Traditional Chinese medicine composition for treating chronic pulmonary heart disease in heart failure stage and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine, and discloses a traditional Chinese medicine composition for treating chronic pulmonary heart disease in the heart failure stage and application of the traditional Chinese medicine composition. 15 g of ginseng; 10 g of herba ephedrae; 15 g of rhizoma belamcandae; 10 g of dried ginger; 5 g of asarum; 15 g of white mulberry root-bark; 30 g of semen lepidii; 30 g of a magnet; 30 g of oyster; 15g of poria with hostwood; 15 g of semen boitae; 15 g of polygala tenuifolia; 15g of schisandra chinensis; the traditional Chinese medicine composition is prepared by the following steps: pretreating the traditional Chinese medicine raw materials, decocting with water twice, and combining filtrate, so that the finally prepared traditional Chinese medicine composition has the effects of tonifying qi and warming yang, tonifying lung and kidney, purging lung and inducing diuresis, reducing phlegm and relieving asthma, and calming heart and tranquilizing, and is suitable for chronic pulmonary heart diseases caused by yang deficiency and water flooding, turbid phlegm obstructing lung and heart and kidney deficiency. The traditional Chinese medicine composition can obviously improve the symptoms of cough and asthma, palpitation, edema, shortness of breath, weakness and restlessness at night, and clinical verification shows that the traditional Chinese medicine composition is definite in curative effect, high in safety and suitable for clinical popularization and application.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition and its application for treating heart failure in chronic pulmonary heart disease. Background Technology

[0002] Chronic pulmonary heart disease (CPHD) is a common and dangerous critical illness. It often develops secondary to chronic respiratory diseases such as chronic obstructive pulmonary disease (COPD), bronchial asthma, and bronchiectasis. Due to its long-term, recurrent, and persistent nature, it gradually leads to pulmonary hypertension, right ventricular hypertrophy and dilation, and ultimately progresses to right ventricular dysfunction and even heart failure. It is a clinically refractory chronic disease. The disease presents with typical clinical symptoms, primarily cough, wheezing, shortness of breath, palpitations, limb edema, shortness of breath, fatigue, and difficulty lying flat. The disease has a long course and is prone to repeated exacerbations. In the late stages, patients experience continuous deterioration of cardiac function, extremely poor quality of life, and a persistently high clinical mortality rate, placing a heavy burden on patients' families and the healthcare system. Currently, Western medicine treatment for pulmonary heart disease in the heart failure stage mainly employs conventional symptomatic methods such as anti-infection, antispasmodics and bronchodilators, diuretics and anti-edema agents, and cardiotonics and vasodilators. While these methods can alleviate some acute symptoms in the short term, long-term use has significant drawbacks, easily inducing adverse reactions such as electrolyte imbalance, bacterial resistance, arrhythmia, and gastrointestinal discomfort. Furthermore, these methods only address the superficial symptoms and cannot address the root cause of the patient's constitution, making long-term disease control difficult and resulting in poor long-term efficacy. Traditional Chinese medicine (TCM) treatment of pulmonary heart disease adheres to a holistic approach, treating multiple organs including the lungs, heart, spleen, and kidneys simultaneously. It possesses unique advantages and application potential in relieving cough and wheezing symptoms, reducing limb edema, improving cardiac function, enhancing exercise tolerance, and reducing the frequency of disease recurrence, making it an important research direction for clinical treatment of this disease. Currently, there are numerous traditional Chinese medicine formulas used in the clinical treatment of pulmonary heart disease. However, most formulas suffer from insufficient targeted compatibility and single-faceted efficacy, making it difficult to simultaneously achieve multiple effects such as invigorating qi and warming yang, tonifying the lungs and kidneys, purging lung heat and promoting diuresis, resolving phlegm and relieving asthma, and calming the mind and soothing the nerves. Specific formulas targeting the core syndromes of pulmonary heart disease in the heart failure stage, including yang deficiency with water retention, phlegm accumulation in the lungs, and deficiency of both heart and kidneys, are scarce. Furthermore, some formulas suffer from unstable efficacy and limited applicability, failing to meet the needs of standardized and precise clinical treatment. Therefore, this invention addresses the shortcomings of existing technologies by developing a traditional Chinese medicine composition with rigorous compatibility, comprehensive efficacy, definite therapeutic effect, and high safety, to fill the gap in clinical treatment. Summary of the Invention

[0003] (a) Technical problems to be solved To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine composition and its application for treating heart failure in chronic pulmonary heart disease. It has the advantages of invigorating qi and warming yang, tonifying the lungs and kidneys, purging lung heat and promoting diuresis, resolving phlegm and relieving asthma, calming the mind and soothing the nerves, and improving cardiac function and exercise tolerance. It solves the problems that conventional Western medicine treatments are prone to adverse reactions and cannot regulate the body's inherent weakness, and that existing traditional Chinese medicines are difficult to achieve multiple effects and have poor efficacy in targeted treatment of heart failure in pulmonary heart disease.

