A traditional Chinese medicine composition with alcoholism-preventing and liver-protecting activities, and a preparation method and application thereof

Abstract

The application provides a traditional Chinese medicine composition with alcoholism relieving and liver protecting activity, a preparation method and application, and relates to the technical field of traditional Chinese medicine compositions.The traditional Chinese medicine composition is composed of radix puerariae, mentha, poria cocos, chrysanthemum, mace, prunus mume, curcuma longa and hovenia acerba; has good alcoholism relieving effect, can prolong alcohol tolerance time and significantly shorten alcoholism relieving time; has prevention and treatment effects on alcoholic liver injury, can effectively improve the liver injury of serum of alcoholic liver injury mice and the activities of ALT, AST, ADH and ALDH, and has good drunkness preventing, alcoholism relieving and liver protecting activity.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, specifically to a traditional Chinese medicine composition with hangover-relieving and liver-protecting activities, its preparation method, and its application. Background Technology

[0002] As an important carrier of traditional Chinese culture, alcohol has been consumed for thousands of years. Ancient Chinese medical texts have a systematic understanding of the medicinal properties of alcohol. The *Huangdi Neijing* records that alcohol is "the essence of water and grain," and that moderate consumption can harmonize the body's vital energy and blood circulation. Ancient people also often used alcohol as a medicinal guide to enhance the efficacy of medicines and achieve health benefits and dispel cold. However, the *Ben Cao Jing Ji Zhu* clearly states that alcohol is "extremely hot and toxic," and Zhu Danxi proposed the view that "alcohol is damp in nature," indicating that excessive drinking inevitably leads to health risks. After alcohol enters the body, 90% needs to be metabolized by the liver, successively converted into acetaldehyde and acetic acid before being excreted. If the intake exceeds the liver's metabolic capacity in a short period, ethanol and its intermediate metabolites will accumulate and damage liver cells, causing acute liver injury. Long-term alcoholism may induce alcoholic liver disease, cardiovascular disease, and digestive tract diseases, and in severe cases, liver transplantation may be necessary. Therefore, the development of drugs for relieving hangovers and protecting the liver has significant clinical value and market demand.

[0003] Current technologies for the prevention and treatment of alcohol-related injuries have significant limitations. While commonly used hepatoprotective drugs such as silymarin, bicyclol, and glutathione can improve liver biochemical indicators and slow disease progression to some extent, they are insufficient to reverse hepatocellular damage or restore normal liver function. Western medicine treatments for alcohol poisoning often employ symptomatic approaches such as emetics, metabolism promoters, and sedation. These drugs typically target single symptoms, requiring combination therapy to cover the entire course of the disease, and carry the risk of side effects. The hangover remedies on the market also have obvious shortcomings. Most existing Chinese medicine hangover remedies are based on a single or a few herbs. For example, the kudzu flower and medicated leaven compound disclosed in patent CN106309959A can only relieve mild alcohol poisoning. Although the mulberry and kudzu flower formula in patent CN112220907A also has a liver-protecting effect, the overall efficacy is limited. Most products can only relieve superficial discomfort such as dizziness and nausea, which is a problem of "treating the symptoms but not the root cause". There is a lack of highly effective and safe preparations that can quickly relieve hangovers and prevent drunkenness, and can also protect liver cells and prevent alcoholic liver damage from the root.

[0004] Traditional Chinese medicine (TCM) has a profound theoretical foundation and practical basis for the diagnosis and treatment of alcohol-related illnesses. Ancient texts categorize alcohol poisoning under terms such as "alcohol poisoning," "alcohol accumulation," and "alcohol jaundice," and record various medicinal and edible herbs with anti-alcohol and liver-protecting effects, including Hovenia dulcis, Pueraria lobata, Poria cocos, and Pueraria lobata flower. Li Gao, in his "Treatise on the Spleen and Stomach," proposed the principle of "sweating and purging" for treating alcohol poisoning, and his "Pueraria lobata flower decoction for alcohol poisoning" became a classic formula, providing a theoretical basis for the development of compound formulas in later generations. Although modern patent literature reports various TCM combinations for alcohol poisoning, most formulas still have room for improvement in terms of the rationality of herb compatibility and synergistic effects. Some products, due to their complex composition or the presence of non-medicinal and edible herbs, pose safety risks.

