Traditional Chinese medicine composition for dispelling effects of alcohol and protecting liver as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, and particularly discloses a traditional Chinese medicine composition for dispelling effects of alcohol and protecting liver, a preparation method and application. The composition is prepared from the following raw materials in parts by weight: 20 to 60 parts of flos puerariae, 12 to 48 parts of semen hoveniae and 5 to 15 parts of fructus schizandrae. The preparation method comprises the following steps: crushing the raw materials, extracting with water, concentrating and drying to obtain an extract A; or further centrifuging, dialyzing and filtering to obtain an extract B; the composition is suitable for preparing medicines for treating acute alcoholism and alcoholic liver injury, or health-care products / foods with functions of dispelling effects of alcohol, protecting liver and protecting gastric mucosa. The composition is simple (three medicinal materials), contains medicinal and edible components (hovenia dulcis thunb and schisandra chinensis), and is high in safety; an extract A (conventional extraction) and an extract B (high-purity active components) are respectively obtained through a double-preparation process; the traditional Chinese medicine composition has the effects of dispelling effects of alcohol, promoting awakening, repairing liver injury, protecting gastric mucosa and promoting alcohol metabolism.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, and in particular to a traditional Chinese medicine composition, preparation method and application for relieving hangovers and protecting the liver. Background Technology

[0002] Alcoholic beverages are widely consumed globally. However, excessive drinking severely disrupts liver metabolism, undermines oxidative stress homeostasis, leads to acute alcohol poisoning, and causes numerous adverse effects on human health, making it a global public health issue. After alcohol is ingested, approximately 25% is absorbed by the stomach, about 95% is metabolized by the liver, and a small amount is metabolized through the lungs, kidneys, and muscles. A single large intake of alcohol can directly damage organs such as the gastric mucosa, liver, and kidneys, and may also trigger various complications.

[0003] Currently, clinical treatments for acute alcohol poisoning mainly include Western medicines such as naloxone and metadoxine. However, these drugs carry potential risks of drug dependence and adverse reactions. In contrast, traditional Chinese medicine (TCM) shows potential advantages in the field of alcohol detoxification and liver protection due to its relatively fewer adverse reactions, milder effects, and more acceptable safety profile.

[0004] In traditional Chinese medicine, kudzu flower, Japanese raisin tree seed, and schisandra fruit are all considered to have potential effects in relieving alcohol intoxication and protecting the liver. Kudzu flower is the flower of *Pueraria lobata* (Willd.) Ohwi or *P. thomsonii* Benth., belonging to the legume family. Its traditional effects include relieving alcohol intoxication, invigorating the spleen, and stopping bleeding. Modern research suggests it may have similar effects. Japanese raisin tree seed is the mature seed of *Hovenia dulcis* Thunnb., *Hovenia acerba* Lindl., or *Hovenia trichocarpa* Chun et Tsiang, belonging to the genus *Hovenia* in the Rhamnaceae family. Its traditional effects include detoxifying alcohol, quenching thirst, relieving irritability, stopping vomiting, and promoting urination and defecation. Studies have reported its protective effects against alcoholic liver damage and gastric mucosal damage. Schisandra chinensis is the dried, ripe fruit of the Schisandra chinensis (Turcz.) Baill., a plant in the Magnoliaceae family. It has astringent and consolidating properties, invigorates qi and promotes the production of body fluids, and tonifies the kidneys and calms the mind. Studies have also indicated that it may possess certain effects in relieving hangovers and protecting the liver.

[0005] Patent searches revealed that the prior art related to the subject matter of this invention mainly includes the following authorized patents:

[0006] 1. Patent Document 1 (CN101766717B): discloses a hangover relief composition (F), which has a complex composition, including glucose, fructose (or fructose, honey), kudzu flower, Japanese raisin tree fruit, and various amino acids (L-alanine, L-ornithine, L-glutamine, L-carnitine, etc.), and may add one or more ingredients such as tea, vitamins, and other amino acids.

[0007] 2. Patent Document 2 (CN102552547B): discloses a formula for an oral hangover remedy, mainly composed of kudzu flower (49%-50%), Japanese raisin tree fruit (49%-50%), tea polyphenols (0.5%-1%) and L-glutamine (0.5%-1%).

[0008] 3. Patent Document 3 (CN104740412B): discloses a hangover remedy composition comprising kudzu flower (3-12 parts), Japanese raisin tree fruit (3-12 parts), hawthorn (3-12 parts), poria cocos peel (1-9 parts), schisandra fruit (2-9 parts), reed rhizome (2-9 parts), tangerine peel (2-12 parts), and safflower (0.1-3 parts), which has the effects of relieving hangovers, preventing drunkenness, nourishing the stomach and protecting the liver, promoting diuresis, promoting blood circulation, and promoting alcohol metabolism and excretion.

[0009] 4. Patent Document 4 (CN106615466B): discloses a liver-nourishing and hangover-relieving health tea, which is composed of 15 medicinal materials in specific weight parts, including peppermint, dried tangerine peel, salvia miltiorrhiza, light bamboo leaves, dried ginger, kudzu flower, wolfberry, chrysanthemum, ganoderma lucidum, jujube seed, schisandra chinensis, poria cocos, alisma plantago-aquatica, jujube seed, and licorice. It has comprehensive health care effects such as nourishing the liver, protecting the liver and relieving hangovers, protecting the gastrointestinal tract, lowering blood lipids, and improving sleep.

[0010] Analysis of existing technologies reveals that:

[0011] 1. The formulation of Patent Document 2 (Pueraria lobata, Japanese raisin tree fruit, tea polyphenols, L-glutamine) has been included within the scope of the claims of Patent Document 1, which has a more complex composition.

[0012] 2. Although patent documents 3 and 4 use a formula containing kudzu flower, Japanese raisin tree fruit, and schisandra fruit, they are both multi-component (8 or 15 ingredients) compound formulas.

[0013] 3. In Patent Document 3, the dosage of Schisandra chinensis ranges from 2 to 9 parts, while in Patent Document 4, the dosage ranges from 7 to 12 parts.

[0014] Current technologies lack solutions for acute alcohol poisoning and alcoholic liver injury based on simplified formulations (especially those containing only three core herbs: Pueraria lobata, Hovenia dulcis, and Schisandra chinensis, with proportions clearly different from those described in references 3 and 4) and systematically validated for their synergistic effects in detoxification, liver protection, and stomach protection. Existing Western medicines raise safety concerns, while some traditional Chinese medicine compound formulas contain numerous components. Therefore, there is a need in this field to develop a traditional Chinese medicine composition with a simplified formulation, high safety profile, clear synergistic effects, and demonstrable significant improvement in acute alcohol poisoning and alcoholic liver injury through systematic experimental data. Summary of the Invention

[0015] The purpose of this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine composition, preparation method and application for relieving hangovers and protecting the liver.

