Traditional Chinese medicine composition for treating chronic obstructive pulmonary disease and preparation method

Abstract

The invention discloses a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease. The traditional Chinese medicine composition is prepared from the following medicinal materials in parts by weight: 20-40 parts of polygonum cuspidatum, 20-40 parts of astragalus membranaceus, 20-40 parts of herba epimedii, 20-40 parts of morinda officinalis, 10-30 parts of folium eriobotryae, 20-40 parts of radix rehmanniae, 3-9 parts of almond, 3-9 parts of mangnolia officinalis and 5-25 parts of ligusticum wallichii. The traditional Chinese medicine composition has the effects of preventing phlegm from forming, relieving cough and asthma, tonifying lung and kidney and dispersing blood stasis, and can be used for treating chronic obstructive pulmonary diseases. In-vivo and in-vitro experiments prove that the traditional Chinese medicine composition has a good treatment effect, and clinical test researches prove that the traditional Chinese medicine composition can safely and effectively improve the symptoms of patients with chronic obstructive pulmonary diseases and improve the living quality of the patients, and has good clinical value and application prospects.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease and a preparation method thereof. Background Art

[0002] Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease in clinical practice. The main characteristics of the disease are persistent airflow limitation and chronic airway inflammation, and its prevalence is increasing year by year. Inhaled smoke and air pollutant particles will be deposited in the airways, inducing oxidative stress, leading to the recruitment of inflammatory cells such as macrophages, neutrophils and T lymphocytes, triggering chronic inflammation and aggravating the inflammatory response, accelerating the occurrence and development of COPD.

[0003] COPD is often classified as "asthma and lung distension" in traditional Chinese medicine. Doctors of different dynasties have different understandings of this disease, but the overall pathogenesis is a mixture of deficiency and excess. Deficiency is mainly caused by internal organ deficiency in the early stage, which is mostly transmitted from the lung to the spleen and kidney. Excess refers to phlegm, water retention, blood stasis and other real evils. In the later stage, with repeated invasion of external evils, phlegm accumulates and becomes blood stasis, which eventually becomes a syndrome of deficiency, phlegm and blood stasis. Deficiency and excess affect each other and promote the aggravation of this disease. Traditional Chinese medicine believes that the occurrence of this disease is mostly caused by long-term lung deficiency and phlegm and blood stasis. The disease is aggravated by repeated external evils. Its pathological factors, phlegm, water retention and blood stasis, can run through the entire disease, and the three can affect and transform each other. Evil qi blocks the lungs, and the lungs lose their ability to purify and clear, or cough and wheeze, or the body fluids fail to be transported and transformed into phlegm. Over time, the lungs become weak, and the qi and yin are damaged, resulting in abnormal function of the lungs' main qi, which then causes the six evils to invade or the evil qi of other organs to invade the lungs, causing lung swelling. Over time, it affects the spleen and kidneys. Over time, lung disease consumes the mother's qi, and the spleen loses its health, leading to both lung and spleen deficiency. Spleen deficiency cannot disperse essence and return to the lungs, and lung disease cannot distribute water essence, which gathers into phlegm. If lung disease lasts for a long time, it affects the kidneys, and the lungs and kidneys are both sick. The kidneys can help the lungs absorb qi, and the essence and qi are depleted. The lungs cannot control qi, and the kidneys cannot absorb qi, which can cause asthma to become increasingly severe, and even worse when moving. In the later stage, the disease affects the heart. The lungs and heart meridians are connected, and they live in the upper part of the body. The lungs face all the meridians, and the lung qi assists the heart in running blood. Over time, lung disease fails to regulate the body, and the heart is not smooth, which causes asthma and restlessness. Heart yang is rooted in the true fire of the Mingmen. If kidney yang is weak, it will further lead to heart and kidney yang failure, and dangerous symptoms of asthma and collapse may occur.

