A traditional Chinese medicine composition with hangover-relieving effects

Abstract

This invention discloses a traditional Chinese medicine composition for relieving hangovers, prepared from the following raw materials in the indicated weight ratios: 2-5 parts germinated barley, 2-5 parts malt, 2-5 parts Japanese raisin tree fruit, 1-3 parts wild kudzu root, 1-3 parts clove, and 1-3 parts dried plum. This composition primarily targets the symptoms of abdominal distension, nausea, and fluid depletion after drinking alcohol. It utilizes common medicinal and edible herbs to regulate qi, strengthen the spleen, relieve nausea and vomiting, promote fluid production, and astringe sweat. It can significantly shorten the sobering-up time, alleviate the discomfort caused by drunkenness, and reduce the damage of alcohol to the body, thus possessing practical application value.

Description

Technical Field

[0001] This invention specifically relates to a traditional Chinese medicine composition with hangover-relieving effects. Background Technology

[0002] Alcohol has a wide range of pharmacological effects on the human body. Acute heavy drinking can cause nausea, vomiting, memory loss, poor concentration, impaired fine motor skills, and emotional instability. In severe cases, it can even lead to death due to respiratory muscle paralysis. Long-term drinking can cause mental disorders, gastric ulcers, fatty liver, alcoholic hepatitis, cirrhosis, and other diseases. Data suggests that the increased incidence of esophageal and liver cancer may also be related to alcohol consumption. Therefore, the development of effective hangover remedies has attracted widespread attention.

[0003] Currently, most hangover remedies developed and used clinically are synthetic drugs. While some traditional Chinese medicine formulas exist, their limited effectiveness and high cost have hindered widespread clinical adoption. Patent CN201310240530.9 discloses a hangover remedy composed of traditional Chinese medicine ingredients, but this formula suffers from the problems of numerous ingredients, high cost, and unsatisfactory hangover relief. Therefore, it is necessary to develop a traditional Chinese medicine formula with good clinical hangover relief and a simple ingredient composition. Summary of the Invention

[0004] To address the above problems, this invention provides a traditional Chinese medicine composition for relieving hangovers, which is prepared from raw materials in the following weight ratios:

[0005] 2-5 parts germinated rice, 2-5 parts malt, 2-5 parts Japanese raisin tree fruit, 1-3 parts kudzu root, 1-3 parts clove, and 1-3 parts dried plum.

[0006] Furthermore, it is prepared from active pharmaceutical ingredients in the following weight ratios:

[0007] 3 parts germinated rice, 3 parts malt, 3 parts Japanese raisin tree fruit, 2 parts kudzu root, 2 parts cloves, and 2 parts dried plum.

[0008] Furthermore, the kudzu root is wild kudzu root; the wild kudzu root is the dried root of the legume Pueraria lobata (Willd.) Ohwi.

[0009] Furthermore, it is a preparation made from fine powder of active pharmaceutical ingredient, or aqueous or alcoholic extract of active pharmaceutical ingredient, plus pharmaceutically acceptable excipients.

[0010] Furthermore, the preparation is an oral preparation.

[0011] Furthermore, the oral preparation is a solution, granules, ointment, pills, tablets, or capsules.

[0012] The present invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, which includes the following steps:

[0013] (1) Weigh the raw materials according to the proportions;

[0014] (2) The active pharmaceutical ingredient is ground into powder, or the water or organic solvent extract of the active pharmaceutical ingredient is added with commonly used pharmaceutical excipients to obtain the product.

[0015] Finally, this invention provides the use of the aforementioned traditional Chinese medicine composition in the preparation of medicaments for the prevention and / or treatment of alcohol poisoning.

[0016] Furthermore, the drug is a drug for the prevention and / or treatment of acute alcohol poisoning.

[0017] Furthermore, the drug has the effect of relieving hangovers.

[0018] The herbal composition for relieving hangovers in this invention includes germinated barley, first recorded in the *Shennong Bencao Jing* (Shennong's Classic of Materia Medica), which is sweet and neutral in nature. It enters the spleen and stomach meridians. It has the effects of strengthening the spleen and resolving dampness, harmonizing the stomach and stopping vomiting, and promoting digestion. It is used for food stagnation, abdominal distension, vomiting and diarrhea, and food retention. Simultaneously, germinated barley has a good effect on reducing the absorption and metabolism of alcohol, improving the liver's ability to detoxify alcohol, and reducing alcohol damage to the liver. The composition also includes malt, which is sweet and slightly warm in nature. It enters the spleen and stomach meridians. It has the effects of promoting digestion, resolving food stagnation, and promoting diuresis and reducing swelling. Germinated barley and malt in the composition help relieve hangovers through their digestive and food-resolving effects; both are the principal ingredients.

