix, Scutellariae Radix, Sophorae Flavescentis Radix, Glycyrrhizae Radix, and Trollius chinensis Bunge, are first reflux-extracted with 70% ethanol for 2 hours at a material-liquid ratio of 1:8, and the extract is collected; the above medicinal residues are reflux-extracted with 70% ethanol for 1 hour at a material-liquid ratio of 1:6, and the extract is collected; the above medicinal residues are further reflux-extracted with distilled water for 2 hours at a material-liquid ratio of 1:8, and the extract is collected; the above medicinal residues are further reflux-extracted with distilled water for 1 hour at a material-liquid ratio of 1:6, and the extract is collected; the above extracts are combined and concentrated to obtain Extract V, and the extract yield is 45.0%.

[0072] Test Example 1: Evaluation of the Antiviral Effect of the Traditional Chinese Medicine Composition 1 This test example measures the inhibitory effect of the traditional Chinese medicine composition on the viral load of mice infected with the novel coronavirus.

[0073] Experimental animals: Balb / c mice, male, 18 - 22 g, purchased from Vital River Laboratory Animal Technology Co., Ltd.

[0074] Test samples: The extract of the traditional Chinese medicine composition prepared in Example 2. According to the extraction rate and the dosage of the medicinal materials, the corresponding dosage of the extract of the traditional Chinese medicine composition is weighed, added with distilled water, and made into a solution for gavage.

[0075] Experimental instrument: Microplate reader.

[0076] Experimental method: Two days before the formal start of the experiment, the BALB / c mice were transferred to the IVC isolation cages in a biosafety level 3 laboratory (BSL-3) for cultivation. Randomly divided into 4 groups, with 10 mice in each group, namely the virus control group, the nirmatrelvir group (150 mg / kg), the molnupiravir group (500 mg / kg), and the traditional Chinese medicine composition group (20 g / kg). The day of virus inoculation was 0 dpi. After the mice were anesthetized with isoflurane, 50 μL of the virus SARS-CoV-2 / C57MA14 (8×MLD50) was inoculated into the mice in the virus control group and the drug treatment group by nasal drip. 12 hours after the mice were inoculated with the virus, the virus control group and the drug treatment group were respectively treated with 0.9% normal saline and the corresponding drugs by oral gavage, once a day, at an interval of 24 hours, and the drug treatment continued until the fifth day after infection (5 dpi). The lung tissue and nasal turbinates of the animals were taken to detect the viral RNA copy number to evaluate the antiviral effect of the traditional Chinese medicine composition.

[0077] Experimental results: Refer to Figure 6A and Figure 6B . Figure 6A It is a test data graph of the virus RNA copy number detected in the lung tissue under the antiviral effect of the traditional Chinese medicine composition on mice; Figure 6B It is a test data graph of the virus RNA copy number detected in the nasal concha under the antiviral effect of the traditional Chinese medicine composition on mice. The results show that compared with the virus control group, the viral loads in the lungs of mice in the nirmatrelvir group and the molnupiravir group were significantly reduced (P<0.001), and the viral load in the lungs of mice in the traditional Chinese medicine composition group was also significantly reduced compared with the model group (P<0.05). Compared with the virus control group, the viral load in the nasal concha of mice in the molnupiravir group was significantly reduced (P<0.001), and the viral load in the nasal concha of mice in the traditional Chinese medicine composition group was also significantly reduced compared with the model group (P<0.05), while there was no significant difference between the nirmatrelvir group and the model group. The above results indicate that the traditional Chinese medicine composition has a definite anti-SARS-CoV-2 effect and is superior to nirmatrelvir in terms of efficacy.

[0078] Test Example 2: Evaluation of the Antiviral Effect of the Traditional Chinese Medicine Composition 2 This test example measures the death protection effect of the traditional Chinese medicine composition on influenza virus-infected mice and its effect on the lung index.

[0079] Experimental animals: Balb / c mice, male, 18 - 22 g, purchased from Vital River Laboratory Animal Technology Co., Ltd.

[0080] Test samples: The extract of the traditional Chinese medicine composition prepared in Example 2. According to the extraction rate and the dose of the medicinal materials, weigh the corresponding dose of the traditional Chinese medicine composition extract, add distilled water to make a solution for gavage.