[0004] (II) Technical Solution To achieve the above objectives, the present invention provides the following technical solution: a traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease, wherein the raw materials and their weight parts of the traditional Chinese medicine composition are as follows: Astragalus membranaceus 29-31 parts; Ginseng 14-16 parts; Ephedra sinica 9-11 parts; Belamcanda chinensis 14-16 parts; Zingiber officinale 9-11 parts; Asarum heterotropoides 4-6 parts; Morus alba root bark 14-16 parts; Lepidium apetalum 29-31 parts; Magnetite 29-31 parts; Ostrea gigas 29-31 parts; Poria cocos 14-16 parts; Platycladus orientalis seed 14-16 parts; Polygala tenuifolia 14-16 parts; Schisandra chinensis 14-16 parts; Glycyrrhiza uralensis (processed) 14-16 parts; and Gecko 1-2 pairs.

[0005] Preferably, the raw materials of the traditional Chinese medicine composition, when decocted, are in the following specific weight parts: Astragalus membranaceus 30g; Ginseng 15g; Ephedra sinica 10g; Belamcanda chinensis 15g; Dried ginger 10g; Asarum heterotropoides 5g; Morus alba root bark 15g; Lepidium apetalum 30g; Magnetite 30g; Ostrea gigas 30g; Poria cocos 15g; Platycladus orientalis seed 15g; Polygala tenuifolia 15g; Schisandra chinensis 15g; Glycyrrhiza uralensis (processed) 15g; and one pair of geckos.

[0006] Preferably, the pretreatment of ephedra and polygala: (1) Remove the woody stems and impurities from the ephedra, cut it into short segments of 0.5-1.0 cm, and obtain cleaned ephedra segments for later use; (2) Remove impurities from Polygala tenuifolia, wash it, soak it in clean water for 2-4 hours, remove the woody core, and obtain clean Polygala tenuifolia pulp for later use.

[0007] Preferably, the pretreatment of the oysters and geckos includes: (1) Wash the raw oysters, take them out, calcine them at 300-350℃ until they are crisp, let them cool, pulverize them, and pass them through an 80-100 mesh sieve to obtain dried oyster powder for later use; (2) Remove the bamboo strips from the gecko, cut off the head, feet and scales, and cut it into small pieces of 1.0-2.0cm to obtain cleaned gecko pieces for later use.

[0008] Preferably, a traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease includes the following preparation steps: Step 1: Weigh out the following ingredients according to the formula: Astragalus membranaceus, ginseng, ephedra, belamcanda chinensis, dried ginger, asarum, mulberry bark, lepidium seed, magnetite, oyster shell, poria cocos, arborvitae seed, polygala tenuifolia, schisandra chinensis, and prepared licorice root. Also, prepare one pair of geckos. Step 2: Soak all medicinal materials except magnetite in water for 30-60 minutes; Step 3: Add 8 to 12 times the total weight of the soaked herbs to water, add magnetite, bring to a boil over high heat at 95 to 100°C, then simmer over low heat at 85 to 90°C for 25 to 30 minutes. Step 4: After the first decoction is completed, filter the liquid and add water to the dregs to decoct again for 20-30 minutes; Step 5: Combine the decoctions from the first and second decoctions, mix them thoroughly, let them stand and settle for 30-40 minutes, and then filter them through medical gauze to obtain a concentrated decoction.

[0009] Preferably, in step two, the initial water level should be 2-3 cm above the surface of the medicine, and the medicine should be turned over every 8-10 minutes during soaking.

[0010] Preferably, in step three, after the medicinal liquid boils, the heat is reduced to a simmer and stirred 2 to 6 times during the decoction process.

[0011] Preferably, in step four, before the second decoction, the water lost due to evaporation is replenished again, to 2 / 3 of the initial water volume, and then simmered at a constant temperature of 85-90℃ for 20-30 minutes.

