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

Abstract

This invention discloses a traditional Chinese medicine composition for treating COPD and its application. The efficacy of this composition is superior to that of salmeterol / fluticasone inhaler, effectively controlling inflammatory responses and improving patients' lung function and airway reactivity. It shows significant efficacy in the clinical treatment of lung and kidney qi deficiency syndrome in patients with stable COPD. The composition uses raw astragalus, American ginseng, and gecko as the principal herbs, and centella asiatica, stir-fried perilla seed, and stir-fried bitter apricot kernel as the assistant herbs to help the principal herbs tonify the lungs and kidneys, and relieve asthma. Because COPD is chronic and difficult to cure, airway hyperresponsiveness easily leads to airway spasm and recurrent cough. Therefore, silkworm and scorpion are added to dispel wind and resolve phlegm, relieving small airway spasm. Scutellaria baicalensis is added to promote upward dispersion, effectively clearing lung heat in the upper burner and mitigating the bitter and cold nature of raw herbs, thus clearing lung heat. It is further combined with roasted gizzard lining to strengthen the spleen and stomach. Prepared licorice is used to harmonize the herbs, which has the effects of tonifying the lungs and spleen, resolving phlegm and relieving cough, relieving asthma and strengthening the kidneys.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for treating COPD and its application. Background Technology

[0002] Chronic obstructive pulmonary disease (COPD) is a common respiratory disease characterized by respiratory symptoms and persistent airflow limitation caused by significant exposure of the airways / alveoli to harmful particles or gases. Based on clinical manifestations and laboratory tests, the disease can be divided into acute exacerbations and stable phases. COPD patients often focus more on the treatment of acute exacerbations and neglect the prevention and treatment of stable phases, thus lacking effective measures for the treatment and prevention of COPD in the stable phase.

[0003] The preferred treatment for stable COPD is long-term use of bronchodilators combined with inhaled corticosteroids. Clinically, salmeterol / fluticasone inhaler is commonly used, but this method has varying degrees of side effects and is relatively expensive. Traditional Chinese medicine, on the other hand, mainly comes from natural medicines and their processed products, has relatively fewer side effects, and is more economical. In traditional Chinese medicine, COPD falls under the category of "lung distension," and its pathogenesis is characterized by deficiency of the root and excess of the branch. The root deficiency stems from the deficiency of the lung, spleen, and kidney, while the branch excess is mainly caused by external pathogens, phlegm, and blood stasis. The "Treatise on the Causes and Symptoms of Various Diseases" states: "The lung governs qi. When pathogens invade the lung, the lung distension occurs. Distension leads to obstruction of the pulmonary ducts, and obstruction leads to sluggish airways, hence the shortness of breath and wheezing."

[0004] In summary, there is an urgent need for a traditional Chinese medicine composition that can control inflammation and improve airway response and lung function in patients with stable COPD, to replace salmeterol / fluticasone inhaler for the clinical treatment of lung and kidney qi deficiency syndrome in stable COPD. This would leverage the advantages of traditional Chinese medicine, stabilize and delay the progression of the disease, reduce the frequency of acute exacerbations of COPD, improve lung function, and provide a new treatment approach for COPD with traditional Chinese medicine. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition for treating COPD and its application, so as to solve the problem of breathing difficulties in COPD patients, improve patients' airway response and lung function, reduce side effects and improve efficacy.

[0006] To address the aforementioned technical problems, this invention provides a traditional Chinese medicine composition for treating COPD and its application, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

[0007] Raw Astragalus membranaceus 30-60 parts, American ginseng 10-30 parts, gecko 15-45 parts, centella asiatica 15-45 parts, stir-fried perilla seed 10-30 parts, stir-fried bitter almond 10-30 parts, silkworm 10-30 parts, scorpion 10-25 parts, scutellaria baicalensis 10-30 parts, charred gizzard lining 15-45 parts, prepared licorice root 10-45 parts.

[0008] It should be noted in the plan that the traditional Chinese medicine composition also includes: 15-45 parts of honeysuckle, 15-45 parts of stir-fried malt, 15-45 parts of charred Shenqu, and 15-45 parts of stir-fried hawthorn.

[0009] It is worth further explaining that the ingredients are: 60 parts raw astragalus, 30 parts American ginseng, 36 parts gecko, 30 parts centella asiatica, 30 parts stir-fried perilla seed, 30 parts stir-fried bitter almond, 30 parts silkworm, 20 parts scorpion, 20 parts scutellaria baicalensis, 30 parts honeysuckle, 30 parts charred medicated leaven, 30 parts stir-fried hawthorn, 30 parts stir-fried malt, 45 parts charred gizzard lining, and 15 parts prepared licorice root.

[0010] In a preferred embodiment, the traditional Chinese medicine composition further includes: 15-45 parts of stir-fried Atractylodes macrocephala and 20-60 parts of stir-fried Dioscorea opposita.

