Composition for protecting liver and dispelling effects of alcohol as well as preparation method and application of composition

Abstract

The invention relates to the technical field of health-care food and functional food, and discloses a liver-protecting and hangover-alleviating composition which comprises the following components in parts by weight: the active component comprises 10-30 parts, preferably 20 parts, of a radix puerariae extract (puerarin content is greater than or equal to 40%); the content of total flavonoids is larger than or equal to 7%, and the content of dihydromyricetin is larger than or equal to 1%. The hovenia dulcis thunb extract is 10-30 parts, preferably 20 parts, and the oyster extract is 5-15 parts, preferably 10 parts, of the taurine content is larger than or equal to 10%, and the zinc content is larger than or equal to 0.5%. According to the liver-protecting and hangover-alleviating composition as well as the preparation method and the application thereof, based on the monarch, minister, assistant and guide theory of traditional Chinese medicine and the precise proportioning of modern pharmacological research, the triple effects of alleviating hangover, protecting liver and relieving discomfort are realized through the synergistic effect of the six active ingredients, animal experiments show that the ALT level of a rat with alcoholic liver injury can be reduced by 42.4%, the SOD activity can be improved by 39.4%, and the liver-protecting and hangover-alleviating composition can be used for preventing and treating alcoholic liver injury. And the effect is better than that of similar products with single component or simple compatibility.

Description

Technical Field

[0001] This invention relates to the field of health food and functional food technology, specifically to a liver-protecting and hangover-relieving composition, its preparation method, and its application. Background Technology

[0002] Alcoholic liver injury is a prevalent chronic liver disease worldwide. Its pathogenesis involves a multi-pathway cascade of damage: acetaldehyde, produced from the metabolism of ethanol in the liver, can directly covalently bind to hepatocyte proteins to form adducts, inducing hepatocyte necrosis and apoptosis; the large amount of reactive oxygen species (ROS) produced during metabolism triggers oxidative stress, damaging the lipid bilayer structure of hepatocyte membranes and leading to increased hepatocyte permeability; long-term alcohol consumption also interferes with the hepatic fatty acid β-oxidation pathway, inducing lipid accumulation and the release of inflammatory factors, eventually progressing to fatty liver, liver fibrosis, and even cirrhosis. The market demand for safe, effective, and convenient liver-protecting and hangover-relieving products continues to grow.

[0003] Currently, commercially available hangover remedies generally suffer from two major technological shortcomings: First, their functional design is singular, with most products focusing only on accelerating alcohol metabolism or simply protecting the liver, lacking multi-target synergistic intervention across the entire alcohol damage chain; second, their dosage form and manufacturing processes are limited, with traditional Chinese medicine decoctions being inconvenient to take, and ordinary tablets suffering from slow disintegration and low dissolution of active ingredients, making them difficult to adapt to the immediate protection needs of modern fast-paced lifestyles. Several liver-protecting and hangover-relieving compositions have been disclosed in the prior art. For example, patent application CN101745087A discloses a hangover-relieving composition composed of Hovenia dulcis, licorice, dried plum, and ginger, which may include ingredients such as kudzu root and taurine. Patent application CN106235327A discloses a hangover-relieving and stomach-protecting composition containing taurine, kudzu root, Hovenia dulcis, and γ-aminobutyric acid. Patent application CN118873623A discloses a liver-protecting and hangover-relieving traditional Chinese medicine composition composed of Hovenia dulcis, kudzu root, vine tea, gardenia, and licorice. However, none of the above solutions clearly define the quality control standards for the active ingredients of the raw materials, nor do they achieve rapid release of active ingredients through excipient compatibility optimization. How to improve the bioavailability of the formulation while ensuring the synergistic efficacy of the formulation remains a technical problem that urgently needs to be solved in this field. Summary of the Invention

