A traditional Chinese medicine composition for strengthening the body resistance and benefiting the lung, 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 benefiting lung, and a preparation method and application thereof.The traditional Chinese medicine composition comprises, in mass parts, radix codonopsis 10-20 parts, radix astragali 10-20 parts, pericarpium citri reticulatae viride 3-15 parts, tuckahoe 10-25 parts, fried lentil 10-40 parts, fried wheat germ 10-30 parts, radix morindae officinalis 5-20 parts, radix ophiopogonis 5-20 parts, fructus schisandrae 5-15 parts, and honey-fried licorice 5-15 parts.The traditional Chinese medicine composition has the effects of benefiting qi and invigorating spleen, and tonifying kidney and filling essence, and can improve the symptoms of spontaneous perspiration, heavy head and body, depression, and dyspnea of long-COVID patients with lung and spleen deficiency and kidney qi deficiency, and significantly improve the happiness and health.

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 benefiting lung, and a preparation method and application thereof. BACKGROUND

[0002] In late 2019, the novel coronavirus infection was prevalent on a large scale in the 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 due to 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 COVID is a condition in which symptoms persist for more than 3 months after infection with the novel coronavirus, and the symptoms and effects last for at least 2 months and cannot be explained by other diagnoses. Based on conservative estimates, the incidence of long COVID accounts for 10% of people infected with the novel coronavirus, and there are 651 million recorded cases of novel coronavirus infection worldwide, so at least 65 million people worldwide are in the state of long COVID. In addition, because there are many unrecorded cases, this number may be higher. Long COVID symptoms seriously affect people's health, well-being and livelihood - it is estimated that one in every ten long COVID patients cannot continue to work.

[0004] The symptoms of long COVID can be divided into three categories: residual symptoms after recovery, organ dysfunction that still exists after recovery, and new symptoms in asymptomatic or mild patients. It can involve multiple systems such as circulation, respiration, urinary, digestive, endocrine, nervous, and mental, including fatigue, chest tightness, shortness of breath, chest pain, palpitations, cognitive dysfunction (brain fog), sleep disorders, gastrointestinal symptoms, anxiety, depression, and many other symptoms. The immune response after infection with the novel coronavirus is characterized by an initial pro-inflammatory response, followed by a chronic immune suppression phase, with persistent inflammation, immune suppression and catabolic syndrome (PICS) being the main features during the recovery period. Studies have shown that the most common symptom of long COVID is persistent fatigue, accounting for 53.1%-72.0%. Both patients with novel coronavirus infection who have been hospitalized in the ICU and patients with mild novel coronavirus infection can experience fatigue symptoms, and the duration often exceeds 6 months. Persistent fatigue, as well as symptoms such as weakness, sweating, shortness of breath, and poor appetite, have a serious adverse impact on patients' work and life.

[0005] Long new crown has the characteristics of long course, easy recurrence, long treatment cycle, etc. If long-term application of western medicine treatment, not only no good effect, but also easy to cause drug resistance, increase the incidence of adverse reactions, even damage the immune function of the body, there is certain limitation. Traditional Chinese medicine has played an important role in the treatment of new coronavirus infection due to multi-target effect and small side effects. At present, there is still a lack of an effective traditional Chinese medicine composition for treating long new crown, so it is necessary to develop an effective traditional Chinese medicine composition for treating long new crown. SUMMARY

[0006] The first object of the present application is to provide a traditional Chinese medicine composition for strengthening the body resistance and benefiting the lung, 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 the application of the traditional Chinese medicine composition.

[0007] According to the first aspect of the present application, a traditional Chinese medicine composition for strengthening the body resistance and benefiting the lung is provided, which comprises, in mass parts, 10-20 parts of radix codonopsis, 10-20 parts of radix astragali, 3-15 parts of pericarpium citri reticulatae, 10-25 parts of poria, 10-40 parts of fried lentil, 10-30 parts of fried wheat germ, 5-20 parts of radix morindae officinalis, 5-20 parts of radix ophiopogonis, 5-15 parts of schisandra chinensis, and 5-15 parts of fried licorice.

