Traditional chinese medicine composition for preventing and treating sarcopenia, method for preparing same, and use thereof

Abstract

Disclosed is a traditional Chinese medicine composition for preventing and / or treating sarcopenia. The traditional Chinese medicine composition comprises, in parts by weight, 9-11 parts of Citri Reticulatae Pericarpium, 9-11 parts of Achyranthis Bidentatae Radix, 9-11 parts of Hordei Germinatus Fructus, 9-11 parts of Drynariae Rhizoma, 9-11 parts of Eucommiae Cortex, 9-11 parts of Lycii Fructus, 13.5-16.5 parts of Astragali Radix, and 13.5-16.5 parts of Cibotii Rhizoma. The traditional Chinese medicine composition in the present invention can improve the muscle strength, muscle mass and muscle functions, reduce the body fat mass, and delay the aging process, and has no significant influence on the food intake, suggesting that the traditional Chinese medicine composition can be used as a medicine for treating sarcopenia.

Description

A traditional Chinese medicine composition for preventing and treating sarcopenia, and its preparation method and use Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a traditional Chinese medicine composition for preventing and treating sarcopenia, and a preparation method and use thereof. Background Art

[0002] Sarcopenia (abbreviated as "sarcopenia") is a common disease in middle-aged and elderly people. Its main clinical manifestation is the chronic and progressive reduction of muscle mass and quantity with aging, leading to loss of muscle strength [Dent E, Morley JE, Cruz-Jentoft AJ, et al. International Clinical Practice Guidelines for Sarcopenia (ICFSR): Screening, Diagnosis and Management. J Nutr Health Aging. 2018; 22(10): 1148-1161.]. Sarcopenia can cause adverse consequences and is closely related to limb dysfunction, reduced self-care ability and a significantly increased risk of fractures in the elderly, bringing great economic and social burdens [Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29; 393(10191): 2636-2646.]. Studies have shown that human muscle reaches its peak at the age of 40, and then muscle mass gradually declines.The 2016 Asian Sarcopenia Management Guidelines estimated the prevalence of sarcopenia in Chinese adults aged 60 to 70 years to be between 4.1% and 11.5%. The prevalence of sarcopenia in men and women aged 70 years and above was 13.2% and 4.8%, respectively. The prevalence increased significantly in people over 80 years of age, reaching a maximum of 50% [Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyère O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoudé M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019. Jan1;48(1):16-31. Liu Juan, Ding Qingqing, Zhou Baiyu, Liu Xiang, Liu Jingmin, Liu Yongming, Ding Guoxian, Zhang Cuntai, Wang Jianye, Yu Pulin, Chinese Society of Geriatrics, Editorial Board of Chinese Journal of Geriatrics. Expert consensus on the diagnosis and treatment of sarcopenia in the elderly in China (2021)[J]. Chinese Journal of Geriatrics, 2021, 40(8):943-952.]. With the advent of an aging society, the incidence of sarcopenia is increasing year by year, seriously affecting the quality of life and health of the elderly.According to epidemiological surveys, the prevalence of sarcopenia in the elderly is 10.8%-38.8% [Chen Shu, Yu Jing, Di Wenjuan, et al. Epidemiological survey of sarcopenia in the elderly in Nanjing community and analysis of its influencing factors [J]. Practical Geriatrics, 2020, 34(08): 793-796. Che Yajie, Yang Xuanxuan, Zhang Ke, et al. Current status and related factors of sarcopenia in the elderly in Urumqi community [J]. Chinese Journal of Osteoporosis and Bone Mineral Diseases, 2020, 13(04): 304-310.], and the prevalence increases significantly with age, reaching 53.2% in the elderly aged 80 years and above [Meng P, Hu YX, Fan L, et al. Sarcopenia and sarcopenic obesity among men aged 80 years and older in Beijing: prevalence and its association with functional performance [J]. Geriatr Gerontol Int. 2014, 14(1): 29-35.]. Therefore, it has attracted widespread attention from scholars at home and abroad, and extensive research has been conducted in the fields of risk factors, pathogenesis, and treatment of the disease. However, there are still differences in the understanding of the disease at home and abroad. In addition, since the cause of sarcopenia is still unknown, it is related to multiple factors and involves complex and interrelated molecular mechanisms, which makes the treatment of the disease difficult. Currently, there is still a lack of a single effective treatment for sarcopenia. Resistance exercise is the main non-drug therapy for improving muscle mass and function, but in reality, elderly patients have poor compliance with resistance exercise. Therefore, exploring effective treatment methods is an important direction in the current research field of sarcopenia treatment.

[0003] Traditional Chinese Medicine (TCM) has accumulated considerable clinical experience in treating sarcopenia. TCM categorizes the clinical manifestations of muscle thinness, weakness, and frailty as "frailty," similar to the clinical manifestations of sarcopenia, which are characterized by decreased muscle mass, strength, or physical function. Because sarcopenia and frailty share a high degree of overlap, TCM often treats sarcopenia from the perspective of frailty, with excellent results. Ancient TCM texts document a close relationship between the pathogenesis of frailty and the spleen and kidneys. The "Suwen (Suwen) Yin Yang Ying Xiang Da Lun" states that "the spleen produces flesh," while the "Suwen (Suwen) Annotations (Suwen) Wu Zang Cheng Cheng Pian" states that "the spleen governs the transportation and transformation of the essence of water and grain to nourish the muscles." Muscles rely on the spleen to transform water and grain into qi and blood for nourishment. A healthy spleen, abundant qi and blood, results in full and strong muscles. The Suwen (Suwen) states, "Why do the five zang organs cause weakness? ... The spleen governs the body's muscles. Heat in the spleen leads to stomach heat and thirst, and muscle insensitivity, resulting in muscle weakness." The Suwen (Suwen) states, "Those with spleen disease feel heavy, prone to muscle weakness, and unable to move their feet." These observations highlight the pathological correlation between the spleen and muscle atrophy. When the spleen is weak and inadequate, it cannot transform food and water into qi and blood, leading to muscle malnutrition and weakness in the limbs, resulting in weakness, wasting, and motor dysfunction. Furthermore, the growth and aging of the human body are governed by the rise and fall of kidney qi. Sarcopenia, an age-related geriatric syndrome, is even more closely linked to kidney qi deficiency. "Suwen: Treatise on Ancient Innocence" states: "At the age of eight, a man's kidney qi is strong, his hair grows, and his teeth change... At fifty-eight, his kidney qi declines, his hair falls, and his teeth wither. At sixty-eight, his yang qi declines from above, his face becomes scorched, and his hair and temples turn gray. At seventy-eight, his liver qi declines, and his tendons become immobile. At eighty-eight, his celestial essence is exhausted, his essence is dwindling, his kidneys weaken, and his physical form reaches its limit, leading to the loss of hair and teeth." This indicates that human growth and aging, including the fullness and firmness of muscles and their weakening and atrophy, change with the rise and fall of kidney qi. With spleen and kidney deficiency, muscle function progressively declines, and the incidence of sarcopenia increases. The spleen and kidney in Traditional Chinese Medicine are closely linked to the pathogenesis of sarcopenia, and treating sarcopenia from the perspective of the spleen and kidney is theoretically feasible. Our previous epidemiological survey of sarcopenia syndromes in Traditional Chinese Medicine found that approximately 80% of patients with sarcopenia exhibit a TCM syndrome of "spleen and kidney deficiency."

[0004] There is no prior art that the Chinese medicine composition claimed in the present invention can be used to prevent and / or treat sarcopenia.

[0005] Summary of the Invention

[0006] Based on this, the present invention provides a traditional Chinese medicine composition for preventing and / or treating sarcopenia, wherein the raw materials of the traditional Chinese medicine composition include 9-11 parts of dried tangerine peel, 9-11 parts of radix achyranthis Bidentatae, 9-11 parts of malt, 9-11 parts of rhizoma drynariae, 9-11 parts of eucommia barbarum, 9-11 parts of fructus wolfberrye, 13.5-16.5 parts of astragalus and 13.5-16.5 parts of citronella; or, the raw materials of the traditional Chinese medicine composition include 9-11 parts of dried tangerine peel, 18-22 parts of radix achyranthis Bidentatae, 13.5-16.5 parts of malt, 9-11 parts of rhizoma drynariae, 4.5-5.5 parts of eucommia barbarum, 9-11 parts of fructus wolfberrye, 13.5-16.5 parts of rhizoma astragali and 13.5-16.5 parts of citronella; 13.5-16.5 parts of wolfberry, 13.5-16.5 parts of astragalus and 9-11 parts of dog spine; or, calculated by weight, the raw materials of the traditional Chinese medicine composition include 13.5-16.5 parts of dried orange peel, 13.5-16.5 parts of cyperus rotundus, 13.5-16.5 parts of malt, 13.5-16.5 parts of drynaria, 13.5-16.5 parts of eucommia, 13.5-16.5 parts of wolfberry, 4.5-5.5 parts of astragalus and 4.5-5.5 parts of dog spine; or, calculated by weight, the raw materials of the traditional Chinese medicine composition include 18-22 parts of dried orange peel, 9-11 parts of cyperus rotundus, 13.5-16.5 parts of malt, 13.5-16.5 parts of drynaria, 13.5-16.5 parts of eucommia, 13.5-16.5 parts of wolfberry, 4.5-5.5 parts of astragalus and 4.5-5.5 parts of dog spine; 13.5-16.5 parts of dried tangerine peel, 13.5-16.5 parts of radix achyranthis Bidentatae, 9-11 parts of malt, 9-11 parts of dried tangerine peel, 4.5-5.5 parts of dried tangerine peel, 4.5-5.5 parts of eucommia bark, 13.5-16.5 parts of radix astragali, and 13.5-16.5 parts of citronella; or, in parts by weight, the raw materials of the traditional Chinese medicine composition include 18-22 parts of dried tangerine peel, 13.5-16.5 parts of radix achyranthis Bidentatae, 9-11 parts of malt, 9-11 parts of dried tangerine peel, 4.5-5.5 parts of eucommia bark, 13.5-16.5 parts of radix astragali, and 13.5-16.5 parts of citronella; or, in parts by weight, the raw materials of the traditional Chinese medicine composition include 18-22 parts of dried tangerine peel, 13.5-16.5 parts of radix achyranthis Bidentatae, 9-11 parts of malt, Alternatively, the raw materials of the traditional Chinese medicine composition include 18-22 parts of dried tangerine peel, 18-22 parts of rhizoma achyranthes, 18-22 parts of malt, 13.5-16.5 parts of rhizoma drynariae, 13.5-16.5 parts of eucommia bark, 4.5-5.5 parts of wolfberry, 13.5-16.5 parts of astragalus and 9-11 parts of dog spine; or, in parts by weight, the raw materials of the traditional Chinese medicine composition include 18-22 parts of dried tangerine peel, 18-22 parts of rhizoma achyranthes, 18-22 parts of malt, 13.5-16.5 parts of rhizoma drynariae, 13.5-16.5 parts of eucommia bark, 13.5-16.5 parts of wolfberry, 13.5-16.5 parts of astragalus and 13.5-16.5 parts of dog spine.

