A Chinese medicine composition for treating chronic obstructive pulmonary disease and its application

Abstract

The present application relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease and application thereof, and an active ingredient of the traditional Chinese medicine composition is prepared from the following raw materials by weight: 10-30 parts of fried astragalus, 2-10 parts of ginseng, 5-15 parts of atractylodes, 5-15 parts of radix morindae officinalis, 1-8 parts of leech, 2-10 parts of fructus aurantii immaturus, and 10-30 parts of mulberry root-bark. Based on the theory of Zongyuan and long-term clinical practice, the present application first proposes that the core pathogenesis of chronic obstructive pulmonary disease is "Zongyuan deficiency", and the traditional Chinese medicine composition formula is synthesized by taking fried astragalus and ginseng as monarch drugs, atractylodes and radix morindae officinalis as ministerial drugs, and leech, fructus aurantii immaturus and mulberry root-bark as auxiliary drugs. The combined use of the drugs has the effects of tonifying Zongyuan, promoting blood circulation to resolve phlegm, relieving cough and asthma. Clinical application shows that the traditional Chinese medicine composition provided by the present application can effectively improve the clinical symptoms such as cough, sputum and asthma of patients with chronic obstructive pulmonary disease, reduce airway mucus hypersecretion, improve exercise tolerance, and possibly reduce acute exacerbation, so as to slow down the development process of chronic obstructive pulmonary disease.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease and application thereof. BACKGROUND

[0002] Chronic obstructive pulmonary disease (COPD for short) is a heterogeneous lung disease characterized by persistent airflow obstruction caused by airway and / or alveolar abnormalities, mainly manifested as symptoms such as cough, sputum, and dyspnea. COPD has a high prevalence, high morbidity and mortality, and a heavy disease burden, and has become a major chronic disease that seriously endangers human health. COPD has an insidious onset and a high rate of missed diagnosis. With the aggravation of population aging, the continuous exposure of risk factors such as environmental pollution, fuel smoke, and high number of smokers, it is estimated that the prevalence of COPD in China will continue to rise. With the gradual progression of the disease, the lung function of patients declines progressively, and affects various organs of the body, seriously affecting the health and quality of life of patients.

[0003] Western medicine treatment for stable COPD includes non-drug and drug treatment. Stable non-drug treatment such as pulmonary rehabilitation is often limited by location and equipment, and is difficult to be widely carried out. Despite standard treatment with western medicine, some patients still have repeated acute exacerbations. According to reports, COPD patients have about 0.5-3.5 acute exacerbations per year, and acute exacerbation is the main reason for COPD patients to be hospitalized. Excluding the influence of factors such as poor treatment compliance and non-standard use of inhaled drugs, there are still problems such as high airway mucus secretion, dyspnea, and repeated acute exacerbations in the treatment of COPD, and there are certain side effects in long-term use of drugs, such as long-term inhaled glucocorticoids may increase the incidence of pneumonia, and the use of bronchodilators may cause sinus tachycardia, muscle tremor, dry mouth, cough, bronchospasm, headache, dizziness, etc., and theophylline drugs may also increase adverse reactions when used with other drugs due to interaction.

[0004] Traditional Chinese medicine believes that COPD belongs to the category of “cough”, “asthma”, and “pulmonary distension”. At present, the Chinese patent drugs for treating COPD are mostly for treating cold, cough, sputum, and wheezing, such as Yupingfeng preparation, Jinshuibao capsule, Bailing capsule, Bushenhuoxue capsule, and Gubenkechuan granules. Among them, Yupingfeng preparation is mainly beneficial to patients with recurrent cold and lung qi deficiency, and has no obvious effect on the symptoms of cough, sputum, and wheezing; Jinshuibao and Bailing capsules are mainly used for patients with lung-kidney deficiency, and cannot cover patients with spleen deficiency; Bushenhuoxue capsule is mainly used for patients with lung heart disease with qi deficiency and blood stasis; Gubenkechuan granules focus on tonifying qi and consolidating the exterior, invigorating the spleen and tonifying the kidney, and do not consider the effects of reducing sputum and promoting blood circulation. At present, there is no drug that has good effect, treats both the symptoms and the root cause, for COPD patients with obvious symptoms of cough, sputum, and wheezing and easy repeated acute exacerbation, and the needs of patients cannot be met. SUMMARY

[0005] In order to solve the above problems, the application provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease and application thereof. The traditional Chinese medicine composition has the main effects of nourishing the spleen and kidney, promoting blood circulation and resolving phlegm, relieving cough and asthma, and is used for treating chronic obstructive pulmonary disease patients with obvious and easily repeated acute exacerbation symptoms of cough, sputum and asthma, and has good clinical application effect.

