Traditional Chinese medicine composition for treating sarcopenia

Abstract

The invention discloses a traditional Chinese medicine composition for treating sarcopenia, the traditional Chinese medicine composition is prepared from six medicines of sugared ginseng, cistanche, rhizoma polygonati, poria cocos, gastrodia elata and bighead atractylodes rhizome through compatibility, the traditional Chinese medicine composition takes spleen strengthening, qi supplementing, kidney tonifying and essence replenishing as the treatment rule, syndrome differentiation treatment is carried out aiming at the spleen and kidney deficiency pathogenesis of sarcopenia, multi-target intervention on sarcopenia is achieved, and the traditional Chinese medicine composition has the advantages that the curative effect is good; the traditional Chinese medicine composition not only can quickly improve muscle strength and endurance functions, but also can continuously promote muscle mass reconstruction, and has dual effects of atrophy resistance and fibrosis resistance, and animal experiment results show that the traditional Chinese medicine composition has a remarkable curative effect on liver and kidney deficiency type sarcopenia.

Description

Technical Field:

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating sarcopenia. Background Art:

[0002] Sarcopenia is a degenerative muscle disease closely related to aging and prone to occur in the elderly population. Sarcopenia may increase the risk of death, especially in the elderly population. In recent years, the world has faced the severe challenge of population aging, which has brought unprecedented pressure and impact to the world economy and the medical field. At present, the treatment methods of sarcopenia mainly focus on exercise intervention, nutritional intervention, etc. There is no clear guideline and expert consensus for drug intervention. Some drugs used to treat other diseases may have potential benefits for muscle function, including testosterone, growth hormone, selective androgen receptor modulators, etc., but the curative effects cannot fully meet the expectations.

[0003] "The spleen governs muscles" is one of the core contents of traditional Chinese medicine theory. The spleen is the foundation of acquired constitution, governing transportation and transformation, ascending and clearing, and is the source of qi and blood generation. If the spleen is deficient, transportation and transformation will fail, qi and blood generation will be insufficient, and the muscles will lose nourishment, thus leading to the occurrence of sarcopenia. Modern research also shows that sarcopenia is closely related to the deficiency of the spleen and kidney, and its core pathogenesis is "spleen deficiency resulting in failure of transportation, qi and blood insufficiency", and the treatment should focus on invigorating the spleen and replenishing qi, and tonifying the kidney and filling essence.

[0004] In the existing Western medicine treatment, sarcopenia faces many dilemmas. For example, although testosterone replacement therapy can improve muscle mass to a certain extent, its cardiovascular risk is relatively high, which may increase the risk of heart attack and stroke. Growth hormone treatment has potential carcinogenic risks, which limits its wide application in clinical practice. In addition, although nutritional supplements (such as protein supplements) are widely used in the treatment of sarcopenia, due to the decline of the digestive and absorptive functions of the elderly, their absorption rate is often low, resulting in insufficient curative effects. [Duan Miao, Shi Liping. Research Progress of Sarcopenia [J]. Advances in Clinical Medicine, 2023, 13(5): 8836-8844. DOI: 10.12677 / acm.2023.1351235]

[0005] The patent with the application number CN202011137742.0 discloses a traditional Chinese medicine composition, a traditional Chinese medicine ointment and an external hot compress plaster for treating muscle atrophy and myasthenia, belonging to the technical field of medicine. The invention selects seven effective Chinese herbal medicines, extracts them to make an ointment preparation, and makes a heat patch by adding a heat-generating granule agent to the outer layer, which is directly applied to the back of the patient, overcoming the problem that the difficulty in swallowing of patients with myasthenia and muscle atrophy affects the drug's efficacy, reducing the pain of the patients, and having a significant therapeutic effect on myasthenia and muscular atrophy. However, the research and development of traditional Chinese patent medicines specifically for sarcopenia are still in their infancy, lacking mature products with clear efficacy. Existing traditional Chinese medicine research mostly focuses on the muscle regeneration-promoting effects of single herbs (such as astragalus polysaccharide and ginsenoside), but the compound compatibility mechanism is unclear, and there is no systematic formula for sarcopenia. Summary of the Invention:

[0006] (I) Technical problems to be solved

[0007] In view of the defects existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating sarcopenia, and proposes a traditional Chinese medicine combined drug for treating sarcopenia with clear pharmacodynamic substances, stable compatibility components, controllable quality, reliable effectiveness and safety, solving the problems that the prior art is unclear about the action mechanism of traditional Chinese medicine on sarcopenia and lacks a traditional Chinese medicine formula for treating sarcopenia with clear components and clear action mechanism.

[0008] (II) Technical solutions

[0009] To solve the above technical problems, the present invention adopts the following technical solutions:

[0010] A traditional Chinese medicine composition for treating sarcopenia, characterized in that the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10-25 parts of sugar ginseng, 10-25 parts of cistanche, 20-45 parts of polygonatum sibiricum, 8-20 parts of poria cocos, 10-25 parts of gastrodia elata, 10-25 parts of atractylodes macrocephala.

[0011] Further, the traditional Chinese medicine composition is made from the following raw materials in parts by weight:

[0012] 15 parts of sugar ginseng, 18 parts of cistanche, 25 parts of polygonatum sibiricum, 15 parts of poria cocos, 15 parts of gastrodia elata, 20 parts of atractylodes macrocephala; or

[0013] 10 parts of sugar ginseng, 15 parts of cistanche, 35 parts of polygonatum sibiricum, 8 parts of poria cocos, 10 parts of gastrodia elata, 15 parts of atractylodes macrocephala; or

[0014] 15 parts of sugar ginseng, 10 parts of cistanche, 20 parts of polygonatum sibiricum, 15 parts of poria cocos, 15 parts of gastrodia elata, 10 parts of atractylodes macrocephala; or

[0015] 10 parts of Radix Ginseng Rubra, 10 parts of Herba Cistanches, 45 parts of Rhizoma Polygonati, 10 parts of Poria, 10 parts of Rhizoma Gastrodiae, 25 parts of Rhizoma Atractylodis Macrocephalae; or 10 parts of Radix Ginseng Rubra, 25 parts of Herba Cistanches, 20 parts of Rhizoma Polygonati, 8 parts of Poria, 15 parts of Rhizoma Gastrodiae, 18 parts of Rhizoma Atractylodis Macrocephalae.

[0016] Further, the traditional Chinese medicine composition further comprises pharmaceutically acceptable excipients.

[0017] Further, the dosage forms of the traditional Chinese medicine composition include decoction, granules, paste, pills, powder, tablets, capsules.

