Use of traditional Chinese medicine composition in preparation of a drug for external pathogenic evil and pestilential qi

Abstract

The present application relates to the technical field of traditional Chinese medicine, and particularly relates to application of a traditional Chinese medicine composition in preparation of a medicine for treating diseases caused by external pathogenic factors and sequelae thereof. In the present application, the traditional Chinese medicine composition is derived from a folk traditional Chinese medicine inheritance compound Nanteng Zhitong prescription, and is prepared from raw materials including Shishengteng, Wacaocen, Ganjiang and Wangguacen. The present application first finds that the traditional Chinese medicine composition has obvious effective therapeutic effect on diseases caused by external pathogenic factors and sequelae thereof. Meanwhile, the traditional Chinese medicine composition has diverse action targets, is not prone to drug resistance, has no or less adverse reactions, and has broad development and popularization prospect.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, and particularly relates to application of a traditional Chinese medicine composition in preparation of a medicine for treating diseases caused by external pathogenic evil and sequelae thereof. BACKGROUND

[0002] External pathogenic evil and pestilential qi refers to a highly contagious epidemic disease that can spread among the population through various routes such as air, food, contact, etc. It is characterized by severe illness, variable disease conditions, rapid transmission, and often has bad, changing and reverse syndromes, so it is also called evil qi, epidemic toxin and evil qi. Because it is different from the general six evils, it is also called "different qi". There are many types of syndromes, such as big head plague, frog plague, dysentery, diphtheria, raw throat and red rash, smallpox, cholera, plague, etc. Traditional Chinese medicine, as a scientific discipline with thousands of years of theoretical accumulation, plays an important role in the clinical drug selection and development of diseases caused by external pathogenic evil and pestilential qi.

[0003] Compound Nanteng analgesic prescription is a folk traditional Chinese medicine prescription, which is mainly prepared from traditional Chinese medicinal materials including stone south vine, grass root, dried ginger and wax gourd root. The prescription is used as an analgesic and has significant effects on various pain, toothache, dysmenorrhea and other symptoms. The existing published patent (publication number CN113599484A) provides a traditional Chinese medicine composition for treating pain. The traditional Chinese medicine composition is prepared from stone south vine, grass root, dried ginger and wax gourd root. The prescription can be used to treat dysmenorrhea, toothache, stomachache, joint pain, labor pain, surgical pain, cancer pain, gout, headache caused by cervical spondylosis, prenatal labor pain, and low back pain, etc., with definite clinical efficacy and good patient feedback.

[0004] With the continuous accumulation of clinical experience and the gradual deepening of modern research, the development of new uses of traditional Chinese medicine has achieved remarkable results. However, due to the conservative thinking of traditional Chinese medicine in academic teaching, the promotion of compound Nanteng analgesic prescription is insufficient, resulting in a lack of new use development of compound Nanteng analgesic prescription in existing research.

[0005] Therefore, the present application is proposed. SUMMARY

[0006] To solve the above technical problems, the present application provides application of a traditional Chinese medicine composition (compound Nanteng analgesic prescription) in preparation of a medicine for preventing or treating diseases caused by external pathogenic evil and pestilential qi or sequelae thereof. The present application researches and finds that the compound Nanteng analgesic prescription has a significant effect on relieving symptoms such as high body temperature, cold and deficiency of spleen and kidney, and consumption of qi and yin caused by external pathogenic evil and pestilential qi.

[0007] Specifically, the technical scheme of the present application is as follows.

[0008] The application provides application of a traditional Chinese medicine composition in preparation of a medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof.

[0009] Specifically, in the traditional Chinese medicine composition, the sources, effects and compatibility principles of the raw materials are preferably as follows.

[0010] The Piper wallichii (Miq.) Hand.-Mazz. stem is preferably collected in autumn and dried. The Piper wallichii (Miq.) Hand.-Mazz. stem is flexible and not easy to break. The Piper wallichii (Miq.) Hand.-Mazz. stem has a fragrant smell and a pungent taste. The Piper wallichii (Miq.) Hand.-Mazz. stem is related to the pericardium meridian and the kidney meridian. The Piper wallichii (Miq.) Hand.-Mazz. stem is used for dispelling wind and dampness, strengthening waist and knees, relieving pain and relieving cough.

[0011] The Silene viscidula Franch. dry root is used. The Silene viscidula Franch. dry root has a slight smell and a bitter and slightly numb taste. The Silene viscidula Franch. dry root is related to the liver, lung, stomach and bladder meridians. The Silene viscidula Franch. dry root is used for dispelling wind and relieving superficies, relieving cough, reducing water and eliminating jaundice and relieving pain.

[0012] The Zingiber officinale Rosc. rhizome is used. The Zingiber officinale Rosc. rhizome is pungent and warm. The Zingiber officinale Rosc. rhizome is related to the spleen, stomach, kidney, heart and lung meridians. The Zingiber officinale Rosc. rhizome is used for warming middle energizer and dispelling cold, and is used for treating cold pain in the abdomen, vomiting and diarrhea, cold limbs and weak pulse, and cold and cough.

[0013] The Trichosanthes cucumeroides (Ser.) Maxim. root is used. The Trichosanthes cucumeroides (Ser.) Maxim. root is bitter and cold. The Trichosanthes cucumeroides (Ser.) Maxim. root is used for dredging channels and relieving pain.

[0014] The known Piper wallichii (Miq.) Hand.-Mazz., Silene viscidula Franch., Zingiber officinale Rosc. and Trichosanthes cucumeroides (Ser.) Maxim. compound preparation (compound south stem pain relieving prescription) is mainly used for pain relieving. The application finds that the Piper wallichii (Miq.) Hand.-Mazz., Silene viscidula Franch., Zingiber officinale Rosc. and Trichosanthes cucumeroides (Ser.) Maxim. compound preparation can also be used for preparing a medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof.

