A Chinese medicine composition for preventing and treating sarcopenia and its preparation method and use

Abstract

The invention discloses a Chinese medicine composition for preventing and / or treating sarcopenia, wherein the raw materials of the Chinese medicine composition include 9-11 parts of dried orange peel, 9-11 parts of Chinese rhizoma rutaecarpa, 9-11 parts of malt, 9-11 parts of drynariae, 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 cibotium barbarum by weight. The Chinese medicine composition of the invention can improve muscle strength, muscle content and muscle function, reduce body fat content, delay the aging process, and has no obvious effect on food intake, indicating that the Chinese medicine composition can be used as a medicine for treating sarcopenia.

Description

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 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 that the prevalence of sarcopenia in the elderly aged 60 to 70 years in China is around 4.1% to 11.5%. The prevalence of sarcopenia in men and women aged 70 years and above is 13.2% and 4.8%, respectively. The incidence rate increases significantly over 80 years old, up to 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, Vandewoud 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. 2019Jan 1; 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 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 extensive attention from scholars at home and abroad, and extensive research has been carried out 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. And because the cause of sarcopenia is still unknown, it is related to multiple factors and involves complex molecular mechanisms that are interrelated, which makes the treatment of the disease difficult. At present, 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 has accumulated certain clinical experience in the treatment of sarcopenia. Traditional Chinese medicine classifies the clinical manifestations of thin body muscles, weakness and powerlessness as weakness, which is similar to the clinical manifestations of sarcopenia, which are muscle mass loss, muscle strength loss or physical function loss. Since sarcopenia and weakness have highly overlapping connotations, traditional Chinese medicine often treats sarcopenia from the perspective of weakness, and the effect is very good. Ancient Chinese medical literature records that the onset of weakness is closely related to the spleen and kidney. "The spleen produces meat" in "Suwen·Yin Yang Ying Xiang Da Lun" and "The spleen is responsible for transporting and transforming the essence of water and grain to nourish muscles" in "Suwen Jizhu·Five Zang Cheng Sheng Pian" reflect the correlation between the spleen and muscles. Muscles need to rely on the spleen to transport water and grain to generate qi and blood to nourish them. When the spleen is healthy, the qi and blood are abundant, and the muscles are plump and strong. The Suwen·Wei Lun states: "Why do the five zang organs cause weakness? ... The spleen governs the muscles of the body. If the spleen is hot, the stomach will be hot and thirsty, and the muscles will be numb, resulting in muscle weakness." The Suwen·Zangqi Fashi Lun states: "People with spleen disease have a heavy body, muscle weakness, and the feet cannot move." These indicate the pathological correlation between the spleen and muscle atrophy. When the spleen is weak and cannot transform water and grain into qi and blood, the muscles will be malnourished, resulting in weakness of the limbs, weakness, and motor dysfunction. In addition, the growth and aging of the human body are dominated by the rise and fall of kidney qi. Sarcopenia, as an age-related geriatric syndrome, is more closely related to the weakness of kidney qi. "Suwen: Ancient Innocence" states: "At the age of eight, the kidney qi is strong, the hair grows and the teeth change... At the age of fifty-eight, the kidney qi declines, the hair falls and the teeth become dry; at the age of sixty-eight, the yang qi is exhausted, the face is burnt, and the hair and temples are white; at the age of seventy-eight, the liver qi is weak, and the tendons cannot move; at the age of eighty-eight, the heavenly essence is exhausted, the essence is less, the kidney storage is weak, the body is at its extreme, and the teeth and hair fall." This shows that the growth and aging of the human body, including the fullness and firmness of muscles and the attenuation and atrophy, change with the rise and fall of kidney qi. With the deficiency of spleen and kidney, the function of muscles progressively declines, and the incidence of sarcopenia increases. The "spleen and kidney" in traditional Chinese medicine are closely related to the onset of sarcopenia. It is feasible to treat sarcopenia from the spleen and kidney in traditional Chinese medicine theory. Our previous epidemiological survey on the syndrome of sarcopenia in traditional Chinese medicine found that about 80% of sarcopenia patients have the syndrome of "deficiency of spleen and kidney" in traditional Chinese medicine.

[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. Summary of the invention

[0005] 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 orange peel, 9-11 parts of Chinese rhizoma cyrtonema, 9-11 parts of malt, 9-11 parts of drynariae, 9-11 parts of eucommia barbarum, 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 orange peel, 18-22 parts of Chinese rhizoma cyrtonema, 13.5-16.5 parts of malt, 9-11 parts of drynariae, 4.5-5.5 parts of eucommia barbarum, 9-11 parts of wolfberry, 13.5-16.5 parts of astragalus and 13.5-16.5 parts of dog spine; 13.5-16.5 parts of wolfberry, 13.5-16.5 parts of astragalus and 9-11 parts of dog spine; or, 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 cyathula, 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, by weight, the raw materials of the traditional Chinese medicine composition include 18-22 parts of dried orange peel, 9-11 parts of cyathula, 13.5-16.5 parts of malt 13.5-16.5 parts of dried radix osmanthus, 4.5-5.5 parts of dried radix osmanthus, 9-11 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 cyathula capitata, 9-11 parts of malt, 9-11 parts of dried radix osmanthus, 4.5-5.5 parts of eucommia bark, 13.5-16.5 parts of wolfberry, 4.5-5.5 ... Alternatively, in parts by weight, the raw materials of the traditional Chinese medicine composition include 18-22 parts of dried orange peel, 18-22 parts of rhizoma achyranthis Bidentatae, 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 9-11 parts of citronella; or, in parts by weight, the raw materials of the traditional Chinese medicine composition include 18-22 parts of dried orange peel, 18-22 parts of rhizoma achyranthis Bidentatae, 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 citronella.

[0006] Further, in parts by weight, the raw materials of the Chinese medicine composition include 9.5-10.5 parts of dried orange peel, 9.5-10.5 parts of Chinese rhizoma cyrtonema, 9.5-10.5 parts of malt, 9.5-10.5 parts of drynaria, 9.5-10.5 parts of eucommia, 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 Chinese medicine composition include about 10 parts of dried orange peel, about 10 parts of Chinese rhizoma cyrtonema, about 10 parts of malt, about 10 parts of drynaria, about 10 parts of eucommia, about 10 parts of wolfberry, about 15 parts of astragalus, and about 15 parts of dog spine. Further, by weight, the raw materials of the Chinese medicine composition include 9.5-10.5 parts of dried orange peel, 19-21 parts of Chinese rhizoma cyrtonema, 14.25-15.75 parts of malt, 9.5-10.5 parts of bone-drying 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, by weight, the raw materials of the Chinese medicine composition include about 10 parts of dried orange peel, about 20 parts of Chinese rhizoma cyrtonema, about 15 parts of malt, about 10 parts of bone-drying rhizome, about 5 parts of eucommia bark, about 15 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 Chinese medicine composition include 14.25-15.75 parts of dried orange peel, 14.25-15.75 parts of Chinese rhizoma rutaecarpa, 14.25-15.75 parts of malt, 14.25-15.75 parts of drynaria, 14.25-15.75 parts of eucommia, 14.25-15.75 parts of wolfberry, 4.75-5.25 parts of astragalus, and 4.75-5.25 parts of dog spine. Further, in parts by weight, the raw materials of the Chinese medicine composition include about 15 parts of dried orange peel, about 15 parts of Chinese rhizoma rutaecarpa, about 15 parts of malt, about 15 parts of drynaria, about 15 parts of eucommia, about 15 parts of wolfberry, about 5 parts of astragalus, and about 5 parts of dog spine. Further, by weight, the raw materials of the Chinese medicine composition include 19-21 parts of dried orange peel, 9.5-10.5 parts of Chinese rhizoma cyrtonema, 14.25-15.75 parts of malt, 4.75-5.25 parts of bone-drying herb, 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 dog spine. Further, by weight, the raw materials of the Chinese medicine composition include about 20 parts of dried orange peel, about 10 parts of Chinese rhizoma cyrtonema, about 15 parts of malt, about 5 parts of bone-drying herb, about 10 parts of eucommia bark, about 15 parts of wolfberry, about 10 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 19-21 parts of dried tangerine peel, 14.25-15.75 parts of Chinese rhizome of radix polygoni aviculare, 9.5-10.5 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, 4.75-5.25 parts of astragalus and 14.25-15.75 parts of cibotium barbarum.Further, by weight, the raw materials of the Chinese medicine composition include about 20 parts of dried orange peel, about 15 parts of Chinese rhizoma cyrtonema, about 10 parts of malt, about 10 parts of bone-drying rhizoma, about 5 parts of eucommia bark, about 15 parts of wolfberry, about 5 parts of astragalus, and about 15 parts of dog spine. Further, by weight, the raw materials of the Chinese medicine composition include 19-21 parts of dried orange peel, 14.25-15.75 parts of Chinese rhizoma cyrtonema, 9.5-10.5 parts of malt, 14.25-15.75 parts of bone-drying rhizoma, 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. Further, by weight, the raw materials of the Chinese medicine composition include about 20 parts of dried orange peel, about 15 parts of Chinese rhizoma cyrtonema, about 10 parts of malt, about 15 parts of bone-drying herb, about 10 parts of eucommia bark, about 5 parts of wolfberry, about 15 parts of astragalus, and about 10 parts of dog spine. Further, by weight, the raw materials of the Chinese medicine composition include 19-21 parts of dried orange peel, 19-21 parts of Chinese rhizoma cyrtonema, 19-21 parts of malt, 14.25-15.75 parts of bone-drying herb, 14.25-15.75 parts of eucommia bark, 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 Chinese medicine composition include about 20 parts of dried orange peel, about 20 parts of Chinese cyperus rotundus, about 20 parts of malt, about 15 parts of bone-drying rhizome, about 15 parts of eucommia bark, about 15 parts of wolfberry, about 15 parts of astragalus, and about 15 parts of dog spine. Further, in weight ratio, the weight ratio of dried orange peel to astragalus is about 0.66, and the weight ratio of Chinese cyperus rotundus to astragalus is about 0.66, and the weight ratio of malt to astragalus is about 0.66, and the weight ratio of bone-drying rhizome to astragalus is about 0.66, and the weight ratio of eucommia bark to astragalus is about 0.66, and the weight ratio of wolfberry to astragalus is about 0.66, and the weight ratio of dog spine to astragalus is about 1. Further, by weight, the weight ratio of dried tangerine peel to astragalus is about 0.66, and the weight ratio of Chinese cyperus rotundus to astragalus is about 1.33, and the weight ratio of malt to astragalus is about 1, and the weight ratio of bone-healing bud to astragalus is about 0.66, and the weight ratio of eucommia to astragalus is about 0.33, and the weight ratio of wolfberry to astragalus is about 1, and the weight ratio of dog spine to astragalus is about 0.66. Further, by weight, the weight ratio of dried tangerine peel to astragalus is about 3, and the weight ratio of Chinese cyperus rotundus to astragalus is about 3, and the weight ratio of malt to astragalus is about 3, and the weight ratio of bone-healing bud to astragalus is about 3, and the weight ratio of eucommia to astragalus is about 3, and the weight ratio of wolfberry to astragalus is about 3, and the weight ratio of dog spine to astragalus is about 1.Further, by weight, the weight ratio of dried orange peel to astragalus is about 2, and the weight ratio of Chinese cyperus rotundus to astragalus is about 1, and the weight ratio of malt to astragalus is about 1.5, and the weight ratio of bone drynaria to astragalus is about 0.5, and the weight ratio of eucommia to astragalus is about 1, and the weight ratio of wolfberry to astragalus is about 1.5, and the weight ratio of dog spine to astragalus is about 1.5. Further, by weight, the weight ratio of dried orange peel to astragalus is about 4, and the weight ratio of Chinese cyperus rotundus to astragalus is about 3, and the weight ratio of malt to astragalus is about 2, and the weight ratio of bone drynaria to astragalus is about 2, and the weight ratio of eucommia to astragalus is about 1, and the weight ratio of wolfberry to astragalus is about 3, and the weight ratio of dog spine to astragalus is about 3. Further, by weight, the weight ratio of dried tangerine peel to astragalus is about 1.33, and the weight ratio of Chinese cyperus rotundus to astragalus is about 1, and the weight ratio of malt to astragalus is about 0.66, and the weight ratio of bone-healing bud to astragalus is about 1, and the weight ratio of eucommia ulmoides to astragalus is about 0.66, and the weight ratio of wolfberry to astragalus is about 0.33, and the weight ratio of dog spine to astragalus is about 0.66. Further, by weight, the weight ratio of dried tangerine peel to astragalus is about 1.33, and the weight ratio of Chinese cyperus rotundus to astragalus is about 1.33, and the weight ratio of malt to astragalus is about 1.33, and the weight ratio of bone-healing bud to astragalus is about 1, and the weight ratio of eucommia ulmoides to astragalus is about 1, and the weight ratio of wolfberry to astragalus is about 1, and the weight ratio of dog spine to astragalus is about 1.