[0012] Preferably, in step five, 3-4 layers of medical gauze are used for filtration, and the final liquid temperature is controlled below 60°C under normal pressure and natural cooling conditions to obtain the finished decoction.

[0013] An application of a traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease: The traditional Chinese medicine composition prepared according to the above method is used to treat heart failure in chronic pulmonary heart disease. The dosage and administration are as follows: one dose per day, decocted in water to obtain 399.5-400.5 ml of juice, taken warm twice a day, morning and evening. One course of treatment is 10-14 days, and 2-3 courses of treatment are used continuously.

[0014] Compared with the prior art, the present invention provides a traditional Chinese medicine composition and its application for treating heart failure in chronic pulmonary heart disease, which has the following beneficial effects: 1. This invention uses Astragalus membranaceus, Ginseng, and Gecko as the principal herbs to greatly replenish vital energy, nourish the lungs and kidneys, and relieve asthma. Ephedra sinica, Belamcanda chinensis, dried ginger, Asarum heterotropoides, Morus alba root bark, and Lepidium apetalum are used as assistant herbs to disperse cold in the lungs, warm the lungs, resolve phlegm, drain the lungs, promote diuresis, relieve asthma, and reduce swelling. Magnetite and Oyster shell are added to calm the mind, subdue yang, and promote the absorption of qi. Poria cocos, Platycladus orientalis seed, and Polygala tenuifolia are added to calm the heart and relieve palpitations. Schisandra chinensis is added to astringe the lungs and nourish the kidneys. Glycyrrhiza uralensis is added as the guiding herb to harmonize the various herbs. This forms a rigorous combination of principal, assistant, and adjuvant herbs that addresses both the root cause and the symptoms. It achieves a comprehensive therapeutic effect of replenishing qi and warming yang, nourishing the lungs and kidneys, draining the lungs and promoting diuresis, resolving phlegm and relieving asthma, and calming the mind. It can address the symptoms of phlegm and fluid retention in the acute phase of pulmonary heart disease, as well as the underlying deficiency of the heart, lungs, spleen, and kidneys in the remission phase. Ultimately, it achieves a comprehensive and multi-target intervention for the heart failure phase of chronic pulmonary heart disease.

[0015] 2. This invention employs scientific pretreatment of ephedra, polygala, oyster shell, and gecko: ephedra is segmented and cut to enhance its lung-clearing and asthma-relieving effects; polygala and licorice are processed with water and the heart removed to moderate their medicinal properties and enhance their calming and tranquilizing effects; oyster shell is calcined and pulverized to enhance its sedative, tranquilizing, and qi-regulating effects; and gecko is descalded with head, feet, and scales and then baked with rice wine to enhance its lung-tonifying, kidney-nourishing, qi-regulating, and asthma-relieving effects. This achieves the goals of reducing drug toxicity, increasing the dissolution rate of active ingredients, and improving bioavailability, making the efficacy more stable and reliable, and further enhancing clinical efficacy.

[0016] 3. This invention employs an optimized decoction process: magnetite and oyster shells are decocted for 30 minutes first to facilitate the full dissolution of the effective components of the mineral-based medicinal materials. The remaining medicinal materials are soaked and then decocted together with the first decoction. After the first decoction is 25-30 minutes, it is filtered. The dregs are then decocted again with water for 20-30 minutes. The two decoctions are combined, allowed to settle, and filtered through multiple layers of gauze. Finally, the temperature of the decoction is controlled below 60℃, which maximizes the extraction of the effective components of each medicinal material, ensures a uniform and stable concentration of the decoction, avoids damage to heat-sensitive components by high temperatures, and ultimately obtains a Chinese herbal decoction with controllable quality and definite efficacy, providing a reliable preparation guarantee for clinical treatment. Attached Figure Description

[0017] Figure 1 This is a flowchart illustrating the preparation process of the present invention. Detailed Implementation

[0018] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. 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 scope of protection of the present invention.

[0019] Please see Figure 1A traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease, wherein the raw materials and their weight parts of the composition are as follows: Astragalus membranaceus 29-31 parts; Ginseng 14-16 parts; Ephedra sinica 9-11 parts; Belamcanda chinensis 14-16 parts; Dried ginger 9-11 parts; Asarum heterotropoides 4-6 parts; Morus alba root bark 14-16 parts; Lepidium apetalum 29-31 parts; Magnetite 29-31 parts; Ostrea gigas 29-31 parts; Poria cocos 14-16 parts; Platycladus orientalis seed 14-16 parts; Polygala tenuifolia 14-16 parts; Schisandra chinensis 14-16 parts; Glycyrrhiza uralensis (processed) 14-16 parts; and Gecko 1-2 pairs.