[0081] Experimental instruments: Precision balance.

[0082] Experimental method: Two days before the formal experiment, BALB / c mice were transferred to IVC isolation cages in a biosafety level 3 laboratory (BSL-3) for cultivation. They were randomly divided into 5 groups, with 10 mice in each group, namely the blank control group, the virus control group, the oseltamivir phosphate group (25 mg / kg), the low-dose traditional Chinese medicine composition group (2.5 g / kg), the medium-dose traditional Chinese medicine composition group (5 g / kg), and the high-dose traditional Chinese medicine composition group (10 g / kg). The day of virus inoculation was designated as 0 dpi. After anesthetizing the mice with isoflurane, 50 µL of virus HINI-UI182 (8×MLD50) was inoculated into the mice in the virus control group and the drug treatment groups by nasal drip. 12 hours after the mice were inoculated with the virus, the virus control group and the drug treatment groups were treated with 0.9% normal saline and the corresponding drugs by oral gavage, respectively, twice a day for 5 consecutive days, and the body weight changes and death conditions of the animals were continuously observed until the 14th day; lung tissues were taken to detect the changes in lung index to evaluate the antiviral effect of the traditional Chinese medicine composition.

[0083] Experimental results: See Figure 7. Figure 7A It is a comparison data graph of the respiratory arrest time experiment under the condition of inoculating the virus into mice. The experimental results show that the survival rate of the mice in the virus control group on the 7th day was 0%, and the survival rate of the mice in the low-dose traditional Chinese medicine composition group (2.5 g / kg) on the 10th day was 0%; the survival rate of the mice in the medium-dose traditional Chinese medicine composition group (5 g / kg) on the 14th day was 16.6%; the survival rate of the mice in the high-dose traditional Chinese medicine composition group (10 g / kg) on the 14th day was 33.3%; the survival rate of the mice in the oseltamivir group on the 14th day was 100%; the research results indicate that the traditional Chinese medicine composition can significantly increase the mortality rate of influenza virus-infected mice and has an anti-influenza virus effect.

[0084] Figure 7B It is a comparison data graph of the lung index experiment under the condition of inoculating the virus into mice. The experimental results show that compared with the blank group, the lung index in the virus control group was significantly increased; the high-dose traditional Chinese medicine composition group (10 g / kg) could significantly reduce the lung index of mice, and compared with the virus control group, the lung index in the oseltamivir phosphate group was also significantly reduced. The above results indicate that the traditional Chinese medicine composition can significantly improve the lung inflammation in influenza virus-infected mice, and the effect is equivalent to that of oseltamivir phosphate.

[0085] Test Example 3: Evaluation of the Antiviral Effect of the Traditional Chinese Medicine Composition 3 This test example measures the inhibitory activity of the traditional Chinese medicine composition against influenza A virus-infected cells.

[0086] Experimental cell line (MDCK cell line): Tested samples: The extract of the traditional Chinese medicine composition prepared in Example 2. According to the extraction rate and the dose of the medicinal materials, the corresponding dose of the traditional Chinese medicine composition extract was weighed, added with distilled water, and made into a solution. H1N1 PR8 influenza virus was used for cell infection.

[0087] Experimental instrument: Microplate reader.

[0088] Experimental method: Inoculate the cells to be tested in a 96-well plate, culture them under suitable conditions until the cells adhere to the wall, and then inoculate the H1N1 PR8 influenza virus on the MDCK cells that have grown into a monolayer. Add the traditional Chinese medicine extract to the cell culture wells and set up multiple replicate wells according to different concentrations. Gently pipette out the culture medium in the 96-well plate, add 100 μL of neutral red staining solution to each well, place it at 37 °C for 1 h for reaction, then take it out, pour out the neutral red staining solution, rinse it with a small stream of water 3 to 5 times, shake it dry, add 100 μL of decolorizing solution to each well, place it in an incubator at 37 °C for 15 min, and measure the absorbance value (A value) at 540 nm with a microplate reader.

