Liver protection composition as well as preparation method, application and product thereof

Abstract

The invention belongs to the technical field of nutritional compositions and biological medicines, and particularly relates to a liver protection composition as well as a preparation method, application and a product thereof. The invention provides a liver protection composition. The liver protection composition is prepared from a silybum marianum extract, a turmeric extract and fucoxanthin. According to the liver protection composition, through the synergistic effect of the three components, the oxidation resistance can be remarkably improved, serum ALT and AST levels and liver indexes of mice in a liver injury model can be reduced, expression of inflammatory factors (IL-6 and TNF-alpha) can be inhibited, the oxidative stress index (SOD) can be improved, the liver protection effect of the liver protection composition is better than that of a single component and a traditional compounding scheme, and the liver protection composition can be widely applied to the field of liver protection. The traditional Chinese medicine composition has the advantages of comprehensive efficacy, strong pertinence and high safety, and has important application value in the field of liver protection.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of nutritional composition and biomedicine, and particularly relates to a liver-protecting composition, a preparation method, application and product thereof. BACKGROUND

[0002] The liver is one of the most important metabolic organs in the human body, with multiple key physiological functions such as detoxification, protein synthesis, energy storage, bile secretion and regulation of material metabolism, and its health status directly affects the overall life activities of the human body. With the change of modern lifestyle, factors such as long-term sleep deprivation, high-fat diet, excessive alcohol consumption, excessive mental stress and environmental pollutant exposure can significantly increase the metabolic load on the liver, causing liver cell damage, inflammatory response and oxidative stress imbalance, and further inducing a series of liver diseases such as fatty liver, liver fibrosis, liver cirrhosis and even liver cancer.

[0003] At present, for the prevention and improvement of liver damage, the common intervention means in the clinical and health care fields include chemical drug treatment, nutritional regulation and natural product intervention. Among them, natural products have attracted widespread attention in the field of liver protection due to their high safety and small side effects. Existing studies have shown that silymarin in the extract of Silybum marianum is a classic liver-protecting active ingredient, which can play a protective role through mechanisms such as stabilizing liver cell membranes, inhibiting liver cell apoptosis and promoting liver cell regeneration; curcumin components in the extract of Curcuma longa have significant anti-inflammatory and antioxidant activities, and can reduce liver inflammatory response and oxidative stress damage; fucoxanthin, as a natural marine algal extract, has been found in recent studies to have biological activities such as regulating lipid metabolism, inhibiting liver steatosis and anti-inflammatory, and has shown potential application value in liver protection. However, the liver-protecting effect of a single component often has limitations, and existing liver-protecting compositions attempt to compound multiple natural plant extracts.

[0004] Silybum marianum and Curcuma longa plant tablets are a dietary supplement with Silybum marianum extract and Curcuma longa extract as the main components, commonly used to support liver health, antioxidant and relieve inflammation. The synergistic effect of the two can help improve liver function, and is suitable for people who drink alcohol for a long time, have greasy diet or need liver conditioning. However, it cannot achieve multi-target synergistic effect of liver cell protection, inflammation inhibition and oxidative stress regulation.

[0005] Patent CN118384194A A kind of composition for improving nonalcoholic fatty liver disease, contains by weight parts: silymarin nano-liposome 12-25 parts, chrysanthemum extract 3-10 parts, fucoxanthin 0.05-0.15 parts, myo-inositol 5-10 parts, choline 5-15 parts, folic acid 0.005-0.015 parts, VB12 0.1-0.3 parts, can effectively reduce the content of liver lipid TG, TC, realize the effect of liver protection.But the formula contains multiple vitamins and nutrients (such as myo-inositol, choline, folic acid, etc.), the component system is complex, possibly because the proportion of auxiliary material is too high and reduces the effective concentration of core liver-protecting component, in turn affect the pertinence and high efficiency of overall efficacy.

[0006] Therefore, it is still a technical problem to be solved in the art to develop a liver-protecting composition that can comprehensively and efficiently improve liver damage. SUMMARY

[0007] To overcome the above-mentioned deficiencies, the present application provides a liver-protecting composition, a preparation method, application and product thereof.

[0008] The technical solution of the present application is as follows: In one aspect, the present application provides a liver-protecting composition, which is composed of silymarin extract, turmeric extract and fucoxanthin.

[0009] Specifically, the liver-protecting composition is composed of 50-200 parts of silymarin extract, 50-150 parts of turmeric extract and 1-10 parts of fucoxanthin by weight.

[0010] Preferably, the liver-protecting composition is composed of 75-200 parts of silymarin extract, 75-150 parts of turmeric extract and 1-5 parts of fucoxanthin by weight.

[0011] Further preferably, the liver-protecting composition comprises 75-76 parts by weight, 76-77 parts by weight, 77-78 parts by weight, 78-79 parts by weight, 79-80 parts by weight, 80-81 parts by weight, 81-82 parts by weight, 82-83 parts by weight, 83-84 parts by weight, 84-85 parts by weight, 85-86 parts by weight, 86-87 parts by weight, 87-88 parts by weight, 88-89 parts by weight, 89-90 parts by weight, 90-91 parts by weight, 91-92 parts by weight, 92-93 parts by weight, 93-94 parts by weight, 94-95 parts by weight, 95-96 parts by weight, 96-97 parts by weight, 97-98 parts by weight, 98-99 parts by weight, 99-100 parts by weight, 100-101 parts by weight, 101-105 parts by weight, 102-103 parts by weight, 103-104 parts by weight, 104-105 parts by weight, 105-106 parts by weight, 106-107 parts by weight, 107-108 parts by weight, 108-109 parts by weight, 109-110 parts by weight, 110-111 parts by weight, 111-112 parts by weight, 112-113 parts by weight, 113-114 parts by weight, 114-115 parts by weight, 115-116 parts by weight, 116-117 parts by weight, 117-118 parts by weight, 118-119 parts by weight, 119-120 parts by weight, 120-121 parts by weight, 121-122 parts by weight, 122-123 parts by weight, 123-124 parts by weight, 124-125 parts by weight, 125-126 parts by weight, 126-127 parts by weight, 127-128 parts by weight, 128-129 parts by weight, 129-130 parts by weight, 130-131 parts by weight, 131-132 parts by weight, 132-133 parts by weight, 133-134 parts by weight, 134-135 parts by weight, 135-136 parts by weight, 136-137 parts by weight, 137-138 parts by weight, 138-139 parts by weight, 139-140 parts by weight, 140-141 parts by weight, 141-142 parts by weight, 142-143 parts by weight, 143-144 parts by weight, 144-145 parts by weight, 145-146 parts by weight, 146-147 parts by weight, 147-148 parts by weight, 148-149 parts by weight, 149-150 parts by weight, 150-151 parts by weight, 151-152 parts by weight, 152-153 parts by weight, 153-154 parts by weight, 154-155 parts by weight, 155-156 parts by weight, 156-157 parts by weight, 157-158 parts by weight, 158-159 parts by weight, 159-160 parts by weight, 160-161 parts by weight, 161-162 parts by weight, 162-163 parts by weight, 163-164 parts by weight, 164-165 parts by weight, 165-166 parts by weight, 166-167 parts by weight, 167-168 parts by weight, 168-169 parts by weight, 169-170 parts by weight, 170-171 parts by weight, 171-172 parts by weight, 172-173 parts by weight, 173-174 parts by weight, 174-175 parts by weight, 175-176 parts by weight, 176-177 parts by weight, 177-178 parts by weight, 178-179 parts by weight, 179-180 parts by weight, 180-181 parts by weight, 181-182 parts by weight, 182-183 parts by weight, 183-184 parts by weight, 184-185 parts by weight, 185-186 parts by weight, 186-187 parts by weight, 187-188 parts by weight, 188-189 parts by weight,189-190 parts by weight, 190-191 parts by weight, 191-192 parts by weight, 192-193 parts by weight, 193-194 parts by weight, 194-195 parts by weight, 195-196 parts by weight, 196-197 parts by weight, 197-198 parts by weight, 198-199 parts by weight, or 199-200 parts by weight of milk thistle extract.

