Traditional Chinese medicine composition for relieving chronic obstructive pulmonary disease and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for relieving chronic obstructive pulmonary disease and application thereof. The traditional Chinese medicine composition comprises 15-30 parts of gypsum, 5-10 parts of wrinkled gianthyssop herb, 5-10 parts of cape jasmine, 5-10 parts of divaricate saposhnikovia root, 15-20 parts of fried coix seed, 5-10 parts of fortune eupatorium herb, 10-15 parts of mulberry leaf, 15-20 parts of fried Chinese yam, 6-10 parts of fried almond, 6-10 parts of perilla leaf and 6-10 parts of caulis perllae. By adjusting the formula of the traditional Chinese medicine composition, the symptoms of the chronic obstructive pulmonary disease can be effectively relieved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and more specifically, to a traditional Chinese medicine composition for alleviating chronic obstructive pulmonary disease and its application. Background Art

[0002] Chronic obstructive pulmonary disease (COPD) is a common and frequently occurring clinical disease, with chronic cough, sputum, dyspnea, wheezing and chest tightness as the main symptoms. COPD is a persistent, progressive chronic airway disease caused by excessive inflammation, which leads to irreversible damage to the airways and lung tissues. Its main characteristics are persistent airflow limitation and various respiratory symptoms. COPD has a high prevalence and mortality rate worldwide and is a major disease that threatens human health. As the mortality rate of cardiovascular and cerebrovascular diseases decreases, chronic respiratory diseases are gradually increasing, causing a huge socioeconomic burden. The main means of treating COPD are often used to prevent and control symptoms, reduce the frequency of aggravation, reduce the severity, increase exercise tolerance, and improve the quality of life to relieve symptoms related to COPD. They mainly include bronchodilators, glucocorticoids, and mucolytics. For patients with COPD in the stable period, oxygen therapy is usually used to increase the concentration of inhaled oxygen, improve lung ventilation, and then improve local and systemic hypoxia, and improve hematological characteristics, exercise tolerance, local and systemic physiology, and mental state. Most of the Western medicines used for COPD have obvious adverse effects and limitations in certain populations. For example, patients with prostatic hypertrophy should not use cholinergic receptor blockers. Not only are glucocorticoids not suitable for long-term oral administration, but the side effects of long-term use of β2 receptor agonists and cholinergic receptor blockers are also very large. Therefore, there is an urgent need for a drug with good therapeutic effect and low side effects. Summary of the invention

[0003] An object of the present invention is to solve at least the above problems and to provide at least the advantages which will be described hereinafter.

[0004] Another object of the present invention is to provide a Chinese medicine composition for relieving chronic obstructive pulmonary disease, which can effectively relieve the related symptoms such as cough, sticky mouth, abdominal distension, decreased appetite, etc. caused by the internal damp-heat pathogenesis of chronic obstructive pulmonary disease by adjusting the formula of the Chinese medicine composition.

[0005] In order to achieve these purposes and other advantages of the present invention, a Chinese medicine composition for relieving chronic obstructive pulmonary disease is provided, comprising the following raw materials:

[0006] Gypsum, Patchouli, Gardenia, Saposhnikovia, stir-fried Coix seeds, Cymbidium orientale, mulberry leaves, stir-fried yam, stir-fried almonds, Perilla leaves, and Perilla stems.

[0007] Preferably, the composition comprises, by weight, 15-30 parts of gypsum, 5-10 parts of patchouli, 5-10 parts of gardenia, 5-10 parts of siler, 15-20 parts of stir-fried coix seeds, 5-10 parts of perilla, 10-15 parts of mulberry leaves, 15-20 parts of stir-fried yam, 6-10 parts of stir-fried almonds, 6-10 parts of perilla leaves, and 6-10 perilla stems.

[0008] Preferably, 20 parts of gypsum, 8 parts of Patchouli, 8 parts of Gardenia, 6 parts of Saposhnikovia divaricata, 18 parts of stir-fried Coix seeds, 6 parts of Perilla frutescens, 12 parts of mulberry leaves, 18 parts of stir-fried yam, 8 parts of stir-fried apricot kernels, 8 parts of Perilla leaves, and 8 parts of Perilla stems.

