A traditional Chinese medicine composition for assisting in protecting liver and a preparation method and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition for liver protection, its preparation method, and its application. By weight, the composition comprises 10-30 parts of kudzu root, 5-30 parts of Ganoderma lucidum, 10-30 parts of Hovenia dulcis fruit, 3-20 parts of licorice root, and 0.2-0.8 parts of turmeric extract. The formulation follows the principles of traditional Chinese medicine (TCM) theory of principal, assistant, and adjuvant herbs, with each ingredient synergistically enhancing its effect. It possesses both hangover-relieving and auxiliary protective effects against chemically induced liver damage, effectively reducing oxidative stress and lipid accumulation in the liver, protecting hepatocyte membranes, and promoting hepatocyte repair. The preparation process uses 30% ethanol reflux extraction, which is stable, controllable, safe, and easily industrialized. It can be formulated into various oral dosage forms, suitable for the daily maintenance needs of high-risk groups for liver damage, and has promising application prospects in the food, health food, and pharmaceutical fields.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition preparation technology, specifically to a food-medicine homology traditional Chinese medicine composition that has both hangover relief and auxiliary protection against chemically induced liver damage, an oral preparation containing the composition, a preparation method thereof, and the application of the composition in the fields of food, health food, and pharmaceuticals. Background Technology

[0002] Patent (application number: 202410147433.3) uses chicken liver active peptide MGH, combined with extracts of mulberry, kudzu root, Ganoderma lucidum, tangerine peel, platycodon, Japanese raisin tree fruit, licorice, and wolfberry, achieving liver-protective effects such as reducing transaminase levels, combating oxidative stress, and reducing the overexpression of inflammatory factors. However, the preparation process of the active ingredient inosine peptide in this patent is relatively complex, and it does not involve the improvement effect on fatty liver caused by alcoholic liver damage. Patent (application number: 202011251119.9) discloses a liver-protective method using Panax notoginseng powder, Ganoderma lucidum, kudzu root, Phyllanthus emblica, Japanese raisin tree fruit, and wolfberry as the main ingredients. While it boasts advantages such as simple ingredients and convenient preparation, it lacks in-depth research on specific indicators for improving liver health, such as triglycerides, malondialdehyde, and liver fat particles, making it impossible for consumers to use the method specifically. Patent (application number: 202411899988.X) discloses a compound with turmeric, kudzu root, salvia miltiorrhiza, schisandra chinensis, and ganoderma lucidum as main ingredients, which has good liver-protecting effects. However, salvia miltiorrhiza and schisandra chinensis require high-concentration ethanol extraction, necessitating production in explosion-proof workshops and using large amounts of ethanol as extraction solvents, increasing production risks and costs. This invention, using jujube seed and licorice, is significantly different. Patent (application number...) Patent application number 202510038360.9 discloses a method for producing a liver-protecting product using Poria cocos, licorice, wolfberry, hawthorn, Japanese raisin tree fruit, tangerine peel, Ganoderma lucidum, kudzu root, cassia seed, corn peptide, and freeze-dried probiotic powder as main ingredients. While the composition suggests liver-protecting and intestinal-benefiting effects, the probiotic preparation and product require low-temperature storage, resulting in a shorter shelf life. Patent application number 202510310310.1 discloses a product containing 25.13% white sugar, 16.67% kudzu root, 16.67% Japanese raisin tree fruit, 8.34% gardenia, 1.67% ginseng, 1.67% Ganoderma lucidum, and 1% Dendrobium officinale. The method for producing liver-protecting products using 1.67% of the following ingredients—Poria cocos, Lonicera japonica, Lycium barbarum, and Glycyrrhiza uralensis—is described as having the effects of detoxifying alcohol, soothing the liver and gallbladder, promoting body fluid production and quenching thirst, invigorating qi and tonifying the kidneys, and refreshing the mind. However, it does not provide scientific research results regarding the specific claims of lowering triglycerides and malondialdehyde, or improving fatty liver. The patent (application number: 202510642632.6) also does not specifically study and verify the specific liver function indicators that can be improved in users, and it does not contain turmeric extract, which is significantly different from this invention. (Patent number: 202510673335).8) A method for preparing a hangover relief product using the following ingredients as raw materials is disclosed: tangerine peel powder, vitamin C, glutathione, *Sanghuang* extract, *Huangjing* extract, *Yinchen* extract, *Banlangen* extract, *Schisandra* extract, ginseng powder, *Ganoderma lucidum* extract, licorice extract, silymarin, puerarin, white tomato powder, watermelon powder, fucoidan, tomato powder, mung bean powder, celery powder, turmeric powder, hawthorn powder, honey powder, corn peptide, soybean peptide powder, xanthan gum, and stevia. Because it uses non-food and non-food / medicinal herbal ingredients such as *Sanghuang*, *Yinchen*, *Banlangen*, and silymarin, the product currently cannot obtain legal health food or food licenses. Furthermore, its complex composition is completely different from the purpose of this invention, which focuses on ethanol metabolism, while this invention studies the improvement of liver function indicators; Patent (Application No.: 202511) Patent 048934.7 discloses a method for manufacturing a liver-protecting product using kudzu root, Japanese raisin tree fruit, milk thistle, turmeric, gastrodia elata, ganoderma lucidum, eucommia ulmoides leaf, cornus officinalis, and corn oligopeptides as main raw materials. This method focuses on lowering liver enzymes and reducing inflammatory responses, but does not improve elevated blood lipids and fatty liver caused by liver damage. Patent (application number: 202511140776.8) discloses a traditional Chinese medicine liver-protecting and hangover-relieving composition. Unlike this invention, the liver-protecting mechanism of this patent's composition is to increase the activity of acetaldehyde dehydrogenase in the body, accelerate alcohol metabolism, and thus reduce alcohol damage to the liver, thereby achieving a liver-protecting effect. This also leads to the possible shortcomings of this composition, namely, it may be ineffective against liver damage caused by other chemical components or staying up late. Patent (202511568004) 4) A method for preparing a liver-protecting composition is disclosed, which uses dihydromyricetin as the main component and focuses on the stability of the active ingredient. This differs significantly from the present invention, which uses kudzu root and Ganoderma lucidum as the main components, and Hovenia dulcis, turmeric, and licorice, which contain dihydromyricetin, as auxiliary components, and focuses more on improving various abnormal liver indicators. Patent (application number: 202511577317.6) provides a method for preparing a liver-protecting composition with liver-protecting effects, but the formula contains 12 medicinal materials. The complexity of Chinese medicinal materials means that the more types of medicinal materials there are, the higher the risk of uncontrollable metabolism of the active ingredients in the body. Compound Chinese medicine products need to be formulated to enhance product efficacy while minimizing the number of medicinal materials to control potential side effects.

