A medicinal composition for relieving physical fatigue, a capsule thereof, and a preparation method thereof

Abstract

This invention provides a pharmaceutical composition, capsules, and preparation method for relieving physical fatigue, belonging to the field of pharmaceutical technology. The pharmaceutical composition of this invention includes extracts of Lycium barbarum, Cuscuta chinensis, Raspberry, Schisandra chinensis, and Astragalus complanatus. The formulation of each component is scientifically sound, with significant synergistic effects, and can quickly replenish the energy substances consumed during physical activity. This invention further provides capsules for relieving physical fatigue, which have high bioavailability, are safe with no side effects, are suitable for a wide range of people, and will not cause dependence with long-term use, showing broad market prospects.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to a pharmaceutical composition, capsule, and preparation method for relieving physical fatigue. Background Technology

[0002] With the fast pace of modern life, physical exhaustion caused by high-intensity physical labor, prolonged exercise, and daily work pressure has become a widespread social phenomenon, seriously affecting people's quality of life and work efficiency. The essence of physical fatigue is that during sustained high-intensity physical activity, excessive contraction of skeletal muscles leads to a large consumption of energy substances, and the accumulation of metabolic products (fatigue toxins) such as lactic acid and carbon dioxide in the body, resulting in discomfort symptoms such as muscle soreness and decreased physical strength. Long-term chronic fatigue can also lead to endocrine disorders, decreased immunity, and increased risk of disease infection. Therefore, developing safe and effective products to alleviate physical fatigue has significant practical importance and broad market prospects.

[0003] Currently, products on the market that relieve physical fatigue mainly include health foods and drugs. Their core ingredients are mostly traditional Chinese medicinal herbs (such as ginseng, astragalus, and maca), B vitamins, taurine, and amino acids. Dosage forms include oral liquids, tablets, capsules, and functional beverages. Among these, capsules are a mainstream dosage form due to their portability, ease of use, and precise dosage, making them more suitable for the needs of professionals and athletes in high-frequency mobile scenarios. However, existing products still have many shortcomings: First, some products use stimulants such as caffeine, which, while providing a quick energy boost, can easily cause side effects such as palpitations and insomnia. Long-term use may also lead to dependence, failing to achieve true physical recovery. Second, traditional herbal products are mostly single-ingredient or simply formulated, with limited efficacy targets and slow onset of action, making it difficult to meet the need for immediate relief of physical fatigue. Third, some compound formulations are unreasonable, with poor synergistic effects between components, low bioavailability, and insufficient long-term effectiveness in relieving fatigue. Therefore, developing a product that relieves physical fatigue with a scientifically formulated recipe, significant synergistic effects of its ingredients, high bioavailability, and both immediate relief and long-lasting maintenance, while being safe and without side effects, remains a technical problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0004] In order to solve the problems existing in the prior art, the first objective of the present invention is to provide a pharmaceutical composition for relieving physical fatigue.

[0005] A second object of the present invention is to provide the use of the above-described pharmaceutical composition in the preparation of products for relieving physical fatigue.

[0006] The third objective of this invention is to provide a capsule for relieving physical fatigue and a method for preparing the same.

[0007] To achieve the above-mentioned objectives, the present invention provides the following technical solution: The present invention provides a pharmaceutical composition for relieving physical fatigue, comprising the following components by mass parts: 100-140 parts of wolfberry extract, 40-60 parts of dodder seed extract, 40-60 parts of raspberry extract, 40-60 parts of schisandra seed extract, and 70-90 parts of astragalus seed extract.

[0008] Preferably, the preparation method of the wolfberry extract, dodder seed extract, raspberry extract or schisandra extract includes the following steps: extracting the raw materials with water, concentrating the extract, drying and pulverizing it to obtain the extract.

[0009] Preferably, the method for extracting the raw material with water includes: adding 9-11 times the mass of water to the raw material, extracting at 95-100℃ for 1-2 hours, filtering to obtain filtrate 1 and filter residue 1; adding 5-7 times the mass of water to filter residue 1, extracting at 95-100℃ for 1-2 hours, filtering to obtain filtrate 2 and filter residue 2; adding 4-6 times the mass of water to filter residue 2, extracting at 95-100℃ for 1-2 hours, filtering to obtain filtrate 3; and combining filtrate 1, filtrate 2, and filtrate 3 to obtain the extract.

[0010] Preferably, the preparation method of the Astragalus complanatus extract includes the following steps: extracting the raw material with 60% ethanol solution, concentrating, drying, and pulverizing the extract to obtain the extract.

[0011] Preferably, the method for extracting the raw material with 60% ethanol solution includes: adding 6-8 times the mass of 60% ethanol solution to the raw material, extracting at 75-85℃ for 1-2 hours, filtering to obtain filtrate 1 and filter residue 1; adding 4-6 times the mass of 60% ethanol solution to filter residue 1, extracting at 75-85℃ for 1-2 hours, filtering to obtain filtrate 2 and filter residue 2; adding 3-5 times the mass of 60% ethanol solution to filter residue 2, extracting at 75-85℃ for 1-2 hours, filtering to obtain filtrate 3; combining filtrate 1, filtrate 2 and filtrate 3 to obtain the extract.

