Traditional Chinese medicine composition for resisting long-term endurance fatigue and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for resisting exercise-induced and stress-induced fatigue as well as a preparation method and application thereof. The traditional Chinese medicine composition provided by the invention is prepared from the following raw material medicines: astragalus membranaceus, codonopsis pilosula, bighead atractylodes rhizome, poria cocos, radix glehniae, schisandra chinensis, pinellia ternate, pericarpium citri reticulatae, rhizoma zingiberis, elecampane, endothelium corneum gigeriae galli, salvia miltiorrhiza, angelica sinensis and honey-fried licorice root, has the effects of tonifying qi and nourishing yin, promoting the circulation of qi and warming the middle warmer, and activating and nourishing blood, and can synergistically exert the effect of resisting two types of fatigue in multiple targets and multiple ways; clinical application confirms that the medicine is definite in curative effect, safe, free of toxic and side effects and convenient for long-term use.

Description

Technical Field

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

[0002] Fatigue is a complex physiological and psychological phenomenon, which can be mainly classified into exercise-induced fatigue, stress-induced fatigue, and pathological fatigue based on its causes. Exercise-induced fatigue is a temporary decline in bodily function caused by high-intensity or prolonged physical activity, manifested as muscle soreness, weakened strength, and shortened exercise time. Its biochemical mechanisms are closely related to energy depletion, accumulation of metabolic products (such as lactic acid and urea nitrogen), oxidative stress, and internal environment disorders. Stress-induced fatigue is mainly caused by factors such as mental stress, emotional tension, and insufficient sleep. It belongs to central fatigue and is often accompanied by insomnia, poor concentration, low mood, and decreased immunity. Its occurrence is related to excessive activation of the hypothalamic-pituitary-adrenal (HPA) axis, imbalance of central neurotransmitters, and suppression of immune function.

[0003] Currently, there are numerous anti-fatigue products on the market. Western medicine primarily employs drug therapies including: antidepressants (fluoxetine), steroids (hydrocortisone), dehydroepiandrosterone (DHEA), magnesium sulfate therapy, immunotherapy, nutritional support, antiviral drugs, and antioxidants. Other treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs), anti-anxiety medications, stimulants, antihistamines, and vasopressors are also used to treat chronic fatigue syndrome. Non-drug therapies mainly include: cognitive behavioral therapy (rational emotive behavior therapy and cognitive restructuring, etc.), rest, and exercise therapy. However, all these methods suffer from problems such as minimal or temporary effects, limited targeting, lack of unified principles and protocols, lack of standardized treatment, and significant side effects. For example, chemically synthesized drugs (such as central nervous system stimulants) may provide temporary alertness, but long-term use can easily lead to dependence and neurotoxicity, masking true physiological fatigue; single-ingredient supplements (such as caffeine and taurine) have limited and short-lived effects.

[0004] Fatigue belongs to the category of "consumptive fatigue" in traditional Chinese medicine. According to traditional Chinese medicine theory, it is mainly related to the dysfunction of the spleen, liver, and kidney. Therefore, the method of invigorating the spleen and replenishing qi, nourishing the liver and kidney is often used for comprehensive conditioning. However, existing traditional Chinese medicine compositions often pay more attention to the effect of anti-exercise fatigue, and lack consideration for stress fatigue. Moreover, there are often problems such as complex prescriptions, numerous medicinal flavors, and unclear action mechanisms, which are not conducive to modern quality control and industrial development. For example, Chinese Patent CN111298062A discloses a traditional Chinese medicine composition for regulating qi-deficiency constitution, which contains 26 medicinal materials such as astragalus membranaceus and codonopsis pilosula. Although it has a certain effect, the prescription is too complex and lacks precise compatibility for specific pathological links of fatigue; Chinese Patent CN117442699A discloses a traditional Chinese medicine composition for anti-fatigue and improving exercise ability, which consists of 4 traditional Chinese medicines, namely alisma orientale, atractylodes macrocephala, poria cocos, and ginger. Although the prescription is simplified, it focuses on invigorating qi and strengthening the spleen, and the action effect is single.

[0005] In recent years, the market demand for products that can simultaneously resist exercise and stress fatigue has increased significantly. Therefore, there is an urgent need in this field for a traditional Chinese medicine composition with a concise prescription, scientific compatibility, clear mechanism, synergistic efficacy, which can quickly eliminate exercise fatigue, effectively relieve stress fatigue, and is safe without side effects. Summary of the Invention

[0006] Aiming at the defects existing in the prior art, the present invention provides a traditional Chinese medicine composition for anti-exercise and stress fatigue, its preparation method and application. This composition is formulated based on the dialectical theory of traditional Chinese medicine and combines the research results of modern traditional Chinese medicine pharmacology. It has scientific compatibility and the effects of replenishing qi and nourishing yin, promoting qi circulation and warming the middle-jiao, activating blood circulation and nourishing blood. It can play a synergistic role against two types of fatigue through multiple targets and multiple pathways, can significantly relieve exercise fatigue, improve sleep, reduce the accumulation of metabolites caused by exercise, and lower the body's stress level, achieving long-term anti-fatigue or preventive anti-fatigue.

[0007] The first object of the present invention is to provide a traditional Chinese medicine composition for anti-exercise and stress fatigue, which contains the following raw medicinal materials: astragalus membranaceus, codonopsis pilosula, atractylodes macrocephala, poria cocos, glehnia littoralis, schizandra chinensis, pinellia ternata, citrus reticulata blanco, dried ginger, Aucklandia lappa, Endothelium Corneum Gigeriae Galli, Salvia miltiorrhiza, Angelica sinensis, roasted licorice root.

[0008] The above traditional Chinese medicine composition contains the following raw medicinal materials in parts by weight: astragalus membranaceus 10 - 40 parts, codonopsis pilosula 5 - 25 parts, atractylodes macrocephala 5 - 25 parts, poria cocos 5 - 30 parts, glehnia littoralis 3 - 15 parts, schizandra chinensis 3 - 9 parts, pinellia ternata 3 - 20 parts, citrus reticulata blanco 5 - 30 parts, dried ginger 3 - 15 parts, Aucklandia lappa 3 - 20 parts, Endothelium Corneum Gigeriae Galli 3 - 15 parts, Salvia miltiorrhiza 3 - 20 parts, Angelica sinensis 3 - 20 parts, roasted licorice root 3 - 12 parts.

[0009] Preferably, the above traditional Chinese medicine composition comprises the following raw medicinal materials in parts by weight: 15 - 35 parts of Astragalus membranaceus, 10 - 20 parts of Codonopsis pilosula, 10 - 20 parts of Atractylodes macrocephala, 10 - 25 parts of Poria cocos, 5 - 12 parts of Glehnia littoralis, 3 - 6 parts of Schisandra chinensis, 5 - 15 parts of Pinellia ternata, 10 - 25 parts of Citrus reticulata Blanco, 5 - 12 parts of Zingiber officinale Rosc., 5 - 15 parts of Aucklandia lappa, 5 - 12 parts of Endothelium corneum gigeriae galli, 5 - 15 parts of Salvia miltiorrhiza, 5 - 15 parts of Angelica sinensis, 5 - 10 parts of Radix Glycyrrhizae Preparata.