[0003] In summary, no existing liver-protection solutions simultaneously meet the following requirements: 1. The core active ingredient composition is simplified to five or fewer ingredients, all of which are food-grade medicinal materials, posing no compliance risks; 2. The formulation is based on the principles of traditional Chinese medicine (TCM) and its formulation design, rather than simply piling up ingredients; 3. It simultaneously achieves the full-chain effects of detoxifying alcohol, assisting in the protection against chemically induced liver damage, and improving alcoholic fatty liver; 4. The preparation process is simple, using low-concentration ethanol extraction, requiring no special production conditions, and is easily scalable. This industry gap is precisely the core technical problem that this invention aims to solve. Summary of the Invention

[0004] In view of this, the present invention proposes a traditional Chinese medicine composition for auxiliary liver protection, an oral preparation containing the composition, its preparation method, and its applications. Addressing the common technical shortcomings of existing liver-protecting compositions, such as complex formulations with poor compliance, singular efficacy failing to simultaneously address both hangover relief and liver damage repair, high production process barriers, and inability to be taken daily for extended periods, the core objective of this invention is to provide a scientifically simple, synergistically effective, and highly safe traditional Chinese medicine composition for auxiliary liver protection. Simultaneously, it provides an oral preparation containing the composition, its industrial-scale preparation method, and related applications, ensuring the core efficacy of auxiliary protection against chemically induced liver damage while also possessing hangover relief properties, thus meeting the needs of daily liver care.

[0005] The technical solution of this invention is implemented as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for assisting liver protection, which is composed of the following raw materials in parts by weight: 10-30 parts of kudzu root, 5-30 parts of Ganoderma lucidum, 10-30 parts of Hovenia dulcis fruit, 3-20 parts of licorice root, and 0.2-0.8 parts of turmeric extract.

[0006] In some embodiments, the origin and legal efficacy of each raw material in the formulation of the present invention are as follows: The fruit of the Japanese raisin tree (Hovenia dulcis) is a plant belonging to the genus Hovenia in the family Rhamnaceae. Hovenia dulcis Thunnb .、Hovenia dulcis Hovenia acerba Lindl And jujube fruit Hovenia trichocarpa Chun et Tsiang The mature seeds are neutral in nature, sweet in taste, and enter the stomach meridian. They have the effects of relieving alcohol poisoning, quenching thirst and relieving irritability, and promoting diuresis and reducing swelling. They are used for drunkenness, thirst, vomiting, and difficulty in urination and defecation. Kudzu root is the wild kudzu plant of the legume family. Pueraria lobata (Willd.) Ohwi The dried root is cool in nature, sweet and pungent in taste, and enters the spleen, stomach and lung meridians. It has the effects of relieving muscle tension and reducing fever, promoting body fluid and quenching thirst, promoting rash eruption, raising yang and stopping diarrhea, clearing the meridians and activating collaterals, and detoxifying alcohol. It is used for exogenous fever and headache, stiff neck and back pain, thirst, diabetes, measles that fail to erupt, dysentery, diarrhea, dizziness and headache, stroke hemiplegia, chest pain and heart pain, and alcohol poisoning. Ganoderma lucidum is a fungus belonging to the Polyporaceae family, specifically the red Ganoderma lucidum. Ganoderma lucidum (Leyss. ex Fr.) Karst. Or Ganoderma lucidum Ganoderma sinense Zhao, Xu et Zhang The dried fruiting body is neutral in nature and sweet in taste. It enters the heart, lung, liver and kidney meridians. It has the effects of tonifying qi and calming the mind, relieving cough and asthma. It is used for restlessness, insomnia and palpitations, cough and asthma due to lung deficiency, shortness of breath due to weakness, and loss of appetite. Licorice is the plant licorice of the legume family. Glycyrrhiza uralensis Fisch. licorice root Glycyrrhiza inflata Bat. Or licorice root Glycyrrhiza glabra L.The dried roots and rhizomes of the plant are neutral in nature and sweet in taste. They enter the heart, lung, spleen, and stomach meridians. They have the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, relieving spasms and pain, and harmonizing the effects of other medicines. They are used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with excessive phlegm, abdominal and limb spasms and pain, carbuncles and boils, and to alleviate the toxicity and harshness of other medicines. Turmeric extract is derived from the ginger plant turmeric. Curcuma longa The dried rhizome of *Curcuma longa* (L.) contains curcumin and turmeric as its main active ingredients. Extracted and purified, it possesses antioxidant, antibacterial, hepatoprotective, and lipid-lowering effects. It can reduce damage to liver cells from toxins, alcohol, and drugs, maintain liver cell membrane stability, and help alleviate chemical liver damage. The turmeric extract is derived from the ginger family plant *Curcuma longa*. Curcuma longa The curcumin was obtained by ethanol extraction from the dried rhizome of L., and the curcumin content was ≥70%.

[0007] All the above raw materials must meet the quality control requirements of the 2025 edition of the Pharmacopoeia of the People's Republic of China. Among them, the mass content of puerarin in kudzu root is ≥2.4%, the content of Ganoderma lucidum polysaccharides and Ganoderma lucidum triterpenes in Ganoderma lucidum meets the pharmacopoeia standards, and the content of glycyrrhizic acid and glycyrrhizin in licorice meets the pharmacopoeia standards, to ensure the quality stability between batches of raw materials and the controllable efficacy of finished products.

[0008] In some embodiments, the formulation of this invention strictly follows the theory of monarch, minister, assistant, and guide in traditional Chinese medicine, with each ingredient acting synergistically and complementing each other. The specific compatibility mechanism is as follows: Principal herbs: Kudzu root and Hovenia dulcis. Kudzu root promotes the upward movement of clear yang, detoxifies alcohol, and unblocks meridians, rapidly breaking down alcohol metabolites and reducing direct damage to liver cells from alcohol. Hovenia dulcis promotes diuresis, reduces swelling, relieves alcohol intoxication, and quenches thirst, facilitating the excretion of alcohol from the body and alleviating the discomfort of drunkenness. The two herbs combined form the core principal herbs, working together to detoxify alcohol, clear damp heat, and reduce the burden of alcohol and metabolism on the liver, forming the core active ingredient of the entire formula. Assistant herb: Ganoderma lucidum. Ganoderma lucidum replenishes qi and calms the mind, strengthens the body's resistance and consolidates its foundation. It can enhance liver metabolism and immunity, promote the repair of damaged liver cells, assist the principal herb in enhancing liver protection, and at the same time take into account the overall condition of the body, avoiding problems such as qi and blood deficiency and restlessness caused by liver damage; Adjuvant: Curcuma extract. Its main component, curcumin, has strong antioxidant and anti-inflammatory effects. It exerts its anti-inflammatory effect by inhibiting the NF-κB pathway, which can scavenge free radicals in the liver, reduce oxidative stress caused by chemical substances (such as alcohol and drug metabolites), protect the integrity of hepatocyte membranes, reduce hepatocyte degeneration and necrosis, enhance the overall liver protection stability of the formula, and assist the principal and assistant drugs in achieving multi-target liver protection. Ingredient: Licorice. Licorice tonifies the spleen and replenishes qi, clears heat and detoxifies, and harmonizes the effects of other herbs. It can mitigate the cooling properties of kudzu root and the irritant properties of turmeric extract, reduce the overall imbalance of the formula, improve product safety and long-term tolerance, and alleviate drug toxicity, ensuring that the entire formula is well-balanced, safe, and effective.

