A Chinese medicine composition for preventing and treating novel coronavirus infection, and its preparation method and application

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: 23-36 honeysuckle, 23-36 forsythia, 23-36 rhizome of reed, 4-8 atractylodes, 12-17 knotweed, 3-7 rhubarb, 15-21 northern adenophora, 4-8 mint, 7-12 patchouli. The Chinese medicine composition has the effects of dispelling wind and clearing heat, removing dampness and turbidity, and promoting blood circulation and detoxification. Clinical trials show that the improvement rate of clinical symptoms of fever, cough, sputum, dry mouth, fatigue, and poor appetite in patients with new crown infection is significantly higher than that of the western medicine treatment group. The total time required for nucleic acid conversion to negative twice, and the time required for the first nucleic acid conversion to negative are both better than those of the western medicine treatment group, which can realize the rapid conversion of infected persons to negative, inhibit re-positive, and effectively cure, shorten the isolation time or hospitalization time of infected persons, and the effect is remarkable. 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] According to the "New Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial Ninth Edition)", the new coronavirus (SARS-CoV-2) belongs to the β-genus coronavirus, has an envelope, and the particles are round or oval with a diameter of 60 to 140nm. It has 5 essential genes, targeting four structural proteins: nucleoprotein (N), viral envelope (E), matrix protein (M) and spike protein (S) and RNA-dependent RNA polymerase (RdRp). The nucleoprotein (N) wraps 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, cases of infection with the Omicron strain have replaced the Delta strain 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 on it.

[0004] Coronavirus belongs to the Coronaviridae family and the Coronavirus genus in terms of systematic classification. Coronavirus is a positive-stranded single-stranded RNA virus with an envelope. Its genetic material is the largest among all RNA viruses and it generally only infects vertebrates such as humans, mice, pigs, cats, dogs, and birds.

[0005] Since the novel coronavirus Omicron variant was first discovered and spread in November 2021, it has grown rapidly and has swept the world. Cases of infection with the Omicron variant have been found in more than 100 countries and regions around the world. Currently, the novel coronavirus Omicron variant is mainly infected with asymptomatic patients.

[0006] Since the outbreak of the novel coronavirus pneumonia (COVID-19), traditional Chinese medicine has played an important role in prevention and treatment. In view of the characteristics of the novel coronavirus infection, especially the Omicron variant, which spreads rapidly and is asymptomatic, we need drugs that can quickly turn negative, inhibit relapse, and effectively cure the infected, so as to shorten the isolation time or hospitalization time of the infected. 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, achieve rapid negative conversion, inhibit relapse, effectively cure, and shorten the isolation time or hospitalization time of the infected. In addition, it is also hoped to propose a preparation method and use of the Chinese medicine composition

[0008] According to the embodiments, a traditional Chinese medicine composition for preventing and treating novel coronavirus infection provided by the present invention is prepared from the following raw materials in parts by weight: 23-36 parts of honeysuckle, 23-36 parts of forsythia, 23-36 parts of reed root, 4-8 parts of atractylodes, 12-17 parts of polygonum cuspidatum, 3-7 parts of rhubarb, 15-21 parts of northern adenophora, 4-8 parts of mint, and 7-12 parts of patchouli.

[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: 28-32% honeysuckle, 28-32% forsythia, 28-32% reed root, 5-6% atractylodes, 14-16% polygonum cuspidatum, 4-6% rhubarb, 18-20% northern adenophora, 5-7% mint, and 8-10% patchouli; more preferably, the weight portions of the raw materials are: 30% honeysuckle, 30% forsythia, 30% reed root, 6% atractylodes, 15% polygonum cuspidatum, 5% rhubarb, 18% northern adenophora, 6% mint, and 9% patchouli.