[0012] Preferably, the concentration is vacuum concentration, with a concentration temperature of 70~80℃ and a vacuum degree of -0.02~-0.06Mpa.

[0013] Preferably, the drying is spray drying, with an inlet air temperature of 130~160℃ and an outlet air temperature of 60~90℃.

[0014] The present invention also provides the use of the above-described pharmaceutical composition in the preparation of products for relieving physical fatigue, said products including health products and pharmaceuticals.

[0015] The present invention also provides a capsule for relieving physical fatigue, comprising the aforementioned pharmaceutical composition and excipients; the excipients include fillers, disintegrants, and lubricants.

[0016] The present invention also provides a method for preparing the above-mentioned capsules, comprising the following steps: The extracts of wolfberry, dodder seed, raspberry, schisandra fruit, and astragalus seed, along with fillers and disintegrants, are mixed and mixed with 85% ethanol solution to form a soft mass. The mass is then granulated through a 16-mesh sieve, dried at 55-60°C, sized through a 14-mesh sieve, mixed with a lubricant, and filled into capsules.

[0017] Compared with the prior art, the beneficial effects of the technical solution of the present invention are as follows: The pharmaceutical composition of this invention has a scientific and rational formulation with significant synergistic effects. By accurately screening active ingredients and optimizing the ratio, the components form a complementary and synergistic mechanism of action. It can not only quickly replenish the energy substances consumed in the human body during physical activities, but also accelerate the clearance of fatigue metabolic products such as lactic acid and carbon dioxide. At the same time, it can regulate the body's energy metabolism pathway and promote mitochondrial function repair. It works simultaneously from the three core links of "replenishment-clearance-repair", effectively solving the defects of existing products with limited efficacy targets of single ingredients and poor synergistic effects, and greatly improving the overall efficacy of relieving physical fatigue.

[0018] The capsule dosage form of this invention has strong adaptability and high bioavailability. The capsule dosage form not only possesses the basic advantages of being convenient to carry, easy to take, and precise in dosage, but also effectively protects the stability of the active ingredients in the composition, preventing their destruction in the stomach. Simultaneously, the capsule can rapidly dissolve and release the active ingredients in the intestine, improving the absorption efficiency and bioavailability of the ingredients, thus solving the problems of poor stability, uneven release rate, and low bioavailability of some existing formulations.

[0019] The pharmaceutical composition and capsules of this invention are safe and have no side effects, and are suitable for a wide range of people. The active ingredients all meet pharmaceutical or food standards, avoiding the addition of stimulating ingredients such as caffeine in existing products. They have no obvious toxic side effects and will not cause dependence with long-term use. Combined with the mild release characteristics of the capsule dosage form, they are suitable for various groups that need to relieve physical fatigue, such as people who are physically exhausted in the workplace, sports enthusiasts, and middle-aged and elderly people with weak constitutions. They have a wide range of applications and broad market prospects. Detailed Implementation

[0020] This invention provides a pharmaceutical composition for relieving physical fatigue, comprising, by weight parts: 100-140 parts of Lycium barbarum extract, 40-60 parts of Cuscuta chinensis extract, 40-60 parts of Rubus idaeus extract, 40-60 parts of Schisandra chinensis extract, and 70-90 parts of Astragalus complanatus extract. Preferably, it comprises: 110-130 parts of Lycium barbarum extract, 45-55 parts of Cuscuta chinensis extract, 45-55 parts of Rubus idaeus extract, 45-55 parts of Schisandra chinensis extract, and 75-85 parts of Astragalus complanatus extract. More preferably, it comprises: 120 parts of Lycium barbarum extract, 50 parts of Cuscuta chinensis extract, 50 parts of Rubus idaeus extract, 50 parts of Schisandra chinensis extract, and 80 parts of Astragalus complanatus extract. The pharmaceutical composition of the present invention is rich in active ingredients such as crude polysaccharides, total flavonoids, and schisandrol A. The components form a complementary and synergistic mechanism of action, which can not only quickly replenish the energy substances consumed in the human body during physical activities, but also accelerate the clearance of fatigue metabolic products such as lactic acid and carbon dioxide, regulate the body's energy metabolism pathways, and relieve physical fatigue.

[0021] In this invention, the extracts of wolfberry, dodder seed, raspberry, and schisandra are all water extracts. The preparation method of the wolfberry extract includes the following steps: extracting the raw material (wolfberry) with water, concentrating the extract, drying, and pulverizing to obtain the extract. The preparation method of the dodder seed extract includes the following steps: extracting the raw material (dodder seed) with water, concentrating the extract, drying, and pulverizing to obtain the extract. The preparation method of the raspberry extract includes the following steps: extracting the raw material (raspberry) with water, concentrating the extract, drying, and pulverizing to obtain the extract. The preparation method of the schisandra extract includes the following steps: extracting the raw material (schisandra fruit) with water, concentrating the extract, drying, and pulverizing to obtain the extract.