[0009] From a modern pharmacological perspective, the entire formula of this invention forms a closed loop of multi-target synergistic liver-protective effects: Puerarin in the principal herb *Pueraria lobata* and dihydromyricetin in *Hovenia dulcis* can accelerate alcohol metabolism by activating alcohol dehydrogenase and aldehyde dehydrogenase, while inhibiting the absorption of intestinal toxins, thus reducing alcohol damage to the liver from the source; Ganoderma lucidum polysaccharides and triterpenoids in the assistant herb *Ganoderma lucidum* can activate the Nrf2 antioxidant pathway, enhance the liver's antioxidant capacity, promote hepatocyte regeneration, and repair damaged hepatocyte membranes; Curcumin in the adjuvant herb *Curcuma longa* extract can reduce liver inflammation by inhibiting the NF-κB inflammatory pathway, while activating the AMPK pathway to reduce hepatic lipid accumulation, reverse the pathological progression of fatty liver, and also improve the bioavailability of other active ingredients; Glycyrrhizic acid and glycyrrhizin in the guiding herb *Glycyrrhiza uralensis* can reduce liver damage by inhibiting hepatocyte apoptosis, while stabilizing the active ingredients of the entire formula and reducing gastrointestinal adverse reactions of irritating components. The synergistic effect of the active ingredients in the five ingredients achieves a full-chain liver-protecting effect, encompassing "blocking damage at its source - anti-inflammatory and antioxidant effects - repairing liver cells - improving lipid metabolism," with effects far exceeding the simple sum of individual ingredients. This implementation method constructs a complete closed-loop compatibility logic of "eliminating pathogens - strengthening the body's resistance - enhancing efficacy - harmonizing," rather than a simple superposition of known liver-protecting ingredients. Instead, it is a systematic compatibility design based on the traditional Chinese medicine theory of "addressing both the root cause and the symptoms, and treating both pathogens and the body's resistance," providing core support from both traditional Chinese medicine theory and modern pharmacology for the creativity of this solution.

[0010] In some embodiments, the weight range of the formulation of this invention is determined based on the theory of monarch-minister-assistant-guide compatibility and pharmacodynamic experimental results: when the dosage of kudzu root and Japanese raisin tree fruit is less than 10 parts, the core effective dosage for detoxifying alcohol and clearing damp heat cannot be achieved; when it is more than 30 parts, it will disrupt the overall compatibility balance of the formulation and increase the cold and cooling properties of the herbs; when the dosage of Ganoderma lucidum is less than 5 parts, the synergistic effect of strengthening the body and repairing liver cells cannot be achieved; when it is more than 30 parts, the production cost will be significantly increased, and there will be no additional synergistic effect; when the dosage of licorice is less than 3 parts, the effect of harmonizing the herbs and balancing their properties cannot be achieved; when it is more than 20 parts, it will increase the overall cloying nature of the formulation, and long-term use may easily lead to the risk of water and sodium retention; when the dosage of turmeric extract is less than 0.2 parts, the synergistic effect of antioxidation and anti-inflammation cannot be achieved; when it is more than 0.8 parts, it will disrupt the overall balance of the herbs and increase gastrointestinal irritation. This embodiment clarifies the basis for setting the numerical range of the formulation, ensuring that the scope of protection of the claims has clear theoretical and experimental support, and avoiding arbitrary limitation without basis.

[0011] In some embodiments, the curcumin content in the turmeric extract is ≥70%. Curcumin is the core active ingredient in turmeric extract that exerts anti-inflammatory, antioxidant, and hepatoprotective effects. Limiting its content to ≥70% ensures the stability and controllability of the core active ingredient in the composition, avoids the impact of batch-to-batch differences in raw materials on product efficacy, and avoids the significant increase in production costs caused by excessive purification. At the same time, curcumin of this purity can form synergistic effects with other traditional Chinese medicine extracts at low doses, breaking through the conventional understanding in the field that "curcumin needs to be added in high doses and with high purity to exert a hepatoprotective effect."

[0012] In some embodiments, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts kudzu root, 20 parts Ganoderma lucidum, 20 parts Hovenia dulcis, 10 parts licorice root, and 0.5 parts turmeric extract. This preferred ratio strictly matches the above-mentioned theory of principal, assistant, adjuvant, and guide herbs. The principal herbs, kudzu root and Hovenia dulcis, are used in sufficient quantities to ensure the core efficacy of detoxifying alcohol and clearing damp heat. The assistant herb, Ganoderma lucidum, is used in a suitable amount to complement the principal herbs, achieving a synergistic effect of strengthening the body's resistance and repairing liver cells. The adjuvant herb, turmeric extract, is added in precise, low doses to enhance efficacy without increasing the adverse effects of the herbs. The guiding herb, licorice root, is used in a balanced amount to ensure a harmonious composition and optimal synergy of the entire formula.

[0013] In a second aspect, the present invention provides an oral preparation for liver protection, comprising an active ingredient and food / pharmaceutical acceptable excipients, wherein the active ingredient is a traditional Chinese medicine composition as described in any one of the first aspects above.

[0014] In some embodiments, the herbal composition accounts for 30% to 60% of the mass of the oral preparation. This range of addition ensures that the final product achieves the expected liver-protecting and hangover-relieving effects, while also meeting the formulation specifications of various foods and health foods. It avoids difficulties in dosage form formation and unpleasant taste caused by excessive addition, and also avoids insufficient efficacy caused by excessive addition, thus adapting to the development needs of different product categories.

[0015] In some embodiments, the dosage form of the oral preparation is any one of tablets, capsules, granules, oral liquids, pills, and syrups. All of the above dosage forms are oral delivery formulations, offering good compliance and adaptability to the needs of different populations: capsules and tablets are highly portable and suitable for daily long-term maintenance for high-risk groups of liver damage; oral liquids and granules are rapidly absorbed and effective, suitable for emergency use before and after alcohol consumption, achieving application coverage across all scenarios.

[0016] Thirdly, the present invention provides a method for preparing the above-mentioned adjuvant hepatoprotective oral preparation, comprising the following steps: Step 1: Add 30% ethanol to the proportioned raw materials of kudzu root, Ganoderma lucidum, licorice, and Japanese raisin tree, and reflux extract twice at 60℃-90℃, each extraction lasting 1.5-3.5 hours. Combine the two extracts, filter, concentrate, and dry to obtain the Chinese herbal extract. Step 2: Mix the Chinese herbal extract obtained in Step 1 with the turmeric extract in the specified ratio to obtain the Chinese herbal composition described in any of the first aspects above. Then add food / pharmaceutical acceptable excipients and process it into an oral preparation.

