A functional composition for protecting liver and relieving alcoholism, and a preparation method and application thereof

Abstract

The application discloses a functional composition for protecting liver and relieving alcoholism, a preparation method and application thereof, and belongs to the technical field of functional food. The composition comprises taurine, cysteine, choline, yeast extract, compound vitamin B, vitamin C, pueraria extract, extract of Chinese olive fruit and natural menthol. The composition realizes in-vivo targeted elimination of acetaldehyde through multi-target synergistic effect of direct combination of cysteine and acetaldehyde, choline regulation of metabolic homeostasis, and compound vitamin B provision of coenzyme support. Experiments prove that for ALDH2 gene defect population, the composition can reduce blood acetaldehyde concentration by more than 60%, increase urine acetaldehyde binder discharge by 5 times, reduce breath alcohol content to zero within 1.5 hours, and significantly protect liver function. The composition can be used for preparing food or health-care food for relieving alcoholism and protecting liver.

Description

Technical Field

[0001] This invention belongs to the field of functional food technology, specifically relating to a functional composition for protecting the liver and relieving hangovers, its preparation method, and its application. This functional composition can be used as a food or health food for consumption before and after drinking alcohol, to accelerate alcohol metabolism, eliminate acetaldehyde, and protect liver function. Background Technology

[0002] Alcohol (ethanol) is a widely used psychoactive substance globally, but excessive drinking can lead to a range of health problems. The 2024 World Health Organization report, "Global Alcohol and Health Status and Treatment of Drug Use Disorders," states that alcohol is the third leading risk factor for preventable death worldwide. Therefore, developing functional foods that can accelerate alcohol metabolism, alleviate hangover symptoms, and protect the liver is of significant practical importance.

[0003] After alcohol enters the body, approximately 90% is metabolized in the liver, primarily relying on two key enzyme systems: alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH). ADH oxidizes ethanol to acetaldehyde, which is 30 times more toxic than ethanol and is a significant carcinogen. ALDH further oxidizes acetaldehyde to non-toxic acetic acid. However, over 30% of East Asian populations have a gene defect in aldehyde dehydrogenase 2 (ALDH2), which prevents the effective clearance of acetaldehyde. This leads to acetaldehyde accumulation after drinking, causing discomfort such as facial flushing, palpitations, and nausea. Long-term accumulation can also increase the risk of esophageal and liver cancer.

[0004] Currently, there are various functional foods on the market that claim to relieve hangovers, most of which are based on traditional Chinese medicine ingredients. However, these products have shortcomings such as unclear mechanisms of action, large individual differences, large dosage requirements, and slow onset of action. In recent years, some studies have attempted to develop hangover relief products based on the principle that the sulfhydryl group of cysteine ​​directly binds to acetaldehyde. For example, patent CN201010100239.8 discloses a composition containing corn oligopeptide powder, taurine, alanine, cysteine, and other components for relieving hangovers and protecting the liver. However, the inventors of this invention found through experiments that the actual acetaldehyde clearance effect of this type of composition with cysteine ​​as the main active ingredient in vivo is not ideal. In the experiment, after ALDH2-deficient individuals took the composition of Example 5 of this patent, the blood acetaldehyde concentration was not significantly different from that of the non-intervention group (see the comparative test data of Example 2 of this invention). The reason for this may be that amino acids such as cysteine ​​are rapidly metabolized and absorbed in the gastrointestinal tract, failing to effectively reach the target site and bind to acetaldehyde.

[0005] Therefore, there is an urgent need for a functional food product that can truly achieve targeted clearance of acetaldehyde in the body, accelerate alcohol metabolism, protect the liver, and is suitable for people with ALDH2 deficiency. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to overcome the shortcomings of existing functional foods for relieving hangovers, such as low acetaldehyde clearance efficiency of cysteine-based compositions and poor effect on people with ALDH2 gene deficiency. The present invention provides a functional composition for relieving hangovers and protecting the liver that can effectively remove ethanol and acetaldehyde, accelerate alcohol metabolism, and protect liver function, especially suitable for people with ALDH2 deficiency, as well as its preparation method and application.

