A liver-protecting and alcohol-reducing composition, preparation and application thereof

Abstract

The present application provides a kind of liver-protecting and alcohol-eliminating composition, which comprises Pueraria lobata extract, jujube seed extract, medlar extract, Ganoderma lucidum extract, ginseng peptide, turmeric extract, poria cocos extract, agastache extract and mint extract. The present application further provides liver-protecting and alcohol-eliminating food, health food and medicine containing the composition, such as solid beverage, liquid beverage and the like. The composition provided by the present application is prepared from pure natural ingredients according to the theory of traditional Chinese medicine, which can effectively promote alcohol metabolism, prevent the formation of alcoholic fatty liver, and promote the repair and growth of liver cells to some extent. The composition and beverage containing the composition provided by the present application have significant liver-protecting and alcohol-eliminating effects and wide market demand, and have important market value and development prospect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a composition, and also to the application of the composition in the preparation of medicines for relieving hangovers and / or protecting against liver damage. Technical Background With rapid socio-economic development and a significant improvement in people's living standards, drinking culture plays an increasingly important role in social interactions. Whether it's business banquets, gatherings with friends, or family meals, drinking has become a common social activity. However, the health hazards of excessive drinking are receiving increasing attention, especially the damage to the liver. Harmful substances such as acetaldehyde produced during alcohol metabolism can damage liver cells, and long-term heavy drinking may lead to serious diseases such as fatty liver, alcoholic hepatitis, and even cirrhosis.

[0002] Furthermore, the increasing health awareness of modern people has led to a growing demand for healthy beverages. People are seeking drinks that can effectively alleviate discomfort after drinking and protect liver health. This demand has spurred the development of hangover-relieving and liver-protecting beverages. The development of these beverages not only meets consumers' needs for health protection after drinking but also brings new growth opportunities to the beverage market, possessing significant social and economic importance. Summary of the Invention

[0003] To overcome the shortcomings of existing technologies, this invention provides a composition. All active ingredients in this composition are derived from substances that are traditionally both food and medicinal herbs, and are formulated and combined according to traditional Chinese medicine theory, achieving excellent effects in protecting the liver and relieving hangovers.

[0004] In a first aspect, the composition provided by the present invention comprises the following components: kudzu root extract, Japanese raisin tree fruit extract, wolfberry fruit extract, mulberry extract, ganoderma lucidum extract, ginseng peptide, turmeric extract, poria cocos extract, patchouli extract, and peppermint extract. The composition is formed by directly mixing the above components.

[0005] The raw material used in this invention is kudzu root, a legume (Pueraria lobata). Pueraria lobata The dried root of *Kudzu* (Willd.) Ohwi is a substance traditionally used as both food and a Chinese medicinal herb. According to the pharmacopoeia, kudzu root is sweet and pungent in taste; cool in nature; and enters the spleen, stomach, and lung meridians. It has the effects of relieving muscle tension and reducing fever, promoting body fluid production and quenching thirst, promoting rash eruption, raising yang and stopping diarrhea, unblocking meridians and activating collaterals, and detoxifying alcohol. As a preferred embodiment of the present invention, the kudzu root extract contains ≥24% puerarin.

[0006] The raw material used in this invention, Hovenia dulcis seeds, is a plant of the Rhamnaceae family (Hovenia dulcis). Hovenia acerbaThe mature seeds of *Hovenia dulcis* (Lindl.) are traditionally considered both a food and a medicinal herb. According to the *Tang Materia Medica*, they are "sweet, neutral, and non-toxic," while the *New Materia Medica* states they "enter the heart and spleen meridians." They are believed to have the effects of relieving alcohol poisoning, quenching thirst and relieving irritability, stopping vomiting, and promoting urination and defecation.

[0007] The raw material used in this invention is Lycium barbarum, a plant belonging to the Solanaceae family (Lycium barbarum var. ningxiaense). Lyciumm barbarum The dried, ripe fruit of *Lycium barbarum* (L.) is a substance traditionally used as both food and a Chinese medicinal herb. According to the pharmacopoeia, *Lycium barbarum* is sweet and neutral in nature, and enters the liver and kidney meridians. It has the effects of nourishing the liver and kidneys, benefiting essence and improving eyesight. As a preferred embodiment of the present invention, the content of *Lycium barbarum* polysaccharides in the *Lycium barbarum* extract is ≥18%.

[0008] The raw material used in this invention is mulberry, a plant belonging to the Moraceae family. Morus alba Mulberries (L.) are mature fruit clusters, traditionally considered both a food and a medicinal herb. The Tang Dynasty Materia Medica records that mulberries are "sweet, cold, and non-toxic," while the New Compendium of Materia Medica states that they "enter the kidneys." The Compendium of Materia Medica states that "mulberry juice, when drunk, can relieve alcohol poisoning, promote urination, reduce swelling, nourish yin and replenish blood, and is used for liver and kidney deficiency, deficiency of essence and blood, dizziness, blurred vision, tinnitus, insomnia, and premature graying of hair." Mulberries also have the effects of promoting body fluid production and relieving dryness, darkening hair and improving eyesight, promoting bowel movement, and beautifying the skin.

[0009] The raw material used in this invention is Ganoderma lucidum, a fungus belonging to the Polyporaceae family. Ganoderma lucidum (Leyss.ex Fr)Karst or Zizhi ( Ganodermasinense Zhao The dried fruiting body of Ganoderma lucidum (Xu et Zhang) is a substance that is traditionally used as both food and Chinese medicinal material. According to the pharmacopoeia, Ganoderma lucidum is sweet and neutral in nature. It enters the heart, lung, liver, and kidney meridians. It has the effects of tonifying qi and calming the mind, relieving cough and asthma. As a preferred embodiment of the present invention, the content of Ganoderma lucidum polysaccharides in the Ganoderma lucidum extract is ≥10%.