[0009] Preferably, it also includes: 2 parts of bluestone, 7 parts of loofah, and 5 parts of Rhizoma Smilacis Glabrae.

[0010] The present invention also provides an application of a Chinese medicine composition for alleviating chronic obstructive pulmonary disease, and an application of the Chinese medicine composition in preparing a medicine for alleviating chronic obstructive pulmonary disease.

[0011] Preferably, the dosage form of the drug includes any one of aerosol, spray, powder, tablet, powder, suspension, granule, capsule, solution, enema or emulsion.

[0012] Preferably, the dosage form of the drug is granules.

[0013] Preferably, the drug also includes pharmaceutically acceptable excipients; the pharmaceutically acceptable excipients include any one or a combination of at least two of carriers, diluents, excipients, fillers, binders, wetting agents, disintegrants, emulsifiers, solubilizers, osmotic pressure regulators, surfactants, coating materials, colorants, pH regulators, antioxidants, antibacterial agents or buffers.

[0014] The present invention has at least the following beneficial effects:

[0015] The present invention can effectively alleviate the symptoms of chronic obstructive pulmonary disease by adjusting the formula of the traditional Chinese medicine composition, namely, raw gypsum, patchouli, gardenia, siler, stir-fried coix seeds, perilla, mulberry leaves, stir-fried yam, stir-fried apricot kernel, perilla leaves and perilla stems, and adding green stone, loofah and rhizome to the traditional Chinese medicine composition can obviously increase the cure rate of the cases.

[0016] Other advantages, objectives and features of the present invention will be embodied in part through the following description, and in part will be understood by those skilled in the art through study and practice of the present invention. DETAILED DESCRIPTION

[0017] The present invention is further described in detail below in conjunction with embodiments so that those skilled in the art can implement the invention with reference to the description.

[0018] The clinical manifestations of chronic obstructive pulmonary disease are frequent coughing, sticky mouth, wheezing, no sputum or sticky sputum, occasional foreign body sensation in the throat, decreased appetite, unformed stool, joint pain, pale tongue with greasy coating, no tortuosity under the tongue, and slippery pulse. The treatment should be to clear the heat of the lungs and spleen, eliminate dampness and stop coughing.

[0019] This Chinese medicine combination prescription is prepared by adding and subtracting medicines on the basis of Xiehuang Powder. The main medicines in the prescription are Patchouli and stir-fried Coix seeds, the assistant medicines are mulberry leaves, apricot kernels, gypsum, perilla leaves, and perilla stems, the adjuvant medicines are Saposhnikovia divaricata, Cyperus rotundus, Chinese yam, Gardenia jasminoides, green stone, and luffa, and the guiding medicine is Rhizoma Smilacis Glabrae.

[0020] This recipe uses Patchouli and stir-fried Coix seeds. Patchouli is pungent and slightly warm. It enters the lung, spleen, and stomach meridians, and is aromatic and dehumidifying. The "Pharmaceutical Chemical Meaning" says that it is "light in body and warm in nature. It can protect the Qi and nourish the lungs and stomach." The "New Materia Medica" says that it "can treat throat paralysis, resolve phlegm, and stop coughing." It strengthens the spleen and stops coughing, resolves dampness and stops vomiting, and removes spleen heat and wakes up the spleen; stir-fried Coix seeds "treat pulmonary atrophy, lung qi, vomiting pus and blood, and coughing, mucus, and saliva" ("Pharmaceutical Properties"). The "Compendium of Materia Medica" says that it "strengthens the spleen and stomach, nourishes the lungs and clears heat, removes wind and overcomes dampness." It can promote diuresis and eliminate dampness, strengthen the spleen and stop coughing, and remove numbness and resolve knots. The two are used together to cultivate the soil and produce gold, strengthen the spleen and stop coughing.