[0010] In a specific embodiment of the first object, the traditional Chinese medicine composition of the present invention comprises the following raw medicinal materials in parts by weight: 20 parts of Astragalus membranaceus, 12 parts of Codonopsis pilosula, 12 parts of Atractylodes macrocephala, 12 parts of Poria cocos, 6 parts of Glehnia littoralis, 3 parts of Schisandra chinensis, 6 parts of Pinellia ternata, 12 parts of Citrus reticulata Blanco, 6 parts of Zingiber officinale Rosc., 6 parts of Aucklandia lappa, 6 parts of Endothelium corneum gigeriae galli, 8 parts of Salvia miltiorrhiza, 8 parts of Angelica sinensis, 6 parts of Radix Glycyrrhizae Preparata.

[0011] In a specific embodiment of the first object, the traditional Chinese medicine composition of the present invention comprises the following raw medicinal materials in parts by weight: 25 parts of Astragalus membranaceus, 15 parts of Codonopsis pilosula, 15 parts of Atractylodes macrocephala, 15 parts of Poria cocos, 8 parts of Glehnia littoralis, 4 parts of Schisandra chinensis, 8 parts of Pinellia ternata, 15 parts of Citrus reticulata Blanco, 8 parts of Zingiber officinale Rosc., 10 parts of Aucklandia lappa, 8 parts of Endothelium corneum gigeriae galli, 10 parts of Salvia miltiorrhiza, 10 parts of Angelica sinensis, 8 parts of Radix Glycyrrhizae Preparata.

[0012] In a specific embodiment of the first object, the traditional Chinese medicine composition of the present invention comprises the following raw medicinal materials in parts by weight: 30 parts of Astragalus membranaceus, 15 parts of Codonopsis pilosula, 10 parts of Atractylodes macrocephala, 12 parts of Poria cocos, 10 parts of Glehnia littoralis, 6 parts of Schisandra chinensis, 10 parts of Pinellia ternata, 10 parts of Citrus reticulata Blanco, 10 parts of Zingiber officinale Rosc., 10 parts of Aucklandia lappa, 10 parts of Endothelium corneum gigeriae galli, 10 parts of Salvia miltiorrhiza, 10 parts of Angelica sinensis, 6 parts of Radix Glycyrrhizae Preparata.

[0013] In a specific embodiment of the first object, the Atractylodes macrocephala in the traditional Chinese medicine composition of the present invention is stir - fried Atractylodes macrocephala.

[0014] In a specific embodiment of the first object, the Citrus reticulata Blanco in the traditional Chinese medicine composition of the present invention is Guangdong Citrus reticulata Blanco.

[0015] In a specific embodiment of the first object, the Endothelium corneum gigeriae galli in the traditional Chinese medicine composition of the present invention is raw Endothelium corneum gigeriae galli.

[0016] In a specific embodiment of the first object, the traditional Chinese medicine composition of the present invention further comprises pharmaceutically acceptable excipients.

[0017] The second object of the present invention is to provide a preparation method of the above traditional Chinese medicine composition. The traditional Chinese medicine composition of the present invention can be made into various clinically acceptable dosage forms, including but not limited to bagged tea, decoction, mixture, extract, powder, granule, etc. The preferred dosage form is granule.

[0018] The preparation method of the traditional Chinese medicine composition is a conventional preparation method such as pulverization, decoction or water extraction and alcohol precipitation. When preparing the traditional Chinese medicine dosage form, pharmaceutically acceptable excipients may be added.

[0019] The third objective of this invention is to provide the application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug that can relieve exercise-induced fatigue, improve sleep, reduce the accumulation of exercise-induced metabolites, and reduce the body's stress level.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] 1. Dual Anti-fatigue Properties. The herbal composition of this invention uniquely integrates the effects of anti-exercise fatigue and anti-stress fatigue. On the one hand, it provides energy and oxygen to muscles and removes metabolic waste by invigorating qi, nourishing blood, and promoting blood circulation, thus combating exercise fatigue; on the other hand, it regulates HPA axis function by nourishing yin, regulating qi, and harmonizing the stomach, stabilizing emotions, improving sleep, and combating stress fatigue, thus having a wide range of clinical applications.

[0022] 2. Synergistic Effect of Multiple Targets. This invention combines modern pharmacological research results of traditional Chinese medicine to exert anti-fatigue effects synergistically from multiple targets, including energy metabolism, oxidative stress, neuroendocrine function, and immune function. Through multiple pathways such as invigorating Qi (Astragalus membranaceus, Codonopsis pilosula, Atractylodes macrocephala), nourishing Yin (Adenophora stricta, Schisandra chinensis), promoting blood circulation (Angelica sinensis, Salvia miltiorrhiza), and harmonizing the stomach (Pinellia ternata, Citrus reticulata, Aucklandia lappa, Zingiber officinale), it comprehensively regulates the complex pathological processes of fatigue, achieving effects superior to drugs with single mechanisms of action. Furthermore, the herbal composition of this invention cleverly combines Qi-tonifying and Qi-regulating herbs, Yin-nourishing and warming herbs, and blood-tonifying and blood-activating herbs, ensuring that the entire formula nourishes without stagnation and eliminates without harming the body's vital energy, making it suitable for long-term use or preventative use.

[0023] 3. High safety and easy to promote. All components of the herbal composition of this invention are traditional Chinese medicinal materials. Long-term clinical application has verified its stable efficacy, lack of toxic side effects, and no risk of dependence. Compared with chemically synthesized drugs and hormone-containing products, its safety is significantly improved, making it suitable for long-term use to regulate sub-health conditions. Various dosage forms can be prepared using the herbal composition of this invention. By optimizing extraction process parameters (such as decoction time, temperature, solvent, etc.), the full extraction of active ingredients and the stability of preparation quality can be ensured, making it suitable for industrial production and easy to promote. Attached Figure Description

[0024] Figure 1 The effect of the traditional Chinese medicine composition prepared in Example 6 of this invention on the exhaustive swimming time of mice (intergroup comparison). ** P<0.01).

[0025] Figure 2 The effect of the traditional Chinese medicine composition prepared in Example 6 of this invention on serum lactate and urea nitrogen levels in mice after exercise (compared with the blank group).** P<0.01; compared with the saline group, ## P<0.01).

[0026] Figure 3 The effect of the traditional Chinese medicine composition prepared in Example 6 of this invention on serum cortisol levels in mice after exercise (compared with the blank group). ** P<0.01; compared with the saline group, ## P<0.01). Detailed Implementation

[0027] The traditional Chinese medicine composition of this invention is made from Astragalus membranaceus, Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Adenophora stricta, Schisandra chinensis, Pinellia ternata, Citrus reticulata peel, Zingiber officinale, Aucklandia lappa, Gallus gallus domesticus gizzard lining, Salvia miltiorrhiza, Angelica sinensis, and Glycyrrhiza uralensis. Astragalus membranaceus and Codonopsis pilosula are the principal herbs, being sweet and warm in nature, tonifying qi and strengthening the body. Atractylodes macrocephala and Poria cocos assist Codonopsis pilosula and Astragalus membranaceus in strengthening the spleen and eliminating dampness, tonifying the middle jiao and preventing dampness stagnation. Adenophora stricta and Schisandra chinensis are sweet and cool in nature, moistening, astringing qi and generating fluids, and together with Codonopsis pilosula and Astragalus membranaceus, they tonify both qi and yin, and prevent dryness and heat from damaging fluids, serving as the assistant herbs. Pinellia ternata and Citrus reticulata peel dry dampness, resolve phlegm, regulate qi and harmonize the stomach. Zingiber officinale, Aucklandia lappa, and Gallus gallus domesticus gizzard lining warm the middle jiao, promote qi circulation, invigorate the spleen, aid digestion, and resolve food stagnation, relieving the stagnation of Codonopsis pilosula and Astragalus membranaceus, serving as the adjuvant herbs. Angelica sinensis and Salvia miltiorrhiza tonify blood, invigorate blood circulation, clear the heart and relieve irritability, and together with Glycyrrhiza uralensis, harmonize qi and blood, serving as the guiding herbs. This formula is gentle and nourishing, regulating both Qi and blood, and is characterized by its ability to both eliminate and replenish, treating both the symptoms and the root cause, making it suitable for long-term use.