[0006] The first aspect of the application provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease. The active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 10-30 parts of fried astragalus, 2-10 parts of ginseng, 5-15 parts of atractylodes, 5-15 parts of dangshen, 1-8 parts of leech, 2-10 parts of dried tangerine peel, and 10-30 parts of mulberry bark.

[0007] In some preferred embodiments, the active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 10-20 parts of fried astragalus, 2-8 parts of ginseng, 5-10 parts of atractylodes, 5-10 parts of dangshen, 1-5 parts of leech, 2-8 parts of dried tangerine peel, and 15-25 parts of mulberry bark.

[0008] In some more preferred embodiments, the active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 15 parts of fried astragalus, 5 parts of ginseng, 8 parts of atractylodes, 8 parts of dangshen, 2 parts of leech, 5 parts of dried tangerine peel, and 20 parts of mulberry bark.

[0009] The second aspect of the application provides a preparation method of the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, which comprises the following steps:

[0010] Ginseng is taken in proportion, and decocted or stewed separately to obtain juice;

[0011] Leech is taken in proportion, and made into powder to obtain leech powder;

[0012] The other raw materials are weighed in proportion, water is added for decoction, filtered, the filter residue is decocted with water again, and filtered again;

[0013] The two filtrates are combined, the ginseng juice and leech powder are added and stirred uniformly, and the traditional Chinese medicine composition is obtained.

[0014] Or the following steps are included:

[0015] Ginseng is taken in proportion, and decocted or stewed separately to obtain juice;

[0016] The other raw materials are weighed in proportion, water is added for decoction, filtered, the filter residue is decocted with water again, and filtered again;

[0017] The two filtrates are combined, the ginseng juice is added and stirred uniformly, and the traditional Chinese medicine composition is obtained.

[0018] In some embodiments, each decoction time is 0.5h-3h. Specifically, the first filtration is added with 10-12 times water, and decocted for 1-3h; the second filtration is added with 7-8 times water, and decocted for 0.5-1h.

[0019] In a third aspect, the application provides another preparation method of the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, comprising the following steps:

[0020] The raw materials are weighed according to the proportion, water is added for decoction, filtration is performed, and the filter residue is added with water for decoction, and filtration is performed;

[0021] The filtrates are combined to obtain an extract, and the extract is concentrated to obtain a concentrated solution;

[0022] The concentrated solution is dried to obtain a dry powder, and excipients are added to the dry powder to obtain the traditional Chinese medicine composition.

[0023] In some embodiments, the first filtration is added with 5-8 times water, and decocted for 1h-3h; the second filtration is added with 5-6 times water, and decocted for 1h-2h.

[0024] Specifically, the excipients include but are not limited to malt dextrin, magnesium stearate, etc.

[0025] In a fourth aspect, the application provides application of the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease or the traditional Chinese medicine composition prepared by the preparation method in the preparation of a medicine for treating chronic obstructive pulmonary disease.

[0026] In a fifth aspect, the application provides a medicine for treating chronic obstructive pulmonary disease, which comprises the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease or the traditional Chinese medicine composition prepared by the preparation method, and a pharmaceutically acceptable excipient.

[0027] In some embodiments, the medicine is a water extract, a tablet, a capsule, a granule, a powder, a pill, a drop, a fruit juice or a syrup.

