Traditional Chinese medicine composition for treating qi deficiency of lung and spleen in recovery phase of viral pneumonia and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating lung-spleen qi deficiency in the recovery stage of viral pneumonia and application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 10-30 parts of astragalus membranaceus, 3-20 parts of honeysuckle, 3-18 parts of scutellaria baicalensis, 3-18 parts of radix bupleuri, 6-30 parts of radix pseudostellariae, 6-30 parts of white poria, 6-30 parts of honey and bran fried bighead atractylodes rhizome, 6-30 parts of eupatorium, 3-18 parts of divaricate saposhnikovia root and 3-18 parts of honey-fried licorice root. The traditional Chinese medicine composition disclosed by the invention is precise and appropriate in compatibility, has the effects of tonifying qi, clearing and dredging, strengthening the spleen, consolidating superficies and the like, effectively relieves the symptom of qi deficiency of the lung and the spleen of a viral pneumonia convalescent patient and a plurality of related physiological indexes, and is widely praised by the patient and has an exact curative effect. Under the guidance of traditional Chinese medicine theories and clinical experience, all the raw material medicines and proportions are selected, the pure traditional Chinese medicine preparation is adopted, toxic and side effects are avoided, the aim of treating viral pneumonia in the recovery period is achieved, and the patient acceptability is high.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating lung and spleen qi deficiency syndrome in the recovery period of viral pneumonia and application thereof. Background Art

[0002] Viral pneumonia is a disease in which viruses invade the respiratory epithelium and alveolar epithelial cells, causing inflammation of the lung interstitium and parenchyma, leading to pulmonary ventilation dysfunction. The main clinical manifestations are fever, headache, body aches, dry cough and lung infiltration. The disease is highly contagious and the course of the disease develops rapidly. Individuals with normal or suppressed immune function can suffer from it. Viruses are common pathogens of community-acquired pneumonia (CAP) in adults besides bacteria, and most of them can heal on their own. Respiratory viruses can be direct pathogens of CAP, and can also make patients susceptible to secondary bacterial pneumonia such as Streptococcus pneumoniae and Staphylococcus aureus; primary viral pneumonia, secondary or combined bacterial infection are not without severe cases. At present, the treatment of viral pneumonia includes antiviral, immunomodulatory, hormones, symptomatic support, etc., but there are difficulties in treatment such as strong viral variability and lack of specific drugs.

[0003] The advantages of traditional Chinese medicine in improving the clinical efficacy of diseases, improving the quality of life of patients, enhancing the body's immune function and promoting health recovery have attracted more and more attention. Viral pneumonia is mainly caused by a series of pathological changes caused by the failure of the lungs to descend due to the external pathogens on the basis of the deficiency of the body. The names of diseases in traditional Chinese medicine mostly belong to the categories of "wind-heat", "epidemic", "cough" and "asthma", and the location of the disease is mostly blamed on the upper part of the body. As stated in "Suwen·Zhizhen Yaoda Lunpian": "All paralysis, asthma and vomiting belong to the upper part" and "All qi stagnation and depression belong to the lungs." There are many kinds of causes of its onset. Most patients with viral pneumonia have weak physical functions and show deficiency of lung and spleen qi and deficiency of qi and yin, which are easy to be affected by external pathogens. Traditional Chinese medicine can regulate the body's immune function, stimulate the body's own disease resistance, promote the repair of diseased tissues, and achieve the effect of combining expelling evil and strengthening the body. In terms of antiviral treatment, on the one hand, it can directly inhibit the virus, and on the other hand, it can regulate the body's immune system to play an antiviral immune regulatory role, thereby eliminating the virus. It has the characteristics of multiple components, multiple targets, and multiple pathways. Traditional Chinese medicine uses syndrome differentiation and treatment in the treatment of viral pneumonia, which is tailored to the individual. The initial intervention of traditional Chinese medicine can not only shorten the course of the disease and reduce the incidence of viral pneumonia developing into critical illness, but also reduce its sequelae and improve clinical efficacy.

[0004] However, there is no report on a Chinese medicine composition for treating lung and spleen qi deficiency syndrome in the recovery period of viral pneumonia and its application. Summary of the invention

[0005] The purpose of the present invention is to provide a Chinese medicine composition for treating lung and spleen qi deficiency syndrome in the recovery period of viral pneumonia and its application in view of the deficiencies in the prior art.