[0018] The present invention also provides a preparation method of a traditional Chinese medicine composition for treating sarcopenia, comprising the following steps:

[0019] S1. Refined processing of Radix Ginseng Rubra, Herba Cistanches, Rhizoma Polygonati, Poria, Rhizoma Gastrodiae, and Rhizoma Atractylodis Macrocephalae respectively: Radix Ginseng Rubra is infiltrated with rice-washing water and then dried at low temperature and sliced; Herba Cistanches is infiltrated with yellow rice wine and steamed until softened; the efficacy activity of Rhizoma Polygonati is enhanced by the traditional nine-steaming and nine-sunning method; Poria is soaked in clear water and then sliced; Rhizoma Gastrodiae is steamed with rice soup to retain volatile components; and Rhizoma Atractylodis Macrocephalae is stir-fried with bran to enhance the spleen-strengthening effect.

[0020] S2. After the herbs processed in step S1 are weighed and mixed in proportion, 8 times the amount of deionized water at 40 - 50 °C is added and soaked for 90 - 120 minutes until fully swollen, and then two-stage dynamic decoction is carried out: for the first decoction, it is brought to a rapid boil over high heat and then slow-cooked over low heat at 85 °C for 60 minutes; for the second decoction, 6 times the amount of water is added and decocted for 45 minutes. Among them, Rhizoma Polygonati and Herba Cistanches need to be separately bagged and decocted for 30 minutes to prevent component complexation due to their large amount of polysaccharide components.

[0021] S3. The medicinal liquids obtained from the two decoctions in step S2 are combined, filtered, concentrated under reduced pressure at 60 °C to a relative density of 1.10 - 1.15, and centrifuged at 3000 rpm for 15 minutes to remove colloids and suspended particles, obtaining a clear concentrated liquid, which is the effective medicinal liquid.

[0022] Further, to ensure the quality of the medicinal liquid, the concentrated liquid obtained in step S3 is sterilized by ultra-high temperature instantaneous sterilization at 135 °C for 5 seconds, inactivating microorganisms while retaining heat-sensitive components, and monitoring the contents of ginsenoside in Radix Ginseng Rubra and acteoside in Herba Cistanches by HPLC method. The qualified quantitative standard for key active components is that the content of ginsenoside Rb1 in Radix Ginseng Rubra is ≥ 0.8 mg / mL and the content of acteoside in Herba Cistanches is ≥ 0.5 mg / mL.

[0023] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition for treating sarcopenia in the preparation of drugs for treating sarcopenia of spleen qi deficiency type.

[0024] This invention originated from the long-term clinical practice of the inventor. It mainly focuses on strengthening the spleen and promoting qi circulation, while also taking into account the effects of tonifying the kidney and replenishing essence, moistening the intestines and promoting defecation, suppressing liver wind, etc. Polygonatum sibiricum is used as an assistant drug to tonify the kidney and replenish essence and enhance the overall function of the body; Codonopsis pilosula and Atractylodes macrocephala are used as the principal drugs to mainly regulate the function of the spleen and stomach and improve the symptoms of weakness of the spleen and qi deficiency; Poria cocos and Gastrodia elata are used as assistant and guiding drugs to strengthen the spleen and promote diuresis, and suppress liver wind. The overall compatibility aims to improve the symptoms of muscle weakness, limb flaccidity, numbness of hands and feet, progressive atrophy of large muscles, gait disorder, etc. caused by deficiency of the spleen and kidney and insufficiency of qi and blood in patients with sarcopenia through strengthening the spleen and replenishing qi and tonifying the kidney and filling essence.

[0025] The dosage form of the traditional Chinese medicine composition of the present invention can be made into a conventional dosage form acceptable in pharmacy by using conventional preparation processes.

[0026] In the application of the present invention, the traditional Chinese medicine composition is one of decoction, powder, capsule, tablet, pill, oral liquid preparation, etc. To enable the above dosage forms to be realized, pharmaceutically acceptable excipients need to be added during the preparation of these dosage forms, such as: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, matrices, etc.

[0027] Fillers include: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; Disintegrants include: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose sodium, etc.; Lubricants include: magnesium stearate, sodium lauryl sulfate, talc powder, silicon dioxide, etc.; Suspending agents include: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.; Binders include, starch paste, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.; Sweeteners include: sodium saccharin, aspartame, sucrose, sodium cyclamate, glycyrrhetinic acid, etc.; Flavoring agents include: sweeteners and various flavors; Preservatives include: parabens, benzoic acid, sodium benzoate, sorbic acid and its salts, benzalkonium bromide, chlorhexidine acetate, eucalyptus oil, etc.; Matrices include: PEG6000, PEG4000, beeswax, etc. To enable the above dosage forms to realize traditional Chinese medicine pharmacy, other pharmaceutically acceptable excipients need to be added during the preparation of these dosage forms.

[0028] Preferably, the sarcopenia treated by the traditional Chinese medicine composition of the present invention is sarcopenia of the spleen qi deficiency type. Because the present invention strengthens the spleen and promotes qi circulation, and tonifies the kidney and replenishes essence, it has particularly good effects in treating sarcopenia of the spleen qi deficiency type.

[0029] The main component of Polygonatum sibiricum, Polygonatum sibiricum polysaccharide (PSP), can positively regulate the biological functions of skeletal muscle cells by activating the PI3K / Akt / mTOR signaling pathway, thereby improving skeletal muscle aging and mitochondrial dysfunction; and it can reduce the expression of P53 and P21 in senescent cells, down-regulate the P53 / P21 signaling pathway, improve the process of cell senescence, and thus delay the occurrence and development of sarcopenia. In this context, the present invention proposes that the core pathogenesis of sarcopenia is "deficiency of the spleen and kidney, and insufficiency of qi and blood", and has developed a formula composed of six traditional Chinese medicines such as Codonopsis pilosula, Cistanche deserticola, and Polygonatum sibiricum. This formula takes strengthening the spleen and replenishing qi, and tonifying the kidney and filling essence as the treatment principle, and dialectically treats the pathogenesis of deficiency of the spleen and kidney in sarcopenia. The results of animal experiments show that this traditional Chinese medicine composition has a significant effect on sarcopenia of the liver and kidney deficiency type.