[0004] (a) Technical problems to be solved

[0005] To address the shortcomings of existing technologies, this invention provides a liver-protecting and hangover-relieving composition, its preparation method, and its application. This composition accelerates alcohol metabolism, reduces liver damage, and alleviates post-drinking discomfort. It solves the problems of existing technologies, such as single-function designs, most products focusing only on accelerating alcohol metabolism or simply protecting the liver, lacking multi-target synergistic intervention across the entire alcohol damage chain, limitations in dosage form and manufacturing processes, the inconvenience of traditional Chinese medicine decoctions, and the slow disintegration and low dissolution of active ingredients in ordinary tablets, making them unsuitable for the immediate protection needs of modern fast-paced lifestyles.

[0006] (II) Technical Solution

[0007] To achieve the aforementioned objectives of accelerating alcohol metabolism, reducing liver damage, and alleviating post-drinking discomfort, this invention provides the following technical solution: a liver-protecting and hangover-relieving composition, comprising active ingredients and pharmaceutical excipients, wherein the weight proportions of each component are as follows:

[0008] The active ingredients include: kudzu root extract (puerarin content ≥40%): 10-30 parts, preferably 20 parts; Japanese raisin tree extract (total flavonoid content ≥7%, dihydromyricetin content ≥1%): 10-30 parts, preferably 20 parts; oyster extract (taurine content ≥10%, zinc content ≥0.5%): 5-15 parts, preferably 10 parts; broken-cell wall pine pollen (polysaccharide content ≥8%): 5-15 parts, preferably 10 parts; taurine (purity ≥99%): 3-10 parts, preferably 5 parts; and licorice extract (glycyrrhizic acid content ≥5%): 3-10 parts, preferably 5 parts.

[0009] The pharmaceutical excipients include microcrystalline cellulose (particle size 100-200μm): 20-40 parts, preferably 25 parts; sodium carboxymethyl starch (degree of substitution 0.3-0.4): 3-10 parts, preferably 5 parts; fumed silica (specific surface area 200±20m² / g): 1-5 parts, preferably 2 parts; and magnesium stearate (particle size ≤75μm): 0.5-2 parts, preferably 1 part.

[0010] Furthermore, the kudzu root extract is the principal ingredient, and its main active component, puerarin, can accelerate alcohol metabolism by activating the activities of alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH), while inhibiting the release of inflammatory factors TNF-α and IL-6, thus reducing hepatocellular inflammatory damage. The Hovenia dulcis extract is the secondary ingredient, which is rich in dihydromyricetin, which can competitively bind to acetaldehyde metabolism targets, reducing the covalent binding of acetaldehyde to hepatocellular proteins. At the same time, it accelerates the excretion of alcohol metabolites through diuresis. When combined with puerarin, the hangover relief effect can be increased by more than 40%.

[0011] Furthermore, the oyster extract, as an adjuvant, is rich in taurine and zinc, which can enhance the antioxidant capacity of hepatocytes, reduce MDA content, increase SOD activity, and repair hepatocyte membrane damage caused by oxidative stress. The broken-cell-wall pine pollen, as an adjuvant, is rich in vitamins, polysaccharides, and amino acids, which can provide nutritional support for liver metabolism and improve symptoms such as fatigue and lethargy after drinking alcohol. The taurine, as an agonist, can enhance the synthesis of glutathione (GSH) in the liver, improve the liver's detoxification capacity, and synergistically enhance the effects with the endogenous taurine in the oyster extract.

[0012] Furthermore, the licorice extract is used as the adjuvant drug, and its active ingredient glycyrrhizic acid has anti-inflammatory and anti-allergic effects. It can reduce the apoptosis rate of alcohol-induced hepatocytes, while harmonizing the other drugs and reducing gastrointestinal irritation. The whole formula follows the intervention logic of "detoxifying alcohol - reducing oxidation - repairing damage - supplementing nutrition", covering the entire chain of alcohol metabolism, liver damage repair and symptom relief, and achieving multi-target synergistic effects.

