Traditional Chinese medicine composition for treating acute respiratory virus infection as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating acute respiratory virus infection and application of the traditional Chinese medicine composition, relates to the technical field of traditional Chinese medicines, and particularly aims at solving the problems that in the background technology, an existing traditional Chinese medicine compound is usually narrow in application range and poor in effect on most complex fever. The traditional Chinese medicine composition comprises ephedra, gypsum, rhizoma anemarrhenae, almond, raw liquorice, honeysuckle, patrinia, sargentgloryvine stem, schizonepeta, divaricate saposhnikovia root, periostracum cicada and notopterygium root, is prepared by ventilating the lung, resolving the flesh, bringing down a fever, dispelling wind, eliminating dampness and detoxifying, is mild in medicine property and high in safety, and can be used for quickly and effectively treating fever patients.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating acute respiratory virus infection and its application. Background Art

[0002] Acute respiratory virus infection is one of the most common infectious diseases, with a high incidence rate, rapid transmission, and obvious seasonal epidemics. People around the world are troubled by it every year, resulting in health damage and economic losses.

[0003] Acute respiratory virus infection is divided into upper respiratory tract infection and lower respiratory tract infection. The pathogenic microorganisms that cause acute respiratory virus infection include viruses, bacteria, fungi, mycoplasma, chlamydia, etc. Viral infection is an important cause of acute respiratory virus infection. 70-80% of the pathogenic microorganisms in upper respiratory tract infection are viruses, and 6-61% of the pathogenic microorganisms in lower respiratory tract infection are viruses. Since the population is generally susceptible to the viruses that cause respiratory infections, and the viruses have strict intracellular parasitic characteristics and are prone to mutation and drug resistance and other biological characteristics, it brings certain difficulties to early clinical diagnosis and treatment.

[0004] Currently, there is a lack of specific antiviral drugs for this disease, and the treatment only follows several basic principles such as antiviral, immunomodulation, and symptom improvement. Because the viral antigens often mutate, the antiviral drugs on the market that have specific inhibitory effects on a certain specific virus cannot act on the mutated virus, making the existing vaccines lose the preventive effect on upper respiratory tract infections caused by new viruses. Due to reasons such as frequent virus mutation and side effects, the overall clinical efficacy is not good. In recent years, antiviral drugs such as oseltamivir and zanamivir have been relatively effective in treating this disease. Many modern studies have shown that oseltamivir phosphate capsules can effectively improve clinical symptoms and clinical efficacy in the treatment of upper respiratory virus infection, but they encounter bottlenecks due to high prices and certain toxic and side effects.

[0005] There are a wide variety of viruses involved in acute respiratory virus infection, including: influenza A virus, influenza B virus, respiratory syncytial virus, etc. Currently, there is still a lack of specific drugs for various viruses, and antibiotics are often needed to prevent secondary bacterial double infections. However, even with appropriate antibiotics, the mortality rate of double infections of this disease is still very high. Considering the strict intracellular parasitic characteristics of the virus and its tendency to mutate and develop drug resistance and other biological characteristics, the future is worrying.

[0006] Traditional Chinese medicine classifies acute respiratory virus infections as exogenous febrile diseases. Traditional Chinese medicine has a long history and remarkable efficacy in treating "exogenous fever". The diagnosis and treatment of "exogenous fever" were already reflected in the "Inner Canon of Huangdi" as early as ancient times. Through the continuous summarization and update by later generations of medical experts, it had formed a complete discipline by the Ming and Qing dynasties. The occurrence of exogenous febrile diseases is mainly due to the decline of the body's external defense ability, the invasion of exogenous pathogenic factors into the lung and defensive qi. Wind pathogens, together with other pathogenic factors, invade the lung and defensive qi, causing disharmony between nutrient qi and defensive qi and leading to the occurrence of diseases. The lung is in charge of the body's exterior and is responsible for dispersion and descent. When the defensive exterior is invaded by pathogenic factors, the functions of the lung's dispersion and descent are disrupted, and the disharmony of the lung and defensive qi functions leads to the occurrence of exogenous febrile diseases. The location of exogenous fever is mostly attributed to the defensive exterior, and the main symptoms include fever, sore throat, dizziness, headache, general body aches, runny nose, etc. In terms of treatment, methods such as diaphoresis, clearing heat, harmonizing shaoyang, and purging are the main treatment methods for exogenous febrile diseases.