[0089] Experimental results: As Figure 8 shown, the traditional Chinese medicine composition at concentrations of 800 μg / mL, 400 μg / mL, and 200 μg / mL has a strong inhibitory effect on the virus, and the virus inhibition rate is close to 100%; when the concentration of the traditional Chinese medicine composition is 100 μg / mL, the virus inhibition rate is 56.7%; when the concentration of the traditional Chinese medicine composition is 50 μg / mL, the virus inhibition rate is 29.8%; when the concentration of the traditional Chinese medicine composition is 25 μg / mL, the virus inhibition rate is weak, which is 28.04%; when the concentration of the traditional Chinese medicine composition is 12.5 μg / mL, there is no obvious inhibitory activity on the virus, and the inhibition rate is 8.26%. The above results indicate that the traditional Chinese medicine composition has an obvious inhibitory effect on influenza virus.

[0090] Test Example 4: Evaluation of the Antiviral Effect of the Traditional Chinese Medicine Composition 4 This test example measures the inhibitory activity of the traditional Chinese medicine composition on the cells infected with the novel coronavirus Omicron pseudovirus.

[0091] Experimental cell line: ACE2-293T cell line.

[0092] Tested sample: The extract of the traditional Chinese medicine composition prepared in Example 2. Weigh the corresponding dose of the traditional Chinese medicine composition extract according to the extraction rate and the dose of the medicinal materials, add distilled water to make a solution. The novel coronavirus Omicron pseudovirus is used for cell infection.

[0093] Experimental instrument: Microplate reader.

[0094] Experimental method: Inoculate the cells to be tested in a 96-well plate and culture them until they adhere to the wall under suitable conditions. Then inoculate the novel coronavirus Omicron pseudovirus on the ACE2-293T cells that have grown into a monolayer. Add the traditional Chinese medicine extract to the cell culture wells and set up multiple replicates at different concentrations. Gently pour out the culture medium in the 96-well plate, add 100 μL of neutral red staining solution to each well, place it at 37 °C for 1 h, then take it out, pour out the neutral red staining solution, rinse it 3 to 5 times with a small stream of water, shake it dry, add 100 μL of decolorizing solution to each well, place it in an incubator at 37 °C for 15 min, and measure the A value at 540 nm with an enzyme-linked immunosorbent assay (ELISA) reader.

[0095] Experimental Results : As Figure 9 shown, the traditional Chinese medicine composition showed a good inhibitory effect on virus entry without significantly affecting cell proliferation. When the concentration of the traditional Chinese medicine composition was 100 μg / mL, the inhibition rate of Omicron pseudovirus entry was close to 100%, and the EC50 of the traditional Chinese medicine composition was 21.53 μg / mL. The results showed that the traditional Chinese medicine composition had an obvious inhibitory effect on Omicron virus.

[0096] Test Example 5: Evaluation of the Antipyretic Effect of the Traditional Chinese Medicine Composition 5 In this test example, the rectal temperature of mice was measured to evaluate the antipyretic effect of the drug of the present invention.

[0097] Experimental animals: C57 mice, male, 18 - 22 g, purchased from Beijing SPF Laboratory Animal Technology Co., Ltd.

[0098] Test samples: The extract of the traditional Chinese medicine composition prepared in Example 1. According to the extraction rate and the dose of the medicinal materials, weigh the corresponding dose of the traditional Chinese medicine composition extract, add distilled water to make a solution for gavage.

[0099] Experimental instrument: Rewod temperature maintenance instrument.

[0100] Experimental method: After the mice were purchased, they were adaptively raised and randomly divided into 7 groups with 10 mice in each group, namely the solvent control group, the LPS model group, the aspirin group (100 mg / kg), the low-dose group of Xiaoxiaochaihu Decoction (10 g / kg), the high-dose group of Xiaoxiaochaihu Decoction (20 g / kg), the low-dose group of the traditional Chinese medicine composition (10 g / kg), and the high-dose group of the traditional Chinese medicine composition (20 g / kg). The administration methods are as follows: Mice in each dose group of the traditional Chinese medicine composition and the aspirin group were continuously intragastrically administered for 6 days (p.o. 20 ml / kg), and the solvent control group and the model group were intragastrically administered with the corresponding dose of distilled water respectively. On the 7th day of the experiment, except for the solvent control group, mice in each group were intraperitoneally injected with LPS (100 μg / kg, 10 ml / kg) to establish a fever model, and the solvent control group was intraperitoneally injected with an equal volume of normal saline. The rectal temperature of the mice was measured 6 h after modeling. One hour before measuring the rectal temperature, each administration group was intragastrically administered once, and the solvent control group and the model group were intragastrically administered with the corresponding dose of distilled water. The antipyretic effect of the traditional Chinese medicine composition was evaluated by detecting the rectal temperature of the mice.