[0021] This prescription uses mulberry leaves, almonds, gypsum, perilla leaves, and perilla stems as auxiliary herbs. Mulberry leaves are sweet, bitter, and cold, and are in the lung and liver meridians. They can dispel wind and heat, cool blood and improve eyesight, and treat lung heat and dry cough caused by chronic obstructive pulmonary disease; almonds can relieve cough and asthma, moisten the intestines and promote bowel movements, and are mainly used to treat cough and asthma, chest fullness and sputum; gypsum enters the lung and stomach meridians, and "Shennong's Herbal Classic" says that it "tastes spicy and is slightly cold. It is mainly used to treat cold and heat in stroke, asthma under the heart, dry mouth and tongue, and inability to breathe, and abdominal pain", and is used to treat lung heat and asthma, and "The Heart of Using Medicines" says that it is "a very cold medicine for the stomach meridian, moisturizing the lungs and removing heat, dispersing yin evil, and soothing the spleen and replenishing qi"; perilla leaves and perilla stems are derived from perilla, spicy, warm, and in the lung and spleen meridians, and can dispel cold, promote qi and harmonize the stomach. Perilla leaves tend to dispel cold evil, while perilla stems tend to regulate qi and harmonize the middle.

[0022] The adjuvants are fangfeng, perilla, yam, gardenia, qinglunshi, and luffa. Fangfeng has a sweet and warm flavor, enters the bladder, lung, and spleen meridians, "it is generally used for wind. It can purge lung fullness, disperse stagnant qi in the head and eyes, and eliminate wind evil in the upper part of the body" ("Medicine Classification"); perilla is pungent and neutral, and it enters the spleen, stomach, and lung meridians. It is aromatic and dehumidifies, wakes up the spleen and stimulates appetite; yam nourishes the lung and spleen, replenishes qi and nourishes yin, and nourishes the spleen, lungs, and kidneys; gardenia is bitter and cold, clears heat and purges fire, "it can cure evil qi in the five internal organs and heat in the stomach" ("Shennong's Herbal Classic"); qinglunshi is sweet and salty, neutral, and enters the lung, heart, and liver meridians, it can reduce phlegm and lower qi, calm the liver and calm the nerves, and is used for stubborn phlegm, cough, reverse breathing, and acute asthma; luffa has a bitter taste, cool nature, and enters the lung, liver, and stomach meridians, it can dehumidify and activate collaterals, and it is mainly used to treat lung heat cough.

[0023] The medicinal properties of this medicine are good for all meridians, "its nature is able to pass through the twelve meridian points" (Compendium of Materia Medica Supplement), dredge the lung meridian, and lead the meridians to the messenger.

[0024] In summary, the whole prescription can clear away heat from the lungs and spleen, eliminate dampness and relieve cough.

[0025] <Example 1>

[0026] A Chinese medicine composition for relieving chronic obstructive pulmonary disease comprises the following raw materials in parts by weight:

[0027] 15 parts of gypsum, 5 parts of patches, 5 parts of gardenia, 5 parts of siler, 15 parts of stir-fried coix seeds, 5 parts of perilla, 10 parts of mulberry leaves, 15 parts of stir-fried yam, 6 parts of stir-fried apricot kernel, 6 parts of perilla leaves, and 6 parts of perilla stems.

[0028] Application of the Chinese medicine composition in medicine for alleviating chronic obstructive pulmonary disease.

[0029] <Example 2>

[0030] A Chinese medicine composition for relieving chronic obstructive pulmonary disease comprises the following raw materials in parts by weight:

[0031] 30 parts of gypsum, 10 parts of patches, 10 parts of gardenia, 10 parts of siler, 20 parts of stir-fried coix seeds, 10 parts of perilla, 15 parts of mulberry leaves, 20 parts of stir-fried yam, 10 parts of stir-fried apricot kernel, 10 parts of perilla leaves, and 10 parts of perilla stems.

[0032] Application of the Chinese medicine composition in medicine for alleviating chronic obstructive pulmonary disease.

[0033] <Example 3>

[0034] A Chinese medicine composition for relieving chronic obstructive pulmonary disease comprises the following raw materials in parts by weight:

[0035] 20 parts of gypsum, 8 parts of patches, 8 parts of gardenia, 6 parts of siler, 18 parts of stir-fried coix seeds, 6 parts of perilla, 12 parts of mulberry leaves, 18 parts of stir-fried yam, 8 parts of stir-fried apricot kernel, 8 parts of perilla leaves, and 8 parts of perilla stems.

[0036] Application of the Chinese medicine composition in medicine for alleviating chronic obstructive pulmonary disease.