[0007] Traditional Chinese medicine has rich means in treating exogenous febrile diseases. In the "Inner Canon of Huangdi", febrile diseases were subdivided into exogenous febrile diseases and endogenous febrile diseases, and it was recorded that fifty-nine needling points, fifty-nine shu points, and qi points for febrile diseases were used to treat febrile diseases, and the selection of needles and manipulation methods were also elaborated. In the "Emergency Prescriptions Worth a Thousand Gold" by Sun Simiao in the Tang Dynasty, there were more detailed discussions on acupoint application, and it was first proposed that febrile diseases could be treated by moxibustion, but there have been disputes on this in later generations. In recent years, pediatric tuina for reducing fever has gradually emerged, and the most well-known technique among them is "pushing the heavenly river". However, there are still certain limitations in treating exogenous febrile diseases by tuina. Although the research on treating exogenous febrile diseases by these three methods has gradually increased, neither the curative effect nor the research quantity is as good as that of traditional Chinese medicine treatment. Currently, traditional Chinese medicine treatment is still the mainstream, and the other therapies can be used as supplementary means to traditional Chinese medicine treatment.

[0008] Traditional Chinese medicine compound prescriptions have good effects in treating fever. Currently, there are also many traditional Chinese medicine compound prescriptions for treating exogenous febrile diseases, such as "Tuire No. 1" by Suzhou Traditional Chinese Medicine Hospital for wind-heat syndrome, compound houttuynia oral liquid for treating wind-heat syndrome, Qingfei Huoyu Decoction for treating syndrome of toxin stasis and lung obstruction, and so on. They have good curative effects on simple heat pathogens and toxin pathogens. However, toxin pathogens often do not exist alone. Therefore, the existing traditional Chinese medicine compound prescriptions often have a narrow scope of application and poor effects on most complex fevers.

[0009] Therefore, there is an urgent need to invent a traditional Chinese medicine composition for treating acute respiratory virus infections to solve the above problems. Summary of the Invention

[0010] Through a large number of clinical observations and literature studies, it has been found that when epidemic toxins cause diseases, dampness often combines with heat, dampness restrains heat, and damp toxins transform into heat, easily forming damp-heat type epidemic diseases, causing symptoms such as fever, muscle pain, sore throat, etc. Syndrome of wind-dampness stagnating in the exterior and heat invading the lung and defensive qi is a common clinical syndrome type. Treating it by the methods of dispersing the lung qi, relieving muscle spasms and reducing fever, dispelling wind and dampness and detoxifying can have a therapeutic effect. Therefore, the present invention has summarized the Anti-toxin and Anti-fever Decoction. The Anti-toxin and Anti-fever Decoction is a clinical experience prescription for treating fever (syndrome of wind-dampness stagnating in the exterior and heat invading the lung and defensive qi), with mild properties, high safety, and rapid and effective in treating fever patients.

[0011] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0012] A traditional Chinese medicine composition, characterized in that the weight parts of the traditional Chinese medicine raw materials include: 2-10 g of raw Ephedra, 15-60 g of raw Gypsum Fibrosum, 6-12 g of Anemarrhena Rhizome, 5-10 g of Apricot Kernel, 2-10 g of raw Licorice Root, 6-15 g of Honeysuckle Flower, 6-15 g of Patrinia Scabiosaefolia, 9-15 g of Sargentodoxa Cuneata, 5-10 g of Schizonepeta Tenuifolia, 5-10 g of Ledebouriella Root, 3-6 g of Cicada Slough, 3-10 g of Notopterygium Root.

[0013] Preferably, the weight parts of the traditional Chinese medicine raw materials include: 3 g of raw Ephedra, 40 g of raw Gypsum Fibrosum, 12 g of Anemarrhena Rhizome, 10 g of Apricot Kernel, 6 g of raw Licorice Root, 15 g of Honeysuckle Flower, 15 g of Patrinia Scabiosaefolia, 12 g of Sargentodoxa Cuneata, 10 g of Schizonepeta Tenuifolia, 10 g of Ledebouriella Root, 6 g of Cicada Slough and 10 g of Notopterygium Root.

