Anti-fatigue traditional Chinese medicine composition as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine compositions or functional foods, and particularly relates to an anti-fatigue traditional Chinese medicine composition and a preparation method and application thereof. The anti-fatigue traditional Chinese medicine composition comprises the following raw materials: red ginseng, American ginseng, sun-dried ginseng, Chinese wolfberry, honey, xylitol and starch. The preparation method comprises the steps of low-temperature drying of ginseng, superfine grinding, decoction and concentration of wolfberry, dissolution and mixing of auxiliary materials, granulation, drying and the like. Through scientific compatibility of various ginsengs and combination of an optimized process, synergistic interaction of effects of various traditional Chinese medicines can be realized, the ginseng health-care food has remarkable effects of resisting fatigue, enhancing immunity and regulating body metabolism, meanwhile, can protect visceral organs and muscle injury induced by movement, and is high in dissolution rate and absorption rate of active ingredients, fresh and sweet in taste, convenient to eat, stable in quality and free of toxic and side effects. And the product is suitable for various sub-health people to eat, and has good safety, practicability and industrial popularization prospects.

Description

A Traditional Chinese Medicine Composition for Combating Fatigue, Its Preparation Method and Application Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition or functional food technology, specifically relating to an anti-fatigue traditional Chinese medicine composition and its preparation method and application. Background Technology

[0002] With the overall improvement of national health awareness, the demand for foods that combine nutritional supplementation and specific health care functions continues to rise in the consumer market. Among them, ginseng-based tonic foods occupy an important position in the functional food field due to their long history of medicinal and edible use.

[0003] Currently, the market offers a wide variety of ginseng products, primarily using a single variety of ginseng as the core ingredient. Common forms include sliced ​​red ginseng, American ginseng lozenges, sun-dried ginseng tea bags, and ginseng oral liquids. However, existing products generally suffer from a lack of diversity in their formulations, often limiting themselves to a single ginseng variety. They fail to fully utilize the complementary effects of different ginseng varieties and cannot achieve synergistic effects through scientific formulation. Consequently, the health benefits of these products are relatively limited, making it difficult to meet the multi-dimensional health needs of modern consumers.

[0004] Meanwhile, existing ginseng products have significant shortcomings in terms of form design and user experience. Traditional sliced ​​and tablet products lack convenience and have a bitter taste that some consumers find unpalatable. While oral liquid products are absorbed quickly, they suffer from inconvenience in carrying, short shelf life, and numerous added ingredients. Powdered products are prone to absorbing moisture and clumping, and their poor solubility affects both the user experience and the absorption of active ingredients. Furthermore, some products, in pursuit of better taste or extended shelf life, excessively add sucrose, preservatives, and other ingredients, which contradicts modern consumers' preference for natural, healthy, and low-sugar products, further limiting their market reach.

[0005] Current ginseng processing methods mostly employ traditional techniques such as conventional pulverization and water extraction, resulting in low extraction and utilization rates of ginseng's active ingredients. Due to the dense cell wall structure of ginseng, conventional pulverization produces relatively large particle sizes, making it difficult for active ingredients to dissolve quickly and fully, thus limiting human absorption and failing to fully realize ginseng's health benefits. While some products utilize extraction technologies to optimize active ingredient dissolution, these are mostly designed for single-variety ginseng and do not adapt the process to the characteristics of compound formulations, making it difficult to balance the synergistic effects of multiple ingredients with product quality stability.

[0006] The fast-paced lifestyle of modern society has led to the increasing prevalence of sub-health issues such as fatigue syndrome and weakened immunity. There is a particular urgent need among working professionals, sports enthusiasts, and the elderly for complex dietary supplements that offer clear anti-fatigue and immune-boosting functions, are convenient to consume, have a good taste, and are formulated with natural ingredients. Existing ginseng products with single ingredients, single effects, and traditional processing methods can no longer meet the market's precise demand for high-quality, complex, nutritionally balanced special dietary foods.

[0007] Therefore, how to rationally combine red ginseng, American ginseng, and sun-dried ginseng through scientific formula design, and combine them with optimized processing technology to develop a compound special dietary food that has synergistic health benefits, excellent taste, and convenient consumption characteristics, in order to solve the many shortcomings of existing technologies, has become a technical problem that urgently needs to be solved in the field of functional foods. Summary of the Invention

[0008] Based on the above technical background, the main objective of this invention is to provide a traditional Chinese medicine composition for relieving fatigue, its preparation method, and its application, so as to overcome the shortcomings of the prior art.

[0009] To achieve the aforementioned objectives, the technical solution adopted by this invention includes:

[0010] The first aspect of the present invention is to provide a traditional Chinese medicine composition for relieving fatigue, the traditional Chinese medicine composition for relieving fatigue comprising the following raw materials in parts by weight: 5-10 parts red ginseng, 35-50 parts American ginseng, 3-8 parts sun-dried ginseng, 5-10 parts wolfberry, 10-20 parts honey, 5-10 parts xylitol, and 3-8 parts starch.

[0011] The anti-fatigue traditional Chinese medicine composition also includes: 5-10 parts by weight of ginseng and 4-6 parts by weight of Ganoderma lucidum.