[0015] In the application, the traditional Chinese medicine composition is used for treating diseases caused by pathogenic factors or sequelae thereof. The treatment method and principle are different from those of traditional pain relieving treatment. The Piper wallichii (Miq.) Hand.-Mazz. is used as a monarch drug, and the Piper wallichii (Miq.) Hand.-Mazz. is used for activating the sweat system of the human body, dredging the skin metabolism channel and eliminating the abnormal heat exchange system. The Silene viscidula Franch. is used as a minister drug, and the Silene viscidula Franch. is used for opening and dredging channels and relieving pain caused by pathogenic factors. The Zingiber officinale Rosc. and the Trichosanthes cucumeroides (Ser.) Maxim. are used as assistant drugs, and the Zingiber officinale Rosc. and the Trichosanthes cucumeroides (Ser.) Maxim. are used for relieving pain, clearing heat and reducing edema. The Zingiber officinale Rosc. and the Trichosanthes cucumeroides (Ser.) Maxim. are used for balancing the cold and warm properties and combining the pungent and bitter properties.

[0016] Based on the above treatment principles, in a preferred embodiment of the present invention, the traditional Chinese medicine composition is prepared from raw materials comprising the following parts by weight: 9-12 parts of *Photinia serratifolia*, 8-10 parts of *Eriocaulon buergerianum* root, 6-7 parts of dried ginger, and 2-2.5 parts of *Trichosanthes kirilowii* root.

[0017] More preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 parts of *Photinia serratifolia*, 10 parts of *Eriocaulon buergerianum* root, 6 parts of dried ginger, and 2 parts of *Trichosanthes kirilowii* root.

[0018] In this invention, the weight of each raw material is preferably calculated based on processed medicinal slices. This invention does not impose particular limitations on the processing and preparation techniques of each processed medicinal slice; conventional methods in the art are sufficient.

[0019] This invention utilizes the aforementioned traditional Chinese medicine composition for diseases caused by exogenous pathogens or their sequelae. Targeting the specific pathogenesis of these diseases, it employs *Photinia serratifolia* to dissipate heat, *Eriocaulon buergerianum* root to relieve pain, dried ginger to expel cold and promote sweating, and *Trichosanthes kirilowii* root to clear heat and detoxify. The four herbs are perfectly and rigorously combined to exert their effects of dissipating heat, relieving exterior symptoms, alleviating pain, and eliminating harmful substances. This combination can significantly and effectively treat diseases caused by exogenous pathogens or their sequelae, especially SARS-CoV-2 infection.

[0020] Furthermore, the active pharmaceutical ingredients in the raw materials of the aforementioned traditional Chinese medicine composition are quite diverse. For example, the active pharmaceutical ingredients of *Photinia serratifolia* mainly include sclerotinol, pipersintenamide, sclerotinone, sclerotinyl alcohol, and isosclerotinyl alcohol. The active pharmaceutical ingredients of *Gynostemma pentaphyllum* root include various triterpenoids or diterpenoids. The active pharmaceutical ingredients of dried ginger mainly include terpenoid volatile oils, various gingerols (gingerol, enophenol, gingerone, gingerol, etc.), diphenylheptane, etc. The active pharmaceutical ingredients of *Trichosanthes kirilowii* root include various tetracyclic triterpenoids. Among these active pharmaceutical ingredients, the content of sclerotinol, 6-gingerol, and cucurbitacin has a more significant impact on the therapeutic effect of diseases caused by external pathogenic factors or their sequelae. Based on this discovery, the present invention optimizes the content of active pharmaceutical ingredients in the aforementioned traditional Chinese medicine composition.

[0021] Specifically, among the active ingredients of the traditional Chinese medicine composition:

[0022] The preferred mass ratio of alkaloid to cucurbitacin is (0.7-1.0):(0.4-1.5), and more preferably 0.9:(0.84-1.05).

[0023] The preferred mass ratio of styracil to 6-gingerol is (0.5-1.0):(1.4-3.0), more preferably (0.5-0.8):(1.4-2.5), and even more preferably (0.65-0.66):(1.7-1.9).

[0024] The Chinese medicine composition containing the above-mentioned proportions of the medicinal active ingredients has better performance in the treatment of diseases caused by pathogenic factors or sequelae thereof. Among them, the content ratio of wall grass alkali and 6-gingerol has a more obvious effect on the curative effect, and an especially outstanding curative effect can be obtained under the preferred ratio.

[0025] When the Chinese medicine composition is used for preparing a medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof, the quality standards of each raw material are preferably limited as follows.

[0026] Rhododendron, according to the determination of alcohol-soluble extract (Chinese Pharmacopoeia, General 2201) hot extraction method, the content is ≥6.6%. According to the determination of high performance liquid chromatography (Chinese Pharmacopoeia, General 0512), the content of wall grass alkali (C 14 H 25 NO), calculated on the basis of dry product, the content of wall grass alkali in rhododendron is ≥0.08%.

[0027] Wall grass root, moisture determination (Chinese Pharmacopoeia, General 0832 fourth method), content ≤12%. According to the determination of water-soluble extract (Chinese Pharmacopoeia, General 2201) hot extraction method, the content is ≥52.0%.

[0028] Dried ginger, moisture determination (Chinese Pharmacopoeia, General 0832 fourth method), content ≤19.0%. Total ash (Chinese Pharmacopoeia, General 2302), content ≤6.0%. According to the determination of water-soluble extract (Chinese Pharmacopoeia, General 2201) hot extraction method, the content is ≥22.0%. Volatile oil (Chinese Pharmacopoeia, General 2204) is determined, the content is ≥0.8% (ml / g). The content of 6-gingerol (C 17 H 26 O4) is ≥0.60%.

[0029] Wangguaroot, according to the determination of water-soluble extract (Chinese Pharmacopoeia, General 2201) hot extraction method, the content is ≥30.0%. According to the determination of high performance liquid chromatography (Chinese Pharmacopoeia, General 0512), the content of cucurbitacin in wangguaroot is ≥0.2% calculated on the basis of dry product.

[0030] The raw materials with the above-mentioned quality standards provide important guarantee for the excellent and stable performance of the application method of the present application in curative effect.

[0031] Further, in the present application, the symptoms of the diseases caused by pathogenic factors or sequelae thereof include at least one of high body temperature, spleen and kidney deficiency, qi and yin consumption, respiratory tract infection.

