Traditional Chinese medicine composition for treating chronic cardiac failure sarcopenia as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating chronic cardiac failure sarcopenia and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 10-20 parts of red ginseng, 10-20 parts of salvia miltiorrhiza, 15-25 parts of beautiful millettia root and 15-25 parts of philippine flemingia root. Based on the theory of tonifying qi, activating blood, invigorating spleen and promoting tissue regeneration in traditional Chinese medicine, the traditional Chinese medicine composition aims at the core pathogenesis of the chronic cardiac failure sarcopenia of qi deficiency, blood stasis and muscle and meat malnutrition. Animal experiments show that the traditional Chinese medicine composition can significantly improve the heart function, increase the skeletal muscle mass and muscle fiber cross-sectional area and enhance muscle strength and exercise tolerance, and the mechanism of the traditional Chinese medicine composition may be related to the reduction of skeletal muscle tissue inflammatory response. Clinical cases prove that the traditional Chinese medicine can effectively improve symptoms such as weakness, shortness of breath and weakness of limbs of patients and improve the life quality. The invention provides a brand-new, effective and safe traditional Chinese medicine treatment scheme for preventing and treating the chronic cardiac failure sarcopenia.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating sarcopenia in chronic heart failure, its preparation method, and its application. Background Technology

[0002] Chronic heart failure (CHF) is the end stage of various heart diseases, affecting a large number of people in my country with poor prognosis and high readmission rates. Sarcopenia is a syndrome characterized by a decline in skeletal muscle mass, strength, and function. It is a common and serious complication of CHF, and the two conditions influence each other, creating a vicious cycle that significantly increases the risk of falls, disability, and death, severely reducing the patient's quality of life.

[0003] Currently, clinical management strategies for CHF-related sarcopenia mainly focus on treating the underlying heart disease, exercise rehabilitation, and nutritional support. However, while exercise intervention is recommended by guidelines, many patients with advanced heart failure cannot tolerate or adhere to it due to severe fatigue, dyspnea, and other symptoms. Regarding drug therapy, apart from standard heart failure treatments (such as beta-blockers and ACE inhibitors), there is a lack of specific drugs directly targeting sarcopenia. Although some studies have explored androgens and growth hormones, their efficacy and safety remain controversial, and potential side effects exist. Currently, there are no approved traditional Chinese medicine compound preparations specifically for the treatment of CHF-related sarcopenia on the domestic or international market.

[0004] Therefore, there is an urgent clinical need for a safe and effective drug that can simultaneously target both heart failure and skeletal muscle atrophy, has multi-target integrated regulatory effects, and is safe. Traditional Chinese medicine has a unique advantage of "holistic regulation" in treating complex chronic diseases and comorbidities. Developing a new traditional Chinese medicine that can invigorate qi and blood circulation, strengthen muscles and promote tissue regeneration has significant clinical significance and market value. Summary of the Invention

[0005] Based on this, the purpose of the present invention is to overcome the shortcomings of the prior art and provide a method that effectively alleviates comorbid symptoms by improving cardiac function, reducing skeletal muscle inflammation and atrophy, and is highly safe.

[0006] To achieve the above objectives, the present invention adopts the following technical solution.

[0007] This invention provides a traditional Chinese medicine composition for treating sarcopenia in chronic heart failure. The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 10-20 parts of red ginseng, 10-20 parts of salvia miltiorrhiza, 15-25 parts of oxtail, and 15-25 parts of smilax glabra.

[0008] In some embodiments of the present invention, the traditional Chinese medicine combination consists of the following raw materials in parts by weight: 15 parts red ginseng, 15 parts salvia miltiorrhiza, 20 parts smilax glabra, and 20 parts smilax china.

[0009] The present invention also discloses a method for preparing the traditional Chinese medicine composition, comprising: weighing the raw materials according to the proportions, extracting them with water, and thus obtaining the composition.