[0012] Preferably, the anti-fatigue traditional Chinese medicine composition comprises the following raw materials in parts by weight: 6-8 parts red ginseng, 6-8 parts ginseng, 4.5-5 parts Ganoderma lucidum, 40-45 parts American ginseng, 4-6 parts sun-dried ginseng, 6-8 parts wolfberry, 13-17 parts honey, 6-8 parts xylitol, and 5-7 parts starch.

[0013] More preferably, the anti-fatigue traditional Chinese medicine composition comprises the following raw materials in parts by weight: 7 parts red ginseng, 7 parts ginseng, 4.7 parts Ganoderma lucidum, 42 parts American ginseng, 5 parts sun-dried ginseng, 7 parts wolfberry, 15 parts honey, 7 parts xylitol, and 6 parts starch.

[0014] Red ginseng, after processing, is mild in nature and has a significant effect on replenishing qi and blood, making it suitable for people with a cold constitution; American ginseng is cool in nature and focuses on replenishing qi and nourishing yin, clearing heat and promoting body fluids, and has a targeted effect on improving symptoms such as fatigue and dryness caused by yin deficiency and excessive fire; sun-dried ginseng retains the natural active ingredients of ginseng, has a mild tonic effect, and can comprehensively regulate the functions of the five internal organs.

[0015] The second aspect of this invention provides a method for preparing a compound special dietary supplement, which is prepared from the anti-fatigue traditional Chinese medicine composition described in the first aspect of this invention. The preparation method includes the following steps: Step 1: Wash and slice red ginseng, American ginseng, and sun-dried ginseng respectively, then perform low-temperature drying treatment, and then pulverize to obtain an ultrafine mixed powder; Step 2: Wash and pit wolfberries, add water and decoct, filter, and concentrate the wolfberry juice to obtain concentrated wolfberry juice; Step 3: Add honey and xylitol to the concentrated wolfberry juice, heat under stirring conditions to completely dissolve xylitol, then add the ultrafine mixed powder, stir evenly, then add starch, stir into a paste, granulate the paste mixture, and dry to obtain the compound special dietary supplement.

[0016] The steps described above are described in detail below.

[0017] In step 1, the conditions for the low-temperature drying treatment are: drying temperature of 40-50℃, drying time of 8-12h, and the moisture content after drying is reduced to below 5%.

[0018] Preferably, the conditions for the low-temperature drying treatment are: drying temperature of 45°C, drying time of 10 h, and the moisture content after drying is reduced to below 5%.

[0019] The dried red ginseng, American ginseng, sun-dried ginseng, ginseng, and Ganoderma lucidum are pulverized to a particle size of 10–20 μm.

[0020] Preferably, the dried red ginseng, American ginseng, sun-dried ginseng, ginseng, and Ganoderma lucidum are pulverized to a particle size of 10–15 μm.

[0021] This invention utilizes ultra-fine pulverization technology to effectively improve the dissolution and absorption rates of active ingredients in ginseng, red ginseng, American ginseng, sun-dried ginseng, and Ganoderma lucidum, thereby enhancing the efficacy of the products.

[0022] In step 2, the decocting temperature is 80-90℃, and the decocting time is 1-2 hours.

[0023] Preferably, the decocting temperature is 85°C and the decocting time is 1.5 h.

[0024] The goji berry juice is concentrated to 1 / 4 to 1 / 2 of its original volume, preferably to 1 / 3 of its original volume.

[0025] In step 3, honey and xylitol are added to the concentrated goji berry juice, and the mixture is heated to 60-70°C, preferably to 65°C, while stirring, so that the xylitol is completely dissolved.

[0026] This invention improves the taste of the product by adding ingredients such as goji berries, honey, and xylitol, making it more delicious and palatable, and more easily accepted by consumers.

[0027] Granulate the paste mixture into particles of 2–4 mm.

[0028] The drying temperature is 50-60℃, the drying time is 4-6 hours, and the moisture content is reduced to below 3% after drying.

[0029] Preferably, the drying temperature is 55°C, the drying time is 5 hours, and the moisture content is reduced to below 3% after drying.

[0030] This invention prepares it into granules, making it more convenient to carry and consume, which is suitable for people living a fast-paced modern life.

[0031] A third aspect of the present invention is to provide the application of the anti-fatigue traditional Chinese medicine composition described in the first aspect of the present invention in the preparation of functional foods.

[0032] The functional foods mentioned include foods that have significant effects on combating fatigue, enhancing immunity, and regulating bodily functions.

[0033] The beneficial effects of this invention are as follows: (1) This invention creatively combines red ginseng, American ginseng, and sun-dried ginseng in a precise combination, with the three complementing each other in their effects: red ginseng is mild and replenishes qi and blood, American ginseng nourishes yin, clears heat and generates fluids, and sun-dried ginseng is mild and regulates the five internal organs. The combination of the above three types of ginseng with ginseng and Ganoderma lucidum can further enhance immune regulation and antioxidant capacity. In addition, wolfberry is added to nourish yin and improve eyesight and harmonize the medicinal properties, forming a multi-component synergistic system. The Chinese medicine composition described in this invention can effectively inhibit the accumulation of serum urea nitrogen, lactic acid and creatine kinase after exercise, enhance lactic acid clearance capacity, reduce muscle damage, and significantly increase liver glycogen reserves. This invention can delay the occurrence of fatigue by optimizing energy metabolism. In addition, this Chinese medicine composition can upregulate the activity of antioxidant enzymes such as SOD, GSH-Px, and CAT, reduce MDA content, alleviate exercise-induced oxidative stress damage, and take into account multiple effects such as anti-fatigue, enhancing immunity and regulating body metabolism, which can meet the multi-dimensional health conditioning needs of modern people.