[0007] Furthermore, the malt is roasted malt.

[0008] According to another aspect of the present invention, a pharmaceutical preparation comprising the above-mentioned traditional Chinese medicine composition is provided.

[0009] Furthermore, the pharmaceutical preparation further comprises one or more drugs and / or extracts for preventing and / or treating sarcopenia.

[0010] Further, the drug is selected from one or more of the following: testosterone, selective androgen receptor modulators, growth hormone, ghrelin and myostatin inhibitors.

[0011] Furthermore, the pharmaceutical preparation contains one or more pharmaceutically acceptable excipients.

[0012] 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 agent, lubricant, dispersant, plasticizer, opacifier and antioxidant.

[0013] Furthermore, the auxiliary material is dextrin.

[0014] Furthermore, the dosage form of the pharmaceutical preparation is powder, tablet, pill, capsule, film, lozenge, granule, injection or oral solution.

[0015] Furthermore, the dosage form of the pharmaceutical preparation is granules.

[0016] 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:

[0017] (1) weighing appropriate amounts of dried tangerine peel, Chinese rhizoma cyrtonemae, malt, drynariae rhizome, eucommia bark, wolfberry, astragalus and cibotium bark, adding water for the first time and boiling for a period of time, filtering to obtain a first filtrate and a first medicinal residue;

[0018] (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

[0019] (3) combining the first filtrate and the second filtrate, concentrating them into a concentrated liquid and then drying them to obtain the Chinese medicine composition.

[0020] 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:

[0021] (1) weighing appropriate amounts of dried tangerine peel, Chinese rhizoma cyrtonemae, malt, drynariae rhizome, eucommia bark, wolfberry, astragalus and cibotium bark, adding water for the first time and boiling for a period of time, filtering to obtain a first filtrate and a first medicinal residue;

[0022] (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;

[0023] (3) combining the first filtrate and the second filtrate to concentrate the filtrate into a concentrate; and

[0024] (4) adding auxiliary materials to the concentrated solution for the first time, and adding auxiliary materials again after drying to obtain the pharmaceutical preparation.

[0025] Furthermore, the malt is roasted malt.

[0026] 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 dried tangerine peel, Rhizoma Achyranthis Bidentatae, Fructus Malti, Rhizoma Drynariae, Eucommia Bark, Fructus Lycii, Radix Astragali and Cibotium Cibotium is 1 to 20, for example, about 10.

[0027] Furthermore, the first boiling time of adding water is 30 to 90 minutes, for example, about 60 minutes, starting from the boiling time.

[0028] 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, Rhizoma Achyranthis Bidentatae, Fructus Malti, Rhizoma Drynariae, Eucommia Bark, Fructus Lycii, Radix Astragali and Cibotium Cibotium is 1 to 20, for example, about 8.

[0029] Furthermore, the second boiling time is 10 to 90 minutes, for example, about 30 minutes, starting from the boiling time.

[0030] Furthermore, the relative density of the concentrated solution at 55° C. to 65° C. is 1.10 to 1.15.

[0031] Furthermore, the drying temperature is 50-70°C, for example, about 60°C.

[0032] Furthermore, the mass / mass (g / g or mg / mg) ratio between the mass of the auxiliary material added for the first time and the mass of the concentrated solution is 0.035 to 0.175, for example, about 0.07.

[0033] Furthermore, the drying is spray drying.

[0034] Furthermore, the step (4) further comprises a granulation step.

[0035] Furthermore, the granulation is dry granulation.

[0036] According to another aspect of the present invention, there is provided a use of the above-mentioned 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.

[0037] Furthermore, the prevention and / or treatment of sarcopenia is manifested as one or more of the following: increasing muscle strength, increasing muscle mass, increasing muscle function, reducing body fat content, and delaying the aging process.

[0038] Beneficial effects of the present invention:

[0039] The 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 Chinese medicine composition can be used as a medicine for treating sarcopenia. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the description of the embodiments will be briefly introduced below. 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.

[0041] Figure 1This is a DEXA graph of the body composition of the traditional Chinese medicine composition of the present invention in SAMP8 sarcopenia model mice. DETAILED DESCRIPTION

[0042] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0043] Unless otherwise indicated, all technical and scientific terms and abbreviations used herein have the meanings commonly understood by those of ordinary skill in the field of the invention or the field in which the terms are used. Although any methods, conditions, substances or materials similar to or equivalent to those disclosed herein may be used in the practice of the present invention, preferred methods, conditions, substances or materials are described herein.

[0044] The present invention is intended to encompass all alternatives, variations and equivalents that may be included in 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 can be used in the practice of the present invention. The present invention is in no way limited to the methods and materials described.

[0045] 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.

[0046] In the present invention, the term "comprising" is synonymous with "including". As used herein, the terms "comprising", "including", "having", "containing" or any other variation thereof are intended to cover a non-exclusive inclusion. For example, a composition, process, method, article, or apparatus comprising the listed 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.

[0047] 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 the treatment of sarcopenia with definite efficacy, natural safety, that is, a Chinese medicine composition for preventing and / or treating sarcopenia, wherein the raw materials of the Chinese medicine composition include 9-11 parts of dried tangerine peel, 9-11 parts of Chinese rhizome of radix polygoni multiflori, 9-11 parts of malt, 9-11 parts of drynariae, 9-11 parts of eucommia barbarum, 9-11 parts of wolfberry, 13.5-16.5 parts of astragalus, and 13.5-16.5 parts of Cibotium barbarum; or, the raw materials of the Chinese medicine composition include 9-11 parts of dried tangerine peel, 18-22 parts of Chinese rhizome of radix polygoni multiflori, 18-22 parts of citronella; or, in parts 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 cyathula, 13.5-16.5 parts of malt, 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 citron; or, in parts 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 cyathula, 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; or, in parts by weight, the raw materials of the traditional Chinese medicine composition include 18-22 parts of dried orange peel, 9-11 parts of Chinese rhizoma cyrtonema, 13.5-16.5 parts of malt, 4.5-5.5 parts of drynaria, 9-11 parts of eucommia, 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 orange peel, 13.5-16.5 parts of Chinese rhizoma cyrtonema, 9-11 parts of malt, 9-11 parts of drynaria, 4.5-5.5 parts of eucommia, 13.5 ~16.5 parts, 4.5~5.5 parts of astragalus and 13.5~16.5 parts of dog spine; or, 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 Chinese rhizoma cyperi, 9~11 parts of malt, 13.5~16.5 parts of drynaria, 9~11 parts of eucommia, 4.5~5.5 parts of wolfberry, 13.5~16.5 parts of astragalus and 9~11 parts of dog spine; or, by weight, the raw materials of the traditional Chinese medicine composition include 18~22 parts of dried orange peel, 18~22 parts of Chinese rhizoma cyperi, 18~22 parts of malt, 13.5~16.5 parts of drynaria, 9~11 parts of eucommia, 4.5~5.5 parts of wolfberry, 13.5~16.5 parts of astragalus and 9~11 parts of dog spine

[0048] 13.5-16.5 parts of Rhizoma Eucommiae, 13.5-16.5 parts of Fructus Lycii, 13.5-16.5 parts of Radix Astragali and 13.5-16.5 parts of Cibotium barometz.

[0049] The tangerine peel, Chinese rhizoma cyrtonema, stir-fried malt, drynariae rhizoma, eucommia bark, astragalus and cibotium are Chinese medicines for both medicinal and edible purposes, wherein astragalus, tangerine peel and stir-fried malt are Chinese medicines for invigorating spleen and replenishing qi, and cibotium bark, eucommia bark, cibotium bark and Chinese rhizoma cyrtonema are Chinese medicines for invigorating liver and kidney and strengthening tendons and bones.