[0030] (III) Beneficial effects

[0031] The beneficial effects produced by the present invention are as follows:

[0032] 1. Therapeutic effect

[0033] (1) Achieve precise treatment for sarcopenia:

[0034] Existing means for treating sarcopenia mostly include exercise intervention, nutritional supplementation, and some drugs with potential risks such as testosterone and growth hormone. These methods either have insufficient efficacy or have problems such as cardiovascular risks and carcinogenic risks. Based on the theory of "the spleen governing muscles" in traditional Chinese medicine and combined with modern pharmacological research, the present invention has developed a traditional Chinese medicine composition for the pathogenesis of deficiency of the spleen and kidney in sarcopenia. The results of animal experiments show that this composition can significantly improve the muscle strength of sarcopenia model mice (P<0.01), increase body weight (the maximum increase is up to 10.96%), extend running endurance, and improve muscle mass.

[0035] (2) Multi-target intervention mechanism:

[0036] The traditional Chinese medicine composition provided by the present invention realizes multi-target intervention for sarcopenia through the comprehensive effects of strengthening the spleen and replenishing qi, and tonifying the kidney and filling essence. It can not only quickly improve muscle strength and endurance function, but also continuously promote muscle mass reconstruction, and has dual effects of anti-atrophy and anti-fibrosis. For example, after drug treatment, the deposition of collagen fibers in mouse muscles is significantly reduced, and the effect is dose-dependent.

[0037] (3) High safety

[0038] Compared with testosterone replacement therapy with cardiovascular risks and growth hormone therapy with potential carcinogenic risks in Western medicine treatment, the traditional Chinese medicine composition provided by the present invention is derived from natural Chinese medicinal materials, and after processing and scientific compatibility, it has higher safety. No serious adverse reactions were found in clinical trials, and the drug stability is good, and the quality can remain qualified for 6 months under the conditions of 40°C / 75% humidity.

[0039] 2. Social effects

[0040] (1) Coping with the challenges of aging

[0041] With the intensification of the global population aging, the incidence of sarcopenia is rising continuously. Especially in the elderly population aged 80 and above, the incidence rate is as high as 11%-50%, and the prevalence rate in the community environment even rises to 29%. The present invention provides a safe and effective treatment plan for elderly sarcopenia patients, which helps to improve the quality of life of patients, reduce the risks of falls and fractures, and relieve the burden of chronic diseases caused by sarcopenia.

[0042] (2) Improving the quality of life of patients

[0043] The clinical trial results show that for the patients using the traditional Chinese medicine composition of the present invention, their grip strength is significantly improved (an average increase of 2.04 kg), the 6-meter walking speed is significantly increased (an average increase of 0.25 m / s), the time of the 10-meter shuttle test is shortened, and the dynamic balance ability and motor coordination are improved simultaneously. These improvements not only help patients recover their daily activity ability, but also enhance their self-care ability, and relieve the nursing burden on families and society.

[0044] (3) Promoting the inheritance and development of traditional Chinese medicine

[0045] The present invention combines traditional Chinese medicine theory and modern pharmacological research to develop a traditional Chinese medicine composition for sarcopenia, which provides new ideas and practical cases for the application of traditional Chinese medicine in the prevention and treatment of modern diseases. Its successful research and development helps to promote the modernization process of traditional Chinese medicine and enhance the influence of traditional Chinese medicine in the international medical field.

[0046] 3. Economic effects

[0047] (1) Reducing medical costs

[0048] Currently, drugs for the treatment of sarcopenia such as growth hormone and testosterone are expensive and have potential risks, resulting in high treatment costs. The traditional Chinese medicine composition provided by the present invention uses natural Chinese medicinal materials, has relatively low costs, and has significant curative effects, which can effectively reduce the treatment costs of patients and relieve the economic burden on the medical system.

[0049] (2) Improving treatment efficiency

[0050] The traditional Chinese medicine composition provided by the present invention shows the characteristics of rapid onset (significantly improving muscle strength within 4 weeks) and continuous intervention (significantly improving body weight and muscle mass within 8 weeks) in both animal experiments and clinical trials. Its rapid therapeutic effect and good compliance can shorten the treatment cycle and improve the utilization efficiency of medical resources.

[0051] (3) Potential market value

[0052] With the advent of an aging society, the market demand for sarcopenia is increasing day by day. The traditional Chinese medicine composition provided by the present invention, as an innovative drug with definite curative effect and safety, has a simple preparation process, is suitable for large-scale popularization and application, has broad market prospects, and promotes the development of related industrial chains at the same time. Brief description of the drawings:

[0053] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below.

[0054] Figure 1 Shows the effect of the traditional Chinese medicine composition described in the present invention on the muscle strength of sarcopenia model mice;

[0055] Figure 2 Shows the effect of the traditional Chinese medicine composition described in the present invention on the body weight of sarcopenia model mice;

[0056] Figure 3 Shows the effect of different ratios of the traditional Chinese medicine composition described in the present invention on the muscle strength of sarcopenia model mice;

[0057] Figure 4 Shows the effect of different ratios of the traditional Chinese medicine composition described in the present invention on the body weight of sarcopenia model mice;

[0058] Figure 5 Shows the effect of different ratios of the traditional Chinese medicine composition described in the present invention on the exhaustion time of sarcopenia model mice;

[0059] Figure 6 Is the HE staining of the quadriceps femoris muscle;

[0060] Figure 7 Is the Sirius red staining of the quadriceps femoris muscle; Detailed implementation manners:

[0061] In order to enable those skilled in the art to more clearly understand the technical solutions of the present invention, the technical solutions of the present invention will be described in detail below in combination with specific embodiments.

[0062] The experimental methods in the following embodiments are all conventional methods unless otherwise specified, and the test materials used in the following embodiments are all commercially available through conventional commercial channels unless otherwise specified.

[0063] Example 1. Preparation of Traditional Chinese Medicine Composition for Treating Sarcopenia

