Traditional Chinese medicine composition for treating stable chronic obstructive pulmonary disease, medicine, preparation method and application thereof

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition, drug, preparation method, and application for treating the stable phase of chronic obstructive pulmonary disease. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-60 parts of peony bark, 15-120 parts of prepared rehmannia root, 10-60 parts of cornus officinalis, 10-60 parts of alisma plantago-aquatica, 15-80 parts of yam, 10-60 parts of epimedium, 10-60 parts of salt-processed morinda root, 6-20 parts of donkey-hide gelatin, 15-80 parts of poria cocos, 10-60 parts of atractylodes macrocephala, 10-40 parts of tangerine peel, 6-40 parts of prepared licorice root, 10-60 parts of prepared pinellia tuber, 15-120 parts of fibrous root, 15-120 parts of codonopsis pilosula, 10-40 parts of saposhnikovia divaricata, 10-120 parts of chicken blood vine, 10-40 parts of notoginseng, 10-40 parts of amomum villosum, and 6-60 parts of jujube. The traditional Chinese medicine composition provided by this invention is significantly superior to conventional Western medicine in improving patients' quality of life, increasing exercise tolerance, improving TCM syndrome scores, and reducing the frequency of acute exacerbations, providing a new approach for the treatment of stable chronic obstructive pulmonary disease.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to traditional Chinese medicine compositions, drugs, their preparation methods, and applications for treating the stable phase of chronic obstructive pulmonary disease. Background Technology

[0002] COPD is a complex, heterogeneous disease with pulmonary and extrapulmonary manifestations. Clinically, it is characterized by persistent airflow limitation and corresponding respiratory symptoms, with smoking being the most common risk factor. Pathologically, COPD is primarily caused by airway inflammation, emphysema, and alveolar destruction, accompanied by irreversible airflow obstruction and a progressive decline in lung function. Etiologically, COPD can be broadly classified into genetically determined COPD, COPD caused by lung developmental abnormalities, environmentally induced COPD, infection-induced COPD, COPD combined with asthma, and COPD of unknown cause, with each etiology exhibiting specificity. Early-stage COPD is often missed due to mild or absent symptoms. As the disease progresses and complications arise, the mortality and disability rates increase. According to the latest statistics from the World Health Organization, COPD has become the third leading cause of death worldwide. The pathophysiological mechanisms of chronic obstructive pulmonary disease (COPD) are complex and remain inconclusive, but are primarily believed to be related to airway inflammation, oxidative stress, protease-antiprotease system imbalance, genetic susceptibility, and immune imbalance. Regarding drug treatment, while traditional medications such as inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) have shown some effectiveness in relieving symptoms and improving quality of life, long-term use can lead to side effects such as osteoporosis, diabetes, and increased risk of infection. Particularly in some patients, ICS may induce corticosteroid resistance, significantly reducing the drug's efficacy. Current drug treatments focus more on symptom management than on fundamental disease reversal, meaning many patients still face frequent acute exacerbations and irreversible decline in lung function.

[0003] Overall, treatment options for chronic obstructive pulmonary disease (COPD) are limited, lacking effective medications, with limited efficacy and poor results from monotherapy. Traditional medications such as inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) have shown some success in relieving symptoms and improving quality of life, but long-term use may lead to side effects such as osteoporosis, diabetes, and increased risk of infection. Novel anti-inflammatory drugs, such as phosphodiesterase-4 inhibitors (PDE4 inhibitors) and phosphodiesterase-3 / 4 inhibitors (PDE3 / 4 dual inhibitors), are used clinically but have not yet demonstrated reliable clinical efficacy. While targeted therapies have shown good efficacy in patients with specific phenotypes, their effectiveness is still limited by factors such as the scope of indications and treatment costs. Summary of the Invention

[0004] Based on this, the purpose of the present invention is to provide a traditional Chinese medicine composition, drug, preparation method and application for treating the stable phase of chronic obstructive pulmonary disease, thereby solving the problems in the prior art.

[0005] To achieve the above objectives, the present invention adopts the following technical solution.

[0006] This invention provides a traditional Chinese medicine composition for treating the stable phase of chronic obstructive pulmonary disease, the composition comprising the following raw materials in parts by weight: 10-60 parts of Moutan bark, 15-120 parts of Rehmannia glutinosa (processed), 10-60 parts of Cornus officinalis (processed with wine), 10-60 parts of Alisma plantago-aquatica, 15-80 parts of Dioscorea opposita, 10-60 parts of Epimedium brevicornu, 10-60 parts of Morinda officinalis (processed with salt), 6-20 parts of donkey-hide gelatin, 15-80 parts of Poria cocos, 10-60 parts of Atractylodes macrocephala, 10-40 parts of Citrus reticulata peel, 6-40 parts of Glycyrrhiza uralensis (processed with honey), 10-60 parts of Pinellia ternata (processed with honey), 15-120 parts of Ficus hirta, 15-120 parts of Codonopsis pilosula (processed with honey), 10-40 parts of Saposhnikovia divaricata, 10-120 parts of Spatholobus suberectus, 10-40 parts of Panax notoginseng, 10-40 parts of Amomum villosum, and 6-60 parts of Ziziphus jujuba.