[0011] In a preferred embodiment, the traditional Chinese medicine composition further includes: 15-45 parts of Adenophora stricta and 15-45 parts of Ophiopogon japonicus.

[0012] In a preferred embodiment, the traditional Chinese medicine composition further includes: 9-27 parts of Pinellia ternata and 12-36 parts of Trichosanthes kirilowii.

[0013] In a preferred embodiment, the traditional Chinese medicine composition further includes: 10-30 parts of Lepidium apetalum and 10-30 parts of Morus alba root bark.

[0014] In a preferred embodiment, the traditional Chinese medicine composition further includes: 10-30 parts of Psoralea corylifolia and 15-45 parts of Cuscuta chinensis.

[0015] It should be noted in the plan that the traditional Chinese medicine composition is a decoction, powder, pill, elixir, granule, spray, tablet, capsule, or compound.

[0016] It is worth further explaining the application of the traditional Chinese medicine composition for treating COPD in the preparation of drugs for treating COPD in the stable phase.

[0017] Compared with the prior art, the traditional Chinese medicine composition for treating COPD and its application provided by the present invention have at least the following beneficial effects:

[0018] The traditional Chinese medicine composition for treating COPD provided by this invention heavily utilizes raw Astragalus membranaceus. Raw Astragalus membranaceus, American ginseng, and gecko are used together as the principal herbs, while Centella asiatica, stir-fried Perilla frutescens seeds, and stir-fried bitter apricot kernels are used together as the assistant herbs to assist the principal herbs in tonifying the lungs and kidneys, and relieving asthma. Because COPD is chronic and difficult to cure, airway hyperresponsiveness easily leads to airway spasm and recurrent cough. Therefore, Bombyx mori and scorpion are added to dispel wind and resolve phlegm, relieving small airway spasm. Scutellaria baicalensis is added to promote upward movement and clear lung heat in the upper burner, and can also moderate the bitter and cold nature of raw herbs, thus clearing and reducing lung heat. It is further combined with roasted gizzard lining to strengthen the spleen and stomach. Prepared licorice root is used to harmonize the various herbs. This traditional Chinese medicine composition has the effects of tonifying the lungs and spleen, resolving phlegm and relieving cough, relieving asthma and strengthening the kidneys. According to clinical efficacy data, the efficacy of this traditional Chinese medicine composition is better than that of salmeterol / fluticasone inhaler. It can effectively control the inflammatory response, improve the patient's lung function and airway response, and has significant efficacy in the clinical treatment of lung and kidney qi deficiency syndrome in patients with stable COPD. Detailed Implementation

[0019] To enable those skilled in the art to better understand the technical solutions of this invention, the technical solutions in the embodiments of this invention will be clearly and completely described below.

[0020] The core of this invention is to provide a traditional Chinese medicine composition for treating COPD and its application, which solves the problem of breathing difficulties in COPD patients, improves airway reactivity and lung function, and enhances efficacy while reducing side effects.

[0021] A traditional Chinese medicine composition for treating COPD, comprising the following raw materials in parts by weight:

[0022] The formula uses raw astragalus, American ginseng, and gecko as the principal herbs. Raw astragalus is used in 30-60 parts, with a heavy emphasis on raw astragalus, which is considered the best among qi-tonifying herbs, capable of both ascending and descending qi, and representing the yang within yang. This differs from processed astragalus root; raw astragalus refers to the unprocessed root, which is sweet and cool in nature, and enters the spleen and lung meridians. American ginseng is used in 10-30 parts, to tonify qi, nourish yin, and generate fluids. The *Zai Xin* states that it is effective for "qi deficiency, cough and asthma, blood loss, and fatigue." "It calms the mind and nourishes the body, and relieves various deficiencies." According to "Medical Records of Integrating Chinese and Western Medicine," it "can supplement the Qi and also nourish the blood." 15-45 parts of gecko enter the lungs to replenish lung Qi and relieve cough and asthma. It also enters the kidneys to strengthen kidney Yang and nourish essence and blood. It is an essential medicine for deficiency of both the lungs and kidneys, kidney failure to receive Qi, and chronic cough and asthma. Preferably, 60 parts of raw astragalus, 30 parts of American ginseng, and 36 parts of gecko represent the optimal ratio of the principal herbs for the best therapeutic effect of this Chinese medicine combination.