[0005] In conclusion, it is particularly important to design a traditional Chinese medicine composition that uses medicinal and edible materials and effectively improves alcoholic liver damage. Summary of the Invention

[0006] To address the aforementioned technical problems, the present invention aims to provide a traditional Chinese medicine composition with hangover-relieving and liver-protecting activities.

[0007] A traditional Chinese medicine composition with hangover-relieving and liver-protecting activities, comprising the following components in parts by weight: 25-30 parts of kudzu root, 10-15 parts of peppermint, 22.5-25 parts of poria cocos, 5-10 parts of chrysanthemum, 10-15 parts of nutmeg, 10-15 parts of dried plum, 10-20 parts of turmeric, and 15 parts of jujube.

[0008] Furthermore, the traditional Chinese medicine composition consists of the following components in parts by weight: 25-30 parts of kudzu root, 10-15 parts of peppermint, 22.5-25 parts of poria cocos, 5-7.5 parts of chrysanthemum, 10-15 parts of nutmeg, 10-15 parts of dried plum, 10-15 parts of turmeric, and 15 parts of jujube.

[0009] The preparation method of the above-mentioned traditional Chinese medicine composition is as follows: soak the traditional Chinese medicine composition in water; decoct; filter; take the filtrate and heat to concentrate.

[0010] Furthermore, the preparation method of the traditional Chinese medicine composition includes the following steps:

[0011] (1) Take the Chinese herbal medicine composition, weigh the medicinal materials according to the weight ratio, add ten times the amount of purified water to soak for 12 hours, decoct for 2 hours and filter; (2) Take the dregs, add ten times the amount of purified water, boil again for 2 hours and filter; (3) Combine the filtrates and heat to concentrate.

[0012] The above-mentioned traditional Chinese medicine composition has the following applications: (1) Application in the preparation of anti-drunkenness and hangover remedies or health products; (2) Application in the preparation of drugs for the prevention or treatment of alcohol poisoning; (3) Application in the preparation of drugs for the prevention or treatment of alcoholic liver injury; (4) Application in the preparation of health products for the prevention of alcoholic liver damage.

[0013] The above-mentioned traditional Chinese medicine composition is prepared into granules, powders, oral liquids or capsules.

[0014] The preparation method of the above-mentioned compound Chinese herbal hangover remedy granules is as follows: (1) Take any one of the traditional Chinese medicine compositions according to claims 1-2, soak it in ten times the amount of purified water for 12 hours, decoct and extract twice, and combine the filtrates; (2) Concentrate the filtrate by heating; (3) Using lactose as an excipient, wet granulation is performed and the granules are dried to obtain granules.

[0015] Preferably, in step (2), the filtrate is combined and then heated and concentrated to 100 mL; in step (3), wet granules are made with lactose as an excipient, extruded through a 14-mesh sieve, dried at 50°C for 2 hours in a drying oven, and then the dried granules are sized through a 16-mesh sieve to obtain granules.

[0016] Preferably, the mass ratio of the concentrate to lactose is 1:4.8.

[0017] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of hangover relief and liver protection drugs.

[0018] The present invention also provides a traditional Chinese medicine composition with hangover relief and liver protection activity, which is composed of kudzu root, peppermint, poria cocos, chrysanthemum, nutmeg, dried plum, turmeric, and jujube.

[0019] Preferably, the mass ratio of kudzu root, peppermint, poria cocos, chrysanthemum, nutmeg, dried plum, turmeric, and jujube is 12:6:9:3:4:6:6:6.

[0020] Preferably, the traditional Chinese medicine composition consists of the following components in parts by weight: 30g of kudzu root, 15g of peppermint, 22.5g of poria cocos, 7.5g of chrysanthemum, 10g of nutmeg, 15g of dried plum, 15g of turmeric, and 15g of jujube.

[0021] Secondly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, the method being: taking the traditional Chinese medicine composition, adding water and boiling; filtering; taking the filtrate, heating and concentrating to obtain the final product.

