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

Abstract

The invention relates to a liver-protecting and hangover-alleviating composition as well as a preparation method and application thereof. The liver-protecting and hangover-alleviating composition is prepared from the following raw materials in parts by weight: 20 to 40 parts of corn extract, 15 to 35 parts of radix puerariae extract, 5 to 25 parts of hovenia dulcis thunb extract, 5 to 25 parts of liquorice extract, 5 to 10 parts of antioxidant and 5 to 10 parts of filling auxiliary materials. Four herbal extracts with a specific proportion relation are creatively used as main components of the composition for protecting the liver and dispelling the effects of alcohol, the four herbal extracts supplement each other and cooperate with each other, the effects of protecting liver injury and promoting repair can be achieved while metabolism is accelerated and toxin removal is promoted, and the composition has excellent effects of dispelling the effects of alcohol and protecting the liver and is wide in adaptability and suitable for popularization and application. The device is suitable for different people.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to a liver-protecting and hangover-relieving composition, its preparation method, and its application. Background Technology

[0002] Drinking alcohol is a long-standing and widespread socio-cultural behavior, prevalent in various settings such as social gatherings, celebrations, and personal leisure. However, alcohol and its metabolites can cause significant damage to the body, especially the liver. After alcohol is ingested, it is primarily metabolized by the liver. The metabolic process begins with the conversion of alcohol to acetaldehyde by alcohol dehydrogenase, followed by its conversion to acetic acid by acetaldehyde dehydrogenase. Acetaldehyde, produced in this process, is significantly more toxic than ethanol and is a key substance causing adverse reactions such as nausea, headache, and facial flushing after drinking. It can also bind to proteins and DNA, causing direct damage. Simultaneously, alcohol metabolism consumes large amounts of reduced coenzymes in the body, disrupting normal energy and material metabolism, triggering oxidative stress and lipid peroxidation, leading to hepatocyte inflammation and fat accumulation. Long-term or excessive drinking can gradually develop into alcoholic hepatitis, liver fibrosis, and even cirrhosis.

[0003] To address the health risks and discomfort associated with alcohol, various hangover remedies and liver protection products have emerged on the market. However, existing solutions have significant limitations: on the one hand, in terms of active ingredients, most traditional hangover remedies primarily focus on accelerating alcohol metabolism or alleviating single symptoms, lacking long-term liver protection. On the other hand, many health supplements contain only a single ingredient or are simply a mixture of a few herbal materials, lacking a scientifically balanced formulation based on synergistic metabolic pathways. This fails to fully leverage their synergistic effects in liver protection and hangover relief, resulting in limited overall effectiveness.

[0004] Therefore, how to develop a compound liver-protecting and hangover-relieving composition with scientifically sound components, synergistic effects, and broad applicability across different application scenarios is an urgent problem to be solved in this field. Summary of the Invention

[0005] In view of the shortcomings of the prior art, the purpose of this invention is to provide a liver-protecting and hangover-relieving composition, its preparation method and application.

[0006] To achieve this objective, the present invention adopts the following technical solution: In a first aspect, the present invention provides a liver-protecting and hangover-relieving composition, wherein the raw materials for preparing the liver-protecting and hangover-relieving composition comprise, by weight, the following components: 20-40 parts of corn extract (e.g., 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40 parts, etc.), 15-35 parts of kudzu root extract (e.g., 15, 17, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 33, 35 parts, etc.), and 5-25 parts of Hovenia dulcis extract (e.g., 5, 7...). 5-25 parts of licorice extract (e.g., 5, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 23, 25, etc.), 5-10 parts of antioxidant (e.g., 5, 6, 7, 8, 9, 10, etc.), and 5-10 parts of filler excipients (e.g., 5, 6, 7, 8, 9, 10, etc.).

[0007] This invention creatively designs a liver-protecting and hangover-relieving composition consisting of herbal extracts, antioxidants, and excipients. The herbal extracts include corn extract, kudzu root extract, Japanese raisin tree fruit extract, and licorice extract. These four extracts work synergistically in a specific ratio to accelerate metabolism, promote toxin removal, protect the liver from damage, and promote repair. This results in excellent hangover-relieving and liver-protecting effects, and is widely applicable to various populations.

[0008] Preferably, the raw materials for preparing the liver-protecting and hangover-relieving composition include the following components by weight: 25-35 parts corn extract, 20-30 parts kudzu root extract, 10-20 parts Japanese raisin tree fruit extract, 10-20 parts licorice extract, 6-8 parts antioxidant, and 6-8 parts filler excipients.

[0009] Preferably, the antioxidant includes any one or a combination of at least two of vitamin C, vitamin E, glutathione, curcumin, and anthocyanins.

[0010] Preferably, the filler material includes any one or a combination of at least two of the following: granulated sugar, starch sugar, sugar alcohol, and starch.

[0011] Preferably, the corn extract is prepared by the following method: (1) Soak the corn kernels and then heat them to denature them, then grind them into a paste to obtain corn slurry; (2) The corn slurry was subjected to ultrasonic treatment and enzymatic hydrolysis, then filtered, concentrated and dried to obtain corn extract.

[0012] This invention utilizes a combination of ultrasonic treatment and enzymatic hydrolysis to extract corn extracts, enabling the targeted and efficient conversion of macromolecular proteins in corn into small molecule active peptides and amino acids with liver-protecting and hangover-relieving effects. The reaction process is mild and efficient, and can achieve green production.