[0022] In this invention, the method for extracting the raw materials with water includes: adding 9-11 times the mass of water to the raw materials, extracting at 95-100℃ for 1-2 hours, filtering to obtain filtrate 1 and filter residue 1; adding 5-7 times the mass of water to filter residue 1, extracting at 95-100℃ for 1-2 hours, filtering to obtain filtrate 2 and filter residue 2; adding 4-6 times the mass of water to filter residue 2, extracting at 95-100℃ for 1-2 hours, filtering to obtain filtrate 3; combining filtrate 1, filtrate 2, and filtrate 3 to obtain the extract. Preferably, 10 times the mass of water is added to the raw materials; preferably 6 times the mass of water is added to filter residue 1; preferably 5 times the mass of water is added to filter residue 2; the extraction time is preferably 1.5 hours. After adding water, the raw materials are preferably soaked at room temperature (15-30℃) for 20-40 minutes before heating and extraction, and the soaking time is preferably 30 minutes.

[0023] In this invention, the preparation method of the Astragalus complanatus extract includes the following steps: extracting the raw material (Astragalus complanatus) with a 60% ethanol solution; concentrating, drying, and pulverizing the extract to obtain the extract. The method of extracting the raw material with a 60% ethanol solution in this invention includes: adding 6-8 times the mass of 60% ethanol solution to the raw material, extracting at 75-85℃ for 1-2 hours, filtering to obtain filtrate 1 and residue 1; adding 4-6 times the mass of 60% ethanol solution to residue 1, extracting at 75-85℃ for 1-2 hours, filtering to obtain filtrate 2 and residue 2; adding 3-5 times the mass of 60% ethanol solution to residue 2, extracting at 75-85℃ for 1-2 hours, filtering to obtain filtrate 3; combining filtrate 1, filtrate 2, and filtrate 3 to obtain the extract. The raw material preferably contains 7 times its mass of 60% ethanol solution; the filter residue 1 preferably contains 5 times its mass of 60% ethanol solution; the filter residue 2 preferably contains 4 times its mass of 60% ethanol solution; the extraction temperature is preferably 80℃, and the extraction time is preferably 1.5h. After adding 60% ethanol solution to the raw material, it is preferably soaked at room temperature (15~30℃) for 20~40min before heating extraction, and the soaking time is preferably 30min.

[0024] In this invention, the concentration of the extract is preferably carried out under reduced pressure, with a concentration temperature of 70-80℃, preferably 71℃, 72℃, 73℃, 74℃, 75℃, 76℃, 77℃, 78℃, or 79℃, and a vacuum degree of -0.02 to -0.06 MPa, preferably -0.03 to -0.05 MPa, and more preferably -0.04 MPa. The extracts of Lycium barbarum, Cuscuta chinensis, Raspberry, and Schisandra chinensis are preferably concentrated under reduced pressure to a specific gravity of 1.08-1.10; the extract of Astragalus complanatus is preferably concentrated under reduced pressure to a specific gravity of 1.10-1.20.

[0025] In this invention, the drying is preferably spray drying, with an inlet air temperature of 130~160℃, preferably 140~150℃, and an outlet air temperature of 60~90℃, preferably 70~80℃.

[0026] In this invention, the pulverization is preferably performed by passing the powder through an 80-mesh sieve. Alternatively, after drying, the powder is pulverized using a stainless steel pulverizer, and then passed through an 80-mesh vibrating sieve.

[0027] The present invention also provides the use of the above-described pharmaceutical composition in the preparation of products for relieving physical fatigue, said products including health products and pharmaceuticals.

[0028] The present invention also provides a capsule for relieving physical fatigue, comprising the aforementioned pharmaceutical composition and excipients; the excipients include a filler, a disintegrant, and a lubricant. The filler preferably comprises microcrystalline cellulose and lactose, the disintegrant is preferably CMS-Na, and the lubricant is preferably magnesium stearate. By mass parts, the pharmaceutical composition, filler, disintegrant, and lubricant of the present invention are preferably (45~55):(35~45):(3~5):(0.4~0.6), more preferably 50:40:4:0.5; the filler may be composed of microcrystalline cellulose and lactose in an equal mass ratio.

[0029] This invention also provides a method for preparing the above-mentioned capsules, comprising the following steps: mixing wolfberry extract, dodder seed extract, raspberry extract, schisandra seed extract, astragalus seed extract, filler, and disintegrant; adding 85% ethanol solution to form a soft mass; granulating through a 16-mesh sieve; drying at 55-60℃; sizing through a 14-mesh sieve; mixing with a lubricant; and filling the capsules. The capsule shell of this invention can be either a gelatin capsule shell or a plant-based capsule shell.

[0030] The capsules described in this invention are suitable for those prone to fatigue (excluding children, pregnant women, and breastfeeding mothers) and can relieve physical fatigue. As an optional implementation, the capsules are 0.4g each, stored in a cool, dry place, and taken orally twice daily, two capsules each time.

[0031] The technical solutions of this invention will be clearly and completely described below with reference to the embodiments thereof. Obviously, the described embodiments are only a part of the embodiments of this invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0032] Unless otherwise specified, the following embodiments are all conventional methods.

[0033] Unless otherwise specified, all materials and reagents used in the following examples are commercially available.

[0034] Example 1 A pharmaceutical composition for relieving physical fatigue comprises, by weight parts: 100 parts of wolfberry extract, 40 parts of dodder seed extract, 40 parts of raspberry extract, 40 parts of schisandra seed extract, and 70 parts of astragalus seed extract.

