Composition containing rhizoma polygonati as well as preparation method and application thereof in prevention and treatment of sarcopenia

Abstract

The invention discloses a composition containing rhizoma polygonati for preventing and / or treating sarcopenia. The composition is prepared from rhizoma polygonati, radix angelicae sinensis, radix codonopsis, radix rehmanniae preparata, herba cistanche, fructus lycii, poria cocos and fructus crataegi. Wherein the mass ratio of the rhizoma polygonati to the radix angelicae sinensis to the radix codonopsis to the radix rehmanniae preparata to the herba cistanche to the fructus lycii to the poria cocos to the fructus crataegi is (6-20) to (3-15) to (6-20) to (7-15) to (3-11) to (10-15) to (6-14) to (3-11). The composition can effectively improve the muscle strength, muscle quality, exercise tolerance, holding power and coordination function of model animals, improves the muscle structure and fibrosis state, and has a good sarcopenia resistance effect and a good clinical application prospect.

Description

Technical Field

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

[0002] Sarcopenia, also known as muscle loss, is a progressive, age-related syndrome characterized by a decrease in overall muscle mass, strength, and / or physical function. With the global aging population, the incidence of sarcopenia is increasing annually. It is estimated that approximately 50 million people worldwide currently suffer from sarcopenia, and the number is expected to exceed 500 million by 2050. Sarcopenia has an insidious onset and can trigger or aggravate multi-system dysfunction, increasing the risk of falls, fractures, frailty, and even death in the elderly. It severely impairs their quality of life and health, and places a heavy medical burden on their families and society. Therefore, how to effectively prevent and treat sarcopenia has become a pressing public health issue.

[0003] Against the backdrop of an accelerating global aging population, sarcopenia has become a core challenge affecting people's quality of life and healthy life expectancy. Recent epidemiological surveys have shown that the prevalence of sarcopenia in Chinese adults aged 60 and over ranges from 5.7% to 23.9%. The onset of sarcopenia increases the risk of fall-related injuries by 85%, hospitalization risk by 31% in severe cases, and medical expenses by 4%.

[0004] Currently, interventions for sarcopenia are limited. Resistance exercise and nutritional support, as mainstream strategies, remain challenging to implement and exhibit wide inter-individual variability in efficacy. Furthermore, there are no FDA-approved specific drugs for sarcopenia. While commonly used medications, such as vitamin D, testosterone, and growth hormone, have demonstrated some clinical efficacy, their mechanisms remain unclear and they carry cardiovascular risks and masculinizing side effects. Due to the complex pathogenesis of sarcopenia, many single-target or single-factor therapies in modern medicine often fail to achieve optimal results. Therefore, achieving comprehensive interventions within this complex pathogenic network remains a significant challenge. Unlike Western medicine, Traditional Chinese Medicine (TCM) offers a unique understanding of sarcopenia. TCM emphasizes holistic syndrome differentiation and treatment, emphasizing the synergistic effects of multiple components, targets, and pathways, offering significant advantages in intervening in complex diseases. Therefore, identifying potential drug candidates for sarcopenia from TCM formulas is of great value.

[0005] Sarcopenia is categorized in Traditional Chinese Medicine (TCM) as "weakness" and "consumption," with corresponding TCM names such as "weakness," "consolidation," "consumption," "deficiency," and "excessive flesh." The onset of this condition is closely linked to dysfunction of the spleen, kidney, and liver, often requiring coordinated intervention across multiple organs to achieve overall improvement. Tang Rongchuan's "Treatise on Blood Symptoms" states: "At birth, the innate gives rise to the acquired; after growth, the acquired gives rise to the innate." The "Nanjing" (Nanjing: Twenty-four Difficulties) states: "If bones and flesh are not in harmony, the flesh will be moist but withered; if the flesh is moist but withered, the teeth will grow but wither, and the hair will be dry and lack lubricity. Without lubricity, the bones will die first." The spleen, the foundation of the acquired constitution, transports and transforms the essence of food and water, providing nutrition for the muscles; the kidneys, the foundation of the innate constitution, govern the bones, produce marrow, and store essence. When the spleen and kidney are in harmony, and the innate and acquired constitutions mutually support each other, bones and flesh will be harmonious, and bones will be strong and fleshy. Conversely, with age, the depletion of Tiangui (vital essence) leads to insufficient kidney essence and poor nourishment of the spleen and stomach, resulting in withered and weak bones, a lack of attachment for flesh, and ultimately weakness and limpness, with both muscles and bones damaged. The liver governs the tendons and vessels, possessing a yin constitution but yang functions, responsible for regulating and dispersing qi. A full liver blood nourishes the tendons, strengthening them and enabling them to fulfill their functions of binding muscles and bones and facilitating joint function. Insufficient liver blood leads to poor nourishment of the tendons and vessels. From the perspective of bone health, the prevention and treatment of sarcopenia emphasizes the coordinated development of muscles and bones, advocating that "muscles serve the function of bones, with equal emphasis on muscles and bones." Through holistic regulation and multi-target intervention, a comprehensive approach encompassing "prevention, diagnosis, treatment, rehabilitation, and nourishment" is implemented. Clinically, the core approach is to strengthen the spleen and kidneys, supplemented by replenishing qi and blood, and replenishing the essence. Furthermore, pathological products such as dampness, phlegm, and blood stasis are considered. Treatment is based on syndrome differentiation, addressing both the symptoms and the root causes, to comprehensively improve overall health.

[0006] The prior art does not disclose a composition comprising Polygonatum sibiricum, a preparation method thereof, and a use thereof for preventing and treating sarcopenia as claimed in the present invention. Summary of the Invention

[0007] Based on this, the present invention provides a composition containing polygonatum for preventing and / or treating sarcopenia, the composition comprising polygonatum, angelica, codonopsis, rehmannia, cistanche, wolfberry, poria and hawthorn;

[0008] The mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is (6-20): (3-15): (6-20): (7-15): (3-11): (10-15): (6-14): (3-11).

[0009] Furthermore, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia root, the cistanche deserticola, the wolfberry, the poria and the hawthorn is (8-18): (4-14): (8-18): (7.5-14): (4-10.5): (8-14): (7-14): (4-10.5). Furthermore, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia root, the cistanche deserticola, the wolfberry, the poria and the hawthorn is (9-16): (5-13): (9-16): (8-13): (5-10): (11-13): (8-13): (5-10). Furthermore, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is (10-15): (6-12): (10-15): (9-12): (6-9): about 12: (9-12): (6-9). Further, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is about 10: about 6: about 15: about 9: about 9: about 12: about 12: about 9. Further, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is about 15: about 6: about 10: about 9: about 9: about 12: about 9: about 6. Furthermore, the mass ratio of the polygonatum, angelica, codonopsis, prepared rehmannia, cistanche deserticola, wolfberry, poria, and hawthorn is about 15:about 12:about 15:about 12:about 6:about 12:about 9:about 9. Furthermore, the mass of the polygonatum is 9-16g, for example, about 10g or about 15g. Furthermore, the mass of the angelica is 5-13g, for example, about 6g or about 12g. Furthermore, the mass of the codonopsis is 9-16g, for example, about 10g or about 15g. Furthermore, the mass of the prepared rehmannia is 8-13g, for example, about 9g or about 12g. Furthermore, the mass of the cistanche deserticola is 5-10g, for example, about 6g or about 9g. Furthermore, the mass of the wolfberry is 11-13g, for example, about 12g. Furthermore, the mass of the Poria cocos is 8 to 13 g, such as about 9 g or about 12 g. Furthermore, the mass of the Hawthorn is 5 to 10 g, such as about 6 g or about 9 g.