[0013] Preferably, the soaking temperature in step (1) is 50-60℃ (e.g., 50℃, 52℃, 54℃, 56℃, 58℃, 60℃, etc.), and the soaking time is 6-10 h (e.g., 6 h, 7 h, 8 h, 9 h, 10 h, etc.).

[0014] Preferably, the heating and denaturation in step (1) is carried out at a temperature of 80-120℃ (e.g., 80℃, 85℃, 90℃, 95℃, 100℃, 105℃, 110℃, 115℃, 120℃, etc.) for a time of 10-30 min (e.g., 10 min, 13 min, 15 min, 17 min, 20 min, 23 min, 25 min, 27 min, 30 min, etc.).

[0015] Preferably, the temperature of the ultrasonic treatment in step (2) is 70-80℃ (e.g., 70℃, 72℃, 74℃, 76℃, 78℃, 80℃, etc.), the time is 10-20 min (e.g., 10 min, 12 min, 14 min, 16 min, 18 min, 20 min, etc.), and the power is 300-400 W (e.g., 320 W, 340 W, 360 W, 380 W, 400 W, etc.).

[0016] Preferably, the enzyme used in step (2) for enzymatic hydrolysis includes any one or a combination of at least two of protease, cellulase, and pectinase.

[0017] Preferably, the enzymatic hydrolysis in step (2) uses a complex enzyme of protease, cellulase and pectinase in a mass ratio of 1:(0.5-1):(0.5-1) (where 0.5-1 can be selected from 0.5, 0.6, 0.7, 0.8, 0.9, 1, etc.).

[0018] This invention uses a compound enzyme to extract corn extract, which can have a synergistic effect, release more water-soluble functional components that are bound by the cell wall, and improve the extraction rate.

[0019] Preferably, the mass of the compound enzyme is 1.5-2.5% of the mass of the corn kernel raw material (e.g., it can be 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, etc.).

[0020] Preferably, the enzymatic hydrolysis in step (2) is performed at a temperature of 50-80℃ (e.g., 50℃, 53℃, 55℃, 57℃, 60℃, 63℃, 65℃, 67℃, 70℃, 73℃, 75℃, 77℃, 80℃, etc.), a pH of 6.5-7.5 (e.g., 6.5, 7, 7.5, etc.), and a time of 6-10 h (e.g., 6 h, 7 h, 8 h, 9 h, 10 h, etc.).

[0021] Preferably, the kudzu root extract is prepared by the following method: The kudzu root raw material was subjected to alcohol extraction, centrifuged, the supernatant was collected and dried to obtain kudzu root extract.

[0022] Preferably, the alcohol extraction is performed using an ethanol solution with a volume fraction of 70-90% (e.g., 70%, 75%, 80%, 85%, 90%, etc.).

[0023] Preferably, the alcohol extraction method includes heating and reflux extraction, and the extraction time is 6-10 h (e.g., 6 h, 7 h, 8 h, 9 h, 10 h, etc.).

[0024] Preferably, the mass ratio of the kudzu root raw material to the ethanol solution is 1:(8-15) (e.g., 1:8, 1:9, 1:10, 1:11, 1:12, 1:13, 1:14, 1:15, etc.).

[0025] Preferably, the centrifugation temperature is 20-40℃ (e.g., 20℃, 23℃, 25℃, 27℃, 30℃, 33℃, 35℃, 37℃, 40℃, etc.), the time is 10-15 min (e.g., 10 min, 11 min, 12 min, 13 min, 14 min, 15 min, etc.), and the rotation speed is 3500-4500 rpm (e.g., 3500 rpm, 3600 rpm, 3700 rpm, 3800 rpm, 3900 rpm, 4000 rpm, 4100 rpm, 4200 rpm, 4300 rpm, 4400 rpm, 4500 rpm, etc.).

[0026] Preferably, the drying method is spray drying, with an inlet air temperature of 150-200℃ (e.g., 150℃, 160℃, 170℃, 180℃, 190℃, 200℃, etc.) and an outlet air temperature of 60-100℃ (e.g., 60℃, 65℃, 70℃, 75℃, 80℃, 85℃, 90℃, 95℃, 100℃, etc.).

[0027] Preferably, the Hovenia dulcis extract is prepared by the following method: The raw material of Japanese raisin tree fruit was soaked, ultrasonically treated, and then extracted with water. The extract was then filtered, concentrated, and vacuum dried to obtain the Japanese raisin tree fruit extract.

[0028] Ultrasonic treatment can effectively break down plant cell walls, allowing the active ingredients inside the cells to be fully released into the solvent. The synergistic effect of ultrasonic treatment and water extraction can improve the extraction rate of active ingredients and increase production efficiency.

[0029] Preferably, the soaking temperature is 10-35℃ (e.g., 10℃, 12℃, 14℃, 16℃, 18℃, 20℃, 22℃, 24℃, 26℃, 28℃, 30℃, 32℃, 34℃, 35℃, etc.), and the soaking time is 1-6 h (e.g., 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, etc.).

[0030] Preferably, the power of the ultrasonic treatment is 200-500 W (e.g., 200 W, 250 W, 300 W, 350 W, 400 W, 450 W, 500 W, etc.), and the time is 5-20 min (e.g., 5 min, 7 min, 9 min, 11 min, 13 min, 15 min, 17 min, 19 min, 20 min, etc.).