[0010] Preferably, in the aforementioned traditional Chinese medicine composition for preventing and treating novel coronavirus infection of the present invention, the Forsythia suspensa is green Forsythia suspensa, the Atractylodes lancea is processed Atractylodes lancea, and the Rhubarb is cooked 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 honeysuckle, forsythia, reed root, atractylodes, knotweed, rhubarb, adenophora, mint and patchouli according to selected weight portions, adding 4-7 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 honeysuckle, forsythia, atractylodes, peppermint and patchouli according to the selected weight parts, mix, add 5-8 times the amount of water to extract volatile oil, extract the oil for 4-6 hours, collect the volatile oil and set aside; after filtering the extract, discard the residue and set aside the filtrate;

[0015] B. Weigh the selected parts by weight of Phragmites australis, Polygonum cuspidatum, Rhubarb and Glehnia littoralis, add 5-8 times the amount of water and boil twice, each time for 1-2 hours. After filtering the extract, discard the residue and use the filtrate for later use;

[0016] C. Combine the extracts of step A and B, concentrate, let stand 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 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 honeysuckle, forsythia, atractylodes, peppermint and patchouli according to the selected weight parts, mix, add 5-8 times the amount of water to extract volatile oil, extract the oil for 4-6 hours, collect the volatile oil and set aside; after filtering the extract, discard the residue and set aside the filtrate;

[0019] B. Weigh the selected parts by weight of Phragmites australis, Polygonum cuspidatum, Rhubarb and Glehnia littoralis, add 5-8 times the amount of water and boil twice, each time for 1-2 hours. After filtering 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, test examples and clinical trials showed that the Chinese medicine composition of the present invention had a significantly higher improvement rate on clinical symptoms of fever, cough, sputum, dry mouth, fatigue and poor appetite in patients infected with the new coronavirus than that of the western medicine treatment group. The total time required for the nucleic acid to turn negative twice and the time required for the first nucleic acid to turn negative were both better than those of the western medicine treatment group, indicating that the present invention can achieve rapid negative conversion of infected persons, inhibit recurrence, effectively cure, and shorten the isolation time or hospitalization time of infected persons, with significant results.

[0023] Compared with the prior art, the Chinese medicine composition of the present invention is obtained through clinical trials based on the clinical characteristics of the novel coronavirus Omicron variant, on the basis of the classic prescription. According to the characteristics of the novel coronavirus infected person, especially the characteristics of the Omicron variant infected person, the present invention believes that "warm evil is received, first of all, the lungs are attacked." The lung governs qi and is combined with fur, so the initial stage of febrile disease is often fever, headache, slight aversion to wind and cold, and poor sweating or no sweating. The lung is affected by warm and hot evil poisons, which fumigate the mouth and throat, so thirst and sore throat; the lung loses the clear and clear, so cough. Therefore, the treatment should be pungent and cool to penetrate the surface, penetrate the evil and dispel filth, and clear away heat and detoxify. The Chinese medicine composition of the present invention uses honeysuckle and forsythia to relieve the surface, clear away heat and detoxify, dispel filth and turbidity, as the main medicine. Polygonum cuspidatum promotes blood circulation and detoxification, can make the blood vessels unblocked, and help to remove toxins and go out; rhubarb clears heat and detoxifies, clears the internal organs, and relieves turbid toxins, taking the meaning of removing firewood from the bottom of the pot, so that heat toxins and turbid toxins come out from the stool. Polygonum cuspidatum and rhubarb clear away heat and resolve turbidity, activate blood circulation and detoxify, while Atractylodes lancea, mint and patchouli dry out dampness and dispel filth, penetrate the surface and expel evil. Phragmites australis clears heat and promotes body fluid; Radix Adenophorae invigorates qi and strengthens the spleen; Phragmites australis and Radix Adenophorae nourish yin, clear the lungs and promote body fluid. The whole prescription can resolve both the exterior and interior, integrating heat-clearing and wind-dispersing, turbid-dispersing and dispelling filth, activating blood circulation and strengthening the body, and also implies the intention of cutting off and reversing the disease. All the medicines work together to dispel wind and heat, dispel dampness and resolve turbidity, activate blood circulation and detoxify. It is mainly used for: plague and exogenous febrile diseases with early onset of warm toxicity, symptoms of fever, headache, slight aversion to wind and cold, poor or no sweating. It plays an active role in the prevention and treatment of coronavirus infection. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It shows the daily temperature fluctuations of fever patients in the two groups.