[0010] According to another aspect of the present invention, a preparation method of the above-mentioned composition is provided, which comprises the following steps: (1) weighing appropriate amounts of Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos and Crataegus pinnatifida, adding water for the first time, heating and extracting after soaking, boiling and continuing to boil for a period of time, filtering to obtain a first filtrate and a first medicinal residue; (2) adding water for the second time to the first medicinal residue, heating and extracting, boiling and continuing to boil for a period of time, filtering to obtain a second filtrate; and (3) combining the first filtrate and the second filtrate, concentrating to a concentrated liquid and then drying to obtain the composition.

[0011] Furthermore, the water is distilled water or ultrapure water. Furthermore, the soaking time is 0.5 to 2 hours. Furthermore, the ratio of the mass of the water in the first water addition to the total mass of the polygonatum, angelica, codonopsis, prepared rehmannia, cistanche, wolfberry, poria and hawthorn is 1 to 20, for example, about 10. Furthermore, the ratio of the mass of the water in the second water addition to the mass of the first medicinal residue or the total mass of the polygonatum, angelica, codonopsis, prepared rehmannia, cistanche, wolfberry, poria and hawthorn is 1 to 20, for example, about 8. Furthermore, in step (1), the time for continuing to decoct after boiling is 0.5 to 2 hours, for example, about 1 hour. Furthermore, in step (2), the time for continuing to decoct after boiling is 0.3 to 1 hour, for example, about 0.5 hour. Furthermore, the drying temperature is 50 to 70°C, for example, about 60°C.

[0012] According to another aspect of the present invention, a pharmaceutical preparation is provided, which comprises the above-mentioned composition and one or more pharmaceutically acceptable excipients. Further, the excipients are 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. Furthermore, the dosage form of the pharmaceutical preparation is a powder, tablet, drop pill, capsule, film, lozenge, granule, injection or oral solution. Furthermore, the pharmaceutical preparation further comprises one or more other drugs for the prevention and / or treatment of sarcopenia. Furthermore, the other drugs are selected from one or more of the following: testosterone, selective androgen receptor modulators, growth hormone, ghrelin and myostatin inhibitors.

[0013] According to another aspect of the present invention, there is provided a use of the above-mentioned composition or pharmaceutical preparation in the preparation of a medicament for preventing and / or treating sarcopenia. Furthermore, the effect of the composition or preparation in preventing and / or treating sarcopenia is achieved through one or more of the following: increasing the expression level of the MyHC gene mRNA, increasing body weight, increasing muscle mass, improving muscle motor function, and improving muscle pathological abnormalities. Furthermore, the muscle mass includes quadriceps femoris mass, gastrocnemius mass, tibialis anterior mass, extensor digitorum longus mass, and / or soleus mass. Furthermore, the improvement of muscle motor function includes improved body exercise endurance, improved muscle strength, and / or improved body balance and coordination ability. Furthermore, the muscle pathological abnormalities include muscle fiber atrophy and / or muscle fibrosis.

[0014] Beneficial effects of the present invention:

[0015] The composition of the present invention can effectively improve the muscle strength, muscle mass, exercise endurance, grip strength, and coordination function of model animals, and improve the muscle structure and fibrosis state, and has good anti-sarcopenia effect and clinical application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without exceeding the scope of protection required by the present invention.

[0017] Figure 1 This is a schematic diagram of the regulatory effects of different drug combinations of the present invention on MyHC expression.

[0018] Figure 2 This is a schematic diagram of the weight change results of mice in Example 2 of the efficacy of the present invention.

[0019] Figure 3 This is a schematic diagram of the skeletal muscle condition in Example 2 of the present invention.

[0020] Figure 4 This is a schematic diagram of skeletal muscle mass in Example 2 of the efficacy of the present invention.

[0021] Figure 5 This is a schematic diagram of the gripping test results of Example 2 of the efficacy of the present invention.

[0022] Figure 6 This is a schematic diagram of the exhaustive running distance results of Example 2 of the efficacy of the present invention.

[0023] Figure 7 This is a schematic diagram of the results of the Rotarod test in Example 2 of the present invention.

[0024] Figure 8 This is a schematic diagram of the grid suspension experiment results of Example 2 of the efficacy of the present invention.

[0025] Figure 9 This is a schematic diagram of the HE staining results of the second efficacy example of the present invention.

[0026] Figure 10 This is a schematic diagram of the Masson staining results of Example 2 of the present invention. DETAILED DESCRIPTION

[0027] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work shall fall within the scope of protection of the present invention.

[0028] Unless otherwise indicated, all technical and scientific terms and abbreviations used herein have the meanings commonly understood by those skilled in the art in the field of the present invention or the field in which the terms are used. Although any methods, conditions, substances or materials similar or equivalent to those disclosed herein can be used in the practice of the present invention, preferred methods, conditions, substances or materials are described herein.

[0029] The present invention is intended to encompass all alternatives, modifications, and equivalents that may come within the scope of the present invention as defined by the claims. Those skilled in the art will recognize many methods and materials similar or equivalent to those described herein that could be used in the practice of the present invention. The present invention is in no way limited to the methods and materials described.

[0030] 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.

[0031] In the present invention, the term "comprising" is synonymous with "including." As used herein, the terms "comprises," "including," "having," "containing," or any other variations thereof, are intended to cover a non-exclusive inclusion. For example, a composition, process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such composition, process, method, article, or apparatus.

[0032] As described in the background technology section, the prior art does not disclose a composition comprising polygonatum, a preparation method thereof, and its use in preventing and treating sarcopenia as claimed in the present invention. To address the above-mentioned issues, the present invention provides a composition comprising polygonatum for preventing and / or treating sarcopenia, the composition comprising polygonatum, angelica sinensis, codonopsis pilosula, rehmannia glutinosa, cistanche deserticola, wolfberry, poria cocos, and hawthorn;

[0033] The mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is (6-20): (3-15): (6-20): (7-15): (3-11): (10-15): (6-14): (3-11).

[0034] In the present invention, when mass ratio, time, mass, ratio, temperature, or other value or parameter is expressed as a range, preferred range, or a range limited by 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 alone. For example, when the range "6 to 20" is disclosed, the described range should be interpreted as including the range "6 to 20", "6 to 16", "6 to 12", "6 to 8", "8 to 20", "8 to 16", "8 to 12", "12 to 20", "12 to 16", "16 to 20", 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.