[0101] Experimental results: See Figure 1 。 Figure 1 It is a test data graph of the effect of the traditional Chinese medicine composition on the rectal temperature of mice. The experimental results show that compared with the solvent control group, the body temperature of mice in the LPS model group increased significantly (P < 0.0001). The high-dose group of Xiaoxiaochaihu Decoction could effectively reduce the body temperature of mice, while the low-dose group of Xiaoxiaochaihu Decoction had no obvious effect on the body temperature of mice; the traditional Chinese medicine composition could effectively reduce the body temperature of mice in the model group. Compared with the model group, the body temperature of mice in the low-dose group and the high-dose group of the traditional Chinese medicine composition decreased significantly (P < 0.05, P < 0.001). Aspirin administration could inhibit the fever of mice in the model group (P < 0.0001). The antipyretic effect of the high-dose administration of the traditional Chinese medicine composition was equivalent to that of aspirin and was superior to the antipyretic effect of Xiaoxiaochaihu Decoction. The above results suggest that the traditional Chinese medicine composition has an antipyretic effect.

[0102] Test Example 6: Evaluation of the Analgesic Effect of the Traditional Chinese Medicine Composition 6 In this test example, the writhing times of mice were measured to evaluate the analgesic effect of the drug of the present invention.

[0103] Experimental animals: ICR mice, male, 18 - 22 g, purchased from Beijing Spearf Bio-Technology Co., Ltd.

[0104] Test samples: The extract of the traditional Chinese medicine composition prepared in Example 1. According to the extraction rate and the dose of the medicinal materials, the corresponding dose of the traditional Chinese medicine composition extract was weighed, added with distilled water, and made into a solution for intragastric administration.

[0105] Experimental instruments: Counter, timer.

[0106] Experimental method: After the mice were purchased, they were adaptively raised and randomly divided into 6 groups with 8 mice in each group, namely the control group, indomethacin group (15 mg / kg), low-dose group of Minor Decoction of Trichosanthes and Bupleurum (10 g / kg), high-dose group of Minor Decoction of Trichosanthes and Bupleurum (20 g / kg), low-dose group of traditional Chinese medicine composition (10 g / kg), and high-dose group of traditional Chinese medicine composition (20 g / kg). The administration method was as follows: Mice in each dose group of the traditional Chinese medicine composition and the indomethacin group were given a single intragastric administration (p.o. 20 ml / kg), and the solvent control group and the model group were respectively given the corresponding dose of distilled water by gavage. 40 minutes after gavage of each group of mice, a pain model was established by intraperitoneal injection of 0.6% glacial acetic acid. The first 3 minutes were the pain latency period. After counting the pain latency period, the number of writhing times of the mice within 15 minutes was counted.

[0107] Experimental results: See Figure 2 . Figure 2 It is a test data graph of the effect of the traditional Chinese medicine composition on analgesia in mice. The experimental results show that compared with the control group, indomethacin can significantly reduce the number of writhing times of mice, with statistical significance (P<0.0001); the low-dose group of Minor Decoction of Trichosanthes and Bupleurum (10 g / kg) and the high-dose group of Minor Decoction of Trichosanthes and Bupleurum (20 g / kg) have no significant analgesic effect on mice; both the low-dose group and the high-dose group of the traditional Chinese medicine composition can significantly reduce the pain sensitivity of mice and the number of writhing times of mice (P<0.01). The above results suggest that the traditional Chinese medicine composition has an obvious analgesic effect, and the effect is better than that of Minor Decoction of Trichosanthes and Bupleurum.