[0050] In the present invention, when weight parts, 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 the range "9 to 11" is disclosed, the described range should be interpreted as including the range "9 to 11", "9 to 10", "10 to 11" and the like. When a numerical range is described in this article, unless otherwise stated, the range is intended to include its end values ​​and all integers and fractions within the range.

[0051] The Chinese medicine composition with the above-mentioned specific ratio of the present invention was used in animal experiments to detect the aging score, grip strength, body composition, behavioral test (running distance and time) and pathological sections of SAMP8 mice intervened with the drug composition of Group 2 for 12 weeks, and the "uniform design" screening and repeated verification were used. The Chinese medicine composition with this dosage ratio was compared with other dosage combinations. The results confirmed that the Chinese medicine composition with the above-mentioned specific ratio 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 has no obvious effect on food intake, indicating that the Chinese medicine composition with the above-mentioned specific ratio can be used to prepare drugs for the prevention and treatment of sarcopenia. In a preferred embodiment, the raw materials of the Chinese medicine composition include 9.5-10.5 parts of dried orange peel, 9.5-10.5 parts of Chinese rhizoma cyrtonema, 9.5-10.5 parts of malt, 9.5-10.5 parts of bone-drying rhizoma, 9.5-10.5 parts of eucommia barbarum, 9.5-10.5 parts of wolfberry, 14.25-15.75 parts of astragalus, and 14.25-15.75 parts of dog spine. In a preferred embodiment, the raw materials of the Chinese medicine composition include about 10 parts of dried orange peel, about 10 parts of Chinese rhizoma cyrtonema, about 10 parts of malt, about 10 parts of bone-drying rhizoma, about 10 parts of eucommia barbarum, about 10 parts of wolfberry, about 15 parts of astragalus, and about 15 parts of dog spine. In a preferred embodiment, the raw materials of the Chinese medicine composition include 9.5-10.5 parts of dried orange peel, 19-21 parts of Chinese rhizoma cyrtonema, 14.25-15.75 parts of malt, 9.5-10.5 parts of bone-drying 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 Chinese medicine composition include about 10 parts of dried orange peel, about 20 parts of Chinese rhizoma cyrtonema, about 15 parts of malt, about 10 parts of bone-drying 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 Chinese medicine composition include 14.25-15.75 parts of dried orange peel, 14.25-15.75 parts of Chinese rhizoma cyrtonema, 14.25-15.75 parts of malt, 14.25-15.75 parts of drynaria, 14.25-15.75 parts of eucommia, 14.25-15.75 parts of wolfberry, 4.75-5.25 parts of astragalus and 4.75-5.25 parts of dog spine. In a preferred embodiment, the raw materials of the Chinese medicine composition include about 15 parts of dried orange peel, about 15 parts of Chinese rhizoma cyrtonema, about 15 parts of malt, about 15 parts of drynaria, about 15 parts of eucommia, about 15 parts of wolfberry, about 5 parts of astragalus and about 5 parts of dog spine.In a preferred embodiment, the raw materials of the Chinese medicine composition include 19-21 parts of dried orange peel, 9.5-10.5 parts of Chinese rhizoma cyrtonema, 14.25-15.75 parts of malt, 4.75-5.25 parts of bone-drying rhizoma, 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 dog spine. In a preferred embodiment, the raw materials of the Chinese medicine composition include about 20 parts of dried orange peel, about 10 parts of Chinese rhizoma cyrtonema, about 15 parts of malt, about 5 parts of bone-drying rhizoma, about 10 parts of eucommia bark, about 15 parts of wolfberry, about 10 parts of astragalus, and about 15 parts of dog spine. In a preferred embodiment, the raw materials of the Chinese medicine composition include 19-21 parts of dried orange peel, 14.25-15.75 parts of Chinese rhizoma cyrtonema, 9.5-10.5 parts of malt, 9.5-10.5 parts of bone-drying herb, 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 dog spine. In a preferred embodiment, the raw materials of the Chinese medicine composition include about 20 parts of dried orange peel, about 15 parts of Chinese rhizoma cyrtonema, about 10 parts of malt, about 10 parts of bone-drying herb, about 5 parts of eucommia bark, about 15 parts of wolfberry, about 5 parts of astragalus and about 15 parts of dog spine. In a preferred embodiment, the raw materials of the Chinese medicine composition include 19-21 parts of dried orange peel and Chinese rhizoma cyrtonema.

[0052] In a preferred embodiment, the raw materials of the Chinese medicine composition include about 20 parts of dried orange peel, about 15 parts of Achyranthes bidentata, about 10 parts of malt, about 15 parts of drynaria, about 10 parts of eucommia, about 5 parts of wolfberry, about 15 parts of astragalus and about 10 parts of citron. In a preferred embodiment, the raw materials of the Chinese medicine composition include 19-21 parts of dried orange peel, 19-21 parts of Chinese rhizoma cyperi, 19-21 parts of malt, 14.25-15.75 parts of drynaria, 14.25-15.75 parts of eucommia, 14.25-15.75 parts of wolfberry, 14.25-15.75 parts of astragalus, and 14.25-15.75 parts of dog spine. In a preferred embodiment, the raw materials of the Chinese medicine composition include about 20 parts of dried orange peel, about 20 parts of Chinese rhizoma cyperi, about 20 parts of malt, about 15 parts of drynaria, about 15 parts of eucommia, about 15 parts of wolfberry, about 15 parts of astragalus, and about 15 parts of dog spine.

[0053] In the present invention, "about" refers to a value within a range of ±10% or ±5% of a specific value. For example, "about 5" includes ±10% of 5, or from 4.5 to 5.5, or includes ±5% of 5, or from 4.75 to 5.25; "about 10" includes ±10% of 10, or from 9 to 11, or includes ±5% of 10, or from 9.5 to 10.5; "about 15" includes ±10% of 15, or from 13.5 to 16.5, or includes ±5% of 15, or from 14.25 to 15.75; "about 20" includes ±10% of 20, or from 18 to 22, or includes ±5% of 20, or from 19 to 21.

[0054] In a preferred embodiment, by weight, the weight ratio of dried orange peel to astragalus is about 0.66, and the weight ratio of Chinese cyperus rotundus to astragalus is about 0.66, and the weight ratio of malt to astragalus is about 0.66, and the weight ratio of bone drynaria to astragalus is about 0.66, and the weight ratio of eucommia to astragalus is about 0.66, and the weight ratio of wolfberry to astragalus is about 0.66, and the weight ratio of dog spine to astragalus is about 1. In a preferred embodiment, by weight, the weight ratio of dried orange peel to astragalus is about 0.66, and the weight ratio of Chinese cyperus rotundus to astragalus is about 1.33, and the weight ratio of malt to astragalus is about 1, and the weight ratio of bone drynaria to astragalus is about 0.66, and the weight ratio of eucommia to astragalus is about 0.33, and the weight ratio of wolfberry to astragalus is about 1, and the weight ratio of dog spine to astragalus is about 0.66. In a preferred embodiment, by weight, the weight ratio of dried orange peel to astragalus is about 3, and the weight ratio of Chinese clematis to astragalus is about 3, and the weight ratio of malt to astragalus is about 3, and the weight ratio of bone drynaria to astragalus is about 3, and the weight ratio of eucommia to astragalus is about 3, and the weight ratio of wolfberry to astragalus is about 3, and the weight ratio of dog spine to astragalus is about 1. In a preferred embodiment, by weight, the weight ratio of dried orange peel to astragalus is about 2, and the weight ratio of Chinese clematis to astragalus is about 1, and the weight ratio of malt to astragalus is about 1.5, and the weight ratio of bone drynaria to astragalus is about 0.5, and the weight ratio of eucommia to astragalus is about 1, and the weight ratio of wolfberry to astragalus is about 1.5, and the weight ratio of dog spine to astragalus is about 1.5. In a preferred embodiment, by weight, the weight ratio of dried orange peel to astragalus is about 4, and the weight ratio of Chinese cyperus rotundus to astragalus is about 3, and the weight ratio of malt to astragalus is about 2, and the weight ratio of bone drynaria to astragalus is about 2, and the weight ratio of eucommia to astragalus is about 1, and the weight ratio of wolfberry to astragalus is about 3, and the weight ratio of dog spine to astragalus is about 3. In a preferred embodiment, by weight, the weight ratio of dried orange peel to astragalus is about 1.33, and the weight ratio of Chinese cyperus rotundus to astragalus is about 1, and the weight ratio of malt to astragalus is about 0.66, and the weight ratio of bone drynaria to astragalus is about 1, and the weight ratio of eucommia to astragalus is about 0.66, and the weight ratio of eucommia to astragalus is about 0.33, and the weight ratio of dog spine to astragalus is about 0.66. In a preferred embodiment, by weight ratio, the weight ratio of dried tangerine peel to astragalus is about 1.33, and the weight ratio of Chinese clematis to astragalus is about 1.33, and the weight ratio of malt to astragalus is about 1.33, and the weight ratio of drynaria to astragalus is about 1, and the weight ratio of eucommia to astragalus is about 1, and the weight ratio of wolfberry to astragalus is about 1, and the weight ratio of dog spine to astragalus is about 1.

[0055] In the present invention, "about" refers to a value within a 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 includes ±5% of 1.5, or from 1.425 to 1.575; "about 0.5" includes ±10% of 0.5, or from 0.45 to 0.55, or includes ±5% of 0.5, or from 0.475 to 0.525; "about 4" includes ±10% of 4, or from 3.6 to 4.4, or includes ±5% of 4, or from 3.8 to 4.2; "about 0.33" includes ±10% of 0.33, or from 0.297 to 0.363, or includes ±5% of 0.33, or from 0.3135 to 0.3465.

[0056] In a preferred embodiment, the malt is roasted malt.

[0057] According to another aspect of the present invention, a pharmaceutical preparation comprising the above-mentioned traditional Chinese medicine composition is provided.

[0058] In a preferred embodiment, the pharmaceutical preparation further comprises one or more drugs and / or extracts for preventing and / or treating sarcopenia.

[0059] 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.

[0060] In a preferred embodiment, the pharmaceutical preparation comprises one or more pharmaceutically acceptable excipients.

[0061] 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 an individual.

[0062] In the present invention, the term "pharmaceutically acceptable excipient" refers to carriers and / or excipients that are pharmacologically and / or physiologically compatible with subjects and active ingredients (i.e., capable of inducing 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).

