A composition containing milk thistle extract and 1,6-diphosphate fructose and its application in liver protection, sobering up and anti-fatigue

Abstract

The invention discloses a composition, which contains milk thistle extract and fructose 1,6-diphosphate or its derivatives or salts thereof; the milk thistle extract is in the form of milk thistle extract microcapsules and / or milk thistle extract liposomes and / or milk thistle extract self-microemulsification forms; the composition of the milk thistle extract and FDP has the effects of reducing liver damage, preventing hangover and resisting fatigue, and is particularly capable of quickly taking effect to reduce liver damage and quickly sobering up.

Description

Technical Field

[0001] The invention relates to a composition, in particular to a composition containing milk thistle extract and 1,6-diphosphate fructose, which has the effects of reducing liver damage and the like, and application thereof. Background Art

[0002] Milk thistle is an annual or biennial herb native to southern Europe and North Africa. It has been cultivated and used for thousands of years in Europe and Africa as a folk medicinal plant. Milk thistle is widely used as a medicine to treat liver and cardiovascular diseases.

[0003] Milk thistle extract is made from the dried fruits of Silybummarianum, and commercial extracts are usually standardized to contain 80% total silymarin. Silymarin is a complex mixture of polyphenols, including seven closely related flavonol-lignin adducts (silybin A, silybin B, isosilybin A, isosilybin B, silybin, isosilybin and silybinin) and a flavonoid taxolin. Silybin is a semi-purified fraction of silybin, mainly a mixture of two diastereoisomers (silybin A and silybin B) in a ratio of approximately 1:1. The silybin mixture exhibits a variety of pharmacological actions, especially in the liver, and there is some clinical evidence that silybin can serve as a supportive element in alcoholic and pediatric "A" cirrhosis. The chemical structure of silybin is

[0004]

[0005] In many countries, silybin can be used directly as a drug or as a drug ingredient, and is used to treat toxic liver damage (for example, IV treatment in the case of death limit); as an auxiliary treatment for chronic hepatitis and cirrhosis. Tianjin Tasly Saint Pharmaceutical Co., Ltd. in China also launched the drug "Silybin Capsule" (National Medicine Standard H20040299), 35mg*30 capsules / box (each capsule contains 35mg of silybin), for the recovery of functional abnormalities in acute and chronic hepatitis and fatty liver. The recommended dosage for adults is 3 times / day, 2-4 capsules / time.

[0006] Fructose 1,6-diphosphate, referred to as FDP, is a cellular metabolite present in the human body. It can regulate the activity of multiple enzyme systems in glucose metabolism, improve the state of cellular hypoxia and ischemia, and is beneficial to the recovery of damaged liver cells. Fructose 1,6-diphosphate generally exists in the form of salts, and sodium salts are mostly used, that is, sodium fructose-1,6-diphosphate. In addition to sodium salts, there are also calcium fructose-1,6-diphosphate, magnesium fructose-1,6-diphosphate, and lithium fructose-1,6-diphosphate. Among them, sodium fructose-1,6-diphosphate and calcium fructose-1,6-diphosphate are more commonly used.

[0007] Beijing Huajin Pharmaceutical Co., Ltd. launched Ruianji sodium fructose diphosphate oral solution (National Medicine Standard H19990353), which is used to improve angina pectoris of coronary heart disease, myocardial infarction, arrhythmia and myocardial ischemia of mental failure, and adjuvant treatment of viral myocarditis. It can also be used to improve the symptoms of hypoxia caused by cerebral infarction, cerebral hemorrhage, etc. Oral, 1-2g (10-20ml), 2-3 times / day. Shanghai Tianlong Pharmaceutical Co., Ltd. launched Lopuxin sodium fructose diphosphate tablets (National Medicine Standard H20010623), 0.25g*24 tablets, suitable for the adjuvant treatment of myocardial ischemia. Oral, 4 tablets / time, 3 times / day.