[0007] In some embodiments of the present invention, the traditional Chinese medicine composition comprises the following parts by weight of raw materials: 10-30 parts of Moutan bark, 15-60 parts of Rehmannia glutinosa (processed), 10-30 parts of Cornus officinalis (processed with wine), 10-20 parts of Alisma plantago-aquatica, 15-40 parts of Dioscorea opposita, 10-30 parts of Epimedium brevicornu, 10-30 parts of Morinda officinalis (processed with salt), 6-15 parts of donkey-hide gelatin, 15-30 parts of Poria cocos, 10-30 parts of Atractylodes macrocephala, 10-20 parts of Citrus reticulata peel, 6-20 parts of Glycyrrhiza uralensis (processed with honey), 10-30 parts of Pinellia ternata (processed with honey), 15-60 parts of Ficus hirta, 15-60 parts of Codonopsis pilosula (processed with honey), 10-20 parts of Saposhnikovia divaricata, 10-60 parts of Spatholobus suberectus, 10-20 parts of Panax notoginseng, 10-20 parts of Amomum villosum, and 6-30 parts of Ziziphus jujuba.

[0008] In some embodiments of the present invention, the raw materials include the following parts by weight: 10 parts of peony bark, 15 parts of prepared rehmannia root, 10 parts of wine-processed cornus fruit, 10 parts of alisma rhizome, 15 parts of yam, 10 parts of epimedium, 10 parts of salt-processed morinda root, 6 parts of donkey-hide gelatin, 15 parts of poria cocos, 10 parts of atractylodes macrocephala, 10 parts of tangerine peel, 6 parts of prepared licorice root, 10 parts of prepared pinellia tuber, 15 parts of five-finger peach, 15 parts of codonopsis root slices, 10 parts of saposhnikovia root, 10 parts of chicken blood vine, 10 parts of notoginseng, 10 parts of amomum villosum, and 6 parts of jujube.

[0009] In some embodiments of the present invention, the traditional Chinese medicine composition further includes 10-20 parts of maltose, used to improve the taste of the traditional Chinese medicine composition.

[0010] In some embodiments of the present invention, the traditional Chinese medicine composition further includes 10-20 parts of xylitol. This can be used to improve the taste of the traditional Chinese medicine composition if the patient has high blood sugar.

[0011] The present invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising: weighing the raw materials peony bark, prepared rehmannia root, wine-processed cornus fruit, alisma rhizome, yam, epimedium, salt-processed morinda root, donkey-hide gelatin, poria cocos, atractylodes macrocephala, tangerine peel, prepared licorice root, prepared pinellia tuber, five-finger peach, codonopsis root slices, saposhnikovia root, chicken blood vine, notoginseng, amomum villosum, and jujube according to the specified ratio, and extracting them with water to obtain the composition.

[0012] In some embodiments of the present invention, the water is 8 to 10 times the weight of the raw material.

[0013] The present invention also provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating the stable phase of chronic obstructive pulmonary disease.

[0014] This invention also discloses a medicament for treating the stable phase of chronic obstructive pulmonary disease, with the aforementioned traditional Chinese medicine composition as the active ingredient.

[0015] In some embodiments of the present invention, the drug further includes pharmaceutically acceptable excipients.

[0016] In some embodiments of the present invention, the dosage form of the drug is a decoction, pill, lozenge, tablet, granule, powder, ointment or capsule.

[0017] In some embodiments of the present invention, the preparation method of the ointment includes: weighing the raw materials peony bark, prepared rehmannia root, wine-processed cornus fruit, alisma rhizome, yam, epimedium, salt-processed morinda root, donkey-hide gelatin, poria cocos, atractylodes macrocephala, tangerine peel, prepared licorice root, prepared pinellia tuber, five-finger peach, codonopsis root slices, saposhnikovia root, chicken blood vine, notoginseng, amomum villosum, and jujube according to the specified ratio, extracting with water, collecting the extract, concentrating the extract to a relative density of 1.4-1.5, and preparing it into an ointment.

[0018] The traditional Chinese medicine composition provided by this invention follows the following compatibility logic: The traditional Chinese medicine composition (Spleen-Strengthening and Kidney-Nourishing Formula) provided by this invention is a self-formulated formula created based on the core pathogenesis of chronic obstructive pulmonary disease (COPD), which is "deficiency of the lung, spleen, and kidney as the root cause, and phlegm and blood stasis as the symptoms." It combines classical Chinese medicine theory with the essence of famous formulas. Its core efficacy is "warming and tonifying the spleen and kidney, strengthening the defensive qi and consolidating the exterior, while simultaneously regulating qi, promoting blood circulation, and resolving phlegm," achieving the treatment principle of "treating the root cause and addressing both the symptoms and the underlying condition." The formulation of this medicine is rooted in traditional Chinese medicine theory and draws on the essence of classic formulas. Its theoretical basis and the logic of the principal, assistant, and adjuvant herbs in the formulation are as follows: The formulation of this medicine closely follows the core theories of traditional Chinese medicine, while also incorporating the essence of classic formulas such as Liu Jun Zi Tang, Jin Gui Shen Qi Wan, and Yu Ping Feng San, precisely addressing the pathogenesis of COPD. 1. Nourishing Earth to Generate Metal, Simultaneously Nourishing the Lung and Spleen: This formula embodies the principles of Liu Jun Zi Tang (Six Gentlemen Decoction), following the theory of "nourishing earth to generate metal" (nourishing the mother to generate the child). Traditional Chinese medicine believes that many lung-tonifying herbs in clinical practice also have spleen-tonifying effects. By tonifying the spleen and stomach qi (nourishing earth), lung qi can be nourished (generating metal), addressing the root cause of lung qi deficiency in COPD patients, while simultaneously protecting the spleen and stomach's digestive function and preventing the internal generation of phlegm and dampness.