[0019] The composition contains Hovenia dulcis, which is sweet in taste and neutral in nature, and enters the spleen and stomach meridians. It has the effects of promoting body fluid production and quenching thirst, and promoting diuresis and reducing swelling. The composition also contains Pueraria lobata, first recorded in the *Shennong Bencao Jing* (Shennong's Classic of Materia Medica), which is sweet in taste and slightly cold in nature, and enters the lung and stomach meridians. It has the effects of relieving exterior syndromes and clearing heat, promoting body fluid production and quenching thirst, and promoting the ascending of clear qi and descending of turbid qi. It is used for unresolved exterior syndromes, feverish thirst, dry throat and mouth, diarrhea, and alcohol poisoning. In this composition, the thirst-quenching and body fluid-producing effects of Pueraria lobata and Hovenia dulcis help to relieve alcohol intoxication; both are used as assistant herbs.

[0020] The formula contains cloves, which are pungent and warm in nature, and enter the spleen, stomach, lung, and kidney meridians. Its functions include warming the middle jiao (spleen and stomach) to relieve pain and warming the kidneys to invigorate yang. The formula also contains dried plums, which are sour and cool in nature, and enter the liver and stomach meridians. Their functions include astringing and stopping diarrhea, and promoting body fluid production and quenching thirst. The combination of cloves and dried plums warms the middle jiao to relieve pain and promotes body fluid production and quenches thirst. The sour taste of dried plums astringes, while the pungent taste of cloves disperses. The combination of these two ingredients limits the dispersing effect of cloves, ensuring that the effects of relieving alcohol intoxication do not harm the body's vital energy. Both are adjuvant herbs. The overall formula is neutral in nature, primarily targeting abdominal distension, nausea, and fluid depletion after drinking alcohol. It uses common medicinal and edible herbs to work together to regulate qi, strengthen the spleen, relieve nausea and vomiting, promote body fluid production, and astringe sweat.

[0021] Animal experiments have shown that the herbal composition of this invention can significantly shorten the sobering-up time, alleviate physical discomfort caused by drunkenness, and reduce the damage of alcohol to the human body, thus possessing practical application value.

[0022] Obviously, based on the above description of the present invention, and according to common technical knowledge and conventional methods in the field, various other modifications, substitutions or alterations can be made without departing from the basic technical concept of the present invention.

[0023] The following detailed embodiments further illustrate the above-described content of the present invention. However, this should not be construed as limiting the scope of the present invention to the following examples. All technologies implemented based on the above-described content of the present invention fall within the scope of the present invention. Attached Figure Description

[0024] Figure 1 The percentage of single herbs in ancient hangover remedies belonging to their respective categories (top 20).

[0025] Figure 2 Experimental flowchart.

[0026] Figure 3 Image of a mouse in a state of intoxication.

[0027] Figure 4 : Sobering-up time for mice

[0028] Figure 5 : Mouse liver organ index.

[0029] Figure 6 : Liver images of mice in each group.

[0030] Figure 7 : Proportion of serum ethanol (ALC) concentration in mice of each group.

[0031] Figure 8 : Proportional activity of alcohol dehydrogenase (ADH) in each group of mice.

[0032] Figure 9 : Proportional activity of aldehyde dehydrogenase (ALDH) in mice of each group.

[0033] Figure 10 The metabolic process of ethanol in the body. Detailed Implementation

[0034] Example 1: Preparation of the composition of the present invention

[0035] Formula: 3g germinated barley, 3g malt, 3g Japanese raisin tree fruit, 2g wild kudzu root, 2g cloves, 2g dried plum.

[0036] Preparation method: Weigh the raw materials according to the above ratio, add 10 times the amount of water, soak for 30 minutes, decoct and extract twice, 1 hour each time, filter with 200 mesh gauze, combine the two filtrates, and concentrate by rotary evaporation to 75 ml to obtain 0.2 g crude drug / mL drug solution.

[0037] Example 2: Preparation of the composition of the present invention

[0038] Formula: 2g germinated barley, 2g malt, 2g Japanese raisin tree fruit, 1g wild kudzu root, 1g clove, 1g dried plum.

[0039] Preparation method: Same as in Example 1.

[0040] Example 3: Preparation of the composition of the present invention

[0041] Formula: 5g germinated barley, 5g malt, 5g Japanese raisin tree fruit, 3g wild kudzu root, 3g cloves, 3g dried plum.

[0042] Preparation method: Same as in Example 1.

[0043] The following experimental examples further illustrate the beneficial effects of the present invention.

