A traditional Chinese medicine composition for treating long-term symptoms after novel coronavirus infection, and a preparation method and application thereof

Abstract

The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for strengthening body resistance and tranquilizing the mind, a preparation method and application thereof. The traditional Chinese medicine composition comprises, in mass parts, the following raw materials: 20-50 parts of common wheat, 10-15 parts of female privet fruit, 10-20 parts of cooked date seed, 10-20 parts of ophiopogon japonicus, 10-20 parts of poria, 10-20 parts of baked licorice, 5-15 parts of dried tangerine or orange peel, 10-20 parts of fried lentil, 10-20 parts of white peony root, and 10-30 parts of Chinese yam. The traditional Chinese medicine composition has the effects of soothing liver and relieving depression, and invigorating spleen and nourishing heart, and can relieve self-hemorrhoids, fatigue, heavy head and body, anxiety, depression, insomnia, and significantly improve happiness, health and social function.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for strengthening body resistance and tranquilizing the mind as well as a preparation method and application thereof. BACKGROUND

[0002] In late 2019, the novel coronavirus infection was prevalent on a large scale in the whole world. Up to now, the number of patients who have "recovered" from the novel coronavirus infection is increasing, but there is more and more evidence that a considerable proportion of people who have been hospitalized for treatment and have "recovered" from the novel coronavirus infection have long-term complications and sequelae in multiple organs and systems, including various somatic and neuropsychiatric symptoms, which generally last for more than 12 weeks.

[0003] According to the definition of the World Health Organization, long-term symptoms after the novel coronavirus infection refer to symptoms that still exist 3 months after the novel coronavirus infection, the symptoms and effects last at least 2 months, and cannot be explained by other diagnoses. The symptoms of long-term symptoms after the novel coronavirus infection include more than 60 multi-system symptoms such as fatigue, dyspnea, cough, changes in smell or taste, insomnia, anxiety and depression, etc. These symptoms can be divided into 3 syndrome groups: respiratory symptoms, general symptoms, and symptoms related to mental health and cognitive impairment. Based on conservative estimates, the incidence of long-term symptoms after the novel coronavirus infection accounts for 10% of the novel coronavirus infection, and there are 651 million recorded cases of the novel coronavirus infection in the world, so at least 65 million people in the world are in the state of long-term symptoms after the novel coronavirus infection, and in addition, because there are many unrecorded cases, this number may be higher. Long-term symptoms after the novel coronavirus infection seriously affect people's health, well-being and livelihood - it is estimated that one out of every ten patients with long-term symptoms after the novel coronavirus infection cannot continue to work.

[0004] Traditional Chinese medicine plays an important role in the treatment of the novel coronavirus infection due to its multi-target effect and small side effects. At present, there is still a lack of a traditional Chinese medicine composition for effectively treating long-term symptoms after the novel coronavirus infection, so it is necessary to develop a traditional Chinese medicine composition that can effectively treat long-term symptoms after the novel coronavirus infection. SUMMARY

[0005] The first object of the present application is to provide a traditional Chinese medicine composition for strengthening body resistance and tranquilizing the mind, the second object of the present application is to provide a preparation method of the traditional Chinese medicine composition, and the third object of the present application is to provide an application of the traditional Chinese medicine composition.

[0006] According to the first aspect of the present application, a traditional Chinese medicine composition for strengthening the body resistance and tranquilizing the mind is provided, which comprises, in parts by mass, the following ingredients: 20-50 parts of common wheat, 10-15 parts of female privet fruit, 10-20 parts of cooked date seed, 10-20 parts of ophiopogon, 10-20 parts of poria, 10-20 parts of baked licorice, 5-15 parts of dried tangerine or orange peel, 10-20 parts of fried lentil, 10-20 parts of white peony root, 10-30 parts of Chinese yam.

[0007] The present application considers that the series of symptoms of patients with long-term symptoms after novel coronavirus infection reflect the pathogenesis characteristics of the evil leaving and the healthy qi not recovering in the recovery period of novel coronavirus infection. The present application aims at the main symptoms of anxiety, restlessness, insomnia, palpitation, dry mouth and bitter taste, stomach distension, poor appetite, pale red tongue, little fur, and thin pulse of patients with long-term symptoms after novel coronavirus infection. It is considered that the syndrome type of long-term symptoms after novel coronavirus infection is liver qi stagnation and heart and spleen deficiency. The present application takes the symptoms of anxiety, insomnia, fatigue and the like caused by liver qi stagnation and heart and spleen deficiency as the foothold, and gives consideration to the nourishment of liver and spleen at the same time, so as to support healthy qi, tranquilize the mind, and promote recovery.

