Composition capable of quickly dispelling effects of alcohol and relieving moderate and mild fatty liver and application thereof

Abstract

The invention discloses a composition capable of quickly dispelling the effects of alcohol and relieving moderate and mild fatty liver and application of the composition, and particularly relates to the technical field of health care products. The composition comprises the silybum marianum extract, the schisandra chinensis extract, the globe artichoke extract and the 1, 6-fructose diphosphate and cyclodextrin-clathrated silybum marianum extract as raw materials, on one hand, the bioavailability of the product is improved, the taste of the product is better, and the taste of the clathrated product is improved due to the fact that silybin is very bitter and cyclodextrin has a shielding property; and on the other hand, the FDP and the three plant extracts have a synergistic effect, and the combined composition can achieve the effects of quickly dispelling the effects of alcohol and relieving moderate and mild fatty liver.

Description

Technical Field

[0001] This invention relates to the field of health product technology, specifically to a composition that can quickly sober you up and relieve mild to moderate fatty liver, and its uses. Background Technology

[0002] Alcoholic liver disease (ALD) refers to a series of liver diseases caused by long-term alcohol consumption, including alcoholic fatty liver (AFL), alcoholic hepatitis (AH), and alcoholic liver fibrosis (ALF). Throughout the ALD process, liver damage progresses gradually, worsening with continued alcohol intake. Approximately 90-95% of long-term alcohol drinkers develop fatty liver and progress to AFL.

[0003] Milk thistle, the dried, mature fruit of the milk thistle plant (Silybum marianum), is a member of the Asteraceae family. It possesses properties of clearing heat and detoxifying, soothing the liver and promoting bile secretion. It is primarily used for liver diseases such as damp-heat in the liver and gallbladder, hypochondriac pain, and jaundice. It is one of the most widely used hepatoprotective drugs in clinical practice and is extensively used in the treatment of alcoholic liver disease and various chronic liver diseases. Milk thistle has been used since ancient times to treat various liver diseases caused by oxidative stress, such as inflammatory liver disease and cirrhosis. Oxidative stress caused by hyperglycemia is involved in the microvascular and macrovascular complications of type II diabetes. Silymarin and silybin can restore reduced glutathione and antioxidant enzymes, protecting endothelial cells from oxidative damage by regulating antioxidant enzyme activity, reduced glutathione, and protein carbonyl levels. Silymarin is a flavonoid derived from milk thistle, initially extracted from the seed coat. Its main active components are silybin, isosilybin, silybinine, and silybinin.

[0004] The applicant's patent application CN118718008A discloses an inclusion complex of silymarin and γ-cyclodextrin. This inclusion complex utilizes the surface binding force of hydrophilic and hydrophobic properties to allow silymarin to be "pressed" into the hollow of γ-cyclodextrin, forming an excellent inclusion effect and high bioavailability.

[0005] Schisandra chinensis is a commonly used traditional Chinese medicine. It is warm in nature and sour in taste, possessing the functions of astringing the lungs and nourishing the kidneys, promoting body fluid production and stopping sweating, and calming the mind and soothing the nerves. It is mainly used to treat chronic cough and asthma, persistent diarrhea, dry mouth due to insufficient body fluids, night sweats, shortness of breath and weak pulse, forgetfulness and insomnia. With the in-depth development of pharmacology, it has been discovered that Schisandra chinensis has anti-inflammatory, immune-enhancing, vasodilating, anti-aging, sedative, and anti-cancer pharmacological effects, as well as hepatoprotective effects. Schisandra chinensis exerts anti-lipogenesis, antioxidant, anti-inflammatory, and anti-apoptotic effects through ADH and CYP2E1, and exerts anti-alcoholic liver damage effects through SIRT1 / AMPK, KEAP-1 / Nrf2, and TLR4 / NF-κB related pathways.

[0006] Artichokes, also known as Japanese artichokes or vegetable artichokes, are perennial herbaceous plants belonging to the genus *Cynara* in the family Asteraceae. Artichokes are rich in various functional components, such as cynarin, inulin, and chlorogenic acid. Cynarin-like substances are particularly important as the core functional components, possessing significant physiological functions. They can be used as raw materials for medicines and health products, and also as drugs to prevent and treat insufficient bile secretion and for liver protection. Summary of the Invention

[0007] The purpose of this invention is to address the shortcomings of the prior art by providing a composition containing a highly bioavailable milk thistle extract.