[0006] The present invention is an empirical prescription obtained by experts of the respiratory department of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine on the basis of long-term clinical treatment of respiratory diseases with lung and spleen qi deficiency syndrome, which is formed by adding and subtracting classic prescriptions such as Yupingfeng Powder and Sijunzi Decoction, and is mainly used to invigorate qi and clear away heat, strengthen the spleen and consolidate the exterior, and effectively alleviate the symptoms of lung and spleen qi deficiency in patients with viral pneumonia, and has been widely praised by patients and has a definite therapeutic effect. Therefore, it is of great clinical and scientific value to find and develop new Chinese medicine preparations with refined formula, definite efficacy, safety and effectiveness from traditional Chinese medicine for the treatment of viral pneumonia.

[0007] The first aspect of the present invention provides a traditional Chinese medicine composition for the recovery period of viral pneumonia, which is prepared from the following raw materials in parts by weight: 10-30 parts of astragalus, 3-20 parts of honeysuckle, 3-18 parts of scutellaria, 3-18 parts of bupleurum, 6-30 parts of pseudostellaria, 6-30 parts of white poria, 6-30 parts of honey-fried atractylodes, 6-30 parts of perilla, 3-18 parts of siler, and 3-18 parts of honey-roasted licorice.

[0008] Furthermore, the Chinese medicine composition is made of the following raw materials in parts by weight: 12-18 parts of Astragalus, 6-18 parts of Honeysuckle, 6-12 parts of Scutellaria, 6-12 parts of Bupleurum, 9-18 parts of Pseudostellariae, 12-18 parts of White Poria, 12-18 parts of Atractylodes macrocephala fried with honey bran, 9-15 parts of Cymbidium, 6-12 parts of Saposhnikovia, and 5-12 parts of honey-roasted Licorice.

[0009] Furthermore, the Chinese medicine composition is made of the following raw materials in parts by weight: 15 parts of Astragalus, 12 parts of Honeysuckle, 9 parts of Scutellaria, 9 parts of Bupleurum, 12 parts of Pseudostellariae, 15 parts of White Poria, 15 parts of Atractylodes macrocephala fried with honey bran, 12 parts of Cymbidium, 9 parts of Saposhnikovia, and 6 parts of honey-roasted Licorice.

[0010] The second aspect of the present invention provides a use of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating lung and spleen qi deficiency syndrome in the recovery period of viral pneumonia.

[0011] Furthermore, the viral pneumonia has the following clinical manifestations: ① fever and (or) respiratory symptoms and other clinical manifestations related to viral pneumonia; ② the above-mentioned imaging characteristics of viral pneumonia; ③ the total white blood cell count is normal or decreased in the early stage of the disease, the lymphocyte count is normal or decreased, and there is viral etiology or serological evidence and epidemiological history. At the same time, pneumonia manifestations can be seen in imaging.

[0012] Furthermore, the drug for treating lung and spleen qi deficiency syndrome in the recovery period of viral pneumonia refers to a drug that improves symptoms such as fatigue, shortness of breath, chest tightness, cough, loss of appetite, fullness, tasteless mouth, loose stools, diarrhea, and spontaneous sweating in patients with lung and spleen qi deficiency syndrome in the recovery period of viral pneumonia.

[0013] The third aspect of the present invention provides a pharmaceutical preparation having the above-mentioned traditional Chinese medicine composition for lung and spleen qi deficiency syndrome in the recovery period of viral pneumonia as an active ingredient, wherein the pharmaceutical preparation is prepared into a commonly used dosage form in pharmacy by conventional preparation methods in the art.

[0014] Furthermore, the pharmaceutical preparation is an oral preparation, including decoction, tablet, capsule, granule, mixture, pill, oral liquid or syrup.

[0015] Furthermore, the pharmaceutical preparation also includes pharmaceutically acceptable excipients, including: emulsifiers, excipients, fillers, binders, wetting agents, disintegrants, absorption promoters, flavoring agents, colorants, cosolvents or water, etc.; fillers such as starch, sucrose, lactose, microcrystalline cellulose, etc.; binders such as cellulose derivatives, alginates, gelatin and polyvinyl pyrrolidone; wetting agents such as glycerol; disintegrants such as sodium carboxymethyl starch, hydroxypropyl cellulose, cross-linked carboxymethyl cellulose, agar, calcium carbonate and sodium bicarbonate; absorption promoters such as quaternary ammonium compounds; surfactants such as cetyl alcohol and sodium lauryl sulfate; adsorption carriers such as kaolin and soap clay; lubricants such as talc, calcium and magnesium stearate, micropowdered silica gel and polyethylene glycol, etc.

