A traditional Chinese medicine compound preparation for relieving fatigue, a preparation method and application thereof

Abstract

The application belongs to the technical field of biological medicine, and discloses a traditional Chinese medicine compound preparation for relieving fatigue, a preparation method and application. The compound preparation is prepared by using ginseng, polygala, acorus gramineus soland, borneol and mint according to a specific weight ratio. According to the characteristics of the traditional Chinese medicines in the compound, a preparation process of separate treatment is adopted. The acorus gramineus soland and the mint are subjected to steam distillation to obtain volatile oil, and the volatile oil is subjected to inclusion with β-cyclodextrin. The ginseng and the polygala are subjected to ethanol reflux extraction, concentration and drying to obtain an extract. The obtained volatile oil inclusion compound and the extract are mixed with borneol and pharmaceutically acceptable excipients to granulate, so as to obtain granules. Animal experiments show that the granules can significantly prolong the weight swimming time, reduce the serum urea and blood lactic acid levels, have excellent fatigue relieving effect, and can be applied to the preparation of anti-fatigue drugs or health foods.

Description

Technical Field

[0001] This invention belongs to the field of biomedical technology, specifically relating to a traditional Chinese medicine compound preparation for relieving fatigue, its preparation method, and its application. Background Technology

[0002] Currently, products for relieving physical fatigue mainly include functional drinks, nutritional supplements, chemical stimulants, and traditional Chinese medicine compound preparations. Among them, traditional Chinese medicine compound anti-fatigue products often combine qi-tonifying and mind-awakening drugs, and are used in the form of decoctions, oral liquids, or ordinary granules. These products mainly involve compounding traditional Chinese medicines with tonifying, intellect-enhancing, and aromatic stimulant effects, and then preparing them into preparations through conventional water decoction or alcohol extraction processes to improve fatigue, lethargy, or low bodily function.

[0003] While current market products can improve fatigue to some extent, they still have the following shortcomings: First, some existing products mainly rely on sugars, electrolytes, caffeine, or single nutrients to provide a short-term boost, with a relatively simple mechanism of action, resulting in limited comprehensive regulatory effects on improving exercise endurance, clearing fatigue metabolites, and restoring the body's energy reserves. Second, although some chemical stimulants or anti-fatigue agents have a rapid onset of action, they suffer from insufficient safety with long-term use, limited applicability, and the body's tendency to develop adaptations, making them unsuitable for long-term conditioning and widespread application. Third, traditional Chinese medicine anti-fatigue regimens are mostly based on decoctions, which generally suffer from drawbacks such as cumbersome preparation, inconvenient portability, poor adherence to medication, insufficient stability of ingredients, and inconsistent quality. Especially for traditional Chinese medicine compound formulas containing both volatile and non-volatile components, existing conventional decoction or single extraction processes are difficult to ensure the full extraction and stable retention of active ingredients with different properties. This can easily lead to the loss of volatile components in herbs such as Acorus tatarinowii and Mentha haplocalyx during extraction, concentration and drying, while the effective components in herbs such as Ginseng and Polygala tenuifolia are difficult to extract optimally under the same process conditions, thus affecting the overall anti-fatigue effect of the compound formula.

[0004] In addition, existing solid dosage forms of traditional Chinese medicine still have shortcomings in terms of uniform dispersion of volatile oils, particle shape, taste improvement, storage stability, and adaptability to industrial production.

[0005] Although these products have a certain basis in anti-fatigue, they generally suffer from problems such as easy loss of volatile components, difficulty in extracting components with different properties, insufficient stability and uniformity of formulations, and unsatisfactory convenience of administration and industrial adaptability. They cannot yet adequately meet the needs of products for relieving physical fatigue in terms of component retention, dosage form optimization, and large-scale preparation.