[0008] In a first aspect, the present invention provides a composition containing a highly bioavailable milk thistle extract, comprising milk thistle extract, fructose 1,6-bisphosphate and plant extracts.

[0009] In some embodiments, the milk thistle extract contains silybin.

[0010] In some embodiments, the content of silybin in the milk thistle extract is not less than 10%, specifically more than 10%, more than 20%, more than 30%, more than 40%, more than 50%, more than 60%, more than 70%, more than 80%, more than 90%, and more than 100%.

[0011] In some embodiments, the milk thistle extract includes, but is not limited to, one or more of the following forms: milk thistle extract solid dispersion, milk thistle extract liposomes, milk thistle extract microcapsules, and milk thistle extract inclusion complexes.

[0012] In some embodiments, the milk thistle extract includes, but is not limited to, one or more of the following: milk thistle extract-phospholipid complex, milk thistle extract-cyclodextrin inclusion complex, and milk thistle extract-organic polymer solid dispersion.

[0013] In some embodiments, the milk thistle extract is in the form of milk thistle extract-cyclodextrin.

[0014] In some embodiments, the cyclodextrin includes, but is not limited to, α-cyclodextrin, β-cyclodextrin, and γ-cyclodextrin.

[0015] In some embodiments, the cyclodextrin is γ-cyclodextrin.

[0016] In some embodiments, the milk thistle extract-cyclodextrin is in inclusion complex form, and the preparation method of the milk thistle extract-cyclodextrin inclusion complex is as follows: (1) Milk thistle extract was added to ethanol and heated until it was clear to obtain milk thistle extract ethanol solution; (2) Add cyclodextrin to water and dissolve it to obtain a cyclodextrin solution; (3) Mix the silymarin ethanol solution and the cyclodextrin solution and continue heating the reaction. (4) The system after the reaction was dried to obtain the product milk thistle extract-cyclodextrin inclusion complex.

[0017] In some embodiments, the fructose 1,6-bisphosphate is a fructose 1,6-bisphosphate salt, including but not limited to one or more combinations of sodium, potassium, magnesium, strontium, or calcium salts.

[0018] In some embodiments, the 1,6-bisphosphate fructose salt is fructose-1,6-bisphosphate sodium salt.

[0019] In some embodiments, the plant extracts include, but are not limited to, one or more of the following: Schisandra chinensis extract, Artichoke extract, Glycyrrhiza uralensis root extract, Zingiber officinale rhizome extract, Ilex pubescens extract, Ginseng extract, Astragalus membranaceus extract, Rheum palmatum extract, Atractylodes macrocephala extract, Polygonum multiflorum extract, Panax notoginseng extract, Bupleurum chinense extract, Cassia tora seed extract, Pueraria lobata extract, Bergamot extract, Eucommia ulmoides leaf extract, Ganoderma lucidum extract, Cordyceps sinensis extract, Glycyrrhiza uralensis extract, Brown algae / microalgae extract, Gynostemma pentaphyllum extract, Taraxacum mongolicum extract, Polygonum cuspidatum extract, Andrographis paniculata extract, Chaenomeles speciosa extract, Rice / rice bran extract, Broccoli extract, Hovenia dulcis extract, Coffee berry extract, Phyllanthus emblica extract, Ginkgo biloba extract, Coptis chinensis extract, Scutellaria baicalensis extract, and Rice bran extract.

[0020] In some embodiments, the plant extract is artichoke extract or schisandra extract.

[0021] In some embodiments, the mass ratio of milk thistle extract, fructose 1,6-bisphosphate, schisandra extract, and artichoke extract in the composition is 1.2-54:2.4-54:0.6-27:0.6-27.

[0022] In some embodiments, the mass ratio of milk thistle extract, fructose 1,6-bisphosphate, schisandra extract, and artichoke extract in the composition is 1.6-18:3.2-18:0.8-9:0.8-9.