[0035] The composition of the present invention uses Polygonatum sibiricum as the main ingredient. Polygonatum sibiricum is sweet and mild in nature and enters the spleen, lung, and kidney meridians. It is excellent at replenishing qi and nourishing yin, strengthening the spleen and moistening the lungs, and benefiting the kidneys and replenishing essence. Its uniqueness lies in simultaneously replenishing the qi and yin of the lungs, spleen, and kidneys. It is a key ingredient in nourishing the internal organs, replenishing qi and blood, and strengthening the bones and muscles. It lays the core of the overall formula to replenish qi and nourish yin, strengthen the spleen and kidneys to combat the pathogenesis of sarcopenia, which is qi and blood deficiency, poor distribution of essence and fine particles, and malnutrition of bones and muscles. It effectively improves muscle weakness and fatigue. Codonopsis pilosula, Rehmannia glutinosa, and Chinese angelica are all auxiliary ingredients. Codonopsis pilosula is sweet and mild in nature and enters the spleen and lung meridians. It is good at strengthening the spleen and lungs, nourishing blood and promoting the production of body fluids. It helps Polygonatum sibiricum to greatly replenish the middle qi, strengthen the spleen and stomach's transportation and transformation functions, promote the biochemical source of qi and blood, and provide an energy foundation for muscles. Rehmannia root (Shengdihuang) is sweet and slightly warm in nature and enters the liver and kidney meridians. It specifically nourishes blood and yin, replenishes essence and fills the marrow. It strongly replenishes liver and kidney essence and blood, and is key to strengthening tendons and bones, and improving muscle atrophy and soreness of the waist and knees caused by essence and marrow deficiency. Angelica root (Danggui) is sweet, pungent, and warm in nature and enters the liver, heart, and spleen meridians. It not only replenishes blood and promotes blood circulation, but also regulates menstruation, relieves pain, and moistens the intestines to promote bowel movements. Its blood-activating effect promotes smooth blood circulation, nourishes tendons and muscles, and alleviates numbness and limited mobility caused by blood deficiency and blood stasis. The three herbs complement each other: Codonopsis pilosula primarily replenishes qi, Rehmannia root nourishes yin, blood, and essence, and Angelica root replenishes blood and promotes blood circulation. Together, they strongly support the main herb, Polygonatum sibiricum, achieving the core goal of replenishing qi and blood, providing muscles with sufficient qi, blood, and essence. Cistanche deserticola, Lycium barbarum, and Poria cocos serve as adjuvants. Cistanche deserticola has a sweet, salty, and warm nature and flavor, and enters the kidney and large intestine meridians. It tonifies kidney yang, benefits essence and blood, and moistens the intestines to promote bowel movements. It warms kidney yang to promote the production of essence and blood, strengthens bones and muscles, and helps angelica to moisten the intestines and promote bowel movements, preventing stagnation caused by tonics. Lycium barbarum has a sweet and neutral nature and enters the liver, kidney, and lung meridians. It nourishes the liver and kidneys, improves essence and eyesight, and synergizes with Rehmannia root to nourish the yin essence of the liver and kidneys. Together with Cistanche deserticola, it forms a dual yin-tonifying force, strengthening the foundation and nourishing the vital energy. Poria cocos has a sweet, mild, and neutral nature and enters the heart, lung, spleen, and kidney meridians. It promotes diuresis, dissipates dampness, strengthens the spleen, and calms the mind. Its spleen-tonifying properties assist Codonopsis pilosula and Polygonatum sibiricum in enhancing the spleen and stomach's ability to transport and transform water and grain essence, preventing the internal accumulation of dampness and turbidity, and ensuring the smooth flow of qi and blood. Its calming effect helps alleviate fatigue and tiredness, and its dampness-clearing properties prevent tonics from promoting dampness and hindering the spleen. The three herbs work together to strengthen the kidneys and spleen, with Cistanche deserticola warming kidney yang, Lycium barbarum nourishing kidney yin, and Poria cocos invigorating the spleen and dispelling dampness. Together, they deepen the kidney-tonifying and spleen-strengthening benefits, assisting the principal and auxiliary herbs in fully mobilizing the body's functions, improving symptoms such as soreness of the waist and knees, fatigue, and poor appetite, while also preventing the stagnation of tonics. Hawthorn, the guiding herb, is sour, sweet, and slightly warm in nature, entering the spleen, stomach, and liver meridians. It promotes digestion and stomachic function, promotes qi circulation and dissipates blood stasis, and clears turbidity and reduces lipids. It harmonizes the various herbs, directing their effects to the limbs, tendons, bones, and muscles. It also promotes qi circulation and dissipates blood stasis, assisting Angelica sinensis in activating blood circulation, slightly unblocking the meridians, improving local microcirculation, and promoting the distribution of qi, blood, and essence to muscle tissue. Simultaneously, it promotes digestion and stomachic function, clears turbidity and reduces lipids, and assists Codonopsis pilosula and Poria cocos in strengthening the spleen and promoting digestion. It prevents tonic herbs like Polygonatum sibiricum and Rehmannia glutinosa from causing stomach stagnation, dissolving phlegm, turbidity, and lipids, ensuring effective absorption and transformation of the tonic, ensuring a nourishing, yet dynamic and orderly formula. All the medicines work together to achieve the core effects of "tonifying qi and blood, strengthening the spleen and benefiting the kidneys".The whole formula replenishes Qi and nourishes blood to nourish muscles, strengthens the spleen and kidneys to strengthen the foundation, and also activates blood circulation to aid transportation, resolves turbidity and prevents stagnation. It is nourishing without being greasy, nourishing without being stagnant, and invigorating without being harmful. It can effectively improve the core symptoms of sarcopenia, such as muscle wasting, limb fatigue, soreness of the waist and knees, fatigue, poor appetite, and decreased mobility, and promote the recovery and growth of muscle tissue function.

[0036] In a preferred embodiment, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia root, the cistanche deserticola, the wolfberry, the poria and the hawthorn is (8-18): (4-14): (8-18): (7.5-14): (4-10.5): (8-14): (7-14): (4-10.5). In a preferred embodiment, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia root, the cistanche deserticola, the wolfberry, the poria and the hawthorn is (9-16): (5-13): (9-16): (8-13): (5-10): (11-13): (8-13): (5-10). In a preferred embodiment, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is (10-15): (6-12): (10-15): (9-12): (6-9): about 12: (9-12): (6-9).

[0037] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 12" includes ±5% of 12, or from 11.4 to 12.6.

[0038] In a preferred embodiment, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is about 10: about 6: about 15: about 9: about 9: about 12: about 12: about 9.

[0039] In the present invention, "about" refers to a value within a range of ±5% of a particular value. For example, "about 10" includes ±5% of 10, or from 9.5 to 10.5; "about 6" includes ±5% of 6, or from 5.7 to 6.3; "about 15" includes ±5% of 15, or from 14.25 to 15.75; "about 9" includes ±5% of 9, or from 8.55 to 9.45; "about 12" includes ±5% of 12, or from 11.4 to 12.6.

[0040] In a preferred embodiment, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is about 15: about 6: about 10: about 9: about 9: about 12: about 9: about 6.

[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 6" includes ±5% of 6, or from 5.7 to 6.3; "about 10" includes ±5% of 10, or from 9.5 to 10.5; "about 9" includes ±5% of 9, or from 8.55 to 9.45; "about 12" includes ±5% of 12, or from 11.4 to 12.6.

[0042] In a preferred embodiment, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is about 15: about 12: about 15: about 12: about 6: about 12: about 9: about 9.

[0043] In the present invention, "about" refers to a value within a range of ±5% of a particular 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 6" includes ±5% of 6, or from 5.7 to 6.3; "about 9" includes ±5% of 9, or from 8.55 to 9.45.

[0044] In a preferred embodiment, the mass of the Polygonatum sibiricum is 9 to 16 g, for example, about 10 g or about 15 g.

[0045] 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 15" includes ±5% of 15, or from 14.25 to 15.75.

[0046] In a preferred embodiment, the weight of the angelica is 5 to 13 g, such as about 6 g or about 12 g.

[0047] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 6" includes ±5% of 6, or from 5.7 to 6.3; "about 12" includes ±5% of 12, or from 11.4 to 12.6.

[0048] In a preferred embodiment, the mass of the Codonopsis pilosula is 9-16 g, for example, about 10 g or about 15 g.

[0049] 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 15" includes ±5% of 15, or from 14.25 to 15.75.

[0050] In a preferred embodiment, the mass of the Rehmannia glutinosa is 8-13 g, such as about 9 g or about 12 g.

[0051] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 9" includes ±5% of 9, or from 8.55 to 9.45; "about 12" includes ±5% of 12, or from 11.4 to 12.6.

[0052] In a preferred embodiment, the mass of the Cistanche deserticola is 5-10 g, for example, about 6 g or about 9 g.

[0053] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 6" includes ±5% of 6, or from 5.7 to 6.3; "about 9" includes ±5% of 9, or from 8.55 to 9.45.

[0054] In a preferred embodiment, the mass of the wolfberry is 11-13 g, for example, about 12 g.

[0055] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 12" includes ±5% of 12, or from 11.4 to 12.6.

[0056] In a preferred embodiment, the mass of the Poria cocos is 8 to 13 g, for example, about 9 g or about 12 g.

[0057] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 9" includes ±5% of 9, or from 8.55 to 9.45; "about 12" includes ±5% of 12, or from 11.4 to 12.6.

[0058] In a preferred embodiment, the mass of the hawthorn is 5-10 g, for example, about 6 g or about 9 g.

