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

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition with hangover-alleviating and liver-protecting effects and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines: semen hoveniae, flos puerariae, rhizoma gastrodiae, pericarpium citri reticulatae, poria cocos, rhizoma alismatis, herba artemisiae scopariae, gynostemma pentaphylla, roasted rhizoma atractylodis macrocephalae, cortex magnoliae officinalis, radix paeoniae alba and honey-fried licorice root. The traditional Chinese medicine composition disclosed by the invention has the effects of relieving alcoholism, resolving damp turbidity, clearing liver and gallbladder and strengthening spleen soil. The traditional Chinese medicine composition disclosed by the invention is particularly suitable for patients suffering from alcohol fever, alcoholic liver, hyperlipidemia and liver and gall diseases mainly caused by damp turbidity and alcohol toxicity. Experimental results show that the traditional Chinese medicine composition has a good treatment effect on acute alcoholic liver injury and chronic alcoholic fatty liver, so that the traditional Chinese medicine composition has a relatively good development and utilization prospect.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition with the effects of relieving alcoholism and protecting liver, and a preparation method and application thereof. BACKGROUND

[0002] Since the liver is the key place for alcohol metabolism, and is also the earliest and most damaged tissue, the morbidity and mortality of alcoholic liver disease (ALD) caused thereby cannot be underestimated. The pathogenesis of alcoholic liver disease is relatively complex, and may be caused by the cross action of various driving factors such as cell damage, oxidative stress, and dysbiosis. Alcoholic fatty liver disease (AFLD) refers to the accumulation of lipid in liver cells caused by long-term heavy drinking, which exceeds 5% of the liver wet weight, or more than 1 / 3 of the liver cells per unit area have fatty degeneration, which is manifested as the deposition of fat in liver cells.

[0003] At present, there is no effective therapeutic drug for alcoholic liver disease. Abstinence is recognized as the best way to prevent or treat this disease. In addition, western medicine for relieving alcoholism mainly adopts the ways of diuresis and symptomatic treatment (for example, giving naloxone to a drunkard), but these ways only have certain curative effect on acute alcoholism or acute alcoholic liver damage, but have no effect on the organ damage caused by chronic alcoholism, especially chronic alcoholic fatty liver.

[0004] In recent years, the effects of traditional Chinese medicine on relieving alcoholism and protecting liver have been continuously verified, various researches on traditional Chinese medicine for treating alcoholic liver disease are also widely and deeply carried out, and the mechanisms of traditional Chinese medicine in playing the effects have also been gradually revealed. According to traditional Chinese medicine theory, alcoholic fatty liver belongs to the categories of “alcoholic distension”, “alcoholic jaundice”, and “alcoholic tympanites”, and the etiology and pathogenesis is long-term heavy drinking, which damages the liver and spleen due to damp-heat evil, the liver loses the function of dredging and the spleen loses the function of transportation, the qi and blood are not in harmony, the phlegm-dampness is internally generated, and the phlegm-dampness and heat are mutually blocked, finally leading to the formation of the syndrome of deficiency in the root and excess in the branch or deficiency and excess, and the syndrome types include alcohol-dampness and stasis accumulation type, liver collateral damaged by damp-heat and stasis type, and liver yin deficiency and stasis toxin accumulation type.

[0005] For example, Chinese patent application CN118831125A discloses a traditional Chinese medicine composition with the effects of protecting liver, relieving alcoholism and reducing lipid, and a preparation method thereof. The preparation raw materials are composed of the following components in mass fraction: 2-6 parts of Chinese jujube fruit, 1-5 parts of Rubus corchorifolius L.f., 1-4 parts of orange peel, and 0.5-3 parts of licorice. The traditional Chinese medicine composition has the effects of protecting liver, relieving alcoholism, nourishing stomach and reducing lipid, and can be used for people who drink alcohol. Chinese patent application CN118831146A discloses a traditional Chinese medicine composition for relieving alcoholism, protecting liver and preventing hangover, and a preparation method thereof. The traditional Chinese medicine composition is prepared by a microbial fermentation method, and the ingredients mainly use traditional Chinese medicinal materials with the same effects on food and medicine. The main components include radix scrophulariae, rhizoma alismatis, flos puerariae, and Chinese jujube fruit. However, the traditional Chinese medicine compositions for relieving alcoholism and protecting liver on the market generally have the disadvantages of unscientific prescription composition, high drug cost, unreasonable administration mode, and insignificant treatment effect.