[0017] This preparation method uses 30% low-concentration ethanol as the extraction solvent, which can simultaneously and efficiently extract core water-soluble and alcohol-soluble active ingredients such as puerarin, dihydromyricetin, glycyrrhizic acid, and Ganoderma lucidum polysaccharides. It also avoids the extraction of a large number of ineffective lipid-soluble impurities by high-concentration ethanol. At the same time, it can achieve large-scale production without the need for an explosion-proof workshop, which greatly reduces the safety risks and solvent costs of production. The method of co-extracting raw medicinal materials and then compounding them with turmeric extract not only retains the synergistic effect of components produced by traditional Chinese medicine compound co-extraction, but also achieves precise feeding of highly active core components, solving the problem of difficult stable control of curcumin content when co-extracting all medicinal materials.

[0018] In some implementations, in step 1, the amount of ethanol added is 8-16 times the total weight of the raw materials, the extraction temperature is 90℃, and the extraction time is 2.5 hours per extraction. These process parameters are the optimal range determined through single-factor gradient experiments and orthogonal experiments. Under these parameter conditions, the extraction rate of the core active ingredients in kudzu root, Japanese raisin tree fruit, and licorice reaches its peak, while also taking into account extraction time, energy consumption, and solvent costs. It exhibits strong batch-to-batch stability and can be directly adapted for industrial-scale production without additional adjustments to the process parameters.

[0019] Fourthly, the present invention provides the use of the traditional Chinese medicine composition described in any one of the first aspects above in the preparation of food, health food or medicine that helps protect against chemically induced liver damage and relieves hangovers.

[0020] In some embodiments, the daily dosage of the health food is 1.0 to 2.0 g of the traditional Chinese medicine composition. This dosage range is based on the safe effective dose determined by pharmacodynamic experiments, which can meet the daily liver care needs without causing overdose. The medicine is mild and has no obvious bias, and long-term continuous use will not increase the metabolic burden on the liver. It is suitable for the daily care needs of high-risk groups for liver damage such as those who drink alcohol or stay up late.

[0021] The present invention has the following advantages over the prior art: This invention strictly adheres to the principles of traditional Chinese medicine (TCM) to construct a simplified formula, using five medicinal and edible ingredients in a closed-loop system to form the core active ingredient composition. Compared to the complex liver-protecting formulas of existing technologies that rely on piling up ingredients, this invention significantly reduces the complexity of compound ingredients and the uncontrollable risks of metabolism in the body while ensuring the dual core efficacy of relieving hangovers and providing auxiliary protection against chemically induced liver damage. The selection of all medicinal and edible ingredients completely solves the pain points of poor compliance and difficulty in industrialization of existing products. The optimized low-concentration ethanol extraction process balances the extraction efficiency of the core active ingredients with the safety of industrial production. It is economical and can be adapted to the development needs of various oral formulations; at the same time, the whole formula is mild and has no obvious cold or hot properties, making it suitable for long-term daily maintenance needs. It achieves a triple balance of efficacy, safety, and industrialization feasibility, filling the industry gap where existing liver protection products cannot simultaneously achieve simplification and compliance, multi-target synergistic liver protection, and long-term safety. It can be directly adapted to the development needs of the three major tracks of ordinary food, health food, and pharmaceuticals. The raw materials are readily available, the cost is controllable, and the process does not require special equipment. It can be directly mass-produced on existing conventional production lines, and has extremely high industrial promotion value and market application prospects. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is an image of an Oil Red O stained section of liver tissue from the normal control group mice in Experiment Example 2 of this invention; Figure 2 This is an image of an Oil Red O stained section of liver tissue from the model control group mice in Experiment Example 2 of this invention; Figure 3 This is an image of an Oil Red O stained section of liver tissue from mice in the low-dose test substance group of Experiment Example 2 of this invention; Figure 4 This is an image of an Oil Red O stained section of liver tissue from mice in the medium-dose test substance group of Experiment Example 2 of this invention; Figure 5 This is an image of an Oil Red O stained section of liver tissue from mice in the high-dose test substance group of Experiment Example 2 of this invention; Figure 6 This is a graph showing the relationship between puerarin extraction rate and extraction time, extraction volume ratio, and extraction temperature in the orthogonal experiment of this invention. Figure 7 This is a graph showing the relationship between the extraction rate of dihydromyricetin and extraction time, extraction volume ratio, and extraction temperature in the orthogonal experiment of this invention. Figure 8 This is a graph showing the relationship between glycyrrhizic acid extraction rate and extraction time, extraction volume ratio, and extraction temperature in the orthogonal experiment of this invention. Detailed Implementation

[0024] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0025] The following examples are used to illustrate the present invention, but are not intended to limit the scope of the invention. Where specific techniques or conditions are not specified in the examples, they should be performed according to the techniques or conditions described in the literature in this field, or according to the product instructions. Raw materials whose manufacturers are not specified are all conventional products that meet relevant national standards and can be purchased through legitimate channels; the turmeric extract is a commercially available product with a curcumin content ≥70%; kudzu root, ganoderma, licorice, and jujube fruit are all medicinal and edible materials that meet the standards of the 2025 edition of the Pharmacopoeia of the People's Republic of China.

[0026] Example 1 1. A traditional Chinese medicine composition for liver protection, its preparation method, and its application, comprising the following raw materials in parts by weight: 10 parts kudzu root, 5 parts Ganoderma lucidum, 10 parts Hovenia dulcis fruit, 3 parts licorice root, and 0.2 parts turmeric extract. The preparation method is as follows: 2. Mix the raw materials of kudzu root, Ganoderma lucidum, licorice, and Japanese raisin tree fruit evenly according to the above ratio, add 30% ethanol with a weight of 10 times the total weight of the raw materials, and reflux extract twice at 60℃ for 1.5 hours each time. Combine the two extracts, filter them with a 200-mesh filter cloth to remove impurities, and place the filtered extract in a vacuum concentration device. Concentrate it to a clear extract with a relative density of 1.10-1.15 (60℃) at 60℃ and a vacuum degree of -0.08MPa. Then, spray dry it (inlet air temperature 180℃, outlet air temperature 80℃) to obtain the Chinese herbal extract.

[0027] 3. Add the prepared Chinese herbal extract to the turmeric extract in the above proportion, mix well, then add 40% starch and 10% dextrin by weight, mix thoroughly, granulate, dry, and encapsulate to obtain capsules (each capsule contains 0.5g of the Chinese herbal extract composition).

[0028] Example 2 1. A traditional Chinese medicine composition for liver protection, its preparation method, and its application, comprising the following raw materials in parts by weight: 20 parts of kudzu root, 12 parts of Ganoderma lucidum, 20 parts of Hovenia dulcis fruit, 6 parts of licorice root, and 0.8 parts of turmeric extract. The preparation method is as follows: 2. Mix the raw materials of kudzu root, Ganoderma lucidum, licorice, and Japanese raisin tree fruit evenly according to the above ratio, add 30% ethanol at 12 times the total weight of the raw materials, and reflux extract twice at 75℃, each extraction lasting 2.5 hours. Combine the two extracts, filter them with a 400-mesh filter cloth to remove impurities, and place the filtered extract in a vacuum concentration device. Concentrate it to a clear extract with a relative density of 1.10-1.15 (60℃) at 60℃ and a vacuum degree of -0.08MPa. Dry it in a plate vacuum at 60℃ until the moisture content is 5%-6%. Collect the material, pulverize it and pass it through a 200-mesh sieve to obtain the Chinese herbal extract.