[0006] Therefore, there is an urgent need for existing technologies to provide a traditional Chinese medicine compound granule formulation with a clear formula, reasonable process, stable components, easy to carry and take, suitable for industrial production, and capable of relieving physical fatigue, as well as its preparation method. Summary of the Invention

[0007] To address the above-mentioned technical problems, the primary objective of this invention is to provide a traditional Chinese medicine compound preparation for relieving fatigue. This formula uses ginseng, polygala, acorus, borneol, and peppermint as main ingredients, and through rational formulation, it combines the effects of invigorating qi and strengthening the body, refreshing the mind, boosting bodily functions, and relieving physical fatigue. Considering that the compound contains both volatile and non-volatile components, this application employs a technical route combining segmented extraction and subsequent integration, thereby improving the product's component stability, ease of administration, and feasibility for industrial production. This technical solution not only retains the overall synergistic advantages of traditional Chinese medicine compound preparations but also overcomes the shortcomings of traditional decoctions, such as cumbersome preparation, inconvenient portability, unstable components, and poor patient compliance. It can be used to prepare products that relieve physical fatigue, improve exercise endurance, and improve fatigue-related biochemical indicators.

[0008] To achieve the above objectives, the present invention adopts the following technical solution: A traditional Chinese medicine compound preparation for relieving fatigue, based on the total mass fraction of raw medicinal materials, comprises the following components in the indicated mass fractions: Ginseng 15-30 parts, Polygala tenuifolia 45-90 parts, Acorus tatarinowii 95-190 parts, Borneol 2.5-5 parts and Mentha 30-60 parts.

[0009] Preferably, the active pharmaceutical ingredient is composed of the following components in parts by weight, based on the total mass of the raw medicinal materials: Ginseng 24 parts, Polygala tenuifolia 72 parts, Acorus tatarinowii 152 parts, Borneol 4 parts and Mentha 48 parts.

[0010] Preferably, the formulation is in the form of granules.

[0011] The above-mentioned ginseng refers to the dried root and rhizome of Panax ginseng (CAMey.), a plant of the Araliaceae family; the polygala refers to the dried root of Polygala tenuifolia Willd., a plant of the Polygalaceae family; the acorus refers to the dried rhizome of Acorus tatarinowii Schott, a plant of the Araceae family; the peppermint refers to the dried aerial parts of Mentha haplocalyx Briq., a plant of the Lamiaceae family; and the borneol refers to medicinal borneol.

[0012] The second objective of this invention is to provide a method for preparing a traditional Chinese medicine compound preparation for relieving fatigue. This method achieves effective extraction, stable integration, and synergistic utilization of volatile and non-volatile components through a reasonable process, and further prepares granules with relatively stable components, easy to carry, convenient to take, and suitable for industrial production. This overcomes the shortcomings of existing technologies in relieving physical fatigue, such as single effect, poor compliance, easy loss of effective components, and insufficient stability of the preparation.

[0013] A method for preparing a traditional Chinese medicine compound preparation for relieving fatigue includes the following steps: S1. Select ginseng, polygala, acorus and mint according to the corresponding mass proportions, dry and grind them into coarse powder for later use; S2. Select borneol powder, crush it, sieve it, and set it aside. S3. Extraction of volatile oil: Mix coarse powder of Acorus calamus and coarse powder of peppermint, extract volatile oil by steam distillation, collect the distillate, let it stand to separate the layers, and obtain the mixed volatile oil of Acorus calamus and peppermint for later use; S4. Volatile oil inclusion: Select the mixed volatile oil of Acorus tatarinowii and peppermint and treat it with β-cyclodextrin. Let it stand, filter, collect the precipitate, dry and pulverize it to obtain volatile oil inclusion powder for later use. S5. Alcohol extraction: Take ginseng crude powder and polygala crude powder, extract with alcohol, filter, combine the extracts, concentrate under reduced pressure to obtain a thick paste, dry to obtain a dry paste powder for later use. S6. Granulation: Mix the dry extract powder, volatile oil inclusion compound powder, borneol and pharmaceutically acceptable excipients evenly, granulate, dry and granulate to obtain the final product.

[0014] Preferably, in step S1, the material is pulverized and then passed through a 20-40 mesh sieve. In step S2, the material is pulverized and then passed through a 100-200 mesh sieve. In S3, the steam distillation extraction process is as follows: add 6 to 10 times the total weight of coarse powder of Acorus tatarinowii and coarse powder of peppermint to water and extract for 3 to 5 hours. In step S4, the weight ratio of the mixed volatile oil of Acorus tatarinowii and peppermint to β-cyclodextrin is 1:5 to 1:20. The volatile oil mixture of Acorus calamus and peppermint is encapsulated with β-cyclodextrin for 1-2 hours, left to stand for 12-24 hours, and then dried and pulverized at 50-60°C.