[0044] Experimental Example 1: Development and Research of Hangover Relief Products Based on Fermentation Technology

[0045] 1. Data collection and mining of traditional Chinese medicines with hangover-relieving effects

[0046] Records of hangover remedies in traditional Chinese medicine begin with the *Shennong Bencao Jing* (Shennong's Classic of Materia Medica), which mentions two herbs: water lily and roe spinach. The Song Dynasty's *Zheng Lei Bencao* (Classified Materia Medica) explicitly records 30 herbs with hangover-relieving effects, among which kudzu flower and Japanese raisin tree fruit became commonly used in later hangover remedies. The Ming Dynasty's *Bencao Gangmu* (Compendium of Materia Medica) contains the most numerous hangover remedies, approximately 107, comprehensively summarizing previous records and essentially encompassing all hangover remedies documented in traditional Chinese medicine. Numerous hangover remedies are recorded in large medical books from the Tang and Song Dynasties to the Ming and Qing Dynasties. The Song Dynasty's *Taiping Shenghui Fang* (Prescriptions for Universal Relief) categorizes hangover remedies into six types: remedies for severe intoxication, remedies for alcohol poisoning, remedies for aversion to alcohol, remedies for indigestion after drinking, remedies for various ailments after drinking, and remedies for abstaining from alcohol. It contains 42 hangover remedies, mostly short prescriptions, essentially summarizing hangover remedies from before the Song Dynasty. The Ming Dynasty medical text *Puji Fang* includes a dedicated section on "detoxifying alcohol," containing over a hundred prescriptions that comprehensively summarize previous methods. Li Dongyuan of the Jin Dynasty, in his *Treatise on the Spleen and Stomach*, stated, "Alcohol is extremely hot and toxic; its flavor and nature are both yang, and it is an intangible substance. If it harms you, you should only try to disperse the toxicity; sweating will bring relief, and this is the most effective method. The next best approach is to promote urination. Both methods eliminate dampness from both the upper and lower parts of the body; how can alcohol cause illness?" He proposed the principle of "eliminating dampness from both the upper and lower parts of the body" for detoxifying alcohol, a principle that was accepted by later generations.

[0047] This study attempts to organize and compile traditional Chinese medicine prescriptions for relieving hangovers, summarize and screen commonly used and effective drugs, and obtain three prescriptions for relieving hangovers based on the principle of food and medicine sharing the same origin. These prescriptions serve the treatment and prevention of alcohol-related diseases and related products can be developed based on them.

[0048] 1.1 Collection and establishment of a database of hangover remedies

[0049] A combination of computer and manual retrieval methods was employed. The computer retrieval tool was the *Chinese Medical Encyclopedia* (upgraded version), which includes over 1600 ancient Chinese medical texts and is the most comprehensive electronic collection of traditional Chinese medicine to date, now widely used for literature retrieval in various research projects. Free-text search was used with the keywords "sobering up," "relief from hangovers," "alcohol poisoning," "alcohol-related injury," and "alcohol accumulation." After selecting the retrieved prescriptions and removing duplicates, a total of 378 prescriptions for sobering up were obtained.

[0050] Manual searching was conducted using the *Comprehensive Dictionary of Traditional Chinese Medicine Prescriptions*. This dictionary is a large-scale reference work on traditional Chinese medicine prescriptions, compiled and edited from prescriptions found in historical TCM texts, containing approximately 100,000 prescriptions from over 1800 TCM literature sources. Manual searching utilized the indications index in Volume 11, searching for prescriptions indicated for "relieving hangovers" or "sobering up." A total of 285 hangover relieving prescriptions were found.

[0051] The hangover remedies obtained from computer and manual searches were combined, and duplicates were removed, resulting in a total of 429 remedies. All remedies were then entered into an Excel spreadsheet after standardizing the herbal names, thus creating a hangover remedy database.

[0052] 1.2 Statistical Analysis

[0053] Of the 429 prescriptions for relieving hangovers, 384 contained single-herb ingredients, with a total frequency of 3087. Among these 384 ingredients, the most frequently occurring single herbs included: licorice root, dried tangerine peel, kudzu root, poria cocos, galangal, ginseng, ginger, Japanese raisin tree fruit, clove, and medicated leaven. The 20 most frequently occurring herbs are listed in Table 1. Figure 1 .

[0054] Table 1. Frequency of Single Herbs in Ancient Hangover Remedies (Top 20)

[0055]

[0056] 1.3 Determination of hangover remedies

[0057] Based on the above statistical results, combined with the characteristics of alcohol intoxication in Traditional Chinese Medicine (TCM), and following the principles of "principal, assistant, adjuvant, and guide" in TCM prescriptions, after preliminary experiments, the following three prescriptions with hangover-relieving effects were used for further efficacy determination experiments:

[0058] Prescription 1: Germinated barley 4g, Japanese raisin tree fruit 3g, Pueraria lobata root 3g, Amomum tsao-ko 2g, mulberry fruit 2g, Lophatherum gracile leaf 1g

[0059] The formula uses sweet and warm germinated barley as the principal ingredient, which aids digestion, harmonizes the stomach, strengthens the spleen, and improves appetite. The sweet and neutral-natured raisin tree fruit detoxifies alcohol, quenches thirst, relieves irritability, and stops vomiting. The pungent and sweet-cooling kudzu root relieves muscle tension, reduces fever, promotes rash eruption, generates fluids, quenches thirst, raises yang, stops diarrhea, unblocks meridians, and detoxifies alcohol. The combination of these two ingredients enhances the detoxifying effect, making them the assistant ingredients. The combination of cardamom and mulberry nourishes yin, generates fluids, warms the middle jiao, and eliminates phlegm. The sweet and bland-tasting, cold-natured bamboo leaves clear heat, purge fire, relieve irritability, and promote urination, serving as the adjuvant ingredients. Overall, the formula is neutral in nature, primarily targeting the symptoms of irritability, fever, and nausea after drinking alcohol. It uses common medicinal and edible herbs to achieve the effects of relieving alcohol intoxication, alleviating irritability, stopping vomiting, and suppressing adverse reactions.