[0028] Compared with the prior art, the application has the following beneficial effects:

[0029] (1) The application provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, which comprises suitable amounts of fried Astragalus membranaceus, Panax ginseng, Atractylodes macrocephala, Morinda officinalis, Hirudo nipponia, Citrus aurantium, and Morus alba. Based on the theory of Zongyuan and long-term clinical practice, the application first proposes that the core pathogenesis of chronic obstructive pulmonary disease is Zongyuan deficiency, and the traditional Chinese medicine composition is synthesized by taking fried Astragalus membranaceus and Panax ginseng as monarch drugs, Atractylodes macrocephala and Morinda officinalis as ministerial drugs, and Hirudo nipponia, Citrus aurantium and Morus alba as auxiliary drugs. The combination of the drugs has the effects of tonifying Zongyuan, promoting blood circulation to remove phlegm and relieving cough and asthma.

[0030] (2) The traditional Chinese medicine composition of the present application is assisted by Citrus aurantium to regulate qi and disperse phlegm, which can enhance the effect of the monarch drug, Radix Astragali and Radix Ginseng, in tonifying the essence of the kidney, and at the same time, it can treat the symptoms of cough, asthma and phlegm in patients with chronic obstructive pulmonary disease; and it is assisted by Folium Mori to treat lung and asthma, so as to moderate the monarch drug which is too warm and tonifying, and at the same time, it can treat the symptoms of cough and asthma. At the same time, modern pharmacological studies have shown that Citrus aurantium has the functions of anti-inflammatory, antioxidant and anti-fatigue, and Folium Mori has the functions of anti-inflammatory, antioxidant, immune activity regulation and anti-depression, and the assistance of Citrus aurantium and Folium Mori can significantly improve the clinical symptoms of cough, phlegm and asthma in patients with chronic obstructive pulmonary disease, and reduce the high secretion of airway mucus.

[0031] (3) Clinical application shows that the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease provided by the present application can effectively improve the clinical symptoms of cough, phlegm and asthma in patients with chronic obstructive pulmonary disease, reduce the high secretion of airway mucus, improve the quality of life, improve the exercise tolerance, and possibly reduce the acute exacerbation, so as to slow down the development process of chronic obstructive pulmonary disease, and has good treatment potential. BRIEF DESCRIPTION OF DRAWINGS

[0032] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the drawings needed to be used in the following embodiment or prior art description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creative labor.

[0033] Figure 1 The graph for the proportion of inhaled drugs in the patients of Example 6 of the present application is shown in the following figure:

[0034] Figure 2 The comparison result graph of CAT scores before and after treatment of the patients of Example 6 of the present application is shown in the following figure:

[0035] Figure 3 The comparison result graph of mMRC scores before and after treatment of the patients of Example 6 of the present application is shown in the following figure:

[0036] Figure 4 The comparison result graph of CASA-Q scores before and after treatment of the patients of Example 6 of the present application is shown in the following figure:

[0037] Figure 5 The comparison result graph of VAS scores of cough, expectoration and asthma before and after treatment of the patients of Example 6 of the present application is shown in the following figure:

[0038] Figure 6 The comparison result graph of 6-minute walk distance (6MWT) before and after treatment of the patients of Example 6 of the present application is shown in the following figure. DETAILED DESCRIPTION

[0039] For the purpose of facilitating the understanding of the present application, a more comprehensive description of the present application will be given below with reference to the embodiments. The preferred embodiments of the present application are given below. However, the present application can be realized in many different forms and is not limited to the embodiments described herein. The purpose of providing these embodiments is to make the disclosure of the present application more thorough and comprehensive. It should be understood that the experimental methods not specified in the following embodiments are generally carried out under conventional conditions or under the conditions recommended by the manufacturers. The various common reagents used in the embodiments are commercially available products.

[0040] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0041] Both Zongqi and Yuanqi are important human QI. Zongqi is the postnatal QI in the chest, and Yuanqi, also known as original QI, is the prenatal QI, which is the original driving force of life activities. Both of them are closely related to the operation of human QI, especially the function of lung governing QI and governing respiration. The main pathogenesis of chronic obstructive pulmonary disease is lung and spleen QI deficiency, which leads to Zongqi deficiency, chronic cough and asthma, and eventually damages the kidney and consumes Yuanqi. At the same time, due to the failure of lung, spleen and kidney, the distribution of body fluid is abnormal, which leads to the generation of phlegm, dampness and blood stasis, and hinders the distribution and nourishment of Yuanqi. The deficiency of Yuanqi and the weakness of distribution can aggravate lung deficiency, and further aggravate cough and asthma. This vicious cycle is difficult to cure. If Zongqi is abundant and has the source of generation and transformation, it can govern respiration, regulate and control, and support the prenatal QI. With the support of Zongqi, Yuanqi is abundant and vigorous. When Zongqi and Yuanqi are vigorous, the respiratory QI is smooth.