[0032] Compared with common exogenous diseases, diseases caused by exogenous pathogenic factors and pestilential qi may have symptoms of deficiency of spleen and kidney and consumption of qi and yin in addition to possible fever, headache, nasal congestion and the like. Among them, the symptoms of deficiency of spleen and kidney are manifested as one or more of shortness of breath, aversion to cold, edema, cold hands and feet, diarrhea and frequent urination. The symptoms of consumption of qi and yin are manifested as one or more of dry cough, little body fluid, fatigue, insomnia, depression and the like. In addition, in respiratory tract infection diseases caused by exogenous pathogenic factors and pestilential qi (such as epidemic viruses like the new coronavirus), there may be obvious manifestations of invasion of dampness on the skin, muscles and bones, such as obvious muscle soreness all over the body, joint soreness, dizziness and the like, and manifestations of dampness affecting the spleen, such as chest distention, loss of appetite, nausea, constipation and the like. There is no special treatment for such diseases caused by exogenous pathogenic factors and pestilential qi or their sequelae in western medicine. Most viruses are not sensitive to antibiotics, and chemical drug treatment is not very mature, and there is a lack of drugs with definite efficacy, small side effects and moderate prices.

[0033] The Chinese medicine composition with the specific formula is used in the treatment of diseases caused by exogenous pathogenic factors and pestilential qi or their sequelae in the present application, and has definite efficacy. It mainly improves the state of the body as a whole, reduces pathological damage, thereby reducing the disease condition, shortening the course of the disease and reducing complications, and objectively plays a good role in non-specific treatment.

[0034] Further, in the present application, the diseases caused by exogenous pathogenic factors and pestilential qi or their sequelae are caused by the disorder of cell inflammatory factors, and the cell inflammatory factors include one or more of TNF-α and IL-1β. In the development process of diseases caused by exogenous pathogenic factors and pestilential qi, a large amount of inflammatory factors such as TNF-α and IL-1β are released by the activation of macrophages, thereby causing symptoms such as pain and fever. The Chinese medicine composition provided in the present application can significantly reduce the release of inflammatory factors TNF-α and IL-1β, thereby playing a therapeutic role.

[0035] The Chinese medicine composition provided in the present application can treat diseases caused by exogenous pathogenic factors and pestilential qi or their sequelae by regulating cell inflammatory factors, has diverse action targets, is not easy to produce drug resistance, and has no or less adverse reactions. Compared with western medicine, the Chinese medicine composition with the specific formula is used in the preparation of a drug for preventing or treating diseases caused by exogenous pathogenic factors and pestilential qi or their sequelae in the present application, has obvious advantages, and has a broad development prospect.

[0036] Further, in the present application, the diseases caused by exogenous pathogenic factors and pestilential qi include viral exogenous diseases. Preferably, the viral exogenous diseases include new coronavirus infection or its sequelae; more preferably, the new coronavirus includes the Omicron variant.

[0037] The traditional Chinese medicine composition has obvious therapeutic effects on diseases caused by external pathogenic evil and pestilential qi, such as infection of a new coronavirus (SARS-CoV-2) and its mutant strains (such as Omicron) and sequelae (such as body fatigue, persistent high fever, muscle soreness, sore throat, dry mouth, diarrhea, pneumonia and the like).

[0038] The new coronavirus belongs to external pathogenic evil and pestilential qi, which is different from general influenza viruses, has unique pathogenicity and infection symptoms, is extremely infectious, has strong virulence, causes acute and critical diseases, and belongs to the category of dampness and toxic epidemic.

[0039] In the present application, the traditional Chinese medicine composition is used for treating new coronavirus infection, and the effect is remarkable: within 1-2 hours after taking the medicine, the symptoms such as fever, pain, dizziness and the like disappear, and only a small number of people (about 5%) will have a fever again the next day, and the body temperature is only below 38℃, without high fever.

[0040] In specific clinical application, the traditional Chinese medicine composition is used for treating new crown positive patients, and the total effective rate is 94.4% (136 / 144). From the number of taking medicine, 63.2% (91 / 144) of the patients take medicine once. From the effects of pain relief and fever reduction, the effective rate of pain relief is 93.8% (135 / 144), and the effective rate of fever reduction is 89.6% (129 / 144). The incidence of adverse reactions is 2.1% (3 / 144), and the main manifestations are skin rash, gastrointestinal irritation and upper body neuralgia.

[0041] The dosage form and preparation method of the traditional Chinese medicine composition are not particularly required, and various oral preparations (such as tablets, capsules, granules, pills, oral liquid and the like) composed of the traditional Chinese medicine composition and pharmaceutically acceptable carriers and / or excipients are all available.

[0042] In an alternative embodiment of the present application, the traditional Chinese medicine composition is a capsule. The capsule is prepared by using the above four medicinal decoction pieces as raw materials, drying at 80℃ (±5℃) for 4 hours, cooling, crushing into fine powder (100 mesh), mixing, granulating (0.5g / pill), and then filling the capsule to obtain the finished product. The capsule is an oral preparation, and the dosage is 3-6 capsules at a time, which should be taken at the right time. The effect is seen within 1-2 hours after use.

[0043] In another alternative embodiment of the present application, the traditional Chinese medicine composition is prepared by the following preparation method:

[0044] S1, the raw materials are weighed according to the formula, extracted with ethanol, and the extract is obtained;

[0045] S2, the residue after ethanol extraction in step S1 is decocted with water, the extract is concentrated, alcohol is added for alcohol precipitation, ethanol is recovered until there is no alcohol taste, and the second extract is obtained;

[0046] S3, combine the extract one in step S1 and the extract two in step S2, add accessories, and granulate.

[0047] More specifically, the preparation method of the traditional Chinese medicine composition is as follows: the above four ingredients are extracted twice by reflux extraction with 80% ethanol, and filtered. The ethanol extract filtrate is concentrated under reduced pressure to recover ethanol to obtain clear extract one, which is used as prepared; the residues are decocted twice with water, filtered, and the two water extract filtrates are combined and concentrated to a relative density of 1.16-1.18 (60°C), and then 70% ethanol is added for alcohol precipitation for 12-24 hours, and the supernatant is collected, and the ethanol is recovered to remove the alcohol taste to obtain clear extract two. The clear extract two and the clear extract one are combined, concentrated under reduced pressure to a relative density of 1.18-1.20 (60°C), and then 1 times the amount of dry extract of dextrin is added, and fluidized bed granulation is performed. The granules are filled into capsules (0.20g) to obtain the product.

[0048] The above preparation method adopts the extraction process route of alcohol extraction followed by water extraction, which can not only improve the content of effective components in the extract, but also reduce the damage of active components with poor stability in the extraction process.