[0012] Still further preferably, the liver-protecting composition comprises 150-151 parts by weight, 151-152 parts by weight, 152-153 parts by weight, 153-154 parts by weight, 154-155 parts by weight, 155-156 parts by weight, 156-157 parts by weight, 157-158 parts by weight, 158-159 parts by weight, 159-160 parts by weight, 160-161 parts by weight, 161-162 parts by weight, 162-163 parts by weight, 163-164 parts by weight, 164-165 parts by weight, 165-166 parts by weight, 166-167 parts by weight, 167-168 parts by weight, 168-169 parts by weight, 169-170 parts by weight, 170-171 parts by weight, 171-172 parts by weight, 172-173 parts by weight, 173-174 parts by weight, 174-175 parts by weight, 175-176 parts by weight, 176-177 parts by weight, 177-178 parts by weight, 178-179 parts by weight, 179-180 parts by weight, 180-181 parts by weight, 181-182 parts by weight, 182-183 parts by weight, 183-184 parts by weight, 184-185 parts by weight, 185-186 parts by weight, 186-187 parts by weight, 187-188 parts by weight, 188-189 parts by weight, 189-190 parts by weight, 190-191 parts by weight, 191-192 parts by weight, 192-193 parts by weight, 193-194 parts by weight, 194-195 parts by weight, 195-196 parts by weight, 196-197 parts by weight, 197-198 parts by weight, 198-199 parts by weight, or 199-200 parts by weight of milk thistle extract.

[0013] Still further preferably, the liver-protecting composition comprises 175 parts by weight of milk thistle extract.

[0014] Further preferably, the liver-protecting composition comprises 75-76 parts by weight, 76-77 parts by weight, 77-78 parts by weight, 78-79 parts by weight, 79-80 parts by weight, 80-81 parts by weight, 81-82 parts by weight, 82-83 parts by weight, 83-84 parts by weight, 84-85 parts by weight, 85-86 parts by weight, 86-87 parts by weight, 87-88 parts by weight, 88-89 parts by weight, 89-90 parts by weight, 90-91 parts by weight, 91-92 parts by weight, 92-93 parts by weight, 93-94 parts by weight, 94-95 parts by weight, 95-96 parts by weight, 96-97 parts by weight, 97-98 parts by weight, 98-99 parts by weight, 99-100 parts by weight, 100-101 parts by weight, 101-105 parts by weight, 102-103 parts by weight, 103-104 parts by weight, 104-105 parts by weight, 105-106 parts by weight, 106-107 parts by weight, 107-108 parts by weight, 108-109 parts by weight, 109-110 parts by weight, 110-111 parts by weight, 111-112 parts by weight, 112-113 parts by weight, 113-114 parts by weight, 114-115 parts by weight, 115-116 parts by weight, 116-117 parts by weight, 117-118 parts by weight, 118-119 parts by weight, 119-120 parts by weight, 120-121 parts by weight, 121-122 parts by weight, 122-123 parts by weight, 123-124 parts by weight, 124-125 parts by weight, 125-126 parts by weight, 126-127 parts by weight, 127-128 parts by weight, 128-129 parts by weight, 129-130 parts by weight, 130-131 parts by weight, 131-132 parts by weight, 132-133 parts by weight, 133-134 parts by weight, 134-135 parts by weight, 135-136 parts by weight, 136-137 parts by weight, 137-138 parts by weight, 138-139 parts by weight, 139-140 parts by weight, 140-141 parts by weight, 141-142 parts by weight, 142-143 parts by weight, 143-144 parts by weight, 144-145 parts by weight, 145-146 parts by weight, 146-147 parts by weight, 147-148 parts by weight, 148-149 parts by weight, or 149-150 parts by weight of curcuma longa extract.

[0015] Still further preferably, the liver-protecting composition comprises 75-76 parts by weight, 76-77 parts by weight, 77-78 parts by weight, 78-79 parts by weight, 79-80 parts by weight, 80-81 parts by weight, 81-82 parts by weight, 82-83 parts by weight, 83-84 parts by weight, 84-85 parts by weight, 85-86 parts by weight, 86-87 parts by weight, 87-88 parts by weight, 88-89 parts by weight, 89-90 parts by weight, 90-91 parts by weight, 91-92 parts by weight, 92-93 parts by weight, 93-94 parts by weight, 94-95 parts by weight, 95-96 parts by weight, 96-97 parts by weight, 97-98 parts by weight, 98-99 parts by weight, or 99-100 parts by weight of curcuma longa extract.

[0016] Still further preferably, the liver-protecting composition comprises 95 parts by weight of curcuma longa extract.

[0017] Further preferably, the liver-protecting composition comprises 1-2 parts, 2-3 parts, 3-4 parts, or 4-5 parts of fucoxanthin by weight.

[0018] Still further preferably, the liver-protecting composition comprises 1-2 parts or 2-3 parts of fucoxanthin by weight.

[0019] Still further preferably, the liver-protecting composition comprises 2 parts of fucoxanthin by weight.

[0020] Specifically, the preparation method of the extract of S. mooreana A. Chev. comprises: (1) The seeds of S. mooreana A. Chev. are put into an oil press to remove the oil in the seeds, thereby obtaining S. mooreana A. Chev. cake; (2) An extraction solvent is added to the S. mooreana A. Chev. cake, and after extraction, an extract is obtained; (3) The extract is concentrated, thereby obtaining a concentrated solution; (4) The concentrated solution is defatted, thereby obtaining S. mooreana A. Chev. extract; (5) The S. mooreana A. Chev. extract is dried after removing the volatile components remaining in the material, thereby obtaining the extract of S. mooreana A. Chev.

[0021] Preferably, the mass ratio of the S. mooreana A. Chev. cake to the extraction solvent in step (2) is 1:1-15.

[0022] Further preferably, the mass ratio of the S. mooreana A. Chev. cake to the extraction solvent in step (2) is 1:1-2, 1:2-3, 1:3-4, 1:4-5, 1:5-6, 1:6-7, 1:7-8:1:8-9, 1:9-10, 1:10-11, 1:11-12, 1:12-13, 1:13-14, or 1:14-15.