[0060] Prescription 2: Malt 4g, Hovenia dulcis 3g, Pueraria lobata 3g, Alpinia officinarum 2g, Chrysanthemum 2g, Imperata cylindrica 1g

[0061] The formula contains malt, which is sweet and neutral in nature, and has the functions of promoting qi circulation, aiding digestion, strengthening the spleen and stomach, reducing lactation and relieving bloating. It is the principal ingredient. Hovenia dulcis is sweet and neutral in nature, and has the functions of detoxifying alcohol, quenching thirst, relieving irritability, and stopping vomiting. Kudzu root is pungent, sweet, and cool in nature, and has the functions of relieving muscle tension and reducing fever, promoting rash eruption, generating fluids and quenching thirst, raising yang and stopping diarrhea, clearing the meridians and activating collaterals, and detoxifying alcohol. The combination of these two ingredients enhances their detoxifying effect and they are the assistant ingredients. Alpinia galanga is added to warm the stomach and stop vomiting; chrysanthemum is added to soothe the liver and improve eyesight; and Imperata cylindrica root is added to clear heat and promote urination. The overall formula is neutral in nature and is mainly used to treat bloating, nausea, and liver yang hyperactivity after drinking alcohol. It uses common medicinal and edible herbs to work together to regulate qi, strengthen the spleen, stop vomiting, and suppress liver yang.

[0062] Prescription 3: Germinated barley 3g, germinated wheat 3g, Japanese raisin tree fruit 3g, wild kudzu root 2g, clove 2g, dried plum 2g

[0063] The formula contains: Germinated barley, sweet and warm in nature, which aids digestion, harmonizes the middle jiao, strengthens the spleen and stimulates appetite; Malt, sweet and neutral in nature, which promotes qi circulation, aids digestion, strengthens the spleen and stimulates appetite, reduces lactation and relieves bloating, and together they are the principal herbs; Raisin tree fruit, sweet and neutral in nature, which detoxifies alcohol, quenches thirst, relieves irritability, and stops vomiting; Kudzu root, pungent, sweet and cool in nature, which relieves muscle tension and reduces fever, promotes rash eruption, generates fluids and quenches thirst, raises yang and stops diarrhea, unblocks meridians and collaterals, and detoxifies alcohol. The combination of these two herbs enhances their detoxifying effect and together they are the assistant herbs; Clove, pungent and warm in nature, which warms the middle jiao and relieves nausea, and Prunus mume, which astringes the lungs, astringes the intestines, and generates fluids. The overall formula is neutral in nature and is mainly used to treat abdominal distension, nausea, and fluid depletion after drinking alcohol. It uses common medicinal and edible herbs to work together to regulate qi, strengthen the spleen, relieve nausea and vomiting, generate fluids and astringe sweat.

[0064] All three prescriptions are based on Chinese medicinal herbs that are both food and medicine. They are combined with the basic pathogenesis of "alcohol-related diseases" and selected appropriate medicinal materials. They are scientifically formulated through the combination of principal, assistant, adjuvant, and guide herbs, thus addressing the core pathogenesis of "alcohol-related diseases" in traditional Chinese medicine.

[0065] 2. Screening and Validation Study of Traditional Chinese Medicine Compound Formulas with Alcohol-Relieving Effects

[0066] 2.1 Test Site

[0067] This experiment was completed in the Laboratory of Pharmacology of Chinese Materia Medica, Chengdu University of Traditional Chinese Medicine, which is one of the first batch of scientific research laboratories of traditional Chinese medicine (Level 3) of the State Administration of Traditional Chinese Medicine, with the certificate registration number: TCM-2009-315.

[0068] 2.2 Experimental Animal Use Permit

[0069] Guinea pigs, rabbits (open environment), mice, mice (barrier environment [IVC]), issued by the Sichuan Experimental Animal Management Committee, permit number: SYXK (Sichuan) 2020-124. This animal experiment was approved by the Experimental Animal Ethics Committee of Chengdu University of Traditional Chinese Medicine (approval number 2023-05).