[0023] Using *Centella asiatica*, stir-fried perilla seeds, and stir-fried bitter almonds as assistant herbs, the three herbs together can assist the principal herb in tonifying the lungs and kidneys, lowering qi, and relieving asthma. *Centella asiatica* is used in 15-45 parts. *Centella asiatica* was first recorded in *Illustrated Materia Medica* and enters the lung, spleen, and kidney meridians. It is good for treating kidney deficiency, lower back pain, seminal emission, and spermatorrhea, and is excellent for regulating qi. Stir-fried perilla seeds and stir-fried bitter almonds are used in 10-30 parts. Both stir-fried perilla seeds and stir-fried bitter almonds can lower qi, resolve phlegm, stop cough, and relieve asthma. They are used for phlegm accumulation and qi stagnation, cough, and asthma. Compared with raw perilla seeds, the pungent and dispersing properties of stir-fried perilla seeds are moderated. Compared with the more toxic raw bitter almonds, the toxicity of stir-fried bitter almonds is weaker. Preferably, 30 parts of *Centella asiatica*, 30 parts of stir-fried perilla seeds, and 30 parts of stir-fried bitter almonds represent the optimal ratio of assistant herbs for the best therapeutic effect of this traditional Chinese medicine composition.

[0024] Because COPD is a chronic and difficult-to-cure disease, airway hyperresponsiveness easily leads to airway spasm, recurrent cough, and a high relapse rate. Therefore, it is necessary to supplement with silkworm pupae, scorpions, scutellaria baicalensis, and roasted chicken gizzard lining, and use roasted licorice root to harmonize the various herbs. Silkworm pupae (10-30 parts) and scorpions (10-25 parts) can dispel wind and resolve phlegm, relieving small airway spasm. Scutellaria baicalensis (10-30 parts) has an ascending and dispersing effect, which is good at clearing lung heat in the upper burner and can moderate the bitter and cold nature of raw herbs, thus clearing and reducing lung heat. It should be noted that... The Scutellaria baicalensis mentioned here refers to Scutellaria baicalensis processed with rice wine and then stir-fried. Combined with 15-45 parts of roasted gizzard lining, it can strengthen the spleen and stomach. Finally, 10-45 parts of roasted licorice root are added to harmonize the other herbs, resulting in this traditional Chinese medicine composition. Together, it achieves the effects of tonifying the lungs and spleen, resolving phlegm and relieving cough, relieving asthma and strengthening the kidneys. Preferably, 30 parts of Bombyx mori, 20 parts of scorpion, 20 parts of Scutellaria baicalensis, 45 parts of roasted gizzard lining, and 15 parts of roasted licorice root represent the optimal ratio of these components for achieving the best therapeutic effect of this traditional Chinese medicine composition.

[0025] Furthermore, the traditional Chinese medicine composition also includes: 15-45 parts of honeysuckle, 15-45 parts of roasted malt, 15-45 parts of roasted medicated leaven, and 15-45 parts of roasted hawthorn. Honeysuckle, with its blood-cooling and stasis-removing properties, can dispel long-term stasis obstructing the lung meridians. Combined with Scutellaria baicalensis, it can work together to detoxify and remove blood stasis. Roasted malt, roasted medicated leaven, and roasted hawthorn are collectively known as the "Three Roasted Delicacies," which, when combined with roasted gizzard lining, can strengthen the spleen and stomach, enhance the spleen-strengthening and stomach-regulating effects, and ensure that the body's vital energy is preserved, preventing the invasion of pathogens. Preferably, 30 parts of roasted medicated leaven, 30 parts of roasted hawthorn, 30 parts of honeysuckle, and 30 parts of roasted malt represent the optimal ratio of these components for achieving the best therapeutic effect in this traditional Chinese medicine composition.

[0026] Based on the above-mentioned traditional Chinese medicine composition, according to some additional symptoms of COPD patients, corresponding components can be selectively added as excipients. Adding 15-45 parts of stir-fried Atractylodes macrocephala and 20-60 parts of stir-fried Dioscorea opposita can target symptoms such as fatigue and poor appetite; preferably, 20 parts of stir-fried Atractylodes macrocephala and 25 parts of stir-fried Dioscorea opposita is the optimal ratio. Adding 15-45 parts of Adenophora stricta and 15-45 parts of Ophiopogon japonicus can target symptoms mainly of dry cough, accompanied by dry mouth and itchy throat; preferably, 15 parts of Adenophora stricta and 20 parts of Ophiopogon japonicus is the optimal ratio. Adding 9 parts of Pinellia ternata... -27 parts, whole Trichosanthes kirilowii 12-36 parts, can be used for symptoms of coughing up yellow phlegm and chest pain. Preferably, the best ratio is 12 parts Pinellia ternata and 18 parts whole Trichosanthes kirilowii. Adding 10-30 parts Lepidium apetalum and 10-30 parts Morus alba root bark can be used for symptoms of shortness of breath and inability to lie down. Preferably, the best ratio is 15 parts Lepidium apetalum and 12 parts Morus alba root bark. Adding 10-30 parts Psoralea corylifolia and 15-45 parts Cuscuta chinensis can be used for symptoms of significant soreness and weakness in the lower back and knees. Preferably, the best ratio is 12 parts Psoralea corylifolia and 15 parts Cuscuta chinensis.