[0064] The preparation of the decoction of the traditional Chinese medicine composition for treating senile sarcopenia requires a systematic process of processing and decocting. First, six medicinal materials such as sugar ginseng and cistanche are processed meticulously: sugar ginseng needs to be moistened with rice-washing water and then dried at low temperature and sliced; cistanche is softened by steaming after being moistened with yellow rice wine; the medicinal effect activity of polygonatum sibiricum is enhanced by the traditional method of steaming nine times and drying nine times; poria cocos is soaked in clear water and then sliced; gastrodia elata is steamed with rice soup to retain volatile components; and atractylodes macrocephala is stir-fried with bran to enhance the spleen-strengthening effect. After the processed medicinal materials are weighed and mixed according to the prescription ratio, 8 times the amount of deionized water at 40 - 50 °C is added and soaked for 90 - 120 minutes until fully swollen, and then two-stage dynamic decoction is carried out: for the first decoction, high heat is used to bring to a rapid boil and then slow fire (85 °C) is used to simmer for 60 minutes; for the second decoction, 6 times the amount of water is added and decocted for 45 minutes. Among them, polygonatum sibiricum and cistanche, due to containing a large amount of polysaccharide components, need to be separately bagged and decocted for 30 minutes to prevent component complexation. The two filtrates are combined and initially filtered through four layers of gauze, and then concentrated to a relative density of 1.10 - 1.15 under reduced pressure at 60 °C, and colloids and suspended particles are removed by centrifugation (3000 rpm, 15 minutes) to obtain a clear concentrated solution. To ensure the quality of the preparation, ultra-high temperature instantaneous sterilization (135 °C, 5 seconds) is used to inactivate microorganisms while retaining heat-sensitive components, and the quantitative standards of key active components such as ginsenoside Rb1 (≥0.8 mg / mL) in sugar ginseng and echinacoside (≥0.5 mg / mL) in cistanche are monitored by HPLC method. The final preparation is packaged in 150 mL vacuum packages, 1 dose per day and taken warm in two divided doses, and it is recommended to take continuously for 12 weeks to fully exert the effects of tonifying the spleen and kidney and strengthening muscles and bones. The whole preparation process needs to strictly control the decocting temperature and time parameters. Among them, the rice soup steaming process of gastrodia elata can increase the retention rate of gastrodin to more than 85%, and the reduced pressure concentration technology can effectively reduce the loss of volatile components. During clinical use, it should be noted to take it at an interval of 2 hours from calcium agents. The stability of the preparation is verified by accelerated test to maintain qualified quality under the conditions of 40 °C / 75% humidity for 6 months.

[0065] Example 2: Animal Experiment of Traditional Chinese Medicine Composition for Treating Sarcopenia

[0066] 1. Experimental animals: 40 male C57BL / 6 mice at 8 weeks old (Henan Skbes Biotechnology Co., Ltd.), with a body weight of (34 ± 3) g. The mice were divided into 4 groups, namely the control group, the model group, the low-concentration drug group of the present invention, and the high-concentration drug group of the present invention, with 10 mice in each group. Except for the control group, the other three groups were intraperitoneally injected with 0.9% sodium chloride solution containing D-gal at a dose of 150 mg / kg according to the body weight of the mice, and the control group was intraperitoneally injected with the same dose of 0.9% sodium chloride solution, and the injection was carried out once every other day. The signs of the mice were observed daily. When obvious signs of aging such as dull hair color, poor skin elasticity, listlessness, significantly reduced food intake, and slow body weight gain appeared, it indicated that the sarcopenia mouse model was successfully constructed.

[0067] 2. Experimental drugs: Codonopsis pilosula, Cistanche deserticola, Polygonatum sibiricum, Poria cocos, Gastrodia elata, Atractylodes macrocephala

[0068] 3. Injection protocol: The low-concentration drug group and the high-concentration drug group of the present invention were respectively gavaged with 60 mg / kg and 120 mg / kg doses of the drug daily, and the control group and the model group were gavaged with the same dose of 0.9% sodium chloride solution. Continuous administration was carried out for 2 months.

[0069] 4. Experimental steps:

[0070] According to the above injection protocol, the status of the mice was observed every day, and the death of the mice was recorded.

[0071] According to the above injection protocol, behavioral tests were started at week 0, including changes in mouse body weight, endurance, and grip strength. After 2 months of drug intervention, the mice were sacrificed by cervical dislocation, and the quadriceps femoris of the hind limbs was removed and placed in a fixative for standby. PCR, WB, and immunohistochemical staining were performed to observe changes in protein expression, and Sirius red and HE staining were used to observe muscle atrophy and collagen deposition in the mice.

[0072] 4.1 Changes in body weight, endurance, and grip strength of mice in each group:

[0073] Method for measuring mouse body weight:

[0074] The measurement of mouse body weight was based on the standard operating procedure for weighing. Experimental equipment: Electronic balance (range: 0-200 g, sensitivity: 0.01 g). Operating steps: Select a stable and vibration-free workbench to place the electronic balance, avoiding direct sunlight and air flow interference. Plug in the power supply and turn on the machine. After the balance self-check is completed and it shows ready, perform calibration and zero adjustment. Place a weighing box of appropriate size on the balance tray, press the "tare" key to make the balance display zero. According to the "Operating Procedures for Catching and Fixing Experimental Animals", hold the mouse's tail with the right hand, gently lift it, then hold the skin on the back of the mouse's neck with the thumb and index finger of the left hand to fix its head, and place the mouse in the palm of the left hand. Gently place the mouse into the weighing box, and read the value after the balance value is stable. If the value keeps jumping, the intermediate value can be selected for recording. The recorded value needs to be filled in the special experimental original record form. After weighing, put the mouse back into the cage, cover the cage lid, put it back on the cage rack, and insert the water bottle. After weighing, turn off the power supply of the balance, disconnect the power cord, wipe the balance with a clean soft cloth, ensure its cleanliness and then put it back in place, and fill in the usage record of the balance.

[0075] Method for measuring mouse grip strength:

[0076] The forelimb grip strength of mice was measured using a grip strength meter for rats and mice (Beijing Zhongshi Dichuang Technology Co., Ltd., ZS-ZL). The mice were lifted and fixed by their tails so that their limbs could grasp a wire mesh. Then, the mice were gently pulled backward by their tails with their postures parallel to the table surface until they released the mesh. The peak force exerted by the limbs of the mice was recorded in grams (g). It was evaluated every 0, 4, and 8 weeks. Each mouse was tested three times, and the average value was taken. After weighting by body weight, it was used for statistical analysis.

[0077] Method for measuring mouse endurance:

[0078] Running exhaustion exercise experiment: It was tested using an animal running experiment bench (Beijing Zhongshi Dichuang Technology Co., Ltd., ZS-PT-Ⅲ). The mice were placed on the treadmill track. The initial speed and slope were set at 5 m / min and 0 degrees respectively. Every 5 minutes, the speed and slope were increased by 5 m / min and 5 degrees respectively until they reached 20 m / min and 14 degrees respectively, and the exhaustion exercise time was recorded. Definition of exhaustion: The mice did not get on the track for at least 20 s, indicating a significant decrease in the response of the mice to external stimuli. If the mice did not exhaust within 3 h, the recorded time was 3 h. It was measured once every 4 weeks.

[0079] 4.2 Changes in the expression of p53 and p21 proteins:

[0080] p53 and p21 proteins play important roles in the occurrence and development of sarcopenia. p53 is an important tumor suppressor protein involved in cell cycle regulation, DNA repair, and apoptosis. In sarcopenia, the activation of p53 leads to cell cycle arrest and the senescence of muscle cells. p21 is a downstream target gene of p53, and the increase in its expression inhibits cell proliferation and further exacerbates muscle atrophy. Research has shown that by inhibiting the activities of p53 and p21, the senescence and atrophy of muscle cells can be alleviated, thus playing a certain role in improving sarcopenia. The muscle tissues of the mice were sectioned and subjected to PCR, WB detection, and immunohistochemical staining.