[0019] 2. Warming the Kidneys and Strengthening the Origin, Nourishing Both the Lungs and Kidneys: Ancient wisdom states, "Excessive wheezing originates in the lungs, while deficient wheezing originates in the kidneys." The lungs belong to the metal element and reside above, while the kidneys belong to the water element and reside below. COPD with deficient wheezing due to lung deficiency falls under the category of "disharmony between heaven and water." This formula draws upon the principle of Jin Kui Shen Qi Wan (Kidney Qi Pill from the Golden Cabinet) to warm and tonify kidney yang and generate kidney qi. It removes the drying and hot herbs Aconite and Cinnamon from the formula, replacing them with Epimedium and Morinda officinalis to warm and tonify the lower abdomen. This aligns with the theory in the *Huangdi Neijing* (Yellow Emperor's Inner Classic) that "yang transforms into qi, and yin forms shape," thus consolidating kidney essence, allowing qi to sink and descend, preventing cold water from attacking the heart and lungs and inducing cough and wheezing, achieving simultaneous nourishment of both the lungs and kidneys.

[0020] 3. Tonify Qi and strengthen the exterior, resist pathogens and prevent disease: Fangfeng is an essential herb for dispelling wind. According to "Ben Cao Qiu Zhen", it can "treat thirty-six kinds of wind". When used with Codonopsis, Ficus hirta, and Atractylodes macrocephala, it contains the meaning of Yu Ping Feng San, which can tonify lung Qi and replenish defensive Qi, significantly enhance the patient's disease resistance, and prevent external pathogens from invading and inducing cough and asthma from the source. This is in line with the pathogenesis of COPD, which is "susceptible to external pathogens and aggravated by the disease".

[0021] 4. Removing blood stasis and resolving phlegm, while addressing both the symptoms and the root cause: Chronic obstructive pulmonary disease (COPD) patients often develop blood stasis due to prolonged illness, leading to chronic deficiency of lung qi and impaired blood circulation. The kidneys govern bones and produce marrow, which in turn generates blood; kidney deficiency further exacerbates blood stasis. Simultaneously, phlegm is a chronic cause of COPD exacerbations; its viscous nature easily binds with blood stasis, creating a vicious cycle. Therefore, blood stasis is a significant pathological product. Based on this, Panax notoginseng, Spatholobus suberectus, and donkey-hide gelatin are added to the formula to remove blood stasis and promote new blood production, precisely resolving the syndrome of phlegm and blood stasis intertwining.

[0022] Based on the above theoretical foundation, this formula follows the principles of classical Chinese medicine prescription, clearly defining the roles of the principal, assistant, adjuvant, and guide herbs, forming a compatibility structure that "nourishes all three organs simultaneously and addresses both the root cause and the symptoms": The formula uses Rehmannia glutinosa (processed) and Codonopsis pilosula as the principal herbs to replenish kidney essence and invigorate the middle energizer. The assistant herbs are Dioscorea opposita, Cornus officinalis (processed with wine), Poria cocos, Atractylodes macrocephala, Ficus hirta, and Saposhnikovia divaricata to assist the principal herbs in strengthening the spleen and kidneys, tonifying the liver and kidneys, and consolidating the defensive qi. The adjuvant herbs are Epimedium brevicornu, Morinda officinalis (processed with salt), Alisma plantago-aquatica, Paeonia suffruticosa, Pinellia ternata (processed), Citrus reticulata, Amomum villosum, Panax notoginseng, and Spatholobus suberectus to assist in warming and tonifying kidney yang, clearing turbidity, regulating qi, and promoting blood circulation. Glycyrrhiza uralensis (processed with honey), jujube, and donkey-hide gelatin not only invigorate the middle energizer and boost qi, playing an auxiliary therapeutic role, but also harmonize the effects of the other herbs. Together, they warm and tonify the spleen and kidneys, consolidate the defensive qi, and simultaneously regulate qi, invigorate blood, and resolve phlegm.

[0023] In traditional Chinese medicine prescriptions, the core functions of the guiding herb are "guiding the medicine to the affected area" and "harmonizing the other herbs" (balancing the properties of the herbs in the prescription). This prescription achieves the core functions of the guiding herb through the efficacy of the herbs themselves and their compatibility, eliminating the need for an additional independent guiding herb.

[0024] The formula contains spleen-tonifying and lung-benefiting herbs such as Codonopsis pilosula, Ficus hirta, and Atractylodes macrocephala. Their target points are the spleen and lung meridians, which can naturally guide the medicinal power of the entire formula to converge on the diseased areas of the lungs, spleen, and kidneys, thus achieving the function of "guiding the meridians and directing the flow of qi".