[0010] The ginseng used in this invention is ginseng (Panax ginseng), a plant belonging to the Araliaceae family. Panax ginseng The dried roots and rhizomes of *Ginseng* (CA Mey.) are substances traditionally used as both food and medicinal materials. Ginseng is described in the *Shennong Bencao Jing* as having a "sweet taste and slightly cold nature," and in the *Bencao Huiyan* as entering the lung and spleen meridians. Ginseng peptides are small-molecule active peptides extracted from ginseng. In a preferred embodiment of this invention, the proportion of peptides with a relative molecular weight less than 1000 Da in the ginseng peptides is ≥80%. In actual production, the ginseng peptides can be purchased directly, or they can be obtained by enzymatically hydrolyzing proteins extracted from ginseng into small-molecule fragments using biotechnology.

[0011] The raw material used in this invention is turmeric, a plant of the ginger family (Zingiberaceae). Curcuma longaThe dried rhizome of turmeric (L.) is a substance traditionally used as both food and Chinese medicinal material. According to the pharmacopoeia, turmeric is pungent and bitter in taste, and warm in nature. It enters the spleen and liver meridians. It has the effects of promoting blood circulation, regulating qi, and relieving pain. As a preferred embodiment of the present invention, the curcumin content in the turmeric extract is ≥10%.

[0012] The raw material used in this invention is Poria cocos, a fungus belonging to the Polyporaceae family. Poria cocos The dried sclerotium of *Poria cocos* (Schw.) Wolf is a substance traditionally used as both food and a Chinese medicinal herb. According to the pharmacopoeia, *Poria cocos* is sweet and bland in taste, and neutral in nature. It enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind.

[0013] The raw material used in this invention, patchouli, is the dried aerial part of the plant *Pogostemon cablin*, belonging to the Lamiaceae family. Traditionally, it is both a food and a medicinal herb. According to the pharmacopoeia, patchouli has the effects of aromatic purification, relieving nausea and vomiting, and releasing exterior pathogens and relieving summer heat.

[0014] The raw material used in this invention is peppermint, a plant belonging to the Lamiaceae family (Mentha haplocalyx). Mentha haplocalyx The dried aerial parts of *Mentha haplocalyx* (Briq.) are traditionally considered both a food and a medicinal herb. According to the pharmacopoeia, peppermint has a pungent and cool flavor. It enters the lung and liver meridians. It has the effects of dispersing wind-heat, clearing the head and eyes, relieving sore throat, promoting rash eruption, and soothing the liver and regulating qi.

[0015] The composition provided by this invention is formulated based on traditional Chinese medicine theory, wherein: kudzu root and Japanese raisin tree fruit are the principal ingredients for relieving hangovers, promoting body fluid production, and quenching thirst; wolfberry fruit and mulberry fruit nourish liver yin and liver blood; Ganoderma lucidum and ginseng are the assistant ingredients for invigorating qi, replenishing deficiency, and protecting the liver; turmeric promotes qi and blood circulation, poria cocos strengthens the spleen and eliminates dampness, and agastache rugosa invigorates the spleen and resolves dampness; and peppermint soothes the liver and clears heat. The components work together to achieve synergistic effects and a balanced regulatory effect.

[0016] All extracts used in this invention are obtained by extraction with water and / or ethanol as solvents. Specifically, each extract can be obtained by extraction with water or a mixture of water and ethanol as solvents, with the raw material and solvent at a mass ratio of 1:(10~20). The extraction can be carried out using conventional Chinese medicine extraction methods in the art, such as heating extraction, ultrasonic extraction, reflux extraction, or a combination of the above methods.

[0017] In one specific embodiment, the kudzu root extract, Japanese raisin tree fruit extract, wolfberry fruit extract, mulberry extract, Ganoderma lucidum extract, turmeric extract, Poria cocos extract, patchouli extract, and / or peppermint extract are prepared by methods including the following steps: taking the corresponding Chinese herbal raw materials, adding water equivalent to 10, 15, or 20 times their mass, extracting by water decoction, and concentrating and drying the resulting extract to obtain the extract.

[0018] As a preferred embodiment of the present invention, the composition comprises the following components in parts by weight: 5-15 parts of kudzu root extract, 2-10 parts of Japanese raisin tree fruit extract, 1-5 parts of wolfberry fruit extract, 1-5 parts of mulberry extract, 1-6 parts of ganoderma lucidum extract, 1-5 parts of ginseng peptide, 2-10 parts of turmeric extract, 1-5 parts of poria cocos extract, 1-5 parts of patchouli extract, and 1-5 parts of peppermint extract.

[0019] As a preferred embodiment of the present invention, the composition comprises the following components in parts by weight: 8-12 parts of kudzu root extract, 4-8 parts of Japanese raisin tree fruit extract, 2-5 parts of wolfberry fruit extract, 1-4 parts of mulberry extract, 4-6 parts of ganoderma lucidum extract, 1.5-3.5 parts of ginseng peptide, 5-8 parts of turmeric extract, 2-5 parts of poria cocos extract, 1-3 parts of patchouli extract, and 2-4 parts of peppermint extract.