[0007] Through long-term exploration and experimentation, as well as numerous trials and efforts, the inventors have continuously reformed and innovated to solve the above-mentioned technical problems. The technical solution provided by this invention is to provide a liver-protecting and hangover-relieving composition, which contains taurine and cysteine, as well as choline, yeast extract, compound vitamin B, vitamin C, kudzu root extract, Japanese raisin tree fruit extract, and natural menthol.

[0008] The above components work synergistically in this invention, acting on various stages of alcohol metabolism to form a complete liver-protecting and hangover-relieving system: Taurine: It can significantly enhance the activities of alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH). In an acute alcohol intake model, pre-administration of taurine can increase ADH activity by approximately 20-30% and ALDH activity by approximately 15-25%. Simultaneously, taurine can also inhibit the activity of cytochrome P450 2E1 (CYP2E1), reducing the production of reactive oxygen species (ROS) during alcohol metabolism.

[0009] Cysteine: The sulfhydryl group (-SH) in its molecule can react directly with acetaldehyde to produce stable 2-methylthiazolidin-4-carboxylic acid (MTCA) and hydroxyethyl mercaptouric acid (SMA), thereby rapidly eliminating acetaldehyde produced in the body after drinking alcohol under physiological conditions. This reaction is a 1:1 molar ratio, and the products have extremely low toxicity. In addition, cysteine ​​can also provide raw materials for the synthesis of glutathione (GSH), enhancing the liver's antioxidant defense capacity.

[0010] Choline, as an essential nutrient for maintaining normal lipid homeostasis in cells, plays multiple key roles in alcohol metabolism: ① maintaining and repairing the integrity of hepatocyte membranes and reducing leakage of cellular contents; ② protecting mitochondrial function and enhancing ATP synthesis; ③ enhancing the activity of antioxidant enzyme systems (SOD, GSH-Px, CAT); ④ inhibiting NF-κB activation and regulating inflammatory responses; ⑤ inhibiting hepatocyte apoptosis; and ⑥ improving lipid metabolism and reducing fatty liver formation. Choline is not a direct catalytic substrate of the ethanol / acetaldehyde core oxidative metabolic pathway, but rather indirectly but crucially regulates the metabolic efficiency of ethanol and acetaldehyde through four core dimensions: regulating the activity of key metabolic enzymes, maintaining hepatic metabolic homeostasis, optimizing the supply of core coenzymes, and mitigating the toxic damage of metabolites.

[0011] Yeast extract: provides glutathione (GSH), the most important antioxidant in the liver. Cysteine, in combination with glutathione, can significantly increase liver GSH levels. Studies have shown that in alcoholic liver disease models, cysteine ​​treatment can increase liver GSH content by 40-50%.

[0012] A complex B vitamin regimen includes vitamins B1, B2, B6, B12, pantothenic acid, niacin, and folic acid. Among these, vitamin B1 (thiamine), in its active form thiamine pyrophosphate (TPP), is a coenzyme for key enzymes such as pyruvate dehydrogenase and α-ketoglutarate dehydrogenase; vitamin B6 (pyridoxine), in its active form pyridoxal phosphate (PLP), can target acetaldehyde and accelerate its clearance; and vitamins B12 and folic acid participate in the homocysteine ​​metabolic pathway, playing a vital role in liver health.

[0013] Vitamin C: Directly eliminates free radicals produced by alcohol metabolism, increases the level and activity of glutathione (GSH), an endogenous antioxidant in the liver, and promotes the excretion of alcohol.

[0014] Kudzu root extract and Hovenia dulcis extract: traditional hangover remedies. Kudzu root primarily relieves symptoms such as thirst and dizziness after drinking by promoting saliva production, quenching thirst, and reducing fever; while Hovenia dulcis primarily eliminates alcohol toxins from the body by detoxifying and promoting urination. The combination of the two has the characteristics of both treating the symptoms and the root cause.

[0015] Natural menthol: provides a refreshing taste, promotes the transmembrane absorption of each component in the gastrointestinal tract, improves the bioavailability of active ingredients, and protects the gastric mucosa from alcohol irritation.