[0008] The Fudaping (fructose phosphate) capsules [Weishijianzi (1997) No. 553] launched by Nanjing Shengnuo Biotechnology Industry Co., Ltd. are composed of 300 mg of sodium fructose diphosphate per capsule, vitamin B 1 30mg / capsule, Vitamin B 6 Health food made of 30mg / capsule and 40mg / capsule of L-aspartic acid as the main raw materials. Animal experiments have shown that it has the health functions of hypoxia resistance and anti-fatigue. Oral administration: 1-2 capsules / time, 2 times / day. Zifu Oral Liquid [Weishijianzi (1998) No. 95] launched by Zhejiang Deqing Dongli Health Products Co., Ltd. mainly consists of sodium fructose diphosphate (FDP, 2500mg / 100ml), L-asparagine, honey, potassium sorbate, and water. Functional tests have confirmed that this product has the health functions of anti-fatigue and hypoxia resistance, 20mlx30 bottles, oral administration, 1-2 bottles / day.

[0009] The invention patent application CN103623022A involves a composition of fructose 1,6-diphosphate, the main ingredients of which include a compound of fructose 1,6-diphosphate metal salt and ginseng, which is a health product used for myocardial nutrition enhancement and immune enhancement. The invention patent application adds or uses Ganoderma lucidum spore powder and selenium acetate to make the above-mentioned effects of enhancing immune cell activity, anti-tumor, and tumor reversal better. Because fructose 1,6-diphosphate increases the ability of red blood cells to adhere to the immune composition during exercise, the ginseng and Ganoderma lucidum polysaccharides in the composition have the effect of immune cell vitality: the application mechanistically enhances immune cell activity, anti-tumor, and tumor reversal. The application is used for myocardial nutrition, especially sports nutrients, and the effect of taking it during physical exercise in middle-aged and elderly people is better.

[0010] US4764508A invention patent application relates to novel compounds comprising silybin, silymarin and lipophilic complexes of silybin with phospholipids, and methods for preparing these complexes by unconventional methods. The absorption of the novel compounds in the gastrointestinal tract is significantly greater, resulting in plasma levels higher than those of individual flavanols. The resulting improvement in pharmacokinetic and pharmacological parameters allows the substance to be advantageously used in the treatment of acute and chronic liver diseases of toxic, metabolic or infectious or degenerative nature.

[0011] CN106727626A discloses the use of 1,6-diphosphate fructose in the preparation of drugs for treating alcoholic liver injury, and uses 1,6-diphosphate fructose to treat acute alcoholic liver injury; CN111494564A discloses a method for preparing a composite liver-protecting and alcohol-relieving tablet, in which silybin and cyclodextrin are prepared together into silybin microcapsules, thereby improving the water solubility of silybin and solving the technical problem that silybin is insoluble in water, and the composite liver-protecting and alcohol-relieving tablet is prepared by synergistic use with lotus leaves, reed roots, dandelions and Cordyceps mycelium.

[0012] The above products and tests all use health products to protect the liver before drinking or drinking alcoholic beverages; however, drinking or drinking alcoholic beverages is often unplanned, and consumers cannot take health products to protect the liver before drinking or drinking alcoholic beverages. They can only use health products to protect the liver after drinking or after the party. Most of the hangover and liver protection products on the market need to be taken in advance, and taken for a long time in advance, in order to play the role of protecting the liver and preventing hangovers.

[0013] In addition, some current products take effect relatively quickly, and the ingredients are directly involved in the energy cycle, but the efficacy reaches a peak very quickly, and then quickly declines; that is, the content of functional ingredients in the blood quickly reaches a peak after ingestion and absorption, and then quickly declines after metabolism, and cannot play a continuous liver protection role unless it is continuously ingested; and the peak value of the functional ingredient content is too high, and there is no evidence that the blood content of the functional ingredient and the liver protection effect show a linear relationship, and a high peak value may also bring certain side effects. Therefore, a product that can take effect quickly and has a certain lasting effect to reduce alcohol damage to the liver is very necessary, and it is even better if the product also has an anti-fatigue effect. Summary of the invention

[0014] The object of the present invention is to provide a composition containing milk thistle extract and fructose 1,6-diphosphate or its derivatives or salts thereof in view of the deficiencies of the prior art.

[0015] Further, the milk thistle extract includes one or more of silybin A, silybin B, isosilybin A, isosilybin B, silybin, isosilybin, silybin, and silybin; further preferably, the milk thistle extract includes a combination of silybin A and other types of milk thistle extracts.

