Composition for preventing and treating sarcopenia as well as preparation method and application thereof
By using a specific proportion of traditional Chinese medicinal compositions such as Polygonatum, yam, Eucommia ulmoides, etc., the problem of lack of effective treatment of sarcopenia in the prior art is solved, and the effect of improving muscle strength, muscle content and function is achieved, reducing body fat and delaying aging is achieved.
Patent Information
- Application Number
- CN202510526058.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-04-24
- Publication Date
- 2025-06-06
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
The prior art lacks effective treatments to prevent and treat sarcopenia, a common disease that affects muscle mass and function in middle-aged and elderly people.
A composition is provided, including Polygonatum, yam, Eucommia ulmoides, mulberries, wolfberry, poria, jujube and turmeric, for the preparation of a medicament for the prevention and/or treatment of sarcopenia by a specific weight ratio combination.
Through animal experiments, this composition can significantly improve the muscle strength, muscle content and muscle function of sarcopenia model mice, reduce body fat content, delay aging, and have no significant impact on the amount of food intake.
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Figure CN120093875A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the field of medical technology, and in particular to a composition for preventing and treating sarcopenia, and a preparation method and use thereof. Background Art
[0002] Sarcopenia (referred to as "sarcopenia") is a common disease in middle-aged and elderly people. Its main clinical manifestation is the chronic and progressive reduction of muscle quality and quantity with the increase of age, leading to the loss of muscle strength. 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. Studies have shown that human muscle reaches its peak at the age of 40, and then muscle quality gradually declines. The 2016 Asian Sarcopenia Management Guidelines estimated that the prevalence of sarcopenia in middle-aged and elderly people aged 60 to 70 in China is about 4.1% to 11.5%, and the prevalence of skeletal sarcopenia in men and women aged 70 and above is 13.2% and 4.8% respectively. The incidence rate of people over 80 years old increases significantly, up to 50%. 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%, and the prevalence increases significantly with age. The prevalence of people aged 80 and above is as high as 53.2%. 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 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 composition for preventing and / or treating sarcopenia, wherein the raw materials of the composition include 9-11 parts of polygonatum, 7.2-8.8 parts of yam, 7.2-8.8 parts of eucommia leaves, 9-11 parts of mulberry, 7.2-8.8 parts of wolfberry, 7.2-8.8 parts of tuckahoe, 9.9-12.1 parts of jujube and 7.2-8.8 parts of turmeric; or, the raw materials of the composition include 9-11 parts of polygonatum, 10.8-13.2 parts of yam, 14.4-17.6 parts of eucommia leaves, 5.4-6.6 parts of mulberry, 7.2-8.8 parts of wolfberry, 7.2-8.8 parts of tuckahoe, 9.9-12.1 parts of jujube and 7.2-8.8 parts of turmeric. 2-8.8 parts, 9.9-12.1 parts of Poria cocos, 4.5-5.5 parts of jujube and 5.4-6.6 parts of turmeric; or, by weight, the raw materials of the composition include 9-11 parts of polygonatum, 14.4-17.6 parts of yam, 10.8-13.2 parts of eucommia leaves, 9-11 parts of mulberry, 4.5-5.5 parts of wolfberry, 9.9-12.1 parts of Poria cocos, 9.9-12.1 parts of jujube and 5.4-6.6 parts of turmeric; or, by weight, the raw materials of the composition include 13.5-16.5 parts of polygonatum, 10.8-13.2 parts of yam, 10.8-13.2 parts of eucommia leaves. 8-13.2 parts, mulberry 9-11 parts, wolfberry 7.2-8.8 parts, Poria 7.2-8.8 parts, jujube 7.2-8.8 parts and turmeric 5.4-6.6 parts; or, by weight, the raw materials of the composition include 13.5-16.5 parts of polygonatum, 10.8-13.2 parts of yam, 10.8-13.2 parts of eucommia leaves, 12.6-15.4 parts of mulberry, 9.9-12.1 parts of wolfberry, 9.9-12.1 parts of Poria, 4.5-5.5 parts of jujube and 3.6-4.4 parts of turmeric; or, by weight, the raw materials of the composition include polygonatum 13.5-16.5 parts, yam 14.4-17.6 parts, eucommia leaves 7.2-8.8 parts, mulberry 5.4-6.6 parts, wolfberry 7.2-8.8 parts, Poria 9.9-12.1 parts, jujube 9.9-12.1 parts and turmeric 3.6-4.4 parts; or, in parts by weight, the raw materials of the composition include 18-22 parts of polygonatum, 10.8-13.2 parts of yam, 7.2-8.8 parts of eucommia leaves, 9-11 parts of mulberry, 4.5-5.5 parts of wolfberry, 9.9-12.1 parts of poria, 4.5-5.5 parts of jujube and 7.2-8.8 parts of turmeric.
[0006] Further, by weight, the raw materials of the composition include 9.5-10.5 parts of polygonatum, 7.6-8.4 parts of yam, 7.6-8.4 parts of eucommia leaves, 9.5-10.5 parts of mulberry, 7.6-8.4 parts of wolfberry, 7.6-8.4 parts of tuckahoe, 10.45-11.55 parts of jujube and 7.6-8.4 parts of turmeric. Further, by weight, the raw materials of the composition include about 10 parts of polygonatum, about 8 parts of yam, about 8 parts of eucommia leaves, about 10 parts of mulberry, about 8 parts of wolfberry, about 8 parts of tuckahoe, about 11 parts of jujube and about 8 parts of turmeric. Further, by weight, the raw materials of the composition include 9.5-10.5 parts of polygonatum, 11.4-12.6 parts of yam, 15.2-16.8 parts of eucommia leaves, 5.7-6.3 parts of mulberry, 7.6-8.4 parts of wolfberry, 10.45-11.55 parts of tuckahoe, 4.75-5.25 parts of jujube and 5.7-6.3 parts of turmeric. Further, by weight, the raw materials of the composition include about 10 parts of polygonatum, about 12 parts of yam, about 16 parts of eucommia leaves, about 6 parts of mulberry, about 8 parts of wolfberry, about 11 parts of tuckahoe, about 5 parts of jujube and about 6 parts of turmeric. Further, by weight, the raw materials of the composition include 9.5-10.5 parts of polygonatum, 15.2-16.8 parts of yam, 11.4-12.6 parts of eucommia leaves, 9.5-10.5 parts of mulberry, 4.75-5.25 parts of wolfberry, 10.45-11.55 parts of tuckahoe, 10.45-11.55 parts of jujube and 5.7-6.3 parts of turmeric. Further, by weight, the raw materials of the composition include about 10 parts of polygonatum, about 16 parts of yam, about 12 parts of eucommia leaves, about 10 parts of mulberry, about 5 parts of wolfberry, about 11 parts of tuckahoe, about 11 parts of jujube and about 6 parts of turmeric. Further, by weight, the raw materials of the composition include 14.25-15.75 parts of polygonatum, 11.4-12.6 parts of yam, 11.4-12.6 parts of eucommia leaves, 9.5-10.5 parts of mulberry, 7.6-8.4 parts of wolfberry, 7.6-8.4 parts of tuckahoe, 7.6-8.4 parts of jujube, and 5.7-6.3 parts of turmeric. Further, by weight, the raw materials of the composition include about 15 parts of polygonatum, about 12 parts of yam, about 12 parts of eucommia leaves, about 10 parts of mulberry, about 8 parts of wolfberry, about 8 parts of tuckahoe, about 8 parts of jujube, and about 6 parts of turmeric. Further, by weight, the raw materials of the composition include 14.25-15.75 parts of polygonatum, 11.4-12.6 parts of yam, 11.4-12.6 parts of eucommia leaves, 13.3-14.7 parts of mulberry, 10.45-11.55 parts of wolfberry, 10.45-11.55 parts of tuckahoe, 4.75-5.25 parts of jujube and 3.8-4.2 parts of turmeric. Further, by weight, the raw materials of the composition include about 15 parts of polygonatum, about 12 parts of yam, about 12 parts of eucommia leaves, about 14 parts of mulberry, about 11 parts of wolfberry, about 11 parts of tuckahoe, about 5 parts of jujube and about 4 parts of turmeric.Further, by weight, the raw materials of the composition include 14.25-15.75 parts of polygonatum, 15.2-16.8 parts of yam, 7.6-8.4 parts of eucommia leaves, 5.7-6.3 parts of mulberry, 7.6-8.4 parts of wolfberry, 10.45-11.55 parts of tuckahoe, 10.45-11.55 parts of jujube and 3.8-4.2 parts of turmeric. Further, by weight, the raw materials of the composition include about 15 parts of polygonatum, about 16 parts of yam, about 8 parts of eucommia leaves, about 6 parts of mulberry, about 8 parts of wolfberry, about 11 parts of tuckahoe, about 11 parts of jujube and about 4 parts of turmeric. Further, by weight, the raw materials of the composition include 19-21 parts of polygonatum, 11.4-12.6 parts of yam, 7.6-8.4 parts of eucommia leaves, 9.5-10.5 parts of mulberry, 4.75-5.25 parts of wolfberry, 10.45-11.55 parts of tuckahoe, 4.75-5.25 parts of jujube and 7.6-8.4 parts of turmeric. Further, by weight, the raw materials of the composition include about 20 parts of polygonatum, about 12 parts of yam, about 8 parts of eucommia leaves, about 10 parts of mulberry, about 5 parts of wolfberry, about 11 parts of tuckahoe, about 5 parts of jujube and about 8 parts of turmeric. Further, in terms of weight ratio, the weight ratio of Chinese yam to polygonatum is about 0.8, the weight ratio of Eucommia leaf to polygonatum is about 0.8, the weight ratio of mulberry to polygonatum is about 1, the weight ratio of wolfberry to polygonatum is about 0.8, the weight ratio of Poria to polygonatum is about 0.8, the weight ratio of jujube to polygonatum is about 1.1, and the weight ratio of turmeric to polygonatum is about 0.8. Further, in terms of weight ratio, the weight ratio of Chinese yam to polygonatum is about 1.2, the weight ratio of Eucommia leaf to polygonatum is about 1.6, the weight ratio of mulberry to polygonatum is about 0.6, the weight ratio of wolfberry to polygonatum is about 0.8, the weight ratio of Poria to polygonatum is about 1.1, the weight ratio of jujube to polygonatum is about 0.5, and the weight ratio of turmeric to polygonatum is about 0.6. Further, by weight, the weight ratio of Chinese yam to polygonatum is about 1.6, the weight ratio of Eucommia leaf to polygonatum is about 1.2, the weight ratio of mulberry to polygonatum is about 1, the weight