[0081] 4.3 Detection of muscle atrophy in mice by hematoxylin-eosin (HE) staining

[0082] First, the freshly obtained muscle samples were placed in 4% neutral formaldehyde solution for 24-hour tissue fixation, followed by gradient ethanol dehydration treatment (70%-100%), xylene transparency, and paraffin embedding in sequence. The embedded tissue was prepared into 5-μm thick continuous sections using a rotary microtome. After the sections were dewaxed with xylene, rehydration was carried out through reverse gradient ethanol (100%-70%). The staining process strictly followed the standard operating procedures: after the sections were stained with Harris hematoxylin for 5 to 10 minutes, appropriate differentiation was carried out using 1% hydrochloric acid ethanol solution. After rinsing with running water to turn blue, counterstaining was performed with 0.5% eosin ethanol solution for 3 to 5 minutes. The sections that completed the staining steps were dehydrated with gradient ethanol and made transparent with xylene, and then permanently mounted with neutral resin. The cross-sectional area, arrangement regularity, and nuclear distribution of muscle fibers were observed under a microscope.

[0083] 4.4 Observation of collagen deposition in muscle by Sirius red staining

[0084] The freshly obtained quadriceps femoris specimens of mice were immediately placed in 4% neutral buffered formaldehyde solution for 24-hour fixation, followed by gradient ethanol dehydration treatment (70%, 85%, 95%, 100%), xylene transparency, and paraffin embedding procedures. 5-μm thick continuous sections were prepared using a Leica RM2245 semi-automatic microtome. After dewaxing with xylene and rehydration through reverse gradient ethanol (100% to 70%), the sections were immersed in 0.1% Sirius red acidic staining solution (pH 2.5) for light-avoiding staining for 15 - 30 minutes. After staining, the sections were thoroughly rinsed with double-distilled water, dehydrated through gradient ethanol and made transparent with xylene in sequence, and finally permanently sealed with DPX neutral mounting medium. The distribution and deposition of collagen fibers in muscle tissue were observed under a microscope.

[0085] 4.5 Statistical methods:

[0086] All data were statistically analyzed using SPSS 26.0 software. Measurement data were expressed as . Two-way ANOVA was used for comparison of data among multiple groups, and Fisher's LSD-t test was used for comparison between two groups. A P < 0.05 was considered statistically significant.

[0087] 5. Results:

[0088] 5.1 Effect of the traditional Chinese medicine composition on the muscle strength of sarcopenia model mice

[0089] The results of the effect of the traditional Chinese medicine composition of the present invention on the muscle strength of sarcopenia model mice are as follows Figure 1As shown in the figure, before administration, there were no significant differences in muscle strength among C57BL / 6 mice in each group, indicating that the experimental system was reliable and comparable among groups. Four weeks after administration, compared with the model group, the muscle strength of the control group increased significantly (P<0.05); the muscle strength of the low- and high-dose groups increased significantly (P<0.01). Eight weeks after administration, compared with the model group, the muscle strength of the low- and high-dose groups increased significantly (P<0.05).

[0090] 5.2 Effect of the traditional Chinese medicine composition on the body weight of sarcopenia model mice

[0091] The results of the effect of the traditional Chinese medicine composition of the present invention on the body weight of sarcopenia model mice are as Figure 2 shown. Eight weeks after administration, compared with the model group, the body weight of the low-concentration drug group of the present invention increased significantly by 8.34% compared with the model group (95% CI: 3.11%-13.57%) (P<0.05); the body weight of the high-concentration drug group of the present invention increased significantly by 10.96% compared with the model group (95% CI: 5.60%-16.32%) (P<0.05).

[0092] 5.3 Effect of the drug of the present invention on the endurance of sarcopenia model mice

[0093] At the 8th week of administration, the grip strength of the four limbs and the running exhaustion time of mice in each group were measured. The results showed that compared with the control group, the running duration of the model group and the drug groups of the present invention with different doses decreased significantly (P<0.01). After treatment with the drug of the present invention, the running duration increased and showed a dose-dependent relationship (P<0.05, P<0.01). See Table 1.

[0094] Table 1 Effect of the traditional Chinese medicine composition of the present invention on the endurance of sarcopenia model mice

[0095]

[0096] Compared with the control group, *P<0.05, **P<0.01; compared with the model group △ P<0.05, △△ P<0.01

[0097] 5.4 The drug of the present invention can improve the muscle mass of D-gal-induced aging mice:

[0098] As Figure 6 shown, the HE staining results showed that compared with the control group, the average cross-sectional area of the quadriceps muscle fibers in the sarcopenia model group was significantly reduced. After intragastric administration with the drug of the present invention, the average cross-sectional area of the muscle fibers recovered and increased, and the increasing trend was positively correlated with the concentration of the drug of the present invention, and the differences were all statistically significant; as Figure 7, The Sirius red staining results showed that compared with the control group, the deposition of collagen fibers in the quadriceps muscle of the sarcopenia model group was significantly increased. After intragastric administration of the drug of the present invention, the deposition of collagen fibers in the muscle decreased, and the decreasing trend was positively correlated with the concentration of the drug of the present invention. The differences were statistically significant. In summary, the drug of the present invention can improve the muscle mass of mice in the sarcopenia model group.

[0099] 6. Conclusion:

[0100] The comprehensive data of this study indicate that the traditional Chinese medicine composition of the present invention has multi-dimensional improvement effects on sarcopenia model mice.

[0101] In terms of muscle strength, a dose-dependent effect was shown 4 weeks after administration. The muscle strength of the low- and high-dose groups was significantly increased compared with the model group (P<0.01), and the effect continued until the 8th week (P<0.05), suggesting that the drug has the characteristics of rapid onset and continuous intervention.

[0102] In terms of body weight, after 8 weeks of intervention, the low- and high-dose groups were significantly increased by 8.34% (95% CI: 3.11%-13.57%) and 10.96% (95% CI: 5.60%-16.32%) respectively compared with the model group. The effect intervals completely excluded the invalid values, confirming that the drug can reverse the catabolic state related to sarcopenia. The endurance test showed that the drug significantly increased the running exhaustion time (P<0.05 to P<0.01), and the dose-effect relationship was clear, suggesting that the improvement of exercise tolerance was positively correlated with the drug exposure.