[0004] COPD is a disease that is favored by TCM. In the stable period, TCM appropriate technical intervention is adopted to guide the relevant theories of TCM "preventing disease before it occurs" and "preventing recurrence after recovery" in the theory of "treating disease before it occurs". This is beneficial for COPD patients. In the short term, it can improve clinical symptoms and improve the quality of life; in the long term, it can reduce the number of acute attacks. In the course of disease development, COPD patients have long-term chronic airway inflammation, and the adverse reactions caused by antibiotics and hormone treatments reduce the patient's own immune regulation ability, destroy the balance of yin and yang in the human body, and the disease is prone to recurrence. TCM treatment methods are diverse, flexible, and have few adverse reactions. Patients have high compliance and good efficacy. It can comprehensively regulate the local and systemic conditions, use TCM appropriate technologies to improve the balance of yin and yang, protect the positive energy, improve the patient's immunity, and prevent recurrence, providing more options for the management of COPD patients in the stable period. A large number of clinical studies have confirmed that TCM treatment of COPD can effectively improve patients' clinical symptoms, improve the quality of life, increase activity endurance, and has good tolerance for long-term treatment.

[0005] However, the existing traditional Chinese medicine treatment schemes have many problems such as complex formula, inconsistent efficacy, and rough preparation process. In particular, for COPD, a disease with a specific pathological mechanism, there is a lack of traditional Chinese medicine compositions with strong pertinence and definite efficacy. Summary of the invention

[0006] In view of the above problems, the present invention provides a Chinese medicine composition for treating chronic obstructive pulmonary disease and a preparation method thereof.

[0007] The technical solution of the present invention is as follows:

[0008] A Chinese medicine composition, which is prepared from the following raw materials in parts by weight:

[0009] 20-40 parts of Polygonum cuspidatum, 20-40 parts of Astragalus, 20-40 parts of Epimedium, 20-40 parts of Morinda officinalis, 10-30 parts of Loquat Leaf, 20-40 parts of Radix Rehmanniae, 3-9 parts of Apricot, 3-9 parts of Magnolia officinalis, and 5-25 parts of Rhizoma Chuanxiong. The above Chinese medicine composition has reasonable compatibility and has the effects of resolving phlegm, relieving cough and relieving asthma, tonifying lung and kidney and removing blood stasis.

[0010] Furthermore, the above-mentioned Chinese medicine composition is composed of the following raw materials in parts by weight: 30 parts of Polygonum cuspidatum, 30 parts of Astragalus, 30 parts of Epimedium, 30 parts of Morinda officinalis, and 30 parts of loquat leaves.

[0011] 30 parts of Radix Rehmanniae, 9 parts of Apricot Kernel, 6 parts of Magnolia Bark, and 15 parts of Ligusticum Chuanxiong.

[0012] Furthermore, the present invention discloses the use of the above-mentioned Chinese medicine composition in preparing a medicine for treating chronic obstructive pulmonary disease.

[0013] Furthermore, in the above-mentioned use, the medicine also includes umeclidinium bromide and vilanterol.

[0014] The invention also discloses a Chinese medicine preparation for treating chronic obstructive pulmonary disease, which contains the Chinese medicine composition or an extract thereof.

[0015] Furthermore, the above-mentioned traditional Chinese medicine preparation is an oral decoction, pill, capsule or granule.

[0016] Furthermore, the above-mentioned traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients.

[0017] Furthermore, the present invention discloses a method for preparing the above-mentioned Chinese medicine preparation, comprising the following steps:

[0018] The preparation method comprises the following steps: mixing Polygonum cuspidatum, Radix Astragali, Herba Epimedii, Morindae Officinalis, Loquat Leaf, Radix Rehmanniae, Apricot Kernel, Magnolia Officinalis and Rhizoma Chuanxiong according to the formula amount, soaking in water, wherein the ratio of the volume of the water to the total mass of the raw materials is 5-10 mL / g; decocting for 1-3 times after soaking for 40-60 minutes, decocting for 1-2 hours each time, filtering, combining the filtrate and obtaining the product. The preparation method is simple and easy to operate, has strong operability and is easy to produce.

[0019] The invention also discloses the use of the above-mentioned traditional Chinese medicine preparation in combination with umeclidinium bromide and vilanterol in preparing a medicine for treating chronic obstructive pulmonary disease.

[0020] Furthermore, in the above use, the Chinese medicine preparation is an oral decoction, and the umeclidinium bromide and vilanterol are inhalation powder sprays.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] (1) The inventors have confirmed through many years of clinical practice that the Chinese medicine composition can effectively alleviate the clinical symptoms of COPD and improve the quality of life of patients.