ratio of wolfberry to polygonatum is about 0.5, the weight ratio of Poria to polygonatum is about 1.1, the weight ratio of jujube to polygonatum is about 1.1, and the weight ratio of turmeric to polygonatum is about 0.6. Further, by weight, the weight ratio of Chinese yam to polygonatum is about 0.8, the weight ratio of Eucommia leaf to polygonatum is about 0.8, the weight ratio of mulberry to polygonatum is about 0.67, the weight ratio of wolfberry to polygonatum is about 0.53, the weight ratio of Poria to polygonatum is about 0.53, the weight ratio of jujube to polygonatum is about 0.53, and the weight ratio of turmeric to polygonatum is about 0.4.Further, by weight, the weight ratio of yam to polygonatum is about 0.8, the weight ratio of eucommia leaf to polygonatum is about 0.8, the weight ratio of mulberry to polygonatum is about 0.93, the weight ratio of wolfberry to polygonatum is about 0.73, the weight ratio of tuckahoe to polygonatum is about 0.73, the weight ratio of jujube to polygonatum is about 0.33, and the weight ratio of turmeric to polygonatum is about 0.27. Further, by weight, the weight ratio of yam to polygonatum is about 1.07, the weight ratio of eucommia leaf to polygonatum is about 0.53, the weight ratio of mulberry to polygonatum is about 0.4, the weight ratio of wolfberry to polygonatum is about 0.53, the weight ratio of tuckahoe to polygonatum is about 0.73, the weight ratio of jujube to polygonatum is about 0.73, and the weight ratio of turmeric to polygonatum is about 0.27. Further, in terms of weight ratio, the weight ratio of yam to polygonatum is about 0.6, the weight ratio of eucommia leaves to polygonatum is about 0.4, the weight ratio of mulberry to polygonatum is about 0.5, the weight ratio of wolfberry to polygonatum is about 0.25, the weight ratio of poria to polygonatum is about 0.55, the weight ratio of jujube to polygonatum is about 0.25, and the weight ratio of turmeric to polygonatum is about 0.4.
[0007] According to another aspect of the present invention, a preparation comprising the above composition is provided. Further, the preparation further comprises one or more drugs and / or extracts for preventing and / or treating sarcopenia. Further, the drug is selected from one or more of the following: testosterone, selective androgen receptor modulators, growth hormone, ghrelin and myostatin inhibitors.
[0008] Further, the preparation comprises one or more pharmaceutically acceptable excipients. Further, the excipients are selected from one or more of the following: diluents, wetting agents, adhesives, disintegrants, inclusion agents, flavoring agents, sustained-release agents, glidants, lubricants, dispersants, plasticizers, opacifiers and antioxidants. Further, the excipients are dextrin and / or sucrose. Further, the dosage form of the preparation is powder, tablet, drop pill, capsule, film, lozenge, granule, injection or oral solution. Further, the dosage form of the preparation is granule.
[0009] According to another aspect of the present invention, a method for preparing the above-mentioned composition is provided, and the method comprises the following steps: (1) weighing appropriate amounts of polygonatum, yam, eucommia leaf, mulberry, wolfberry, poria, jujube and turmeric, adding water to boil for a period of time for the first 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, filtering to obtain a second filtrate and a second medicinal residue; and (3) combining the first filtrate and the second filtrate, concentrating them into a concentrated liquid and then drying them to obtain the composition.
[0010] According to another aspect of the present invention, there is provided a method for preparing the above-mentioned preparation, which comprises the following steps: (1) weighing appropriate amounts of polygonatum, yam, eucommia leaf, mulberry, wolfberry, poria, jujube and turmeric, adding water to boil for a period of time for the first 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, filtering to obtain a second filtrate and a second medicinal residue; (3) combining the first filtrate and the second filtrate and concentrating them into a concentrated solution; and (4) adding auxiliary materials to the concentrated solution for the first time, and adding auxiliary materials for the second time after drying to obtain the preparation.
[0011] Further, the volume / mass (mL / g or L / kg) ratio of the volume of the water added in the first water addition to the total mass of the medicinal materials of polygonatum, yam, eucommia leaf, mulberry, wolfberry, Poria, jujube and turmeric is 1 to 20, for example, about 10. Further, the time of the first water addition and decoction is 30 to 90 minutes from the time of boiling, for example, about 60 minutes. Further, the volume / mass (mL / g or L / kg) ratio of the volume of the water added in the second water addition to the total mass of the medicinal materials of polygonatum, yam, eucommia leaf, mulberry, wolfberry, Poria, jujube and turmeric is 1 to 20, for example, about 8. Further, the time of the second water addition and decoction is 10 to 90 minutes from the time of boiling, for example, about 30 minutes. Further, the relative density of the concentrated solution at 55°C to 65°C is 1.10 to 1.15. Further, the drying temperature is 50-70°C, for example, about 60°C. Further, the mass / mass (g / g or mg / mg) ratio between the mass of the first added auxiliary material and the mass of the concentrated solution is 0.035-0.175, for example, about 0.07. Further, the drying is spray drying. Further, the step (4) further includes a granulation step. Further, the granulation is dry granulation.
[0012] According to another aspect of the present invention, there is provided a use of the above-mentioned composition or the above-mentioned preparation in the preparation of medicines, foods and / or health products for preventing and / or treating sarcopenia.
[0013] Further, the composition or the preparation prevents and / or treats sarcopenia in one or more of the following ways: improving the apparent aging degree, increasing muscle strength, increasing muscle content, reducing body fat content, reducing the degree of fat infiltration in the body, improving muscle function, improving skeletal muscle pathological abnormalities, and delaying the aging process. Further, the apparent aging includes one or more of the following: body reactivity, body passivity, skin, hair, eyes and spine-related aging. Further, the skeletal muscle pathological abnormalities include one or more of the following: abnormal muscle fiber arrangement, reduced cross-sectional area and reduced intermuscular space.
[0014] Beneficial effects of the present invention:
[0015] 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 14 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. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] 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.
[0017] Figure 1 DEXA images of body composition of mice in each group.
[0018] Figure 2 The following are the HE-stained sections of skeletal muscle of mice in each group. DETAILED DESCRIPTION
[0019] 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.
[0020] 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.
[0021] 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.
[0022] 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.
[0023] 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.
[0024] As described in the background technology section, there is no prior art that the composition claimed in the present invention can be used to prevent and / or treat sarcopenia. In order to solve the above problems, the present invention provides a composition for preventing and / or treating sarcopenia, in which the raw materials of the composition include 9-11 parts of polygonatum, 7.2-8.8 parts of yam, 7.2-8.8 parts of eucommia leaves, 9-11 parts of mulberry, 7.2-8.8 parts of wolfberry, 7.2-8.8 parts of poria, 9.9-12.1 parts of jujube and 7.2-8.8 parts of turmeric; or, in weight parts, the raw materials of the composition include 9-11 parts of polygonatum, 10.8-13.2 parts of yam, 14.4-17.6 parts of eucommia leaves, 5.4-6.6 parts of mulberry, wolfberry, 7.2-8.8 parts of tuckahoe, 9.9-12.1 parts of poria, 4.5-5.5 parts of jujube and 5.4-6.6 parts of turmeric; or, in parts by weight, the raw materials of the composition include 9-11 parts of polygonatum, 14.4-17.6 parts of yam, 10.8-13.2 parts of eucommia leaves, 9-11 parts of mulberry, 4.5-5.5 parts of wolfberry, 9.9-12.1 parts of tuckahoe, 9.9-12.1 parts of jujube and 5.4-6.6 parts of turmeric; or, in parts by weight, the raw materials of the composition include 13.5-16.5 parts of polygonatum, 10.8-13.2 parts of yam, 10.8-13.2 parts of eucommia leaves 0.8-13.2 parts, mulberry 9-11 parts, wolfberry 7.2-8.8 parts, Poria 7.2-8.8 parts, jujube 7.2-8.8 parts and turmeric 5.4-6.6 parts; or, by weight, the raw materials of the composition include 13.5-16.5 parts of polygonatum, 10.8-13.2 parts of yam, 10.8-13.2 parts of eucommia leaves, 12.6-15.4 parts of mulberry, 9.9-12.1 parts of wolfberry, 9.9-12.1 parts of Poria, 4.5-5.5 parts of jujube and 3.6-4.4 parts of turmeric; or, by weight, the raw materials of the composition include turmeric 13.5-16.5 parts, yam 10.8-13.2 parts, eucommia leaves 10.8-13.2 parts, mulberry 12.6-15.4 parts, wolfberry 9.9-12.1 parts, Poria 9.9-12.1 parts, jujube 4.5-5.5 parts and turmeric 3.6-4.4 parts. The raw materials of the composition include 13.5-16.5 parts of polygonatum, 14.4-17.6 parts of yam, 7.2-8.8 parts of eucommia leaves, 5.4-6.6 parts of mulberries, 7.2-8.8 parts of wolfberries, 9.9-12.1 parts of poria, 9.9-12.1 parts of jujube and 3.6-4.4 parts of turmeric; or, in parts by weight, the raw materials of the composition include 18-22 parts of polygonatum, 10.8-13.2 parts of yam, 7.2-8.8 parts of eucommia leaves, 9-11 parts of mulberries, 4.5-5.5 parts of wolfberries, 9.9-12.1 parts of poria, 4.5-5.5 parts of jujube and 7.2-8.8 parts of turmeric.