[0016] Further, the milk thistle extract is in the form of milk thistle extract microcapsules and / or milk thistle extract liposomes and / or milk thistle extract self-microemulsification forms, preferably one or more of the forms of milk thistle extract-phospholipids, milk thistle extract-phospholipids-cholesterol, and milk thistle extract-cyclodextrin.

[0017] More preferably, the liposome form of milk thistle extract-phospholipid-cholesterol and the form of milk thistle extract-phospholipid complex are combined, or the liposome form of milk thistle extract-phospholipid-cholesterol and the form of milk thistle extract-cyclodextrin are combined.

[0018] Further, the salt of fructose 1,6-diphosphate includes a mixture of one or more of sodium fructose-1,6-diphosphate, magnesium fructose-1,6-diphosphate, calcium fructose-1,6-diphosphate and strontium fructose-1,6-diphosphate. Preferably, the salt of fructose 1,6-diphosphate is sodium fructose-1,6-diphosphate.

[0019] Furthermore, the content of milk thistle extract in the composition is 1-99% (w / w), preferably 10-60% (w / w), and more preferably 20-40% (w / w); the content of sodium fructose-1,6-diphosphate is 1-99% (w / w), preferably 40-90% (w / w), and more preferably 60-80% (w / w).

[0020] Furthermore, the silybin (silybin A and silybin B) in the milk thistle extract accounts for more than 20% of the total content of silybin A, silybin B, isosilybin A, isosilybin B, silybin, isosilybin, silybinin, and silybin, and is more than 30%, more than 40%, more than 50%, more than 60%, more than 70%, more than 80%, more than 90%, more than 95%, more than 96%, more than 97%, more than 98%, more than 99% or 100%.

[0021] The purity of the milk thistle extract is 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, 95% or more, 96% or more, 97% or more, 98% or more, 99% or more or 100%.

[0022] The present invention also provides a product, comprising the above composition, wherein the product dosage form is one of injection, oral liquid, tablet, hard capsule, soft capsule, candy, solid beverage, liquid beverage, and paste.

[0023] Furthermore, the product also includes auxiliary materials; wherein the auxiliary materials include: water, excipients, pigments, sweeteners, pH adjusters, thickeners, binders, disintegrants, and fillers.

[0024] The present invention also provides the use of the composition in liver injury medicines, health foods, dietary supplements and foods;

[0025] or / and application in liver protection drugs, health foods, dietary supplements and foods;

[0026] or / and use in intoxicating drugs, health foods, dietary supplements and foods;

[0027] or / and application in anti-fatigue drugs, health foods, dietary supplements and foods;

[0028] or / and application in cardioprotective medicines, health foods, dietary supplements and foods;

[0029] Or / and application in antidepressant and antianxiety medicines, health foods, dietary supplements and foods.

[0030] Compared with single milk thistle extract and single fructose 1,6-diphosphate, the combination of milk thistle extract and fructose 1,6-diphosphate can produce synergistic effects in multiple organs and tissues. Especially in terms of liver protection. Milk thistle extract scavenges free radicals, stabilizes cell membranes, and repairs cells; FDP can regulate cell metabolism, and at the same time, it also acts as a high-energy fermentation substrate to directly produce ATP and provide energy. The combination can better remove intracellular reactive oxygen free radicals and fight inflammation; repair and stabilize cells, improve the detoxification ability of cells, and avoid further damage to tissue cells under adverse conditions such as drinking, excessive fatigue, and trauma. Therefore, the combination also has good performance and application prospects in anti-fatigue effects, myocardial cell protection, anti-depression and anxiety effects. Take liver protection and myocardial protection as examples:

[0031] Regarding the liver protection effect: Milk thistle extract can clear active oxygen free radicals in stem cells, stabilize liver cell membranes, protect the liver, and strengthen detoxification. FDP, as a metabolic regulator, can reduce ischemia-reperfusion injury in liver cells. At the same time, FDP is also an intermediate product of intracellular metabolism and an effective substrate for glycogen synthesis. It can effectively promote glycogen synthesis in liver cells in a short period of time. Therefore, milk thistle extract and FDP work together in liver protection, which greatly improves the protective effect on the liver compared to single-ingredient solutions.