[0035] Preparation method of wolfberry extract: Add 10 times the mass of water to wolfberries, soak at room temperature (20℃) for 30 min, extract at 95℃ for 1.5 h, filter to obtain filtrate 1 and residue 1; add 6 times the mass of water to residue 1, extract at 95℃ for 1.5 h, filter to obtain filtrate 2 and residue 2; add 5 times the mass of water to residue 2, extract at 95℃ for 1.5 h, filter to obtain filtrate 3; combine filtrate 1, filtrate 2, and filtrate 3 to obtain the extract. Concentrate the extract under reduced pressure at 75℃ and a vacuum degree of -0.05 MPa until the specific gravity is 1.08. Then, homogenize the extract through a homogenizer, and then spray dry it through an atomizer into a spray drying tower. The inlet temperature of the drying tower is controlled at 150℃, and the outlet temperature is controlled at 80℃. After drying and powder collection, transfer the powder to a pulverizing chamber. The dried crude product is pulverized using a stainless steel pulverizer and passed through an 80-mesh vibrating sieve to obtain the wolfberry extract.

[0036] Preparation method of Cuscuta chinensis extract: Cuscuta chinensis was soaked in 10 times its weight of water at room temperature (20℃) for 30 min, then extracted at 95℃ for 1.5 h. The extract was filtered to obtain filtrate 1 and residue 1. Residue 1 was then soaked in 6 times its weight of water at 95℃ for 1.5 h, and filtered to obtain filtrate 2 and residue 2. Residue 2 was then soaked in 5 times its weight of water at 95℃ for 1.5 h, and filtered to obtain filtrate 3. Filtrates 1, 2, and 3 were combined to obtain the extract. The extract was concentrated under reduced pressure at 75℃ and a vacuum degree of -0.04 MPa until the specific gravity reached 1.08. The concentrate was then homogenized in a homogenizer via a feed pipe, and then atomized into a spray drying tower. The inlet temperature of the drying tower was controlled at 150℃, and the outlet temperature was controlled at 80℃. After drying and powdering, the product is transferred to a pulverizing chamber. The dried crude product is pulverized using a stainless steel pulverizer and passed through an 80-mesh vibrating sieve to obtain dodder extract.

[0037] Preparation method of raspberry extract: Add 10 times the mass of water to raspberries, soak at room temperature (20℃) for 30 min, extract at 95℃ for 1.5 h, filter to obtain filtrate 1 and residue 1; add 6 times the mass of water to residue 1, extract at 95℃ for 1.5 h, filter to obtain filtrate 2 and residue 2; add 5 times the mass of water to residue 2, extract at 95℃ for 1.5 h, filter to obtain filtrate 3; combine filtrate 1, filtrate 2 and filtrate 3 to obtain the extract. Concentrate the extract under reduced pressure at 75℃ and a vacuum degree of -0.06 MPa until the specific gravity is 1.09. Then, homogenize the extract through a homogenizer, and then spray dry it through an atomizer into a spray drying tower. The inlet temperature of the drying tower is controlled at 130℃ and the outlet temperature is controlled at 90℃. After drying and powder collection, transfer the powder to a pulverizing chamber. The dried crude product is pulverized using a stainless steel pulverizer and passed through an 80-mesh vibrating sieve to obtain the raspberry extract.

[0038] Preparation method of Schisandra chinensis extract: Add 10 times the mass of water to Schisandra chinensis, soak at room temperature (20℃) for 30 min, extract at 95℃ for 1.5 h, filter to obtain filtrate 1 and residue 1; add 6 times the mass of water to residue 1, extract at 95℃ for 1.5 h, filter to obtain filtrate 2 and residue 2; add 5 times the mass of water to residue 2, extract at 95℃ for 1.5 h, filter to obtain filtrate 3; combine filtrate 1, filtrate 2, and filtrate 3 to obtain the extract. Concentrate the extract under reduced pressure at 75℃ and a vacuum degree of -0.05 MPa until the specific gravity is 1.10. Then, homogenize the extract through a homogenizer, and then spray dry it through an atomizer into a spray drying tower. The inlet temperature of the drying tower is controlled at 160℃, and the outlet temperature is controlled at 90℃. After drying and powder collection, transfer the powder to a pulverizing chamber. The dried crude product is pulverized using a stainless steel pulverizer and passed through an 80-mesh vibrating sieve to obtain the Schisandra chinensis extract.

[0039] Preparation method of Astragalus complanatus extract: Add 7 times the mass of 60% ethanol solution to Astragalus complanatus, soak at room temperature (22℃) for 30 min, extract at 80℃ for 1.5 h, filter to obtain filtrate 1 and residue 1; add 5 times the mass of 60% ethanol solution to residue 1, extract at 80℃ for 1.5 h, filter to obtain filtrate 2 and residue 2; add 4 times the mass of 60% ethanol solution to residue 2, extract at 80℃ for 1.5 h, filter to obtain filtrate 3; combine filtrate 1, filtrate 2 and filtrate 3 to obtain the extract. Concentrate the extract under reduced pressure at 75℃ and a vacuum degree of -0.04 MPa until the specific gravity reaches 1.12. Then, homogenize the extract through a homogenizer, and then spray it into a spray drying tower through an atomizer. The inlet temperature of the drying tower is controlled at 140℃, and the outlet temperature is controlled at 70℃. After drying and collecting the powder, the product is transferred to a pulverizing chamber. The dried crude product is pulverized using a stainless steel pulverizer and passed through an 80-mesh vibrating sieve to obtain Astragalus complanatus extract.