[0031] Preferably, the water extraction temperature is 90-100℃ (e.g., 90℃, 95℃, 100℃, etc.), the time is 1-2 h (e.g., 1 h, 1.2 h, 1.4 h, 1.6 h, 1.8 h, 2 h, etc.), and the material-to-liquid ratio is 1:(4-12)g / mL (e.g., 1:4 g / mL, 1:5 g / mL, 1:6 g / mL, 1:7 g / mL, 1:8 g / mL, 1:9 g / mL, 1:10 g / mL, 1:11 g / mL, 1:12 g / mL, etc.).

[0032] Preferably, the water extraction step is repeated at least three times.

[0033] Preferably, the drying method is vacuum drying, and the temperature is 80-95℃ (e.g., 80℃, 82℃, 85℃, 87℃, 89℃, 91℃, 93℃, 95℃, etc.).

[0034] Preferably, the licorice extract is prepared by the following method: The licorice raw material was soaked, ultrasonically treated, and then extracted with water. The extract was then filtered, concentrated, and vacuum dried to obtain the licorice extract.

[0035] Preferably, the soaking temperature is 10-35℃ (e.g., 10℃, 11℃, 12℃, 13℃, 14℃, 15℃, 16℃, 17℃, 18℃, 19℃, 20℃, 21℃, 22℃, 23℃, 24℃, 25℃, 26℃, 27℃, 28℃, 29℃, 30℃, 31℃, 32℃, 33℃, 34℃, 35℃, etc.), and the soaking time is 4-8 h (e.g., 4 h, 5 h, 6 h, 7 h, 8 h, etc.).

[0036] Preferably, the power of the ultrasonic treatment is 250-450 W (e.g., 250 W, 300 W, 350 W, 400 W, 450 W, etc.), and the time is 10-20 min (e.g., 10 min, 12 min, 14 min, 16 min, 18 min, 20 min, etc.).

[0037] Preferably, the water extraction temperature is 90-100℃ (e.g., 90℃, 91℃, 92℃, 93℃, 94℃, 95℃, 97℃, 100℃, etc.), the time is 0.5-2 h (e.g., 0.5 h, 0.7 h, 1.0 h, 1.3 h, 1.5 h, 1.7 h, 2 h, etc.), and the material-to-liquid ratio is 1:(6-10)g / mL (e.g., 1:6 g / mL, 1:7 g / mL, 1:8 g / mL, 1:9 g / mL, 1:10 g / mL, etc.).

[0038] Preferably, the water extraction step is repeated at least three times.

[0039] Preferably, the drying method is vacuum drying, and the temperature is 85-95℃ (e.g., 85℃, 87℃, 89℃, 91℃, 93℃, 95℃, etc.).

[0040] In a second aspect, the present invention provides a method for preparing the liver-protecting and hangover-relieving composition as described in the first aspect, the preparation method comprising the following steps: The corn extract, kudzu root extract, Japanese raisin tree fruit extract, licorice extract, antioxidants, and filler excipients were sieved and then mixed to obtain the liver-protecting and hangover-relieving composition.

[0041] Preferably, the standard sieve mesh number used in the sieving is 40-100 mesh (e.g., 40 mesh, 45 mesh, 50 mesh, 55 mesh, 60 mesh, 65 mesh, 70 mesh, 75 mesh, 80 mesh, 85 mesh, 90 mesh, 95 mesh, 100 mesh, etc.).

[0042] Preferably, the mixing time is 15-40 min (e.g., 15 min, 20 min, 25 min, 30 min, 35 min, 40 min, etc.).

[0043] All other specific point values ​​not listed above within the numerical ranges mentioned above can be selected and are all within the protection scope of this invention. For the sake of brevity, they will not be described in detail here.

[0044] Thirdly, the present invention provides the application of the liver-protecting and hangover-relieving composition as described in the first aspect in the preparation of liver-protecting and hangover-relieving products.

[0045] Compared with the prior art, the present invention has the following beneficial effects: This invention creatively provides a liver-protecting and hangover-relieving composition composed of herbal extracts, antioxidants, and excipients. The herbal extracts include corn extract, kudzu root extract, Japanese raisin tree fruit extract, and licorice extract. These four extracts work synergistically in a specific ratio to accelerate metabolism, promote toxin removal, and provide antioxidant, anti-inflammatory, and repair-promoting effects. This results in excellent hangover-relieving and liver-protecting effects. Furthermore, the composition is scientifically formulated, widely adaptable, and suitable for different groups of people.

[0046] Furthermore, this invention employs specific methods to extract corn extract, kudzu root extract, Japanese raisin tree fruit extract, and licorice extract, which significantly improves the extraction rate and production efficiency. The methods are also simple to operate, highly safe, and enable green production. Detailed Implementation

[0047] To further illustrate the technical means and effects of the present invention, the following describes the technical solution of the present invention in conjunction with preferred embodiments of the present invention. However, the present invention is not limited to the scope of the embodiments.

[0048] Preparation Example 1-1 This preparation example provides a corn extract, prepared by the following method: (1) After washing the corn kernels, soak them at 55℃ for 8 hours, raise the temperature to 100℃ and keep it for 20 minutes, then grind the corn kernels to obtain corn slurry; (2) The corn slurry was ultrasonically treated at 75°C for 15 min with an ultrasonic power of 350 W. Then, a complex enzyme of protease, cellulase and pectinase with a mass ratio of 1:0.5:0.5 was used for enzymatic hydrolysis. The mass of the complex enzyme was 2.0% of the mass of the corn kernel raw material. The enzymatic hydrolysis was carried out at 60°C and pH 7 for 8 h. After enzymatic hydrolysis, the mixture was filtered, the filtrate was concentrated and dried to obtain the corn extract.

