Traditional Chinese medicine composition for treating chronic obstructive pulmonary disease as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine preparation, in particular to a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 15-25 parts of radix fici simplicissimae, 15-25 parts of herba asari, 10-20 parts of fructus chebulae, 10-20 parts of discolor bulbophyllum herb, 10-20 parts of gecko, 10-20 parts of cortex magnoliae officinalis, 10-15 parts of kadsura longepedunculata, 5-10 parts of folium microcotis, 10-15 parts of semen coicis, 10-15 parts of achyranthes aspera, 10-15 parts of radix astragali and 10-15 parts of honey-fried licorice root. The preparation method comprises the following steps: weighing the traditional Chinese medicine composition according to the formula dosage, then adding water which is 5-20 times of the total weight of the traditional Chinese medicine composition, and decocting for three times to obtain a traditional Chinese medicine decoction; combining the traditional Chinese medicine decoction, filtering, and concentrating until the relative density is 1.05-1.10 to obtain a traditional Chinese medicine extract; and adding clinically acceptable auxiliary materials into the traditional Chinese medicine extract, and preparing by adopting a conventional preparation mode. The traditional Chinese medicine can achieve the treatment purposes of simultaneously treating lung, spleen, kidney and heart, diminishing inflammation, relieving asthma, harmonizing yin and yang and eliminating lung distension.

Description

Technical Field

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

[0002] Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease, with clinical features of persistent respiratory symptoms (cough, sputum, wheezing, etc.) and irreversible airflow limitation, mostly due to long-term and large-scale exposure to toxic particles or gases, as well as airway and / or alveolar abnormalities caused by host factors. In recent years, the prevalence of COPD has gradually increased worldwide, and 70% to 80% of COPD are not clearly diagnosed, significantly increasing the probability of acute exacerbation and hospitalization of the disease in the future. COPD is divided into a stable phase and an acute exacerbation phase. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) will aggravate the damage to the patient's lung function, and may often be complicated by respiratory failure, heart failure, cor pulmonale, pulmonary thromboembolism, etc., which seriously threatens the patient's life.

[0003] COPD has a long course of disease, and is easily caused by the influence of multiple factors such as infection and weather changes, and acute exacerbations. Repeated acute exacerbations can cause a sharp decline in lung function, and can be complicated with cor pulmonale, pulmonary hypertension, etc., resulting in low quality of life for patients, and even life-threatening. More and more studies have shown that traditional Chinese medicine combined with conventional Western medicine treatment can significantly improve COPD patient symptoms, improve quality of life, and significantly shorten hospital stay, reduce acute exacerbations, and reduce the economic burden on patients. However, although the current Chinese medicine composition for the treatment of COPD can achieve the effects of relieving lung distension, relieving cough, and relieving asthma, it is not possible to achieve the simultaneous treatment of the lung, spleen, kidney, and heart, and the COPD disease effect with symptoms such as airway inflammation, obstruction, and severe damage to lung function is not obvious enough, so it is still not possible to achieve the purpose of rapid relief until cure. Summary of the invention

[0004] In view of the deficiencies in the prior art, the present invention provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, and a preparation method and application thereof.

[0005] Specifically, the present invention provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, characterized in that the traditional Chinese medicine composition is composed of the following raw materials: ginseng, asarum, terminalia chebula, lotus root, gecko, Magnolia officinalis, Schisandra chinensis, Buza leaves, Coix seeds, Achyranthes bidentata, Astragalus membranaceus, and roasted liquorice.

[0006] As a further illustration of the present invention, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 15-25 parts of gentian peach, 15-25 parts of asarum, 10-20 parts of terminalia chebula, 10-20 parts of stone lotus root, 10-20 parts of gecko, 10-20 parts of magnolia bark, 10-15 parts of schisandra chinensis, 5-10 parts of buzia leaf, 10-15 parts of coix seed, 10-15 parts of achyranthes bidentata, 10-15 parts of astragalus, and 10-15 parts of roasted licorice.

[0007] As a further illustration of the present invention, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 20 parts of licorice, 20 parts of asarum, 15 parts of terminalia chebula, 20 parts of lotus root, 15 parts of gecko, 10 parts of magnolia bark, 15 parts of schisandra chinensis, 10 parts of buzia leaves, 15 parts of coix seeds, 10 parts of achyranthes bidentata, 15 parts of astragalus, and 15 parts of roasted licorice.