[0007] Furthermore, in parts by weight, the raw materials of the traditional Chinese medicine composition include 9.5-10.5 parts of dried orange peel, 9.5-10.5 parts of Chinese clematis root, 9.5-10.5 parts of malt, 9.5-10.5 parts of drynaria rhizome, 9.5-10.5 parts of Eucommia bark, 9.5-10.5 parts of wolfberry, 14.25-15.75 parts of astragalus, and 14.25-15.75 parts of dog spine. Further, in parts by weight, the raw materials of the traditional Chinese medicine composition include about 10 parts of dried orange peel, about 10 parts of Chinese clematis root, about 10 parts of malt, about 10 parts of drynaria rhizome, about 10 parts of Eucommia bark, about 10 parts of wolfberry, about 15 parts of astragalus, and about 15 parts of dog spine. Furthermore, in parts by weight, the raw materials of the traditional Chinese medicine composition include 9.5-10.5 parts of dried orange peel, 19-21 parts of Chinese rhizome of radix achyranthis Bidentatae, 14.25-15.75 parts of malt, 9.5-10.5 parts of drynaria rhizome, 4.75-5.25 parts of eucommia bark, 14.25-15.75 parts of wolfberry, 14.25-15.75 parts of astragalus, and 9.5-10.5 parts of dog spine. Further, in parts by weight, the raw materials of the traditional Chinese medicine composition include about 10 parts of dried orange peel, about 20 parts of Chinese rhizome of radix achyranthis Bidentatae, about 15 parts of malt, about 10 parts of drynaria rhizome, about 5 parts of eucommia bark, about 15 parts of wolfberry, about 15 parts of astragalus, and about 10 parts of dog spine. Furthermore, in parts by weight, the raw materials of the traditional Chinese medicine composition include 14.25-15.75 parts of dried orange peel, 14.25-15.75 parts of radix polygoni multiflori, 14.25-15.75 parts of malt, 14.25-15.75 parts of rhizoma drynariae, 14.25-15.75 parts of eucommia bark, 14.25-15.75 parts of lycium barbarum, 4.75-5.25 parts of astragalus, and 4.75-5.25 parts of citronella. Further, in parts by weight, the raw materials of the traditional Chinese medicine composition include about 15 parts of dried orange peel, about 15 parts of radix polygoni multiflori, about 15 parts of malt, about 15 parts of rhizoma drynariae, about 15 parts of eucommia bark, about 15 parts of lycium barbarum, about 5 parts of astragalus, and about 5 parts of citronella. Furthermore, in parts by weight, the raw materials of the traditional Chinese medicine composition include 19-21 parts of dried tangerine peel, 9.5-10.5 parts of radix achyranthis Bidentatae, 14.25-15.75 parts of malt, 4.75-5.25 parts of rhizoma drynariae, 9.5-10.5 parts of eucommia bark, 14.25-15.75 parts of wolfberry, 9.5-10.5 parts of astragalus, and 14.25-15.75 parts of citronella. Further, in parts by weight, the raw materials of the traditional Chinese medicine composition include about 20 parts of dried tangerine peel, about 10 parts of radix achyranthis Bidentatae, about 15 parts of malt, about 5 parts of rhizoma drynariae, about 10 parts of eucommia bark, about 15 parts of wolfberry, about 10 parts of astragalus, and about 15 parts of citronella. Furthermore, in parts by weight, the raw materials of the traditional Chinese medicine composition include 19-21 parts of dried tangerine peel, 14.25-15.75 parts of Chinese clematis root, 9.5-10.5 parts of malt, 9.5-10.5 parts of drynaria rhizome, 4.75-5.25 parts of eucommia ulmoides, 14.25-15.75 parts of wolfberry, 4.75-5.25 parts of astragalus and 14.25-15.75 parts of dog spine.Furthermore, in parts by weight, the raw materials of the traditional Chinese medicine composition include about 20 parts of dried tangerine peel, about 15 parts of Chinese rhizome of radix polygoni multiflori, about 10 parts of malt, about 10 parts of drynaria rhizome, about 5 parts of eucommia bark, about 15 parts of wolfberry, about 5 parts of astragalus, and about 15 parts of dog spine. Further, in parts by weight, the raw materials of the traditional Chinese medicine composition include 19-21 parts of dried tangerine peel, 14.25-15.75 parts of Chinese rhizome of radix polygoni multiflori, 9.5-10.5 parts of malt, 14.25-15.75 parts of drynaria rhizome, 9.5-10.5 parts of eucommia bark, 4.75-5.25 parts of wolfberry, 14.25-15.75 parts of astragalus, and 9.5-10.5 parts of dog spine. Furthermore, in parts by weight, the raw materials of the traditional Chinese medicine composition include about 20 parts of dried tangerine peel, about 15 parts of Chinese rhizome of radix achyranthis Bidentatae, about 10 parts of malt, about 15 parts of drynaria rhizome, about 10 parts of eucommia bark, about 5 parts of wolfberry, about 15 parts of astragalus, and about 10 parts of dog spine. Further, in parts by weight, the raw materials of the traditional Chinese medicine composition include 19-21 parts of dried tangerine peel, 19-21 parts of Chinese rhizome of radix achyranthis Bidentatae, 19-21 parts of malt, 14.25-15.75 parts of drynaria rhizome, 14.25-15.75 parts of eucommia bark, 14.25-15.75 parts of wolfberry, 14.25-15.75 parts of astragalus, and 14.25-15.75 parts of dog spine. Furthermore, in parts by weight, the raw materials of the traditional Chinese medicine composition include about 20 parts of dried orange peel, about 20 parts of Chinese clematis root, about 20 parts of malt, about 15 parts of drynaria root, about 15 parts of Eucommia bark, about 15 parts of wolfberry fruit, about 15 parts of astragalus root, and about 15 parts of dog spine. Further, in parts by weight, the weight ratio of dried orange peel to astragalus root is about 0.66, the weight ratio of Chinese clematis root to astragalus root is about 0.66, the weight ratio of malt to astragalus root is about 0.66, the weight ratio of drynaria root to astragalus root is about 0.66, the weight ratio of Eucommia bark to astragalus root is about 0.66, the weight ratio of wolfberry fruit to astragalus root is about 0.66, and the weight ratio of dog spine to astragalus root is about 1. Further, by weight, the weight ratio of dried tangerine peel to astragalus is about 0.66, the weight ratio of radix achyranthis Bidentatae to astragalus is about 1.33, the weight ratio of malt to astragalus is about 1, the weight ratio of rhizoma drynariae to astragalus is about 0.66, the weight ratio of eucommia ulmoides to astragalus is about 0.33, the weight ratio of fructus lycii to astragalus is about 1, and the weight ratio of citronella to astragalus is about 0.66. Further, by weight, the weight ratio of dried tangerine peel to astragalus is about 3, the weight ratio of radix achyranthis Bidentatae to astragalus is about 3, the weight ratio of malt to astragalus is about 3, the weight ratio of rhizoma drynariae to astragalus is about 3, the weight ratio of eucommia ulmoides to astragalus is about 3, the weight ratio of fructus lycii to astragalus is about 3, and the weight ratio of citronella to astragalus is about 1.Further, in terms of weight ratio, the weight ratio of dried tangerine peel to astragalus is about 2, and the weight ratio of radix achyranthis Bidentatae to astragalus is about 1, and the weight ratio of malt to astragalus is about 1.5, and the weight ratio of drynaria rhizome to astragalus is about 0.5, and the weight ratio of eucommia ulmoides to astragalus is about 1, and the weight ratio of wolfberry fruit to astragalus is about 1.5, and the weight ratio of citronella to astragalus is about 1.5. Further, in terms of weight ratio, the weight ratio of dried tangerine peel to astragalus is about 4, and the weight ratio of radix achyranthis Bidentatae to astragalus is about 3, and the weight ratio of malt to astragalus is about 2, and the weight ratio of drynaria rhizome to astragalus is about 2, and the weight ratio of eucommia ulmoides to astragalus is about 1, and the weight ratio of wolfberry fruit to astragalus is about 3, and the weight ratio of citronella to astragalus is about 3. Further, in terms of weight ratio, the weight ratio of dried tangerine peel to astragalus is about 1.33, and the weight ratio of radix achyranthis Bidentatae to astragalus is about 1, and the weight ratio of malt to astragalus is about 0.66, and the weight ratio of rhizoma drynariae to astragalus is about 1, and the weight ratio of eucommia ulmoides to astragalus is about 0.66, and the weight ratio of wolfberry fruit to astragalus is about 0.33, and the weight ratio of citronella to astragalus is about 0.66. Further, in terms of weight ratio, the weight ratio of dried tangerine peel to astragalus is about 1.33, and the weight ratio of radix achyranthis Bidentatae to astragalus is about 1.33, and the weight ratio of malt to astragalus is about 1.33, and the weight ratio of rhizoma drynariae to astragalus is about 1, and the weight ratio of eucommia ulmoides to astragalus is about 1, and the weight ratio of wolfberry fruit to astragalus is about 1, and the weight ratio of citronella to astragalus is about 1.

[0008] Furthermore, the malt is roasted malt.

[0009] According to another aspect of the present invention, a pharmaceutical preparation comprising the above-mentioned traditional Chinese medicine composition is provided.

[0010] Furthermore, the pharmaceutical preparation further comprises one or more drugs and / or extracts for preventing and / or treating sarcopenia.

[0011] Furthermore, the drug is selected from one or more of the following: testosterone, selective androgen receptor modulators, growth hormone, ghrelin and myostatin inhibitors.

[0012] Furthermore, the pharmaceutical preparation contains one or more pharmaceutically acceptable excipients.

[0013] Furthermore, the auxiliary material is selected from one or more of the following: diluent, wetting agent, binder, disintegrant, inclusion agent, flavoring agent, sustained-release agent, retention aid, lubricant, dispersant, plasticizer, opacifier and antioxidant.

[0014] Furthermore, the auxiliary material is dextrin.

[0015] Furthermore, the dosage form of the pharmaceutical preparation is powder, tablet, pill, capsule, film, lozenge, granule, injection or oral solution.

[0016] Furthermore, the dosage form of the pharmaceutical preparation is granules.

[0017] According to another aspect of the present invention, there is provided a method for preparing the above-mentioned Chinese medicine composition, the method comprising the following steps:

[0018] (1) Weighing appropriate amounts of dried tangerine peel, Chinese clematis root, malt, drynaria root, eucommia bark, wolfberry fruit, astragalus root and dog spine, adding water for the first time and boiling for a period of time, filtering to obtain a first filtrate and a first medicinal residue;

[0019] (2) adding water to the first medicinal residue for a second time and boiling for a period of time, and filtering to obtain a second filtrate and a second medicinal residue; and

[0020] (3) combining the first filtrate and the second filtrate, concentrating the filtrate into a concentrated solution, and then drying the concentrated solution to obtain the Chinese medicine composition.

[0021] According to another aspect of the present invention, there is provided a method for preparing the above-mentioned pharmaceutical preparation, the method comprising the following steps:

[0022] (1) Weighing appropriate amounts of dried tangerine peel, Chinese clematis root, malt, drynaria root, eucommia bark, wolfberry fruit, astragalus root and dog spine, adding water for the first time and boiling for a period of time, filtering to obtain a first filtrate and a first medicinal residue;

[0023] (2) adding water to the first medicinal residue for a second time and boiling for a period of time, and filtering to obtain a second filtrate and a second medicinal residue;

[0024] (3) combining the first filtrate and the second filtrate and concentrating the mixture into a concentrated solution; and

[0025] (4) Adding excipients to the concentrated solution for the first time, and then adding excipients again after drying to obtain the pharmaceutical preparation.

[0026] Furthermore, the malt is roasted malt.

[0027] Furthermore, the volume / mass (ml / g or L / kg) ratio of the volume of the water added for the first time to the total mass of the medicinal materials of dried tangerine peel, cyperus rotundus, malt, drynariae rhizome, eucommia bark, wolfberry fruit, astragalus and dog spine is 1 to 20, for example, about 10.

[0028] Furthermore, the first boiling time is 30 to 90 minutes, for example, about 60 minutes, starting from the boiling time.

[0029] Furthermore, the volume / mass (ml / g or L / kg) ratio of the volume of the water added for the second time to the total mass of dried tangerine peel, cyperus rotundus, malt, drynariae rhizome, eucommia bark, wolfberry fruit, astragalus and dog spine is 1 to 20, for example, about 8.

[0030] Furthermore, the second boiling time is 10 to 90 minutes, for example, about 30 minutes, starting from the boiling time.

[0031] Furthermore, the relative density of the concentrated solution at 55° C. to 65° C. is 1.10 to 1.15.

[0032] Furthermore, the drying temperature is 50-70°C, for example, about 60°C.

[0033] Furthermore, the mass / mass (g / g or mg / mg) ratio between the mass of the first added auxiliary material and the mass of the concentrated solution is 0.035 to 0.175, for example, about 0.07.

[0034] Furthermore, the drying is spray drying.

[0035] Furthermore, the step (4) further comprises a granulation step.

[0036] Furthermore, the granulation is dry granulation.

[0037] According to another aspect of the present invention, there is provided a use of the above-mentioned traditional Chinese medicine composition or the above-mentioned pharmaceutical preparation in the preparation of medicines, foods and / or health products for preventing and / or treating sarcopenia.

[0038] Furthermore, the prevention and / or treatment of sarcopenia is manifested as one or more of the following: increased muscle strength, increased muscle mass, increased muscle function, reduced body fat content, and delayed aging process.

[0039] Beneficial effects of the present invention:

[0040] The traditional Chinese medicine composition of the present invention can improve muscle strength, muscle content and muscle function, reduce body fat content, and delay the aging process, and has no obvious effect on food intake, indicating that the traditional Chinese medicine composition can be used as a drug for treating sarcopenia. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without exceeding the scope of protection required by the present invention.

[0042] FIG1 is a DEXA diagram of the body composition of SAMP8 sarcopenia model mice subjected to the Chinese medicine composition of the present invention. DETAILED DESCRIPTION

[0043] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work shall fall within the scope of protection of the present invention.

[0044] Unless otherwise indicated, all technical and scientific terms and abbreviations used herein have the meanings commonly understood by those skilled in the art in the field of the present invention or the field in which the terms are used. Although any methods, conditions, substances or materials similar or equivalent to those disclosed herein can be used in the practice of the present invention, preferred methods, conditions, substances or materials are described herein.

[0045] The present invention is intended to encompass all alternatives, modifications, and equivalents that may come within the scope of the present invention as defined by the claims. Those skilled in the art will recognize many methods and materials similar or equivalent to those described herein that could be used in the practice of the present invention. The present invention is in no way limited to the methods and materials described.

[0046] As used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0047] In the present invention, the term "comprising" is synonymous with "including." As used herein, the terms "comprises," "including," "having," "containing," or any other variations thereof, are intended to cover a non-exclusive inclusion. For example, a composition, process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such composition, process, method, article, or apparatus.