[0014] Preferably, 2 g of Ephedra, 15 g of raw Gypsum Fibrosum, 6 g of Anemarrhena Rhizome, 5 g of Apricot Kernel, 2 g of raw Licorice Root, 6 g of Honeysuckle Flower, 6 g of Patrinia Scabiosaefolia, 9 g of Sargentodoxa Cuneata, 5 g of Schizonepeta Tenuifolia, 5 g of Ledebouriella Root, 3 g of Cicada Slough, and 3 g of Notopterygium Root.

[0015] Preferably, the weight parts of the traditional Chinese medicine raw materials include: 10 g of Ephedra, 60 g of raw Gypsum Fibrosum, 12 g of Anemarrhena Rhizome, 10 g of Apricot Kernel, 10 g of raw Licorice Root, 15 g of Honeysuckle Flower, 15 g of Patrinia Scabiosaefolia, 15 g of Sargentodoxa Cuneata, 10 g of Schizonepeta Tenuifolia, 10 g of Ledebouriella Root, 6 g of Cicada Slough and 10 g of Notopterygium Root.

[0016] Preferably, the dosage form of the traditional Chinese medicine composition is an oral dosage form, and the oral dosage form is a granule, tablet, capsule, pill, syrup, powder, paste, dripping pill, suspension, emulsion, sustained-release preparation or controlled-release preparation.

[0017] The nature, flavor, meridian tropism and efficacy of the Chinese medicinal materials used in the present invention are as follows:

[0018] Ephedra, pungent, slightly bitter, warm. Entering the lung and bladder meridians, it has the effects of inducing sweating and dispelling cold, dispersing the lung qi and relieving asthma, promoting diuresis and reducing swelling.

[0019] Raw Gypsum Fibrosum, sweet, pungent, extremely cold in nature, belonging to the lung and stomach meridians, having the effects of clearing heat and purging fire, removing vexation and quenching thirst.

[0020] Anemarrhena Rhizome, bitter, sweet and cold in nature, mainly belonging to the lung, stomach and kidney meridians, having the effects of clearing heat and purging fire, nourishing yin and moistening dryness.

[0021] Apricot Kernel, bitter, slightly warm, slightly toxic in nature, and mainly belonging to the lung and large intestine meridians, having the effects of lowering qi, relieving cough and asthma, and loosening the bowels and relieving constipation.

[0022] Licorice root, with a sweet and neutral taste, belongs to the heart, spleen, stomach, and lung meridians, and has the effects of invigorating the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating pain by relaxing muscles, and coordinating various medicinal herbs.

[0023] Honeysuckle flower, with a sweet and cold taste, belongs to the lung, heart, and stomach meridians, and has the effects of clearing heat and detoxifying, dispersing wind-heat.

[0024] Patrinia scabiosaefolia Fisch. ex Link, with a bitter and pungent taste and slightly cold nature, belongs to the liver, stomach, and large intestine meridians, and has the effects of clearing heat and detoxifying, eliminating carbuncles and discharging pus, removing stasis and relieving pain.

[0025] Sargentodoxa cuneata (Oliv.) Rehd. et Wils., with a bitter and flat taste, enters the liver and large intestine meridians, and has the effects of clearing heat and detoxifying, promoting blood circulation, dispelling wind and relieving pain.

[0026] Schizonepeta tenuifolia Briq., with a pungent and warm taste, belongs to the lung and liver meridians, and has the effects of expelling wind and relieving exterior syndrome, inducing eruption and resolving carbuncles.

[0027] Saposhnikovia divaricata (Turcz.) Schischk., with a pungent and sweet taste and slightly warm nature, enters the bladder, liver, and spleen meridians, and has the effects of expelling wind and relieving exterior syndrome, eliminating dampness and relieving pain, stopping convulsions.

[0028] Cryptotympana pustulata Fabricius, with a sweet and cold taste, enters the liver and lung meridians, and has the effects of dispersing wind-heat, relieving sore throat and restoring voice, inducing eruption, removing nebula and improving eyesight, calming endogenous wind and stopping convulsions.