[0006] Therefore, in order to meet the clinical treatment requirements, the inventors have developed a series of traditional Chinese medicine compositions for relieving alcoholism and protecting liver, which have good curative effects, no toxic side effects, easily available raw materials, and low cost. SUMMARY

[0007] The present application aims to overcome the deficiencies in the prior art, and provides a traditional Chinese medicine composition with the effects of relieving alcoholism and protecting liver, and a preparation method and use thereof.

[0008] Specifically, the present application is realized through the following technical solutions:

[0009] In a first aspect, the present application provides a traditional Chinese medicine composition with the effects of relieving alcoholism and protecting liver, which is prepared from the following raw medicinal materials in weight fraction: 5-50 parts of Chinese jujube fruit, 5-50 parts of flos puerariae, 5-40 parts of rhizoma gastrodiae, 5-40 parts of pericarpium citri reticulatae, 1-30 parts of poria cocos, 1-30 parts of rhizoma alismatis, 5-40 parts of herba artemisiae, 5-40 parts of gynostemma pentaphyllum, 1-30 parts of fried atractylodes rhizome, 5-40 parts of magnolia officinalis, 1-20 parts of radix paeoniae alba, and 1-20 parts of fried licorice.

[0010] As an optional mode, in the above traditional Chinese medicine composition, the traditional Chinese medicine composition is prepared from the following raw medicinal materials in weight fraction: 5-30 parts of Chinese jujube fruit, 5-30 parts of flos puerariae, 5-20 parts of rhizoma gastrodiae, 5-20 parts of pericarpium citri reticulatae, 1-15 parts of poria cocos, 1-15 parts of rhizoma alismatis, 5-20 parts of herba artemisiae, 5-20 parts of gynostemma pentaphyllum, 1-15 parts of fried atractylodes rhizome, 5-20 parts of magnolia officinalis, 1-15 parts of radix paeoniae alba, and 1-15 parts of fried licorice.

[0011] As an optional mode, in the above traditional Chinese medicine composition, the traditional Chinese medicine composition is prepared from the following raw medicinal materials in weight fraction: 15 parts of Chinese jujube fruit, 15 parts of flos puerariae, 12 parts of rhizoma gastrodiae, 12 parts of pericarpium citri reticulatae, 9 parts of poria cocos, 9 parts of rhizoma alismatis, 12 parts of herba artemisiae, 12 parts of gynostemma pentaphyllum, 9 parts of fried atractylodes rhizome, 12 parts of magnolia officinalis, 6 parts of radix paeoniae alba, and 6 parts of fried licorice.

[0012] As an optional mode, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition has the effects of resolving alcohol toxicity, removing dampness and turbidity, resolving liver and gallbladder, and supporting spleen and earth.

[0013] In a second aspect, the present application provides a preparation method of the traditional Chinese medicine composition of the first aspect, which comprises the following steps: crushing the following components: Fructus Hoveniae, Flos Puerariae, Gastrodia, Pericarpium Citri Reticulatae, Poria, Alisma, Herba Artemisiae Scopariae, Gynostemma, Fried Atractylodes, Magnolia Officinalis, Radix Paeoniae Alba, and Radix Glycyrrhizae, and then decocting them with water, mixing the filtrate, and preparing a concentrated liquid through concentration.

[0014] As an optional mode, in the above-mentioned preparation method, the decoction is performed twice, the first time of decoction is filtered after 1-3 hours to obtain a first filtrate, the filter residue is added with water and decocted for 1-3 hours to obtain a second filtrate, and the first filtrate and the second filtrate are combined.

[0015] As an optional mode, in the above-mentioned preparation method, the solid-liquid ratio of the first decoction and the second decoction is 1:4, the decoction time of the first decoction and the second decoction is 2 hours, and the water used in the first decoction and the second decoction is distilled water; preferably, the concentration is reduced pressure concentration.

[0016] In a third aspect, the present application provides a use of the traditional Chinese medicine composition of the first aspect or the traditional Chinese medicine composition prepared by the preparation method of the second aspect in the preparation of a medicine for treating alcoholic liver disease.

[0017] As an optional mode, in the above-mentioned use, the alcoholic liver disease is acute alcoholic liver injury and / or chronic alcoholic fatty liver.

[0018] Preferably, the medicine is suitable for patients with alcoholism, alcoholic liver, hyperlipidemia, and liver and gallbladder diseases mainly caused by dampness and turbidity and alcohol toxicity.