[0020] Specifically, the raw materials for the Chinese herbal composition, when decocted, are in the following weight proportions: Astragalus membranaceus 30g; Ginseng 15g; Ephedra sinica 10g; Belamcanda chinensis 15g; Dried ginger 10g; Asarum heterotropoides 5g; Morus alba root bark 15g; Lepidium apetalum 30g; Magnetite 30g; Ostrea gigas 30g; Poria cocos 15g; Platycladus orientalis seed 15g; Polygala tenuifolia 15g; Schisandra chinensis 15g; Glycyrrhiza uralensis (processed) 15g; and one pair of geckos.

[0021] Specifically, the action table of the active pharmaceutical ingredient is as follows: Table 1

[0022] First, Astragalus, Ginseng, and Gecko are used as the main ingredients (principal herbs) in the formula. These three herbs work from the root, greatly replenishing the body's vital energy, strengthening the functions of the lungs, spleen, and kidneys, helping to regulate breathing and calm wheezing, thereby improving heart and lung function and correcting the underlying weakness. Second, two groups of herbs are arranged in the formula to assist the main ingredients (assistant herbs): the first group consists of Ephedra, Belamcanda chinensis, Dried Ginger, and Asarum, mainly responsible for promoting lung qi, dispelling cold, and resolving phlegm in the lungs, making breathing smoother; the second group consists of Mulberry Bark and Lepidium Seed, mainly responsible for clearing excess fluid from the lungs, eliminating edema, and calming wheezing. These two groups of herbs work together... When used together, this formula can not only promote lung qi and resolve phlegm and fluid retention, but also eliminate dampness, addressing the practical problems of "phlegm, water, and qi reversal" that arise during the course of the disease. Finally, the formula uses magnetite and oyster shell to calm the mind and help suppress the upward-flowing qi, gather kidney qi, and calm palpitations. Poria cocos, cypress seed, and polygala tenuifolia are used to calm the mind and improve palpitations and insomnia. Schisandra chinensis is used to astringe lung qi and nourish kidney yin, while preventing the dispersing drugs from depleting the body's vital energy. Finally, roasted licorice is used as the guiding herb, which can not only replenish the middle qi and restore the normal function of blood vessels, but also harmonize the properties of all the drugs, making the entire formula work synergistically.

[0023] In summary, the traditional Chinese medicine formula of this invention achieves both symptomatic and root-cause treatment, emphasizing both tonification and elimination of pathogens. Its combination is mild in nature, providing warming tonification without causing excessive heat, and promoting diuresis and eliminating dampness without harming the body's vital energy. It addresses both the acute symptoms of excessive phlegm and fluid in the acute phase and the underlying deficiency of the heart, lungs, spleen, and kidneys during the remission phase. Together, they exert a comprehensive effect of warming and tonifying Yang energy, nourishing the lungs and kidneys, purging the lungs and promoting diuresis, resolving phlegm and relieving asthma, and calming the mind and soothing the nerves. It can be used flexibly according to the situation, whether in the acute phase or the stable phase of pulmonary heart disease.

[0024] Specifically, the pretreatment of ephedra and polygala: (1) Remove the woody stems and impurities from the ephedra, cut it into short segments of 0.5-1.0 cm, and obtain cleaned ephedra segments for later use; (2) Remove impurities from Polygala tenuifolia, wash it, soak it in clean water for 2-4 hours, remove the woody core, and obtain clean Polygala tenuifolia flesh for later use. Cutting Ephedra into sections increases the surface area, which is conducive to the dissolution of effective components such as ephedrine; removing the woody stem reduces impurities and reduces irritation; removing the woody core of Polygala tenuifolia can eliminate the irritating sensation in the throat and reduce adverse reactions. Soaking it in water makes it easier to decoct the effective components and improve the efficacy.

[0025] Specifically, the pretreatment of oysters and geckos: (1) Wash the raw oysters, take them out, calcine them at 300-350℃ until they are crisp, let them cool, pulverize them, and pass them through an 80-100 mesh sieve to obtain dried oyster powder for later use; (2) Remove the bamboo strips from the gecko, cut off the head, feet and scales, and cut it into small pieces of 1.0-2.0cm to obtain cleaned gecko pieces for later use. After calcination, the oyster becomes crisp and the calcium carbonate and other components are more easily extracted, which enhances the effects of calming the mind, nourishing yin and yang. After crushing and sieving, the contact area is increased and the bioavailability is improved. Removing the head, feet and scales from the gecko reduces the fishy smell and makes it easier to take. Cutting it into pieces helps the effective components dissolve and retains the effects of nourishing the lungs and kidneys and relieving asthma.