[0028] (1) Astragalus membranaceus

[0029] The dried root of *Astragalus membranaceus* or *Astragalus mongholicus*, both belonging to the legume family. It has a sweet taste and slightly warm nature. It enters the spleen and lung meridians. It has the functions of tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, generating fluids and nourishing blood, promoting circulation and relieving pain, promoting pus drainage and detoxification, and promoting wound healing and tissue regeneration. It is used to treat symptoms such as qi deficiency and fatigue, poor appetite and loose stools, qi sinking, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, internal heat and thirst, blood deficiency and chlorosis, hemiplegia, numbness and pain, carbuncles that are difficult to heal, and chronic ulcers that do not heal.

[0030] Modern research has confirmed that Astragalus membranaceus exerts its anti-fatigue effects through multiple pathways and targets, including regulating the body's energy metabolism, oxidative stress, immune function, and neuroendocrine system, and has a good effect on improving both exercise-induced and stress-induced fatigue. Studies have found that Astragalus membranaceus can reduce cortisol levels through the hypothalamus-pituitary-adrenal (HPA) axis, alleviating stress-induced fatigue; it also has effects such as dilating blood vessels, enhancing myocardial contractility, improving tissue oxygen supply, reducing blood lactate levels, and accelerating lactate clearance, effectively relieving exercise-induced fatigue. Its core components (polysaccharides, saponins, flavonoids, etc.) can improve mitochondrial function, promote glucose metabolism and fatty acid oxidation, increase ATP synthesis, and alleviate energy depletion; inhibit excessive ROS production, reduce mitochondrial membrane potential decline, and maintain cellular energy supply; promote macrophage and T cell activity by activating the TLR4 / NF-κB pathway, reduce the release of inflammatory factors (such as IL-6 and TNF-α), and reduce chronic fatigue-related inflammatory responses. Animal experiments have confirmed that fatigue model mice treated with Astragalus membranaceus extract showed prolonged swimming time and improved related biochemical indicators. Clinical studies have confirmed that Astragalus compound formulas (such as Buzhong Yiqi Decoction) can significantly improve the clinical symptoms of patients with chronic fatigue syndrome (CFS).

[0031] (2) Codonopsis pilosula

[0032] The dried root of *Codonopsis pilosula*, *Codonopsis lanceolata*, or *Codonopsis chuanxiong*, all belonging to the Campanulaceae family. It has a sweet taste and neutral properties. It enters the spleen and lung meridians. It has the effects of strengthening the spleen and lungs, nourishing blood and promoting body fluid production, enhancing immunity, and combating fatigue. It is used to treat symptoms such as spleen and lung qi deficiency, qi and blood insufficiency, and qi and body fluid depletion.

[0033] Modern research indicates that Codonopsis pilosula exerts its anti-fatigue effects primarily through mechanisms such as regulating energy metabolism, reducing oxidative stress, promoting glycogen storage, and improving cardiovascular function. It is particularly suitable for those experiencing fatigue due to qi deficiency, low immunity, and insufficient exercise endurance. Studies have found that the active components of Codonopsis pilosula (such as polysaccharides and saponins) can enhance mitochondrial respiratory chain activity, increase ATP synthesis, and improve liver and muscle glycogen reserves, thus regulating energy metabolism; it can also reduce post-exercise blood lactate (BLA) levels, accelerate lactate clearance, and reduce muscle H+. + It accumulates and delays exercise-induced fatigue; it increases the activity of superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px), reduces malondialdehyde (MDA) accumulation, protects cells from oxidative damage, and delays muscle fatigue; it improves skeletal muscle energy metabolism and enhances exercise endurance; it dilates blood vessels, increases myocardial blood flow, and enhances hypoxia tolerance. Animal experiments have confirmed that Codonopsis pilosula extract can prolong swimming time, reduce lactic acid, and increase glycogen reserves in fatigue model mice.

[0034] (3) Atractylodes macrocephala

[0035] The dried rhizome of a plant belonging to the genus Atractylodes in the family Asteraceae. It is warm in nature and has a bitter-sweet taste. It enters the spleen and stomach meridians. It has the functions of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It is used for symptoms such as poor appetite due to spleen deficiency, abdominal distension and diarrhea, edema, spontaneous sweating, and threatened abortion.

[0036] Modern research shows that Atractylodes macrocephala exerts its anti-fatigue effects primarily through mechanisms such as enhancing energy metabolism, reducing lactic acid accumulation, promoting muscle repair, and antioxidation. It is particularly suitable for spleen-deficiency type fatigue (loss of appetite, abdominal distension, and weakness), exercise-induced fatigue (decreased muscle endurance and lactic acid accumulation), stress-induced fatigue (general weakness, poor concentration, memory loss, depression, anxiety, and sleep disorders), and chronic fatigue syndrome (long-term fatigue and low immunity). Studies have confirmed that Atractylodes macrocephala can increase liver glycogen content after exercise, reduce energy depletion, and prolong exercise endurance; lower blood lactate (BLA) and blood urea nitrogen (BUN) levels, reduce post-exercise lactic acid accumulation, and delay the onset of fatigue; upregulate the expression of myogenic genes such as Myf5 and MyoD, promote skeletal muscle repair, and increase muscle mass; promote mitochondrial biosynthesis, increase ATP production, and improve central fatigue; and enhance adrenal cortex function, improving the body's stress resistance, making it suitable for stress-induced fatigue. Animal experiments have confirmed that Atractylodes macrocephala extract can prolong the swimming time under load in fatigue model mice, increase the hypoxia tolerance of mice, reduce the blood lactate content in mice, increase the liver glycogen content, and increase the spleen and thymus coefficients, thus exhibiting a significant anti-fatigue effect.

[0037] (4) Poria cocos (Schw.) Wolí

[0038] The dried sclerotium of the fungus *Poria cocos* (family Poriaceae). It is neutral in nature and sweet and bland in taste. It has the effects of dispelling dampness and promoting diuresis, strengthening the spleen and stomach, and calming the mind and soothing the nerves. It is used for symptoms such as difficulty urinating, edema and abdominal distension, phlegm retention and dizziness, spleen deficiency and poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0039] Modern research shows that Poria cocos exerts its anti-fatigue effect through mechanisms such as regulating energy metabolism, immune function, and anti-oxidative stress, making it particularly suitable for fatigue caused by spleen deficiency and dampness. Studies have confirmed that Poria cocos can promote protein synthesis, increase glycogen reserves and ATP synthesis, reduce free radical damage to the body, improve energy metabolism in myocardial and brain tissues, combat hypoxic damage, improve endurance, alleviate exercise load stress, and reduce fatigue levels. Its active ingredients, Poria cocos polysaccharides and triterpenoids, can increase superoxide dismutase (SOD) activity and inhibit malondialdehyde (MDA) synthesis, exhibiting significant free radical scavenging capabilities. Animal experiments have shown that Poria cocos polysaccharides can significantly reduce serum urea nitrogen levels in fatigue model mice after swimming exhaustion, slow down the decomposition rate of nitrogenous substances in the mice, effectively improve the body's stress response to exercise load; and inhibit the accumulation and production of lactic acid after exercise, thereby slowing down the onset of fatigue and reducing its severity; at the same time, it can increase SOD activity in mouse liver tissue, prevent lipid peroxidation, and exert an anti-fatigue effect.