[0063] In a preferred embodiment, 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 agent, lubricant, dispersant, plasticizer, opacifier and antioxidant.

[0064] Those skilled in the art will know how to select specific chemical substances within the scope of the above-mentioned auxiliary material category.For example, the diluent can be selected from one or more of the following: icing sugar, starch, compressible starch, lactose, dextrin, mannitol, sorbitol, microcrystalline cellulose, calcium sulfate and calcium carbonate.The wetting agent can be selected from one or more of the following: polyoxymethylene stearate, poloxamer, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene hydrogenated castor oil, polyoxyethylene alkyl ether, polysorbate such as polysorbate 80, cetyl alcohol, glycerol fatty acid ester (such as triacetin, glyceryl monostearate and the like), 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.The adhesive can be selected from one or more of the following: 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 is 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 is micropowder 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 pre-gelatinized corn starch. The plasticizer may be dibutyl sebacate and / or various citric acid esters. The opacifier is titanium dioxide. The antioxidant may be selected from one or more of the following: sodium bisulfite, sodium pyrosulfite, sodium sulfite and sodium thiosulfate.

[0065] These excipients are preferably pharmaceutically inert, or may have a synergistic or additive effect to enhance the therapeutic activity of the pharmaceutical composition, and the above-mentioned excipients are only listed. The excipients actually used in the present invention are not limited to the above-mentioned excipients and can be adjusted according to actual conditions to achieve the effects of the present invention.

[0066] In a preferred embodiment, the auxiliary material is dextrin.

[0067] In a preferred embodiment, the dosage form of the pharmaceutical preparation is powder, tablet, pill, capsule, film, lozenge, granule, injection or oral solution.

[0068] In a preferred embodiment, the dosage form of the pharmaceutical preparation is granules.

[0069] 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:

[0070] (1) weighing appropriate amounts of dried tangerine peel, Chinese rhizoma cyrtonemae, malt, drynariae rhizome, eucommia bark, wolfberry, astragalus and cibotium bark, adding water for the first time and boiling for a period of time, filtering to obtain a first filtrate and a first medicinal residue;

[0071] (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

[0072] (3) combining the first filtrate and the second filtrate, concentrating them into a concentrated liquid and then drying them to obtain the Chinese medicine composition.

[0073] 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:

[0074] (1) weighing appropriate amounts of dried tangerine peel, Chinese rhizoma cyrtonemae, malt, drynariae rhizome, eucommia bark, wolfberry, astragalus and cibotium bark, adding water for the first time and boiling for a period of time, filtering to obtain a first filtrate and a first medicinal residue;

[0075] (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;

[0076] (3) combining the first filtrate and the second filtrate to concentrate the filtrate into a concentrate; and

[0077] (4) adding auxiliary materials to the concentrated solution for the first time, and adding auxiliary materials again after drying to obtain the pharmaceutical preparation.

[0078] In a preferred embodiment, the malt is roasted malt.

[0079] In a preferred embodiment, 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, Achyranthes bidentata, malt, Drynaria fortunei, Eucommia ulmoides, Lycium barbarum, Astragalus membranaceus and Cibotium barometz is 1 to 20, for example, about 10.

[0080] In the present invention, "about" refers to a value within the range of ±10% or ±5% of a specific 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.

[0081] In a preferred embodiment, the first decoction time is 30 to 90 minutes, such as about 60 minutes, starting from the boiling time.

[0082] In the present invention, "about" refers to a value within a range of ±10% or ±5% of a specific value. For example, "about 60" includes ±10% of 60, or from 54 to 66, or includes ±5% of 60, or from 57 to 63.

[0083] In a preferred embodiment, the volume / mass (ml / g or L / kg) ratio of the volume of water added for the second time to the total mass of dried tangerine peel, Chinese rhizoma cyperi, malt, drynariae rhizoma, eucommia bark, wolfberry, astragalus and Cibotium bark is 1 to 20, for example, about 8.

[0084] 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.

[0085] In a preferred embodiment, the second decoction time is 10 to 90 minutes, for example, about 30 minutes, starting from the boiling time.

[0086] In the present invention, "about" refers to a value within a range of ±10% or ±5% of a specific 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.

[0087] In a preferred embodiment, the relative density of the concentrated solution at 55°C to 65°C is 1.10 to 1.15.

[0088] In a preferred embodiment, the drying temperature is 50-70°C, such as about 60°C.

[0089] In the present invention, "about" refers to a value within a range of ±10% or ±5% of a specific value. For example, "about 60" includes ±10% of 60, or from 54 to 66, or includes ±5% of 60, or from 57 to 63.

[0090] In a preferred embodiment, the mass / mass (g / g or mg / mg) ratio between the mass of the auxiliary material added for the first time and the mass of the concentrated solution is 0.035 to 0.175, such as about 0.07.

[0091] Normally, the mass of the extract after evaporation of the concentrated solution is about 35% of the mass of the concentrated solution. Therefore, in theory, the mass / mass (g / g or mg / mg) ratio between the mass of the first added auxiliary material and the mass of the theoretical extract of the concentrated solution is 0.1 to 0.5, for example, about 0.2.

[0092] In the present invention, "about" refers to a value within the range of ±10% or ±5% of a specific 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.

[0093] In a preferred embodiment, the drying is spray drying.

[0094] In a preferred embodiment, the step (4) further comprises a granulation step.

[0095] In a preferred embodiment, the granulation is dry granulation.

[0096] 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:

[0097] (1) Weigh appropriate amounts of astragalus, dried orange peel, roasted malt, Cibotium barometz, Eucommia barbarum, Chinese wolfberry, Achyranthes bidentata and Drynaria fortunei according to the proportion;

[0098] (2) The above eight ingredients were extracted twice with water. The first time, 10 times the amount of water was added and boiled for 1 hour.

[0099] (3) Add 8 times the amount of water to the product obtained in step (2) and boil for another 0.5 hours;

[0100] (4) filtering the decoction obtained in step (3), combining the decoctions, and concentrating to a relative density of 1.10-1.15 (55-65° C.);

[0101] (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, dry granulate to make 1000g.

[0102] According to another aspect of the present invention, there is provided a use of the above-mentioned 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.

[0103] 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.

[0104] 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.

[0105] In the present invention, the term "treatment" includes alleviating, inhibiting or improving the symptoms or conditions of a disease; inhibiting the occurrence of complications; improving or preventing potential metabolic syndrome; inhibiting the occurrence of a disease or symptom, such as controlling the development of a disease or condition; alleviating a disease or symptom; reducing a disease or symptom; 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 preparation, after administration, can improve a disease, symptom or condition, especially improve its severity, delay the onset, slow the progression of the disease, or reduce the duration of the disease. Whether fixed or temporary administration, continuous or intermittent administration, can be attributed to or related to the administration.

[0106] The present invention also provides the above composition or the above pharmaceutical preparation for preventing and / or treating sarcopenia in a subject.

[0107] 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.

[0108] In the present invention, the term "subject" is a mammal. The mammal may be a human, a non-human primate, a mouse, a rat, a dog, a cat, a horse or a 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.

[0109] 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 body 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., weeks to months) or longer time periods (months to years).

[0110] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are only used to illustrate the present invention and are not intended to limit the scope of the present invention. The experimental methods in the following examples without specifying specific conditions are usually carried out according to conventional conditions or conditions recommended by the manufacturer.

[0111] Unless otherwise defined, all professional and scientific terms used herein have the same meanings as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described herein can be applied to the methods of the present invention. The preferred implementation methods and materials described herein are for demonstration purposes only.

[0112] The above features mentioned in the present invention or the features mentioned in the embodiments can be combined in any way. All the features disclosed in this patent specification can be used in combination with any combination form, and each feature disclosed in the specification can be replaced by any alternative feature that can provide the same, equal or similar purpose. Therefore, unless otherwise specified, the disclosed features are only general examples of equal or similar features.

[0113] Example

[0114] Preparation Example

[0115] 1. Experimental instruments and materials

[0116] 1.1 Experimental instruments

[0117] The A60 multifunctional split medicine 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.

[0118] 1.2 Experimental Reagents

[0119] Tangerine peel, Achyranthes bidentata, roasted malt, Drynaria fortunei, Eucommia bark, 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 Scientific Co., Ltd.; water was ultrapure water, and the other reagents were of analytical grade.

[0120] 2. Experimental content

[0121] 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) is prepared, and eight traditional Chinese medicines in the prescription, including astragalus, tangerine peel, stir-fried malt, dog spine, eucommia, wolfberry, Chinese rhizome and drynaria, are used as investigation factors, each factor takes 3 levels (i.e., 3 different doses with increasing gradient), the investigation dose is between 5-20g, and each factor and level are arranged according to the uniform design table, and a prescription design is carried out to construct a total of 27 groups of drug compositions.

[0122] Table 1 Uniform experimental design scheme

[0123]

[0124]

[0125] Preparation Example 1

[0126] The Chinese medicinal materials of the pharmaceutical composition include 10g of dried tangerine peel, 10g of Chinese rhizoma cyrtonema, 10g of roasted malt, 5g of drynariae, 5g of eucommia bark, 5g of wolfberry, 5g of astragalus and 5g of dog spine, and are decocted in water twice, with the first decoction being 1 hour and the second decoction being 0.5 hour from boiling time. The mass of water used for the first decoction is 0.55kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.44kg (8 times the mass of the total medicinal materials). The concentrate is concentrated into a concentrated solution, and dried at a temperature of 60°C to obtain a pharmaceutical composition of group 1.

[0127] Preparation Example 2

[0128] Take Chinese medicinal materials 10g of dried tangerine peel, 10g of Rhizoma Cyathulae, 10g of roasted malt, 10g of Rhizoma Drynariae, 10g of Eucommia bark, 10g of Fructus Lycii, 15g of Radix Astragali and 15g of Cibotium barometz, and decoct them in water twice, with the first decoction being 1 hour and the second decoction being 0.5 hour starting from boiling. 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). The mixture is concentrated into a concentrated solution and dried at 60°C to obtain a pharmaceutical composition of Group 2.

[0129] Preparation Example 3

[0130] Take Chinese medicinal materials 10g of dried tangerine peel, 10g of Rhizoma Cyathulae, 10g of roasted malt, 15g of Rhizoma Drynariae, 15g of Eucommia bark, 15g of Fructus Lycii, 10g of Radix Astragali and 10g of Cibotium barometz, and decoct them in water twice, the first decoction is 1 hour and the second decoction is 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 a temperature of 60°C to obtain the pharmaceutical composition of Group 3.