[0016] Based on the above technical solution, the present invention can be further improved as follows: In some embodiments of the present invention, the composition comprises the following components in weight percentages: 10-25% taurine, 10-25% cysteine, 10-25% choline, 5-10% yeast extract, 2-8% complex vitamin B, 1-5% vitamin C, 1-5% kudzu root extract, 1-5% Hovenia dulcis fruit extract, 0.02-0.2% natural menthol, and the balance being food-acceptable excipients, wherein the sum of the contents of all components is 100%. Among them, the content range of each component satisfies the following: the sum of the upper limit of any component and the lower limit of other components is ≤100, and the sum of the lower limit of any component and the upper limit of other components is ≥100.

[0017] In some embodiments of the present invention, the cysteine ​​may be selected from D-cysteine, L-cysteine, acetylcysteine, or a combination thereof.

[0018] In some embodiments of the present invention, the choline may be selected from choline chloride, choline tartrate, betaine, glycerophosphate choline, phosphatidylcholine, or a combination thereof.

[0019] In some embodiments of the present invention, the yeast extract contains 20-99% glutathione.

[0020] In some embodiments of the present invention, the complex vitamin B preferably includes vitamin B1, vitamin B2, vitamin B6, vitamin B12, pantothenic acid, niacin, and folic acid.

[0021] Preferably, the mass ratio of each vitamin in the compound vitamin B is: Vitamin B1: Vitamin B2: Vitamin B6: Vitamin B12: Pantothenic acid: Niacin: Folic acid = 400-500: 400-500: 300-500: 1-5: 1500-2000: 4500-5500: 100-200.

[0022] In some embodiments of the present invention, the composition may be prepared as an oral solid dosage form (such as tablets, capsules, granules, powders) or an oral liquid dosage form.

[0023] This invention also provides a method for preparing the above-mentioned hepatoprotective and hangover-relieving functional composition, comprising mixing the components with food-acceptable excipients to form an oral formulation. The food-acceptable excipients include binders (such as hydroxypropyl methylcellulose, polyvinylpyrrolidone, copovidone, etc.), excipients (such as microcrystalline cellulose, dextrin, starch, xylitol, mogrosides, etc.), lubricants (such as magnesium stearate), sweeteners, etc.

[0024] The present invention also provides the application of the aforementioned liver-protecting and hangover-relieving functional composition in the preparation of food or health food for liver protection and hangover relief.

[0025] Compared with the prior art, the present invention has the following unexpected beneficial effects: 1. Significantly improves acetaldehyde removal efficiency Experiments conducted on individuals with ALDH2 gene defects (50mL of 52% ABV liquor, consumed within 10 minutes) showed that: After taking the composition of Example 2 of the present invention, the blood acetaldehyde concentration decreased from 21.7 μmol / L to 8.7 μmol / L within 1 hour, a decrease of 60%; while the comparative test case (Example 5 of patent CN201010100239.8) only decreased from 21.7 μmol / L to 19.5 μmol / L, a decrease of less than 10%.

[0026] The concentration of SMA (hydroxyethyl mercaptouric acid), the final product of acetaldehyde-cysteine ​​conjugate, in urine reached 11.8 mg / g creatinine after 3 hours, which is more than 5 times that of the control group (2.3 mg / g creatinine), proving that acetaldehyde was bound in large quantities and excreted from the body.

[0027] 2. Accelerates alcohol metabolism and shortens the time it takes to regain sobriety after drinking. In individuals with ALDH2 deficiency, breath alcohol content decreased to 0 mg / 100 mL after administration of the composition of Example 2 of this invention within 1.5 hours; while in the control group, it remained at 13.1 mg / 100 mL within 1.5 hours and 6.6 mg / 100 mL within 2 hours.

[0028] In normal individuals, after taking the composition of Example 2 of this invention, the breath alcohol content decreased to 8.2 mg / 100 mL in 1 hour, to 2.6 mg / 100 mL in 1.25 hours, and to 0 in 1.5 hours; while in the control group, it remained at 13.6 mg / 100 mL in 1.5 hours.