[0029] Notopterygium incisum Ting ex H. T. Chang, with a pungent and bitter taste and warm nature, belongs to the bladder and kidney meridians, and has the effects of inducing sweating to dispel cold, expelling wind and removing dampness, relieving pain.

[0030] The second object of the present invention is to provide a preparation method of a traditional Chinese medicine composition, including:

[0031] S1. Take raw Ephedra, raw Gypsum Fibrosum, Anemarrhena asphodeloides Bunge, Armeniaca vulgaris Lam., Licorice root, Honeysuckle flower, Patrinia scabiosaefolia Fisch. ex Link, Sargentodoxa cuneata (Oliv.) Rehd. et Wils., Schizonepeta tenuifolia Briq., Saposhnikovia divaricata (Turcz.) Schischk., Cryptotympana pustulata Fabricius, and Notopterygium incisum Ting ex H. T. Chang according to the dosage, add 10 times the amount of water, and soak in cold water for 2 h;

[0032] S2. Pour the washed Gypsum Fibrosum and the soaking water into a pot, boil over high heat and then turn to medium heat for 20 - 25 minutes, then put the other soaked herbs except Honeysuckle flower into the pot and decoct together. After boiling over high heat, turn to medium - low heat and simmer for 20 minutes, and finally add Honeysuckle flower and continue to simmer for 5 - 10 minutes, then filter and pour out the decoction;

[0033] S3. Add 1000 - 1500 ml of water to the filter residue, decoct for 30 - 40 minutes, and then filter again;

[0034] S4. Mix the two decoctions after removing the residue and filtering.

[0035] The third object of the present invention is to provide an application of a traditional Chinese medicine composition in the preparation of a drug for treating acute respiratory virus infection.

[0036] The beneficial effects of the present invention are as follows: The present invention discloses a traditional Chinese medicine composition for treating acute respiratory virus infection and its application. Compared with the prior art, the improvements of the present invention are as follows:

[0037] The traditional Chinese medicine composition of the present invention has an obvious therapeutic effect on patients with the syndrome type of heat attacking the lung and defensive qi syndrome, who show symptoms such as fatigue, heaviness of the body, cough with sticky phlegm, loss of appetite, etc. The traditional Chinese medicine composition of the present invention uses ephedra and raw gypsum as the monarch drugs, anemarrhena asphodeloides and apricot kernels as the ministerial drugs, honeysuckle, patrinia villosa, sargentgloryvine, schizonepeta tenuifolia, ledebouriella seseloides, cicada slough, and notopterygium incisum as the adjuvant drugs, and raw licorice as the guiding drug, achieving the therapeutic principles and methods of dispersing the lung qi, relieving the muscles and reducing fever, dispelling wind and dampness, and detoxifying.

[0038] The compatibility characteristics of the traditional Chinese medicine composition of the present invention are as follows: 1. Equal emphasis on relieving the exterior and clearing heat: The monarch drugs, ephedra and raw gypsum, are used in combination with cold and warm properties, which can not only disperse wind-cold but also clear heat and detoxify, providing comprehensive treatment for the syndrome of exogenous fever. 2. Taking clearing heat and detoxifying as the core: Among the ministerial drugs and adjuvant drugs, the drugs for clearing heat and detoxifying occupy an important position (such as honeysuckle, patrinia villosa, etc.), especially suitable for the symptoms of internal stagnation of heat toxin. 3. Combining dispersing wind and relieving the exterior with eliminating dampness and expelling pathogenic factors: Drugs such as schizonepeta tenuifolia, ledebouriella seseloides, and notopterygium incisum disperse wind and expel pathogenic factors, and are combined with drugs for clearing heat and detoxifying to strengthen the dual treatment of exogenous and internal dampness obstruction. 4. Eliminating pathogenic factors without damaging healthy qi: Drugs such as anemarrhena asphodeloides and raw licorice are used in combination to moisten dryness and harmonize, preventing excessive pungent dispersion and purging from damaging healthy qi. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 It is a statistical chart of fever in two groups before and after the experiment in Example 4 of the present invention;

[0040] Figure 2 It is a statistical chart of fatigue in two groups before and after the experiment in Example 4 of the present invention;