[0131] Preparation Example 4

[0132] Take Chinese medicinal materials 10g of dried tangerine peel, 15g of Rhizoma Cyathulae, 20g of roasted malt, 5g of Rhizoma Drynariae, 10g of Eucommia bark, 15g of Fructus Lycii, 5g of Radix Astragali and 10g of Cibotium barometz, decocted in water twice, the first decoction was 1 hour and the second decoction was 0.5 hour starting from boiling. 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). The mixture was concentrated into a concentrated solution and dried at 60°C to obtain the pharmaceutical composition of Group 4.

[0133] Preparation Example 5

[0134] Take Chinese medicinal materials 10g of dried tangerine peel, 15g of Rhizoma Cyathulae, 20g of roasted malt, 10g of Rhizoma Drynariae, 15g of Eucommia bark, 5g of Fructus Lycii, 15g of Radix Astragali and 10g of Cibotium barometz, and decocted them in water twice, with the first decoction being 1 hour and the second decoction being 0.5 hour starting from boiling. 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 5.

[0135] Preparation Example 6

[0136] Take Chinese medicinal materials 10g of dried tangerine peel, 15g of Rhizoma Cyathulae, 20g of roasted malt, 15g of Rhizoma Drynariae, 5g of Eucommia bark, 10g of Fructus Lycii, 10g of Radix Astragali and 15g of Cibotium barometz, and decocted them 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 concentrated solution and dried at 60°C to obtain the pharmaceutical composition of Group 6.

[0137] Preparation Example 7

[0138] Take Chinese medicinal materials 10g of dried tangerine peel, 20g of Rhizoma Cyathulae, 15g of roasted malt, 5g of Rhizoma Drynariae, 15g of Eucommia bark, 10g of Fructus Lycii, 5g of Radix Astragali and 15g of Cibotium barometz, and decocted 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 a temperature of 60°C to obtain the pharmaceutical composition of Group 7.

[0139] Preparation Example 8

[0140] Take Chinese medicinal materials 10g of dried tangerine peel, 20g of Rhizoma Cyathulae, 15g of roasted malt, 10g of Rhizoma Drynariae, 5g of Eucommia bark, 15g of Fructus Lycii, 15g of Radix Astragali and 10g of Cibotium barometz, 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 concentrated solution and dried at 60°C to obtain the pharmaceutical composition of Group 8.

[0141] Preparation Example 9

[0142] Take Chinese medicinal materials 10g of dried tangerine peel, 20g of Rhizoma Cyathulae, 15g of roasted malt, 15g of Rhizoma Drynariae, 10g of Eucommia bark, 5g of Fructus Lycii, 10g of Radix Astragali and 5g of Cibotium barometz, and decocted 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 0.9kg (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 9.

[0143] Preparation Example 10

[0144] Take Chinese medicinal materials 15g of dried tangerine peel, 10g of Rhizoma Cyathulae, 20g of roasted malt, 5g of Rhizoma Drynariae, 15g of Eucommia bark, 10g of Fructus Lycii, 15g of Radix Astragali and 10g of Cibotium barometz, decocted in water twice, the first decoction was 1 hour and the second decoction 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 concentrated solution and dried at 60°C to obtain the pharmaceutical composition of group 10.

[0145] Preparation Example 11

[0146] Take Chinese medicinal materials 15g of dried tangerine peel, 10g of Rhizoma Cyathulae, 20g of roasted malt, 10g of Rhizoma Drynariae, 5g of Eucommia bark, 15g of Fructus Lycii, 10g of Radix Astragali and 5g of Cibotium barometz, 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 0.9kg (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). The mixture was concentrated into a concentrated solution and dried at 60°C to obtain the pharmaceutical composition of Group 11.

[0147] Preparation Example 12

[0148] Take Chinese medicinal materials 15g of dried orange peel, 10g of Rhizoma Cyathulae, 20g of roasted malt, 15g of Rhizoma Drynariae, 10g of Eucommia bark, 5g of Fructus Lycii, 5g of Radix Astragali and 15g of Cibotium barometz, decocted in water twice, the first decoction was 1 hour from boiling time, and the second time was 0.5 hours. The mass of water used for the first decoction was 0.95kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction was 0.76kg (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 12.

[0149] Preparation Example 13

[0150] Take Chinese medicinal materials 15g of dried tangerine peel, 15g of Rhizoma Cynoglossi, 15g of roasted malt, 5g of Rhizoma Drynariae, 5g of Eucommia bark, 5g of Fructus Lycii, 15g of Radix Astragali and 15g of Cibotium barometz, decocted in water twice, the first decoction was 1 hour and the second decoction was 0.5 hour starting from boiling. The mass of water used for the first decoction was 0.9kg (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). The mixture was concentrated into a concentrated solution and dried at 60°C to obtain the pharmaceutical composition of Group 13.

[0151] Preparation Example 14

[0152] Take Chinese medicinal materials 15g of dried tangerine peel, 15g of Rhizoma Cyathulae, 15g of roasted malt, 10g of Rhizoma Drynariae, 10g of Eucommia bark, 10g of Fructus Lycii, 10g of Radix Astragali and 10g of Cibotium barometz, 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 0.95kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction was 0.76kg (8 times the mass of the total medicinal materials). The mixture was concentrated into a concentrated solution and dried at 60°C to obtain the pharmaceutical composition of group 14.

[0153] Preparation Example 15

[0154] Take Chinese medicinal materials 15g of dried tangerine peel, 15g of Rhizoma Cyathulae, 15g of roasted malt, 15g of Rhizoma Drynariae, 15g of Eucommia bark, 15g of Fructus Lycii, 5g of Radix Astragali and 5g of Cibotium barometz, decocted in water twice, the first decoction was 1 hour and the second decoction 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 concentrated solution and dried at 60°C to obtain a pharmaceutical composition of Group 15.

[0155] Preparation Example 16

[0156] Take Chinese medicinal materials 15g of dried tangerine peel, 20g of Rhizoma Cynoglossi, 10g of roasted malt, 5g of Rhizoma Drynariae, 10g of Eucommia bark, 15g of Fructus Lycii, 15g of Radix Astragali and 5g of Cibotium barometz, 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 0.95kg (10 times the mass of total medicinal materials), and the mass of water used for the second decoction was 0.76kg (8 times the mass of total medicinal materials). Concentrate into a concentrate and dry at 60°C to obtain the pharmaceutical composition of group 16.

[0157] Preparation Example 17

[0158] Take Chinese medicinal materials 15g of dried tangerine peel, 20g of Rhizoma Cyathulae, 10g of roasted malt, 10g of Rhizoma Drynariae, 15g of Eucommia bark, 5g of Fructus Lycii, 10g of Radix Astragali and 15g of Cibotium barometz, 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). Concentrate into a concentrate and dry at a temperature of 60°C to obtain the pharmaceutical composition of Group 17.

[0159] Preparation Example 18

[0160] Take Chinese medicinal materials 15g of dried tangerine 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 decocted 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 0.9kg (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 60°C to obtain the pharmaceutical composition of Group 18.

[0161] Preparation Example 19

[0162] Take Chinese medicinal materials 20g of dried tangerine peel, 10g of Rhizoma Cyathulae, 15g of roasted malt, 5g of Rhizoma Drynariae, 10g of Eucommia bark, 15g of Fructus Lycii, 10g of Radix Astragali and 15g of Cibotium barometz, 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). Concentrate into a concentrate and dry at a temperature of 60°C to obtain the pharmaceutical composition of Group 19.

[0163] Preparation Example 20

[0164] Take Chinese medicinal materials 20g of dried tangerine peel, 10g of Rhizoma Cyathulae, 15g of roasted malt, 10g of Rhizoma Drynariae, 15g of Eucommia bark, 5g of Fructus Lycii, 5g of Radix Astragali and 10g of Cibotium barometz, 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 0.9kg (10 times the mass of total medicinal materials), and the mass of water used for the second decoction was 0.72kg (8 times the mass of total medicinal materials). The mixture was concentrated into a concentrated solution and dried at 60°C to obtain a pharmaceutical composition of Group 20.

[0165] Preparation Example 21

[0166] Take Chinese medicinal materials 20g of dried tangerine peel, 10g of Rhizoma Cyathulae, 15g of roasted malt, 15g of Rhizoma Drynariae, 5g of Eucommia bark, 10g of Fructus Lycii, 15g of Radix Astragali and 5g of Cibotium barometz, 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 0.95kg (10 times the mass of total medicinal materials), and the mass of water used for the second decoction was 0.76kg (8 times the mass of total medicinal materials). Concentrate into a concentrate and dry at 60°C to obtain the pharmaceutical composition of Group 21.

[0167] Preparation Example 22

[0168] Take Chinese medicinal materials 20g of dried tangerine peel, 15g of Rhizoma Cyathulae, 10g of roasted malt, 5g of Rhizoma Drynariae, 15g of Eucommia bark, 10g of Fructus Lycii, 10g of Radix Astragali and 5g of Cibotium barometz, 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 0.9kg (10 times the mass of total medicinal materials), and the mass of water used for the second decoction was 0.72kg (8 times the mass of total medicinal materials). The mixture was concentrated into a concentrated solution and dried at 60°C to obtain the pharmaceutical composition of Group 22.

[0169] Preparation Example 23

[0170] Take Chinese medicinal materials 20g of dried tangerine peel, 15g of Rhizoma Cyathulae, 10g of roasted malt, 10g of Rhizoma Drynariae, 5g of Eucommia bark, 15g of Fructus Lycii, 5g of Radix Astragali and 15g of Cibotium barometz, 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 0.95kg (10 times the mass of total medicinal materials), and the mass of water used for the second decoction was 0.76kg (8 times the mass of total medicinal materials). The mixture was concentrated into a concentrated solution and dried at 60°C to obtain the pharmaceutical composition of Group 23.

[0171] Preparation Example 24

[0172] Take Chinese medicinal materials 20g of dried tangerine peel, 15g of Rhizoma Cyathulae, 10g of roasted malt, 15g of Rhizoma Drynariae, 10g of Eucommia bark, 5g of Fructus Lycii, 15g of Radix Astragali and 10g of Cibotium barometz, 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 0.9kg (10 times the mass of total medicinal materials), and the mass of water used for the second decoction was 0.72kg (8 times the mass of total medicinal materials). The mixture was concentrated into a concentrated solution and dried at 60°C to obtain a pharmaceutical composition of group 24.