[0049] Among them, the alcohol extraction first helps to fully dissolve the volatile oil components in the raw material medicine (such as dried ginger) and the gingerol components with blood-activating and pain-relieving activity, such as gingerol, as well as the cucurbitacin components in the raw material medicine (such as cucurbit root) and the alkaloid components with blood-activating and pain-relieving activity in the raw material medicine (such as stone south vine), such as wall grass base, pseudo-bay brocade amide A, and piperine. The water extraction afterwards helps to fully dissolve the water-soluble components (n-butanol fraction) with anti-inflammatory and pain-relieving activity in the raw material medicine (such as wall grass). The above preparation method helps to improve the content of effective components in the extract, and further helps to further reduce the dosage.

[0050] Further, the above preparation method of the present application adopts the process route of alcohol extraction followed by water extraction, and the obtained extract has a high solid content, and there are problems such as numbness in taste when taking the extract directly as granules. In order to reduce the dosage of the preparation, the above preparation method of the present application further combines the alcohol precipitation process, and optimizes the capsule preparation process, so that the finally prepared product has the advantages of small dosage and no bad smell.

[0051] In addition, if the powder is directly used as medicine, it needs to be irradiated for sterilization to eliminate pathogenic microorganisms. The above preparation method of the present application adopts the steps of alcohol extraction followed by water extraction, and in the process of using ethanol for extraction, not only the effective components can be extracted, but also the pathogenic microorganisms can be eliminated at the same time.

[0052] Therefore, the traditional Chinese medicine composition prepared by the above preparation method of the present application can further reduce the daily dosage and ensure the safety requirements such as microbial limit of the medicine.

[0053] In the present application, the traditional Chinese medicine composition can be used as a single pharmaceutical ingredient, or can be used in combination with other drugs to treat diseases caused by external pathogenic evil or its sequelae, and helps to reduce adverse reactions.

[0054] Beneficial effects:

[0055] The present application provides a traditional Chinese medicine composition in the preparation of a drug for preventing or treating diseases caused by external pathogenic evil or its sequelae, the traditional Chinese medicine composition is derived from the folk Chinese medicine inheritance compound Nanteng analgesic prescription, which is prepared from 5-15 parts of stone ivy, 5-15 parts of wall grass root, 1-10 parts of dried ginger and 1-10 parts of wax gourd root by weight. The traditional Chinese medicine composition is targeted at the special pathogenesis of diseases caused by external pathogenic evil or its sequelae, and has a positive therapeutic effect on diseases caused by external pathogenic evil or its sequelae. At the same time, the traditional Chinese medicine composition has multiple target points, is not easy to produce drug resistance, and has no or less adverse reactions, and has a broad development and popularization prospect. BRIEF DESCRIPTION OF DRAWINGS

[0056] In order to more clearly illustrate the technical solutions in the present application or prior art, the following will describe the drawings needed to be used in the embodiments or prior art description.

[0057] Figure 1 It is a TLC chart for identifying stone ivy in the traditional Chinese medicine composition capsule granules in experimental example 2 of the present application using method I. Among them, A is the control product, B is the control medicinal material, C-E are three batches of preparations, F is a negative preparation, and 1 represents wall grass alkaloid.

[0058] Figure 2 It is a TLC chart for identifying wall grass in the traditional Chinese medicine composition capsule granules in experimental example 2 of the present application using method I. Among them, A is the control product, B is the control medicinal material, C-E are three batches of preparations, F is a negative preparation, and 1 represents β ecdysterone.

[0059] Figure 3 It is a body temperature change curve of rats in each group in experimental example 4 of the present application.

[0060] Figure 4 It is the body temperature change rate result of rats in each group from 6 to 7 hours in experimental example 4 of the present application.

[0061] Figure 5 It is the HE staining result of hypothalamic tissue of rats in each group in experimental example 4 of the present application.

[0062] Figure 6 It is the serum inflammatory factor detection result of rats in each group in experimental example 4 of the present application.

[0063] Figure 7 It is the effect statistical result of using the traditional Chinese medicine composition capsule granules to treat new crown positive patients in experimental example 6 of the present application. DETAILED DESCRIPTION

[0064] The technical solutions provided by the present application are described in detail below in conjunction with the examples, but they should not be construed as limiting the scope of protection of the present application. If not specifically indicated, the experimental methods used in the examples are conventional methods; the materials, reagents, etc. used can be obtained from commercial channels.

[0065] Example 1

[0066] The present example provides an application of a traditional Chinese medicine composition in the preparation of a medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof, and the prescription of the traditional Chinese medicine composition is as follows in terms of weight parts:

[0067] Rhynchosia volubilis 5 parts, Euphorbia humifusa 5 parts, Zingiber officinale 3 parts, Benincasa cerifera 1 part.

[0068] In the present example, the preparation method of the medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof is as follows:

[0069] The above four pieces of decoction pieces are respectively put into FZG-15 vacuum drying machines, and the temperature is raised to 80℃ (±5℃) to start timing, and each is dried for 4 hours, and the temperature is recorded every 1 hour. After cooling and standing for 1 hour, the four pieces of decoction pieces are respectively put into high-efficiency pulverizers, and the screen mesh size is 80, and they are pulverized. After sieving (100 meshes), they are weighed, and Rhynchosia volubilis, Euphorbia humifusa, Benincasa cerifera and Zingiber officinale (5:5:1:3) are added to a SYH-400 three-dimensional motion mixer at a frequency of 20 Hz (equivalent to 7 revolutions per minute), mixed for 15 minutes, discharged, and packed into capsules (0.5 g per capsule) or double-layered medicinal polyethylene plastic bags, and sealed for storage.

[0070] Example 2

[0071] The present example provides an application of a traditional Chinese medicine composition in the preparation of a medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof, and the prescription of the traditional Chinese medicine composition is as follows in terms of weight parts:

[0072] Rhynchosia volubilis 6 parts, Euphorbia humifusa 4 parts, Zingiber officinale 3 parts, Benincasa cerifera 1 part.

[0073] In the present example, the preparation method of the medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof is referred to Example 1.

[0074] Example 3

[0075] The present example provides an application of a traditional Chinese medicine composition in the preparation of a medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof, and the prescription of the traditional Chinese medicine composition is as follows in terms of weight parts:

[0076] Rhynchosia volubilis 10 parts, Euphorbia humifusa 8.5 parts, Zingiber officinale 7 parts, Benincasa cerifera 2.5 parts.