[0025] In the present invention, except for polygonatum, the other Chinese medicinal herbs including yam, eucommia leaf, mulberry, wolfberry, poria, jujube and turmeric are both medicinal and edible Chinese medicines, among which polygonatum, yam and eucommia leaf are all important herbs for tonifying spleen and kidney, mulberry and wolfberry nourish liver and kidney, benefit essence and nourish blood, poria and turmeric strengthen spleen and eliminate dampness, calm the mind and soothe the nerves, and jujube nourishes the middle and replenishes qi, nourishes blood and soothes the nerves, and together play the effects of tonifying kidney and strengthening spleen.
[0026] In the present invention, when weight parts, ratios, time, relative 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 10.5", "9 to 10", "9 to 9.5", "9.5 to 11", "9.5 to 10.5", "9.5 to 10", "10 to 11", "10 to 10.5", "10.5 to 11", etc. 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.
[0027] In a preferred embodiment, the raw materials of the composition include, by weight, 9.5-10.5 parts of polygonatum, 7.6-8.4 parts of yam, 7.6-8.4 parts of eucommia leaves, 9.5-10.5 parts of mulberry, 7.6-8.4 parts of wolfberry, 7.6-8.4 parts of poria, 10.45-11.55 parts of jujube and 7.6-8.4 parts of turmeric.
[0028] In a preferred embodiment, the raw materials of the composition include, by weight, about 10 parts of polygonatum, about 8 parts of yam, about 8 parts of eucommia leaves, about 10 parts of mulberry, about 8 parts of wolfberry, about 8 parts of poria, about 11 parts of jujube and about 8 parts of turmeric.
[0029] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 10" includes ±5% of 10, or from 9.5 to 10.5; "about 8" includes ±5% of 8, or from 7.6 to 8.4; "about 11" includes ±5% of 11, or from 10.45 to 11.55.
[0030] In a preferred embodiment, the raw materials of the composition include, by weight, 9.5-10.5 parts of polygonatum, 11.4-12.6 parts of yam, 15.2-16.8 parts of eucommia leaves, 5.7-6.3 parts of mulberry, 7.6-8.4 parts of wolfberry, 10.45-11.55 parts of poria, 4.75-5.25 parts of jujube and 5.7-6.3 parts of turmeric.
[0031] In a preferred embodiment, the raw materials of the composition include, by weight, about 10 parts of polygonatum, about 12 parts of yam, about 16 parts of eucommia leaves, about 6 parts of mulberry, about 8 parts of wolfberry, about 11 parts of poria, about 5 parts of jujube and about 6 parts of turmeric.
[0032] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 10" includes ±5% of 10, or from 9.5 to 10.5; "about 12" includes ±5% of 12, or from 11.4 to 12.6; "about 16" includes ±5% of 16, or from 15.2 to 16.8; "about 6" includes ±5% of 6, or from 5.7 to 6.3; "about 8" includes ±5% of 8, or from 7.6 to 8.4; "about 11" includes ±5% of 11, or from 10.45 to 11.55; "about 5" includes ±5% of 5, or from 4.75 to 5.25.
[0033] In a preferred embodiment, the raw materials of the composition include, by weight, 9.5-10.5 parts of polygonatum, 15.2-16.8 parts of yam, 11.4-12.6 parts of eucommia leaves, 9.5-10.5 parts of mulberry, 4.75-5.25 parts of wolfberry, 10.45-11.55 parts of poria, 10.45-11.55 parts of jujube and 5.7-6.3 parts of turmeric.
[0034] In a preferred embodiment, the raw materials of the composition include, by weight, about 10 parts of polygonatum, about 16 parts of yam, about 12 parts of eucommia leaves, about 10 parts of mulberry, about 5 parts of wolfberry, about 11 parts of poria, about 11 parts of jujube and about 6 parts of turmeric.
[0035] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 10" includes ±5% of 10, or from 9.5 to 10.5; "about 16" includes ±5% of 16, or from 15.2 to 16.8; "about 12" includes ±5% of 12, or from 11.4 to 12.6; "about 5" includes ±5% of 5, or from 4.75 to 5.25; "about 11" includes ±5% of 11, or from 10.45 to 11.55; "about 6" includes ±5% of 6, or from 5.7 to 6.3.
[0036] In a preferred embodiment, the raw materials of the composition include, by weight, 14.25-15.75 parts of polygonatum, 11.4-12.6 parts of yam, 11.4-12.6 parts of eucommia leaves, 9.5-10.5 parts of mulberry, 7.6-8.4 parts of wolfberry, 7.6-8.4 parts of poria, 7.6-8.4 parts of jujube and 5.7-6.3 parts of turmeric.
[0037] In a preferred embodiment, the raw materials of the composition include, by weight, about 15 parts of polygonatum, about 12 parts of yam, about 12 parts of eucommia leaves, about 10 parts of mulberry, about 8 parts of wolfberry, about 8 parts of poria, about 8 parts of jujube and about 6 parts of turmeric.
[0038] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 15" includes ±5% of 15, or from 14.25 to 15.75; "about 12" includes ±5% of 12, or from 11.4 to 12.6; "about 10" includes ±5% of 10, or from 9.5 to 10.5; "about 8" includes ±5% of 8, or from 7.6 to 8.4; "about 6" includes ±5% of 6, or from 5.7 to 6.3.
[0039] In a preferred embodiment, the raw materials of the composition include, by weight, 14.25-15.75 parts of polygonatum, 11.4-12.6 parts of yam, 11.4-12.6 parts of eucommia leaves, 13.3-14.7 parts of mulberry, 10.45-11.55 parts of wolfberry, 10.45-11.55 parts of poria, 4.75-5.25 parts of jujube and 3.8-4.2 parts of turmeric.
[0040] In a preferred embodiment, the raw materials of the composition include, by weight, about 15 parts of polygonatum, about 12 parts of yam, about 12 parts of eucommia leaves, about 14 parts of mulberry, about 11 parts of wolfberry, about 11 parts of poria, about 5 parts of jujube and about 4 parts of turmeric.
[0041] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 15" includes ±5% of 15, or from 14.25 to 15.75; "about 12" includes ±5% of 12, or from 11.4 to 12.6; "about 14" includes ±5% of 14, or from 13.3 to 14.7; "about 11" includes ±5% of 11, or from 10.45 to 11.55; "about 5" includes ±5% of 5, or from 4.75 to 5.25; "about 4" includes ±5% of 4, or from 3.8 to 4.2.
[0042] In a preferred embodiment, the raw materials of the composition include, by weight, 14.25-15.75 parts of polygonatum, 15.2-16.8 parts of yam, 7.6-8.4 parts of eucommia leaves, 5.7-6.3 parts of mulberry, 7.6-8.4 parts of wolfberry, 10.45-11.55 parts of poria, 10.45-11.55 parts of jujube and 3.8-4.2 parts of turmeric.
[0043] In a preferred embodiment, the raw materials of the composition include, by weight, about 15 parts of polygonatum, about 16 parts of yam, about 8 parts of eucommia leaves, about 6 parts of mulberry, about 8 parts of wolfberry, about 11 parts of poria, about 11 parts of jujube and about 4 parts of turmeric.
[0044] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 15" includes ±5% of 15, or from 14.25 to 15.75; "about 16" includes ±5% of 16, or from 15.2 to 16.8; "about 8" includes ±5% of 8, or from 7.6 to 8.4; "about 6" includes ±5% of 6, or from 5.7 to 6.3; "about 11" includes ±5% of 11, or from 10.45 to 11.55; "about 4" includes ±5% of 4, or from 3.8 to 4.2.
[0045] In a preferred embodiment, the raw materials of the composition include, by weight, 19-21 parts of polygonatum, 11.4-12.6 parts of yam, 7.6-8.4 parts of eucommia leaves, 9.5-10.5 parts of mulberry, 4.75-5.25 parts of wolfberry, 10.45-11.55 parts of poria, 4.75-5.25 parts of jujube and 7.6-8.4 parts of turmeric.
[0046] In a preferred embodiment, the raw materials of the composition include, by weight, about 20 parts of polygonatum, about 12 parts of yam, about 8 parts of eucommia leaves, about 10 parts of mulberry, about 5 parts of wolfberry, about 11 parts of poria, about 5 parts of jujube and about 8 parts of turmeric.
[0047] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 20" includes ±5% of 20, or from 19 to 21; "about 12" includes ±5% of 12, or from 11.4 to 12.6; "about 8" includes ±5% of 8, or from 7.6 to 8.4; "about 10" includes ±5% of 10, or from 9.5 to 10.5; "about 5" includes ±5% of 5, or from 4.75 to 5.25; "about 11" includes ±5% of 11, or from 10.45 to 11.55.