[0070] 3. Pharmacodynamic Evaluation of Chinese Medicine Prescriptions for Intervening in Acute Alcoholism in Mice <00​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​An acute alcohol poisoning animal model was induced in mice by gavage with baijiu (a type of Chinese liquor) over a short period of time. The dosage of baijiu was determined as follows: According to literature, in mouse acute alcohol intoxication models, the rate of intoxication increased with increasing baijiu dosage. The optimal dosage (52° Erguotou baijiu) was 0.02 mL / g. -1 At that time, the intoxication rate reached 100%, but as the dosage of baijiu (Chinese liquor) increased, the mortality rate of the mice also continued to rise. 0.020 mL / g -1 The alcohol dosage not only achieved a 100% intoxication rate in mice, but also a 0% mortality rate. Therefore, 0.020 mL / g was selected. -1 The optimal dose of baijiu (Chinese liquor) for this experimental mouse model of acute alcohol intoxication.

[0085] 3.1.2.2 Experimental Grouping

[0086] All male mice were randomly divided into 4 groups according to their body weight: a blank control group of 6 mice per group and a drug treatment group of 12 mice per group. The groups were divided into 6 mice per cage: blank control group, prescription group 1-1 (numbers 1-6), prescription group 1-2 (numbers 7-12), prescription group 2-1 (numbers 1-6), prescription group 2-2 (numbers 7-12), prescription group 3-1 (numbers 1-6), and prescription group 3-2 (numbers 7-12).

[0087] 3.1.2.3 Preparation of Drug Solution

[0088] Take 15g of the prescribed amount of medicinal materials, add 10 times the amount of water, soak for 30 minutes, decoct and extract twice, 1 hour each time, filter through 200-mesh gauze, combine the two filtrates, and concentrate by rotary evaporation to 75ml to obtain a solution of 0.2g crude drug / mL. (All three prescriptions were prepared using this method.)

[0089] 3.1.2.4 Experimental methods and drug administration

[0090] Dosage: The clinical daily dose is 15g. This experiment was conducted based on the clinical dose of 15g. Assuming a human body weight of 60kg, the clinical dose is 0.25g crude drug / kg. The equivalent dose for mice is 12 times that for humans, therefore the mouse dose is 3g crude drug / kg. Assuming a mouse body weight of 20g, 0.06g crude drug / 20g is required. Since the typical gavage volume for mice is 0.3mL / 20g, the required drug solution is 0.2g crude drug / mL.

[0091] Administration: The normal control group was administered an equal volume of purified water by gavage daily. Groups 1, 2, and 3 were administered the corresponding prescription drug solution at a dose of 3 g / kg by gavage once daily for 5 consecutive days. One hour after the last administration, 52° liquor was administered at a dose of 0.020 mL / g. -1 Mice were given oral gavage, which caused acute alcohol poisoning.

[0092] 3.2 Pharmacological Study of the Optimal Hangover Remedy

[0093] 3.2.1 Experimental Materials

[0094] 3.2.1.1 Test drug and reagent

[0095] (1) The best hangover remedy selected by experiment 3.1.

[0096] (2) Hongxing Erguotou, batch number 20220707-371114, purchased from Hongqi Chain Supermarket, Beijing Hongxing Co., Ltd.

[0097] 3.2.1.2 Laboratory Animals

[0098] Similar to the experimental animals in 3.1.1.2, the animals were restored to their original feeding state for 3 days after the previous experimental steps were completed.

[0099] 3.2.1.3 Instruments and Consumables

[0100]

[0101] 3.2.2 Experimental Methods

[0102] 3.2.2.1 Model Replication Principle

[0103] An animal model of acute alcohol poisoning was created in mice by administering baijiu (a type of Chinese liquor) via gavage within a short period of time.

[0104] 3.2.2.2 Experimental Grouping

[0105] All male mice were randomly divided into 4 groups according to their body weight: a blank control group of 6 mice per group and a drug treatment group of 12 mice per group. The groups were divided into 6 mice per cage: blank control group, low-dose group 1 (1-6), low-dose group 2 (7-12), medium-dose group 1 (1-6), medium-dose group 2 (7-12), high-dose group 1 (1-6), and high-dose group 2 (7-12).

[0106] 3.2.2.3 Preparation of Drug Solution

[0107] Preparation of medium-dose group of medicinal solution: Take the prescribed amount of medicinal materials, add 10 times the amount of water, soak for 30 minutes, decoct and extract twice, 1 hour each time, filter with 200 mesh gauze, combine the two filtrates, and concentrate by rotary evaporation to 75 mL to obtain 0.2 g crude drug / mL medicinal solution.

[0108] Preparation of high-dose group drug solution: The prepared medium-dose group drug solution was further concentrated by rotary evaporation to 0.4g crude drug / mL drug solution.

[0109] Preparation of low-dose group drug solution: Dilute the prepared medium-dose group drug solution with distilled water to 0.1g crude drug / mL drug solution.

[0110] 3.2.2.4 Experimental methods and drug administration

[0111] The normal control group was administered an equal volume of purified water by gavage daily. The high-dose, medium-dose, and low-dose groups were administered the corresponding prescription drug solution at 3 g / kg by gavage once daily for 5 consecutive days. One hour after the last administration, 0.020 mL / g of 52° liquor was administered. -1 Mice were administered alcohol via gavage to induce acute alcohol poisoning. One hour after administration, the mice were enucleated to collect blood, euthanized by cervical dislocation, and their livers were dissected. The times of administration, alcohol administration, and blood collection were precisely recorded at the last administration, with one mouse administered approximately every 3 minutes, and so on.