[0040] Example 2 A pharmaceutical composition for relieving physical fatigue, comprising, by weight parts: 140 parts of Lycium barbarum extract, 60 parts of Cuscuta chinensis extract, 60 parts of Rubus idaeus extract, 60 parts of Schisandra chinensis extract, and 90 parts of Astragalus complanatus extract.

[0041] The preparation methods for Lycium barbarum extract, Cuscuta chinensis extract, Raspberry extract, Schisandra chinensis extract, and Astragalus complanatus extract are the same as in Example 1.

[0042] Example 3 A pharmaceutical composition for relieving physical fatigue comprises, by weight parts: 120 parts of wolfberry extract, 50 parts of dodder seed extract, 50 parts of raspberry extract, 50 parts of schisandra seed extract, and 80 parts of astragalus seed extract.

[0043] The preparation methods for Lycium barbarum extract, Cuscuta chinensis extract, Raspberry extract, Schisandra chinensis extract, and Astragalus complanatus extract are the same as in Example 1.

[0044] Comparative Example 1 A pharmaceutical composition that differs from Example 3 in that it does not contain wolfberry extract.

[0045] Comparative Example 2 A pharmaceutical composition that differs from Example 3 in that it does not contain Astragalus complanatus extract.

[0046] Comparative Example 3 A pharmaceutical composition that differs from Example 3 in that it does not contain dodder extract.

[0047] Comparative Example 4 A pharmaceutical composition that differs from Example 3 in that it does not contain raspberry extract.

[0048] Comparative Example 5 A pharmaceutical composition that differs from Example 3 in that it does not contain Schisandra chinensis extract.

[0049] Comparative Example 6 A pharmaceutical composition, differing from Example 3 in that: the extract of Astragalus complanatus is an aqueous extract; Preparation method of Astragalus complanatus extract: Add 10 times the mass of water to Astragalus complanatus seeds, soak at room temperature (20℃) for 30 min, extract at 95℃ for 1.5 h, filter to obtain filtrate 1 and residue 1; add 6 times the mass of water to residue 1, extract at 95℃ for 1.5 h, filter to obtain filtrate 2 and residue 2; add 5 times the mass of water to residue 2, extract at 95℃ for 1.5 h, filter to obtain filtrate 3; combine filtrate 1, filtrate 2, and filtrate 3 to obtain the extract. Concentrate the extract under reduced pressure at 75℃ and a vacuum degree of -0.05 MPa until the specific gravity reaches 1.10. Then, homogenize the extract through a homogenizer, and then spray dry it through an atomizer into a spray drying tower. The inlet temperature of the drying tower is controlled at 160℃, and the outlet temperature is controlled at 90℃. After drying and powder collection, transfer the powder to a pulverizing chamber. The dried crude product is pulverized using a stainless steel pulverizer and passed through an 80-mesh vibrating sieve to obtain the Astragalus complanatus extract.

[0050] Experimental Example 1 Animal experiments were conducted using the pharmaceutical compositions of Examples 3 and Comparative Examples 1-6: 1. Weighted swimming experiment: One hundred and ten SPF-grade ICR mice, weighing 20 ± 2 g, were selected and acclimatized for one week after quarantine. They were then randomly divided into 11 groups of 10 mice each, as follows: Example 3 low-dose group (0.6 g / kg), Example 3 medium-dose group (1.2 g / kg), Example 3 high-dose group (2.4 g / kg), Comparative Example 1 (2.4 g / kg), Comparative Example 2 (2.4 g / kg), Comparative Example 3 (2.4 g / kg), Comparative Example 4 (2.4 g / kg), Comparative Example 5 (2.4 g / kg), Comparative Example 6 (2.4 g / kg), blank group, and positive control group. Different doses of the drug were administered by gavage at a dose of 1 mL / 10 g of body weight. The blank group and positive control group were administered the corresponding amounts of purified water and inosine oral solution by gavage, respectively.

[0051] During the experiment, the mice were administered medication by gavage once daily according to their groups for 21 consecutive days. During this period, the animals were ensured access to food and water, and their condition was observed and recorded in detail. For the first 7 days, the mice underwent adaptive swimming training. Before each swimming session, the mice were gavaged, and one hour later, each group of mice was placed in a bucket (water temperature 30℃, water depth 20cm) and swam for 20 minutes. For the next 14 days, at fixed times, lead weights were attached to the mice's tails, and they underwent 20 minutes of weighted swimming training (the load being 5% of the mouse's body weight). On day 21, the mice underwent a weighted swimming test to exhaustion. The time from when the mice entered the tank and began swimming until they sank below the surface for 5 seconds and no longer resurfaced was recorded. The results are shown below: Table 1. Statistics on the time of exhaustive weight-bearing swimming in each group of mice (n=10)

[0052] The results showed that the drug combination in Example 3 could significantly increase the duration of weight-bearing swimming in mice, and with increasing dosage, the time to exhaustion swimming was significantly prolonged, which could effectively improve the exercise endurance of mice.