[0023] Still further preferably, the mass ratio of the S. mooreana A. Chev. cake to the extraction solvent in step (2) is 1:3-4, 1:4-5, 1:5-6, 1:6-7, 1:7-8:1:8-9, 1:9-10, 1:10-11, 1:11-12, 1:12-13, 1:13-14, or 1:14-15.

[0024] Still further preferably, the mass ratio of the S. mooreana A. Chev. cake to the extraction solvent in step (2) is 1:3.

[0025] Preferably, the extraction solvent in step (2) is any one or more of ethyl acetate, ethanol, and acetone.

[0026] Further preferably, the extraction solvent in step (2) is ethyl acetate.

[0027] Still further preferably, the ethyl acetate is 80% v / v-95% v / v ethyl acetate.

[0028] Still more preferably, the ethyl acetate is 90% v / v to 95% v / v ethyl acetate.

[0029] Preferably, the extraction in step (2) is extraction at 60-80°C for 10-30h.

[0030] Preferably, the concentration in step (3) is concentration at 75-100°C for 15-20h.

[0031] More preferably, the concentration in step (3) is concentration at 75-100°C for 16h.

[0032] Still more preferably, the concentration in step (3) is concentration at 75-85°C for 13.5h, and then adjusting the temperature to 90-100°C for 2.5h.

[0033] Preferably, the defatting in step (4) is: after the concentrated solution is allowed to stand, the oil that separates out is removed by suction; a defatting solvent is added, the mixture is stirred and then allowed to stand, and the defatting solvent is removed by suction. The defatting step is repeated twice more to obtain the S. mooreana extract.

[0034] More preferably, the defatting solvent is added in an amount of 1-2 times the volume of the concentrated solution.

[0035] More preferably, the defatting solvent comprises any one or more of acetone, ethyl acetate, and ethanol.

[0036] Still more preferably, the defatting solvent is acetone.

[0037] More preferably, the standing is standing for at least 30 min.

[0038] More preferably, the stirring and then standing is stirring for at least 10 min, and then standing for at least 10 min.

[0039] Preferably, the method for removing residual volatile components from the material in step (5) comprises the following steps: 1) temperature 50-70°C, vacuum degree -0.01 ~ -0.03 MPa, for 20-40 min; 2) stirring, temperature increased to 60-80°C, for 20-40 min; 3) after the foam disappears, temperature increased to 80-95°C, vacuum degree controlled at -0.03 ~ -0.06 MPa, for 100-150 min.

[0040] More preferably, step 1) is temperature 60-70°C, vacuum degree -0.01 ~ -0.03 MPa, for 20-40 min.

[0041] Still further preferably, step 1) is at a temperature of 60-70°C, a vacuum degree of -0.01 ~ -0.03 MPa, and a holding time of 30 min.

[0042] Further preferably, step 2) is stirring, a temperature rising to 70-80°C, and a holding time of 20-40 min. Still further preferably, step 2) is stirring, a temperature rising to 70-80°C, and a holding time of 30 min.

[0043] Further preferably, step 3) is a temperature rising to 85-95°C after the foam disappears, a vacuum degree controlled at -0.03 ~ -0.06 Mpa, and a holding time of 100-150 min.

[0044] Still further preferably, step 3) is a temperature rising to 85-95°C after the foam disappears, a vacuum degree controlled at -0.03 ~ -0.06 Mpa, and a holding time of 120 min.

[0045] Preferably, the drying in step (5) is at 80-90°C, -0.06 ~ -0.10 Mpa vacuum drying for 3-5 h.

[0046] Further preferably, the drying in step (5) is at 80-90°C, -0.08 Mpa vacuum drying for 4 h.

[0047] Specifically, the content of the water fly extract is 40%-55% w / w, and the content of dihydroquercetin is 1%-5% w / w.

[0048] Preferably, the content of the water fly extract is 42%-49% w / w, and the content of dihydroquercetin is 1%-4% w / w.

[0049] Further preferably, the content of the water fly extract is 45%-49% w / w, and the content of dihydroquercetin is 2%-4% w / w.

[0050] Preferably, the water fly extract contains water fly bine, isowater fly bine, water fly tine, and water fly ning.

[0051] Further preferably, the water fly extract contains 40%-60% w / w water fly bine, 10%-20% w / w isowater fly bine, 20%-30% w / w water fly tine, and 5%-15% w / w water fly ning.

[0052] Still further preferably, the water fly extract contains 43%-56% w / w water fly bine, 12%-21% w / w isowater fly bine, 23%-25% w / w water fly tine, and 7%-12% w / w water fly ning.

[0053] More preferably, the silymarin comprises 49%-56% w / w silybin, 12%-14% w / w isosilybin, 23%-25% w / w silychristin, and 7%-10% w / w silydianin.

[0054] The present application does not limit the preparation method of the silybum extract, and any preparation method of the curcuma extract falls within the protection scope of the present application; in addition, as long as the product contains the silybum extract of the present application (for example, liposomes, co-crystals, micelles, etc. prepared from the silybum extract of the present application), it also falls within the protection scope of the present application.

[0055] Specifically, the preparation method of the curcuma extract comprises: S1, crushing and sieving the curcuma raw material to obtain curcuma powder; S2, adding an extraction solvent to the curcuma powder, extracting, filtering the extraction liquid to obtain a filtrate; S3, concentrating the filtrate to obtain an extract; S4, after impurity removal, recrystallizing, filtering, and collecting the precipitate; S5, drying the precipitate to obtain the curcumin extract.

[0056] Preferably, the mesh size of the sieve used in the sieving in step S1 is 1.0-1.4 cm.

[0057] Further preferably, the mesh size of the sieve used in the sieving in step S1 is 1.2 cm.

[0058] Preferably, the mass ratio of the curcuma powder to the extraction solvent in step S2 is 1:8-12.

[0059] Further preferably, the mass ratio of the curcuma powder to the extraction solvent in step S2 is 1:8-9, 1:9-10, 1:10-11, or 1:11-12.

[0060] Still further preferably, the mass ratio of the curcuma powder to the extraction solvent in step S2 is 1:10.

[0061] Preferably, the extraction solvent in step S2 is ethyl acetate and / or ethanol.

[0062] Further preferably, the extraction solvent in step S2 is ethanol.

[0063] Still further preferably, the ethanol is 70% v / v-96% v / v ethanol.

[0064] More preferably, the ethanol is 90% v / v-96% v / v ethanol.

[0065] Preferably, the temperature of the extraction in step S2 is room temperature, which includes 20-25℃.

[0066] Preferably, the time of the extraction in step S2 is 4-6h.

[0067] Further preferably, the time of the extraction in step S2 is 5h.

[0068] Preferably, the filtration in step S2 uses a 300-mesh filter bag.

[0069] Preferably, the concentration in step S3 includes: concentrating the filtrate to a specific gravity of 1.25-1.32, and continuing to concentrate to a solid content of 85% or more to obtain the extract.

[0070] Further preferably, the vacuum degree of the concentration is -0.06 ~ -0.09 mpa, and the temperature is 50-70℃.

