Traditional Chinese medicine composition for preventing and treating novel coronavirus infection, preparation method and application thereof

Abstract

The invention discloses a Chinese medicine composition for preventing and treating novel coronavirus infection, which is prepared from the following raw materials in parts by weight: 30-50 of Astragalus, 20-40 of Polygonum cuspidatum, 20-40 of Verbena, 10-20 of Scutellaria baicalensis, 5-15 of Forsythia, 2-8 of Cyperus rotundus, 5-12 of Patchouli, 2-7 of Rhubarb, 20-40 of Coix seeds, 20-40 of Feather of Astragalus, 5-12 of Trichosanthes, and 5-12 of Licorice. The Chinese medicine composition has the effects of invigorating qi and strengthening spleen, clearing away heat and removing dampness, promoting blood circulation and detoxifying. Clinical trials show that it can significantly shorten the total time and hospitalization time for patients with novel coronavirus infection, especially patients with long-term positive nucleic acid test, for patients with novel coronavirus infection, which is significantly better than the Western medicine treatment group, and realizes the rapid negative conversion of infected persons, inhibits re-positive, and effectively cures, with remarkable effects. In addition, the invention also discloses the preparation method and use of the Chinese medicine composition.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition for preventing and / or treating novel coronavirus infection. In addition, the present invention also relates to a preparation method and use of the traditional Chinese medicine composition. Background Art

[0002] The new coronavirus (SARS-CoV-2) belongs to the β-genus coronavirus. It has an envelope, and the particles are round or oval, with a diameter of 60 to 140 nm. It has 5 essential genes, which target four structural proteins, namely nucleoprotein (N), viral envelope (E), matrix protein (M) and spike protein (S), and RNA-dependent RNA polymerase (RdRp). The nucleoprotein (N) encapsulates the RNA genome to form the nucleocapsid, which is surrounded by the viral envelope (E). The viral envelope is embedded with proteins such as matrix protein (M) and spike protein (S). The spike protein enters the cell by binding to angiotensin-converting enzyme 2 (ACE-2). When isolated and cultured in vitro, the new coronavirus can be found in human respiratory epithelial cells in about 96 hours, while it takes about 4 to 6 days to isolate and culture in Vero E6 and Huh-7 cell lines.

[0003] Like other viruses, the genome of the new coronavirus will also mutate, and some mutations will affect the biological characteristics of the virus. For example, changes in the affinity of the S protein to ACE-2 will affect the ability of the virus to invade cells, replicate, and spread, the production of antibodies during the recovery period and after vaccination, and the neutralizing ability of antibody drugs, which has attracted widespread attention. The World Health Organization (WHO) has proposed five "variants of concern" (VOC), namely Alpha, Beta, Gamma, Delta, and Omicron. At present, the Omicron variant has replaced Delta as the main epidemic strain. Existing evidence shows that the Omicron strain is more transmissible than the Delta strain, and its pathogenicity has been weakened. The diagnostic accuracy of the PCR test routinely used in my country has not been affected, but it may reduce the neutralizing effect of some monoclonal antibody drugs.

[0004] It can be seen that the current novel coronavirus Omicron variant has high infectivity and low pathogenicity. Most of the infected people are asymptomatic or have mild symptoms, while severe and critical cases are rare. The clinical symptoms are mainly upper respiratory tract infection symptoms such as fever, fatigue, muscle aches, sore throat, and cough, and lower respiratory tract infection symptoms are rare.

[0005] In many studies, it is often used as a surrogate indicator of infectiousness, that is, the duration of viral shedding in patients is used as the infectious period. Since coronavirus RNA detection is more sensitive than virus isolation, most studies use qualitative or quantitative detection of viral RNA as a marker of infectious coronavirus. Continuous viral shedding in the respiratory tract is associated with disease prognosis. Early detection of patients with long-term positive nucleic acid is of great significance for guiding the treatment of COVID-19 patients. Currently, glucocorticoids are used together with other drugs to treat SARS-CoV-2 infection. The use of glucocorticoids may delay the clearance of the virus in patients. The time of viral nucleic acid clearance may be related to host immunity. Elderly patients, patients with a history of hypertension, and patients using glucocorticoids have an increased risk of continuous positive nucleic acid. Although there is no direct evidence to confirm the correlation between the severity of the disease and viral shedding, high viral load in critically ill patients may also be a risk factor for prolonged viral clearance. The time of viral nucleic acid clearance may be related to host immunity. Proinflammatory cytokines and chemokines play an important role in immune response during viral infection and are associated with the clinical outcome and prognosis of COVID-19. When the host's immune system is insufficient to inhibit viral replication, continuous positive SARS-CoV-2 nucleic acid may occur.