[0008] In the prescription, common wheat is sweet in taste and cool in nature, and belongs to the heart meridian, which has the effects of nourishing heart yin, benefiting heart qi, tranquilizing the mind, and removing heat. Poria is sweet in taste and flat in nature, and belongs to the heart meridian, which can calm the soul and nourish the spirit. Both of them are sweet and flat in nature, and can make the heart qi sufficient, the yin liquid sufficient, and the mind calm, so they are the monarch drugs. Female privet fruit can tonify the middle, calm the five viscera, and nourish the spirit. Cooked date seed is sour and sweet in taste, and can converge and enter the heart. White peony root is bitter and sour in taste, and cold in nature, which can astringe yin and benefit the nutrient aspect, and tonify without purgation. Ophiopogon is sweet and bitter in taste, and can treat heart and lung deficiency heat. The four drugs are the ministerial drugs, which can assist the monarch drugs in benefiting qi and generating fluid, and nourishing the spirit and tranquilizing the mind. Fried lentil is sweet in taste, warm in nature, and can tonify the deficiency of spleen and stomach, and is light, clear and slow in supplementing. Chinese yam is sweet in taste, and flat in nature, which can assist the five viscera, strengthen the bones and muscles, and calm the mind. Dried tangerine or orange peel is bitter and pungent in taste, and warm in nature, which can dry and ventilate, and has the functions of tonifying and purgation, ascending and descending, and ventilating the five viscera, and has the functions of regulating qi and drying dampness. Fried lentil, Chinese yam, and dried tangerine or orange peel are the auxiliary drugs, which can tonify the spleen and make the tonification not greasy. Baked licorice can tonify heart qi and regulate various drugs, and is the guide drug. The combination of various drugs can effectively relieve the symptoms of self-humidification, lassitude, heaviness of head and body, fatigue, anxiety, and depression of patients with long-term symptoms after novel coronavirus infection, and significantly improve the health, happiness, and social function.

[0009] The raw materials of the present application are as follows:

[0010] Common wheat: the dried light and thin fruit of Triticum aestivum L. of the family Poaceae. It is sweet in taste and cool in nature, and belongs to the heart meridian.

[0011] Female privet fruit: the dried mature fruit of Ligustrum lucidum Ait. of the Oleaceae family. It belongs to the liver and kidney meridians, and is sweet and bitter in taste, and cool in nature.

[0012] Dried mature seed of Ziziphus jujuba Mill. var. spinosa (Bunge) Hu ex H. F. Chou of Rhamnaceae. Liver, gallbladder and heart channels. Sweet and sour, neutral.

[0013] Radix Ophiopogonis: Rhizome of Liriope muscari (Maxim.) Baill. of Liliaceae. Lung, stomach and heart channels. Sweet and bitter, cold.

[0014] Fushen: Part of the intermediate (white Fuling) of Fuling Nucleus with pine roots or fine pine heart. Heart channel. Sweet and neutral.

[0015] Gancao: Dried root of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. of Leguminosae. Heart, lung, spleen and stomach channels. Sweet and neutral.

[0016] Chenpi: Pericarp of Citrus reticulata Bianco of Rutaceae. Warm, bitter and pungent.

[0017] Flat bean: White seeds of Dolichos lablab L. of Leguminosae. Spleen and stomach channels. Sweet and neutral.

[0018] Baishao: Dried root of Paeonia lactiflora Pall. of Ranunculaceae. Liver and spleen channels. Bitter, sour and cold.

[0019] Huai Shan: Dried rhizome of Dioscorea opposita Thunb. of Dioscoreaceae. Lung, spleen, kidney and stomach. Neutral, sweet and non-toxic.

[0020] In some embodiments, the raw material composition includes, in mass parts: 30 parts of triticum repenense, 12 parts of ligustrum lucidum, 15 parts of dried jujube seeds, 10 parts of radix ophiopogonis, 10 parts of fushen, 10 parts of fried licorice, 5 parts of dried tangerine or orange peel, 15 parts of fried flat bean, 15 parts of white peony root, and 15 parts of dioscorea opposita.