[0025] The herbs in this formula are balanced in terms of their warming and cooling properties, without any obvious bias towards hot or cold. The warming and tonifying properties of Epimedium and Morinda officinalis are balanced by the sweet and neutral properties of Atractylodes macrocephala and Ficus hirta, preventing them from causing dryness and damaging body fluids. The blood-activating properties of Panax notoginseng are restrained by the qi-tonifying properties of Codonopsis pilosula and Atractylodes macrocephala, preventing them from depleting qi. The combination of herbs is naturally harmonious, requiring no additional harmonizing herbs.

[0026] This formula is meticulously crafted and meticulously formulated: it is guided by classical TCM theories (such as tonifying the earth element to generate metal element and transforming yang into qi and yin to form shape), drawing on the essence of classic formulas, and closely adhering to the core pathogenesis of COPD: "deficiency of the lung, spleen, and kidney as the root cause, and phlegm, fluid retention, and blood stasis as the manifestation." The principal herb directly targets the core deficiency, the assistant herbs assist in enhancing the tonifying and pathogenic effects, and the adjuvant herbs resolve concurrent symptoms of phlegm and blood stasis. All the herbs in the formula also serve as guiding herbs. The entire formula revolves around the core objective of "warming and tonifying the lung, spleen, and kidney while resolving phlegm, fluid retention, and blood stasis," achieving the treatment approach of "treating the root cause and addressing both the root and the symptoms." It is precisely adapted to the pathogenesis of COPD and fully embodies the core ideas of TCM's syndrome differentiation and treatment and holistic concept.

[0027] In some embodiments of the present invention, the water extraction is performed 1 to 3 times.

[0028] Preferably, the water extraction is performed twice.

[0029] Based on the technical solution of the present invention, the present invention has the following beneficial effects compared with the prior art: (1) The traditional Chinese medicine composition provided in this invention is a natural Chinese medicine treatment with multiple therapeutic effects and significant efficacy. It is significantly superior to conventional Western medicine umebotomycin bromide and vilanterol inhalation powder in terms of improving patients' quality of life, increasing exercise tolerance, improving CAT score, mMRC score, and reducing the number of acute exacerbations (P<0.05). The total effective rate in treating patients with stable COPD (lung and kidney deficiency syndrome) is as high as 90.91%, and the clinical efficacy is definite.

[0030] (2) The herbal paste provided in this invention is a pure Chinese medicine compound preparation developed based on the classic formula "Liu Jun Zi Tang" and "Jin Gui Shen Qi Wan". It is applied under the guidance of the holistic view and syndrome differentiation and treatment theory of traditional Chinese medicine, thus having the characteristics of multi-component, multi-link, and multi-target comprehensive regulation of human functions. Since it mainly works by improving the body's immunity, anti-allergy, and relieving tracheal spasm, its side effects are relatively small compared to chemical and biochemical drugs. It has the advantages of being natural, low-toxicity, and without side effects.

[0031] (3) The traditional Chinese medicine composition provided in this invention has high patient acceptance and can relieve cough, wheezing and shortness of breath, as well as symptoms such as ① lower back pain and weakness; ② poor appetite; ③ spontaneous sweating, aversion to wind, and susceptibility to colds.

[0032] (4) It is inexpensive, has few contraindications, and is easy to promote. Attached Figure Description

[0033] Figure 1 This is a flowchart illustrating the preparation process of the traditional Chinese medicine composition of this invention into an ointment. Detailed Implementation

[0034] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the embodiments thereof. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of the present invention.

[0035] The following description is based on specific embodiments.

[0036] Example 1: A traditional Chinese medicine composition for treating the stable phase of chronic obstructive pulmonary disease and its preparation method A traditional Chinese medicine composition for treating the stable phase of chronic obstructive pulmonary disease includes the following raw materials in parts by weight: 10g of peony bark, 15g of prepared rehmannia root, 10g of wine-processed cornus fruit, 10g of alisma rhizome, 15g of yam, 10g of epimedium, 10g of salt-processed morinda root, 6g of donkey-hide gelatin, 15g of poria cocos, 10g of atractylodes macrocephala, 10g of tangerine peel, 6g of prepared licorice root, 10g of prepared pinellia tuber, 15g of five-finger peach, 15g of codonopsis root slices, 10g of saposhnikovia root, 10g of chicken blood vine, 10g of notoginseng, 10g of amomum villosum, and 6g of jujube.

[0037] A method for preparing a traditional Chinese medicine composition for treating the stable phase of chronic obstructive pulmonary disease includes the following steps: Weigh the above-mentioned raw materials according to weight, and pulverize them into coarse powder. Extract each coarse powder twice with water under reflux. Combine the two filtrates to complete the preparation of the traditional Chinese medicine composition. In the two reflux extractions, the first extraction uses 10 times the amount of water and is carried out for 1 hour at 100℃; the second extraction uses 8 times the amount of water and is carried out for 0.5 hours at 100℃.