[0026] Specifically, a traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease includes the following preparation steps: Step 1: Weigh out the following ingredients according to the formula: Astragalus membranaceus, ginseng, ephedra, belamcanda chinensis, dried ginger, asarum, mulberry bark, lepidium seed, magnetite, oyster shell, poria cocos, arborvitae seed, polygala tenuifolia, schisandra chinensis, and prepared licorice root. Also, prepare one pair of geckos. Step 2: Soak all medicinal materials except magnetite in water for 30-60 minutes; Step 3: Add 8 to 12 times the total weight of the soaked herbs to water, add magnetite, bring to a boil over high heat at 95 to 100°C, then simmer over low heat at 85 to 90°C for 25 to 30 minutes. Step 4: After the first decoction is completed, filter the liquid and add water to the dregs to decoct again for 20-30 minutes; Step 5: Combine the decoctions from the first and second decoctions, mix them thoroughly, let them stand and settle for 30-40 minutes, and then filter them through medical gauze to obtain a concentrated decoction.

[0027] Specifically, in step two, the initial water level should be 2-3 cm above the surface of the herbs. During soaking, the herbs should be turned over every 8-10 minutes to fully moisten the herbs, promote the initial swelling of the active ingredients, prevent floating herbs from being undercooked, and ensure even cooking.

[0028] Specifically, in step three, after the medicinal liquid boils, reduce the heat to a simmer and stir 2 to 6 times during the decoction process to prevent burning. By controlling the temperature, avoid high temperature damage to heat-sensitive components, and stirring prevent local overheating and scorching, thus ensuring stable extraction of medicinal components.

[0029] Specifically, in step four, before the second decoction, the water lost due to evaporation is replenished again, to 2 / 3 of the initial water volume, and then decocted at a constant temperature of 85-90℃ for 20-30 minutes. This ensures maximum utilization of the medicinal materials by fully extracting the residual effective components from the dregs, while constant temperature control guarantees extraction efficiency and component stability.

[0030] Specifically, in step five, 3-4 layers of medical gauze are used to filter out precipitated impurities. Under normal pressure and natural cooling conditions, the temperature of the final decoction is controlled below 60℃ to obtain the finished decoction. By effectively removing insoluble impurities and precipitates, the decoction avoids deterioration of components due to prolonged high-temperature storage, ensuring the clarity and stability of the decoction, and making it easy to take and store.

[0031] An application of a traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease: The traditional Chinese medicine composition prepared according to the above method is used to treat heart failure in chronic pulmonary heart disease. The dosage and administration are as follows: one dose per day, decocted in water to obtain 399.5-400.5 ml of juice, taken warm twice a day, morning and evening. One course of treatment is 10-14 days, and 2-3 courses of treatment are used continuously.

[0032] Specifically, the functions and indications are as follows: This Chinese herbal composition is based on tonifying qi and warming yang, purging lung qi and promoting diuresis, resolving phlegm and relieving asthma, and calming the mind and soothing the nerves. It is good at warming and tonifying the yang of the heart and kidneys to transform qi and promote diuresis, and also tonifies the qi of the lungs and spleen to consolidate the exterior and retain fluids. It is supplemented with herbs that clear phlegm and turbidity, purify and descend lung qi, and calm the mind. The whole formula works together to treat both the root cause and the symptoms. It is primarily used to treat patients with chronic pulmonary heart disease (cor pulmonale) during acute exacerbations and remissions who exhibit symptoms of Yang deficiency with water retention, phlegm obstructing the lungs, and deficiency of both heart and kidney. Symptoms include cough, wheezing, chest tightness, rattling phlegm in the throat, difficulty lying flat, shortness of breath and weakness upon exertion, palpitations, accompanied by facial and limb edema, aversion to cold and cold limbs, purplish lips, pale and swollen or purplish tongue with teeth marks on the edges, white and greasy tongue coating, and a deep, thready, weak or intermittent pulse. It is especially suitable for patients with systemic circulatory congestion (jugular venous distension, hepatomegaly and tenderness, pitting edema of the lower extremities) complicated by hypoxemia (cyanosis, dyspnea) due to right heart failure. It can significantly improve cardiopulmonary function indicators (such as a decrease in BNP levels and an increase in 6-minute walking distance), reduce the dosage of diuretics, and lower the risk of electrolyte imbalance.