[0048] As described in the background technology section, common drugs used to treat sarcopenia in the prior art are prone to adverse reactions, poor efficacy, and lack of treatment specificity. In order to solve the above problems, the present invention provides a drug for treating sarcopenia with definite efficacy, natural safety, that is, a traditional Chinese medicine composition for preventing and / or treating sarcopenia, wherein the raw materials of the traditional Chinese medicine composition include 9-11 parts of dried tangerine peel, 9-11 parts of Chinese clematis root, 9-11 parts of malt, 9-11 parts of drynaria rhizome, 9-11 parts of eucommia bark, 9-11 parts of wolfberry, 13.5-16.5 parts of astragalus and 13.5-16.5 parts of dog spine; or, the raw materials of the traditional Chinese medicine composition include 9-11 parts of dried tangerine peel, 18-22 parts of Chinese clematis root, 13.5-16.5 parts of malt, 9-11 parts of bone drynaria, 9-11 parts of eucommia bark, 9-11 parts of wolfberry, 13.5-16.5 parts of astragalus and 13.5-16.5 parts of dog spine; 9-11 parts of drynaria, 4.5-5.5 parts of eucommia, 13.5-16.5 parts of wolfberry, 13.5-16.5 parts of astragalus and 9-11 parts of dog spine; or, calculated by weight, the raw materials of the traditional Chinese medicine composition include 13.5-16.5 parts of dried orange peel, 13.5-16.5 parts of cyperus rotundus, 13.5-16.5 parts of malt, 13.5-16.5 parts of drynaria, 13.5-16.5 parts of eucommia, 13.5-16.5 parts of wolfberry, 4.5-5.5 parts of astragalus and 4.5-5.5 parts of dog spine; or, calculated by weight, the raw materials of the traditional Chinese medicine composition include 18-22 parts of dried orange peel, 13.5-16.5 parts of cyperus rotundus, 13.5-16.5 parts of malt, 13.5-16.5 parts of drynaria, 13.5-16.5 parts of eucommia, 13.5-16.5 parts of wolfberry, 4.5-5.5 parts of astragalus and 4.5-5.5 parts of dog spine; 18-22 parts of dried tangerine peel, 13.5-16.5 parts of radix achyranthis Bidentatae, 9-11 parts of malt, 9-11 parts of drynariae, 4.5-5.5 parts of eucommia bark, 13.5-16.5 parts of wolfberry, 9-11 parts of astragalus and 13.5-16.5 parts of dog spine; or, in parts by weight, the raw materials of the traditional Chinese medicine composition include 18-22 parts of dried tangerine peel, 13.5-16.5 parts of radix achyranthis Bidentatae, 9-11 parts of malt, 9-11 parts of drynariae, 4.5-5.5 parts of eucommia bark, 13.5-16.5 parts of wolfberry, 4.5-5.5 parts of astragalus and 13.5-16.5 parts of dog spine; or, in parts by weight, the raw materials of the traditional Chinese medicine composition include 18-22 parts of dried tangerine peel, 13.5-16.5 parts of radix achyranthis Bidentatae, 9-11 parts of malt, The raw materials include 18-22 parts of dried tangerine peel, 13.5-16.5 parts of Chinese cyperus rotundus, 9-11 parts of malt, 13.5-16.5 parts of drynaria rhizome, 9-11 parts of eucommia bark, 4.5-5.5 parts of wolfberry, 13.5-16.5 parts of astragalus and 9-11 parts of dog spine; or, in parts by weight, the raw materials of the traditional Chinese medicine composition include 18-22 parts of dried tangerine peel, 18-22 parts of Chinese cyperus rotundus, 18-22 parts of malt, 13.5-16.5 parts of drynaria rhizome, 13.5-16.5 parts of eucommia bark, 13.5-16.5 parts of wolfberry, 13.5-16.5 parts of astragalus and 13.5-16.5 parts of dog spine.

[0049] The dried tangerine peel, Chinese rhizome of Chinese yarrow, fried malt, drynaria rhizome, eucommia bark, wolfberry fruit, astragalus and cibotium bark are Chinese medicines for both medicinal and edible purposes. Among them, astragalus, dried tangerine peel and fried malt are Chinese medicines for invigorating spleen and replenishing qi, while cibotium bark, eucommia bark, wolfberry and Chinese rhizome of Chinese yarrow are Chinese medicines for invigorating liver and kidney and strengthening tendons and bones.

[0050] In the present invention, when parts by weight, ratios, time, density, temperature, or other values ​​or parameters are expressed as ranges, preferred ranges, or a series of upper preferred values ​​and lower preferred values, this should be understood as specifically disclosing all ranges formed by any pairing of any range upper limit or preferred value with any range lower limit or preferred value, regardless of whether the range is disclosed separately. For example, when a range of "9 to 11" is disclosed, the described range should be interpreted as including ranges of "9 to 11", "9 to 10", "10 to 11", etc. When a numerical range is described herein, unless otherwise stated, the range is intended to include its end values ​​and all integers and fractions within the range.

[0051] The above-mentioned specific ratio of the Chinese medicine composition of the present invention was used in animal experiments to detect the aging score, grip strength, body composition, behavioral tests (running distance and time) and pathological sections of SAMP8 mice that were intervened with the drug composition in Group 2 for 12 weeks. The "uniform design" screening and repeated verification were used. The Chinese medicine composition with this dosage ratio was compared with other dosage combinations for control studies. The results confirmed that the above-mentioned specific ratio of the Chinese medicine composition can significantly improve the muscle strength, muscle content and muscle function of SAMP8 sarcopenia model mice, reduce body fat content, delay the aging process, and have no obvious effect on food intake. This shows that the above-mentioned specific ratio of the Chinese medicine composition can be used to prepare drugs for the prevention and treatment of sarcopenia. In a preferred embodiment, the raw materials of the traditional Chinese medicine composition include 9.5-10.5 parts of dried orange peel, 9.5-10.5 parts of radix achyranthis Bidentatae, 9.5-10.5 parts of malt, 9.5-10.5 parts of rhizoma drynariae, 9.5-10.5 parts of eucommia bark, 9.5-10.5 parts of wolfberry, 14.25-15.75 parts of astragalus, and 14.25-15.75 parts of citronella. In a preferred embodiment, the raw materials of the traditional Chinese medicine composition include about 10 parts of dried orange peel, about 10 parts of radix achyranthis Bidentatae, about 10 parts of malt, about 10 parts of rhizoma drynariae, about 10 parts of eucommia bark, about 10 parts of citronella, about 15 parts of astragalus, and about 15 parts of citronella. In a preferred embodiment, the raw materials of the traditional Chinese medicine composition include 9.5-10.5 parts of dried orange peel, 19-21 parts of Chinese rhizome of radix achyranthis Bidentatae, 14.25-15.75 parts of malt, 9.5-10.5 parts of drynariae rhizome, 4.75-5.25 parts of eucommia bark, 14.25-15.75 parts of wolfberry, 14.25-15.75 parts of astragalus, and 9.5-10.5 parts of dog spine. In a preferred embodiment, the raw materials of the traditional Chinese medicine composition include about 10 parts of dried orange peel, about 20 parts of Chinese rhizome of radix achyranthis Bidentatae, about 15 parts of malt, about 10 parts of drynariae rhizome, about 5 parts of eucommia bark, about 15 parts of wolfberry, about 15 parts of astragalus, and about 10 parts of dog spine. In a preferred embodiment, the raw materials of the traditional Chinese medicine composition include 14.25-15.75 parts of dried orange peel, 14.25-15.75 parts of radix achyranthis Bidentatae, 14.25-15.75 parts of malt, 14.25-15.75 parts of rhizoma drynariae, 14.25-15.75 parts of eucommia barbarum, 14.25-15.75 parts of fructus lycii, 4.75-5.25 parts of astragalus, and 4.75-5.25 parts of citronella. In a preferred embodiment, the raw materials of the traditional Chinese medicine composition include about 15 parts of dried orange peel, about 15 parts of radix achyranthis Bidentatae, about 15 parts of malt, about 15 parts of rhizoma drynariae, about 15 parts of eucommia barbarum, about 15 parts of fructus lycii, about 5 parts of astragalus, and about 5 parts of citronella.In a preferred embodiment, the raw materials of the traditional Chinese medicine composition include 19-21 parts of dried orange peel, 9.5-10.5 parts of radix achyranthis Bidentatae, 14.25-15.75 parts of malt, 4.75-5.25 parts of rhizoma drynariae, 9.5-10.5 parts of eucommia bark, 14.25-15.75 parts of wolfberry, 9.5-10.5 parts of astragalus, and 14.25-15.75 parts of citronella. In a preferred embodiment, the raw materials of the traditional Chinese medicine composition include about 20 parts of dried orange peel, about 10 parts of radix achyranthis Bidentatae, about 15 parts of malt, about 5 parts of rhizoma drynariae, about 10 parts of eucommia bark, about 15 parts of wolfberry, about 10 parts of astragalus, and about 15 parts of citronella. In a preferred embodiment, the raw materials of the traditional Chinese medicine composition include 19-21 parts of dried tangerine peel, 14.25-15.75 parts of radix achyranthis Bidentatae, 9.5-10.5 parts of malt, 9.5-10.5 parts of rhizoma drynariae, 4.75-5.25 parts of eucommia bark, 14.25-15.75 parts of wolfberry, 4.75-5.25 parts of astragalus, and 14.25-15.75 parts of citronella. In a preferred embodiment, the raw materials of the traditional Chinese medicine composition include about 20 parts of dried tangerine peel, about 15 parts of radix achyranthis Bidentatae, about 10 parts of malt, about 10 parts of rhizoma drynariae, about 5 parts of eucommia bark, about 15 parts of wolfberry, about 5 parts of astragalus, and about 15 parts of citronella. In a preferred embodiment, the raw materials of the traditional Chinese medicine composition include 19-21 parts of dried tangerine peel, 14.25-15.75 parts of radix achyranthis Bidentatae, 9.5-10.5 parts of malt, 14.25-15.75 parts of rhizoma drynariae, 9.5-10.5 parts of eucommia bark, 4.75-5.25 parts of wolfberry, 14.25-15.75 parts of astragalus, and 9.5-10.5 parts of citronella. In a preferred embodiment, the raw materials of the traditional Chinese medicine composition include about 20 parts of dried tangerine peel, about 15 parts of radix achyranthis Bidentatae, about 10 parts of malt, about 15 parts of rhizoma drynariae, about 10 parts of eucommia bark, about 5 parts of wolfberry, about 15 parts of astragalus, and about 10 parts of citronella. In a preferred embodiment, the raw materials of the traditional Chinese medicine composition include 19-21 parts of dried orange peel, 19-21 parts of radix achyranthis Bidentatae, 19-21 parts of malt, 14.25-15.75 parts of rhizoma drynariae, 14.25-15.75 parts of eucommia bark, 14.25-15.75 parts of wolfberry, 14.25-15.75 parts of astragalus, and 14.25-15.75 parts of citronella. In a preferred embodiment, the raw materials of the traditional Chinese medicine composition include about 20 parts of dried orange peel, about 20 parts of radix achyranthis Bidentatae, about 20 parts of malt, about 15 parts of rhizoma drynariae, about 15 parts of eucommia bark, about 15 parts of citronella, about 15 parts of radix astragali, and about 15 parts of citronella.

[0052] In the present invention, "about" refers to a value within a range of ±10% or ±5% of a particular value. For example, "about 5" includes ±10% of 5, or from 4.5 to 5.5, or ±5% of 5, or from 4.75 to 5.25; "about 10" includes ±10% of 10, or from 9 to 11, or ±5% of 10, or from 9.5 to 10.5; "about 15" includes ±10% of 15, or from 13.5 to 16.5, or ±5% of 15, or from 14.25 to 15.75; "about 20" includes ±10% of 20, or from 18 to 22, or ±5% of 20, or from 19 to 21.

[0053] In a preferred embodiment, the weight ratio of dried tangerine peel to astragalus is about 0.66, the weight ratio of radix achyranthis Bidentatae to astragalus is about 0.66, the weight ratio of malt to astragalus is about 0.66, the weight ratio of rhizoma drynariae to astragalus is about 0.66, the weight ratio of eucommia ulmoides to astragalus is about 0.66, the weight ratio of wolfberry fruit to astragalus is about 0.66, and the weight ratio of citronella to astragalus is about 1. In a preferred embodiment, the weight ratio of dried tangerine peel to astragalus is about 0.66, the weight ratio of radix achyranthis Bidentatae to astragalus is about 1.33, the weight ratio of malt to astragalus is about 1, the weight ratio of rhizoma drynariae to astragalus is about 0.66, the weight ratio of eucommia ulmoides to astragalus is about 0.33, the weight ratio of wolfberry fruit to astragalus is about 1, and the weight ratio of citronella to astragalus is about 0.66. In a preferred embodiment, the weight ratio of dried tangerine peel to astragalus is about 3, the weight ratio of radix achyranthis Bidentatae to astragalus is about 3, the weight ratio of malt to astragalus is about 3, the weight ratio of rhizoma drynariae to astragalus is about 3, the weight ratio of eucommia ulmoides to astragalus is about 3, the weight ratio of wolfberry fruit to astragalus is about 3, and the weight ratio of citronella to astragalus is about 1. In a preferred embodiment, the weight ratio of dried tangerine peel to astragalus is about 2, the weight ratio of radix achyranthis Bidentatae to astragalus is about 1, the weight ratio of malt to astragalus is about 1.5, the weight ratio of rhizoma drynariae to astragalus is about 0.5, the weight ratio of eucommia ulmoides to astragalus is about 1, the weight ratio of wolfberry fruit to astragalus is about 1.5, and the weight ratio of citronella to astragalus is about 1.5. In a preferred embodiment, the weight ratio of dried tangerine peel to astragalus is about 4, the weight ratio of radix achyranthis Bidentatae to astragalus is about 3, the weight ratio of malt to astragalus is about 2, the weight ratio of rhizoma drynariae to astragalus is about 2, the weight ratio of eucommia ulmoides to astragalus is about 1, the weight ratio of wolfberry fruit to astragalus is about 3, and the weight ratio of citronella to astragalus is about 3. In a preferred embodiment, the weight ratio of dried tangerine peel to astragalus is about 1.33, the weight ratio of radix achyranthis Bidentatae to astragalus is about 1, the weight ratio of malt to astragalus is about 0.66, the weight ratio of rhizoma drynariae to astragalus is about 1, the weight ratio of eucommia ulmoides to astragalus is about 0.66, the weight ratio of radix achyranthis Bidentatae to astragalus is about 0.33, and the weight ratio of citronella to astragalus is about 0.66. In a preferred embodiment, based on weight ratio, the weight ratio of dried tangerine peel to astragalus is about 1.33, the weight ratio of Achyranthes bidentata to astragalus is about 1.33, the weight ratio of malt to astragalus is about 1.33, the weight ratio of Drynaria fortunei to astragalus is about 1, the weight ratio of Eucommia ulmoides to astragalus is about 1, the weight ratio of wolfberry to astragalus is about 1, and the weight ratio of Cibotium barbarum to astragalus is about 1.