[0038] Example 2: A traditional Chinese medicine composition for treating the stable phase of chronic obstructive pulmonary disease and its preparation method. A traditional Chinese medicine composition for treating the stable phase of chronic obstructive pulmonary disease includes the following raw materials in parts by weight: 60g of peony bark, 120g of prepared rehmannia root, 60g of cornus fruit, 60g of alisma rhizome, 80g of yam, 60g of epimedium root, 60g of salt-processed morinda root, 20g of donkey-hide gelatin, 80g of poria cocos, 60g of atractylodes macrocephala rhizome, 40g of tangerine peel, 40g of prepared licorice root, 60g of prepared pinellia tuber, 120g of five-finger peach root, 120g of codonopsis root slices, 40g of saposhnikovia root, 120g of chicken blood vine, 40g of notoginseng, 40g of amomum fruit, and 60g of jujube.

[0039] A method for preparing a traditional Chinese medicine composition for treating the stable phase of chronic obstructive pulmonary disease includes the following steps: Weigh the above-mentioned raw materials according to weight, and pulverize them into coarse powder. Extract each coarse powder with water three times under reflux. Combine the filtrates from the three extractions to complete the preparation of the traditional Chinese medicine composition. In the two reflux extractions, the first extraction uses 10 times the amount of water and is carried out for 1 hour at 100℃; the second extraction uses 8 times the amount of water and is carried out for 0.5 hours at 100℃; the third extraction uses 8 times the amount of water and is carried out for 0.5 hours at 100℃.

[0040] Example 3: A traditional Chinese medicine composition for treating the stable phase of chronic obstructive pulmonary disease and its preparation method. A traditional Chinese medicine composition for treating the stable phase of chronic obstructive pulmonary disease includes the following raw materials in parts by weight: 30g of peony bark, 60g of prepared rehmannia root, 30g of wine-processed cornus fruit, 20g of alisma rhizome, 40g of yam, 30g of epimedium root, 30g of salt-processed morinda root, 15g of donkey-hide gelatin, 30g of poria cocos, 30g of atractylodes macrocephala rhizome, 20g of tangerine peel, 20g of prepared licorice root, 30g of prepared pinellia tuber, 60g of five-finger peach root, 60g of codonopsis root slices, 20g of saposhnikovia root, 60g of chicken blood vine, 20g of notoginseng, 20g of amomum fruit, and 30g of jujube.

[0041] A method for preparing a traditional Chinese medicine composition for treating the stable phase of chronic obstructive pulmonary disease includes the following steps: Weigh the above-mentioned raw materials according to weight, and pulverize them into coarse powder. Add water to each coarse powder for reflux extraction, collect the filtrate, and complete the preparation of the traditional Chinese medicine composition. During the reflux extraction process, add 10 times the amount of water, extract for 1 hour, and the extraction temperature is 100℃.

[0042] Example 4: A traditional Chinese medicine paste for treating the stable phase of chronic obstructive pulmonary disease and its preparation method. A traditional Chinese medicine paste for treating the stable phase of chronic obstructive pulmonary disease contains the following raw materials in parts by weight: 10g of peony bark, 15g of prepared rehmannia root, 10g of wine-processed cornus fruit, 10g of alisma rhizome, 15g of yam, 10g of epimedium, 10g of salt-processed morinda root, 6g of donkey-hide gelatin, 15g of poria cocos, 10g of atractylodes macrocephala, 10g of tangerine peel, 6g of prepared licorice root, 10g of prepared pinellia tuber, 15g of five-finger peach, 15g of codonopsis root slices, 10g of saposhnikovia root, 10g of chicken blood vine, 10g of notoginseng, 10g of amomum villosum, and 6g of jujube.

[0043] A method for preparing a traditional Chinese medicine paste for treating the stable phase of chronic obstructive pulmonary disease, comprising: 1. Extraction: The above 22 herbs are pulverized into coarse powder, and then subjected to the first extraction. During the first extraction, water with a weight of 10 times that of the herbs is added, and extraction is carried out for 1 hour, yielding filtrate 1 and residue 1. This step uses water as a solvent to dissolve the active ingredients in the herbs.

[0044] 2. Secondary and tertiary extraction: Secondary extraction: Collect the residue after the first extraction, add 10 times the amount of water each time, and extract for 1 hour to obtain filtrate 2 and residue 2 filtrate 3 respectively.

[0045] Three extractions: Collect the residue 2 after the second extraction, add 10 times the amount of water each time, and extract for 1 hour to obtain filtrate 3 and residue 3 respectively.

[0046] Multiple extractions are performed to extract the active ingredients from the medicinal materials as fully as possible and to reduce the residue of active ingredients in the dregs.

[0047] 3. Concentration and drying stage: Low-temperature concentration under negative pressure: Filtrates 1, 2, and 3 are combined and concentrated under reduced pressure at 60°C to obtain an extract with a relative density of 1.4–1.5 (1.38 in this embodiment). The reduced-pressure concentration is performed at a lower pressure (-0.06 to -0.08 MPa; in this embodiment, the specific pressure is -0.07 MPa), which lowers the boiling point of the solvent, prevents the active ingredients from being destroyed at high temperatures, and accelerates the concentration process.

[0048] 4. Extraction: The extract is then dried under reduced pressure to obtain a dry extract. Reduced pressure drying also utilizes a low-pressure environment to evaporate moisture from the material at a lower temperature, ensuring the quality of the medicine.

[0049] 5. Packaging and drying of the paste Packaging: The prepared herbal paste is packaged to obtain the final product.

[0050] 6. Filling and Packaging Packaged in 200g containers using glass, plastic, or ceramic materials.