[0027] The various traditional Chinese medicine compositions composed of the aforementioned components can be formulated into dosage forms such as decoctions, powders, pills, granules, sprays, tablets, capsules, or mixtures. The preparation methods for various dosage forms can be found in the prior art and are not the subject of this invention, so they will not be elaborated upon. The most basic powder method will be used for illustration in the subsequent embodiments. This traditional Chinese medicine composition for treating COPD can be used to prepare drugs for treating COPD in the stable phase. Based on the inventor's more than 40 years of clinical experience, this traditional Chinese medicine composition has shown significant efficacy in the treatment of patients with COPD in the stable phase.

[0028] Example 1

[0029] A traditional Chinese medicine composition for treating COPD, comprising the following raw materials in parts by weight: 30 parts raw Astragalus membranaceus, 10 parts American ginseng, 15 parts gecko, 15 parts centella asiatica, 10 parts stir-fried perilla seed, 10 parts stir-fried bitter almond, 10 parts silkworm, 10 parts scorpion, 10 parts Scutellaria baicalensis, 15 parts charred gizzard lining, and 10 parts prepared licorice root. Preferably, for the functions of detoxification, blood stasis removal, spleen and stomach invigoration, and strengthening the body's vital energy, the composition also includes 15 parts honeysuckle, 15 parts stir-fried malt, 15 parts charred medicated leaven, and 15 parts stir-fried hawthorn.

[0030] In actual clinical practice, if COPD patients feel weak and have poor appetite, 15 parts of stir-fried Atractylodes macrocephala and 20 parts of stir-fried Dioscorea opposita can be added to the above-mentioned raw materials to strengthen the spleen and replenish qi.

[0031] In actual clinical practice, if COPD patients present with dry cough as the main symptom, accompanied by dry mouth and itchy throat, then 15 parts of Adenophora stricta and 15 parts of Ophiopogon japonicus are added to the above-mentioned raw materials to nourish yin and promote body fluid production.

[0032] In actual clinical practice, if a patient with COPD coughs up yellow phlegm and experiences chest pain, then 9 parts of Pinellia ternata and 12 parts of Trichosanthes kirilowii are added to the above-mentioned raw materials to dry dampness, resolve phlegm, and relieve chest tightness and regulate qi.

[0033] In actual clinical practice, if a COPD patient is unable to lie down due to wheezing, 10 parts of Lepidium apetalum and 10 parts of Morus alba root bark are added to the above-mentioned raw materials to clear heat, resolve phlegm, purge the lungs, and relieve asthma.

[0034] In actual clinical practice, if COPD patients experience significant lower back and knee weakness, 10 parts of Psoralea corylifolia and 15 parts of Cuscuta chinensis are added to the above-mentioned raw materials to tonify the kidneys and replenish essence.

[0035] It should be noted that the above-mentioned stir-fried Atractylodes macrocephala, stir-fried Dioscorea opposita; Adenophora stricta, Ophiopogon japonicus; Pinellia ternata, Trichosanthes kirilowii; Lepidium apetalum, Morus alba root bark; Psoralea corylifolia, Cuscuta chinensis are used as excipients. These can be added in multiple groups based on the patient's multiple corresponding additional symptoms.

[0036] The raw materials and corresponding excipients of the traditional Chinese medicine composition are weighed in appropriate amounts according to the above ratio, ground into powder and mixed together, then filtered through a 100-mesh sieve to make a powder. The powder is given to patients with COPD to take 10g twice a day, half an hour after meals.

[0037] Example 2

[0038] A traditional Chinese medicine composition for treating COPD, comprising the following raw materials in parts by weight: 60 parts raw Astragalus membranaceus, 30 parts American ginseng, 45 parts gecko, 45 parts centella asiatica, 30 parts stir-fried perilla seed, 30 parts stir-fried bitter apricot kernel, 30 parts silkworm, 25 parts scorpion, 30 parts Scutellaria baicalensis, 45 parts charred gizzard lining, and 45 parts prepared licorice root. Preferably, for the functions of detoxification, blood stasis removal, spleen and stomach invigoration, and strengthening the body's vital energy, the composition also includes 45 parts honeysuckle, 45 parts stir-fried malt, 45 parts charred medicated leaven, and 45 parts stir-fried hawthorn.

[0039] In actual clinical practice, if COPD patients feel weak and have poor appetite, 45 parts of stir-fried Atractylodes macrocephala and 60 parts of stir-fried Dioscorea opposita can be added to the above-mentioned raw materials to strengthen the spleen and replenish qi.

[0040] In actual clinical practice, if COPD patients present with dry cough as the main symptom, accompanied by dry mouth and itchy throat, then 45 parts of Adenophora stricta and 45 parts of Ophiopogon japonicus are added to the above-mentioned raw materials to nourish yin and promote body fluid production.