[0040] (5) Glehnia littoralis Fr.Schmidt ex Miq.

[0041] The dried root of *Gnaphalium affine*, a plant in the Apiaceae family. It is slightly cold in nature and has a sweet and slightly bitter taste. It enters the lung and stomach meridians. It has the functions of nourishing yin and clearing the lungs, benefiting the stomach and promoting the production of body fluids. It is used for symptoms such as dry cough due to lung heat, cough with sputum and blood due to overwork, stomach yin deficiency, fluid depletion due to febrile diseases, dry throat and thirst, etc.

[0042] Studies have confirmed that the active ingredient in *Adenophora stricta*, polysaccharide, activates the PI3K / Akt pathway, promotes the translocation of glucose transporter GLUT4, increases muscle and liver glycogen synthesis, and delays exercise-induced fatigue. Saponins regulate cortisol levels through the hypothalamus-pituitary-adrenal (HPA) axis, alleviating stress-induced fatigue and improving sleep quality, indirectly enhancing physical recovery efficiency. Polyacetylenes (such as falciferol and ginsenoside) protect mitochondrial membrane integrity, increase ATP production efficiency, and reduce lactic acid accumulation. Flavonoids (such as quercetin) reduce the release of the inflammatory factor TNF-α, lowering fatigue-related inflammatory responses. Animal experiments have demonstrated that *Adenophora stricta* extract significantly prolongs the weight-bearing swimming time in fatigue model mice, enhances hypoxia tolerance, significantly increases serum lactic acid recovery rate, reduces serum malondialdehyde (MDA) levels, and increases the activities of superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GSH-Px), scavenging free radicals and repairing oxidative damage. Clinical trials have confirmed that the compound preparation of North American ginseng can improve microcirculation and increase tissue oxygen supply in patients with chronic fatigue syndrome. It is especially suitable for maintaining physical strength in high-altitude hypoxic environments, and can significantly eliminate muscle fatigue caused by exercise, enhance physical strength, endurance, hypoxia tolerance and non-specific resistance.

[0043] (6) Schisandra chinensis (Turcz.) Baill.

[0044] The dried, ripe fruit of Schisandra chinensis, a plant in the Magnoliaceae family. It is warm in nature and has a sour and sweet taste. It enters the lung, heart, and kidney meridians. It has astringent and consolidating effects, replenishes qi and generates fluids, tonifies the kidneys and calms the mind. It is used for chronic cough and wheezing, nocturnal emission, frequent urination, chronic diarrhea, night sweats, thirst due to fluid depletion, internal heat and thirst, palpitations, and insomnia.

[0045] Studies have confirmed that Schisandra chinensis extract, specifically Schisandra polysaccharide, can increase liver / muscle glycogen reserves, delaying exhaustion; reduce fatigue metabolites such as blood lactate (BLA) and blood urea nitrogen (BUN), alleviating fatigue; activate the Nrf2 / ARE pathway, clearing free radical accumulation after exercise and alleviating post-exercise damage; regulate tricarboxylic acid cycle metabolism, restoring energy metabolism homeostasis; and increase the expression of mitochondrial transcription factor A (TFAM) and nuclear respiratory factor-1 (NRF-1), repairing mitochondrial damage caused by exercise-induced fatigue. Schisandrin B can promote muscle protein synthesis and inhibit catabolism by activating the mTOR pathway, delaying fatigue. Schisandrin A can alleviate stress fatigue by regulating the hypothalamus-pituitary-adrenal (HPA) axis function and reducing cortisol levels. Animal experiments have shown that Schisandra chinensis decoction can prolong the swimming time under load by 35% in fatigue model mice, increase liver glycogen by 28%, and reduce blood urea nitrogen (BUN) by 22%; Schisandra chinensis compound extract can further prolong the swimming time of mice under exhaustion by 50%, and its antioxidant capacity is better than that of the single extract.

[0046] (7) Pinellia ternata(Thunb.)Breit.

[0047] The dried tuber of Pinellia ternata, a plant in the Araceae family. It is warm in nature, pungent in taste, and poisonous. It enters the spleen, stomach, and lung meridians. It has the functions of drying dampness and resolving phlegm, relieving nausea and vomiting, and dissipating lumps and nodules. It is used for symptoms such as damp phlegm, cold phlegm, cough with excessive phlegm, phlegm-dampness dizziness and palpitations, wind-phlegm dizziness, phlegm-induced headache, vomiting and nausea, chest and epigastric fullness, and globus hystericus.

[0048] Modern research indicates that Pinellia ternata exerts its anti-fatigue effects primarily through regulating neuroendocrine function, energy metabolism, and through antioxidant and cell protection mechanisms. It is particularly suitable for fatigue caused by spleen deficiency and dampness (persistent fatigue, heaviness in the head and body, limb pain, and poor concentration). Studies have confirmed that Pinellia ternata can moderately activate the HPA axis, promote cortisol secretion, and enhance the body's ability to adapt to stress, thereby alleviating stress-induced fatigue. Furthermore, it can effectively alleviate anxiety, irritability, and other emotional disturbances often associated with fatigue by regulating the levels of monoamine neurotransmitters (such as serotonin and dopamine) in the brain, improving sleep quality, and indirectly promoting fatigue recovery. Its active ingredient, Pinellia ternata lectin, can weaken the release of acetylcholine quanta at motor nerve endings, thereby inhibiting sustained muscle contraction, reducing fatigue, and improving muscle endurance. The alkaloids and polysaccharides in Pinellia ternata can inhibit the NF-κB signaling pathway, reduce the production and release of pro-inflammatory factors such as tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6), alleviate inflammatory responses, reduce tissue damage, and promote bodily recovery. Animal experiments have shown that compound preparations of Pinellia ternata (such as stomach and granules) can effectively prolong the exhaustive swimming time and treadmill exercise time of fatigue model mice.

[0049] (8) Dried tangerine peel (Citrus reticulata Blanco)

[0050] The dried, mature peel of the citrus fruit and its cultivated varieties, belonging to the Rutaceae family. It is warm in nature and bitter and pungent in taste. It enters the lung and spleen meridians. It has the functions of regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It is used for symptoms such as abdominal distension, poor appetite, vomiting and diarrhea, and cough with excessive phlegm.