[0023] (2) The Chinese medicine composition follows the principle of "monarch, minister, assistant and envoy" and rationally compatibility of Chinese medicine prescriptions. It is characterized by resolving phlegm, relieving cough and relieving asthma, and nourishing the lung and kidney qi, and promoting qi and blood circulation. In the prescription, astragalus is sweet and warm, enters the lung and spleen meridians, has the function of nourishing, enhancing the yang of the lung, strengthening the body's defense and strengthening the exterior, moving the spleen and eliminating dampness, and eliminating the source of phlegm, and is the monarch drug. Epimedium is pungent, sweet and warm, and is a good product for warming and nourishing kidney yang; Morinda officinalis is pungent, sweet and slightly warm, and has the effect of warming and nourishing kidney yang. Epimedium, Morinda officinalis and astragalus are combined to treat the lung and kidney together; loquat leaf is bitter and slightly cold, can resolve phlegm and relieve cough, and reduce adverse reactions and stop vomiting; apricot kernel is bitter and slightly warm, and has the function of descending qi, relieving cough and relieving asthma, and moistening the intestines and promoting bowel movements; Magnolia officinalis is bitter, pungent and warm, and can dry out dampness and eliminate phlegm, and reduce qi and eliminate fullness. The three together play the role of resolving phlegm and relieving cough, and the above five flavors are all minister drugs. Polygonum cuspidatum, slightly bitter and slightly cold, has the effects of relieving cough and reducing phlegm, removing dampness and clearing heat, promoting blood circulation and dispersing blood stasis; Radix Rehmanniae, sweet and cold, nourishes kidney yin, clears heat and cools blood, and can restrain the warm and dry nature of the ministerial medicine; Rhizoma Chuanxiong, pungent and slightly warm, is a blood-qi medicine, promoting qi and promoting blood circulation, and is a total adjuvant. Rhizoma Chuanxiong can also lead the medicine upward and serve as a guiding medicine. Compared with the previous Chinese medicine composition (Polygonum cuspidatum, Astragalus, Epimedium, Morinda officinalis, Loquat Leaf, Radix Rehmanniae, Inula, and Rhizoma Chuanxiong), Inula is removed, and Magnolia officinalis and Apricot are added, which enhances the expectorant and asthma-relieving effects of the Chinese medicine composition. Magnolia officinalis and Loquat Leaf can synergistically increase the expectorant power; Apricot and Magnolia officinalis are combined, so that the cough and asthma-relieving effects of the composition are enhanced. This addition and subtraction of the taste of the medicine is more suitable for the clinical treatment of patients with chronic obstructive pulmonary disease.

[0024] (3) It has little toxic side effects and can be taken for a long time. It also has a simple drug composition and low treatment cost, which is conducive to promotion.

[0025] (4) Clinical trials and animal experiments have confirmed that the Chinese medicine composition has all the main, secondary, auxiliary and guiding ingredients, and the compatibility is rigorous and reasonable. It has the effects of resolving phlegm, relieving cough and asthma, and nourishing the lungs and kidneys, while also taking into account the function of removing blood stasis, and can significantly improve the inflammatory response and clinical symptoms of COPD. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 HE staining of mouse lung tissue;

[0027] Figure 2 AB-PAS staining of mouse lung tissue. DETAILED DESCRIPTION

[0028] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0029] Example 1

[0030] Decoction

[0031] This embodiment provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease. The raw materials include, by weight, 15 g of Polygonum cuspidatum, 15 g of Astragalus membranaceus, 15 g of Epimedium brevicornum, 9 g of Morinda officinalis, 12 g of Eriobotrya japonica leaf, 15 g of Rehmannia glutinosa, 6 g of Apricot kernel, 3 g of Magnolia officinalis, and 9 g of Ligusticum chuanxiong.

[0032] According to the above formula, weigh the raw materials, add water and boil. For the first time, add 10 times the total weight of the raw materials (the 10 times amount means 1 g of raw materials plus 10 mL of water, and so on) water and boil for 2 hours, collect the first supernatant; for the second time, add 8 times the total weight of the raw materials and boil for 1 hour, collect the second supernatant, and combine the above supernatants to obtain the Chinese medicine composition decoction of the present invention.

[0033] The dosage of the decoction is 150 ml at a time, twice a day. One course of treatment is 30 days, and generally three courses of treatment are required.