[0016] The technical solution adopted by this invention to solve its technical problem is:

[0017] A traditional Chinese medicine composition for relieving hangovers and protecting the liver, characterized in that it is composed of the following raw materials in parts by weight:

[0018] 20-60 parts of kudzu flower, 12-48 parts of Japanese raisin tree fruit, and 5-15 parts of schisandra fruit.

[0019] Preferably, the weight parts of the raw materials in the composition are:

[0020] 50 parts of kudzu flower, 30 parts of Japanese raisin tree fruit, and 12 parts of schisandra fruit.

[0021] The preparation method of the traditional Chinese medicine composition with hangover relief and liver protection effects as described above includes the following steps:

[0022] (1) Grind and mix kudzu flower, Japanese raisin tree fruit, and schisandra fruit;

[0023] (2) Add water to the mixed raw materials at a material-to-liquid ratio of 1:5-1:20 g / mL, and extract twice at 80-100℃ for 2-4 hours each time. Combine the extracts.

[0024] (3) Concentrate the extract to 1 / 3-1 / 5 of its original volume;

[0025] (4) The concentrate was freeze-dried / spray-dried / vacuum-dried to obtain extract A;

[0026] (5) Centrifuge the concentrate in step (3) at 12,000-15,000 rpm for 15-30 min and remove the supernatant;

[0027] (6) Dialyze the supernatant with deionized water for 24 hours using a dialysis bag with a molecular weight cutoff of 3000-4000 Da.

[0028] (7) The dialysate was filtered through a 0.4-0.5 μm filter membrane, and the filtrate was freeze-dried / spray-dried / vacuum-dried to obtain extract B.

[0029] The above-mentioned traditional Chinese medicine composition is used in the preparation of drugs or functional foods for relieving hangovers and protecting the liver, treating alcoholic liver damage and gastric mucosal damage.

[0030] The advantages and positive effects of this invention are as follows:

[0031] 1. Significant synergistic effects in detoxifying and protecting organs:

[0032] (1) Highly effective hangover relief and sobering up: In a mouse model of acute alcohol poisoning, extracts A and B of the herbal composition of this invention both showed significant hangover relief effects and could synergistically shorten the sobering up time of intoxicated mice.

[0033] (2) Excellent liver protection: It has a significant therapeutic effect on a mouse model of alcoholic liver injury and can synergistically and significantly reduce alcohol-induced liver injury.

[0034] (3) Effective gastric mucosal protection: It can synergistically and significantly reduce the damage of alcohol to the gastric mucosa in mice.

[0035] 2. Simplified formulation and high safety:

[0036] (4) Simple and reliable ingredients: The core formula consists of only three Chinese medicinal materials: kudzu flower, Japanese raisin tree fruit, and schisandra fruit. The simple ingredients effectively reduce the risk of adverse interactions between drugs.

[0037] (5) Excellent safety: Hovenia dulcis and Schisandra chinensis are both food and medicine, which further reduces the incidence of adverse reactions and has high overall safety.

[0038] 3. Innovative extraction process and highly effective active ingredients:

[0039] (6) High activity of extract B: Extract B was obtained by a novel extraction method. Experiments have shown that, with the same amount of raw medicinal materials but a much lower extraction rate than extract A, extract B still exhibits significant effects in relieving hangovers and protecting organs, indicating that it contains highly active components.

[0040] 4. Simple preparation process and potential low dosage advantage:

[0041] (7) The process is environmentally friendly and simple: the preparation methods of extracts A and B are simple (mainly water extraction), and no organic solvents or complex carriers are required, which is environmentally friendly.

[0042] (8) Potential dose advantage: When treating acute alcohol poisoning and alcoholic liver injury under the same conditions, less mass of extract A is required than extract B, which may further reduce the risk of potential toxic side effects and adverse reactions.

[0043] 5. Clear application value and development prospects:

[0044] (9) Multi-purpose potential: The traditional Chinese medicine composition and its extracts of the present invention are suitable for preparing drugs, health foods or foods for relieving hangovers, treating alcoholic liver damage, protecting gastric mucosa and promoting alcohol excretion.

[0045] (10) Broad development prospects: Based on its simple and readily available components (including food and medicine homologous raw materials), high safety, low cost and clear efficacy, this invention has good practical application value and industrial development prospects. Attached Figure Description

[0046] Figure 1 The effect of extract A from the traditional Chinese medicine composition of this invention on blood ethanol concentration (BAC) in mice after recovery from acute alcohol poisoning is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0047] Figure 2 The effect of extract A from the traditional Chinese medicine composition of this invention on serum aspartate aminotransferase (AST) levels in mice with acute alcohol poisoning is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0048] Figure 3 The effect of extract A from the traditional Chinese medicine composition of this invention on serum alanine aminotransferase (ALT) levels in mice with acute alcohol poisoning is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0049] Figure 4 The image shows a pathological section of liver tissue from mice with acute alcohol poisoning, stained with hematoxylin and eosin (HE) by extract A of the traditional Chinese medicine composition of this invention.

[0050] Figure 5 The effect of extract A from the traditional Chinese medicine composition of this invention on the activity of superoxide dismutase (SOD) in the liver of mice with acute alcohol poisoning is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0051] Figure 6 The effect of extract A from the traditional Chinese medicine composition of this invention on the activity of glutathione peroxidase (GSH-Px) in the liver of mice with acute alcohol poisoning is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0052] Figure 7 The image shows the MDA of the liver of mice with acute alcohol poisoning, based on extract A of the traditional Chinese medicine composition of this invention. Note: Different letters indicate statistically significant differences, P < 0.05.

[0053] Figure 8 The image shows a pathological section of gastric tissue from mice with acute alcohol poisoning, stained with hematoxylin and eosin (HE) by extract A of the traditional Chinese medicine composition of this invention.