[0042] The traditional Chinese medicine composition for treating chronic obstructive pulmonary disease provided by the present application comprises:

[0043]

Honeyed Astragalus Root

[0044]

Ginseng

[0045]

White Atractylodes Rhizome

[0046]

Radix Morindae Officinalis

[0047]

Leech

[0048]

Exocarpium Citri Grandis

[0049]

Cortex Mori

[0050] Based on the theory of Zongyuan and long-term clinical practice, the present application first proposes that the core pathogenesis of chronic obstructive pulmonary disease is "Zongyuan deficiency". The present application uses Zhi Huangqi and Renshen as the monarch drugs, Baizhu and Badijitian as the ministerial drugs, and Shuizhi, Huazao Hong, and Sangbaipi as the auxiliary drugs to synthesize a traditional Chinese medicine composition formula. The combination of these drugs can jointly play the functions of tonifying Zongyuan, promoting blood circulation and resolving phlegm, and relieving cough and asthma.

[0051] The present application uses Huazao Hong to regulate qi, unblock the middle, and resolve phlegm. It is known as "South Ginseng" and can strengthen the functions of the monarch drugs Zhi Huangqi and Renshen in tonifying the qi of Zongyuan. At the same time, it can also consider the symptoms of cough, asthma, and phlegm in patients with chronic obstructive pulmonary disease. Then, Sangbaipi is used to purge the lung and relieve asthma. Its sweet nature can regulate the monarch drugs and treat the symptoms of cough and asthma. In addition, modern pharmacological research shows that Huazao Hong has functions such as anti-inflammatory, antioxidant, and anti-fatigue, and Sangbaipi has functions such as anti-inflammatory, antioxidant, immune activity regulation, and anti-depression. Huazao Hong contains many active substances such as flavonoids, polysaccharides, volatile oils, and inositol, which can dilute sputum and help expectoration. Naringin can effectively scavenge free radicals and help reduce the damage of oxidative stress to cells and tissues, which is closely related to its antioxidant and anti-fatigue mechanisms. In addition, naringin can inhibit the contraction caused by the influx of extracellular calcium under high calcium conditions, suggesting that the mechanism of Huazao Hong in relieving asthma may be related to blocking Ca2+ channels and inhibiting airway smooth muscle M receptors and H1 receptors. The stilbenes, flavonoids, and polysaccharides in Sangbaipi have certain antioxidant capacity, and polysaccharides can improve lung tissue inflammation and reduce airway mucus hypersecretion by reducing the infiltration of inflammatory cells in the alveolar wall. Clinical application shows that the traditional Chinese medicine composition of the present application can significantly improve the clinical symptoms of cough, phlegm, and asthma in patients with chronic obstructive pulmonary disease and reduce airway mucus hypersecretion. This is closely related to the antioxidant and anti-inflammatory functions of Huazao Hong and Sangbaipi.

[0052] The pharmaceutically acceptable adjuvant in the present application includes but is not limited to (1) diluents, such as starch, powdered sugar, dextrin, lactose, pregelatinized starch, microcrystalline fiber, inorganic calcium salt (such as calcium sulfate, calcium hydrogen phosphate, medicinal calcium carbonate, etc.), mannitol, vegetable oil, polyethylene glycol, etc.; (2) binders, such as distilled water, ethanol, starch paste, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose and ethyl cellulose, hydroxypropyl methyl cellulose, etc.; (3) disintegrants, such as dry starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, etc.; (4) lubricants, such as magnesium stearate, microfine silica, talc, hydrogenated vegetable oil, polyethylene glycol, magnesium lauryl sulfate, etc.; (5) solvents, such as water, ethanol solution, etc.

[0053] In the present application, the "parts" or "parts by weight" refer to the relative mass ratio between the related substances, rather than indicating the specific mass number of the specific substance. According to the actual situation of production and clinic, 1 part or 1 part by weight can be 1 g, 10 g, 500 g, 1 kg, and other arbitrary mass numbers.