[0053] 2. Pole Climbing Experiment: Mice were grouped and administered medication as in the "Weighted Swimming Experiment," undergoing continuous gavage for 21 days. One hour after the last gavage, mice from each group were placed sequentially on a 30cm long acrylic glass pole. The pole frame was placed in a bucket of water 10cm deep at 30℃, placing the mice's muscles in a state of static tension. The time it took for the mice to fall from the glass pole into the water was recorded. The experiment was stopped after the mice fell into the water for the third time, and the total time of the three falls was recorded as the mouse's pole climbing time. The results are shown below: Table 2. Statistics of pole-climbing time for mice in each group (n=10)

[0054] The results showed that the drug combination in Example 3 significantly improved the pole climbing time of mice, and the climbing time was significantly prolonged with increasing dosage, which could effectively improve the exercise endurance of mice.

[0055] 3. Effects on energy metabolism in mice After the mice completed the drug administration, energy metabolism-related indicators were measured (to assess the improvement in energy metabolism): Mice were immediately sacrificed after the pole-climbing experiment, and serum and liver tissue were collected. Serum lactate (LA) was measured using the lactate dehydrogenase method, reflecting the degree of lactate accumulation after exercise; liver glycogen (HG) was measured using the anthrone colorimetric method, reflecting the body's energy reserves; and serum urea nitrogen (BUN) was measured using the urease method, reflecting the degree of protein catabolism (protein catabolism increases during fatigue, leading to elevated BUN). The test results are shown below: Table 3. Improvement in energy metabolism in each group of mice (n=5)

[0056] The results showed that the drug combination in Example 3 could improve energy metabolism, enhance exercise endurance, and relieve fatigue by increasing energy reserves, reducing lactic acid buildup and protein breakdown.

[0057] Example 4 A capsule for relieving physical fatigue, comprising, by weight: 45 parts of the pharmaceutical composition of Example 1, 35 parts of filler, 3 parts of disintegrant, and 0.4 parts of lubricant; the filler is composed of microcrystalline cellulose and lactose in equal weight ratio, the disintegrant is CMS-Na, and the lubricant is magnesium stearate.

[0058] Capsule preparation method: Mix wolfberry extract, dodder seed extract, raspberry extract, schisandra extract, astragalus seed extract, filler and disintegrant, add 85% ethanol solution to make soft material, granulate through 16 mesh sieve, dry at 55℃, granulate through 14 mesh sieve, mix with lubricant, and fill into capsules (gelatin capsule shell).

[0059] Example 5 A capsule for relieving physical fatigue, comprising, by weight: 55 parts of the pharmaceutical composition of Example 2, 45 parts of filler, 5 parts of disintegrant, and 0.6 parts of lubricant; the filler is composed of microcrystalline cellulose and lactose in equal weight ratio, the disintegrant is CMS-Na, and the lubricant is magnesium stearate.

[0060] Capsule preparation method: Mix wolfberry extract, dodder seed extract, raspberry extract, schisandra extract, astragalus seed extract, filler and disintegrant, add 85% ethanol solution to make soft material, granulate through 16 mesh sieve, dry at 60℃, granulate through 14 mesh sieve, mix with lubricant, and fill into capsules (gelatin capsule shell).

[0061] Example 6 A capsule for relieving physical fatigue, comprising, by weight: 50 parts of the pharmaceutical composition of Example 3, 40 parts of filler, 4 parts of disintegrant, and 0.5 parts of lubricant; the filler is composed of microcrystalline cellulose and lactose in equal weight ratio, the disintegrant is CMS-Na, and the lubricant is magnesium stearate.

[0062] Capsule preparation method: Mix wolfberry extract, dodder seed extract, raspberry extract, schisandra extract, astragalus seed extract, filler and disintegrant, add 85% ethanol solution to make soft material, granulate through 16 mesh sieve, dry at 60℃, granulate through 14 mesh sieve, mix with lubricant, and fill into capsules (gelatin capsule shell).

[0063] Experimental Example 2 Animal experiments were conducted using the capsules (Goji Berry and Five-Seed Capsules) prepared in Example 6. 1. Laboratory animals and grouping: Twenty-five male SPF-grade SD rats, weighing 242.2–292.2 g, were acclimatized for one week (in a standardized environment with a temperature of 22±2℃, humidity of 55±10%, and a 12-hour / 12-hour light-dark cycle). After the acclimatization period, the SD rats were randomly divided into five groups (n=5) according to their body weight: a solvent control group (Veh), a model control group-hydrocortisone (HC-M), a group containing Lycium barbarum and Polygonum multiflorum capsules-hydrocortisone (HC-GWC), a model control group-adenine (Ade-M), and a group containing Lycium barbarum and Polygonum multiflorum capsules-adenine (Ade-GWC). The HC-M and HC-GWC groups received daily subcutaneous injections of 25 mg / kg. -1 A rat model of kidney-yang deficiency was established using hydrocortisone for 15 consecutive days. The Ade-M and Ade-GWC groups were also used to establish a rat model of kidney-yang deficiency by daily gavage administration of 200 mg / kg adenine solution for 30 consecutive days. The solvent control group received an equal volume of physiological saline subcutaneously and was allowed free access to food and drink. After each day's modeling period, the wolfberry and five-seed capsule intervention group received the drug by gavage at a dose of 0.170 g / kg, the HC-GWC group received the drug for 15 days, and the Ade-GWC group received the drug for 30 days.