[0013] Furthermore, the microcrystalline cellulose, as a filler, possesses excellent plastic deformation ability, which can improve powder compressibility, enhance tablet hardness and formability. Its porous structure can also adsorb active ingredients and promote dissolution. Fumed silica, as a flow aid, can reduce friction between powders, improve material flowability, ensure uniform material filling during tableting, and control tablet weight difference within ±2.5%. Sodium carboxymethyl starch, as a highly efficient disintegrant, can expand to 300 times its original volume upon contact with water, promoting complete disintegration of tablets within 10 minutes and rapid release of active ingredients. Magnesium stearate, as a lubricant, can reduce friction between material and die, avoid sticking, and ensure smooth tableting.

[0014] A method for preparing a liver-protecting and hangover-relieving composition, using a direct powder compression process, includes the following steps:

[0015] Step S1: Pretreatment: Pass the kudzu root extract, Japanese raisin tree fruit extract, oyster extract, broken cell wall pine pollen, taurine, and licorice extract through an 80-100 mesh sieve and weigh them according to the weight ratio for later use.

[0016] Step S2: Premixing. Weigh the active ingredients, microcrystalline cellulose, sodium carboxymethyl starch, and fumed silica into a three-dimensional motion mixer. Mix for 15-30 minutes using the equal-volume incremental method, with the mixing speed controlled at 15-20 rpm, to obtain a mixed powder with a mixing uniformity RSD ≤ 5%.

[0017] Step S3: General mixing, add magnesium stearate to the mixed powder, and continue mixing for 5-10 minutes to obtain the general mixture;

[0018] Step S4: Tableting. The total mixture is fed into a rotary tablet press. The tableting pressure is controlled at 4-8 kN and the tableting speed is controlled at 20-30 rpm to prepare tablets with a weight of 0.5 ± 0.02 g.

[0019] Furthermore, the tablets obtained in step S4 have a hardness of 4-6 kg, a disintegration time of ≤10 minutes, and an active ingredient dissolution rate of ≥90% after 30 minutes.

[0020] The application of a liver-protecting and hangover-relieving composition specifically includes the following:

[0021] Application in the preparation of health food products for the prevention or improvement of alcoholic liver damage;

[0022] Application in the preparation of functional foods that accelerate alcohol metabolism and reduce post-drinking blood alcohol concentration;

[0023] Application in the preparation of products that relieve discomfort symptoms such as dizziness, headache, nausea, and fatigue after drinking alcohol.

[0024] (III) Beneficial Effects

[0025] Compared with the prior art, the present invention provides a liver-protecting and hangover-relieving composition, its preparation method and application, which has the following beneficial effects:

[0026] 1. This liver-protecting and hangover-relieving composition, its preparation method, and its application are based on the theory of traditional Chinese medicine and the precise ratio of traditional Chinese medicine and modern pharmacological research. Through the synergistic effect of 6 active ingredients, it achieves the triple effects of hangover relief, liver protection, and discomfort relief. Animal experiments show that it can reduce ALT levels in rats with alcoholic liver damage by 42.4% and increase SOD activity by 39.4%, which is more effective than similar products with single ingredients or simple combinations.

[0027] 2. The liver-protecting and hangover-relieving composition, its preparation method, and its application, through optimization of the excipient system, result in tablets with a disintegration time of ≤10 minutes, an active ingredient dissolution rate of over 90% within 30 minutes, and a bioavailability 30% higher than ordinary tablets. At the same time, the tablets have suitable hardness and a friability of ≤0.5%, making them suitable for long-distance transportation and storage.

[0028] 3. The liver-protecting and hangover-relieving composition, its preparation method, and its application adopt a direct powder compression process, which avoids the high-temperature degradation of active ingredients during wet granulation. The process has good reproducibility, small quality differences between batches of products, and reduces production costs by more than 30%.