[0048] In a preferred embodiment, in terms of weight ratio, the weight ratio of yam to polygonatum is about 0.8, the weight ratio of eucommia leaves to polygonatum is about 0.8, the weight ratio of mulberry to polygonatum is about 1, the weight ratio of wolfberry to polygonatum is about 0.8, the weight ratio of poria to polygonatum is about 0.8, the weight ratio of jujube to polygonatum is about 1.1, and the weight ratio of turmeric to polygonatum is about 0.8.
[0049] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 0.8" includes ±5% of 0.8, or from 0.76 to 0.84; "about 1" includes ±5% of 1, or from 0.95 to 1.05; "about 1.1" includes ±5% of 1.1, or from 1.045 to 1.155.
[0050] In a preferred embodiment, in terms of weight ratio, the weight ratio of yam to polygonatum is about 1.2, the weight ratio of eucommia leaves to polygonatum is about 1.6, the weight ratio of mulberry to polygonatum is about 0.6, the weight ratio of wolfberry to polygonatum is about 0.8, the weight ratio of poria to polygonatum is about 1.1, the weight ratio of jujube to polygonatum is about 0.5, and the weight ratio of turmeric to polygonatum is about 0.6.
[0051] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 1.2" includes ±5% of 1.2, or from 1.14 to 1.26; "about 1.6" includes ±5% of 1.6, or from 1.52 to 1.68; "about 0.6" includes ±5% of 0.6, or from 0.57 to 0.63; "about 0.8" includes ±5% of 0.8, or from 0.76 to 0.84; "about 1.1" includes ±5% of 1.1, or from 1.045 to 1.155; "about 0.5" includes ±5% of 0.5, or from 0.475 to 0.525.
[0052] In a preferred embodiment, in terms of weight ratio, the weight ratio of yam to polygonatum is about 1.6, the weight ratio of eucommia leaves to polygonatum is about 1.2, the weight ratio of mulberry to polygonatum is about 1, the weight ratio of wolfberry to polygonatum is about 0.5, the weight ratio of poria to polygonatum is about 1.1, the weight ratio of jujube to polygonatum is about 1.1, and the weight ratio of turmeric to polygonatum is about 0.6.
[0053] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 1.2" includes ±5% of 1.2, or from 1.14 to 1.26; "about 1.6" includes ±5% of 1.6, or from 1.52 to 1.68; "about 1" includes ±5% of 1, or from 0.95 to 1.05; "about 0.5" includes ±5% of 0.5, or from 0.475 to 0.525; "about 1.1" includes ±5% of 1.1, or from 1.045 to 1.155; "about 0.6" includes ±5% of 0.6, or from 0.57 to 0.63.
[0054] In a preferred embodiment, in terms of weight ratio, the weight ratio of yam to polygonatum is about 0.8, the weight ratio of eucommia leaves to polygonatum is about 0.8, the weight ratio of mulberry to polygonatum is about 0.67, the weight ratio of wolfberry to polygonatum is about 0.53, the weight ratio of poria to polygonatum is about 0.53, the weight ratio of jujube to polygonatum is about 0.53, and the weight ratio of turmeric to polygonatum is about 0.4.
[0055] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 0.8" includes ±5% of 0.8, or from 0.76 to 0.84; "about 0.67" includes ±5% of 0.67, or from 0.6365 to 0.7035; "about 0.53" includes ±5% of 0.53, or from 0.5035 to 0.5565; "about 0.4" includes ±5% of 0.4, or from 0.38 to 0.42.
[0056] In a preferred embodiment, in terms of weight ratio, the weight ratio of yam to polygonatum is about 0.8, the weight ratio of eucommia leaves to polygonatum is about 0.8, the weight ratio of mulberry to polygonatum is about 0.93, the weight ratio of wolfberry to polygonatum is about 0.73, the weight ratio of poria to polygonatum is about 0.73, the weight ratio of jujube to polygonatum is about 0.33, and the weight ratio of turmeric to polygonatum is about 0.27.
[0057] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 0.8" includes ±5% of 0.8, or from 0.76 to 0.84; "about 0.93" includes ±5% of 0.93, or from 0.8835 to 0.9765; "about 0.73" includes ±5% of 0.73, or from 0.6935 to 0.7665; "about 0.33" includes ±5% of 0.33, or from 0.3135 to 0.3465; "about 0.27" includes ±5% of 0.27, or from 0.2565 to 0.2835.
[0058] In a preferred embodiment, by weight ratio, the weight ratio of yam to polygonatum is about 1.07, the weight ratio of eucommia leaf to polygonatum is about 0.53, the weight ratio of mulberry to polygonatum is about 0.4, the weight ratio of wolfberry to polygonatum is about 0.53, the weight ratio of poria to polygonatum is about 0.73, the weight ratio of jujube to polygonatum is about 0.73, and the weight ratio of turmeric to polygonatum is about 0.27.
[0059] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 1.07" includes ±5% of 1.07, or from 1.0165 to 1.1235; "about 0.53" includes ±5% of 0.53, or from 0.5035 to 0.5565; "about 0.4" includes ±5% of 0.4, or from 0.38 to 0.42; "about 0.73" includes ±5% of 0.73, or from 0.6935 to 0.7665; "about 0.27" includes ±5% of 0.27, or from 0.2565 to 0.2835.
[0060] In a preferred embodiment, by weight ratio, the weight ratio of yam to polygonatum is about 0.6, the weight ratio of eucommia leaf to polygonatum is about 0.4, the weight ratio of mulberry to polygonatum is about 0.5, the weight ratio of wolfberry to polygonatum is about 0.25, the weight ratio of poria to polygonatum is about 0.55, the weight ratio of jujube to polygonatum is about 0.25, and the weight ratio of turmeric to polygonatum is about 0.4.
[0061] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 0.6" includes ±5% of 0.6, or from 0.57 to 0.63; "about 0.4" includes ±5% of 0.4, or from 0.38 to 0.42; "about 0.5" includes ±5% of 0.5, or from 0.475 to 0.525; "about 0.25" includes ±5% of 0.25, or from 0.2375 to 0.2625; "about 0.55" includes ±5% of 0.55, or from 0.5225 to 0.5775.
[0062] According to another aspect of the present invention, a preparation comprising the above composition is provided.
[0063] In a preferred embodiment, the preparation further comprises one or more drugs and / or extracts for preventing and / or treating sarcopenia.
[0064] 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.
[0065] In a preferred embodiment, the formulation comprises one or more pharmaceutically acceptable excipients.
[0066] 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.
[0067] 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).
[0068] In a preferred embodiment, the auxiliary material is selected from one or more of the following: diluents, wetting agents, binders, disintegrants, inclusion agents, flavoring agents, sustained-release agents, glidants, lubricants, dispersants, plasticizers, opacifiers and antioxidants.
[0069] 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.
[0070] 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.
[0071] In a preferred embodiment, the auxiliary material is dextrin and / or sucrose.
[0072] In a preferred embodiment, the preparation is in the form of powder, tablet, pill, capsule, film, lozenge, granule, injection or oral solution.
[0073] In a preferred embodiment, the preparation is in the form of granules.
[0074] According to another aspect of the present invention, a method for preparing the above-mentioned composition is provided, and the method comprises the following steps: (1) weighing appropriate amounts of polygonatum, yam, eucommia leaf, mulberry, wolfberry, poria, jujube and turmeric, adding water to boil for a period of time for the first 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, filtering to obtain a second filtrate and a second medicinal residue; and (3) combining the first filtrate and the second filtrate, concentrating them into a concentrated liquid and then drying them to obtain the composition.
[0075] According to another aspect of the present invention, there is provided a method for preparing the above-mentioned preparation, which comprises the following steps: (1) weighing appropriate amounts of polygonatum, yam, eucommia leaf, mulberry, wolfberry, poria, jujube and turmeric, adding water to boil for a period of time for the first 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, filtering to obtain a second filtrate and a second medicinal residue; (3) combining the first filtrate and the second filtrate and concentrating them into a concentrated solution; and (4) adding auxiliary materials to the concentrated solution for the first time, and adding auxiliary materials for the second time after drying to obtain the preparation.
[0076] In a preferred embodiment, the volume / mass (mL / g or L / kg) ratio between the volume of the water added for the first time and the total mass of the medicinal materials of polygonatum, yam, eucommia leaf, mulberry, wolfberry, poria, jujube and turmeric is 1 to 20, for example about 10.
[0077] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 10" includes ±5% of 10, or from 9.5 to 10.5.
[0078] In a preferred embodiment, the first decoction time is 30 to 90 minutes, such as about 60 minutes, starting from the boiling time.
[0079] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 60" includes ±5% of 60, or from 57 to 63.
[0080] In a preferred embodiment, 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 the medicinal materials of polygonatum, yam, eucommia leaf, mulberry, wolfberry, poria, jujube and turmeric is 1 to 20, for example, about 8.
[0081] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 8" includes ±5% of 8, or from 7.6 to 8.4.
[0082] In a preferred embodiment, the second decoction time is 10 to 90 minutes, for example, about 30 minutes, starting from the boiling time.
[0083] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 30" includes ±5% of 30, or from 28.5 to 31.5.
[0084] In a preferred embodiment, the relative density of the concentrated solution at 55°C to 65°C is 1.10 to 1.15.
[0085] In a preferred embodiment, the drying temperature is 50-70°C, such as about 60°C.
[0086] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 60" includes ±5% of 60, or from 57 to 63.