[0034] Example 2

[0035] Decoction

[0036] This embodiment provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease. The raw materials include, by weight, 30 g of Polygonum cuspidatum, 30 g of Astragalus membranaceus, 30 g of Epimedium brevicornum, 15 g of Morinda officinalis, 10 g of Eriobotrya japonica leaf, 30 g of Rehmannia glutinosa, 9 g of Apricot kernel, 3 g of Magnolia officinalis, and 10 g of Ligusticum chuanxiong.

[0037] According to the above formula, weigh the raw materials, add water and boil them. For the first time, add 10 times the total weight of the raw materials and boil them for 2 hours, and collect the first supernatant; for the second time, add 8 times the total weight of the raw materials and boil them for 1 hour, collect the second supernatant, and combine the above supernatants to obtain the Chinese medicine composition decoction of the present invention.

[0038] The dosage of the decoction is 150 ml at a time, twice a day. One course of treatment is 30 days, and generally three courses of treatment are required.

[0039] Example 3

[0040] Decoction

[0041] This embodiment provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease. The raw materials include, by weight, 25 g of Polygonum cuspidatum, 40 g of Astragalus membranaceus, 40 g of Epimedium brevicornum, 25 g of Morinda officinalis, 30 g of Eriobotrya japonica leaf, 40 g of Rehmannia glutinosa, 9 g of Apricot kernel, 9 g of Magnolia officinalis, and 10 g of Ligusticum chuanxiong.

[0042] According to the above formula, weigh the raw materials, add water and boil them. For the first time, add 10 times the total weight of the raw materials and boil them for 2 hours, and collect the first supernatant; for the second time, add 8 times the total weight of the raw materials and boil them for 1 hour, collect the second supernatant, and combine the above supernatants to obtain the Chinese medicine composition decoction of the present invention.

[0043] The dosage of the decoction is 150 ml at a time, twice a day. One course of treatment is 30 days, and generally three courses of treatment are required.

[0044] Example 4

[0045] Capsules

[0046] This embodiment provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease. The raw materials include, by weight, 30 g of Polygonum cuspidatum, 9 g of Astragalus, 20 g of Epimedium, 18 g of Morinda officinalis, 18 g of Eriobotrya japonica, 9 g of Rehmannia glutinosa, 9 g of Apricot kernel, 6 g of Magnolia officinalis, and 15 g of Ligusticum chuanxiong.

[0047] According to the above formula and dosage, the raw materials are weighed, decocted in the same manner as in Examples 1 to 3, the supernatants are combined, concentrated into dry paste powder, and packaged into capsules, with each capsule containing 0.5 g of medicine.

[0048] The dosage of capsules is 3 to 4 capsules at a time, three times a day. One course of treatment is 30 days, and generally three courses of treatment are required.

[0049] Example 5

[0050] Capsules

[0051] This embodiment provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease. The raw materials include, by weight, 40 g of Polygonum cuspidatum, 40 g of Astragalus membranaceus, 18 g of Epimedium brevicornum, 21 g of Morinda officinalis, 2 g of Eriobotrya japonica leaf, 40 g of Rehmannia glutinosa, 6 g of Apricot kernel, 6 g of Magnolia officinalis, and 7.5 g of Ligusticum chuanxiong.

[0052] According to the above formula and dosage, the raw materials are weighed, decocted in the same manner as in Examples 1 to 3, the supernatants are combined, concentrated into dry paste powder, and packaged into capsules, with each capsule containing 0.5 g of medicine.

[0053] The dosage of capsules is 3 to 4 capsules at a time, three times a day. One course of treatment is 30 days, and generally three courses of treatment are required.

[0054] Example 6

[0055] Capsules

[0056] This embodiment provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease. The raw materials include, by weight, 40 g of Polygonum cuspidatum, 40 g of Astragalus, 25 g of Epimedium, 30 g of Morinda officinalis, 20 g of Eriobotrya japonica leaf, 40 g of Rehmannia glutinosa, 6 g of Apricot kernel, 3 g of Magnolia officinalis, and 6 g of Ligusticum chuanxiong.

[0057] According to the above formula and dosage, the raw materials are weighed, decocted in the same manner as in Examples 1 to 3, the supernatants are combined, concentrated into dry paste powder, and packaged into capsules, with each capsule containing 0.5 g of medicine.

[0058] The dosage of capsules is 3 to 4 capsules at a time, three times a day. One course of treatment is 30 days, and generally three courses of treatment are required.