[0054] The following is described in conjunction with specific examples.

[0055] Example 1

[0056] The present example provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, the active ingredients of the traditional Chinese medicine composition are prepared from the following parts by weight of raw materials: Zhi Huangqi 15 g, Renshen 5 g, Baizhu 8 g, Baguantian 8 g, Shuizhi 2 g, Huazao 5 g, Sangbaipi 20 g.

[0057] The specific preparation method is as follows:

[0058] (1) The single Renshen is weighed according to the proportion, 10 times water is added, and the water stewing method is used, and the juice is taken after 2 hours of slow fire stewing for standby;

[0059] (2) The single Shuizhi is weighed and powdered for standby;

[0060] (3) The other raw materials are weighed according to the proportion, 10 times water is added, soaked for 30 minutes, boiled with strong fire, then slow-cooked with weak fire for 1 hour, filtered to get the filtrate; the filter residue is added with 7 times water, boiled with strong fire, then slow-cooked with weak fire for 40 minutes, filtered again to get the filtrate;

[0061] (4) The two filtrates are combined, the Renshen stewing juice is added, and the Shuizhi powder is stirred evenly, to get the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease.

[0062] Example 2

[0063] The embodiment provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, and active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 15g of fried astragalus, 5g of ginseng, 8g of atractylodes, 8g of leydig, 2g of leech, 5g of dried tangerine peel, and 20g of mulberry bark.

[0064] The specific preparation method is as follows:

[0065] (1) Ginseng is weighed according to the proportion, 10 times water is added, soaked for 30 minutes, boiled with strong fire and then slowly boiled with weak fire for 1 hour, filtered to obtain the filtrate; the filter residue is added with 7 times water again, boiled with strong fire and then slowly boiled with weak fire for 40 minutes, filtered again to obtain the filtrate, and the juice is taken for standby;

[0066] (2) The single flavor leech is weighed according to the proportion, and the powder is taken for standby;

[0067] (3) The other raw materials are weighed according to the proportion, 10 times water is added, soaked for 30 minutes, boiled with strong fire and then slowly boiled with weak fire for 1 hour, filtered to obtain the filtrate; the filter residue is added with 7 times water again, boiled with strong fire and then slowly boiled with weak fire for 40 minutes, filtered again to obtain the filtrate;

[0068] (4) The two filtrates are combined, the ginseng decoction is added, the leech powder is stirred uniformly, and the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease is obtained.

[0069] Embodiment 3

[0070] The embodiment provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, and active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 15g of fried astragalus, 5g of ginseng, 8g of atractylodes, 8g of leydig, 2g of leech, 5g of dried tangerine peel, and 20g of mulberry bark.

[0071] The specific preparation method is as follows:

[0072] (1) Ginseng is weighed according to the proportion, 10 times water is added, soaked for 30 minutes, boiled with strong fire and then slowly boiled with weak fire for 1 hour, filtered to obtain the filtrate; the filter residue is added with 7 times water again, boiled with strong fire and then slowly boiled with weak fire for 40 minutes, filtered again to obtain the filtrate, and the juice is taken for standby;

[0073] (2) The other raw materials are weighed according to the proportion, 10 times water is added, soaked for 30 minutes, boiled with strong fire and then slowly boiled with weak fire for 1 hour, filtered to obtain the filtrate; the filter residue is added with 7 times water again, boiled with strong fire and then slowly boiled with weak fire for 40 minutes, filtered again to obtain the filtrate;

[0074] (3) The two filtrates are combined, the ginseng decoction is added, the leech powder is stirred uniformly, and the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease is obtained.

[0075] Embodiment 4

[0076] The present embodiment provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, and the active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: Radix Astragali 15 g, Radix Ginseng 5 g, Rhizoma Atractylodis Macrocephalae 8 g, Radix Morindae Officinalis 8 g, Hirudo 3 g, Fructus Aurantii Immaturus 5 g, and Cortex Mori 20 g.