[0108] Test Example 7: Evaluation of the Anti-inflammatory Effect of the Traditional Chinese Medicine Composition 7 In this test example, the anti-inflammatory effect of the drug of the present invention was evaluated by measuring the weight of the left lung of mice.

[0109] Experimental animals: ICR mice, male, 18 - 22 g, purchased from Beijing Spearf Bio-Technology Co., Ltd.

[0110] Test samples: The extract of the traditional Chinese medicine composition prepared in Example 2. According to the extraction rate and the dose of the medicinal materials, the corresponding dose of the extract of the traditional Chinese medicine composition was weighed, added with distilled water, and made into a solution for gavage.

[0111] Experimental instruments: Counter, timer.

[0112] Experimental method: After the mice were purchased, they were adaptively raised and randomly divided into 7 groups, with 10 mice in each group, namely the solvent control group, the LPS model group, the dexamethasone group (4 mg / kg), the low-dose group of Xiaoxiaochuangtang (10 g / kg), the high-dose group of Xiaoxiaochuangtang (20 g / kg), the low-dose group of the traditional Chinese medicine composition (10 g / kg), and the high-dose group of the traditional Chinese medicine composition (20 g / kg). The administration methods are as follows: Five days before modeling, the administration groups started to administer drugs, and continuous gavage administration (p.o. 20 ml / kg) was carried out for 6 days. The mice in the dexamethasone group started to administer drugs on the day of modeling. The blank control group and the model group were given the corresponding volume of distilled water. One hour after the drugs were administered on the 6th day, except for the blank control group, the mice in each group were anesthetized with ether, and then LPS (0.5 μL / g) was dropped into the mouths of the mice to cause aspiration into the lungs of the mice to establish a pneumonia model. The mice were sacrificed 24 hours after modeling. One hour before sacrifice, each administration group was given the drug again. The blank control group and the model group were gavaged with the corresponding dose of distilled water. The left lungs of the mice were taken out and weighed wet. Immediately after weighing the wet weight, they were placed in an oven at 80 °C to dry. After 48 hours, they were taken out and weighed dry. The wet weight / dry weight results were used to evaluate the degree of pulmonary edema in the mice; the lower right lobe of the right lung of the mice was taken out for HE staining for pathological evaluation.

[0113] Experimental results: See Figure 3 and Figure 4 . Figure 3 is the experimental test data graph of the anti-inflammatory effect of the traditional Chinese medicine composition on mice, Figure 4 is the experimental test data graph of HE staining of the lower right lobe of the right lung of mice by the traditional Chinese medicine composition. The results show that compared with the blank control group, the wet / dry weight ratio of the lungs in the LPS model group was significantly increased, with a significant difference (P < 0.0001); the high-dose group of Xiaoxiaochuangtang could effectively reduce the degree of pulmonary edema in mice, while the low-dose group of Xiaoxiaochuangtang had no obvious effect on pulmonary edema in mice; compared with the model group, the wet / dry weight ratio in the dexamethasone group decreased (P < 0.001), and both the low-dose group and the high-dose group of the traditional Chinese medicine composition significantly reduced the wet / dry weight ratio of the lungs (P < 0.001). The HE staining results showed that the lung tissue structure in the model group was disordered, the alveolar wall was significantly thickened, the alveoli were incomplete or even invisible, and there was inflammatory cell infiltration. The alveolar structure in the dexamethasone group and the low- and high-dose groups of the traditional Chinese medicine composition was more complete than that in the model group, the degree of thickening of the alveolar wall was lower, and the inflammatory cell infiltration decreased. The above results suggest that the traditional Chinese medicine composition has an anti-inflammatory effect, and the effect is equivalent to that of dexamethasone and superior to Xiaoxiaochuangtang.

[0114] Test Example 8: Evaluation of the Antitussive Effect of the Traditional Chinese Medicine Composition 8 In this test example, the cough frequency of mice was measured to evaluate the antitussive effect of the drug of the present invention.

[0115] Experimental animals: ICR mice, male, 18 - 22 g, purchased from Beijing Spearf Bio-Technology Co., Ltd.

[0116] Test sample: The extract of the traditional Chinese medicine composition prepared in Example 1. According to the extraction rate and the dosage of the medicinal materials, weigh the corresponding dosage of the extract of the traditional Chinese medicine composition, add distilled water to make a solution for gavage.