[0064] 2. General physical signs observation The tail color, tongue color, teeth marks, tongue saliva, arched back, curling up, and huddling of the rats were observed and recorded daily. On the day before the end of the experiment, the general symptoms were quantitatively scored and statistically analyzed.

[0065] Table 4 Animal Symptom Observation Scores

[0066] Note: # indicates that compared with the solvent control group, P<0.05; ## indicates that compared with the solvent control group, P<0.01. This indicates that compared with the model control group, P < 0.05. This indicates that compared with the model control group, P < 0.01.

[0067] The results showed that, compared with the Veh group, the general symptom observation scores of both the HC-M and Ade-M groups were significantly higher (P < 0.01), indicating that the two kidney-yang deficiency models were successfully established. After intervention with Lycium barbarum and Schisandra chinensis capsules, the HC-GWC and Ade-GWC groups showed a decreasing trend compared with their respective model control groups, but the difference did not reach statistical significance.

[0068] 3. Forced swimming experiment During the last week of drug administration, a weight-bearing swimming experiment was conducted. A lead weight, equal to 5% of the rat's own weight, was attached to the rat's tail and the rat was placed in a constant-temperature water tank (60 × 60 × 70 cm) at a depth of 0.3 m and a temperature of 25 ± 1℃. The time from when the rat entered the constant-temperature water tank until it could no longer float to the surface and sank to the bottom of the tank was recorded as the weight-bearing swimming time of the rat.

[0069] Table 5 Forced Swimming Time

[0070] Note: # indicates that compared with the solvent control group, P<0.05; ## indicates that compared with the solvent control group, P<0.01. This indicates that compared with the model control group, P < 0.05. This indicates that compared with the model control group, P < 0.01.

[0071] The results showed that the forced swimming time in both model groups was significantly shortened compared to the Veh group. Intervention with Lycium barbarum and Schisandra chinensis capsules significantly prolonged the swimming time in the Ade-GWC group, but had no significant effect on improving the swimming time in the hydrocortisone model rats.

[0072] 4. Sample Collection and Processing After the experiment, rats were fasted but allowed free access to water for 12 hours. Rats were anesthetized with isoflurane, and blood was collected from the abdominal aorta. A portion of the blood was anticoagulated with EDTA-K2, and plasma was separated by centrifugation for the detection of corticotropin-releasing hormone (CRH) and adrenocorticotropic hormone (ACTH). The remaining blood was allowed to stand, then centrifuged at 4000 r / min for 10 min at 4°C to separate serum for the detection of testosterone (T), estradiol (E2), corticosterone (CORT), cyclic adenosine monophosphate (cAMP), and cyclic guanosine monophosphate (cGMP). The heart, liver, spleen, lungs, kidneys, epididymis, testes, thyroid gland, adrenal glands, and thymus were quickly dissected, rinsed with physiological saline, blotted dry with filter paper, weighed, and the organ coefficient (organ weight / body weight × 100%) was calculated.

[0073] 5. Sperm quality One epididymal tail was collected, chopped, and placed in pre-warmed physiological saline at 37°C to prepare a sperm suspension. At least 200 sperm were counted under an optical microscope using eosin staining, and the sperm viability (number of live sperm / total sperm count × 100%) was calculated.

[0074] Table 6 Animal sperm survival rate

[0075] Note: # indicates that compared with the solvent control group, P<0.05; ## indicates that compared with the solvent control group, P<0.01. This indicates that compared with the model control group, P < 0.05. This indicates that compared with the model control group, P < 0.01.

[0076] The results showed that both kidney-yang deficiency models led to a significant decrease in sperm survival rate. After intervention with Lycium barbarum and Five-Seed Capsules, sperm survival rate increased to 69±11% in the hydrocortisone model and to 79±6% in the adenine model, showing an improving trend, but the difference was not statistically significant.

[0077] 6. Biochemical indicator testing The levels of CRH and ACTH in animal plasma and T, E2, CORT, cAMP, and cGMP in serum were detected using ELISA kits. Corticotropin-releasing hormone (CRH, batch number: 202512), adrenocorticotropic hormone (ACTH, batch number: 202512), testosterone (T, batch number: 202512), estradiol (E2, batch number: 202512), corticosterone (CORT, batch number: 202512), cyclic adenosine monophosphate (cAMP, batch number: 202512), and cyclic guanosine monophosphate (cGMP, batch number: 202512) were all purchased from Jiangsu Enzyme Immunoassay Co., Ltd. The kit instructions were strictly followed, and the levels of each indicator in animal serum or plasma were calculated based on the standard curve.

[0078] Table 7. Content of various indicators in serum or plasma

[0079] Note: # indicates that compared with the solvent control group, P<0.05; ## indicates that compared with the solvent control group, P<0.01. This indicates that compared with the model control group, P < 0.05. This indicates that compared with the model control group, P < 0.01.