[0008] The second aspect of the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for treating chronic obstructive pulmonary disease.

[0009] As a further illustration of the present invention, the dosage form of the drug for treating COPD is an oral preparation, and the oral preparation is selected from any one of granules, tablets, capsules, powders, decoctions or pills.

[0010] The third aspect of the present invention provides a method for preparing a Chinese medicine composition for treating chronic obstructive pulmonary disease, comprising the following steps: S1, weighing the above-mentioned Chinese medicine composition according to the dosage of the formula, and then adding 5-20 times the total weight of the above-mentioned Chinese medicine composition of water to decoct three times to obtain a Chinese medicine decoction; S2, combining the Chinese medicine decoctions obtained by decocting three times in step S1, filtering and concentrating to a relative density of 1.05-1.10 to obtain a Chinese medicine extract; S3. Add clinically acceptable excipients to the traditional Chinese medicine extract obtained in step S2, and prepare it in a conventional preparation method to prepare any one of clinically acceptable granules, tablets, capsules, powders, decoctions or pills.

[0011] As a further illustration of the present invention, when preparing granules, step S3 specifically includes: Step S31, adding dextrin in an amount of 3-7% by weight of the total weight of the Chinese medicine composition to the Chinese medicine extract obtained in step S2, and spray drying to obtain a spray-dried powder; Step S32: Add dextrin (18% by weight of the total weight of the granular preparation to be prepared) to the dry powder obtained in step S31 and mix well to prepare the final granular preparation.

[0012] Five-fingered peach: sweet, spicy, neutral in nature. It enters the spleen meridian, lung meridian, and liver meridian. It has the functions of strengthening the spleen and lungs, promoting qi and removing dampness, and relaxing muscles and activating collaterals. Traditional Chinese medicine practitioners or folk doctors of ethnic minorities in Lingnan region often use it to treat spleen deficiency edema, poor appetite and weakness, tuberculosis cough, night sweats, leucorrhea, postpartum milklessness, irregular menstruation, rheumatic pain, edema, etc.

[0013] Asarum: spicy, warm in nature. Enters the heart, lung, and kidney meridians. Has the effects of dispelling cold, dispelling wind and relieving pain, opening the orifices, and warming the lungs and eliminating phlegm.

[0014] Terminalia chebula flesh: bitter, sour, astringent, neutral in nature. Enters the lung and large intestine meridians. It has the effects of "reinforcing the lungs, astringing the intestines, and relieving qi", and can treat symptoms such as "chronic cough, aphonia, chronic diarrhea, chronic dysentery, rectal prolapse, bloody stool, metrorrhagia, leucorrhea, spermatorrhea, and frequent urination".

[0015] Stone lotus root: sweet in taste, cool in nature. It enters the lung and spleen meridians. It has the effects of nourishing yin and moistening the lungs, cooling blood and stopping bleeding. It can be used to treat hemoptysis caused by tuberculosis, neurasthenia and other symptoms.

[0016] Gecko: salty, neutral in nature. Enters the lung and kidney meridians. Gecko is an important medicine for lung and kidney deficiency, kidney failure to absorb qi, chronic cough and asthma. It has the functions of tonifying the kidney and supporting yang, nourishing essence and blood, and can be used to treat impotence, spermatorrhea and other diseases caused by deficiency of essence and blood.

[0017] Magnolia officinalis: pungent in taste, warm in nature. Enters the spleen, stomach and large intestine meridians. It has the effects of promoting qi and eliminating dampness, warming the middle and relieving pain, and relieving asthma. It can be used to treat food stagnation and qi stagnation, abdominal distension and constipation, dampness blocking the middle jiao, abdominal distension, vomiting and diarrhea, phlegm and qi stagnation, chest fullness, asthma and cough.

[0018] Schisandrae Chinensis: sour, sweet, warm in nature. Enters the lung, heart, and kidney meridians. Has the effects of astringing, strengthening qi, promoting the production of body fluid, and tonifying the kidney and calming the mind. Used for chronic cough, weak asthma, nocturnal emission, frequent urination, chronic diarrhea, spontaneous sweating, night sweats, thirst due to loss of body fluid, shortness of breath and weak pulse, internal heat and thirst, palpitations and insomnia.