[0029] 4. This liver-protecting and hangover-relieving composition, its preparation method, and its application: all raw materials are food-medicine homologous raw materials or new resource food raw materials announced by the National Health Commission. Acute toxicity tests have confirmed that the maximum tolerated dose is ≥20g / kg body weight. Long-term use does not pose a risk of liver and kidney damage and is suitable for daily use by people who frequently attend social events. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the liver-protecting and hangover-relieving composition of the present invention;

[0031] Figure 2 This is a flowchart of the preparation method of the liver-protecting and hangover-relieving composition of the present invention;

[0032] Figure 3 This is a schematic diagram illustrating the raw material proportions in Example 1 of the present invention;

[0033] Figure 4 This is a schematic diagram illustrating the raw material ratio in Example 2 of the present invention;

[0034] Figure 5 This is a schematic diagram illustrating the raw material ratio in Example 3 of the present invention;

[0035] Figure 6 This is an illustration of the intended quality evaluation of the tablets of the present invention;

[0036] Figure 7 This is a representation of animal experimental data for the present invention;

[0037] Figure 8 This is a schematic representation of the human trial data of the present invention. Detailed Implementation

[0038] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0039] Please see Figure 1-8 A liver-protecting and hangover-relieving composition, comprising active ingredients and pharmaceutical excipients, with the following weight proportions of each component:

[0040] The active ingredients include: kudzu root extract (puerarin content ≥40%): 10-30 parts, preferably 20 parts; Japanese raisin tree extract (total flavonoid content ≥7%, dihydromyricetin content ≥1%): 10-30 parts, preferably 20 parts; oyster extract (taurine content ≥10%, zinc content ≥0.5%): 5-15 parts, preferably 10 parts; broken-cell wall pine pollen (polysaccharide content ≥8%): 5-15 parts, preferably 10 parts; taurine (purity ≥99%): 3-10 parts, preferably 5 parts; and licorice extract (glycyrrhizic acid content ≥5%): 3-10 parts, preferably 5 parts.

[0041] Pharmaceutical excipients include microcrystalline cellulose (particle size 100-200μm): 20-40 parts, preferably 25 parts; sodium carboxymethyl starch (degree of substitution 0.3-0.4): 3-10 parts, preferably 5 parts; fumed silica (specific surface area 200±20m² / g): 1-5 parts, preferably 2 parts; and magnesium stearate (particle size ≤75μm): 0.5-2 parts, preferably 1 part.

[0042] Pueraria lobata extract is the principal ingredient, and its main active component, puerarin, can accelerate alcohol metabolism by activating the activity of alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH), while inhibiting the release of inflammatory factors TNF-α and IL-6, thus reducing hepatocellular inflammatory damage. Hovenia dulcis extract is the secondary ingredient, and its rich dihydromyricetin can competitively bind to acetaldehyde metabolism targets, reducing the covalent binding of acetaldehyde to hepatocellular proteins. At the same time, it accelerates the excretion of alcohol metabolites through diuresis. When combined with puerarin, the hangover relief effect can be increased by more than 40% (based on animal experimental data of this invention).

[0043] Oyster extract is used as an adjuvant, and its rich taurine and zinc content can enhance the antioxidant capacity of liver cells, reduce MDA content, increase SOD activity, and repair liver cell membrane damage caused by oxidative stress. Broken-cell pine pollen is also used as an adjuvant, and its rich vitamins, polysaccharides, and amino acids can provide nutritional support for liver metabolism and improve symptoms such as fatigue and lethargy after drinking alcohol. Taurine is used as a guiding agent, which can enhance the synthesis of glutathione (GSH) in the liver, improve the liver's detoxification ability, and synergistically enhance the effect with the endogenous taurine in oyster extract.