[0015] Preferably, in step S3, the steam distillation extraction process is as follows: add water in a mixture of coarse powder of Acorus tatarinowii and coarse powder of peppermint, which is 8 times the total weight of the mixture, and extract for 4 hours; In step S4, the weight ratio of the mixed volatile oil of Acorus tatarinowii and peppermint to β-cyclodextrin is 1:10.

[0016] Preferably, in step S5, the alcohol extraction process is as follows: add 6-10 times the total weight of ginseng crude powder and polygala crude powder, with a mass concentration of 70% ethanol, heat to 70-90℃ and reflux for extraction 2-3 times, 1.0-1.6h / extraction, combine the extracts and filter, reduce pressure under -0.06-0.09 MPa, concentrate to 50-60℃, and obtain a thick paste with a relative density of 1.25-1.30.

[0017] Preferably, in step S5, the alcohol extraction process is as follows: 8 times the total weight of ginseng crude powder and polygala crude powder, with a mass concentration of 70%, is added, heated to 80°C and refluxed twice, 1.1h / time. The extracts are combined and filtered, and then concentrated to 55°C under reduced pressure at -0.08MPa.

[0018] Preferably, in S6, pharmaceutically acceptable excipients include dextrin and steviol glycosides; The amount of dextrin added is 20-40% of the weight of the dry extract powder; The amount of steviol glycosides added is 0.5-2% of the weight of the dry extract powder; The granulation process is carried out under a 14-20 mesh sieve; the particles are dried at 50-60°C until the moisture content of the particles is not higher than 5%; and the particles are sized under a 14-20 mesh sieve.

[0019] The application of a traditional Chinese medicine compound preparation for relieving fatigue in the preparation of drugs or health foods for relieving physical fatigue, wherein relieving physical fatigue includes improving exercise endurance, reducing serum urea after exercise, and improving blood lactate levels.

[0020] Compared with the prior art, the present invention has at least the following technical effects: (I) This invention provides a traditional Chinese medicine compound preparation for relieving fatigue. The formula uses ginseng, polygala, acorus, borneol and peppermint as the main raw materials and is prepared into granules through reasonable combination, so that it has the effects of invigorating qi and strengthening the body, refreshing the mind with fragrance, boosting function and relieving physical fatigue.

[0021] (II) In a method for preparing a traditional Chinese medicine compound preparation for relieving fatigue, this application adopts a technical route combining segmented extraction and subsequent integration, taking into account the characteristic that the compound contains both volatile and non-volatile components. Specifically, it employs key combined process steps and parameters such as volatile oil extraction, β-cyclodextrin inclusion complexation, 70% ethanol reflux extraction, vacuum concentration, spray drying, mixing and granulation, and drying and granulation. Acorus tatarinowii and peppermint are used to extract volatile oils, while ginseng and polygala tenuifolia are used for alcohol extraction of effective components. This further achieves segmented extraction and synergistic retention of volatile and non-volatile components, thereby improving the product's component stability, ease of use, and feasibility for industrial production. Simultaneously, the volatile oil inclusion complexation technology reduces the loss of volatile components during subsequent drying, mixing, and storage, improving the stability and uniformity of the preparation.

[0022] (III) The formulation of this traditional Chinese medicine compound preparation for relieving fatigue is based on the functional positioning of relieving physical fatigue. It has established a complete system of formulation design, dosage form conversion and preparation process. When using it, the granules can be dissolved in warm water. The dosage of this compound preparation is controlled by the equivalent amount of raw medicinal materials. The test samples are prepared into stock solution and working solution that are easy to administer by gavage, so as to ensure the accuracy and repeatability of the administration in animal experiments.

[0023] (iv) This technical solution not only retains the overall synergistic advantages of traditional Chinese medicine compound prescriptions, but also overcomes the defects of traditional decoctions such as cumbersome decoction preparation, inconvenience of carrying, unstable composition, and poor compliance. It uses indicators such as weight-bearing swimming time, serum urea, and blood lactate as the main detection indicators to comprehensively evaluate the effect of this patented product in relieving physical fatigue from the aspects of exercise endurance, accumulation of metabolites, and fatigue recovery ability. This further ensures that it can be used to prepare products that relieve physical fatigue, improve exercise endurance, and improve fatigue-related biochemical indicators. Detailed Implementation

[0024] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the present invention will be briefly described below in conjunction with the description of the embodiments or the prior art. It should be noted that the description of these embodiments is for the purpose of helping to understand the present invention, but does not constitute a limitation of the present invention.