[0010] The present invention also discloses a drug for treating sarcopenia in chronic heart failure, wherein the drug uses the aforementioned traditional Chinese medicine composition as its active ingredient.

[0011] In some embodiments of the present invention, the drug further includes pharmaceutically acceptable excipients.

[0012] In some embodiments of the present invention, the pharmaceutically acceptable excipients include at least one of binders, fillers, diluents, lubricants, disintegrants, colorants, flavorings, humectants, suspending agents, emulsifiers, and preservatives.

[0013] The present invention also discloses the use of the traditional Chinese medicine composition in the preparation of a medicament for treating sarcopenia of chronic heart failure.

[0014] This invention relates to a traditional Chinese medicine composition based on the TCM pathogenesis of "qi deficiency and blood stasis, leading to malnourishment of muscles and tendons," treating the condition by "tonifying qi and promoting blood circulation, strengthening the spleen and promoting muscle regeneration." The composition comprises four herbs: red ginseng, danshen, *Niu Dali* (a type of herb), and *Qianjinba* (another type of herb). Modern pharmacological studies have shown that red ginseng and danshen improve cardiac function, have anti-inflammatory and antioxidant effects; *Niu Dali* and *Qianjinba* have anti-inflammatory, anti-fatigue, and muscle-strengthening effects. Red ginseng (warm in nature, sweet and slightly bitter) greatly tonifies vital energy, restores the pulse, and consolidates the body; danshen (slightly cold in nature, bitter) invigorates blood, removes blood stasis, clears the heart, and relieves irritability; these two herbs together serve as the principal herbs, tonifying qi and promoting blood circulation to treat the root cause of heart failure; *Niu Dali* (neutral in nature, sweet) tonifies the kidneys and strengthens muscles; *Qianjinba* (neutral in nature, sweet and bland) strengthens the spleen, removes dampness, strengthens muscles and tendons, and promotes blood circulation; these two herbs together serve as the assistant herbs, strengthening the spleen and promoting muscle regeneration to treat the symptoms of sarcopenia; the four herbs work together to regulate the heart, spleen, and kidneys, treating both qi and blood, achieving a synergistic and enhanced effect.

[0015] Based on the technical solution of the present invention, the present invention has the following beneficial effects compared with the prior art:

[0016] The traditional Chinese medicine composition for treating sarcopenia in chronic heart failure provided by this invention can synergistically improve cardiac and skeletal muscle function by reducing inflammatory responses in skeletal muscle tissue and improving muscle fiber structure. Comprehensive analysis, including cardiac function assessment, skeletal muscle mass and function measurement, histopathological analysis, and single-cell sequencing mechanism exploration, has confirmed the therapeutic effect of this traditional Chinese medicine composition. This invention provides valuable insights into this traditional Chinese medicine composition as a promising candidate for the prevention and treatment of sarcopenia associated with chronic heart failure, highlighting its potential to synergistically improve cardiac function while precisely intervening in the inflammatory mechanisms of skeletal muscle. Overall, this composition represents a significant advancement in the management strategy for comorbidities of chronic heart failure.

[0017] Verification has shown that the traditional Chinese medicine composition for treating sarcopenia in chronic heart failure provided by this invention can significantly improve cardiac function (increase LVEF), increase skeletal muscle mass and muscle fiber cross-sectional area, and enhance muscle strength and exercise endurance in heart failure mice.