[0037] <Example 4>

[0038] A Chinese medicine composition for relieving chronic obstructive pulmonary disease comprises the following raw materials in parts by weight:

[0039] 20 parts of gypsum, 8 parts of patches, 8 parts of gardenia, 6 parts of siler, 18 parts of stir-fried coix seeds, 6 parts of perilla, 12 parts of mulberry leaves, 18 parts of stir-fried yam, 8 parts of stir-fried apricot kernel, 8 parts of perilla leaves, and 8 parts of perilla stems.

[0040] It also includes: 2 parts of bluestone, 7 parts of loofah, and 5 parts of Rhizoma Smilacis Glabrae.

[0041] <Comparative Example 1>

[0042] A Chinese medicine composition for relieving chronic obstructive pulmonary disease comprises the following raw materials in parts by weight:

[0043] 20 parts of gypsum, 8 parts of patches, 8 parts of gardenia, 6 parts of siler, 18 parts of stir-fried coix seeds, 6 parts of perilla, 12 parts of mulberry leaves, 18 parts of stir-fried yam, 8 parts of stir-fried apricot kernel, 8 parts of perilla leaves, and 8 parts of perilla stems.

[0044] Also includes: 2 parts of bluestone.

[0045] <Effect Evaluation>

[0046] 1. Animal Experiments

[0047] 1.1 Drug preparation

[0048] The preparation method of the Chinese medicine composition in Example 3, Example 4 and Comparative Example 1 is as follows: respectively take the medicinal materials in the Chinese medicine composition, mix them according to proportion, add 1.2L of water to soak for 30min, decoct on high heat until the water boils, continue to decoct on low heat for 30min, filter to obtain a first filtrate and a filter residue, add 1.2L of water to the filter residue, decoct on high heat until the water boils, continue to decoct on low heat for 30min, filter to obtain a second filtrate, combine the first filtrate and the second filtrate, and concentrate under reduced pressure to 200mL to obtain a Chinese medicine liquid, wherein the amount of gypsum used is 20g.

[0049] 1.2 Construction of experimental animal COPD model

[0050] 90 clean-grade healthy SD male rats, aged 10 to 12 weeks, weighing (230 ± 20) g, were raised in cages after 7 days of adaptive feeding, at room temperature (25 ± 1) ° C, with adequate food and drinking water, and a 12-h day / night cycle every day. They were randomly divided into nine groups, one of which was a blank group, one was a model group, and seven were drug-treated groups, of which three were used for the high-dose group, low-dose group, and medium-dose group corresponding to Example 3, and the other three were used for the high-dose group, low-dose group, and medium-dose group corresponding to Example 4. The remaining group was used for the high-dose group corresponding to Comparative Example 1, with 10 rats in each group. This experiment passed the experimental animal welfare ethics review of Capital Medical University, ethics number: AEEI-2023-304.

[0051] 1.3 Materials

[0052] A homemade fumigation box (with an air outlet on the top of the fumigation box) was used, the tar content of the cigarette was 15 mg, the nicotine content of the smoke was 1.1 mg, and the lipopolysaccharide was prepared into a 200 μg / 200 μL lipopolysaccharide solution using normal saline.

[0053] 1.4 Construction of animal model

[0054] The animal model of chronic obstructive pulmonary disease in rats was prepared by fumigation combined with lipopolysaccharide, as follows: 0.2 mL of lipopolysaccharide solution was injected into the trachea of ​​the rats in the model group and the treatment group on the 1st and 14th days of the experiment, and the rats were placed in a homemade fumigation box on the 2nd to 28th days (except the 14th day), with 10 cigarettes / time, 0.5h / time, 2 times / day, and 7h interval between the two times. Starting from the 29th day of the experiment, the drug was administered 1h before fumigation, once / day, for 28 consecutive days.

[0055] In the high-dose group, each mouse was gavaged with 4 mL of Chinese medicine solution per day; in the medium-dose group, each mouse was gavaged with 2 mL of Chinese medicine solution per day; in the low-dose group, each mouse was gavaged with 1 mL of Chinese medicine solution per day; and in the model group and the blank group, each mouse was gavaged with 2 mL of normal saline per day for 28 consecutive days.