[0051] The clinical efficacy evidence and implementation plan are as follows: 1. Western Medicine Diagnostic Criteria Based on the GOLD Global Initiative for Chronic Obstructive Lung Disease and the Chinese Guidelines for the Diagnosis and Management of Chronic Obstructive Lung Disease at the Primary Care Level (2024), the Western medicine diagnostic criteria for this study are as follows: (1) Patients with dyspnea, chronic cough or sputum secretion, a history of recurrent respiratory infections or exposure to risk factors for the disease. (2) A vital capacity of FEV1 / FVC < 0.7 after inhalation of bronchodilators is a prerequisite for the diagnosis of this disease.

[0052] (3) Exclude other diseases that may cause airflow limitation. 2. Diagnostic criteria for stable COPD The stable phase refers to a period in which a patient's main respiratory symptoms, including cough, sputum production, and dyspnea, remain at baseline levels or experience only slight fluctuations, indicating a relatively stable condition. During this period, symptom severity is usually within the patient's manageable range and does not require significant adjustments to the medication regimen.

[0053] Referring to the "Diagnostic Criteria for Chronic Obstructive Pulmonary Disease in Traditional Chinese Medicine (2011 Edition)," the TCM diagnosis is pulmonary distension. Based on clinical practice and the mentor's clinical experience, the characteristics of the syndrome of lung and kidney deficiency are summarized as follows: Main symptoms: cough, wheezing, and phlegm.

[0054] Secondary symptoms: fatigue, lower back pain, poor appetite, spontaneous sweating.

[0055] Tongue and pulse: The tongue is pale and the pulse is deep and weak.

[0056] Diagnostic criteria for lung and kidney deficiency syndrome in stable COPD: The diagnosis can be made if two of the main symptoms and two of the secondary symptoms are present.

[0057] 3. Inclusion criteria (1) Meets the above-mentioned Western medicine diagnostic criteria for stable COPD, and the condition has been stable for more than 1 month, with COPD airflow limitation being moderate or severe.

[0058] (2) Meets the diagnostic criteria of TCM syndrome.

[0059] (3) No gender restrictions, age 40 to 80 years old.

[0060] (4) Agree to conduct this study and sign an informed consent form.

[0061] (5) Inclusion criteria should be met. If an individual is participating in other clinical trials, they should stop the trial and wash out the drug 2 weeks after the trial before being enrolled.

[0062] 4. Exclusion criteria (1) Patients who do not meet the above inclusion criteria.

[0063] (2) Patients who are known to be allergic to the ingredients of the drug used in this study.

[0064] (3) Patients with serious liver, heart, kidney, digestive, or hematopoietic system diseases.

[0065] (4) Special populations such as pregnant women, breastfeeding women, patients with mental illness, and patients with poor compliance who cannot cooperate with treatment and observation.

[0066] (5) Other conditions that absolutely or relatively prohibit the 6-minute walk test, such as a resting heart rate >120 beats / min, systolic blood pressure >180 mmHg and diastolic blood pressure >100 mmHg, or patients with limited lower limb movement who cannot complete the 6-minute walk test.

[0067] (6) Those who are currently participating in other clinical trials.

[0068] (7) Patients whose symptoms are caused by lung cancer, severe bronchiectasis, active pulmonary tuberculosis, primary interstitial lung disease, pulmonary fibrosis, pulmonary cysts, etc.

[0069] 5. Elimination criteria During the clinical trial execution phase, researchers have a responsibility and obligation to terminate a subject's participation in the study under the following specific circumstances, i.e., withdrawal. Additionally, participants may voluntarily decide to withdraw from the study, a situation defined as dropout.

[0070] (1) Those who fail to take medication as required.

[0071] (2) Other drugs that may interfere with the results were used during the treatment process, and the efficacy could not be determined.

[0072] (3) Those who terminate the trial on their own for various reasons.

[0073] (4) Those who are lost to follow-up for various reasons.

[0074] (5) Poor compliance during the trial, with drug use not reaching 80% of the prescribed amount (the reasons for exclusion cases in this trial should be explained, and the original data should be kept for future reference), or exceeding the prescribed amount by 120%.

[0075] 6. Treatment Plan Seventy patients with stable COPD and lung-kidney deficiency syndrome (31 males and 29 females, from the respiratory outpatient department of the First Affiliated Hospital of Guangzhou University of Chinese Medicine; there were no significant differences in gender, age, disease duration, or severity of illness among the patients, making them comparable) who met the inclusion and exclusion criteria were randomly divided into two groups (control group and experimental group), with 40 patients in each group. The control group received routine Western medicine treatment: umeclidinium bromide and vilanterol inhalation powder; the experimental group received the same treatment as the control group, plus a spleen-strengthening and kidney-tonifying herbal paste, for 3 months. The observation points for each indicator were day 1 after enrollment, month 3 after medication, and the number of acute exacerbations within 6 months after medication. After the experiment, the TCM syndrome scores, CAT scores, mMRC scores, 6-minute walk test, and number of acute exacerbations were statistically analyzed in both groups.