[0029] 3. Add the obtained Chinese herbal extract to the turmeric extract in the above proportion, mix well, then add 20% sucrose and 30% starch by weight, mix thoroughly, and then make into granules. Dry and granulate to obtain granules (each bag contains 1.0g of Chinese herbal extract).

[0030] Example 3 1. A traditional Chinese medicine composition for liver protection, its preparation method, and its application, comprising the following raw materials in parts by weight: 30 parts of kudzu root, 30 parts of Ganoderma lucidum, 20 parts of Hovenia dulcis fruit, 20 parts of licorice root, and 0.5 parts of turmeric extract. The preparation method is as follows: 2. Mix the raw materials of kudzu root, Ganoderma lucidum, licorice, and Japanese raisin tree fruit evenly according to the above ratio, add 30% ethanol at 15 times the total weight of the raw materials, and reflux extract twice at 90℃, each extraction for 3.5 hours. Combine the two extracts, filter with an 800-mesh filter cloth to remove impurities, and place the filtered extract in a vacuum concentration device. Concentrate it to a clear extract with a relative density of 1.10-1.15 (60℃) at 60℃ and a vacuum degree of -0.08MPa. Then, spray dry (inlet air temperature 180℃, outlet air temperature 80℃) to obtain the Chinese herbal extract.

[0031] 3. Add the prepared Chinese herbal extract to the turmeric extract in the above proportion, mix well, then add an appropriate amount of purified water and 2% allulose by volume, filter, fill and sterilize after fully dissolving to obtain oral liquid (each bottle contains 10ml, containing 0.8g of Chinese herbal extract).

[0032] Example 4 1. A traditional Chinese medicine composition for liver protection, its preparation method, and its application, comprising the following raw materials in parts by weight: 25 parts of kudzu root, 15 parts of Ganoderma lucidum, 25 parts of Hovenia dulcis fruit, 8 parts of licorice root, and 0.6 parts of turmeric extract. The preparation method is the same as in Example 2, and the mixture is made into tablets (each tablet contains 0.3g of the extract of the traditional Chinese medicine composition).

[0033] Example 5: Example of the lower limit endpoint value of claim 1 (capsule) 1. A traditional Chinese medicine composition for liver protection, comprising the following raw materials in parts by weight: 10 parts of kudzu root, 5 parts of Ganoderma lucidum, 10 parts of Japanese raisin tree fruit, 3 parts of licorice root, and 0.2 parts of turmeric extract, wherein the turmeric extract contains ≥70% curcumin by mass.

[0034] 2. The preparation method is as follows: Mix the proportioned kudzu root, Ganoderma lucidum, licorice, and Japanese raisin tree fruit evenly, add 10 times the total weight of the raw materials in 30% ethanol (volume concentration), and reflux extract twice at 90℃ for 2.5 hours each time. Combine the two extracts, filter with a 400-mesh filter cloth to remove impurities, and concentrate the filtrate under reduced pressure at 60℃ and a vacuum degree of -0.08MPa to a clear extract with a relative density of 1.10-1.15 (measured at 60℃). Spray dry to obtain the Chinese herbal extract. Mix the Chinese herbal extract with the proportioned turmeric extract evenly, add 45% of the total weight of pregelatinized starch and 5% of crospovidone, mix thoroughly, and then dry granulate. After granulation, add 0.5% magnesium stearate and mix well. Fill into hard capsules to obtain capsules (each capsule contains 0.5g of the Chinese herbal extract).

[0035] 3. This embodiment is the lowest dose endpoint formulation within the protection scope of claim 1, and falls entirely within the numerical protection scope of claim 1. It can stably achieve the core effects of assisting in the protection of chemically induced liver damage and relieving hangovers, and is used to verify the technical feasibility of the lower limit of the numerical range of the claim.

[0036] Example 6: Upper Limit Endpoint Value Example (Granules) 1. A traditional Chinese medicine composition for liver protection, comprising the following raw materials in parts by weight: 30 parts of kudzu root, 30 parts of Ganoderma lucidum, 30 parts of Japanese raisin tree fruit, 20 parts of licorice root, and 0.8 parts of turmeric extract, wherein the turmeric extract contains ≥90% curcumin by mass.

[0037] 2. Preparation method is as follows: Mix the proportioned kudzu root, Ganoderma lucidum, licorice, and Japanese raisin tree fruit evenly, add 12 times the total weight of the raw materials in 30% ethanol (volume concentration), and reflux extract twice at 90℃, each extraction lasting 2.5 hours. Combine the two extracts, filter with a 400-mesh filter cloth to remove impurities, and concentrate the filtrate under reduced pressure at 60℃ and a vacuum degree of -0.08MPa to a clear extract with a relative density of 1.10-1.15 (measured at 60℃). After vacuum drying, pulverize and pass through a 200-mesh sieve to obtain the herbal extract. Mix the herbal extract evenly with the proportioned turmeric extract, add 25% mannitol and 25% maltodextrin by weight, mix thoroughly, wet granulate, dry at 60℃, and granulate to obtain granules (each bag contains 1.0g of the herbal extract composition).

[0038] 3. This embodiment is the highest dose end of the protection range of claim 1, which falls completely within the numerical protection range of claim 1. It can stably achieve the core effects of assisting in the protection of chemically induced liver damage and relieving hangovers, and is used to verify the technical feasibility of the upper limit of the numerical range of the claim.

[0039] Example 7: Preferred Formulation Example (Oral Liquid) 1. A traditional Chinese medicine composition for liver protection, comprising the following raw materials in parts by weight: 30 parts of kudzu root, 20 parts of Ganoderma lucidum, 20 parts of Japanese raisin tree fruit, 10 parts of licorice root, and 0.5 parts of turmeric extract, wherein the turmeric extract contains ≥70% curcumin by mass.

[0040] 2. Preparation method is as follows: Mix the proportioned kudzu root, Ganoderma lucidum, licorice, and Japanese raisin tree fruit evenly, add 10 times the total weight of the raw materials in 30% ethanol (volume concentration), and reflux extract twice at 90℃, each extraction lasting 2.5 hours. Combine the two extracts, filter with an 800-mesh filter cloth to remove impurities, and concentrate the filtrate under reduced pressure at 60℃ and a vacuum degree of -0.08MPa to a clear extract with a relative density of 1.10-1.15 (measured at 60℃). Spray dry to obtain the Chinese herbal extract. Mix the Chinese herbal extract with the proportioned turmeric extract evenly, add purified water to make up the volume, and then add 2% allulose and 0.1% potassium sorbate (volume mass ratio). After stirring and dissolving thoroughly, filter through a 0.22μm microporous membrane, fill into 10ml oral liquid bottles, and sterilize at 121℃ for 15 minutes to obtain the oral liquid (each 10ml bottle contains 0.8g of the Chinese herbal extract).