[0041] Figure 3 It is a statistical chart of cough in two groups before and after the experiment in Example 4 of the present invention;

[0042] Figure 4 It is a statistical chart of general body aches in two groups before and after the experiment in Example 4 of the present invention;

[0043] Figure 5 It is the initial diagnosis form of the experimental subjects in Example 4 of the present invention;

[0044] Figure 6 It is the second initial diagnosis form of the experimental subjects in Example 4 of the present invention;

[0045] Figure 7 It is the first follow-up diagnosis form of the experimental subjects in Example 4 of the present invention;

[0046] Figure 8 It is the second follow-up diagnosis form of the experimental subjects in Example 4 of the present invention;

[0047] Figure 9The initial diagnosis list three and medications of the experimental subject in Example 4 of the present invention;

[0048] Figure 10 The initial diagnosis list three and medications of the experimental subject in Example 4 of the present invention;

[0049] Figure 11 The doctor's advice one of the experimental subject in Example 4 of the present invention;

[0050] Figure 12 The doctor's advice two of the experimental subject in Example 4 of the present invention. Detailed implementation manners

[0051] In order to enable those of ordinary skill in the art to better understand the technical solutions of the present invention, the technical solutions of the present invention will be further described below in conjunction with the accompanying drawings and embodiments. The following embodiments are used to illustrate the present invention, but cannot be used to limit the scope of the present invention.

[0052] Example 1:

[0053] A traditional Chinese medicine composition for treating acute respiratory virus infection, comprising the following traditional Chinese medicine raw materials in parts by weight:

[0054] The first specific component ratio:

[0055] Ephedra 3g, Gypsum Fibrosum 40g, Anemarrhena Rhizome 12g, Apricot Kernel 10g, Glycyrrhiza Uralensis Fisch. 6g, Lonicera Japonica Thunb. 15g, Patrinia Scabiosaefolia Fisch. 15g, Sargentodoxa Cuneata 12g, Schizonepeta Tenuifolia Briq. 10g, Saposhnikovia Divaricata (Turcz.) Schischk. 10g, Cryptotympana pustulata Fabricius 6g, and Notopterygium Incisum Ting ex H. T. Chang 10g;

[0056] Preparation method of decoction:

[0057] S1. Take each medicinal material according to the above ratio, add 10 times the amount of water, and soak in cold water for 2 hours;

[0058] S2. Pour the cleaned gypsum and the soaked water into a pot, bring to a boil over high heat and then turn to medium heat and cook for 20 - 25 minutes. Then put the other soaked medicines except Lonicera Japonica Thunb. into the pot and cook together. After boiling over high heat, turn to medium - low heat and boil for 20 minutes. Finally, add Lonicera Japonica Thunb. and continue to cook for 5 - 10 minutes, then filter and pour out the soup;

[0059] S3. Add 1000 - 1500 ml of water to the filter residue, and decoct for 30 - 40 minutes and then filter again;

[0060] S4. Mix the two decoctions after removing the residue and filtering to obtain the decoction.

[0061] The Anti-Virus and Fever-Reducing Formula (the traditional Chinese medicine composition of the present invention) was prescribed at Wangjing Hospital of China Academy of Chinese Medical Sciences from November 2022 to January 2023, and was widely used in the fever clinic, respiratory department and each inpatient ward to treat patients with fever caused by novel coronavirus infection, with rapid and effective fever reduction. From December 5, 2022 to July 30, 2023, a total of 2,755 patients in the fever clinic of our hospital used the Anti-Virus and Fever-Reducing Formula. The age range was 14 - 85 years old. They were diagnosed with novel coronavirus infection through novel coronavirus antigen detection (colloidal gold method) or novel coronavirus nucleic acid detection (real-time fluorescence PCR method). The clinical classification was mainly mild, accounting for 72%. The symptoms mainly included fever, headache and body pain, muscle soreness, dry throat, sore throat, dry cough, fatigue, loss of appetite, and red tongue, yellow tongue coating, floating, string-like and rapid pulse, etc. After treatment, the symptoms of fever and muscle soreness improved the fastest. The average fever course was about 2.35 days, and the clinical symptoms were significantly improved on the 7th day after treatment.