[0076] 1) Control group The control group received routine Western medicine treatment according to the Global Initiative on Chronic Obstructive Pulmonary Disease (2021): umeclidinium bromide and vilanterol inhalation powder (trade name: Oulexin, drug specification: 62.5ug / 25ug, National Drug Approval Number H20180005, Import Drug Registration Certificate Number JX20160112), inhaled once daily, one inhalation per dose, for a course of 12 weeks. For patients with sputum, ambroxol hydrochloride dispersible (executive standard WS1XG-051-2011, manufactured by Qianyuan Pharmaceutical Co., Ltd., National Drug Approval Number H20060254) could be added, 2 tablets three times daily, taken orally after meals. For patients with shortness of breath, compound methoxyphenamine capsules (executive standard YBH282022, manufactured by First Third Pharmaceutical (Shanghai) Co., Ltd., National Drug Approval Number H20033669) could be added, 2 tablets three times daily, taken orally after meals.

[0077] 2) Experimental group In addition to conventional Western medicine treatment, the herbal paste prepared in Example 4 (hereinafter referred to as the Spleen-Strengthening and Kidney-Nourishing Herbal Paste) was administered. The Spleen-Strengthening and Kidney-Nourishing Herbal Paste (is an in-house herbal paste from the First Affiliated Hospital of Guangzhou University of Chinese Medicine. Its ingredients are: Moutan bark, Rehmannia root, Cornus fruit, Alisma rhizome, Dioscorea rhizome, Epimedium root, Morinda root (salted), Donkey-hide gelatin, Poria cocos, Atractylodes rhizome, Tangerine peel, Prepared licorice root, Prepared Pinellia rhizome, Ficus hirta, Codonopsis root slices, Saposhnikovia root, Spatholobus stem, Panax notoginseng, Amomum villosum, and Jujube). Directions for use: Take one spoonful of the ointment from the jar, dissolve it in warm water, and then take it once a day for 12 weeks.

[0078] 3) Statistical Analysis: After 12 weeks of treatment, the efficacy evaluation indicators for both groups included TCM symptom scores, CAT scores, six-minute walk test, mMRC scores, and the number of acute exacerbations. These indicators were then statistically analyzed. Data were processed using Excel and analyzed using SPSS 25.0. For unordered categorical variables in count data, the χ² test was used for inter-group comparisons. Quantitative data were expressed as mean ± standard deviation (x ± s). The Kolmogorov-Smirnov method was used for normality testing, and the Levene method was used for homogeneity of variance testing. Independent samples t-tests were used for normally distributed and homogeneous quantitative data. For intra-group comparisons before and after treatment, paired samples t-tests were used for differences conforming to a normal distribution; otherwise, the rank-sum test was used. The statistical significance level was set at α = 0.05. A p-value > 0.05 was considered statistically insignificant, and a p-value < 0.05 was considered statistically significant.

[0079] 4) During the treatment period, observe the adverse reactions and side effects of the two groups of patients.

[0080] 7. Experimental Results 1) As shown in Tables 1-8, the efficacy of TCM symptom scores was compared: the total effective rate in the experimental group was 90.91%, which was higher than that in the control group (75.76%), and the difference between the two groups was statistically significant (P<0.05). Comparison of total TCM symptom scores: intra-group comparison revealed that the total symptom scores of both groups showed a significant decreasing trend after treatment (P<0.05). Further inter-group comparison showed that the experimental group had a more significant improvement in total symptom scores compared to the control group, with a statistically significant difference (P<0.05). In addition, the experimental group showed more significant improvement than the control group in CAT scale scores, 6-minute walk test scores, mMRC scale scores, and the number of acute exacerbations (P<0.05).

[0081] Table 1 Comparison of CAT scores before and after treatment in the two groups of patients ( ±s) Note: P A value < 0.05 indicates a statistically significant difference. z △ , P △ For comparison within the group before and after treatment, t , P This is for comparison between groups before and after treatment; "-" in the table indicates that the item is not present.

[0082] Table 2 Comparison of mMRC scores before and after treatment in the two groups ( ±s) Note: P A value < 0.05 indicates a statistically significant difference. △ , P △ For comparison within the group before and after treatment, z , P This is for comparison between groups before and after treatment; "-" in the table indicates that the item is not present.

[0083] Table 3 Comparison of 6-minute walking distances before and after treatment in the two groups ( ±s) Note: P A value < 0.05 indicates a statistically significant difference. t △ , P △ For comparison within the group before and after treatment, t , P This is for comparison between groups before and after treatment; "-" in the table indicates that the item is not present.

[0084] Table 4 Comparison of individual main symptoms of TCM syndromes before and after treatment in the two groups of patients ( P50 ( P25 , P75 )) Note: P <0.05 is statistically significant, z △ , P △ For comparison within the group before and after treatment, Z , P This is for comparison between groups before and after treatment; "-" in the table indicates that the item is not present.

[0085] Table 5. Comparison of individual TCM syndromes before and after treatment in the two groups of patients ( P50 ( P25 , P75 )) Note: P <0.05 is statistically significant, z △ , P △ For comparison within the group before and after treatment, Z , P This is for comparison between groups before and after treatment; the "-" in the table indicates that this item is not included.

[0086] Table 6 Comparison of total TCM syndrome scores before and after treatment in the two groups of patients ( ±s) Note: P <0.05 is considered statistically significant. t △ , P △ For comparison within the group before and after treatment, t , P This is for comparison between groups before and after treatment; "-" indicates that this item is not available.