[0006] Traditional Chinese medicine has played an important role in preventing and treating novel coronavirus pneumonia. The drugs currently on the market for the treatment of novel coronavirus pneumonia or epidemic diseases mainly include Lianhua Qingwen Capsules, Jinhua Qinggan Granules, Xuebijing Injection, Qingfei Paidu Granules, Huashi Baidu Granules and Xuanfei Baidu Granules. Among them, Xuebijing Injection is mainly used for systemic inflammatory response syndrome and / or multiple organ failure in severe and critical cases of novel coronavirus pneumonia. Lianhua Qingwen Capsules and Jinhua Qinggan Granules are mainly used in the routine treatment of novel coronavirus pneumonia, and can be used for fever, cough and fatigue caused by mild and common types. The above three medicines are either used for severe and critical patients, or are symptomatic treatment drugs. Qingfei Paidu Granules, Huashi Baidu Granules and Xuanfei Baidu Granules represented by Sanfang are mainly used for the treatment of epidemic diseases for different syndromes. Summary of the invention

[0007] In view of the above-mentioned deficiencies in the prior art, according to an embodiment of the present invention, it is hoped to provide a Chinese medicine composition for preventing and treating novel coronavirus infection, aiming to prevent and / or treat novel coronavirus infection.

[0008] According to the embodiments, the present invention provides a traditional Chinese medicine composition for preventing and treating novel coronavirus infection, which is prepared from the following raw materials in parts by weight: 30-50 parts of Astragalus, 20-40 parts of Polygonum cuspidatum, 20-40 parts of Verbena, 10-20 parts of Scutellaria, 5-15 parts of Forsythia, 2-8 parts of Cyperus rotundus, 5-12 parts of Patchouli, 2-7 parts of Rhubarb, 20-40 parts of Coix seeds, 20-4 parts of Psoralea corylifolia, 5-12 parts of Trichosanthes peel, and 5-12 parts of Licorice.

[0009] Preferably, in the aforementioned traditional Chinese medicine composition for preventing and treating novel coronavirus infection of the present invention, the weight portions of the raw materials are: 38-47 astragalus, 26-34 knotweed, 26-34 verbena, 12-17 scutellaria, 9-14 forsythia, 5-7 cyrtomium, 7-11 patchouli, 3-6 rhubarb, 26-34 coix seed, 26-34 herba schizonepetae, 7-11 trichosanthes peel, and 7-11 licorice; the more preferred weight portions of the raw materials are: 45 astragalus, 30 knotweed, 30 verbena, 15 scutellaria, 12 forsythiae, 6 cyrtomium, 9 patchouli, 5 rhubarb, 30 coix seed, 30 herba schizonepetae, 9 trichosanthes peel, and 9 licorice.

[0010] Preferably, in the aforementioned traditional Chinese medicine composition for preventing and treating novel coronavirus infection of the present invention, the rhubarb is processed rhubarb.

[0011] The Chinese medicine composition for preventing and treating novel coronavirus infection of the present invention can be prepared into decoction, tablet, capsule, powder, granule, oral liquid, pill, tincture, syrup, suppository, gel, spray or injection according to conventional methods.

[0012] According to the embodiments, the present invention provides a method for preparing a decoction of a traditional Chinese medicine composition for preventing and treating novel coronavirus infection, comprising the following steps: weighing astragalus, polygonum cuspidatum, verbena, scutellaria baicalensis, forsythia suspensa, cyrtomium, patchouli, rhubarb, coix seed, herba ophiopogonis, trichosanthes peel and licorice by weight, adding 4-10 times the amount of water and decocting twice, each time for 0.5-2 hours, combining the decoctions, filtering, and concentrating to 2-4 times the amount to obtain the decoction.