[0032] Protective effect on myocardial cells: Milk thistle extract can reduce the degree of damage to myocardial cells, increase SOD activity, inhibit cell membrane potential, and improve mitochondrial function. FDP can directly pass through the myocardial cell membrane as an exogenous substrate to produce ATP for myocardial function. At the same time, FDP also participates in regulating myocardial cell sugar metabolism, restoring and improving heart function. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 This is a graph showing the effects of different groups on alcohol-induced liver damage after 1 hour of exposure;

[0034] Figure 2 This is a diagram showing the effects of different groups on liver damage in alcohol-induced models after 2 hours of action;

[0035] Figure 3 This is a diagram showing the effects of different groups on liver damage in alcohol-induced models after 3 hours of action; DETAILED DESCRIPTION

[0036] In order to facilitate the understanding of those skilled in the art, the present invention is further described below in conjunction with embodiments, and the contents mentioned in the implementation modes are not intended to limit the present invention.

[0037] Example 1

[0038] A composition contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin (including silybin A and silybin B) in the milk thistle extract accounts for 80% of the milk thistle extract, and the milk thistle extract is in the form of a milk thistle-phospholipid complex, wherein the milk thistle extract is 40% (w / w) and the sodium fructose-1,6-diphosphate is 60% (w / w).

[0039] Example 2

[0040] A composition contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 70% of the milk thistle extract, and the milk thistle extract is in the form of a milk thistle-phospholipid complex, wherein the milk thistle extract is 20% (w / w) and the sodium fructose-1,6-diphosphate is 80% (w / w).

[0041] Example 3

[0042] A composition contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 90% of the milk thistle extract, and the milk thistle extract is in the form of a milk thistle-phospholipid complex, wherein the milk thistle extract is 33.3% (w / w) and the sodium fructose-1,6-diphosphate is 66.7% (w / w).

[0043] Example 4

[0044] A composition contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 80% of the milk thistle extract, the milk thistle extract is in the form of a milk thistle-phospholipid complex, the milk thistle extract is 1% (w / w), and the sodium fructose-1,6-diphosphate is 99% (w / w).

[0045] Example 5

[0046] A composition contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 80% of the milk thistle extract, the milk thistle extract is in the form of a milk thistle-phospholipid complex, the milk thistle extract is 99% (w / w), and the sodium fructose-1,6-diphosphate is 1% (w / w).

[0047] Example 6

[0048] A composition contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 80% of the milk thistle extract, and the milk thistle extract is in the form of a milk thistle-phospholipid complex, wherein the milk thistle extract is 10% (w / w) and the sodium fructose-1,6-diphosphate is 90% (w / w).

[0049] Example 7

[0050] A composition contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 80% of the milk thistle extract, and the milk thistle extract is in the form of a milk thistle-phospholipid complex, wherein the milk thistle extract is 20% (w / w) and the sodium fructose-1,6-diphosphate is 80% (w / w).

[0051] Example 8

[0052] A composition contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 80% of the milk thistle extract, the milk thistle extract is in the form of a milk thistle-phospholipid complex, the milk thistle extract is 50% (w / w), and the sodium fructose-1,6-diphosphate is 50% (w / w).

[0053] Example 9

[0054] A composition contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 90% of the milk thistle extract, and the milk thistle extract is in the form of a milk thistle-phospholipid complex, wherein the milk thistle extract is 40% (w / w) and the sodium fructose-1,6-diphosphate is 60% (w / w).

[0055] Example 10

[0056] A composition contains milk thistle extract and magnesium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 95% of the milk thistle extract, the milk thistle extract is in the form of a milk thistle-phospholipid complex, the milk thistle extract is 33.3% (w / w), and the sodium fructose-1,6-diphosphate is 66.7% (w / w).

[0057] Embodiment 11

[0058] An oral drinking product contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 80% of the milk thistle extract, the milk thistle extract is in the form of a milk thistle-phospholipid complex, the milk thistle extract is 1.2g / 100ml, and the sodium fructose-1,6-diphosphate is 2.4g / 100ml.