[0077] The specific preparation method is as follows:

[0078] (1) The single Radix Ginseng is weighed according to the proportion, 10 times water is added, and the water decoction method is used. After 2 hours of slow fire steaming and decoction, the juice is taken and reserved;

[0079] (2) The other raw materials are weighed according to the proportion, 10 times water is added, and soaked for 30 minutes. After boiling with strong fire, it is slowly decocted with weak fire for 1 hour, and then filtered to obtain the filtrate. The filter residue is added with 7 times water, boiled with strong fire, and then slowly decocted with weak fire for 40 minutes. The filtrate is obtained by filtering again;

[0080] (3) The two filtrates are combined, the Radix Ginseng decoction is added, and the Hirudo powder is stirred uniformly. Thus, the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease is obtained.

[0081] Example 5

[0082] The present embodiment provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, and the active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: Radix Astragali 15 g, Radix Ginseng 5 g, Rhizoma Atractylodis Macrocephalae 8 g, Radix Morindae Officinalis 8 g, Hirudo 2 g, Fructus Aurantii Immaturus 5 g, and Cortex Mori 20 g.

[0083] The specific preparation method is as follows:

[0084] (1) The raw materials are weighed according to the proportion, and 7 times water is added for decoction for 2 hours, and then filtered;

[0085] (2) The residue is added with 6 times water for decoction for 1 hour, and then filtered;

[0086] (3) The filtrates are combined to obtain the extract, which is centrifuged or filtered, and concentrated under reduced pressure to obtain the concentrated liquid;

[0087] (4) The concentrated liquid is spray dried to obtain the dry powder, and thus the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease is obtained.

[0088] Example 6

[0089] The above traditional Chinese medicine composition for treating chronic obstructive pulmonary disease is used for treating chronic obstructive pulmonary disease, and the specific method is as follows:

[0090] (1) General information

[0091] 30 patients were collected from April 2023 to November 2023 in the respiratory department of Guangdong Provincial Hospital of Chinese Medicine, all male, with an average age of (69.30±7.56) years old. According to the GOLD 2024 lung function classification, 43.3% of patients were at stage 2, 36.7% at stage 3, and 20.0% at stage 4.

[0092] (2) Inclusion criteria

[0093] ① 40 years old ≤ age ≤ 85 years old;

[0094] ② Meet the diagnostic criteria of chronic obstructive pulmonary disease defined by Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD 2023 edition), with lung function classification at stage 2 to stage 4;

[0095] ③ Patients with obvious symptoms of cough and sputum;

[0096] ④ Patients in stable phase, no respiratory tract infection and acute exacerbation of chronic obstructive pulmonary disease in the past 4 weeks;

[0097] ⑤ TCM syndrome of qi deficiency and phlegm stasis;

[0098] ⑥ Signed informed consent form.

[0099] (3) Exclusion criteria

[0100] ① Combined with bronchiectasis, asthma, obstructive sleep apnea syndrome, lung malignancy, active tuberculosis and other diseases;

[0101] ② Patients with current or recent 4 weeks of pulmonary infection;

[0102] ③ Patients with severe cardiovascular, cerebrovascular, liver and kidney diseases, mental illness or cancer;

[0103] ④ Not willing to accept research measures or other reasons cannot cooperate.

[0104] (4) Treatment regimen

[0105] Patients enrolled were given the water extract of the traditional Chinese medicine composition prepared in Example 1, one dose per day, taken twice a day at half an hour after breakfast and dinner, about 250-300 mL each time.

[0106] Basic treatment: according to the Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Edition) and GOLD Guidelines (2023 Edition), routine inhalation therapy was given.

[0107] (5) Treatment course

[0108] 60 days.

[0109] (6) Observation index

[0110] ① COPD Assessment Test (CAT) score: This is an 8-item test to assess the comprehensive symptoms of COPD. The score ranges from 0 to 40 points. The higher the score, the more severe the symptoms.

[0111] ② The modified Medical Research Council Questionnaire (mMRC) assesses dyspnea symptoms in patients with COPD. It correlates well with other indicators of health status and can predict long-term mortality risk.

[0112] ③ Cough and Sputum Assessment Questionnaire (CASA-Q): This questionnaire assesses the symptoms and impact of cough and sputum. It includes 20 items covering cough symptoms, cough impact, sputum symptoms, and sputum impact. Each question is scored from 0 to 4 points. The regional score is calculated as (total score of all questions in each region / maximum score in each region) multiplied by 100. A higher score indicates better health status.