[0025] Figure 2 Kaplan-Meier chart showing the total time required for two negative conversions after diagnosis for patients in the experimental group and the control group.

[0026] Figure 3 Kaplan-Meier graph showing the time of first nucleic acid negative conversion after diagnosis in the experimental group and the control group.

[0027] Figure 4 Kaplan-Meier chart showing the time from "first negative to re-positive and then negative again" for patients in the experimental group and the control group.

[0028] Figure 5Kaplan-Meier chart showing the time of nucleic acid "first negative and then positive again" for patients in the experimental group and the control group. DETAILED DESCRIPTION

[0029] 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.

[0030] 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.

[0031] Example 1-5 (Preparation of decoction)

[0032] Weigh the weights of honeysuckle, forsythia, reed root, atractylodes, polygonum cuspidatum, rhubarb, adenophora, mint and patchouli listed in Table 0 respectively, decoct twice, add 600 ml of water each time, decoct for 1 hour each time, combine the decoctions, filter, and obtain 500 ml of decoction.

[0033] Table 0. Weight parts of each raw material in Examples 1-5

[0034] API Example 1 Example 2 Example 3 Example 4 Example 5 honeysuckle 23g 36g 30g 28g 32g Forsythia 36g 23g 30g 32g 28g Phragmites australis 23g 23g 30g 28g 32g Atractylodes macrocephala 8g 4g 6g 6g 5g Knotweed 12g 17g 15g 14g 16g rhubarb 7g 3g 5g 4g 6g Adenophora scabra 15g 21g 18g 20g 18g Mint 8g 4g 6g 5g 7g Patchouli 7g 12g 9g 10g 8g

[0035] Example 6 (Preparation of decoction)

[0036] Weigh 30g of honeysuckle, 30g of forsythia, 30g of reed root, 6g of atractylodes, 15g of polygonum cuspidatum, 5g of rhubarb, 18g of northern adenophora, 6g of mint and 9g of patchouli, decoct twice, add 500ml of water each time, decoct for 1 hour each time, combine the decoctions, filter, and obtain 400ml of decoction.

[0037] Example 7 (Preparation of decoction)

[0038] Weigh 30g of honeysuckle, 30g of green forsythia, 30g of reed root, 6g of processed atractylodes, 15g of polygonum cuspidatum, 5g of cooked rhubarb, 18g of northern adenophora, 6g of mint and 9g of patchouli, decocted in water twice, adding 600ml of water each time, decocting for 0.5 hour each time, combining the decoctions, filtering, and obtaining 500ml of decoction.

[0039] Example 8 (Preparation of granules)

[0040] A. Weigh 3000g of honeysuckle, 2800g of forsythia, 600g of atractylodes, 600g of mint and 900g of patchouli, mix them, add 8 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;

[0041] B. Weigh 2800g of Phragmites australis, 1500g of Polygonum cuspidatum, 500g of Rhubarb and 1600g of Adenophora scabra, add 6 times the amount of water and boil twice, each time for 1.5 hours. After filtering the extract, discard the residue and use the filtrate for later use;

[0042] C. Combine the extracts, concentrate to a relative density of about 1.07 (80-85° C.), let stand to precipitate, filter, spray-dry the filtrate, collect the spray-dried powder, spray the volatile oil obtained in step A, mix well, and obtain the granules of the Chinese medicine composition of the present invention.

[0043] Example 9 (Preparation of capsules)

[0044] A. Weigh 2800g of honeysuckle, 3000g of green forsythia, 600g of processed atractylodes, 600g of mint and 1000g of patchouli, mix them, add 6 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;

[0045] B. Weigh 3000g of Phragmites australis, 1400g of Polygonum cuspidatum, 500g of Rhubarb and 1600g of Glehnia littoralis, add 8 times the amount of water and boil twice, each time for 1 hour. After filtering the extract, discard the residue and use the filtrate for later use;

[0046] C. Combine the extracts, concentrate to a relative density of about 1.15 (60-65°C), spray dry, and collect the spray-dried powder for later use;

[0047] D. Add ethanol to dissolve the volatile oil obtained in step A, spray the spray-dried 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.