[0059] Example 12

[0060] An oral drinking product contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 80% of the milk thistle extract, the milk thistle extract is in the form of milk thistle extract-phospholipid-cholesterol liposomes, the milk thistle extract is 0.6g / 100ml, and the sodium fructose-1,6-diphosphate is 1.2g / 100ml.

[0061] Embodiment 13

[0062] An oral drinking product contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 80% of the milk thistle extract, the milk thistle extract is in the form of milk thistle extract-phospholipid-cholesterol liposomes, the milk thistle extract is 2.4g / 100ml, and the sodium fructose-1,6-diphosphate is 4.8g / 100ml.

[0063] Embodiment 14

[0064] An oral drinking product contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 60% of the milk thistle extract, the milk thistle extract is in the form of a milk thistle extract-phospholipid complex, the milk thistle extract is 2.4g / 100ml, and the sodium fructose-1,6-diphosphate is 4.8g / 100ml.

[0065] Embodiment 15

[0066] An oral drinking product contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 90% of the milk thistle extract, the milk thistle extract is in the form of a milk thistle-phospholipid complex, the milk thistle extract is 1.2g / 100ml, and the sodium fructose-1,6-diphosphate is 2.4g / 100ml.

[0067] Example 16

[0068] An oral drinking product contains milk thistle extract and sodium fructose-1,6-diphosphate, wherein silybin in the milk thistle extract accounts for 80% of the milk thistle extract, the milk thistle extract is in the form of a milk thistle-phospholipid complex, the milk thistle extract is 1.2g / 100ml, and the sodium fructose-1,6-diphosphate is 2.4g / 100ml; it also contains a sweetener and an acidulant to mask the unpleasant taste of the product.

[0069] Embodiment 17

[0070] An oral drinking product contains milk thistle extract and sodium fructose-1,6-diphosphate. Silybin in the milk thistle extract accounts for 80% of the milk thistle extract. The milk thistle extract is in the form of a milk thistle-phospholipid complex. The milk thistle extract is 1.2g / 100ml and the sodium fructose-1,6-diphosphate is 2.4g / 100ml. A thickener is also contained to enhance the thickness of the product.

[0071] Comparative Example 1

[0072] An oral drinking product contains milk thistle extract, in which silybin accounts for 80% of the milk thistle extract, the milk thistle extract is in the form of a milk thistle-phospholipid complex, and the milk thistle extract is 1.2 g / 100 ml.

[0073] Comparative Example 2

[0074] An oral drinking product contains fructose-1,6-diphosphate sodium, wherein the fructose-1,6-diphosphate sodium is 2.4 g / 100 ml.

[0075] The test was conducted using Example 11, Comparative Example 1 and Comparative Example 2, which do not contain other functional ingredients. The technical solution of the present invention brings significant beneficial effects.

[0076] Animals: SPF male mice (20±2g): The mice were placed in an animal laboratory, cultured at room temperature, and the air humidity was about 55% to 65%. They were raised in separate cages, fed with daily mouse food and distilled water, and the amount of food and water they consumed was not restricted.

[0077] Animal test on liver protection effect:

[0078] Grouping: 50 mice were randomly divided into 5 groups, namely: blank group, model control group, composition group (Example 11), milk thistle group (Comparative Example 1), FDP group (Comparative Example 2).

[0079] Modeling: Each group of mice was fasted for 12 h, the blank control group was gavaged with a volume of normal saline, and the other four groups were gavaged with the alcohol product Niulanshan Erguotou (commercially available, with an alcohol content of 52 degrees), and the gavage volume was calculated according to the weight of the mice (10 mL / kg body weight); 30 minutes after gavage with the alcohol product, the combination group (Example 11), the milk thistle group (Comparative Example 1), and the FDP group (Comparative Example 2) were gavaged with the corresponding group's product (2 mL / kg body weight), and the blank control group and the model control group were gavaged with the corresponding volume of normal saline.

[0080] Sampling and testing: After 1 hour of intervention, the mice were killed and blood was collected. After resting, the blood was centrifuged at 3000 rpm for 15 minutes to obtain serum, which was frozen for AST and ALT testing. Subsequently, the AST and ALT levels in the serum were detected using a kit.