[0077] In this embodiment, the preparation method of the medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof is as follows:

[0078] Example 4

[0079] This embodiment provides an application of a traditional Chinese medicine composition in preparing a medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof, and the prescription of the traditional Chinese medicine composition is as follows:

[0080] Rhynchosia volubilis 9 parts, Euphorbia humifusa 10 parts, Zingiber officinale 7 parts, Benincasa cerifera 2.5 parts.

[0081] The above four pieces of decoction pieces are dried at 80°C for 4 hours, cooled, and then crushed into fine powder (100 mesh), mixed, and filled into capsules (0.5g per capsule, equivalent to 0.63g of decoction pieces), to make 1000 capsules, i.e. the capsule granules are obtained.

[0082] Example 5

[0083] This embodiment provides an application of a traditional Chinese medicine composition in preparing a medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof, and the prescription of the traditional Chinese medicine composition is as follows:

[0084] Rhynchosia volubilis 6 parts, Euphorbia humifusa 8 parts, Zingiber officinale 6 parts, Benincasa cerifera 8 parts.

[0085] In this embodiment, the preparation method of the medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof is as follows:

[0086] The above four pieces of decoction pieces are dried at 80°C for 4 hours, cooled, and then crushed into fine powder (100 mesh), mixed, and filled into capsules (0.5g per capsule, equivalent to 0.63g of decoction pieces), to make 1000 capsules, i.e. the capsule granules are obtained.

[0087] Example 6

[0088] This embodiment provides an application of a traditional Chinese medicine composition in preparing a medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof, and the prescription of the traditional Chinese medicine composition is as follows:

[0089] In this embodiment, the preparation method of the medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof is as follows:

[0090] The four above-mentioned ingredients were extracted twice by refluxing with 80% ethanol, and the filtrate was obtained. The ethanol was removed from the filtrate under reduced pressure to obtain clear paste 1, which was used as prepared. The residue was decocted twice with water, and the two water extracts were combined and concentrated to a relative density of 1.16-1.18 (60°C). Then, 70% ethanol was added, and the mixture was alcohol-precipitated for 12-24 hours. The supernatant was collected, and the ethanol was removed to obtain clear paste 2. Clear paste 2 and clear paste 1 were combined, and concentrated under reduced pressure to a relative density of 1.18-1.20 (60°C). Then, 1 times the amount of dry paste of dextrin was added, and the mixture was fluidized bed granulated. The granules were filled into capsules (0.20 g) to obtain the product.

[0091] Experimental Example 1

[0092] In this experimental example, the capsule granules prepared in Example 1 were subjected to identification test for their properties, effective ingredients, and specifications, and the results were as follows:

[0093] (1) Properties: hard capsules, the contents were brownish yellow or brownish red granules, and the taste was slightly bitter.

[0094] (2) Identification:

[0095] Method I: about 1 g of the contents of the product was finely ground, and added to 10 ml of 95% ethanol, and ultrasonically treated for 20 minutes. The filtrate was evaporated to dryness, and the residue was dissolved in 1 ml of 95% ethanol to obtain a test solution. 1 g of the powder of Rubus corchorifolius was added to 10 ml of 95% ethanol, and ultrasonically treated for 20 minutes. The filtrate was evaporated to dryness, and the residue was dissolved in 1 ml of 95% ethanol to obtain a control medicinal material solution. The control sample solution was prepared by adding the wall grass alkaloid control sample to ethanol to obtain a solution containing 0.1 mg per 1 ml. The two solutions were spotted on the same silica gel GF254 thin layer plate, and developed with petroleum ether (60-90°C) : ethyl acetate (4:1) as the developing agent. The plate was dried, and examined under ultraviolet light (254 nm). The test sample chromatogram showed the same color fluorescent spots at the same positions as the control sample chromatogram.

[0096] Method II: Take the contents of the capsules, grind finely, weigh about 1 g, add 95% ethanol 10 ml, ultrasonic treatment for 20 minutes, filter, evaporate the filtrate to dryness, add 95% ethanol 1 ml to the residue to dissolve as the test solution. Take the Radix Rubi parvifolii powder 1 g, add 95% ethanol 10 ml, ultrasonic treatment for 20 minutes, filter, evaporate the filtrate to dryness, add 95% ethanol 1 ml to the residue to dissolve as the control medicinal material solution. Take the β-ecdysterone reference substance, add ethanol to prepare a solution containing 0.5 mg per 1 ml as the reference solution. Test according to the thin layer chromatography (General Rule 0502), take 2-4 μl of the above two solutions and spot on the same silica gel GF254 thin layer plate, develop with petroleum ether (60-90 ℃) : n-butanol (1:2) as the developing agent, take out. Dry, place under ultraviolet light (254 nm) and observe. In the test sample chromatogram, there are fluorescent spots of the same color at the positions corresponding to the reference sample chromatogram.

[0097] (3) Inspection: In accordance with the relevant provisions of the Capsules in the Chinese Pharmacopoeia (2020 edition) (General Rule 0103).

[0098] Experimental Example 2

[0099] In this experimental example, three batches of traditional Chinese medicine composition capsule particles (batch numbers: 20220201, 20220202 and 20220203) were prepared according to the prescription and method of Example 1, and the quality of the three batches of traditional Chinese medicine composition was detected, as follows:

[0100] According to the method I in Experimental Example 1, the monarch drug Rubia cordifolia and the ministerial drug Rubia cordifolia in the traditional Chinese medicine composition capsule particles were identified. The results are shown in Figure 1 and Figure 2 .

[0101] The contents of wallenberglavine and 6-gingerol in the three batches of preparations were determined by external standard one-point method, and the results are shown in Table 1 below:

[0102] Table 1 Content determination results of different batches of capsule contents by external standard one-point method (n = 2)

[0103] Batch number Wallenroot base content (mg / g, %) Gingerol content (g / g, %) 20220201 67.2 0.151 20220202 70.6 0.172 20220203 58.8 0.223 Average content 65.5 0.184

[0104] The total number of aerobic bacteria, the total number of mold and yeast, and Escherichia coli in the three batches of preparations were detected by the methods of Chinese Pharmacopoeia General Rules 1105 and 1106: the total number of aerobic bacteria in the three batches was <10 (CFU / g); the total number of mold and yeast was <10 (CFU / g); and Escherichia coli was not detected.