[0087] Table 7 Comparison of the number of acute exacerbations in the two groups of patients 6 months before and after treatment (P50 (P25, P75)) Note: P <0.05 is statistically significant, z △ , P △ For comparison within the group before and after treatment, z , P This is for comparison between groups before and after treatment; "-" indicates that this item is not available.

[0088] Table 8 Comparison of the efficacy of total TCM syndrome scores between the two groups of patients Note: P <0.05 indicates a statistically significant difference.

[0089] 2) Safety indicators: No significant adverse reactions or side effects occurred in either group during the treatment period. Specific observation indicators included clinical adverse reaction symptoms such as vomiting, diarrhea, fever, palpitations, and dyspnea, as well as laboratory safety indicators such as liver and kidney function and complete blood count. The above results indicate that the treatment regimen used in this study has good safety.

[0090] In summary, this fully demonstrates that the spleen-strengthening and kidney-tonifying herbal paste can effectively treat lung and kidney deficiency syndrome in the stable phase of COPD, and its clinical efficacy is definite.

[0091] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0092] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

Claims

1. A traditional Chinese medicine composition for treating the stable phase of chronic obstructive pulmonary disease, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-60 parts of Moutan bark, 15-120 parts of Rehmannia glutinosa (processed), 10-60 parts of Cornus officinalis (processed with wine), 10-60 parts of Alisma plantago-aquatica, 15-80 parts of Dioscorea opposita, 10-60 parts of Epimedium brevicornu, 10-60 parts of Morinda officinalis (processed with salt), 6-20 parts of donkey-hide gelatin, 15-80 parts of Poria cocos, 10-60 parts of Atractylodes macrocephala, 10-40 parts of Citrus reticulata peel, 6-40 parts of Glycyrrhiza uralensis (processed with honey), 10-60 parts of Pinellia ternata (processed with honey), 15-120 parts of Ficus hirta, 15-120 parts of Codonopsis pilosula (processed with honey), 10-40 parts of Saposhnikovia divaricata, 10-120 parts of Spatholobus suberectus, 10-40 parts of Panax notoginseng, 10-40 parts of Amomum villosum, and 6-60 parts of Ziziphus jujuba.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-30 parts of Moutan bark, 15-60 parts of Rehmannia glutinosa (processed), 10-30 parts of Cornus officinalis (processed with wine), 10-20 parts of Alisma plantago-aquatica, 15-40 parts of Dioscorea opposita, 10-30 parts of Epimedium brevicornu, 10-30 parts of Morinda officinalis (processed with salt), 6-15 parts of donkey-hide gelatin, 15-30 parts of Poria cocos, 10-30 parts of Atractylodes macrocephala, 10-20 parts of Citrus reticulata peel, 6-20 parts of Glycyrrhiza uralensis (processed with honey), 10-30 parts of Pinellia ternata (processed with honey), 15-60 parts of Ficus hirta, 15-60 parts of Codonopsis pilosula (processed with honey), 10-20 parts of Saposhnikovia divaricata, 10-60 parts of Spatholobus suberectus, 10-20 parts of Panax notoginseng, 10-20 parts of Amomum villosum, and 6-30 parts of Ziziphus jujuba.

3. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 2, characterized in that, include: Weigh the raw materials according to the specified ratio: peony bark, prepared rehmannia root, cornus fruit, alisma rhizome, yam, epimedium, salt-processed morinda root, donkey-hide gelatin, poria cocos, atractylodes macrocephala, tangerine peel, prepared licorice root, prepared pinellia tuber, five-finger peach, codonopsis root slices, saposhnikovia root, chicken blood vine, notoginseng, amomum villosum, and jujube. Extract with water to obtain the final product.

4. The preparation method according to claim 3, characterized in that, The amount of water is 8 to 10 times the weight of the raw material.

5. The method for preparing the drug as described in claim 3, characterized in that, The number of water extractions is 1 to 3 times.

6. The use of the traditional Chinese medicine composition according to any one of claims 1 to 2 in the preparation of a medicament for treating the stable phase of chronic obstructive pulmonary disease.

7. A drug for treating the stable phase of chronic obstructive pulmonary disease, characterized in that, The traditional Chinese medicine composition according to any one of claims 1 to 2 is the active ingredient.

8. The drug as described in claim 7, characterized in that, The drug also includes pharmaceutically acceptable excipients.

9. The drug as described in claim 7, characterized in that, The dosage form of the drug is decoction, pill, lozenge, tablet, granule, powder, ointment or capsule.

10. The medicament as claimed in claim 7, characterized in that, The preparation method of the ointment includes: weighing the raw materials peony bark, prepared rehmannia root, wine-processed cornus fruit, alisma rhizome, yam, epimedium, salt-processed morinda root, donkey-hide gelatin, poria cocos, atractylodes macrocephala, tangerine peel, prepared licorice root, prepared pinellia tuber, five-finger peach, codonopsis root slices, saposhnikovia root, chicken blood vine, notoginseng, amomum villosum, and jujube according to the specified ratio, extracting with water, collecting the extract, concentrating the extract to a relative density of 1.4-1.5, and preparing it into an ointment.

Images