[0034] (2) The preparation method of the present invention adopts a combined process of low-temperature drying and ultra-fine pulverization. Low-temperature drying can avoid the degradation of heat-sensitive active ingredients (such as ginsenosides and polysaccharides) in raw materials such as ginseng, and can control the moisture content to below 5%, effectively preventing the raw materials from absorbing moisture and deteriorating. Ultra-fine pulverization can control the particle size of the raw materials to 10-20 μm. By destroying the structure of plant cell walls, it can significantly improve the dissolution rate and human absorption rate of active ingredients in raw materials such as ginseng, solving the problems of coarse particles and insufficient dissolution of ingredients in traditional pulverization processes. At the same time, the present invention decocts and concentrates wolfberries to a suitable volume, which can fully extract active ingredients such as wolfberry polysaccharides and retain their flavor substances. After granulation, low-temperature drying to a moisture content of below 3% can further improve product stability, avoid moisture absorption and clumping, and extend shelf life.

[0035] (3) This invention overcomes the shortcoming of the bitter taste of traditional ginseng products by using a combination of honey and xylitol to flavor the product, replacing added sugars such as sucrose. This not only gives the product a sweet taste and improves its acceptability, but also aligns with the modern consumer's health concept of natural and low-sugar products, making it suitable for all types of people. At the same time, this invention prepares the composition into granules, which, compared with traditional sliced, oral liquid, and powder products, has the advantages of being convenient to carry, easy to consume, and easy to control the dosage. It can be adapted to various groups and the fast-paced lifestyle of modern times, solving the problems of insufficient convenience of consumption, poor taste, and inconvenience of carrying existing products.

[0036] (4) All raw materials used in this invention are food-grade ingredients or food-grade excipients, without the addition of artificial preservatives, flavorings or other harmful substances, and their safety is controllable. The traditional Chinese medicine composition described in this invention has good safety and can be consumed for a long time. This product is suitable for sub-healthy people with fatigue syndrome, decreased immunity, etc., and can also protect against exercise-induced organ and muscle damage, meeting the recovery needs of athletes. It has a wide range of applicable scenarios and populations. Attached Figure Description

[0037] Figure 1 shows the effects of the traditional Chinese medicine composition on the weight-bearing swimming time and fatigue-related metabolites in mice: This indicates that there are significant differences between different groups (P<0.05).

[0038] Figure 2 shows the effect of the traditional Chinese medicine composition on the degree of liver damage in mice under load.

[0039] Figure 3 shows the effect of the traditional Chinese medicine composition on energy substances in mice.

[0040] Figure 4 shows the effect of the traditional Chinese medicine composition on the antioxidant activity of mouse liver; This indicates a significant difference compared to group C (p < 0.05).

[0041] Figure 5 shows the effect of the traditional Chinese medicine composition on the pathological changes of mouse liver tissue (HE, ×400).

[0042] Figure 6 shows the effect of the traditional Chinese medicine composition on the pathological changes of the gastrocnemius muscle tissue in mice (HE, ×200). Detailed Implementation

[0043] The present invention will now be described in detail, and its features and advantages will become clearer and more apparent from these descriptions.

[0044] The present invention is further illustrated below by specific examples. These examples are for illustrative purposes only and are not intended to limit the scope of the invention. All raw materials used in the embodiments of the present invention were commercially available.

[0045] Example 1: A traditional Chinese medicine composition for relieving fatigue, the composition comprising the following raw materials in parts by weight: 5 parts red ginseng, 3 parts American ginseng, 3 parts sun-dried ginseng, 5 parts wolfberry, 10 parts honey, 5 parts xylitol, and 3 parts starch.

[0046] A method for preparing a compound special dietary supplement, wherein the compound special dietary supplement is prepared from the above-mentioned traditional Chinese medicine composition, the preparation method includes the following steps: weighing each raw material according to the above-mentioned weight parts, washing the raw materials obtained above, slicing them, and then drying them at a low temperature of 45°C for 10 hours, reducing the moisture content to below 5% after drying, and pulverizing the dried red ginseng, American ginseng, and sun-dried ginseng to a particle size of 10-15 μm to obtain an ultrafine mixed powder.

[0047] Wash and pit the goji berries, add water and boil them at a temperature of 85°C for 1.5 hours. After boiling, filter the juice and concentrate it to 1 / 3 of its original volume to obtain concentrated goji berry juice.