[0054] Figure 9 The effect of extract A from the traditional Chinese medicine composition of this invention on the level of nitric oxide (NO) in the gastric tissue of mice with acute alcohol poisoning is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0055] Figure 10 The effect of extract A from the traditional Chinese medicine composition of this invention on the activity of alcohol dehydrogenase (ADH) in the liver of mice with acute alcohol poisoning is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0056] Figure 11 The effect of extract A from the traditional Chinese medicine composition of this invention on the activity of catalase (CAT) in the liver of mice with acute alcohol poisoning is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0057] Figure 12 The effect of extract A from the traditional Chinese medicine composition of this invention on the activity of acetaldehyde dehydrogenase (ALDH) in the liver of mice with acute alcohol poisoning is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05).

[0058] Figure 13 The effect of extract B from the traditional Chinese medicine composition of this invention on the walking distance on a balance beam in mice after recovery from acute alcohol poisoning is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0059] Figure 14 The effect of extract B from the traditional Chinese medicine composition of this invention on the balance beam behavioral score of mice after recovery from acute alcohol poisoning is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0060] Figure 15 The effect of extract B from the traditional Chinese medicine composition of this invention on the duration of climbing behavior in mice after recovery from acute alcohol poisoning is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0061] Figure 16The effect of extract B from the traditional Chinese medicine composition of this invention on blood ethanol concentration (BAC) in mice after recovery from acute alcohol poisoning is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0062] Figure 17 The effect of extract B from the traditional Chinese medicine composition of this invention on serum aspartate aminotransferase (AST) levels in mice with alcoholic liver injury is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0063] Figure 18 The effect of extract B from the traditional Chinese medicine composition of this invention on serum alanine aminotransferase (ALT) levels in mice with alcoholic liver injury is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0064] Figure 19 The image shows a pathological section of liver tissue from mice with alcoholic liver injury stained with hematoxylin and eosin (HE) by extract B of the traditional Chinese medicine composition of this invention.

[0065] Figure 20 The effect of extract B from the traditional Chinese medicine composition of this invention on the activity of superoxide dismutase (SOD) in the liver of mice with alcoholic liver injury is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0066] Figure 21 The effect of extract B from the traditional Chinese medicine composition of this invention on the activity of glutathione peroxidase (GSH-Px) in the liver of mice with alcoholic liver injury is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0067] Figure 22 The effect of extract B from the traditional Chinese medicine composition of this invention on the malondialdehyde (MDA) content in the liver of mice with alcoholic liver injury is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0068] Figure 23 The image shows a pathological section of gastric tissue from mice with alcoholic liver injury stained with hematoxylin and eosin (HE) by extract B of the traditional Chinese medicine composition of this invention.

[0069] Figure 24 The effect of extract B of the traditional Chinese medicine composition of this invention on the level of nitric oxide (NO) in the gastric tissue of mice with alcoholic liver injury is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0070] Figure 25The effect of extract B from the traditional Chinese medicine composition of this invention on the activity of alcohol dehydrogenase (ADH) in the liver of mice with alcoholic liver injury is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0071] Figure 26 The effect of extract B of the traditional Chinese medicine composition of this invention on the activity of catalase (CAT) in the liver of mice with alcoholic liver injury is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05)

[0072] Figure 27 The effect of extract B from the traditional Chinese medicine composition of this invention on the activity of aldehyde dehydrogenase (ALDH) in the liver of mice with alcoholic liver injury is shown in the figure. (Note: Different letters in the figure indicate statistically significant differences between groups, P<0.05) Detailed Implementation

[0073] The present invention will be further described below with reference to the embodiments. The following embodiments are descriptive and not limiting, and should not be used to limit the scope of protection of the present invention.

[0074] The various experimental operations involved in the specific embodiments are all conventional techniques in the field. For parts not specifically annotated in this document, those skilled in the art can refer to various commonly used reference books, scientific and technological documents or related instructions and manuals prior to the filing date of this invention to carry out the operations.

[0075] Specifically, the relevant preparation and testing methods are as follows:

[0076] Example 1: Preparation of Extract A from Traditional Chinese Medicine Composition

[0077] (1) Raw material processing and weighing: The kudzu flower, Japanese raisin tree fruit and schisandra fruit are crushed separately. Weigh 50 parts of kudzu flower, 30 parts of Japanese raisin tree fruit and 12 parts of schisandra fruit by weight and mix them together.

[0078] (2) Water extraction: Add 20 times the volume (v / w) of water to the mixture obtained in step (1) and soak for 60 minutes. Then, perform reflux extraction at 80°C, for a total of two extractions, each lasting 2 hours. Combine the two extracts.

[0079] (3) Concentration: The combined extracts are concentrated to 1 / 5-1 / 3 of their original volume under reduced pressure.

[0080] (4) Freeze-drying: The concentrate is placed at -80℃ and freeze-dried under vacuum for 48 hours to obtain a dried powder, which is the extract A of the traditional Chinese medicine composition.

[0081] Example 2: Preparation of Extract B from Traditional Chinese Medicine Composition

[0082] (1) Raw material processing and weighing: The kudzu flower, Japanese raisin tree fruit and schisandra fruit are crushed separately. Weigh 50 parts of kudzu flower, 30 parts of Japanese raisin tree fruit and 12 parts of schisandra fruit by weight and mix them together.

[0083] (2) Water extraction: Add 20 times the volume (v / w) of water to the mixture obtained in step (1) and soak for 60 minutes. Then, perform reflux extraction at 80°C, for a total of two extractions, each lasting 2 hours. Combine the two extracts.

[0084] (3) Concentration: The combined extracts are concentrated to 1 / 5-1 / 3 of their original volume under reduced pressure.

[0085] (4) Ultracentrifugation: Centrifuge the concentrate at 14,500 rpm for 30 minutes.

[0086] (5) Dialysis: Collect the supernatant after centrifugation in step (4) and transfer it into a dialysis bag with a molecular weight cutoff of 3,500 Da. Under stirring conditions, use 20 times the total mass of the supernatant as the dialysis fluid and dialyze for 24 hours.

[0087] (6) Filtration: Take the liquid in the dialysis bag and filter it with a microporous membrane with a pore size of 0.45μm.

[0088] (7) Freeze-drying: Collect the filtrate and freeze-dry it under vacuum at -80°C for 48 hours to obtain a dried powder, which is the extract B of the Chinese herbal composition.

[0089] Example 3: Preparation of a special dietary food for relieving hangovers and protecting the liver

[0090] (1) Provide raw materials: Provide extract A of traditional Chinese medicine composition prepared according to the method described in Example 1, honey, glycine, vitamin C and vitamin B6.