[0013] According to an embodiment, the present invention provides a method for preparing a Chinese medicine composition granule for preventing and treating novel coronavirus infection, comprising the following steps:

[0014] A. Weigh Fructus Forsythiae and Pogostemon Cablin by weight, mix, add 5-10 times amount of water to extract volatile oil, extract oil for 4-8 hours, collect volatile oil and set aside; after filtering the extract, discard the residue and set aside the filtrate;

[0015] B. Weigh astragalus, polygonum cuspidatum, verbena, scutellaria, cyperus rotundus, rhubarb, coix seed, euphorbia pulex, trichosanthes peel and liquorice by weight, add 5-8 times the amount of water and boil twice, each time for 1-2 hours, filter the extract, discard the residue and use the filtrate for later use;

[0016] C. Combine the filtrates from step A and step B, concentrate, allow to settle, filter, spray dry the filtrate, collect the spray-dried powder, add the volatile oil obtained from step A, mix well, and obtain the product.

[0017] According to an embodiment, the present invention provides a method for preparing a Chinese medicine composition capsule for preventing and treating novel coronavirus infection, comprising the following steps:

[0018] A. Weigh Fructus Forsythiae and Pogostemon Cablin by weight, mix, add 5-10 times amount of water to extract volatile oil, extract oil for 4-8 hours, collect volatile oil and set aside; after filtering the extract, discard the residue and set aside the filtrate;

[0019] B. Weigh astragalus, polygonum cuspidatum, verbena, scutellaria, cyperus rotundus, rhubarb, coix seed, euphorbia pulex, trichosanthes peel and liquorice by weight, add 5-8 times the amount of water and boil twice, each time for 1-2 hours, filter the extract, discard the residue and use the filtrate for later use;

[0020] C. Combine the filtrates from step A and step B, concentrate, dry and set aside;

[0021] D. Add ethanol to dissolve the volatile oil obtained in step A, spray it into the dry powder obtained in step C, add pharmaceutically acceptable excipients, granulate, dry at low temperature, and put into capsules to obtain the product.

[0022] Subsequent examples and test examples show that the Chinese medicine composition of the present invention has the effects of invigorating Qi and strengthening the spleen, clearing away heat and dampness, promoting blood circulation and detoxifying. For patients infected with the new coronavirus, especially those with long-term positive nucleic acid test, it can significantly shorten the total time required for the patient's nucleic acid to turn negative twice and the length of hospitalization, which is significantly better than the Western medicine treatment group, and can achieve rapid negative conversion of infected patients, inhibit recurrence, and effectively cure, with remarkable results.

[0023] Compared with the prior art, the Chinese medicine composition of the present invention is obtained through clinical trials based on the classic prescriptions according to the clinical characteristics of the novel coronavirus Omicron variant, especially the clinical characteristics of patients with long-term positive nucleic acid.

[0024] According to the characteristics of patients infected with novel coronavirus, especially those infected with Omicron variant and patients with long-term positive nucleic acid, the present invention uses Astragalus membranaceus to nourish the triple energizer and strengthen the defense, internally nourish the qi of the spleen and lung, and externally consolidate the exterior and stop sweating, and is the main medicine; Polygonum cuspidatum, Verbena officinalis, Pteris fasciata, and processed Rhubarb clear away heat and dampness, promote blood circulation and detoxify, Scutellaria baicalensis and Cyperus rotundus clear heat and cool blood, Forsythia suspensa and Patchouli dry dampness and dispel filth, penetrate the exterior and expel evil, and are all ministerial medicines; Trichosanthes peel nourishes yin, clears the lungs and produces body fluid, and Coix seeds strengthen the spleen and eliminate dampness, and are all adjuvant medicines; Licorice harmonizes various medicines and is the guiding medicine, and the traditional Chinese medicine composition of the present invention is constructed, and the whole prescription nourishes qi and strengthens the spleen, clears heat and promotes dampness, promotes blood circulation and detoxifies, plays an active preventive and therapeutic role on coronavirus infection, and can significantly shorten the total time required for the patient's nucleic acid to turn negative twice and the hospitalization time for patients infected with Omicron variant of novel coronavirus, especially patients with long-term positive nucleic acid. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 This is the Kaplan-Meier chart of the time for the first nucleic acid test to turn negative in the experimental group and the control group.