[0022] Preferably, the method for using traditional Chinese medicine composition includes the following steps: (1) Take the Chinese herbal medicine composition, add ten times the amount of purified water to soak for 12 hours, decoct for 2 hours and filter; (2) Take the dregs, add ten times the amount of purified water, boil again for 2 hours and filter; (3) Combine the filtrates and heat to concentrate.

[0023] Preferably, step (3) involves heating and concentrating the solution to 1.1 g / mL.

[0024] Thirdly, the present invention provides an application of the above-mentioned traditional Chinese medicine composition in the preparation of a hangover remedy and liver-protecting drug.

[0025] In the herbal combination of this application: The principal herbs (primarily for detoxifying alcohol): kudzu root and jujube.

[0026] Kudzu root relieves muscle tension and promotes sweating, while Japanese raisin tree fruit (Hovenia dulcis) clears heat, promotes urination, and relieves thirst and irritability. Both are classic Chinese medicine herbs for "detoxifying alcohol," acting directly on the entire process of alcohol metabolism. They play a key role in accelerating ethanol decomposition and alleviating thirst and irritability after drinking, hence they are the principal herbs.

[0027] Assistant herbs (to assist in protecting the liver and spleen): Turmeric and Poria.

[0028] Turmeric promotes qi circulation, removes blood stasis, unblocks meridians, and relieves pain, focusing on preventing and treating liver qi stagnation and blood stasis caused by alcohol; Poria strengthens the spleen and promotes diuresis, guiding the damp-heat generated by alcohol to be excreted through urine. The two work synergistically with the principal herb to enhance the therapeutic effect from both "liver protection" and "dampness removal" aspects, hence they are considered assistant herbs.

[0029] Adjuvant herbs (for regulating the spleen and stomach and clearing heat): dried plum, nutmeg, and chrysanthemum.

[0030] Ume plum astringes the lungs, promotes the production of body fluids, and astringes the intestines to stop diarrhea; nutmeg warms the middle jiao, promotes qi circulation, and astringes the intestines to stop diarrhea. Together, they address symptoms such as gastrointestinal dysfunction, nausea, and vomiting after drinking alcohol. Chrysanthemum clears the liver, improves eyesight, and disperses wind-heat, targeting the excessive liver fire caused by alcohol consumption. These three ingredients play a supporting role in regulating and moderating the effects of the other herbs, thus serving as adjuvant herbs.

[0031] Guide herbs (for directing other herbs upwards and clearing the channels): Peppermint.

[0032] Peppermint, with its light and ascending properties, has the effects of dispersing wind-heat and clearing the head and eyes. It can guide the medicinal power upwards, directly reaching the head and face affected by alcohol, relieving headaches and dizziness after drinking, and harmonizing other medicines, thus serving as an adjuvant.

[0033] The traditional Chinese medicine composition provided by this invention can accelerate ethanol metabolism, reduce blood alcohol concentration, prolong alcohol tolerance time, and significantly shorten sobering time, thus having a good sobering effect; it can relieve symptoms of discomfort after drinking such as headache and nausea, and can effectively improve liver damage and ADH and ALDH activity in the serum of mice with alcoholic liver injury, thus having good anti-drunkenness, sobering and liver-protecting activities. Detailed Implementation

[0034] To make the objectives, technical solutions, and advantages of the present invention clearer, the present invention will be further illustrated by the following embodiments. However, the following embodiments are illustrative and are only used to specifically describe the present invention, and not to limit the present invention.

[0035] Example 1 Example 1 of this invention provides a method for preparing a traditional Chinese medicine composition with hangover relief and liver protection effects, comprising the following steps: Take 30g of kudzu root, 15g of peppermint, 22.5g of poria cocos, 7.5g of chrysanthemum, 10g of nutmeg, 15g of dried plum, 15g of turmeric, and 15g of jujube. Place them in a decoction pot, add 10 times the amount of purified water, soak for 12 hours, then decoct for 2 hours. Filter and extract the filtrate. Perform a second extraction on the dregs, adding 10 times the amount of purified water again, without soaking, and decoct for 2 hours. After decoction, combine the two filtrates and concentrate to a relative density of 1.1 (60℃).