[0054] In the present invention, "about" refers to a value within the range of ±10% or ±5% of a specific value. For example, "about 0.66" includes ±10% of 0.66, or from 0.594 to 0.726, or includes ±5% of 0.66, or from 0.627 to 0.693; "about 1.33" includes ±10% of 1.33, or from 1.197 to 1.463, or includes ±5% of 1.33, or from 1.2635 to 1.3965; "about 3" includes ±10% of 3, or from 2.7 to 3.3, or includes ±5% of 3, or from 2.85 to 3.15; "about 2" includes ±10% of 2, or from 1.8 to 2.2, or includes ±5% of 2, or from 1.9 to 2.1 ... "About 1.5" includes ±10% of 1.5, or from 1.35 to 1.65, or ±5% of 1.5, or from 1.425 to 1.575, inclusive; "about 0.5" includes ±10% of 0.5, or from 0.45 to 0.55, or ±5% of 0.5, or from 0.475 to 0.525, inclusive; "about 4" includes ±10% of 4, or from 3.6 to 4.4, or ±5% of 4, or from 3.8 to 4.2, inclusive; "about 0.33" includes ±10% of 0.33, or from 0.297 to 0.363, or ±5% of 0.33, or from 0.3135 to 0.3465, inclusive.

[0055] In a preferred embodiment, the malt is roasted malt.

[0056] According to another aspect of the present invention, a pharmaceutical preparation comprising the above-mentioned traditional Chinese medicine composition is provided.

[0057] In a preferred embodiment, the pharmaceutical preparation further comprises one or more drugs and / or extracts for preventing and / or treating sarcopenia.

[0058] In a preferred embodiment, the drug is selected from one or more of the following: testosterone, selective androgen receptor modulators, growth hormone, ghrelin, and myostatin inhibitors.

[0059] In a preferred embodiment, the pharmaceutical preparation comprises one or more pharmaceutically acceptable excipients.

[0060] In the present invention, the term "pharmaceutically acceptable" refers to a substance, such as a carrier or diluent, that does not abrogate the biological activity or properties of the compound and is relatively non-toxic, i.e., a substance that does not cause undesirable biological effects or interact in a deleterious manner with any of its components when administered to a subject.

[0061] In the present invention, the term "pharmaceutically acceptable excipient" refers to carriers and / or excipients that are pharmacologically and / or physiologically compatible with the subject and the active ingredient (i.e., capable of eliciting the desired therapeutic effect without causing any undesirable local or systemic effects), which are well known in the art (see, for example, Remington's Pharmaceutical Sciences. Edited by Gennaro AR, 19th ed. Pennsylvania: Mack Publishing Company, 1995).

[0062] In a preferred embodiment, the excipient is selected from one or more of the following: diluent, wetting agent, binder, disintegrant, inclusion agent, flavoring agent, sustained-release agent, retention aid, lubricant, dispersant, plasticizer, opacifier and antioxidant.

[0063] Those skilled in the art will know how to select the specific chemical substance within the scope of above-mentioned auxiliary material classification.For example, this diluent can be selected from following one or more: Icing Sugar, starch, compressible starch, lactose, dextrin, mannitol, sorbitol, microcrystalline cellulose, calcium sulfate and calcium carbonate.This wetting agent can be selected from following one or more: stearic acid polyoxymethylene, poloxamer, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene hydrogenated castor oil, polyoxyethylene alkyl ether, polysorbate such as polysorbate 80, spermol, glycerol fatty acid ester (such as triacetin, glyceryl monostearate and analogue), polyoxyethylene fatty acid ester, polyethylene glycol fatty acid ester, sodium lauryl sulfate, sorbitol fatty acid ester, sucrose fatty acid ester, polyoxyethylene ether, benzalkonium chloride, polyoxyethylene castor oil and docusate sodium.This adhesive can be selected from following one or more: polyvinyl pyrrolidone, hydroxypropyl cellulose, polyethylene glycol and methylcellulose. The disintegrant may be selected from one or more of the following: carboxymethylcellulose, carboxymethylcellulose calcium salt, and sodium carboxymethylcellulose. The inclusion agent may be hydroxypropyl beta-cyclodextrin. The flavoring agent may be selected from one or more of the following: sorbitol, glucose, mannose, sucrose, and lactose. The sustained-release agent may be selected from one or more of the following: sodium carboxymethylcellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl methylcellulose, microcrystalline cellulose, hydroxyethyl cellulose, gum arabic, gelatin, and shellac. The glidant may be micropowdered silica gel. The lubricant may be selected from one or more of the following: calcium stearate, talc, magnesium stearate, stearic acid, and colloidal silicon dioxide. The dispersant may be selected from one or more of the following: cross-linked sodium carboxymethylcellulose, sodium starch glycolate, and pregelatinized corn starch. The plasticizer may be dibutyl sebacate and / or various citric acid esters. The opacifier may be titanium dioxide. The antioxidant may be selected from one or more of the following: sodium bisulfite, sodium metabisulfite, sodium sulfite, and sodium thiosulfate.

[0064] These excipients are preferably pharmaceutically inert, or may have a synergistic or additive effect to enhance the therapeutic activity of the pharmaceutical composition. The above excipients are merely enumerated. The excipients actually used in the present invention are not limited to the above excipients and may be adjusted according to actual conditions to achieve the effects of the present invention.

[0065] In a preferred embodiment, the auxiliary material is dextrin.

[0066] In a preferred embodiment, the dosage form of the pharmaceutical preparation is powder, tablet, pill, capsule, film, lozenge, granule, injection or oral solution.

[0067] In a preferred embodiment, the dosage form of the pharmaceutical preparation is granules.

[0068] According to another aspect of the present invention, there is provided a method for preparing the above-mentioned Chinese medicine composition, the method comprising the following steps:

[0069] (1) Weighing appropriate amounts of dried tangerine peel, Chinese clematis root, malt, drynaria root, eucommia bark, wolfberry fruit, astragalus root and dog spine, adding water for the first time and boiling for a period of time, filtering to obtain a first filtrate and a first medicinal residue;

[0070] (2) adding water to the first medicinal residue for a second time and boiling for a period of time, and filtering to obtain a second filtrate and a second medicinal residue; and

[0071] (3) combining the first filtrate and the second filtrate, concentrating the filtrate into a concentrated solution, and then drying the concentrated solution to obtain the Chinese medicine composition.

[0072] According to another aspect of the present invention, there is provided a method for preparing the above-mentioned pharmaceutical preparation, the method comprising the following steps:

[0073] (1) Weighing appropriate amounts of dried tangerine peel, Chinese clematis root, malt, drynaria root, eucommia bark, wolfberry fruit, astragalus root and dog spine, adding water for the first time and boiling for a period of time, filtering to obtain a first filtrate and a first medicinal residue;

[0074] (2) adding water to the first medicinal residue for a second time and boiling for a period of time, and filtering to obtain a second filtrate and a second medicinal residue;

[0075] (3) combining the first filtrate and the second filtrate and concentrating the mixture into a concentrated solution; and

[0076] (4) Adding excipients to the concentrated solution for the first time, and then adding excipients again after drying to obtain the pharmaceutical preparation.

[0077] In a preferred embodiment, the malt is roasted malt.

[0078] In a preferred embodiment, the volume / mass (ml / g or L / kg) ratio of the volume of water added for the first time to the total mass of dried tangerine peel, cyperus rotundus, malt, drynariae rhizome, eucommia bark, wolfberry fruit, astragalus and dog spine is 1 to 20, for example, about 10.

[0079] In the present invention, "about" refers to a value within a range of ±10% or ±5% of a particular value. For example, "about 10" includes ±10% of 10, or from 9 to 11, or includes ±5% of 10, or from 9.5 to 10.5.

[0080] In a preferred embodiment, the first decocting time is 30 to 90 minutes, for example, about 60 minutes, starting from the time of boiling.

[0081] In the present invention, "about" refers to a value within a range of ±10% or ±5% of a particular value. For example, "about 60" includes ±10% of 60, or from 54 to 66, or includes ±5% of 60, or from 57 to 63.

[0082] In a preferred embodiment, the volume / mass (ml / g or L / kg) ratio of the volume of water in the second addition to the total mass of the medicinal materials of dried tangerine peel, Achyranthes bidentata, malt, Rhizoma Drynariae, Eucommia ulmoides, Lycium barbarum, Astragalus membranaceus and Cibotium bark is 1 to 20, for example, about 8.

[0083] In the present invention, "about" refers to a value within a range of ±10% or ±5% of a specific value. For example, "about 8" includes ±10% of 8, or from 7.2 to 8.8, or includes ±5% of 8, or from 7.6 to 8.4.

[0084] In a preferred embodiment, the second decoction time is 10 to 90 minutes, for example, about 30 minutes, starting from the time of boiling.

[0085] In the present invention, "about" refers to a value within a range of ±10% or ±5% of a particular value. For example, "about 30" includes ±10% of 30, or from 27 to 33, or includes ±5% of 30, or from 28.5 to 31.5.

[0086] In a preferred embodiment, the relative density of the concentrated solution at 55° C. to 65° C. is 1.10 to 1.15.

[0087] In a preferred embodiment, the drying temperature is 50-70°C, such as about 60°C.

[0088] In the present invention, "about" refers to a value within a range of ±10% or ±5% of a particular value. For example, "about 60" includes ±10% of 60, or from 54 to 66, or includes ±5% of 60, or from 57 to 63.

[0089] In a preferred embodiment, the mass / mass (g / g or mg / mg) ratio between the mass of the first added auxiliary material and the mass of the concentrated solution is 0.035 to 0.175, for example, about 0.07.

[0090] Typically, the mass of the extract after evaporation of the concentrate is about 35% of the mass of the concentrate. Therefore, in theory, the mass / mass (g / g or mg / mg) ratio between the mass of the first added excipient and the mass of the theoretical extract of the concentrate is 0.1 to 0.5, for example, about 0.2.

[0091] In the present invention, "about" refers to a value within a range of ±10% or ±5% of a particular value. For example, "about 0.2" includes ±10% of 0.2, or from 0.19 to 0.21, or includes ±5% of 0.2, or from 0.19 to 0.21.

[0092] In a preferred embodiment, the drying is spray drying.

[0093] In a preferred embodiment, the step (4) further comprises a granulation step.

[0094] In a preferred embodiment, the granulation is dry granulation.

[0095] According to another aspect of the present invention, there is provided a method for preparing the above-mentioned pharmaceutical preparation, the method comprising the following steps:

[0096] (1) Weigh appropriate amounts of Astragalus, Tangerine Peel, Roasted Malt, Cibotium Bark, Eucommia Bark, Lycium Barbarum, Achyranthes Bidentatae, and Drynariae Rhizoma according to the given ratio;

[0097] (2) The above eight herbs were extracted twice with water, the first time adding 10 times the amount of water and boiling for 1 hour;

[0098] (3) Add 8 times the amount of water obtained in step (2) and boil for another 0.5 hours;

[0099] (4) Filter the decoction obtained in step (3), combine the decoctions, and concentrate to a relative density of 1.10-1.15 (55-65°C);

[0100] (5) Add 20% dextrin to the product obtained in step (4) according to the solid content, spray dry, add appropriate amount of dextrin to the spray-dried powder, and dry granulate to make 1000g.

[0101] According to another aspect of the present invention, there is provided a use of the above-mentioned traditional Chinese medicine composition or the above-mentioned pharmaceutical preparation in the preparation of medicines, foods and / or health products for preventing and / or treating sarcopenia.

[0102] In a preferred embodiment, the prevention and / or treatment of sarcopenia is manifested as one or more of the following: increased muscle strength, increased muscle mass, increased muscle function, reduced body fat content, and delayed aging process.

[0103] In the present invention, the term "treatment" also includes "prevention", unless there is a specific description to the contrary. The terms "treatment" and "therapeutically" should be understood accordingly.

[0104] In the present invention, the term "treat" includes alleviating, inhibiting, or ameliorating the symptoms or conditions of a disease; inhibiting the development of complications; ameliorating or preventing potential metabolic syndrome; inhibiting the development of a disease or symptom, such as controlling the progression of a disease or condition; alleviating a disease or symptom; causing a disease or symptom to regress; alleviating complications caused by a disease or symptom, or preventing or treating signs caused by a disease or symptom. As used herein, a pharmaceutical composition or a pharmaceutical formulation, upon administration, can improve a disease, symptom, or condition, particularly by improving its severity, delaying its onset, slowing its progression, or reducing its duration. Whether the administration is fixed or temporary, continuous or intermittent, it can be attributable to or related to the administration.

[0105] The present invention also provides the above composition or pharmaceutical preparation for preventing and / or treating sarcopenia in a subject.

[0106] The present invention also provides a method for preventing and / or treating sarcopenia in a subject, comprising administering an effective amount of the above composition or the above pharmaceutical preparation to the subject.

[0107] In the present invention, the term "subject" refers to a mammal. The mammal may be a human, non-human primate, mouse, rat, dog, cat, horse, or cow, but is not limited to these examples. Mammals other than humans can be advantageously used as subjects representing sarcopenia models. Preferably, the subject is a human.