[0019] As an optional mode, in the above-mentioned use, the dosage form of the medicine is granules, tablets, oral liquid, or capsules.

[0020] Compared with the prior art, the present application has the following beneficial effects:

[0021] (1) The traditional Chinese medicine composition of the present application has the effects of resolving alcohol toxicity, removing dampness and turbidity, resolving liver and gallbladder, and supporting spleen and earth. The traditional Chinese medicine composition of the present application is particularly suitable for patients with alcoholism, alcoholic liver, hyperlipidemia, and liver and gallbladder diseases mainly caused by dampness and turbidity and alcohol toxicity.

[0022] (2) The experimental results show that the traditional Chinese medicine composition of the present application has good therapeutic effects on acute alcoholic liver injury and chronic alcoholic fatty liver, and therefore has good development and utilization prospects.

[0023] (3) The traditional Chinese medicine composition in the present application is prepared by using modern preparation technology and deep optimization on the basis of traditional Chinese medicine prescription, and has simple preparation method, and the traditional Chinese medicine composition in the present application can be prepared into granules, tablets, oral liquid or capsules and various dosage forms. DETAILED DESCRIPTION

[0024] The traditional Chinese medicine composition has the effects of removing alcohol toxin, removing dampness and turbidity, removing liver and gallbladder and supporting spleen and earth. The traditional Chinese medicine composition is particularly suitable for alcoholism, alcoholic liver, hyperlipidemia and liver and gallbladder diseases mainly caused by dampness and turbidity.

[0025] The effects and indications of each medicinal ingredient in the traditional Chinese medicine composition are shown as follows:

[0026] “Hovenia dulcis Thunb.” is the fruit or seed with fleshy peduncle of Hovenia dulcis Thunb. in Rhamnaceae. It is sweet and sour in taste, and is neutral in nature. It is related to the spleen meridian. It can drain water and relieve edema and remove alcohol toxin. Hovenia dulcis Thunb. has significant diuretic effect, Hovenia dulcis Thunb. saponin has antihypertensive effect, and Hovenia dulcis Thunb. homogenate has the effects of anti-lipid peroxidation and enhancing cold and heat tolerance.

[0027] “Pueraria lobata (Willd.) Ohwi” is the flower of Pueraria lobata (Willd.) Ohwi and P. thomsonii Benth. in Leguminosae. It is sweet in taste and cool in nature. It is related to the spleen and stomach meridians. It can remove alcohol and invigorate the spleen, and stop bleeding. It is used for treating alcoholism, heatiness, thirst, headache, dizziness, abdominal fullness, vomiting, acid regurgitation, loss of appetite, hematemesis and hematochezia. It has the effects of removing alcohol and protecting liver.

[0028] “Gastrodia elata Bl.” is the dried tuber of Gastrodia elata Bl. in Orchidaceae. It is sweet in taste and neutral in nature, and is related to the liver meridian. It has the effects of calming wind and convulsion, suppressing liver yang and removing wind and dredging collaterals. It is used for treating liver wind, convulsion, dizziness, headache, numbness of limbs, hemiplegia and rheumatic arthralgia.

[0029] “Citrus reticulata Blanco” is the dried mature pericarp of Citrus reticulata Blanco and its cultivated varieties in Rutaceae. It is pungent and bitter in taste, and is warm in nature. It is related to the spleen and lung meridians. It has the effects of regulating qi and invigorating the spleen, drying dampness and reducing phlegm. It is used for treating qi stagnation of the spleen and stomach, vomiting, hiccup, damp phlegm, cold phlegm cough and chest stuffiness.

[0030] “Poria cocos (Schw.) Wolf” is the dried sclerotium of Poria cocos (Schw.) Wolf in Polyporaceae. It is sweet and bland, and is neutral. It can drain dampness, promote urination, invigorate the spleen and stomach, calm the heart and tranquilize the mind. It is used for treating dysuria, edema, phlegm and cough, vomiting, spleen deficiency, diarrhea, palpitation, insomnia, forgetfulness and leukorrhea.

[0031] "Zexie" is the dry tuber of Alisma orientalis (Sam.) Juzep. of Alismaceae. It is sweet and cold in nature, and belongs to kidney and urinary bladder meridians. It has the effects of promoting diuresis and removing dampness, and can treat edema, dysuria, diarrhea, oliguria, dizziness due to phlegm, and dysuria with pain.