[0020] As a preferred embodiment of the present invention, the composition comprises the following components in parts by weight: 8 parts of kudzu root extract, 4 parts of Japanese raisin tree fruit extract, 2 parts of wolfberry fruit extract, 1 part of mulberry extract, 4 parts of Ganoderma lucidum extract, 1.5 parts of ginseng peptide, 5 parts of turmeric extract, 2 parts of Poria cocos extract, 1 part of patchouli extract, and 2 parts of peppermint extract.

[0021] As a preferred embodiment of the present invention, the composition comprises the following components in parts by weight: 12 parts of kudzu root extract, 8 parts of Japanese raisin tree fruit extract, 5 parts of wolfberry fruit extract, 4 parts of mulberry extract, 6 parts of Ganoderma lucidum extract, 3.5 parts of ginseng peptide, 8 parts of turmeric extract, 5 parts of Poria cocos extract, 3 parts of patchouli extract, and 4 parts of peppermint extract.

[0022] This invention optimizes the dosage of each component in the composition, enabling the components to work synergistically and achieve the best overall effect of relieving hangovers and protecting the liver.

[0023] Secondly, the present invention provides a formulation comprising the composition described in the first aspect of the present invention and excipients. The excipients are generally pharmaceutically or food-grade acceptable excipients.

[0024] As a preferred embodiment of the present invention, the preparation is an oral dosage form, such as tablets, capsules, powders (including solid beverages), granules (including solid beverages), or oral liquids (including liquid beverages).

[0025] As a preferred embodiment of the present invention, the preparation is a liquid beverage, a solid beverage, a compressed candy, a paste, a honey pill, a functional jelly, a biscuit, etc.

[0026] As a preferred embodiment of the present invention, the formulation is a liquid beverage comprising the composition provided in the first aspect of the present invention, as well as a flavoring agent, a preservative and water.

[0027] As a preferred embodiment of the present invention, the concentration of the composition in the liquid beverage is 20-100 g / L, more preferably 40-60 g / L. Controlling the active ingredient within this concentration ensures that the daily intake of the active ingredient is adequate for the human body when a single dose of approximately 30 mL is taken, achieving optimal hangover relief and liver protection effects.

[0028] This invention employs flavoring agents in beverage preparation to mask the bitterness of the composition itself, thereby enhancing the beverage's flavor. The flavoring agents may include sweeteners, acidulants, and flavorings. Sweeteners may include honey, sucrose, fructose, sugar alcohols (such as sorbitol and xylitol), and fruit extracts (such as monk fruit extract). Acidulants may include citric acid, malic acid, tartaric acid, and ascorbic acid. Flavorings may be natural flavorings such as lemon essential oil, orange peel oil, and peppermint oil, or synthetic flavorings such as strawberry flavoring, mango flavoring, and pineapple flavoring. Flavoring agents can be added individually or in combination with other flavoring agents and other substances that adjust the taste.

[0029] This invention utilizes preservatives in beverage preparation, effectively extending the shelf life and ensuring product safety and quality. The preservatives can be sodium benzoate, potassium sorbate, parabens, ε-polylysine, etc. Preservatives can be added individually or in combination. In actual production, the pH of the beverage can be adjusted to a suitable range (generally acidic) to maximize the effectiveness of the preservatives. Preservatives are typically used in conjunction with other preservation measures (such as low-temperature storage and aseptic packaging) to achieve optimal preservation results.

[0030] In actual production, the liquid beverage formulation can be prepared by mixing the composition with excipients including flavoring agents and preservatives in a certain proportion, adding water and mixing thoroughly.

[0031] In one specific embodiment, the liquid beverage formulation contains 20-40 parts of the composition, 10-30 parts of the flavoring agent, 0.1-0.8 parts of the preservative, and 500-1000 parts of water. More preferably, the liquid beverage formulation contains 30 parts of the composition, 12-15 parts of the flavoring agent, 0.2-0.3 parts of the preservative, and 500-600 parts of water. The flavoring agent may be xylitol, and the preservative may be potassium sorbate.

[0032] As a preferred embodiment of the present invention, the formulation is a solid beverage comprising the composition provided in the first aspect of the present invention, as well as flavoring agents, preservatives and fillers.

[0033] In addition to the flavoring agents and preservatives mentioned above, the solid beverage provided by this invention also incorporates fillers with good filling and stability properties, thereby increasing the volume of the solid beverage, making the product more fluffy, preventing the raw materials from absorbing moisture and clumping, and improving the product's stability. The fillers can be commonly used in the art, such as dextrin, maltodextrin, carrageenan, xanthan gum, etc. A single filler can be added, or multiple fillers or a mixture with other stabilizing substances can be used as needed.

[0034] In actual production, the solid beverage formulation can be made by mixing the composition with excipients including flavoring agents, fillers, and preservatives in proportion, and then granulating it using methods such as wet granulation, dry granulation, rapid stirring granulation, or fluidized bed granulation.

[0035] In one specific embodiment, the solid beverage formulation contains 20-40 parts of the composition, 10-15 parts of a flavoring agent, 15-20 parts of a filler, and 0.005-0.05 parts of a preservative. The flavoring agent may be xylitol, and the preservative may be ε-polylysine.

[0036] Thirdly, the present invention provides the use of the composition and / or the formulation in the preparation of a medicine for relieving hangovers and / or protecting against alcoholic liver injury, or in the preparation of a health product for adjunctive protection against chemical liver injury.

[0037] As a preferred embodiment of the present invention, the medicine or health product is an oral dosage form, such as tablets, capsules, powders (including solid beverages), granules (including solid beverages), or oral liquids (including liquid beverages).

[0038] As a preferred embodiment of the present invention, the medicine or health product is a liquid beverage, a solid beverage, a compressed candy, a paste, a honey pill, a functional jelly, a biscuit, etc.