[0021] In some embodiments, the dosage form of the traditional Chinese medicine composition is oral solution, powder or granules.

[0022] In some embodiments, it further includes a pharmaceutically acceptable excipient.

[0023] In some embodiments, the excipient is at least one of sustained-release agent, excipient, filler, binder, humectant, disintegrating agent, absorption promoter, adsorption carrier, surfactant, lubricant.

[0024] According to a second aspect of the present application, there is provided a preparation method of the above-mentioned traditional Chinese medicine composition for strengthening body resistance and tranquilizing the mind, when the dosage form of the traditional Chinese medicine composition is an oral solution, the preparation method comprises the following steps:

[0025] The raw materials are soaked in 8-12 times of water by weight for 20-40 minutes, then heated to boiling, and kept at a slight boil for 1-2 hours. The filtrate is obtained by filtration. The filtrate is repeatedly decocted 1-2 times. After the oral solution is cooled, it is also subjected to sub-packaging, thereby facilitating carrying and distribution.

[0026] According to a third aspect of the present application, there is provided a preparation method of the above-mentioned traditional Chinese medicine composition for strengthening body resistance and tranquilizing the mind, when the dosage form of the traditional Chinese medicine composition is a powder, the preparation method comprises the following steps:

[0027] The raw materials are respectively crushed or chopped, then the crushed or chopped raw materials are respectively passed through 10-mesh and 50-mesh screens. The coarse particles that cannot pass through the 10-mesh screen are further crushed or chopped. The powder located between the 10-mesh screen and the 50-mesh screen is taken. Then the raw material powders are mixed according to the proportion, and are loaded into a packaging bag and sealed.

[0028] According to a fourth aspect of the present application, there is provided a use of the above-mentioned traditional Chinese medicine composition for strengthening body resistance and tranquilizing the mind in the preparation of a medicine for treating long-term symptoms after novel coronavirus infection.

[0029] In some embodiments, the syndrome type of the long-term symptoms after novel coronavirus infection is liver qi stagnation and heart and spleen deficiency.

[0030] In some embodiments, the symptoms of the long-term symptoms after novel coronavirus infection include anxiety and / or restlessness and / or fatigue.

[0031] Compared with the prior art, the present application has the following beneficial effects:

[0032] (1) The traditional Chinese medicine composition of the present application has the effects of soothing the liver and relieving depression, invigorating the spleen and nourishing the heart. It not only calms the heart and tranquilizes the mind, but also takes care of the liver and spleen, strengthens body resistance, tranquilizes the mind, and promotes recovery. It can effectively relieve symptoms such as sweating, lassitude, heaviness in head and body, fatigue, anxiety, and depression of long-term symptoms after novel coronavirus infection, and significantly improves health, happiness, and social function.

[0033] (2) The traditional Chinese medicine composition of the present application does not use large doses of heavy tranquilizers, but adjusts the functions of the heart, liver, and spleen to restore the balance of yin and yang and blood, thereby achieving the effect of effectively treating long-term symptoms after novel coronavirus infection.

[0034] (3) The traditional Chinese medicine composition of the present application can significantly improve the total score of the health status questionnaire SF-36, the body function, the role limitation, the overall health feeling, the life vitality, the social function, the utility index score of the European five-dimensional health scale EQ-5D-5L, the fatigue severity scale FSS score, the anxiety and depression scores of the hospital anxiety and depression scale (HADS), significantly improve the health feeling, happiness and social function of the patients with long-term symptoms after novel coronavirus infection. DETAILED DESCRIPTION

[0035] The present application will be further described in conjunction with specific examples. It is to be noted that the following examples are only for better explaining the content of the present application, and do not limit the scope of protection of the present application. The process steps not disclosed in the examples are prior art. Unless otherwise specified, the following raw materials are commercially available.

[0036] Example 1

[0037] The Fuzheng Anshen oral solution of the present example comprises the following raw materials: floating wheat 30g, female privet fruit 12g, cooked date kernel 15g, ophiopogon 10g, fushen 10g, fried licorice 10g, dried tangerine or orange peel 5g, fried lentil 15g, white peony root 15g, and Chinese yam 15g.