[0029] 3. Protects liver function In individuals with ALDH2 deficiency, 2 hours after taking the composition of Example 2 of this invention, ALT (alanine aminotransferase) was 23 U / L (comparative test case: 26 U / L), AST (aspartate aminotransferase) was 35 U / L (comparative test case: 35 U / L, but with a smaller increase), MDA (malondialdehyde, a lipid peroxidation indicator) was 3.5 nmol / mL (comparative test case: 5.6 nmol / mL), GSH (glutathione) rose to 265 mg / L (comparative test case: 185 mg / L), and triglycerides (TG) were 1.45 mmol / L (comparative test case: 1.61 mmol / L).

[0030] 4. Particularly suitable for individuals with ALDH2 gene defects. More than 30% of the East Asian population worldwide has an ALDH2 gene deficiency, making them unable to effectively metabolize acetaldehyde. The composition of this invention directly chemically binds acetaldehyde via cysteine, while choline and B-complex vitamins maintain metabolic homeostasis and provide coenzyme support, achieving a significant hangover-relieving and liver-protecting effect in individuals with ALDH2 deficiency, filling a gap in existing functional foods for this population.

[0031] 5. Good security During the experiment, no obvious adverse reactions were observed in the subjects, indicating that the composition of the present invention has good food safety.

[0032] In summary, the composition of this invention achieves a more significant liver-protecting and hangover-relieving effect than existing cysteine-based hangover-relieving products through the multi-target synergistic effects of taurine (enhancing enzyme activity), cysteine ​​(chemically scavenging acetaldehyde), choline (cell protection and metabolic regulation), complex vitamin B (coenzyme supply), vitamin C (antioxidant), kudzu root / honeysuckle fruit (traditional hangover remedy), and natural menthol (promoting absorption), and has a clear prospect for industrial application. Detailed Implementation

[0033] The following description is based on specific embodiments.

[0034] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Therefore, the following detailed description of the embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely to represent selected embodiments of the present invention.

[0035] In this invention, unless otherwise specified, all equipment and raw materials are available from the market or commonly used in the industry. Unless otherwise specified, the methods in the following embodiments are conventional methods in the art.

[0036] Example 1

[0037] This embodiment provides a functional composition for protecting the liver and relieving hangovers, the components and dosages of which are shown in Table 1 below.

[0038] Table 1 Tablet components and dosage

[0039] The mass ratio of each vitamin in the compound vitamin B is: VB1:VB2:VB6:VB12:pantothenic acid:niacin:folic acid = 450:450:400:2:1750:5000:150.

[0040] Tablet preparation method: Take 1.35g of hydroxypropyl methylcellulose (binder), slowly add 12.15g of boiling water, and stir to fully dissolve and disperse to obtain a binder solution for granulation; Take 36g taurine, 36g cysteine, 36g betaine, 36g microcrystalline cellulose (excipient), 23.1g xylitol (sweetener), 4.5g vitamin C, 3g kudzu root extract, 3g Japanese raisin tree fruit extract, and 2.4g mogroside (sweetener), pass them through a 30-mesh sieve, and mix them evenly. Transfer the above materials into the granulator, slowly add the binder solution after starting the machine, stir and mix, and extrude the granules through a 16-mesh sieve. The wet granules are transferred into a fluidized bed, heated and dried at 60°C until the moisture content is below 1.0%. They are then removed and cooled to room temperature. Take another 15g yeast extract, 9g compound vitamin B, 3g sodium carboxymethyl cellulose (disintegrant), 1.47g magnesium stearate (lubricant), and 0.18g natural menthol, pass them through an 80-mesh sieve, mix them evenly, and transfer them together with the dried granules into a V-type mixer and start the machine to mix. The mixed materials are loaded into the hopper of a rotary tablet press. The relative humidity of the environment is controlled to be below 40%. The press is started and the tablet weight is controlled between 0.7±0.01g to obtain tablets.

[0041] Example 2

[0042] This embodiment provides a functional composition for liver protection and hangover relief, in the form of compressed candy. This formulation is the sample used in subsequent functional verification tests. The components and dosages are shown in Table 2 below.