[0091] (2) Ingredient mixing: Mix the herbal extract A, honey, glycine, vitamin C and vitamin B6 evenly according to the following weight ratio:

[0092] The composition contains: herbal extract A: 5-18 parts, honey: 1-5 parts, glycine: 0.1-1 part, vitamin C: 0.01-0.1 part, and vitamin B6: 0.01-0.05 parts.

[0093] (1) Drying treatment: The homogeneous mixture obtained in step 2 is dried (e.g., spray drying, freeze drying or low temperature vacuum drying) to obtain the dried product.

[0094] (2) Obtaining the product: The dried product obtained in step 3 is subjected to molding treatment (such as granulation, tableting, or direct packaging) to obtain the special dietary food. The special dietary food is in the form of powder, granules, tablets, etc., and has both hangover relief and liver protection functions as well as nutritional supplementation.

[0095] Example 4: Preparation of a special dietary food for relieving hangovers and protecting the liver

[0096] (1) Provide raw materials: Provide extract B of traditional Chinese medicine composition prepared according to the method described in Example 2, honey, glycine, vitamin C and vitamin B6.

[0097] (2) Ingredient mixing: Mix the Chinese herbal medicine composition extract B, honey, glycine, vitamin C and vitamin B6 evenly according to the following weight ratio:

[0098] The composition of traditional Chinese medicine extract B: 1-3 parts, honey: 1-5 parts, glycine: 0.1-1 part, vitamin C: 0.01-0.1 part, vitamin B6: 0.01-0.05 parts

[0099] (3) Drying treatment: The homogeneous mixture obtained in step 2 is dried (e.g., spray drying, freeze drying or low temperature vacuum drying) to obtain the dried product.

[0100] (4) Obtaining the product: The dried product obtained in step 3 is subjected to molding treatment (such as granulation, tableting, or direct packaging) to obtain the special dietary food. The special dietary food is in the form of powder, granules, tablets, etc., and has both hangover relief and liver protection functions as well as nutritional supplementation.

[0101] The pharmacological experiments of the traditional Chinese medicine composition of this invention, which has the functions of relieving hangovers and protecting the liver, have demonstrated its effectiveness in preventing and treating alcohol poisoning and alcoholic liver damage. Specific data are as follows:

[0102] I. Effects of Extract A from Traditional Chinese Medicine Composition on a Mouse Model of Acute Alcohol Poisoning

[0103] 1. Laboratory animals

[0104] Sixty male SPF-grade Kunming mice, weighing 18-20g, were used.

[0105] 2. Animal grouping and modeling

[0106] Male Kunming mice were randomly divided into 6 groups (n=10): normal group, model group (14 mL / kg 56° baijiu), positive control group (300 mg / kg metadoxine), single drug group (10 g / kg kudzu flower and schisandra chinensis), two drug group (10 g / kg kudzu flower and schisandra chinensis), and extract A group (10 g / kg traditional Chinese medicine combination). Mice were acclimatized for one week and then randomly divided into groups of 10 mice each according to body weight. After grouping, each group of mice underwent three days of acclimatization training on an open field apparatus and treadmill. After training, except for the normal control group, all other groups of mice were administered 56° baijiu (14 mL / kg) by gavage to establish an acute alcohol poisoning model. The normal group was administered an equal volume of 0.9% saline by gavage. 30 minutes later, the positive control group was administered metadoxine (300 mg / kg) by gavage. The other drug groups were administered the equivalent dose to mice at the same time as the positive control group, and the normal group was administered an equal volume of 0.9% saline by gavage.

[0107] The single-drug group, namely 10g / kg of kudzu root extract, is prepared as follows:

[0108] Powder the kudzu flowers, accurately weigh 50 parts of kudzu flowers, add 20 times the total volume of water and soak for 60 minutes, extract twice at 80℃ for 2 hours each time, concentrate the extract to 500 mL, freeze dry in vacuum at -80℃ for 48 hours to make powder, and obtain kudzu flower extract. Calculate the extract dosage corresponding to 10 g / kg of crude drug according to the extraction rate.

[0109] The two drug groups, namely, 10g / kg of raw kudzu flower and schisandra fruit, are prepared as follows:

[0110] Pulverum flowers and Schisandra chinensis were crushed. 50 parts of kudzu flowers and 12 parts of Schisandra chinensis were accurately weighed, mixed well, and soaked in 20 times the total volume of water for 60 minutes. The mixture was extracted twice at 80℃ for 2 hours each time. The extract was concentrated to 500 mL and freeze-dried under vacuum at -80℃ for 48 hours to obtain kudzu flower and Schisandra chinensis extracts. The extract dosage corresponding to 10 g / kg of crude drug was calculated according to the extraction rate.

[0111] Extract A, consisting of 10 g / kg of crude kudzu flower, schisandra fruit, and jujube fruit, is prepared as follows:

[0112] Powdered kudzu flower, Japanese raisin tree fruit, and schisandra fruit were used to make a powder. 50 parts of kudzu flower, 30 parts of Japanese raisin tree fruit, and 12 parts of schisandra fruit were accurately weighed, mixed well, and soaked in 20 times the total volume of water for 60 minutes. The powder was extracted twice at 80℃ for 2 hours each time. The extract was concentrated to 500 mL and freeze-dried under vacuum at -80℃ for 48 hours to make powder, thus obtaining the traditional Chinese medicine composition A for relieving hangovers and protecting the liver. The dosage of the extract corresponding to 10 g / kg of raw herbs was calculated according to the extraction rate.

[0113] 3. Detection indicators

[0114] Timing was initiated at the time of gavage administration. The recovery of the righting reflex in mice was used as an indicator of sobering up. The time required for the mice to recover the righting reflex after administration was recorded, i.e., the sobering-up time. Immediately after sobering up, the mice were placed in an open field apparatus and a treadmill, and their activity level was recorded for 5 minutes to assess their behavioral recovery ability after sobering up. After gavage administration, mice in each group were placed in metabolic cages, and urine was collected from each group for 6 hours to detect urine volume and urinary sodium. Six hours after administration, the mice were sacrificed, and blood, liver, stomach, and kidneys were collected, weighed, and serum AST, ALT, and blood ethanol (BAC), liver tissue ADH, ALDH, CAT, SOD, MDA, GSH-px, and stomach tissue NO were measured according to commercially available kits. The stomach and liver of the mice were used for HE staining and pathological sectioning.