[0048] Test example (clinical treatment effect - the effect of the Chinese medicine composition of the present invention on the negative conversion of nucleic acid in patients infected with the Omicron strain)

[0049] 1 Materials and methods

[0050] 1.1 General Information

[0051] 2,315 people infected with the new coronavirus were collected as test subjects.

[0052] Inclusion criteria: The patients met the clinical diagnosis and confirmation criteria of the Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Trial Ninth Edition) 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 for pharyngeal swabs, sputum, and lower respiratory tract secretions by real-time fluorescence reverse transcription polymerase chain reaction. The results showed that the severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) nucleic acid was positive.

[0053] 1.2 Experimental Design This trial is a cohort trial. 2315 patients with asymptomatic, mild, and severe novel coronavirus pneumonia were enrolled consecutively and assigned to the experimental group and the control group in order:

[0054] 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.

[0055] Control group: only received Western medicine treatment according to the "Diagnosis and Treatment Plan for New Coronavirus Pneumonia (Trial Ninth Edition)".

[0056] 1.3 Test methods

[0057] 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. Secondary endpoints included the rate of improvement of clinical symptoms, the time for the first nucleic acid conversion to negative, the re-positive rate, the time for re-conversion to negative after re-positive, and the occurrence of adverse events. On the basis of respecting the original data, the specific definitions are as follows:

[0058] The time between two negative nucleic acid conversions, the time of the first negative nucleic acid conversion, re-positive, the time from the first negative to the second negative after re-positive, the time between the first negative and the second negative after re-positive

[0059] Definition criteria: For patients with positive nucleic acid test and 2 or more consecutive negative results after the last positive test, the interval between the first negative test and the confirmed date is determined as the "first nucleic acid negative test time", and the interval between the second negative test and the confirmed date is determined as the "two nucleic acid negative test times". Re-positive refers to patients who test positive again after the first negative nucleic acid test. "The time from the first negative to the second negative test after re-positive" is the interval between the second negative test and the first negative test after re-positive. "The time from the first negative to the two negative tests after re-positive" is the interval between the two negative tests and the first negative test after re-positive. Patients with continuous negative nucleic acid test, those whose nucleic acid test did not turn negative before discharge, and those who did not have nucleic acid test or incomplete nucleic acid test results during hospitalization will be discussed separately, and those with missing data will be counted as "missing".

[0060] 1.4 Data Analysis

[0061] 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.

[0062] 2. Test results

[0063] 2.1 Basic characteristics of patients

[0064] A total of 2315 patients were included in this trial, including 1846 asymptomatic patients, 397 mild cases and 72 severe cases. There was no statistically significant difference between the groups (P>0.05). Among them, 1163 patients in the experimental group received treatment with the decoctions of Examples 1-7, and 1152 patients in the control group received pure Western medicine treatment. The median age of the patients in the experimental group was 44 years old, with an IQR of (20-65) years old; the median age of the patients in the control group was 44 years old, with an IQR of (20-66) years old. The proportion of males and females was basically the same, with 672 males (57.8%) in the experimental group and 631 males (54.8%) in the control group; 491 females (42.2%) in the experimental group and 521 females (45.2%) in the control group. See Table 1 for details.

[0065] The top 10 symptoms of patients in this trial were cough, expectoration, fever, dry mouth, fatigue, anorexia, sore throat, nausea, and diarrhea. There was no significant statistical difference in symptoms between the experimental group and the control group (P>0.05). See Table 2 for details.

[0066] Table 1. Basic characteristics of patients

[0067]

[0068] Table 2. Basic TCM symptom characteristics of hospitalized patients

[0069]

[0070] 2.2 Patients’ fever improved

[0071] The number of patients with fever in the experimental group and the control group were 103 and 78 respectively. The results showed that the median number of days for fever reduction in the experimental group was 1 day IQR (1.0-1.0), and the median number of days for fever reduction in the control group was 2 days IQR (1.5-3.0). Figure 1 shown.