[0036] Example 2 Example 2 of this invention provides a method for preparing a traditional Chinese medicine composition with hangover relief and liver protection effects. The difference from Example 1 is that the weights of each raw material are as follows: 30g of kudzu root, 15g of peppermint, 22.5g of poria cocos, 7.5g of chrysanthemum, 10g of nutmeg, 15g of dried plum, 15g of turmeric, and 15g of jujube.

[0037] Example 3 Example 3 of this invention provides a method for preparing a traditional Chinese medicine composition with hangover relief and liver protection effects. The difference from Example 1 is that the weights of each raw material are: 25g of kudzu root, 10g of peppermint, 25g of poria cocos, 10g of chrysanthemum, 15g of nutmeg, 15g of dried plum, 10g of turmeric, and 15g of jujube.

[0038] Example 4 Example 4 of this invention provides a method for preparing a traditional Chinese medicine composition with hangover relief and liver protection effects. The difference from Example 1 is that the weights of each raw material are: 30g of kudzu root, 10g of peppermint, 25g of poria cocos, 5g of chrysanthemum, 10g of nutmeg, 10g of dried plum, 20g of turmeric, and 15g of jujube.

[0039] Example 5 Example 5 of the present invention provides a method for preparing a traditional Chinese medicine composition with hangover relief and liver protection effects. The difference from Example 1 is that 10 times the amount of purified water is added for the first time, without soaking, and the mixture is decocted for 2 hours.

[0040] The weight parts of each raw material component in Examples 1-5 are shown in Table 1:

[0041] Verification Example 1 Investigation of the optimal induced intoxication dose in mice laboratory animals Twenty-five SPF-grade male KM mice, weighing 18-22g and aged 6-8 weeks, were selected. They were housed in a barrier environment and acclimatized for 3-5 days before the experiment.

[0042] Experimental methods Twenty-five SPF-grade male KM mice were selected and fasted for 12 hours with free access to water. The mice were weighed, marked, and randomly divided into five groups of five mice each, with data recorded. Based on the mice's body weight, different doses of 56° Red Star Erguotou liquor were administered by gavage: Group 1 received 10.00 mL / kg of liquor; Group 2 received 12.50 mL / kg; Group 3 received 15.00 mL / kg; Group 4 received 17.50 mL / kg; and Group 5 received 20.00 mL / kg.

[0043] The timing of administering baijiu (a type of Chinese liquor) to mice was initiated by gavage. The mice's behavior was observed and recorded, and the time when the righting reflex disappeared was recorded as the mouse's tolerance time. The timing of the return of the righting reflex after its disappearance was also initiated by gavage, and the time when it reappeared was recorded as the mouse's sobering-up time. Within 24 hours of gavage administration, the mice were regularly observed for mortality. An acute alcohol intoxication model in mice was established using the dose that resulted in the highest rate of intoxication and the lowest mortality rate, thus determining the optimal dosage.

[0044] The results of gavage experiments on mice with different alcohol gradients are shown in Table 2. Alcohol doses exceeding 15.00 mL / kg resulted in death; at alcohol doses below 15.00 mL / kg, although all mice survived, some were not intoxicated; while at an alcohol dose of 15.00 mL / kg, almost all mice survived, and the intoxication rate was 100%, with all mice in a state of complete intoxication. Therefore, the following examples selected an alcohol dose of 15.00 mL / kg for experiments on anti-drunkenness, alcohol detoxification, and liver protection activity.

[0045] Table 2 Results of the acute alcohol intoxication model in mice (n=5)

[0046] As shown in Table 2, the intoxication rate in mice increased significantly with increasing oral alcohol dosage, while mortality began to occur after the dosage exceeded 15.00 mL / kg. At a dosage of 15.00 mL / kg, the intoxication rate in mice reached 100% without any deaths, effectively establishing an acute intoxication model without causing fatal toxicity. Therefore, this dosage was determined as the optimal dosage for evaluating the efficacy of the present invention.