[0016] The fourth aspect of the present invention provides a use of the pharmaceutical preparation as described above in the preparation of a drug for treating lung and spleen qi deficiency syndrome in the recovery period of viral pneumonia.

[0017] The mechanism of action of the Chinese medicine composition of the present invention is as follows: Astragalus invigorates qi and consolidates the exterior, and honeysuckle clears away heat and detoxifies as the main medicine; Scutellaria baicalensis clears away heat and detoxifies, and Bupleurum chinense clears away depression and relieves depression as the assistant medicine; Pseudostellaria chinensis, Poria cocos, and Atractylodes macrocephala are adjuvants, which invigorate qi and strengthen the spleen, enhance the function of invigorating the middle qi and invigorating qi, and can also nourish yin; Perilla frutescens invigorates the spleen and eliminates dampness, guides evil out, and Saposhnikovia divaricata disperses wind and resists evil; and Radix Glycyrrhizae uralensis harmonizes the various medicines as the envoy. The above medicines are used together to have the effects of invigorating qi and clearing away, invigorating the spleen and consolidating the exterior, so they can play a good therapeutic effect on the lung and spleen qi deficiency syndrome in the recovery period of viral pneumonia.

[0018] The pathogenesis of viral pneumonia in the early stage is mainly caused by dampness, epidemic toxins and other solid evils. At this stage, the evil is strong but the righteousness is sufficient, and the treatment idea is also mainly to clear and harmonize. For example, the Xuanfei Baidu prescription for common dampness and toxicity in the lung syndrome, in which ephedra clears the lungs and relieves the exterior, gypsum, coix seed, atractylodes, patchouli, artemisia annua and other drugs clear heat and transform dampness, the whole prescription is aimed at dispelling solid evil in the acute stage of the disease. In the recovery stage of viral pneumonia, the main deficiency of the body is often accompanied by the lingering evil, mostly due to deficiency of both qi and yin, and deficiency of lung and spleen qi, and the treatment idea is also mainly to strengthen the body and clear the remaining evil. The Chinese medicine composition of the present invention is aimed at the syndrome of deficiency of lung and spleen qi, and takes invigorating qi, clearing and sowing, strengthening spleen and consolidating the exterior as the treatment method, and adds and subtracts Yupingfeng powder and Sijunzi decoction. In the prescription, honeysuckle clears away heat and detoxicates, and prevents the residual evil from being exhausted in the late stage of the disease. Astragalus belongs to the lung and spleen meridians, invigorates qi and consolidates the exterior. In order to prevent the residual evil from recurring, raw astragalus is selected to clear and nourish the lung and spleen, and the two are together as the main medicine; Scutellaria baicalensis clears away heat and detoxicates, and Bupleurum clears and sows and relieves depression to regulate the whole body qi and prevents qi from being stagnant due to excessive qi invigoration. As the minister medicine, it is compatible with the main medicine honeysuckle to achieve the effect of clearing and sowing; Pseudostellaria chinensis, Poria cocos, and Atractylodes macrocephala are adjuvants, and are matched with roasted liquorice to have the meaning of Sijunzi decoction, which cultivates soil to produce gold, plays the role of invigorating qi and strengthening spleen, and enhances the function of invigorating the middle and replenishing qi. Pseudostellaria chinensis is specially selected to have the effect of invigorating qi and promoting body fluid and nourishing yin, and improves the phenomenon of qi and yin depletion in the recovery period of fever. The spleen fails to disperse essence and produces dampness. Perilla frutescens strengthens the spleen and eliminates dampness, draws out pathogens. Saposhnikovia divaricata, together with Astragalus membranaceus and Atractylodes macrocephala, forms Yupingfeng Powder to consolidate the exterior, resist pathogens and stop sweating, to prevent the body from being affected by external pathogens again due to physical weakness during the recovery period. Roasted licorice is used to harmonize the various medicines.

[0019] The present invention has the advantages that:

[0020] 1. The Chinese medicine composition of the present invention is well-matched and has the effects of invigorating qi, clearing away heat, strengthening the spleen and consolidating the exterior, etc. It effectively alleviates the symptoms of lung and spleen qi deficiency and related multiple physiological indicators in patients in the recovery period of viral pneumonia, and has been widely praised by patients and has a definite therapeutic effect.

