Composition with liver protection effect as well as preparation method and application thereof

Abstract

The invention provides a composition with a liver protection effect as well as a preparation method and application thereof. The composition with the liver protection effect is prepared from the following substrates in parts by mass: 10 to 30 parts of silybum marianum powder, 15 to 40 parts of radix puerariae powder, 20 to 35 parts of radix salviae miltiorrhizae powder, 5 to 15 parts of aronia fruit freeze-dried powder and 8 to 20 parts of hovenia dulcis thunb powder. The preparation method comprises the following steps: mixing the raw materials of the substrate, performing enzymolysis by using a compound enzyme, fermenting an enzymolysis product by using a compound strain to obtain a fermentation product, and freeze-drying the fermentation product to obtain the composition with the liver protection effect. Wherein the compound enzyme comprises cellulase and pectinase; the composite strains are acetobacter pasteurianus and bacillus inulin. The composition with the liver protection effect can effectively improve the liver function level.

Description

Technical Field

[0001] The present invention relates to the field of health care products, and in particular to a composition with liver protection efficacy, a preparation method and an application thereof. Background Art

[0002] In recent years, with the increasing incidence of liver diseases, the demand for liver-protecting health products and drugs has continued to grow. Traditional liver-protecting products are mostly based on a single active ingredient, and there are problems such as a single target of action of the ingredient and insufficient synergistic enhancement. At the same time, the active ingredients in plant raw materials are often complex in molecular structure or wrapped by cell walls, resulting in low extraction efficiency and limited bioavailability. In the prior art, although there have been attempts to improve the release of plant components by using enzymatic hydrolysis or fermentation processes, problems such as a single enzyme type and unreasonable strain compatibility still lead to insignificant improvement in product activity. For example, conventional fermentation processes mostly use a single strain (such as lactic acid bacteria or acetic acid bacteria), which is difficult to fully degrade the cellulose and pectin in the raw materials, and lack the ability to directional conversion of liver-protecting active ingredients. Therefore, the development of a composition that improves liver protection efficacy by combining the synergistic compatibility of multiple raw materials, composite enzymatic hydrolysis and directional fermentation technology has become a technical problem that needs to be solved urgently. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to provide a composition with liver protection effect and its preparation method and application, which can effectively improve the liver function level.

[0004] The technical solutions of the present invention are as follows:

[0005] In a first aspect, the present invention provides a method for preparing a composition having liver-protecting efficacy, comprising the following steps:

[0006] a) enzymatic hydrolysis: mixing the substrate raw materials of the composition to obtain a raw material powder, using sterile deionized water to prepare the raw material powder into a raw material liquid with a concentration of 11-13wt%, adding a complex enzyme to the raw material liquid for enzymatic hydrolysis to obtain an enzymatic hydrolysis liquid, wherein the added amount of the complex enzyme is 1-3wt% of the mass of the raw material liquid, the complex enzyme is a mixture of cellulase and pectinase in a mass ratio of 1: (0.5-0.7), the cellulase activity is 30,000 U / g, the pectinase activity is 30,000 U / g, the enzymatic hydrolysis temperature is 40-55°C, the enzymatic hydrolysis time is 2-4h, and the enzymatic hydrolysis pH is 4.0-5.5;

[0007] b) Composite fermentation: sterile deionized water is used to prepare the enzymatic hydrolyzate into a mixed solution with a concentration of 10-12 wt%, the mixed solution is sterilized and inoculated with a mixed bacterial solution, and fermented at 30-37 ° C for 48-72 h to obtain a fermentation solution, and the fermentation solution is sterilized and filtered, concentrated, and spray-dried to obtain a liver protection composition, wherein the mass ratio of the mixed bacterial solution to the mixed solution is 1: (11-12), the mixed bacterial solution is composed of an Acetobacter pasteurian bacterial solution and a Lactobacillus inulinus bacterial solution, the ratio of the viable bacteria count of the Acetobacter pasteurian bacterial solution to the Lactobacillus inulinus bacterial solution is 1: (0.5-1.5), and the viable bacteria count of the Acetobacter pasteurian bacterial solution is 1×10 8 -1×10 10 CFU / g, the viable bacteria count of the inulin sporolactobacillus culture liquid is 1×10 8 -1×10 10 CFU / g;

[0008] The Acetobacter pasteurianus deposit number is: CGMCC No.12930;

[0009] The preservation number of the Sporolactobacillus inulinus is: CGMCC No.2185.