[0059] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 6" includes ±5% of 6, or from 5.7 to 6.3; "about 9" includes ±5% of 9, or from 8.55 to 9.45.

[0060] According to another aspect of the present invention, there is provided a method for preparing the above-mentioned composition, the preparation method comprising the following steps:

[0061] (1) Weighing appropriate amounts of polygonatum, angelica, codonopsis, rehmannia, cistanche, wolfberry, poria and hawthorn, adding water for the first time, soaking and then heating for extraction, boiling and continuing to boil for a period of time, filtering to obtain a first filtrate and a first medicinal residue; (2) adding water for the second time to the first medicinal residue, heating and extracting, boiling and continuing to boil for a period of time, filtering to obtain a second filtrate; and (3) combining the first filtrate and the second filtrate, concentrating to a concentrated liquid and then drying to obtain the composition.

[0062] In a preferred embodiment, the water is distilled water or ultrapure water.

[0063] In a preferred embodiment, the soaking time is 0.5 to 2 hours.

[0064] In a preferred embodiment, the ratio of the mass of the water added for the first time to the total mass of the polygonatum, angelica, codonopsis, rehmannia, cistanche, wolfberry, poria and hawthorn is 1 to 20, for example, about 10.

[0065] 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.

[0066] In a preferred embodiment, the ratio of the mass of the water in the second addition to the mass of the first medicinal residue or the total mass of the polygonatum, angelica, codonopsis, rehmannia, cistanche, wolfberry, poria and hawthorn is 1 to 20, for example, about 8.

[0067] 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.

[0068] In a preferred embodiment, in step (1), the boiling time is 0.5 to 2 hours, for example, about 1 hour.

[0069] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 1" includes ±5% of 1, or from 0.95 to 1.05.

[0070] In a preferred embodiment, in step (2), the time for continuing to boil after boiling is 0.3 to 1 hour, for example, about 0.5 hour.

[0071] In the present invention, "about" refers to a value within a range of ±5% of a specific value. For example, "about 0.5" includes ±5% of 0.5, or from 0.475 to 0.525.

[0072] In a preferred embodiment, the drying temperature is 50-70°C, such as about 60°C.

[0073] 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.

[0074] According to another aspect of the present invention, a method for preparing the above-mentioned composition is provided, which comprises the following steps: taking appropriate amounts of polygonatum, angelica, codonopsis, rehmannia, cistanche, wolfberry, poria and hawthorn, soaking them in water for 0.5-2 hours, and then decocting them twice in succession, adding water 10 times the total weight of the raw materials and decocting them for the first time, filtering to obtain a first decoction and a residue, adding water 8 times the weight of the residue to the residue and decocting it, filtering and discarding the residue to obtain a second decoction; and finally, combining the filtrates obtained from the two times and concentrating them to obtain a concentrated liquid that is dried to obtain the desired Chinese medicine composition.

[0075] According to another aspect of the present invention, a pharmaceutical preparation is provided, which comprises the above-mentioned composition and one or more pharmaceutically acceptable excipients. In a preferred embodiment, the excipient is selected from one or more of the following: a diluent, a wetting agent, a binder, a disintegrant, an inclusion agent, a flavoring agent, a sustained-release agent, a glidant, a lubricant, a dispersant, a plasticizer, a sunscreen and an antioxidant. In a preferred embodiment, the dosage form of the pharmaceutical preparation is a powder, a tablet, a drop pill, a capsule, a film, a lozenge, a granule, an injection or an oral solution. In a preferred embodiment, the pharmaceutical preparation further comprises one or more other drugs for the prevention and / or treatment of sarcopenia. In a preferred embodiment, the other drugs are selected from one or more of the following: testosterone, a selective androgen receptor modulator, growth hormone, ghrelin and a myostatin inhibitor.

[0076] According to another aspect of the present invention, there is provided a use of the above-mentioned composition or the above-mentioned pharmaceutical preparation in the preparation of a medicament for preventing and / or treating sarcopenia. In a preferred embodiment, the effect of the composition or the preparation in preventing and / or treating sarcopenia is achieved through one or more of the following: increasing the expression level of MyHC gene mRNA, increasing body weight, increasing muscle mass, improving muscle motor function, and improving muscle pathological abnormalities. In a preferred embodiment, the muscle mass includes quadriceps femoris mass, gastrocnemius mass, tibialis anterior mass, extensor digitorum longus mass, and / or soleus mass. In a preferred embodiment, the improvement of muscle motor function includes improved body exercise endurance, improved muscle strength, and / or improved body balance and coordination ability. In a preferred embodiment, the muscle pathological abnormalities include muscle fiber atrophy and / or muscle fibrosis.

[0077] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are intended to illustrate the present invention only and are not intended to limit the scope of the invention. The experimental methods in the following examples, for which specific conditions are not specified, are generally based on conventional conditions or conditions recommended by the manufacturer.

[0078] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those familiar to those skilled in the art. Furthermore, any methods and materials similar or equivalent to those described herein can be applied to the methods of the present invention. The preferred embodiments and materials described herein are for illustrative purposes only.

[0079] The above-mentioned features of the present invention or the features described in the embodiments may be combined in any combination. All features disclosed in this patent specification may be used in any combination, and each feature disclosed in the specification may be replaced by any alternative feature that can provide the same, equal, or similar purpose. Therefore, unless otherwise specified, the features disclosed are only general examples of equal or similar features.

[0080] Example

[0081] Preparation Example

[0082] 1. Experimental reagents

[0083] Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida were purchased from Wangjing Hospital of China Academy of Chinese Medical Sciences. Ultrapure water was used, and all other reagents were of analytical grade.

[0084] 2. Experimental content

[0085] The preparation example of the present invention adopts uniform design experimental scheme to carry out prescription optimization, and with reference to the document "Improved Application of Uniform Design in the Selection of Small Compound Prescriptions of Traditional Chinese Medicine", a uniform design table (as shown in Table 1) is constructed. With eight Chinese medicines in the prescription, including Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos and Crataegus pinnatifida, as investigation factors, each factor is set to 3 different dosage levels (increasing in a gradient). By rationally arranging each medicinal material factor and its dosage level through the uniform design table, 27 groups of Chinese medicine compounds with different combinations are finally constructed for subsequent optimization screening and drug efficacy verification.

[0086] Table 1 Uniform experimental design scheme

[0087]

[0088]

[0089] Preparation Example 1

[0090] The Chinese medicinal materials for the pharmaceutical composition include 5g of polygonatum, 6g of angelica, 5g of codonopsis, 6g of prepared rehmannia, 6g of cistanche, 6g of wolfberry, 9g of poria and 6g of hawthorn, and are decocted in water twice, the first decoction being 1 hour and the second being 0.5 hour from boiling. The mass of water used for the first decoction is 0.49kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.392kg (8 times the mass of the total medicinal materials). The concentrate is concentrated into a concentrate and dried at 60°C to obtain a pharmaceutical composition of group 1.

[0091] Preparation Example 2

[0092] The Chinese medicinal materials for the pharmaceutical composition include 5g of polygonatum, 6g of angelica, 5g of codonopsis, 9g of prepared rehmannia, 9g of cistanche, 12g of wolfberry, 15g of poria and 12g of hawthorn, and are decocted in water twice, the first decoction being 1 hour and the second being 0.5 hour from boiling. The mass of water used for the first decoction is 0.73kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.584kg (8 times the mass of the total medicinal materials). The concentrate is concentrated into a concentrate and dried at 60°C to obtain a pharmaceutical composition of group 2.

[0093] Preparation Example 3

[0094] The Chinese medicinal materials for the pharmaceutical composition include 5g of polygonatum, 6g of angelica, 5g of codonopsis, 12g of prepared rehmannia, 12g of cistanche, 9g of wolfberry, 12g of poria, and 9g of hawthorn. The ingredients are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour, starting from boiling. The mass of water used for the first decoction is 0.7kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.56kg (8 times the mass of the total medicinal materials). The ingredients are concentrated into a concentrate and dried at 60°C to obtain a pharmaceutical composition of group 3.