[0072] 2.3 Comparison of improvement in clinical symptoms of patients

[0073] The improvement rates of clinical symptoms of fever, cough, sputum, dry mouth, fatigue, and poor appetite in the experimental group were higher than those in the control group, and the differences were statistically significant (P < 0.05). See Table 3.

[0074] Table 3. Clinical symptoms of patients in the experimental group and the control group after 4 days of treatment

[0075]

[0076] 2.4 Comparison of the time between two nucleic acid negative conversions after the patient was diagnosed

[0077] The median total time of "two nucleic acid negative conversion times" of patients in the experimental group was 8 days (95% CI: 7.96-8.04) and 10 days (95% CI: 9.94-10.06). The "two nucleic acid negative conversion times" of the experimental group were shorter than those of the control group.

[0078] The results of the Log-rank test showed that the difference in the distribution of “two nucleic acid negative conversion times” between the experimental group and the control group was statistically significant, χ 2 =1453.907, P<0.001.

[0079] The use of the Chinese medicine composition of the present invention is an independent risk factor affecting the time of nucleic acid conversion to negative twice after COVID-19 patients are diagnosed (P<0.001), and the risk of negative conversion time is less than that of patients in the control group, HR=0.234 (95%CI: 0.213-0.257). Figure 2 shown.

[0080] 2.5 Comparison of the time of first nucleic acid negative conversion in patients

[0081] The median time for the first nucleic acid test to turn negative was 5 days (95% CI: 4.96-5.04) and 6 days (95% CI: 5.92-6.08) in the experimental group and the control group, respectively. The time for the first nucleic acid test to turn negative was shorter in the experimental group than in the control group.

[0082] The results of the Log-rank test showed that the difference in the distribution of “time of first nucleic acid conversion to negative” between the experimental group and the control group was statistically significant, χ 2 =975.307, P<0.001.

[0083] The use of the Chinese medicine composition of the present invention is an independent factor affecting the time of the first nucleic acid conversion to negative in COVID-19 patients (P<0.001), and the risk of negative conversion time is less than that of patients in the control group, HR=0.275 (95%CI: 0.249-0.304). Figure 3 shown.

[0084] 2.6 Comparison of the number of people who tested positive again after nucleic acid turned negative

[0085] The results showed that 1056 people in the experimental group had nucleic acid re-positive results (90.8%), and 1102 people in the control group had nucleic acid re-positive results (95.7%). 2 The test comparison found that there was a statistically significant difference in the nucleic acid re-positive rate between the experimental group and the control group, χ 2 =21.623(P<0.001).

[0086] Table 4. Comparison of the number of patients in the experimental group and the control group who had their nucleic acid tested negative for the first time and then tested positive for the second time

[0087]

[0088] 2.7 Comparison of time from first negative to re-negative after re-positive

[0089] The median time from the first negative to the next negative after re-positive nucleic acid test in the experimental group and the control group was 2 (95% CI: 1.98-2.02) days and 2 (95% CI: 1.96-2.04) days, respectively.

[0090] The results of the Log-rank test showed that the difference in the distribution of "time from first negative to negative again after re-positive" between the experimental group and the control group was statistically significant, χ 2 =127.660, P<0.001.

[0091] The use of the Chinese medicine composition of the present invention is an independent factor affecting the time from the first negative to the re-positive and then negative of COVID-19 patients (P<0.001), which is lower than that of the patients in the control group, HR=0.785 (95%CI:0.718-0.859). Figure 4 shown.

[0092] 2.8 Comparison of the time from the first negative test to the second negative test after re-positive

[0093] The median time from the first negative to the second negative after re-positivity in the experimental group and the control group was 3 (95% CI: 2.98-3.03) days and 3 (95% CI: 2.96-3.04) days respectively.

[0094] The results of the Log-rank test showed that the difference in the distribution of "time from first negative to two negative conversions after re-positive" between the experimental group and the control group was statistically significant, χ 2 =119.727, P<0.001.