[0117] Experimental instruments: Counter, timer.

[0118] Experimental method: After the mice were purchased, they were adaptively fed and randomly divided into 6 groups with 10 mice in each group, namely the solvent control group, pentoxyverine citrate group (30 mg / kg), low-dose group of Xiaoxiaochong decoction (10 g / kg), high-dose group of Xiaoxiaochong decoction (20 g / kg), low-dose group of traditional Chinese medicine composition (10 g / kg), and high-dose group of traditional Chinese medicine composition (20 g / kg). The administration methods are as follows: The mice in the Xiaoxiaochong decoction group, each dose group of traditional Chinese medicine composition, and pentoxyverine citrate group were continuously administered by gavage (p.o. 20 ml / kg) for 7 days, and the solvent control group was gavaged with the corresponding dose of distilled water. 1 hour after the administration on the 7th day, the mice were placed in an inverted hood, a 50 mg cotton ball injected with 0.3 mL of ammonia water was placed in the hood, and after 2 minutes, the mice were taken out and placed in an inverted 1000 mL beaker, and the number of coughs of the mice within 3 minutes was recorded to evaluate the antitussive effect of the traditional Chinese medicine composition.

[0119] Experimental results: See Figure 5A 。 Figure 5A It is a test data graph of the effect of the traditional Chinese medicine composition on the antitussive effect of mice. The experimental results show that the high-dose group of Xiaoxiaochong decoction can effectively reduce the number of coughs of mice, while the low-dose group of Xiaoxiaochong decoction has no obvious effect on the cough of mice; compared with the control group, the number of coughs in the low-dose and high-dose groups of the traditional Chinese medicine composition group is significantly reduced (P<0.05), and the administration of pentoxyverine citrate also reduces the number of coughs of mice (P<0.01). The above results indicate that the traditional Chinese medicine composition has a significant antitussive effect, is equivalent to the positive drug pentoxyverine citrate, and is superior to Xiaoxiaochong decoction.

[0120] Test Example 9: Evaluation of the Expectorant Effect of the Traditional Chinese Medicine Composition 9 This test example measures the number of coughs of mice to evaluate the expectorant effect of the drug of the present invention.

[0121] Experimental animals: ICR mice, male, 18 - 22 g, purchased from Beijing Spearf Bio-Technology Co., Ltd.

[0122] Test sample: The extract of the traditional Chinese medicine composition prepared in Example 1. According to the extraction rate and the dosage of the medicinal materials, weigh the corresponding dosage of the extract of the traditional Chinese medicine composition, add distilled water to make a solution for gavage.

[0123] Experimental instruments: Microplate reader.

[0124] Experimental method: After adaptive feeding of mice, they were randomly divided into 6 groups with 10 mice in each group, namely the solvent control group, the ammonium chloride group (1 mg / kg), the low-dose group of Minor Decoction of Trichosanthes and Bile (10 g / kg), the high-dose group of Minor Decoction of Trichosanthes and Bile (20 g / kg), the low-dose group of traditional Chinese medicine composition (10 g / kg), and the high-dose group of traditional Chinese medicine composition (20 g / kg). The administration method was as follows: Mice in each dose administration group were continuously administered for 7 d. 1 h after the last administration, 5% phenol red was intraperitoneally injected, and the mice were euthanized 0.5 h later. The tissues around the trachea were removed, and a section of the trachea from below the thyroid cartilage to the tracheal bifurcation was taken and placed in 0.1 mL of 1 moL·L-1 NaOH. After soaking for 4 h, it was centrifuged at 800 g·min-1 for 15 min, and the supernatant was taken to measure the absorbance at 546 nm. The content of phenol red in the trachea of mice in each group was calculated according to the standard curve.