[0021] 2. It has few medicinal flavors, is easy to prepare, has abundant and readily available raw materials, is low in cost, and is suitable for promotion;

[0022] 3. The present invention is guided by traditional Chinese medicine theory and clinical experience, selects various raw materials and proportions, uses pure Chinese medicine preparations, has no toxic side effects, achieves the purpose of treating viral pneumonia in the recovery period, and has high patient acceptance. DETAILED DESCRIPTION

[0023] The specific implementation methods provided by the present invention are described in detail below in conjunction with examples.

[0024] Embodiment 1: Chinese medicine composition of the present invention

[0025] 15 parts of Astragalus, 12 parts of Honeysuckle, 9 parts of Scutellaria, 9 parts of Bupleurum, 12 parts of Pseudostellariae Radix, 15 parts of White Poria, 15 parts of Atractylodes macrocephala stir-fried with honey bran, 12 parts of Cyperus rotundus, 9 parts of Saposhnikovia divaricata, and 6 parts of honey-roasted Licorice.

[0026] Embodiment 2: Chinese medicine composition of the present invention

[0027] 25 parts of Astragalus, 15 parts of Honeysuckle, 12 parts of Scutellaria, 9 parts of Bupleurum, 15 parts of Pseudostellariae Radix, 18 parts of White Poria, 18 parts of Atractylodes macrocephala stir-fried with honey bran, 12 parts of Cyperus rotundus, 9 parts of Saposhnikovia divaricata, and 6 parts of honey-roasted Licorice.

[0028] Embodiment 3: Chinese medicine composition of the present invention

[0029] 15 parts of Astragalus, 20 parts of Honeysuckle, 12 parts of Scutellaria, 12 parts of Bupleurum, 12 parts of Pseudostellariae Radix, 15 parts of White Poria, 15 parts of Atractylodes macrocephala stir-fried with honey bran, 15 parts of Cyperus rotundus, 9 parts of Saposhnikovia divaricata, and 6 parts of honey-roasted Licorice root.

[0030] Embodiment 4: Chinese medicine composition of the present invention

[0031] 12 parts of Astragalus, 9 parts of Honeysuckle, 6 parts of Scutellaria, 6 parts of Bupleurum, 15 parts of Pseudostellariae Radix, 18 parts of White Poria, 15 parts of Atractylodes macrocephala stir-fried with honey bran, 9 parts of Perilla frutescens, 9 parts of Saposhnikovia divaricata, 9 parts of honey-roasted Licorice root.

[0032] Embodiment 5: Chinese medicine composition of the present invention

[0033] 30 parts of Astragalus, 18 parts of Honeysuckle, 12 parts of Scutellaria, 9 parts of Bupleurum, 18 parts of Pseudostellariae Radix, 18 parts of White Poria, 18 parts of Atractylodes macrocephala fried with honey bran, 21 parts of Cyperus rotundus, 9 parts of Saposhnikovia divaricata, and 6 parts of honey-roasted Licorice.

[0034] Embodiment 6: Chinese medicine composition of the present invention

[0035] 12 parts of Astragalus, 18 parts of Honeysuckle, 9 parts of Scutellaria, 9 parts of Bupleurum, 18 parts of Pseudostellariae, 15 parts of White Poria, 15 parts of Atractylodes macrocephala stir-fried with honey bran, 12 parts of Perilla frutescens, 18 parts of Saposhnikovia divaricata, and 6 parts of honey-roasted Licorice.

[0036] Embodiment 7: Chinese medicine composition of the present invention

[0037] 30 parts of Astragalus, 9 parts of Honeysuckle, 6 parts of Scutellaria, 6 parts of Bupleurum, 30 parts of Pseudostellariae, 30 parts of White Poria, 15 parts of Atractylodes macrocephala stir-fried with honey bran, 18 parts of Cyperus rotundus, 6 parts of Saposhnikovia divaricata, and 9 parts of honey-roasted Licorice.

[0038] Embodiment 8: Chinese medicine composition of the present invention

[0039] 30 parts of Astragalus, 18 parts of Honeysuckle, 9 parts of Scutellaria, 12 parts of Bupleurum, 12 parts of Pseudostellariae Radix, 30 parts of White Poria, 30 parts of Atractylodes macrocephala stir-fried with honey bran, 21 parts of Cyperus rotundus, 18 parts of Saposhnikovia divaricata, and 6 parts of honey-roasted Licorice.