[0041] 3. This embodiment is the optimal formulation within the scope of protection of claim 1, strictly matching the theory of monarch, minister, assistant and guide in the specification. The dosage of each raw material is within the numerical range of claim 1, resulting in the best synergistic effect. The medicine is mild and suitable for long-term daily maintenance.

[0042] Extraction process research experimental example Experimental Example 1: Process Research I. Examination of the gradient of extraction times The extraction was carried out at a temperature of 85℃, with 30% ethanol as the solvent and a solvent ratio of 10 times. The extraction time was 2.5 hours per extraction. The yields of dry extract, puerarin, dihydromyricetin, and glycyrrhizic acid were investigated after 1, 2, 3, and 4 extractions.

[0043]

[0044]

[0045]

[0046] Based on the experimental results, taking into account extraction time, energy consumption, reagent and labor costs, extraction was performed twice.

[0047] II. Examination of Time Gradient Extraction The extraction was performed twice at a temperature of 85℃, with 30% ethanol as the solvent and a solvent ratio of 10. The yields of dry extract, puerarin, dihydromyricetin, and glycyrrhizic acid were examined at extraction times of 1.5h, 2.0h, 2.5h, 3.0h, and 3.5h.

[0048]

[0049]

[0050]

[0051] According to the experimental results, for kudzu root and Japanese raisin tree fruit, the longer the extraction time, the better, and for licorice root, the extraction yield is highest at 2.5 hours. Considering the time, labor costs, and dry extract yield, the orthogonal experiment can be set with gradients of 2.0 hours, 2.5 hours, and 3.0 hours.

[0052] III. Investigation of the extraction solvent multiple gradient Extraction was performed twice at 85℃ with 30% ethanol as solvent, each time for 2.5 hours. The yields of dry extract, puerarin, dihydromyricetin, and glycyrrhizic acid were investigated at solvent ratios of 8, 10, 12, 14, and 16.

[0053]

[0054]

[0055]

[0056] According to the experimental results, the extraction rates of kudzu root, Japanese raisin tree fruit, and licorice reached their highest values ​​at 16x, 10x, and 12x solvents, respectively, and the content of active ingredients reached their highest values ​​at 12x, 10x, and 8x, respectively. Considering the overall cost, orthogonal experiments can be set with gradients of 8X, 10X, and 12X.

[0057] IV. Investigation of Temperature Gradient Extraction The solvent was set to 30% ethanol, and the extraction was performed twice, each time for 2.5 hours. The solvent ratio was 10 times. The yields of dry extract, puerarin, dihydromyricetin, and glycyrrhizic acid were set at temperatures of 50℃, 60℃, 70℃, 80℃, and 90℃.

[0058]

[0059]

[0060]

[0061] According to the experimental results, the extraction rate of active ingredients of kudzu root and Japanese raisin tree fruit is the highest when extracted at 90℃. Orthogonal experiments can be conducted by setting temperature gradients of 70℃, 80℃, and 90℃.

[0062] V. Orthogonal Experiment Orthogonal design:

[0063] result: 5.1 Kudzu root

[0064]

[0065] like Figure 6 The results show that for puerarin extraction alone, the optimal extraction time is 2.5 hours, 10 times the solvent, and 90°C.

[0066] 5.2 Zhizizi

[0067]

[0068] like Figure 7 As shown, considering only the extraction of Hovenia dulcis seeds, the optimal extraction time is 2.5 hours, 12 times the solvent, and 90℃.

[0069] 5.3 Licorice

[0070]

[0071] like Figure 8 As shown, for licorice extraction alone, the optimal extraction time is 2.0 hours, 10 times the solvent, and 90℃.

[0072] Considering overall cost, the optimal extraction process for the formulation is 10 times the amount of solvent, 90℃ extraction, twice, 2.5 hours each time.

[0073] Example of experimental verification of auxiliary protection against chemically induced liver injury Experimental Example 2: Validation of auxiliary protective function against chemically induced liver injury To verify the adjuvant protective effect of the herbal composition of this invention on chemically induced liver injury, the following experiments were conducted: 1. Experimental subjects: 60 SPF-grade Kunming mice, weighing 18-22g, were used for the experiment after 5 days of acclimatization feeding.

[0074] 2. Experimental grouping: The subjects were randomly divided into 5 groups: blank control group, model control group, low-dose group of Example 2, medium-dose group of Example 2, and high-dose group of Example 2. The dosage of the low-dose group was 0.083 g / kg bw, the medium-dose group was 0.167 g / kg bw, and the high-dose group was 0.233 g / kg bw (calculated as extract of the composition).

[0075] 3. Gavage: After 5 days of acclimatization, starting from day 6 of the experiment, each experimental group was orally administered the test substance (10 mL / kg bw) between 8:00 and 9:00 AM daily. The blank control group and the model group were given an equal volume of purified water. This was continued for 28 days. After the last administration, the mice were fasted for 2 hours but allowed free access to water, and then administered 53% ethanol (12.6 mL / kg bw) by gavage. The normal control group received the same dose of purified water to establish an acute alcoholic liver injury model. The animals were then sacrificed after 16 hours of fasting, and serum and liver were collected.

[0076] 4. Weight changes: Starting from day 1 when mice were given gavage, their weight was measured and recorded for 7 days as a cycle.

[0077] 5. Blood and Liver Tissue Collection: After a 16-hour period of fasting followed by unrestricted water intake following the last gavage, mice in each group were anesthetized with isoflurane inhalation. Blood was collected, and serum was obtained by centrifugation at 4°C. The centrifuged serum was stored at -20°C for future testing. After blood collection, liver tissue was quickly removed (two portions: one fixed in 10% formaldehyde solution, and one 0.1g sample for assays). The liver tissue was rinsed with ice-cold saline, dried with filter paper, weighed, aliquoted, and stored at -20°C for future testing.

[0078] 6. Determination of MDA, TG, and GSH activities in mouse liver tissue: Liver samples were removed from a -20°C freezer, thawed at room temperature, and accurately weighed (0.1 g). The samples were homogenized and mixed with pre-cooled physiological saline or PBS solution to prepare a 10% tissue homogenate. The homogenate was centrifuged at 4°C, and the supernatant was collected. Following the kit instructions, the MDA, TG, and GSH activities in the liver tissue were determined. The kits used are: Malondialdehyde (MDA) Content Detection Kit (Upgraded Version) (TBARS Method), Micro-method, Catalog No.: BC6415, 100T; Triglyceride (TG) Content Detection Kit, Micro-method, Catalog No.: BC0625, Specification: 100T / 96S; Reduced Glutathione (GSH) Content Detection Kit, Micro-method, Catalog No.: BC1175, 100T / 96S.