[0026] Figure 2This is the Kaplan-Meier graph of the total time required for the nucleic acid test to turn negative twice in the experimental group and the control group.

[0027] Figure 3 Kaplan-Meier chart of the total time required for asymptomatic infection to turn negative twice.

[0028] Figure 4 This is the Kaplan-Meier chart of the total time required for mild patients to convert to negative twice.

[0029] Figure 5 Kaplan-Meier chart showing the total time required for two negative conversions in critically ill patients.

[0030] Figure 6 This is the Kaplan-Meier diagram of hospital stay between the experimental group and the control group.

[0031] Figure 7 This is the Kaplan-Meier chart of hospitalization time for asymptomatic infection patients.

[0032] Figure 8 This is a Kaplan-Meier chart of hospitalization time for patients with mild symptoms.

[0033] Fig. 9 Kaplan-Meier chart of hospital stay for critically ill patients. DETAILED DESCRIPTION

[0034] The present invention is further explained below in conjunction with specific examples. It should be understood that these examples are only used to illustrate the present invention and are not used to limit the scope of the present invention. After reading the present invention, various equivalent modifications of the present invention by those skilled in the art all fall within the scope defined by the claims attached to this application.

[0035] If no specific experimental steps or conditions are specified in the examples, the conventional experimental steps or conditions described in the literature in the field can be used. If no manufacturer is specified for the reagents or instruments used, they are all conventional reagent products that can be obtained commercially.

[0036] Example 1-5 (Preparation of decoction)

[0037] Weigh the weights of Astragalus, Polygonum cuspidatum, Verbena, Scutellaria, Forsythia, Cynomorium, Patchouli, Rhubarb, Coix seeds, Psoralea corylifolia, Trichosanthes peel and Licorice listed in Table 1 respectively, decoct twice, add 1000 ml of water each time, decoct for 1 hour each time, combine the decoctions, filter, and obtain 600 ml of decoction.

[0038] Table 1. Weight of each raw material in Examples 1-5

[0039] API Example 1(g) Example 2(g) Example 3(g) Example 4(g) Example 5(g) Astragalus 30 38 47 50 40 Knotweed 40 34 26 20 28 Verbena 20 26 34 40 32 Scutellaria baicalensis 20 17 12 10 18 Forsythia 5 9 14 15 12 Guanzhong 8 7 5 2 6 Patchouli 5 11 7 12 9 rhubarb 7 6 3 2 4 Job's tears 20 34 26 40 28 Ghost Arrow Feather 40 26 34 20 32 Trichosanthes peel 5 11 7 12 8 Licorice 12 7 11 5 10

[0040] Example 6 (Preparation of decoction)

[0041] Weigh 45g of Astragalus, 28g of Polygonum cuspidatum, 26g of Verbena, 15g of Scutellaria, 12g of Forsythia, 6g of Cynomorium, 9g of Patchouli, 5g of Rhubarb, 30g of Coix seeds, 32g of Psoralea corylifolia, 8g of Trichosanthes peel and 9g of Licorice, decoct twice, add 1000ml of water each time, decoct for 1 hour each time, combine the decoctions, filter, and obtain 400ml of decoction.

[0042] Example 7 (Preparation of decoction)

[0043] Weigh 45g of Astragalus, 30g of Polygonum cuspidatum, 30g of Verbena, 15g of Scutellaria, 12g of Forsythia, 6g of Cynomorium, 9g of Patchouli, 5g of Rhubarb, 30g of Coix seeds, 30g of Psoralea corylifolia, 9g of Trichosanthes peel and 9g of Licorice, decocted in water twice, adding 1200ml of water each time, decocting for 0.5 hour each time, combining the decoctions, filtering, and obtaining 500ml of decoction.

[0044] Example 8 (Preparation of granules)

[0045] A. Weigh 1100 g of Fructus Forsythiae and 1000 g of Pogostemon cablin by weight, mix them, add 8 times the amount of water to extract volatile oil, extract the oil for 6 hours, collect the volatile oil and set aside; after filtering the extract, discard the residue and set aside the filtrate;

[0046] B. Weigh 4800g of Astragalus, 2800g of Polygonum cuspidatum, 3000g of Verbena, 1600g of Scutellaria baicalensis, 700g of Cynomorium, 500g of Rhubarb, 3000g of Coix seeds, 3000g of Radix Psoraleae, 600g of Peel of Trichosanthes and 900g of Licorice by weight, add 6 times the amount of water and boil twice, each time for 2 hours, filter the extract, discard the residue, and use the filtrate for later use;

[0047] C. Combine the extracts, concentrate to a relative density of about 1.08 (80-85° C.), allow to settle, filter, spray-dry the filtrate, collect the spray-dried powder, add the volatile oil obtained in step A, mix well, and obtain the granules of the Chinese medicine composition of the present invention.