[0040] Example 9: Chinese medicine composition of the present invention

[0041] 10 parts of Astragalus, 3 parts of Honeysuckle, 3 parts of Scutellaria, 3 parts of Bupleurum, 6 parts of Pseudostellariae Radix, 6 parts of White Poria, 6 parts of Atractylodes macrocephala stir-fried with honey bran, 6 parts of Cyperus rotundus, 3 parts of Saposhnikovia divaricata, and 3 parts of honey-roasted Licorice.

[0042] Embodiment 10: Chinese medicine composition of the present invention

[0043] 20 parts of Astragalus, 6 parts of Honeysuckle, 18 parts of Scutellaria, 18 parts of Bupleurum, 9 parts of Pseudostellariae, 12 parts of White Poria, 12 parts of Atractylodes macrocephala stir-fried with honey bran, 30 parts of Cyperus rotundus, 12 parts of Saposhnikovia divaricata, and 18 parts of honey-roasted Licorice.

[0044] Example 11: Preparation of the Chinese medicine composition decoction of the present invention

[0045] The conventional preparation method of Chinese medicine decoction is adopted, that is, the Chinese medicine composition described in any one of Examples 1-11 is added with water and boiled into a decoction.

[0046] Example 12: Preparation of Chinese medicine composition tablets of the present invention

[0047] Weigh the Chinese medicine raw materials according to the ratio described in any one of Examples 1-11, add water and boil twice, each time for 1 hour, add 12 times the amount of water for the first time, and add 8 times the amount of water for the second time, filter the drug residue, combine the two filtrates, combine the aqueous solutions and concentrate them to a relative density of 1.05-1.06 (70°C), add ethanol to make the alcohol content reach 55%, let it stand, filter, recover the ethanol from the filtrate and concentrate it to a fluid extract with a relative density of 1.12-1.16 (60°C); mix the above-mentioned drug residue fine powder, inclusion compound, fluid extract and appropriate amount of excipients, granulate in one step, tablet press, and film coat to obtain.

[0048] Example 13: Preparation of the Chinese medicine composition granules of the present invention

[0049] Weigh the Chinese medicinal raw materials according to the ratio described in any one of Examples 1-11, add water and boil twice, each time for 1 hour, add 12 times the amount of water for the first time, and add 8 times the amount of water for the second time, filter the drug residue, combine the two filtrates, combine with the above aqueous solution and concentrate to a relative density of 1.05-1.06 (70°C), add ethanol to make the alcohol content reach 55%, let it stand, filter, recover ethanol from the filtrate and concentrate it to a fluid extract with a relative density of 1.12-1.16 (60°C); mix the above-mentioned drug fine powder, inclusion compound, fluid extract and appropriate amount of auxiliary materials and granulate them in one step to obtain.

[0050] Example 14: Preparation of the Chinese medicine composition capsule of the present invention

[0051] Weigh the Chinese medicinal raw materials according to the ratio described in any one of Examples 1-11, add water and boil twice, each time for 1 hour, add 12 times the amount of water for the first time, and add 8 times the amount of water for the second time, filter the drug residue, combine the two filtrates, combine with the above aqueous solution and concentrate to a relative density of 1.05-1.06 (70°C), add ethanol to make the alcohol content reach 55%, let it stand, filter, recover ethanol from the filtrate and concentrate it to a fluid extract with a relative density of 1.12-1.16 (60°C); mix the above-mentioned drug fine powder, inclusion compound, fluid extract and appropriate amount of excipients, and fill capsules to obtain.

[0052] Example 15: Preparation of the Chinese medicine composition mixture / oral liquid / syrup of the present invention

[0053] Weigh the Chinese medicinal materials according to the ratio described in any one of Examples 1-11, add 8-10 times the amount of water, decoct for 3 hours, and filter out the medicinal juice. Add 8 times the amount of water again, decoct for 2 hours, filter out the medicinal juice, combine the two decoctions, let stand, filter out the supernatant, concentrate, cool, add 2 times the amount of alcohol of the concentrate, stir and precipitate overnight. Take the supernatant, concentrate to a thick extract; add appropriate pharmaceutical excipients to prepare a mixture, oral liquid or syrup.