[0010] The substrate raw materials of the composition include the following raw materials in parts by weight:

[0011] Milk thistle powder: 10-30 parts;

[0012] Kudzu root powder: 15-40 parts;

[0013] Salvia miltiorrhiza powder: 20-35 parts;

[0014] Aronia berry freeze-dried powder: 5-15 servings;

[0015] Hovenia dulcis powder: 8-20 parts.

[0016] Preferably, the composition substrate raw materials include the following raw materials in parts by weight:

[0017] Milk thistle powder: 20-30 parts;

[0018] Kudzu root powder: 25-40 parts;

[0019] Salvia miltiorrhiza powder: 30-35 parts;

[0020] Aronia berry freeze-dried powder: 5-10 servings;

[0021] Hovenia dulcis powder: 15-20 parts.

[0022] Furthermore, the substrate raw materials of the composition include the following raw materials in parts by weight:

[0023] Milk thistle powder: 20 parts;

[0024] Kudzu root powder: 25 parts;

[0025] Salvia miltiorrhiza powder: 30 parts;

[0026] Aronia berry freeze-dried powder: 10 parts;

[0027] Hovenia dulcis powder: 15 parts.

[0028] In a second aspect, the present invention provides a use of a composition with liver-protecting efficacy prepared by the preparation method described in the first aspect in the preparation of a health product or medicine with liver-protecting efficacy.

[0029] In a third aspect, the present invention provides a liver protection preparation, which comprises the composition with liver protection efficacy prepared by the preparation method described in the first aspect.

[0030] Preferably, the liver protection preparation is in the form of any one of tablets, capsules, ointments, pills, and oral liquids.

[0031] In a fourth aspect, the present invention provides a liver-protecting tablet, characterized in that it comprises the following components in parts by weight:

[0032] 30-35 parts of the composition with liver-protecting efficacy prepared by the preparation method of the first aspect;

[0033] Microcrystalline cellulose: 10-30 parts;

[0034] Lactose: 20-40 parts:

[0035] Magnesium stearate: 0.01-1 part;

[0036] Skimmed milk powder: 10-30 parts;

[0037] Sodium carboxymethyl starch: 5-15 parts.

[0038] The preparation method of the liver protection tablet comprises the following steps:

[0039] Step 1: Mix the microcrystalline cellulose, lactose, skimmed milk powder, and sodium carboxymethyl starch, add the mixture to a dry granulator, and collect granules of 10-120 mesh;

[0040] Step 2: mixing the composition having liver protection effect, the particles collected in step 1, and magnesium stearate to obtain a mixture;

[0041] Step 3: Put the mixture into the tablet press and adjust the pressure to 10-40kN to obtain liver protection tablets.

[0042] Compared with the prior art, the present invention has the following beneficial effects:

[0043] The synergistic effect of the composition of the present invention is achieved through a three-dimensional network of multi-component targeted regulation and process synergy as follows:

[0044] 1. In terms of preparation technology, cellulase and pectinase with a mass ratio of 1: (0.5-0.7) are used to perform compound enzymolysis on the substrate raw materials to break the cell wall and release the active ingredients;

[0045] 2. Regarding the compatibility of the substrate raw materials, the active ingredients silymarin, flavonoids, and polysaccharides in milk thistle powder activate the Nrf2 / ARE antioxidant pathway. Simultaneously, the isoflavones, terpenes, and polysaccharides in kudzu root powder inhibit the NF-κB inflammatory pathway, creating a dual "oxidation-inflammation" blockade, enhancing the liver-protecting efficacy of the combination. The anthocyanins in aronia berry lyophilized powder chelate metal ions, and the polysaccharides, saponins, and polyphenols in Hovenia dulcis powder synergistically enhance free radical scavenging and toxin metabolism in the body. The polysaccharides and saponins in salvia miltiorrhiza powder activate the PI3K / Akt anti-apoptosis pathway. These ingredients form a closed loop of "damage repair-metabolic balance" by improving microcirculation, further enhancing the liver-protecting efficacy of the combination.