[0059] Example 7

[0060] Granules

[0061] This embodiment provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease. The raw materials include, by weight, 360 g of Polygonum cuspidatum, 360 g of Astragalus, 270 g of Epimedium, 280 g of Morinda officinalis, 280 g of Eriobotrya japonica, 360 g of Rehmannia glutinosa, 100 g of Apricot kernel, 70 g of Magnolia officinalis, and 140 g of Ligusticum chuanxiong.

[0062] According to the above formula, weigh the raw materials, decoct twice, add 10 times the amount of water for the first time, and decoct for 2 hours; add 8 times the amount of water for the second time, and decoct for 1 hour; combine the decoctions, concentrate to an appropriate amount (specific gravity: 1.15-1.20), add ethanol to make the ethanol content 70%, refrigerate overnight, filter, recover ethanol, and concentrate to an extract with a relative density of 1.26-1.28 (20°C). Add dextrin and powdered sugar to make the ratio of extract: dextrin: powdered sugar 1:2:0.5, granulate, pass through a 10-mesh sieve, dry at 60-70°C, pass through a 12-mesh sieve, granulate to obtain 1000 grams of finished granules, and pack 12 grams / bag, 12 bags / bag.

[0063] Dosage: Three times a day, one bag each time. 30 days is a course of treatment. Generally three courses are required.

[0064] Example 8

[0065] Animal experiments

[0066] 1. Materials and Methods

[0067] 1. Animal grouping

[0068] Thirty SPF C57BL / 6 mice, weighing 18-22 g, were randomly divided into three groups: a blank control group, a COPD model group, and a Chinese medicine composition gavage group, with 10 mice in each group.

[0069] 2. Intervention methods

[0070] COPD model group and Chinese medicine composition gavage group were treated with COPD model: LPS (50ug / mouse) was dripped into the COPD model group and Chinese medicine composition gavage group through the nose on the 1st day and the 14th day, respectively, and normal saline was dripped into the blank control group through the nose. On the 2nd to 13th day and the 15th to 56th day, the COPD model group and the Chinese medicine composition gavage group mice were placed in a semi-enclosed glass fumigation box, and smoked twice a day, 10 cigarettes each time, and 30 minutes each time. On the 29th to 56th day, the blank control group and the COPD model group were gavaged with normal saline, 0.5ml / mouse / day, and the Chinese medicine composition gavage group was gavaged with the Chinese medicine composition Example 2 decoction, 0.5ml / mouse / day.

[0071] 3. Pulmonary function test

[0072] Mice were anesthetized by intraperitoneal injection of 2% pentobarbital (75 mg / kg), and tracheal intubation was performed after the trachea was exposed, and the airway was kept open during the operation. The pulmonary function instrument was connected, and the FEV0.05, FEV0.1, FEV0.2 and PEF of mice in each group were detected using small animal pulmonary function analysis software.

[0073] 4. HE staining to detect pathological morphological changes of lung tissue

[0074] After the left lung specimens were fixed, the tissues were dehydrated, then embedded in paraffin, sliced, baked, stained with hematoxylin-eosin, and sealed with neutral gum before observation under a microscope and photography.

[0075] 5. AB-PAS staining test

[0076] Mouse left lung sections were dewaxed and washed with distilled water for 2 min; stained with Alcian blue for 20 min, washed 3 times with distilled water, 2 min each time; added with oxidant for 5 min, and washed twice with distilled water; stained with Schiff Reagent for 20 min, and rinsed with tap water for 10 min; stained with hematoxylin for 5 min, and washed with water; differentiated with acidic differentiation solution for 2 s, and washed with water; blued with Scott blue solution, and washed with water for 3 min; dried at room temperature, made transparent with xylene, and sealed; observed and photographed under a microscope.

[0077] 2. Results

[0078] 1. Pulmonary function test of mice in each group

[0079] Compared with the blank control group, the FEV0.05, FEV0.1, FEV0.2 and PEF in the COPD model group were significantly reduced; compared with the COPD model group, the above indicators in the Chinese medicine combination gavage group were significantly improved (P < 0.05).

[0080] Table 1 Mouse lung function test

[0081]

[0082] 2. HE staining of lung tissues of mice in each group

[0083] The normal group had normal tracheal and alveolar morphology, no pathological exudation, and no obvious pathological manifestations; the COPD model group had a large amount of inflammatory exudation around the alveoli and trachea, inflammatory cell infiltration, congestion around the bronchi, and some alveoli fused to form bullae; after intragastric administration of the Chinese medicine composition, the inflammatory infiltration was significantly alleviated, and the bullae were significantly reduced compared with the COPD model group. Figure 1 .