[0054] Example 16: Clinical observation on the efficacy of the present invention in treating lung and spleen deficiency syndrome in the recovery period of viral pneumonia (I)

[0055] 1 General Information

[0056] 1.1 Case source

[0057] A total of 92 patients with lung and spleen qi deficiency syndrome in the recovery period of viral pneumonia who were admitted to Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from February 19, 2020 to March 28, 2020 were selected, including 54 males, accounting for 58.69%, and 38 females, accounting for 41.30%; the average age was 60.25 years old.

[0058] 1.2 Diagnostic criteria

[0059] 1.2.1 Western medicine diagnostic criteria

[0060] Refer to the diagnostic criteria for viral pneumonia in the "Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Adults in China (2016 Edition)" and "Internal Medicine (9th Edition)":

[0061] (1) Clinical manifestations: fever and / or respiratory symptoms and other clinical manifestations related to viral pneumonia;

[0062] (2) having radiological features of viral pneumonia (bilateral, multilobar interstitial infiltration, ground-glass opacity, and possibly consolidation);

[0063] (3) In the early stage of the disease, the total white blood cell count is normal or decreased, the lymphocyte count is normal or decreased, and there is viral etiology or serological evidence and epidemiological history.

[0064] 1.2.2 TCM diagnostic criteria

[0065] It meets the criteria for the recovery period of "deficiency of the body's health and retention of evil" - lung and spleen qi deficiency syndrome in the "Guidelines for Diagnosis and Treatment of Community-Acquired Pneumonia in Traditional Chinese Medicine (2018 Revised Edition)" (clinical manifestations: shortness of breath, fatigue, poor appetite, nausea, fullness, weak bowel movements, loose and uncomfortable stools. Pale and fat tongue, greasy white tongue coating).

[0066] 1.3 Inclusion criteria

[0067] (1) Patients who meet the above-mentioned Western medical diagnosis of viral pneumonia and meet the TCM differentiation of lung and spleen qi deficiency syndrome;

[0068] (2) Aged between 18 and 90, regardless of gender;

[0069] (3) The patient had not participated in any clinical trial research within 3 months before the trial;

[0070] (4) Fully understand this clinical study, sign the informed consent and cooperate with regular follow-up;

[0071] 1.4 Exclusion criteria

[0072] (1) Pneumonia caused by other pathogens;

[0073] (2) Those who are allergic to the drugs used;

[0074] (3) those who did not meet the inclusion criteria;

[0075] (4) Patients who have participated in clinical trial research within 12 weeks.

[0076] 1.5 Elimination criteria

[0077] (1) Cases that did not meet the inclusion criteria and were mistakenly included should be excluded;

[0078] (2) Other diseases and concurrent medications that may affect treatment are discovered during treatment;

[0079] (3) Before data are compiled, those that are found to be unsuitable for the research project should be excluded.

[0080] 1.6 Shedding Standard

[0081] (1) Those who were lost to follow-up during the clinical study;

[0082] (2) Those who cannot continue to receive treatment due to serious adverse reactions or unexpected circumstances during treatment;

[0083] (3) Patients with poor compliance and incomplete data during clinical research.

[0084] 2. Treatment options:

[0085] The enrolled patients were divided into a Chinese medicine treatment group and a basic treatment group, each with 46 cases. The Chinese medicine treatment group selected the Chinese medicine composition decoction in the prescription amount of Example 1, which was decocted in the Chinese medicine pharmacy, once a day, divided into morning and evening, and each time took 200 ml. At the same time, combined with basic treatment (including bed rest, oxygen inhalation, breathing exercises, etc.), the basic treatment group used basic treatment alone.

[0086] 3. Observation indicators

[0087] 3.1 Efficacy indicators:

[0088] Observe the improvement of patients' symptoms such as fatigue, poor appetite, nausea, loose stools and diarrhea, shortness of breath, fullness and cough.

[0089] 3.2 Safety observation:

[0090] Pay attention to observe and report adverse reactions in a timely manner. Observation indicators include nausea, abdominal pain, vomiting and other symptoms.

[0091] 4. Efficacy evaluation

[0092] 4.1 Efficacy evaluation criteria:

[0093] Refer to the post-treatment evaluation criteria of the "Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Adults in China (2016 Edition)"; Traditional Chinese Medicine symptoms include fatigue, poor appetite, nausea, loose stools, diarrhea, shortness of breath, fullness, cough and other symptoms as the efficacy evaluation criteria: ① Effective: symptoms disappear, ② Ineffective: symptoms do not improve or worsen.