[0108] The "effective amount" of the pharmaceutical composition or preparation used in the present invention can obtain the desired treatment and / or prevention effect. The amount effective for this purpose will depend on, for example, the pharmaceutical composition, the mode of administration, the stage and severity of the disease to be treated, the individual's weight and overall health, and the judgment of the prescribing physician. The dosage can be given once a week, or once every two days or every day, or even several times a day. The dosage unit can be given in a short period of time (e.g., several weeks to several months) or a longer period of time (several months to several years).

[0109] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are intended to illustrate the present invention only and are not intended to limit the scope of the invention. The experimental methods in the following examples, for which specific conditions are not specified, are generally based on conventional conditions or conditions recommended by the manufacturer.

[0110] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those familiar to those skilled in the art. Furthermore, any methods and materials similar or equivalent to those described herein can be applied to the methods of the present invention. The preferred embodiments and materials described herein are for illustrative purposes only.

[0111] The above-mentioned features of the present invention or the features described in the embodiments may be combined in any combination. All features disclosed in this patent specification may be used in any combination, and each feature disclosed in the specification may be replaced by any alternative feature that can provide the same, equal, or similar purpose. Therefore, unless otherwise specified, the features disclosed are only general examples of equal or similar features.

[0112] Example

[0113] Preparation Example

[0114] 1. Experimental instruments and materials

[0115] 1.1 Experimental Instruments

[0116] The A60 multifunctional split decoction pot is produced by Kangyashun Electric Appliance Co., Ltd. in Hu'an District, Chaozhou City; the RE52-98 rotary evaporator is produced by Shanghai Yarong Biochemical Instrument Factory; the DHG-9070A vertical electric constant temperature blast drying oven is produced by Shanghai Leigu Instrument Co., Ltd.; the FA1204B electronic analytical balance is produced by Shanghai Tianmei Balance Instrument Co., Ltd.

[0117] 1.2 Experimental Reagents

[0118] Tangerine peel, Achyranthes bidentata, roasted malt, Drynaria fortunei, Eucommia ulmoides, Lycium barbarum, Astragalus membranaceus, and Cibotium barometz were purchased from Leiyunshang Pharmaceutical Group Co., Ltd.; dextrin, batch number T14A10Z95117, was purchased from Shanghai Yuanye Biotechnology Co., Ltd.; sucrose, batch number 201229, was purchased from Xilong Science Co., Ltd.; water was ultrapure water, and all other reagents were of analytical grade.

[0119] 2. Experimental content

[0120] The preparation example of the present invention adopts a uniform design experimental scheme: referring to the literature (Liang Maoxin, Li Dongan. Improved application of uniform design in the selection of small compound prescriptions of traditional Chinese medicine [J]. World Science and Technology - Ideas and Methods for Modernization of Traditional Chinese Medicine, 2006, 8(02): 53-56.), a uniform design scheme (as shown in Table 1) was prepared, and eight traditional Chinese medicines in the prescription, including astragalus, tangerine peel, stir-fried malt, dog spine, eucommia, wolfberry, Chinese clematis and drynaria, were used as investigation factors. Each factor took three levels (i.e., three different doses with increasing gradients), and the investigation dose was between 5 and 20 g. The factors and levels were arranged according to the uniform design table, and the prescription design was carried out to construct a total of 27 groups of pharmaceutical compositions.

[0121] Table 1 Uniform experimental design scheme

[0122] Preparation Example 1

[0123] The Chinese medicinal materials for the pharmaceutical composition include 10g of dried tangerine peel, 10g of radix achyranthis Bidentatae, 10g of roasted malt, 5g of rhizoma drynariae, 5g of eucommia bark, 5g of fructus wolfberrye, 5g of astragalus and 5g of rhizoma cynomorii, and are decocted in water twice, with the first decoction being 1 hour and the second decoction being 0.5 hour, the mass of water used for the first decoction being 0.55kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction being 0.44kg (8 times the mass of the total medicinal materials), and the mixture is concentrated into a concentrated solution, and dried at a temperature of 60°C to obtain a pharmaceutical composition of group 1.

[0124] Preparation Example 2

[0125] Take Chinese medicinal materials 10g of dried tangerine peel, 10g of rhizoma cyperi, 10g of roasted malt, 10g of rhizoma drynariae, 10g of eucommia bark, 10g of fructus wolfberry, 15g of astragalus and 15g of rhizoma cyperi, decocted in water twice, the first decocting time was 1 hour and the second decocting time was 0.5 hour from boiling. The mass of water used for the first decocting was 0.9kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decocting was 0.72kg (8 times the mass of the total medicinal materials). The mixture was concentrated into a concentrate and dried at a temperature of 60°C to obtain a pharmaceutical composition of group 2.

[0126] Preparation Example 3

[0127] Take Chinese medicinal materials 10g of dried tangerine peel, 10g of rhizoma cyperi, 10g of roasted malt, 15g of rhizoma drynariae, 15g of eucommia bark, 15g of fructus wolfberry, 10g of astragalus and 10g of rhizoma cyperi, decocted in water twice, the first time decocted for 1 hour and the second time for 0.5 hour from boiling time, the first decocting water mass is 0.95kg (being 10 times the mass of total medicinal materials), the second decocting water mass is 0.76kg (being 8 times the mass of total medicinal materials), be concentrated into concentrated solution, and dry at a temperature of 60℃ to obtain the pharmaceutical composition of group 3.

[0128] Preparation Example 4

[0129] Take Chinese medicinal materials 10g of dried tangerine peel, 15g of rhizoma cyperi, 20g of roasted malt, 5g of rhizoma drynariae, 10g of eucommia bark, 15g of fructus wolfberry, 5g of astragalus and 10g of rhizoma cyperi, decocted in water twice, the first time decocted for 1 hour and the second time for 0.5 hour from boiling time, the mass of water used for the first decoction was 0.90kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction was 0.72kg (8 times the mass of the total medicinal materials), concentrated into a concentrate, and dried at a temperature of 60°C to obtain the pharmaceutical composition of group 4.

[0130] Preparation Example 5

[0131] Take Chinese medicinal materials 10g of dried tangerine peel, 15g of radix achyranthis Bidentatae, 20g of roasted malt, 10g of rhizoma drynariae, 15g of eucommia bark, 5g of fructus wolfberry, 15g of astragalus and 10g of rhizoma cynomorii, decocted in water twice, the first decocting for 1 hour and the second decocting for 0.5 hour from boiling time, the mass of water used for the first decocting is 1kg (10 times the mass of the total medicinal materials), the mass of water used for the second decocting is 0.8kg (8 times the mass of the total medicinal materials), concentrated into a concentrate, and dried at a temperature of 60°C to obtain the pharmaceutical composition of group 5.

[0132] Preparation Example 6

[0133] Take Chinese medicinal materials 10g of dried tangerine peel, 15g of cyperus rotundus, 20g of roasted malt, 15g of drynaria rhizome, 5g of eucommia bark, 10g of wolfberry fruit, 10g of astragalus and 15g of dog spine, decoct in water twice, the first decoction is 1 hour from boiling time, and the second decoction is 0.5 hour. The mass of water used for the first decoction is 1kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.8kg (8 times the mass of the total medicinal materials). Concentrate into a concentrate and dry at a temperature of 60°C to obtain the pharmaceutical composition of group 6.

[0134] Preparation Example 7

[0135] Take Chinese medicinal materials 10g of dried tangerine peel, 20g of radix achyranthis Bidentatae, 15g of roasted malt, 5g of drynaria rhizome, 15g of eucommia bark, 10g of wolfberry fruit, 5g of astragalus and 15g of dog spine, decocted in water twice, the first decocting for 1 hour and the second 0.5 hour from boiling time, the first decocting water mass is 0.95kg (being 10 times the mass of total medicinal materials), the second decocting water mass is 0.76kg (being 8 times the mass of total medicinal materials), be concentrated into concentrated solution, and dry at a temperature of 60°C to obtain the pharmaceutical composition of group 7.

[0136] Preparation Example 8

[0137] Take the Chinese medicinal materials 10g of dried tangerine peel, 20g of radix achyranthis Bidentatae, 15g of roasted malt, 10g of drynaria rhizome, 5g of eucommia bark, 15g of wolfberry fruit, 15g of astragalus and 10g of dog spine, decocted in water twice, the first decoction was 1 hour and the second time was 0.5 hour starting from boiling. The mass of water used for the first decoction was 1kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction was 0.8kg (8 times the mass of the total medicinal materials). The mixture was concentrated into a concentrate and dried at 60°C to obtain the pharmaceutical composition of group 8.

[0138] Preparation Example 9

[0139] Take Chinese medicinal materials 10g of dried tangerine peel, 20g of radix achyranthis Bidentatae, 15g of roasted malt, 15g of drynaria rhizome, 10g of eucommia bark, 5g of wolfberry fruit, 10g of astragalus and 5g of dog spine, decoct in water twice, the first decoction is 1 hour from boiling time, the second decoction is 0.9kg (being 10 times the weight of total medicinal materials), the second decoction is 0.72kg (being 8 times the weight of total medicinal materials), be concentrated into concentrated solution, and dry at a temperature of 60℃ to obtain the pharmaceutical composition of group 9.

[0140] Preparation Example 10

[0141] Take Chinese medicinal materials 15g of dried tangerine peel, 10g of cyperus rotundus, 20g of roasted malt, 5g of drynaria rhizome, 15g of eucommia bark, 10g of wolfberry fruit, 15g of astragalus and 10g of dog spine, decoct in water twice, the first decoction is 1 hour and the second time is 0.5 hour from boiling time, the water mass used for the first decoction is 1kg (10 times the mass of the total medicinal materials), and the water mass used for the second decoction is 0.8kg (8 times the mass of the total medicinal materials), concentrate to a concentrate, and dry at a temperature of 60°C to obtain the pharmaceutical composition of group 10.

[0142] Preparation Example 11

[0143] Take Chinese medicinal materials 15g of dried tangerine peel, 10g of cyperus rotundus, 20g of roasted malt, 10g of drynaria rhizome, 5g of eucommia bark, 15g of wolfberry fruit, 10g of astragalus and 5g of dog spine, decoct in water twice, the first decoction is 1 hour from boiling time, and the second decoction is 0.5 hour. The mass of water used for the first decoction is 0.9kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.72kg (8 times the mass of the total medicinal materials). Concentrate into a concentrate and dry at a temperature of 60°C to obtain the pharmaceutical composition of group 11.

[0144] Preparation Example 12

[0145] Take Chinese medicinal materials 15g of dried tangerine peel, 10g of rhizoma cyperi, 20g of roasted malt, 15g of rhizoma drynariae, 10g of eucommia bark, 5g of wolfberry fruit, 5g of astragalus and 15g of dog spine, decoct in water twice, the first decoction is 1 hour from boiling time, the second decoction is 0.5 hours, the mass of water used for the first decoction is 0.95kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.76kg (8 times the mass of the total medicinal materials), concentrate to a concentrate, and dry at a temperature of 60°C to obtain the pharmaceutical composition of group 12.

[0146] Preparation Example 13

[0147] Take Chinese medicinal materials 15g of dried tangerine peel, 15g of rhizoma cyperi, 15g of roasted malt, 5g of rhizoma drynariae, 5g of eucommia bark, 5g of fructus wolfberry, 15g of astragalus and 15g of rhizoma cyperi, decocted in water twice, the first decocting time was 1 hour and the second decocting time was 0.5 hour, the mass of water used for the first decocting was 0.9kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decocting was 0.72kg (8 times the mass of the total medicinal materials), concentrated into a concentrate, and dried at a temperature of 60°C to obtain the pharmaceutical composition of group 13.

[0148] Preparation Example 14

[0149] Take 15g of Chinese medicinal materials, including dried tangerine peel, 15g of Chinese clematis root, 15g of fried malt, 10g of drynaria rhizome, 10g of eucommia bark, 10g of wolfberry fruit, 10g of astragalus and 10g of dog spine, and decoct them in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.95kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.76kg (8 times the mass of the total medicinal materials). Concentrate into a concentrate and dry at 60°C to obtain the pharmaceutical composition of group 14.

[0150] Preparation Example 15

[0151] Take Chinese medicinal materials 15g of dried tangerine peel, 15g of rhizoma cyperi, 15g of roasted malt, 15g of rhizoma drynariae, 15g of eucommia bark, 15g of fructus wolfberry, 5g of astragalus and 5g of rhizoma cyperi, decocted in water twice, the first decocting for 1 hour and the second 0.5 hour from boiling time, the first decocting water mass is 1kg (being 10 times the mass of total medicinal materials), the second decocting water mass is 0.8kg (being 8 times the mass of total medicinal materials), be concentrated into concentrated solution, and dry at a temperature of 60℃ to obtain the pharmaceutical composition of group 15.

[0152] Preparation Example 16

[0153] Take Chinese medicinal materials 15g of dried tangerine peel, 20g of rhizoma cyperi, 10g of stir-fried malt, 5g of rhizoma drynariae, 10g of eucommia bark, 15g of fructus wolfberry, 15g of astragalus and 5g of rhizoma cyperi, decocted in water twice, decocted for 1 hour for the first time and for 0.5 hour for the second time from boiling time, the water mass used for the first decoction was 0.95kg (10 times the mass of the total medicinal materials), and the water mass used for the second decoction was 0.76kg (8 times the mass of the total medicinal materials), concentrated into a concentrate, and dried at a temperature of 60°C to obtain the pharmaceutical composition of group 16.

[0154] Preparation Example 17

[0155] Take Chinese medicinal materials 15g of dried tangerine peel, 20g of rhizoma cyperi, 10g of roasted malt, 10g of rhizoma drynariae, 15g of eucommia bark, 5g of wolfberry fruit, 10g of astragalus and 15g of dog spine, decoct in water twice, the first decoction is 1 hour from boiling time, the second time is 0.5 hour, the first decoction water mass is 1kg (being 10 times the mass of total medicinal materials), the second decoction water mass is 0.8kg (being 8 times the mass of total medicinal materials), be concentrated into concentrated solution, and dry at a temperature of 60℃ to obtain the pharmaceutical composition of group 17.