[0095] Preparation Example 4

[0096] The Chinese medicinal materials for the pharmaceutical composition include 5g of polygonatum, 9g of angelica, 15g of codonopsis, 6g of prepared rehmannia, 12g of cistanche, 12g of wolfberry, 15g of poria, and 9g of hawthorn. The ingredients are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour, starting from boiling. The mass of water used for the first decoction is 0.83kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.664kg (8 times the mass of the total medicinal materials). The ingredients are concentrated into a concentrate and dried at 60°C to obtain a pharmaceutical composition of group 4.

[0097] Preparation Example 5

[0098] The Chinese medicinal materials for the pharmaceutical composition include 5g of polygonatum, 9g of angelica, 15g of codonopsis, 9g of prepared rehmannia, 6g of cistanche, 9g of wolfberry, 12g of poria, and 6g of hawthorn. The materials are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.71kg (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 materials are concentrated into a concentrated liquid and dried at 60°C to obtain a pharmaceutical composition of group 5.

[0099] Preparation Example 6

[0100] The Chinese medicinal materials for the pharmaceutical composition include 5g of polygonatum, 9g of angelica, 15g of codonopsis, 12g of prepared rehmannia, 9g of cistanche, 6g of wolfberry, 9g of poria, and 12g of hawthorn. The materials are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.77kg (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 materials are concentrated into a concentrated liquid and dried at 60°C to obtain a pharmaceutical composition of group 6.

[0101] Preparation Example 7

[0102] The Chinese medicinal materials for the pharmaceutical composition include 5g of polygonatum, 12g of angelica, 10g of codonopsis, 6g of prepared rehmannia, 9g of cistanche, 9g of wolfberry, 12g of poria, and 12g of hawthorn. The materials are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.75kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.6kg (8 times the mass of the total medicinal materials). The materials are concentrated into a concentrated liquid and dried at 60°C to obtain the pharmaceutical composition of group 7.

[0103] Preparation Example 8

[0104] The Chinese medicinal materials for the pharmaceutical composition include 5g of polygonatum, 12g of angelica, 10g of codonopsis, 9g of prepared rehmannia, 12g of cistanche, 6g of wolfberry, 9g of poria, and 9g of hawthorn. The materials are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.72kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.576kg (8 times the mass of the total medicinal materials). The materials are concentrated into a concentrated liquid and dried at 60°C to obtain a pharmaceutical composition of group 8.

[0105] Preparation Example 9

[0106] The Chinese medicinal materials for the pharmaceutical composition include 5g of polygonatum, 12g of angelica, 10g of codonopsis, 12g of prepared rehmannia, 6g of cistanche, 12g of wolfberry, 15g of poria, and 6g of hawthorn. The materials are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.78kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.624kg (8 times the mass of the total medicinal materials). The materials are concentrated into a concentrated liquid and dried at 60°C to obtain the pharmaceutical composition of group 9.

[0107] Preparation Example 10

[0108] The Chinese medicinal materials for the pharmaceutical composition include 10g of polygonatum, 6g of angelica, 15g of codonopsis, 6g of prepared rehmannia, 6g of cistanche, 6g of wolfberry, 15g of poria, and 12g of hawthorn. The materials are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.76kg (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 materials are concentrated into a concentrated liquid and dried at 60°C to obtain a pharmaceutical composition of group 10.

[0109] Preparation Example 11

[0110] The Chinese medicinal materials for the pharmaceutical composition include 10g of polygonatum, 6g of angelica, 15g of codonopsis, 9g of prepared rehmannia, 9g of cistanche, 12g of wolfberry, 12g of poria, and 9g of hawthorn. The materials are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.82kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.656kg (8 times the mass of the total medicinal materials). The materials are concentrated into a concentrated liquid and dried at 60°C to obtain a pharmaceutical composition of group 11.

[0111] Preparation Example 12

[0112] The Chinese medicinal materials for the pharmaceutical composition include 10g of polygonatum, 6g of angelica, 15g of codonopsis, 12g of prepared rehmannia, 12g of cistanche, 9g of wolfberry, 9g of poria, and 6g of hawthorn, and are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.79kg (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 concentrate and dried at 60°C to obtain a pharmaceutical composition of group 12.

[0113] Preparation Example 13

[0114] The Chinese medicinal materials for the pharmaceutical composition include 10g of polygonatum, 9g of angelica, 10g of codonopsis, 6g of prepared rehmannia, 12g of cistanche, 12g of wolfberry, 12g of poria, and 6g of hawthorn, and are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.77kg (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 concentrate and dried at 60°C to obtain a pharmaceutical composition of group 13.

[0115] Preparation Example 14

[0116] The Chinese medicinal materials for the pharmaceutical composition include 10g of polygonatum, 9g of angelica, 10g of codonopsis, 9g of prepared rehmannia, 6g of cistanche, 9g of wolfberry, 9g of poria, and 12g of hawthorn. The materials are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.74kg (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 materials are concentrated into a concentrated liquid and dried at 60°C to obtain a pharmaceutical composition of group 14.

[0117] Preparation Example 15

[0118] The Chinese medicinal materials for the pharmaceutical composition include 10g of polygonatum, 9g of angelica, 10g of codonopsis, 12g of rehmannia, 9g of cistanche, 6g of wolfberry, 15g of poria, and 9g of hawthorn. The materials are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.8kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.64kg (8 times the mass of the total medicinal materials). The materials are concentrated into a concentrated liquid and dried at 60°C to obtain a pharmaceutical composition of group 15.

[0119] Preparation Example 16

[0120] The Chinese medicinal materials for the pharmaceutical composition include 10g of polygonatum, 12g of angelica, 5g of codonopsis, 6g of rehmannia, 9g of cistanche, 9g of wolfberry, 9g of poria, and 9g of hawthorn. The herbs are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.69kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.552kg (8 times the mass of the total medicinal materials). The herbs are concentrated into a concentrated liquid and dried at 60°C to obtain a pharmaceutical composition of group 16.

[0121] Preparation Example 17

[0122] The Chinese medicinal materials for the pharmaceutical composition include 10g of polygonatum, 12g of angelica, 5g of codonopsis, 9g of rehmannia, 12g of cistanche, 6g of wolfberry, 15g of poria, and 6g of hawthorn. The materials are decocted in water twice, with the first decoction taking 1 hour and the second time taking 0.5 hours from boiling. The mass of water used for the first decoction is 0.75kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.6kg (8 times the mass of the total medicinal materials). The materials are concentrated into a concentrated liquid and dried at 60°C to obtain the pharmaceutical composition of group 17.

[0123] Preparation Example 18

[0124] The Chinese medicinal materials for the pharmaceutical composition include 10g of polygonatum, 12g of angelica, 5g of codonopsis, 12g of prepared rehmannia, 6g of cistanche, 12g of wolfberry, 12g of poria, and 12g of hawthorn. The materials are decocted in water twice, with the first decoction taking 1 hour and the second time taking 0.5 hours from boiling. 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 materials are concentrated into a concentrated liquid and dried at 60°C to obtain the pharmaceutical composition of group 18.

[0125] Preparation Example 19

[0126] The Chinese medicinal materials for the pharmaceutical composition include 15g of polygonatum, 6g of angelica, 10g of codonopsis, 6g of prepared rehmannia, 6g of cistanche, 6g of wolfberry, 12g of poria, and 9g of hawthorn. The materials are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.7kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.56kg (8 times the mass of the total medicinal materials). The materials are concentrated into a concentrated liquid and dried at 60°C to obtain a pharmaceutical composition of group 19.