[0039] As a preferred embodiment of the present invention, the drug achieves the effects of alcohol dehydrogenase and / or aldehyde dehydrogenase protection against alcoholic liver injury by increasing the activity of alcohol dehydrogenase and / or aldehyde dehydrogenase in vivo, or the health product achieves an auxiliary protective effect against chemically induced liver injury by increasing the activity of alcohol dehydrogenase and / or aldehyde dehydrogenase in vivo. Experiments have shown that the composition provided by the present invention can increase the activity of alcohol dehydrogenase and aldehyde dehydrogenase in the liver tissue of mice with alcoholic liver injury, accelerate the metabolism of alcohol in the body, reduce the residence time of alcohol in the body, and achieve the effects of alcohol detoxification and liver protection.

[0040] As a preferred embodiment of the present invention, the drug may achieve detoxification and / or protection against alcoholic liver damage by promoting fat metabolism in the body, or the health product may achieve an auxiliary protective effect against chemically induced liver damage by promoting fat metabolism in the body. Specifically, the composition provided by the present invention can reduce the content of fat, preferably triglycerides, in the liver tissue of mice with alcoholic liver damage, prevent its accumulation in hepatocytes, thereby avoiding the formation of alcoholic fatty liver and achieving a liver-protective effect.

[0041] As a preferred embodiment of the present invention, the drug may achieve the effects of alcohol detoxification and / or protection against alcoholic liver injury by promoting the secretion of hepatocyte growth factor in the body, or the health product may achieve an auxiliary protective effect against chemically induced liver injury by promoting the secretion of hepatocyte growth factor in the body. Specifically, the composition provided by the present invention can increase the content of hepatocyte growth factor in the liver tissue of mice with alcoholic liver injury, thereby promoting the repair and growth of hepatocytes to a certain extent, avoiding a series of degenerative damages to hepatocytes, and achieving a liver-protective effect.

[0042] Compared with existing technologies, the composition provided by this invention is formulated from pure natural ingredients according to traditional Chinese medicine theory. It can effectively increase the content of alcohol dehydrogenase and aldehyde dehydrogenase in liver cells to promote alcohol metabolism, effectively reduce the content of triglycerides in liver cells, thereby inhibiting fat accumulation in liver cells and preventing the formation of alcoholic fatty liver. It can also effectively increase the content of liver cell growth factors, thereby promoting liver cell repair and growth to a certain extent. The composition provided by this invention has significant hangover relief and liver protection effects and broad market demand, possessing significant market value and development prospects. Attached Figure Description

[0043] Figure 1 Schematic diagram of Oil Red O staining results for liver tissue. Detailed Implementation

[0044] The following embodiments are provided to further illustrate various aspects of the invention. These embodiments are non-limiting and should not be construed as limiting any aspect of the invention. The scope of protection of the invention is limited only by the claims. Various modifications and improvements can be made to various aspects of the invention by those skilled in the art without departing from the scope of the claims, and these modifications and improvements also fall within the scope of protection of the invention.

[0045] Additionally, it should be noted that, unless otherwise specified, all materials and reagents used in the following embodiments are commonly used in the art and can be obtained through conventional commercial means; all methods used are conventional methods known to those skilled in the art.

[0046] Example The following are ingredients used in the composition of the experimental examples: The kudzu root extract was prepared by the following method: Kudzu root purchased from Tongrentang was boiled in water three times for three hours each time, with the total amount of water used for extraction equivalent to 20 times the weight of the kudzu root. The extract was collected, centrifuged, filtered, and the filtrate was collected and spray-dried to obtain the final product. Using the detection method for puerarin in the Chinese Pharmacopoeia (2020), the puerarin content in the kudzu root extract was determined to be 24%.

[0047] The extract of Hovenia dulcis was prepared by the following method: Hovenia dulcis purchased from Tongrentang was boiled in water three times for three hours each time. The total amount of water used for extraction was equivalent to 20 times the mass of the Chinese herb. The extract was collected, centrifuged and filtered, and the filtrate was collected and spray-dried to obtain the final product.

[0048] The wolfberry extract was prepared by the following method: Wolfberries purchased from Tongrentang were boiled in water three times, each time for 3 hours. The total amount of water used for extraction was equivalent to 20 times the mass of the wolfberry. The extract was collected, centrifuged, filtered, and the filtrate was collected and spray-dried to obtain the final product. The polysaccharide content in the wolfberry extract was determined to be 18% using the phenol-sulfuric acid method.

[0049] Mulberry extract was prepared by the following method: mulberries purchased from Tongrentang were boiled in water three times for three hours each time. The total amount of water used for extraction was equivalent to 20 times the mass of the mulberry. The extract was collected, centrifuged and filtered, and the filtrate was collected and spray-dried to obtain the final product.

[0050] The Ganoderma lucidum extract (CAS No. 223751-82-4) was purchased from Fufeng Sinote Biotechnology Co., Ltd. The polysaccharide content in the extract was determined to be 10% using the phenol-sulfuric acid method.

[0051] The turmeric extract was prepared by the following method: Turmeric purchased from Tongrentang was boiled in water three times for three hours each time, with the total amount of water used for extraction equivalent to 20 times the mass of the turmeric. The extract was collected, centrifuged, filtered, and the filtrate was collected and spray-dried to obtain the final product. Using the method for detecting curcumin content in the Chinese Pharmacopoeia (2020), the curcumin content in the turmeric extract was determined to be 10%.