[0019] Buzha leaves: slightly sour, cool in nature. Enters the spleen and stomach meridians. Has the effects of digesting food, removing stagnation, clearing away heat and removing dampness. Used for food stagnation, cold and fever, damp-heat jaundice.

[0020] Coix seeds: sweet, light, cool in nature. Enter the spleen, lung, and kidney meridians. It has the effects of strengthening the spleen, eliminating dampness, removing numbness and stopping diarrhea. It can be used to treat edema, beriberi, and urinary problems.

[0021] Achyranthes bidentata: slightly bitter, cool. Enters the lung, liver, and stomach meridians. Has the effects of promoting blood circulation and dispersing blood stasis, unblocking joints, clearing away heat and detoxifying, and reducing swelling and promoting diuresis. It is mainly used to treat amenorrhea, dysmenorrhea, chronic rheumatic arthritis, lumbar muscle strain, sore throat, edema caused by rheumatic heart disease, urinary tract infection, stomach fire toothache, and snake bites.

[0022] Astragalus: sweet in taste, warm in nature. Enters the lung and spleen meridians. Astragalus is a tonic medicine that is good at replenishing qi. Astragalus is a medicine that replenishes qi and consolidates the exterior. It is used for spontaneous sweating and fatigue due to exterior deficiency. It is also used for edema caused by qi deficiency. Astragalus has the effects of diuresis, detoxification, sore astringence and tissue regeneration. It is used to strengthen the spleen and stomach. It is used for qi deficiency, lack of strength, less appetite, and sinking of qi in the middle, long-term diarrhea and dysentery, rectal prolapse and blood in the stool.

[0023] Roasted Licorice: sweet, neutral in nature. It enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving pain, and harmonizing various medicines. It is used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with sputum, abdominal and limb cramps and pain, carbuncle, sore and ulcer, and relieves drug toxicity and potency.

[0024] Explanation of the prescription: COPD belongs to the category of "lung distension" and "asthma" in traditional Chinese medicine. The term "lung distension" was first seen in "Lingshu·Jingmai Pian", which proposed that lung distension is a symptom of asthma and cough caused by stagnation of lung qi. The pathogenesis of COPD is mainly root deficiency and superficial excess. The root deficiency mainly refers to the dysfunction of viscera and disharmony of yin and yang; the deficiency of lung qi leads to superficial deficiency, insufficiency of defense, and susceptibility to invasion by external pathogens, and the loss of power of lung qi to descend, resulting in cough, asthma and other symptoms. The superficial excess refers to phlegm, fluid and blood stasis, which are the pathological products of chronic lung diseases that are not cured. The invention uses five-fingered ginseng, asarum and terminalia chebula pulp as the main drugs. The five-fingered ginseng has the effects of promoting qi and relieving depression, relieving cough and resolving phlegm. In addition, asarum and terminalia chebula pulp have the effects of warming the lungs and transforming fluid, nourishing yin and restraining the lungs, and can treat both the symptoms and the root causes, so as to achieve the purpose of treating lung distension and asthma at the same time; the stone lotus root, gecko and magnolia bark are the assistant drugs, among which the stone lotus root and gecko are used together, and have the effects of nourishing yin, nourishing blood and tonifying the kidney, and in addition, the magnolia bark is used together, so as to achieve the effects of tonifying both the lungs and kidneys, relieving pain and relieving asthma; the southern schisandra chinensis and scutellaria baicalensis are used as auxiliary drugs to tonify the kidney and calm the heart, descend qi and resolve phlegm, coix seed, rhizoma achyranthis Bidentatae and astragalus root can strengthen the spleen and relieve pain, resist inflammation and tonify qi, and in addition, roasted licorice can lead the drugs upward and harmonize the medicinal properties, so as to finally achieve the therapeutic purposes of treating the lungs, spleen, kidney and heart at the same time, relieving inflammation and relieving asthma, harmonizing yin and yang, and eliminating lung distension.