[0041] In actual clinical practice, if a patient with COPD coughs up yellow phlegm and experiences chest pain, 27 parts of Pinellia ternata and 36 parts of Trichosanthes kirilowii are added to the above-mentioned raw materials to dry dampness, resolve phlegm, and relieve chest tightness and regulate qi.

[0042] In actual clinical practice, if a COPD patient is unable to lie down due to wheezing, 30 parts of Lepidium apetalum and 30 parts of Morus alba root bark are added to the above-mentioned raw materials to clear heat, resolve phlegm, purge the lungs, and relieve asthma.

[0043] In actual clinical practice, if COPD patients experience significant lower back and knee weakness, then in addition to the above-mentioned raw materials, 30 parts of Psoralea corylifolia and 45 parts of Cuscuta chinensis are added to tonify the kidneys and replenish essence.

[0044] It should be noted that the above-mentioned stir-fried Atractylodes macrocephala, stir-fried Dioscorea opposita; Adenophora stricta, Ophiopogon japonicus; Pinellia ternata, Trichosanthes kirilowii; Lepidium apetalum, Morus alba root bark; Psoralea corylifolia, Cuscuta chinensis are used as excipients. These can be added in multiple groups based on the patient's multiple corresponding additional symptoms.

[0045] The raw materials and corresponding excipients of the traditional Chinese medicine composition are weighed in appropriate amounts according to the above ratio, ground into powder and mixed together, then filtered through a 100-mesh sieve to make a powder. The powder is given to patients with COPD to take 10g twice a day, half an hour after meals.

[0046] Example 3

[0047] A traditional Chinese medicine composition for treating COPD, comprising the following raw materials in parts by weight: 60 parts raw Astragalus membranaceus, 30 parts American ginseng, 36 parts gecko, 30 parts centella asiatica, 30 parts stir-fried perilla seed, 30 parts stir-fried bitter almond, 30 parts silkworm, 20 parts scorpion, 20 parts Scutellaria baicalensis, 45 parts charred gizzard lining, and 15 parts prepared licorice root. Preferably, for the functions of detoxification, blood stasis removal, spleen and stomach invigoration, and strengthening the body's vital energy, the composition also includes 30 parts honeysuckle, 30 parts stir-fried malt, 30 parts charred medicated leaven, and 30 parts stir-fried hawthorn.

[0048] In actual clinical practice, if COPD patients feel weak and have poor appetite, 20 parts of stir-fried Atractylodes macrocephala and 25 parts of stir-fried Dioscorea opposita can be added to the above-mentioned raw materials to strengthen the spleen and replenish qi.

[0049] In actual clinical practice, if COPD patients present with dry cough as the main symptom, accompanied by dry mouth and itchy throat, then 15 parts of Adenophora stricta and 20 parts of Ophiopogon japonicus should be added to the above-mentioned raw materials to nourish yin and promote body fluid production.

[0050] In actual clinical practice, if a patient with COPD coughs up yellow phlegm and experiences chest pain, 12 parts of Pinellia ternata and 18 parts of Trichosanthes kirilowii can be added to the above-mentioned raw materials to dry dampness, resolve phlegm, and relieve chest tightness and regulate qi.

[0051] In actual clinical practice, if a COPD patient is unable to lie down due to wheezing, 15 parts of Lepidium apetalum and 12 parts of Morus alba root bark are added to the above-mentioned raw materials to clear heat, resolve phlegm, purge the lungs, and relieve asthma.

[0052] In actual clinical practice, if COPD patients experience significant lower back and knee weakness, 12 parts of Psoralea corylifolia and 15 parts of Cuscuta chinensis are added to the above-mentioned raw materials to tonify the kidneys and replenish essence.

[0053] It should be noted that the above-mentioned stir-fried Atractylodes macrocephala, stir-fried Dioscorea opposita; Adenophora stricta, Ophiopogon japonicus; Pinellia ternata, Trichosanthes kirilowii; Lepidium apetalum, Morus alba root bark; Psoralea corylifolia, Cuscuta chinensis are used as excipients. These can be added in multiple groups based on the patient's multiple corresponding additional symptoms.

[0054] The raw materials and corresponding excipients of the traditional Chinese medicine composition are weighed in appropriate amounts according to the above proportions, ground into powder and mixed together, and then filtered through a 100-mesh sieve to make a powder. The powder is taken twice a day, 10g each time, by patients with COPD half an hour after meals. This embodiment is the best implementation of the present invention.

[0055] Next, a clinical controlled study was conducted to further verify the clinical efficacy of the traditional Chinese medicine composition. Salmeterol / fluticasone inhaler was used as the control group, and the traditional Chinese medicine composition (basic formula) composed of the raw materials in Example 3 was used as the treatment group. It should be noted that the clinical controlled study was approved by the Medical Ethics Committee of Helan County Traditional Chinese Medicine Hospital, Yinchuan City, Ningxia Hui Autonomous Region (No. 2021-1), and all patients participating in the study voluntarily signed informed consent forms.