[0048] Honey and xylitol were added to concentrated wolfberry juice, and the mixture was heated to 65°C under stirring to completely dissolve the xylitol. Then, ultrafine powder was added and stirred evenly. Next, starch was added and stirred into a paste. The paste mixture was granulated and dried at 55°C for 5 hours. After drying, the moisture content was reduced to below 3%, thus obtaining the compound special dietary supplement.

[0049] Example 2: A traditional Chinese medicine composition for relieving fatigue, the composition comprising the following raw materials in parts by weight: 8 parts red ginseng, 5 parts American ginseng, 5 parts sun-dried ginseng, 8 parts wolfberry, 15 parts honey, 8 parts xylitol, and 5 parts starch.

[0050] A method for preparing a compound special dietary supplement, wherein the compound special dietary supplement is prepared from the above-mentioned traditional Chinese medicine composition, the preparation method includes the following steps: weighing each raw material according to the above-mentioned weight parts, washing the raw materials obtained above, slicing them, and then drying them at a low temperature of 45°C for 10 hours, reducing the moisture content to below 5% after drying, and pulverizing the dried red ginseng, American ginseng, and sun-dried ginseng to a particle size of 10-15 μm to obtain an ultrafine mixed powder.

[0051] Wash and pit the goji berries, add water and boil at 85°C for 1.5 hours. After boiling, filter and concentrate the goji berry juice to 1 / 3 of its original volume to obtain concentrated goji berry juice.

[0052] Honey and xylitol were added to concentrated wolfberry juice, and the mixture was heated to 60°C under stirring to completely dissolve the xylitol. Then, ultrafine powder was added and stirred evenly. Next, starch was added and stirred into a paste. The paste mixture was granulated and dried at 50°C for 6 hours. After drying, the moisture content was reduced to below 3% to obtain the compound special dietary supplement.

[0053] Example 3: A traditional Chinese medicine composition for relieving fatigue, the composition comprising the following raw materials in parts by weight: 10 parts red ginseng, 8 parts American ginseng, 8 parts sun-dried ginseng, 10 parts wolfberry, 20 parts honey, 10 parts xylitol, and 8 parts starch.

[0054] A method for preparing a compound special diet, wherein the compound special diet is prepared from the above-mentioned traditional Chinese medicine composition, the preparation method includes the following steps: weighing each raw material according to the above-mentioned weight parts, washing the raw materials obtained above, slicing them, and then drying them at a low temperature of 50°C for 8 hours, reducing the moisture content to below 5% after drying, and pulverizing the dried red ginseng, American ginseng, and sun-dried ginseng to a particle size of 10-15 μm to obtain an ultrafine mixed powder.

[0055] Wash and pit the goji berries, add water and boil at 90°C for 2 hours. After boiling, filter and concentrate the goji berry juice to 1 / 3 of its original volume to obtain concentrated goji berry juice.

[0056] Honey and xylitol were added to concentrated wolfberry juice, and the mixture was heated to 60°C under stirring to completely dissolve the xylitol. Then, ultrafine powder was added and stirred evenly. Next, starch was added and stirred into a paste. The paste mixture was granulated and dried at 60°C for 4 hours. After drying, the moisture content was reduced to below 3% to obtain the compound special dietary supplement.

[0057] Example 4: A traditional Chinese medicine composition for relieving fatigue, the composition comprising the following raw materials in parts by weight: 7 parts red ginseng, 7 parts ginseng, 4.7 parts Ganoderma lucidum, 42 parts American ginseng, 5 parts sun-dried ginseng, 7 parts wolfberry, 15 parts honey, 7 parts xylitol, and 6 parts starch.

[0058] A method for preparing a compound special dietary supplement, wherein the compound special dietary supplement is prepared from the above-mentioned traditional Chinese medicine composition, the preparation method includes the following steps: weighing each raw material according to the above-mentioned weight parts, washing the raw materials obtained above, slicing them, and then drying them at a low temperature of 45°C for 10 hours, reducing the moisture content to below 5% after drying, and pulverizing the dried red ginseng, American ginseng, sun-dried ginseng, ginseng, and Ganoderma lucidum to a particle size of 10-15 μm to obtain an ultrafine mixed powder.

[0059] Wash and pit the goji berries, add water and boil at 85°C for 1.5 hours. After boiling, filter and concentrate the goji berry juice to 1 / 3 of its original volume to obtain concentrated goji berry juice.

[0060] Honey and xylitol were added to concentrated wolfberry juice, and the mixture was heated to 65°C under stirring to completely dissolve the xylitol. Then, ultrafine powder was added and stirred evenly. Next, starch was added and stirred into a paste. The paste mixture was granulated and dried at 55°C for 5 hours. After drying, the moisture content was reduced to below 3%, thus obtaining the compound special dietary supplement.

[0061] Example 5: A traditional Chinese medicine composition for relieving fatigue, the composition comprising the following raw materials in parts by weight: 6 parts red ginseng, 6 parts ginseng, 4.5 parts Ganoderma lucidum, 40 parts American ginseng, 4 parts sun-dried ginseng, 6 parts wolfberry, 13 parts honey, 6 parts xylitol, and 5 parts starch.