[0025] Compared with the prior art, the present invention has the following beneficial technical effects: The invention uses five-fingered ginseng, asarum and terminalia chebula pulp as the main drugs. The five-fingered ginseng has the effects of promoting qi and relieving depression, relieving cough and resolving phlegm. In addition, asarum and terminalia chebula pulp have the effects of warming the lungs and transforming fluid, nourishing yin and restraining the lungs, and can treat both the symptoms and the root causes, so as to achieve the purpose of treating lung distension and asthma at the same time; the stone lotus root, gecko and magnolia bark are the assistant drugs, among which the stone lotus root and gecko are used together, and have the effects of nourishing yin, nourishing blood and tonifying the kidney, and in addition, the magnolia bark is used together, so as to achieve the effects of tonifying both the lungs and kidneys, relieving pain and relieving asthma; the southern schisandra chinensis and scutellaria baicalensis are used as auxiliary drugs to tonify the kidney and calm the heart, descend qi and resolve phlegm, coix seed, rhizoma achyranthis Bidentatae and astragalus root can strengthen the spleen and relieve pain, resist inflammation and tonify qi, and in addition, roasted licorice can lead the drugs upward and harmonize the medicinal properties, so as to finally achieve the therapeutic purposes of treating the lungs, spleen, kidney and heart at the same time, relieving inflammation and relieving asthma, harmonizing yin and yang, and eliminating lung distension. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 This is a pathological section of rat lung tissue. Figure 1 (a) is the lung tissue of the blank group, Figure 1 (b) Lung tissue of the model group.

[0027] Figure 2 This is a pathological section of rat lung tissue. Figure 2 (a) is the lung tissue of the model group, Figure 2 (b) is the lung tissue of the high-dose group in Example 1. DETAILED DESCRIPTION

[0028] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. 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 A traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: 20 parts of licorice, 20 parts of asarum, 15 parts of terminalia chebula, 20 parts of lotus root, 15 parts of gecko, 10 parts of magnolia bark, 15 parts of schisandra chinensis, 10 parts of buzia leaves, 15 parts of coix seeds, 10 parts of cyathula capitata, 15 parts of astragalus, and 15 parts of roasted liquorice.

[0030] Example 2 A traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: 15 parts of licorice, 15 parts of asarum, 10 parts of terminalia chebula, 10 parts of lotus root, 10 parts of gecko, 15 parts of magnolia bark, 10 parts of schisandra chinensis, 5 parts of buzia leaves, 10 parts of coix seeds, 12 parts of cyathula, 10 parts of astragalus, and 10 parts of roasted liquorice.

[0031] Example 3 A traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: 25 parts of quinquefolius, 25 parts of asarum, 20 parts of terminalia chebula, 15 parts of lotus root, 20 parts of gecko, 20 parts of magnolia bark, 12 parts of schisandra chinensis, 7 parts of buzia leaves, 12 parts of coix seeds, 15 parts of cyathula, 12 parts of astragalus, and 12 parts of roasted liquorice.

[0032] Comparative Examples 1-8 all provide a traditional Chinese medicine composition, and the specific raw medicinal materials and their amounts of the traditional Chinese medicine compositions of Comparative Examples 1-8 are detailed in Table 1 below.

[0033] Table 1 Raw materials and their dosage

[0034] In the table, 20* in Comparative Example 4 means that 20 parts of Asarum were replaced by 20 parts of Processed Pinellia, and 15 parts of Terminalia chebula were replaced by 15 parts of Tangerine Peel. “—” means that the corresponding raw medicinal materials were not added to the Chinese medicine composition.

[0035] The raw medicinal materials in the above embodiments and comparative examples are all commercially available Chinese herbal medicine slices.

[0036] The Chinese medicine compositions provided in the above embodiments and comparative examples are prepared into granular preparations for treating COPD, and the specific preparation process is as follows: S1. Weigh the Chinese medicine composition provided in the above embodiments and comparative examples according to the dosage of the formula, then add 10 times the total weight of the Chinese medicine composition of water and boil three times to obtain a Chinese medicine decoction; S2, combining the Chinese medicine decoctions obtained by decocting three times in step S1, filtering and concentrating to a relative density of 1.05-1.10 (60° C.) to obtain a Chinese medicine extract; S3, adding 5% dextrin by weight of the total weight of the Chinese medicine composition to the Chinese medicine extract obtained in step S2, and spray drying to obtain a spray-dried powder; S4. Add dextrin (18% by weight of the total weight of the granule preparation to be prepared) to the dry powder obtained in step S3 and mix well to prepare the final granule preparation.