[0079] 7. Animal weight gain:

[0080] Note: Compared with the normal control group, "*" indicates P<0.05, and "**" indicates P<0.01. 8. Weight results showed that the weight of mice in each group continued to increase, and the total weight gain was within the normal range. Compared with the normal control group, there was no statistically significant difference in weekly weight and weight gain among mice in the model control group and each test group within 4 weeks.

[0081] 9. Results of liver biochemical index detection: Effects of different doses on the levels of MDA, GSH and TG in the liver of mice with acute alcoholic liver injury (x±s, n=10).

[0082]

[0083] Note: Compared with the normal control group, "#" indicates P < 0.05, "##" indicates P < 0.01; compared with the model control group, "$" indicates P < 0.05, "$$" indicates P < 0.01. 10. The results showed that, compared with the normal control group, the levels of malondialdehyde (MDA) and triglycerides (TG) in the liver tissue of the model control group were significantly increased (P<0.01), while the level of reduced glutathione (GSH) was significantly decreased, thus establishing the acute alcoholic liver injury model. Compared with the model control group, the levels of malondialdehyde (MDA) in the liver of the low, medium, and high dose groups were decreased (P<0.05), the levels of triglycerides (TG) were decreased (P<0.01), and the level of reduced glutathione (GSH) was significantly increased (P<0.01).

[0084] 11. Subsequently, the liver tissue was sent for external examination and stained with Oil Red O. The tissue was then observed under a microscope and scored. The results are as follows:

[0085] Note: Compared with the normal group, "*" P<0.05, "**" P<0.01; compared with the model control group, "$" P<0.05, "$$" P<0.01; Staining steps: 1. Steps for Oil Red O staining of cell slides 1.1. Fixation: After adding a general-purpose fixative to the well plate and fixing for 15 minutes, remove the fixative from the wells and wash with ultrapure water 3-4 times.

[0086] 1.2. Membrane breaking: Add membrane breaking solution to the well plate and break the membrane for 15 minutes. Aspirate the membrane breaking solution from the well and wash with ultrapure water 3-4 times.

[0087] 1.3. Oil Red O staining: Mix 5 parts saturated Oil Red O staining solution with 5 parts distilled water thoroughly (prepare 1 day in advance), filter once in the dark the next day to obtain the cell Oil Red O working solution; wash the slide with 60% isopropanol to remove residual water, and let it air dry naturally before placing it in a new six-well plate. Add the prepared Oil Red O working solution and stain in the dark for 30 minutes; Differentiation: Take out the slide and immerse it in 60% isopropanol for 3 seconds to differentiate, then place it back in the original six-well plate and wash 3 times with distilled water; 1.4.1.5. Nucleus staining: Take the cell slide and stain it with hematoxylin for 5-15 seconds, wash with water and invert blue for 1 second, rinse briefly with tap water, and place it back in the well plate; 1.6. Mounting: Take a clean glass slide, write the number on it, add glycerol gelatin to the center of the slide, take out the slide, place the side with cells facing down, and mount it with glycerol gelatin mounting medium.

[0088] 2. Steps for staining frozen sections with Oil Red O 2.1. Fixation of frozen sections: Remove the frozen sections from the -20°C freezer and allow them to return to room temperature, then let them air dry naturally.

[0089] 2.2. Oil Red Staining: Mix 6 parts saturated Oil Red 0 staining solution with 4 parts distilled water thoroughly, let stand overnight at 4°C, filter once with qualitative filter paper the next day, and filter a second time after standing at 4°C for 24 hours to obtain Oil Red 0 working solution. Immerse the sections in the Oil Red staining solution for 8-10 minutes (cover and protect from light).

[0090] 2.3. Background Differentiation: Remove the sections, hold for 3 seconds, then immerse them sequentially in two tanks of 60% isopropanol for differentiation, 3 seconds and 5 seconds respectively. Immerse the sections sequentially in three tanks of pure water for washing, 10 seconds each.

[0091] 2.4. Hematoxylin staining: Remove the sections, let them stand for 3 seconds, then immerse them in hematoxylin for counterstaining for 0.5-3 minutes. Rinse with pure water in three tanks for 5 seconds, 10 seconds, and 30 seconds respectively. Differentiate with differentiation solution for 2-8 seconds, rinse with water in two tanks for 10 seconds each, and then rinse with blue solution for 1 second. Gently immerse the sections in tap water in two tanks for 5 seconds and 10 seconds respectively, and examine the staining effect under a microscope.

[0092] 2.5. Mounting: Mount the slide with glycerin gelatin mounting medium.

[0093] 2.6. Microscopic examination, image acquisition and analysis.

[0094] 12. Pathological results showed that 70 fields of view (occupying 1 / 2 of the total field, with a recording area of ​​approximately 32 mm) were continuously recorded using a 40x objective lens. 2The main observation was the distribution, extent, and area of ​​lipid droplets in the liver. The normal control group showed a small number of scattered lipid droplets and a lower overall score; the model control group showed large areas of lipid droplets throughout the liver tissue, indicating severe lipid accumulation, and a significantly higher score. Compared with the model control group, the low, medium, and high doses significantly reduced lipid accumulation in the liver tissue, resulting in significantly lower scores (p<0.05, p<0.01, p<0.01); there were no statistically significant differences in scores among the other groups.

[0095] 13. Scoring criteria: Lipid droplets are scattered and sparse in hepatocytes (0 points); Lipid droplet-containing hepatocytes account for no more than 1 / 4 (1 point); Lipid droplet-containing hepatocytes account for no more than 1 / 2 (2 points); Lipid droplet-containing hepatocytes account for no more than 3 / 4 (3 points); Liver tissue is almost completely replaced by lipid droplets (4 points).

[0096] 14. It should be noted that the traditional Chinese medicine composition of this invention can be used to prepare foods, health foods, or medicines that assist in liver protection. The amount added to these foods, health foods, or medicines is 30wt% to 60wt%, and the specific amount can be adjusted according to product requirements. For example, when preparing liver-protecting health foods, the composition of this invention can be mixed with appropriate excipients to form dosage forms such as capsules, granules, and oral liquids. The daily dosage is 1.0 to 2.0g of the extract of the composition of this invention, and the specific dosage can be adjusted according to individual population differences.

[0097] Comparative Example 1: Comparative Example of Incomplete Formula (Group Lacking Principal Herb) 1. Formula: 20 parts Ganoderma lucidum, 10 parts licorice, 0.5 parts turmeric extract (the principal ingredients of this invention, kudzu root and Japanese raisin tree fruit, are missing; the other ingredients and proportions are completely consistent with those in Example 7).

[0098] 2. Preparation method: The preparation method is completely consistent with that in Example 7, and capsules are prepared.

[0099] 3. Verification method: The animal experimental method, modeling conditions, and detection indicators are completely consistent with those of Experiment Example 2, and the experiment is carried out in parallel.