[0084] 3. AB-PAS staining of lung tissues of mice in each group

[0085] Compared with the blank group, the airway mucus secretion of mice in the COPD model group increased significantly; the airway mucus secretion of mice treated with the Chinese medicine composition was significantly reduced. Figure 2 .

[0086] Example 9

[0087] Clinical trials

[0088] 1. Clinical data

[0089] 1.1 General Information

[0090] All patients were recruited from the outpatient department and ward of the Department of Respiratory and Critical Care Medicine of Shanghai Pudong District Central Hospital from January 2023 to December 2023. A total of 120 cases were included and randomly divided into a control group and a treatment group. There were 60 cases in the control group, including 32 males and 28 females, with an average age of 59.67±10.15 years and an average course of disease of 10.7±6.81 years; there were 60 cases in the treatment group, including 35 males and 25 females, with an average age of 61.32±8.31 years and an average course of disease of 11.31±7.47 years; there was no statistical difference in age, gender, and course of disease between the two groups, and they were comparable.

[0091] 1.2 Case selection

[0092] 1.2.1 Western medicine diagnostic criteria

[0093] The diagnostic criteria for stable COPD are formulated in accordance with the Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2013 Revised Edition): (1) a history of exposure to risk factors; (2) clinical manifestations of chronic cough, sputum, and dyspnea; (3) pulmonary function tests showing forced expiratory volume in one second / forced vital capacity (FEV1 / FVC) < 70% after the use of bronchodilators; and (4) symptoms of cough, sputum, and wheezing are stable.

[0094] 1.2.2 TCM diagnostic criteria

[0095] The diagnostic criteria for phlegm-dampness accumulation in the lungs and lung-kidney qi deficiency syndrome refer to the "Diagnostic Criteria for Traditional Chinese Medicine Syndrome of Chronic Obstructive Pulmonary Disease (2011 Edition)".

[0096] 1.2.3 Inclusion criteria

[0097] Meet the above-mentioned Chinese and Western medicine diagnostic criteria; age range 40 to 75 years old; be informed of this study and sign the informed consent form.

[0098] 1.2.4 Exclusion criteria

[0099] Patients in the acute exacerbation of COPD; patients with other types of lung diseases such as tuberculosis, lung infection, and lung abscess; patients with serious disorders of the heart, brain, liver, kidney and other systems; patients with mental disorders or tumors; and patients with allergic constitutions are excluded.

[0100] 2. Treatment methods

[0101] Control group 1: Umeclidinium and vilanterol inhalation powder spray was given, with a specification of 62.5ug:25μg (umeclidinium / vilanterol), and the drug batch number was HJ20180005, 1 inhalation each time, 1 time a day. Control group 2: Based on the treatment of control group 1, the existing Chinese medicine composition was given, and the drug composition was: Polygonum cuspidatum 30g, Astragalus 30g, Epimedium 30g, Morinda officinalis 30g, Loquat leaf 30g, Rehmannia glutinosa 30g, Inula 9g, and Chuanxiong 15g; 1 dose / day, taken twice a day, morning and evening. Treatment group: Based on the treatment of control group 1, the decoction of Chinese medicine composition Example 2 was given for treatment, with the drug composition: Polygonum cuspidatum 30g, Astragalus 30g, Epimedium 30g, Morinda officinalis 15g, Eriobotrya japonica 10g, Radix Rehmanniae 30g, Apricot kernel 9g, Magnolia officinalis 3g, Ligusticum chuanxiong 10g; 1 dose / day, taken twice in the morning and evening. The three groups were treated for 12 weeks.

[0102] 3. Observation indicators and statistical methods

[0103] The changes in the patients' TCM syndrome scores, lung function, mMRC scale, CAT questionnaire scores, and 6-minute walk test were recorded before and after treatment.

[0104] SPSS 21.0 statistical software was used for analysis. One-way analysis of variance (ANOVA) was used to compare the differences among the groups. P < 0.05 indicated that the difference was statistically significant.