[0038] The preparation method comprises the following steps:

[0039] The raw materials are added to 1500mL of water, and decocted for 1.5 hours to 300-400ml to obtain the Fuzheng Anshen oral solution.

[0040] Example 2

[0041] The Fuzheng Anshen oral solution of the present example comprises the following raw materials: floating wheat 30g, female privet fruit 12g, cooked date kernel 15g, ophiopogon 10g, fushen 10g, fried licorice 10g, dried tangerine or orange peel 5g, fried lentil 15g, white peony root 15g, and Chinese yam 15g.

[0042] The preparation method comprises the following steps:

[0043] (1) The raw materials are soaked in 10 times the weight of water for 30 minutes, then heated to boiling, and kept at a slight boil for 1 hour. After separation, the first decoction and the residue are obtained. The residue obtained after the first decoction is added with 8 times the weight of water corresponding to the total mass of the raw materials, heated to boiling, and kept at a slight boil for 1 hour. After separation, the second decoction and the residue are obtained. The first decoction and the second decoction are combined to obtain the Fuzheng Anshen oral solution.

[0044] (2) The obtained Fuzheng Anshen oral solution is cooled and then packaged.

[0045] Example 3

[0046] The raw material composition of the Fuzheng Anshen oral solution of the present embodiment is as follows: floating wheat 30g, lycium fruit 12g, cooked date seed 15g, ophiopogon 10g, poria 10g, baked licorice 10g, dried tangerine or orange peel 5g, fried lentil 15g, white peony root 15g, and Chinese yam 20g.

[0047] The preparation method thereof comprises the following steps:

[0048] (1) Take floating wheat, crush, and pass through 10-mesh and 50-mesh screens. The coarse particles that cannot pass through the 10-mesh screen are further crushed. Take the powder between the 10-mesh and 50-mesh screens;

[0049] (2) According to the method of step (1), lycium fruit, cooked date seed, ophiopogon, poria, baked licorice, dried tangerine or orange peel, fried lentil, white peony root, and Chinese yam are crushed into powder respectively;

[0050] (3) Mix the powder of each raw material uniformly, and then put it into a sealing bag. Seal the bag.

[0051] Example 4

[0052] The raw material composition of the Fuzheng Anshen oral solution of the present embodiment is as follows: floating wheat 30g, lycium fruit 12g, cooked date seed 15g, ophiopogon 15g, poria 15g, baked licorice 15g, dried tangerine or orange peel 10g, fried lentil 15g, white peony root 15g, and Chinese yam 20g.

[0053] The preparation method thereof is similar to that of Example 1.

[0054] Example 5

[0055] The raw material composition of the Fuzheng Anshen oral solution of the present embodiment is as follows: floating wheat 20g, lycium fruit 10g, cooked date seed 10g, ophiopogon 10g, poria 10g, baked licorice 10g, dried tangerine or orange peel 5g, fried lentil 10g, white peony root 10g, and Chinese yam 10g.

[0056] The preparation method thereof is similar to that of Example 1.

[0057] Example 6

[0058] The raw material composition of the Fuzheng Anshen oral solution of the present embodiment is as follows: floating wheat 50g, lycium fruit 15g, cooked date seed 20g, ophiopogon 20g, poria 20g, baked licorice 20g, dried tangerine or orange peel 15g, fried lentil 20g, white peony root 20g, and Chinese yam 30g.

[0059] The preparation method thereof is similar to that of Example 1.

[0060] In the following, in order to illustrate the treatment effect of the traditional Chinese medicine composition of the present application on the long-term symptoms after the novel coronavirus infection, the Fuzheng Anshen oral solution prepared in Example 1 is used for clinical test.

[0061] I. Related standards

[0062] (I) Diagnostic criteria

[0063] 1. Western medicine disease diagnosis

[0064] Refer to the diagnostic criteria of the Expert Consensus on Diagnosis and Treatment of Long-term Symptoms after COVID-19 Infection issued by the Chinese Association of Traditional Chinese Medicine:

[0065] (1) According to the New Coronavirus Infection Diagnosis and Treatment Scheme (Trial Tenth Edition), it is diagnosed as new coronavirus infection and more than 3 months;

[0066] (2) Related symptoms or signs persist for more than 2 months;

[0067] (3) The relevant symptoms or signs caused by other underlying diseases should be excluded in combination with detailed medical history.