[0094] 4.2 Evaluation method:

[0095] The number of cases and percentage of disappearance of TCM symptoms such as fatigue, poor appetite, nausea, loose stools, diarrhea, shortness of breath, fullness and cough.

[0096] 5. Results

[0097] 5.1 Symptom improvement

[0098] Table 1 Summary of clinical symptoms of patients in the TCM treatment group

[0099]

[0100] Table 2 Summary of clinical symptoms of patients in the basic treatment group

[0101]

[0102] The difference in the effective rate of each symptom between the two groups was tested by paired chi-square test, and the difference was statistically significant (p < 0.01). The effective rate of each symptom in the Chinese medicine treatment group was better than that in the basic treatment group.

[0103] 5.2 Safety Analysis:

[0104] No adverse reactions such as nausea, vomiting, and abdominal pain were observed after oral administration of Chinese medicine.

[0105] 6. Conclusion

[0106] The Chinese medicine composition of the present invention can significantly improve the symptoms of fatigue, poor appetite, nausea, loose stools, diarrhea, shortness of breath, fullness, cough and the like in patients with lung and spleen qi deficiency syndrome in the recovery period of viral pneumonia, and has good clinical value.

[0107] Example 17: Clinical Observation on the Therapeutic Effect of the Present Invention on the Treatment of Lung and Spleen Qi Deficiency Syndrome in the Recovery Stage of Viral Pneumonia (II)

[0108] 1 General Information

[0109] 1.1 Case source

[0110] A total of 96 patients in the recovery period of viral pneumonia (lung and spleen qi deficiency syndrome) admitted to Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from April 20 to July 20, 2022 were selected as research subjects, including 42 males, accounting for 43.75%, and 54 females, accounting for 56.25%, with an average age of 48.15 years.

[0111] 1.2 Diagnostic criteria

[0112] 1.2.1 Western medicine diagnostic criteria

[0113] Refer to the diagnostic criteria for viral pneumonia in the "Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Adults in China (2016 Edition)" and "Internal Medicine (9th Edition)".

[0114] 1.2.2 TCM diagnostic criteria

[0115] It meets the criteria of the recovery period "Deficiency of the body's health and retention of evil" - lung and spleen qi deficiency syndrome in the "Guidelines for Diagnosis and Treatment of Community-Acquired Pneumonia in Traditional Chinese Medicine (2018 Revised Edition)" (clinical manifestations: shortness of breath, fatigue, poor appetite, nausea, fullness, weak bowel movements, loose and uncomfortable stools. Pale and fat tongue, greasy white tongue coating).

[0116] 1.3 Inclusion criteria

[0117] (1) Patients who meet the above-mentioned Western medical diagnostic criteria and meet the TCM syndrome differentiation of lung and spleen qi deficiency;

[0118] (2) Aged between 18 and 90, regardless of gender;

[0119] (3) The patient had not participated in any clinical trial research within 3 months before the trial;

[0120] (4) Fully understand this clinical study, sign the informed consent and cooperate with regular follow-up;

[0121] 1.4 Exclusion criteria

[0122] (1) Pneumonia caused by other pathogens;

[0123] (2) Those who are allergic to the drugs used;

[0124] (3) those who did not meet the inclusion criteria;

[0125] (4) Patients who have participated in clinical trial research within 12 weeks.

[0126] (5) Pregnant or breastfeeding women;

[0127] (6) Those who are considered unsuitable for inclusion in this trial by other researchers.

[0128] 2. Treatment options:

[0129] The patients were divided into a Chinese medicine treatment group and a breathing exercise group, each with 48 cases. The Chinese medicine treatment group selected the Chinese medicine composition decoction in the amount prescribed in Example 1, which was decocted in a Chinese medicine pharmacy, once a day, taken in the morning and evening, and 200 ml was taken each time. The breathing exercise group used the six-character breathing exercise Chinese medicine exercise alone for recovery exercise.

[0130] 3. Observation indicators

[0131] 3.1 Efficacy indicators:

[0132] Observe the patients for symptoms such as fatigue, shortness of breath, chest tightness, cough, loss of appetite, fullness, tasteless mouth, loose stools and diarrhea, and spontaneous sweating.

[0133] 3.2 Safety observation:

[0134] Pay attention to observe and report adverse reactions in a timely manner. Observation indicators include nausea, abdominal pain, vomiting and other symptoms.