[0113] ④ Cough Visual Analogue Scale (VAS): Mark the corresponding scale on the line segment marked 0-10 cm to indicate the degree of cough according to the patient's feeling, with 0 representing no cough and 10 representing unbearable severe cough;

[0114] Sputum Visual Analog Scale (VAS): Mark the corresponding scale on the line segment marked 0-10 cm according to the patient's feeling to indicate the amount of sputum, 0 represents no sputum, and 10 represents a very large amount of sputum;

[0115] Visual Analog Scale (VAS) for shortness of breath: Mark the corresponding scale on the line segment marked 0-10 cm according to the patient's feeling to indicate the severity of shortness of breath, 0 represents no shortness of breath, and 10 represents very severe shortness of breath.

[0116] ⑤6-minute walk distance (6MWT): Assess the patient's exercise endurance by measuring the distance he or she can walk briskly on a flat, hard ground within 6 minutes.

[0117] The above indicators were evaluated before and after treatment and recorded in the clinical case observation form.

[0118] (7) Statistical methods

[0119] Epidata 3.1 was used for data management. SPSS 25.0 was used for statistical analysis. Descriptive data were presented, with enumeration data presented as rates or percentages. Normally distributed measurement data were compared before and after treatment using the paired sample t-test, while non-normally distributed data were compared using the Wilcoxon signed-rank test. Enumeration data were compared before and after treatment using the chi-square test or Fisher's exact test. P < 0.05 was considered statistically significant.

[0120] (8) The main inhaled drug used by patients was budeglucofol (43.33%). Common inhaled drugs used by patients included Figure 1 shown.

[0121] (9) Results

[0122] ① Comparison of CAT scores before and after treatment

[0123] like Figure 2 As shown in Table 1, the CAT score of patients after treatment was reduced by 3.53 points compared with that before treatment, indicating that symptoms such as cough, sputum, and wheezing can be improved (P<0.01).

[0124] Table 1 Comparison of CAT scores of patients before and after treatment

[0125]

[0126] Note: Compared with before treatment, **P<0.01

[0127] ② Comparison of mMRC scores before and after treatment

[0128] like Figure 3 As shown in Table 2, the mMRC score of patients after treatment was reduced by 0.16 points compared with that before treatment (P<0.05), indicating that the severity of dyspnea can be alleviated.

[0129] Table 2 Comparison of mMRC scores of patients before and after treatment

[0130]

[0131] Note: Compared with before treatment, *P<0.05

[0132] ③Comparison of CASA-Q scores before and after treatment

[0133] like Figure 4 As shown in Table 3, the CASA-Q cough symptom score increased by 15.28 points (P < 0.01); the cough impact score increased by 2.13 points (P < 0.05); the sputum symptom score increased by 14.72 points (P < 0.01); and the sputum impact score increased by 2.64 points (P < 0.01). These results suggest that treatment can alleviate airway mucus hypersecretion.

[0134] Table 3 Comparison of CASA-Q scores before and after treatment

[0135]

[0136]

[0137] Note: compared with before treatment, *P<0.05, **P<0.01

[0138] (4) Comparison of cough VAS, expectoration VAS and asthma VAS scores of patients before and after treatment

[0139] As Figure 5 As shown in Table 4, the cough VAS score of the patients was reduced by 1.00 (P<0.01) compared with before treatment; the expectoration VAS score was reduced by 1.10 (P<0.01); and the asthma VAS score was reduced by 1.03 (P<0.01).

[0140] Table 4 Comparison of cough VAS, expectoration VAS and asthma VAS scores of patients before and after treatment

[0141]

[0142] Note: compared with before treatment, **P<0.01

[0143] (5) Comparison of 6-minute walk distance (6MWT) of patients before and after treatment

[0144] As Figure 6 As shown in Table 5, the 6-minute walk distance of the patients was increased by 41.9 m (P<0.01) after treatment compared with before treatment, indicating that the exercise tolerance can be increased.

[0145] Table 5 Comparison of 6-minute walk distance (6MWT) of patients before and after treatment

[0146]

[0147] Note: compared with before treatment, *P<0.01

[0148] (6) Safety evaluation

[0149] No adverse events were found during the test period. Only 1 case of acute exacerbation occurred during the test period, and the incidence of acute exacerbation was 3.33%.