[0068] Satisfy the above 3 standards, that is, it can be diagnosed as long-term symptoms after COVID-19 infection.

[0069] 2. Diagnosis criteria of TCM syndrome

[0070] Liver qi stagnation and heart and spleen deficiency: anxiety, irritability, insomnia, palpitation, dry mouth and bitter taste, stomach distension, poor appetite, pale red tongue, little fur, and thin pulse.

[0071] (II) Inclusion criteria

[0072] 1. Refer to the diagnostic criteria of the Expert Consensus on Diagnosis and Treatment of Long-term Symptoms after COVID-19 Infection issued by the Chinese Association of Traditional Chinese Medicine, and those diagnosed as long-term symptoms after COVID-19 infection;

[0073] 2. Meet the liver qi stagnation and heart and spleen deficiency;

[0074] 3. Use the Fuzheng Anshen Oral Solution of Example 1 for treatment.

[0075] (III) Exclusion criteria

[0076] 1. Those with consciousness disorders, cognitive dysfunction or mental disorders who cannot cooperate to complete the questionnaire and other information collection;

[0077] 2. Allergic to known traditional Chinese medicines;

[0078] 3. Those who do not cooperate to take traditional Chinese medicine;

[0079] 4. Pregnant women;

[0080] 5. Those with obvious abnormalities of organ function such as acute myocardial infarction, respiratory failure, liver failure, etc.;

[0081] 6. Those who participated in other experimental researches recently;

[0082] 7. Other cases not suitable for inclusion.

[0083] II. Study Design

[0084] Retrospective, observational, self-controlled study design.

[0085] III. Case Source

[0086] The cases were sourced from patients with long-term symptoms after COVID-19 infection who visited the Guangdong Provincial Hospital of Traditional Chinese Medicine from April 2023 to July 2023.

[0087] IV. Observation Indicators and Time Points

[0088] (1) General information: gender, age, date of birth, occupation, height, weight, etc.

[0089] (2) COVID-19-related medical history: time of onset, length of hospital stay, treatment measures, time of discharge, post-discharge symptoms, and related treatment, etc.

[0090] (3) Other disease-related information: past medical history, whether the past disease has worsened after discharge, post-discharge respiratory tract infection, etc.

[0091] (4) TCM syndrome score scale;

[0092] (5) Respiratory function-related scale: Modified British Medical Research Council (mMRC) scale;

[0093] (6) Quality of life: Short-Form Health Survey (SF-36), EuroQol-5D-5L (EQ-5D-5L), Fatigue Severity Scale (FSS);

[0094] (7) Psychological state: Hospital Anxiety and Depression Scale (HADS);

[0095] (8) Blood routine.

[0096] V. TCM Dialectical Treatment Plan

[0097] The Fuzheng Anshen Oral Solution of Example 1 was used, with one dose of 300-400 ml, one dose per day, and one dose taken in two divided doses; Course of treatment: 7 days.

[0098] Patients who took the TCM dialectical treatment plan were included in the Fuzheng Anshen Decoction group.

[0099] Patients who took the TCM dialectical treatment plan did not take other Chinese medicines in principle.

[0100] VI. Statistical Methods

[0101] All data were input into Excel database and analyzed by SPSS 22.0 software. Measurement data were expressed as mean ± standard deviation, and comparisons between groups were made by t test or analysis of variance; multi-time point data were analyzed by repeated measurement data method; non-normally distributed data were analyzed by non-parametric test; categorical variables were expressed as number and percentage, and comparisons between groups were made by χ2 test or exact probability method; single factor correlation was analyzed by Pearson analysis; and prognosis risk factors were predicted by multiple logistic regression analysis. P<0.05 was considered statistically significant.

[0102] In this study, intention-to-treat (ITT) analysis was used, which means that the results of a clinical trial include follow-up data of all patients. The advantage of ITT analysis is that there is no bias, and every study subject, whether followed up to the observation endpoint or not, will participate in the final statistical analysis according to the original grouping, without destroying the comparability between groups.