[0046] 3. Co-fermentation with Acetobacter pasteurianus (CGMCC No. 12930) and Sporolactobacillus inulinus (CGMCC No. 2185) is used to further release the active substances of flavonoids, polyphenols and polysaccharides in the substrate raw materials and increase the organic acids and complex enzymes produced by the fermentation of the bacteria to improve bioavailability. DETAILED DESCRIPTION

[0047] In order to enable those skilled in the art to better understand the technical solutions in the embodiments of the present invention and to make the above-mentioned objects, features and advantages of the present invention more obvious and understandable, the specific implementation methods of the present invention are further described below.

[0048] The endpoints of the ranges disclosed herein and any values ​​are not limited to the exact ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For data ranges, the endpoints of each range, the endpoints of each range and individual point values, and the individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed in this article.

[0049] The sources of some raw materials in this experiment are as follows:

[0050] Milk thistle powder: Milk thistle was purchased from Guangzhou Qingping Chinese Medicinal Materials Market. The purchased milk thistle was screened and impurities removed, then ground, passed through an 80-mesh sieve, and powdered, which was sealed and stored for later use.

[0051] Pueraria root powder: Pueraria root was purchased from Guangzhou Qingping Chinese Medicinal Materials Market. The purchased Pueraria root was screened and removed of impurities, then ground, passed through an 80-mesh sieve, and powdered. The powder was sealed and stored for later use.

[0052] Salvia miltiorrhiza powder: Salvia miltiorrhiza was purchased from Guangzhou Qingping Chinese Medicinal Materials Market. The purchased Salvia miltiorrhiza was screened and impurities removed, then ground, passed through an 80-mesh sieve, and powdered, which was sealed and stored for later use.

[0053] Aronia berry freeze-dried powder was purchased from Ningxia Vanilla Biotechnology Co., Ltd.

[0054] Hovenia dulcis fruit powder: Hovenia dulcis fruit was purchased from Guangzhou Qingping Chinese Medicinal Materials Market. The purchased Hovenia dulcis fruit was screened and impurities removed, then ground, passed through an 80-mesh sieve, and powdered, which was sealed and stored for later use.

[0055] Cellulase: purchased from Shaanxi Chenming Biotechnology Co., Ltd., with an enzyme activity of 30,000 U / g.

[0056] Pectinase: purchased from Shaanxi Chenming Biotechnology Co., Ltd., with an enzyme activity of 30,000 U / g.

[0057] The mass fractions of the raw materials of the liver protection composition substrate and the preparation method thereof are as follows:

[0058] Liver protection composition substrate raw material parts by mass:

[0059] Substrate raw material group 1:

[0060] Milk thistle powder: 20 parts;

[0061] Kudzu root powder: 25 parts;

[0062] Salvia miltiorrhiza powder: 30 parts;

[0063] Aronia berry freeze-dried powder: 10 parts;

[0064] Hovenia dulcis powder: 15 parts.

[0065] Substrate raw material group 2:

[0066] Milk thistle powder: 10 parts;

[0067] Pueraria root powder: 15 parts;

[0068] Salvia miltiorrhiza powder: 20 parts;

[0069] Aronia berry freeze-dried powder: 15 parts;

[0070] Hovenia dulcis powder: 8 parts.

[0071] Substrate raw material group 3:

[0072] Milk thistle powder: 30 parts;

[0073] Pueraria root powder: 40 parts;

[0074] Salvia miltiorrhiza powder: 35 parts;

[0075] Aronia berry freeze-dried powder: 5 parts;

[0076] Hovenia dulcis powder: 20 parts.

[0077] Substrate raw material group ①: different from composition 1, it does not contain wild aronia berry freeze-dried powder, and the missing mass parts are made up with sterile deionized water.

[0078] Substrate raw material group ②: different from composition 1, it does not contain Hovenia dulcis fruit powder, and the missing parts by mass are made up with sterile deionized water.