[0150] In summary, the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease provided by the application can improve the clinical symptoms such as cough, sputum and asthma of patients with chronic obstructive pulmonary disease, reduce airway mucus hypersecretion, improve the quality of life, improve exercise tolerance, and possibly reduce acute exacerbation, thereby slowing down the development process of chronic obstructive pulmonary disease, and having good treatment potential; in line with the characteristics of TCM syndromes of chronic obstructive pulmonary disease "qi deficiency and phlegm stasis", having the effects of tonifying the primordial qi, promoting blood circulation to remove phlegm, relieving cough and asthma, treating both symptoms and root causes, and simultaneously treating both the root and the branch, the application provides a drug selection for the treatment of clinical chronic obstructive pulmonary disease, and has a broad application prospect.

[0151] The application is further described in detail with specific examples, but it should be understood that the specific description herein should not be construed to limit the scope of the application, and various modifications made by those skilled in the art after reading the description are within the scope of the application.

Claims

1. A Chinese medicine composition for treating chronic obstructive pulmonary disease, characterized in that: The active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 10-30 parts of roasted astragalus, 2-10 parts of ginseng, 5-15 parts of atractylodes, 5-15 parts of Morinda officinalis, 1-8 parts of leech, 2-10 parts of dried orange peel, and 10-30 parts of white mulberry bark.

2. The Chinese medicine composition for treating chronic obstructive pulmonary disease according to claim 1, characterized in that: The active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 10-20 parts of roasted astragalus, 2-8 parts of ginseng, 5-10 parts of atractylodes, 5-10 parts of Morinda officinalis, 1-5 parts of leech, 2-8 parts of dried orange peel, and 15-25 parts of mulberry bark.

3. The Chinese medicine composition for treating chronic obstructive pulmonary disease according to claim 1, characterized in that: The active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 15 parts of roasted astragalus, 5 parts of ginseng, 8 parts of atractylodes macrocephala, 8 parts of Morinda officinalis, 2 parts of leech, 5 parts of dried orange peel, and 20 parts of mulberry bark.

4. The method for preparing the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease according to any one of claims 1 to 3, characterized in that: The steps include: Take ginseng in proportion and fry or stew it separately to get the juice; Take leeches in proportion and make them into powder to obtain leech powder; Weigh other raw materials in proportion, add water to boil, filter, add water to boil the residue, and filter again; Combine the two filtrates, add the ginseng decoction or stewed juice and leech powder and mix evenly to obtain the mixture; Or include the following steps: Take ginseng in proportion and fry or stew it separately to get the juice; Weigh other raw materials in proportion, add water to boil, filter, add water to boil the residue, and filter again; Combine the two filtrates, add the ginseng decoction or stewed juice and stir evenly to obtain the product.

5. The method for preparing the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease according to claim 4, characterized in that: The decoction time for each time is 0.5h-3h.

6. The method for preparing the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease according to any one of claims 1 to 3, characterized in that: The steps include: Weigh the raw materials of each flavor according to the proportion, add water to boil, filter, add water to boil the residue, and filter; The two filtrates were combined to obtain an extract, which was concentrated to obtain a concentrate; The concentrated liquid is dried to obtain dry powder, and excipients are added to the dry powder to obtain the product.

7. The method for preparing the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease according to claim 6, characterized in that: Add 5-8 times the amount of water for the first filtration and boil for 1h-3h; add 5-6 times the amount of water for the second filtration and boil for 1h-2h.

8. Use of the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease according to any one of claims 1 to 3 or the traditional Chinese medicine composition prepared according to the preparation method according to any one of claims 4 to 7 in preparing a medicament for treating chronic obstructive pulmonary disease.

9. A drug for treating chronic obstructive pulmonary disease, characterized in that: The medicine is composed of the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease according to any one of claims 1 to 3 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 7, and pharmaceutically acceptable excipients.

10. The drug for treating chronic obstructive pulmonary disease according to claim 9, characterized in that: The medicine is in the form of water extract, tablet, capsule, granule, powder, pill, drop or syrup.

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