[0008] The present application considers that long new crown patients have symptoms such as fatigue, weakness, chest tightness, shortness of breath, sweating, cough, expectoration, soreness of waist and knees, stomach distension, poor appetite, loose or sticky stool, pale tongue, white and greasy fur, and weak pulse, which are considered as lung and spleen deficiency and kidney qi deficiency, so the composition of the present application is proposed according to the pathogenesis and clinical manifestations.

[0009] In the prescription, radix codonopsis and radix astragali enter the spleen and lung, tonify the middle and lung, and reinforce the body resistance and stop sweating, which are the monarch drugs. Poria tonifies the spleen, removes dampness, calms the heart and tranquilizes the mind, fried lentil tonifies qi and harmonizes the center, removes dampness, pericarpium citri reticulatae regulates qi, tonifies the spleen, removes dampness and reduces phlegm, and the three drugs of poria, fried lentil and pericarpium citri reticulatae are used together to tonify the spleen without stagnation and remove dampness without consuming yin; radix morindae officinalis tonifies the kidney and assists yang, removes wind and removes dampness; the four drugs of poria, fried lentil, pericarpium citri reticulatae and radix morindae officinalis are used together to tonify the spleen and the kidney, which are the ministerial drugs. Fried wheat germ eliminates food retention and tonifies the stomach, and also soothes the liver and relieves depression, which is used together with radix codonopsis and radix astragali to transport and transform the tonifying and nourishing effect without distension; radix ophiopogonis and schisandra chinensis prevent the warm and dry effect of other drugs, and schisandra chinensis can also prevent the loss of qi and yin, which are the auxiliary drugs. Fried licorice tonifies the spleen and benefits qi, and harmonizes other drugs, which is the assistant drug. The combination of the above drugs can tonify qi, tonify the spleen, tonify the kidney and fill essence, which can significantly improve the clinical symptoms of long new crown patients.

[0010] The raw materials of the present application are as follows:

[0011] Dangshen: The dried root of Codonopsis pilosula (Franch.) Nannf., Codonopsis pilosula Nannf. var. modesta (Nannf.) L. T. Shen, or Codonopsis tangshen Oliv. of the family Campanulaceae. It belongs to the meridians of the spleen and lung. It is sweet in taste and neutral in nature.

[0012] Huangqi: The dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. of the family Leguminosae. It belongs to the meridians of the lung and spleen. It is sweet in taste and warm in nature.

[0013] Chenpi: The dried mature pericarp of Citrus reticulata and its cultivated varieties of the family Rutaceae. It is acrid and bitter in taste and warm in nature. It belongs to the meridians of the spleen and lung.

[0014] Fuling: The dried sclerotium of Poria cocos (Schw.) Wolf of the family Fomes. It belongs to the meridians of the heart, lung, spleen, and kidney. It is sweet and bland in taste and neutral in nature.

[0015] Chao Danpi: The white seeds of the plant Dolichos lablab of the family Leguminosae. It enters the meridians of the spleen and stomach. It is sweet in taste and neutral in nature.

[0016] Chao Mai: The mature fruit of Hordeum vulgare L. of the family Gramineae dried by germination. It belongs to the meridians of the spleen and stomach. It is sweet in taste and neutral in nature.

[0017] Bajitian: The dried root of Morinda officinalis How of the family Rubiaceae. It belongs to the meridians of the kidney and liver. It is sweet, acrid, and slightly warm in nature.

[0018] Maidong: The tuber of Rehmannia glutinosa of the family Ranunculaceae. It enters the meridians of the lung, stomach, and heart. It is sweet and bitter in taste and cold in nature.

[0019] Wuweizi: The dried mature fruit of Schisandra chinensis (Turcz.) Baill. or Schisandra sphenanthera Rehd. et Wils. of the family Magnoliaceae. It belongs to the meridians of the lung, heart, and kidney. It is sour and sweet in taste and warm in nature.