[0018] Research has shown that the traditional Chinese medicine composition provided by this invention can effectively improve symptoms such as fatigue, shortness of breath, weakness in the limbs, and unsteady gait in clinical applications, while also improving upper limb grip strength, increasing calf circumference, and enhancing exercise endurance and quality of life. Preliminary animal experiments have demonstrated that this traditional Chinese medicine composition can dose-dependently improve cardiac and skeletal muscle function. Single-cell sequencing technology has revealed that its mechanism of action may be related to the downregulation of inflammatory responses in endothelial cells and fibroblasts in skeletal muscle tissue. Furthermore, the traditional Chinese medicine composition provided by this invention has a simplified formulation, with all four herbs being listed in the pharmacopoeia or commonly used traditional Chinese medicinal materials. It is highly safe, low-cost, and has a mature and simple preparation process, making it easy to industrialize. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 These are images showing the gross morphology and cardiac function of the hearts of mice in different treatment groups; among them... Figure 1 In the image, A represents a comparison of the gross morphology of the hearts of mice in different treatment groups; Figure 1 In the diagram, B represents the pathological morphology of myocardial tissue stained with HE from mice in different treatment groups; Figure 1 In the figure, C represents a comparison of cardiac function parameters such as left ventricular ejection fraction (LVEF) in mice from different treatment groups; Figure 1 The "D" in the figure represents a comparison of the specific values ​​of left ventricular ejection fraction (LVEF) in mice from different treatment groups.

[0021] Figure 2 The graph shows skeletal muscle-related indices in mice from different treatment groups; among them, Figure 2 In the figure, A represents a comparison of the gross morphology of the gastrocnemius muscle in mice from different treatment groups; Figure 2 In the figure, B represents a comparison of the gastrocnemius muscle / body weight ratio in mice under different treatments; Figure 2 In the figure, C represents a comparison of the forelimb tensile test results of mice in different treatment groups; Figure 2 In the figure, D represents a comparison of the rotarod movement time test results of mice in different treatment groups; Figure 2 In the image, E represents the HE staining pathological morphology of gastrocnemius muscle tissue from mice in different treatment groups; Figure 2The figure below, F, represents a comparison of the calculated cross-sectional area (CSA) of the gastrocnemius muscle fibers in mice from different treatment groups.

[0022] Figure 3 Single-cell sequencing of skeletal muscle tissue from mice in the Con group, H group, and high-dose traditional Chinese medicine group to identify cell types.

[0023] Figure 4 This is a diagram showing transcriptional changes and signaling pathway enrichment analysis in mouse skeletal muscle endothelial cells; among them, Figure 4 In the diagram, A represents the differential gene volcano diagram of endothelial cells between the HF group and the Con group; Figure 4 In the diagram, B represents the differential gene volcano diagram of endothelial cells between the high-dose traditional Chinese medicine group and the HF group; Figure 4 In the diagram, C represents the enrichment analysis of the interferon-α response signaling pathway in endothelial cells of the HF and Con groups; Figure 4 In the diagram, D represents the enrichment analysis of the interferon-γ response signaling pathway in endothelial cells between the high-dose traditional Chinese medicine group and the HF group.

[0024] Figure 5 This image shows a diagram illustrating transcriptional changes and signaling pathway enrichment in mouse skeletal muscle fibroblasts; among them... Figure 5 In the diagram, A represents the differential gene volcano diagram of fibroblasts between the HF group and the Con group; Figure 5 In the diagram, B represents the differential gene volcano diagram of fibroblasts composed of the high-dose traditional Chinese medicine group and HF. Figure 5 In the diagram, C represents the enrichment analysis of the interferon-α response signaling pathway in fibroblasts composed of the HF group and Con; Figure 5 In the diagram, D represents the enrichment analysis of the interferon-α response signaling pathway in fibroblasts composed of the high-dose group of traditional Chinese medicine and HF. Detailed Implementation

[0025] 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.

[0026] The following description is based on specific embodiments.

[0027] Experimental materials: The Chinese herbal raw materials used in this invention, namely red ginseng, salvia miltiorrhiza, oxalis, and qianjinba, were all purchased from the First Affiliated Hospital of Guangzhou University of Chinese Medicine and were identified as meeting the standards of the Chinese Pharmacopoeia.

[0028] Example 1: A traditional Chinese medicine composition for treating sarcopenia in chronic heart failure and its preparation method

[0029] A traditional Chinese medicine composition for treating sarcopenia in chronic heart failure, comprising the following raw materials: 15g red ginseng, 15g salvia miltiorrhiza, 20g smilax glabra, and 20g smilax china.