[0071] Preferably, the step of removing impurities from the extract in step S4 includes: heating the extract to 50-60℃, adding ethanol, stirring at 50-60℃ for 10-20min, standing for 12-18h, and collecting the precipitate.

[0072] Further preferably, the ethanol in the step of removing impurities from the extract in step S4 is 80-85% v / v ethanol.

[0073] Still further preferably, the ethanol in the step of removing impurities from the extract in step S4 is 85% v / v ethanol.

[0074] Further preferably, the amount of ethanol added in the step of removing impurities from the extract in step S4 is 2-3 times the weight of the extract.

[0075] Still further preferably, the amount of ethanol added in the step of removing impurities from the extract in step S4 is 2 times the weight of the extract.

[0076] Preferably, the recrystallization in step S4 is recrystallization with ethanol, and the crystalline precipitate is collected, Further preferably, the ethanol in the step of recrystallization in step S4 is 80-85% v / v ethanol.

[0077] Still further preferably, the ethanol in the step of recrystallization in step S4 is 85% v / v ethanol.

[0078] Further preferably, the amount of ethanol added in the step of recrystallization in step S4 is 1-2 times the weight of the precipitate.

[0079] Still more preferably, the amount of ethanol added in the recrystallization step in step S4 is 1 times the weight of the precipitate.

[0080] Preferably, the drying in step S5 comprises vacuum drying, freeze drying or spray drying.

[0081] Further preferably, the drying in step S5 is spray drying.

[0082] In particular, the content of total curcuminoids in the curcumin extract is 55%-70% w / w.

[0083] Preferably, the content of total curcuminoids in the curcumin extract is 58%-68% w / w.

[0084] Further preferably, the content of total curcuminoids in the curcumin extract is 65%-68% w / w.

[0085] Preferably, the total curcuminoids comprise curcumin, demethylated curcumin and bisdemethylated curcumin.

[0086] Further preferably, the total curcuminoids comprise 45-70% w / w curcumin, 20-30% w / w demethylated curcumin and 10-25% w / w bisdemethylated curcumin.

[0087] Still more preferably, the total curcuminoids comprise 47%-68% w / w curcumin, 21-30% w / w demethylated curcumin and 11%-23% w / w bisdemethylated curcumin.

[0088] The present application does not limit the preparation method of curcumin extract, and any curcumin extract falls within the protection scope of the present application; in addition, as long as the product comprises the curcumin extract of the present application (for example, liposomes, co-crystals, micelles and the like prepared by using the curcumin extract of the present application), it also falls within the protection scope of the present application.

[0089] In another aspect, the present application provides a preparation method of the liver-protecting composition of any one of the above, which comprises mixing the extract of Silybum marianum, the curcumin extract and fucoxanthin by weight.

[0090] In still another aspect, the present application provides the use of the liver-protecting composition of any one of the above in the preparation of a product, which comprises any one or more of the following: (1) a functional food or health product having an auxiliary protective effect on chemical liver injury; (2) a drug for preventing or treating liver injury.

[0091] In another aspect, the present application provides a functional food comprising the liver-protecting composition according to any one of the above.

[0092] In particular, the dosage form of the functional food includes a liquid dosage form, a solid dosage form, or a semi-solid dosage form.

[0093] Preferably, the functional food includes, but is not limited to, a candy, a soy milk, a yogurt, a canned food, a biscuit, a chocolate, a pastry, a butter, a cheese, a cream, a milk powder, a formula milk powder, an ice cream, a jam, a puree, a preserved fruit, a preserved vegetable, a dried fruit, a bread, an egg roll, a protein beverage, a solid beverage, a lactic acid bacteria beverage, a plant protein beverage, a carbonated beverage, a coffee, or an extruded food.

[0094] Preferably, the functional food includes a human food or an animal food.

[0095] In particular, the functional food further comprises a nutritionally acceptable nutrient.

[0096] Preferably, the nutritionally acceptable nutrient includes one or more of a dietary fiber, a protein, a lipid substance, a mineral, and a vitamin.

[0097] In another aspect, the present application provides a health care product comprising the liver-protecting composition according to any one of the above.

[0098] Preferably, the dosage form of the health care product includes a tablet, a capsule, a soft capsule, a granule, a pill, a gummy candy, a powder, an oral solution, or a drop.

[0099] In particular, the health care product further comprises a nutritionally acceptable nutrient.

[0100] Preferably, the nutritionally acceptable nutrient includes one or more of a dietary fiber, a protein, a lipid substance, a mineral, and a vitamin.

[0101] In another aspect, the present application provides a pharmaceutical product comprising the liver-protecting composition according to any one of the above.

[0102] Preferably, the dosage form of the pharmaceutical product includes one or more of a tablet, a pill, a powder, a suspension, a gel, an emulsion, a cream, a granule, a capsule, a suppository, an injection, a spray, and a needle.

[0103] In particular, the pharmaceutical product further comprises a pharmaceutically acceptable excipient.

[0104] Preferably, the pharmaceutically acceptable adjuvant includes one or more than two combinations of wetting agents, emulsifiers, preservatives, antioxidants, buffers, diluents, lubricants, solutes, suspending agents, solubilizers, thickening agents, stabilizers, sweeteners, and spices.

[0105] In another aspect, the present application provides a method for assisting in protecting chemical liver injury, the method comprising using the liver-protecting composition, functional food or health product according to any one of the above.

[0106] Specifically, the method comprises administering an effective amount of the liver-protecting composition, functional food or health product to a subject.

[0107] Preferably, the subject is a mammal.

[0108] Further preferably, the subject is a human.

[0109] In another aspect, the present application provides a method for preventing or treating liver injury, the method comprising using the liver-protecting composition or drug product according to any one of the above.

[0110] Specifically, the method comprises administering an effective amount of the drug product to a subject.

[0111] Preferably, the subject is a mammal.

[0112] Further preferably, the subject is a human.

[0113] The beneficial effects of the present application are: The liver-protecting composition of the present application plays a role in multiple pathological links of liver injury: the extract of Silybum marianum protects hepatocytes by stabilizing hepatocyte membranes and promoting hepatocyte regeneration; the extract of Curcuma longa reduces liver inflammation and oxidative stress damage by anti-inflammatory and antioxidant effects; and fucoxanthin regulates lipid metabolism and inhibits liver steatosis. The three components synergistically cover multiple targets of "hepatocyte protection-inflammation inhibition-oxidative stress regulation-lipid metabolism improvement", which can comprehensively cope with chemical liver injury, fatty liver and other liver problems, and solve the defect of limited effect of single target intervention in the prior art.

[0114] The liver-protecting composition of the present application is made of natural product extracts, has no obvious toxic and side effects, is suitable for long-term use, is suitable for people who need liver protection due to long-term overtime, high-fat diet, excessive drinking and the like, and is suitable for liver injury prevention and adjuvant therapy scenarios, and has a wide range of application scenarios. BRIEF DESCRIPTION OF DRAWINGS

[0115] Figure 1 The serum ALT and AST determination results are shown in the figure; * in the figure represents a significant difference from the blank group P <0.05; ** represents a significant difference from the blank groupP <0.01; **** indicates a significant difference in the blank group. P <0.0001; ### indicates a significant difference from the model group. P <0.001; #### indicates a significant difference from the model group. P <0.0001; @ indicates a significant difference compared to the positive control group, P<0.05; @@ indicates a significant difference compared to the positive control group. P <0.01; @@@@ indicates a significant difference compared to the positive control group. P <0.0001.