[0025] This invention relates to a self-formulated prescription based on traditional Chinese medicine theory and experience in medication. According to the principles of traditional Chinese medicine, physical fatigue can be related to factors such as insufficient vital energy, malnourishment of the sensory orifices, and phlegm-dampness obstructing the orifices. This prescription uses ginseng to tonify vital energy and strengthen the body; a large dosage of acorus tatarinowii is used for its aromatic properties of resolving dampness, opening the orifices, and refreshing the mind; polygala tenuifolia is combined with acorus tatarinowii to calm the mind, improve intelligence, resolve phlegm, and open the orifices; peppermint is used for its dispersing, clearing, aromatic, and refreshing properties; and borneol is used for its aromatic and orifice-opening properties, forming a prescription structure that combines tonifying vital energy with aromatic and refreshing effects.

[0026] Example 1: A traditional Chinese medicine compound preparation for relieving fatigue: Ginseng 15g, Polygala tenuifolia 45g, Acorus tatarinowii 95g, Borneol 2.5g and Mentha 30g.

[0027] Example 2: (Optimal Ratio) A traditional Chinese medicine compound preparation for relieving fatigue, with a medium dosage ratio: Based on a total of 100%, it consists of 8.00% ginseng, 24.00% polygala tenuifolia, 50.67% acorus tatarinowii, 1.33% borneol, and 16.00% peppermint.

[0028] Based on an adult's total daily intake of 37.5 g of raw herbs, the equivalent amounts for each herb are: ginseng 3.0 g, polygala 9.0 g, acorus tatarinowii 19.0 g, borneol 0.5 g, and peppermint 6.0 g.

[0029] Based on a total of 300 g of raw medicinal materials per batch, the following amounts are calculated for each ingredient: ginseng 24.0 g, polygala 72.0 g, acorus tatarinowii 152.0 g, borneol 4.0 g, and peppermint 48.0 g.

[0030] Functional positioning of this dosage ratio mode: Ginseng primarily replenishes vital energy, enhances the body's adaptability and anti-fatigue capabilities, and its ginsenosides and other components help improve energy metabolism and oxidative stress. Polygala tenuifolia primarily benefits intelligence, calms the mind, and harmonizes the heart and kidneys, helping to improve lethargy and functional decline under fatigue. Acorus tatarinowii, with its aromatic and refreshing properties, plays a crucial role in boosting spirits and improving sluggishness and weakness. Borneol, with its pungent and penetrating properties, opens the orifices and refreshes the mind; a small amount added enhances the overall aromatic and refreshing effect of the formula and promotes the release of active ingredients. Peppermint, with its pungent and cooling aroma, has the effect of refreshing the mind, enhancing alertness, and reducing accumulated fatigue. The combined effects of these herbs are to replenish vital energy, invigorate the mind, improve endurance, and relieve physical fatigue.

[0031] Example 3: A traditional Chinese medicine compound preparation for relieving fatigue: Ginseng 30g, Polygala tenuifolia 45-90g, Acorus tatarinowii 190g, Borneol 5g and Mentha 60g.