[0048] Example 9 (Preparation of capsules)

[0049] A. Weigh 1200 g of Forsythia suspensa and 900 g of Patchouli by weight, mix them, add 10 times the amount of water to extract volatile oil, extract the oil for 5 hours, collect the volatile oil and set aside; after filtering the extract, discard the residue and set aside the filtrate;

[0050] B. Weigh 4500g of Astragalus, 3000g of Polygonum cuspidatum, 3000g of Verbena, 1500g of Scutellaria baicalensis, 600g of Cynomorium, 500g of Rhubarb, 3000g of Coix seeds, 3000g of Radix Psoraleae, 600g of Peel of Trichosanthes and 900g of Licorice by weight, add 8 times the amount of water and boil twice, each time for 1.5 hours, filter the extract, discard the residue, and use the filtrate for later use;

[0051] C. Combine the filtrates from step A and step B, concentrate to a relative density of about 1.15 (60-65° C.), dry under vacuum decompression, and grind into fine powder for later use;

[0052] D. Add ethanol to dissolve the volatile oil obtained in step A, spray the fine powder obtained in step C, add dextrin, make granules, dry at low temperature, and put into capsules to obtain the Chinese medicine composition capsules of the present invention.

[0053] Test example (clinical treatment effect - clinical efficacy of the Chinese medicine composition of the present invention on patients with long-term positive omeprazole)

[0054] 1 Materials and methods

[0055] 1.1 General Information

[0056] A total of 377 patients with long-term positive COVID-19 infection were collected as research subjects.

[0057] 1.2 Inclusion criteria:

[0058] (1) The patients met the clinical diagnosis and confirmation criteria of the Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Trial Version 9) issued by the General Office of the National Health Commission and the General Office of the State Administration of Traditional Chinese Medicine. All patients were tested by real-time fluorescence reverse transcription polymerase chain reaction method for specimens such as pharyngeal swabs, sputum, and lower respiratory tract secretions, and the results showed that severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) nucleic acid was positive.

[0059] (2) All patients had two consecutive positive nucleic acid test results for more than or equal to 8 days.

[0060] 1.2 Experimental design

[0061] This trial is a cohort study. 377 patients with asymptomatic, mild, and severe COVID-19 were enrolled consecutively and assigned to the experimental group and the control group in sequence.

[0062] The experimental group received only the decoction of Example 1-7, once in the morning and evening (40 minutes after meals), taken warm, for 7 days as a course of treatment.

[0063] Control group: received basic Western medicine treatment according to the "Diagnosis and Treatment Plan for New Coronavirus Pneumonia (Trial Ninth Edition)".

[0064] 1.3 Test methods

[0065] Relevant data of patients were collected, including basic information, medical history, clinical symptoms, treatment and nucleic acid test results. A team of physicians with rich clinical experience evaluated and integrated data from different databases, and data reviewers verified the data without knowing the treatment plan of the included subjects. In order to reduce the impact of selection bias on the results, cases were excluded only when data of key variables (nucleic acid test results) were missing, otherwise they were included in the statistical analysis. The primary endpoint of this trial was the comparison of the time between two nucleic acid conversions to negative. The secondary endpoint was the comparison of the length of hospital stay of patients. On the basis of respecting the original data, the specific definitions are as follows:

[0066] Definition criteria for the two nucleic acid negative conversion times and the patient's hospitalization time: For patients with positive nucleic acid tests and two or more consecutive negative tests after the last positive test, the last time of negative conversion is determined as the two nucleic acid negative conversion times; the time of the first nucleic acid negative conversion after the patient's admission is determined as the first negative conversion time. The hospitalization time is determined by the physician's judgment of the patient's discharge time. Those whose nucleic acid tests have not turned negative before discharge and those who have not had nucleic acid tests during hospitalization or whose nucleic acid results are incomplete will be discussed separately, and those with missing data will be counted as "missing".