[0049] Preparation Examples 1-2 This preparation example provides a corn extract, prepared by the following method: (1) After washing the corn kernels, soak them at 60°C for 6 hours, raise the temperature to 110°C and keep it for 10 minutes, then grind the corn kernels to obtain corn slurry; (2) The corn slurry was ultrasonically treated at 70°C for 20 min with an ultrasonic power of 400 W. Then, a complex enzyme of protease, cellulase and pectinase in a mass ratio of 1:1:1 was used for enzymatic hydrolysis. The mass of the complex enzyme was 2.5% of the mass of the corn kernel raw material. The enzymatic hydrolysis was carried out at 65°C and pH 7.3 for 7 h. After enzymatic hydrolysis, the mixture was filtered, the filtrate was concentrated and dried to obtain the corn extract.

[0050] Preparation Examples 1-3 This preparation example provides a corn extract, prepared by the following method: (1) After washing the corn kernels, soak them at 50°C for 10 h, raise the temperature to 80°C and keep it for 30 min, then grind the corn kernels to obtain corn slurry; (2) The corn slurry was ultrasonically treated at 80℃ for 10 min with an ultrasonic power of 300 W. Then, it was enzymatically hydrolyzed with a complex enzyme of protease, cellulase and pectinase in a mass ratio of 1:0.7:0.5. The mass of the complex enzyme was 1.5% of the mass of the corn kernel raw material. The enzymatic hydrolysis was carried out at 50℃ and pH 7 for 8.5 h. After enzymatic hydrolysis, the mixture was filtered, the filtrate was concentrated and dried to obtain the corn extract.

[0051] Preparation Examples 1-4 This preparation example provides a corn extract. The preparation method differs from that of Preparation Example 1-1 only in that the complex enzyme in step (2) is replaced with a single protease, and the mass of the protease is 2.0% of the mass of the corn kernel raw material. All other conditions remain unchanged.

[0052] Preparation Examples 1-5 This preparation example provides a corn extract. The difference between the preparation method and that of Preparation Example 1-1 is that step (2) is as follows: the corn slurry is enzymatically hydrolyzed using a complex enzyme of protease, cellulase and pectinase in a mass ratio of 1:0.5:0.5. The mass of the complex enzyme is 2.0% of the mass of the corn kernel raw material. The enzymatic hydrolysis is carried out at 60°C and pH 7 for 10 h. After enzymatic hydrolysis, the mixture is filtered, the filtrate is concentrated and dried to obtain the corn extract.

[0053] Preparation Example 2-1 This preparation example provides a kudzu root extract, prepared by the following method: After washing the kudzu root raw material, it was extracted by heating and reflux with an 80% ethanol solution for 8 h. The mass ratio of kudzu root raw material to ethanol solution was 1:10. After extraction, the mixture was centrifuged at 4000 rpm for 15 min at 20℃. The supernatant was collected and spray-dried. The inlet air temperature of the spray dryer was 180℃ and the outlet air temperature was 80℃ to obtain the kudzu root extract.

[0054] Preparation Example 2-2 This preparation example provides a kudzu root extract, prepared by the following method: After washing the kudzu root raw material, it was extracted by heating and reflux with a 90% ethanol solution for 6 h. The mass ratio of kudzu root raw material to ethanol solution was 1:15. After extraction, it was centrifuged at 4500 rpm for 10 min at 25℃. The supernatant was collected and spray-dried. The inlet air temperature of the spray dryer was 200℃ and the outlet air temperature was 100℃ to obtain the kudzu root extract.

[0055] Preparation Examples 2-3 This preparation example provides a kudzu root extract, prepared by the following method: After washing the kudzu root raw material, it was extracted by heating and reflux for 10 h using a 70% (v / v) ethanol solution with a mass ratio of 1:8. After extraction, the mixture was centrifuged at 3500 rpm for 15 min at 30℃, and the supernatant was collected and spray-dried. The inlet air temperature of the spray dryer was 150℃ and the outlet air temperature was 60℃ to obtain the kudzu root extract.

[0056] Preparation Examples 2-4 This preparation example provides a kudzu root extract, prepared by the following method: After washing the kudzu root raw material, it was extracted with boiling water for 8 hours, with a mass ratio of kudzu root raw material to water of 1:10. After extraction, it was centrifuged at 4000 rpm for 15 minutes at 35℃, and the supernatant was collected for spray drying. The inlet air temperature of the spray drying was 180℃ and the outlet air temperature was 80℃ to obtain the kudzu root extract.

[0057] Preparation Example 3-1 This preparation example provides a Hovenia dulcis extract, prepared by the following method: After washing the raw material of Hovenia dulcis, it was soaked at 30℃ for 2 h. After soaking, it was sonicated at 350 W for 10 min. Then, the raw material was extracted three times in boiling water (the material-to-liquid ratio of the three boiling water extractions was 1:10 g / mL, 1:6 g / mL, and 1:6 g / mL, respectively), and the extraction time was 1.5 h each time. After filtration, concentration, and vacuum drying at 90℃, Hovenia dulcis extract was obtained.

[0058] Preparation Example 3-2 This preparation example provides a Hovenia dulcis extract, prepared by the following method: After washing the raw material of Hovenia dulcis, it was soaked at 25℃ for 3 hours. After soaking, it was sonicated at 350 W for 20 minutes. Then, the raw material was extracted three times in boiling water (the material-to-liquid ratio of the three boiling water extractions was 1:12 g / mL, 1:4 g / mL, and 1:4 g / mL, respectively), and the extraction time was 2 hours each time. The extract was obtained by filtration, concentration, and vacuum drying at 85℃.