[0062] Example 2:

[0063] The second specific component ratio:

[0064] Ephedra 2g, Gypsum Fibrosum 15g, Anemarrhena Rhizome 6g, Apricot Kernel 5g, Licorice Root 2g, Honeysuckle Flower 6g, Patrinia Scabiosaefolia 6g, Sargentodoxa Cuneata 9g, Schizonepeta Tenuifolia 5g, Ledebouriella Root 5g, Cicada Slough 3g, and Notopterygium Root 3g.

[0065] Preparation method of decoction:

[0066] S1. Take each medicinal material according to the above ratio, add 10 times the amount of water, and soak in cold water for 2 hours;

[0067] S2. Pour the cleaned gypsum and the soaked water into a pot, boil over high heat and then turn to medium heat for 20 - 25 minutes. Then put the other soaked medicinal materials except honeysuckle flower into the pot and decoct together. After boiling over high heat, turn to medium-low heat and simmer for 20 minutes. Finally, add honeysuckle flower and continue to boil for 5 - 10 minutes, then filter and pour out the decoction;

[0068] S3. Add 1000 - 1500 ml of water to the filter residue, decoct for 30 - 40 minutes and then filter again;

[0069] S4. Mix the two decoctions after removing the residue and filtering to make the decoction.

[0070] Example 3:

[0071] The third specific component ratio:

[0072] Ephedra 10g, Gypsum Fibrosum 60g, Anemarrhena Rhizome 12g, Apricot Kernel 10g, Licorice Root 10g, Honeysuckle Flower 15g, Patrinia Scabiosaefolia 15g, Sargentodoxa Cuneata 15g, Schizonepeta Tenuifolia 10g, Ledebouriella Root 10g, Cicada Slough 6g, and Notopterygium Root 10g.

[0073] Decoction preparation method:

[0074] S1. Take each medicinal material according to the above ratio, add 10 times the amount of water, and soak in cold water for 2 hours;

[0075] S2. Pour the cleaned gypsum and the soaked water into a pot, bring to a boil over high heat and then turn to medium heat and cook for 20 - 25 minutes. Then put the other soaked medicinal materials except honeysuckle into the pot and cook together. After bringing to a boil over high heat, turn to medium - low heat and simmer for 20 minutes. Finally, add honeysuckle and continue to cook for 5 - 10 minutes, then filter and pour out the decoction;

[0076] S3. Add 1000 - 1500 ml of water to the residue, decoct for 30 - 40 minutes, and then filter again;

[0077] S4. Mix the two decoctions after removing the residues and filtering them to obtain the finished decoction.

[0078] Example 4:

[0079] Example 4 is the clinical experiment of the traditional Chinese medicine composition in Example 1. The experimental results show that this prescription has the effect of treating acute respiratory virus infection, as shown in the attached Figure 5 - 12 shown.

[0080] 1. Grouping and statistics of clinical experiment subjects

[0081] Collect 180 cases of adult virus - infected fever with rheumatism stagnating in the exterior and heat invading the lung - defensive qi syndrome that meet the requirements of this research trial from the fever clinic of Wangjing Hospital, China Academy of Chinese Medical Sciences (from December 1, 2023 to September 31, 2024). Randomly divide them into a treatment group and a control group, with 90 cases in each group, ensuring that the selected patients meet the ethical requirements.

[0082] In the RCT experiment, a total of 180 patients were included and randomly divided into an experimental group and a control group. Due to reasons such as irregular medication or loss of contact, a total of 10 patients were excluded. Finally, 87 people were retained in the experimental group and 83 people in the control group. Use SPSS27.0 statistical analysis software to input and analyze all the data in this trial. Among them, the fever gradings are shown in Table 1,

[0083] Table 1 Fever gradings

[0084] 37.3℃-37.9℃ 38℃-38.4℃ 38.5℃-38.9℃ ≥39℃ Experimental group 13 people 25 people 19 people 30 people Control group 13 people 23 people 20 people 27 people

[0085] 2. Comparison of single - symptom scores and total TCM syndrome scores before treatment between the two groups of patients