[0087] 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.
[0088] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 0.07" includes ±5% of 0.07, or from 0.0665 to 0.0735.
[0089] In a preferred embodiment, the drying is spray drying.
[0090] In a preferred embodiment, the step (4) further comprises a granulation step.
[0091] In a preferred embodiment, the granulation is dry granulation.
[0092] According to another aspect of the present invention, there is provided a use of the above-mentioned composition or the above-mentioned preparation in the preparation of medicines, foods and / or health products for preventing and / or treating sarcopenia.
[0093] 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.
[0094] 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.
[0095] In a preferred embodiment, the composition or preparation prevents and / or treats sarcopenia in one or more of the following ways: improving the apparent degree of aging, increasing muscle strength, increasing muscle content, reducing body fat content, reducing the degree of body fat infiltration, improving muscle function, improving skeletal muscle pathological abnormalities, and delaying the aging process.
[0096] In a preferred embodiment, the apparent aging includes one or more of the following: body reactivity, body passivity, skin, hair, eyes and spine related aging.
[0097] In a preferred embodiment, the skeletal muscle pathological abnormality includes one or more of the following: abnormal muscle fiber arrangement, reduced cross-sectional area, and reduced intermuscular space.
[0098] The polygonatum sibiricum, yam, eucommia leaf, mulberry, wolfberry fruit, tuckahoe, jujube and turmeric of the invention are both food and medicine, and the medicine and food have the same origin.
[0099] According to another aspect of the present invention, there is further provided the above-mentioned composition or the above-mentioned pharmaceutical preparation for preventing and / or treating sarcopenia in a subject.
[0100] According to another aspect of the present invention, there is further provided 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.
[0101] 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.
[0102] 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).
[0103] 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.
[0104] 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.
[0105] 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.
[0106] Preparation Example
[0107] 1. Experimental instruments and materials
[0108] 1.1 Main experimental instruments
[0109] 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.
[0110] 1.2 Experimental Reagents
[0111] Polygonatum sibiricum, yam, eucommia leaf, mulberry, wolfberry, poria, jujube, and turmeric were purchased from Leiyunshang Pharmaceutical Group Co., Ltd.; dextrin, batch number T14A10Z95117, was purchased from Shanghai Yuanye Biotechnology Co., Ltd.; sucrose, batch number 201229, was purchased from Xilong Science Co., Ltd.; water was high-purity water, and the other reagents were of analytical grade.
[0112] 2. Experimental content
[0113] 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 Chinese medicines in the prescription, namely, polygonatum, yam, eucommia leaf, mulberry, wolfberry, poria, jujube and turmeric, are used as investigation factors, and each factor takes 3 levels (i.e., 3 different doses with increasing gradient), and the investigation dose is between 4-20g. The factors and levels are arranged according to the uniform design table, and the prescription design is carried out (as shown in Table 1), and a total of 27 groups of drug compositions are constructed.
[0114] Table 1 Uniform experimental design scheme
[0115]
[0116]
[0117] Preparation Example 1
[0118] The Chinese medicinal materials of the pharmaceutical composition include 10g of polygonatum, 8g of yam, 8g of eucommia leaves, 6g of mulberry, 5g of wolfberry, 5g of poria, 5g of jujube and 4g of turmeric, and are decocted in water twice, with the first decoction being 1 hour and the second decoction being 0.5 hour starting from boiling time. The mass of water used for the first decoction is 0.51kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.408kg (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.
[0119] Preparation Example 2
[0120] The Chinese medicinal materials of the pharmaceutical composition include 10g of polygonatum, 8g of yam, 8g of eucommia leaves, 10g of mulberry, 8g of wolfberry, 8g of poria, 11g of jujube and 8g of turmeric, 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 0.71kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.568kg (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.
[0121] Preparation Example 3
[0122] The Chinese medicinal materials of the pharmaceutical composition include 10g of polygonatum, 8g of yam, 8g of eucommia leaves, 14g of mulberry, 11g of wolfberry, 11g of poria, 8g of jujube and 6g of turmeric, 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 0.76kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.608kg (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.
[0123] Preparation Example 4
[0124] The Chinese medicinal materials of the pharmaceutical composition include 10g of polygonatum, 12g of yam, 16g of eucommia leaves, 6g of mulberry, 8g of wolfberry, 11g of poria, 5g of jujube and 6g of turmeric, 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 being 0.74kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction being 0.592kg (8 times the mass of the total medicinal materials), and the concentrate is concentrated into a concentrated liquid, and dried at a temperature of 60°C to obtain a pharmaceutical composition.
[0125] Preparation Example 5
[0126] The Chinese medicinal materials of the pharmaceutical composition include 10g of polygonatum, 12g of yam, 16g of eucommia leaves, 10g of mulberry, 11g of wolfberry, 5g of poria, 11g of jujube and 4g of turmeric, 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 0.79kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.632kg (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.
[0127] Preparation Example 6
[0128] The Chinese medicinal materials of the pharmaceutical composition include 10g of polygonatum, 12g of yam, 16g of eucommia leaves, 14g of mulberry, 5g of wolfberry, 8g of poria, 8g of jujube and 8g of turmeric, and are decocted in water for two times, the first decoction is 1 hour and the second decoction is 0.5 hour from boiling time, the mass of water used for the first decoction is 0.81kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.648kg (8 times the mass of the total medicinal materials), and the concentrate is concentrated into a concentrated solution, and dried at a temperature of 60°C to obtain a pharmaceutical composition.
[0129] Preparation Example 7
[0130] The Chinese medicinal materials of the pharmaceutical composition include 10g of polygonatum, 16g of yam, 12g of eucommia leaves, 6g of mulberry, 11g of wolfberry, 8g of poria, 5g of jujube and 8g of turmeric, 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 0.76kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.608kg (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.
[0131] Preparation Example 8
[0132] The Chinese medicinal materials of the pharmaceutical composition include 10g of polygonatum, 16g of yam, 12g of eucommia leaves, 10g of mulberry, 5g of wolfberry, 11g of poria, 11g of jujube and 6g of turmeric, 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 0.81kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.648kg (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.
[0133] Preparation Example 9
[0134] The Chinese medicinal materials of the pharmaceutical composition include 10g of polygonatum, 16g of yam, 12g of eucommia leaves, 14g of mulberry, 8g of wolfberry, 5g of poria, 8g of jujube and 4g of turmeric, 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 being 0.77kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction being 0.616kg (8 times the mass of the total medicinal materials), and the concentrate is concentrated into a concentrated solution, and dried at a temperature of 60°C to obtain a pharmaceutical composition.
[0135] Preparation Example 10
[0136] The Chinese medicinal materials of the pharmaceutical composition include 15g of polygonatum, 8g of yam, 16g of eucommia leaves, 5g of mulberry, 11g of wolfberry, 8g of poria, 11g of jujube and 6g of turmeric, 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 0.81kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.648kg (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.
[0137] Preparation Example 11
[0138] The Chinese medicinal materials of the pharmaceutical composition include 15g of polygonatum, 8g of yam, 16g of eucommia leaves, 10g of mulberry, 5g of wolfberry, 11g of poria, 8g of jujube and 4g of turmeric, 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 being 0.77kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction being 0.616kg (8 times the mass of the total medicinal materials), and the concentrate is concentrated into a concentrated solution, and dried at a temperature of 60°C to obtain a pharmaceutical composition.
[0139] Preparation Example 12
[0140] The Chinese medicinal materials of the pharmaceutical composition include 15g of polygonatum, 8g of yam, 16g of eucommia leaves, 14g of mulberry, 8g of wolfberry, 5g of poria, 5g of jujube and 8g of turmeric, 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 0.79kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.632kg (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.
[0141] Preparation Example 13
[0142] The Chinese medicinal materials of the pharmaceutical composition include 15g of polygonatum, 12g of yam, 12g of eucommia leaves, 6g of mulberry, 5g of wolfberry, 5g of poria, 11g of jujube and 8g of turmeric, 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 0.74kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.592kg (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.
[0143] Preparation Example 14
[0144] The Chinese medicinal materials of the pharmaceutical composition include 15g of polygonatum, 12g of yam, 12g of eucommia leaves, 10g of mulberry, 8g of wolfberry, 8g of poria, 8g of jujube and 6g of turmeric, 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 0.79kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.632kg (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.
[0145] Preparation Example 15
[0146] The Chinese medicinal materials of the pharmaceutical composition include 15g of polygonatum, 12g of yam, 12g of eucommia leaves, 14g of mulberry, 11g of wolfberry, 11g of poria, 5g of jujube and 4g of turmeric, and are decocted 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 kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is kg (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.
[0147] Preparation Example 16
[0148] The Chinese medicinal materials of the pharmaceutical composition include 15g of polygonatum, 16g of yam, 8g of eucommia leaves, 6g of mulberry, 8g of wolfberry, 11g of poria, 11g of jujube and 4g of turmeric, 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 0.79kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.632kg (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.
[0149] Preparation Example 17
[0150] The Chinese medicinal materials of the pharmaceutical composition include 15g of polygonatum, 16g of yam, 8g of eucommia leaves, 10g of mulberry, 11g of wolfberry, 5g of poria, 8g of jujube and 8g of turmeric, 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 0.81kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.648kg (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.
[0151] Preparation Example 18
[0152] The Chinese medicinal materials of the pharmaceutical composition include 15g of polygonatum, 16g of yam, 8g of eucommia leaves, 14g of mulberry, 5g of wolfberry, 8g of poria, 5g of jujube and 6g of turmeric, and are decocted in water for two times, the first decoction is 1 hour and the second decoction is 0.5 hour from boiling time, the mass of water used for the first decoction is 0.77kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.616kg (8 times the mass of the total medicinal materials), and the concentrate is obtained, and the concentrate is dried at a temperature of 60°C to obtain a pharmaceutical composition.