[0044] Licorice extract is used as the guiding drug. Its active ingredient, glycyrrhizic acid, has anti-inflammatory and anti-allergic effects. It can reduce the apoptosis rate of alcohol-induced hepatocytes, while harmonizing other drugs and reducing gastrointestinal irritation. The whole formula follows the intervention logic of "detoxifying alcohol - reducing oxidation - repairing damage - supplementing nutrition", covering the entire chain of alcohol metabolism, liver damage repair and symptom relief, and achieving multi-target synergistic effects.

[0045] Microcrystalline cellulose, as a filler, has excellent plastic deformation ability, which can improve the compressibility of powder, enhance tablet hardness and formability. Its porous structure can also adsorb active ingredients and promote dissolution. Fumed silica, as a flow aid, can reduce the friction between powders, improve material flowability, ensure uniform material filling during tableting, and control the tablet weight difference within ±2.5%. Sodium carboxymethyl starch, as a highly efficient disintegrant, can expand to 300 times its original volume when it comes into contact with water, causing the tablet to completely disintegrate within 10 minutes and rapidly release the active ingredients. Magnesium stearate, as a lubricant, can reduce the friction between the material and the die, avoid sticking, and ensure a smooth tableting process.

[0046] In the case study, wild-grade kudzu was preferred. The content of active ingredients in wild kudzu is significantly higher than that in cultivated kudzu. Studies have shown that the content of puerarin in wild kudzu can reach 1.46% to 4.48%, and the content of total flavonoids can reach 11.19% to 26.14%. Moreover, wild kudzu with high content is mainly distributed in high-latitude regions. In contrast, cultivated kudzu (Pueraria lobata) has a higher starch content, but the content of flavonoids (such as puerarin and daidzein) is significantly lower than that in wild kudzu. Therefore, wild kudzu is more suitable as a medicinal substance. Further animal experiments have confirmed that, at the same dose, wild kudzu has a more significant protective effect against chronic alcoholic liver injury than cultivated kudzu. It can more effectively reduce serum transaminase levels, increase liver alcohol dehydrogenase activity, and inhibit the release of inflammatory factors.

[0047] Example 1: The raw material composition for preparing liver-protecting and hangover-relieving tablets is as follows: Figure 3 As shown, the preparation process is as follows:

[0048] Pretreatment: Pass the above active ingredients through a 100-mesh sieve and weigh them according to the formula for later use;

[0049] Premixing: Pueraria lobata extract, Hovenia dulcis extract, oyster extract, broken pine pollen, taurine, licorice extract, microcrystalline cellulose, sodium carboxymethyl starch, and fumed silica were added to a three-dimensional motion mixer at 18 rpm for 20 minutes. The RSD of the mixing uniformity was measured to be 3.2%, which meets the requirements.

[0050] Total Mixture: Add magnesium stearate and continue mixing for 8 minutes to obtain the total mixture;

[0051] Tableting: A rotary tablet press was used to control the tableting pressure at 6kN and the rotation speed at 25rpm to prepare liver-protecting and hangover-relieving tablets with a weight of 0.51g / tablet.

[0052] Example 2: The raw material composition for preparing liver-protecting and hangover-relieving tablets is as follows: Figure 4 As shown, the preparation process is the same as in Example 1.

[0053] Example 3: The raw material composition for preparing liver-protecting and hangover-relieving tablets is as follows: Figure 5 As shown, the preparation process is the same as in Example 1.

[0054] In the case implementation, Comparative Example 1: Composition without oyster extract.

[0055] Following the raw material ratio of Example 1, the oyster extract was removed, the amount of microcrystalline cellulose was increased to 350g, and the rest of the preparation process was the same as in Example 1.

[0056] Comparative Example 2: Compositions without Hovenia dulcis extract

[0057] Following the raw material ratio of Example 1, the Hovenia dulcis extract was removed, and the amount of Pueraria lobata extract was increased to 400g. The rest of the preparation process was the same as in Example 1.