[0030] A method for preparing a traditional Chinese medicine composition for treating sarcopenia in chronic heart failure includes the following steps:

[0031] Place all the above-mentioned medicinal materials in a pot, add water equal to 5-8 times their weight, and soak for about 30 minutes. First, bring to a boil over high heat for 10 minutes, then reduce to low heat and simmer for 60 minutes. When the water volume is reduced to about 60% of the initial volume, stop heating and filter out the dregs using a strainer. Reheat the filtered liquid and simmer until it is concentrated to about 30% of the original volume.

[0032] Example 2: A traditional Chinese medicine composition for treating sarcopenia in chronic heart failure and its preparation method

[0033] A traditional Chinese medicine composition for treating sarcopenia in chronic heart failure, comprising the following raw materials: 10g red ginseng, 10g salvia miltiorrhiza, 15g smilax glabra, and 15g smilax china.

[0034] The preparation method is the same as in Example 1.

[0035] Example 3: A traditional Chinese medicine composition for treating sarcopenia in chronic heart failure and its preparation method

[0036] A traditional Chinese medicine composition for treating sarcopenia in chronic heart failure, comprising the following raw materials: 20g red ginseng, 20g salvia miltiorrhiza, 25g smilax glabra, and 25g smilax china.

[0037] The preparation method is the same as in Example 1.

[0038] Efficacy verification of traditional Chinese medicine composition for treating sarcopenia in chronic heart failure

[0039] I. Experimental Methods

[0040] The traditional Chinese medicine decoction was prepared according to the method shown in Example 1 for efficacy verification. Specifically, in order to study the therapeutic effect of the traditional Chinese medicine composition provided by the present invention on sarcopenia of chronic heart failure, a mouse model of chronic heart failure induced by coronary artery ligation was established, and the mouse was treated with the traditional Chinese medicine composition. Then, the efficacy was evaluated and pharmacological analysis was performed.

[0041] (1) Animal model preparation

[0042] The experiment used 8-week-old SPF-grade C57BL / 6J mice to establish a chronic heart failure model by ligating the left anterior descending coronary artery. Mice were anesthetized by intraperitoneal injection of sodium pentobarbital and fixed to the operating table. A small skin incision of approximately 1.2 cm was made on the left chest of the mouse, and a purse-string suture was performed. The pectoralis major and pectoralis minor muscles were dissected and separated, exposing the fourth intercostal space. The thoracic cavity was opened in the fourth intercostal space using mosquito forceps, and the heart was gently squeezed out. The left anterior descending coronary artery was located approximately 3 mm from its origin and sutured and ligated with 8-0 sutures. Ligation was considered successful when the anterior wall of the left ventricle turned white. In the sham surgery group, after open-chest surgery, only sutures were threaded but not ligated. The heart was immediately placed back into the thoracic cavity, and air was manually expelled and the muscles and skin closed using the previously prepared purse-string sutures. The mice were allowed to recover, and their respiratory status was observed during the recovery period.

[0043] (2) Grouping and administration

[0044] After successful modeling, mice were randomly divided into a sham-operated group (Con), a model group (HF), a low-dose traditional Chinese medicine group (YQSJ-LOW), a medium-dose traditional Chinese medicine group (YQSJ-MID), a high-dose traditional Chinese medicine group (YQSJ-HIGH), and an empagliflozin group. The specific administration regimen was as follows: the original adult dose was 70 g / day. Based on a standard body weight of 60 kg, the equivalent daily dose for mice was 70 g ÷ 60 kg × 9.1 = 10.617 g / kg, which was used as the YQSJ-MID group. 5.308 g / kg was the YQSJ-LOW group, and 21.233 g / kg was the YQSJ-HIGH group. The administration volume was 0.1 mL / 10 g via gavage. The Con and HF groups were administered the same volume of distilled water via gavage. The Empagliflozin group was administered empagliflozin 10 mg / kg / day via gavage. Mice were given gavage at a fixed time once a day for 8 consecutive weeks. During the treatment period, mice in each group had free access to water and food.