[0032] A method for preparing a traditional Chinese medicine compound preparation for relieving fatigue: S1. Weigh out the raw materials of ginseng, polygala, acorus, borneol and peppermint according to the above proportions. After removing impurities and non-medicinal parts, dry the ginseng, polygala, acorus and peppermint separately and grind them into coarse powder, preferably through a 20-mesh sieve, for later use; grind or finely grind the borneol separately for later use. S2. Mix coarse powder of Acorus tatarinowii and coarse powder of peppermint, place them in a volatile oil extraction device, add water in a volume of 8 times the total weight of the medicinal materials, and extract the volatile oil by steam distillation. The extraction time is preferably 4 hours. Collect the distillate, let it stand to separate the layers, and obtain the mixed volatile oil of Acorus tatarinowii and peppermint for later use. S3. Take an appropriate amount of β-cyclodextrin and add it to purified water. Stir and dissolve it at 60°C to prepare a saturated solution. Slowly add the above-mentioned Acorus tatarinowii-peppermint mixed volatile oil under stirring. Continue stirring for 1 hour to allow the volatile oil and β-cyclodextrin to fully contact and form an inclusion system. After standing for 24 hours, filter, collect the precipitate, dry and pulverize it at 60°C to obtain the volatile oil inclusion powder for later use. S4. Take ginseng coarse powder and polygala coarse powder, mix them and put them into an extraction tank. Add 70% ethanol, which is 8 times the total weight of the powder. Heat and reflux to extract twice, preferably for 1.5 hours each time. Combine the two extracts and filter to obtain the ethanol extract filtrate. S5. The above alcohol extract filtrate is subjected to reduced pressure to recover ethanol, and concentrated to a thick paste with a relative density of 1.25~1.30 at 60℃ for later use. S6. Add an appropriate amount of purified water to the obtained thick paste to adjust the concentration, preferably so that the relative density of the liquid is 1.05~1.10, and then dry it by spray drying to obtain dry paste powder for later use. S7. Add the obtained dry powder, volatile oil inclusion complex powder, borneol, and excipients dextrin and steviol glycosides into a mixer according to the formula and mix thoroughly. It is preferable to premix the borneol with a portion of the dextrin before mixing with the remaining materials to improve the uniformity of dispersion. Then, add 85% ethanol as a wetting agent to the uniformly mixed powder while stirring to make a soft material that can be formed into a ball when squeezed by hand and dispersed when lightly pressed. S8. Put the above soft material into a swing granulator or extrusion granulator and pass it through a 20-mesh sieve to make wet granules. S9. Spread the obtained wet granules evenly on a drying tray and dry them under forced air at 60℃ until the moisture content of the granules is no more than 5%. After drying, sieve through a 20-mesh sieve to remove excessively fine powder and excessively large granules, and obtain a finished product with uniform granules. S10. Finally, the finished product granules are packaged according to the specified dosage, preferably 5-10 g per bag, sealed in aluminum foil composite film bags, and stored in a cool, dry, and light-proof place.

[0033] Experimental and test data: The following experiments of this invention are all based on the granules prepared with fixed formulations in Example 2. The low, medium, and high dose animal groups prepared below are all based on Example 2, and the dosage was adjusted only by crude drug equivalent.

[0034] Comparative experimental study on the effects of the traditional Chinese medicine compound granules of the present invention in improving / relieving physical fatigue (refer to "Methods for Functional Testing and Evaluation of Health Foods (2023 Edition)"). The experimental method used in this study referenced the "Test Method for Relieving Physical Fatigue" in the "Methods for Functional Testing and Evaluation of Health Foods (2023 Edition)," specifically as follows: Experimental methods: Laboratory animals: Purebred mice are recommended, adult mice, weighing 18-22g.

[0035] Dosage grouping and administration time of test samples: The experiment included three dosage groups and one blank control group. The administration time of test samples was 30 days, which could be extended to 45 days if necessary.

[0036] Experimental procedure: 30 minutes after the last administration of the test sample, mice with a lead weight of 5% of their body weight loaded at the base of their tails were placed in a swimming tank to swim. The water depth was no less than 30 cm, and the water temperature was 25℃±1.0℃. The time from the start of swimming to death was recorded, i.e., the weighted swimming time of the mice.

[0037] 1.1 Laboratory Animals and Environment Eight-week-old male SPF-grade Kunming mice, weighing 18–22 g, were selected. Mice were housed in an SPF-grade barrier environment with free access to food and water. The laboratory temperature was controlled at 22±2℃, and the relative humidity at 50%±10%, using a 12 h / 12 ​​h light-dark cycle. Animals underwent a 7-day acclimatization period before the formal experiments. During the experiments, the housing environment was kept stable, minimizing the impact of noise, disturbance, and temperature and humidity fluctuations on the experimental results.

[0038] 1.2 Test Samples and Dosage Grouping The test sample was a compound Chinese medicine granule prepared according to Example 2, and the dosage was calculated based on the equivalent of crude drug.

[0039] According to the requirements of the experiment on alleviating physical fatigue, the animals were randomly divided into a blank control group, a low-dose group, a medium-dose group, and a high-dose group, with 10 animals in each group, for a total of 40 animals. The drug dosages for the low, medium, and high-dose groups were 2.0 g crude drug / kg, 4.0 g crude drug / kg, and 8.0 g crude drug / kg, respectively. The blank control group was given an equal volume of purified water or a corresponding blank carrier.