[0127] Preparation Example 20

[0128] The Chinese medicinal materials for the pharmaceutical composition include 15g of polygonatum, 6g of angelica, 10g of codonopsis, 9g of prepared rehmannia, 9g of cistanche, 12g of wolfberry, 9g of poria, and 6g of hawthorn, and are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.76kg (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 concentrate and dried at 60°C to obtain a pharmaceutical composition of group 20.

[0129] Preparation Example 21

[0130] The Chinese medicinal materials for the pharmaceutical composition include 15g of polygonatum, 6g of angelica, 10g of codonopsis, 12g of prepared rehmannia, 12g of cistanche, 9g of wolfberry, 15g of poria, and 12g of hawthorn. The materials are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.91kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.728kg (8 times the mass of the total medicinal materials). The materials are concentrated into a concentrated liquid and dried at 60°C to obtain a pharmaceutical composition of group 21.

[0131] Preparation Example 22

[0132] The Chinese medicinal materials for the pharmaceutical composition include 15g of polygonatum, 9g of angelica, 5g of codonopsis, 6g of rehmannia, 12g of cistanche, 12g of wolfberry, 9g of poria, and 12g of hawthorn. The herbs are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.8kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.64kg (8 times the mass of the total medicinal materials). The herbs are concentrated into a concentrated liquid and dried at 60°C to obtain a pharmaceutical composition of group 22.

[0133] Preparation Example 23

[0134] The Chinese medicinal materials for the pharmaceutical composition include 15g of polygonatum, 9g of angelica, 5g of codonopsis, 9g of prepared rehmannia, 6g of cistanche, 9g of wolfberry, 15g of poria, and 9g of hawthorn. The materials are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.77kg (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 materials are concentrated into a concentrated liquid and dried at 60°C to obtain a pharmaceutical composition of group 23.

[0135] Preparation Example 24

[0136] The Chinese medicinal materials for the pharmaceutical composition include 15g of polygonatum, 9g of angelica, 5g of codonopsis, 12g of rehmannia, 9g of cistanche, 6g of wolfberry, 12g of poria, and 6g of hawthorn, and are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.74kg (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 concentrate and dried at 60°C to obtain a pharmaceutical composition of group 24.

[0137] Preparation Example 25

[0138] The Chinese medicinal materials for the pharmaceutical composition include 15g of polygonatum, 12g of angelica, 15g of codonopsis, 6g of prepared rehmannia, 9g of cistanche, 9g of wolfberry, 15g of poria, and 6g of hawthorn. The materials are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.87kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.696kg (8 times the mass of the total medicinal materials). The materials are concentrated into a concentrated liquid and dried at 60°C to obtain a pharmaceutical composition of group 25.

[0139] Preparation Example 26

[0140] The Chinese medicinal materials for the pharmaceutical composition include 15g of polygonatum, 12g of angelica, 15g of codonopsis, 9g of rehmannia, 12g of cistanche, 6g of wolfberry, 12g of poria, and 12g of hawthorn. The materials are decocted in water twice, with the first decoction taking 1 hour and the second time taking 0.5 hour from the boiling point. The mass of water used for the first decoction is 0.93kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.744kg (8 times the mass of the total medicinal materials). The materials are concentrated into a concentrate and dried at 60°C to obtain a pharmaceutical composition of group 26.

[0141] Preparation Example 27

[0142] The Chinese medicinal materials for the pharmaceutical composition include 15g of polygonatum, 12g of angelica, 15g of codonopsis, 12g of prepared rehmannia, 6g of cistanche, 12g of wolfberry, 9g of poria, and 9g of hawthorn. The materials are decocted in water twice, with the first decoction being 1 hour and the second being 0.5 hour starting from boiling. The mass of water used for the first decoction is 0.9kg (10 times the mass of the total medicinal materials), and the mass of water used for the second decoction is 0.72kg (8 times the mass of the total medicinal materials). The materials are concentrated into a concentrated liquid and dried at 60°C to obtain a pharmaceutical composition of group 27.

[0143] Efficacy Examples

[0144] Pharmacological Example 1

[0145] 1. Experimental Materials

[0146] 1.1 Experimental Animals

[0147] Healthy SPF-grade Sprague-Dawley rats (weighing 200–250 g) were purchased from Spectrum Biotechnology (Beijing) Co., Ltd. Rats were housed in an SPF animal room maintained at a temperature of (24 ± 1)°C, a relative humidity of 50%–70%, and a 12-hour light-dark cycle. All experimental procedures strictly adhered to animal ethics regulations.

[0148] 1.2 Experimental Drugs

[0149] The drugs used in the experiments were the Chinese medicine compositions prepared in Examples 1 to 27, and the Chinese medicinal materials used included: polygonatum, angelica, codonopsis, rehmannia root, cistanche deserticola, wolfberry, tuckahoe and hawthorn.

[0150] 2. Experimental methods

[0151] 2.1 Preparation of drug-containing serum

[0152] SD rats were divided into 28 groups (27 drug-containing serum groups and 5 blank groups, a total of 140 rats). The rats in each drug-containing serum group were gavaged with the Chinese medicine composition of Examples 1-27 corresponding to the human clinical equivalent dose, once a day, for 7 consecutive days. Fasted for 12 hours before the last dose, but not water. Within 0.5 to 3 hours after the last dose, the rats were anesthetized and blood was collected through the abdominal aorta. The collected blood was allowed to stand for 30 minutes and then centrifuged at 3000 rpm for 15 minutes at 4°C to separate the serum. The resulting serum was inactivated in a 56°C water bath for 30 minutes, and stored at -20°C or -80°C after aliquoting to avoid repeated freezing and thawing.

[0153] 2.2 Cell experiments

[0154] A C2C12 mouse skeletal muscle cell line was used as the experimental model. Cells were cultured in complete medium and, after reaching 80% confluency, replaced with 2% horse serum differentiation medium. After 5 days of differentiation induction, cells were treated with D-galactose (20 g / L) combined with medicated serum for 48 hours. A model group, a blank serum group, and 27 medicated serum-treated groups were established.

[0155] 2.3、Indicator detection

[0156] After treatment, the expression level of the muscle marker gene (MyHC) was assessed by real-time fluorescence quantitative PCR. Total RNA was extracted using the Trizol method, and the purity (A260 / A280 = 1.8-2.1) and concentration were determined. cDNA was synthesized using a kit. The upstream primer sequence for the MyHC gene was 5'-ATGGAGGAGGAGGAGGAGGA-3', and the downstream primer sequence was 5'-TCAGCTGCTGCTGCTGCTGC-3'. The upstream primer sequence for the internal reference gene β-actin was 5'-CTGAACGTGAAATTGTCCGAGA-3', and the downstream primer sequence was 5'-TTGCCAATGGTGATGACCTG-3'. The reaction system consisted of 20 μL (2 μL cDNA, 0.5 μM each of the upstream and downstream primers, and 10 μL SYBR Green Mix). The reaction procedure was as follows: initial denaturation at 95°C for 5 min, followed by 40 cycles of 95°C for 10 sec, 58°C for 20 sec, and 72°C for 20 sec. Data calculation: using 2 -ΔΔCt The relative expression of MyHC mRNA was analyzed by the method (with β-actin as the internal reference).

[0157] 2.4 Statistical Analysis

[0158] Experimental data were statistically analyzed using SPSS 26.0 software. Measurement data are presented as mean ± standard deviation (mean ± SD). Inter-group comparisons were performed using one-way ANOVA. P < 0.05 indicated statistically significant differences.

[0159] 3. Experimental results

[0160] Real-time fluorescence quantitative PCR was used to measure MyHC mRNA expression in C2C12 cells. The effects of different Chinese herbal medicine combinations (Groups 1–27) on MyHC mRNA expression were analyzed. The results are shown in the figure. Significant differences between combinations 1–27 and the model group are marked with an asterisk (*), *P < 0.05, ***P < 0.001.