[0105] 4. Results

[0106] (1) The comparison of TCM syndrome scores among the three groups is shown in Table 2. After treatment, the TCM syndrome scores of the three groups were significantly decreased compared with those before treatment (P<0.05). After treatment with the Chinese medicine composition, the improvement of the patients in the treatment group was significantly better than that in the control group 2 (P<0.05).

[0107] Table 2 Changes in TCM syndrome scores before and after treatment

[0108]

[0109] (2) Comparison of lung function among the three groups is shown in Table 3. After 12 weeks of treatment, compared with control group 1, FEV1, FEV1, and FEV1 / FVC in the treatment group and control group 2 improved more significantly (P < 0.05). The improvement of lung function in the treatment group was more obvious than that in control group 2 (P < 0.05).

[0110] Table 3 Changes in lung function before and after treatment

[0111]

[0112] (3) The comparison of the number of acute exacerbations in the three groups within one year is shown in Table 4. Compared with the control group 1, the number of acute exacerbations in the treatment group and the control group 2 was significantly reduced within one year after taking the Chinese medicine composition (P < 0.05), and the number of acute exacerbations in the treatment group was even less (P < 0.05).

[0113] Table 4 Changes in the number of acute exacerbations before and after treatment in one year

[0114]

[0115] (4) The comparison of mMRC scales among the three groups is shown in Table 5. Compared with control group 1 and control group 2, the symptom of dyspnea was significantly improved after taking the Chinese medicine composition provided by the present invention for 12 weeks (P<0.05).

[0116] Table 5 Changes in mMRC scale before and after treatment

[0117]

[0118]

[0119] (5) Comparison of CAT questionnaire scores among the three groups is shown in Table 6. After 12 weeks of treatment, the symptoms of patients in the treatment group and control group 2 were more significantly improved than those in control group 1 (P < 0.05), and the score change in the treatment group was more significant (P <

[0120] 0.05).

[0121] Table 6 Changes in CAT questionnaire scores before and after treatment

[0122]

[0123] (6) Comparison of the 6-minute walk test among the three groups is shown in Table 7. Compared with the control group 1, the activity tolerance of the patients in the treatment group and the control group 2 was significantly improved after 12 weeks of treatment with the Chinese medicine composition (P < 0.05), and the therapeutic effect of the treatment group was significantly better than that of the control group 2 (P < 0.05).

[0124] Table 7 Changes in 6-minute walking test before and after treatment

[0125]

[0126] Example 10

[0127] Clinical Cases

[0128] Zhao, male, 58 years old, had repeated coughing, expectoration and asthma for more than 10 years. Most of the sputum was white and sticky, which worsened every winter in recent years, accompanied by asthma and dyspnea, often felt chest tightness and discomfort, and could not lie flat at night. The symptoms were relieved by Western medicine treatment, but it was easy to relapse and the effect was poor. In order to seek further treatment, the patient came for treatment. He had a smoking history of more than 20 years, 10 cigarettes / day, had not quit smoking, and had no history of chronic diseases such as hypertension and diabetes. The tongue was pale, the tongue coating was white and greasy, and the pulse was thin and rapid. The syndrome was diagnosed as phlegm and dampness in the lungs and lung and kidney qi deficiency. The drug formula was the Chinese medicine composition formula in Example 3. After taking the medicine for 2 weeks, the patient's cough and asthma were significantly alleviated, and the amount of sputum was reduced. After continuing to take the medicine for 10 days, cough and asthma were significantly improved, and the quality of life was significantly improved. After 1 year of follow-up, the patient did not experience acute exacerbation and was in stable condition.

[0129] Embodiment 11

[0130] Clinical Cases

[0131] Song, male, 72 years old, shortness of breath and fatigue for more than 3 years, fatigue aggravated in the past month. The patient was diagnosed with COPD 3 years ago, with daily cough and wheezing, and shortness of breath after activities was significantly aggravated. In the past month, he felt that his physical strength had declined, and he was short of breath and weak, especially after physical activity. Occasionally, he had cough, less sputum, and white color. He took Western medicine for maintenance treatment, but the symptoms improved limitedly. In order to seek further Chinese medicine treatment, he came for treatment. He had a smoking history of more than 40 years and had quit smoking for 3 years. He had a history of hypertension for 5 years and was well controlled by conventional drugs. The tongue was dark red, the fur was thick and greasy, and the pulse was deep and weak. The syndrome was diagnosed as phlegm and dampness in the lungs, and the lung and kidney qi deficiency and blood stasis syndrome. The drug formula is the Chinese medicine composition formula in Example 1. After taking the medicine for 7 days, the patient's shortness of breath and fatigue symptoms were relieved, and his physical strength was restored. After continuing to take the medicine for 14 days, the patient's shortness of breath after activity was significantly alleviated, and the symptoms of cough and asthma did not recur, and the condition was stable.