[0051] Modern research shows that dried tangerine peel exerts its anti-fatigue effects primarily through multiple pathways, including regulating energy metabolism, anti-oxidation, and regulating neuroendocrine function and gut microbiota. It is particularly suitable for fatigue caused by Qi deficiency (shortness of breath upon exertion, spontaneous sweating, sallow complexion, and weakness in the limbs), phlegm-dampness (heaviness in the body, dizziness, drowsiness, postprandial fatigue, and sticky stools), and Yin deficiency (irritability, frequent awakenings at night, and alternating fatigue and insomnia). Studies have confirmed that the active ingredient in dried tangerine peel, tangerine flavonoids, can activate the AMPK signaling pathway, promote liver and muscle glycogen reserves, and enhance physical endurance; enhance lactate dehydrogenase (LDH) activity, accelerate the conversion of lactate to pyruvate, lower blood lactate levels, and delay exercise-induced fatigue; and provide antioxidant protection, scavenging free radicals, alleviating muscle soreness and related tissue damage caused by oxidative stress, and improving the body's recovery ability. Norihesperidin can activate the PPAR-γ / PGC-1α pathway, promote mitochondrial synthesis, increase ATP production efficiency, and improve exercise endurance. Tangerine peel polysaccharides can regulate the production of short-chain fatty acids (SCFAs) by intestinal flora, inhibit tryptophan hydroxylase 2 (TPH2) activity, reduce the synthesis of 5-hydroxytryptamine (5-HT) in the brain, and relieve central fatigue.

[0052] (9) Dried ginger (Zingiber officinale Rosc.)

[0053] The dried rhizome of ginger, a plant in the ginger family (Zingiberaceae). It is warm in nature and pungent in taste. It enters the spleen, stomach, and lung meridians. It has the functions of warming the middle jiao and dispelling cold, restoring yang and unblocking the meridians, and warming the lungs and resolving phlegm. It is used for symptoms such as cold pain in the epigastrium and abdomen, vomiting and diarrhea, cold limbs and weak pulse, and cough with phlegm due to cold.

[0054] Modern research shows that dried ginger exerts its anti-fatigue effects mainly through regulating energy metabolism, reducing the accumulation of metabolic products, reducing oxidative damage, regulating neuroendocrine function, and enhancing immunity. It is particularly suitable for fatigue caused by Yang deficiency (cold limbs, aversion to cold, etc.) and fatigue following mental exhaustion or physical overexertion, characterized by muscle soreness, difficulty concentrating, insomnia, and excessive dreaming. Studies have confirmed that dried ginger can inhibit lactate dehydrogenase (LDH) activity, reduce blood lactate concentration, and alleviate muscle soreness; upregulate PGC-1α expression, promote mitochondrial biosynthesis, and improve ATP production efficiency; activate the AMPK signaling pathway, increase glycogen reserves in the liver and muscles, and delay the onset of exercise-induced fatigue; regulate the hypothalamus-pituitary-adrenal (HPA) axis, balance cortisol secretion, enhance stress adaptability, and delay stress fatigue. Its active ingredient, gingerol, can inhibit norepinephrine-mediated vasoconstriction, increase skeletal muscle blood flow, and improve exercise endurance. Gingerol can inhibit the expression of cyclooxygenase-2 (COX-2) and tumor necrosis factor-α (TNF-α), reducing the release of inflammatory factors after exercise. Ginger polysaccharides can enhance NK cell activity, improve immunity, and effectively improve weakness and fatigue. Animal experiments have shown that dried ginger extract can prolong the swimming time of fatigue model mice, improve hypoxia tolerance, and enhance heat and cold resistance; it can also increase the content of SOD and catalase (CAT), reduce lipid peroxidation in the body, reduce the production of free radicals, effectively resist the damage of free radicals to the body, and significantly enhance the anti-fatigue ability of mice.

[0055] (10) Aucklandia lappa Decne.

[0056] The dried root of *Saussurea costus*, a plant in the Asteraceae family. It is warm in nature and pungent and bitter in taste. It enters the spleen, stomach, large intestine, triple burner, and gallbladder meridians. It has the functions of regulating qi and relieving pain, strengthening the spleen and promoting digestion. It is used for symptoms such as chest and rib pain, abdominal distension and pain, tenesmus after diarrhea, indigestion, and loss of appetite.

[0057] Studies have confirmed that the volatile oils of Aucklandia lappa (α-terpinene, β-elemene, etc.) can penetrate the blood-brain barrier, promote the release of monoamine neurotransmitters such as serotonin (5-HT) and norepinephrine (NE) in the brain, enhance central excitability, and quickly relieve mental fatigue; it can also enhance mitochondrial function, optimize the efficiency of the tricarboxylic acid cycle (TCA), accelerate the conversion of glucose into ATP, reduce blood lactate levels after exercise, relieve exercise-induced fatigue, promote ammonia metabolism, reduce urea nitrogen accumulation in muscles, and delay physical exhaustion. Its active ingredients, flavonoids (such as quercetin) and sesquiterpene lactones (such as costunolide), activate the Nrf2 pathway, upregulate the expression of antioxidant enzymes such as HO-1, scavenge reactive oxygen species (ROS), inhibit lipid peroxidation, and reduce cell damage. Animal experiments have shown that Aucklandia lappa extract can prolong the swimming exhaustion time of fatigued mice by more than 30%, while reducing serum lactate levels and accelerating recovery. The Mu Xiang compound (Gui Pi Tang) promotes autophagy in damaged mitochondria by inhibiting the protein expression of mitochondrial deubiquitinating enzyme USP30, preventing excessive ROS accumulation, improving mitochondrial oxidative energy supply, and relieving fatigue.

[0058] (11) Gallus gallus domesticus Brisson

[0059] The dried inner wall of the gizzard of the domestic chicken (Pheasantidae). It is neutral in nature and sweet in taste. It enters the spleen, stomach, small intestine, and bladder meridians. It has the functions of strengthening the stomach and promoting digestion, astringing essence and stopping seminal emission, and clearing urinary tract stones and dissolving stones. It is used for indigestion, vomiting and diarrhea, infantile malnutrition, enuresis, seminal emission, painful urinary stones, and gallbladder distension and hypochondriac pain.

[0060] Studies have confirmed that chicken gizzard lining contains 17 essential amino acids (such as leucine, arginine, and glutamic acid), which can quickly replenish energy substrates consumed during exercise; it also contains various trace elements (such as iron, copper, and zinc), which, as cofactors of superoxide dismutase (SOD) and catalase (CAT), can scavenge free radicals generated during exercise, reduce blood lactate levels, accelerate ammonia metabolism, and reduce the accumulation of fatigue toxins in muscles. When used raw, this product can directly activate gastrointestinal motility, making it suitable for fatigue caused by food stagnation; roasting increases the polysaccharide content, enhancing its spleen-strengthening and diarrhea-relieving effects, making it suitable for fatigue caused by spleen deficiency and diarrhea; vinegar processing increases the dissolution rate of small-molecule amino acids, making them more easily able to cross the blood-brain barrier, making it suitable for mental fatigue. Its active ingredient, chicken gizzard lining polysaccharide, enhances insulin sensitivity, promotes the expression of glucose transporter GLUT4, increases glycogen synthesis efficiency, and strengthens energy supply by activating the AMPK pathway. Animal experiments have confirmed that chicken gizzard lining compound can increase the number of struggling attempts, crossing grids, standing up, and exhaustive swimming time in fatigue model mice, while reducing immobility time; it can significantly improve the behavioral characteristics of chronic fatigue syndrome model rats, increase the level of interleukin-2 (IL-2) in rat serum, decrease the level of TNF-α, increase the thymus index and spleen index, and has a significant effect on improving immunity. Clinical trials have confirmed that chicken gizzard lining can significantly reduce serum lactate levels in patients with chronic fatigue syndrome, prolong exhaustive exercise time, and improve physical strength.