[0103] Seven, trial results

[0104] The number of follow-up cases is shown in Table 1:

[0105] Table 1 Number of follow-up cases

[0106]

[0107] As can be seen from Table 1, there were 32 patients in the Fuzheng Anshen Fang group, of which only 11 had baseline records, and 21 had baseline and 7-day follow-up records.

[0108] The baseline data of the patients are shown in Table 2:

[0109] Table 2 Baseline data of patients

[0110]

[0111] Note: There were 32 patients in the Fuzheng Anshen Fang group, of which 10 were male and 21 were female, male + female = 31, and 1 was missing.

[0112] As can be seen from Table 2, in the Fuzheng Anshen Fang group, males accounted for 32.3%, females accounted for 67.7%, the median age was 53 years, and the mean BMI was 22.984 with a standard deviation of 4.506.

[0113] The history of convalescent period of patients in the Fuzheng Anshen Fang group is shown in Table 3:

[0114] Table 3 History of convalescent period of patients

[0115]

[0116]

[0117] Note: Fuzheng Anshen Decoction group a total of 32 cases, different symptoms of the missing value is inconsistent, see table.

[0118] As can be seen from Table 3, the four most common symptoms in the recovery period of patients are fatigue, insomnia, fatigue and palpitation, while diarrhea, constipation and abdominal distension are less common.

[0119] The self-control situation of TCM syndrome score after taking medicine by patients is shown in Table 4:

[0120] Table 4 Analysis of TCM syndrome score changes

[0121]

[0122]

[0123]

[0124] Note: Fuzheng Anshen Decoction group a total of 32 cases, 1 case is missing in the table.

[0125] As can be seen from Table 4, the difference in symptom scores of self-hair, fatigue and lack of strength, and heavy head and body before and after treatment is statistically significant (P<0.05). It shows that the traditional Chinese medicine composition of the application can significantly improve the symptoms of self-hair, fatigue and lack of strength, and heavy head and body of patients with long-term symptoms after novel coronavirus infection.

[0126] The analysis of SF-36 score changes in health status questionnaire after taking medicine by patients is shown in Table 5:

[0127] Table 5 Analysis of SF-36 score changes in health status questionnaire

[0128]

[0129]

[0130] Note: Fuzheng Anshen Decoction group a total of 32 cases, 1 case is missing in the table.

[0131] As can be seen from Table 5, the difference in total score of SF-36, body function, role limitation, overall health, vitality and social function before and after treatment is statistically significant (P<0.05). It shows that the traditional Chinese medicine composition of the application can significantly improve the body function, role limitation, overall health, vitality and social function of patients with long-term symptoms after novel coronavirus infection.

[0132] The analysis of EQ-5D-5L score changes in European five-dimensional health scale after taking medicine by patients is shown in Table 6:

[0133] Table 6 Analysis of EQ-5D-5L score changes in European five-dimensional health scale

[0134]

[0135] Note: The total number of Fuzheng Anshen Fang group is 32, and 1 case is missing in the table.

[0136] As can be seen from Table 6, the difference in EQ-5D-5L health questionnaire utility index score before and after treatment is statistically significant (P<0.05). It shows that the traditional Chinese medicine composition of the application can effectively improve the overall health status of patients with long-term symptoms after novel coronavirus infection.

[0137] The change analysis of the fatigue severity scale FSS score of the patients after taking medicine is shown in Table 7:

[0138] Table 7 Change analysis of fatigue severity scale FSS score

[0139]

[0140] Note: The total number of Fuzheng Anshen Fang group is 32, and 1 case is missing in the table.

[0141] As can be seen from Table 7, the difference in fatigue severity scale FSS score before and after treatment is statistically significant (P<0.05). It shows that the traditional Chinese medicine composition of the application can significantly improve the fatigue symptoms of patients with long-term symptoms after novel coronavirus infection.

[0142] The change analysis of the hospital anxiety and depression scale (HADS) score of the patients after taking medicine is shown in Table 8:

[0143] Table 8 Change analysis of hospital anxiety and depression scale score

[0144]

[0145] Note: The total number of Fuzheng Anshen Fang group is 32, and 1 case is missing in the table.

[0146] As can be seen from Table 8, the difference in anxiety and depression score before and after treatment is statistically significant (P<0.05). It shows that the traditional Chinese medicine composition of the application can significantly improve the anxiety and depression symptoms of patients with long-term symptoms after novel coronavirus infection.