[0173] Preparation Example 25

[0174] Take Chinese medicinal materials 20g of dried tangerine peel, 20g of Rhizoma Cyathulae, 20g of roasted malt, 5g of Rhizoma Drynariae, 5g of Eucommia bark, 5g of Fructus Lycii, 10g of Radix Astragali and 10g of Cibotium barometz, 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 0.95kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction was 0.76kg (8 times the mass of the total medicinal materials). The mixture was concentrated into a concentrated solution and dried at 60°C to obtain a pharmaceutical composition of Group 25.

[0175] Preparation Example 26

[0176] Take Chinese medicinal materials 20g of dried tangerine peel, 20g of Rhizoma Cyathulae, 20g of roasted malt, 10g of Rhizoma Drynariae, 10g of Eucommia bark, 10g of Fructus Lycii, 5g of Radix Astragali and 5g of Cibotium barometz, and decocted them in water twice, starting from boiling, the first decoction was 1 hour, and the second time was 0.5 hour. 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). Concentrate into a concentrate, and dry at a temperature of 60°C to obtain the pharmaceutical composition of Group 26.

[0177] Preparation Example 27

[0178] Take Chinese medicinal materials 20g of dried tangerine peel, 20g of Rhizoma Cyathulae, 20g of roasted malt, 15g of Rhizoma Drynariae, 15g of Eucommia bark, 15g of Fructus Lycii, 15g of Radix Astragali and 15g of Cibotium barometz, 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 1.35kg (10 times the mass of total medicinal materials), and the mass of water used for the second decoction was 1.08kg (8 times the mass of total medicinal materials). Concentrate into a concentrate and dry at a temperature of 60°C to obtain the pharmaceutical composition of Group 27.

[0179] Efficacy Example

[0180] Pharmacological Efficacy Example 1

[0181] 1. Experimental Materials

[0182] 1.1 Experimental Animals

[0183] SAMP8 male mice, 16 weeks old, weighing 30±2g, were purchased from Beijing Huafukang Biotechnology Co., Ltd. The experimental animals were fed in the SPF animal room of Shanghai Experimental Animal Center, with a temperature of (24±1)℃, a relative humidity of 50%-70%, and a light-dark cycle of 12h / 12h. The experimental operation procedures strictly followed the relevant regulations and regulations of the Ethics Committee of Shanghai Experimental Animal Center.

[0184] 1.2 Experimental drugs

[0185] Experimental drugs: Astragalus, tangerine peel, fried malt, Cibotium barbarum, Eucommia bark, Lycium barbarum, Rhizoma Cynoglossi, and Rhizoma Drynariae.

[0186] 2. Experimental methods

[0187] 2.1. Uniform design of drug screening experiments

[0188] After 1 week of adaptive feeding with ordinary feed, 232 16-week-old SAMP8 mice were randomly divided into a model group (8 mice), a normal group (8 mice) and a drug administration group (216 mice). The mice in the drug administration group were respectively given a uniformly designed dosing regimen, and the extract of the pharmaceutical composition of the above-mentioned preparation examples 1-27 was prepared with ultrapure water to 1.41 g crude drug / ml, and the mice were gavaged at 0.1 ml / g body weight for 12 weeks.

[0189] 2.2. Screening indicators: Mouse grip strength and muscle content.

[0190] 2.3 Statistical Methods

[0191] The data were analyzed using SPSS 25.0 software package. The q test was used for comparison between groups, and p < 0.05 was considered statistically significant.

[0192] 3. Uniform design drug screening experiment results

[0193] The screening experiment results are shown in Table 2.

[0194] Table 2 Screening test results

[0195]

[0196]

[0197] The values ​​are expressed as mean ± standard deviation. Compared with the model group, *P<0.05, **P<0.01, ***P<0.001 for combination 1-27;

[0198] According to the test results, the drug combination in 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 no obvious efficacy was observed in the other groups, and Group 3 even showed a further decrease in muscle strength.

[0199] Efficacy Example 2

[0200] The efficacy of the pharmaceutical composition of Group 2 in treating sarcopenia was further verified by using the composite model and evaluation indexes of the preparation example and the efficacy example 1.

[0201] 1. Materials

[0202] 1.1 Experimental Animals

[0203] SAMP8 male mice, 16 weeks old, weighing 30±2g, were purchased from Beijing Huafukang Biotechnology Co., Ltd. The experimental animals were fed in the SPF animal room of Shanghai Experimental Animal Center, with a temperature of (24±1)℃, a relative humidity of 50%-70%, and a light-dark cycle of 12h / 12h. The experimental operation procedures strictly followed the relevant regulations and regulations of the Ethics Committee of Shanghai Experimental Animal Center.

[0204] 1.2 Experimental drugs

[0205] Experimental drugs: Astragalus, dried orange peel, roasted malt, Cibotium barometz, Eucommia barbata, Lycium barbarum, Rhizoma Cynoglossi, Rhizoma Drynariae. The extract powder of the drug composition of group 2 contains 3.44g of crude drugs per gram. Experimental drugs: Rogai calcitriol capsules (0.25ug), purchased from Catalent Germany Eberbach GmbH.

[0206] 1.3 Experimental instruments

[0207] Dual-energy X-ray absorptiometry (iNSiGHT VET DXA, OsteoSys, KOREAN); YLS-13A muscle strength tester, Jinan Yiyan Technology Co., Ltd.; small animal treadmill (animal experiment treadmill), Beijing Zhongshidichuang Technology Development Co., Ltd.

[0208] 2. Experimental methods

[0209] 2.1 Grouping and Dosing

[0210] After 1 week of adaptive feeding with ordinary feed, 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 of 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 were used as a negative control group.

[0211] The extract powder of the pharmaceutical composition of group 2 was dissolved in ultrapure water. Each administration group was given different concentrations of the extract powder solution of the pharmaceutical composition of group 2 by intragastric administration for 12 consecutive weeks, once a day, with an intragastric volume of 0.1 mL / 10 g.

[0212] Vitamin D was dissolved in corn oil. The positive control group was given vitamin D solution by gavage for 12 consecutive weeks, once a day, with a gavage volume of 0.1 mL / 10 g.

[0213] 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.

[0214] 2.2. Detection indicators and methods

[0215] 2.2.1. General determination

[0216] The body weight and food intake of mice were measured according to conventional methods.

[0217] Method for determination of mouse weight and food intake: The weight of mice was determined according to the standard operating procedure for weighing. Experimental equipment: electronic balance (range: 0-200g, sensitivity 0.01g). Operation steps: Select a suitable height and stable position to place the electronic scale; plug in the power supply, turn on the machine, and after the electronic balance is ready, put a weighing box of appropriate size on it and adjust it to zero. According to the "Operational Procedures for Grasping and Fixing Experimental Animals", grab the mouse from the feeding box, put it in the weighing box, and read the reading after the value stabilizes. If the value keeps jumping, select the middle value and record it. The read value is recorded in a dedicated original experimental record sheet. Put the mouse back in the cage, cover the cage lid, put it back in the cage rack, and plug in the drinking bottle. After weighing, put the mouse cage neatly, turn off the balance, disconnect the power supply, wipe the electronic balance clean and put it back in place, and fill in the use record of the electronic balance.

[0218] The food intake of mice was measured using the 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 raised 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. The data dashboard can monitor data such as the amount of food (grams). Mouse feed was purchased from the Shanghai Laboratory Animal Research Center and produced in accordance with the standardized quality requirements of laboratory animal compound feed.

[0219] 2.2.2 Aging score

[0220] The aging rating scale was used to evaluate the degree of apparent aging, which includes reactive, passive, skin and hair, eye and spine-related aging, and is divided into 11 categories. Each category is scored from 0 to 4 points and is evaluated every 0, 4, 8, and 12 weeks.

[0221] 2.2.3. Mouse muscle strength measurement

[0222] 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. Then, the mice were gently pulled back by their tails, with their posture parallel to the surface of the table, until they released the mesh. The peak force exerted by the mouse limbs was recorded in grams (g). Evaluations were performed every 0, 4, 8, and 12 weeks, and each mouse was tested three times, and the average was taken and weighted for statistical analysis.

[0223] 2.2.4. Body composition of mice

[0224] Three days before the mice were killed, dual-energy X-ray absorptiometry (DEXA) was used to measure body composition, including body fat content and muscle content of the mice, and the data were analyzed using the software provided by the manufacturer.

[0225] 2.2.5. Mouse muscle function assay

[0226] Running exhaustion experiment: Use a mouse treadmill for testing. Place the mouse on the treadmill track. Set the initial speed and slope to 5 m / min and 0 degrees, respectively. Increase by 5 m / min and 5 degrees every 5 minutes until reaching 20 m / min and 14 degrees, respectively. Record the exhaustion time. Exhaustion definition: If the mouse does not go on the track for at least 20 seconds, it is judged that the mouse's response to external stimuli has decreased significantly. If the mouse does not exhaust for more than 3 hours, the recording time is 3 hours. Measure once every 4 weeks.

[0227] 2.2.6 Statistical methods

[0228] 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 among the groups. P < 0.05 was considered statistically significant.

[0229] 3. Results

[0230] 3.1 Effect of the drug composition of group 2 on food intake of SAMP8 sarcopenia model mice

[0231] 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 is reliable and the groups are 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, the low-dose group and the positive drug control group; the food intake of the low-dose group and the 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 4 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 8 weeks after administration, and the food intake of the medium and high-dose groups of the drug composition in Group 2 tended to increase compared with the model group, the low-dose group and the positive drug control group.

[0232] Table 3 Effect of the drug composition of group 2 on the food intake of SAMP8 sarcopenia model mice

[0233]

[0234]

[0235] 3.2 Effect of the drug composition of group 2 on the aging degree of SAMP8 sarcopenia model mice

[0236] The results are shown in Table 4. Before administration, there was no significant difference in the aging scores of SAMP8 mice among the groups, indicating that the experimental system was reliable and the groups were comparable. Four weeks after administration, compared with the model group, the aging scores of the low, medium, high dose groups and the positive drug control group were significantly reduced (P < 0.01); there was no statistical difference in the aging scores among the administration groups. Four weeks after administration, compared with the model group, the aging scores of the low, medium, high dose groups and the positive drug control group were significantly reduced (P < 0.01); there was no statistical difference in the aging scores among the administration groups. After 12 weeks of administration, compared with the negative control group, the aging scores of each group were significantly increased (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 drug control group and the drug-administered groups, but there was a decreasing trend compared with the low and medium dose groups.