[0061] (12) Angelica sinensis (Oliv.) Diels

[0062] The dried root of Angelica sinensis, a plant in the Apiaceae family. It is warm in nature and sweet and pungent in taste. It enters the liver, heart, and spleen meridians. It has the functions of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. It is used for symptoms such as blood deficiency, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic pain, traumatic injuries, carbuncles and sores, and constipation due to intestinal dryness.

[0063] Studies have confirmed that Angelica sinensis polysaccharides, the effective component of Angelica sinensis, can significantly increase liver and muscle glycogen reserves by activating the AMPK / PGC-1α pathway, directly delaying the body's exhaustion state; and can significantly increase the glutamate (GLU) / gamma-aminobutyric acid (GABA) ratio in the brain, alleviating central fatigue. Angelica sinensis polypeptides and polysaccharides can increase lactate dehydrogenase (LDH) activity, reduce blood lactate levels after exercise, and promote ATP synthesis; while reducing serum creatine kinase (CK) activity, protecting the energy transport function of muscle cells. Ferulic acid can directly scavenge reactive oxygen species (ROS), increase the activity of superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px), reduce fatigue caused by oxidative stress; and can dilate blood vessels, relieving limb weakness caused by blood deficiency. Angelica sinensis compound formulas (such as Angelica sinensis blood-tonifying decoction) can reduce plasma cortisol levels, relieve stress-induced fatigue; and improve the immunosuppressive state of chronic fatigue syndrome (CFS). Animal experiments have confirmed that Angelica sinensis compound (Angelica sinensis blood-nourishing decoction) can improve the oxygen-carrying capacity of tissues in fatigue model mice; it can also restore muscle contraction function in mice by accelerating lactic acid elimination.

[0064] (13) Salvia miltiorrhiza Bge.

[0065] The dried root and rhizome of *Salvia miltiorrhiza*, a plant in the Lamiaceae family. Slightly cold in nature, bitter in taste, and entering the heart and liver meridians. It has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling the blood and reducing swelling. It is used for chest pain, abdominal and hypochondriac pain, abdominal masses, painful arthralgia, insomnia, irregular menstruation, dysmenorrhea, amenorrhea, sores and swelling.

[0066] Modern research indicates that Danshen (Salvia miltiorrhiza) exerts its anti-fatigue effects primarily through regulating energy metabolism, antioxidation, inhibiting inflammatory responses, and protecting mitochondria. Studies have confirmed that Danshen can lower cortisol levels, alleviating stress-induced fatigue; inhibit the release of pro-inflammatory factors IL-1β, IL-6, and TNF-α, reducing inflammation-mediated fatigue; and protect hippocampal neurons through the PIK3CA-mediated phospholipid metabolism pathway, indirectly alleviating mental fatigue. Its active ingredient, Danshen polysaccharide, can activate the AMPK / PGC-1α pathway, promoting the synthesis of liver and muscle glycogen; increase lactate dehydrogenase (LDH) activity, accelerate the tricarboxylic acid cycle, and alleviate exercise-induced fatigue caused by lactate accumulation. Tanshinone IIA and tanshinone can directly scavenge ROS, increase the activity of superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px), inhibiting oxidative damage; and protect cell membrane integrity, reduce MDA content, and alleviate skeletal muscle damage after exercise. Animal experiments have confirmed that tanshinone, an extract of Salvia miltiorrhiza, can significantly prolong the swimming time under load in fatigue model mice; and can reduce serum urea nitrogen and lactic acid levels in mice, reduce protein breakdown, increase liver glycogen content, and improve the body's exercise capacity.

[0067] (14) Prepared licorice root (Glycyrrhiza uralensis)

[0068] The dried roots and rhizomes of *Glycyrrhiza uralensis*, *Glycyrrhiza inflata*, or *Glycyrrhiza glabra*, all belonging to the legume family. It is neutral in nature and sweet in taste. It enters the heart, lung, spleen, and stomach meridians. It has the functions of tonifying the spleen and stomach, replenishing qi and restoring pulse. It is used for symptoms such as spleen and stomach weakness, fatigue, palpitations, and irregular pulse.

[0069] Studies have confirmed that glycyrrhizic acid (18β-glycyrrhetinic acid), the active ingredient in licorice, can promote liver glycogen synthesis and improve energy supply efficiency during exercise; it can also reduce exercise-induced muscle fiber damage and protect muscle structural integrity by inhibiting the release of creatine kinase (CK) and lactate dehydrogenase (LDH); and it has a mild sedative effect, which can improve anxiety and sleep disorders by inhibiting excessive central nervous system excitation, reducing the vicious cycle of fatigue-insomnia. Animal experiments have confirmed that roasted licorice extract can significantly increase liver glycogen content in fatigue model mice, prolong the time spent swimming to exhaustion, increase the number of struggles in the tail-hanging test, reduce the resting time, and improve physical endurance.

[0070] The present invention will be further illustrated below with reference to specific embodiments. These embodiments should be understood as illustrative only and not as limiting the scope of protection of the present invention. After reading the description of the present invention, those skilled in the art can make various alterations or modifications to the present invention, and these equivalent changes and modifications also fall within the scope defined by the claims of the present invention.

[0071] Examples 1-6 illustrate the preparation of the traditional Chinese medicine compositions of the present invention.

[0072] Example 1: Preparation of bagged tea preparation

[0073]

Preparation

[0074] Example 2: Preparation of decoction

[0075] [Preparation] Weigh out 300g of Astragalus membranaceus, 150g of Codonopsis pilosula, 100g of Atractylodes macrocephala, 120g of Poria cocos, 100g of Adenophora stricta, 60g of Schisandra chinensis, 100g of Pinellia ternata (processed with ginger), 100g of Citrus reticulata peel, 100g of Zingiber officinale (dried), 100g of Aucklandia lappa, 100g of chicken gizzard lining, 100g of Salvia miltiorrhiza, 100g of Angelica sinensis, and 60g of Glycyrrhiza uralensis (processed with honey). Add 6 times the amount of water and soak for 1 hour. Decoction twice, 45 minutes each time. Filter and combine the decoctions. Package in 150ml bags. This decoction can be consumed directly.

[0076] Example 3: Preparation of the mixture

[0077] [Preparation Method] Prepare the decoction according to the method in Example 2. Concentrate the filtrate to a clear paste with a relative density of 1.18-1.22. Add ethanol to make the alcohol content reach 60%. Let stand, filter, recover the ethanol from the filtrate and concentrate to a thick paste with a relative density of 1.20-1.24. Add 3 times the amount of water, stir well, refrigerate for at least 12 hours, filter, heat the filtrate to boiling for 30 minutes, and when the temperature drops to 60°C, add sodium benzoate, refrigerate for at least 12 hours, and filter. Separately, take 150g of sucrose, add water and boil to make a syrup, combine it with the above decoction, add water to adjust to 1000ml, stir well, sterilize, and the product is ready. Package in 150ml bottles. This mixture can be taken directly.

[0078] Example 4: Preparation of decoction paste

[0079] [Preparation Method] Prepare the decoction according to the method in Example 2, concentrate it into a clear paste with a relative density of 1.21-1.25, add 50g of refined honey to every 100g of clear paste, heat to melt, mix well, and the product is ready. Package in 15g bags. This paste can be taken by dissolving it in warm water.