[0079] Substrate raw material group ③: different from composition 1, it does not contain Hovenia dulcis fruit powder and Aronia berry freeze-dried powder, and the missing parts by mass are made up with sterile deionized water.

[0080] Substrate raw material group ④, unlike composition 1, does not contain milk thistle powder, kudzu root powder, and salvia miltiorrhiza powder, and the missing parts by mass are made up with sterile deionized water.

[0081] The preparation method of composition 1 comprises the following steps:

[0082] a) Enzymolysis: The raw materials in substrate raw material group 1 are mixed to obtain raw material powder, and the raw material powder is prepared into a raw material liquid with a concentration of 12 wt% using sterile deionized water. A complex enzyme is added to the raw material liquid for enzymolysis to obtain an enzymatic hydrolysis liquid; wherein the amount of the complex enzyme added is 2 wt% of the mass of the raw material liquid, the complex enzyme is a mixture of cellulase and pectinase in a mass ratio of 1:0.6, the cellulase activity is 30,000 U / g, the pectinase activity is 30,000 U / g, the enzymatic hydrolysis temperature is 50° C., the enzymatic hydrolysis time is 3 h, and the enzymatic hydrolysis pH is 5.0;

[0083] b) Composite fermentation: using sterile deionized water to prepare the enzymatic hydrolyzate into a mixed solution with a concentration of 11 wt%, sterilizing the mixed solution and inoculating the mixed bacterial solution, fermenting at 34° C. for 64 h to obtain a fermentation solution, sterilizing the fermentation solution and filtering, concentrating, and spray drying to obtain a liver protection composition, wherein the mass ratio of the mixed bacterial solution to the mixed solution is 1:12, the mixed bacterial solution is composed of an Acetobacter pasteurian culture solution and a Lactobacillus inulinus culture solution, the ratio of the viable bacteria count of the Acetobacter pasteurian culture solution to the Lactobacillus inulinus culture solution is 1:1, and the viable bacteria count of the Acetobacter pasteurian culture solution is 1×10 9 CFU / g, the viable bacteria count of the inulin sporolactobacillus culture liquid is 1×10 9 CFU / g;

[0084] The Acetobacter pasteurianus deposit number is: CGMCC No.12930;

[0085] The preservation number of the Sporolactobacillus inulinus is: CGMCC No.2185.

[0086] The preparation method of composition 2 comprises the following steps:

[0087] a) Enzymolysis: The raw materials in substrate raw material group 2 are mixed to obtain raw material powder, and the raw material powder is prepared into a raw material liquid with a concentration of 11 wt% using sterile deionized water. A composite enzyme is added to the raw material liquid for enzymolysis to obtain an enzymatic hydrolysis liquid, wherein the amount of the composite enzyme added is 1 wt% of the raw material liquid mass, the composite enzyme is a mixture of cellulase and pectinase in a mass ratio of 1:0.7, the cellulase activity is 30,000 U / g, the pectinase activity is 30,000 U / g, the enzymatic hydrolysis temperature is 55° C., the enzymatic hydrolysis time is 4 h, and the enzymatic hydrolysis pH is 4.0;

[0088] b) Composite fermentation: using sterile deionized water to prepare the enzymatic hydrolyzate into a mixed solution with a concentration of 10 wt%, sterilizing the mixed solution and inoculating the mixed bacterial solution, fermenting at 30° C. for 72 h to obtain a fermentation solution, sterilizing the fermentation solution and filtering, concentrating, and spray drying to obtain a liver protection composition, wherein the mass ratio of the mixed bacterial solution to the mixed solution is 1:11, the mixed bacterial solution is composed of an Acetobacter pasteurian culture solution and a Sporobacter inulinus culture solution, the ratio of the number of viable bacteria of the Acetobacter pasteurian culture solution to the Sporobacter inulinus culture solution is 1:0.5, and the number of viable bacteria of the Acetobacter pasteurian culture solution is 1×10 8 CFU / g, the viable bacteria count of the inulin sporolactobacillus culture liquid is 1×10 8 CFU / g;

[0089] The Acetobacter pasteurianus deposit number is: CGMCC No.12930;

[0090] The preservation number of the Sporolactobacillus inulinus is: CGMCC No.2185.