[0147] The change analysis of the dyspnea score scale (mMRC scale) score of the patients after taking medicine is shown in Table 9:

[0148] Table 9 Change analysis of dyspnea score scale score

[0149]

[0150]

[0151] Note: According to Table 1, there are 32 cases in the Fuzheng Anshen Fang group, of which 21 cases have baseline and 7-day follow-up records. Therefore, in Table 9, the total number of baseline is 19 / 61.3% = 31 cases, and 1 case is missing. The total number of 7-day is 16 / 76.2% = 21 cases.

[0152] As can be seen from Table 9, there is no statistically significant difference in the difference in the score of the scale for difficulty in breathing (mMRC scale) before and after treatment.

[0153] In summary, after taking the traditional Chinese medicine composition of the present application for 7 days, the symptoms of self-hemorrhage, lassitude, and heavy head and body of patients with long-term symptoms after novel coronavirus infection were significantly improved, and the difference was statistically significant. The total score of the health status questionnaire SF-36, the scores of physical function, role limitation, overall health feeling, life vitality, and social function, the utility index score of the European Five-Dimensional Health Scale EQ-5D-5L, the score of the Fatigue Severity Scale FSS, and the scores of anxiety and depression of the Hospital Anxiety and Depression Scale (HADS) before and after treatment were statistically significant. Therefore, the traditional Chinese medicine composition of the present application can significantly improve the symptoms of self-hemorrhage, lassitude, heavy head and body, fatigue, anxiety, and depression of patients with long-term symptoms after novel coronavirus infection, and significantly improve the health feeling, happiness, and social function.

[0154] The above only describes some specific embodiments of the present application. For those skilled in the art, without departing from the inventive concept, several modifications and improvements can be made, which are all within the scope of protection of the present application.

Claims

1. A traditional Chinese medicine composition for treating liver qi stagnation and heart and spleen deficiency syndrome type long-term symptoms after novel coronavirus infection, characterized in that, The raw medicinal material composition of the application comprises, by mass fraction: 20-50 parts of common wheat, 10-15 parts of female privet fruit, 10-20 parts of cooked date seed, 10-20 parts of ophiopogon, 10-20 parts of poria, 10-20 parts of fried licorice, 5-15 parts of dried tangerine or orange peel, 10-20 parts of fried lentil, 10-20 parts of white peony root, and 10-30 parts of Chinese yam.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw medicinal material composition of the application comprises, by mass fraction: 20-50 parts of common wheat, 10-15 parts of female privet fruit, 10-20 parts of cooked date seed, 10-20 parts of ophiopogon, 10-20 parts of poria, 10-20 parts of fried licorice, 5-15 parts of dried tangerine or orange peel, 10-20 parts of fried lentil, 10-20 parts of white peony root, and 10-30 parts of Chinese yam.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The dosage form of the traditional Chinese medicine composition is oral solution, powder or granules.

4. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The application also includes pharmaceutically acceptable adjuvants.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, The adjuvant is at least one of sustained-release agent, excipient, filler, binder, humectant, disintegrant, absorption promoter, adsorption carrier, surfactant, lubricant.

6. The preparation method of the traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, When the dosage form of the traditional Chinese medicine composition is oral solution, the preparation method comprises the following steps: The raw medicinal material is soaked in 8-12 times of water by weight for 20-40 minutes, then heated to boiling, and kept at micro-boiling for 1-2 hours. The filtrate is obtained by filtering and repeating the decoction of the residue 1-2 times.

7. The preparation method of the traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, When the dosage form of the traditional Chinese medicine composition is powder, the preparation method comprises the following steps: The raw medicinal materials are respectively crushed or cut into pieces, then the crushed or cut raw medicinal materials are respectively passed through 10-mesh and 50-mesh screen, the coarse particles that cannot pass through the 10-mesh screen are further crushed or cut into pieces, the powder between the 10-mesh and 50-mesh screens is taken, then the raw medicinal material powders are mixed according to the ratio, and the mixture is sealed in a packaging bag.

8. Use of the traditional Chinese medicine composition of any one of claims 1-5 in the preparation of a drug for treating long-term symptoms after novel coronavirus infection of liver-Qi stagnation and heart and spleen deficiency syndrome.

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