[0115] 4. Results Analysis

[0116] 4.1 Effects of herbal extract A on sobering time and activity level in mice with acute alcohol poisoning

[0117] As shown in Table 1, compared with the acute alcohol poisoning model group, the recovery time of mice in the positive drug group was significantly shorter, and their activity level was significantly increased. The recovery time of mice in the single-drug group and the two-drug group was shorter than that of the positive drug group, and their activity level was lower than that of the positive drug group. The recovery time of mice in the extract A group was significantly shorter than that of the model group, the positive drug group, the single-drug group, and the two-drug group, and their activity level was significantly higher than that of all single-drug groups and the two-drug group, and approached the level of the normal control group.

[0118] Table 1. Effects of extract A from the traditional Chinese medicine composition on sobering time and activity level in mice with acute alcohol poisoning.

[0119]

[0120] Note: Different letters indicate statistically significant differences, P < 0.05.

[0121] 4.2 Effect of extract A from the traditional Chinese medicine composition on BAC in mice after acute alcohol poisoning and subsequent recovery

[0122] like Figure 1 As shown, the BAC in the acute alcohol poisoning model group was 184.32 μg / mL. The BAC in the positive control group was significantly lower than that in the model group. The average BAC in the single-drug group was 149.79 μg / mL, and the average BAC in the two-drug group was 145.74 μg / mL, both significantly lower than that in the model group. The BAC in the extract A group (129.27 μg / mL) was significantly lower than that in the model group, the positive control group, the single-drug group, and the two-drug group. This indicates that extract A may accelerate the sobering-up time by reducing BAC, and also demonstrates that the combination of kudzu flower, Japanese raisin tree fruit, and schisandra fruit has a synergistic effect in reducing BAC.

[0123] 4.3 Effects of Extract A from Traditional Chinese Medicine Composition on Liver Tissue of Mice with Acute Alcohol Poisoning

[0124] AST and ALT are indicators of liver function. Figure 2 and Figure 3 As shown, the AST and ALT levels in the normal group were 12.80 and 9.22 U / gprot, respectively, while those in the model group were 47.47 and 47.82 U / gprot, respectively, significantly higher than those in the normal group, indicating that alcohol significantly affects liver function. The AST and ALT levels in the positive control group were significantly lower than those in the model group. The AST and ALT levels in the single-drug and two-drug groups were decreased. The AST and ALT levels in the extract A group were 16.20 and 12.94 U / gprot, respectively, significantly lower than those in the model group, single-drug group, and two-drug group, and close to normal levels, indicating that extract A has a therapeutic effect on liver injury in mice with acute alcohol poisoning. This also demonstrates that the combination of kudzu flower, Japanese raisin tree fruit, and schisandra fruit has a synergistic effect in protecting liver function. Figure 4 As shown, hematoxylin and eosin (HE) was used to observe the pathological changes in the liver. The model group showed extensive hepatocyte necrosis and cytoplasmic vacuolation (semi-transparent appearance) in the liver tissue, indicating that alcohol caused liver damage in mice. The pathological damage in the liver tissue of each treatment group was improved to varying degrees. The extract A group showed a significant reduction in hepatocyte necrosis and vacuolation, with a pathological state close to that of the normal control group, indicating that extract A can effectively improve alcohol-induced liver damage.

[0125] Oxidative stress is closely related to liver damage, such as Figures 5-7 As shown, the levels of antioxidants SOD and GSH-px, and oxidant MDA in liver tissue were measured. In the normal group, SOD, GSH-px, and MDA were 97.92 U / mgprot, 100.19 U / mgprot, and 3.16 nmol / mgprot, respectively. In the model group, SOD, GSH-px, and MDA were 75.75 U / mgprot, 46.81 U / mgprot, and 7.82 nmol / mgprot, respectively, indicating a significant decrease in antioxidant enzyme activity and a significant increase in lipid peroxidation. In the positive control group, SOD and GSH-px were significantly increased, and MDA was significantly decreased. The single-drug group and the two-drug group showed weak recovery levels of antioxidant enzymes. The SOD, GSH-px, and MDA of extract A group were 90.04 U / mgprot, 86.40 U / mgprot, and 4.38 nmol / mgprot, respectively, and its enzyme activity recovery effect was significantly stronger than that of the single-drug group and the two-drug group. This indicates that extract A reduces alcohol-induced liver damage by improving the liver's antioxidant capacity. It also demonstrates that the combination of kudzu flower, Japanese raisin tree fruit, and schisandra fruit has a synergistic effect in alleviating liver damage.

[0126] 4.4 Effects of Extract A from Traditional Chinese Medicine Composition on Gastric Tissue of Mice with Acute Alcohol Poisoning

[0127] like Figure 8 As shown, HE staining was used to observe the pathological changes in gastric tissue. The gastric mucosa in the model group showed cell atrophy, adhesion, and unclear structure, indicating that alcohol has a significant stimulating effect on gastric mucosal cells, causing gastric tissue damage. Gastric mucosal damage was improved in all treatment groups. The pathological state of the gastric mucosa in the extract A group was significantly improved, approaching that of the normal control group, indicating that extract A can effectively improve the damage of alcohol to the stomach.

[0128] The levels of NO, an inflammatory marker, in gastric tissue were further examined. Figure 9 As shown, the NO content in the normal group was 0.84 μmol / gprot, and in the model group it was 4.38 μmol / gprot, significantly higher than that in the normal group, indicating that alcohol induced a gastric inflammatory response. The NO content in the single-drug group was 3.82 μmol / gprot, in the two-drug group it was 2.54 μmol / gprot, and in the extract A group it was 1.64 μmol / gprot, significantly lower than that in the single-drug and two-drug groups, indicating that extract A has a good therapeutic effect on alcohol-induced gastric inflammation. This also demonstrates that the combination of kudzu flower, Japanese raisin tree fruit, and schisandra fruit has a synergistic effect in reducing gastric inflammatory responses.