[0116] Figure 2 These are the results of liver index measurement; the ** in the figure represent significant differences compared to the control group. P <0.01; *** indicates a significant difference from the control group. P <0.001; **** indicates a significant difference in the blank group. P <0.0001; # indicates a significant difference from the model group. P <0.05; ## indicates a significant difference from the model group. P <0.01; @ indicates a significant difference compared to the positive control group (P<0.05); @@ indicates a significant difference compared to the positive control group. P <0.01.

[0117] Figure 3 These are the results of measurements of liver inflammatory factors and oxidative stress levels; * indicates a significant difference compared to the control group. P <0.05; ** indicates a significant difference from the control group. P <0.01; *** indicates a significant difference from the control group. P <0.001; **** indicates a significant difference in the blank group. P <0.0001; # indicates a significant difference from the model group. P <0.05; ## indicates a significant difference from the model group. P <0.01; ### indicates a significant difference from the model group. P <0.001; #### indicates a significant difference from the model group. P <0.0001; @ indicates a significant difference compared to the positive control group, P<0.05; @@ indicates a significant difference compared to the positive control group. P <0.01; @@@ indicates a significant difference compared to the positive control group. P <0.001; @@@@ indicates a significant difference compared to the positive control group. P <0.0001. DETAILED DESCRIPTION

[0118] The application will be further clarified by the following examples which are intended to be exemplary of the present application. The following examples are not intended to limit the application but are intended to further clarify the application. The experimental methods used in the following examples are routine unless otherwise specified. The materials, reagents, etc. used in the following examples are commercially available unless otherwise specified.

[0119] Basic Example 1 HPLC method for determining the active ingredients in the extract of S. marianum, the chromatographic column Cosmosil 5C18-MS-II packed column (φ4.6 / 250 mm); flow rate: 1 mL / min; detection wavelength: 210 nm; 50% methanol aqueous solution isocratic elution, 60 min). At the same time, using the standard of silybin, isosilybin, silychristin, silydianin and taxifolin, a calibration curve was established for the analysis of the content of active ingredients in the extract of S. marianum.

[0120] Basic Example 2 HPLC method for determining the active ingredients in the extract of C. longa, the chromatographic column: WelchromTM-C18 column (4.6 mm × 250 mm, 5 µm, Welch Materrial. Inc); flow rate: 1 mL / min; detection wavelength: 260 nm; mobile phase: acetonitrile-3% glacial acetic acid (50:50). At the same time, using the standard of curcumin, desmethoxycurcumin, bisdemethoxycurcumin, a calibration curve was established for the analysis of the content of active ingredients in the extract of C. longa.

[0121] Example 1 A liver-protecting composition, which is composed of 175 parts of S. marianum extract, 95 parts of C. longa extract and 2 parts of fucoxanthin. The preparation method of the liver-protecting composition is as follows: 1. Preparation of S. marianum extract (1) Put the S. marianum seeds into an oil press to remove the oil in the seeds, and obtain S. marianum cake.

[0122] (2) According to the mass ratio of 1:3 of S. marianum cake to extraction solvent, add 95% v / v ethyl acetate to the S. marianum cake, and extract at 60°C for 20 h to obtain an extract; (3) The extract is placed in a concentration tank, and maintained at 85°C for 13.5 h, and then the temperature is adjusted to 100°C for 2.5 h to obtain a concentrated solution; (4) De-fatting: suck the concentrated solution into a de-fatting and residual removal machine, and stand for 30 min. The oil separated out is pumped out. Add 2 times the volume of acetone to the concentrated solution, stir for 10 min, stand for 10 min, and pump out the acetone. Repeat the above de-fatting steps for 2 more times to obtain S. marianum extract.

[0123] (5) The water fly aloe extract is heated, the temperature in the tank is controlled at 60°C, the vacuum degree is controlled at -0.01 to -0.03 MPa, and is maintained for 30 min. The stirring is started, the temperature in the tank is raised to 70°C, and is maintained for 30 min. After the foam in the tank disappears, the vacuum degree is controlled at -0.03 to -0.06 MPa, and the temperature is controlled at 85°C, and is maintained for 120 min, and the residual removal is completed.

[0124] (6) The extract after the residual removal is vacuum dried at -0.08 MPa and 80°C for 4 h, and the water fly aloe extract is obtained.

[0125] In the water fly aloe extract prepared by the above method, the water fly aloe extract contains water fly aloe and dihydroquercetin, wherein the content of the water fly aloe is 45% w / w, and the content of the dihydroquercetin is 2% w / w. The proportion of each effective component in the water fly aloe includes 56% w / w of water fly aloe bin, 12% w / w of isofly aloe bin, 25% w / w of water fly aloe ting, and 7% w / w of water fly aloe ning.

[0126] 2. Preparation of turmeric extract S1, the turmeric raw material is taken to a crusher for coarse crushing, the screen mesh aperture is 1.2 cm, and the turmeric powder is obtained.

[0127] S2, according to the mass ratio of 1:10 of the turmeric powder and the extraction solvent, 96% v / v ethanol is added to the turmeric powder, and the stirring extraction is performed at room temperature for 5.0 h. The extraction liquid is filtered by using a 300-mesh filter bag, and the filtrate is obtained.

[0128] S3, the vacuum degree of the filtrate is controlled at -0.06 to -0.09 MPa, and the temperature is 70°C. The concentration is performed until the specific gravity is 1.25-1.32, and the concentration is continuously performed until the solid content is more than 85%, and the extract is obtained.

[0129] S4, the extract is heated to 60°C, 85% v / v ethanol is added, the addition amount of the 85% v / v ethanol is 2 times the weight of the extract, the heating and insulation (60°C) are continuously performed for 10 min, the natural cooling is performed, the closed standing is performed for 12 h, the precipitate is taken, and the precipitate is added with 85% v / v ethanol for recrystallization. The addition amount of the 85% v / v ethanol is 1 times the weight of the precipitate, the crystalline precipitate is collected, and the precipitate is obtained after the filtration.

[0130] S5, the precipitate is spray dried, and the turmeric extract is obtained.

[0131] In the turmeric extract prepared by the above method, the total curcumin component content is 65% w / w, wherein the proportion of each effective component includes 60% w / w of curcumin, 25% w / w of desmethyl gingerol, and 15% w / w of bisnor-methoxy curcumin.

[0132] 3. Preparation of liver protection composition Mixing 175 parts of the extract of S. chinensis, 95 parts of the extract of C. longa and 2 parts of fucoxanthin homogeneously, a liver-protecting composition of Example 1 is obtained.

[0133] Example 2 A liver-protecting composition is composed of 75 parts of the extract of S. chinensis, 150 parts of the extract of C. longa and 5 parts of fucoxanthin. The preparation method of the liver-protecting composition is as follows: 1. Preparation of the extract of S. chinensis (1) Put the seeds of S. chinensis into an oil press to remove the oil in the seeds, and obtain S. chinensis cake.