[0052] The Poria cocos extract was prepared by the following method: Poria cocos purchased from Tongrentang was boiled in water three times for three hours each time. The total amount of water used for extraction was equivalent to 20 times the mass of the Chinese herbal medicine. The extract was collected, centrifuged and filtered, and the filtrate was collected and spray-dried to obtain the final product.

[0053] The agastache extract was prepared by the following method: Agastache purchased from Tongrentang was boiled in water three times for three hours each time. The total amount of water used for extraction was equivalent to 20 times the mass of the agastache. The extract was collected, centrifuged and filtered, and the filtrate was collected and spray-dried to obtain the extract.

[0054] Peppermint extract was prepared by the following method: Peppermint purchased from Tongrentang was boiled in water three times for three hours each time. The total amount of water used for extraction was equivalent to 20 times the weight of the Chinese herb. The extract was collected, centrifuged and filtered, and the filtrate was collected and spray-dried to obtain the extract.

[0055] Ginseng peptides were purchased from Fufeng Sinote Biotechnology Co., Ltd. The assay was performed using the GB / T 22492 method, and the proportion of protein hydrolysates with a relative molecular weight less than 1000 Da was 80%.

[0056] Example 1 This embodiment provides a composition composed of the following components: 8 g of kudzu root extract, 4 g of Japanese raisin tree fruit extract, 2 g of wolfberry fruit extract, 1 g of mulberry extract, 4 g of Ganoderma lucidum extract, 1.5 g of ginseng peptide, 5 g of turmeric extract, 2 g of Poria cocos extract, 1 g of patchouli extract, and 2 g of peppermint extract.

[0057] Example 2 This embodiment provides a composition composed of the following components: 12 g of kudzu root extract, 8 g of Japanese raisin tree fruit extract, 5 g of wolfberry fruit extract, 4 g of mulberry extract, 6 g of ganoderma lucidum extract, 3.5 g of ginseng peptide, 8 g of turmeric extract, 5 g of poria cocos extract, 3 g of patchouli extract, and 4 g of peppermint extract.

[0058] Example 3 This embodiment provides a composition composed of the following components: 5 g of kudzu root extract, 10 g of Japanese raisin tree fruit extract, 1 g of wolfberry fruit extract, 5 g of mulberry extract, 1 g of ganoderma lucidum extract, 5 g of ginseng peptide, 2 g of turmeric extract, 5 g of poria cocos extract, 1 g of patchouli extract, and 1 g of peppermint extract.

[0059] Example 4 This embodiment provides a composition composed of the following components: 15 g of kudzu root extract, 2 g of Japanese raisin tree fruit extract, 5 g of wolfberry fruit extract, 1 g of mulberry extract, 5 g of ganoderma lucidum extract, 1 g of ginseng peptide, 10 g of turmeric extract, 1 g of poria cocos extract, 5 g of patchouli extract, and 5 g of peppermint extract.

[0060] Example 5 This embodiment provides an oral liquid (also known as a liquid beverage) prepared by the following method: 30 g of the composition provided in Example 1, 12 g of xylitol, 0.25 g of potassium sorbate (calculated as sorbic acid), and purified water added to a total volume of 500 mL.

[0061] In the oral liquid provided in this embodiment, the composition provided in Example 1 can be replaced with the composition provided in Examples 2 to 4 to obtain the corresponding oral liquid.

[0062] Example 6 This embodiment provides a solid beverage (granules) prepared by the following method: 30 g of the composition provided in Example 1, 12 g of xylitol, 18 g of maltodextrin and 0.009 g of ε-polylysine are mixed and granulated by dry granulation to obtain the product.

[0063] In the solid beverage provided in this embodiment, replacing the composition provided in Example 1 with the compositions provided in Examples 2 to 4 can yield the corresponding granules.

[0064] Comparative Example 1 This comparative example provides a composition that, compared to Example 1 of the present invention, does not contain mulberry extract and Ganoderma lucidum extract in the "medicine". The specific composition is as follows: 8 g of kudzu root extract, 4 g of Japanese raisin tree fruit extract, 3 g of wolfberry fruit extract, 5.5 g of ginseng peptide, 5 g of turmeric extract, 3 g of Poria cocos extract, 1 g of patchouli extract, and 2 g of peppermint extract.

[0065] Comparative Example 2 This comparative example provides a composition that, compared to Example 1 of the present invention, does not contain wolfberry extract and ginseng peptide in the "medicine". The specific composition is as follows: 8 g of kudzu root extract, 4 g of Japanese raisin tree fruit extract, 3 g of mulberry extract, 5.5 g of Ganoderma lucidum extract, 5 g of turmeric extract, 3 g of Poria cocos extract, 1 g of patchouli extract, and 2 g of peppermint extract.

[0066] Comparative Example 3 This comparative example provides a composition that, compared to Example 1 of the present invention, does not contain patchouli extract in the "adjuvant medicine". The specific composition is as follows: 8 g of kudzu root extract, 4 g of Japanese raisin tree fruit extract, 2 g of wolfberry fruit extract, 1 g of mulberry extract, 4 g of Ganoderma lucidum extract, 1.5 g of ginseng peptide, 5 g of turmeric extract, 4 g of Poria cocos extract, and 2 g of peppermint extract.

[0067] Comparative Example 4 This comparative example provides a composition that, compared to Example 1 of the present invention, does not contain turmeric extract in the "adjuvant medicine". The specific composition is as follows: 8 g of kudzu root extract, 4 g of Japanese raisin tree fruit extract, 2 g of wolfberry fruit extract, 1 g of mulberry extract, 4 g of Ganoderma lucidum extract, 1.5 g of ginseng peptide, 5 g of Poria cocos extract, 3 g of patchouli extract, and 2 g of peppermint extract.