[0033] The traditional Chinese medicine composition prepared above is applied in the following examples, specifically: Example 1

[0034] Ten patients who met the diagnostic criteria for chronic pulmonary heart disease and were diagnosed with Yang deficiency with water retention, phlegm obstructing the lungs, and deficiency of both heart and kidney according to traditional Chinese medicine were selected and treated with the Chinese herbal composition of this invention.

[0035] Treatment method: The herbal composition described in Example 1 of this invention is used, specifically: Astragalus membranaceus 30g, Ginseng 15g, Ephedra sinica 10g, Belamcanda chinensis 15g, Dried ginger 10g, Asarum heterotropoides 5g, Morus alba root bark 15g, Lepidium apetalum 30g, Magnetite 30g, Ostrea gigas 30g, Poria cocos 15g, Platycladus orientalis seed 15g, Polygala tenuifolia 15g, Schisandra chinensis 15g, Glycyrrhiza uralensis (processed) 15g, and one pair of geckos. Prepare the decoction according to the method described in this invention (steps one to five). One dose is taken daily, decocted in water to obtain 400ml of liquid, and taken warm twice a day, morning and evening. One course of treatment is 14 days, and two consecutive courses of treatment are recommended.

[0036] Observation indicators: Traditional Chinese medicine symptom scores (cough, wheezing, chest tightness, palpitations, edema, fatigue, insomnia, etc.); cardiac function classification (NYHA classification); 6-minute walk test; plasma brain natriuretic peptide (BNP) level; safety indicators (liver and kidney function, complete blood count, electrolytes).

[0037] Efficacy criteria: Clinical control: symptoms basically disappear, and cardiac function improves by ≥2 grades; Marked effect: symptoms are significantly reduced, and cardiac function improves by 1 grade; Effective: symptoms are somewhat reduced, and cardiac function does not worsen; Ineffective: symptoms and cardiac function do not improve or worsen.

[0038] Conclusion on efficacy: After treatment, among the 10 patients, 3 achieved clinical control, 4 showed significant improvement, 2 showed improvement, and 1 showed no improvement, with a total effective rate of 90%. Patients' symptoms such as cough, wheezing, edema, and palpitations were significantly improved, the average 6-minute walking distance increased by 85m, and the average BNP level decreased by 45%. No significant adverse reactions occurred during the treatment period.

[0039] Comparative Example 1 Ten patients who met the same diagnostic criteria were selected and treated with conventional Western medicine.

[0040] Treatment methods: Hydrochlorothiazide 25mg twice daily for diuresis, digoxin 0.125mg once daily for cardiotonic effects, isosorbide dinitrate 10mg three times daily for vasodilators, and antibiotics and oxygen therapy as needed based on the patient's condition. The course of treatment is the same as in Example 1.

[0041] Therapeutic conclusion: Among the 10 patients, 1 case achieved clinical control, 2 cases showed significant improvement, 6 cases showed improvement, and 1 case showed no improvement, with a total effective rate of 70%. Patient symptoms improved, but some patients experienced adverse reactions such as hypokalemia (3 cases) and nausea (2 cases). The average 6-minute walking distance increased by 42m, and the average BNP level decreased by 28%.

[0042] Example 2

[0043] Ten patients who met the same diagnostic criteria were selected and treated with the traditional Chinese medicine composition of this invention, but the dosage was slightly adjusted within the range.

[0044] Treatment method: The formula was adjusted to: Astragalus membranaceus 31g, Ginseng 14g, Ephedra sinica 11g, Belamcanda chinensis 14g, Dried ginger 11g, Asarum heterotropoides 4g, Morus alba root bark 16g, Lepidium apetalum 29g, Magnetite 31g, Ostrea gigas 29g, Poria cocos 16g, Platycladus orientalis seed 14g, Polygala tenuifolia 16g, Schisandra chinensis 14g, Prepared licorice root 16g, and one pair of geckos. The preparation method and course of treatment are the same as in Example 1.

[0045] Conclusion on efficacy: Among the 10 patients, 2 cases achieved clinical control, 5 cases showed significant improvement, 2 cases showed improvement, and 1 case showed no improvement, with a total effective rate of 90%. The efficacy was comparable to that of Example 1, with significant symptom improvement and no adverse reactions.