[0056] I. Sample Description

[0057] The cases were collected from 80 patients with stable COPD (Chronic Obstructive Pulmonary Disease) of the lung-kidney qi deficiency type who visited the Department of Pulmonary Diseases of Helan County Traditional Chinese Medicine Hospital from June 2021 to May 2022. The 80 patients were randomly divided into a control group and an observation group, with 40 patients in each group. Specifically:

[0058] Control group: 28 males and 12 females; age 49-74 years, mean (61.68±7.43) years; disease duration 1.5-16.5 years, median disease duration 5.0 (3.0, 7.0) years.

[0059] Observation group: 26 males and 14 females; age 43-75 years, mean (61.73±8.01) years; disease duration 2-15 years, median disease duration 6.0 (3.6, 8.4) years.

[0060] The comparison of age and duration of illness between the two groups showed no statistically significant difference (P>0.05), indicating comparability.

[0061] II. Diagnostic Criteria

[0062] 1. Western medicine diagnostic criteria: Referring to the diagnostic criteria for COPD (Chronic Obstructive Pulmonary Disease) in remission in the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2013 Revised Edition)", the criteria are: 1) shortness of breath, recurrent cough, and sputum production; 2) forced expiratory volume in the first second (FEV1) / forced vital capacity (FVC) < 70%.

[0063] 2. Traditional Chinese Medicine Diagnosis Criteria: Referring to the diagnosis criteria for lung and kidney qi deficiency in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)," the clinical manifestations are: chest tightness and wheezing, cough, shortness of breath and obvious fatigue, pale tongue with thin white coating, and deep and thready pulse.

[0064] 3. Inclusion criteria: 1) Stable COPD patients who meet the diagnostic criteria; 2) Diagnosed with lung distension (lung and kidney qi deficiency syndrome) according to traditional Chinese medicine; 3) Lung function classification of I-III; 4) Have not participated in other clinical drug studies in the past month; 5) Age between 40 and 75 years; 6) Willing to participate in this study and sign the informed consent form.

[0065] Exclusion criteria: 1) Pregnant and lactating women; 2) Women with various mental disorders; 3) Women with severe cardiovascular or pulmonary diseases, endocrine disorders, or autoimmune diseases; 4) Other diseases that cause changes in ventilation function; 5) Patients with severe liver or kidney diseases (severe liver diseases refer to cirrhosis, portal hypertension, and esophageal variceal bleeding; severe kidney diseases include dialysis and kidney transplantation); 6) Patients with drug allergies.

[0066] III. Treatment Methods

[0067] Control group: In accordance with the "2017 GOLD Global Strategy for the Diagnosis, Treatment and Prevention of Chronic Obstructive Pulmonary Disease", a combination bronchodilator combined with inhaled corticosteroids was selected. The specific medication was salmeterol / fluticasone inhaler (160ug / 4.5ug x 60 inhalations, brand name: Symbicort, manufactured by AstraZeneca, import drug registration certificate number: H20090774), once daily, one inhalation each time, for a course of 8 weeks.

[0068] Treatment group: The Chinese herbal composition based on the basic formula in the best embodiment 3 was used, namely, 60g of raw Astragalus membranaceus, 30g of American ginseng, 36g of gecko, 30g of Centella asiatica, 30g of stir-fried Perilla frutescens seeds, 30g of stir-fried bitter apricot kernels, 30g of Bombyx mori, 20g of scorpion, 20g of Scutellaria baicalensis, 30g of honeysuckle, 30g of stir-fried malt, 30g of charred Shenqu (medicated leaven), 30g of stir-fried hawthorn, 45g of charred gizzard lining, and 15g of prepared licorice root. The powder was filtered through a 100-mesh sieve and administered to the patient twice daily, 10g each time, half an hour after meals. The course of treatment was 12 weeks.

[0069] Both groups received COPD (Chronic Obstructive Pulmonary Disease) health education, smoking cessation, oxygen therapy, and breathing exercises.

[0070] IV. Observation of therapeutic effects

[0071] 1. Observation indicators

[0072] 1) The improvement of serum leukotriene B4 (LTB-4), interleukin-8 (IL-8), and tumor necrosis factor-α (TNF-α) levels before and after treatment was compared between the two groups of patients using ELISA.

[0073] 2) The improvement of lung function indicators FEV1 and FEV1 / FVC before and after drug treatment in the two groups of patients was detected and compared using the MIR Spirolab III pulmonary function instrument (Italy).

[0074] 3) Compare the improvement of dyspnea score (mMRC) and COPD assessment test (CAT) score before and after treatment in the two groups of patients.