[0068] Comparative Example 5 This comparative example provides a composition in which, compared with Example 1 of the present invention, the "medicinal agent" is replaced by perilla extract (extracted using the same process as peppermint extract) instead of peppermint extract. The specific composition is as follows: 8 g of kudzu root extract, 4 g of Japanese raisin tree fruit extract, 2 g of wolfberry fruit extract, 1 g of mulberry extract, 4 g of ganoderma lucidum extract, 1.5 g of ginseng peptide, 5 g of turmeric extract, 3 g of poria cocos extract, and 2 g of perilla extract.

[0069] Comparative Example 6 This comparative example provides a composition in which, compared with Example 1 of the present invention, the "medicinal agent" is replaced by licorice extract (extracted using the same process as peppermint extract) instead of peppermint extract. The specific composition is as follows: 8 g of kudzu root extract, 4 g of Japanese raisin tree fruit extract, 2 g of wolfberry fruit extract, 1 g of mulberry extract, 4 g of Ganoderma lucidum extract, 1.5 g of ginseng peptide, 5 g of turmeric extract, 3 g of Poria cocos extract, and 2 g of licorice extract.

[0070] Experimental Example 1: Cell Model and Viability Detection 1. Establishment of a hepatocellular alcoholic injury model L-02 hepatocytes in the logarithmic growth phase were digested with 0.25% trypsin, centrifuged, and then prepared into 1×10⁻⁶ cells. 5 Cell suspension was seeded at 100 μL / well in 96-well plates. After complete cell adhesion, the cells were divided into a control group and nine groups with different ethanol concentrations, with three replicates per group. The control group was treated with complete culture medium, while the nine ethanol groups were treated with culture medium containing 1.0%, 1.5%, 2.0%, 2.5%, 3.0%, 3.5%, 4.0%, 4.5%, and 5.0% ethanol, respectively. After 24 hours of culture, the cell viability of each group was determined using the MTT assay.

[0071] The results showed that as the ethanol concentration increased, the cell viability gradually decreased and the cell condition gradually deteriorated. To balance the sensitivity of enzyme activity detection with cell viability (not less than 60%), this example subsequently used a 3.0% ethanol aqueous solution for modeling.

[0072] 2. Activity detection of alcohol dehydrogenase and acetaldehyde dehydrogenase When alcohol enters the body, it is oxidized to acetaldehyde by alcohol dehydrogenase (ADH), and then oxidized to acetic acid by aldehyde dehydrogenase (ALDH), which is further converted into water and carbon dioxide and excreted. These two enzymes play a major role in alcohol metabolism. The activity of ADH and ALDH is direct molecular evidence to verify the liver-protecting and hangover-relieving effects, and can clarify whether the product works by regulating key enzymes in alcohol metabolism.

[0073] In this experiment, L-02 hepatocytes in the logarithmic growth phase were digested with 0.25% trypsin, centrifuged, and then prepared into 1×10⁻⁶ cells. 5 Cell suspension of 100 μL / well was seeded into 96-well plates. After culturing for 24 h, blank group, model group (3.0% ethanol), 4 example groups (3.0% ethanol + 0.1 mg / mL of the compositions described in Examples 1-4), and 6 comparative groups (3.0% ethanol + 0.1 mg / mL of the compositions described in Comparative Examples 1-6) were set up. After culturing for another 24 h, the culture medium was aspirated, cells were lysed with cell lysis buffer, and the extraction solution provided in the ADH kit (Beijing Mairuida Technology Co., Ltd.) was added. The supernatant was collected by centrifugation (operated on ice), and the absorbance values ​​were measured at 340 nm after 15 s and 75 s. The ADH activity results were calculated according to the kit instructions.

[0074] In this experimental example, while performing ADH detection, duplicate wells were set up, and ALDH activity was detected using an ALDH kit (Shanghai Jizhi Biochemical Technology Co., Ltd.), and cell viability was detected using the MTT assay.

[0075] The results are shown in Table 1 (five replicates were performed for each group, and the average value was taken).

[0076] Table 1: Results of ADH and ALDH activity and survival rate in hepatocytes

[0077] As shown in Table 1, 1) Regarding ADH activity: The activity of alcohol dehydrogenase in the model group increased slightly due to ethanol stimulation. The composition provided by this invention can further significantly improve the activity of alcohol dehydrogenase, thereby promoting the metabolism of ethanol. Among them, Examples 1 and 2 showed the best effects; 2) Regarding ALDH activity: The activity of acetaldehyde dehydrogenase in the model group increased slightly. The composition provided by this invention can significantly improve the activity of acetaldehyde dehydrogenase, thereby further promoting metabolism. Among them, Examples 1 and 2 showed the best effects; 3) Regarding cell survival rate: There was no significant difference in cell survival rate among the various examples and comparative examples, but all were significantly better than the model group, demonstrating a certain degree of cell protection.

[0078] 3. Triglyceride content detection The liver synthesizes triglycerides (TG) from glucose and fatty acids, which is the most common form of fat storage in animals. During the metabolism of ethanol in the liver, fatty acid oxidation is inhibited, while the liver promotes the synthesis of triglycerides, leading to the accumulation of triglycerides in hepatocytes (fatty degeneration), which is an early marker of alcoholic liver injury.