[0134] (2) Add 90% v / v ethyl acetate to the S. chinensis cake at a mass ratio of 1:15 of the S. chinensis cake to the extraction solvent, and extract at 80°C for 20 h to obtain an extract; (3) Concentrate the extract in a concentration tank at 75°C for 13.5 h, and then adjust the temperature to 90°C for 2.5 h to obtain a concentrated solution; (4) De-fat: suck the concentrated solution into a de-fatting and residual removal machine, and stand for 30 min. Remove the oil that is separated out. Add 1-fold volume of acetone to the concentrated solution, stir for 10 min, stand for 10 min, and remove the acetone. Repeat the de-fatting step twice to obtain a S. chinensis extract.

[0135] (5) Warm the S. chinensis extract, control the temperature in the tank at 70°C, and control the vacuum degree at -0.01 to -0.03 MPa for 30 min. Start stirring, and raise the temperature in the tank to 80°C for 30 min. When the foam in the tank disappears, control the vacuum degree at -0.03 to -0.06 MPa, and control the temperature at 95°C. After keeping for 120 min, complete the removal of residual.

[0136] (6) Dry the extract after the removal of residual at -0.08 MPa and 90°C for 4 h to obtain the extract of S. chinensis.

[0137] The extract of S. chinensis prepared by the above method contains silymarin and dihydroquercetin, wherein the content of silymarin is 49% w / w, and the content of dihydroquercetin is 4% w / w. The proportion of each effective component in silymarin includes 53% w / w silybin, 14% w / w isosilybin, 23% w / w silychristin and 10% w / w silydianin.

[0138] 2. Preparation of the extract of C. longa S1. Take the raw material of C. longa, coarsely crush it in a crusher, and obtain C. longa powder with a screen mesh size of 1.2 cm.

[0139] S2, curcuma powder is added to 90% v / v ethanol at a mass ratio of 1:10, and stirred at room temperature for 5.0 h. The extract is filtered with a 300-mesh filter bag to obtain a filtrate.

[0140] S3, the vacuum degree of the filtrate is controlled to -0.06 ~ -0.09 mpa, and the temperature is 50℃. The filtrate is concentrated to a specific gravity of 1.25-1.32, and then continuously concentrated to a solid content of more than 85% to obtain an extract.

[0141] S4, the extract is heated to 50℃, and 85% v / v ethanol is added at a dosage of 2 times the weight of the extract. The mixture is continuously heated, kept at 50℃, stirred for 10 min, naturally cooled, and statically placed in a closed container for 18 h. The precipitate is collected, and the precipitate is recrystallized by adding 85% v / v ethanol at a dosage of 1 times the weight of the precipitate. The crystalline precipitate is collected after filtration to obtain a precipitate.

[0142] S5, the precipitate is spray-dried to obtain a curcuma extract.

[0143] The curcuma extract prepared by the above method has a total curcumin content of 68% w / w, wherein the proportions of the effective components include 68% w / w of curcumin, 21% w / w of demethylcurcumin, and 11% w / w of bisdemethoxycurcumin.

[0144] 3. Preparation of a liver-protecting composition 75 parts of the extract of Silybum marianum, 150 parts of the curcuma extract, and 5 parts of fucoxanthin are uniformly mixed to obtain the liver-protecting composition of Example 2.

[0145] Example 3 A liver-protecting composition is composed of 200 parts of the extract of Silybum marianum, 75 parts of the curcuma extract, and 1 part of fucoxanthin. The preparation method of the liver-protecting composition is as follows: 1. Preparation of the extract of Silybum marianum (1) The seeds of Silybum marianum are put into an oil press to remove the oil in the seeds to obtain Silybum marianum cake.

[0146] (2) 80% v / v ethyl acetate is added to the Silybum marianum cake at a mass ratio of 1:1, and the mixture is refluxed at 60℃ for 20 h to obtain an extract; (3) The extract is placed in a concentration tank and maintained at 100℃ for 16 h to obtain a concentrated solution; (4) Defatting: the concentrated solution is sucked into a defatting and residual removal machine, and the oil is removed after standing for 30 min. 2 times the volume of acetone is added to the concentrated solution, stirred for 10 min, and then stood for 10 min. The acetone is removed. The above defatting step is repeated twice to obtain a Silybum marianum extract.

[0147] (5) The temperature of the extract of Silybum marianum is raised, the temperature in the tank is controlled at 50°C, the vacuum degree is controlled at -0.01 ~ -0.03 MPa, and maintained for 30 min. The stirring is started, the temperature in the tank is raised to 60°C, and maintained for 30 min. When the foam in the tank disappears, the vacuum degree is controlled at -0.03 ~ -0.06 MPa, and the temperature is controlled at 80°C, and maintained for 120 min, and the residual removal is completed.

[0148] (6) The extract after the residual removal is vacuum dried at -0.08 MPa and 80°C for 4 h, and the extract of Silybum marianum is obtained.

[0149] The extract of Silybum marianum prepared by the above method contains silymarin and dihydroquercetin, wherein the content of silymarin is 42% w / w, and the content of dihydroquercetin is 1% w / w. The proportion of each active ingredient in silymarin includes 43% w / w silychristin, 21% w / w isosilychristin, 24% w / w silydianin, and 12% w / w silybin.

[0150] 2. Preparation of turmeric extract The turmeric extract is prepared according to the method described in Example 1.

[0151] 3. Preparation of liver-protecting composition 200 parts of the extract of Silybum marianum, 75 parts of the turmeric extract, and 1 part of fucoxanthin are uniformly mixed to obtain the liver-protecting composition of Example 3.

[0152] Example 4 A liver-protecting composition, which is composed of 175 parts of the extract of Silybum marianum, 95 parts of the turmeric extract, and 2 parts of fucoxanthin. The preparation method of the liver-protecting composition is as follows: 1. Preparation of extract of Silybum marianum The extract of Silybum marianum is prepared according to the method described in Example 1.

[0153] 2. Preparation of turmeric extract S1, the turmeric raw material is coarsely crushed in a pulverizer, and the screen mesh aperture is 1.2 cm to obtain turmeric powder.

[0154] S2, according to the mass ratio of 1:10 of the turmeric powder to the extraction solvent, 70% v / v ethanol is added to the turmeric powder, and stirred at room temperature for 5.0 h. The extraction liquid is filtered by a 300-mesh filter bag to obtain the filtrate.

[0155] S3, the vacuum degree of the filtrate is controlled at -0.06 ~ -0.09 MPa, and the temperature is 70°C. The filtrate is concentrated to a solid content of more than 85% to obtain the extract.

[0156] S4, the extract is heated to 60℃, 85% v / v ethanol is added, the amount of 85% v / v ethanol added is 3 times the weight of the extract, heating and stirring (60℃) is continued for 10 min, it is allowed to cool naturally, it is closed and left to stand for 12 h, the precipitate is taken, the precipitate is recrystallized by adding 85% v / v ethanol, the amount of 85% v / v ethanol added is 2 times the weight of the precipitate, the crystalline precipitate is collected, and after filtration, the precipitate is obtained.