[0045] (3) General indicator testing

[0046] During the experiment, the growth, food and water intake, coat color and luster, mental state and other general conditions of the mice in each group were observed and recorded daily, and their body weight was recorded.

[0047] (4) Cardiac function testing

[0048] Cardiac function was assessed using a Vevo 2100 imaging system (Visual Sonics, Toronto, Canada) before surgery and at week 8 post-surgery. Mice were anesthetized and maintained with 1% isoflurane. Cardiac function parameters were collected from each group of mice, including changes in left ventricular ejection fraction (LVEF), left ventricular fractional shortening (LVFS), left ventricular internal diameter at end-diastole (LVIDd), and left ventricular internal diameter at end-systole (LVIDs).

[0049] (4) Forelimb tensile strength test

[0050] An electronic dynamometer was used to measure the pulling force of the mouse's forelimbs. Mice were trained to pull the dynamometer taut with both forelimbs. The mouse's tail was then gently pulled horizontally to lift the mouse off the dynamometer until its forelimbs left the dynamometer. The mouse's body was kept horizontal throughout the process, and the dynamometer readings were recorded. Each mouse underwent three tests, and the average value was calculated. Each test was conducted at least 30 minutes apart.

[0051] (5) Rotary bar fatigue test

[0052] Before the test, each mouse underwent three acclimatization training sessions, each lasting 5 minutes. The mouse was placed on a motorized rotundus with a rubber surface and a diameter of 3 cm. The initial rotation speed was set to 5 revolutions per minute (rpm), gradually increasing to 40 rpm over 5 minutes. The time from when the mouse was placed on the rotundus to when it fell was recorded. Each mouse was tested three times, with intervals of at least 30 minutes between each test. The final result was the average of the three tests.

[0053] (6) Sampling of cardiac and skeletal muscle tissue

[0054] After the experiment, mice were anesthetized by intraperitoneal injection of 0.5% sodium pentobarbital and fixed to a foam board. The chest wall was cut open, the thoracic cavity was opened, and the heart was exposed. The abdominal aorta was cut, and a perfusion needle was inserted into the apex of the left ventricle to inject 0.9% physiological saline into the heart until the liver and kidneys turned pale. After drying, the heart was placed on filter paper and weighed, and the weight was recorded. The bilateral gastrocnemius muscles of the mice were quickly separated and weighed. One side of the gastrocnemius muscle was fixed by immersion in paraformaldehyde solution and stored overnight at room temperature. The other side of the gastrocnemius muscle was flash-frozen in liquid nitrogen and stored at -80°C.

[0055] (7) HE staining to observe histopathological morphology

[0056] Tissues fixed in 4% paraformaldehyde were dehydrated and cleared with ethanol and xylene, then embedded in paraffin, sectioned, dewaxed with xylene, stained with hematoxylin and eosin, cleared with xylene, mounted with neutral resin, and images were acquired using a panoramic digital imaging system to observe the morphological changes of cardiac and gastrocnemius muscle tissues in each group. The cross-sectional area (CSA) of muscle fibers was calculated using Image-Pro Plus.

[0057] II. Experimental Results

[0058] (1) The traditional Chinese medicine composition improves the general condition of mice with heart failure.

[0059] Mice in the Con group were more active and had shiny fur. Compared with the Con group, rats in the HF group were weaker after surgery and had relatively dry fur. Mice treated with the herbal composition of this invention and empagliflozin showed improvements in both fur and activity levels.