[0037] 1. Animal experiments: 1.1 Experimental agents: granular preparations prepared according to the above-mentioned Example 1 and Comparative Examples 1-8 and the provided Chinese medicine formula; aminophylline tablets, national medicine standard number H37020945, Shandong Luxi Pharmaceutical Co., Ltd.

[0038] 1.2 Experimental animals: 152 SPF Wistar male rats were purchased from the Experimental Animal Center of Heilongjiang University of Traditional Chinese Medicine. The rats were placed in SPF conditions for 3 days before the experiment.

[0039] 1.3 Animal model construction and group administration The rats were divided into a control group and a model group, including 13 rats in the blank group and 139 rats in the model group. The rats in the model group were fumigated with combined tracheal instillation of LPS to replicate the COPD rat model. Specifically, the rats in the model group were placed in a fumigation box and fumigated with 10 cigarettes once a day for 30 minutes each time for a total of 56 days. On the 1st, 7th, 15th and 21st days, 200 μL of LPS (lipopolysaccharide) (1 mg / mL) was dripped into the trachea of ​​each rat through a long needle under ether anesthesia, and no fumigation was performed on the same day. The remaining 13 rats served as the blank control group, and only on the 1st, 7th, 15th and 21st days, an equal volume of 0.9% sodium chloride injection was injected into the airway using the same method. After 60 days of modeling, 3 rats were randomly selected from the blank group and the model group for lung tissue pathology examination. The results are as follows: Figure 1 As shown, Figure 1 (a) shows that the alveolar structure of the rats in the blank group was basically normal, and no obvious inflammatory cell infiltration and exudation were observed in the septa. Figure 1 (b) shows that compared with the blank group, the alveoli of the rats in the model group were significantly enlarged, the alveolar walls were broken in many places, and fused to form bullae, accompanied by a large number of inflammatory cell infiltration. The above pathological manifestations are consistent with the lung pathological changes of COPD, indicating that the model was successful.

[0040] The remaining 10 rats in the blank group were intragastrically administered with 10 mL / (kg·d) of normal saline, and the remaining 136 rats in the successfully modeled group were randomly divided into 13 groups, specifically divided as follows: 13 rats in the model group, 13 rats in the high-dose group of Example 1, and the remaining positive control group, low-dose group of Example 1, medium-dose group of Example 1, and high-dose group of Comparative Examples 1-8 were 10 rats in each group, and were intragastrically administered daily according to the following doses: 10 mL / (kg·d) normal saline in the model group, positive control group: aminophylline group 27 mg / (kg·d), low-dose group of Example 1: 3.5 g / (kg·d), medium-dose group of Example 1: 7 g / (kg·d), high-dose group of Example 1: 14 g / (kg·d), high-dose group of Comparative Examples 1-8: 14 g / (kg·d). The drug was administered continuously for four weeks. After four weeks of administration, 3 rats were randomly selected from the model group and the high-dose group of Example 1, respectively, for lung tissue pathological examination. The results are as follows Figure 2 As shown, Figure 2 (a) shows that the lung tissue structure of rats in the model group was disordered, the alveoli were fused and irregular in shape, the pulmonary interstitial edema, the alveolar septa were broken, and there was inflammatory cell infiltration. Figure 2 (b) shows that compared with the model group, the alveolar wall of the Chinese medicine group of the rats in the high-dose group of Example 1 was relatively thin, the inflammatory cell infiltration was less, the alveolar septum rupture was not obvious, and the pulmonary interstitial and alveolar edema was lighter, indicating that the Chinese medicine granules provided by the present invention have a significant improvement effect on the lung function of rats.

[0041] The drugs used in the three dosage groups (low, medium and high) of the above-mentioned Example 1 are Chinese medicine granule preparations obtained by using the granule preparation preparation method of the Chinese medicine formula provided in Example 1, and the drugs used in the high-dose groups of the above-mentioned Comparative Examples 1-8 are Chinese medicine granule preparations obtained by using the granule preparation preparation method of the Chinese medicine formula provided in Comparative Examples 1-8.