[0237] Table 4 Effect of sarcopenia on the aging degree of SAMP8 sarcopenia model mice

[0238]

[0239] 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;

[0240] 3.3 Effect of the drug composition of Group 2 on the muscle strength of SAMP8 sarcopenia model mice 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 composition administration groups of 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 tended to increase compared with the positive drug control group, and increased with the increase of drug concentration.

[0241] Table 5 Effects of the drug composition of Group 2 on the muscle strength of SAMP8 sarcopenia model mice

[0242]

[0243] 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.

[0244] 3.4 Effect of the drug composition of group 2 on body fat content and muscle content in SAMP8 sarcopenia model mice

[0245] The results are shown in Table 6. Twelve weeks after administration, there was no statistical difference in muscle mass among the groups, but each drug-administered group had an increasing trend compared with the model group; the muscle mass of the medium-dose group was slightly increased compared with the negative control group. Twelve weeks after administration, compared with the model group, the percentage of body fat content in the high-dose group was significantly reduced (P<0.05), and the percentage of body fat content in the medium-dose group and the negative control group was significantly reduced (P<0.01); compared with the low-dose group, the percentage of body fat content in the medium-dose group and the negative control group was significantly reduced (P<0.05); compared with the medium dose, the percentage of body fat content in the positive drug control group was significantly increased (P<0.05); compared with the positive drug control group, the percentage of body fat content in the negative control group was significantly increased (P<0.05). DEXA diagram of body composition of SAMP8 mice is shown in Figure 1 shown.

[0246] Table 6 Effects of the drug composition of Group 2 on body fat content and muscle content in SAMP8 sarcopenia model mice

[0247]

[0248] 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.

[0249] 3.5 Effect of the drug composition of group 2 on muscle function of SAMP8 sarcopenia model mice

[0250] The results are shown in Table 7. Compared with the model group, the running time of the high-dose group was significantly increased (P < 0.05), and the running time of the negative control group, low-medium-dose group, and positive drug control group showed an increasing trend; there was no statistical difference in the running distance between the other drug groups, but with the increase of drug dose, the running distance showed an increasing trend. Compared with the model group, the running time of the medium-dose group and the negative control group was significantly increased (P < 0.05), and the running time of the high-dose group was significantly increased (P < 0.01); there was no statistical difference in the running time of the low-dose group, medium-dose group, and high-dose group, but there was an increasing trend; compared with the negative control group and the positive drug control group, the running time of the high-dose group was significantly increased (P < 0.05).

[0251] Table 7 Effects of the drug composition of Group 2 on muscle function in SAMP8 sarcopenia model mice

[0252]

[0253] Note: Compared with the model group, *P<0.05, **P<0.01; compared with the high-dose group, △ P<0.05, △△ P < 0.01;

[0254] 4 Summary

[0255] 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.

[0256] 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 used to help understand the method of the present invention and its core idea. At the same time, changes or deformations made by those skilled in the art based on the ideas of the present invention, the specific implementation methods and application scope of the present invention, all belong to the scope of protection of the present invention. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A Chinese medicine composition for preventing and / or treating sarcopenia, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition are prepared from 9-11 parts of dried orange peel, 9-11 parts of Chinese rhizoma cyrtonema, 9-11 parts of malt, 9-11 parts of drynariae, 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, in parts by weight, the raw materials of the traditional Chinese medicine composition are prepared from 9-11 parts of dried orange peel, 18-22 parts of Chinese rhizoma cyrtonema, 13.5-16.5 parts of malt, 9-11 parts of drynariae, 4.5-5.5 parts of eucommia bark, 13.5-16.5 parts of wolfberry, and 13.5-16.5 parts of astragalus. and 9-11 parts of Cibotium barometz; or, in parts by weight, the raw materials of the Chinese medicine composition are 13.5-16.5 parts of dried orange peel, 13.5-16.5 parts of Achyranthes bidentata, 13.5-16.5 parts of malt, 13.5-16.5 parts of Drynaria fortunei, 13.5-16.5 parts of Eucommia barbarum, 13.5-16.5 parts of Lycium barbarum, 4.5-5.5 parts of Astragalus membranaceus and 4.5-5.5 parts of Cibotium barometz; or, in parts by weight, the raw materials of the Chinese medicine composition are 18-22 parts of dried orange peel, 9-11 parts of Achyranthes bidentata, 13.5-16.5 parts of malt, 4.5-16.5 parts of Drynaria fortunei ~5.5 parts, 9-11 parts of Eucommia barbarum, 13.5-16.5 parts of Astragalus membranaceus and 13.5-16.5 parts of Cibotium barometz; or, in parts by weight, the raw materials of the traditional Chinese medicine composition are prepared from 18-22 parts of dried orange peel, 13.5-16.5 parts of Achyranthes bidentata, 9-11 parts of malt, 9-11 parts of Drynaria fortunei, 4.5-5.5 parts of Eucommia barbarum, 13.5-16.5 parts of Astragalus membranaceus and 13.5-16.5 parts of Cibotium barometz; or, in parts by weight, the raw materials of the traditional Chinese medicine composition are prepared from 18-22 parts of dried orange peel, 13.5-16.5 parts of Achyranthes bidentata, 9-11 parts of malt, 9-11 parts of Drynaria fortunei, 4.5-5.5 parts of Eucommia barbarum, 13.5-16.5 parts of Astragalus membranaceus and 13.5-16.5 parts of Cibotium barometz; The raw materials of the traditional Chinese medicine composition are prepared from 13.5-16.5 parts of Rhizoma Aucklandiae, 9-11 parts of malt, 13.5-16.5 parts of Rhizoma Drynariae, 9-11 parts of Eucommia barbarum, 4.5-5.5 parts of Lycium barbarum, 13.5-16.5 parts of Astragalus membranaceus and 9-11 parts of Cibotium barbarum; or, in parts by weight, the raw materials of the traditional Chinese medicine composition are prepared from 18-22 parts of Citrus reticulatae, 18-22 parts of Achyranthes bidentatae, 18-22 parts of malt, 13.5-16.5 parts of Rhizoma Drynariae, 13.5-16.5 parts of Eucommia barbarum, 13.5-16.5 parts of Astragalus membranaceus and 13.5-16.5 parts of Cibotium barbarum.

2. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition are prepared from 9.5-10.5 parts of dried tangerine peel, 9.5-10.5 parts of Chinese rhizoma cyperi, 9.5-10.5 parts of malt, 9.5-10.5 parts of drynaria, 9.5-10.5 parts of eucommia, 9.5-10.5 parts of wolfberry, 14.25-15.75 parts of astragalus and 14.25-15.75 parts of cibotium barbarum.

3. The Chinese medicine composition according to claim 1, characterized in that In parts by weight, the raw materials of the traditional Chinese medicine composition are prepared from 10 parts of dried tangerine peel, 10 parts of Chinese rhizoma cyperi, 10 parts of malt, 10 parts of drynariae, 10 parts of eucommia bark, 10 parts of wolfberry, 15 parts of astragalus and 15 parts of cibotium bark.

4. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition are made of 9.5-10.5 parts of dried tangerine peel, 19-21 parts of Chinese rhizoma cyperi, 14.25-15.75 parts of malt, 9.5-10.5 parts of drynaria, 4.75-5.25 parts of eucommia, 14.25-15.75 parts of wolfberry, 14.25-15.75 parts of astragalus and 9.5-10.5 parts of cibotium barometz.

5. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition are prepared from 10 parts of dried tangerine peel, 20 parts of Chinese rhizoma cyrtonema, 15 parts of malt, 10 parts of drynariae, 5 parts of eucommia bark, 15 parts of wolfberry, 15 parts of astragalus and 10 parts of cibotium bark.

6. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition are made of 14.25-15.75 parts of dried tangerine peel, 14.25-15.75 parts of Chinese rhizoma cyperi, 14.25-15.75 parts of malt, 14.25-15.75 parts of drynaria, 14.25-15.75 parts of eucommia, 14.25-15.75 parts of wolfberry, 4.75-5.25 parts of astragalus and 4.75-5.25 parts of cibotium barometz.

7. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition are prepared from 15 parts of dried tangerine peel, 15 parts of Chinese rhizoma cyperi, 15 parts of malt, 15 parts of drynariae, 15 parts of eucommia bark, 15 parts of wolfberry, 5 parts of astragalus and 5 parts of cibotium bark.

8. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition are made of 19-21 parts of dried tangerine peel, 9.5-10.5 parts of Chinese rhizoma cyperi, 14.25-15.75 parts of malt, 4.75-5.25 parts of drynaria, 9.5-10.5 parts of eucommia, 14.25-15.75 parts of wolfberry, 9.5-10.5 parts of astragalus and 14.25-15.75 parts of cibotium barometz.

9. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition are prepared from 20 parts of dried tangerine peel, 10 parts of Chinese rhizoma cyperi, 15 parts of malt, 5 parts of drynariae, 10 parts of eucommia bark, 15 parts of wolfberry, 10 parts of astragalus and 15 parts of cibotium bark.

10. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition are made of 19-21 parts of dried tangerine peel, 14.25-15.75 parts of Chinese rhizoma cyperi, 9.5-10.5 parts of malt, 9.5-10.5 parts of drynaria, 4.75-5.25 parts of eucommia, 14.25-15.75 parts of wolfberry, 4.75-5.25 parts of astragalus and 14.25-15.75 parts of cibotium barometz.

11. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition are prepared from 20 parts of dried tangerine peel, 15 parts of Chinese rhizoma cyperi, 10 parts of malt, 10 parts of drynariae, 5 parts of eucommia bark, 15 parts of wolfberry, 5 parts of astragalus and 15 parts of cibotium bark.