[0156] Preparation Example 18

[0157] Take 15g of Chinese medicinal materials, including dried orange peel, 20g of Rhizoma Cyathulae, 10g of roasted malt, 15g of Rhizoma Drynariae, 5g of Eucommia bark, 10g of Fructus Lycii, 5g of Radix Astragali and 10g of Cibotium barometz, and decoct them in water twice. The first decoction is for 1 hour and the second time is for 0.5 hour, with the mass of water used for the first decoction being 0.9kg (10 times the mass of the total medicinal materials) and the mass of water used for the second decoction being 0.72kg (8 times the mass of the total medicinal materials). The decoction is concentrated into a concentrate and dried at 60°C to obtain the pharmaceutical composition of group 18.

[0158] Preparation Example 19

[0159] Take Chinese medicinal materials 20g of dried tangerine peel, 10g of cyperus rotundus, 15g of roasted malt, 5g of drynaria rhizome, 10g of eucommia bark, 15g of wolfberry fruit, 10g of astragalus and 15g of dog spine, decoct in water twice, the first decoction is 1 hour from boiling time, and the second time is 0.5 hour. The mass of water used for the first decoction is 1kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.8kg (8 times the mass of the total medicinal materials). Concentrate into a concentrate and dry at a temperature of 60°C to obtain the pharmaceutical composition of group 19.

[0160] Preparation Example 20

[0161] Take Chinese medicinal materials 20g of dried tangerine peel, 10g of rhizoma cyperi, 15g of roasted malt, 10g of rhizoma drynariae, 15g of eucommia bark, 5g of fructus wolfberry, 5g of astragalus and 10g of rhizoma cyperi, decocted in water twice, the first time for 1 hour and the second time for 0.5 hour from boiling time, the mass of water used for the first decoction is 0.9kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.72kg (8 times the mass of the total medicinal materials), concentrated into a concentrate, and dried at a temperature of 60°C to obtain the pharmaceutical composition of group 20.

[0162] Preparation Example 21

[0163] Take Chinese medicinal materials 20g of dried tangerine peel, 10g of radix achyranthis Bidentatae, 15g of roasted malt, 15g of drynaria rhizome, 5g of eucommia bark, 10g of wolfberry fruit, 15g of astragalus and 5g of dog spine, decocted in water twice, the first decocting for 1 hour and the second 0.5 hour from boiling time, the mass of water used for the first decocting is 0.95kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decocting is 0.76kg (8 times the mass of the total medicinal materials), concentrated into a concentrate, and dried at a temperature of 60°C to obtain the pharmaceutical composition of group 21.

[0164] Preparation Example 22

[0165] Take Chinese medicinal materials 20g of dried tangerine peel, 15g of rhizoma cyperi, 10g of roasted malt, 5g of rhizoma drynariae, 15g of eucommia bark, 10g of fructus wolfberry, 10g of astragalus and 5g of rhizoma cyperi, decocted in water twice, the first decocting time was 1 hour and the second 0.5 hour from boiling time, the first decocting water mass was 0.9kg (10 times the mass of the total medicinal materials), and the second decocting water mass was 0.72kg (8 times the mass of the total medicinal materials), concentrated into a concentrate, and dried at a temperature of 60°C to obtain the pharmaceutical composition of group 22.

[0166] Preparation Example 23

[0167] Take Chinese medicinal materials 20g of dried tangerine peel, 15g of rhizoma cyperi, 10g of roasted malt, 10g of rhizoma drynariae, 5g of eucommia bark, 15g of wolfberry, 5g of astragalus and 15g of dog spine, decocted in water twice, the first decocting time was 1 hour and the second 0.5 hour from boiling time, the first decocting water mass was 0.95kg (10 times the mass of the total medicinal materials), and the second decocting water mass was 0.76kg (8 times the mass of the total medicinal materials), concentrated into a concentrate, and dried at a temperature of 60°C to obtain the pharmaceutical composition of group 23.

[0168] Preparation Example 24

[0169] Take Chinese medicinal materials 20g of dried tangerine peel, 15g of radix achyranthis Bidentatae, 10g of roasted malt, 15g of drynaria rhizome, 10g of eucommia bark, 5g of wolfberry fruit, 15g of astragalus and 10g of dog spine, decocted in water twice, the first decocting time is 1 hour and the second decocting time is 0.5 hour from boiling. The mass of water used for the first decocting is 0.9kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decocting is 0.72kg (8 times the mass of the total medicinal materials). Concentrate into a concentrate and dry at a temperature of 60°C to obtain the pharmaceutical composition of group 24.

[0170] Preparation Example 25

[0171] Take Chinese medicinal materials 20g of dried tangerine peel, 20g of rhizoma cyperi, 20g of roasted malt, 5g of rhizoma drynariae, 5g of eucommia bark, 5g of fructus wolfberry, 10g of astragalus and 10g of rhizoma cyperi, decocted in water twice, the first time decocted for 1 hour and the second time for 0.5 hour from boiling time, the first decocting water mass is 0.95kg (being 10 times the mass of total medicinal materials), the second decocting water mass is 0.76kg (being 8 times the mass of total medicinal materials), be concentrated into concentrated solution, and dry at a temperature of 60℃ to obtain the pharmaceutical composition of group 25.

[0172] Preparation Example 26

[0173] Take Chinese medicinal materials 20g of dried tangerine peel, 20g of Rhizoma Cyathulae, 20g of roasted malt, 10g of Rhizoma Drynariae, 10g of Eucommia ulmoides, 10g of Fructus Lycii, 5g of Radix Astragali and 5g of Cibotium barometz, decoct in water twice, the first decoction is 1 hour and the second decoction is 0.5 hour starting from boiling time. The mass of water used for the first decoction is 1kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.8kg (8 times the mass of the total medicinal materials). Concentrate into a concentrate and dry at a temperature of 60°C to obtain the pharmaceutical composition of group 26.

[0174] Preparation Example 27

[0175] Take Chinese medicinal materials 20g of dried tangerine peel, 20g of rhizoma cyperi, 20g of roasted malt, 15g of rhizoma drynariae, 15g of eucommia bark, 15g of fructus wolfberry, 15g of astragalus and 15g of rhizoma cyperi, decocted in water twice, the first time decocted for 1 hour and the second time for 0.5 hour from boiling time, the first decocting water mass is 1.35kg (being 10 times the mass of total medicinal materials), the second decocting water mass is 1.08kg (being 8 times the mass of total medicinal materials), be concentrated into concentrated solution, and dry at a temperature of 60℃ to obtain the pharmaceutical composition of group 27.

[0176] Efficacy Examples

[0177] Pharmacological Example 1

[0178] 1. Experimental Materials

[0179] 1.1 Experimental Animals

[0180] SAMP8 male mice, 16 weeks old, weighing 30 ± 2 g, were purchased from Beijing Huafukang Biotechnology Co., Ltd. Experimental animals were maintained in an SPF-grade animal room at the Shanghai Laboratory Animal Center, with a temperature of (24 ± 1)°C, a relative humidity of 50%–70%, and a 12-hour light / dark cycle. Experimental procedures strictly adhered to the relevant regulations and guidelines of the Ethics Committee of the Shanghai Laboratory Animal Center.

[0181] 1.2 Experimental Drugs

[0182] Experimental drugs: Astragalus, dried tangerine peel, fried malt, Cibotium barbarum, Eucommia ulmoides, Lycium barbarum, Achyranthes bidentata, and Drynaria fortunei.

[0183] 2. Experimental methods

[0184] 2.1. Uniform design of drug screening experiments

[0185] After 1 week of adaptive feeding with a standard diet, 232 16-week-old SAMP8 mice were randomly divided into a model group (8 mice), a normal group (8 mice), and a drug-treated group (216 mice). The mice in the drug-treated groups were administered the extracts of the pharmaceutical compositions of Examples 1-27 described above, prepared with ultrapure water at a concentration of 1.41 g crude drug / ml, by gavage at a rate of 0.1 ml / g body weight for 12 weeks.

[0186] 2.2. Screening indicators: Mouse grip strength and muscle content.

[0187] 2.3 Statistical Methods

[0188] The data were statistically analyzed using SPSS 25.0 software package. The q test was used for comparison between groups, and p < 0.05 was considered statistically significant.

[0189] 3. Uniform design drug screening experiment results

[0190] The results of the screening experiment are shown in Table 2.

[0191] Table 2 Screening test results

[0192] The values ​​are expressed as mean ± standard deviation. *P < 0.05, **P < 0.01, ***P < 0.001 for combination 1-27 compared with the model group;

[0193] According to the test results, the drug composition of Group 2 had the best efficacy (***P<0.001) based on the main efficacy indicator muscle strength. In addition, Groups 8, 15, 19, 23, 24 and 27 also showed significant differences compared with the model group (*P<0.05), while the other groups did not show obvious therapeutic effects, and Group 3 even showed a further decrease in muscle strength.

[0194] Pharmacological Example 2

[0195] The efficacy of the pharmaceutical composition of Group 2 in treating sarcopenia was further verified by using the composite model and evaluation indicators of the Preparation Example and the Efficacy Example 1.

[0196] 1. Materials

[0197] 1.1 Experimental Animals

[0198] SAMP8 male mice, 16 weeks old, weighing 30 ± 2 g, were purchased from Beijing Huafukang Biotechnology Co., Ltd. Experimental animals were maintained in an SPF-grade animal room at the Shanghai Laboratory Animal Center, with a temperature of (24 ± 1)°C, a relative humidity of 50%–70%, and a 12-hour light / dark cycle. Experimental procedures strictly adhered to the relevant regulations and guidelines of the Ethics Committee of the Shanghai Laboratory Animal Center.

[0199] 1.2 Experimental Drugs

[0200] Experimental drugs: Astragalus, dried tangerine peel, roasted malt, Cibotium barbarum, Eucommia bark, Lycium barbarum, Achyranthes bidentata, and Drynaria fortunei. The extract powder of Group 2 contained 3.44 g of crude drugs per gram. Experimental drug: Luogai calcitriol capsules (0.25 μg), purchased from Catalent Germany Eberbach GmbH.

[0201] 1.3 Experimental Instruments

[0202] Dual-energy X-ray absorptiometry (iNSiGHT VET DXA, OsteoSys, Korea); YLS-13A muscle strength tester, Jinan Yiyan Technology Co., Ltd.; small animal treadmill (animal experiment treadmill), Beijing Zhongshidichuang Technology Development Co., Ltd.

[0203] 2. Experimental methods

[0204] 2.1 Grouping and Dosing

[0205] After adaptive feeding with ordinary feed for one week, 40 SAMP8 mice were randomly divided into a model group, a low-dose group (7.08 g / kg.d), a medium-dose group (14.17 g / kg.d) and a high-dose group (28.33 g / kg.d crude drug) of the drug composition of group 2, and a positive drug control group (vitamin D 0.1 ug / kg.d), with 8 mice in each group; 8 16-week-old SAMP8 mice served as a negative control group.

[0206] The extract powder of the pharmaceutical composition of Group 2 was dissolved in ultrapure water. Each medication group was given different concentrations of the extract powder solution of the pharmaceutical composition of Group 2 by gavage once a day for 12 consecutive weeks, with a gavage volume of 0.1 mL / 10 g.

[0207] Vitamin D was dissolved in corn oil. The positive control group was given vitamin D solution by gavage once a day for 12 consecutive weeks, with a gavage volume of 0.1 mL / 10 g.

[0208] The model group was given ultrapure water by gavage for 12 consecutive weeks, once a day, with a gavage volume of 0.1 mL / 10 g.

[0209] 2.2 Detection indicators and methods

[0210] 2.2.1 General determination

[0211] The body weight and food intake of mice were measured according to conventional methods.

[0212] Method for measuring mouse body weight and food intake: Mouse weight was measured according to standard weighing procedures. Experimental equipment: electronic balance (range: 0-200g, sensitivity 0.01g). Operating steps: Select a suitable height and stable position to place the electronic scale; plug in the power supply, turn on the electronic balance, and after it is ready, place an appropriately sized weighing box on it and adjust it to zero. According to the "Operational Procedures for Grasping and Fixing Laboratory Animals", grab the mouse from the feeding box, place it in the weighing box, and read the value after the value stabilizes. If the value fluctuates continuously, select the middle value and record it in a dedicated experimental original record sheet. Place the mouse back in the cage, cover the cage, return it to the cage rack, and insert the water bottle. After weighing, put the mouse cage in order, turn off the balance, disconnect the power supply, wipe the electronic balance clean, and return it to its original position. Fill in the electronic balance usage record.

[0213] The food intake of mice was measured using a rat and mouse diet and water intake monitoring system. The XR1130 rat and mouse diet and water intake monitoring system is a system used to regularly measure the food intake behavior of rats and mice housed in a single laboratory. It was purchased from Shanghai Xinruan Information Technology Co., Ltd. The measurement time is set to weekly. Through regular measurements, the software records the food intake of each activity cage. Food can be added midway, and the data can automatically accumulate the amount of food in the trough. Data such as food intake (grams) can be monitored through the data dashboard. Mouse feed was purchased from the Shanghai Laboratory Animal Research Center and produced according to the standardized quality requirements of laboratory animal compound feed.

[0214] 2.2.2 Aging score

[0215] The degree of apparent aging was assessed using the Aging Rating Scale, which includes 11 categories, including reactive, passive, skin and hair, eye, and spine-related aging. Each category is scored from 0 to 4 points, and assessments were conducted every 0, 4, 8, and 12 weeks.