[0042] The remaining 10 rats in the model group, the remaining 1 rat in the high-dose group of Example 1, and the 10 rats in each of the positive control group, the low-dose group of Example 1, the medium-dose group of Example 1, and the high-dose groups of Comparative Examples 1-8 were subjected to the following detection and analysis of lung function-related indicators.

[0043] 1.4 Testing indicators:

[0044] Lung function indicators:

[0045] After the last oral administration, rats in each group were anesthetized by intraperitoneal injection of 60 mg / kg of Zotal 50 in the tail, and trachea was intubated. The forced vital capacity (FVC), the maximum exhaled volume in 50 ms (FEV50), and the functional residual capacity (FRC) were measured using the PFT pulmonary function testing system.

[0046] Cytokine indicators:

[0047] Rats in each group were euthanized by bleeding, and 6 mL of 0.9% sodium chloride injection was injected into the right lung from the tracheal opening for alveolar lavage. The alveolar lavage fluid was collected, and the white blood cell count and classification of the alveolar lavage fluid were detected by a veterinary five-differentiation blood cell analyzer. The levels of TNF-α and IL-6 in the alveolar lavage fluid were detected by a rat ELISA kit.

[0048] 1.5 Statistical methods:

[0049] SPSS17.0 statistical software package was used to analyze and organize the data, and two-sample t-test was used for comparison between groups. The difference was considered statistically significant when P < 0.05. 1.6 Experimental results: 1.61 Changes in lung function are shown in Table 2. Table 2 Changes in lung function of rats in each group Note: Compared with the blank group, # P<0.05, ## P < 0.01 and ### P<0.001; compared with the model group, * P<0.05, ** P < 0.01 and ***P<0.001; compared with the high-dose group in Example 1, Δ P<0.05, ΔΔ P < 0.01 and ΔΔΔ P<0.001(n=10). As shown in Table 2, compared with the blank group, the FVC and FEV50 of the rats in the model group were significantly reduced, and the FRC was significantly increased; compared with the rats in the model group, the FVC and FEV50 of the rats in the positive group, Example 1 (low), Example 1 (medium), Example 1 (high), and Comparative Example 1-8 groups were significantly increased, and the FRC was significantly reduced; compared with the rats in Example 1 (high) group, the FVC and FEV50 of the rats in Comparative Example 1-8 groups were significantly reduced, and the FRC was significantly increased, indicating that the Chinese medicine granules provided by the present invention have a significant improvement effect on the lung function of rats, and the effect is significantly better than the Chinese medicine granules provided in the comparative example.

[0050] 1.62 Cytokine indicators, see Table 3.

[0051] Table 3 Changes of TNF-α and IL-6 in rats in each group

[0052] Note: Compared with the blank group, # P<0.05, ## P < 0.01 and ### P<0.001; compared with the model group, * P<0.05, ** P < 0.01 and *** P<0.001; compared with the high-dose group in Example 1, ∆ P<0.05, ∆∆ P < 0.01 and ∆∆∆ P<0.001(n=10).

[0053] As shown in Table 3, compared with the blank group, the TNF-α and IL-6 of the model group rats were significantly increased; compared with the model group rats, the TNF-α and IL-6 of the positive group, Example 1 (low), Example 1 (medium), Example 1 (high), and Comparative Example 1-8 rats were significantly reduced; compared with the Example 1 (high) group rats, the TNF-α and IL-6 of the Comparative Example 1-8 rats were increased, indicating that the Chinese medicine granules provided by the present invention have a significant improvement effect on rat lung cells, and the effect is significantly better than the Chinese medicine granules provided in the comparative example.

[0054] Clinical Trials 2.1 General Information 80 patients with COPD obstructive pulmonary disease who were hospitalized in the Affiliated Hospital of Heilongjiang University of Chinese Medicine from August 2023 to August 2024 were selected. The stratified randomization method was used to select the appropriate segment length and divide them into the treatment group and the control group at a ratio of 1:1. With the help of SAS statistical software, the seed number was given to generate the random arrangement of the treatment (treatment drug and control drug) received by the 80 subjects, that is, the treatment allocation corresponding to the serial number 01 to 80 was listed. There were 40 cases in the treatment group, 27 males and 13 females, with an average age of (67.2±6.4) years and an average course of (6.3±3.4) years. There were 40 cases in the control group, 25 males and 15 females, with an average age of (66.7±7.1) years and an average course of (6.2±3.6) years.