[0020] Radix Glycyrrhizae: the dried root of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L. in the family Leguminosae. It pertains to the heart, lung, spleen, and stomach meridians. It is sweet in taste and neutral in nature.

[0021] In some embodiments, the raw material composition thereof includes, in parts by mass: Radix Codonopsis 15 parts, Radix Astragali 15 parts, Pericarpium Citri Reticulatae 10 parts, Poria 15 parts, Fried Lens 15 parts, Fried Malt 20 parts, Radix Morindae Officinalis 10 parts, Radix Ophiopogonis 10 parts, Fructus Schisandrae 5 parts, and Radix Glycyrrhizae 10 parts.

[0022] In some embodiments, the dosage form of the traditional Chinese medicine composition is an oral solution, a powder, or a granule.

[0023] In some embodiments, the traditional Chinese medicine composition further includes a pharmaceutically acceptable excipient.

[0024] In some embodiments, the excipient is at least one of a sustained-release agent, an excipient, a filler, a binder, a humectant, a disintegrant, an absorption enhancer, an adsorption carrier, a surfactant, or a lubricant.

[0025] According to a second aspect of the present application, there is provided a preparation method of the traditional Chinese medicine composition for strengthening the body resistance and benefiting the lung as described above, when the dosage form of the traditional Chinese medicine composition is an oral solution, the preparation method includes the following steps:

[0026] The raw materials are soaked in 8-12 times by weight of water for 20-40 minutes, then heated to boiling, and kept at a slight boil for 1-2 hours. The filtrate is obtained by filtration, and the filtrate is repeatedly decocted 1-2 times. The filtrate is combined to obtain the traditional Chinese medicine composition. After the oral solution is cooled, it is further divided into portions, which facilitates carrying and distribution.

[0027] According to a third aspect of the present application, there is provided a preparation method of the traditional Chinese medicine composition for strengthening the body resistance and benefiting the lung as described above, when the dosage form of the traditional Chinese medicine composition is a powder, the preparation method includes the following steps:

[0028] The raw materials are respectively crushed or cut into pieces, then the crushed or cut 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 cut into pieces. The powder located between the 10-mesh and 50-mesh screens is obtained. Then, the powder of each raw material is mixed according to the ratio, and is loaded into a packaging bag and sealed.

[0029] According to a fourth aspect of the present application, there is provided a use of the traditional Chinese medicine composition for strengthening the body resistance and benefiting the lung as described above in the preparation of a medicament for treating long new coronavirus.

[0030] In some embodiments, the syndrome type of long-COVID is deficiency of both lung and spleen and deficiency of kidney-Qi. Specifically, the symptoms of long-COVID include fatigue, lassitude, chest tightness, shortness of breath, sweating, cough, expectoration, soreness of waist and knees, stomach distension, poor appetite, loose or sticky stool, pale tongue, white and greasy fur, and weak pulse.

[0031] According to a fifth aspect of the present application, there is provided a use of the above-mentioned Chinese medicine composition for strengthening the body resistance and tonifying the lung in the preparation of a health food substitute tea.

[0032] In the Chinese medicine composition of the present application, the radix codonopsis, astragalus root, radix morindae officinalis, radix ophiopogonis and schisandra chinensis belong to the medicinal materials in the list of health food ingredients, the tangerine peel, tuckahoe, fried lentil, fried wheat germ and licorice belong to the medicinal materials in the list of both food and medicine, and the raw materials have the characteristics of food and medicine homology and safe medication, and can be used for the preparation of food and medicine homology substitute tea.

[0033] The preparation method of the food and medicine homology substitute tea of the present application comprises the following steps: drying the radix codonopsis, astragalus root, tangerine peel, tuckahoe, fried lentil, fried wheat germ, radix morindae officinalis, radix ophiopogonis, schisandra chinensis and licorice to less than 3.0% of water, removing impurities and inferior raw materials, and then weighing each raw material according to the raw material ratio after ultraviolet sterilization, and mixing uniformly to obtain the food and medicine homology substitute tea.