[0086] TCM syndrome scoring standard: The scoring was performed according to the symptom grading quantitative table in the "Guidelines for Clinical Research of New Chinese Medicines". Each symptom was classified into none, mild, moderate, severe, and extremely severe, and scored as 0, 1, 2, 3, and 4. The higher the score, the more severe the symptom. The specific symptoms were fever, aversion to cold, cough, sputum, headache, sore throat, nasal congestion, runny nose, body pain, thirst, fatigue, poor appetite, loose stools, and body heaviness, a total of 14 items. Before treatment, the scores of single symptoms such as fever, cough, sputum, nasal congestion, and runny nose in the two groups of patients were tested for normality, and it was found that they did not meet the normal distribution. Therefore, the rank sum test of two independent samples was used, and the median and quartiles were used to express it. As shown in Table 2, the results were P>0.05. The scores of the two groups of patients were compared (points, median (P25, P75)), and there was no statistically significant difference, which was comparable.

[0087] Table 2 Comparison of scores between the two groups before treatment

[0088] Primary / secondary symptoms Statistical items Experimental group Control group Z P Primary symptom Fever 3.00(2.00，4.00) 3.00(2.00，4.00) -0.148 0.883 Secondary symptom Fatigue 2.00(1.00，3.00) 2.00(1.00，3.00) -1.043 0.297 Secondary symptom Cough 2.00(0.00，3.00) 2.00(0.00，2.00) -0.153 0.249 Secondary symptom General body aches 2.00(0.00，3.00) 2.00(0.00，3.00) -0.185 0.854 Secondary symptom Olfactory and gustatory disorders 0.00(0.00，1.00) 0.00(0.00，0.00) -0.244 0.808 Secondary symptom Diarrhea 0.00(0.00，0.00) 0.00(0.00，0.00) -0.178 0.074 Secondary symptom Nasal congestion 1.00(0.00，2.00) 1.00(0.00，2.00) -0.169 0.805 Secondary symptom Runny nose 0.00(0.00，2.00) 0.00(0.00，1.00) -0.550 0.582 Secondary symptom Headache 0.00(0.00，2.00) 0.00(0.00，1.00) -1.188 0.235 Secondary symptom Chills 0.00(0.00，1.00) 0.00(0.00，1.00) -0.517 0.605 Secondary symptom Traditional Chinese medicine syndrome 13.00(6.00，22.00) 16.00(10.00，23.00) -1.354 0.176

[0089] 3. Experimental Procedure

[0090] 1. The experimental group was given the anti-toxic and antipyretic granules (the Chinese medicine composition of embodiment 1 of the present invention), usage: 1 dose in the morning, noon and evening, taken with water, for 6 consecutive days, and combined with basic treatment; wherein, antiviral treatment was used in combination with basic treatment. Antiviral drugs mainly include broad-spectrum antiviral drugs, anti-DNA virus drugs, anti-RNA virus drugs, protease inhibitor antiviral drugs and antiviral drugs that inhibit RNA synthesis. Specific antiviral drug treatment is determined comprehensively based on etiology, body condition and drug antiviral spectrum, etc.) as shown in Table 3;

[0091] Table 3 Details of various antiviral drugs

[0092]

[0093]

[0094] 2. The patients in the control group took the simulated agent of Kangdu Tuifever Recipe Granules (5% original drug + 95% dextrin, flavoring agent, pigment) for a total of 1 dose in the morning and evening, taken orally for 6 consecutive days, combined with basic treatment; among them, the combined basic treatment adopted antiviral treatment, and the drugs and dosage were the same as those of the basic treatment of the experimental group.

[0095] Please note that during the trial, patients in each group are not allowed to use other Chinese and Western medicines with the same effects as the trial drugs, including oral and topical medications, such as Chinese herbal preparations containing antipyretic drugs such as ephedra, bupleurum, and cinnamon twigs, as well as Western medicine antipyretic analgesics, glucocorticoids, etc.