[0023] In some embodiments, the mass ratio of milk thistle extract, fructose 1,6-bisphosphate, schisandra extract, and artichoke extract in the composition is preferably 2-6:4-6:1-3:1-3.

[0024] In some embodiments, the mass ratio of milk thistle extract, fructose 1,6-bisphosphate, schisandra extract, and artichoke extract in the composition is preferably 2-6:4-6:1-3:2.

[0025] In some embodiments, the mass ratio of silymarin, fructose 1,6-bisphosphate, schisandra extract, and artichoke extract in the composition is 0.4-1.2:4-6:1-3:1-3.

[0026] In some embodiments, the mass ratio of milk thistle extract to composition volume in the composition is 4.8-216 mg: 1 mL.

[0027] In some embodiments, the mass ratio of milk thistle extract to composition volume in the composition is 6.4-72 mg: 1 mL.

[0028] In some embodiments, the mass ratio of milk thistle extract to the volume of the composition is 8-24 mg: 1 mL.

[0029] In some embodiments, the mass ratio of silymarin to the volume of the composition is 1.6 mg to 14.4 mg: 1 mL, specifically 1.6 mg: 1 mL, 3.2 mg: 1 mL, 4.8 mg: 1 mL, 6.4 mg: 1 mL, 8 mg: 1 mL, 9.6 mg: 1 mL, 11.2 mg: 1 mL, 12.8 mg: 1 mL, and 14.4 mg: 1 mL.

[0030] In some embodiments, the mass ratio of fructose 1,6-bisphosphate to the volume of the composition is 9.6-216 mg:1 mL.

[0031] In some embodiments, the mass ratio of fructose 1,6-bisphosphate to the volume of the composition is 12.8-72 mg: 1 mL.

[0032] In some embodiments, the mass ratio of fructose 1,6-bisphosphate to the volume of the composition is 16-24 mg: 1 mL.

[0033] In some embodiments, the mass ratio of artichoke extract to volume of the composition is 2.4-108 mg: 1 mL.

[0034] In some embodiments, the mass ratio of artichoke extract to volume of the composition is 3.2-36 mg: 1 mL.

[0035] In some embodiments, the mass ratio of artichoke extract to volume of the composition is 4-12 mg: 1 mL.

[0036] In some embodiments, the mass ratio of Schisandra chinensis extract to the volume of the composition is 2.4-108 mg: 1 mL.

[0037] In some embodiments, the mass ratio of Schisandra chinensis extract to the volume of the composition is 3.2-36 mg: 1 mL.

[0038] In some embodiments, the mass ratio of Schisandra chinensis extract to the volume of the composition is 4-12 mg: 1 mL.

[0039] In a second aspect, the present invention provides a product comprising the above-described composition as an active ingredient and a food-acceptable additive.

[0040] In some embodiments, the product dosage form is one of the following: injection, oral liquid, tablet, capsule, powder, candy, jelly, crystal ball, solid beverage, liquid beverage, and paste.

[0041] In some embodiments, the product dosage form is an oral liquid.

[0042] In some embodiments, the oral solution contains, but is not limited to, one or a combination of sorbitol, maltitol, mannitol, erythritol, and steviol glycosides.

[0043] In some embodiments, the oral liquid includes, but is not limited to, one or a combination of xanthan gum, sodium alginate, microcrystalline cellulose, sodium carboxymethyl cellulose, and gelatin.

[0044] In some embodiments, the oral liquid includes, but is not limited to, one or a combination of citric acid, fruit acid, malic acid, acetic acid, sodium citrate, and potassium citrate.

[0045] In some embodiments, the oral liquid includes, but is not limited to, one or more of the following: licorice root extract, ginger root and rhizome powder, citric acid, fumaric acid, tartaric acid, tea polyphenols, and allicin.

[0046] In some embodiments, the composition is prepared by mixing sodium fructose 1,6-bisphosphate, milk thistle extract, artichoke extract, schisandra extract, and other excipients, heating and stirring, and finally spraying with natural blueberry spray to obtain the product.

[0047] In some embodiments, the dosage of the composition or product is 1-2 bottles per day, taken half an hour before drinking alcohol.