[0132] Example 12

[0133] Clinical Cases

[0134] Liu, male, 63 years old, has been suffering from shortness of breath and fatigue for 5 years. His recent symptoms have been relieved but he is prone to fatigue, accompanied by a slight cough. The patient was diagnosed with COPD 5 years ago due to shortness of breath and cough. His condition is sometimes light and sometimes heavy. His usual symptoms are shortness of breath and fatigue after activities. He feels shortness of breath and chest tightness after walking a little farther every day, accompanied by a slight cough and coughing a small amount of yellow sticky phlegm. The current condition is relatively stable, but the patient is prone to fatigue, has a lighter cough in the morning, and has frequent urination at night. Symptoms have been relieved by western medicine treatment, but fatigue and shortness of breath are still obvious. In order to seek Chinese medicine conditioning, he came for treatment. He has a history of smoking for more than 20 years and has quit smoking for 10 years. There is no history of diabetes, coronary heart disease, etc. The tongue is pale, the tongue coating is white and greasy, and the pulse is deep and weak. The syndrome differentiation is phlegm and dampness in the lungs, and the syndrome of lung and kidney qi deficiency. The drug formula is the Chinese medicine composition formula in Example 2. After taking the medicine for 3 weeks, the patient's conscious shortness of breath symptoms were alleviated, the number of nocturia decreased, and the quality of sleep improved.

[0135] The above are only a few preferred embodiments of the present invention, and the description is relatively specific and detailed, but it cannot be understood as limiting the scope of the present invention. It should be pointed out that for ordinary technicians in this field, several modifications and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention.

Claims

1. A Chinese medicine composition, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 20-40 parts of Polygonum cuspidatum, 20-40 parts of Astragalus, 20-40 parts of Epimedium, 20-40 parts of Morinda officinalis, 10-30 parts of Eriobotrya japonica, 20-40 parts of Radix Rehmanniae, 3-9 parts of Apricot, 3-9 parts of Magnolia officinalis, and 5-25 parts of Ligusticum chuanxiong.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 30 parts of Polygonum cuspidatum, 30 parts of Astragalus, 30 parts of Epimedium, 30 parts of Morinda officinalis, 30 parts of loquat leaves, 30 parts of Rehmannia glutinosa, 9 parts of Apricot kernel, 6 parts of Magnolia officinalis, and 15 parts of Ligusticum chuanxiong.

3. Use of the Chinese medicine composition as claimed in claim 1 or 2 in the preparation of a medicament for treating chronic obstructive pulmonary disease.

4. The use according to claim 3, characterized in that The drug also includes umeclidinium bromide and vilanterol.

5. A Chinese medicine preparation for treating chronic obstructive pulmonary disease, characterized in that: Contains the Chinese medicine composition or extract thereof as described in claim 1 or 2.

6. The Chinese medicine preparation according to claim 5, characterized in that: The preparation is oral decoction, pills, capsules or granules.

7. The Chinese medicine preparation according to claim 5, characterized in that: The preparation also includes pharmaceutically acceptable excipients.

8. The method for preparing the Chinese medicine preparation according to claim 5, characterized in that: The following steps are involved: Mix Polygonum cuspidatum, Astragalus, Epimedium, Morinda officinalis, loquat leaf, Radix Rehmanniae, Apricot, Magnolia officinalis and Rhizoma Chuanxiong according to the formula amount, soak in water, the ratio of the volume of water to the total mass of the raw materials is 5-10mL / g; after soaking for 40-60min, decoct for 1-3 times, each time for 1-2 hours, filter, and combine the filtrate to obtain the product.

9. Use of the Chinese medicine preparation according to claim 5 in combination with umeclidinium bromide and vilanterol in the preparation of a medicament for treating chronic obstructive pulmonary disease.

10. The use according to claim 9, characterized in that The Chinese medicine preparation is an oral decoction, and the umeclidinium bromide and vilanterol are inhalation powder sprays.

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