[0056] 1.5 Experimental testing

[0057] After the experiment, the surviving rats in each group were weighed, blood was collected, and serum was separated by centrifugation. The TNF-α and LTB4 levels in the serum were determined by Elisa method. After blood collection, the surviving animals in each group were killed, and the lungs were taken to weigh the lung wet weight and calculate the lung coefficient. Lung coefficient (%) = 100*lung wet weight / animal body weight. The results of the lung coefficient and serum TNF-a and LTB4 levels of rats in each group are shown in Table 1 (N is the number of survivors);

[0058] Table 1 shows the lung coefficient and serum TNF-α of rats

[0059]

[0060] Among them, a means p < 0.05 compared with the blank group, aa means p < 0.01 compared with the blank group, b means p < 0.05 compared with the model group, and bb means p < 0.01 compared with the model group;

[0061] Comparative analysis of the data in Table 1 shows that both the high-dose group and the low-dose group of Example 3 and Example 4 can significantly reduce the lung coefficient of rats, as well as the inflammatory indicators of TNF-α and LTB4 in serum, and Example 4 is better than Example 3, which indicates that Qinglanshi, Luffa and Rhizoma Lulutong in the Chinese medicine combination can relieve the symptoms of chronic obstructive pulmonary disease.

[0062] Pathological observation of lung tissue: Lung tissue was fixed with 4% paraformaldehyde, dehydrated with different concentrations of ethanol gradient, and then transparentized with xylene, embedded in paraffin, adhered to the slide, and then placed in a 60℃ constant temperature box for 1-2 hours, dewaxed with xylene, and rehydrated with different concentrations of ethanol; stained with HE and Masson, dehydrated, transparent, air-dried, sealed, and observed under an optical microscope;

[0063] The observation results are as follows: compared with the blank group, the lung tissue of the rats in the model group had a large number of inflammatory cell infiltrations, the alveolar wall structure was severely damaged and thinned, the alveoli were over-expanded, ruptured, and the number was reduced; compared with the model group, the inflammatory infiltration of the lung tissue of the rats in each group of the drug administration group of the present invention was reduced, and the alveolar structure was improved to varying degrees.

[0064] 2. Clinical Trials

[0065] 1. Research plan:

[0066] 1.1 Intervention drugs

[0067] Example 3, Example 4 and Comparative Example 1 were prepared into Chinese medicine granules;

[0068] Example 3: 20g of raw gypsum, 8g of patchouli, 8g of gardenia, 6g of siler, 18g of stir-fried coix seed, 6g of perilla, 12g of mulberry leaf, 18g of stir-fried yam, 8g of stir-fried apricot kernel, 8g of perilla leaf, and 8g of perilla stem.

[0069] Example 4: 20g of raw gypsum, 8g of patchouli, 8g of gardenia, 6g of siler, 18g of stir-fried coix seed, 6g of perilla, 12g of mulberry leaf, 18g of stir-fried yam, 8g of stir-fried apricot kernel, 8g of perilla leaf, 8g of perilla stem, 2g of greenstone, 7g of luffa, and 5g of Rhizoma Smilacis Glabrae.

[0070] Each dose is divided into 2 bags, 1 bag at a time, 2 times a day. The Chinese medicine test group was prepared by Beijing Chunfeng Chinese Medicine Co., Ltd. with full-ingredient Chinese medicine formula granules in accordance with GMP standards.

[0071] Chinese medicine placebo: The Chinese medicine granule placebo used in the control group is a granule containing 5% of the Chinese medicine ingredient of Example 4, and the matrix uses soluble starch and dextrin as auxiliary materials. It is produced by Beijing Chunfeng Chinese Medicine Co., Ltd. The outer packaging of the placebo is the same as that of the test drug.

[0072] Western medicine: Tiotropium bromide powder for inhalation (2.5 micrograms / spray), 1 spray each time, once a day.

[0073] 1.2 Administration

[0074] (1) Experimental group: Tiotropium bromide powder for inhalation combined with Chinese medicine granules (Chinese medicine granules prepared in Examples 3 and 4), treatment course: 2 weeks (the experimental group consists of two groups, Example 3 group and Example 4 group, 40 people in each group).

[0075] (2) Control group: Tiotropium bromide powder for inhalation combined with Chinese medicine placebo granules, treatment course: 2 weeks.