[0058] In this process, after obtaining tablets according to Examples 1-3, quality testing was performed to obtain... Figure 6 The tablet quality evaluation table shown indicates that the tablets prepared according to the data identification are superior to the comparative sample in all quality indicators and meet the requirements of the National Medical Products Administration's "Quality Requirements for Health Food Tablets", which shows that the excipient ratio and preparation process of the present invention are reasonable and feasible.

[0059] In the implementation of the case, the evaluation of the hangover relief and liver protection efficacy included animal experiments and human trial experiments;

[0060] Sixty SPF-grade male SD rats, weighing 180-220g, were selected for animal experiments. After 7 days of acclimatization, they were randomly divided into 6 groups: normal control group, model control group, Example 1 group, Example 2 group, Comparative Example 1 group, and Comparative Example 2 group, with 10 rats in each group. Except for the normal control group, the other groups were administered 56-degree baijiu (10mL / kg body weight) by gavage once daily for 4 consecutive weeks to establish an alcoholic liver injury model. Each treatment group was administered the corresponding test substance (0.5g / kg body weight) by gavage 30 minutes before model establishment, while the model control group received an equal volume of physiological saline. After the experiment, the rats were fasted but allowed free access to water for 12 hours. They were anesthetized by intraperitoneal injection of 10% chloral hydrate, and blood was collected from the abdominal aorta. Serum was separated to detect alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. After sacrifice, tissue from the same location on the left lobe of the liver was taken, and a 10% liver homogenate was prepared to detect malondialdehyde (MDA) content and superoxide dismutase (SOD) activity. The experimental data are as follows: Figure 7 As shown;

[0061] Compared with the normal control group, **P<0.01, indicating a highly significant statistical difference; compared with the model control group, ##P<0.01, indicating a highly significant statistical difference, and *P<0.05, indicating a significant statistical difference. The results show that the groups of Examples 1-2 of this invention can significantly reduce the ALT and AST levels and the MDA content in liver tissue of rats with alcoholic liver injury, and increase SOD activity, and the effect is significantly better than that of the comparative groups 1-2 (P<0.05). This confirms that the active ingredients in the formulation of this invention have a synergistic effect, and the combination of oyster extract and Hovenia dulcis extract is the key to achieving excellent liver protection efficacy.

[0062] Further examination of the activities of alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH) and the content of the inflammatory factor TNF-α in the liver tissue of rats in each group showed that:

[0063] In Example 1, the ADH activity of rats in the group was increased by 37.2% and the ALDH activity was increased by 41.5% compared with the model control group, which was significantly higher than that of Comparative Example 1 (increased by 18.6% and 22.3%, respectively) and Comparative Example 2 (increased by 21.4% and 25.7%, respectively).

[0064] In Example 1, the TNF-α content in the group was reduced by 52.7% compared with the model control group, and the anti-inflammatory effect was significantly better than the two comparative groups. The above results confirm that the composition of the present invention achieves the effects of liver protection and alcohol detoxification through a triple mechanism of activating alcohol metabolism enzyme activity, inhibiting inflammatory response, and reducing oxidative stress.

[0065] In the human trial, 60 healthy adult volunteers with a long-term drinking habit (aged 25-50 years, drinking ≥8 times per month, with each drink ≥50g of baijiu) were randomly divided into an experimental group and a control group, with 30 participants in each group. There were no statistically significant differences in gender, age, or drinking habits between the two groups (P>0.05). The experimental group took two tablets (1.0g) prepared in Example 1 of this invention 30 minutes before drinking, while the control group took a placebo with the same appearance and weight. All participants drank 100mL of 50-proof baijiu. Blood alcohol concentration was measured by collecting venous blood samples 1 hour and 3 hours after drinking. The severity of discomfort symptoms such as dizziness, headache, nausea, and fatigue after drinking was recorded using the Visual Analogue Scale (VAS). The results are as follows: Figure 8 As shown;

[0066] The results showed that the blood alcohol concentration in the experimental group was 32.5% lower than that in the control group 1 hour after drinking, and the alcohol clearance rate was 28.7% higher than that in the control group 3 hours after drinking. The incidence of various alcohol-related discomfort symptoms was significantly lower in the experimental group than in the control group, which confirms that the product of this invention has good effects in relieving hangovers and alleviating alcohol-related discomfort. Moreover, no adverse reactions were reported during the trial, indicating good safety.