[0048] Thirdly, the present invention provides the use of the aforementioned compositions or products in the preparation of hepatoprotective, alcohol-relieving, or fatigue-relieving pharmaceuticals, health foods, dietary supplements, and / or foods.

[0049] In some embodiments, the present invention provides the use of the aforementioned compositions or products in the preparation of pharmaceuticals, health foods, dietary supplements and / or foods for relieving fatty liver, quickly sobering up or relieving fatigue. Beneficial effects

[0050] Using milk thistle extract encapsulated with cyclodextrin as a raw material improves the product's bioavailability and enhances its flavor. This is because silybin is very bitter, and cyclodextrin has a masking effect, thus improving the flavor of the encapsulated product.

[0051] The combination of silymarin, FDP, and two plant extracts works synergistically to quickly sober up and relieve mild to moderate fatty liver.

[0052] The composition of this invention is used after drinking alcohol. Patent 202011261048.X describes how the combination of milk thistle and FDP enhances the activity of alcohol-degrading enzymes, aiding in the breakdown of ethanol in alcohol and enabling rapid alcohol decomposition and excretion from the body, thus primarily providing a fast-acting effect. Further screening and research in this invention revealed that artichoke extract and schisandra extract, in addition to their synergistic effect with milk thistle extract, also interact with FDP. It is speculated that this may be because the organic acids in schisandra extract, such as citric acid and malic acid, can participate in the tricarboxylic acid cycle, enhancing cellular energy production and providing faster energy to the body; artichoke extract and FDP synergistically increase the activity of alcohol-degrading enzymes. These four substances all have synergistic effects, therefore, they can be used for rapid sobering up. Attached Figure Description

[0053] Figure 1 The results show the total cholesterol (TC) content of mice in each group.

[0054] Figure 2 The results show the triglyceride (TG) content of mice in each group.

[0055] Figure 3 The results show the detection results of HDL-C content in mice in each group.

[0056] Figure 4 The results of H&E pathological staining of liver tissue from mice in each group are shown. Detailed Implementation

[0057] To facilitate understanding by those skilled in the art, the present invention will be further described below with reference to embodiments. The content mentioned in the embodiments is not intended to limit the present invention.

[0058] For experiments not specifically described in the examples, the procedures or conditions should be followed according to the conventional experimental procedures described in the literature in this field. Reagents or instruments whose manufacturers are not specified are all commercially available conventional reagent products.

[0059] Milk thistle extract: This is an extract of milk thistle (Silybum marianum), which can be purchased from the market.

[0060] Artichoke extract: An extract prepared from the leaves or inflorescences of artichoke (Cynara scolymus L.) containing ≥5.0% cynarin. This extract may be commercially available.

[0061] Schisandra chinensis extract: An extract from the mature fruit of Schisandra chinensis. This extract is commercially available. Example 1

[0062] A composition of 25 mL, comprising 400 mg of milk thistle extract-γ-cyclodextrin inclusion complex (80 mg of silybin), 500 mg of sodium fructose 1,6-bisphosphate, 200 mg of artichoke extract, and 200 mg of schisandra extract. Example 2

[0063] A composition of 25 mL, comprising 200 mg of milk thistle extract-γ-cyclodextrin inclusion complex (40 mg of silybin), 600 mg of sodium fructose 1,6-bisphosphate, 300 mg of artichoke extract, and 200 mg of schisandra extract. Example 3

[0064] A composition of 25 mL, comprising 600 mg of milk thistle extract-γ-cyclodextrin inclusion complex (120 mg of silybin), 400 mg of sodium fructose 1,6-bisphosphate, 100 mg of artichoke extract, and 200 mg of schisandra extract. Example 4

[0065] A composition of 25 mL, comprising 400 mg of milk thistle extract-γ-cyclodextrin inclusion complex (40 mg of silybin), 500 mg of sodium fructose 1,6-bisphosphate, 200 mg of artichoke extract, and 200 mg of schisandra extract. Example 5

[0066] A composition of 25 mL, comprising 400 mg of milk thistle extract-γ-cyclodextrin inclusion complex (120 mg of silybin), 500 mg of sodium fructose 1,6-bisphosphate, 200 mg of artichoke extract, and 200 mg of schisandra extract. Example 6

[0067] A composition of 25 mL, comprising 400 mg of milk thistle extract-γ-cyclodextrin inclusion complex (160 mg of silybin), 500 mg of sodium fructose 1,6-bisphosphate, 200 mg of artichoke extract, and 200 mg of schisandra extract.