[0076] Forty subjects were recruited in each group. This clinical trial was approved by the Ethics Committee of Beijing Chaoyang Hospital Affiliated to Capital Medical University, with the ethics number 2022-Ke-487-6.

[0077] 1.3 Research subjects (including inclusion and exclusion criteria)

[0078] Western medicine diagnostic criteria: According to the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)" [5] The diagnosis of COPD is mainly based on the exposure history of risk factors such as tobacco and fuel smoke, symptoms such as chronic cough, sputum and dyspnea, physical signs such as percussion hyperresonance, pulmonary function tests and other clinical data, and excludes other diseases that may cause similar symptoms and persistent airflow limitation, and is determined by comprehensive analysis. Pulmonary function tests showing persistent airflow limitation are a prerequisite for the diagnosis of COPD, and FEV1 / FVC < 70% after inhalation of bronchodilators clearly indicates the presence of persistent airflow limitation.

[0079] TCM syndrome diagnostic criteria: Syndrome of internal accumulation of damp-heat, clinical manifestations include frequent coughing, sticky mouth, wheezing, no sputum or sticky sputum, occasional foreign body sensation in the throat, decreased appetite, unformed stool, joint pain, pale tongue with greasy coating, no tortuosity of sublingual collaterals, and slippery pulse.

[0080] 1.3.1 Inclusion criteria

[0081] ① Meet the diagnostic criteria for COPD; ② Age ≥ 18 years old; ③ 0 or 1 acute exacerbation in the past year, meeting the low-risk population criteria for groups A and B in the 2023 version of the GOLD guidelines; ④ Meet the diagnostic criteria for internal damp-heat syndrome; ⑤ Sign the informed consent form.

[0082] 1.3.2 Exclusion criteria

[0083] ① Pregnant and lactating women; ② Patients with unconsciousness, dementia and various mental illnesses; ③ Patients with malignant tumors; ④ Those who are participating in clinical trials of other drugs; ⑤ Those with contraindications to tiotropium bromide powder inhalation, such as narrow-angle glaucoma, prostatic hyperplasia or bladder neck obstruction, and those who are allergic to the Chinese medicinal ingredients contained in the Fei Xin An Jia Wei Fang.

[0084] 1.4 Observation indicators

[0085] The main outcome indicator is the total effective rate of symptom score, and the secondary outcome indicators include lung function, mMRC dyspnea questionnaire, etc. Safety indicators include blood routine, urine routine, stool routine, liver function, kidney function test before and after the trial.

[0086] 2. Clinical Results

[0087] 2.1 Observation of efficacy

[0088] 2.1.1 Comparison of clinical efficacy

[0089] After 2 weeks of medication, the efficacy results are shown in Table 2;

[0090] Table 2 Comparison of clinical efficacy (n=40)

[0091] Group control Significant effect efficient invalid Total effective rate (%) Example 3 10 18 10 2 <![CDATA[95.00 # ]]> Example 4 15 22 2 1 <![CDATA[97.50 # ]]> Control group 3 8 16 13 67.5％

[0092] Note: Compared with the control group, # indicates P < 0.05.

[0093] 2.1.2 Comparison of lung function

[0094] The subjects’ FEV1 / FVC and FEV1 were measured, as shown in Table 3. FEV1 represents the volume of air exhaled in the first second of maximum exhalation after maximal deep breathing, and FEV1 / FVC refers to the ratio of forced expiratory volume in the first second to all expiratory volumes;

[0095] Table 3 Comparison of lung function before and after treatment (x±s, n=40)

[0096]

[0097]

[0098] Note: Compared with the same group before and after treatment, # indicates P < 0.05; compared with the control group after treatment, △ indicates P < 0.05;

[0099] Comparison within the groups before and after treatment showed that the lung function FEV1 / FVC and FEV1 of the Example 3 and Example 4 groups were significantly higher after treatment than before treatment, and the difference was statistically significant (P < 0.05); comparison between the Example 3 and Example 4 groups after treatment and the control group after treatment showed that the Example 3 and Example 4 groups were higher than the control group, and the difference was statistically significant (P < 0.05).

[0100] 2.1.3mMRC Dyspnea Questionnaire

[0101] The modified British Medical Research Council (mMRC) dyspnea questionnaire was used to assess the severity of dyspnea, and the data were recorded before and after treatment. The statistical results are shown in Table 5 , and the dyspnea questionnaire is shown in Table 4 .