[0125] Experimental results: See Figure 5B . Figure 5B The expectorant effect of the drug of the present invention was evaluated based on the phenol red concentration. The experimental results showed that compared with the model group, ammonium chloride could significantly increase the phenol red concentration in mice, with statistical difference (P<0.05); the low-dose group of Minor Decoction of Trichosanthes and Bile (10 g / kg) and the high-dose group of Minor Decoction of Trichosanthes and Bile (20 g / kg) had no obvious expectorant effect on mice; both the low-dose group and the high-dose group of traditional Chinese medicine composition could significantly increase the phenol red concentration in mice (P<0.01). The above results suggest that the traditional Chinese medicine composition has an obvious expectorant effect, which is equivalent to that of ammonium chloride and superior to Minor Decoction of Trichosanthes and Bile.

[0126] Through the description of the technical solution of the present invention above, the beneficial effects of the present invention are further illustrated. The present invention combines the concept of "preventing disease before it occurs, preventing deterioration during the disease, and preventing recurrence after recovery" in traditional Chinese medicine with the treatment principle of "early detection and early treatment" of diseases, and assisted by the characteristics of traditional Chinese medicine with multi-target and multi-system overall regulation, and is widely used in the prevention and treatment of antiviral, antipyretic analgesic and antitussive anti-inflammatory effects.

[0127] By deeply implementing the concept of quantitative pharmacology through the formula of the present invention, the traditional Chinese medicine formula of the present invention can further reduce the potential safety hazards in long-term medication and improve the compliance of patients. Traditional Chinese medicine is the material basis for the global community of human health to face chronic diseases and has important potential value in the treatment of chronic diseases.

[0128] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the scope of the technical concept of the present invention, various simple modifications can be made to the technical solutions of the present invention. These simple modifications all fall within the protection scope of the present invention. In addition, it should be noted that the various specific technical features described in the above specific embodiments can be combined in any way without conflict. To avoid unnecessary repetition, the present invention will not separately describe various possible combination methods. In addition, any combination can be made between various different embodiments of the present invention, as long as it does not violate the idea of the present invention, it should also be regarded as the content disclosed by the present invention.

Claims

1. A Chinese medicine composition for treating viral colds, characterized in that: The Chinese medicine composition for treating viral colds is composed of extracts of the following Chinese medicine raw materials, each of which includes the following Chinese medicine raw material components by mass: 5-20 parts of whole Trichosanthes, 1-15 parts of Pinellia, 1-10 parts of Coptis, 1-15 parts of Bupleurum, 1-15 parts of Scutellaria, 1-10 parts of Sophora flavescens, 1-10 parts of raw Licorice and 1-10 parts of Nasturtium; The preparation method of the extract of each Chinese medicine raw material comprises the following steps: Step S1: weighing Chinese medicinal raw materials according to their weight, wherein the Chinese medicinal raw materials are whole Trichosanthes, Pinellia, Coptis, Bupleurum, Scutellaria, Sophora flavescens, raw Licorice and Nasturtium; Step S2: adding distilled water or 70% ethanol in an amount of 5 to 30 times the amount of the Chinese medicine raw material obtained in step S1, soaking, refluxing and filtering to obtain a first extract and a medicine residue; Step S3: soaking the medicinal residue obtained in step S2 with 0.5 to 10 times of distilled water or 70% ethanol, and combining the filtrates extracted 1 to 3 times by heating and refluxing to obtain a second extract and the medicinal residue; Step S4: soaking the medicinal residue obtained in step S3 with 0.5 to 10 times the amount of distilled water or 70% ethanol, and combining the filtrates extracted 1 to 3 times by heating and refluxing to obtain a third extract; Step S5: combining the first extract obtained in step S2, the second extract obtained in step S3 and the third extract obtained in step S4 to obtain a Chinese medicine composition extract; Step S6: removing excess solvent from the extract of the Chinese medicine composition in step S5 by rotary evaporation to obtain a Chinese medicine extract.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition comprises the following traditional Chinese medicine raw material components in parts by mass: 7-15 parts of whole trichosanthes, 3-10 parts of pinellia, 3-6 parts of coptis, 6-10 parts of bupleurum, 6-10 parts of scutellaria, 6-10 parts of sophora flavescens, 3-10 parts of raw liquorice and 6-10 parts of trollius.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition comprises the following Chinese medicine raw material components in parts by mass: 10-20 parts of whole Trichosanthes kirilowii, 6-12 parts of Pinellia ternata, 3-6 parts of Coptis chinensis, 9-12 parts of Bupleurum chinense, 9-12 parts of Scutellaria baicalensis, 10-15 parts of Sophora flavescens, 6-10 parts of raw Licorice root and 6-10 parts of Nasturtium.