[0059] Preparation Example 3-3 This preparation example provides a Hovenia dulcis extract, prepared by the following method: After washing the raw material of Hovenia dulcis, it was soaked at 35℃ for 1 hour. After soaking, it was sonicated at 500 W for 5 minutes. Then, the raw material was extracted three times in boiling water (the material-to-liquid ratio of the three boiling water extractions was 1:10 g / mL, 1:12 g / mL, and 1:4 g / mL, respectively), and the extraction time was 1 hour each time. The extract was obtained by filtration, concentration, and vacuum drying at 95℃.

[0060] Preparation Examples 3-4 This preparation example provides a Hovenia dulcis extract. The only difference between this preparation method and that of Preparation Example 3-1 is that the water is not subjected to ultrasonic treatment beforehand, and the boiling water extraction time is changed to 2 hours each time, while the other conditions remain unchanged.

[0061] Preparation Example 4-1 This preparation example provides a licorice extract, prepared by the following method: After washing the licorice raw material, it was soaked at 25℃ for 6 hours. After soaking, it was sonicated at 400 W for 15 minutes. Then, the raw material was extracted three times in boiling water (the material-to-liquid ratio of the three boiling water extractions was 1:10 g / mL, 1:6 g / mL, and 1:6 g / mL, respectively), and the extraction time was 1.5 hours each time. The licorice extract was obtained by filtration, concentration, and vacuum drying at 90℃.

[0062] Preparation Example 4-2 This preparation example provides a licorice extract, prepared by the following method: After washing the licorice raw material, it was soaked at 30℃ for 8 hours. After soaking, it was sonicated at 250 W for 20 minutes. Then, the raw material was extracted three times in boiling water (the material-to-liquid ratio of the three boiling water extractions was 1:10 g / mL, 1:10 g / mL, and 1:6 g / mL, respectively), and the extraction time was 2 hours each time. The licorice extract was obtained by filtration, concentration, and vacuum drying at 85℃.

[0063] Preparation Example 4-3 This preparation example provides a licorice extract, prepared by the following method: After washing the licorice raw material, it was soaked at 35℃ for 4 h. After soaking, it was sonicated at 450 W for 10 min. Then, the raw material was extracted three times in boiling water (the material-to-liquid ratio of the three boiling water extractions was 1:10 g / mL, 1:6 g / mL, and 1:8 g / mL, respectively), and the extraction time was 0.5 h each time. The licorice extract was obtained by filtration, concentration, and vacuum drying at 95℃.

[0064] Example 1 This embodiment provides a liver-protecting and hangover-relieving composition, prepared by the following method: 31.6 parts of corn extract obtained in Preparation Example 1-1, 26.3 parts of kudzu root extract obtained in Preparation Example 2-1, 13.1 parts of Japanese raisin tree extract obtained in Preparation Example 3-1, 13.1 parts of licorice extract obtained in Preparation Example 4-1, 7.9 parts of vitamin C, and 8 parts of starch were passed through an 80-mesh sieve and then mixed in a mixer for 30 minutes to obtain the liver-protecting and hangover-relieving composition.

[0065] Example 2 This embodiment provides a liver-protecting and hangover-relieving composition, prepared by the following method: The corn extract obtained in Preparation Examples 1-2, 24 parts of kudzu root extract obtained in Preparation Examples 2-2, 16 parts of Japanese raisin tree extract obtained in Preparation Example 3-2, 11 parts of licorice extract obtained in Preparation Example 4-2, 7 parts of vitamin E microcapsule powder, and 6 parts of starch sugar were all passed through an 80-mesh sieve and then mixed in a mixer for 40 minutes to obtain the liver-protecting and hangover-relieving composition.

[0066] Example 3 This embodiment provides a liver-protecting and hangover-relieving composition, prepared by the following method: 25 parts of corn extract obtained in Preparation Examples 1-3, 22 parts of kudzu root extract obtained in Preparation Examples 2-3, 18 parts of Japanese raisin tree extract obtained in Preparation Examples 3-3, 20 parts of licorice extract obtained in Preparation Examples 4-3, 8 parts of glutathione, and 7 parts of white sugar were passed through an 80-mesh sieve and then mixed in a mixer for 15 minutes to obtain the liver-protecting and hangover-relieving composition.

[0067] Example 4 This embodiment provides a liver-protecting and hangover-relieving composition. The only difference between this embodiment and Example 1 is that the corn extract obtained in Preparation Example 1-1 is replaced with the corn extract obtained in Preparation Example 1-4, while the other conditions remain unchanged.

[0068] Example 5 This embodiment provides a liver-protecting and hangover-relieving composition. The only difference between this embodiment and Example 1 is that the corn extract obtained in Preparation Example 1-1 is replaced with the corn extract obtained in Preparation Example 1-5, while the other conditions remain unchanged.

[0069] Example 6 This embodiment provides a liver-protecting and hangover-relieving composition. The only difference between this embodiment and Example 1 is that the equal proportion of the Hovenia dulcis extract obtained in Preparation Example 3-1 is replaced with the Hovenia dulcis extract obtained in Preparation Example 3-4, while the other conditions remain unchanged.

[0070] Example 7 This embodiment provides a liver-protecting and hangover-relieving composition. The only difference between this embodiment and Example 1 is that the kudzu root extract obtained in Preparation Example 2-1 is replaced with the kudzu root extract obtained in Preparation Example 2-4, while the other conditions remain unchanged.