[0060] (2) Improvement of cardiac function in mice with heart failure by traditional Chinese medicine composition

[0061] Gross observation of the heart revealed that the hearts of mice in the Con group were normal, without infarct areas, and generally full; the hearts of rats in the HF group were generally significantly enlarged, with obvious infarct areas, manifested as significant thinning of the anterior wall of the left ventricle. After treatment with the traditional Chinese medicine combination or empagliflozin, the heart volume of the mice was smaller than that of the HF group, and the myocardial infarction area was significantly reduced (e.g., ...). Figure 1 (As shown in A in the diagram).

[0062] The results are as follows Figure 1 The echocardiogram results of C and D showed that, compared with the Con group, the LVEF level of mice in the HF group was significantly reduced (P<0.0001); compared with the HF group, the LVEF of the low, medium and high dose groups of the traditional Chinese medicine composition and the empagliflozin group were significantly increased (P<0.0001), suggesting that the traditional Chinese medicine composition can effectively improve the cardiac function level of mice with heart failure after myocardial infarction.

[0063] (3) Traditional Chinese medicine composition improves cardiomyocyte structure and fibrosis in heart failure mice

[0064] HE staining results showed that the myocardial tissue of mice in the Con group was regularly and orderly arranged and dense; the myocardial tissue of mice in the HF group was disordered, with loose and swollen interstitial tissues, partial tissue rupture, and extensive collagen fiber proliferation; after drug intervention, the myocardial structure of mice in all doses of the traditional Chinese medicine combination and the empagliflozin group was significantly improved compared with the HF group, with significantly reduced collagen fiber proliferation and a more orderly arrangement (e.g., ...). Figure 1 (As shown in B in the diagram).

[0065] (4) Traditional Chinese medicine composition improves skeletal muscle mass in mice with heart failure

[0066] Gross morphology of the gastrocnemius muscle observed by the naked eye: The gastrocnemius muscles of mice in the Con group were full and elastic. The gastrocnemius muscles of mice in the HF group showed signs of muscle atrophy and loosening. After drug intervention, the condition of the gastrocnemius muscles in mice in all doses of the traditional Chinese medicine group and the empagliflozin group improved (e.g., Figure 2 (As shown in A in the diagram).

[0067] Compared with the Con group, the gastrocnemius muscle / body weight ratio of mice in the HF group was significantly decreased (P<0.01); compared with the HF group, the gastrocnemius muscle / body weight ratio of mice in the medium and high dose traditional Chinese medicine groups was significantly increased (P<0.05 or P<0.01). This suggests that the traditional Chinese medicine composition can effectively improve skeletal muscle mass in mice with heart failure (e.g., ...). Figure 2 (As shown in B in the diagram).

[0068] (5) Traditional Chinese medicine composition improves forelimb traction in mice with heart failure

[0069] Forelimb traction results showed that compared with the Con group, the forelimb traction value of mice in the HF group was significantly reduced (P < 0.0001). After drug intervention, the forelimb traction value of mice in each dose of traditional Chinese medicine group and the empagliflozin group was significantly increased (P < 0.0001), suggesting that the traditional Chinese medicine composition can effectively improve skeletal muscle function in mice with heart failure (e.g., ...). Figure 2 (as shown in C).

[0070] (6) Traditional Chinese medicine composition improves motor function in mice with heart failure

[0071] Rotarosing results showed that, compared with the Con group, the HF group mice had a significantly reduced rotarosing time (P < 0.0001). After drug intervention, the rotarosing time of mice in the medium and high dose traditional Chinese medicine groups significantly increased (P < 0.05 or P < 0.01), suggesting that the traditional Chinese medicine composition can effectively improve skeletal muscle function in heart failure mice (e.g., ...). Figure 2 (as shown in D in the diagram).

[0072] (7) The traditional Chinese medicine composition improved the pathological tissue structure and muscle fiber cross-sectional area of ​​skeletal muscle in mice with heart failure.