[0157] S5, the precipitate is spray dried to obtain the turmeric extract.

[0158] The total curcuminoid content of the turmeric extract prepared by the above method is 58% w / w, and the proportions of the various active ingredients include 47% w / w of curcumin, 30% w / w of demethylangol, and 23% w / w of bisdemethoxycurcumin.

[0159] 3. Preparation of a liver-protecting composition 175 parts of the extract of Silybum marianum, 95 parts of the turmeric extract, and 2 parts of fucoxanthin are mixed uniformly to obtain the liver-protecting composition of Example 1.

[0160] Example 5 A liver-protecting composition, which is composed of 50 parts of the extract of Silybum marianum, 150 parts of the turmeric extract, and 10 parts of fucoxanthin. The preparation method of the liver-protecting composition is as follows: 1. Preparation of the extract of Silybum marianum The extract of Silybum marianum is prepared according to the method described in Example 1.

[0161] 2. Preparation of the turmeric extract The turmeric extract is prepared according to the method described in Example 1.

[0162] 3. Preparation of the composition 50 parts of the extract of Silybum marianum, 150 parts of the turmeric extract, and 10 parts of fucoxanthin are mixed uniformly to obtain the liver-protecting composition of Example 5.

[0163] Example 6 A liver-protecting composition, which is composed of 70 parts of the extract of Silybum marianum, 50 parts of the turmeric extract, and 8 parts of fucoxanthin. The preparation method of the liver-protecting composition is as follows: 1. Preparation of the extract of Silybum marianum The extract of Silybum marianum is prepared according to the method described in Example 1.

[0164] 2. Preparation of the turmeric extract The turmeric extract is prepared according to the method described in Example 1.

[0165] 3. Preparation of the composition Example 6

[0166] Comparative Example 1 A milk thistle extract was prepared according to the method described in Example 1.

[0167] Comparative Example 2 A turmeric extract was prepared according to the method described in Example 1.

[0168] Comparative Example 3 Comparative Example 3 is fucoxanthin.

[0169] Comparative Example 4 A liver-protecting composition consisting of 175 parts of milk thistle extract and 97 parts of turmeric extract. The liver-protecting composition was prepared as follows: 1. Preparation of milk thistle extract The milk thistle extract was prepared according to the method described in Example 1.

[0170] 2. Preparation of turmeric extract The turmeric extract was prepared according to the method described in Example 1.

[0171] 3. Preparation of liver-protecting composition The liver-protecting composition of Comparative Example 4 was prepared by mixing 175 parts of milk thistle extract and 97 parts of turmeric extract.

[0172] Comparative Example 5 A liver-protecting composition consisting of 175 parts of milk thistle extract, 95 parts of turmeric extract and 2 parts of lutein. The liver-protecting composition was prepared as follows: 1. Preparation of milk thistle extract The milk thistle extract was prepared according to the method described in Example 1.

[0173] 2. Preparation of turmeric extract The turmeric extract was prepared according to the method described in Example 1.

[0174] 3. Preparation of liver-protecting composition The liver-protecting composition of Comparative Example 5 was prepared by mixing 175 parts of milk thistle extract, 95 parts of turmeric extract and 2 parts of lutein.

[0175] Experimental Example 1 Antioxidant efficacy of liver-protecting composition The antioxidant capacity of the liver-protecting composition was determined by 2,2'-azinonobiy (3-ethylbenzothiazoline 6-sulfonate) radical scavenging experiment (ABTS method) with Trolox as a standard solution. A 500 μg / mL sample solution was prepared, and the sample was divided into the liver-protecting composition of Example 1-Example 6, the extract of Silybum marianum of Comparative Example 1, the extract of Curcuma longa of Comparative Example 2, fucoxanthin of Comparative Example 3, and the liver-protecting composition of Comparative Example 4-Comparative Example 5. 200 μL of PBS (as a blank control), each sample, and each concentration of Trolox standard solution (0.15 mM, 0.30 mM, 0.60 mM, 1.20 mM, and 1.50 mM for drawing a standard curve) were added to a 96-well plate. 10 μL of ABTS working solution was added to each well and mixed uniformly. The absorbance was determined at 734 nm for 60 min, and the antioxidant capacity was calculated according to the standard curve. The determination results are shown in Table 1: Table 1

[0176] Note: ** in the table represents a significant difference compared with Example 1 P <0.01); **** represents a significant difference compared with Example 1 P <0.0001).

[0177] The results show that the liver-protecting composition of Example 1-Example 6 has good antioxidant capacity. It can be proved by Comparative Example 1-Comparative Example 3 that the combination of the extract of Silybum marianum, the extract of Curcuma longa, and fucoxanthin has a synergistic effect.

[0178] Experimental Example 2: Liver-protecting effect of the liver-protecting composition 1. Experimental grouping After 8-week-old healthy male Kunming mice were adaptively fed for one week, they were randomly divided into 12 groups, including a blank group, a model group, a positive control group, Example 1 group-Example 6 group, Comparative Example 1 group-Comparative Example 3 group, and each group had 5 mice.

[0179] 2. Experimental process The blank group: the mice were given the same volume of PBS by gavage; The model group: the mice were given the same volume of PBS by gavage; The positive control group: the mice were given 200 mg / kg acetylcysteine by gavage; Example 1 group: the mice were given 10 mg / kg of the liver-protecting composition of Example 1 by gavage.

[0180] Example 2 group: the mice were given 10 mg / kg of the liver-protecting composition of Example 2 by gavage.

[0181] Example 3 group: Mice were administered the hepatoprotective composition of Example 3 by gavage at a dose of 10 mg / kg.

[0182] Example 4 group: Mice were administered the hepatoprotective composition of Example 4 by gavage at a dose of 10 mg / kg.

[0183] Example 5 group: Mice were administered the hepatoprotective composition of Example 5 by gavage at a dose of 10 mg / kg.

[0184] Example 6 group: Mice were administered the hepatoprotective composition of Example 6 by gavage at a dose of 10 mg / kg.

[0185] Comparative Example 1: Mice were administered 10 mg / kg of milk thistle extract from Comparative Example 1 via gavage; Comparative Example 2: Mice were administered 10 mg / kg of turmeric extract from Comparative Example 2 by gavage; Comparative Example 3: Mice were administered 10 mg / kg of fucoxanthin from Comparative Example 3 by gavage.

[0186] Mice were administered the above-mentioned drugs via gavage, once daily for 7 consecutive days. Mice were weighed after the last gavage. One hour after the last gavage, an acute liver injury model was established in mice (mice were fasted for 12 hours prior to modeling to minimize interference from the contents). Mice were intraperitoneally injected with 400 mg / kg of acetaminophen to establish the acute liver injury model; the control group received the same volume of PBS intraperitoneally. Six hours after the intraperitoneal injection of acetaminophen, blood was collected by enucleation using enzyme-free centrifuge tubes for AST and ALT determination. Mice were euthanized by cervical dislocation, and the livers were collected and weighed. The collected livers were stored at -80°C for subsequent detection of inflammatory factor levels.