[0055] 2.2 Diagnostic criteria TCM diagnostic criteria: According to the TCM diagnosis and treatment guidelines for chronic obstructive pulmonary disease (2011 edition) for the differentiation of phlegm-dampness obstructing the lung syndrome: ① Coughing and expectoration, with a lot of white, sticky or foamy sputum; ② Wheezing or shortness of breath; ③ Sticky mouth, poor appetite or little food intake; ④ Fullness in the stomach; ⑤ Greasy white tongue coating, slippery or stringy pulse. If two of ① and ② are met, plus any two of ③, ④, and ⑤, the diagnosis can be made.

[0056] Western medicine diagnostic criteria: Based on the diagnostic criteria for AECOPD in the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease" issued by the Chronic Obstructive Pulmonary Disease Group of the Chinese Medical Association's Respiratory Diseases Society in 2021.

[0057] 2.3 Case inclusion criteria ①Meet the diagnostic criteria for AECOPD. ②Meet the diagnostic criteria for TCM syndrome. ③Age 40-85 years old.

[0058] 2.4 Case Exclusion Criteria ① Patients who need to be admitted to the ICU or require invasive mechanical ventilation treatment; ② Patients with mental illness or patients with neurological impairment who cannot cooperate; ③ Patients with other lung diseases, such as lung cancer, tuberculosis, interstitial pneumonia, pulmonary fungal infection, etc. ④ Patients with allergic constitution or allergy to research drugs. ⑤ Patients with severe heart failure (heart function grade III and above) or severe liver and kidney damage.

[0059] 2.5 Treatment methods Taking the formula of the Chinese medicine composition provided in Example 1 above, referring to the method for preparing Chinese medicine granules in the Chinese Pharmacopoeia (2020 edition), the pharmaceutical factory of the First Affiliated Hospital of Heilongjiang University of Chinese Medicine prepared Chinese medicine bagged granules, each bag containing 10g of crude drug, constituting the Chinese medicine oral granules for the treatment group.

[0060] The treatment group took 1 bag (containing 10 g of crude drug) 3 times a day before meals, and 1 course of treatment was 6 weeks.

[0061] The control group took aminophylline tablets (Shandong Luxi Pharmaceutical Co., Ltd., national medicine standard number H37020945), 4 tablets each time, 3 times a day, for 6 weeks, and then various indicators were tested.

[0062] 2.6 Criteria for determining efficacy Formulated in accordance with the "Guidelines for Clinical Research of New Chinese Medicines" (Trial Implementation). Markedly effective: The main symptoms such as cough, sputum, and wheezing are significantly improved and the lung rales are significantly reduced, and the symptom score is reduced by 70% to 95%. Effective: The main symptoms such as cough, sputum, and wheezing are improved and the lung rales are reduced, and the symptom score is reduced by 30% to 70%. Ineffective: The main symptoms such as cough, sputum, and wheezing and lung rales are not significantly improved or improved, or even aggravated, and the symptom score is reduced by less than 30%. Total effective rate = (markedly effective number + effective number) / number of cases × 100%.

[0063] 2.7 Statistical methods SPSS 17.0 statistical software package was used to analyze the data. The chi-square test was used for comparison between the groups. The difference was considered statistically significant when P < 0.05.

[0064] 2.8 Experimental Results The comparison of clinical efficacy between the two groups of patients is shown in Table 4.

[0065] Table 4 Comparison of clinical efficacy between the two groups of patients

[0066] Note: Compared with the control group, * P<0.05.

[0067] As can be seen from Table 4, the total effective rate of the treatment group was 87.5%, and the total effective rate of the control group was 70.0%, and the clinical efficacy of the treatment group was significantly better than that of the control group ( * P<0.05), indicating that the efficacy of the Chinese medicine composition provided in the present application is superior to that of traditional Western medicine preparations for the treatment of COPD, and has obvious clinical advantages.