[0080] Example 5: Preparation of Powder

[0081] [Preparation Method] The decoction was prepared according to the method in Example 2, and then concentrated and dried: The original Chinese medicine liquid was placed in a concentration and drying device, and concentrated and dried under vacuum at low temperature (vacuum degree 0.08MPa, temperature 60℃) to obtain Chinese medicine blocks. After pulverizing, it was passed through a 100-mesh sieve, and packaged in bags of 9g / bag. This powder can be taken directly by dissolving in water.

[0082] Example 6: Preparation of Granules

[0083] [Preparation Method] The decoction was prepared according to the method in Example 2. The filtrate was concentrated to a clear paste with a relative density of 1.18-1.22. Ethanol was added to bring the alcohol content to 60%. The mixture was allowed to stand, filtered, and the ethanol was recovered from the filtrate and concentrated to a thick paste with a relative density of 1.20-1.24. Dextrin was added and stirred evenly. An appropriate amount of 90% ethanol was added, and the mixture was spray-dried into granules using a spray dryer. The compressed air pressure at the nozzle was controlled at 0.8 MPa, the air inlet temperature was 160°C, and the air volume was 45 m³ / h. 3 It takes approximately 1 hour to produce the product. After sieving, it is packaged in 9g bags. This granule can be taken directly with water.

[0084] Examples 7-9 further illustrate the beneficial effects of the herbal composition of the present invention on anti-exercise and stress-induced fatigue through test examples.

[0085] Example 7: Population Trial

[0086] 1. Experimental Drugs and Subjects

[0087] This invention: the granules prepared in Example 6.

[0088] The study subjects were 54 officers and soldiers who visited the Department of Traditional Chinese Medicine at this unit from June 1 to June 30, 2024. Their chief complaints included fatigue, excessive sweating, dizziness, insomnia, poor appetite, dry mouth, bloating, abdominal distension, or diarrhea.

[0089] 2. Experimental Methods

[0090] The group of this invention: The patient was treated with the compound Chinese medicine granules of this invention, with each dose equivalent to 60 grams of raw herbs, twice a day, for a total of 2 weeks.

[0091] 3. Efficacy Evaluation Criteria

[0092] Referring to the nimodipine method, the reduction rate of the FS-14 scale and PSQI scale scores was used as the efficacy evaluation criteria: a reduction rate <20% was considered ineffective; 20% ≤ reduction rate <50% was considered effective; 50% ≤ reduction rate <95% was considered significantly effective; and 95% ≤ reduction rate ≤100% was considered basically cured. Reduction rate = (pre-treatment score - post-treatment score) / pre-treatment score × 100%, and the total effective rate = (number of basically cured + significantly effective + effective cases) / total number of cases × 100%.

[0093] 4. Treatment Results

[0094] The results showed that after taking the compound herbal granules of this invention, soldiers experienced a significant decrease in physical fatigue, sleep quality, sleep onset time, sleep duration, sleep efficiency, and the incidence of daytime dysfunction (P < 0.05) (see Table 1); the total effective rates for improving fatigue and insomnia symptoms were 83.33% and 53.70%, respectively (see Table 2); the total scores of the FS-14 scale and PSQI scale decreased significantly (P < 0.01), and the scores of all factors except sleep disorders and hypnotic drug factors decreased significantly (P < 0.05) (see Table 3). This indicates that the compound herbal granules of this invention have the effects of relieving fatigue, promoting sleep onset, improving sleep quality, prolonging sleep duration, and restoring daytime function. They are effective in improving fatigue, especially exercise-induced fatigue, and sleep disorders in soldiers, and are worthy of clinical promotion and application.

[0095] Table 1. Comparison of the incidence of fatigue and insomnia among officers and soldiers before and after treatment [n(%)]

[0096]

[0097] Table 2 Comparison of the overall effective rate of improvement in fatigue and insomnia symptoms among officers and soldiers [n(%)]

[0098]

[0099]

[0100] Table 3 Comparison of FS-14 and PSQI scores of soldiers before and after treatment [scores, M(P)] 25,P 75) ]

[0101]

[0102] Example 8: Individual Trial Case

[0103] Case 1: Yin Moumou, male, 28 years old, soldier.

[0104] The patient complained of fatigue and weakness, excessive sweating, especially after activity, dizziness, heaviness in the head, and abdominal pain and diarrhea easily after improper eating. Examination revealed: thin build, sallow complexion, pale tongue with thin white coating, and weak pulse.

[0105] Analysis of the syndrome differentiation: The patient's usual training tasks are heavy and his work and rest are irregular, which easily depletes his qi and damages his yin. His diet is also relatively monotonous, with excessive consumption of rich, fatty, cold, and hard foods, which easily leads to insufficient qi and internal accumulation of phlegm and dampness, hence the symptoms of fatigue, excessive sweating, dizziness, and diarrhea. The diagnosis is asthenia, and the syndrome differentiation is spleen deficiency with dampness accumulation. The treatment principle is to tonify qi and nourish yin, strengthen the spleen and eliminate dampness. The granules prepared in Example 6 of this invention are administered.

[0106] Follow-up: After 2 weeks of medication, the patient's fatigue and excessive sweating improved significantly, and the frequency of abdominal pain and diarrhea decreased significantly.

[0107] Case 2: Li Moumou, female, 38 years old, programmer.

[0108] The patient complained of difficulty falling asleep, frequent dreams, and easy awakening for the past three months (sleeping only 3-4 hours per night), and difficulty falling back asleep after waking. During the day, the patient experienced extreme fatigue, poor concentration, palpitations, forgetfulness, poor appetite, abdominal distension after meals, and loose stools. Examination revealed a sallow complexion, pale lips, a pale and swollen tongue with teeth marks on the edges, a thin, slightly greasy white coating, and a weak, thready pulse.

[0109] Analysis of the syndrome differentiation: The patient has been engaged in high-intensity mental work for a long time, resulting in excessive thinking and depletion of spleen qi. Spleen deficiency leads to insufficient production of qi and blood, and blood deficiency fails to nourish the heart, causing the heart to be unable to store the spirit, resulting in insomnia, frequent dreams and easy awakening, fatigue, palpitations, and forgetfulness; it also fails to nourish the muscles of the limbs, resulting in weakness. Poor appetite, abdominal distension after meals, and loose stools are also caused by spleen deficiency and impaired digestive function. The diagnosis is insomnia, and the syndrome differentiation is deficiency of both heart and spleen. The treatment principle is to tonify qi and strengthen the spleen, nourish blood and calm the mind. The granules prepared in Example 6 of this invention are administered.

[0110] Follow-up: After 2 weeks of medication, the patient's difficulty falling asleep, mental fatigue, palpitations, and forgetfulness improved significantly, and sleep time was extended (5-6 hours per night).

[0111] Example 9: Pharmacodynamic Experiment

[0112] 1. Experimental Materials

[0113] 1.1 Traditional Chinese Medicine Composition: The traditional Chinese medicine composition prepared in Example 6 was dissolved in physiological saline to form low, medium and high dose traditional Chinese medicine compositions. After preparation, it was stored at 4°C and preheated to 37°C before each gavage.

[0114] 1.2 Experimental animals: Male SPF-grade ICR mice aged 4-6 weeks were acclimatized for 1 week. During the experiment, the mice had free access to food and water.