[0079] L-02 hepatocytes in the logarithmic growth phase were digested with 0.25% trypsin, centrifuged, and then prepared into 1×10⁻⁶ cells. 5 Cell suspension at a concentration of 100 μL / well was seeded into 96-well plates. After culturing for 24 h, blank control group, model group (3.0% ethanol), 4 example groups (3.0% ethanol + 0.1 mg / mL of the compositions described in Examples 1-4), and 6 comparative groups (3.0% ethanol + 0.1 mg / mL of the compositions described in Comparative Examples 1-6) were set up. After culturing for another 24 h, the culture medium was aspirated, and the cells were lysed with cell lysis buffer. The triglyceride (TG) content was detected using a triglyceride assay kit (A110-1-1) purchased from Nanjing Jiancheng Biotechnology Institute and a fully automated biochemical analyzer (Boke Biotechnology, BK-280). The TG content is shown in Table 2 (each group was performed in 5 replicates, and the results were averaged).

[0080] Table 2: TG content detection results

[0081] As shown in Table 2, the triglyceride content in the model group increased due to ethanol stimulation. The composition provided by the present invention can significantly reduce the triglyceride content, thereby alleviating alcohol-induced lipid metabolism abnormalities. Among them, Examples 1 and 2 showed the best results.

[0082] Based on the results of the above cell experiments, among the various examples and comparative examples, Examples 1 and 2 showed the best overall effect.

[0083] Experimental Example 2: Animal Model and Activity Detection 1. Establishment of animal models An acute alcoholic liver injury model was established in mice. A blank control group and a model group were set up. Example 1, which showed the best results in cell experiments, was selected as the experimental group (divided into low, medium, and high doses), while Comparative Example 1 was used as the control (medium dose). The low, medium, and high doses of this invention were calculated with reference to the usage and dosage restrictions of each component in the Chinese Pharmacopoeia (2020 edition). The medium dose group corresponds to the mouse gavage dose converted from the daily adult dose (2 g of the composition). The low dose was half the concentration of the medium dose, and the high dose was twice the concentration of the medium dose. The grouping and modeling methods are detailed in Table 3. The drugs in each group were prepared by dissolving the compositions provided in the corresponding examples and comparative examples in water using ultrasonication, and then preparing them according to the concentrations in Table 3.

[0084] Table 3: Grouping and Modeling Methods of Animal Models

[0085] Eight hours after the ethanol (Erguotou) gavage was completed, the mice were sacrificed and liver tissue was taken for further testing.

[0086] 2. Detection of ADH enzyme activity in liver tissue The alcohol dehydrogenase assay kit (A083-2-1) purchased from Nanjing Jiancheng Bioengineering Institute was used to detect the liver tissue homogenate supernatant samples of 6 groups of mice according to the instructions of the kit. The average ADH enzyme activity of each group was obtained, as shown in Table 4.

[0087] Table 4: Results of ADH Activity Detection

[0088] As shown in Table 4, the activity of alcohol dehydrogenase in the model group increased due to ethanol stimulation. The dosage group in the composition of Example 1 provided by the present invention can further significantly increase the activity of alcohol dehydrogenase, thereby helping to accelerate the metabolism of alcohol.

[0089] 3. Detection of ALDH enzyme activity in liver tissue The acetaldehyde dehydrogenase assay kit (A075-1-1) purchased from Nanjing Jiancheng Bioengineering Institute was used to detect the supernatant of liver tissue homogenate samples from six groups of mice using spectrophotometry according to the kit's instructions. The average ALDH enzyme activity of each group was obtained, as shown in Table 5.

[0090] Table 5: ALDH Activity Detection Results

[0091] As shown in Table 5, the rapid increase in acetaldehyde concentration due to a large intake of alcohol in a short period exceeded the processing capacity of acetaldehyde dehydrogenase, resulting in significant inhibition of acetaldehyde dehydrogenase activity in the model group. The composition provided by this invention can reverse this inhibition, thereby restoring acetaldehyde dehydrogenase activity and facilitating rapid alcohol metabolism. Among them, the dosage group in Example 1 showed the best reversal effect.

[0092] 4. Detection of triglyceride content in liver tissue For liver tissue homogenate supernatant samples from 6 groups of mice, the triglyceride (TG) content was detected using a triglyceride detection kit (A110-1-1) purchased from Nanjing Jiancheng Biotechnology Institute and an automated biochemical analyzer (Boke Biotechnology, BK-280). The average TG content of each group was obtained, as shown in Table 6.

[0093] Table 6: TG Content Detection Results

[0094] As shown in Table 6, the test results indicate that the triglyceride level in the model group was significantly higher than that in the blank group. The dosage group in the composition of Example 1 provided by this invention can significantly reduce the triglyceride content, proving that it effectively improves alcohol-induced lipid metabolism abnormalities, reduces the burden on the liver by reducing lipid accumulation, and thus prevents the occurrence of alcoholic fatty liver.

[0095] 5. Oil Red O staining of liver tissue Oil Red O fat staining assay can reflect the degree of alcohol-induced hepatocyte membrane damage or fatty degeneration by showing the lipid permeability in liver tissue.

[0096] In this experimental case, the left lobe of the liver of the euthanized mice was rinsed with physiological saline and then briefly fixed with 4% neutral buffered formalin. After washing with 60% isopropanol for 30 seconds, the cells were stained with Oil Red O working solution in the dark for 10 minutes, differentiated with 60% isopropanol for 10 seconds, rinsed with distilled water for 10 seconds, and then counterstained with hematoxylin. The cells were then mounted with glycerol gelatin and observed under a scanning electron microscope.