[0161] The experimental results showed that compared with the model group, groups 11, 20 and 27 showed a significant increase in MyHC expression levels, and the drug combination in group 20 had the best therapeutic effect. This suggests that the above three Chinese medicine compositions may have potential advantages in promoting the expression of muscle differentiation marker genes and deserve further study. The remaining combinations did not show a significant promoting effect, and some combinations even showed expression levels lower than the model group, indicating that different drug combinations have significant differences in the regulatory effects of MyHC expression. Figure 1 shown.

[0162] Pharmacological Example 2

[0163] The efficacy of the pharmaceutical composition of Group 20 in treating sarcopenia was further verified by using the composite model and evaluation indicators of the Preparation Example and the Efficacy Example 1.

[0164] 1. Experimental Materials

[0165] 1.1 Experimental Animals

[0166] Six-month-old male SAMP8 mice were selected as model animals, and SAMR1 mice were used as negative control animals, purchased from Sibeifu (Beijing) Biotechnology Co., Ltd. All mice were housed in single cages in a constant temperature and humidity animal room with a temperature controlled at (24±1)°C, a relative humidity of 50% to 70%, and a light-dark cycle of 12 hours. Mice were free to eat standard feed and drink water. All experimental operations strictly complied with animal ethics regulations. Referring to previous studies, SAMP8 mice entered the pre-sarcopenia stage at 8 months of age and showed a typical sarcopenia state at 10 months of age. Therefore, during the experiment, SAMP8 mice were raised to 8 months of age before intervention.

[0167] 1.2 Experimental Drugs

[0168] The traditional Chinese medicine composition in Group 20 consisted of the extract powder obtained in the aforementioned preparation example. The equivalent human dose, calculated based on body surface area, was divided into three dose groups: low-dose (4.94 g / kg), medium-dose (9.88 g / kg), and high-dose (19.76 g / kg). The drug was dissolved in ultrapure water and administered by gavage. The control and model groups received equal volumes of distilled water.

[0169] 1.3 Experimental Grouping

[0170] A total of 32 8-month-old SAMP8 mice were randomly divided into the model group, low-dose group, medium-dose group, and high-dose group, with 8 mice in each group. Eight SAMR1 mice of the same age were also selected as the negative control group. Mice in each group were administered once daily by gavage for 8 consecutive weeks. The gavage volume was uniformly 0.1 mL / 10 g body weight.

[0171] 2. Experimental methods

[0172] 2.1. Weight Monitoring

[0173] The body weight of mice was recorded weekly during the intervention period.

[0174] 2.2 Muscle mass detection

[0175] After 8 weeks of intervention, the mice were killed, and the quadriceps femoris, gastrocnemius, tibialis anterior, extensor digitorum longus, and soleus muscles were dissected and weighed. The skeletal muscle mass index (i.e., the ratio of skeletal muscle mass to body weight) was calculated to evaluate the changes in total skeletal muscle mass.

[0176] 2.3 Mouse muscle function test

[0177] 2.3.1. Grip test

[0178] A mouse grip strength meter (Jiangsu Saiangsi Biotechnology Co., Ltd.) was used to record the maximum grip force (unit: N) during the process of gently pulling the mouse's tail until the claw was released. Each mouse was tested three times, and the average value was taken and normalized according to body weight.

[0179] 2.3.2 Running to exhaustion experiment

[0180] Testing was performed after three days of training and adaptation. A motorized treadmill (Anhui Zhenghua Biological Instrument Equipment Co., Ltd.) was used, with an initial speed of 10 m / min. After two minutes of running, the speed was increased by 2 m / min every two minutes, ultimately reaching 20 m / min. Mice were considered exhausted when they remained in the tail shock zone for 10 consecutive seconds and stopped running. Total running time and distance were recorded.

[0181] 2.3.3 Rotarod test

[0182] After three days of training and adaptation, formal testing was performed. A rotarod (Anhui Zhenghua Biological Instrument Equipment Co., Ltd.) was used, with the rotation speed gradually increased from 4 rpm to 40 rpm and maintained. The time each mouse spent on the rotarod and the rotation speed at the time of falling were recorded.

[0183] 2.3.4 Suspension experiment

[0184] The mice were placed in the center of an inverted wire grid (Shanghai Yuyan Scientific Instrument Co., Ltd.), and the time from the start of hanging to the fall was recorded, and the "hanging index" normalized to body weight was used as an indicator.

[0185] 2.4 Histological Analysis

[0186] After killing mice, gastrocnemius muscles were obtained, fixed with muscle fixative, embedded in paraffin, and sectioned. Muscle fiber morphology was observed under a microscope, and the cross-sectional area (CSA) and collagen fiber volume fraction were determined using ImageJ image analysis software.

[0187] 2.5 Statistical Methods

[0188] Experimental data were statistically analyzed using SPSS 26.0 software. Measurement data are presented as mean ± standard deviation (mean ± SD). Inter-group comparisons were performed using one-way ANOVA. P < 0.05 indicated statistically significant differences.

[0189] 3. Experimental results

[0190] 3.1. Changes in mouse body weight

[0191] The results are as follows Figure 2 As shown in the figure, before the intervention, there was no statistical difference in the body weight of SAMP8 mice in each group, indicating that the experimental system was stable and reliable, and the groups were comparable. During the experiment, the body weight of mice in the model group continued to decrease, showing typical signs of sarcopenia. The body weight of mice in the control group increased slightly in the early stage and tended to stabilize in the later stage. In the drug intervention group, the body weight of mice in the high-dose group gradually increased, and was significantly higher than that of the model group by the 8th week; although the low and medium-dose groups also showed an upward trend, the difference was not statistically significant. There was a significant difference in body weight between the negative control group and the model group. The above results indicate that the drug composition of Group 20 can effectively slow down the weight loss of sarcopenic mice under high-dose intervention conditions and improve their overall nutritional and physiological status.

[0192] 3.2 Skeletal muscle mass

[0193] The results are as follows Figure 3 、 Figure 4As shown in the results, after 8 weeks of intervention, the muscle mass of mice in various skeletal muscles (quadriceps femoris, gastrocnemius, tibialis anterior, extensor digitorum longus, and soleus) showed significant differences. Among them, the mass of the five muscles of mice in the model group was lower than that in the control group, and the difference was significant, indicating that the sarcopenia model was successfully established. Compared with the model group, the low, medium, and high-dose groups showed statistical differences in the quadriceps femoris and tibialis anterior muscles; significant increases were also observed in the gastrocnemius, extensor digitorum longus, and soleus muscles in the high-dose group. The above results suggest that the pharmaceutical composition of Group 20 has a good muscle-building effect, showing potential application value in intervening in the process of sarcopenia.

[0194] 3.3 Muscle Function

[0195] The results are as follows Figure 5 As shown in the results of the grip strength test, the grip strength of mice in the medium and high dose groups was significantly better than that of the model group. After further standardization by body weight (grip strength index), the grip strength index of the medium and high dose groups was also significantly higher than that of the model group, indicating that the pharmaceutical composition of Group 20 has a good effect in improving muscle strength. Figure 6 As shown in the figure, the mice's exercise endurance performance was evaluated by exhaustive running test. After 8 weeks of intervention, compared with the model group, the running distance and running time before exhaustion of mice in the medium-dose group and the high-dose group were significantly prolonged, and the difference was statistically significant, suggesting that the drug composition has the effect of improving exercise endurance. Figure 7 As shown in the rotarod test, the high-dose group had significantly higher rotarod residence time and maximum rotarod speed than the model group, indicating that it has a positive effect on improving coordination and balance ability. Figure 8 As shown, in the grid suspension test, the raw hanging time values did not show statistical differences between the groups. However, after weight normalization, the hanging time of the medium-dose and high-dose groups was significantly better than that of the model group, further supporting the potential effect of the drug composition in combating myasthenia gravis. In summary, the drug composition in Group 20 showed significant improvement trends in multiple functional indicators, especially in improving exercise endurance, muscle strength, and balance and coordination.