[0040] 1.3 Dosing cycle and gavage volume All treatment groups were administered the medication by gavage once daily for 30 consecutive days. The gavage volume was uniformly 10 mL / kg body weight. The blank control group received the same volume of purified water or blank carrier via gavage. All fatigue-related tests were generally performed 30 minutes after the last administration.

[0041] 1.4 Preparation of Mother Liquor (300 g of crude drug) Following the formulation pattern of Example 2, a batch of 300 g of total crude drug equivalent was prepared. Specifically, 24 g of ginseng, 72 g of polygala tenuifolia, 152 g of acorus tatarinowii, 4 g of borneol, and 48 g of peppermint were weighed. After preparation according to the established method, the resulting test sample was converted into a stock solution based on the crude drug equivalent. The extract corresponding to 300 g of total crude drug was considered as one batch, and purified water was used to make up to 375 mL. The solution was thoroughly mixed to obtain a stock solution with a crude drug equivalent concentration of 0.8 g / mL. The stock solution should be prepared and used immediately; if necessary, it can be stored at 4°C for a short period of time, and then brought to room temperature and thoroughly mixed before use.

[0042] 1.5 Preparation and dilution of working solution Working solutions were prepared based on the 0.8 g crude drug equivalent / mL mother liquor obtained in Example 2: The high-dose group used the mother liquor directly at a concentration of 0.8 g / mL; the medium-dose group mixed the mother liquor with purified water at a 1:1 volume ratio to a concentration of 0.4 g / mL; and the low-dose group mixed the mother liquor with purified water at a 1:3 volume ratio to a concentration of 0.2 g / mL. Each working solution was prepared fresh and thoroughly mixed before administration. The formulations and preparation processes of the low, medium, and high-dose groups were identical, differing only in the crude drug equivalent dosage.

[0043] 1.6 Weighted Swimming Experiment The experimental setup consisted of a swimming tank with a water depth of at least 30 cm and a water temperature controlled at 25±1℃. A lead weight equivalent to 5% of the mouse's body weight was fixed to the base of the mouse's tail, and each mouse was placed individually in the tank to begin timing. Exhaustion was determined by the mouse's nose remaining submerged for 10 seconds without surfacing. The duration from entry into the water to exhaustion was recorded as the weighted swimming time. A longer weighted swimming time indicates better exercise endurance and a more significant effect of the test sample in alleviating physical fatigue. After the experiment, the mean and standard deviation of the swimming times for each group were statistically analyzed, and one-way ANOVA was used for inter-group comparisons.

[0044] 1.7 Serum urea determination (fully automated biochemical analyzer) Mice were placed in 30℃ water for 90 minutes of weightless swimming, followed by a 60-minute rest. After the rest period, whole blood samples were collected using the tail tip sampling method without anticoagulant. The samples were incubated at 4℃ for approximately 3 hours to allow the blood to clot, then centrifuged at 2000 r / min for 15 minutes to separate the serum. The obtained serum was analyzed according to the instructions of the kit accompanying the fully automated biochemical analyzer to determine serum urea levels. Elevated serum urea levels generally indicate increased protein metabolism and exacerbated fatigue. If the serum urea level in the tested sample group was significantly lower than that in the blank control group, it indicates that the sample has a certain effect in alleviating physical fatigue.

[0045] 1.8 Blood lactate determination A three-time-point blood sampling method was used: the first time point was before swimming; the second time point was immediately after the mice swam in 30℃ water without load for 10 minutes; and the third time point was after a 20-minute rest period following swimming. 20 μL of tail blood was collected at each time point and immediately added to 40 μL of membrane-breaking fluid or lactate assay solution. The mixture was thoroughly shaken and measured using a lactate analyzer. Blood lactate levels at each time point were recorded, and the peak concentration was extracted as the result of the test. If necessary, the trend or degree of recovery of blood lactate levels could also be calculated according to the kit instructions. If the increase in blood lactate after swimming was smaller in the test sample group than in the blank control group, or if the blood lactate level decreased faster during the recovery period, it suggests that the test sample helps reduce post-exercise lactate accumulation and promote fatigue recovery.

[0046] 1.9 Statistical Judgment Experimental data are expressed as mean ± standard deviation. Measurement data such as body weight, weight-bearing swimming time, serum urea, area under the curve of blood lactate, and liver or muscle glycogen content were first tested for normality and homogeneity of variance. Data that conformed to a normal distribution and had homogeneity of variance were compared between groups using one-way ANOVA. If the overall differences were statistically significant, further statistical analysis was performed using pairwise comparisons between multiple experimental groups and one control group.