[0097] Take one representative staining result from each group, such as Figure 1 As shown (fat droplets appear red, and hematoxylin counterstaining of cell nuclei appears blue). From Figure 1 It is known that the composition provided in Example 1 of this application has the lowest degree of lipid permeation at medium doses, with no significant difference compared with the blank group, and is significantly better than the model group and Comparative Example 1 at the same dose, proving that the experimental group can alleviate liver cell membrane damage caused by alcohol and reduce lipid permeation in liver tissue.

[0098] 6. Detection of hepatocyte growth factor content Hepatocyte growth factor (HGF) is a pleiotropic cytokine secreted by interstitial cells (such as hepatic stellate cells and fibroblasts) that plays a crucial role in liver injury repair and regeneration. Detection of this indicator can provide key evidence for the regulation of liver regenerative capacity and anti-fibrotic potential.

[0099] The HGF detection kit (purchased from NeoBioscience, catalog number EMC037) was used. Standards 1-6 of known concentrations provided in the kit were used to measure OD values, and a standard curve was plotted as follows: y = -2.5164x 2 +18.014x -1.5892, R 2 = 0.9995. OD values ​​of liver tissue homogenate supernatants from the six groups of mice were measured and substituted into the standard curve equation to calculate the average HGF content of each group, as shown in Table 7.

[0100] Table 7: HGF content detection results

[0101] The results are shown in Table 7. The results show that the HGF level in the model group decreased significantly. The composition provided by the present invention can increase the HGF content. In particular, the dosage group in Example 1 can significantly increase the HGF level to a level similar to that in the blank group, suggesting that it promotes hepatocyte regeneration and thus supports the liver's self-repair.

[0102] Based on the above animal experimental results, the composition provided by this invention can effectively increase the content of alcohol dehydrogenase and aldehyde dehydrogenase in hepatocytes, effectively reduce the content of triglycerides in hepatocytes, prevent fat accumulation in hepatocytes, and effectively increase the content of hepatocyte growth factors, thus exerting a comprehensive effect to achieve liver protection and alcohol detoxification. The composition provided in Example 1 showed the best overall effect at medium doses.

[0103] Unless otherwise stated, the technical terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. This invention may also be practiced using any methods and materials similar to or equivalent to those described herein. While specific embodiments and preferred methods and materials are described herein, they do not impose any limitation on the invention.

Claims

1. A composition, characterized in that, The composition comprises the following components in parts by weight: 8-12 parts of kudzu root extract, 4-8 parts of Japanese raisin tree fruit extract, 2-5 parts of wolfberry fruit extract, 1-4 parts of mulberry extract, 4-6 parts of ganoderma lucidum extract, 1.5-3.5 parts of ginseng peptide, 5-8 parts of turmeric extract, 2-5 parts of poria cocos extract, 1-3 parts of patchouli extract, and 2-4 parts of peppermint extract. The kudzu root extract, Japanese raisin tree fruit extract, wolfberry fruit extract, mulberry extract, Ganoderma lucidum extract, turmeric extract, Poria cocos extract, patchouli extract, and / or peppermint extract are prepared by methods including the following steps: taking the corresponding Chinese herbal raw materials, adding water equivalent to 10-20 times their mass, and extracting by water decoction; filtering and drying the obtained extract to obtain the extract; the ginseng peptide is prepared by methods including the following steps: extracting total protein from the Chinese herbal medicine ginseng, and enzymatically hydrolyzing it to obtain ginseng peptide. The puerarin content in the kudzu root extract is ≥24%; the curcumin content in the turmeric extract is ≥10%; the wolfberry polysaccharide content in the wolfberry extract is ≥18%; the ganoderma lucidum polysaccharide content in the ganoderma lucidum extract is ≥10%; and the proportion of peptides with a relative molecular weight of less than 1000 Da in the ginseng peptide is ≥80%.

2. A formulation, characterized in that, Includes the composition and excipients as described in claim 1.

3. The formulation according to claim 2, characterized in that, The beverage is a liquid beverage, and the excipients include flavoring agents, preservatives, and water.

4. The formulation according to claim 3, characterized in that, The liquid beverage contains 20-100 g / L of the composition.

5. The formulation according to claim 3, characterized in that, The liquid beverage contains 40-60 g / L of the composition.

6. The formulation according to claim 2, characterized in that, The beverage is a solid beverage, and the excipients include flavoring agents, preservatives, and fillers.

7. The formulation according to claim 6, characterized in that, The solid beverage formulation is prepared by a method including the following steps: mixing the composition with excipients including flavoring agents, fillers, and preservatives in a certain proportion, and granulating by wet granulation, dry granulation, rapid stirring granulation, or fluidized bed granulation.

8. The use of the composition of claim 1 and / or the formulation of any one of claims 2 to 7 in the preparation of a medicine for relieving hangovers and / or protecting against alcoholic liver injury, or in the preparation of a health product for adjuvant protection against chemical liver injury.

9. The application according to claim 8, characterized in that, The drug achieves alcohol detoxification and / or protection against alcoholic liver damage by increasing the activity of alcohol dehydrogenase and / or aldehyde dehydrogenase in the body, or the health product achieves an auxiliary protective effect against chemically induced liver damage by increasing the activity of alcohol dehydrogenase and / or aldehyde dehydrogenase in the body. And / or, the drug achieves alcohol detoxification and / or protection against alcoholic liver damage by promoting fat metabolism in the body, or the health product achieves an auxiliary protective effect against chemically induced liver damage by promoting fat metabolism in the body. And / or, the drug achieves alcohol detoxification and / or protection against alcoholic liver damage by promoting the secretion of hepatocyte growth factor in the body, or the health product achieves an auxiliary protective effect against chemically induced liver damage by promoting the secretion of hepatocyte growth factor in the body.

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