[0071] Comparative Example 1 This comparative example provides a liver-protecting and hangover-relieving composition. The only difference between this preparation method and Example 1 is that corn extract is not added, and the reduced amount of corn extract is proportionally allocated to kudzu root extract, Japanese raisin tree extract, and licorice extract, while the other conditions remain unchanged.

[0072] Comparative Example 2 This comparative example provides a liver-protecting and hangover-relieving composition. The only difference between this preparation method and Example 1 is that kudzu root extract is not added, and the reduced amount of kudzu root extract is proportionally allocated to corn extract, Japanese raisin tree extract, and licorice extract, while the other conditions remain unchanged.

[0073] Comparative Example 3 This comparative example provides a liver-protecting and hangover-relieving composition. The only difference between this preparation method and Example 1 is that Hovenia dulcis extract is not added, and the reduced amount of Hovenia dulcis extract is proportionally allocated to corn extract, kudzu root extract, and licorice extract, while the other conditions remain unchanged.

[0074] Comparative Example 4 This comparative example provides a liver-protecting and hangover-relieving composition. The only difference between this preparation method and Example 1 is that licorice extract is not added, and the reduced amount of licorice extract is proportionally allocated to corn extract, kudzu root extract, and Japanese raisin tree extract, while the other conditions remain unchanged.

[0075] Test Example 1 This test example examines the hepatoprotective and hangover-relieving compositions obtained in Examples 1-7 and Comparative Examples 1-4 to test their protective performance against chemical liver injury.

[0076] One hundred and thirty male Wistar rats, weighing 180-220 g, were selected. They were quarantined for one week before the experiment. Throughout the experiment, the animals had free access to food and water. The room temperature was 20-23℃ and the relative humidity was 50%-75%.

[0077] Rats were randomly divided into 13 groups of 10 rats each. Eleven groups were the experimental groups of Examples 1-7 and Comparative Examples 1-4 of this invention, while the remaining two groups were the liver injury model control group and the blank control group, respectively. Based on a dosage design of 855 mg / kg bw (equivalent to 15 times the recommended human dose) and a standard gavage volume of 2 mL / 100g bw, the hepatoprotective and hangover-relieving compositions for each group were prepared into a 5.7% (w / v) solution with distilled water. Rats in each group were administered this solution once daily by gavage for 30 consecutive days. On day 31 of the experiment, after a 16-hour overnight fast, the experimental and model groups were administered a single gavage of 5 mL / kg bw of 3% carbon tetrachloride (CC14), followed by administration of the test substance 4 hours later. Rats in each group were euthanized by femoral vein pleophoresis 48 hours after administration of carbon tetrachloride. Blood was collected, serum was separated, and serum biochemical tests were performed. The activities of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were measured. Liver tissue was taken from each animal, fixed, and subjected to routine liver tissue pathological examination. The weight of mice was monitored during the experiment. The results of various tests are shown in Tables 1-3. As shown in Table 1, there were no significant differences in animal body weight between the various examples, the comparative group, and the model control group throughout the experiment, indicating that the test substance had no adverse effects on the growth and development of rats. After administration of 3% carbon tetrachloride, the body weight of the animals in the model group and the various examples and the comparative group decreased to varying degrees, but the differences were not significant (P>0.05). The serum biochemical test results are shown in Table 2. The results showed that ALT and AST levels in the blank control group were within the normal range, while the serum ALT and AST activity levels in the carbon tetrachloride liver injury model control group were significantly increased compared to the blank control group (P<0.01), indicating the successful establishment of the chemical liver injury model. Compared to the model control group, ALT and AST activities decreased in a dose-dependent manner after administration of the hepatoprotective and hangover-relieving compositions obtained in Examples 1-3 (P<0.05), indicating that the hepatoprotective and hangover-relieving compositions designed in this invention have an anti-inflammatory effect against the elevated transaminase levels caused by chemical liver injury.

[0078] Compared to Examples 1-3, the hepatoprotective and hangover-relieving composition showed a decrease in efficacy when using a single enzyme for corn extract extraction, but still exhibited a significant dose-dependent decreasing trend in ALT and AST activities, as seen in Example 4. The liver damage recovery effects in the experimental groups of Examples 5-7 were worse than those in Examples 1-3, indicating that the hepatoprotective and hangover-relieving composition obtained using the specific extraction method designed in this invention for corn extract, kudzu root extract, and Japanese raisin tree extract has a better hepatoprotective effect. The ALT and AST activity recovery effects in the experimental groups of Comparative Examples 1-4 were significantly reduced, indicating a synergistic effect among corn extract, kudzu root extract, Japanese raisin tree extract, and licorice extract; the absence of any one of these extracts would lead to a significant decrease in hepatoprotective efficacy. The pathological examination results are shown in Table 3. Based on the presence and degree of lesions, scores were assigned according to the evaluation criteria. The results showed that the liver structure of the control group was basically normal. The liver damage caused by carbon tetrachloride in rats mainly consisted of four lesion types: ballooning degeneration of centrilobular hepatocytes, fatty degeneration, cytoplasmic aggregation, and necrosis. In the experimental groups using the liver-protecting and hangover-relieving compositions of Examples 1-3, the average scores for cytoplasmic aggregation and necrosis, as well as the total lesion score, were significantly lower than those of the model control group (P<0.05), indicating that the liver-protecting and hangover-relieving compositions provided by this invention have a protective effect against liver damage caused by carbon tetrachloride.