[0062] A method for preparing a compound special dietary supplement, wherein the compound special dietary supplement is prepared from the above-mentioned traditional Chinese medicine composition, the preparation method includes the following steps: weighing each raw material according to the above-mentioned weight parts, washing the raw materials obtained above, slicing them, and then drying them at a low temperature of 40°C for 12 hours, reducing the moisture content to below 5% after drying, and pulverizing the dried red ginseng, American ginseng, sun-dried ginseng, ginseng, and Ganoderma lucidum to a particle size of 10-15 μm to obtain an ultrafine mixed powder.

[0063] Wash and pit the goji berries, add water and boil at 80°C for 2 hours. After boiling, filter and concentrate the goji berry juice to 1 / 3 of its original volume to obtain concentrated goji berry juice.

[0064] Honey and xylitol were added to concentrated wolfberry juice, and the mixture was heated to 60°C under stirring to completely dissolve the xylitol. Then, ultrafine powder was added and stirred evenly. Next, starch was added and stirred into a paste. The paste mixture was granulated and dried at 50°C for 6 hours. After drying, the moisture content was reduced to below 3% to obtain the compound special dietary supplement.

[0065] Example 6: A traditional Chinese medicine composition for relieving fatigue, the composition comprising the following raw materials in parts by weight: 8 parts red ginseng, 8 parts ginseng, 5 parts Ganoderma lucidum, 45 parts American ginseng, 6 parts sun-dried ginseng, 8 parts wolfberry, 17 parts honey, 8 parts xylitol, and 7 parts starch.

[0066] A method for preparing a compound special diet, wherein the compound special diet is prepared from the above-mentioned traditional Chinese medicine composition, the preparation method includes the following steps: weighing each raw material according to the above-mentioned weight parts, washing the raw materials obtained above, slicing them, and then drying them at a low temperature of 50°C for 8 hours, reducing the moisture content to below 5% after drying, and pulverizing the dried red ginseng, American ginseng, sun-dried ginseng, ginseng, and Ganoderma lucidum to a particle size of 10-15 μm to obtain an ultrafine mixed powder.

[0067] Wash and pit the goji berries, add water and boil at 90°C for 1 hour. After boiling, filter and concentrate the goji berry juice to 1 / 3 of its original volume to obtain concentrated goji berry juice.

[0068] Honey and xylitol were added to concentrated wolfberry juice, and the mixture was heated to 70°C under stirring to completely dissolve the xylitol. Then, ultrafine powder was added and stirred evenly. Next, starch was added and stirred into a paste. The paste mixture was granulated and dried at 60°C for 4 hours. After drying, the moisture content was reduced to below 3% to obtain the compound special dietary supplement.

[0069] Experimental Example 1: Effect of the Traditional Chinese Medicine Composition on Mouse Body Weight. Changes in mouse body weight can serve as an important indicator for evaluating the health effects of the traditional Chinese medicine composition described in Example 4 on mice. The preparation of the drug solution can also be adjusted based on changes in body weight. The specific experimental procedure was as follows: 50 mice were divided into 5 groups: a blank control group (Group C), a positive control group (Group PC), and various dosage groups of the traditional Chinese medicine composition (including a low-dose LD group, a medium-dose MD group, and a high-dose HD group; each dosage group was administered the compound special diet prepared in Example 4 dissolved in water via gavage). Experiments were conducted on the mice in each group. For the blank control group, no drug solution was administered via gavage. For the positive control group, mice were administered 0.21 g of rhodioloside via gavage. For the low-dose LD group, mice were administered 0.468 g of the compound special diet via gavage. For the medium-dose MD group, mice were administered 0.99 g of the compound special diet via gavage. For the high-dose HD group, mice were administered 1.98 g of the compound special diet via gavage. The experiment lasted for 28 days. The body weight of mice in each group was measured on days 0, 7, 14, 21 and 28. The results are shown in Table 1.

[0070] Table 1. Effects of Traditional Chinese Medicine Composition on Mouse Body Weight

[0071] As shown in Table 1, after 28 days of intervention, there were no significant differences in mouse body weight changes among the blank control group (Group C, i.e., mice not fed the herbal composition), the positive control group (Group PC), and the various dosage groups of the herbal composition (low-dose LD group, medium-dose MD group, and high-dose HD group) (P>0.05). Throughout the feeding period, the mice exhibited normal daily activities and good mental state, and no deaths occurred. These results indicate that the anti-fatigue herbal composition described in this invention has no significant effect on the normal growth of mice.

[0072] Experimental Example 2: Effects of Traditional Chinese Medicine Composition on Organ Indices in Mice. The organs of mice in each group were tested 28 days after the experiment in Experimental Example 1. The test results are shown in Table 2.

[0073] Table 2 Effects of Traditional Chinese Medicine Compositions on Organ Indices in Mice

[0074] As shown in Table 2, there were no significant differences in the heart, spleen, lung, and kidney indices among the blank control group, positive control group, and different dosage groups (P>0.05). Compared with the blank control group, the liver index of the positive control group was significantly lower than that of the blank control group (P<0.01), and the liver index of the medium-dose group of the traditional Chinese medicine composition was significantly lower than that of the blank control group (P<0.05). The significantly lower liver index in the positive control group compared to the blank control group may be due to the influence of the positive drug rhodioloside on the metabolic function of the mouse liver. The liver index of the high-dose group of the traditional Chinese medicine composition was significantly lower than that of the blank control group, while the low-dose and medium-dose groups did not show a consistent trend. In addition, no liver lesions were observed in the high-dose group mice during the sampling process. Therefore, it is speculated that the reason for this phenomenon may be that the metabolism of the substance in the body varies at different dosages, thus affecting its effect on the liver.