[0068] In summary, the present invention uses five-fingered ginseng, asarum and terminalia chebula as the main drugs. The five-fingered ginseng has the effects of promoting qi and relieving depression, relieving cough and reducing phlegm. In addition, asarum and terminalia chebula have the effects of warming the lungs and transforming fluid, nourishing yin and restraining the lungs, and can treat both the symptoms and the root causes, so as to achieve the purpose of treating lung distension and asthma at the same time; the stone lotus root, gecko and magnolia bark are the assistant drugs, among which the stone lotus root and gecko are used together, and have the effects of nourishing yin, nourishing blood and tonifying the kidney, and in addition, the magnolia bark is used together, so as to achieve the effect of tonifying both the lungs and kidneys, relieving pain and relieving asthma; the southern schisandra chinensis and scutellaria baicalensis are used as auxiliary drugs to tonify the kidney and calm the heart, descend qi and resolve phlegm, coix seed, rhizoma achyranthis Bidentatae and astragalus membranaceus can invigorate the spleen and relieve pain, and resist inflammation and tonify qi, and in addition, the roasted licorice can lead the drugs upward and harmonize the medicinal properties, so as to finally achieve the therapeutic purposes of treating the lungs, spleen, kidney and heart at the same time, reducing inflammation and relieving asthma, harmonizing yin and yang, and eliminating lung distension.

[0069] It should be noted that, in this article, terms such as "comprises", "includes" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or apparatus that includes a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or apparatus.

[0070] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating chronic obstructive pulmonary disease, characterized in that: The Chinese medicine composition is composed of the following raw materials: five-fingered peach, asarum, terminalia chebula pulp, lotus root on stone, gecko, magnolia bark, schisandra chinensis, buzi leaves, coix seeds, cyathula officinalis, astragalus and roasted liquorice.

2. The Chinese medicine composition for treating COPD according to claim 1, characterized in that: The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 15-25 parts of quinquefolius, 15-25 parts of asarum, 10-20 parts of terminalia chebula pulp, 10-20 parts of lotus root, 10-20 parts of gecko, 10-20 parts of magnolia bark, 10-15 parts of schisandra chinensis, 5-10 parts of buzia leaves, 10-15 parts of coix seeds, 10-15 parts of cyathula officinalis, 10-15 parts of astragalus, and 10-15 parts of roasted liquorice.

3. The Chinese medicine composition for treating COPD according to claim 1, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 20 parts of quinquefolius, 20 parts of asarum, 15 parts of terminalia chebula, 20 parts of lithospermum officinale, 15 parts of gecko, 10 parts of magnolia bark, 15 parts of schisandra chinensis, 10 parts of buzia leaves, 15 parts of coix seeds, 10 parts of cyathula capitata, 15 parts of astragalus, and 15 parts of roasted liquorice.

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

5. The use according to claim 4, characterized in that: The dosage form of the drug for treating COPD is an oral preparation, which is selected from any one of granules, tablets, capsules, powders, decoctions or pills.

6. A method for preparing a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, characterized in that: The following steps are involved: S1. Weigh the Chinese medicine composition provided by any one of claims 2-3 according to the dosage of the formula, then add 5-20 times the total weight of the Chinese medicine composition of water and boil three times to obtain a Chinese medicine decoction; S2, combining the Chinese medicine decoctions obtained by decocting three times in step S1, filtering and concentrating to a relative density of 1.05-1.10 to obtain a Chinese medicine extract; S3. Add clinically acceptable excipients to the traditional Chinese medicine extract obtained in step S2, and prepare it in a conventional preparation method to prepare any one of clinically acceptable granules, tablets, capsules, powders, decoctions or pills.

7. The method for preparing the Chinese medicine composition for treating COPD according to claim 6, characterized in that: When preparing granules, step S3 specifically includes: Step S31, adding dextrin in an amount of 3-7% by weight of the total weight of the Chinese medicine composition to the Chinese medicine extract obtained in step S2, and spray drying to obtain a spray-dried powder; Step S32: Add dextrin (18% by weight of the total weight of the granular preparation to be prepared) to the dry powder obtained in step S31 and mix well to prepare the final granular preparation.

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