[0067] 1.4 Data Analysis

[0068] SPSS 25.0 software was used for statistical analysis, and P < 0.05 was considered statistically significant. 2 The continuous variables were described as median (interquartile range [IQR]). The Mann-Whitney U test was used for comparison between two groups, and the Kruskal-Wallis H test was used for comparison between multiple groups. The time index and classification (asymptomatic, mild, severe) index were included in the Cox regression model for multivariate regression analysis. The baseline level of each group was adjusted. The two negative nucleic acid conversions were used as the treatment outcome evaluation index to evaluate the efficacy differences between different drug treatment groups.

[0069] 2. Test results

[0070] 2.1 Basic characteristics of the two groups of patients

[0071] A total of 377 patients were included in this trial, including 303 asymptomatic patients, 46 mild cases and 28 severe cases. The median age was 52 years old, IQR (35-64) years old, the youngest age was 5 years old, and the oldest age was 96 years old. There were 229 males and 148 females. Among them, 207 were in the experimental group and 170 were in the control group. The age of the patients in the experimental group was 50.24±17.11 years old, and the age of the patients in the control group was 48.66±17.621 years old. There was no statistical difference between the two groups (P>0.05). There were 122 males and 85 females in the experimental group; there were 107 males and 63 females in the control group. There was no statistical difference between the two groups (P>0.05). There were 161 asymptomatic infections in the experimental group and 142 asymptomatic infections in the control group. There was no statistical difference between the two groups (P>0.05). There were 60 patients with underlying diseases in the experimental group. See Table 2 for details.

[0072] Table 2. Basic characteristics of patients

[0073]

[0074] 2.2 Basic symptom characteristics of the two groups of patients at the time of enrollment

[0075] In this study, the top five symptoms of patients at enrollment were cough, expectoration, fever, sore throat, and dry throat. There was no statistically significant difference in symptoms between the experimental group and the control group (P>0.05). See Table 3 for details.

[0076] Table 3. Basic TCM symptom characteristics of patients at enrollment

[0077]

[0078] 2.3 Comparison of the time of first nucleic acid negative conversion before enrollment between the two groups of patients

[0079] The median time for the first nucleic acid test to turn negative in the experimental group was 7 days (6.55-7.45) days, and the median time for the first nucleic acid test to turn negative in the control group was 7 days (6.93-7.07) days. The time between the two nucleic acid test turns negative in the experimental group was shorter than that in the control group. The results of the Log-rank test showed that there was no statistical difference in the distribution of the "total time required for two nucleic acid test turns negative" between the experimental group and the control group, χ2=3.11, P=0.078. Figure 1 .

[0080] 2.4 Comparison of the total time required for nucleic acid test to turn negative twice between the two groups of patients

[0081] The median time required for the nucleic acid test to turn negative twice in the experimental group was 12 days (11.85-12.18) days, and the median time required for the nucleic acid test to turn negative twice in the control group was 16 days (15.554-16.446) days. The time required for the nucleic acid test to turn negative twice in the experimental group was shorter than that in the control group.

[0082] The results of the Log-rank test showed that the difference in the distribution of "the total time required for two nucleic acid tests to turn negative" between the experimental group and the control group was statistically significant, χ2=240.281, P<0.001;

[0083] The test can affect the speed of nucleic acid conversion to negative (P < 0.001). Compared with the control group, the speed of nucleic acid conversion to negative in patients using the test was faster than that in the control group, HR = 5.13 (95% CI: 4.007-6.567). Figure 2 .

[0084] 2.5 Subgroup analysis of the total time required for nucleic acid to turn negative twice in different types of patients

[0085] Asymptomatic infection: The median time required for the two nucleic acid tests to turn negative was 12 days (11.80-12.20) for the experimental group and 16 days (15.50-16.49) for the control group. The time required for the two nucleic acid tests to turn negative was shorter in the experimental group than in the control group.

[0086] Mild patients: The median time required for the two nucleic acid tests to turn negative was 11 days (10.46-11.54) for the experimental group and 16 days (15.19-16.81) for the control group. The time required for the two nucleic acid tests to turn negative was shorter in the experimental group than in the control group.