[0047] For non-normally distributed or unequal variance data, appropriate variable transformations can be performed. If the transformed data meets the requirements of normality and homogeneity of variance, the transformed data should be used for analysis of variance. If the transformed data still does not meet the requirements of normality or homogeneity of variance, the rank-sum test should be used for statistical analysis. All statistical tests are two-tailed, and a p-value < 0.05 is considered statistically significant.

[0048] 2. Experimental Results 2.1 The changes in mouse body weight are shown in Table 1.

[0049] Table 1. Changes in mouse body weight

[0050] The data in the table represent the mean values ​​of each group, n=10. There were no statistically significant differences between the treatment groups and the blank control group at any time point. P >0.05). There were no significant differences in body weight among the groups of mice before acclimatization, before drug administration, and after 30 days of continuous drug administration.

[0051] 2.2 In the weighted swimming experiment, the time to exhaustion for mice in the blank control group was 23.15±4.76 min. Compared with the blank control group, each dosage group in the example could prolong the time to exhaustion for mice to varying degrees, with the low-dose group at 30.51±5.83 min, the medium-dose group at 31.95±3.27 min, and the high-dose group at 41.35±7.98 min.

[0052] Table 2 Results of the Swimming Exhaustion Experiment

[0053] (Note: Data are expressed as mean ± standard deviation, n=10; compared with the blank control group, *P<0.05, **P<0.01, ***P<0.001.) Conclusion: The swimming exhaustion time of mice in the low-dose, medium-dose, and high-dose groups was significantly longer than that in the blank control group, and the trend of prolongation became more pronounced with increasing dosage, with the high-dose group showing the most significant effect. These results suggest that the high-dose group may alleviate physical fatigue to some extent by improving the exercise endurance of mice.

[0054] 2.3 In the serum urea assay, the serum urea level in the blank control group was 13.43 ± 2.54 mmol / L. Compared with the blank control group, the serum urea levels in each dosage group of the example were reduced, with the low-dose group at 10.09 ± 1.31 mmol / L, the medium-dose group at 7.83 ± 1.09 mmol / L, and the high-dose group at 6.07 ± 0.45 mmol / L.

[0055] Table 3 Mouse serum urea test

[0056] (Note: Data are expressed as mean ± standard deviation, n=10; compared with the blank control group, *P<0.05, **P<0.01, ***P<0.001.) Conclusion: With increasing dosage, serum urea levels in mice gradually decreased, with the most significant decrease observed in the high-dose group. This suggests that Example 2 can reduce urea accumulation after exercise and improve the body's enhanced protein catabolism state, thereby having a certain effect in relieving physical fatigue.

[0057] 2.4 In the blood lactate assay, the blood lactate level in the blank control group was 11.05 ± 1.37 mmol / L; the low-dose, medium-dose, and high-dose groups were 9.65 ± 1.09 mmol / L, 7.88 ± 0.54 mmol / L, and 4.53 ± 0.19 mmol / L, respectively. Compared with the blank control group, the blood lactate levels in all treatment groups were significantly reduced, showing a dose-dependent decreasing trend, with the high-dose group showing the most significant effect.

[0058] Table 4. Mouse blood lactate test

[0059] (Note: Data are expressed as mean ± standard deviation, n=10; compared with the blank control group, *P<0.05, **P<0.01, ***P<0.001.) Conclusion: This traditional Chinese medicine compound preparation can effectively promote the clearance of blood lactic acid after exercise, reduce lactic acid accumulation, and has a positive effect on relieving physical fatigue.

[0060] Finally, it should be noted that the above description is merely a preferred embodiment of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine compound preparation for relieving fatigue, characterized in that, Based on the total mass fraction of the raw medicinal materials, the active pharmaceutical ingredient consists of the following components in the indicated mass fractions: Ginseng 15-30 parts, Polygala tenuifolia 45-90 parts, Acorus tatarinowii 95-190 parts, Borneol 2.5-5 parts and Mentha 30-60 parts.