[0032] "Yinchen" is the dry aboveground part of Artemisia scoparza Waldst.et Kit. or Artemisia capillaris Thunb. of Compositae. It is bitter and pungent in flavor, and cold in nature. It has the effects of clearing damp-heat and promoting bile discharge. It is used to treat jaundice, damp-heat, summer-heat, and pruritus.

[0033] "Guanxuelan" is the whole plant of Gynostemma pentaphyllum (Thunb.) Makino of Cucurbitaceae. It is bitter and slightly sweet in flavor, and cool in nature. It belongs to lung, spleen, and kidney meridians. It has the effects of tonifying qi and spleen, reducing phlegm and relieving cough, and nourishing heart and tranquilizing mind. It is used to treat weakness after illness, deficiency of qi and yin, lung heat and phlegm, and cough, asthma, palpitation, and insomnia.

[0034] "Baizhu" is the rhizome of Atractylodes Macrocephala of Compositae. It is bitter and sweet in flavor, and warm in nature. It belongs to spleen and stomach meridians. It has the effects of tonifying qi and spleen, drying dampness and promoting diuresis, stopping sweating, and stabilizing fetus. It is used to treat deficiency of spleen, poor appetite, abdominal distention and diarrhea, dizziness due to phlegm, edema, sweating, and unstable fetus.

[0035] "Houpu" is the dry bark, root bark, and branch bark of Magnolia officinalis Rehd.et Wils. or Magnolia offinalis Rehd.et Wils. var. biloba Rehd.et Wils. of Magnoliaceae. It is bitter and pungent in flavor, and warm in nature. It belongs to spleen, stomach, lung, and large intestine meridians. It has the effects of drying dampness and reducing phlegm, and can be used to treat dampness in middle-jiao, abdominal fullness, food accumulation and qi stagnation, abdominal distention and constipation, lung qi not descending, phlegm and asthma, dampness and diarrhea, and Meiniqi caused by stagnation of qi and phlegm.

[0036] "Baishao" is the root of Paeonia lactiflora Pall. of Ranunculaceae. It is bitter and sour in flavor, and cold in nature. It belongs to liver and spleen meridians. It has the effects of nourishing blood and yin, soothing liver and relieving pain, and suppressing liver yang. It is used to treat deficiency of liver blood, irregular menstruation, disharmony between liver and spleen, chest and abdominal pain, and tetanus and pain in limbs.

[0037] "Gancao" is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. of Leguminosae. Gancao is flat, sweet in taste, and belongs to heart meridian, stomach meridian, spleen meridian and lung meridian. Gancao can tonify the spleen and boost qi, relieve cough and reduce phlegm, relieve pain and adjust the nature of drugs. It is a kind of qi-tonifying drug. It is used to treat weak spleen and stomach, deficiency of middle qi, cough and asthma, carbuncle and sore, abdominal pain, and to relieve the toxicity of drugs.

[0038] The application will be further described below with reference to specific examples. It should be understood that the specific examples described herein are intended to explain the application, but not to limit the scope of the application.

[0039] If a specific technique or condition is not specified in the examples, the technique or condition described in the literature in the art or according to the product manual is used. If the manufacturer of the reagent or instrument is not specified, it is a conventional product that can be purchased through a regular channel.

[0040] In the following examples, the experimental methods are conventional methods unless otherwise specified. The test materials used in the following examples are commercially available products unless otherwise specified.

[0041] Preparation examples:

[0042] Example 1

[0043] A traditional Chinese medicine composition with the effects of relieving alcoholism and protecting liver, which is made of the following raw medicinal materials: Hovenia dulcis Thunb. 15g, Pueraria lobata 15g, Gastrodia 12g, Citrus reticulata 12g, Poria cocos 9g, Alisma orientalis 9g, Artemisia capillaris 12g, Gynostemma pentaphyllum 12g, Poria cocos 9g, Magnolia officinalis 12g, Paeonia lactiflora 6g, and Glycyrrhiza uralensis 6g.

[0044] The preparation method of the traditional Chinese medicine composition comprises the following steps: grinding Hovenia dulcis Thunb., Pueraria lobata, Gastrodia, Citrus reticulata, Poria cocos, Alisma orientalis, Artemisia capillaris, Gynostemma pentaphyllum, Poria cocos, Magnolia officinalis, Paeonia lactiflora, and Glycyrrhiza uralensis, and then decocting them with water, twice, with a solid-liquid ratio of 1:4, and a decocting time of 2 hours for each time, using distilled water for each time, mixing the filtrates after decocting, and concentrating under reduced pressure to obtain a concentrated solution of 100mL.