[0034] The obtained food and medicine homology substitute tea is packaged with gauze tea bags, and is used by brewing with 100mL of warm boiled water for drinking.

[0035] The food and medicine homology substitute tea of the present application can tonify Qi and invigorate the spleen, tonify the kidney and fill essence without warming dryness, soothe the liver and regulate Qi, and digest and open the stomach without stagnation, and is suitable for long-term drinking. The food and medicine homology substitute tea of the present application has a good improvement effect on the symptoms of long-COVID such as spontaneous sweating, heavy head and body, depression, and difficulty breathing.

[0036] Compared with the prior art, the present application has the following beneficial effects:

[0037] (1) The present application adopts the method of TCM syndrome differentiation and treatment, and can improve the clinical symptoms such as spontaneous sweating, heavy head and body, depression, and difficulty breathing of long-COVID patients with deficiency of both lung and spleen and deficiency of kidney-Qi by tonifying Qi and invigorating the spleen, and tonifying the kidney and filling essence. The present application does not use any medicine for relieving cough and expanding the chest, but can improve the respiratory system symptoms such as difficulty breathing, cough and expectoration of long-COVID patients by selecting the medicine for tonifying Qi and invigorating the spleen, and tonifying the kidney and filling essence.

[0038] (2) The present application is aimed at the characteristics of long new coronavirus course, easy recurrence and long treatment cycle. The selected traditional Chinese medicinal materials are either traditional Chinese medicinal materials in the "list of items that can be used for health food" or traditional Chinese medicinal materials in the "list of items that are both food and medicine". The raw materials have the characteristics of homology of medicine and food and safety of medicine, and the obtained traditional Chinese medicine composition is suitable for long-term drinking. The traditional Chinese medicine composition of the present application is compatible, can tonify qi and invigorate the spleen, tonify the kidney and replenish essence without warming and drying, soothe the liver and regulate qi, promote digestion and stimulate appetite without stagnation, invigorate the spleen, transform dampness, relieve cough and not injure yin, so that the qi, blood, yin and yang of the lung, spleen and kidney return to a state of balance, thereby effectively improving the symptoms of long new coronavirus.

[0039] (3) Huangqi can tonify qi and consolidate the exterior, and also can promote qi. Although a large dose of Huangqi can more quickly tonify primordial qi, it is easy to cause patients to have symptoms of upper fire such as insomnia, restlessness, oral ulcer, sore throat and the like due to the effect of promoting qi. Patients are easy to have aggravated cough due to adverse qi, so the traditional Chinese medicine composition of the present application only uses a small dose of Huangqi, which is compatible with Dangshen, Zhigancao, and Bajitian to tonify the lung, spleen and kidney successively, so that the tonifying effect of the lung, spleen and kidney reaches the best. Through the compatibility with Wuweizi and Maidong, the tonifying effect is not drying. Through the compatibility with Chao Maidan, Chenpi, Fuling and Chao Dandou, the tonifying effect is not stagnation, which can well avoid the occurrence of insomnia, restlessness, oral ulcer, sore throat, aggravated cough and the like.

[0040] (4) The traditional Chinese medicine composition of the present application can significantly improve the symptoms of spontaneous perspiration and heavy head and body of long new coronavirus patients, improve the scores of the SF-36 questionnaire of health status survey, the EQ-5D-5L utility index score, the health status score, the HADS depression score, the mMRC scale score, and significantly improve the health and happiness of long new coronavirus patients. DETAILED DESCRIPTION

[0041] The present application will be further described in detail below in combination with specific examples. It should be noted that the following examples are only used to better explain the content of the present application, and do not limit the scope 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.

[0042] Example 1

[0043] The raw material composition of the tonifying lung and strengthening body oral solution of the present example is as follows: Dangshen 15g, Huangqi 15g, Chenpi 10g, Fuling 15g, Chao Dandou 15g, Chao Maidan 20g, Bajitian 10g, Maidong 10g, Wuweizi 5g, Zhigancao 10g.