[0153] Preparation Example 19
[0154] The Chinese medicinal materials of the pharmaceutical composition include 20g of polygonatum, 8g of yam, 12g of eucommia leaves, 6g of mulberry, 8g of wolfberry, 11g of poria, 8g of jujube and 8g of turmeric, 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 0.81kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.648kg (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.
[0155] Preparation Example 20
[0156] The Chinese medicinal materials of the pharmaceutical composition include 20g of polygonatum, 8g of yam, 12g of eucommia leaves, 10g of mulberry, 11g of wolfberry, 5g of poria, 5g of jujube and 6g of turmeric, 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 being 0.77kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction being 0.616kg (8 times the mass of the total medicinal materials), and the concentrate is concentrated into a concentrated solution, and dried at a temperature of 60°C to obtain a pharmaceutical composition.
[0157] Preparation Example 21
[0158] The Chinese medicinal materials of the pharmaceutical composition include 20g of polygonatum, 8g of yam, 12g of eucommia leaves, 14g of mulberry, 5g of wolfberry, 8g of poria, 11g of jujube and 4g of turmeric, 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 being 0.82kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction being 0.656kg (8 times the mass of the total medicinal materials), and the concentrate is concentrated into a concentrated solution, and dried at a temperature of 60°C to obtain a pharmaceutical composition.
[0159] Preparation Example 22
[0160] The Chinese medicinal materials of the pharmaceutical composition include 20g of polygonatum, 12g of yam, 8g of eucommia leaves, 6g of mulberry, 11g of wolfberry, 8g of poria, 8g of jujube and 4g of turmeric, 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 0.77kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.616kg (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.
[0161] Preparation Example 23
[0162] The Chinese medicinal materials of the pharmaceutical composition include 20g of polygonatum, 12g of yam, 8g of eucommia leaves, 10g of mulberry, 5g of wolfberry, 11g of poria, 5g of jujube and 8g of turmeric, 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 0.79kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.632kg (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.
[0163] Preparation Example 24
[0164] The Chinese medicinal materials of the pharmaceutical composition include 20g of polygonatum, 12g of yam, 8g of eucommia leaves, 14g of mulberry, 8g of wolfberry, 5g of poria, 11g of jujube and 6g of turmeric, 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 being 0.84kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction being 0.672kg (8 times the mass of the total medicinal materials), and the concentrate is concentrated into a concentrated solution, and dried at a temperature of 60°C to obtain a pharmaceutical composition.
[0165] Preparation Example 25
[0166] The Chinese medicinal materials of the pharmaceutical composition include 20g of polygonatum, 16g of yam, 16g of eucommia leaves, 6g of mulberry, 5g of wolfberry, 5g of poria, 8g of jujube and 6g of turmeric, 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 being 0.82kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction being 0.656kg (8 times the mass of the total medicinal materials), and the concentrate is concentrated into a concentrated solution, and dried at a temperature of 60°C to obtain a pharmaceutical composition.
[0167] Preparation Example 26
[0168] The Chinese medicinal materials of the pharmaceutical composition include 20g of polygonatum, 16g of yam, 16g of eucommia leaves, 10g of mulberry, 8g of wolfberry, 8g of poria, 5g of jujube and 4g of turmeric, 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 being 0.87kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction being 0.696kg (8 times the mass of the total medicinal materials), and the concentrate is concentrated into a concentrated solution, and dried at a temperature of 60°C to obtain a pharmaceutical composition.
[0169] Preparation Example 27
[0170] The Chinese medicinal materials of the pharmaceutical composition include 20g of polygonatum, 16g of yam, 16g of eucommia leaves, 14g of mulberry, 11g of wolfberry, 11g of poria, 11g of jujube and 8g of turmeric, 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 1.07kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.856kg (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.
[0171] Efficacy Example
[0172] Pharmacological Efficacy Example 1
[0173] 1. Experimental Materials
[0174] 1.1 Experimental Animals
[0175] 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.
[0176] 1.2 Experimental drugs
[0177] Experimental drugs: polygonatum, yam, eucommia leaf, mulberry, wolfberry, tuckahoe, jujube and turmeric.
[0178] 2. Experimental methods
[0179] 2.1. Uniform design of drug screening experiments
[0180] 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.
[0181] 2.2. Screening indicators: Mouse grip strength and muscle content.
[0182] 2.3 Statistical Methods
[0183] The data were analyzed using SPSS 25.0 software package. The q test was used for comparison between groups, and P < 0.05 indicated statistical significance.
[0184] 3. Uniform design drug screening experiment results
[0185] The screening experiment results are shown in Table 2.
[0186] Table 2 Screening test results
[0187]
[0188]
[0189] 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;
[0190] According to the test results, the drug combination of Group 14 had the best efficacy (***P<0.001) based on the main efficacy indicator muscle strength. In addition, Group 2, Group 4, Group 8, Group 15, Group 16 and Group 23 also showed significant differences compared with the model group (*P<0.05), while other groups did not show obvious efficacy, and Group 5 even showed a further decrease in muscle strength.
[0191] Efficacy Example 2
[0192] The efficacy of the pharmaceutical composition of Group 14 in treating sarcopenia was further verified by using the composite model and evaluation indexes of the preparation example and the efficacy example 1.
[0193] 1. Experimental Materials
[0194] 1.1 Experimental Animals
[0195] 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.
[0196] 1.2 Experimental drugs
[0197] Experimental drugs: Polygonatum sibiricum, Chinese yam, Eucommia ulmoides leaf, mulberry, Lycium barbarum, Poria cocos, jujube and turmeric. The extract powder of the drug composition of group 14 contains 2.97g of crude drugs per gram. Experimental drugs: Rogai calcitriol capsules (0.25ug), purchased from Catalent Germany Eberbach GmbH.
[0198] 1.3 Experimental instruments
[0199] 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.
[0200] 2. Experimental methods
[0201] 2.1 Grouping and Dosing
[0202] After 1 week of adaptive feeding with ordinary feed, 40 SAMP8 mice were randomly divided into a model group, a low-dose group (6.59 g / kg.d), a medium-dose group (13.17 g / kg.d) and a high-dose group (26.34 g / kg.d crude drug) of the drug composition of Group 14, 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 the normal group.
[0203] The extract powder of the pharmaceutical composition of group 14 was dissolved in ultrapure water. Each administration group was given different concentrations of the extract powder solution of the pharmaceutical composition of group 14 by intragastric administration for 12 consecutive weeks, once a day, with an intragastric volume of 0.1 mL / 10 g.
[0204] 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.
[0205] 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.
[0206] 2.2. Detection indicators and methods
[0207] 2.2.1. Aging score
[0208] 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, with each category scored from 0 to 4 points, and evaluated once at 0 and 12 weeks.
[0209] 2.2.2. Mouse muscle strength measurement
[0210] 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 conducted once at 0 and 12 weeks, and each mouse was tested three times, and the average was taken and weighted for statistical analysis.
[0211] 2.2.3. Body composition of mice
[0212] 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.
[0213] 2.2.4. Mouse muscle function assay
[0214] 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 15 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 significantly decreased. If the mouse does not exhaust for more than 3 hours, the recording time is 3 hours. Measure once every 4 weeks.
[0215] 2.2.5 Effects of mouse skeletal muscle pathological sections
[0216] After 12 weeks of drug intervention, the animals were killed by dislocation of the neck after blood collection, and the bilateral tibialis anterior muscles of the mice were separated. One side of the tibialis anterior muscle was frozen in a -80℃ refrigerator, and the other side was fixed with 4% paraformaldehyde for 24 hours, dehydrated, paraffin-embedded, and cut into 5μm paraffin sections. For skeletal muscle tissue sections, HE staining was used to detect the morphology and number of mouse skeletal muscle fibers. The sections were observed and images were collected using an optical microscope.
[0217] 2.2.6 Statistical methods
[0218] 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.
[0219] 3. Experimental results
[0220] 3.1. Effect of the drug composition of group 14 on the aging degree of SAMP8 sarcopenia model mice
[0221] The results are shown in Table 3. Before administration, there was no significant difference in the aging scores of SAMP8 mice among the groups, indicating that the groups were comparable. After 12 weeks of administration, compared with the normal group, the aging score of the model group was significantly increased (P < 0.001); compared with the model group, the aging scores of the low and medium groups were significantly reduced (P < 0.01), the aging scores of the high-dose group were significantly reduced (P < 0.001), and the aging scores of the vitamin D group were significantly reduced (P < 0.01). In addition, compared with the vitamin D group, the aging scores of the medium and high-dose groups showed a downward trend.
[0222] Table 3 Effect of sarcopenia on the aging degree of SAMP8 sarcopenia model mice
[0223]
[0224]
[0225] The experimental results are expressed as mean and standard deviation. Compared with the normal group, the model group *P<0.05; **P<0.01, ***P<0.001; compared with the model group, the drug administration groups # P < 0.05; ## P<0.01, ### P<0.001.