[0081] The above test method was repeated with 40 mice and divided into 4 groups, namely: model group, composition group (Example 11), milk thistle group (Comparative Example 1), FDP group (Comparative Example 2). Blood was collected from the mice 2 hours after treatment, and the ALT and AST levels in the serum were tested in the same way.

[0082] The above test method was repeated with 40 mice and divided into 4 groups, namely: model group, composition group (Example 11), milk thistle group (Comparative Example 1), FDP group (Comparative Example 2). Blood was collected from the mice 3 hours after treatment, and the ALT and AST levels in the serum were tested in the same way.

[0083] Table 1 Effects of different groups on liver protection in alcohol-induced models under 1h action

[0084] ALT(U / L) AST(U / L) Blank group 51.2±7.2 114.5±10.8 Model Group 109.2±11.9 233.2±20.3 Combination group 75.9±8.0 182.9±16.9 Milk Thistle Group 100.7±9.1 221.7±18.4 FDP Group 95.2±11.6 213.2±17.6

[0085] Table 2 Effects of different groups on liver protection in alcohol-induced models under 2h action

[0086] ALT(U / L) AST(U / L) Model Group 105.2±11.7 229.8±21.1 Combination group 68.3±11.6 168.9±15.1 Milk Thistle Group 94.7±7.2 203.2±15.7 FDP Group 86.1±10.8 201.7±15.3

[0087] Table 3 Effects of different groups on liver protection in alcohol-induced models under 3h action

[0088]

[0089]

[0090] It can be seen from the data in Tables 1-3 that under different action times, the levels of alanine aminotransferase and aspartate aminotransferase in mice in the combination group, milk thistle group, and FDP group were significantly reduced (relative to the model group p < 0.01), indicating that milk thistle, FDP and other combinations have the effect of alleviating alcohol-induced liver damage.

[0091] As time went on, the levels of alanine aminotransferase and aspartate aminotransferase in mice gradually decreased (the same indicators between each hour, p<0.05).

[0092] For the indicators of ALT or AST, the difference between the model group and the corresponding group was defined as the reduction amount of a certain group, the difference between the model group and the combination group was defined as the reduction amount of the combination group, the difference between the model group and silymarin was defined as the reduction amount of the silymarin group, the difference between the model group and FDP was defined as the reduction amount of the FDP group, and the reduction amount of the silymarin group and the reduction amount of the FDP group were defined as the sum of the reduction amounts of individual use.

[0093] From Table 2-3 and the instruction manual Figure 2-3 There was no significant difference between the reduction in the combined group and the reduction in the single group at 2h and 3h (p>0.05), but according to Table 1 and the appendix to the instructions, Figure 1The reduction in the combination group was significantly greater than the sum of the reductions in the individual use groups (p<0.05), indicating that when the combination of milk thistle extract and FDP, i.e., milk thistle extract and FDP, are used together, they can more quickly reduce liver damage.

[0094] The synergistic mechanism and rapid onset of action are still under study, but the more likely scenario is that FDP enters the cell and participates in the tricarboxylic acid cycle, enhancing cell energy production, which is conducive to the transport of milk thistle extract into the cell and improves bioavailability; on the other hand, the role of milk thistle extract in repairing cells and stabilizing the target cell membrane also promotes the subsequent penetration and transport of FDP and milk thistle into the target cell. This makes the cell structure and cell membrane more stable, and the two-directional action mechanisms promote each other and synergize.

[0095] Sobering effect test:

[0096] 40 mice were randomly divided into 4 groups, namely: control group, composition group (Example 11), milk thistle group (Comparative Example 1), FDP group (Comparative Example 2), and the three groups were gavaged with Niulanshan Erguotou (commercially available, with an alcohol content of 52 degrees), and the gavage volume was calculated according to the weight of the mice (20mL / kg body weight), and all mice showed a drunken state of drowsiness or inability to walk normally. Then each group was immediately gavaged with the product of the corresponding group (2mL / kg body weight), and the control group was gavaged with a corresponding volume of physiological saline, and the mice were touched to observe the standing (the four limbs can support the body, and the posterior abdomen and front chest can leave the ground) and walking of the mice to judge the sobering condition of the mice.