[0100] 4. Validation Results: Compared with the model control group, the liver MDA and TG levels in the comparative group of mice did not decrease significantly, the GSH level did not increase significantly, and the pathological score did not improve significantly, with no statistically significant differences (P>0.05). This demonstrates that the principal herbs, Pueraria lobata and Hovenia dulcis, are fundamental to the core efficacy of this treatment; their absence results in the loss of the hepatoprotective effect of the composition.

[0101] Comparative Example 2: Comparative Example of Incomplete Formula (Group Lacking Adjuvant Drugs) 1. Formula: 30 parts of kudzu root, 20 parts of Ganoderma lucidum, 20 parts of Hovenia dulcis fruit, and 10 parts of licorice root (the turmeric extract, an adjuvant of this invention, is missing; the other ingredients and proportions are completely consistent with those in Example 7).

[0102] 2. Preparation method: The preparation method is completely consistent with that in Example 7, and capsules are prepared.

[0103] 3. Verification method: The animal experimental method, modeling conditions, and detection indicators are completely consistent with those of Experiment Example 2, and the experiment is carried out in parallel.

[0104] 4. Verification Results: Compared with the model control group, the liver MDA content of mice in this comparative group decreased by only 12.3%, GSH content increased by only 28.7%, TG content decreased by only 21.5%, and the pathological score decreased by only 2.98 points; while in the whole formula group of Example 7, MDA decreased by 45.3%, GSH increased by 72.8%, TG decreased by 73.9%, and the pathological score decreased to 2.05 points. This demonstrates that the low-dose turmeric extract has a significant synergistic effect with the other four medicinal materials. The liver-protective effect of the composition is greatly reduced after the absence of these ingredients. The combination of the five medicinal materials in this scheme is not a simple additive but produces an unexpected synergistic effect.

[0105] Comparative Example 3: The closest comparable to the prior art 1. The formula consists of: 30 parts kudzu root, 20 parts Ganoderma lucidum, 20 parts Hovenia dulcis, 10 parts licorice, 10 parts turmeric, 10 parts Schisandra chinensis, 15 parts yam, 10 parts jujube, 10 parts dandelion, 10 parts chrysanthemum, 10 parts Polygonatum odoratum, and 10 parts dried tangerine peel.

[0106] 2. Preparation method: The preparation method is completely consistent with that of Example 7 of the present invention. Specifically, all the medicinal materials in the above proportions are mixed evenly, and 10 times the total weight of the raw materials are added to 30% ethanol with a volume concentration of 10%. The mixture is refluxed and extracted twice at 90°C for 2.5 hours each time. The two extracts are combined and filtered through an 800-mesh filter cloth to remove impurities. The filtrate is concentrated under reduced pressure at 60°C and a vacuum degree of -0.08MPa to a clear extract with a relative density of 1.10 to 1.15 (measured at 60°C). The extract powder is spray-dried to obtain the extract powder. The extract powder is added to 45% of the total weight of pregelatinized starch and 5% of cross-linked povidone. After thorough mixing, the mixture is dry-granulated. After granulation, 0.5% of magnesium stearate is added and mixed evenly. The mixture is then filled into No. 0 hard capsules to obtain capsules with the same concentration as in Example 7 (each capsule contains 0.5g of extract powder).

[0107] 3. Verification method: The animal experimental method, modeling conditions, drug dosage, and detection indicators are completely consistent with those of Experiment Example 2 of the present invention, and the experiments are carried out in parallel.

[0108] 4. Validation results: Compared with the model control group, the MDA level in the liver of mice in this comparative group decreased by 32.1%, GSH increased by 45.6%, TG decreased by 38.2%, and the pathological score decreased to 2.62 points; while the MDA level in the whole formula group of Example 7 of this invention decreased by 45.3%, GSH increased by 72.8%, TG decreased by 73.9%, and the pathological score decreased to 2.05 points.

[0109] Comparative Example 4: Single Herb Equal Amount Comparative Example (Turmeric Extract Single Herb Group) 1. Formula: 0.5 parts of turmeric extract, added with starch and dextrin to make capsules, and the dosage is exactly the same as the dosage of turmeric extract in Example 7.

[0110] 2. Verification method: The animal experimental method, modeling conditions, and detection indicators are completely consistent with those of Experiment Example 2, and the experiment is carried out in parallel.

[0111] 3. Validation results: Compared with the model control group, the liver injury indicators of mice in this comparative group were not significantly improved (P>0.05), which proved that the low dose of turmeric extract in this regimen alone had no significant liver protection effect. It could only exert a synergistic effect when combined with the other four medicinal materials, which further verified the synergistic effect of the regimen.

[0112] The parallel comparison results of the core efficacy indicators of each comparative example and Example 7 are shown in the table below (x±s, n=10).

[0113] Note: Compared with the model control group, “$” indicates P < 0.05, and “$$” indicates P < 0.01; The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for liver protection, characterized in that, It is composed of the following raw materials in parts by weight: 10-30 parts of kudzu root, 5-30 parts of Ganoderma lucidum, 10-30 parts of Japanese raisin tree fruit, 3-20 parts of licorice root, and 0.2-0.8 parts of turmeric extract.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The curcumin content in the turmeric extract is ≥70%.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, It is composed of the following ingredients in parts by weight: 30 parts kudzu root, 20 parts Ganoderma lucidum, 20 parts Hovenia dulcis, 10 parts licorice, and 0.5 parts turmeric extract.

4. An oral preparation for adjuvant liver protection, characterized in that, It includes an active ingredient and food / pharmaceutical acceptable excipients, wherein the active ingredient is the traditional Chinese medicine composition according to any one of claims 1-3.

5. The oral formulation according to claim 4, characterized in that, The traditional Chinese medicine composition accounts for 30% to 60% of the mass of the oral preparation.

6. The oral formulation according to claim 4, characterized in that, The dosage form of the oral preparation is any one of tablets, capsules, granules, oral liquids, pills, or syrups.

7. A method for preparing the adjuvant hepatoprotective oral preparation according to claim 4, characterized in that, Includes the following steps: Step 1: Add 30% ethanol to the proportioned raw materials of kudzu root, Ganoderma lucidum, licorice, and Japanese raisin tree, and reflux extract twice at 60℃-90℃, each extraction lasting 1.5-3.5 hours. Combine the two extracts, filter, concentrate, and dry to obtain the Chinese herbal extract. Step 2: Mix the Chinese herbal extract obtained in Step 1 with the turmeric extract in the specified ratio to obtain the Chinese herbal composition according to any one of claims 1-3. Then add food or pharmaceutically acceptable excipients and process it into an oral preparation.

8. The preparation method according to claim 7, characterized in that, In step 1, the amount of ethanol added is 8-16 times the total weight of the raw materials, the extraction temperature is 90℃, and the extraction time is 2.5h each time.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of food, health food or medicine that helps protect against chemically induced liver damage and relieves hangovers.

10. The application according to claim 9, characterized in that, The daily dosage of the health food is 1.0 to 2.0g of the traditional Chinese medicine composition.

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