[0129] 4.5 Effects of Extract A from Traditional Chinese Medicine Composition on Alcohol Metabolizing Enzymes

[0130] In the liver, alcohol is primarily metabolized into acetaldehyde by alcohol dehydrogenase (ADH) and catalase (CAT), and acetaldehyde is then metabolized into acetic acid by aldehyde dehydrogenase (ALDH). Figures 10-12 As shown, the levels of ADH, CAT, and ALDH in the liver of the normal group were 66.10, 70.33, and 83.13 U / mgprot, respectively, while those in the model group were 37.03, 45.87, and 39.67 U / mgprot, respectively. This indicates that alcohol intake significantly inhibits the activity of key alcohol-metabolizing enzymes, thereby inhibiting alcohol metabolism. The positive control group showed significantly higher ADH and ALDH levels than the normal group, while CAT levels were comparable to those in the normal group, suggesting that metadoxine promotes alcohol metabolism by increasing alcohol-metabolizing enzymes, consistent with its mechanism of action. Both the single-drug group and the two-drug group significantly increased the activity of the three enzymes. However, in the extract A group, the ADH, CAT and ALDH levels increased to 68.84, 66.28 and 81.72 U / mgprot, respectively, which were significantly higher than those in the model group, the single-drug group and the two-drug group, and approached or reached the level of the normal control group. This indicates that extract A promotes alcohol metabolism by increasing the activity of key enzymes in the alcohol metabolism pathway. At the same time, it demonstrates that the combination of kudzu flower, Japanese raisin tree fruit and schisandra fruit has a synergistic effect in promoting alcohol metabolism enzymes.

[0131] The above data indicate that extract A of the traditional Chinese medicine composition can significantly shorten the recovery time from acute alcohol poisoning in mice, significantly reduce their post-recovery BAC, and significantly improve their activity level after recovery. Extract A can significantly improve liver function abnormalities caused by acute alcohol poisoning (reducing AST and ALT), alleviate liver tissue pathological damage (reducing necrosis and vacuolation), enhance liver antioxidant capacity (increasing SOD and GSH-Px), and inhibit lipid peroxidation (reducing MDA). Extract A can significantly alleviate gastric mucosal pathological damage caused by acute alcohol poisoning and reduce gastric tissue inflammation levels (NO). Extract A can significantly increase the activity of key enzymes in alcohol metabolism (ADH, CAT, ALDH). In terms of key indicators such as hangover recovery time, BAC, liver function (AST / ALT), liver oxidative stress (SOD / GSH-Px / MDA), gastric inflammation (NO), and the activity of alcohol-metabolizing enzymes (ADH / CAT / ALDH), the improvement effect of extract A group was significantly better than that of the single-drug group and the two-drug group, suggesting that the combined application of kudzu flower, Japanese raisin tree fruit, and schisandra fruit has a synergistic effect in exerting the above-mentioned effects.

[0132] II. Effects of Extract B from Traditional Chinese Medicine Composition on Acute Alcohol Poisoning Mouse Model

[0133] 1. Laboratory animals and grouping

[0134] Forty male SPF-grade Kunming mice, weighing 18-20g, were used. After three days of acclimatization feeding and behavioral training, the mice were randomly divided into four groups (n=10) according to their weight: a normal group, a model group, a low-dose extract B group (5g / kg crude drug), and a high-dose extract B group (10g / kg crude drug).

[0135] Except for the normal group, all other groups were administered 56° liquor (14 mL / kg) by gavage. The normal group was administered an equal volume of 0.9% saline by gavage. After 30 minutes, the low-dose group and the high-dose group of extract B were administered the extract. The normal group and the model group were administered an equal volume of 0.9% saline by gavage. The sobering-up time and behavioral data after sobering up were recorded.

[0136] The preparation method of extract B is as follows:

[0137] Pulsed kudzu flower, Japanese raisin tree fruit, and schisandra fruit were accurately weighed. 50 parts of kudzu flower, 30 parts of Japanese raisin tree fruit, and 12 parts of schisandra fruit were mixed and soaked in 20 times the total volume of water for 60 min. The mixture was extracted twice at 80℃ for 2 h each time. The extract was concentrated to 500 mL and centrifuged at 14500 rpm for 30 min. The supernatant was placed in a 3500 Da dialysis bag and dialyzed with 20 times the total mass of deionized water for 24 h. The liquid in the dialysis bag was filtered through a 0.45 μM filter membrane. The filtrate was collected and freeze-dried at -80℃ for 48 h to obtain powder. The powder was then sealed and stored.

[0138] 2. Detection indicators

[0139] The study recorded the sobering time of mice, their activity level after 5 minutes of sobering, the number of times they were electrocuted on the treadmill within 1 minute, the walking distance and score on the balance beam within 1 minute, and the climbing time on the climbing device within 1 minute. The behavioral data were used to explore the effect of extract B on acute alcohol poisoning.

[0140] 3. Results Analysis

[0141] 3.1 Effects of herbal extract B on sobering time and activity level in mice with acute alcohol poisoning

[0142] As shown in Table 2, compared with the model group, the low-dose and high-dose groups of extract B significantly shortened the sobering-up time of mice and increased their activity levels. In particular, the high-dose group showed a better sobering effect, with values ​​close to those of the normal group.

[0143] Table 2. Effects of extract B from the traditional Chinese medicine composition on sobering time and activity level in mice with acute alcohol poisoning.

[0144]

[0145] Note: Different letters indicate statistically significant differences, P < 0.05.

[0146] The above results indicate that extract B can not only significantly shorten the recovery time of mice with acute alcohol poisoning, but also effectively improve the activity level of mice after recovery, suggesting that it has the potential to alleviate alcohol-induced neurological inhibition and adverse conditions after intoxication.

[0147] 3.2 Effects of herbal extract B on the behavior of mice after acute alcohol poisoning and subsequent recovery

[0148] like Figure 13 and Figure 14 As shown, the balance beam walking ability test was used to assess the neuromotor coordination of mice after acute alcohol poisoning had subsided. Normal mice walked a distance of 206.67 cm with a score of 2.83, while the model group mice walked a significantly shorter distance of 58 cm with a score of 0.3. This indicates that the neuromotor coordination of the model group mice was significantly inhibited after alcohol metabolism. The high-dose extract B group increased the walking distance to 140 cm and the score to 2, demonstrating that high-dose extract B significantly improved the neuromotor coordination of mice after acute alcohol poisoning had subsided.

[0149] like Figure 15As shown, the climbing ability test was used to assess the muscle strength / muscle endurance of mice after acute alcohol poisoning had recovered. The climbing time of the normal group mice was 60 s, while the climbing time of the model group was significantly shortened to 2.33 s. This result indicates that the muscle strength or muscle endurance of the model group mice was significantly reduced after alcohol metabolism.

[0150] The attachment time in the low-dose group of extract B increased to 20.83 s, and the attachment time in the high-dose group of extract B increased to 43.50 s. These results demonstrate that extract B (especially the high dose) can significantly improve muscle strength or muscle endurance in mice after they regain consciousness from acute alcohol poisoning, showing a dose-dependent effect.