[0047] Verification Example 2 Mouse alcohol metabolism and detoxification experiment Twenty-five SPF-grade male mice were selected and fasted for 12 hours with unlimited access to water. The mice were weighed, marked, and randomly divided into five groups of five mice each: a model group, a positive control group, a low-dose hangover remedy group, and a high-dose hangover remedy group. Records were kept. The model group was administered 10.00 mL / kg of physiological saline by gavage, the positive control group was administered 13.00 mL / kg of Haiwang Jinzun oral liquid (a commercially available product), and the low-dose and high-dose groups were administered 10.00 mL / kg of a low-concentration and a high-concentration traditional Chinese medicine composition, respectively. The traditional Chinese medicine composition used was the one obtained in Example 1. Thirty minutes after the last gavage, 15.00 mL / kg of 56° Hongxing Erguotou liquor was administered by gavage. The intoxication rate, tolerance time, and sobering-up time were measured.

[0048] The results of the alcohol metabolism and detoxification experiment in mice are shown in Table 3. Compared with the model group, the alcohol tolerance time of the positive group, low-dose group, and high-dose group were significantly different (P<0.01); compared with the model group, the sobering-up time of the low-dose group was different (P<0.05), and the sobering-up time of the positive group and the high-dose group were significantly different (P<0.01). The results indicate that this detoxification formula can prolong the alcohol tolerance time and shorten the sobering-up time.

[0049] Table 3. Effects of hangover remedies on the duration of alcohol tolerance and sobering up in mice (n=5)

[0050] Note: Compared with the model group, P<0.05, P<0.01.

[0051] As shown in Table 3, compared with the model group that was only administered saline by gavage, the mice that took the herbal composition of this invention had an alcohol tolerance time of approximately 6 times longer under the same alcohol load, while their sobering-up time decreased sharply from 400±10 min to 60±10 min. This significant difference (P<0.01) strongly demonstrates that the composition of this invention can not only effectively improve the body's resistance to alcohol and delay the onset of intoxication, but also greatly accelerate the sobering-up process after intoxication.

[0052] Example 3 Acute alcohol intoxication experiment in mice The traditional Chinese medicine composition selected was the one obtained in Example 1. 1. Hangover relief effect Twenty-five mice were randomly divided into five groups of five each: a control group, a model group, a positive control group, a low-dose group, and a high-dose group. The model group was administered 10.00 mL / kg of physiological saline by gavage, the positive control group was administered 13.00 mL / kg of Haiwang Jinzun oral liquid by gavage, and the low-dose and high-dose hangover remedy groups were administered 10.00 mL / kg of the low-concentration and high-concentration hangover remedy, respectively, for 14 consecutive days. Thirty minutes after the last gavage, the model group, positive control group, low-dose group, medium-dose group, and high-dose group were administered 15.00 mL / kg of 56° Hongxing Erguotou (a type of Chinese liquor), while the control group was administered the same volume of physiological saline by gavage.

[0053] On the last day, 90 minutes after gavage, blood was collected from the orbital rim. Immediately after blood collection, the liver was dissected, and the liver was placed in a 2mL cryovial, flash-frozen in liquid nitrogen, and then stored at -80°C for later analysis. The activities of ADH and ALDH, the alcohol-degrading markers, in mouse liver homogenate were determined according to the ADH and ALDH detection kit instructions.

[0054] 2. Liver-protective effect The administration regimen was the same as described in section 1. On the last day, 90 minutes after gavage, blood was collected from the orbital rim. After standing at room temperature for 1 hour, the blood was centrifuged for 15 minutes at 3500 rpm using a microcentrifuge at 4°C. The supernatant serum was collected and separated. Simultaneously, liver tissue was collected in 2 mL cryovials, flash-frozen in liquid nitrogen, and then stored at -80°C for analysis. The activities of each indicator in the serum of mice in each group were measured according to the instructions of the ALT and AST assay kits.

[0055] 3. Results The results of the detection of ADH and ALDH activity indicators for alcohol detoxification are shown in Table 4. Compared with the blank group, the ADH content in the model group was lower (P<0.01). Compared with the model group, the ADH and ALDH activities in each dose group were significantly increased (P<0.01).