[0226] 3.2 Effect of the drug composition of group 14 on the muscle strength of SAMP8 sarcopenia model mice
[0227] The results are shown in Table 4. Before administration, there was no significant difference in the muscle strength of SAMP8 mice among the groups, indicating that the experimental system was reliable and the groups were comparable. 12 weeks after administration, compared with the normal group, the muscle strength of the model group decreased significantly (P < 0.01); compared with the model group, the muscle strength of the low and medium dose groups of group 14 increased significantly (P < 0.01), the muscle strength of the high dose group increased significantly (P < 0.001), and the muscle strength of the vitamin D group showed an increasing trend. In addition, compared with the vitamin D group, the muscle strength of the low, medium and high dose groups of group 14 showed an increasing trend.
[0228] Table 4 Effects of the drug composition of group 14 on the muscle strength of SAMP8 sarcopenia model mice
[0229]
[0230]
[0231] The experimental results are expressed as mean and standard deviation. Compared with the normal group, the model group *P<0.05; **P<0.01, ***P<0.001; compared with the model group, the drug administration groups # P < 0.05; ##P<0.01, ### P<0.001.
[0232] 3.3 Effect of the drug composition of group 14 on body fat content and muscle content in SAMP8 sarcopenia model mice
[0233] The results are shown in Table 5. 12 weeks after administration, compared with the normal group, the fat content of the model group increased significantly (P < 0.01); compared with the model group, the fat content of the low-dose group in group 14 decreased significantly (P < 0.05), the fat content of the medium-dose group decreased significantly (P < 0.001), the fat content of the high-dose group decreased significantly (P < 0.05), and the vitamin D group showed a decreasing trend; compared with the vitamin D group, the fat content of the medium- and high-dose groups in group 14 showed a decreasing trend. In addition, compared with the normal group, the muscle content of the model group decreased significantly (P < 0.01); compared with the model group, the muscle content of the low-dose group in group 14 showed an increasing trend, the muscle content of the medium-dose group increased significantly (P < 0.01), the muscle content of the high-dose group increased significantly (P < 0.05), and the vitamin D group showed an increasing trend; compared with the vitamin D group, the muscle content of the medium- and high-dose groups in group 14 showed an increasing trend. Dual-energy X-ray analysis of body composition revealed that group 14 and vitamin D groups showed significantly reduced fat infiltration and increased muscle content compared with the model group, and the medium-dose group in group 14 had the best therapeutic effect (results Figure 1 shown).
[0234] Table 5 Effects of the drug composition of group 14 on body fat content and muscle content in SAMP8 sarcopenia model mice
[0235]
[0236] The experimental results are expressed as mean and standard deviation. Compared with the normal group, the model group *P<0.05; **P<0.01, ***P<0.001; compared with the model group, the drug administration groups # P < 0.05; ## P<0.01, ### P<0.001.
[0237] 3.4 Effect of the drug composition of group 14 on muscle function of SAMP8 sarcopenia model mice
[0238] The results are shown in Table 6. Compared with the normal group, the running distance of the model group showed a downward trend, and the running time decreased significantly (P < 0.05); compared with the model group, the running distance of the medium and high dose groups in Group 14 increased significantly (P < 0.05), and the running time increased significantly (P < 0.01). The running distance and running time of the low dose group and the vitamin D group showed an upward trend; compared with the vitamin D group, the running time and running distance of the low, medium and high dose groups in Group 14 showed an upward trend.
[0239] Table 6 Effects of the drug composition of group 14 on muscle function of SAMP8 sarcopenia model mice
[0240]
[0241]
[0242]
[0243] The experimental results are expressed as mean and standard deviation. Compared with the normal group, the model group *P<0.05; **P<0.01, ***P<0.001; compared with the model group, the drug administration groups # P < 0.05; ## P<0.01, ### P<0.001.
[0244] Effect of the drug combination of group 3.5 on skeletal muscle pathological sections of SAMP8 sarcopenia model mice
[0245] HE pathological staining was used to analyze the pathological damage of skeletal muscle in SAMP8 mice. Figure 2 As shown. The skeletal muscle tissue of the normal group mice was arranged completely, regularly and clearly; in the SAMP8 mouse model group, the skeletal muscle was abnormal and uneven, with a smaller cross-sectional area and wider intermuscular space; both group 14 and vitamin D could significantly improve the pathological changes. After intervention, the muscle fiber morphology of the mice was improved compared with the model group, the arrangement was neater than before, the intermuscular space was smaller than before, and the cross-sectional area was larger, indicating that group 14 helped to restore the skeletal muscle pathological damage of aging mice, and the performance of the medium and high dose groups was particularly outstanding.
[0246] 4. Experimental conclusion
[0247] Based on animal experiments, it was found that the drug composition of Group 14 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 14 can be used as a drug for the treatment of sarcopenia.
[0248] 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 composition for preventing and / or treating sarcopenia, characterized in that: In parts by weight, the raw materials of the composition include 9-11 parts of polygonatum, 7.2-8.8 parts of yam, 7.2-8.8 parts of eucommia leaves, 9-11 parts of mulberry, 7.2-8.8 parts of wolfberry, 7.2-8.8 parts of tuckahoe, 9.9-12.1 parts of jujube and 7.2-8.8 parts of turmeric; or, in parts by weight, the raw materials of the composition include 9-11 parts of polygonatum, 10.8-13.2 parts of yam, 14.4-17.6 parts of eucommia leaves, 5.4-6.6 parts of mulberry, 7.2-8.8 parts of wolfberry, 9.9-12.1 parts of tuckahoe, 4 .5-5.5 parts and 5.4-6.6 parts of turmeric; or, in parts by weight, the raw materials of the composition include 9-11 parts of polygonatum, 14.4-17.6 parts of yam, 10.8-13.2 parts of eucommia leaves, 9-11 parts of mulberry, 4.5-5.5 parts of wolfberry, 9.9-12.1 parts of tuckahoe, 9.9-12.1 parts of jujube and 5.4-6.6 parts of turmeric; or, in parts by weight, the raw materials of the composition include 13.5-16.5 parts of polygonatum, 10.8-13.2 parts of yam, 10.8-13.2 parts of eucommia leaves, 9-11 parts of mulberry 1-8.8 parts, wolfberry 7.2-8.8 parts, Poria 7.2-8.8 parts, jujube 7.2-8.8 parts and turmeric 5.4-6.6 parts; or, in parts by weight, the raw materials of the composition include 13.5-16.5 parts of polygonatum, 10.8-13.2 parts of yam, 10.8-13.2 parts of eucommia leaves, 12.6-15.4 parts of mulberry, 9.9-12.1 parts of wolfberry, 9.9-12.1 parts of Poria, 4.5-5.5 parts of jujube and 3.6-4.4 parts of turmeric; or, in parts by weight, the raw materials of the composition include 13.5-16.5 parts of polygonatum, 10.8-13.2 parts of yam, 10.8-13.2 parts of eucommia leaves, 12.6-15.4 parts of mulberry, 9.9-12.1 parts of wolfberry, 9.9-12.1 parts of Poria, 4.5-5.5 parts of jujube and 3.6-4.4 parts of turmeric 6.5 parts, yam 14.4-17.6 parts, eucommia leaves 7.2-8.8 parts, mulberry 5.4-6.6 parts, wolfberry 7.2-8.8 parts, Poria 9.9-12.1 parts, jujube 9.9-12.1 parts and turmeric 3.6-4.4 parts; or, in parts by weight, the raw materials of the composition include 18-22 parts of polygonatum, 10.8-13.2 parts of yam, 7.2-8.8 parts of eucommia leaves, 9-11 parts of mulberry, 4.5-5.5 parts of wolfberry, 9.9-12.1 parts of Poria, 4.5-5.5 parts of jujube and 7.2-8.8 parts of turmeric.