[0044] The preparation method thereof comprises the following steps:

[0045] Each raw material is added to 1500 ml of water, decocted for 1.5 hours to 300-400 ml, to obtain the Fuzheng Yifei oral solution.

[0046] Example 2

[0047] The Fuzheng Yifei oral solution of this example has the following raw material composition: Dangshen 15 g, Huangqi 15 g, Chenpi 10 g, Fuling 15 g, Chao Danpi 15 g, Chao Mayi 15 g, Baghtian 10 g, Maidong 10 g, Wuyi 5 g, Zhigancao 10 g.

[0048] The preparation method thereof includes the following steps:

[0049] Each raw material is added to 1500 ml of water, decocted for 1.5 hours to 300-400 ml, to obtain the Fuzheng Yifei oral solution.

[0050] Example 3

[0051] The Fuzheng Yifei oral solution of this example has the following raw material composition: Dangshen 15 g, Huangqi 15 g, Chenpi 10 g, Fuling 15 g, Chao Danpi 15 g, Chao Mayi 20 g, Baghtian 10 g, Maidong 10 g, Wuyi 5 g, Zhigancao 10 g.

[0052] The preparation method thereof includes the following steps:

[0053] (1) The raw materials are added to 10 times the weight of water, soaked 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 to 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 Yifei oral solution.

[0054] (2) The obtained Fuzheng Yifei oral solution is cooled and then packaged.

[0055] Example 4

[0056] The Fuzheng Yifei powder of this example has the following raw material composition: Dangshen 15 g, Huangqi 15 g, Chenpi 10 g, Fuling 15 g, Chao Danpi 15 g, Chao Mayi 20 g, Baghtian 10 g, Maidong 10 g, Wuyi 5 g, Zhigancao 10 g.

[0057] The preparation method thereof includes the following steps:

[0058] (1) Dangshen is crushed and passed through 10-mesh and 50-mesh sieves. The coarse particles that cannot pass through the 10-mesh sieve are further crushed. The powder located between the 10-mesh and 50-mesh sieves is taken.

[0059] (2) According to the method of step (1), Astragalus, dried tangerine or orange peel, tuckahoe, fried lentil, fried wheat, Ba Ji Tian, Ophiopogon, Schisandra, and licorice are ground into powder;

[0060] (3) Mix the powder of each raw material evenly, put it into a packaging bag, and seal it. When taking, it can be taken with 150 mL of warm water.

[0061] Example 5

[0062] The Fuzheng Yifei oral solution of this example has the following raw material composition: Dangshen 10g, Huangqi 10g, Chenpi 3g, Fuling 10g, Fried lentil 10g, Fried wheat 10g, Ba Ji Tian 5g, Ophiopogon 5g, Schisandra 7g, and licorice 5g.

[0063] Its preparation method is similar to that of Example 1.

[0064] Example 6

[0065] The Fuzheng Yifei oral solution of this example has the following raw material composition: Dangshen 20g, Huangqi 20g, Chenpi 15g, Fuling 25g, Fried lentil 40g, Fried wheat 30g, Ba Ji Tian 20g, Ophiopogon 20g, Schisandra 15g, and licorice 15g.

[0066] Its preparation method is similar to that of Example 1.

[0067] Next, to illustrate the therapeutic effect of the traditional Chinese medicine composition of the present application on long COVID, a clinical trial was conducted using the Fuzheng Yifei oral solution prepared in Example 1.

[0068] I. Related standards

[0069] (I) Diagnostic criteria

[0070] 1. Western medicine disease diagnosis

[0071] Refer to the diagnostic criteria in the "Long COVID TCM Diagnosis and Treatment Expert Consensus" published by the Chinese Medicine Association:

[0072] (1) According to the "New Coronavirus Infection Diagnosis and Treatment Scheme" (Tenth Edition), it is diagnosed as new coronavirus infection and more than 3 months;

[0073] (2) Related symptoms or signs persist for more than 2 months;

[0074] (3) For related symptoms or signs caused by other underlying diseases, detailed medical history should be combined to rule out.

[0075] If the above three standards are met, it can be diagnosed as long COVID.