[0046] Comparative Example 2 Ten patients who met the same diagnostic criteria were selected and treated with a combination of traditional Chinese medicines lacking flavor.

[0047] Treatment method: The formula is based on Example 1, except that ginseng is removed, and the rest remains the same. The preparation method is the same as in Example 1, and the course of treatment is the same.

[0048] Therapeutic conclusion: Of the 10 patients, 1 case achieved clinical control, 3 cases showed significant improvement, 3 cases showed improvement, and 3 cases showed no improvement, with a total effective rate of 70%. The improvement in shortness of breath and fatigue was not significant, and the improvement in cardiac function was slow, suggesting that ginseng is indispensable as the principal herb.

[0049] Example 3

[0050] Ten patients who met the same diagnostic criteria were selected and treated with the traditional Chinese medicine composition of this invention, but the preparation method was slightly adjusted.

[0051] Treatment method: The formula is the same as in Example 1, but the decoction process is changed: after the first decoction for 30 minutes, filter, add water to the dregs and decoct again for 25 minutes, combine the decoctions and concentrate to 400ml. The rest is the same as in Example 1.

[0052] Conclusion on efficacy: Among the 10 patients, 2 cases achieved clinical control, 5 cases showed significant improvement, 2 cases showed improvement, and 1 case showed no improvement, with a total effective rate of 90%. The efficacy was basically consistent with that in Example 1, indicating that the preparation method is stable and reliable within a certain range.

[0053] Comparative Example 3 Ten patients who met the same diagnostic criteria were selected and treated with a combination of traditional Chinese medicines lacking flavor.

[0054] Treatment method: The formula is based on Example 1, except that Lepidium seed and mulberry bark are removed, and the rest remains the same. The preparation method is the same as in Example 1, and the course of treatment is the same.

[0055] Therapeutic conclusion: Of the 10 patients, 0 had clinical control, 2 showed significant improvement, 4 showed improvement, and 4 showed no improvement, with a total effective rate of 60%. The patients' edema and shortness of breath symptoms were poorly relieved, suggesting that Lepidium apetalum and Morus alba root bark play a key role in purging lung heat and promoting diuresis.

[0056] The application effects of the traditional Chinese medicine combination drugs in the examples and comparative examples were statistically analyzed, as shown in Table 2 below: Table 2. Statistical Analysis of Application Effects in Examples and Comparative Examples

[0057] Table 2 shows that the total effective rate of the traditional Chinese medicine composition of the present invention (Examples 1-3) in treating patients with chronic pulmonary heart disease in the heart failure stage reached 90%, which was significantly higher than that of the comparative examples (60%-70%). In terms of improving the 6-minute walking distance and reducing BNP levels, the group of the present invention was significantly better than the conventional Western medicine treatment group and the control group without traditional Chinese medicine. No obvious adverse reactions were found, showing good efficacy and safety. Although comparative example 1 (conventional Western medicine treatment) had a certain effect, it had the side effect of electrolyte disturbance. The efficacy of comparative examples 2 and 3 was significantly reduced due to the lack of the principal drug ginseng or the assistant drugs lepidium seed and mulberry bark, respectively, which shows the rationality and scientific nature of the formulation of the present invention.

[0058] In summary, the traditional Chinese medicine composition provided by this invention utilizes the principles of invigorating qi and warming yang, tonifying the lungs and kidneys, purging lung heat and promoting diuresis, resolving phlegm and relieving asthma, and calming the mind and soothing the nerves as its therapeutic approach. The formulation is rigorous and scientific, achieving a holistic approach that addresses both the root cause and symptoms, and combines tonification and purgation. Clinical observation results show that this composition can significantly improve the clinical symptoms of cough, wheezing, edema, and palpitations in patients with pulmonary heart disease in the heart failure stage, effectively improve cardiac function and exercise tolerance, and reduce plasma brain natriuretic peptide (BNP) levels. Furthermore, it demonstrates high safety with no significant adverse reactions observed. Compared with conventional Western medicine treatment and a control group lacking specific traditional Chinese medicine ingredients, this invention exhibits significant advantages in overall efficacy and symptom improvement, fully demonstrating the unique value of traditional Chinese medicine in treating pulmonary heart disease in the heart failure stage, and possesses important clinical application significance.