[0045] Example 2

[0046] A traditional Chinese medicine composition with the effects of relieving alcoholism and protecting liver, which is made of the following raw medicinal materials: Hovenia dulcis 17g, Flos Puerariae 17g, Gastrodia 10g, Pericarpium Citri Reticulatae Viride 12g, Poria 9g, Alisma 9g, Herba Artemisiae Scopariae 12g, Gynostemma pentaphyllum 10g, Fried Atractylodes 9g, Magnolia officinalis 12g, Radix Paeoniae Alba 6g, and Radix Glycyrrhizae 6g.

[0047] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0048] Comparative Example 1

[0049] A traditional Chinese medicine composition, which is made of the following raw medicinal materials: Hovenia dulcis 21g, Flos Puerariae 21g, Gastrodia 12g, Pericarpium Citri Reticulatae Viride 12g, Poria 9g, Alisma 9g, Herba Artemisiae Scopariae 12g, Fried Atractylodes 9g, Magnolia officinalis 12g, Radix Paeoniae Alba 6g, and Radix Glycyrrhizae 6g.

[0050] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0051] Comparative Example 2

[0052] A traditional Chinese medicine composition, which is made of the following raw medicinal materials: Hovenia dulcis 15g, Flos Puerariae 15g, Fructus Amomi Rotundus 12g, Pericarpium Citri Reticulatae Viride 12g, Poria 9g, Alisma 9g, Herba Artemisiae Scopariae 12g, Gynostemma pentaphyllum 12g, Fried Atractylodes 9g, Magnolia officinalis 12g, Radix Paeoniae Alba 6g, and Radix Glycyrrhizae 6g.

[0053] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0054] Comparative Example 3

[0055] Haiwang Jintan tablet (Shenzhen Haiwang Health Technology Development Co., Ltd.) positive control: grind the Haiwang Jintan tablet, dissolve in deionized water to prepare 100mL of Haiwang Jintan solution 100mg / mL.

[0056] Effect Example

[0057] Effect Example 1: the treatment effect of the traditional Chinese medicine composition on acute alcoholic liver injury

[0058] 63 male (6-8 weeks old, 18-22g) C57BL / 6 mice (purchased from Heilongjiang University of Chinese Medicine Experimental Animal Center) were randomly divided into 7 groups, 9 in each group. They are normal group, model group, Example 1 group, Example 2 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group.

[0059] After the experimental animals were acclimated for one week, the test substances prepared in the "Preparation of Examples" section were administered to the Example 1-2 and Comparative Example 1-3 groups by gavage, with a gavage volume of 0.1 mL / 10 g of body weight. The normal group and the model group were administered physiological saline by gavage, with a gavage volume of 0.1 mL / 10 g of body weight. Gavage was continued for two weeks. Twelve hours after the last gavage, the normal group was administered distilled water by gavage at a dose of 0.1 mL / 10 g of body weight, and the other groups were administered a 50% ethanol solution by gavage at a dose of 0.1 mL / 10 g of body weight. The animals were then fasted, and 12 hours later they were euthanized.

[0060] The blood of the experimental animals in each group was collected using centrifuge tubes containing an anticoagulant, and the livers of the mice in each group were isolated.

[0061] 2. Evaluation index

[0062] 2.1 Determination of serum biochemical index levels

[0063] After the blood samples of the mice in each group were collected and centrifuged at 3000 g for 15 min using a low-speed centrifuge, the supernatant was taken and used to determine the levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in the plasma using a kit.

[0064] 2.2 Determination of liver oxidative damage-related index levels

[0065] After the isolated livers of the mice in each group were washed with ice-cold physiological saline and the water was absorbed with filter paper, a portion of the tissue was taken, physiological saline was added, and homogenization was performed, followed by centrifugation to obtain the supernatant, which was used to determine the levels of glutathione (GSH) and superoxide dismutase (SOD) in the mouse liver tissue using a kit.

[0066] 3. Statistical method

[0067] The results were analyzed using SPSS 27.0 statistical software, and the data were expressed as the mean ± standard deviation. One-way ANOVA was used for comparison among multiple groups, and t-test was used for comparison between two groups. Differences were considered statistically significant at p<0.05.