[0187] 3. Serum ALT and AST measurements (n=5) Mouse blood was centrifuged at 5000 rpm at 4°C for 10 min, and the supernatant was collected to obtain mouse serum samples. The levels of ALT and AST in the serum were measured using AST and ALT kits.

[0188] Elevated levels of biomarkers such as ALT and AST are important indicators used to assess the degree of liver damage. Measurement results are as follows: Figure 1 As shown, the results indicated that the ALT and AST levels in the model group mice were 2074.86±51.82 and 1956.94±98.44, respectively, which were significantly higher than those in the normal control group. P <0.0001). This indicates that the liver injury model of the present invention was successfully constructed. The liver-protective compositions of Examples 1-6 were all able to effectively reduce ALT and AST levels, showing significant differences compared with the model group ( P <0.0001).

[0189] The liver-protecting compositions of Examples 1-5 have better effects of reducing ALT and AST than the positive control drug acetylcysteine, and the liver-protecting composition of Example 6 has effects of reducing ALT and AST that are not as good as the positive control drug acetylcysteine but have no significant difference from the positive control group. Among them, the ALT level and AST level of the Example 1 group, the Example 2 group, and the Example 5 group have significant reductions compared with the positive control group. The liver-protecting composition of Example 1 has the best effect of reducing ALT and AST, and the ALT and AST levels are reduced by 94.75% and 88.84%, respectively, compared with the model group.

[0190] 4, Liver index (n=5) After the mice are executed by decapitation, the liver is collected to ensure its integrity, the blood adsorbed on the liver and spleen is washed with normal saline, and the excess water is absorbed with filter paper and weighed, and the liver weight is recorded. The liver index calculation formula is as follows:

[0191] The determination results are shown in Table 2. Figure 2 The liver index of the model group mice is significantly increased, and has a significant difference compared with the blank group ( P <0.0001), and the liver-protecting compositions of Examples 1-6 can significantly reduce the liver index and have a significant difference from the model group. Among them, the liver-protecting compositions of Examples 1, 2, 4, and 5 can restore the liver index to the normal level (no significant difference from the blank group).

[0192] 5, Determination of liver inflammatory factor level and oxidative stress level (n=3) According to the detailed steps in the ELISA kit instructions, the contents of IL-6, TNF-α, and SOD in the mouse liver are determined. The determination results are shown in Table 3. Figure 3 The liver-protecting compositions of Examples 1-6 of the present application can restore the IL-6 expression level to the normal level (no significant difference from the blank group), and the effect of reducing IL-6 is better than that of the positive control group. The liver-protecting compositions of Examples 1-5 of the present application can restore the TNF-α expression level to the normal level, and the liver-protecting composition of Example 6 has a significant difference from the blank group, but the effect of reducing TNF-α expression is still better than that of the positive control group. The above results show that the liver-protecting compositions of Examples 1-6 of the present application can effectively inhibit the expression of inflammatory factors, thereby achieving the liver-protecting effect.

[0193] The liver-protecting compositions of Examples 1-6 of the present application can significantly increase the SOD level, and have a significant difference from the model group ( P ​<0.0001), which indicates that the liver-protecting composition of the present application can produce a liver-protecting effect by inhibiting the level of oxidative stress, wherein the effect of improving the SOD level of Example 1 is the best, is superior to the positive control group, and can restore the SOD to the normal level (no significant difference with the blank group).

[0194] The above detailed description is a specific description of one of the feasible embodiments of the present application, which is not used to limit the patent scope of the present application. It should be noted that any equivalent implementation or change made without departing from the present application shall be included in the scope of the technical solutions of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. A liver-protecting composition, characterized in that, The liver-protecting composition consists of milk thistle extract, turmeric extract and fucoxanthin.

2. The liver-protecting composition according to claim 1, characterized in that, The liver-protecting composition comprises, by weight, 50-200 parts milk thistle extract, 50-150 parts turmeric extract and 1-10 parts fucoxanthin.

3. The liver-protecting composition according to claim 1, characterized in that, The liver-protecting composition comprises, by weight, 75-200 parts milk thistle extract, 75-150 parts turmeric extract and 1-5 parts fucoxanthin.

4. The liver-protecting composition according to claim 2, characterized in that, The liver-protecting composition comprises, by weight, 150-200 parts milk thistle extract, 75-100 parts turmeric extract and 1-3 parts fucoxanthin.

5. The liver-protecting composition according to claim 1, characterized in that, The method for preparing the milk thistle extract includes: (1) Milk thistle seeds are put into an oil press to remove the oil from the seeds, and milk thistle cake is obtained; (2) Add extraction solvent to milk thistle cake, and after extraction, obtain the extract; (3) The extract is concentrated to obtain a concentrated solution; (4) The concentrate was defatted to obtain milk thistle extract; (5) Milk thistle extract: After removing the residual volatile components in the material, it is dried to obtain milk thistle extract.

6. The liver-protecting composition according to claim 1, characterized in that, The preparation method of the turmeric extract includes: S1. Turmeric raw material is crushed and sieved to obtain turmeric powder; S2. Add extraction solvent to turmeric powder, extract, filter the extract to obtain filtrate; S3. Concentrate the filtrate to obtain an extract; S4. After removing impurities from the extract, recrystallize, filter, and collect the precipitate; S5. After precipitation and drying, curcumin extract is obtained.

7. A method for preparing the liver-protecting composition according to any one of claims 1-6, characterized in that, The preparation method includes mixing milk thistle extract, turmeric extract and fucoxanthin in parts by weight.

8. The use of the liver-protecting composition according to any one of claims 1-6 in the preparation of the product, characterized in that, The products mentioned include any one or more of the following: (1) Functional foods or health products that have an auxiliary protective effect against chemically induced liver injury; (2) Drugs for the prevention or treatment of liver damage.

9. A functional food, characterized in that, The functional food comprises the liver-protecting composition according to any one of claims 1-6.

10. The functional food according to claim 9, characterized in that, The dosage forms of the functional foods mentioned include liquid, solid, or semi-solid dosage forms.

11. The functional food according to claim 9, characterized in that, The functional foods mentioned also include nutritionally acceptable nutrients.

12. A health product, characterized in that, The health product comprises the liver-protecting composition according to any one of claims 1-6.

13. The health product according to claim 12, characterized in that, The dosage forms of the health products include tablets, capsules, soft capsules, granules, pills, gel candies, powders, oral liquids, or drops.

14. The health product according to claim 12, characterized in that, The health products mentioned also include nutritionally acceptable nutritional additives.

15. The health product according to claim 14, characterized in that, The nutritional additives include any one or more of the following: dietary fiber, protein, lipids, minerals, and vitamins.

16. A medicine, characterized in that, The medicine comprises the liver-protecting composition according to any one of claims 1-6.

17. The pharmaceutical product according to claim 16, characterized in that, The dosage forms of the medicine include any one or more of the following: tablets, pills, powders, suspensions, gels, emulsions, creams, granules, capsules, suppositories, injections, sprays, and injections.

18. The pharmaceutical product according to claim 16, characterized in that, The medicine also includes pharmaceutically acceptable excipients.

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