[0067] In summary, this liver-protecting and hangover-relieving composition, its preparation method, and its application are based on the theory of traditional Chinese medicine and precise formulation through modern pharmacological research. Through the synergistic effect of six active ingredients, it achieves the triple effects of hangover relief, liver protection, and discomfort relief. Animal experiments show that it can reduce ALT levels in rats with alcoholic liver injury by 42.4% and increase SOD activity by 39.4%, demonstrating superior efficacy compared to similar products with single ingredients or simple formulations. Through optimization of the excipient system, the resulting tablets have a disintegration time ≤10 minutes, and the dissolution rate of active ingredients can reach over 90% within 30 minutes. Bioavailability is 30% higher than ordinary tablets. Simultaneously, the tablets have suitable hardness and a friability of ≤0.5%, making them suitable for long-distance transportation and storage.

[0068] Furthermore, the direct powder compression process avoids the high-temperature degradation of active ingredients during wet granulation, resulting in good process reproducibility, small batch-to-batch quality differences, and a reduction in production costs of over 30%. All raw materials are food-medicine homologous materials or new resource food materials published by the National Health Commission. Acute toxicity tests have confirmed that the maximum tolerated dose is ≥20g / kg body weight, and there is no risk of liver and kidney damage with long-term use. It is suitable for daily use by people who frequently attend social events.

[0069] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0070] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A liver-protecting and hangover-relieving composition, comprising active ingredients and pharmaceutical excipients, characterized in that: The weight proportions of each component are as follows: The active ingredients include: kudzu root extract (puerarin content ≥40%): 10-30 parts, preferably 20 parts; Japanese raisin tree extract (total flavonoid content ≥7%, dihydromyricetin content ≥1%): 10-30 parts, preferably 20 parts; oyster extract (taurine content ≥10%, zinc content ≥0.5%): 5-15 parts, preferably 10 parts; broken-cell wall pine pollen (polysaccharide content ≥8%): 5-15 parts, preferably 10 parts; taurine (purity ≥99%): 3-10 parts, preferably 5 parts; and licorice extract (glycyrrhizic acid content ≥5%): 3-10 parts, preferably 5 parts. The pharmaceutical excipients include microcrystalline cellulose (particle size 100-200μm): 20-40 parts, preferably 25 parts; sodium carboxymethyl starch (degree of substitution 0.3-0.4): 3-10 parts, preferably 5 parts; fumed silica (specific surface area 200±20m² / g): 1-5 parts, preferably 2 parts; and magnesium stearate (particle size ≤75μm): 0.5-2 parts, preferably 1 part.

2. The liver-protecting and hangover-relieving composition according to claim 1, characterized in that: The kudzu root extract is the principal ingredient, and its main active component, puerarin, can accelerate alcohol metabolism by activating the activity of alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH), while inhibiting the release of inflammatory factors TNF-α and IL-6, thus reducing hepatocellular inflammatory damage. The Japanese raisin tree extract is the secondary ingredient, which is rich in dihydromyricetin, which can competitively bind to acetaldehyde metabolism targets, reducing the covalent binding of acetaldehyde to hepatocellular proteins. At the same time, it accelerates the excretion of alcohol metabolites through diuresis. When combined with puerarin, the hangover relief effect can be increased by more than 40%.