[0043] Table 2. Components and Dosage of Compressed Candy

[0044] The complex vitamin B includes vitamin B1, vitamin B2, vitamin B6, vitamin B12, pantothenic acid, niacin, and folic acid. The mass ratio of each vitamin is the same as in Example 1, namely, vitamin B1: vitamin B2: vitamin B6: vitamin B12: pantothenic acid: niacin: folic acid = 450:450:400:2:1750:5000:150.

[0045] Among them, microcrystalline cellulose (MCC) is a filler / excipient, hydroxypropyl methylcellulose (HPMC) is a dry binder / filler, mogroside is a sweetener, magnesium stearate is a lubricant, and natural menthol is a flavoring agent / penetration enhancer.

[0046] Preparation method: Weigh out yeast extract, compound vitamin B, vitamin C, kudzu root extract, Japanese raisin tree fruit extract, mogroside, magnesium stearate, and natural menthol according to Table 2. Pass all materials through a 60-mesh sieve and premix for 5 minutes to obtain premixed powder.

[0047] Weigh out taurine, L-cysteine, choline tartrate, microcrystalline cellulose, and hydroxypropyl methylcellulose, pass them through a 40-mesh sieve, and add them to the premixed powder.

[0048] Add all the above materials to the mixing tank and mix at 20 rpm for 10 minutes to ensure uniformity.

[0049] The mixed materials are loaded into the hopper of a rotary tablet press. The relative humidity of the environment is controlled to be below 40%. The press is started and the tablet weight is controlled between 0.7±0.035g to obtain compressed candy, about 300 tablets in total.

[0050] The mass percentages of each component in the composition of this embodiment (based on total dry matter mass, approximately 218.5 g) are as follows: taurine approximately 16.5%, L-cysteine ​​approximately 16.5%, tartrate choline approximately 16.5%, microcrystalline cellulose approximately 16.5%, hydroxypropyl methylcellulose approximately 12.5%, yeast extract approximately 6.9%, complex vitamin B approximately 4.1%, vitamin C approximately 2.1%, kudzu root extract approximately 1.4%, Japanese raisin tree fruit extract approximately 1.4%, mogroside approximately 1.1%, magnesium stearate approximately 0.7%, and natural menthol approximately 0.08%.

[0051] Example 3

[0052] This embodiment provides a functional composition for protecting the liver and relieving hangovers, the components and dosages of which are shown in Table 3 below.

[0053] Table 3. Components and Dosage of Solid Beverages

[0054] The complex vitamin B includes vitamin B1, vitamin B2, vitamin B6, vitamin B12, pantothenic acid, niacin, and folic acid. The mass ratio of each vitamin is the same as in Example 1, namely, vitamin B1: vitamin B2: vitamin B6: vitamin B12: pantothenic acid: niacin: folic acid = 450:450:400:2:1750:5000:150.

[0055] Preparation method: Take 36g taurine, 36g cysteine, 36g choline chloride, 36g microcrystalline cellulose, 23.1g xylitol, 4.5g vitamin C, 3g kudzu root extract, 3g Japanese raisin tree fruit extract, and 2.4g mogroside, pass them through a 60-mesh sieve, and mix them evenly. Take another 15g of yeast extract, 9g of B complex vitamins, 1.5g of magnesium stearate, and 0.18g of natural menthol, pass them through a 60-mesh sieve, and mix them evenly. The mixed materials are loaded into the hopper of the solid beverage filling machine. The relative humidity of the environment is controlled to be below 40%. The machine is turned on and the bags are filled. The weight of each bag is controlled between 3.0±0.01g to obtain the solid beverage.

[0056] Example 4

[0057] This embodiment provides a functional composition for protecting the liver and relieving hangovers, the components and dosages of which are shown in Table 4 below.

[0058] Table 4. Capsule Components and Dosage

[0059] The complex vitamin B includes vitamin B1, vitamin B2, vitamin B6, vitamin B12, pantothenic acid, niacin, and folic acid. The mass ratio of each vitamin is the same as in Example 1, namely, vitamin B1: vitamin B2: vitamin B6: vitamin B12: pantothenic acid: niacin: folic acid = 450:450:400:2:1750:5000:150.