[0075] Experiment Example 3: Effect of Traditional Chinese Medicine Composition on Swimming Time to Exhaustion under Weight-Bearing Conditions in Mice. The swimming time to exhaustion under weight-bearing conditions in each group of mice after 30 days of the experiment in Experiment Example 1 was measured. The test results are shown in Figure 1.

[0076] As shown in Figure 1, after 30 days of continuous administration, compared with the blank control group, the swimming time to exhaustion under load increased with increasing dosage of the traditional Chinese medicine composition, and this effect was dose-dependent. In particular, the swimming time to exhaustion under load was significantly prolonged in the medium- and high-dose groups and the positive control group (P<0.05). The results indicate that the traditional Chinese medicine composition in the medium- and high-dose groups has significant anti-fatigue effects, while the low-dose group did not show significant anti-fatigue effects, suggesting that the anti-fatigue effect of this traditional Chinese medicine composition is dose-dependent.

[0077] Experiment Example 4: Effects of Traditional Chinese Medicine Composition on Blood Urea Nitrogen, Whole Blood Lactate, and Creatine Kinase Levels in Mice. During strenuous swimming exercise, ammonia produced by amino acid metabolism reduces endurance and induces fatigue. Blood urea nitrogen (BUN) levels reflect the body's protein and amino acid metabolism status; elevated BUN levels after exercise indicate accumulated fatigue.

[0078] Figure 1 shows the experimental results, indicating that the BUN content in the medium-dose group was significantly lower than that in the control group (P < 0.05), suggesting that the medium-dose traditional Chinese medicine composition can effectively inhibit exercise-induced excessive amino acid breakdown and reduce the risk of ammonia poisoning. Simultaneously, the levels of whole blood lactate (LD) and creatine kinase (CK) in the treated group were also significantly reduced, indicating that the traditional Chinese medicine composition can enhance lactate clearance and reduce exercise-induced muscle damage, further supporting its anti-fatigue effect. The changes in the indicators shown in Figure 1 indicate that the traditional Chinese medicine composition can not only delay the onset of fatigue but also promote post-exercise recovery. The medium-dose group showed the most significant effect, indicating that its effect has a certain dose-dependent nature. Combined with changes in organ indices, no obvious toxic reactions were observed, suggesting that the traditional Chinese medicine composition is effective and safe in anti-fatigue applications. Therefore, this traditional Chinese medicine composition can synergistically regulate energy metabolism, reduce fatigue accumulation, and promote bodily recovery through multiple pathways. Its anti-fatigue effect increases with increasing dosage, especially with the medium and high-dose groups showing significant effects in reducing fatigue.

[0079] Experimental Example 5: Effects of Traditional Chinese Medicine Composition on Liver Damage in Mice. Prolonged exercise also affects hepatic lipid metabolism, and ALT and AST are the most sensitive indicators reflecting liver metabolism. Fatigue affects the metabolic function of the mouse liver and damages hepatocytes, leading to increased ALT and AST activity in mouse serum. The activities of ALT and AST in the serum of mice after the weighted swimming experiment in Experimental Example 3 were tested, and the results are shown in Figure 2.

[0080] As shown in Figure 2, after 28 days of administration, the activities of ALT and AST in the serum of mice in the blank control group were higher than those in the other three groups; the activity of ALT in the serum of mice in the high-dose group (HD) was significantly lower than that in the other three groups (P < 0.01), and the activities of AST in the serum of mice in both the high-dose and medium-dose groups were significantly lower than those in the other two groups (p < 0.05). These results indicate that the traditional Chinese medicine composition has a significant effect on reducing the activities of ALT and AST in mouse serum, and the HD group is superior to the MD group. The reduction effect was most significant in the high-dose group. These results suggest that the traditional Chinese medicine composition has a significant protective effect against exercise-induced liver function damage. This effect may be closely related to its enhancement of antioxidant capacity, stabilization of cell membrane structure, and regulation of energy metabolism, thereby reducing the metabolic burden on the liver and maintaining the normal physiological function of hepatocytes.

[0081] Experiment Example 6: Effect of Traditional Chinese Medicine Composition on Energy Metabolism in Mice. The liver glycogen reserves of mice after the weighted swimming experiment in Experiment Example 3 were tested, and the test results are shown in Figure 3.