[0075] The mMRC score is a modified version of the British Medical Research Council's breathlessness measurement questionnaire. It evaluates the severity of dyspnea and is divided into four levels: 0 to IV. Level 0 indicates that you do not usually experience dyspnea except during strenuous exercise; Level I indicates shortness of breath when walking briskly on flat ground or uphill; Level II indicates shortness of breath when walking slower than your peers on flat ground or when you need to stop and catch your breath while walking at your own pace on flat ground; Level III indicates shortness of breath when walking 100 meters or a few minutes on flat ground; and Level IV indicates shortness of breath that prevents you from leaving the room.

[0076] The CAT score is a comprehensive symptom score, which is divided into 3 levels according to the severity of the symptoms. Each item has a maximum score of 5 points, and the score ranges from 0 to 40 points. The higher the score, the more severe the symptoms affect the patient. Specifically, 0-10 points: mild impact; 11-20 points: moderate impact; 21-30 points: severe impact; 31-40 points: very severe impact.

[0077] 2. Clinical efficacy evaluation criteria

[0078] According to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)," the following criteria were defined: Significantly effective: After treatment, symptoms such as chest tightness, shortness of breath, cough, and sputum were significantly relieved, and the TCM syndrome score decreased by ≥70%; Effective: After treatment, symptoms such as chest tightness, shortness of breath, cough, and sputum improved, and wheezing sounds on lung auscultation improved, with a TCM syndrome score decrease of 30% ≤ <70%; Ineffective: After treatment, symptoms such as chest tightness, shortness of breath, cough, and sputum did not improve, and the TCM syndrome score decreased by <30%.

[0079] Overall effective rate = (number of cases with significant effect + number of cases with effect) / total number of cases × 100%.

[0080] 3. Statistical methods

[0081] The obtained data were analyzed using SPSS 22.0. Normally distributed continuous data were expressed as mean ± standard deviation (x ± s), and non-normally distributed continuous data were expressed as M(Q1, Q3). Independent samples t-tests and Mann-Whitney U tests were used for between-group comparisons, paired samples t-tests for within-group comparisons, chi-square tests for count data, and rank-sum tests for ordinal data. A p-value < 0.05 or p-value < 0.01 indicated a statistically significant difference.

[0082] V. Results

[0083] 1. Serum levels of LTB4, IL-8, and TNF-α

[0084] Before medication, there were no statistically significant differences in serum LTB4, IL-8, and TNF-α levels between the two groups (P > 0.05). However, after drug treatment, the serum levels in both groups decreased significantly (P < 0.01), with a more significant decrease in the observation group (P < 0.01). This indicates that the traditional Chinese medicine composition provided by this invention can effectively control the inflammatory response, as detailed in Table 1.

[0085] Table 1: Comparison of serum TNF-α, IL-8, and LTB4 levels before and after treatment in two groups of COPD patients in stable phase.

[0086]

[0087] Note: Compared with the group before treatment, *P<0.05, **P<0.01; compared with the control group after treatment, #P<0.05, ##P<0.01; compared with the control group before treatment, ▲ P < 0.05 ▲▲ P < 0.01.

[0088] 2. Lung function indicators

[0089] Comparing FEV1 and FEV1 / FVC between the two groups of patients, the results showed no statistically significant differences before treatment (P>0.05). However, after treatment, the pulmonary function indicators of both groups showed significant improvement (P<0.05), and the improvement in the observation group was more significant, with a statistically significant difference (P<0.05). This indicates that the traditional Chinese medicine composition provided by this invention has a better effect on improving pulmonary function than the control group, as detailed in Table 2.

[0090] Table 2: Comparison of pulmonary function indicators before and after treatment in two groups of COPD patients in the stable phase

[0091]

[0092] Note: Compared with the group before treatment, *P<0.05, **P<0.01; compared with the control group after treatment, #P<0.05, ##P<0.01; compared with the control group before treatment, ▲ P < 0.05 ▲▲ P < 0.01.

[0093] 3. CAT and mMRC scores

[0094] Before treatment, there was no statistically significant difference in CAT and mMRC scores between the two groups (P>0.05). However, after administration, the mMRC score of the control group was significantly lower than before administration (P<0.05). After taking the traditional Chinese medicine composition, the CAT and mMRC scores of the observation group were significantly lower than before administration (P<0.01), and the reduction effect in the observation group was better than that in the control group. The differences were statistically significant (P<0.05). This indicates that the traditional Chinese medicine composition provided by this invention can improve the airway response of patients, as detailed in Table 3.

[0095] Table 3: Comparison of CAT and mMRC scores before and after treatment in two groups of COPD patients in stable phase

[0096]

[0097]

[0098] Note: Compared with the group before treatment, *P<0.05, **P<0.01; compared with the control group after treatment, #P<0.05, ##P<0.01; compared with the control group before treatment, ▲ P < 0.05 ▲▲ P < 0.01.