[0115] 2 Experimental Methods

[0116] 2.1 Exhaustion Swimming Experiment: Thirty male ICR mice were randomly divided into four groups: a control group, a saline group, a low-dose traditional Chinese medicine (TCM) group (1 g / kg BW), a medium-dose TCM group (2 g / kg BW), and a high-dose TCM group (4 g / kg BW), with six mice in each group. Each group was administered a saline / TCM combination via gavage for 14 consecutive days, once daily. The volume administered per mouse (ml) was 0.01 × the mouse's body weight (g). One hour after the last administration, except for the control group, mice in the other groups were placed in a swimming tank (50cm × 50cm × 40cm, water depth 30cm, water temperature 25±1.0℃) with a 5% body weight lead wire loaded onto their tails. The time from the start of swimming to exhaustion (the mouse exhibiting irregular movements and unable to maintain its body on the water surface for ≥7 seconds) was recorded.

[0117] 2.2 Index detection: Blood was collected from the orbital sinus of mice immediately after the exhaustive swimming experiment. The supernatant was collected after centrifugation and stored at -80℃ for the determination of serum lactate, blood urea nitrogen and cortisol content in mice.

[0118] 3 Experimental Results

[0119] 3.1 Exhaustion swimming time: Compared with the saline group, the low, medium, and high dose groups of this invention significantly prolonged the exhaustion swimming time of mice (P<0.01); the medium and high dose groups of this invention were more effective than the low dose group (P<0.01), while there was no significant difference in effect between the medium and high dose groups (P>0.05). See Figure 1 .

[0120] 3.2 Serum lactate and urea nitrogen: Compared with the control group, serum lactate and urea nitrogen levels in mice were significantly increased after exercise (P<0.01); compared with the saline group, the low, medium, and high dose groups of this invention significantly reduced serum lactate and urea nitrogen levels after exercise (P<0.01); the medium and high dose groups of this invention were more effective than the low dose group (P<0.01), while there was no significant difference in the effects between the medium and high dose groups (P>0.05). See Figure 2 .

[0121] 3.3 Serum Cortisol: Compared with the blank group, serum cortisol levels in mice were significantly increased after exercise (P<0.01); compared with the saline group, the low, medium, and high dose groups of this invention significantly reduced serum cortisol levels after exercise (P<0.01); the medium and high dose groups of this invention were more effective than the low dose group (P<0.01), while there was no significant difference in effectiveness between the medium and high dose groups (P>0.05). See Figure 3 .

[0122] 4. Conclusion

[0123] The traditional Chinese medicine composition of this invention has a significant anti-fatigue effect, the mechanism of which may be related to reducing the accumulation of exercise-induced metabolites and lowering the body's stress level. Furthermore, the anti-fatigue effect of the traditional Chinese medicine composition of this invention is dose-dependent; in the model of this study, a dose of 2 g / kg BW may be close to the maximum effective dose.

Claims

1. A traditional Chinese medicine composition for combating exercise-induced and stress-induced fatigue, characterized in that, It is made from the following raw materials in parts by weight: Astragalus membranaceus 10-40 parts, Codonopsis pilosula 5-25 parts, Atractylodes macrocephala 5-25 parts, Poria cocos 5-30 parts, Adenophora stricta 3-15 parts, Schisandra chinensis 3-9 parts, Pinellia ternata 3-20 parts, Citrus reticulata 5-30 parts, Zingiber officinale 3-15 parts, Aucklandia lappa 3-20 parts, Gallus gallus domesticus gizzard lining 3-15 parts, Salvia miltiorrhiza 3-20 parts, Angelica sinensis 3-20 parts, Glycyrrhiza uralensis (processed) 3-12 parts.

2. The traditional Chinese medicine composition for resisting exercise and stress fatigue according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Astragalus membranaceus 15-35 parts, Codonopsis pilosula 10-20 parts, Atractylodes macrocephala 10-20 parts, Poria cocos 10-25 parts, Adenophora stricta 5-12 parts, Schisandra chinensis 3-6 parts, Pinellia ternata 5-15 parts, Citrus reticulata 10-25 parts, Zingiber officinale 5-12 parts, Aucklandia lappa 5-15 parts, Gallus gallus domesticus gizzard lining 5-12 parts, Salvia miltiorrhiza 5-15 parts, Angelica sinensis 5-15 parts, and Glycyrrhiza uralensis (processed) 5-10 parts.

3. The traditional Chinese medicine composition for resisting exercise and stress fatigue according to claim 2, characterized in that, It is made from the following raw materials in parts by weight: Astragalus membranaceus 20 parts, Codonopsis pilosula 12 parts, Atractylodes macrocephala 12 parts, Poria cocos 12 parts, Adenophora stricta 6 parts, Schisandra chinensis 3 parts, Pinellia ternata 6 parts, Citrus reticulata 12 parts, Zingiber officinale 6 parts, Aucklandia lappa 6 parts, Gallus gallus domesticus gizzard 6 parts, Salvia miltiorrhiza 8 parts, Angelica sinensis 8 parts, Glycyrrhiza uralensis 6 parts.

4. The traditional Chinese medicine composition for resisting exercise and stress fatigue according to claim 2, characterized in that, It is made from the following raw materials in parts by weight: Astragalus membranaceus 25 parts, Codonopsis pilosula 15 parts, Atractylodes macrocephala 15 parts, Poria cocos 15 parts, Adenophora stricta 8 parts, Schisandra chinensis 4 parts, Pinellia ternata 8 parts, Citrus reticulata 15 parts, Zingiber officinale 8 parts, Aucklandia lappa 10 parts, Gallus gallus domesticus gizzard lining 8 parts, Salvia miltiorrhiza 10 parts, Angelica sinensis 10 parts, Glycyrrhiza uralensis (processed) 8 parts.

5. The traditional Chinese medicine composition for resisting exercise and stress fatigue according to claim 2, characterized in that, It is made from the following raw materials in parts by weight: Astragalus membranaceus 30 parts, Codonopsis pilosula 15 parts, Atractylodes macrocephala 10 parts, Poria cocos 12 parts, Adenophora stricta 10 parts, Schisandra chinensis 6 parts, Pinellia ternata 10 parts, Citrus reticulata 10 parts, Zingiber officinale 10 parts, Aucklandia lappa 10 parts, Gallus gallus domesticus gizzard lining 10 parts, Salvia miltiorrhiza 10 parts, Angelica sinensis 10 parts, and Glycyrrhiza uralensis 6 parts.

6. The traditional Chinese medicine composition for resisting exercise and stress fatigue according to any one of claims 1-5, characterized in that, The Atractylodes macrocephala mentioned is stir-fried Atractylodes macrocephala, the Citrus reticulata peel mentioned is Guangchenpi, and the chicken gizzard lining mentioned is raw chicken gizzard lining.

7. The traditional Chinese medicine composition for resisting exercise and stress fatigue according to any one of claims 1-6, wherein the preparation method is pulverization, decoction or water extraction and alcohol precipitation.

8. A traditional Chinese medicine preparation, characterized in that, The traditional Chinese medicine composition according to any one of claims 1-7 is used as the active ingredient.

9. A traditional Chinese medicine preparation according to claim 7, wherein the dosage form is a bagged tea preparation, decoction, compound preparation, paste, powder or granules, preferably granules.

10. Use of the traditional Chinese medicine composition according to claims 1-7 or the traditional Chinese medicine preparation according to claims 8-9 in the preparation of traditional Chinese medicine for resisting exercise and stress fatigue.

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