[0151] The above experiments showed that mice in the acute alcohol poisoning model group exhibited a significantly prolonged recovery time from intoxication. After recovery, the mice in the model group showed reduced activity and weakened muscle strength, leading to a significant decrease in their motor behavioral indicators. Extract B significantly shortened the recovery time from intoxication in mice with acute alcohol poisoning. Simultaneously, Extract B significantly improved the overall condition of the mice after recovery, manifested in a marked increase in activity and motor behavioral indicators. These results demonstrate that Extract B has the effect of improving the symptoms of acute alcohol poisoning (including promoting awakening) and alleviating the adverse conditions after intoxication.

[0152] III. Effects of Extract B from Traditional Chinese Medicine Composition on a Mouse Model of Alcoholic Liver Injury

[0153] 1. Laboratory animals and grouping

[0154] Forty male SPF-grade Kunming mice, weighing 18-20g, were used. After three days of acclimatization feeding, behavioral training was conducted, and then the mice were randomly divided into four groups (n=10) according to their weight: normal group, model group, low-dose extract B group (5g / kg crude drug), and high-dose extract B group (10g / kg crude drug).

[0155] Except for the normal group, each group was pretreated by gavage with 56° liquor (10mL / kg), while the normal group was gavage with an equal volume of 0.9% saline. After 30 minutes, each group was treated with the medication. This process was repeated daily, with the liquor administered first and the medication administered later, for 15 consecutive days.

[0156] The preparation method of extract B is as follows:

[0157] Pulsed kudzu flower, Japanese raisin tree fruit, and schisandra fruit were accurately weighed. 50 parts of kudzu flower, 30 parts of Japanese raisin tree fruit, and 12 parts of schisandra fruit were mixed and soaked in 20 times the total volume of water for 60 min. The mixture was extracted twice at 80℃ for 2 h each time. The extract was concentrated to 500 mL and centrifuged at 14500 rpm for 30 min. The supernatant was placed in a 3500 Da dialysis bag and dialyzed with 20 times the total mass of deionized water for 24 h. The liquid in the dialysis bag was filtered through a 0.45 μM filter membrane. The filtrate was collected and freeze-dried at -80℃ for 48 h to obtain powder. The powder was then sealed and stored.

[0158] 2. Detection indicators

[0159] Mice were sacrificed 30 minutes after administration on day 15. Blood, liver, and stomach tissues were collected. Serum AST, ALT, and BAC, liver ADH, ALDH, CAT, SOD, MDA, and GSH-px, and stomach NO were measured using commercially available kits. Mice stomachs and livers were used for HE staining and pathological sectioning.

[0160] 3. Results Analysis

[0161] 3.1 Effects of herbal extract B on BAC in mice with alcoholic liver injury

[0162] like Figure 16 As shown, after 15 days of alcohol modeling, the blood alcohol concentration (BAC) in the alcoholic liver injury model group (383.85 μg / mL) was significantly higher than that in the acute alcohol poisoning model group (184.32 μg / mL). Compared with the alcoholic liver injury model group, the BAC in the low-dose extract B group was 359.82 μg / mL, and the BAC in the high-dose extract B group was significantly reduced (282.29 μg / mL). This indicates that the high-dose extract B can eliminate blood alcohol content.

[0163] 3.2 Effects of extract B from the traditional Chinese medicine composition on liver tissue of mice with alcoholic liver injury

[0164] like Figure 17 and Figure 18 As shown, liver function was assessed. In the normal group, AST and ALT were 33.24 and 40.12 U / L, respectively, while in the model group, AST and ALT were 125.97 and 187.00 U / L, respectively, representing increases of approximately 3-5 times compared to the normal group. This indicates that long-term alcohol consumption causes liver damage. Extract B was able to lower these levels; the high-dose group showed AST and ALT of 68.24 and 120.41 U / L, respectively, significantly lower than the model group, indicating that the high-dose extract B could improve liver function.

[0165] like Figure 19As shown, the liver tissue in the alcoholic liver injury model group exhibited extensive hepatocyte necrosis and abnormal nucleocytoplasmic ratio, among other pathological changes. The high-dose extract B group showed a significant reduction in hepatocyte necrosis, indicating that extract B can protect the liver.

[0166] like Figures 20-22 As shown, the levels of SOD, GSH-PX, and MDA in the normal group were 53.00 U / mgprot, 153.16 μmol / mgprot, and 2.19 nmol / mgprot, respectively, while those in the model group were 19.17 U / mgprot, 71.42 μmol / mgprot, and 9.91 nmol / mgprot, respectively. This indicates a significant decrease in antioxidant enzyme activity, a significant increase in lipid peroxidation products, and liver tissue damage. Extract B significantly reversed the activity of these three enzymes, especially in the high-dose group. The levels of SOD, GSH-PX, and MDA in the high-dose group were 43.93 U / mgprot, 127.87 μmol / mgprot, and 4.16 nmol / mgprot, respectively, indicating that extract B can significantly increase antioxidant enzyme activity and reduce lipid peroxidation levels, thereby improving liver tissue damage.

[0167] 3.3 Effects of herbal extract B on gastric tissue of mice with alcoholic liver injury

[0168] like Figure 23 As shown, observation of gastric tissue revealed redness and swelling in the alcoholic liver injury model group, and HE staining showed gastric cell adhesion and necrosis. High-dose extract B significantly improved the pathological damage in the gastric tissue. Further analysis of NO levels in the gastric tissue was performed. Figure 24 The NO content in the normal group was 1.37 μmol / gport, and in the model group it was 6.48 μmol / gport, indicating that alcohol-induced gastric tissue inflammation was enhanced. The NO content in the high-dose extract B group was 1.77 μmol / gport, which is close to the normal level.

[0169] 3.4 Effects of herbal extract B on alcohol metabolism enzymes

[0170] like Figures 25-27As shown, the levels of ADH, CAT, and ALDH in the liver of the normal group were 57.93, 23.46, and 233.77 U / mgprot, respectively, while those in the model group were 23.49, 10.43, and 83.72 U / mgprot, respectively. This indicates that long-term alcohol intake significantly inhibits the activity of key alcohol-metabolizing enzymes. Extract B can activate all three enzymes. In the high-dose group, the levels of ADH, CAT, and ALDH were 57.23, 19.75, and 197.88 U / mgprot, respectively, which are close to normal levels. This suggests that extract B promotes alcohol metabolism by increasing key enzymes in the alcohol metabolism pathway, thereby reducing blood BAC.