[0068] Comparative Example 1 A composition of 25 mL, containing 400 mg of silymarin extract - γ - cyclodextrin inclusion compound (80 mg of silybin) and 500 mg of sodium 1,6 - diphosphate.

[0069] Control Example 2 A composition of 25 mL, containing 200 mg of artichoke extract and 500 mg of sodium 1,6 - diphosphate.

[0070] Control Example 3 A composition of 25 mL, containing 200 mg of schisandra chinensis extract and 500 mg of sodium 1,6 - diphosphate.

[0071] Control Example 4 A composition of 25 mL, containing 400 mg of silymarin extract - γ - cyclodextrin inclusion compound (80 mg of silybin), 200 mg of artichoke extract, and 200 mg of schisandra chinensis extract.

[0072] Example 7 Hangover effect test: Sixty mice were randomly and evenly divided into 4 groups, namely: control group, Example 1 group, Control Example 1 group, Control Example 2 group, Control Example 3 group, and Control Example 4 group. Three groups were respectively intragastrically administered Niulanshan Erguotou (commercially available, alcohol content 52 degrees), and the intragastric administration volume was calculated according to the body weight of the mice (20 mL / kg body weight). All the mice showed drunkenness with lethargy or inability to walk normally. Then, each group was immediately intragastrically administered the product of the corresponding group (2 mL / kg body weight). The control group was intragastrically administered the corresponding volume of normal saline. The mice were touched, and the standing (the four limbs could support the body, and both the posterior abdomen and the anterior chest could leave the ground) and walking conditions of the mice were observed to evaluate the hangover situation of the mice.

[0073] Table 1 Influence of different groups on the hangover situation of drunken mice Duration of action 0.5h 1h 1.5h 2h 2.5h 3h 4h control group No change No change No change No change One stands and walks slowly Four were standing and walking slowly, and one was able to walk normally. Three stood and walked slowly, three walked normally, and the other four remained drowsy and unchanged. Example 1 Group 3 standing and walking slowly Five were standing and walking slowly, while three were able to walk normally. Four stood and walked slowly, while six were able to walk normally. Two can stand and walk slowly, and eight can walk normally. 10 can walk normally 10 can walk normally 10 can walk normally Comparative Example 1 No change No change 2 can walk slowly Four can walk slowly, and one can walk normally. 7 can walk slowly, and 3 can walk normally. Four can walk slowly, and six can walk normally. One can walk slowly, and nine can walk normally. Comparative Example 2 No change No change One can walk slowly Three can walk slowly, and one can walk normally. Five can walk slowly, and three can walk normally. Six can walk slowly, and four can walk normally. 3 can walk slowly, and 7 can walk normally. Comparative Example 3 Groups No change No change One can walk slowly Three can walk slowly, and one can walk normally. Four can walk slowly, and two can walk normally. 7 can walk slowly, and 3 can walk normally. Four can walk slowly, and six can walk normally. Comparative Example 4 Groups No change No change No change One can walk slowly Three can walk slowly, and one can walk normally. Six can walk slowly, and two can walk normally. Six can walk slowly, and four can walk normally. The above data indicate that the hangover effect of Example 1 is better than that of Control Example 1, Control Example 2, Control Example 3, and Control Example

[0074] Example 8 Evaluation experiment on the efficacy of improving non - alcoholic fatty liver in mice 1 Experimental materials 1.1 Sample information Samples: Each group of samples was diluted to the same concentration with pure water and directly intragastrically administered, prepared and used on the same day every day.

[0075] 1.2 Experimental animals Forty SPF - grade, 6 - week - old, male C57BL / 6J mice. Purchased from Changzhou Cavens Experimental Animal Co., Ltd., experimental animal license number: SCXK(Su)2021 - 0013. All experimental animals were adaptively raised for two weeks before the formal experiment.