[0076] 2. TCM syndrome diagnostic criteria

[0077] Deficiency of both lung and spleen, deficiency of kidney-Qi: fatigue, weakness, chest tightness, shortness of breath, sweating, cough, expectoration, soreness of waist and knees, stomach distention, poor appetite, loose or sticky stool, pale tongue, white and greasy fur, weak pulse.

[0078] (II) Inclusion criteria

[0079] 1. Patients diagnosed as long-COVID according to the diagnostic criteria of "Long-COVID TCM Diagnosis and Treatment Expert Consensus" issued by the Chinese Society of Traditional Chinese Medicine;

[0080] 2. Patients with deficiency of both lung and spleen, deficiency of kidney-Qi;

[0081] 3. Patients treated with Fuzheng Yifei Oral Solution of Example 1.

[0082] (III) Exclusion criteria

[0083] 1. Patients with consciousness disorders, cognitive dysfunction or mental disorders, who cannot complete the questionnaire and other information collection;

[0084] 2. Patients allergic to known traditional Chinese medicines;

[0085] 3. Patients who do not cooperate to take traditional Chinese medicines;

[0086] 4. Pregnant women;

[0087] 5. Patients with obvious abnormalities of organ function such as acute myocardial infarction, respiratory failure, liver failure, etc;

[0088] 6. Patients who participated in other trial studies recently;

[0089] 7. Other cases not suitable for inclusion.

[0090] II. Research design

[0091] Retrospective, observational, self-controlled research design.

[0092] III. Case source

[0093] The cases were sourced from long-COVID patients who visited Guangdong Provincial Hospital of Chinese Medicine from April 2023 to July 2023.

[0094] IV. Observation indicators and time points

[0095] (1) General information: gender, age, date of birth, occupation, height, weight, etc;

[0096] (2) New crown-related medical history: onset time, hospitalization time, treatment measures, discharge time, post-discharge symptoms and related treatment, etc;

[0097] (3) Other disease-related information: past medical history, whether the past disease has worsened after this discharge, post-discharge respiratory tract infection, etc;

[0098] (4) TCM syndrome score scale;

[0099] (5) Respiratory function related scale: dyspnea score scale (mMRC scale);

[0100] (6) Quality of life: health status questionnaire SF-36, European five-dimensional health scale EQ-5D-5L, fatigue severity scale FSS;

[0101] (7) Psychological state: hospital anxiety and depression scale (HADS);

[0102] (8) Blood routine.

[0103] Five, TCM treatment program:

[0104] The Fuzheng Yifei oral solution of Example 1 was used, one dose of which was 300-400 ml, one dose per day, and one dose was taken twice a day; course of treatment: 7 days.

[0105] Patients who used the TCM treatment program were included in the Fuzheng Yifei prescription group.

[0106] Patients who used the TCM treatment program did not take other Chinese medicines in principle.

[0107] Six, statistical methods

[0108] All data were input into the Excel database and analyzed using SPSS 22.0 software. Measurement data were expressed as mean ± standard deviation, and t test or analysis of variance was used for comparison between groups; repeated measurement data were analyzed using the method of repeated measurement data; non-parametric data were analyzed using non-parametric test; categorical variables were expressed as number and percentage, and χ2test or exact probability method was used for comparison between groups; single factor correlation was analyzed using Pearson analysis; and multiple logistic regression analysis was used for prognosis risk factor prediction. P<0.05 was considered to have statistically significant difference.

[0109] This study used intention-to-treat analysis (ITT analysis), 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 research object will participate in the final statistical analysis according to the original grouping method regardless of whether it is followed up to the observation endpoint, which will not destroy the comparability between groups.

[0110] Seven, test results

[0111] The number of follow-up cases is shown in Table 1:

[0112] Table 1 Number of follow-up cases

[0113]

[0114] As can be seen from Table 1, there are 55 cases in the Fuzheng Yifei prescription group, of which only 33 cases have baseline records, 22 cases have baseline records and follow-up records for 7 days.