[0102] Table 4 Dyspnea Questionnaire

[0103]

[0104] Table 5 Statistical results of dyspnea severity before and after treatment (x±s, n=40)

[0105] Group Before treatment After treatment Example 3 2.70±0.32 1.20±0.16#△ Example 4 2.76±0.37 1.01±0.20#△ Control group 2.75±0.45 1.93±0.62#

[0106] Note: Compared with the same group before treatment, # indicates P < 0.05; compared with the control group after treatment, △ indicates P < 0.05;

[0107] Intra-group comparison before and after treatment, the dyspnea degree of Example 3 and Example 4 was significantly lower after treatment than before treatment, and the difference was statistically significant (P < 0.05); in inter-group comparison between the treatment group and the control group after treatment, Example 3 and Example 4 were higher than the control group, and the difference was statistically significant (P < 0.05).

[0108] 2.2 Safety Observation

[0109] No abnormalities were found in the blood routine, urine routine, stool routine, liver function and kidney function tests of the experimental group and the control group before and after the experiment.

[0110] Although the embodiments of the present invention have been disclosed as above, they are not limited to the applications listed in the specification and the implementation modes. They can be fully applied to various fields suitable for the present invention. For those familiar with the art, additional modifications can be easily implemented. Therefore, without departing from the general concept defined by the claims and the scope of equivalents, the present invention is not limited to the specific details and the embodiments shown and described herein.

Claims

1. A Chinese medicine composition for alleviating chronic obstructive pulmonary disease, characterized in that: Including the following ingredients: Gypsum, Patchouli, Gardenia, Saposhnikovia, stir-fried Coix seeds, Cymbidium orientale, mulberry leaves, stir-fried yam, stir-fried almonds, Perilla leaves, and Perilla stems.

2. The Chinese medicine composition for alleviating chronic obstructive pulmonary disease according to claim 1, characterized in that: Calculated by weight, it includes 15-30 parts of gypsum, 5-10 parts of patchouli, 5-10 parts of gardenia, 5-10 parts of siler, 15-20 parts of stir-fried coix seeds, 5-10 parts of perilla, 10-15 parts of mulberry leaves, 15-20 parts of stir-fried yam, 6-10 parts of stir-fried almonds, 6-10 parts of perilla leaves, and 6-10 perilla stems.

3. The Chinese medicine composition for alleviating chronic obstructive pulmonary disease according to claim 2, characterized in that: 20 parts of gypsum, 8 parts of patches, 8 parts of gardenia, 6 parts of siler, 18 parts of stir-fried coix seeds, 6 parts of perilla, 12 parts of mulberry leaves, 18 parts of stir-fried yam, 8 parts of stir-fried apricot kernel, 8 parts of perilla leaves, and 8 parts of perilla stems.

4. The Chinese medicine composition for alleviating chronic obstructive pulmonary disease according to claim 3, characterized in that: Also includes: 2 parts of bluestone, 7 parts of loofah, and 5 parts of Rhizoma Smilacis Glabrae.

5. The use of the Chinese medicine composition for alleviating chronic obstructive pulmonary disease according to any one of claims 1 to 4, characterized in that: Application of the traditional Chinese medicine composition in preparing medicine for alleviating chronic obstructive pulmonary disease.

6. The use of the Chinese medicine composition for alleviating chronic obstructive pulmonary disease according to claim 5, characterized in that: The dosage form of the drug includes any one of aerosol, spray, powder spray, tablet, powder, suspension, granule, capsule, solution, enema or emulsion.

7. The use of the Chinese medicine composition for alleviating chronic obstructive pulmonary disease according to claim 6, characterized in that: The dosage form of the medicine is granules.

8. The use of the Chinese medicine composition for alleviating chronic obstructive pulmonary disease according to claim 6, characterized in that: The drug also includes pharmaceutically acceptable excipients; the pharmaceutically acceptable excipients include any one or a combination of at least two of carriers, diluents, excipients, fillers, binders, wetting agents, disintegrants, emulsifiers, solubilizers, osmotic pressure regulators, surfactants, coating materials, colorants, pH regulators, antioxidants, antibacterial agents or buffers.

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