[0105] Experimental Example 3

[0106] In this experimental example, the active ingredients of the drugs in Examples 1-3 were determined by external standard one-point method, and the results are shown in Table 2.

[0107] Table 2 Determination results of the active ingredients in the drugs in Examples 1-3 (n=2)

[0108]

[0109] Experimental Example 4

[0110] In this experimental example, the dry yeast-induced fever model of rats was used to evaluate the antipyretic activity of the capsule particles (Compound Nanteng Analgesic Capsules) prepared in Example 1. The details are as follows:

[0111] (1) Experimental animals, materials and instruments

[0112] Experimental animals: SPF grade SD rats, weighing 180-220 g, half male and half female, with certificate number 202342564.

[0113] Experimental materials: dry yeast (Angel Yeast Co., Ltd., batch number 4205A202206), 0.9% sterile physiological saline (Jiangsu Zhenmei Biological Technology Co., Ltd., batch number 20230116), 4% polychloromethyl formaldehyde fixative (Biosharp, batch number 22315976), positive drug ibuprofen (Shandong Xinhua Pharmaceutical Co., Ltd., batch number 2212627), carboxymethylcellulose sodium (analytical pure, National Pharmaceutical Group Chemical Reagent Co., Ltd., batch number 20190604).

[0114] Experimental instruments: pipette (Finnpipette, 20-200Ml; Eppendorf AG, Germany), electric heating incubator (Wuhan Yiheng Suzhen Scientific Instrument Co., Ltd.), plate washer (Tianshi, 998 plate washer, Beijing Toplab Analytical Instrument Co., Ltd.), enzyme label instrument (Rayto, RT-6100, 450nm, Shenzhen Rayto Life Science Co., Ltd.), centrifuge (TG16W, Changsha Xiangzhi Centrifuge Instrument Co., Ltd.), refrigerated centrifuge (TGL16M, Shanghai Luxiang Instrument Co., Ltd.), constant temperature shaker (HT-111B, Shanghai Hetai Scientific Instrument Co., Ltd.), electronic balance (AE1204, Shanghai Liangping Instrument and Meter Co., Ltd.), cell crusher (JY98-IIIN model, Shanghai Ruiyan Instrument Co., Ltd.).

[0115] (2) Experimental method

[0116] Preparation of the drug solution: 0.11 g of ibuprofen tablets, 0.21 g of the contents of Compound Nanteng Analgesic Capsules, and 0.84 g of the contents of Compound Nanteng Analgesic Capsules were weighed and ground into fine powder, and each was suspended in 50 mL of 0.5% CMC-Na aqueous solution as the drug solution, which was used for the positive drug group, the low-dose Compound Nanteng Analgesic Capsule group, and the high-dose Compound Nanteng Analgesic Capsule group, respectively.

[0117] Establishment of fever model: The rats were adaptively fed for 7 days, and the anal temperature of the rats was measured 3 days in advance, once in the morning and once in the afternoon every day. The rats were selected at a fixed time to adapt to the anal temperature measurement operation. After the adaptation was completed, the rats with body temperature of 36-38.4℃ and body temperature change of no more than 0.5℃ were selected for the experiment. The rats were fasted for 6 hours before the experiment modeling, and the anal temperature of the rats was measured 3 times to take the average value as the basal body temperature. Except for the blank control group, the rats in each group were subcutaneously injected with 20% dry yeast saline suspension at a dose of 10 mL / kg to establish the rat fever model. The anal temperature of the rats in each group was measured every 1 hour after modeling. The rats were administered at the 5th hour after measuring the anal temperature, and the anal temperature of the rats was detected every 0.5 hour after administration. The body temperature change of the rats was analyzed for 5-8 hours.

[0118] Grouping, administration and sampling: 50 SPF SD rats (180-220g) were adaptively fed for 7 days, and then randomly divided into 5 groups, 10 rats in each group, half male and half female, namely blank control group (NC), model control group (M), positive control group (Y), low-dose compound Nanteng analgesic capsule group (JL) and high-dose compound Nanteng analgesic capsule group (JH). The rats in each group were allowed to freely eat and drink during feeding. The method of modeling first and then administration was adopted. Except for the NC and M groups, the Y group was administered by gavage at a dose of 0.021 g / kg, the JL group was administered by gavage at a dose of 0.16 g / kg, and the JH group was administered by gavage at a dose of 0.63 g / kg. After the last temperature measurement, the rats were anesthetized by intraperitoneal injection of 1% sodium pentobarbital at a dose of 40 mg / kg and a volume of 4 mg / kg. The abdominal aorta was sampled, and the serum was obtained by centrifugation at 3000 r / min after standing at room temperature for 1 hour. The serum was stored at -20℃. The rats were immediately sacrificed by decapitation after blood sampling, and the whole brain was quickly removed. The hypothalamus was removed in ice bath and stored in 4% paraformaldehyde fixing solution. It was used for biochemical index detection and HE staining pathological detection, respectively.

[0119] HE staining pathological detection: The hypothalamus stored in 4% paraformaldehyde fixing solution was trimmed, dehydrated, sliced, stained, and mounted after sectioning, and then observed under a microscope.

[0120] Serum inflammatory factors IL-1β and PGE2 detection: The serum stored at -20℃ was thawed at 2-8℃, and then diluted according to the standard, added with sample, enzyme, washed plate, developed, and terminated according to the standard. The blank hole was adjusted to 0, and the absorbance of each hole was measured by enzyme label at 450 nm to detect the IL-1β and PGE2 levels in the serum of rats.

[0121] (3) Statistical analysis

[0122] The data were processed by Graphpad Prism 9.0 software, and the data were represented by P<0.05 indicated that the difference was statistically significant.

[0123] (4) Experimental results

[0124] a. Body temperature change:

[0125] The body temperature change curve of rats in each group is shown in Figure 3 .

[0126] The body temperature change rate of 6-7h fever rats in each group is shown in Table 3, Figure 4 . Figure 4 compared with the NC group, ### P<0.001; compared with the M group, * P<0.05, ** P<0.01, *** P<0.001.

[0127] Table 3 Body temperature change rate of 6-7h fever rats

[0128]

[0129]

[0130] The results show that after dry yeast induces fever in rats, the body temperature is constant, indicating that the fever rat model is successful and has a long duration. After 5h of administration, the positive drug group can effectively reduce the temperature of the fever rats. The JL group has no significant antipyretic effect, but shows a certain trend of body temperature decrease. The JH group can effectively reduce the body temperature of the fever rats and has a long duration, and the antipyretic effect is more significant at 6-7h.