[0112] 4. Observation Indicators

[0113] During the experiment (3.1), the general physical signs of the mice were observed every two days, including body weight, food intake, and water intake. After the mice were given alcohol in the last experiment, the time to intoxication and the time to sober up were continuously observed.

[0114] During the experiment (3.2), the general physical signs of the mice were observed every two days, including weight, food intake, and water intake. One hour after the last experiment, the mice were enucleated to collect blood, euthanized by cervical dislocation, and their livers were harvested and weighed.

[0115] 4.1 General physical signs

[0116] The weight of mice in each group was measured, and the weight of mice in each group was measured every 2 days thereafter. The amount of food and water consumed was recorded daily, and the experimental data was properly recorded.

[0117] 4.2 Observation of intoxication

[0118] Experiment 3.1 One hour after the last administration of the drug, the mice were given liquor. After the administration of the liquor, the mice were continuously observed and recorded for symptoms such as death, vomiting, and weakness. The disappearance and recovery time of the righting reflex were also recorded (the mice were gently turned over and placed in a supine position. If they could not right themselves within 30 seconds, they were considered drunk, and the intoxication latency period was recorded; the recovery of the righting reflex was considered sobering up).

[0119] 4.3 Organ Index Detection

[0120] Experiment 3.2: The mice were euthanized by removing their eyeballs for blood collection and dislocating their necks. The livers of each mouse were harvested, weighed, and the organ index of each organ or tissue was calculated using the formula: Organ Index = Organ Weight / Body Weight × 100%

[0121] 4.4 Blood ethanol (ALC) concentration determination

[0122] The serum ethanol (ALC) content in mice was determined using a serum ethanol assay kit, following the kit's instructions.

[0123] Its calculation formula is:

[0124]

[0125] In the formula, △A 样 : Change in sample absorbance; △A 标 : Change in absorbance of standard; T: Reaction time (1 min); C 标 Standard concentration

[0126] 4.5 Assay for alcohol dehydrogenase (ADH) activity

[0127] The activity of alcohol dehydrogenase (ADH) in mouse liver was measured using a kit according to the kit instructions.

[0128] Its calculation formula is:

[0129]

[0130] In the formula, △A 样 : Change in sample absorbance; △A 空 : Change in absorbance of blank sample; V 反总 The total volume of the reaction system is 1.5 mL; V 样总 : 0.9 mL of extraction liquid was added during homogenization; ε: NADH molar extinction coefficient 6.22 × 10⁻⁶ -3 ; d: Cuvette optical path length 0.5 cm; V 样 : Sample volume: 0.05 mL; W: Liver sample volume (g); T: Reaction time: 10 min.

[0131] 4.6 Assay of acetaldehyde dehydrogenase (ALDH) activity

[0132] The aldehyde dehydrogenase (ALDH) activity in mouse liver was measured using an aldehyde dehydrogenase assay kit, following the kit's instructions.

[0133] Its calculation formula is:

[0134]

[0135] In the formula, △A 样 : Change in sample absorbance; V 反总 The total volume of the reaction system is 1 mL; V 样总 : Add 1 mL of extraction liquid when preparing the homogenate; ε: NADH molar extinction coefficient 6.22 × 10⁻⁶ -3 ; d: Cuvette optical path length 0.5 cm; V 样 Sample volume: 0.1 mL; W: Liver sample volume (g); T: Reaction time: 5 min.

[0136] 4.7 Experimental Procedure

[0137] like Figure 2

[0138] 5. Statistical methods

[0139] Statistical analysis was performed using SPSS 21.0 software. All data were expressed as mean plus or minus standard deviation. The LSD test was used to determine if homogeneity of variance was satisfied; otherwise, Dunnett's T3 test was used. All analytical results are expressed as P < 0.05, and P < 0.01, indicating a statistically significant difference.

[0140] 6. Results

[0141] 6.1 General physical signs

[0142] Before, during and after administration, the activity rhythm, body shape and behavior of mice in the blank control group and the administration group were not significantly abnormal. The mice did not experience adverse reactions such as nausea, vomiting or regurgitation after administration.

[0143] One hour after drug administration in Experiment 3.1, and approximately 20 minutes after administration of the corresponding amount of baijiu (Chinese liquor), both the blank control group and the drug administration group exhibited varying degrees of intoxication, including but not limited to slowed reaction, unsteady gait, and delayed righting reflex. About one hour after alcohol administration, most mice entered a state of intoxication (the righting reflex completely disappeared, see details...). Figure 3 Only a few mice in the treatment group remained conscious, but their behavior became significantly less active (the righting reflex was still present). No mice in any group showed any abnormalities such as vomiting or death.

[0144] About an hour later, the mice gradually regained their righting reflex, but their behavior was still slower than that of normal mice. About 3-4 hours later, all the mice woke up and returned to normal.