[0216] 2.2.3. Mouse muscle strength measurement

[0217] The forelimb grip strength of mice was measured using a YLS-13A muscle strength tester (Jinan Yiyan Technology Co., Ltd., Jinan, China). The mice were lifted and fixed by their tails so that their limbs could grasp a wire mesh. The mice were then gently pulled back by their tails, with their posture parallel to the table surface, until they released the mesh. The peak force exerted by the mouse's limbs was recorded in grams (g). Evaluations were performed every 0, 4, 8, and 12 weeks, with each mouse tested three times, the average value was taken, and the weight was used for statistical analysis.

[0218] 2.2.4. Body composition determination of mice

[0219] Three days before the mice were sacrificed, dual-energy X-ray absorptiometry (DEXA) was used to measure body composition, including body fat content and muscle content, and the data were analyzed using the software provided by the manufacturer.

[0220] 2.2.5. Mouse muscle function assay

[0221] Running to exhaustion: A treadmill test was conducted using mice. Mice were placed on a treadmill track with an initial speed of 5 m / min and an incline of 0 degrees. The speed and incline were increased by 5 m / min and 5 degrees every 5 minutes until reaching 20 m / min and 14 degrees, respectively. The time to exhaustion was recorded. Exhaustion was defined as a significant decrease in the mouse's response to external stimuli after a minimum of 20 seconds without stepping off the track. If the mouse did not reach exhaustion for more than 3 hours, the time was recorded as 3 hours. Measurements were performed every 4 weeks.

[0222] 2.2.6 Statistical methods

[0223] The experimental data were analyzed using SPSS 21.0 software. The measurement data were expressed as mean ± standard deviation. One-way ANOVA was used for comparison between groups. P < 0.05 was considered statistically significant.

[0224] 3. Results

[0225] 3.1 Effect of the drug composition in group 2 on food intake in SAMP8 sarcopenia model mice

[0226] The results are shown in Table 3. Before administration, there was no significant difference in the food intake of SAMP8 mice among the groups, indicating that the experimental system was reliable and the groups were comparable. Four weeks after administration, the food intake of the medium and high-dose groups of the drug composition in Group 2 increased compared with the model group, low-dose group and positive drug control group; the food intake of the low-dose group and positive drug control group decreased compared with before administration. Eight weeks after administration, there was no statistical difference in food intake among the groups; the food intake of each group decreased compared with four weeks after administration, among which the positive drug control group decreased significantly compared with before. Twelve weeks after administration, there was no statistical difference in food intake among the groups; the food intake of each group increased compared with eight weeks after administration, and the food intake of the medium and high-dose groups of the drug composition in Group 2 showed a trend of increasing compared with the model group, low-dose group and positive drug control group.

[0227] Table 3 Effects of the pharmaceutical composition of Group 2 on food intake in SAMP8 sarcopenia model mice

[0228] 3.2 Effect of the drug composition of Group 2 on the aging degree of SAMP8 sarcopenia model mice

[0229] The results are shown in Table 4. Before administration, there were no significant differences in the aging scores of SAMP8 mice between the groups, indicating that the experimental system was reliable and the groups were comparable. Four weeks after administration, the aging scores of the low-, medium-, and high-dose groups, as well as the positive control group, were significantly lower than those of the model group (P < 0.01); there were no statistically significant differences in aging scores between the treatment groups. Four weeks after administration, the aging scores of the low-, medium-, and high-dose groups, as well as the positive control group, were significantly lower than those of the model group (P < 0.01); there were no statistically significant differences in aging scores between the treatment groups. After 12 weeks of administration, the aging scores of each group were significantly increased compared with the negative control group (P < 0.01); compared with the model group, the aging scores of the low, medium and high dose groups were significantly decreased (P < 0.01); compared with the low dose group, the aging score of the high dose group was significantly decreased (P < 0.01), and the aging score of the medium dose group showed a decreasing trend; compared with the medium dose group, the aging score of the high dose group was significantly decreased (P < 0.05); there was no statistical difference between the positive control group and the drug-administered groups, but there was a decreasing trend in the low and medium dose groups.

[0230] Table 4 Effect of sarcopenia on aging in SAMP8 sarcopenia model mice

[0231] Note: Compared with the model group, **P<0.01; compared with the low-dose group, △ P<0.05, △△ P<0.01; compared with the medium dose, □ P<0.05, □□ P < 0.01;

[0232] 3.3 Effect of the drug composition of group 2 on muscle strength of SAMP8 sarcopenia model mice

[0233] The results are shown in Table 5. Before administration, there was no significant difference in the muscle strength of SAMP8 mice between the groups, indicating that the experimental system is reliable and the groups are comparable. Four weeks after administration, compared with the model group, the muscle strength of the positive drug control group was significantly increased (P < 0.05); the muscle strength of the medium and high dose groups was significantly increased (P < 0.01). Compared with the low dose group, the muscle strength of the medium dose group was significantly increased (P < 0.05), and the muscle strength of the high dose group was significantly increased (P < 0.01). Compared with the positive drug control group, the muscle strength of the high dose group was significantly increased (P < 0.05). Eight weeks after administration, compared with the model group and the positive drug control group, the muscle strength of the medium and high dose groups was significantly increased (P < 0.01); among the drug combination administration groups in Group 2, the medium dose group had an increasing trend compared with the lower dose group and the high dose group, and the high dose group had an increasing trend compared with the lower dose group. Twelve weeks after administration, compared with the model group, the muscle strength of each drug-treated group and the negative control group was significantly increased (P<0.01). The muscle strength of the low-, medium-, and high-dose groups showed an increasing trend compared with the positive drug control group, and increased with the increase of drug concentration.

[0234] Table 5 Effects of the pharmaceutical composition of Group 2 on muscle strength in SAMP8 sarcopenia model mice

[0235] Note: Compared with the model group, *P<0.05, **P<0.01; compared with the low-dose group, △ P<0.05, △△ P<0.01; compared with the medium dose group, ○ P<0.05, ○○ P<0.01; compared with the high-dose group, □ P<0.05, □□ P<0.01.

[0236] 3.4 Effect of the drug composition of group 2 on body fat content and muscle content in SAMP8 sarcopenia model mice

[0237] The results are shown in Table 6. Twelve weeks after administration, there were no statistically significant differences in muscle mass between the groups, but muscle mass in each treatment group showed an upward trend compared to the model group. Muscle mass in the medium-dose group was slightly higher than in the negative control group. Twelve weeks after administration, compared with the model group, the high-dose group had a significantly lower percentage of body fat (P < 0.05), and the medium-dose and negative control groups had significantly lower percentages of body fat (P < 0.01). Compared with the low-dose group, the medium-dose and negative control groups had significantly lower percentages of body fat (P < 0.05). Compared with the medium-dose group, the positive control group had a significantly higher percentage of body fat (P < 0.05). Compared with the positive control group, the negative control group had a significantly higher percentage of body fat (P < 0.05). DEXA images of body composition in SAMP8 mice are shown in Figure 1.

[0238] Table 6 Effects of the pharmaceutical composition of Group 2 on body fat content and muscle content in SAMP8 sarcopenia model mice

[0239] Note: Compared with the model group, *P<0.05, **P<0.01; compared with the low-dose group, △ P<0.05; compared with the medium dose, □ P<0.05, □□ P<0.01; compared with the positive drug control group, ○ P<0.05.

[0240] 3.5 Effect of the drug composition of group 2 on muscle function in SAMP8 sarcopenia model mice

[0241] The results are shown in Table 7. Compared with the model group, the running time in the high-dose group was significantly increased (P < 0.05), and the running time in the negative control group, low-medium-dose group, and positive drug control group showed an increasing trend. There was no statistical difference in running distance among the other drug groups, but there was an increasing trend in running distance with increasing drug dose. Compared with the model group, the running time in the medium-dose group and negative control group was significantly increased (P < 0.05), and the running time in the high-dose group was significantly increased (P < 0.01). There was no statistical difference in running time among the low-dose group, medium-dose group, and high-dose group, but there was an increasing trend. Compared with the negative control group and positive drug control group, the running time in the high-dose group was significantly increased (P < 0.05).

[0242] Table 7 Effects of the pharmaceutical composition of Group 2 on muscle function in SAMP8 sarcopenia model mice

[0243] Note: Compared with the model group, *P<0.05, **P<0.01; compared with the high-dose group, △ P<0.05,△△ P < 0.01;

[0244] 4 Summary

[0245] Based on animal experiments, it was found that the drug composition of Group 2 can improve the muscle strength, muscle content and muscle function of SAMP8 sarcopenia model mice, reduce body fat content, delay the aging process, and has no obvious effect on food intake, indicating that the drug composition of Group 2 can be used as a drug for the treatment of sarcopenia.

[0246] The embodiments of the present invention are described in detail above. Specific examples are used herein to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only intended to help understand the method of the present invention and its core concept. At the same time, changes or modifications made by those skilled in the art based on the concept of the present invention, the specific implementation methods of the present invention, and the scope of application are all within the scope of protection of the present invention. In summary, the contents of this specification should not be understood as limiting the present invention.

Claims

1. A traditional Chinese medicine composition for preventing and / or treating sarcopenia, characterized in that, The raw materials of the traditional Chinese medicine composition, by weight, include 9-11 parts of dried tangerine peel, 9-11 parts of achyranthes bidentata, 9-11 parts of malt, 9-11 parts of drynaria rhizome, 9-11 parts of eucommia ulmoides, 9-11 parts of wolfberry fruit, 13.5-16.5 parts of astragalus membranaceus and 13.5-16.5 parts of cibotium barometz; or, the raw materials of the traditional Chinese medicine composition, by weight, include 9-11 parts of dried tangerine peel, 18-22 parts of achyranthes bidentata, 13.5-16.5 parts of malt, 9-11 parts of drynaria rhizome, 4.5-5.5 parts of eucommia ulmoides, 13.5-16.5 parts of wolfberry fruit, 13.5-16.5 parts of astragalus membranaceus and 9-11 parts of cibotium barometz; or, the raw materials of the traditional Chinese medicine composition, by weight, include 13.5-16.5 parts of dried tangerine peel, 13.5-16.5 parts of achyranthes bidentata, 13.5-16.5 parts of malt, 13.5-16.5 parts of drynaria rhizome, 13.5-16.5 parts of eucommia ulmoides, 13.5-16.5 parts of wolfberry fruit, 4.5-5.5 parts of astragalus membranaceus and 4.5-5.5 parts of cibotium barometz; or, the raw materials of the traditional Chinese medicine composition, by weight, include 18-22 parts of dried tangerine peel, 9-11 parts of achyranthes bidentata, 13.5-16.5 parts of malt, 4.5-5.5 parts of drynaria rhizome, 9-11 parts of eucommia ulmoides, 13.5-16.5 parts of wolfberry fruit, 9-11 parts of astragalus membranaceus and 13.5-16.5 parts of cibotium barometz; or, the raw materials of the traditional Chinese medicine composition, by weight, include 18-22 parts of dried tangerine peel, 13.5-16.5 parts of achyranthes bidentata, 9-11 parts of malt, 9-11 parts of drynaria rhizome, 4.5-5.5 parts of eucommia ulmoides, 13.5-16.5 parts of wolfberry fruit, 4.5-5.5 parts of astragalus membranaceus and 13.5-16.5 parts of cibotium barometz; or, the raw materials of the traditional Chinese medicine composition, by weight, include 18-22 parts of dried tangerine peel, 13.5-16.5 parts of achyranthes bidentata, 9-11 parts of malt, 13.5-16.5 parts of drynaria rhizome, 9-11 parts of eucommia ulmoides, 4.5-5.5 parts of wolfberry fruit, 13.5-16.5 parts of astragalus membranaceus and 9-11 parts of cibotium barometz; or, the raw materials of the traditional Chinese medicine composition, by weight, include 18-22 parts of dried tangerine peel, 18-22 parts of achyranthes bidentata, 18-22 parts of malt, 13.5-16.5 parts of drynaria rhizome, 13.5-16.5 parts of eucommia ulmoides, 13.5-16.5 parts of wolfberry fruit, 13.5-16.5 parts of astragalus membranaceus and 13.5-16.5 parts of cibotium barometz.