[0131] b. HE staining pathological detection results:

[0132] The HE staining results of hypothalamic tissue of rats in each group are shown in Figure 5 .

[0133] The results show that the hypothalamic tissue structure of rats in the NC group is normal, the cell shape is regular, the nucleus is round, located in the central position of the cell, and the boundary is clear. Compared with the NC group, a large number of neurons in the hypothalamic tissue of rats in the M group are pyknotic, the staining is deepened, the cell shape is irregular, and the cell nucleus boundary is not clear. Compared with the M group, the number of neurons in the Y group and the JH group is rich, the distribution is uniform, the shape is regular, and the cell nucleus boundary is clear; the JL group has a large number of pyknotic neurons, the staining is deepened, and the cell nucleus boundary is not clear.

[0134] c. Serum inflammatory factors IL-1β and PGE2 results:

[0135] The serum inflammatory factor detection results of rats in each group are shown in Table 4, Figure 6 . Figure 6 compared with the NC group, ###P<0.001; compared with M group, *** P<0.001.

[0136] Table 4 Serum inflammatory factor IL-1β and PGE2 concentration

[0137]

[0138] The results show that, compared with the NC group, the concentration of inflammatory factors in the M group is significantly increased, indicating that the fever modeling can cause the increase of serum IL-1β and PGE2 levels in rats; compared with the M group, the Y group, the JL group and the JH group have a significant inhibitory effect on IL-1β and PGE2, and the inhibitory effect is stronger with the increase of the dose. It is shown that the compound Nanteng analgesic capsule may play a certain antipyretic effect by inhibiting serum inflammatory factors and reducing endogenous pyrogen-induced fever, and at the same time, by protecting and regulating the hypothalamic tissue to regulate the body temperature.

[0139] In summary, the compound Nanteng analgesic capsule provided by the present application has antipyretic effect, which may be through inhibiting inflammatory mediators in serum to reduce endogenous pyrogen-induced fever, and at the same time, by protecting and regulating the hypothalamic tissue to regulate the body temperature.

[0140] Experimental Example 5

[0141] In this experimental example, 103 patients with pain or fever were treated with the traditional Chinese medicine composition capsule particles prepared in Example 6, including 51 male patients and 52 female patients. 68 patients with pain were treated, including female physiological pain, headache, back pain and surgical pain, etc. Within 30 minutes after taking, 38 patients (55.88%) experienced pain relief, and 30 patients (44.12%) experienced complete pain relief. 35 patients with fever caused by external evil qi were treated, and the average body temperature before taking was 38.6 degrees. After taking the preparation, all patients were defervesced within 2 hours. 35 patients with fever caused by external evil qi were treated. Results: The average body temperature before taking was 38.6 degrees. After taking the preparation, all patients were defervesced within 2 hours.

[0142] This experimental example also provides the following typical cases:

[0143] Zheng, female, born in January 1981. The date of treatment was August 9, 2016. Complaint: painful during menstruation. Take 3 pills of the preparation, and the pain is basically relieved within 30 minutes.

[0144] Shang, female, born in April 1975. The date of treatment was March 18, 2017. Complaint: chills, headache and head swelling, weakness, fever 38.6 degrees. Take 3 pills of the preparation, and the sweating, headache and dizziness are relieved within 45 minutes.

[0145] Zhang, female, born in July 1975, date of visit: February 28, 2019. Complaint: breast cancer surgery, pain, and difficulty falling asleep after chemotherapy. Take 3 pills, and the pain is relieved after half an hour, and sleep peacefully.

[0146] Li, male, born in May 1987, date of visit: December 23, 2022. Complaint: caused by external evil and evil qi, morning fever 38.3 degrees, upper body aching, cough. Take 3 pills. Two hours after taking the medicine, the whole body sweats, the fever subsides, and the aching phenomenon is also improved.

[0147] Experimental Example 6

[0148] This experimental example uses the capsule particles of the traditional Chinese medicine composition prepared in Example 1 to treat new crown positive patients: from early December 2022 to January 10, 2023, the total number of new crown positive patients participating in taking the capsule particles of the traditional Chinese medicine composition of the invention is 144, of which 85 are males and 59 are females. Take medicine once a day, 2-3 pills each time, a total of 1-3 times.

[0149] The statistical results are as follows:

[0150] The total effective rate of the traditional Chinese medicine composition capsule particles of the invention for new crown positive patients is 94.4% (136 / 144). From the number of times of taking medicine, 63.2% (91 / 144) is effective for taking medicine once. From the effects of pain relief and fever relief, the effective rate of pain relief is 93.8% (135 / 144), and the effective rate of fever relief is 89.6% (129 / 144). The incidence of adverse reactions is about 2.1% (3 / 144), mainly manifested as skin rash, gastrointestinal irritation, and upper body nerve pain. Figure 7 ).

[0151] Comparison of efficacy: 5 cases of new crown positive patients treated with Xuanfei failure virus particles were collected, with a total effective rate of 100%, 2 cases taking 2 times effective, and 3 cases taking 3 times effective. Compared with the treatment of new crown positive patients with the traditional Chinese medicine composition capsule particles of the invention, the efficacy is comparable, but there is no one-time effective. The one-time effective rate of the traditional Chinese medicine composition capsule particles of the invention for treating new crown positive patients is 63.2%.

[0152] Experimental Example 7

[0153] This experimental example uses the capsule particles prepared in Example 1 to treat new crown positive patients of the Omicron variant, and provides the following typical cases:

[0154] Shen, female, 52 years old. On the morning of December 17, 2022, the body temperature was 37.2 degrees, and by 11 pm, the body temperature rose to 38.4 degrees, the throat was inflamed and painful, and the head was severely painful. Take 3 pills before going to bed, and two hours later, the whole body sweats, the headache disappears, the body temperature returns to normal, and the mental state recovers.

[0155] Zhuang, male, 41 years old. On the evening of December 19, 2022, he felt fever and fatigue, with a body temperature of 37.5 degrees. On the morning of December 20, he had repeated low fever and took 2 tablets of ibuprofen, but the fever did not subside. At noon on December 20, he took three tablets of the product, and sweated and subsided the fever about an hour later. Thereafter, he occasionally had a cough, and the antigen test was negative.