[0068] 4. Experimental results

[0069] 4.1 Determination results of serum biochemical index levels

[0070] The levels of AST and ALT in the plasma of the mice in each group are shown in Table 1 below. Compared with the normal group, the levels of AST and ALT in the model group were significantly increased, indicating that the modeling was successful. The Example 1 and Example 2 groups had very significant reducing effects on the increases in ALT and AST caused by alcohol ( *** p<0.001), indicating that the traditional Chinese medicine composition had a good protective effect on acute liver damage caused by alcohol, and its effect was better than that of the positive control drug, Huaiwangjintan (see Comparative Example 3).

[0071] From the results of Comparative Examples 1-2, it can also be seen that when the medicinal ingredients in the traditional Chinese medicine composition of the present application are replaced or removed, the protective effect of the traditional Chinese medicine composition on the increase of ALT and AST caused by alcohol is significantly weakened, indicating that the curative effect of the traditional Chinese medicine composition of the present application on acute liver injury caused by alcohol is closely related to the types of medicinal ingredients in the traditional Chinese medicine composition.

[0072] Table 1: Effect of the traditional Chinese medicine composition of the present application on the levels of AST and ALT in the plasma of mice

[0073]

[0074]

[0075] Note: compared with the model group, * p < 0.05; ** p < 0.01; *** p < 0.001.

[0076] 4.2 Determination results of liver oxidative damage related index levels

[0077] The levels of GSH and SOD in the liver tissue homogenate of each group of mice are shown in Table 2 below. Compared with the normal group, the GSH and SOD of the model group were significantly reduced, indicating that the modeling was successful. The groups of Example 1 and Example 2 had very significant increasing effects on the decrease of GSH and SOD caused by alcohol *** p < 0.001), indicating that the traditional Chinese medicine composition of the present application has a good protective effect on acute liver injury caused by alcohol, and its effect is better than that of the positive control drug Huaiwangjintan (see Comparative Example 3 group).

[0078] From the results of Comparative Examples 1-2, it can also be seen that when the medicinal ingredients in the traditional Chinese medicine composition of the present application are replaced or removed, the protective effect of the traditional Chinese medicine composition on the decrease of GSH and SOD caused by alcohol is significantly weakened, indicating that the curative effect of the traditional Chinese medicine composition of the present application on acute liver injury caused by alcohol is closely related to the types of medicinal ingredients in the traditional Chinese medicine composition.

[0079] Table 2: Effect of the traditional Chinese medicine composition of the present application on the levels of GSH and SOD in the liver tissue of mice

[0080] Group GSH (U / L) SOD (U / mL) Normal group 534.187 ± 58.152 *** ]] 273.462 ± 28.770 *** ]] Model group 245.613±32.958 125.038±19.475 Example 1 group 484.074 ± 28.957 *** ]] 218.355 ± 23.564 *** ]] Example 2 group 452.181 ± 23.014 *** ]] 205.461 ± 18.298 *** ]] Comparative example 1 group 308.262±37.786 148.914±21.391 Comparative example 2 group 310.083±41.465 152.825±19.623 Comparative example 3 group 386.49 0 ± 43.561 ** ]] 194.767 ± 28.366 *** ]]

[0081] Note: compared with the model group, ** p < 0.01; *** p < 0.001.

[0082] Example 2: Therapeutic effect of the traditional Chinese medicine composition of the present application on chronic alcoholic fatty liver disease

[0083] 63 male (6-8 weeks old, 18-22 g) C57BL / 6 mice (purchased from Heilongjiang University of Chinese Medicine Experimental Animal Center) were randomly divided into 7 groups, 9 in each group. They were normal group, model group, example 1 group, example 2 group, comparative example 1 group, comparative example 2 group, and comparative example 3 group.

[0084] After the experimental animals were adaptively fed for one week, in addition to the normal group of mice drinking pure water freely every day, the rest of the animals in each group were given 10% ethanol by gavage once a day for the first week, with a gavage volume of 0.1 mL / 10 g of body weight, and 50% ethanol was used for gavage for the rest of the time. After gavage with ethanol, examples 1-2 and comparative examples 1-3 were given the test substances prepared in the "Preparation Examples" section by gavage, with a gavage volume of 0.1 mL / 10 g of body weight. The normal group and the model group were given physiological saline by gavage, with a gavage volume of 0.1 mL / 10 g of body weight. The experiment lasted for 10 weeks. After the last gavage, the experimental animals in each group were euthanized after 12 hours of fasting.