[0060] Preparation method: Take 36g taurine, 36g cysteine, 36g phosphatidylcholine, 36g microcrystalline cellulose, 15g yeast extract, 9g compound vitamin B, 4.5g vitamin C, 3g kudzu root extract, 3g Japanese raisin tree fruit extract, 3g sodium carboxymethyl cellulose, 1.47g magnesium stearate, and 0.18g natural menthol, and pass them through a 60-mesh sieve separately, then mix them evenly. Add the above materials to the V-type mixer and start the mixer; load the mixed materials into the hopper of the capsule filling machine, control the relative humidity of the environment to be below 40%, start the machine to fill #0 capsules, and control the weight of the contents of each capsule to be between 0.5±0.01g to obtain capsules.

[0061] Comparative test cases Refer to the fifth embodiment of the prior art CN201010100239.8.

[0062] Table 5 Comparison of Compressed Candy Components and Dosage

[0063] Preparation method: First, crush and sieve the corn oligopeptide powder, taurine, alanine, cysteine, brown rice germ, povidone, hydroxypropyl methylcellulose, and microcrystalline cellulose; then weigh out the crushed and sieved materials according to the formula. Add the weighed materials into the mixer and mix them evenly; Add an appropriate amount of alcohol and granulate using a granulator; The prepared granules are dried using a drying device, and then granulated using a granulator. Magnesium stearate and silicon dioxide were added and mixed. The mixed material was then compressed into tablets using a tableting machine to obtain the compressed candy for the comparative test.

[0064] Functional verification test 1. Experimental subjects and grouping Twenty-four healthy subjects were selected, 12 males and 12 females, all with a history of alcohol consumption. They were divided into two groups based on their aldehyde dehydrogenase 2 (ALDH2) genotype: Group 1 (Normal population): 12 cases, 6 males and 6 females with normal ALDH2 genotype.

[0065] Group 2 (ALDH2 defect group): 12 cases, ALDH2 genotype defect ("red face" genotype), 6 males and 6 females.

[0066] There were no statistically significant differences between the two groups of subjects in terms of age, gender, health status, and other basic information (P > 0.05), making them comparable.

[0067] 2. Experimental Materials Ethanol standard solution, acetaldehyde standard solution, tert-butanol standard solution (internal standard). Alcohol content breathalyzer Iodine disinfectant solution, Automated headspace gas chromatography-mass spectrometry (ACGS) system 52% ABV light-aroma baijiu The compressed candy prepared in Example 2, Compressed candy prepared in the comparative test example.

[0068] 3. Test Methods This experiment lasted for 3 days. Each day, alcohol consumption began at 3 PM, with each participant drinking 50 mL of 52% ABV light-aroma baijiu (Chinese liquor) within 10 minutes. The experimental arrangements for each group of subjects were as follows: Day 1 (control group): only alcohol consumption, no intervention.

[0069] Day 2 (Comparative Test Group): Before drinking alcohol, take the same compressed candy as the comparative test group (prepared according to the formula disclosed in Example 5 of Patent CN201010100239.8).

[0070] Day 3 (Example 2 group): Take the compressed candy prepared in Example 2 of this invention before drinking alcohol.

[0071] Sample collection: Breathalyzer tests and venous blood samples were taken before drinking (0 hours) and at 0.25 hours, 0.5 hours, 0.75 hours, 1 hour, 1.25 hours, 1.5 hours, and 2 hours after drinking. Each blood sample was taken by a professional nurse from a tertiary hospital in accordance with standard medical examination procedures.

[0072] Urine was collected before drinking (0 hours) and at 1 hour, 2 hours and 3 hours after drinking.