[0156] Wang, male, 40 years old. On the morning of December 20, 2022, he had a high fever of 40 degrees and a whole body cold. He took one tablet of ibuprofen, but the fever did not subside. At 9 am the next morning, he took three tablets of the product, and sweated and subsided the fever 40 minutes later. The next day, he had a slight recurrence and took three tablets again, and the fever subsided without further recurrence.

[0157] Feng, male, 31 years old. On December 21, 2022, he had a fever of 38.4 degrees, headache, cough, and an uncomfortable throat. He took three tablets of the product, and the fever subsided within an hour, and all symptoms were alleviated.

[0158] Experimental Example 8

[0159] This experimental example uses the capsule particles prepared in Example 4 to treat patients positive for the new coronavirus variant Omicron, and provides the following typical cases:

[0160] Zhuang, female, 19 years old. On December 22, 2022, she felt cold in her hands and feet, headache, and fatigue, with a body temperature of 37.6. She rested in bed, and her temperature was 38.3 degrees in the evening. She took three tablets of the product, sweated, and subsided the fever. The next day, she had a low fever of about 37.5, and took three tablets again. On the third day, she had no fever, occasional cough, and slight acid pain in her whole body, and recovered a few days later.

[0161] Zhang, male, 50 years old. On December 17, 2022, he had a fever of 37.8 degrees, and his temperature rose to 38.8 degrees at about 8 am. He took three tablets of the product, and the fever subsided after two hours. The next day, he had a fever again, and continued to take three tablets, and the fever subsided without recurrence.

[0162] Fan, female, 30 years old. On December 23, 2022, she had a headache and a very hot forehead during the day, a fever of 39.8 degrees at night, a headache and dizziness, and a loss of appetite. She took three tablets of the product, and sweated, the headache disappeared, and the fever subsided after two hours. She had a normal temperature of 36.6 degrees on the afternoon of December 24, a stuffy nose, and fatigue, and took three tablets of the product again. Thereafter, her temperature was normal at 36.6 degrees, and she had no discomfort.

[0163] The above examples only express several embodiments of the present application, facilitate the specific and detailed understanding of the technical solutions of the present application, but cannot be understood as a limitation on the protection scope of the invention patent. It should be noted that for ordinary skilled persons in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are within the protection scope of the present application.

Claims

1. The use of a traditional Chinese medicine composition in the preparation of a medicament for preventing or treating diseases caused by pathogenic factors and evil qi or their sequelae, characterized in that, The traditional Chinese medicine composition is prepared from the following raw medicinal materials by weight: Adenia hindsiana 5-15 parts, Euphorbia humifusa 5-15 parts, Zingiber officinale 1-10 parts, Benincasa cerifera 1-10 parts. 2.The application of the traditional Chinese medicine composition of claim 1 in the preparation of a medicine for preventing or treating diseases caused by pathogenic factors and sequelae, characterized in that, The traditional Chinese medicine composition is prepared from the following raw medicinal materials by weight: Adenia hindsiana 9-12 parts, Euphorbia humifusa 8-10 parts, Zingiber officinale 6-7 parts, Benincasa cerifera 2-2.5 parts. 3.The application of the traditional Chinese medicine composition of claim 2 in the preparation of a medicine for preventing or treating diseases caused by pathogenic factors and sequelae, characterized in that, The traditional Chinese medicine composition is prepared from the following raw medicinal materials by weight: Adenia hindsiana 10 parts, Euphorbia humifusa 10 parts, Zingiber officinale 6 parts, Benincasa cerifera 2 parts.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicine for preventing or treating diseases caused by pathogenic factors and evils or their sequelae, characterized in that, In the traditional Chinese medicine composition, the mass ratio of euphorbia humifusa alkaloid to cucurbitacin is (0.7-1.0):(0.4-1.5).

5. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for preventing or treating diseases caused by pathogenic factors or sequelae thereof, characterized in that, In the traditional Chinese medicine composition, the mass ratio of euphorbia humifusa alkaloid to 6-gingerol is (0.5-1.0):(1.4-3.0).

6. The use of the traditional Chinese medicine composition according to claim 4 in the preparation of a medicament for preventing or treating diseases caused by pathogenic factors and sequelae thereof, characterized in that, In the traditional Chinese medicine composition, the mass ratio of euphorbia humifusa alkaloid to 6-gingerol is (0.5-1.0):(1.4-3.0).

7. The use of the traditional Chinese medicine composition according to claim 5 in the preparation of a medicament for preventing or treating diseases caused by pathogenic factors or sequelae thereof, characterized in that, In the traditional Chinese medicine composition, the mass ratio of euphorbia humifusa alkaloid to 6-gingerol is (0.5-0.8):(1.4-2.5).

8. The use of the traditional Chinese medicine composition according to any one of claims 1-3, 6-7 in the preparation of a medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof, characterized in that, The disease caused by external pathogenic evil and pestilential qi or its sequelae is caused by the disorder of cell inflammatory factors, the cell inflammatory factors including at least one of TNF-α and IL-1β.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-3, 6-7 in the preparation of a medicine for preventing or treating diseases caused by pathogenic factors or sequelae thereof, characterized in that, The disease caused by external pathogenic evil and pestilential qi includes viral exogenous disease.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-3, 6-7 in the preparation of a medicament for preventing or treating diseases caused by pathogenic factors or sequelae thereof, characterized in that, The symptoms of the disease caused by external pathogenic evil and pestilential qi or its sequelae include at least one of high body temperature, spleen and kidney deficiency and coldness, consumption of qi and yin, and respiratory tract infection.

11. The use of the traditional Chinese medicine composition according to any one of claims 1-3, 6-7 in the preparation of a medicament for preventing or treating diseases caused by pathogenic factors or sequelae thereof, characterized in that, The traditional Chinese medicine composition is prepared by a preparation method comprising the following steps: S1, weighing each raw medicinal material according to the prescription, extracting with ethanol to obtain extract one; S2, decocting and extracting the residue after ethanol extraction in step S1 with water, concentrating the extract, alcohol precipitating, recovering ethanol until no alcohol taste, and obtaining extract two; S3, combining extract one in step S1 and extract two in step S2, adding auxiliary materials, and granulating.

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