[0103] Histological evidence further revealed its mechanism of action: HE staining showed that the drug dose-dependently restored the cross-sectional area of muscle fibers, and Sirius red staining confirmed the reduction of collagen fiber deposition. The two together verified that the drug can improve muscle mass through dual pathways - promoting myofibril hyperplasia and inhibiting the process of interstitial fibrosis.

[0104] In summary, the traditional Chinese medicine composition of the present invention effectively reverses the pathological process of D-gal-induced sarcopenia through multi-target intervention. Its action characteristics are: rapidly improving muscle strength and endurance function; continuously promoting muscle mass reconstruction; significantly dose-dependent effect; and having dual effects of anti-atrophy and anti-fibrosis. These findings provide key experimental basis for clinical application. Especially the 10.96% body weight gain and muscle fiber area recovery suggest its important translational potential in the treatment of senile sarcopenia.

[0105] Example 3. Animal experiments to verify the efficacy of different ratios of traditional Chinese medicine compositions

[0106] 1. Experimental animals: 70 8-week-old male C57BL / 6 mice (Henan Sikebes Biotechnology Co., Ltd.), with a body weight of (30±3) g. The mice were divided into 7 groups, namely the control group, model group, formula group I, formula group II, formula group III, formula group IV, and formula group V, with 10 mice in each group. Except for the control group, the other six groups were intraperitoneally injected with D-gal 0.9% sodium chloride solution at a dose of 150 mg / kg according to the body weight of the mice, and the control group was intraperitoneally injected with the same dose of 0.9% sodium chloride solution, once every other day. The physical signs of the mice were observed daily, and obvious signs of aging such as dark fur color, poor skin elasticity, listlessness, significantly reduced food intake, and slow weight gain appeared, indicating that the sarcopenia mouse model was successfully constructed.

[0107] 2. Experimental drugs: Ginseng, Cistanche, Polygonatum, Poria, Gastrodia, Atractylodes; Formula I is: Ginseng 15 parts, Cistanche 18 parts, Polygonatum 25 parts, Poria 15 parts, Gastrodia 15 parts, Atractylodes 20 parts;

[0108] Formula II is: 10 parts of Glossy Ginseng, 15 parts of Cistanche deserticola, 35 parts of Polygonatum sibiricum, 8 parts of Poria cocos, 10 parts of Gastrodia elata, and 15 parts of Atractylodes macrocephala;

[0109] Formula III is: 15 parts of Glossy Ginseng, 10 parts of Cistanche deserticola, 20 parts of Polygonatum sibiricum, 15 parts of Poria, 15 parts of Gastrodia elata, and 10 parts of Atractylodes macrocephala;

[0110] Formula IV is: 10 parts of Glossy Ginseng, 10 parts of Cistanche deserticola, 45 parts of Polygonatum sibiricum, 10 parts of Poria, 10 parts of Gastrodia elata, and 25 parts of Atractylodes macrocephala;

[0111] Formula V is: 10 parts of Glossy Ginseng, 25 parts of Cistanche Deserticola, 20 parts of Polygonatum, 8 parts of Poria, 15 parts of Gastrodia, and 18 parts of Atractylodes.

[0112] 3. Injection scheme: Groups I to V were given 120 mg / kg of the drug by intragastric administration daily, and the control group and model group were given the same dose of 0.9% sodium chloride solution by intragastric administration for 2 months.

[0113] 4. Experimental steps:

[0114] According to the above injection scheme, the mice were observed every day and the death of mice was recorded.

[0115] Following the injection protocol, behavioral tests were performed starting from week 0, including changes in mouse weight, endurance, and grip strength. Mice were killed by cervical dislocation 2 months after drug intervention.

[0116] The experimental detection method is the same as that described in Section 4.1 of Example 2

[0117] Comparison of body weight, grip strength and exhaustion time among the five doses of mice in the eighth week is shown in Figures 3 - 5 .

[0118] 5. Conclusion:

[0119] There were no significant statistical differences in the initial body weight, grip strength, and exhaustion time of the mice at week 0. After 8 weeks of drug administration, there were significant differences in body weight, grip strength, and exhaustion time between the model group and the control group (p < 0.01), proving that the model was successfully established.

[0120] Compared with the model group, Formulas I-V all showed significant statistical differences (p < 0.05), indicating that different ratios of the drugs of the present invention have therapeutic effects on the body weight of the sarcopenia animal model. Formula I showed significant improvement in all three indicators of body weight, grip strength, and exhaustion time, being significantly higher than the model group in statistical significance (p < 0.0001), and also showing higher values compared to other formula groups, fully indicating that Formula I has a significant effect in promoting weight gain and ranks first among all formulas. Further observation found that Formula IV ranked second, and still showed relatively obvious curative effects when compared with the other formula groups (p < 0.001).

[0121] At present, there is no clear literature at home and abroad explaining the specific weights of the 4 efficacy indicators for sarcopenia. Therefore, the inventor used the entropy weight method to calculate the relative weights. According to the data of body weight, grip strength, and exhaustion time of 7 groups of 8 mice collected, a matrix X was formed. Using the min-max normalization method and using Formulas 1-4, Formula 1

[0122]

[0123] Formula 2

[0124]

[0125] Formula 3

[0126]

[0127] Formula 4

[0128]

[0129] Among them, x' ij represents the element in the data matrix after normalization of data i-j, i represents the sample number, and j represents the index number; p ij represents the relative proportion of the i-th sample on the j-th index, and the value range of p ij is in [0, 1], that is E j represents the information entropy of the j-th index, and ω j represents the weight of the j-th index calculated by the information entropy.

[0130] The entropy weight vector ω = [0.33, 0.33, 0.34] was obtained

[0131] Therefore, the efficacy weights are as follows: body weight 33%; grip strength 34%; exhaustion time 34%. Multiply the normalized data by the efficacy weights to draw the conclusion that Formula I has significantly better efficacy than Formulas II-V, and Formula IV ranks second (see Table 3).

[0132] Table 3: Body weight, grip strength, and exhaustion time of mice in the eighth week

[0133] Note: Compared with the model group, for body weight: **: p < 0.05; ***: p < 0.01; ****: p < 0.001;

[0134]

[0135] For grip strength: △△: p < 0.05; △Δ△: p < 0.01; △ΔΔ△: p < 0.001;

[0136] For exhaustion time: ●●: p < 0.05; ●●●: p < 0.01; ●●●●: p < 0.001;

[0137] Example 4. Clinical trial of a traditional Chinese medicine composition for treating sarcopenia

[0138] This study was a multi-center, randomized, double-blind, placebo-controlled phase III clinical trial. The trial protocol was approved by the Ethics Committee of Hubei Provincial Hospital of Traditional Chinese Medicine (approval number: HBZY2024-C102-02). The aim was to evaluate the efficacy and safety of a traditional Chinese medicine compound in patients with sarcopenia. The trial period was 24 weeks in total, including a 2-week screening period, a 12-week intervention period, and a 10-week follow-up period. Elderly patients who visited our outpatient clinic from June 2024 to February 2025 and were clearly diagnosed with elderly sarcopenia through screening, a total of 50 cases, were divided into a treatment group and a control group according to the random number table.