[0079] The effects of the liver-protecting and hangover-relieving compositions used in Examples 4-7 were somewhat lower than those in Examples 1-3, and the effects of the liver-protecting and hangover-relieving compositions used in Comparative Examples 1-4 were significantly lower. This indicates that the liver-protecting and hangover-relieving compositions designed in this invention have excellent effects. If the preparation method of the herbal extract is changed, or if any herbal extract is missing, the excellent technical effects of this invention cannot be obtained.

[0080] The evaluation criteria are as follows: Ballooning degeneration: Hepatocytes are swollen, enlarged, and have loose, pale-stained cytoplasm, appearing vacuolated. 0: None; 1: Mild, a few cells are involved (<25%); 2: Moderate, about 25-50% of cells are involved; 3: Severe, about 50-75% of cells are involved; 4: Very severe, almost all cells are involved (>75%).

[0081] Steroid degeneration: Lipid droplets of varying sizes appear in hepatocytes (usually macrovesicles). 0: None; 1: Mild, scattered cell involvement (<25%); 2: Moderate, approximately 25-50% of cells involved; 3: Severe, approximately 50-75% of cells involved; 4: Very severe, diffuse steatosis (>75%).

[0082] Cytoplasmic aggregation: Deeply stained cytoplasm, increased eosinophilicity, and cell shrinkage in hepatocytes are manifestations of early apoptosis / necrosis. 0: None; 1: Occasionally seen scattered cells; 2: Frequent, appearing in small clusters; 3: Widespread, forming obvious lesions; 4: Appearing in large patches.

[0083] Necrosis: Cell nuclei condense, fragment, or dissolve; cell structure disappears; often accompanied by inflammatory cell infiltration. 0: No necrosis; 1: Punctate necrosis (single or a few hepatocytes); 2: Focal necrosis (small area of ​​cell cluster necrosis); 3: Bridging necrosis (necrotic area connecting central vein-portal area or central vein-central vein); 4: Large-area confluent necrosis.

[0084] Total score = sum of scores for the four pathological changes (with the necrosis score doubled).

[0085] The results of this experiment show that the serum ALT activity of the animal model was significantly reduced compared with that of the control group; liver tissue lesions were also significantly alleviated. According to the evaluation criteria, the composition can be determined to have an auxiliary protective function against chemically induced liver injury.

[0086] Test Example 2 This test case involves human trials of the liver-protecting and hangover-relieving compositions obtained in Examples 1-7 and Comparative Examples 1-4.

[0087] This test used commercially available 52° Luzhou Laojiao Erqu Baijiu and a MrBlack alcohol meter.

[0088] In accordance with the relevant requirements of the reference standard GB19522-2024 "Thresholds and Testing of Blood and Breath Alcohol Content for Vehicle Drivers", the blood ethanol concentration standard for this experiment is established, which requires that the ethanol content in every 100 mL of blood be greater than or equal to 20 mg.

[0089] Twelve healthy adults weighing 70±2 kg and aged 25-50 years were selected as volunteers. There was no significant difference in the alcohol limit among the 12 volunteers. A 12-day food trial was conducted.

[0090] Blank control group: First, a blank control experiment was conducted. Each of the 12 volunteers drank 100 mL of baijiu (Chinese liquor). After 10 minutes of equilibration, they consumed 3.42 g of purified water. Subsequently, the ethanol content in human breath was measured at 0, 1, 2, 3, 4, 5, and 6 hours.

[0091] Experimental group: On the second day, 12 volunteers from the same batch, at the same time and place, drank 100 mL of alcohol and equilibrated for 10 minutes. They then took the liver-protecting and hangover-relieving composition of Example 1 of this invention. Based on the recommended range and the usual intake for adults, the dosage was determined to be 3.42g per person. The human breath ethanol content was then measured at 0, 1, 2, 3, 4, 5, and 6 hours.

[0092] From day 3 to day 12, 12 volunteers in the same batch, at the same time and place, drank 100 mL of alcohol and then took the liver-protecting and hangover-relieving compositions of Examples 2-7 and Comparative Examples 1-4 of this invention in sequence after 10 minutes of balancing. The dosage was the same as on day 1. Subsequently, the human breath ethanol content was measured at 0, 1, 2, 3, 4, 5, and 6 hours.

[0093] The average values ​​of the test results for the experimental group and the blank control group are shown in Table 4 (unit: mg / 100 mL). The results showed that, as in Examples 1-3, the liver-protecting and hangover-relieving composition obtained using the technical solution of this invention has excellent hangover-relieving effects, with a significantly faster alcohol decomposition rate in the body compared to the blank control group. Changing the specific extraction methods of corn extract, kudzu root extract, or Japanese raisin tree extract in this invention leads to a decrease in the hangover-relieving effect and a slower alcohol decomposition rate. Removing any of the herbal extracts in the liver-protecting and hangover-relieving composition of this invention results in a significant reduction in the hangover-relieving effect, indicating that the corn extract, kudzu root extract, Japanese raisin tree extract, and licorice extract used in this invention have a synergistic effect; removing any one of them will worsen the effect of the liver-protecting and hangover-relieving composition.

[0094] The applicant declares that the technical solution of this invention is illustrated by the above embodiments, but this invention is not limited to the above embodiments, that is, it does not mean that this invention must rely on the above embodiments to be implemented. Those skilled in the art should understand that any improvements to this invention, equivalent substitutions of raw materials for the products of this invention, addition of auxiliary components, selection of specific methods, etc., all fall within the protection scope and disclosure scope of this invention.