[0085] The blood of the experimental animals in each group was collected using a centrifuge tube containing an anticoagulant, and the livers of the mice in each group were separated.

[0086] 2. Evaluation index

[0087] 2.1 Serum biochemical index level determination

[0088] After the collected blood samples of the mice in each group were centrifuged at 3000 g for 15 min using a low-speed centrifuge, the supernatant was taken and used to determine the levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in the plasma using a kit.

[0089] 2.2 Liver injury-related index level determination

[0090] After the separated livers of the mice in each group were washed with ice-cold physiological saline and the water was absorbed with filter paper, part of the tissue was taken, physiological saline was added, homogenate treatment was performed, and the supernatant was taken after centrifugation, the levels of triglyceride (TG), malondialdehyde (MDA), superoxide dismutase (SOD), and TNF-α in the mouse liver tissue were determined using a kit.

[0091] 3. Statistical method

[0092] The results were analyzed using SPSS 27.0 statistical software, and the data were represented as mean ± standard deviation. Single factor analysis of variance was used for comparison among multiple groups, and t-test was used for comparison between two groups. p<0.05 indicated that the difference was statistically significant.

[0093] 4. Experimental results

[0094] 4.1 Serum biochemical index level determination results

[0095] The levels of AST and ALT in the plasma of mice in each group are shown in Table 3 below. Compared with the normal group, the levels of AST and ALT in the model group were significantly increased, indicating that the modeling was successful. The groups of Example 1 and Example 2 had very significant reducing effects on the increase of ALT and AST caused by chronic alcohol use (p<0.001), indicating that the traditional Chinese medicine composition of the present application has a good protective effect on chronic alcoholic fatty liver, and its effect is better than that of the positive control drug, Huaiwangjintan (see the group of Comparative Example 3). *** p<0.001), indicating that the traditional Chinese medicine composition of the present application has a good protective effect on chronic alcoholic fatty liver, and its effect is better than that of the positive control drug, Huaiwangjintan (see the group of Comparative Example 3).

[0096] It can also be seen from the results of Comparative Examples 1-2 that when the medicinal ingredients in the traditional Chinese medicine composition of the present application are replaced or removed, the protective effect of the traditional Chinese medicine composition on the increase of ALT and AST caused by chronic alcohol use is significantly weakened, indicating that the curative effect of the traditional Chinese medicine composition of the present application on chronic alcoholic fatty liver is closely related to the types of medicinal ingredients in the traditional Chinese medicine composition.

[0097] Table 3: Effect of the traditional Chinese medicine composition of the present application on the levels of AST and ALT in the plasma of mice

[0098] Group ALT (U / L) AST (U / L) Normal group 9.218 ± 1.134 *** ]] 12.680±1.603 Model group 28.076±3.197 25.743±4.185 Example 1 group 14.625 ± 2.362 *** ]] 16.629 ± 2.952 *** ]] Example 2 group 15.182 ± 2.620 *** ]] 17.086 ± 2.564 *** ]] Comparative example 1 group 23.394±3.738 22.578±3.230 Comparative example 2 group 22.157±3.166 21.095±3.198 Comparative example 3 group 19.235 ± 3.061 ** ]] 19.181 ± 2.736 * ]]

[0099] Note: compared with the model group, * p<0.05; *** p<0.001.

[0100] 4.2 Determination results of liver damage related index levels

[0101] The levels of TG, MDA, SOD and TNF-α in the liver tissue homogenate of mice in each group are shown in Table 4 below. Compared with the normal group, TG, MDA and TNF-α in the model group were significantly increased, and SOD was significantly decreased, indicating that the modeling was successful.

[0102] The groups of Example 1 and Example 2 had very significant improving effects on the increase of TG, MDA and TNF-α and the decrease of SOD caused by chronic alcohol use (p<0.001), indicating that the traditional Chinese medicine composition of the present application has a good protective effect on chronic alcoholic fatty liver, and its effect is better than that of the positive control drug, Huaiwangjintan (see the group of Comparative Example 3). *** p<0.001), indicating that the traditional Chinese medicine composition of the present application has a good protective effect on chronic alcoholic fatty liver, and its effect is better than that of the positive control drug, Huaiwangjintan (see the group of Comparative Example 3). * p<0.05; *** p<0.001).