[0087] Severe patients: The median time required for the nucleic acid test to turn negative twice was 12 days (10.89-113.11) days for the experimental group, and 15 days (11.90-18.10) days for the control group. The time required for the nucleic acid test to turn negative twice was shorter in the experimental group than in the control group.

[0088] The results of the Log-rank test showed that the difference in the distribution of "the total time required for two nucleic acid tests to turn negative" between the experimental group and the control group was statistically significant, χ2=234.282, P<0.001;

[0089] The test can affect the speed of nucleic acid turning negative (P < 0.001). Compared with the control group, the speed of nucleic acid turning negative in the test group was faster than that in the control group, HR = 5.06 (95% CI: 3.95-6.49). Figure 3 , 4 、5.

[0090] 2.6 Comparison of hospital stay between the two groups

[0091] The median "hospitalization time" of the experimental group was 14 days (13.80-14.20) days, and the median "hospitalization time" of the control group was 18 days (17.56-18.44) days. The time between the two nucleic acid negative conversions in the experimental group was shorter than that in the control group.

[0092] The results of the Log-rank test showed that the difference in the distribution of “hospitalization time” between the experimental group and the control group was statistically significant, χ2=184.117, P<0.001;

[0093] The test can affect the length of hospital stay (P < 0.001). Compared with the control group, the length of hospital stay of patients using nucleic acid in the test group was shorter than that in the control group, HR = 5.362 (95% CI: 4.18-6.88). Figure 6 .

[0094] 2.7 Subgroup analysis of hospital stay of different types of patients

[0095] Asymptomatic infection: The median "hospitalization time" of the experimental group was 13 days (12.77-13.23) days, and the median "hospitalization time" of the control group was 18 days (17.50-18.50) days. The time between the two nucleic acid negative conversions in the experimental group was shorter than that in the control group.

[0096] Mild patients: The median "hospitalization time" of the experimental group was 13 days (12.63-13.37) days, and the median "hospitalization time" of the control group was 18 days (17.19-18.81) days. The time between the two nucleic acid negative tests in the experimental group was shorter than that in the control group.

[0097] Severely ill patients: The median "hospitalization time" of the experimental group was 16 days (15.31-16.69) days, and the median "hospitalization time" of the control group was 20 days (18.48-21.52) days. The time between the two nucleic acid negative tests in the experimental group was shorter than that in the control group.

[0098] The results of the Log-rank test showed that the difference in the distribution of “hospitalization time” between the experimental group and the control group was statistically significant, χ2=258.928, P<0.001;

[0099] The test can affect the length of hospital stay (P < 0.001). Compared with the control group, the length of hospital stay of patients using nucleic acid in the test group was shorter than that in the control group, HR = 5.827 (95% CI: 4.52-7.52). Figure 7 , 8 、9.

[0100] 2.8 Comparison of adverse reactions between the two groups

[0101] After treatment, all patients were discharged from the hospital with negative results of nucleic acid tests on respiratory specimens for two consecutive times (with a sampling interval of at least 1 day), and there were no deaths. No patients in the experimental group reported obvious adverse reactions, and the clinical safety of the drug was good.

[0102] The experimental results show that the Chinese medicine composition of the present invention has the effects of invigorating Qi and strengthening the spleen, clearing away heat and dampness, promoting blood circulation and detoxifying. For patients infected with the new coronavirus, especially those with long-term positive nucleic acid, it can significantly shorten the total time required for the patient's nucleic acid to turn negative twice and the length of hospitalization, which is significantly better than the Western medicine treatment group. It can achieve rapid negative conversion of infected persons, inhibit recurrence, and effectively cure, with significant effects. It is effective for asymptomatic infected persons, mild patients and severe patients.

Claims

1. A Chinese medicine composition for preventing and treating novel coronavirus infection, characterized in that: The invention is prepared from the following raw materials in parts by weight: 30-50 parts of astragalus, 20-40 parts of polygonum cuspidatum, 20-40 parts of verbena, 10-20 parts of scutellaria, 5-15 parts of forsythia, 2-8 parts of cyrtomium, 5-12 parts of patchouli, 2-7 parts of rhubarb, 20-40 parts of coix seed, 20-40 parts of euphorbia pulex, 5-12 parts of trichosanthes peel and 5-12 parts of liquorice.