[0196] 3.4 Histological Analysis

[0197] HE staining was used to observe changes in muscle tissue structure and to determine the cross-sectional area (CSA) of muscle fibers (results are shown in Figure 9After 8 weeks of intervention, the cross-sectional area of muscle fibers in the low-, medium-, and high-dose groups of mice increased significantly compared with the model group, indicating that the drug composition of Group 20 can effectively slow down muscle fiber atrophy and improve muscle structure. Masson staining results showed that the volume fraction of collagen fibers in the muscles of mice in the medium- and high-dose groups was significantly reduced compared with the model group, indicating that the degree of fibrosis was reduced and the muscle tissue structure was significantly repaired. Although there was a certain improvement trend in the low-dose group, the difference was not statistically significant (results as shown). Figure 10 The above results indicate that the pharmaceutical composition of Group 20 can significantly improve muscle atrophy and fibrosis at the tissue morphology level, further verifying its tissue protective effect against sarcopenia.

[0198] 4. Experimental Summary

[0199] In summary, there is currently a lack of systematic and effective Traditional Chinese Medicine intervention options for sarcopenia in the elderly. Based on the TCM pathogenesis of "spleen and kidney deficiency, insufficient Qi and blood," and combining years of clinical experience with modern research findings, the inventors have innovatively proposed a treatment strategy of "tonifying Qi and blood, strengthening the spleen and kidneys," and have developed a traditional Chinese medicine compound, the Huangjing Yangji Recipe, with Polygonatum sibiricum as the main ingredient. This formula features rigorous compatibility, clear distinctions between the main, secondary, and adjuvant ingredients, consistent drug-indication relationships, and synergistic dosages, forming a scientifically sound intervention system that provides a systematic solution to the causes and manifestations of sarcopenia.

[0200] The present invention screened for the optimal drug combination using a uniform design method and systematically validated its efficacy using in vitro cell models and an in vivo SAMP8 mouse model. The results showed that the drug combination effectively improved muscle strength, muscle mass, exercise endurance, grip strength, and coordination in model animals, as well as muscle structure and fibrosis, demonstrating promising anti-sarcopenia effects and promising clinical application prospects.

[0201] This invention not only establishes a clear pharmacological mechanism basis, but also integrates traditional prescription wisdom with modern experimental methods, providing a repeatable, evaluable and popularizable technical solution for traditional Chinese medicine intervention in sarcopenia in the elderly.

[0202] The embodiments of the present invention are described in detail above. Specific examples are used herein to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only intended to help understand the method of the present invention and its core concept. At the same time, changes or modifications made by those skilled in the art based on the concept of the present invention, the specific implementation methods of the present invention, and the scope of application are all within the scope of protection of the present invention. In summary, the contents of this specification should not be understood as limiting the present invention.

Claims

1. A composition comprising Polygonatum sibiricum for preventing and / or treating sarcopenia, characterized in that: The composition comprises polygonatum, angelica, codonopsis, rehmannia, cistanche, wolfberry, tuckahoe and hawthorn; The mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is (6-20): (3-15): (6-20): (7-15): (3-11): (10-15): (6-14): (3-11).

2. The composition according to claim 1, characterized in that The mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is (8-18): (4-14): (8-18): (7.5-14): (4-10.5): (8-14): (7-14): (4-10.5); Preferably, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is (9-16): (5-13): (9-16): (8-13): (5-10): (11-13): (8-13): (5-10); Preferably, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is (10-15): (6-12): (10-15): (9-12): (6-9): about 12: (9-12): (6-9).

3. The composition according to claim 2, characterized in that The mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is about 10: about 6: about 15: about 9: about 9: about 12: about 12: about 9; Preferably, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is about 15: about 6: about 10: about 9: about 9: about 12: about 9: about 6; Preferably, the mass ratio of the polygonatum, the angelica, the codonopsis, the rehmannia, the cistanche, the wolfberry, the poria and the hawthorn is about 15: about 12: about 15: about 12: about 6: about 12: about 9: about 9; More preferably, the mass of the Polygonatum sibiricum is 9 to 16 g, for example, about 10 g or about 15 g; More preferably, the mass of the angelica is 5 to 13 g, such as about 6 g or about 12 g; More preferably, the mass of the Codonopsis pilosula is 9 to 16 g, such as about 10 g or about 15 g; More preferably, the mass of the cooked rehmannia root is 8 to 13 g, such as about 9 g or about 12 g; More preferably, the mass of the Cistanche deserticola is 5 to 10 g, for example, about 6 g or about 9 g; More preferably, the mass of the wolfberry is 11 to 13 g, for example about 12 g; More preferably, the mass of the Poria cocos is 8 to 13 g, such as about 9 g or about 12 g; More preferably, the mass of the hawthorn is 5-10 g, such as about 6 g or about 9 g.

4. A method for preparing the composition according to any one of claims 1 to 3, characterized in that: The preparation method comprises the following steps: (1) Weigh appropriate amounts of Polygonatum sibiricum, Angelica sinensis, Codonopsis pilosula, Rehmannia glutinosa, Cistanche deserticola, Lycium barbarum, Poria cocos, and Crataegus pinnatifida, add water for the first time, soak, heat and extract, continue to boil for a period of time, filter, and obtain a first filtrate and a first medicinal residue; (2) adding water to the first medicinal residue for a second time, heating and extracting, continuing to boil for a period of time after boiling, and filtering to obtain a second filtrate; 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.

5. The preparation method according to claim 4, characterized in that The water is distilled water or ultrapure water; Preferably, the soaking time is 0.5 to 2 hours; Preferably, the ratio between the mass of the water added for the first time and the total mass of the polygonatum, angelica, codonopsis, rehmannia, cistanche, wolfberry, poria and hawthorn is 1 to 20, for example, about 10; Preferably, the ratio of the mass of the water in the second addition of water to the mass of the first medicinal residue or the total mass of the polygonatum, angelica, codonopsis, rehmannia, cistanche, wolfberry, poria and hawthorn is 1 to 20, for example, about 8; Preferably, in step (1), the time of continuing to boil after boiling is 0.5 to 2 hours, for example, about 1 hour; Preferably, in step (2), the time of continuing to boil after boiling is 0.3 to 1 hour, for example, about 0.5 hour; More preferably, the drying temperature is 50-70°C, such as about 60°C.

6. A pharmaceutical preparation, characterized in that The pharmaceutical preparation comprises the composition according to any one of claims 1 to 3, and one or more pharmaceutically acceptable excipients.

7. The pharmaceutical preparation according to claim 6, characterized in that The excipients are 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; Preferably, the dosage form of the pharmaceutical preparation is powder, tablet, pill, capsule, film, lozenge, granule, injection or oral solution; More preferably, the pharmaceutical preparation further comprises one or more other drugs for preventing and / or treating sarcopenia; Still preferably, the other drugs are selected from one or more of the following: testosterone, selective androgen receptor modulators, growth hormone, ghrelin and myostatin inhibitors.

8. Use of the composition according to any one of claims 1 to 3 or the pharmaceutical preparation according to claim 6 or 7 in the preparation of a medicament for preventing and / or treating sarcopenia.

9. The use according to claim 8, characterized in that The composition or the preparation prevents and / or treats sarcopenia in one or more of the following ways: increasing the expression level of MyHC gene mRNA, increasing body weight, increasing muscle mass, improving muscle motor function, and improving muscle pathological abnormalities.

10. The use according to claim 9, characterized in that The muscle mass includes quadriceps femoris mass, gastrocnemius mass, tibialis anterior mass, extensor digitorum longus mass and / or soleus mass; Preferably, the improvement of muscle motor function includes improving the body's exercise endurance, improving muscle strength and / or improving the body's balance and coordination ability; Preferably, the muscle pathological abnormality includes muscle fiber atrophy and / or muscle fibrosis.

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