2. A traditional Chinese medicine compound preparation for relieving fatigue according to claim 1, characterized in that, Based on the total mass fraction of the raw medicinal materials, the active pharmaceutical ingredient consists of the following components in the indicated mass fractions: Ginseng 24 parts, Polygala tenuifolia 72 parts, Acorus tatarinowii 152 parts, Borneol 4 parts and Mentha 48 parts.

3. A traditional Chinese medicine compound preparation for relieving fatigue according to claim 1 or 2, characterized in that, The formulation is in the form of granules.

4. A method for preparing a traditional Chinese medicine compound preparation for relieving fatigue as described in claim 1 or 2, characterized in that, Includes the following steps: S1. Select ginseng, polygala, acorus and mint according to the corresponding mass proportions, dry and grind them into coarse powder for later use; S2. Select borneol powder, crush it, sieve it, and set it aside. S3. Extraction of volatile oil: Mix coarse powder of Acorus calamus and coarse powder of peppermint, extract volatile oil by steam distillation, collect the distillate, let it stand to separate the layers, and obtain the mixed volatile oil of Acorus calamus and peppermint for later use; S4. Volatile oil inclusion: Select the mixed volatile oil of Acorus tatarinowii and peppermint and treat it with β-cyclodextrin. Let it stand, filter, collect the precipitate, dry and pulverize it to obtain volatile oil inclusion powder for later use. S5. Alcohol extraction: Take ginseng crude powder and polygala crude powder, extract with alcohol, filter, combine the extracts, concentrate under reduced pressure to obtain a thick paste, dry to obtain a dry paste powder for later use. S6. Granulation: Mix the dry extract powder, volatile oil inclusion compound powder, borneol and pharmaceutically acceptable excipients evenly, granulate, dry and granulate to obtain the final product.

5. The preparation method according to claim 4, characterized in that, In S1, the material is pulverized and then passed through a 20-40 mesh sieve; In step S2, the material is pulverized and then passed through a 100-200 mesh sieve. In S3, the steam distillation extraction process is as follows: add 6 to 10 times the total weight of coarse powder of Acorus tatarinowii and coarse powder of peppermint to water and extract for 3 to 5 hours. In S4, The weight ratio of the mixed volatile oil of Acorus calamus and peppermint to β-cyclodextrin is 1:5 to 1:20; The volatile oil mixture of Acorus calamus and peppermint is encapsulated with β-cyclodextrin for 1-2 hours, left to stand for 12-24 hours, and then dried and pulverized at 50-60°C.

6. The preparation method according to claim 5, characterized in that, In S3, the steam distillation extraction process is as follows: add 8 times the total weight of coarse powder of Acorus tatarinowii and coarse powder of peppermint to water and extract for 4 hours; In step S4, the weight ratio of the mixed volatile oil of Acorus tatarinowii and peppermint to β-cyclodextrin is 1:

10.

7. The preparation method according to claim 4, characterized in that, In step S5, the alcohol extraction process is as follows: add 6 to 10 times the total weight of ginseng crude powder and polygala crude powder, with a mass concentration of 70% ethanol, heat to 70 to 90°C and reflux for extraction 2 to 3 times, 1.0 to 1.6 hours per extraction, combine the extracts and filter, reduce pressure under -0.06 to -0.09 MPa, concentrate to 50 to 60°C, and obtain a thick paste with a relative density of 1.25 to 1.

30.

8. The preparation method according to claim 7, characterized in that, In S5, the alcohol extraction process is as follows: add 8 times the total weight of ginseng crude powder and polygala crude powder, with a mass concentration of 70% ethanol, heat to 80℃ and reflux extract twice, 1.1h / time, combine the extracts and filter, reduce pressure at -0.08 MPa and concentrate to 55℃.

9. The preparation method according to claim 4, characterized in that, In S6, pharmaceutically acceptable excipients include dextrin and steviol glycosides; The amount of dextrin added is 20-40% of the weight of the dry extract powder; The amount of steviol glycosides added is 0.5-2% of the weight of the dry extract powder; The granulation process is carried out under a 14-20 mesh sieve; the particles are dried at 50-60°C until the moisture content of the particles is not higher than 5%; and the particles are sized under a 14-20 mesh sieve.

10. The application of a traditional Chinese medicine compound preparation for relieving fatigue as described in claim 1 or 2 in the preparation of a drug or health food for relieving physical fatigue, characterized in that, The relief of physical fatigue includes improving exercise endurance, reducing post-exercise serum urea levels, and improving blood lactate levels.

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