[0115] The baseline data of the patients are shown in Table 2:

[0116] Table 2 Baseline data of patients

[0117]

[0118] Note: There are 55 cases in the Fuzheng Yifei prescription group, of which 25 cases are male and 29 cases are female, and 54 cases are male+female, and 1 case is missing.

[0119] The rehabilitation history of the patients in the Fuzheng Yifei prescription group is shown in Table 3:

[0120] Table 3 Rehabilitation history of patients

[0121]

[0122] Note: There are 55 cases in the Fuzheng Yifei prescription group, and the missing values are different when different symptoms are counted, see the table for details.

[0123] As can be seen from Table 3, the three most common symptoms in the rehabilitation period of the patients are fatigue, weakness and shortness of breath, while diarrhea, constipation and abdominal distension are less common.

[0124] The self-before-and-after comparison of TCM syndrome scores after the patients take medicine is shown in Table 4:

[0125] Table 4 Analysis of changes in TCM syndrome scores

[0126]

[0127] Note: There are 55 cases in the Fuzheng Yifei prescription group, and 1 case is missing in the table.

[0128] As can be seen from Table 4, the difference in symptom scores of spontaneous sweating 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 spontaneous sweating and heavy head and body of long-COVID patients.

[0129] The change analysis of SF-36 scores of health status questionnaire after the patients take medicine is shown in Table 5:

[0130] Table 5 Change analysis of SF-36 scores of health status questionnaire

[0131]

[0132] Note: There are 55 cases in the Fuzheng Yifei prescription group, and 1 case is missing in the table.

[0133] As can be seen from Table 5, the differences in scores of self-evaluation of body function, overall health feeling and health change before and after treatment have statistical significance (P<0.05). It is shown that the Chinese medicinal composition can significantly improve the body function, overall health feeling and health change of long-COVID patients.

[0134] The analysis of score change of the European five-dimensional health scale EQ-5D-5L after the patients take medicine is shown in Table 6:

[0135] Table 6 European five-dimensional health scale EQ-5D-5L

[0136]

[0137] Note: There are 55 cases in the Fuzheng Yifei Decoction group, and one case is missing in the table.

[0138] As can be seen from Table 6, the differences in scores of utility index and health status of the European five-dimensional health scale EQ-5D-5L before and after taking medicine have statistical significance (P<0.05). It is shown that the Chinese medicinal composition can significantly improve the health status of long-COVID patients.

[0139] The analysis of score change of the fatigue severity scale FSS after the patients take medicine is shown in Table 7:

[0140] Table 7 Analysis of score change of the fatigue severity scale FSS

[0141]

[0142] Note: There are 55 cases in the Fuzheng Yifei Decoction group, and one case is missing in the table.

[0143] As can be seen from Table 7, the differences in scores of the fatigue severity scale FSS before and after treatment have no statistical significance.

[0144] The analysis of score change of the hospital anxiety and depression scale (HADS) after the patients take medicine is shown in Table 8:

[0145] Table 8 Analysis of score change of the hospital anxiety and depression scale

[0146]

[0147] Note: There are 55 cases in the Fuzheng Yifei Decoction group, and one case is missing in the table.

[0148] As can be seen from Table 8, the differences in scores of depression before and after treatment have statistical significance (P<0.05). It is shown that the Chinese medicinal composition can significantly improve the depression symptoms of long-COVID patients.

[0149] The analysis of score change of the dyspnea score scale (mMRC scale) after the patients take medicine is shown in Table 9:

[0150] Table 9 Analysis of changes in the scores of the dyspnea score scale

[0151]

[0152] Note: According to Table 1, there are 55 cases in the Fuzheng Yifei Decoction group, of which 22 cases have baseline and 7-day follow-up records. Therefore, in Table 9, the total number of cases at baseline is 33 / 61.1% = 54 cases, and 1 case is missing, and the total number of cases at 7 days is 19 / 86.4% = 22 cases.