[0145] 6.2 Effects of the Three Prescriptions on Sobering Time

[0146] The results are shown in Table 2 and Figure 4 .

[0147] Table 2. Effects of three prescriptions on sobering time.

[0148]

[0149] Note: (1) Compared with the blank control group, *P<0.05;

[0150] (2) Comparison of the rate of change between the drug administration group and the blank control group.

[0151] Conclusion: The sobering-up time of prescription group 3 was significantly different from that of the blank control group, and the number of undrunk mice in prescription group 3 was the largest. In addition, the average sobering-up time of prescription group 3 was shorter than that of prescription group 1 and prescription group 2, indicating that prescription 3 can make intoxicated mice sober up faster than prescription group 1 and prescription group 2. The prescription 3 solution will be used in subsequent experiments.

[0152] 6.3 Effects of the Optimal Prescription (Prescription 3) on Organ Indices

[0153] The results are shown in Table 3 and Figures 5-6 .

[0154] Table 3. Effects of Prescription 3 on Liver Index in Mice

[0155]

[0156] Note: The rate of change was compared between the drug administration group and the blank control group.

[0157] As shown in Table 3, compared with the blank control group, the liver index of the treated mice was not significantly different (P>0.05), and there were no significant differences among the treated groups (P>0.05). Regarding the rate of change of organ indices in each treated group, all treated groups showed a decrease compared with the blank control group, with the high-dose group showing the smallest change, followed by the medium-dose group, and the low-dose group showing the largest. However, the changes in the treated groups were not significant compared with the blank control group. Figure 8 The appearance of the livers of mice in the treatment group was not significantly different from that of mice in the blank control group. There were no lesions such as cirrhosis, cysts, or atrophy. Therefore, it can be concluded that prescription 3 does not have the effect of changing the liver index of mice.

[0158] Conclusion: The above results indicate that the prescription solution 3 does not have a trend of altering liver indices in mice.

[0159] 6.4 Blood alcohol (ALC) content detection

[0160] The results are shown in Table 4 and Figure 7 .

[0161] Table 4. Effects of Prescription 3 on serum ethanol (ALC) levels in intoxicated mice.

[0162]

[0163] Note: (1) Compared with the blank control group, *P<0.05; **P<0.01;

[0164] (2) Comparison of the rate of change between the drug administration group and the blank control group.

[0165] 6.5 Detection of alcohol dehydrogenase (ADH) content

[0166] The results are shown in Table 5 and Figure 8 .

[0167] Table 5. Effects of Prescription 3 on the activity of alcohol dehydrogenase (ADH) in intoxicated mice.

[0168]

[0169] Note: (1) Compared with the blank control group, **P<0.01;

[0170] (2) Comparison of the rate of change between the drug administration group and the blank control group.

[0171] 6.6 Detection of acetaldehyde dehydrogenase (ALDH) content

[0172] The results are shown in Table 6 and Figure 9 .

[0173] Table 6. Effects of Prescription 3 on the activity of aldehyde dehydrogenase (ALDH) in intoxicated mice.

[0174]

[0175] Note: (1) Compared with the blank control group, **P<0.01;

[0176] (2) Comparison of the rate of change between the drug administration group and the blank control group.

[0177] Regarding blood ethanol (ALC) levels, the high-dose and medium-dose groups showed significant differences compared to the control group (P<0.01), while the low-dose group showed no significant difference. This demonstrates that the clinically equivalent doses of the three prescriptions significantly reduced blood ethanol levels in intoxicated mice. The rate of change showed that the blood ethanol concentration in the treated groups decreased by more than 50%-76% compared to the control group, with a clear downward trend. Regarding alcohol dehydrogenase (ADH) activity, the treated groups showed significant differences compared to the control group (P<0.01). This demonstrates that even without reaching the clinically equivalent dose, the three prescriptions significantly increased alcohol dehydrogenase activity in the liver. The rate of change showed that the alcohol dehydrogenase activity in the treated groups was significantly higher than that in the control group, with no significant difference between the treated groups. Regarding aldehyde dehydrogenase (ALDH) activity, the high-dose and medium-dose groups showed significant differences compared to the blank control group (P<0.01), while the low-dose group showed no significant difference. This demonstrates that the clinically equivalent dosage of the three prescriptions can significantly increase aldehyde dehydrogenase activity in the liver. In terms of the rate of change, the aldehyde dehydrogenase activity of the treated groups was increased to varying degrees compared to the blank control group, with the high-dose and medium-dose groups differing from the low-dose group by approximately 20%, which is a significant difference.

[0178] Based on the three indicators, the clinically equivalent doses of the prescription group 3 significantly reduced the ethanol content in the serum of intoxicated mice and significantly increased the activity of alcohol dehydrogenase and aldehyde dehydrogenase in the liver. The metabolic process of ethanol in the body is ethanol → acetaldehyde → acetic acid. Enhancing the activity of alcohol dehydrogenase and aldehyde dehydrogenase can accelerate this process, allowing ethanol in the body to be metabolized more quickly, thereby improving the intoxication condition.