[0073] HE staining results showed that the gastrocnemius muscle tissue structure of mice in the Con group was intact, with tightly and neatly arranged muscle fibers, clear boundaries, and no obvious atrophy, breakage, or necrosis of muscle cells; the gastrocnemius muscle fibers of mice in the HF group were disordered and loosely arranged, with increased intercellular spaces, significantly reduced cross-sectional area, muscle cell atrophy, and a small amount of autolysis of muscle fibers; the muscle fiber arrangement in each dose of traditional Chinese medicine group and the empagliflozin group was more regular than that in the HF group, with increased cross-sectional area and narrowed intercellular spaces. This suggests that the traditional Chinese medicine composition can effectively improve the pathological tissue structure of skeletal muscle in mice with heart failure (e.g., Figure 2 (As shown in E in the figure).

[0074] Image-Pro Plus calculations of muscle fiber cross-sectional area showed that, compared with the Con group, the CSA of mice in the HF group was significantly reduced (P < 0.0001). After drug intervention, the CSA of mice in each dose of traditional Chinese medicine group and the empagliflozin group was significantly increased (P < 0.05 or P < 0.0001), suggesting that the traditional Chinese medicine composition can effectively improve the cross-sectional area of ​​skeletal muscle in mice with heart failure (e.g., muscle fiber cross-sectional area). Figure 2 (As shown in F in the image).

[0075] (8) Single-cell sequencing analysis revealed that the mechanism of action of the traditional Chinese medicine composition involved the reduction of inflammation in endothelial cells and fibroblasts.

[0076] The results are as follows Figure 3 As shown, single-cell sequencing of mouse skeletal muscle tissue from the Con group, HF group, and high-dose traditional Chinese medicine group was performed, and 11 cell types, including endothelial cells, fibroblasts, myocytes, macrophages, T cells, and Achilles tendon cells, were identified using the SingleR gene contrast annotation tool.

[0077] The results are as follows Figure 4 and 5 As shown, differential gene and GSEA enrichment analysis of endothelial cells and fibroblasts revealed that, compared with the blank control group, the cellular inflammatory response signals and related gene sets of HF endothelial cells and fibroblasts were upregulated (P<0.05). The traditional Chinese medicine composition of the present invention can effectively reverse the inflammatory activation state and restore the homeostasis of endothelial cells and fibroblasts (P<0.05).

[0078] Clinical application cases

[0079] Case 1:

[0080] Ms. Zhang, a 65-year-old patient with a 12-year history of chronic heart failure, regularly took Western medicine to treat her heart failure. She presented with fatigue, shortness of breath, and weakness in her limbs for three months. Three months prior, she developed fatigue and shortness of breath, which had gradually worsened recently, accompanied by lower limb weakness and unsteady gait. Initial physical examination revealed a pulse of 88 beats / min, respiratory rate of 18 breaths / min, and blood pressure of 130 / 85 mmHg. Her upper limb grip strength was 14 kg, calf circumference was 28 cm, walking speed was slow, and gait was slightly unsteady. She was classified as New York Heart Association Class II. Traditional Chinese medicine diagnosed her with Qi deficiency and blood stasis syndrome. She was prescribed a decoction prepared with this herbal combination (red ginseng 15g, danshen 15g, *Achyranthes bidentata* 20g, *Smilax glabra* 20g), one dose daily, decocted to 250 mL, taken in two divided doses morning and evening, for three consecutive months. After treatment, the patient's symptoms improved significantly, with relief from fatigue and shortness of breath, increased lower limb strength, more stable gait, increased upper limb grip strength and calf circumference compared to the initial diagnosis, and a significant improvement in the patient's quality of life.