[0059] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating chronic pulmonary heart disease in heart failure stage, characterized in that, The raw materials and their weight ranges for the traditional Chinese medicine composition are as follows: Astragalus membranaceus 29-31 parts; Ginseng 14-16 parts; Ephedra sinica 9-11 parts; Belamcanda chinensis 14-16 parts; Dried ginger 9-11 parts; Asarum heterotropoides 4-6 parts; Morus alba root bark 14-16 parts; Lepidium apetalum 29-31 parts; Magnetite 29-31 parts; Ostrea gigas 29-31 parts; Poria cocos 14-16 parts; Platycladus orientalis seed 14-16 parts; Polygala tenuifolia 14-16 parts; Schisandra chinensis 14-16 parts; Glycyrrhiza uralensis (processed) 14-16 parts; and Gecko 1-2 pairs.

2. The traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease according to claim 1, characterized in that, The raw materials of the aforementioned traditional Chinese medicine composition, when decocted, are specifically in the following weight proportions: Astragalus membranaceus 30g; Ginseng 15g; Ephedra sinica 10g; Belamcanda chinensis 15g; Dried ginger 10g; Asarum heterotropoides 5g; Morus alba root bark 15g; Lepidium apetalum 30g; Magnetite 30g; Ostrea gigas 30g; Poria cocos 15g; Platycladus orientalis seed 15g; Polygala tenuifolia 15g; Schisandra chinensis 15g; Glycyrrhiza uralensis (processed) 15g; and one pair of geckos.

3. The traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease according to claim 1, characterized in that, The pretreatment of ephedra and polygala: (1) Remove the woody stems and impurities from the ephedra, cut it into short segments of 0.5-1.0 cm, and obtain cleaned ephedra segments for later use; (2) Remove impurities from Polygala tenuifolia, wash it, soak it in clean water for 2-4 hours, remove the woody core, and obtain clean Polygala tenuifolia pulp for later use.

4. The traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease according to claim 1, characterized in that, The pretreatment of oysters and geckos: (1) Wash the raw oysters, take them out, calcine them at 300-350℃ until they are crisp, let them cool, pulverize them, and pass them through an 80-100 mesh sieve to obtain dried oyster powder for later use; (2) Remove the bamboo strips from the gecko, cut off the head, feet and scales, and cut it into small pieces of 1.0-2.0cm to obtain cleaned gecko pieces for later use.

5. The traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease according to claim 1, characterized in that, The preparation steps include the following: Step 1: Weigh out the following ingredients according to the formula: Astragalus membranaceus, ginseng, ephedra, belamcanda chinensis, dried ginger, asarum, mulberry bark, lepidium seed, magnetite, oyster shell, poria cocos, arborvitae seed, polygala tenuifolia, schisandra chinensis, and prepared licorice root. Also, prepare one pair of geckos. Step 2: Soak all medicinal materials except magnetite in water for 30-60 minutes; Step 3: Add 8 to 12 times the total weight of the soaked herbs to water, add magnetite, bring to a boil over high heat at 95 to 100°C, then simmer over low heat at 85 to 90°C for 25 to 30 minutes. Step 4: After the first decoction is completed, filter the liquid and add water to the dregs to decoct again for 20-30 minutes; Step 5: Mix the decoctions from the first and second decoctions, let them stand and settle for 30-40 minutes, then filter with medical gauze to obtain a concentrated decoction.

6. The traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease according to claim 5, characterized in that, In step two, the initial water level should be 2-3 cm above the surface of the medicine, and the medicine should be turned over every 8-10 minutes during soaking.

7. The traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease according to claim 5, characterized in that, In step three, after the medicinal liquid boils, reduce the heat to low and keep it at a gentle boil, stirring 2 to 6 times during the decoction process.

8. The traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease according to claim 5, characterized in that, In step four, before the second decoction, the water lost due to evaporation is replenished again, to 2 / 3 of the initial water volume, and then simmered at a constant temperature of 85-90℃ for 20-30 minutes.

9. A traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease according to claim 5, characterized in that, In step five, 3-4 layers of medical gauze are used for filtration, and the final liquid temperature is controlled below 60°C under normal pressure and natural cooling conditions to obtain the finished decoction.

10. An application of a traditional Chinese medicine composition for treating heart failure in chronic pulmonary heart disease, characterized in that, The traditional Chinese medicine composition prepared according to claim 5 is used to treat heart failure in chronic pulmonary heart disease. The dosage and administration are as follows: one dose per day, decocted in water to obtain 399.5-400.5 ml of juice, taken orally twice a day, morning and evening. One course of treatment is 10-14 days, and 2-3 courses of treatment are used continuously.

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