[0076] 1.3 Instruments, Consumables and Reagents Electronic balance (Mettler-Toledo, ME204TE); multi-functional vortex mixer (JOANLAB, VM-500pro); benchtop high-speed refrigerated centrifuge (Eppendorf, 5425R); tissue homogenizer (Shanghai Jingxin, JXFSTPRP-CLN).

[0077] Triglyceride reagent kit (Cat. A110-1-1, Nanjing Jiancheng); Total cholesterol reagent kit (Cat. A111-1-1, Nanjing Jiancheng); High-density lipoprotein cholesterol reagent kit (Cat. A112-1-1, Nanjing Jiancheng); 4% paraformaldehyde (Lot: 23187852, Biosharp); XTMRCD60 feed (60% fat energy supply, 0.1% methionine, choline-deficient feed, Jiangsu Xietong Pharmaceutical Biotechnology Co., Ltd.); XTMRCD10-C feed (10% fat energy supply, normal methionine and choline content feed, Jiangsu Xietong Pharmaceutical Biotechnology Co., Ltd.).

[0078] 2. Evaluation Methods 2.1 Establishing a fatty liver model 2.1.1 Experimental Preparation After receiving the experimental mice, they were acclimatized for two weeks. XTMRCD60 feed was stored at -20℃, and one packet was used at a time, allowing it to reach room temperature before use. When introducing high-fat feed, it should not be added directly, but rather gradually increased in proportion to prevent the animals from refusing to eat due to maladaptation.

[0079] 2.1.2 Constructing a mouse model of fatty liver Forty mice were randomly divided into four groups. The normal group (n=10) was fed the control diet (XTMRCD10-C), and the other three groups (n=10) were fed the modeling high-fat diet (XTMRCD60) for two consecutive weeks, with normal drinking water.

[0080] 2.1.3 Model Qualification Two weeks after modeling, 10 mice from the model group and 10 mice from the control group were randomly selected for orbital blood collection, and serum was collected to detect the levels of total cholesterol (TC) and triglycerides (TG).

[0081] 2.2 Experimental Grouping and Processing (1) Control group (n=10): Starting from day 15, the same volume of physiological saline was administered by gavage once a day until day 42 of the experiment, during which time the control diet was fed.

[0082] (2) Model group (n=10): Starting from day 15, the same volume of physiological saline was administered by gavage once a day until day 42 of the experiment, during which time the model feed was fed.

[0083] (3) Milk thistle extract group (n=10): Milk thistle extract was administered by gavage starting on day 15, once a day, until day 42 of the experiment, during which time the modeling diet was fed.

[0084] (4) Sample group of Example 1 (n=10): Sample of Example 1 was gavaged once a day starting on day 15 and continued until day 42 of the experiment, during which time the model feed was fed.

[0085] 2.3 Detection of animal physiological indicators During the experiment, the mice's activity, mental state, and eating habits were observed. The mice's weight was recorded once a week, and the weight of each group of mice was weighed again before the final collection of samples.

[0086] 2.4 Terminal sampling 2.4.1 Preparation of serum samples Blood was collected from the fundus venous plexus of mice without anticoagulation. After the whole blood was allowed to stand for 10 min, it was centrifuged at 3500 rpm / min for 10 min, and the supernatant was collected, labeled, and stored at -80℃ for analysis.

[0087] 2.4.2 Liver tissue preservation After blood collection, liver samples were taken from the mice, weighed, and photographed for recording. The liver index was calculated (= liver wet weight / final body weight * 100%). Half of the livers from each group of mice were stored in 2 volumes of 4% paraformaldehyde, and the other half were frozen at -80°C. The group information was marked.

[0088] 2.5 Indicator Testing 2.5.1 Determination of the content of biochemical indicators in serum The testing was conducted strictly in accordance with the instructions for the triglyceride (TG), total cholesterol (TC), and high-density lipoprotein cholesterol (HDL-C) assay kits.

[0089] 2.5.2 Liver tissue H&E pathological staining After the administration of the drug, liver tissue from 6 mice in each group was randomly selected, fixed in 4% paraformaldehyde, and the samples were pretreated by Nanjing Fris Biotechnology Co., Ltd. to prepare paraffin sections for H&E pathological staining, and a relevant report was issued.