[0097] Table 4 Effects of different groups on sobering up of drunk mice

[0098]

[0099]

[0100] From the results in Table 4, it can be seen that the combination of milk thistle extract and FDP helps the drunk mice to sober up quickly. In 0.5 hours, mice were able to stand (the posterior abdomen of the mice left the bottom surface), and in 4 hours, 10 mice could walk normally. The effects shown in Table 4 also prove that the combination of milk thistle extract and FDP helps to reduce liver damage more quickly.

[0101] Fatigue test:

[0102] 40 mice were randomly divided into 4 groups, namely: a control group, a composition group (Example 11), a milk thistle group (Comparative Example 1), and an FDP group (Comparative Example 2). The mice were gavaged three times, and each group was gavaged with the product of the corresponding group each time (2 mL / kg body weight). The interval between the three gavages was 4 hours; 1 hour after the last gavage, a weighted swimming exhaustive swimming time test was performed; the blank control group was gavaged with a corresponding amount of normal saline.

[0103] A lead wire weighing 5% of the mouse's body weight was placed at the base of the mouse's tail as a weight, and the water temperature was (25±1)°C, ensuring that the mouse's tail did not touch the bottom of the box in the water. When the mouse's head sank into the water and could not float to the surface within 10 seconds, this time was the mouse's exhaustive swimming time.

[0104] Table 5 Effects of different groups on the exhaustive swimming time of mice

[0105] Group Exhaustive swimming time (min) Blank control group 12.1±2.6 Combination group 18.9±2.9 Milk Thistle Group 15.5±3.3 FDP Group 16.7±2.1

[0106] As shown in Table 5, compared with the blank control group, the exhaustive swimming time of mice in the combination group was significantly prolonged (p<0.01), indicating that the combination of milk thistle extract and FDP also has a significant effect on anti-fatigue.

[0107] Conclusion: The combination of milk thistle extract and FDP has the effect of reducing liver damage, hangover and fatigue, especially it can act quickly to reduce liver damage and sober up, especially to reduce liver damage caused by drinking or excessive fatigue.

[0108] It will be understood by those skilled in the art that, unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as generally understood by those skilled in the art in the art to which the present invention belongs. It should also be understood that terms such as those defined in general dictionaries should be understood to have meanings consistent with the meanings in the context of the prior art, and will not be interpreted with idealized or overly formal meanings unless specifically defined as herein.

[0109] It should be understood that the detailed description of the technical solutions of the present invention by means of the preferred embodiments is illustrative rather than restrictive. A person skilled in the art may modify the technical solutions described in the embodiments, or replace some of the technical features by equivalents, based on reading the specification of the present invention; and these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A composition, characterized in that: Containing 20-50% by weight of milk thistle extract in the form of phospholipids and 50-80% by weight of fructose-1,6-diphosphate or its derivatives, or its salts; Wherein, the milk thistle extract includes one or more of silybin A, silybin B, isosilybin A, isosilybin B, silybin, isosilybin, silybin, and silybin; and / or One or more derivatives of silybin A, silybin B, isosilybin A, isosilybin B, silybin, isosilybin, silybin, and silybin; Silybin in the milk thistle extract accounts for more than 20% of the milk thistle extract.

2. The composition according to claim 1, characterized in that: The salt of fructose-1,6-diphosphate includes a mixture of one or more of sodium fructose-1,6-diphosphate, magnesium fructose-1,6-diphosphate, calcium fructose-1,6-diphosphate and strontium fructose-1,6-diphosphate.

3. A product comprising the composition according to any one of claims 1-2, wherein the product dosage form is one of oral liquid, tablet, hard capsule, soft capsule, candy, solid beverage, liquid beverage, and paste.

4. The product according to claim 3, characterized in that It also includes auxiliary materials, including: water, excipients, pigments, sweeteners, pH regulators, thickeners, binders, disintegrants, and fillers.

5. Use of the composition according to any one of claims 1-2 or the product according to any one of claims 3-4 in the preparation of liver protection drugs, health foods, dietary supplements and / or foods; or / and use in the preparation of intoxicating drugs, health foods, dietary supplements and / or foods; Or / and use in the preparation of anti-fatigue medicines, health foods, dietary supplements and / or foods.

Images