4. The Chinese medicine composition according to claim 3, characterized in that: The Chinese medicine composition includes the following Chinese medicine raw material components in parts by mass: 20 parts of whole trichosanthes, 10 parts of pinellia, 6 parts of coptis, 10 parts of bupleurum, 10 parts of scutellaria, 6 parts of sophora flavescens, 6 parts of raw liquorice and 6 parts of trollius.

5. A method for preparing a Chinese medicine composition, characterized in that: It includes the following steps: Step S1: weighing Chinese medicinal raw materials according to the mass fraction, wherein the Chinese medicinal raw materials are 5-20 parts of whole Trichosanthes, 1-15 parts of Pinellia ternata, 1-10 parts of Coptis chinensis, 1-15 parts of Bupleurum chinense, 1-15 parts of Scutellaria baicalensis, 1-10 parts of Sophora flavescens, 1-10 parts of raw Licorice and 1-10 parts of Nasturtium; after removing impurities in the Chinese medicinal raw materials, quickly washing the surfaces of the above Chinese medicinal raw materials with clean room temperature water or purified water; Step S2: washing the Chinese medicinal raw material obtained in step S1 with clean water, and then placing it in a cool room at a temperature of 18 degrees Celsius to 25 degrees Celsius for natural cooling; adding distilled water or 70% ethanol in an amount of 8 to 25 times the amount of the obtained Chinese medicinal raw material, soaking the mixed Chinese medicinal raw material for 1 hour to 10 hours, and obtaining a first extract and a medicinal residue after soaking, reflux filtering; Step S3: soaking the medicinal residue obtained in step S2 in 0.5 to 10 times the amount of distilled water or 70% ethanol for 1 to 5 hours, heating the soaked Chinese medicine raw material medicinal residue to boiling over a low heat, and keeping boiling for 15 to 30 minutes, combining the filtrates obtained by heating and refluxing extraction for 1 to 3 times, and obtaining a second extract and medicinal residue; Step S4: soaking the medicinal residue obtained in step S3 in 0.5 to 10 times the amount of distilled water or 70% ethanol for 1 to 5 hours, heating the soaked Chinese medicine raw material medicinal residue to boiling over a low heat, and keeping boiling for 15 to 30 minutes, and combining the filtrates obtained by heating and reflux extraction for 1 to 3 times to obtain a third extract; the medicinal residue obtained in step S3 is the solid obtained after passing through the reflux extraction device in step S3; Step S5: combining the first extract obtained in step S2, the second extract obtained in step S3 and the third extract obtained in step S4 to obtain a Chinese medicine composition extract; Step S6: removing excess solvent from the extract of the Chinese medicine composition in step S5 by rotary evaporation to obtain a Chinese medicine extract.

6. The method for preparing the Chinese medicine composition according to claim 5, characterized in that: The distilled water or 70% ethanol added in step S2 is 10 times the amount of the Chinese medicine raw material obtained in step S1, and the extraction is heated under reflux for 2 hours.

7. The method for preparing the Chinese medicine composition according to claim 5, characterized in that: In step S6, the rotary evaporation temperature is set to any temperature between 40 degrees Celsius and 60 degrees Celsius.

8. A pharmaceutical preparation, characterized in that It is made of the Chinese medicine composition described in any one of claims 1 to 4 and a pharmaceutically acceptable carrier, and the dosage form is any pharmaceutically acceptable dosage form; or, it is made of the Chinese medicine extract prepared by the preparation method of the Chinese medicine composition described in any one of claims 5 to 7 and a pharmaceutically acceptable carrier, and the dosage form is any pharmaceutically acceptable dosage form.

9. The pharmaceutical preparation according to claim 8, characterized in that The pharmaceutical preparation is in the form of an oral preparation.

10. Use of the Chinese medicine composition according to any one of claims 1 to 4 or the pharmaceutical preparation according to any one of claims 8 to 9 in the preparation of antiviral, antipyretic, analgesic, antitussive and anti-inflammatory drugs.

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