[0179] 7. Conclusion

[0180] Acute alcohol poisoning, also known as drunkenness, is called "alcohol disease" or "alcohol accumulation" in traditional Chinese medicine. The main component of baijiu (a type of Chinese liquor) is ethanol. After entering the body, ethanol is mainly absorbed into the bloodstream through the gastrointestinal tract, and the vast majority is metabolized in the liver. Alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH) are important enzymes in the ethanol metabolic pathway. ADH in the hepatocyte cytoplasm, the ALOD system in microsomes, and catalase in peroxidases oxidize ethanol to acetaldehyde. Acetaldehyde is then converted to acetic acid under the action of ALDH. Acetic acid, under the action of acetyl-CoA synthase, generates acetyl-CoA, which participates in the tricarboxylic acid cycle in extrahepatic tissues, producing carbon dioxide, water, and ATP. Figure 10 .

[0181] Studies have shown that individual differences in ADH and ALDH levels determine the varying degrees of ethanol tolerance and the rate of ethanol metabolism. Current research on hangover relief mechanisms mainly focuses on two aspects: one is promoting hangover relief by directly accelerating ethanol oxidation metabolism in the body, such as by enhancing the activity of ADH and ALDH enzymes; the other is promoting positive ethanol oxidation metabolism by enhancing the ability to scavenge free radicals, such as by enhancing the activity of SOD, GST, and catalase.

[0182] This experiment validated the effects of prescriptions 1, 2, and 3 in a mouse model. Through five consecutive days of preventative administration, the researchers observed whether the three prescriptions could directly shorten the duration of intoxication in mice with acute alcohol poisoning. The results showed that, based on sobering-up time data, the three prescriptions reduced the intoxication rate and shortened the duration of intoxication in mice to varying degrees. However, only prescription 3 (3g of germinated rice, 3g of malt, 3g of Japanese raisin tree fruit, 2g of wild kudzu root, 2g of clove, and 2g of dried plum) showed a statistically significant difference compared to the control group, indicating a clear sobering effect. Further experimental studies using prescription 3 revealed that mice treated with prescription 3 for five days showed a significant reduction in blood ethanol levels after intoxication compared to the untreated group, and the activities of alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH) in their livers were enhanced to varying degrees, demonstrating a good sobering and liver-protective effect.

[0183] In summary, from the perspective of Traditional Chinese Medicine (TCM), Prescription 3 primarily addresses the symptoms of abdominal distension, nausea, and fluid depletion following alcohol intoxication, working synergistically to regulate Qi, strengthen the spleen, relieve nausea and vomiting, promote fluid production, and astringe sweat, thus relieving alcohol accumulation. From the perspective of modern biochemistry, the decoction of Prescription 3 significantly reduced blood ethanol levels in mice with acute alcohol poisoning and significantly increased the activities of alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH) in the liver of mice with acute alcohol poisoning, suggesting its hepatoprotective and alcohol-relieving effects. The TCM composition of this invention is precisely formulated and has outstanding effects in relieving alcohol poisoning and protecting the liver, possessing practical application value.

Claims

1. A traditional Chinese medicine composition with hangover-relieving effect, prepared from the following raw materials in the indicated weight ratios: 2-5 parts germinated rice, 2-5 parts malt, 2-5 parts Japanese raisin tree fruit, 2-3 parts wild kudzu root, 2-3 parts cloves, and 1-3 parts dried plum.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: It is prepared from the following raw materials in the indicated weight ratios: 3 parts germinated rice, 3 parts malt, 3 parts Japanese raisin tree fruit, 2 parts wild kudzu root, 2 parts cloves, and 2 parts dried plum.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that: The wild kudzu root is the legume plant *Pueraria lobata*. Pueraria lobata The dried root of (Willd.) Ohwi.

4. The traditional Chinese medicine composition according to claim 1, characterized in that: It is a preparation made from fine powder of active pharmaceutical ingredient, or water extract or alcohol extract of active pharmaceutical ingredient, plus pharmaceutically acceptable excipients.

5. The traditional Chinese medicine composition according to claim 4, characterized in that: The preparation is an oral preparation.

6. The traditional Chinese medicine composition according to claim 5, characterized in that: The oral preparations are solutions, granules, ointments, pills, tablets, or capsules.

7. A method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 6, characterized in that: It includes the following steps: (1) Weigh the raw materials according to the proportions; (2) The active pharmaceutical ingredient is ground into powder, or the active pharmaceutical ingredient is extracted with water or organic solvent, and then the pharmaceutical excipients are added.

8. Use of the traditional Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicament for the prevention and / or treatment of alcohol poisoning.

9. The use according to claim 8, characterized in that: The drug is a medication for the prevention and / or treatment of acute alcohol poisoning.

10. The use according to claim 9, characterized in that: The drug has the effect of relieving hangovers.

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