[0090] 2.6 Data Processing and Statistical Methods The experimental data are expressed as mean ± standard error (Mean ± SEM). All data were processed and statistically analyzed using GraphPad Prism 8.0. The t-test was used to compare the means of two groups, and the ANOVA test was used to compare the means of multiple groups. p < 0.05 was considered statistically significant.

[0091] 3. Evaluation Results 3.1 Results of serum biochemical index determination 3.1.1 Results of Total Cholesterol (TC) Content Measurement Fatty liver mice exhibited a decreased ability to process and clear cholesterol from their livers, leading to elevated blood cholesterol levels. The total cholesterol content in the serum of each group of mice was measured. Figure 1 As shown, the TC content in the model group was significantly higher than that in the control group; compared with the model group, the TC content in both the milk thistle extract group and the sample group of the examples was significantly reduced, and the sample group of Example 1 was more effective.

[0092] 3.1.2 Results of Triglyceride (TG) Content Determination In mice with fatty liver, excessive fat deposition in the liver leads to the entry of excess lipids into the bloodstream, resulting in elevated triglyceride levels in the blood. Serum triglyceride levels in each group of mice were measured, and the results are as follows: Figure 2 As shown, the TG content in the model group was significantly higher than that in the control group. Compared with the model group, both the milk thistle extract group and the Example 1 group could reduce the TG content, but the milk thistle extract group had a less significant and statistically insignificant effect, while the Example 1 sample group showed a significant reduction, with its TG content being lower than that in the control group.

[0093] 3.1.3 Results of High-Density Lipoprotein Cholesterol (HDL-C) Content Measurement HDL acts as a carrier for removing cholesterol from the blood, transporting it back to the liver for metabolism. In cases of fatty liver, this metabolic process is disrupted, leading to decreased HDL biosynthesis or increased HDL clearance, thus causing a decrease in serum HDL-C levels. HDL-C levels in each group of mice were measured, and the results are as follows: Figure 3 The results showed that, compared with the control group, the HDL-C level in the model group was significantly lower; compared with the model group, both the milk thistle extract group and the sample group of Example 1 significantly increased the HDL-C content. The HDL-C content in the milk thistle extract group was about twice that of the model group, while the HDL-C content in the sample group of Example 1 was 3-4 times that of the model group and higher than that of the control group, indicating that the sample group of Example 1 was more effective in increasing the HDL-C content.

[0094] 3.2 Liver tissue H&E pathological staining (200×) and scoring results The pathological features of fatty liver are mainly hepatocellular steatosis, focal necrosis, inflammatory cell infiltration, and fibrosis. A scoring system was established based on these features: 0 points for no lesions, 1 point for mild, 2 points for mild, 3 points for moderate, and 4 points for severe. The livers of mice in each group were paraffin-embedded, sectioned, and stained with H&E. Figure 4 As shown, the liver tissue structure of the control group was discernible, with enlarged hepatocytes and small, diffuse vacuolar degeneration within the hepatocytes. In the model group, fatty degeneration of hepatocytes was observed, with numerous vacuoles and diffuse fat droplets of varying sizes. Focal necrosis and inflammatory cell infiltration were also present in the liver tissue, accompanied by mild interstitial fibrosis. In the other sample groups, the fatty degeneration, focal necrosis, inflammatory cell infiltration, and fibrosis of the hepatocytes of mice were all improved to varying degrees. The scoring results are as follows: model group 7.00 points, milk thistle extract group 6.5 points, and Example 1 sample group 5.5 points.

[0095] In summary, the sample group in Example 1 can alleviate non-alcoholic fatty liver disease in mice, and the effect is significantly better than that of the milk thistle extract group. It should be understood that the above detailed description of the technical solutions of the present invention with reference to preferred embodiments is illustrative and not restrictive. Those skilled in the art can modify the technical solutions described in the embodiments or make equivalent substitutions for some of the technical features based on reading this specification; however, these modifications or substitutions do not cause the essence of the corresponding technical solutions to depart from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A composition containing a highly bioavailable milk thistle extract, characterized in that, It contains milk thistle extract, fructose 1,6-bisphosphate and other plant extracts.

2. The composition according to claim 1, characterized in that, The milk thistle extract contains silybin, and the content of silybin in the milk thistle extract is not less than 10%.