[0073] Testing indicators: Breath alcohol content (mg / 100mL). Blood ethanol concentration (mg / 100mL). Blood acetaldehyde concentration (μmol / L) Concentration (mg / L) of MTCA (2-methylthiazolidin-4-carboxylic acid), the acetaldehyde-cysteine ​​conjugate product, in blood. Concentration of SMA (hydroxyethyl mercaptouric acid), the final product of acetaldehyde-cysteine ​​conjugate, in urine (mg / g creatinine). Blood liver function indicators: ALT (alanine aminotransferase, U / L), AST (aspartate aminotransferase, U / L), MDA (malondialdehyde, nmol / mL), GSH (glutathione, mg / L), TG (triglycerides, mmol / L).

[0074] The concentrations of ethanol and acetaldehyde in blood samples were determined by automated headspace gas chromatography-mass spectrometry. After solid phase extraction-acetylation-high performance liquid chromatography-mass spectrometry analysis, the concentration of MTCA, the acetaldehyde-cysteine ​​conjugate product, was determined.

[0075] All operations strictly followed the double-blind randomization principle. Data were processed using SPSS 26.0 software, and repeated measures ANOVA was used to compare differences between groups.

[0076] 4. Test Results 4.1 Results of breath alcohol content measurement Table 6. Results of breath alcohol content (mg / 100 mL) determination

[0077] Note: Normal population 11 = Normal population without intervention; Normal population 12 = Normal population + control group; Normal population 13 = Normal population + Example 2; ALDH2 deficiency 21 = ALDH2 deficiency population without intervention; ALDH2 deficiency 22 = ALDH2 deficiency population + control group; ALDH2 deficiency 23 = ALDH2 deficiency population + Example 2. The same applies below.

[0078] Results analysis: In individuals with ALDH2 deficiency, the breath alcohol content dropped to 0 within 1.5 hours after taking Example 2, while the control group still had a content of 6.6 mg / 100 mL after 2 hours. In healthy individuals, the content in Example 2 dropped to 0 within 1.5 hours, while the control group still had a content of 13.6 mg / 100 mL after 1.5 hours.

[0079] 4.2 Results of blood ethanol concentration measurement Table 7 Results of blood ethanol concentration (mg / 100 mL) measurement

[0080] Results analysis: The ethanol concentrations showed little difference among the groups, indicating that the composition of the present invention mainly affects the acetaldehyde metabolism process rather than ethanol absorption.

[0081] 4.3 Results of blood acetaldehyde concentration measurement Table 8 Results of blood acetaldehyde concentration measurement

[0082] Results Analysis: In the ALDH2-deficient population, after taking the control test, the acetaldehyde concentration decreased from a peak of 21.7 μmol / L to 19.5 μmol / L (1 hour), a decrease of approximately 10%; while after taking Example 2, the acetaldehyde concentration decreased from 21.7 μmol / L to 8.7 μmol / L (1 hour), a decrease of 60%. Two hours after taking Example 2, the acetaldehyde concentration had dropped to 1.3 μmol / L, approaching the level of the normal population.

[0083] 4.4 Results of Blood MTCA Concentration Measurement Table 9 Results of blood MTCA concentration measurement

[0084] Results analysis: MTCA is a direct product of the binding of cysteine ​​and acetaldehyde. In ALDH2-deficient individuals, after taking Example 2, the MTCA concentration reached 7.4 mg / L after 1 hour, significantly higher than the 4.5 mg / L in the control group, indicating that Example 2 promoted greater binding of acetaldehyde and cysteine.

[0085] 4.5 Results of urine SMA concentration measurement Table 10 Results of SMA Concentration Measurement in Urine

[0086] Results Analysis: SMA is the metabolic end product of acetaldehyde-cysteine ​​conjugate and can be excreted in urine. In ALDH2-deficient individuals, after taking Example 2, the urinary SMA concentration reached 11.8 mg / g creatinine after 3 hours, more than 5 times that of the control group (2.3 mg / g creatinine), demonstrating that the composition of this invention significantly promotes the chemical binding and excretion of acetaldehyde.

[0087] 4.6 Results of Liver Function Indicators Table 11 ALT (U / L):

[0088] Table 12 AST (U / L):

[0089] Table 13 MDA (nmol / mL):

[0090] Table 14 GSH (mg / L):

[0091] Table 15 TG (mmol / L):

[0092] Results analysis: In the ALDH2-deficient population, compared with the control group, the levels of ALT, AST, MDA, and TG in the Example 2 group were significantly reduced, while GSH was significantly increased, indicating that the composition of the present invention has a better hepatoprotective effect.