[0080] The results showed that, compared with the Veh group, the plasma CRH and ACTH levels in both model groups were significantly lower. After intervention with Goji Berry Five-Seed Capsules, the ACTH levels in both groups were significantly higher than those in their respective model groups, and the CRH levels also showed an increasing trend, but there was no statistically significant difference. Compared with the Veh group, serum testosterone (T) levels in both model groups showed a decreasing trend, while after intervention with Goji Berry Five-Seed Capsules, T levels significantly increased. Although serum estradiol (E2) decreased in the model groups, the difference was not statistically significant, and no significant change was observed after intervention. The COR content in the model groups was significantly lower than that in the solvent control group, and although there was a rebound trend after intervention, the difference did not reach a statistically significant level. The cAMP levels in both model groups were significantly lower, while the cGMP levels increased. After intervention with Goji Berry Five-Seed Capsules, the cAMP level showed an increasing trend, while the cGMP level decreased accordingly, and this decrease was also significant in the adenine model.

[0081] 7. Organ coefficient statistics The organ coefficient statistics are shown in the table below.

[0082] Table 8. Effects of Lycium barbarum and Five-Seed Capsules on Organ Coefficients in a Hydrocortisone Model

[0083] Table 9. Effects of Lycium barbarum and Five-Seed Capsules on Organ Coefficients in the Adenine Model

[0084] Note: # indicates that compared with the solvent control group, P<0.05; ## indicates that compared with the solvent control group, P<0.01. This indicates that compared with the model control group, P < 0.05. This indicates that compared with the model control group, P < 0.01.

[0085] The results showed that both kidney-yang deficiency models induced significant changes in the coefficients of multiple organs, with a significant decrease in the thymus coefficient, indicating impaired immune function. In the hydrocortisone model, intervention with Lycium barbarum and Five-Seed Capsule significantly reduced the abnormally high cardiac and epididymal coefficients induced by the model. In the adenine model, while Lycium barbarum and Five-Seed Capsule showed some numerical correction of the significantly increased kidney coefficient and other abnormal changes, the effect was not statistically significant.

[0086] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A pharmaceutical composition for relieving physical fatigue, characterized in that, By weight, it includes the following components: 100-140 parts of wolfberry extract, 40-60 parts of dodder seed extract, 40-60 parts of raspberry extract, 40-60 parts of schisandra seed extract, and 70-90 parts of astragalus seed extract.

2. The pharmaceutical composition according to claim 1, characterized in that, The preparation method of the wolfberry extract, dodder seed extract, raspberry extract or schisandra extract includes the following steps: extracting the raw materials with water, concentrating the extract, drying and pulverizing the extract to obtain the extract.

3. The pharmaceutical composition according to claim 2, characterized in that, The method for extracting the raw material with water includes: adding 9-11 times the mass of water to the raw material, extracting at 95-100℃ for 1-2 hours, filtering to obtain filtrate 1 and residue 1; adding 5-7 times the mass of water to residue 1, extracting at 95-100℃ for 1-2 hours, filtering to obtain filtrate 2 and residue 2; adding 4-6 times the mass of water to residue 2, extracting at 95-100℃ for 1-2 hours, filtering to obtain filtrate 3; combining filtrate 1, filtrate 2 and filtrate 3 to obtain the extract.

4. The pharmaceutical composition according to claim 1, characterized in that, The preparation method of the Astragalus complanatus extract includes the following steps: extracting the raw material with 60% ethanol solution, concentrating, drying and pulverizing the extract to obtain the extract.

5. The pharmaceutical composition according to claim 4, characterized in that, The method for extracting the raw material with 60% ethanol solution includes: adding 6-8 times the mass of 60% ethanol solution to the raw material, extracting at 75-85℃ for 1-2 hours, filtering to obtain filtrate 1 and residue 1; adding 4-6 times the mass of 60% ethanol solution to residue 1, extracting at 75-85℃ for 1-2 hours, filtering to obtain filtrate 2 and residue 2; adding 3-5 times the mass of 60% ethanol solution to residue 2, extracting at 75-85℃ for 1-2 hours, filtering to obtain filtrate 3; combining filtrate 1, filtrate 2 and filtrate 3 to obtain the extract.

6. The pharmaceutical composition according to claim 2 or 4, characterized in that, The concentration is performed under reduced pressure, with a concentration temperature of 70~80℃ and a vacuum degree of -0.02~-0.06Mpa.

7. The pharmaceutical composition according to claim 2 or 4, characterized in that, The drying process is spray drying, with an inlet air temperature of 130~160℃ and an outlet air temperature of 60~90℃.

8. The use of the pharmaceutical composition according to any one of claims 1 to 7 in the preparation of a product for relieving physical fatigue, characterized in that, The products include health supplements and pharmaceuticals.

9. A capsule for relieving physical fatigue, characterized in that, The pharmaceutical composition and excipients according to any one of claims 1 to 7 are included; the excipients include fillers, disintegrants and lubricants.

10. The method for preparing the capsule according to claim 9, characterized in that, Includes the following steps: The extracts of wolfberry, dodder seed, raspberry, schisandra fruit, and astragalus seed, along with fillers and disintegrants, are mixed and mixed with 85% ethanol solution to form a soft mass. The mass is then granulated through a 16-mesh sieve, dried at 55-60°C, sized through a 14-mesh sieve, mixed with a lubricant, and filled into capsules.

Images