[0103] It can also be seen from the results of the comparative example 1-2 group that when the medicinal ingredients in the traditional Chinese medicine composition of the present application are replaced or removed, the improvement effect of the traditional Chinese medicine composition on the increase of TG, MDA and TNF-α and the decrease of SOD caused by chronic alcohol consumption is significantly weakened, which indicates that the curative effect of the traditional Chinese medicine composition of the present application on chronic alcoholic fatty liver is closely related to the types of medicinal ingredients in the traditional Chinese medicine composition.

[0104] Table 4: Influence of the traditional Chinese medicine composition of the present application on the levels of TG, MDA, SOD and TNF-α in the liver tissue of mice

[0105]

[0106] Note: compared with the model group, * p < 0.05; ** p < 0.01; *** p < 0.001.

[0107] Obviously, those skilled in the art can make various modifications and variations to the present application without departing from the spirit and scope of the present application. Thus, if these modifications and variations of the present application belong to the scope of the claims of the present application and their equivalent technologies, the present application also intends to include these modifications and variations.

Claims

1. A traditional Chinese medicine composition with hangover-relieving and liver-protecting effects, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 5-50 parts of Hovenia dulcis, 5-50 parts of Pueraria lobata, 5-40 parts of Gastrodia elata, 5-40 parts of Citrus reticulata peel, 1-30 parts of Poria cocos, 1-30 parts of Alisma plantago-aquatica, 5-40 parts of Artemisia capillaris, 5-40 parts of Gynostemma pentaphyllum, 1-30 parts of stir-fried Atractylodes macrocephala, 5-40 parts of Magnolia officinalis, 1-20 parts of Paeonia lactiflora, and 1-20 parts of prepared Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 5-30 parts of Hovenia dulcis, 5-30 parts of Pueraria lobata, 5-20 parts of Gastrodia elata, 5-20 parts of Citrus reticulata peel, 1-15 parts of Poria cocos, 1-15 parts of Alisma plantago-aquatica, 5-20 parts of Artemisia capillaris, 5-20 parts of Gynostemma pentaphyllum, 1-15 parts of stir-fried Atractylodes macrocephala, 5-20 parts of Magnolia officinalis, 1-15 parts of Paeonia lactiflora, and 1-15 parts of prepared Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition according to claim 2, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15 parts of Japanese raisin tree fruit, 15 parts of kudzu flower, 12 parts of gastrodia elata, 12 parts of dried tangerine peel, 9 parts of poria cocos, 9 parts of alisma plantago-aquatica, 12 parts of artemisia capillaris, 12 parts of gynostemma pentaphyllum, 9 parts of stir-fried atractylodes macrocephala, 12 parts of magnolia officinalis, 6 parts of white peony root, and 6 parts of prepared licorice root.

4. The traditional Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition has the effects of relieving alcohol poisoning, resolving dampness and turbidity, relieving liver and gallbladder ailments, and strengthening the spleen.

5. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The preparation method includes the following steps: crushing the following ingredients into powder: Hovenia dulcis, Pueraria lobata, Gastrodia elata, Citrus reticulata peel, Poria cocos, Alisma plantago-aquatica, Artemisia capillaris, Gynostemma pentaphyllum, stir-fried Atractylodes macrocephala, Magnolia officinalis, Paeonia lactiflora, and prepared Glycyrrhiza uralensis; adding water to decoct the powder; mixing the filtrate; and concentrating the filtrate to obtain a concentrated solution.

6. The preparation method according to claim 5, characterized in that: The decoction is prepared twice. After the first decoction is prepared for 1-3 hours, the liquid is filtered to obtain the first filtrate. The residue is then added to water and decocted for another 1-3 hours, and filtered to obtain the second filtrate. The first and second filtrates are combined.

7. The preparation method according to claim 6, characterized in that: The ratio of material to liquid in the first and second decoctions is 1:4, the decoction time for both is 2 hours, and the water used in both decoctions is distilled water; preferably, the concentration is vacuum concentration.

8. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4, or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 5 to 7, in the preparation of a medicament for treating alcoholic liver disease.

9. The use according to claim 8, characterized in that: The alcoholic liver disease is acute alcoholic liver injury and / or chronic alcoholic fatty liver. Preferably, the drug is suitable for patients with alcoholism, alcoholic liver, hyperlipidemia, and liver and gallbladder diseases mainly caused by dampness and turbidity due to alcohol poisoning.

10. The use according to claim 8, characterized in that: The dosage form of the drug is granules, tablets, oral liquid, or capsules.

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