[0135] 4. Efficacy evaluation

[0136] 4.1 Efficacy evaluation criteria:

[0137] The TCM symptoms include fatigue, shortness of breath, chest tightness, cough, loss of appetite, fullness in the stomach, tasteless mouth, loose stools and diarrhea, spontaneous sweating, etc. as the efficacy evaluation criteria: ① Effective: Symptoms disappear ② Ineffective: Symptoms are not improved or worsen.

[0138] 4.2 Evaluation method:

[0139] The number of cases and percentage of disappearance of TCM symptoms such as fatigue, shortness of breath, chest tightness, cough, loss of appetite, fullness in the stomach, tasteless mouth, loose stools and diarrhea, and spontaneous sweating.

[0140] 5. Results

[0141] 5.1 Symptom improvement

[0142] Table 3 Summary of clinical symptoms of patients in the Chinese medicine treatment group

[0143]

[0144]

[0145] Table 4 Summary of clinical symptoms of patients in the breathing exercise group

[0146]

[0147] The difference in the effective rate of each symptom between the two groups was tested by paired chi-square test, and the difference was statistically significant (p < 0.01). The effective rate of each symptom in the Chinese medicine treatment group was better than that in the breathing exercise group.

[0148] 5.2 Security Analysis

[0149] No adverse reactions such as nausea, vomiting, and abdominal pain were observed after oral administration of Chinese medicine.

[0150] 6. Conclusion

[0151] The Chinese medicine composition of the present invention can significantly improve the symptoms of fatigue, shortness of breath, chest tightness, cough, loss of appetite, fullness, tasteless mouth, loose stools, diarrhea, spontaneous sweating and the like in patients in the recovery period of viral pneumonia (lung and spleen qi deficiency syndrome), and has good clinical value.

[0152] The above is only a preferred embodiment of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention. These improvements and supplements should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating lung and spleen deficiency syndrome in the recovery period of viral pneumonia, characterized in that: The drug is prepared from the following raw materials in parts by weight: 10-30 parts of astragalus, 3-20 parts of honeysuckle, 3-18 parts of scutellaria, 3-18 parts of bupleurum, 6-30 parts of pseudostellaria, 6-30 parts of white tuckahoe, 6-30 parts of honey-fried atractylodes, 6-30 parts of perilla, 3-18 parts of siler, and 3-18 parts of honey-fried liquorice.

2. The Chinese medicine composition according to claim 1, characterized in that: The drug is prepared from the following raw materials in parts by weight: 12-18 parts of astragalus, 6-18 parts of honeysuckle, 6-12 parts of scutellaria, 6-12 parts of bupleurum, 9-18 parts of pseudostellaria, 12-18 parts of white tuckahoe, 12-18 parts of honey-fried atractylodes, 9-15 parts of perilla, 6-12 parts of siler and 5-12 parts of honey-fried liquorice.

3. The Chinese medicine composition according to claim 2, characterized in that: The drug is prepared from the following raw materials in parts by weight: 15 parts of astragalus, 12 parts of honeysuckle, 9 parts of scutellaria, 9 parts of bupleurum, 12 parts of pseudostellaria, 15 parts of white tuckahoe, 15 parts of honey-fried atractylodes, 12 parts of perilla, 9 parts of siler and 6 parts of honey-fried liquorice.

4. Use of the Chinese medicine composition as claimed in any one of claims 1 to 3 in preparing a drug for treating lung and spleen qi deficiency syndrome in the recovery period of viral pneumonia.

5. The use according to claim 4, characterized in that: The drug for treating lung and spleen qi deficiency syndrome in the recovery period of viral pneumonia refers to a drug for improving the symptoms of fatigue, shortness of breath, chest tightness, cough, loss of appetite, fullness, tasteless mouth, loose stools, diarrhea, and spontaneous sweating in patients with lung and spleen qi deficiency syndrome in the recovery period of viral pneumonia.

6. A pharmaceutical preparation using the Chinese medicine composition as claimed in any one of claims 1 to 3 as an active ingredient, characterized in that: The pharmaceutical preparation is prepared into a common dosage form in pharmacy by conventional preparation methods in the art.

7. The pharmaceutical preparation according to claim 6, characterized in that The pharmaceutical preparation is an oral preparation; the oral preparation includes decoction, tablet, capsule, granule, mixture, pill, oral liquid or syrup.

8. Use of the pharmaceutical preparation according to claim 6 or 7 in preparing a drug for treating lung-spleen deficiency syndrome in the recovery period of viral pneumonia.

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