[0081] Case 2:

[0082] Mr. Li, a 70-year-old patient, had a history of heart failure for over 5 years, complicated by hypertension and diabetes. He presented with shortness of breath and weakness after exertion. He had a 30-year history of hypertension. Five years ago, an ultrasound at another hospital revealed cardiomegaly and left ventricular diastolic dysfunction, leading to a diagnosis of chronic heart failure. Six months prior, he experienced significant shortness of breath after exercise, lower limb weakness, joint stiffness, particularly in the knees, and gait instability. Physical examination revealed significant muscle atrophy in both lower limbs, with muscle strength grade 4. Traditional Chinese medicine diagnosed him with spleen and kidney deficiency and prescribed a decoction prepared from this herbal combination (red ginseng 15g, salvia miltiorrhiza 15g, *Achyranthes bidentata* 20g, *Smilax glabra* 20g), one dose daily, decocted to 300mL, taken in two divided doses morning and evening, for 45 consecutive days. After treatment, the patient's shortness of breath significantly improved, lower limb muscle strength increased, activity level increased, and gait became significantly more stable.

[0083] Case 3:

[0084] Ms. Wang, a 76-year-old patient with a history of heart failure for over 20 years, presented with palpitations and fatigue. An echocardiogram revealed an ejection fraction (EF) of 43%. Physical examination revealed fatigue, a calf circumference of 27.6 cm, upper limb grip strength of 11.2 kg, slow walking speed, and a slightly unsteady gait. Traditional Chinese medicine (TCM) diagnosis was Qi deficiency and blood stasis. She was treated with a decoction prepared from a specific herbal combination (red ginseng 15g, danshen 15g, *Achyranthes bidentata* 20g, *Smilax glabra* 20g), one dose daily, decocted to 250 mL, taken in two divided doses morning and evening, for 70 consecutive days. After treatment, her calf circumference increased to 28.1 cm, upper limb grip strength increased to 11.7 kg, her mental state significantly improved, and she no longer experienced significant palpitations or fatigue. A follow-up echocardiogram showed an EF of 50%, significantly improved exercise tolerance, and increased walking distance.

[0085] In summary, the traditional Chinese medicine composition for treating sarcopenia in chronic heart failure provided by this invention can improve cardiac function and inhibit fibrosis of cardiac tissue. Regarding skeletal muscle atrophy, the traditional Chinese medicine composition of this invention can increase skeletal muscle mass, tensile strength, and motor function, improve skeletal muscle tissue structure, increase skeletal muscle cross-sectional area, and reduce inflammatory responses in endothelial cells and fibroblasts, thereby exerting a therapeutic effect on heart failure-related sarcopenia. This invention provides strong theoretical and scientific evidence for the treatment strategy of sarcopenia in chronic heart failure and broadens its application prospects.

[0086] 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.

[0087] 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 sarcopenia in chronic heart failure, characterized in that, The herbal combination consists of the following raw materials in parts by weight: 10-20 parts red ginseng, 10-20 parts salvia miltiorrhiza, 15-25 parts smilax glabra, and 15-25 parts smilax china.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The herbal combination consists of the following raw materials in parts by weight: 15 parts red ginseng, 15 parts salvia miltiorrhiza, 20 parts smilax glabra, and 20 parts smilax china.

3. The method for preparing the traditional Chinese medicine composition as described in claim 1 or 2, characterized in that, include: Weigh the raw materials according to the specified ratio, extract with water, and the product is obtained.

4. A drug for treating sarcopenia in chronic heart failure, characterized in that, The drug uses the traditional Chinese medicine composition as described in claim 1 or 2 as its active ingredient.

5. The drug as described in claim 4, characterized in that, The drug also includes pharmaceutically acceptable excipients.

6. The drug as described in claim 5, characterized in that, The pharmaceutically acceptable excipients include at least one of binders, fillers, diluents, lubricants, disintegrants, colorants, flavorings, humectants, suspending agents, emulsifiers, and preservatives.

7. The drug as described in claim 4, characterized in that, The dosage form of the drug is decoction, granules, pills, capsules, tablets, powders, or oral liquid.

8. The use of the traditional Chinese medicine composition as described in claim 1 or 2 in the preparation of a medicament for treating sarcopenia of chronic heart failure.

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