3. The composition according to any one of claims 1-2, wherein the milk thistle extract is one or a combination of several of the following forms: milk thistle extract solid dispersion, milk thistle extract liposomes, milk thistle extract microcapsules, and milk thistle extract inclusion complex.

4. The composition according to any one of claims 1-2, wherein the milk thistle extract is one or more of the following: milk thistle extract-phospholipid complex, milk thistle extract-cyclodextrin inclusion complex, and milk thistle extract-organic polymer solid dispersion.

5. The composition of claim 4, wherein the milk thistle extract is in the form of a milk thistle extract-cyclodextrin inclusion complex.

6. The composition according to claim 1, characterized in that: The 1,6-bisphosphate fructose is a 1,6-bisphosphate fructose salt, preferably one or a combination of sodium, potassium, magnesium, strontium, or calcium salts.

7. The composition of claim 6, wherein the fructose 1,6-bisphosphate is fructose-1,6-bisphosphate sodium salt.

8. The composition according to claim 1, characterized in that: The other plant extracts include one or more of the following: Schisandra chinensis extract, Artichoke extract, Licorice root extract, Ginger rhizome extract, Ilex pubescens extract, Ginseng extract, Astragalus membranaceus extract, Rheum palmatum extract, Atractylodes macrocephala extract, Polygonum multiflorum extract, Panax notoginseng extract, Bupleurum chinense extract, Cassia tora extract, Pueraria lobata extract, Bergamot extract, Eucommia ulmoides leaf extract, Ganoderma lucidum extract, Cordyceps sinensis extract, Licorice extract, Brown algae / microalgae extract, Gynostemma pentaphyllum extract, Taraxacum mongolicum extract, Polygonum cuspidatum extract, Andrographis paniculata extract, Chaenomeles speciosa extract, Rice / rice bran extract, Broccoli extract, Hovenia dulcis extract, Coffee berry extract, Phyllanthus emblica extract, Ginkgo biloba extract, Coptis chinensis extract, Scutellaria baicalensis extract, and Rice bran extract.

9. The composition according to claim 8, characterized in that, The mass ratio of milk thistle extract, fructose 1,6-bisphosphate, schisandra extract, and artichoke extract in the composition is 1.2-54:2.4-54:0.6-27:0.6-27, preferably 1.6-18:3.2-18:0.8-9:0.8-9.

10. The composition according to claim 8, characterized in that, The mass ratio of silymarin, fructose 1,6-bisphosphate, schisandra extract, and artichoke extract in the composition is 0.4-1.2:4-6:1-3:1-3.

11. A product characterized in that, The composition includes any one of claims 1-10 and food-acceptable additives.

12. The product as described in claim 11, characterized in that, The product dosage form is one of the following: injection, oral liquid, tablet, capsule, powder, candy, jelly, crystal ball, solid beverage, liquid beverage, or paste.

13. The product as described in claim 12, characterized in that, The product is in the form of an oral liquid.

14. The product as described in claim 13, characterized in that, The oral liquid also contains one or more of the following: sorbitol, maltitol, mannitol, erythritol, and steviol glycosides.

15. The product as described in claim 13, characterized in that, The oral liquid also contains one or more of xanthan gum, sodium alginate, microcrystalline cellulose, sodium carboxymethyl cellulose, and gelatin.

16. The product as described in claim 13, characterized in that, The oral liquid also contains one or more of the following: licorice root extract, ginger root and rhizome powder, citric acid, fumaric acid, tartaric acid, tea polyphenols, and allicin.

17. The product as described in claim 13, characterized in that, The oral liquid also contains one or more of the following: orange juice concentrate, lemon juice concentrate, and grapefruit juice concentrate.

18. The use of the composition according to any one of claims 1-10 or the product according to any one of claims 11-17 in the preparation of pharmaceuticals, health foods, dietary supplements and / or foods for liver protection, intoxication relief or fatigue relief.

19. The use of the composition according to any one of claims 1-10 or the product according to any one of claims 11-17 in the preparation of pharmaceuticals, health foods, dietary supplements and / or foods for relieving fatty liver, quickly sobering up or relieving fatigue.

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