2. The traditional Chinese medicine composition according to claim 1, wherein, The raw materials of the traditional Chinese medicine composition, by weight, include 9.5-10.5 parts of dried tangerine peel, 9.5-10.5 parts of achyranthes bidentata, 9.5-10.5 parts of malt, 9.5-10.5 parts of drynaria rhizome, 9.5-10.5 parts of eucommia ulmoides, 9.5-10.5 parts of wolfberry fruit, 14.25-15.75 parts of astragalus membranaceus and 14.25-15.75 parts of cibotium barometz; Preferably, the raw materials of the traditional Chinese medicine composition, by weight, include about 10 parts of dried tangerine peel, about 10 parts of achyranthes bidentata, about 10 parts of malt, about 10 parts of drynaria rhizome, about 10 parts of eucommia ulmoides, about 10 parts of wolfberry fruit, about 15 parts of astragalus membranaceus and about 15 parts of cibotium barometz; More preferably, based on parts by weight, the raw materials of the traditional Chinese medicine composition include 9.5 - 10.5 parts of dried tangerine peel, 19 - 21 parts of achyranthes bidentata, 14.25 - 15.75 parts of malt, 9.5 - 10.5 parts of drynaria rhizome, 4.75 - 5.25 parts of eucommia ulmoides, 14.25 - 15.75 parts of wolfberry fruit, 14.25 - 15.75 parts of astragalus membranaceus, and 9.5 - 10.5 parts of cibotium barometz; More preferably, based on parts by weight, the raw materials of the traditional Chinese medicine composition include approximately 10 parts of dried tangerine peel, approximately 20 parts of achyranthes bidentata, approximately 15 parts of malt, approximately 10 parts of drynaria rhizome, approximately 5 parts of eucommia ulmoides, approximately 15 parts of wolfberry fruit, approximately 15 parts of astragalus membranaceus, and approximately 10 parts of cibotium barometz; Also preferably, based on parts by weight, the raw materials of the traditional Chinese medicine composition include 14.25 - 15.75 parts of dried tangerine peel, 14.25 - 15.75 parts of achyranthes bidentata, 14.25 - 15.75 parts of malt, 14.25 - 15.75 parts of drynaria rhizome, 14.25 - 15.75 parts of eucommia ulmoides, 14.25 - 15.75 parts of wolfberry fruit, 4.75 - 5.25 parts of astragalus membranaceus, and 4.75 - 5.25 parts of cibotium barometz; Also preferably, based on parts by weight, the raw materials of the traditional Chinese medicine composition include approximately 15 parts of dried tangerine peel, approximately 15 parts of achyranthes bidentata, approximately 15 parts of malt, approximately 15 parts of drynaria rhizome, approximately 15 parts of eucommia ulmoides, approximately 15 parts of wolfberry fruit, approximately 5 parts of astragalus membranaceus, and approximately 5 parts of cibotium barometz; Even more preferably, based on parts by weight, the raw materials of the traditional Chinese medicine composition include 19 - 21 parts of dried tangerine peel, 9.5 - 10.5 parts of achyranthes bidentata, 14.25 - 15.75 parts of malt, 4.75 - 5.25 parts of drynaria rhizome, 9.5 - 10.5 parts of eucommia ulmoides, 14.25 - 15.75 parts of wolfberry fruit, 9.5 - 10.5 parts of astragalus membranaceus, and 14.25 - 15.75 parts of cibotium barometz; Even more preferably, based on parts by weight, the raw materials of the traditional Chinese medicine composition include approximately 20 parts of dried tangerine peel, approximately 10 parts of achyranthes bidentata, approximately 15 parts of malt, approximately 5 parts of drynaria rhizome, approximately 10 parts of eucommia ulmoides, approximately 15 parts of wolfberry fruit, approximately 10 parts of astragalus membranaceus, and approximately 15 parts of cibotium barometz; Particularly preferably, based on parts by weight, the raw materials of the traditional Chinese medicine composition include 19 - 21 parts of dried tangerine peel, 14.25 - 15.75 parts of achyranthes bidentata, 9.5 - 10.5 parts of malt, 9.5 - 10.5 parts of drynaria rhizome, 4.75 - 5.25 parts of eucommia ulmoides, 14.25 - 15.75 parts of wolfberry fruit, 4.75 - 5.25 parts of astragalus membranaceus, and 14.25 - 15.75 parts of cibotium barometz; Particularly preferably, based on parts by weight, the raw materials of the traditional Chinese medicine composition include approximately 20 parts of dried tangerine peel, approximately 15 parts of achyranthes bidentata, approximately 10 parts of malt, approximately 10 parts of drynaria rhizome, approximately 5 parts of eucommia ulmoides, approximately 15 parts of wolfberry fruit, approximately 5 parts of astragalus membranaceus, and approximately 15 parts of cibotium barometz; Especially preferably, based on parts by weight, the raw materials of the traditional Chinese medicine composition include 19 - 21 parts of dried tangerine peel, 14.25 - 15.75 parts of achyranthes bidentata, 9.5 - 10.5 parts of malt, 14.25 - 15.75 parts of drynaria rhizome, 9.5 - 10.5 parts of eucommia ulmoides, 4.75 - 5.25 parts of wolfberry fruit, 14.25 - 15.75 parts of astragalus membranaceus, and 9.5 - 10.5 parts of cibotium barometz; Particularly preferably, by weight, the raw materials of the traditional Chinese medicine composition include about 20 parts of dried tangerine peel, about 15 parts of achyranthes bidentata, about 10 parts of malt, about 15 parts of drynaria rhizome, about 10 parts of eucommia ulmoides, about 5 parts of wolfberry fruit, about 15 parts of astragalus membranaceus and about 10 parts of cibotium barometz; More particularly preferably, by weight, the raw materials of the traditional Chinese medicine composition include 19 - 21 parts of dried tangerine peel, 19 - 21 parts of achyranthes bidentata, 19 - 21 parts of malt, 14.25 - 15.75 parts of drynaria rhizome, 14.25 - 15.75 parts of eucommia ulmoides, 14.25 - 15.75 parts of wolfberry fruit, 14.25 - 15.75 parts of astragalus membranaceus and 14.25 - 15.75 parts of cibotium barometz; More particularly preferably, by weight, the raw materials of the traditional Chinese medicine composition include about 20 parts of dried tangerine peel, about 20 parts of achyranthes bidentata, about 20 parts of malt, about 15 parts of drynaria rhizome, about 15 parts of eucommia ulmoides, about 15 parts of wolfberry fruit, about 15 parts of astragalus membranaceus and about 15 parts of cibotium barometz; Particularly and most preferably, by weight ratio, the weight ratio of dried tangerine peel to astragalus membranaceus is about 0.66, and the weight ratio of achyranthes bidentata to astragalus membranaceus is about 0.66, and the weight ratio of malt to astragalus membranaceus is about 0.66, and the weight ratio of drynaria rhizome to astragalus membranaceus is about 0.66, and the weight ratio of eucommia ulmoides to astragalus membranaceus is about 0.66, and the weight ratio of wolfberry fruit to astragalus membranaceus is about 0.66, and the weight ratio of cibotium barometz to astragalus membranaceus is about 1; Particularly and most preferably, by weight ratio, the weight ratio of dried tangerine peel to astragalus membranaceus is about 0.66, and the weight ratio of achyranthes bidentata to astragalus membranaceus is about 1.33, and the weight ratio of malt to astragalus membranaceus is about 1, and the weight ratio of drynaria rhizome to astragalus membranaceus is about 0.66, and the weight ratio of eucommia ulmoides to astragalus membranaceus is about 0.33, and the weight ratio of wolfberry fruit to astragalus membranaceus is about 1, and the weight ratio of cibotium barometz to astragalus membranaceus is about 0.66; Particularly and most preferably, by weight ratio, the weight ratio of dried tangerine peel to astragalus membranaceus is about 3, and the weight ratio of achyranthes bidentata to astragalus membranaceus is about 3, and the weight ratio of malt to astragalus membranaceus is about 3, and the weight ratio of drynaria rhizome to astragalus membranaceus is about 3, and the weight ratio of eucommia ulmoides to astragalus membranaceus is about 3, and the weight ratio of wolfberry fruit to astragalus membranaceus is about 3, and the weight ratio of cibotium barometz to astragalus membranaceus is about 1; Particularly and most preferably, by weight ratio, the weight ratio of dried tangerine peel to astragalus membranaceus is about 2, and the weight ratio of achyranthes bidentata to astragalus membranaceus is about 1, and the weight ratio of malt to astragalus membranaceus is about 1.5, and the weight ratio of drynaria rhizome to astragalus membranaceus is about 0.5, and the weight ratio of eucommia ulmoides to astragalus membranaceus is about 1, and the weight ratio of wolfberry fruit to astragalus membranaceus is about 1.5, and the weight ratio of cibotium barometz to astragalus membranaceus is about 1.5; Particularly and most preferably, by weight ratio, the weight ratio of dried tangerine peel to astragalus membranaceus is about 4, and the weight ratio of achyranthes bidentata to astragalus membranaceus is about 3, and the weight ratio of malt to astragalus membranaceus is about 2, and the weight ratio of drynaria rhizome to astragalus membranaceus is about 2, and the weight ratio of eucommia ulmoides to astragalus membranaceus is about 1, and the wolfberry fruit to astragalus membranaceus weight ratio is about 3, and the weight ratio of cibotium barometz to astragalus membranaceus is about 3; Particularly preferably, by weight ratio, the weight ratio of tangerine peel to astragalus membranaceus is about 1.33, the weight ratio of achyranthes bidentata to astragalus membranaceus is about 1, the weight ratio of fructus hordei germinatus to astragalus membranaceus is about 0.66, the weight ratio of drynaria rhizome to astragalus membranaceus is about 1, the weight ratio of eucommia ulmoides to astragalus membranaceus is about 0.66, the weight ratio of wolfberry fruit to astragalus membranaceus is about 0.33, and the weight ratio of cibotium barometz to astragalus membranaceus is about 0.66; Particularly preferably, by weight ratio, the weight ratio of tangerine peel to astragalus membranaceus is about 1.33, the weight ratio of achyranthes bidentata to astragalus membranaceus is about 1.33, the weight ratio of fructus hordei germinatus to astragalus membranaceus is about 1.33, the weight ratio of drynaria rhizome to astragalus membranaceus is about 1, the weight ratio of eucommia ulmoides to astragalus membranaceus is about 1, the weight ratio of wolfberry fruit to astragalus membranaceus is about 1, and the weight ratio of cibotium barometz to astragalus membranaceus is about 1; Most preferably, the fructus hordei germinatus is stir-fried fructus hordei germinatus.

3. A pharmaceutical preparation comprising the traditional Chinese medicine composition according to claim 1 or 2.

4. The pharmaceutical preparation according to claim 3, characterized in that, The pharmaceutical preparation further comprises one or more drugs and / or extracts for preventing and / or treating sarcopenia; Preferably, the drug is selected from one or more of the following: testosterone, selective androgen receptor modulators, growth hormone, ghrelin, and myostatin inhibitors; More preferably, the pharmaceutical preparation comprises one or more pharmaceutically acceptable excipients; Still more preferably, the excipients are selected from one or more of the following: diluents, wetting agents, binders, disintegrants, inclusion agents, flavoring agents, sustained-release agents, retention aids, lubricants, dispersants, plasticizers, light-blocking agents, and antioxidants; Still more preferably, the excipient is dextrin; Particularly preferably, the dosage form of the pharmaceutical preparation is powder, tablet, dripping pill, capsule, film, lozenge, granule, injection, or oral liquid; Particularly preferably, the dosage form of the pharmaceutical preparation is granule.

5. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The method comprises the following steps: (1) Weigh appropriate amounts of tangerine peel, achyranthes bidentata, fructus hordei germinatus, drynaria rhizome, eucommia ulmoides, wolfberry fruit, astragalus membranaceus, and cibotium barometz. After the first water decoction for a period of time, filter to obtain a first filtrate and a first medicinal residue; (2) In the first medicinal residue, add water for the second decoction for a period of time, then filter to obtain a second filtrate and a second medicinal residue; and (3) Combine the first filtrate and the second filtrate, concentrate to a concentrated solution and then dry to obtain the traditional Chinese medicine composition.

6. A method for preparing the pharmaceutical preparation according to claim 3 or 4, characterized in that, The method comprises the following steps: (1) Weigh appropriate amounts of tangerine peel, achyranthes bidentata, fructus hordei germinatus, drynaria rhizome, eucommia ulmoides, wolfberry fruit, astragalus membranaceus, and cibotium barometz. After the first water decoction for a period of time, filter to obtain a first filtrate and a first medicinal residue; (2) In the first medicinal residue, add water for the second decoction for a period of time, then filter to obtain a second filtrate and a second medicinal residue; (3) Combine the first filtrate and the second filtrate, and concentrate to a concentrated solution; and (4) Add excipients to the concentrated solution for the first time, and then add excipients again after drying to obtain the pharmaceutical preparation.

7. The method according to claim 5 or 6, characterized in that, The fructus hordei germinatus is stir-fried fructus hordei germinatus; Preferably, the ratio of the volume of water in the first addition of water to the total mass of the medicinal materials of tangerine peel, achyranthes bidentata, malt, drynaria rhizome, eucommia ulmoides, wolfberry fruit, astragalus membranaceus and cynomorium songaricum in terms of volume / mass (ml / g or L / kg) is 1 to 20, such as about 10; Preferably, the time for decocting with the first addition of water is 30 to 90 minutes counted from the time of boiling, such as about 60 minutes; More preferably, the ratio of the volume of water in the second addition of water to the total mass of the medicinal materials of tangerine peel, achyranthes bidentata, malt, drynaria rhizome, eucommia ulmoides, wolfberry fruit, astragalus membranaceus and cynomorium songaricum in terms of volume / mass (ml / g or L / kg) is 1 to 20, such as about 8; More preferably, the time for decocting with the second addition of water is 10 to 90 minutes counted from the time of boiling, such as about 30 minutes; Also preferably, the relative density of the concentrated liquid is 1.10 to 1.15 at 55°C to 65°C; Also preferably, the drying temperature is 50 to 70°C, such as about 60°C.

8. The method according to claim 6, wherein The ratio of the mass of the first added adjuvant to the mass of the concentrated liquid in terms of mass / mass (g / g or mg / mg) is 0.035 to 0.175, such as about 0.07; Preferably, the drying is spray drying; More preferably, the step (4) further includes a granulation step; More preferably, the granulation is dry granulation.

9. Use of the traditional Chinese medicine composition according to claim 1 or 2 or the pharmaceutical preparation according to claim 3 or 4 in the preparation of medicaments, foods and / or health products for preventing and / or treating sarcopenia.

10. The use according to claim 9, characterized in that, The prevention and / or treatment of sarcopenia is manifested as one or more of the following conditions: increasing muscle strength, increasing muscle mass, increasing muscle function, reducing body fat content, and delaying the aging process.

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