2. The composition according to claim 1, characterized in that In parts by weight, the raw materials of the composition include 9.5-10.5 parts of polygonatum, 7.6-8.4 parts of yam, 7.6-8.4 parts of eucommia leaves, 9.5-10.5 parts of mulberry, 7.6-8.4 parts of wolfberry, 7.6-8.4 parts of tuckahoe, 10.45-11.55 parts of jujube and 7.6-8.4 parts of turmeric; Preferably, the raw materials of the composition include about 10 parts of polygonatum, about 8 parts of yam, about 8 parts of eucommia leaves, about 10 parts of mulberry, about 8 parts of wolfberry, about 8 parts of tuckahoe, about 11 parts of jujube and about 8 parts of turmeric in parts by weight; Preferably, in parts by weight, the raw materials of the composition include 9.5-10.5 parts of polygonatum, 11.4-12.6 parts of yam, 15.2-16.8 parts of eucommia leaves, 5.7-6.3 parts of mulberry, 7.6-8.4 parts of wolfberry, 10.45-11.55 parts of tuckahoe, 4.75-5.25 parts of jujube and 5.7-6.3 parts of turmeric; More preferably, the raw materials of the composition include about 10 parts of polygonatum, about 12 parts of yam, about 16 parts of eucommia leaves, about 6 parts of mulberry, about 8 parts of wolfberry, about 11 parts of tuckahoe, about 5 parts of jujube and about 6 parts of turmeric, by weight. More preferably, the raw materials of the composition include 9.5-10.5 parts of polygonatum, 15.2-16.8 parts of yam, 11.4-12.6 parts of eucommia leaves, 9.5-10.5 parts of mulberry, 4.75-5.25 parts of wolfberry, 10.45-11.55 parts of tuckahoe, 10.45-11.55 parts of jujube and 5.7-6.3 parts of turmeric in parts by weight; Preferably, the raw materials of the composition include about 10 parts of polygonatum, about 16 parts of yam, about 12 parts of eucommia leaves, about 10 parts of mulberry, about 5 parts of wolfberry, about 11 parts of tuckahoe, about 11 parts of jujube and about 6 parts of turmeric in parts by weight; Preferably, the raw materials of the composition include 14.25-15.75 parts of polygonatum, 11.4-12.6 parts of yam, 11.4-12.6 parts of eucommia leaves, 9.5-10.5 parts of mulberry, 7.6-8.4 parts of wolfberry, 7.6-8.4 parts of tuckahoe, 7.6-8.4 parts of jujube and 5.7-6.3 parts of turmeric in parts by weight; More preferably, the raw materials of the composition include about 15 parts of polygonatum, about 12 parts of yam, about 12 parts of eucommia leaves, about 10 parts of mulberry, about 8 parts of wolfberry, about 8 parts of tuckahoe, about 8 parts of jujube and about 6 parts of turmeric in parts by weight; More preferably, the raw materials of the composition include, by weight, 14.25-15.75 parts of polygonatum, 11.4-12.6 parts of yam, 11.4-12.6 parts of eucommia leaves, 13.3-14.7 parts of mulberry, 10.45-11.55 parts of wolfberry, 10.45-11.55 parts of tuckahoe, 4.75-5.25 parts of jujube and 3.8-4.2 parts of turmeric; Particularly preferably, the raw materials of the composition include about 15 parts of polygonatum, about 12 parts of yam, about 12 parts of eucommia leaves, about 14 parts of mulberry, about 11 parts of wolfberry, about 11 parts of tuckahoe, about 5 parts of jujube and about 4 parts of turmeric, by weight. Particularly preferably, the raw materials of the composition include, by weight, 14.25-15.75 parts of polygonatum, 15.2-16.8 parts of yam, 7.6-8.4 parts of eucommia leaves, 5.7-6.3 parts of mulberry, 7.6-8.4 parts of wolfberry, 10.45-11.55 parts of tuckahoe, 10.45-11.55 parts of jujube and 3.8-4.2 parts of turmeric; Particularly preferably, the raw materials of the composition include about 15 parts of polygonatum, about 16 parts of yam, about 8 parts of eucommia leaves, about 6 parts of mulberry, about 8 parts of wolfberry, about 11 parts of tuckahoe, about 11 parts of jujube and about 4 parts of turmeric in parts by weight; Particularly preferably, the raw materials of the composition include, by weight, 19-21 parts of polygonatum, 11.4-12.6 parts of yam, 7.6-8.4 parts of eucommia leaves, 9.5-10.5 parts of mulberry, 4.75-5.25 parts of wolfberry, 10.45-11.55 parts of tuckahoe, 4.75-5.25 parts of jujube and 7.6-8.4 parts of turmeric; Particularly preferably, the raw materials of the composition include, by weight, about 20 parts of polygonatum, about 12 parts of yam, about 8 parts of eucommia leaves, about 10 parts of mulberry, about 5 parts of wolfberry, about 11 parts of tuckahoe, about 5 parts of jujube and about 8 parts of turmeric; Particularly preferably, in terms of weight ratio, the weight ratio of yam to polygonatum is about 0.8, the weight ratio of eucommia leaf to polygonatum is about 0.8, the weight ratio of mulberry to polygonatum is about 1, the weight ratio of wolfberry to polygonatum is about 0.8, the weight ratio of tuckahoe to polygonatum is about 0.8, the weight ratio of jujube to polygonatum is about 1.1, and the weight ratio of turmeric to polygonatum is about 0.8; Particularly preferably, in terms of weight ratio, the weight ratio of yam to polygonatum is about 1.2, the weight ratio of eucommia leaf to polygonatum is about 1.6, the weight ratio of mulberry to polygonatum is about 0.6, the weight ratio of wolfberry to polygonatum is about 0.8, the weight ratio of tuckahoe to polygonatum is about 1.1, the weight ratio of jujube to polygonatum is about 0.5, and the weight ratio of turmeric to polygonatum is about 0.6; Particularly preferably, in terms of weight ratio, the weight ratio of yam to polygonatum is about 1.6, the weight ratio of eucommia leaf to polygonatum is about 1.2, the weight ratio of mulberry to polygonatum is about 1, the weight ratio of wolfberry to polygonatum is about 0.5, the weight ratio of tuckahoe to polygonatum is about 1.1, the weight ratio of jujube to polygonatum is about 1.1, and the weight ratio of turmeric to polygonatum is about 0.6; Particularly preferably, in terms of weight ratio, the weight ratio of yam to polygonatum is about 0.8, the weight ratio of eucommia leaf to polygonatum is about 0.8, the weight ratio of mulberry to polygonatum is about 0.67, the weight ratio of wolfberry to polygonatum is about 0.53, the weight ratio of tuckahoe to polygonatum is about 0.53, the weight ratio of jujube to polygonatum is about 0.53, and the weight ratio of turmeric to polygonatum is about 0.4; Particularly preferably, in terms of weight ratio, the weight ratio of yam to polygonatum is about 0.8, the weight ratio of eucommia leaf to polygonatum is about 0.8, the weight ratio of mulberry to polygonatum is about 0.93, the weight ratio of wolfberry to polygonatum is about 0.73, the weight ratio of tuckahoe to polygonatum is about 0.73, the weight ratio of jujube to polygonatum is about 0.33, and the weight ratio of turmeric to polygonatum is about 0.27; Particularly preferably, in terms of weight ratio, the weight ratio of yam to polygonatum is about 1.07, the weight ratio of eucommia leaf to polygonatum is about 0.53, the weight ratio of mulberry to polygonatum is about 0.4, the weight ratio of wolfberry to polygonatum is about 0.53, the weight ratio of tuckahoe to polygonatum is about 0.73, the weight ratio of jujube to polygonatum is about 0.73, and the weight ratio of turmeric to polygonatum is about 0.27; Particularly preferably, in terms of weight ratio, the weight ratio of yam to polygonatum is about 0.6, the weight ratio of eucommia leaves to polygonatum is about 0.4, the weight ratio of mulberry to polygonatum is about 0.5, the weight ratio of wolfberry to polygonatum is about 0.25, the weight ratio of poria to polygonatum is about 0.55, the weight ratio of jujube to polygonatum is about 0.25, and the weight ratio of turmeric to polygonatum is about 0.
4.
3. A preparation comprising the composition of claim 1 or 2.
4. The preparation according to claim 3, characterized in that The preparation further comprises one or more drugs and / or extracts for preventing and / or treating sarcopenia; Preferably, the drug is selected from one or more of the following: testosterone, selective androgen receptor modulators, growth hormone, ghrelin and myostatin inhibitors; More preferably, the formulation comprises one or more pharmaceutically acceptable excipients; Preferably, 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; Still more preferably, the auxiliary material is dextrin and / or sucrose; Particularly preferably, the dosage form of the preparation is powder, tablet, pill, capsule, film, lozenge, granule, injection or oral solution; Particularly preferably, the preparation is in the form of granules.
5. A method for preparing the composition according to claim 1 or 2, characterized in that: The preparation method comprises the following steps: (1) weighing appropriate amounts of polygonatum, yam, eucommia leaf, mulberry, wolfberry, poria, jujube and turmeric, 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 composition.
6. A method for preparing the preparation according to claim 3 or 4, characterized in that: The preparation method comprises the following steps: (1) weighing appropriate amounts of polygonatum, yam, eucommia leaf, mulberry, wolfberry, poria, jujube and turmeric, 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 for the second time after drying to obtain the preparation.
7. The preparation method according to claim 5 or 6, characterized in that: The volume / mass (mL / g or L / kg) ratio of the volume of the water added in the first step to the total mass of the medicinal materials of polygonatum, yam, eucommia leaf, mulberry, wolfberry, tuckahoe, jujube and turmeric is 1 to 20, for example, about 10; Preferably, the first decoction time is 30 to 90 minutes from boiling, for example, about 60 minutes; More preferably, 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 the medicinal materials of polygonatum, yam, eucommia leaf, mulberry, wolfberry, tuckahoe, jujube and turmeric is 1 to 20, for example, about 8; More preferably, the second decoction time is 10 to 90 minutes, for example, about 30 minutes, starting from the boiling time. Preferably, the relative density of the concentrated solution at 55°C to 65°C is 1.10 to 1.15; Also preferably, the drying temperature is 50-70°C, such as about 60°C.
8. The method according to claim 6, characterized in that The mass / mass (g / g or mg / mg) ratio between the mass of the first added auxiliary material and the mass of the concentrated solution is 0.035 to 0.175, for example, about 0.07; Preferably, the drying is spray drying; More preferably, the step (4) further comprises a granulation step; More preferably, the granulation is dry granulation.
9. Use of the composition according to claim 1 or 2 or the preparation according to claim 3 or 4 in the preparation of medicines, foods and / or health products for preventing and / or treating sarcopenia.
10. The use according to claim 9, characterized in that The composition or the preparation prevents and / or treats sarcopenia in one or more of the following ways: improving the apparent aging degree, increasing muscle strength, increasing muscle content, reducing body fat content, reducing the degree of body fat infiltration, improving muscle function, improving skeletal muscle pathological abnormalities, and delaying the aging process; Preferably, the epigenetic aging includes one or more of the following: body reactivity, body passivity, skin, hair, eyes and spine-related aging; Preferably, the skeletal muscle pathological abnormalities include one or more of the following: abnormal muscle fiber arrangement, reduced cross-sectional area and reduced intermuscular space.
Citation Information
Patent Citations
Composition for delaying muscle attenuation and preparation method and application thereof
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Traditional Chinese medicine composition for preventing and treating sarcopenia as well as preparation method and application of traditional Chinese medicine composition
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