[0099] 4. Clinical efficacy

[0100] After 12 weeks of drug treatment, the effective rates in the observation group and the control group were 92.5% (37 / 40) and 72.5% (29 / 40), respectively. The intergroup comparison (χ²) showed... 2 The difference was statistically significant (P < 0.05), indicating that the efficacy of the traditional Chinese medicine composition provided by this invention is superior to that of salmeterol / fluticasone inhaler, as detailed in Table 4.

[0101] Table 4: Comparison of clinical efficacy between the two groups of COPD patients in the stable phase

[0102]

[0103] Note: Compared with the control group, # P < 0.05 ## P < 0.01.

[0104] In summary, the traditional Chinese medicine composition provided by this invention has significant therapeutic effects on patients with stable COPD of the lung-kidney qi deficiency type. This composition effectively controls inflammatory responses, improves airway reactivity and lung function, and its efficacy surpasses that of salmeterol / fluticasone inhaler. It can replace salmeterol / fluticasone inhaler in clinical treatment of stable COPD patients, leveraging the advantages of traditional Chinese medicine to provide more economical and affordable treatment options for COPD patients. This stabilizes and delays the progression of the disease, reduces the frequency of acute exacerbations, and improves lung function. Furthermore, it can be used to prepare medications for treating stable COPD, providing a new TCM treatment approach for COPD.

[0105] This invention utilizes raw Astragalus membranaceus, with Astragalus membranaceus, American ginseng, and gecko as the principal herbs, and stir-fried Centella asiatica, Perilla frutescens, and stir-fried bitter apricot kernel as the assistant herbs. These herbs assist the principal herbs in tonifying the lungs and kidneys, and relieving asthma. Because COPD is a chronic and difficult-to-cure disease, airway hyperresponsiveness easily leads to airway spasm and recurrent cough. Therefore, Bombyx mori and scorpion are added to dispel wind and resolve phlegm, relieving small airway spasm. Scutellaria baicalensis is added to promote upward dispersion, effectively clearing lung heat in the upper burner and mitigating the bitter and cold nature of raw herbs, thus clearing and reducing lung heat. It is further combined with roasted chicken gizzard to strengthen the spleen and stomach, and roasted licorice root to harmonize the various herbs. This Chinese medicine composition has the effects of tonifying the lungs and spleen, resolving phlegm and relieving cough, relieving asthma and strengthening the kidneys. According to clinical efficacy data, the efficacy of this Chinese medicine composition is superior to that of salmeterol / fluticasone inhaler, effectively controlling the inflammatory response, improving patients' lung function and airway response, and showing significant efficacy in the clinical treatment of lung and kidney qi deficiency in patients with stable COPD.

[0106] Other embodiments of the invention will readily occur to those skilled in the art upon consideration of the specification and practice of the applications disclosed herein. This invention is intended to cover any variations, uses, or adaptations of the invention that follow the general principles of the invention and incorporate common knowledge or customary techniques in the art disclosed herein. The specification and examples are to be considered exemplary only, and the true scope of the invention is indicated by the claims.

[0107] It should be understood that the present invention is not limited to the precise values ​​described above and shown in the embodiments, and various modifications and changes can be made without departing from its scope. The embodiments of the present invention described above do not constitute a limitation on the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating COPD, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: Raw Astragalus 30-60 parts, American Ginseng 10-30 parts, stir-fried Perilla Seed 10-30 parts, stir-fried Bitter Almond 10-30 parts, Centella asiatica 15-45 parts, Bombyx mori 10-30 parts, Scorpion 10-25 parts, Scutellaria baicalensis 10-30 parts, charred Gizzard Lining 15-45 parts, Gecko 15-45 parts, prepared Licorice Root 10-45 parts, Honeysuckle 15-45 parts, stir-fried Malt 15-45 parts, charred Shenqu 15-45 parts, stir-fried Hawthorn 15-45 parts.

2. The traditional Chinese medicine composition for treating COPD according to claim 1, characterized in that, Raw Astragalus 60 parts, American Ginseng 30 parts, Gecko 36 parts, Centella asiatica 30 parts, Fried Perilla Seed 30 parts, Fried Bitter Almond 30 parts, Bombyx Batryticatus 30 parts, Scorpion 20 parts, Scutellaria baicalensis 20 parts, Honeysuckle 30 parts, Fried Shenqu 30 parts, Fried Hawthorn 30 parts, Fried Malt 30 parts, Fried Gizzard Lining 45 parts, Prepared Licorice 15 parts.

3. A traditional Chinese medicine composition for treating COPD according to any one of claims 1-2, characterized in that, The traditional Chinese medicine composition is a decoction, powder, pill, elixir, granule, spray, tablet, capsule, or compound preparation.

4. The use of the traditional Chinese medicine composition for treating COPD according to any one of claims 1-2 in the preparation of a drug for treating COPD in the stable phase.