2. The Chinese medicine composition for preventing and treating novel coronavirus infection according to claim 1, characterized in that: The weight proportions of the raw materials are respectively: 38-47 parts of Astragalus, 26-34 parts of Polygonum cuspidatum, 26-34 parts of Verbena, 12-17 parts of Scutellaria, 9-14 parts of Forsythia, 5-7 parts of Cyperus rotundus, 7-11 parts of Patchouli, 3-6 parts of Rhubarb, 26-34 parts of Coix seeds, 26-34 parts of Psoralea corylifolia, 7-11 parts of Trichosanthes peel and 7-11 parts of Licorice.

3. The Chinese medicine composition for preventing and treating novel coronavirus infection according to claim 1, characterized in that: The weight proportions of the raw materials are respectively: 45 parts of Astragalus, 30 parts of Polygonum cuspidatum, 30 parts of Verbena, 15 parts of Scutellaria baicalensis, 12 parts of Forsythia suspensa, 6 parts of Cynomorium wilfordii, 9 parts of Patchouli grandiflora, 5 parts of Rhubarb, 30 parts of Coix seeds, 30 parts of Psoralea corylifolia, 9 parts of Trichosanthes peel, and 9 parts of Licorice.

4. The Chinese medicine composition for preventing and treating novel coronavirus infection according to any one of claims 1 to 3, characterized in that: Rhubarb is processed rhubarb.

5. The Chinese medicine composition for preventing and treating novel coronavirus infection according to any one of claims 1 to 3, characterized in that: The dosage form of the Chinese medicine composition is a decoction, tablet, capsule, powder, granule, oral liquid, pill, tincture, syrup, suppository, gel, spray or injection prepared according to conventional methods.

6. A method for preparing the decoction of the Chinese medicine composition for preventing and treating novel coronavirus infection according to claim 5, characterized in that: Weigh astragalus, polygonum cuspidatum, verbena, scutellaria, forsythia, cyrtomium, patchouli, rhubarb, coix seed, herba ophiopogonis, trichosanthes peel and liquorice by weight, add 4-10 times the amount of water and boil twice, each time for 0.5-2 hours, combine the decoctions, filter, and concentrate to 2-4 times the amount to obtain the product.

7. A method for preparing the Chinese medicine composition granules for preventing and treating novel coronavirus infection according to claim 5, characterized in that: The steps include: A. Weigh Fructus Forsythiae and Pogostemon Cablin by weight, mix, add 5-10 times amount of water to extract volatile oil, extract oil for 4-8 hours, collect volatile oil and set aside; after filtering the extract, discard the residue and set aside the filtrate; B. Weigh astragalus, polygonum cuspidatum, verbena, scutellaria, cyperus, rhubarb, coix seed, euphorbia pulex, trichosanthes peel and liquorice by weight, add 5-8 times the amount of water and boil twice, each time for 1-2 hours, filter the extract, discard the residue and use the filtrate for later use; C. Combine the filtrates from step A and B, concentrate, allow to settle, filter, spray-dry the filtrate, collect the spray-dried powder, add the volatile oil obtained from step A, mix well, and obtain the product.

8. A method for preparing the Chinese medicine composition capsule for preventing and treating novel coronavirus infection according to claim 5, characterized in that: The steps include: A. Weigh Fructus Forsythiae and Pogostemon Cablin by weight, mix, add 5-10 times amount of water to extract volatile oil, extract oil for 4-8 hours, collect volatile oil and set aside; after filtering the extract, discard the residue and set aside the filtrate; B. Weigh astragalus, polygonum cuspidatum, verbena, scutellaria, cyperus, rhubarb, coix seed, euphorbia pulex, trichosanthes peel and liquorice by weight, add 5-8 times the amount of water and boil twice, each time for 1-2 hours, filter the extract, discard the residue and use the filtrate for later use; C. Combine the filtrates from step A and step B, concentrate, dry and set aside; D. Add ethanol to dissolve the volatile oil obtained in step A, spray it into the dry powder obtained in step C, add pharmaceutically acceptable excipients, granulate, dry at low temperature, and put into capsules to obtain the product.

9. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for preventing and / or treating novel coronavirus infection.

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