[0095] The use of the Chinese medicine composition of the present invention is an independent risk factor affecting the time from the first negative to the second negative conversion after the COVID-19 patients (P<0.001), which is also lower than that of the patients in the control group, HR=0.767 (95%CI: 0.701-0.840). Figure 5 shown.

[0096] 2.9 Adverse Reactions

[0097] 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. Three patients in the experimental group had symptoms of slightly increased bowel movements, but no obvious discomfort was reported. The clinical safety of the drug was good, as shown in Table 5.

[0098] Table 5

[0099]

[0100] The results of clinical trials show that the Chinese medicine composition of the present invention has a significantly higher improvement rate on the clinical symptoms of fever, cough, sputum, dry mouth, fatigue, and poor appetite in patients infected with the new coronavirus than the Western medicine treatment group. The total time required for the nucleic acid to turn negative twice and the time required for the first nucleic acid to turn negative are both better than those of the Western medicine treatment group, indicating that the Chinese medicine composition of the present invention can achieve rapid negative conversion of infected persons, inhibit recurrence, effectively cure, and shorten the isolation time or hospitalization time of infected persons, with significant results.

Claims

1. A Chinese medicine composition for preventing and treating novel coronavirus infection, characterized in that: The drug is prepared from the following raw materials in parts by weight: 23-36 parts of honeysuckle, 23-36 parts of forsythia, 23-36 parts of reed root, 4-8 parts of atractylodes, 12-17 parts of polygonum cuspidatum, 3-7 parts of rhubarb, 15-21 parts of northern adenophora, 4-8 parts of mint and 7-12 parts of patchouli.

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: 28-32 parts of honeysuckle, 28-32 parts of forsythia, 28-32 parts of reed root, 5-6 parts of atractylodes, 14-16 parts of polygonum cuspidatum, 4-6 parts of rhubarb, 18-20 parts of northern adenophora, 5-7 parts of mint and 8-10 parts of patchouli.

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: 30 parts of honeysuckle, 30 parts of forsythia, 30 parts of reed root, 6 parts of atractylodes, 15 parts of polygonum cuspidatum, 5 parts of rhubarb, 18 parts of northern adenophora, 6 parts of mint and 9 parts of patchouli.

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

5. The Chinese medicine composition for preventing and treating novel coronavirus infection according to claim 4, 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 a decoction of a Chinese medicine composition for preventing and treating novel coronavirus infection as claimed in any one of claims 1 to 3, characterized in that: The method comprises the following steps: weighing honeysuckle, forsythia, reed root, atractylodes, polygonum cuspidatum, rhubarb, adenophora scabra, mint and patchouli according to weight, adding 4-7 times amount of water and boiling twice, each time for 0.5-2 hours, combining the decoctions, filtering and concentrating to 2-4 times amount to obtain the product.

7. A method for preparing a granule of a Chinese medicine composition for preventing and treating novel coronavirus infection as claimed in any one of claims 1 to 3, characterized in that: The steps include: A. Weigh honeysuckle, forsythia, atractylodes, mint and patchouli by weight, mix, add 5-8 times the amount of water to extract volatile oil, extract oil for 4-6 hours, collect volatile oil and set aside; after filtering the extract, discard the residue and set aside the filtrate; B. Weigh Phragmites australis, Polygonum cuspidatum, Rhubarb and Glehnia littoralis by weight, add 5-8 times the amount of water and boil twice, each time for 1-2 hours. After filtering 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 a Chinese medicine composition capsule for preventing and treating novel coronavirus infection as claimed in any one of claims 1 to 3, characterized in that: The steps include: A. Weigh honeysuckle, forsythia, atractylodes, mint and patchouli by weight, mix, add 5-8 times the amount of water to extract volatile oil, extract oil for 4-6 hours, collect volatile oil and set aside; after filtering the extract, discard the residue and set aside the filtrate; B. Weigh Phragmites australis, Polygonum cuspidatum, Rhubarb and Glehnia littoralis by weight, add 5-8 times the amount of water and boil twice, each time for 1-2 hours. After filtering 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 5 in the preparation of a medicament for preventing and / or treating novel coronavirus infection.

Images