[0082] As shown in Figure 3, the traditional Chinese medicine composition significantly increased liver glycogen reserves in mice. Compared with the blank control group, the liver glycogen content in the medium and high dose groups was significantly increased (P < 0.05), with the high dose group showing a particularly significant increase in liver glycogen content (P < 0.01). This indicates that the traditional Chinese medicine composition can maintain energy supply during exercise by promoting glycogen synthesis or reducing consumption, thereby delaying the onset of fatigue. This effect corresponds to the prolonged swimming time and the decrease in blood lactate and BUN levels, further confirming the positive role of the traditional Chinese medicine composition in regulating energy metabolism. Simultaneously, the efficient reserve of liver glycogen helps stabilize blood glucose levels during continuous exercise, reducing the metabolic burden from protein breakdown for energy, thereby reducing the production of blood urea nitrogen. Combined with the significant decrease in BUN and lactate concentrations, this indicates that the traditional Chinese medicine composition not only enhances energy reserves but also optimizes the body's utilization efficiency of energy substances and reduces the accumulation of fatigue-related metabolites. In summary, the traditional Chinese medicine composition can effectively enhance the anti-fatigue ability of mice through multiple synergistic pathways. The medium and high dose groups showed the most significant effects, indicating that the traditional Chinese medicine composition has the potential to be further developed into a functional anti-fatigue product.

[0083] Example 7: Effects of Traditional Chinese Medicine Composition on Oxidative Stress in Mice. During physical activity, a large amount of reactive oxygen species (ROS) are generated. These free radicals easily lead to lipid peroxidation damage in skeletal muscle and liver mitochondria. SOD and GSH-Px are important antioxidant enzymes in the body, capable of scavenging superoxide anions and reducing oxidative damage. The levels of SOD, GSH-Px, MDA, and CAT in mice from Example 3 after 28 days of administration were tested. The results are shown in Figure 4.

[0084] As shown in Figure 4, after 28 days of administration, the liver SOD and GSH-Px activities in the high-dose group were significantly higher than those in the control group (P < 0.01), while the MDA content was significantly lower (P < 0.05). These results indicate that the traditional Chinese medicine composition described in this invention can effectively enhance the antioxidant capacity of mice and alleviate exercise-induced oxidative stress damage. The medium and low-dose groups showed similar trends, but the high-dose group showed the most significant effect. The increased SOD activity helps accelerate the clearance of superoxide free radicals, while the enhanced GSH-Px effectively blocks the lipid peroxidation chain reaction and reduces MDA production, thereby protecting cell membrane integrity. This effect synergizes with improved liver function and optimized energy metabolism, further supporting the maintenance of physiological homeostasis under high-intensity exercise. These results demonstrate that the traditional Chinese medicine composition described in this invention can exert a significant anti-fatigue effect by enhancing antioxidant enzyme activity and reducing free radical accumulation. SOD and CAT are indicators for evaluating oxidative damage in mice. GSH-Px is a major protective enzyme that clears lipid peroxidation products produced by cells. As shown in Figure 4, the GSH-Px content was increased in the high, medium, and low dose groups of the traditional Chinese medicine composition compared with the blank group. The medium dose group showed a significant difference compared with the blank group (P < 0.05). As an enzyme that resists oxidative damage, the content of CAT was increased in the high dose group, which was significantly higher than that in the other four groups (P < 0.01). These results indicate that the high dose of the traditional Chinese medicine composition is more effective in resisting oxidative damage.

[0085] Experiment Example 8: Effects of Traditional Chinese Medicine Composition on Liver and Gastrocnemius Muscle Cells in Mice. HE staining was performed on the liver and gastrocnemius muscle of mice in each group 28 days after administration in Experiment Example 3. The HE staining results of the liver in each group are shown in Figure 5, and the HE staining results of the gastrocnemius muscle in each group are shown in Figure 6.

[0086] As shown in Figure 5, the liver lobule structure of mice in the high-dose group was intact and clear, with polygonal hepatocytes arranged in cords with clear boundaries. The hepatocyte nuclei were large and round with clear nuclear membranes, and no obvious fatty deformation or inflammatory cell infiltration was observed. The liver tissue structure of the positive control group and the medium-dose group was basically normal, with occasional mild hepatocyte edema. The nuclear morphology was clear, and no obvious inflammatory infiltration was observed. The low-dose group showed hepatocyte fatty degeneration, but to a lesser extent. The blank control group showed obvious liver lobule structure disorder, irregular arrangement of hepatocyte cords, and some cell nuclei condensation, fragmentation, and dissolution. These results indicate that the traditional Chinese medicine composition has a certain protective effect against exercise-induced liver injury, especially the high- and medium-dose groups, which have more significant protective effects. The liver pathological changes in the high-dose group were the mildest, close to those in the positive control group, indicating that the high-dose water extract had the strongest inhibitory effect on hepatocyte damage.

[0087] Figure 6 shows the HE staining results of the gastrocnemius muscles of mice in each group. As can be seen from Figure 6, the pathological damage score increases sequentially, with the positive drug group showing the lowest score and the best structural integrity. Furthermore, the degree of pathological damage to the gastrocnemius muscle is negatively correlated with the dosage of the food-derived drug. The order is: positive drug group > high-dose group > medium-dose group > low-dose group > blank group. Figure 6 shows that in the positive drug group, muscle fibers are neatly arranged with clear striations, and cell nuclei are centrally located, without obvious degeneration or inflammatory infiltration. The high-dose group shows relatively uniform size, with a few abnormal morphologies, sparsely distributed cell nuclei, and occasional aggregation. The medium and low-dose groups also show a similar protective trend, with occasional mild muscle fiber swelling. In contrast, the blank group shows disordered muscle fiber arrangement, with some areas exhibiting breakage, necrosis, and interstitial inflammatory cell infiltration.