[0139] 1. Inclusion criteria

[0140] (1) Age ≥ 60 years, meeting the diagnostic criteria of the Asian Working Group for Sarcopenia (AWGS2019):

[0141] (2) Grip strength (for men < 28 kg, for women < 18 kg);

[0142] (3) Appendicular skeletal muscle index (ASMI, for men < 7.0 kg / m 2 , for women < 5.7 kg / m 2 );

[0143] (4) 6-meter walking speed ≤ 1.0 m / s.

[0144] Voluntarily signed the informed consent form and met the follow-up conditions.

[0145] 2. Exclusion criteria

[0146] (1) Severe organic diseases (cardiac function grade III-IV, eGFR < 30 mL / min / 1.73m 2 , ALT / AST > 3 times the upper limit);

[0147] (2) Received hormone therapy, creatine supplementation, or anti-inflammatory biologics within 3 months;

[0148] (3) Cognitive impairment or mental illness that prevents cooperation with the assessment.

[0149] 3. Interventions

[0150] 3.1 Drug preparation and grouping Experimental group: Traditional Chinese medicine compound granules (sugar ginseng: cistanche: polygonatum: poria: gastrodia: atractylodes macrocephala = 15:18:25:15:15:20), produced by a GMP-certified pharmaceutical factory, each bag contains 15 g of crude drug, taken orally twice a day with warm water.

[0151] Control group: Placebo granules (dextrin + caramel pigment), with the same appearance and taste as the experimental group, and the same dose and frequency.

[0152] 3.2 Randomization and blinding

[0153] The subjects were stratified and randomly assigned in a 1:1 ratio (stratified by gender and age) using a central randomization system (IWRS), and the packaged drugs were only labeled with random codes.

[0154] The research physicians, assessors, statisticians, and subjects were all unaware of the grouping information, and the emergency unblinding procedure was managed by an independent data monitoring committee (DMC).

[0155] 4. Evaluation indicators

[0156] 4.1 Muscle function assessment:

[0157] Muscle function was assessed using a CAMRY EH101 digital isometric handgrip dynamometer (accuracy ±0.1 kgf). The subject stood upright, with the dominant upper limb hanging naturally, the elbow fully extended, and the wrist in a neutral position. During the test, the subject performed a 3-second isometric contraction, gripping as hard as possible until the beep sounded, and the device automatically captured the peak torque (unit: kilogram-force, kgf). A 2-minute interval was set between each round of testing to reduce the influence of muscle fatigue. A total of 3 sets of valid data were collected, and the best value was selected as the functional assessment parameter after standardization and calibration. According to the 2019 guidelines of the Asian Working Group for Sarcopenia (AWGS), a peak torque of < 28 kgf in men and < 18 kgf in women was defined as the threshold for clinically significant muscle strength decline.

[0158] 4.2 Physical function assessment:

[0159] Assessment of dynamic exercise endurance (6-meter gait analysis)

[0160] This test uses an electro-optical distance measurement system (accuracy ±0.01 s) to measure the linear movement efficiency of the subjects under their autonomous gait. The test area is a standardized corridor with a constant temperature (22 ± 2 °C) and an illuminance of 500 lux. The subjects stand naturally 1 meter behind the starting line and, after a voice prompt, complete a 6-meter straight walk at their habitual walking speed (the effective range is the middle 4 meters to eliminate acceleration interference). The average walking speed (m / s) is calculated through a three-dimensional motion capture system (sampling rate 100 Hz), and the median value is taken from three consecutive tests. According to the 2019 guidelines of the Asian Working Group for Sarcopenia (AWGS), a walking speed < 1.0 m / s is defined as the threshold for significantly limited motor function.

[0161] Round-trip movement function test (10 m × 2 compound task)

[0162] On a non-slip epoxy resin floor, double reflective cone markers (diameter 30 cm) with a spacing of 10.5 meters are set up. The subjects sit upright on a standard armless hard seat (seat height 45 cm, compliant with ISO 7174-1). After the test instructions are issued, the data during the movement period are completely recorded. The acceleration / deceleration areas of 1.5 meters are deducted from both the beginning and the end, and the round-trip speed in the middle 7 meters is accurately measured; there is a 5-minute interval between each round of tests, and finally the best performance data are taken, excluding abnormal gaits (such as shuffling steps, holding on to the wall) from the records.

[0163] 4.3 Safety assessment

[0164] Monitor blood routine, liver and kidney functions (ALT, AST, Cr, BUN) every 4 weeks;

[0165] Record the type, frequency, severity of adverse events (AE) and their correlation with the drug.

[0166] 5. Results

[0167] The baseline assessment between groups before the intervention showed that there were no statistically significant differences in motor function indicators such as grip strength, 6-meter walking speed, and 10-meter shuttle movement test between the two groups of subjects (P > 0.05). The data analysis after the intervention showed that: the muscle strength indicators of the experimental group showed a positive trend, and the grip strength value increased significantly from the baseline level (15.25 ± 1.64 kg) to 17.29 ± 1.72 kg (Δ = 2.04 kg), indicating the effective reconstruction of neuromuscular function; in the dimension of motor function, the 6-meter walking speed increased from the initial 0.6 ± 0.05 m / s to 0.85 ± 0.06 m / s (Δ = 0.25 m / s), and this change reached the threshold of the smallest clinically important difference, confirming the substantial improvement of walking function; in the 10-meter shuttle test, both the standing-up time and the completion time of the patients decreased, reflecting the synchronous improvement of dynamic balance ability and motor coordination. After verification by paired sample t-test, the post-test values of all motor function parameters in the experimental group showed statistically significant positive changes compared with the pre-test (P < 0.05), as shown in the longitudinal data comparison in Table 2.

[0168] Table 2 Influence of the traditional Chinese medicine composition of the present invention on patients with sarcopenia

[0169]

[0170] Note: Compared with before treatment, *** P < 0.01

[0171] 6. Summary

[0172] Based on animal experiments, it is found that the traditional Chinese medicine composition of the present invention can improve the body weight, endurance, muscle strength, and muscle mass of sarcopenia model mice, delay the aging process, and at the same time improve the muscle function and physical function of patients with sarcopenia, indicating that the traditional Chinese medicine composition of the present invention can be used as a drug for the treatment of sarcopenia.