[0153] As can be seen from Table 9, the difference in the dyspnea score scale before and after treatment is statistically significant (P<0.05). This shows that the traditional Chinese medicine composition of the present application can significantly improve the symptoms of dyspnea in long-COVID patients.

[0154] In summary, after long-COVID patients take the traditional Chinese medicine composition of the present application for 7 days, the symptoms of spontaneous sweating and heavy head and body are significantly improved, and the difference is statistically significant; the scores of the SF-36 health survey questionnaire in terms of physical function, overall health perception, and self-evaluation of health changes, the utility index scores of the European Five-Dimensional Health Scale EQ-5D-5L, the health scores, the depression scores of the Hospital Anxiety and Depression Scale (HADS), and the scores of the dyspnea score scale (mMRC scale) before and after treatment are statistically significant. This shows that the traditional Chinese medicine composition of the present application can significantly improve the symptoms of spontaneous sweating, heavy head and body, depression, and dyspnea in long-COVID patients, and significantly improve the perception of health and happiness, etc.

[0155] 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 long new coronavirus, characterized in that, It is made from the following raw materials in parts by weight: Codonopsis pilosula 10-20 parts, Astragalus membranaceus 10-20 parts, Citrus reticulata peel 3-15 parts, Poria cocos 10-25 parts, stir-fried Dolichos lablab 10-40 parts, stir-fried Hordeum vulgare 10-30 parts, Morinda officinalis 5-20 parts, Ophiopogon japonicus 5-20 parts, Schisandra chinensis 5-15 parts, and prepared Glycyrrhiza uralensis 5-15 parts.

2. The traditional Chinese medicine composition for treating long new coronavirus according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Codonopsis pilosula 15 parts, Astragalus membranaceus 15 parts, Citrus reticulata peel 10 parts, Poria cocos 15 parts, stir-fried Dolichos lablab 15 parts, stir-fried Hordeum vulgare 20 parts, Morinda officinalis 10 parts, Ophiopogon japonicus 10 parts, Schisandra chinensis 5 parts, and prepared Glycyrrhiza uralensis 10 parts.

3. The traditional Chinese medicine composition for treating long-COVID according to claim 1 or 2, characterized in that, The dosage form of the traditional Chinese medicine composition is an oral solution, powder, or granule.

4. The traditional Chinese medicine composition for treating long-COVID according to claim 1 or 2, characterized in that, It also includes pharmaceutically acceptable excipients.

5. The traditional Chinese medicine composition for treating long COVID according to claim 4, characterized in that, The excipients are at least one of the following: sustained-release agent, filler, binder, wetting agent, disintegrant, absorption promoter, adsorbent carrier, surfactant, and lubricant.

6. The preparation method of the traditional Chinese medicine composition for treating long new crown of any one of claims 1-5, characterized in that, When the dosage form of the traditional Chinese medicine composition is an oral solution, its preparation method includes the following steps: Soak the raw materials in 8-12 times their weight of water for 20-40 minutes, then heat to boiling and maintain a gentle boil for 1-2 hours. Filter the mixture and boil the residue 1-2 times. Combine the filtrates to obtain the final product.

7. The preparation method of the traditional Chinese medicine composition for treating long new crown of any one of claims 1-5, characterized in that, When the dosage form of the traditional Chinese medicine composition is a powder, its preparation method includes the following steps: Crush or chop each raw material separately, then pass the crushed or chopped raw materials through 10-mesh and 50-mesh sieves respectively. Continue to crush or chop the coarse particles that cannot pass through the 10-mesh sieve, and take the powder that is between the 10-mesh and 50-mesh sieves. Then mix the powders of each raw material according to the formula, put them into a packaging bag, and seal it.

8. The use of the traditional Chinese medicine composition for treating chronic COVID-19 according to any one of claims 1-5 in the preparation of a medicament for treating chronic COVID-19.

9. Use according to claim 8, characterized in that, The symptoms of COVID-19 include fatigue.

10. Use according to claim 8, characterized in that, The syndrome of the long-term COVID-19 is characterized by deficiency of both lung and spleen and insufficiency of kidney qi.

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