[0171] The above experiments show that extract B of the traditional Chinese medicine composition has a good therapeutic effect on acute alcohol poisoning and alcoholic liver injury. In the acute phase, extract B can shorten the intoxication time of mice and restore their behavioral ability, showing potential to alleviate hangovers. After long-term drinking, extract B accelerates alcohol metabolism by increasing alcohol-metabolizing enzymes, protects the liver by inhibiting oxidative stress, and improves liver function. It also has a therapeutic effect on gastric tissue damage caused by long-term drinking.

[0172] The above experiments showed that extract B of the traditional Chinese medicine composition significantly reduced BAC in mice with alcoholic liver injury; significantly improved liver function in mice with alcoholic liver injury (reducing serum AST and ALT levels); alleviated alcohol-induced pathological damage to liver tissue (reducing hepatocyte necrosis); enhanced the liver's antioxidant defense capacity (increasing SOD and GSH-Px activity) and inhibited lipid peroxidation (reducing MDA level); improved the pathological state of gastric tissue in mice with alcoholic liver injury and alleviated gastric inflammation (reducing NO level); and increased the activity of key alcohol-metabolizing enzymes (ADH, CAT, ALDH). Furthermore, combined with previous experimental results (shortening the time to recovery from intoxication, improving post-recovery activity and behavioral indicators), extract B exhibited a comprehensive ameliorative effect on both acute alcohol poisoning and alcoholic liver injury.

[0173] In summary, the experimental data demonstrate that extract A of the traditional Chinese medicine composition possesses the effects of relieving alcohol intoxication, protecting the liver, and protecting the stomach, and the combination of kudzu flower, schisandra fruit, and Japanese raisin tree fruit exhibits a synergistic effect. Extract B of the traditional Chinese medicine composition has the effects of relieving alcohol intoxication, alleviating behavioral abnormalities after drinking, and combating alcoholic liver and stomach damage. The extraction rate of extract A is 26.6%, and when the raw drug dosage is 10 g / kg, it is equivalent to an extract dosage of 2.66 g / kg. The extraction rate of extract B is 4.4%, and when the raw drug dosage is 5 g / kg and 10 g / kg, it is equivalent to extract dosages of 0.22 g / kg and 0.44 g / kg, respectively. Based on the above extraction rate and equivalent dosage data, under the premise of achieving comparable or even superior therapeutic effects, the dosage required for extract B is significantly lower than that for extract A. Extract B has therapeutic effects on acute alcohol poisoning and alcoholic liver damage, and can effectively alleviate behavioral abnormalities after drinking. Combined with its significantly low dosage characteristics, extract B has a clear advantage in improving patient medication adherence and potentially reducing the risk of dose-related adverse reactions.

[0174] Based on the analysis of existing similar products and technologies, the outstanding advantages of this traditional Chinese medicine composition are as follows:

[0175] (1) Simplified formulation:

[0176] Compared to relevant patent literature retrieved (especially prior art related to this invention's patent applications), this composition consists of only three medicinal herbs. The formula is concise, the ingredients are relatively simple, and it effectively exerts its hangover-relieving effect through the synergistic effect between the herbs.

[0177] (2) The preparation process is suitable for industrial production:

[0178] Both extracts A and B are prepared using water as the extraction solvent, eliminating the need for organic solvents and thus exhibiting environmentally friendly characteristics. The process flow is simple, key process parameters are highly controllable, and it possesses good scalability and industrial production potential.

[0179] (3) Comprehensive efficacy verification:

[0180] Existing patented technologies related to hangover relief generally suffer from the problem of using only single evaluation indicators, typically focusing only on shortening the duration of intoxication and a few liver function indicators. This patented study, however, constructs a more comprehensive efficacy evaluation system, systematically examining changes in histopathology and biochemical indicators of major organs such as the liver and stomach, from sobering-up time and post-drunken behavioral manifestations. This system provides multi-dimensional experimental data support for the hangover relief, liver protection, and stomach protection effects of the traditional Chinese medicine composition extracts A and B, significantly enhancing the persuasiveness of the product's efficacy.

[0181] Although embodiments of the invention have been disclosed for illustrative purposes, those skilled in the art will understand that various substitutions, variations, and modifications are possible without departing from the spirit and scope of the invention and the appended claims. Therefore, the scope of the invention is not limited to the contents disclosed in the embodiments.

Claims

1. A traditional Chinese medicine composition for relieving hangovers and protecting the liver, characterized in that, It consists of the following raw materials in parts by weight: 20-60 parts of kudzu flower, 12-48 parts of Japanese raisin tree fruit, and 5-15 parts of schisandra fruit.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The weight parts of the raw materials are: 50 parts of kudzu flower, 30 parts of Japanese raisin tree fruit, and 12 parts of schisandra fruit.

3. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: (1) Grind kudzu flower, Japanese raisin tree fruit, and schisandra fruit into powder and mix them to obtain mixed raw materials; (2) Soak the mixed raw materials in water and extract them twice at 80-100℃ for 2-4 hours each time, and combine the extracts; (3) Concentrate the extract to 1 / 3-1 / 5 of its original volume; (4) The concentrated liquid is dried to obtain the Chinese herbal composition extract A.

4. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: (1) Grind kudzu flower, Japanese raisin tree fruit, and schisandra fruit into powder and mix them to obtain mixed raw materials; (2) Soak the mixed raw materials in water and extract them twice at 80-100℃ for 2-4 hours each time, and combine the extracts; (3) Concentrate the extract to 1 / 3-1 / 5 of its original volume; (4) Centrifuge the concentrate at 12,000-15,000 rpm for 15-30 min and take the supernatant; (5) Dialyze the supernatant for 24 hours using a dialysis bag with a molecular weight cutoff of 3000-4000 Da. The dialysis fluid is deionized water. (6) Take the liquid in the dialysis bag and filter it through a 0.45μm filter membrane. Dry the filtrate to obtain the traditional Chinese medicine composition extract B.

5. The preparation method according to claim 3 or 4, characterized in that: In step (2), the ratio of raw materials to water is 1:5-1:20 g / mL.

6. The preparation method according to claim 3 or 4, characterized in that: The drying process is freeze drying, spray drying, or vacuum drying.

7. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicine for treating acute alcohol poisoning.

8. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for treating alcoholic liver injury.

9. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament having at least one of the following effects: (a) relieving hangovers and protecting the liver; (b) protecting the gastric mucosa; (c) promoting alcohol excretion.

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