[0095] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the scope of the technical concept of the present invention, various simple modifications can be made to the technical solution of the present invention, and these simple modifications all fall within the protection scope of the present invention.

[0096] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present invention will not describe the various possible combinations separately.

Claims

1. A liver-protecting and hangover-preventing composition, characterized in that, The raw materials for preparing the liver-protecting and alcoholism-relieving composition include the following components in parts by weight: corn extract 20-40 parts, radix puerariae extract 15-35 parts, jujube seed extract 5-25 parts, licorice extract 5-25 parts, antioxidant 5-10 parts, and filling auxiliary 5-10 parts.

2. The liver protecting and hangover alleviating composition according to claim 1, characterized in that, The raw materials for preparing the liver-protecting and alcoholism-relieving composition include the following components in parts by weight: corn extract 25-35 parts, radix puerariae extract 20-30 parts, jujube seed extract 10-20 parts, licorice extract 10-20 parts, antioxidant 6-8 parts, and filling auxiliary 6-8 parts.

3. The liver-protecting and hangover-preventing composition according to claim 1 or 2, characterized in that, The antioxidant includes any one or a combination of at least two of vitamin C, vitamin E, glutathione, curcuma, and anthocyanin. Preferably, the filling auxiliary includes any one or a combination of at least two of white granulated sugar, starch sugar, sugar alcohol, and starch.

4. The liver-protecting and hangover-alleviating composition according to any one of claims 1 to 3, characterized by, The corn extract is prepared by the following method: (1) soaking the corn kernels, heating and denaturing, and grinding to obtain corn slurry; (2) ultrasonic treatment, enzymatic hydrolysis, filtration, concentration, and drying to obtain the corn extract; Preferably, the soaking temperature in step (1) is 50-60°C, and the soaking time is 6-10 h. Preferably, the heating and denaturing in step (1) is performed at a temperature of 80-120°C for 10-30 min. Preferably, the ultrasonic treatment in step (2) is performed at a temperature of 70-80°C for 10-20 min at a power of 300-400 W. Preferably, the enzyme used in the enzymatic hydrolysis in step (2) includes any one or a combination of at least two of protease, cellulase, and pectinase. Preferably, the enzyme used in the enzymatic hydrolysis in step (2) includes a compound enzyme of protease, cellulase, and pectinase at a mass ratio of 1:(0.5-1):(0.5-1). Preferably, the mass of the compound enzyme is 1.5-2.5% of the mass of the corn kernels. Preferably, the enzymatic hydrolysis in step (2) is performed at a temperature of 50-80°C, a pH of 6.5-7.5, and for 6-10 h.

5. The liver-protecting and hangover-alleviating composition according to any one of claims 1 to 4, characterized by, The radix puerariae extract is prepared by the following method: alcohol extraction, centrifugation, collection of the supernatant, and drying to obtain the radix puerariae extract; Preferably, the alcohol extraction is performed using an ethanol solution with a volume fraction of 70-90%. Preferably, the alcohol extraction is performed by heating and reflux extraction for 6-10 h. Preferably, the mass ratio of the radix puerariae raw material to the ethanol solution is 1:(8-15). Preferably, the centrifugation is performed at a temperature of 20-40°C for 10-15 min at a speed of 3500-4500 rpm. Preferably, the drying is performed by spray drying at an inlet temperature of 150-200°C and an outlet temperature of 60-100°C.

6. The liver-protective and hangover-alleviating composition according to any one of claims 1 to 5, characterized by, The jujube seed extract is prepared by the following method: soaking, ultrasonic treatment, water extraction, filtration, concentration, and vacuum drying to obtain the jujube seed extract; Preferably, the soaking is performed at a temperature of 10-35°C for 1-6 h. Preferably, the ultrasonic treatment has a power of 200-500 W and a time of 5-20 min. Preferably, the water extraction has a temperature of 90-100℃, a time of 1-2 h, and a solid-liquid ratio of 1:(4-12) g / mL. Preferably, the water extraction is repeated for at least 3 times. Preferably, the drying is performed by vacuum drying at a temperature of 80-95℃.

7. The liver-protective and hangover-alleviating composition according to any one of claims 1 to 6, characterized by, The licorice extract is prepared by the following method: The licorice raw material is soaked, ultrasonically treated, and then water extracted to obtain the licorice extract by filtration, concentration, and vacuum drying. Preferably, the soaking has a temperature of 10-35℃ and a time of 4-8 h. Preferably, the ultrasonic treatment has a power of 250-450 W and a time of 10-20 min. Preferably, the water extraction has a temperature of 90-100℃, a time of 0.5-2 h, and a solid-liquid ratio of 1:(6-10) g / mL. Preferably, the water extraction is repeated for at least 3 times. Preferably, the drying is performed by vacuum drying at a temperature of 85-95℃.

8. A process for the preparation of a liver-protective and hangover- alleviating composition as claimed in any one of claims 1 to 7, wherein, The preparation method comprises the following steps: The corn extract, the pueraria extract, the jujube seed extract, the licorice extract, the antioxidant, and the filling excipient are respectively sieved and then mixed to obtain the liver-protecting and alcohol-dissolving composition.

9. The liver protecting and hangover alleviating composition according to claim 8, characterized in that, The sieving uses a standard mesh number of 40-100 mesh. Preferably, the mixing has a time of 15-40 min.

10. Use of the liver-protecting and alcohol-dissolving composition according to any one of claims 1-7 in the preparation of a liver-protecting and alcohol-dissolving product.

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