12. The Chinese medicine composition according to claim 1, characterized in that: The raw materials of the traditional Chinese medicine composition are made of 19-21 parts of dried tangerine peel, 14.25-15.75 parts of Chinese rhizoma cyperi, 9.5-10.5 parts of malt, 14.25-15.75 parts of drynaria, 9.5-10.5 parts of eucommia, 4.75-5.25 parts of wolfberry, 14.25-15.75 parts of astragalus and 9.5-10.5 parts of cibotium barometz.

13. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition are prepared from 20 parts of dried tangerine peel, 15 parts of Chinese rhizoma cyperi, 10 parts of malt, 15 parts of drynariae, 10 parts of eucommia bark, 5 parts of wolfberry, 15 parts of astragalus and 10 parts of cibotium bark.

14. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition are made of 19-21 parts of dried tangerine peel, 19-21 parts of Chinese rhizoma cyperi, 19-21 parts of malt, 14.25-15.75 parts of drynaria, 14.25-15.75 parts of eucommia, 14.25-15.75 parts of wolfberry, 14.25-15.75 parts of astragalus and 14.25-15.75 parts of cibotium barometz.

15. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, the raw materials of the traditional Chinese medicine composition are prepared from 20 parts of dried tangerine peel, 20 parts of Chinese rhizoma cyperi, 20 parts of malt, 15 parts of drynariae, 15 parts of eucommia bark, 15 parts of wolfberry, 15 parts of astragalus and 15 parts of cibotium bark.

16. The Chinese medicine composition according to claim 1, characterized in that: In terms of weight ratio, the weight ratio of dried tangerine peel to astragalus is 0.66, the weight ratio of Chinese clematis to astragalus is 0.66, the weight ratio of malt to astragalus is 0.66, the weight ratio of drynaria to astragalus is 0.66, the weight ratio of eucommia to astragalus is 0.66, the weight ratio of wolfberry to astragalus is 0.66, and the weight ratio of dog spine to astragalus is 1.

17. The Chinese medicine composition according to claim 1, characterized in that: In terms of weight ratio, the weight ratio of dried tangerine peel to astragalus is 0.66, and the weight ratio of Chinese clematis to astragalus is 1.33, and the weight ratio of malt to astragalus is 1, and the weight ratio of drynaria to astragalus is 0.66, and the weight ratio of eucommia to astragalus is 0.33, and the weight ratio of wolfberry to astragalus is 1, and the weight ratio of dog spine to astragalus is 0.

66.

18. The Chinese medicine composition according to claim 1, characterized in that: In terms of weight ratio, the weight ratio of dried tangerine peel to astragalus is 3, the weight ratio of Chinese clematis to astragalus is 3, the weight ratio of malt to astragalus is 3, the weight ratio of drynaria to astragalus is 3, the weight ratio of eucommia to astragalus is 3, the weight ratio of wolfberry to astragalus is 3, and the weight ratio of dog spine to astragalus is 1.

19. The Chinese medicine composition according to claim 1, characterized in that: In terms of weight ratio, the weight ratio of dried tangerine peel to astragalus is 2, and the weight ratio of Chinese clematis to astragalus is 1, and the weight ratio of malt to astragalus is 1.5, and the weight ratio of drynaria to astragalus is 0.5, and the weight ratio of Eucommia ulmoides to astragalus is 1, and the weight ratio of wolfberry to astragalus is 1.5, and the weight ratio of Cibotium barometz to astragalus is 1.

5.

20. The Chinese medicine composition according to claim 1, characterized in that: In terms of weight ratio, the weight ratio of dried tangerine peel to astragalus is 4, the weight ratio of Chinese rhizome Achyranthes bidentata to astragalus is 3, the weight ratio of malt to astragalus is 2, the weight ratio of drynaria to astragalus is 2, the weight ratio of eucommia to astragalus is 1, the weight ratio of wolfberry to astragalus is 3, and the weight ratio of Cibotium barometz to astragalus is 3.

21. The Chinese medicine composition according to claim 1, characterized in that: In terms of weight ratio, the weight ratio of dried tangerine peel to astragalus is 1.33, and the weight ratio of Chinese clematis to astragalus is 1, and the weight ratio of malt to astragalus is 0.66, and the weight ratio of drynaria to astragalus is 1, and the weight ratio of eucommia to astragalus is 0.66, and the weight ratio of wolfberry to astragalus is 0.33, and the weight ratio of dog spine to astragalus is 0.

66.

22. The Chinese medicine composition according to claim 1, characterized in that: In terms of weight ratio, the weight ratio of dried tangerine peel to astragalus is 1.33, the weight ratio of Chinese clematis to astragalus is 1.33, the weight ratio of malt to astragalus is 1.33, the weight ratio of drynaria to astragalus is 1, the weight ratio of eucommia to astragalus is 1, the weight ratio of wolfberry to astragalus is 1, and the weight ratio of dog spine to astragalus is 1.

23. The Chinese medicine composition according to claim 1, characterized in that: The malt is roasted malt.

24. A pharmaceutical preparation made from the Chinese medicine composition according to any one of claims 1 to 23.

25. The pharmaceutical preparation according to claim 24, characterized in that The pharmaceutical preparation comprises one or more pharmaceutically acceptable excipients.

26. The pharmaceutical preparation according to claim 25, characterized in that The auxiliary material is selected from one or more of the following: diluent, wetting agent, binder, disintegrant, inclusion agent, flavoring agent, sustained-release agent, glidant, lubricant, dispersant, plasticizer, opacifier and antioxidant.

27. The pharmaceutical preparation according to claim 25, characterized in that The auxiliary material is dextrin.

28. The pharmaceutical preparation according to claim 24, characterized in that The dosage form of the pharmaceutical preparation is powder, tablet, pill, capsule, film, lozenge, granule, injection or oral solution.

29. The pharmaceutical preparation according to claim 24, characterized in that The dosage form of the pharmaceutical preparation is granules.

30. A method for preparing the Chinese medicine composition according to any one of claims 1 to 23, characterized in that: The method comprises the following steps: (1) weighing appropriate amounts of dried tangerine peel, Chinese rhizoma cyrtonemae, malt, drynariae rhizome, eucommia bark, wolfberry, astragalus and cibotium bark, adding water for the first time and boiling for a period of time, filtering to obtain a first filtrate and a first medicinal residue; (2) adding water to the first medicinal residue for a second time and boiling for a period of time, and then filtering to obtain a second filtrate and a second medicinal residue; as well as (3) The first filtrate and the second filtrate are combined, concentrated into a concentrated liquid, and then dried to obtain the traditional Chinese medicine composition.

31. A method for preparing a pharmaceutical preparation according to any one of claims 24 to 29, characterized in that The method comprises the following steps: (1) weighing appropriate amounts of dried tangerine peel, Chinese rhizoma cyrtonemae, malt, drynariae rhizome, eucommia bark, wolfberry, astragalus and cibotium bark, adding water for the first time and boiling for a period of time, filtering to obtain a first filtrate and a first medicinal residue; (2) adding water to the first medicinal residue for a second time and boiling for a period of time, and then filtering to obtain a second filtrate and a second medicinal residue; (3) combining the first filtrate and the second filtrate to concentrate the filtrate into a concentrated solution; as well as (4) adding auxiliary materials to the concentrated solution for the first time, and adding auxiliary materials again after drying to obtain the pharmaceutical preparation.

32. The method according to claim 30 or 31, characterized in that The malt is roasted malt.

33. The method according to claim 30 or 31, characterized in that The volume / mass ratio of the water added for the first time to the total mass of dried orange peel, Rhizoma Cyathulae, Fructus Malti, Rhizoma Drynariae, Eucommia, Fructus Lycii, Radix Astragali and Cibotium Cibotium is 1 to 20, in units of ml / g or L / kg.

34. The method according to claim 30 or 31, characterized in that The volume / mass ratio of the water added for the first time to the total mass of dried orange peel, Rhizoma Cyathulae, Fructus Malti, Rhizoma Drynariae, Eucommia Bark, Fructus Lycii, Radix Astragali and Cibotium Cibotium is 10, and the unit is ml / g or L / kg.

35. The method according to claim 30 or 31, characterized in that The first time of adding water and boiling is 30 to 90 minutes from the time of boiling.

36. The method according to claim 30 or 31, characterized in that The first time of adding water and boiling is 60 minutes, starting from the time of boiling.

37. The method according to claim 30 or 31, characterized in that The volume / mass ratio of the water added for the second time to the total mass of dried tangerine peel, cyperus rotundus, malt, drynariae rhizome, eucommia bark, wolfberry, astragalus and Cibotium barbarum is 1-20, and the unit is ml / g or L / kg.

38. The method according to claim 30 or 31, characterized in that The volume / mass ratio of the water added for the second time to the total mass of dried tangerine peel, Rhizoma Achyranthis Bidentatae, Fructus Malti, Rhizoma Drynariae, Eucommia Bark, Fructus Lycii, Radix Astragali and Cibotium Cibotium is 8, in units of ml / g or L / kg.

39. The method according to claim 30 or 31, characterized in that The second time of boiling with water is 10 to 90 minutes, starting from the boiling time.

40. The method according to claim 30 or 31, characterized in that The second time of boiling with water is 30 minutes from the time of boiling.

41. The method according to claim 30 or 31, characterized in that The relative density of the concentrated solution at 55° C. to 65° C. is 1.10 to 1.

15.

42. The method according to claim 30 or 31, characterized in that The drying temperature is 50-70°C.

43. The method according to claim 30 or 31, characterized in that The drying temperature is 60°C.

44. The method according to claim 31, characterized in that The mass / mass ratio between the mass of the auxiliary material added for the first time and the mass of the concentrated solution is 0.035 to 0.175, in units of g / g or mg / mg.

45. The method according to claim 31, characterized in that The mass / mass ratio between the mass of the auxiliary material added for the first time and the mass of the concentrated solution is 0.07, in units of g / g or mg / mg.

46. ​​The method according to claim 31, characterized in that The drying is spray drying.

47. The method according to claim 31, characterized in that The step (4) further comprises a granulation step.

48. The method according to claim 31, characterized in that The granulation is dry granulation.

49. Use of the Chinese medicine composition according to any one of claims 1 to 23 or the pharmaceutical preparation according to any one of claims 24 to 29 in the preparation of a medicament for preventing and / or treating sarcopenia.

50. The use according to claim 49, characterized in that The prevention and / or treatment of sarcopenia is manifested in one or more of the following: increasing muscle strength, increasing muscle mass, increasing muscle function, reducing body fat content, and delaying the aging process.

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