[0093] 5. Safety Evaluation No significant adverse reactions were observed in any of the subjects during the entire experiment, indicating that the compressed candy prepared in Example 2 of this invention has good food safety.

[0094] The liver-protecting and hangover-relieving functional composition provided by this invention uses commercially available raw materials, has a simple preparation process, and is suitable for industrial production. This composition can be used as a functional food or health food for consumption before and after drinking alcohol, and has broad market application prospects.

[0095] In the description of this invention, it should be understood that "-" and "~" represent a range between two values, and this range includes the endpoints. For example, "AB" represents a range greater than or equal to A and less than or equal to B. "A~B" represents a range greater than or equal to A and less than or equal to B.

[0096] In the description of this invention, the term "and / or" is merely a description of the relationship between related objects, indicating that there can be three relationships. For example, A and / or B can represent three cases: A exists alone, A and B exist simultaneously, and B exists alone.

[0097] In the description of the invention, the numerical values ​​of time, temperature, ratio, and mass involved can be based on actual measurements, standard equipment parameters, simplified rounding results, or within an acceptable error range, ensuring the practicality and repeatability of the invention.

[0098] In the description of this invention, the terms “about” or “approximately” are used to express approximate values ​​or ranges, allowing for a certain degree of error to ensure the flexibility and practicality of the description, while remaining within an acceptable range of error, with the maximum error not exceeding 10% of the corresponding value or range.

[0099] The above are merely preferred embodiments of the present invention. It should be noted that the above preferred embodiments should not be considered as limitations on the present invention, and the scope of protection of the present invention should be determined by the scope defined in the claims. For those skilled in the art, several improvements and modifications can be made without departing from the spirit and scope of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A liver-protecting and hangover-relieving composition comprising taurine and cysteine, characterized in that, It also contains choline, yeast extract, B complex vitamins, vitamin C, kudzu root extract, Japanese raisin tree fruit extract, and natural menthol.

2. The composition according to claim 1, characterized in that, Based on the total dry matter mass, the composition comprises the following components in the following mass percentages: taurine 10-25%, cysteine ​​10-25%, choline 10-25%, yeast extract 5-10%, complex vitamin B 2-8%, vitamin C 1-5%, kudzu root extract 1-5%, Japanese raisin tree fruit extract 1-5%, natural menthol 0.02-0.2%, and the balance being food-grade excipients, the sum of the contents of all components being 100%. Among them, the content range of each component satisfies the following: the sum of the upper limit of any component and the lower limit of other components is ≤100, and the sum of the lower limit of any component and the upper limit of other components is ≥100.

3. The composition according to claim 1 or 2, characterized in that, The cysteine ​​is selected from D-cysteine, L-cysteine, acetylcysteine, or combinations thereof; the choline is selected from choline chloride, tartrate choline, betaine, glycerophosphate choline, phosphatidylcholine, or combinations thereof.

4. The composition according to claim 1 or 2, characterized in that, The yeast extract contains glutathione, and the content of glutathione is 20-99%.

5. The composition according to claim 1 or 2, characterized in that, The B complex vitamins include vitamin B1, vitamin B2, vitamin B6, vitamin B12, pantothenic acid, niacin, and folic acid.

6. The composition according to claim 1, characterized in that, The composition is an oral solid dosage form or an oral liquid dosage form.

7. The composition according to claim 6, characterized in that, The oral solid dosage form is a tablet, capsule, granule, or powder.

8. A method for preparing the liver-protecting and hangover-relieving composition of claim 1, characterized in that, This includes mixing the components with food-acceptable excipients to prepare an oral formulation.

9. The method according to claim 8, characterized in that, The excipients include one or more of the following: adhesives, excipients, lubricants, and sweeteners.

10. The use of the liver-protecting and hangover-relieving functional composition according to claim 1 in the preparation of food or health food for liver protection and hangover relief.

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