[0088] The above results collectively demonstrate that the food-derived traditional Chinese medicine composition prepared in this invention, after being administered to mice via gavage, increased the time mice could swim under load and inhibited the accumulation of harmful substances caused by excessive fatigue, such as serum urea nitrogen, lactate, and creatine kinase. Simultaneously, the traditional Chinese medicine composition also regulated the level of liver glycogen in mice, enhancing their glycogen reserve capacity. Detection of oxidative stress levels in mice revealed that the traditional Chinese medicine composition prepared in this invention can inhibit the production of MDA in the liver and serum of mice by increasing antioxidant-related enzymes (SOD, GSH-Px, and CAT), thereby improving the oxidative stress response in fatigued mice. These results indicate that this anti-fatigue traditional Chinese medicine composition can alleviate exercise-induced fatigue through a multi-pathway synergistic effect, and its mechanism of action involves energy metabolism regulation and oxidative damage inhibition, possessing potential value for functional food development. Furthermore, this invention further confirms that this food-derived medicine has a positive effect on regulating immune function and promoting bodily recovery, especially showing a more significant anti-fatigue effect in the medium and high dose groups. Combined with the trend of body weight change, the body weight of mice in each treatment group steadily increased, and no obvious toxic reactions were observed, suggesting good safety. Meanwhile, the MD group performed best in multiple indicators, suggesting that the medium-dose traditional Chinese medicine composition is the optimal effective dose range.

[0089] The present invention has been described in detail above with reference to specific embodiments and exemplary examples; however, these descriptions should not be construed as limiting the present invention. Those skilled in the art will understand that various equivalent substitutions, modifications, or improvements can be made to the technical solutions and embodiments of the present invention without departing from the spirit and scope of the invention, and all such modifications and improvements fall within the scope of the present invention. The scope of protection of the present invention is defined by the appended claims.

Claims

1. A traditional Chinese medicine composition for relieving fatigue, characterized in that, The anti-fatigue traditional Chinese medicine composition comprises the following raw materials in parts by weight: 5-10 parts red ginseng, 35-50 parts American ginseng, 3-8 parts sun-dried ginseng, 5-10 parts wolfberry, 10-20 parts honey, 5-10 parts xylitol, and 3-8 parts starch.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The anti-fatigue traditional Chinese medicine composition also includes: 5-10 parts by weight of ginseng and 4-6 parts by weight of Ganoderma lucidum.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The anti-fatigue traditional Chinese medicine composition comprises the following raw materials in parts by weight: 6-8 parts red ginseng, 6-8 parts ginseng, 4.5-5 parts Ganoderma lucidum, 40-45 parts American ginseng, 4-6 parts sun-dried ginseng, 6-8 parts wolfberry, 13-17 parts honey, 6-8 parts xylitol, and 5-7 parts starch.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The anti-fatigue traditional Chinese medicine composition comprises the following raw materials in parts by weight: 7 parts red ginseng, 7 parts ginseng, 4.7 parts Ganoderma lucidum, 42 parts American ginseng, 5 parts sun-dried ginseng, 7 parts wolfberry, 15 parts honey, 7 parts xylitol, and 6 parts starch.

5. A method for preparing a compound special dietary supplement, characterized in that, The compound special dietary supplement is prepared from the anti-fatigue traditional Chinese medicine composition according to any one of claims 1 to 4. The preparation method includes the following steps: Step 1: Wash and slice red ginseng, American ginseng, and sun-dried ginseng respectively, then perform low-temperature drying treatment, and then pulverize to obtain ultrafine mixed powder; Step 2: Wash and pit wolfberries, add water to decoct, filter, and concentrate the wolfberry juice to obtain concentrated wolfberry juice; Step 3: Add honey and xylitol to the concentrated wolfberry juice, heat under stirring conditions to completely dissolve xylitol, then add ultrafine mixed powder, stir evenly, then add starch, stir into a paste, granulate the paste mixture, and dry to obtain the compound special dietary supplement.

6. The preparation method according to claim 5, characterized in that, In step 1, the conditions for the low-temperature drying process are as follows: the drying temperature is 40-50℃, the drying time is 8-12 h, and the moisture content is reduced to below 5% after drying; the dried red ginseng, American ginseng, sun-dried ginseng, ginseng, and Ganoderma lucidum are pulverized to a particle size of 10-20 μm.

7. The preparation method according to claim 5, characterized in that, In step 2, the decocting temperature is 80-90℃, and the decocting time is 1-2 hours.

8. The preparation method according to claim 5, characterized in that, In step 3, honey and xylitol are added to the concentrated goji berry juice, and the mixture is heated to 60-70°C while stirring.

9. The preparation method according to claim 5, characterized in that, In step 3, the paste mixture is granulated into particles of 2-4 mm; the drying temperature is 50-60°C, the drying time is 4-6 h, and the moisture content is reduced to below 3% after drying.

10. The use of an anti-fatigue traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of functional foods.

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