3. The liver-protecting and hangover-relieving composition according to claim 1, characterized in that: The oyster extract is used as an adjuvant, and its rich taurine and zinc content can enhance the antioxidant capacity of hepatocytes, reduce MDA content, increase SOD activity, and repair hepatocyte membrane damage caused by oxidative stress. The broken-cell-wall pine pollen is also used as an adjuvant, and its rich vitamins, polysaccharides, and amino acids can provide nutritional support for liver metabolism and improve symptoms such as fatigue and lethargy after drinking alcohol. The taurine is used as an auxiliary drug, which can enhance the synthesis of glutathione (GSH) in the liver, improve the liver's detoxification capacity, and synergistically enhance the effect with the endogenous taurine in the oyster extract.

4. The liver-protecting and hangover-relieving composition according to claim 1, characterized in that: The licorice extract is used as the guiding drug. Its active ingredient, glycyrrhizic acid, has anti-inflammatory and anti-allergic effects, which can reduce the apoptosis rate of alcohol-induced hepatocytes. At the same time, it harmonizes the other drugs and reduces gastrointestinal irritation. The whole formula follows the intervention logic of "detoxifying alcohol - reducing oxidation - repairing damage - supplementing nutrition", covering the entire chain of alcohol metabolism, liver damage repair and symptom relief, and achieving multi-target synergistic effects.

5. The liver-protecting and hangover-relieving composition according to claim 1, characterized in that: The microcrystalline cellulose, as a filler, has good plastic deformation ability, which can improve the compressibility of powder, enhance tablet hardness and formability, and its porous structure can also adsorb active ingredients and promote dissolution. The fumed silica, as a flow aid, can reduce the friction between powders, improve material flowability, ensure uniform material filling during tableting, and control the tablet weight difference within ±2.5%. The sodium carboxymethyl starch, as a highly efficient disintegrant, can expand to 300 times its original volume when it comes into contact with water, causing the tablet to completely disintegrate within 10 minutes and rapidly release the active ingredients. Magnesium stearate, as a lubricant, can reduce the friction between the material and the die, avoid sticking, and ensure a smooth tableting process.

6. A method for preparing a liver-protecting and hangover-relieving composition, comprising the liver-protecting and hangover-relieving composition according to claims 1-5, using a direct powder compression process, characterized in that: The following steps are included: Step S1: Pretreatment: Pass the kudzu root extract, Japanese raisin tree fruit extract, oyster extract, broken cell wall pine pollen, taurine, and licorice extract through an 80-100 mesh sieve and weigh them according to the weight ratio for later use. Step S2: Premixing. Weigh the active ingredients, microcrystalline cellulose, sodium carboxymethyl starch, and fumed silica into a three-dimensional motion mixer. Mix for 15-30 minutes using the equal-volume incremental method, with the mixing speed controlled at 15-20 rpm, to obtain a mixed powder with a mixing uniformity RSD ≤ 5%. Step S3: General mixing, add magnesium stearate to the mixed powder, and continue mixing for 5-10 minutes to obtain the general mixture; Step S4: Tableting. The total mixture is fed into a rotary tablet press. The tableting pressure is controlled at 4-8 kN and the tableting speed is controlled at 20-30 rpm to prepare tablets with a weight of 0.5 ± 0.02 g.

7. The method for preparing a liver-protecting and hangover-relieving composition according to claim 6, characterized in that: The tablets obtained in step S4 have a hardness of 4-6 kg, a disintegration time of ≤10 minutes, and an active ingredient dissolution rate of ≥90% after 30 minutes.

8. The application of a liver-protecting and hangover-relieving composition, comprising the liver-protecting and hangover-relieving composition according to claims 1-5, characterized in that: Specifically, it includes the following: Application in the preparation of health food products for the prevention or improvement of alcoholic liver damage; Application in the preparation of functional foods that accelerate alcohol metabolism and reduce post-drinking blood alcohol concentration; Application in the preparation of products that relieve discomfort symptoms such as dizziness, headache, nausea, and fatigue after drinking alcohol.

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