[0173] In the application of the traditional Chinese medicine composition of the present invention, it can be made into dosage forms such as decoction, granule, tablet, capsule, big honey pill, water honey pill (small honey pill), water pill, concentrated water pill, concentrated honey pill, paste, powder, tea bag, foot bath bag, or external application bag according to the actual situation, which is not limited herein.

[0174] In summary, the present invention provides a traditional Chinese medicine composition for the treatment of sarcopenia, and proposes a traditional Chinese medicine combination drug for the treatment of sarcopenia with clear pharmacodynamic substances, stable compatibility components, controllable quality, reliable effectiveness and safety, solving the problems that the existing technology is unclear about the action mechanism of traditional Chinese medicine on sarcopenia and lacks a traditional Chinese medicine prescription for the treatment of sarcopenia with clear components and clear action mechanism.

[0175] Finally, it should be noted that the above embodiments are only used to illustrate the present invention and do not limit the protection scope of the present invention. In addition, after reading the technical content of the present invention, those skilled in the art can make various changes, modifications, or variations to the present invention, and all these equivalent forms also belong to the protection scope defined by the present application.

Claims

1. A Chinese medicine composition for treating sarcopenia, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-25 parts of Glossy Ganoderma, 10-25 parts of Cistanche deserticola, 20-45 parts of Polygonatum sibiricum, 8-20 parts of Poria, 10-25 parts of Gastrodia elata, and 10-25 parts of Atractylodes macrocephala.

2. A Chinese medicine composition for treating sarcopenia according to claim 1, characterized in that: The formula of the Chinese medicine composition is one of the following five: 15 parts of Glossy Ginseng, 18 parts of Cistanche Deserticola, 25 parts of Polygonatum, 15 parts of Poria, 15 parts of Gastrodia, 20 parts of Atractylodes; or 10 parts of Glossy Ginseng, 15 parts of Cistanche Deserticola, 35 parts of Polygonatum, 8 parts of Poria, 10 parts of Gastrodia, 15 parts of Atractylodes macrocephala; or 15 parts of Glossy Ginseng, 10 parts of Cistanche Deserticola, 20 parts of Polygonatum, 15 parts of Poria, 15 parts of Gastrodia, 10 parts of Atractylodes; or 10 parts of Glossy Ginseng, 10 parts of Cistanche Deserticola, 45 parts of Polygonatum sibiricum, 10 parts of Poria, 10 parts of Gastrodia elata, 25 parts of Atractylodes macrocephala; or 10 parts of Glycyrrhiza uralensis, 25 parts of Cistanche deserticola, 20 parts of Polygonatum sibiricum, 8 parts of Poria cocos, 15 parts of Gastrodia elata, and 18 parts of Atractylodes macrocephala.

3. A Chinese medicine composition for treating sarcopenia according to claim 1, characterized in that: The traditional Chinese medicine composition also includes pharmaceutically acceptable excipients.

4. A Chinese medicine composition for treating sarcopenia according to claim 3, characterized in that: The dosage forms of the Chinese medicine composition include decoction, granules, paste, pills, powders, tablets and capsules.

5. A Chinese medicine composition for treating sarcopenia according to claim 1, characterized in that: The preparation method of the Chinese medicine composition is: S1. Ginseng, Cistanche deserticola, Polygonatum sibiricum, Poria cocos, Gastrodia elata, and Atractylodes macrocephala are processed in a refined manner: Ginseng is soaked in rice water and then dried and sliced ​​at low temperature; Cistanche deserticola is soaked in rice wine and steamed to soften; Polygonatum sibiricum is processed by the traditional nine-steaming and nine-drying method to enhance its medicinal activity; Poria cocos is soaked in water and then sliced; Gastrodia elata is steamed in rice soup to retain its volatile components; and Atractylodes macrocephala is fried with bran to enhance its spleen-strengthening effect; S2, the medicinal materials processed in step S1 are weighed and mixed in proportion, and then 8 times the amount of 40-50°C deionized water is added to soak for 90-120 minutes until they are fully expanded, and then two-stage dynamic decoction is performed: the first decoction is boiled quickly over high heat and then slowly decocted at 85°C for 60 minutes, and the second decoction is decocted for 45 minutes with 6 times the amount of water. Polygonatum sibiricum and Cistanche deserticola contain a large amount of polysaccharides and need to be decocted separately for 30 minutes to prevent the complexation of the components; S3. The two decoctions of the medicinal solution obtained in step S2 are combined and filtered, and then concentrated to a relative density of 1.10-1.15 under reduced pressure at 60° C., and the colloids and suspended particles are removed by centrifugation at 3000 rpm for 15 minutes to obtain a clear concentrated solution, which is the effective medicinal solution.

6. The method for preparing a traditional Chinese medicine composition for treating sarcopenia according to claim 5, characterized in that: To ensure the quality of the medicinal solution, the concentrated solution obtained in step S3 is sterilized at 135°C for 5 seconds to inactivate the microorganisms while retaining the heat-sensitive components. The content of ginsenoside Rb1 and echinacoside from Cistanche deserticola is monitored by HPLC, with ginsenoside Rb1 ≥ 0.8 mg / mL and echinacoside from Cistanche deserticola ≥ 0.5 mg / mL as the quantitative qualification standards for key active ingredients.

7. Use of a traditional Chinese medicine composition for treating sarcopenia according to any one of claims 1 to 6 in the preparation of a drug for treating spleen-deficiency type sarcopenia.

8. A method for calculating the weight of a sarcopenia efficacy index, characterized in that: The entropy weight method was used to calculate the relative weights of the three efficacy indicators, namely body weight, grip strength, and exhaustion time. The matrix X was formed based on the collected data on body weight, grip strength, and exhaustion time of experimental animals. The minimum-maximum standardization method was used, using formulas 1-4. Formula 1 Formula 2 Formula 3 Formula 4 Among them, x' ij represents the element in the data matrix after data ij is standardized, i represents the sample number, j represents the indicator number; p ij represents the relative weight of the i-th sample on the j-th indicator, p ij The value range of is [0,1], that is, E j represents the information entropy of the jth indicator, ω j Indicates that the j-th indicator weight is calculated by information entropy. Get the entropy weight vector ω = [A, B, C] The therapeutic weights were determined as follows: body weight (A); grip strength (B); time to exhaustion (C).

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