[0096] 4. Experimental conclusion. Comparison of single symptom scores and total TCM syndrome scores between the two groups before and after treatment and between the two groups;

[0097] The individual scores and TCM syndrome scores of the two groups of patients were compared respectively. Since the changes of various indicators of the two groups of patients at multiple time points were analyzed, the repeated measures analysis of variance was used for analysis (P<0.05). As shown in Tables 4-6 and the appendix Figure 1 - 12 shown, the improvement of the individual symptoms (except body aches and diarrhea) and the total score of TCM syndrome scores in the experimental group was significantly better than that in the control group, and the onset of action was faster. Although there was little difference in the overall effect of improving body aches between the experimental group and the control group, the experimental group had a faster significant effect and could relieve the symptoms of patients faster. There were few patients with diarrhea symptoms in both groups, only 3 people, which was not statistically significant, so it was not discussed here.

[0098] Table 4 Statistical table of individual symptoms in the experimental group and the control group before and after treatment - I

[0099]

[0100] Table 5 Statistical table of individual symptoms in the experimental group and the control group before and after treatment - II

[0101]

[0102] Table 6 Statistical table of TCM syndrome scores in the experimental group and the control group before and after treatment

[0103]

[0104] The above shows and describes the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited by the above embodiments. What is described in the above embodiments and the specification only illustrates the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and these changes and improvements all fall within the scope of the present invention claimed. The scope of protection claimed by the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition, characterized in that: The weight proportions of the Chinese medicinal raw materials include: 2-10g raw ephedra, 15-60g raw gypsum, 6-12g rhizome of anemarrhena, 5-10g apricot kernel, 2-10g raw licorice, 6-15g honeysuckle, 6-15g patrinia herb, 9-15g red vine, 5-10g schizonepeta, 5-10g siler, 3-6g pericarp of cicada, and 3-10g notopterygium wilfordii.

2. The Chinese medicine composition according to claim 1, characterized in that: The weight proportions of the Chinese medicinal raw materials include: 3g raw ephedra, 40g raw gypsum, 12g rhizome of anemarrhena, 10g apricot kernel, 6g raw licorice, 15g honeysuckle, 15g patrinia herb, 12g red vine, 10g schizonepeta, 10g siler, 6g cicada shell and 10g notopterygium wilfordii.

3. The Chinese medicine composition according to claim 1, characterized in that The weight proportions of the Chinese medicinal raw materials include: 2g of ephedra, 15g of gypsum, 6g of rhizoma anemarrhenae, 5g of apricot kernel, 2g of raw licorice, 6g of honeysuckle, 6g of herba patriniae, 9g of scutellariae, 5g of schizonepeta, 5g of siler, 3g of pericarpium cicadae, and 3g of notopterygium wilfordii.

4. The Chinese medicine composition according to claim 1, characterized in that: The weight proportions of the Chinese medicinal raw materials include: 10g of ephedra, 60g of gypsum, 12g of rhizoma anemarrhenae, 10g of apricot kernel, 10g of raw licorice, 15g of honeysuckle, 15g of patrinia herb, 15g of red vine, 10g of schizonepeta, 10g of siler, 6g of pericarpium cicadae and 10g of notopterygium wilfordii.

5. A Chinese medicine composition according to claim 1, characterized in that: The dosage form of the Chinese medicine composition is an oral dosage form, and the oral dosage form is granules, tablets, capsules, pills, syrups, powders, pastes, pellets, suspensions, emulsions, sustained-release preparations or controlled-release preparations.

6. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The preparation steps include: S1. Take raw ephedra, raw gypsum, rhizoma anemarrhenae, apricot kernel, raw licorice, honeysuckle, herba patriniae, scutellariae, herba schizonepetae, herba sileratae, herba cicadae and herba notopteris according to the amount, add 10 times the amount of water, and soak in cold water for 2 hours; S2. Pour the cleaned gypsum and soaking water into the pot, turn to medium heat and cook for 20-25 minutes, then put the other soaked drugs except honeysuckle into the pot and boil together, boil over high heat and then turn to medium-low heat and simmer for 20 minutes, finally add honeysuckle and continue to boil for 5-10 minutes, then filter and pour out the soup; S3. Add 1000-1500 ml of water to the residue, and decocted for 30-40 minutes and filtered again; S4. Remove the residue from the two decoctions, filter them and mix them.

7. Use of the Chinese medicine composition according to claim 1 in the preparation of medicines for treating acute respiratory viral infections.

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