[0056] Table 4. Effects of hangover remedies on ADH and ALDH levels in mouse liver tissue (n=5)

[0057] Note: Compared with the control group, P < 0.01; compared with the model group, P < 0.01; P < 0.05.

[0058] As shown in Table 4, the ADH (alcohol dehydrogenase) content in the liver tissue of the model group mice was significantly lower than that in the blank group, indicating that alcohol intake inhibited the activity of metabolic enzymes. However, after taking the drug solution obtained in the example, the activities of both ADH and ALDH (acetaldehyde dehydrogenase) significantly rebounded and were superior to those in the model group (P<0.01, P<0.05). This confirms from a molecular biological perspective that the present invention achieves its alcohol detoxification and liver protection mechanism by upregulating the activity of key metabolic enzymes in the liver, thereby accelerating alcohol breakdown and reducing the metabolic burden on the liver.

Claims

1. A traditional Chinese medicine composition with hangover-relieving and liver-protecting activities, characterized in that, The traditional Chinese medicine composition consists of the following components in parts by weight: 25-30 parts of kudzu root, 10-15 parts of peppermint, 22.5-25 parts of poria cocos, 5-10 parts of chrysanthemum, 10-15 parts of nutmeg, 10-15 parts of dried plum, 10-20 parts of turmeric, and 15 parts of jujube.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following components in parts by weight: 25-30 parts of kudzu root, 10-15 parts of peppermint, 22.5-25 parts of poria cocos, 5-7.5 parts of chrysanthemum, 10-15 parts of nutmeg, 10-15 parts of dried plum, 10-15 parts of turmeric, and 15 parts of jujube.

3. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-2, characterized in that, The method is as follows: soak the Chinese herbal medicine composition in water; decoct; filter; take the filtrate, heat and concentrate to obtain the final product.

4. The preparation method according to claim 3, characterized in that, The method includes the following steps: (1) Take the Chinese herbal medicine composition, weigh the medicinal materials according to the weight ratio, add ten times the amount of purified water to soak for 12 hours, decoct for 2 hours and filter; (2) Take the dregs, add ten times the amount of purified water, boil again for 2 hours and filter; (3) Combine the filtrates and heat to concentrate.

5. The application of the traditional Chinese medicine composition according to any one of claims 1-2 in the following aspects: (1) Application in the preparation of anti-drunkenness and hangover remedies or health products; (2) Application in the preparation of drugs for the prevention or treatment of alcohol poisoning; (3) Application in the preparation of drugs for the prevention or treatment of alcoholic liver injury; (4) Application in the preparation of health products for the prevention of alcoholic liver damage.

6. The traditional Chinese medicine composition according to any one of claims 1-2, characterized in that, The traditional Chinese medicine composition is prepared into granules, powders, oral liquids, or capsules.

7. A traditional Chinese medicine compound hangover relieving granule, characterized in that, The preparation method of the traditional Chinese medicine compound hangover relieving granules is as follows: (1) Take the traditional Chinese medicine composition according to any one of claims 1-2, soak it in ten times the amount of purified water for 12 hours, decoct and extract twice, and combine the filtrates; (2) Concentrate the filtrate by heating; (3) Using lactose as an excipient, wet granulation is performed and the granules are dried to obtain granules.

8. The traditional Chinese medicine compound hangover relieving granules according to claim 7, characterized in that, In step (2), the filtrate is combined and then heated and concentrated to 100 mL; in step (3), wet granules are made with lactose as an excipient, extruded through a 14-mesh sieve, dried at 50°C for 2 hours in a drying oven, and then the dried granules are sized by passing through a 16-mesh sieve to obtain granules.

9. The traditional Chinese medicine compound hangover relieving granules according to claim 8, characterized in that, The mass ratio of the concentrate to lactose is 1:4.

8.

10. The use of a traditional Chinese medicine composition as described in any one of claims 1 to 2, or a traditional Chinese medicine composition prepared by the preparation method as described in any one of claims 3 to 4, in the preparation of a hangover remedy and liver-protecting drug.

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