[0091] Composition 3:

[0092] a) Enzymolysis: The raw materials in substrate raw material group 3 are mixed to obtain raw material powder, and the raw material powder is prepared into a raw material liquid with a concentration of 13 wt% using sterile deionized water. A composite enzyme is added to the raw material liquid for enzymolysis to obtain an enzymatic hydrolysis liquid, wherein the amount of the composite enzyme added is 1 wt% of the raw material liquid mass, the composite enzyme is a mixture of cellulase and pectinase in a mass ratio of 1:0.5, the cellulase activity is 30,000 U / g, the pectinase activity is 30,000 U / g, the enzymatic hydrolysis temperature is 40° C., the enzymatic hydrolysis time is 2 h, and the enzymatic hydrolysis pH is 5.5;

[0093] b) Composite fermentation: sterile deionized water is used to prepare the enzymatic hydrolyzate into a mixed solution with a concentration of 12 wt %, the mixed solution is sterilized, and a mixed bacterial solution is inoculated, and fermented at 37° C. for 48 h to obtain a fermentation solution, and the fermentation solution is sterilized, filtered, concentrated, and spray-dried to obtain a liver protection composition, wherein the mass ratio of the mixed bacterial solution to the mixed solution is 1:12, the mixed bacterial solution is composed of an Acetobacter pasteurian culture solution and a Sporobacter inulinus culture solution, the ratio of the viable bacteria count of the Acetobacter pasteurian culture solution to the Sporobacter inulinus culture solution is 1:1.5, and the viable bacteria count of the Acetobacter pasteurian culture solution is 1×10 10 CFU / g, the viable bacteria count of the inulin sporolactobacillus culture liquid is 1×10 10 CFU / g;

[0094] The Acetobacter pasteurianus deposit number is: CGMCC No.12930;

[0095] The preservation number of the Sporolactobacillus inulinus is: CGMCC No.2185.

[0096] The preparation method of composition ① is different from that of composition 1 in that substrate raw material group ① is used to replace substrate raw material group 1, and the remaining steps and parameters are the same as those of composition 1.

[0097] The preparation method of composition ② is different from that of composition 1 in that substrate raw material group ② is used to replace substrate raw material group 1, and the remaining steps and parameters are the same as those of composition 1.

[0098] The preparation method of composition ③ is different from that of composition 1 in that substrate raw material group ③ is used to replace substrate raw material group 1, and the remaining steps and parameters are the same as those of composition 1.

[0099] The preparation method of composition ④ is different from that of composition 1 in that substrate raw material group ④ is used to replace substrate raw material group 1, and the remaining steps and parameters are the same as those of composition 1.

[0100] The preparation method of composition ⑤ is different from that of composition 1 in that, in the composite fermentation step, the composite bacterial solution is replaced by the Acetobacter pasteurian bacterial solution, the mass ratio of the Acetobacter pasteurian bacterial solution to the mixed solution is 1:12, and the number of viable bacteria in the Acetobacter pasteurian bacterial solution is 1×10 9 CFU / g.

[0101] The preparation method of composition ⑥ is different from that of composition 1 in that, in the composite fermentation step, the composite bacterial solution is replaced by the inulin spore Lactobacillus inoculum bacterial solution, the mass ratio of the inulin spore Lactobacillus inoculum bacterial solution to the mixed solution is 1:12, and the number of viable bacteria of the inulin spore Lactobacillus inoculum bacterial solution is 1×10 9 CFU / g.

[0102] The preparation method of composition ⑦ is different from that of composition 1 in that no composite fermentation is performed, and the enzymatic hydrolysate is filtered, concentrated, and spray-dried to obtain the liver-protecting composition.

[0103] The preparation method of composition ⑧ is different from that of composition 1 in that the ratio of the viable bacteria count of Acetobacter pasteurianus culture liquid to Sporolactobacillus inulinus culture liquid in the mixed bacterial liquid is 2:1, and the remaining steps and parameters are the same as those of composition 1.

[0104] The preparation method of composition ⑨ is different from that of composition 1 in that commercial Acetobacter pasteurianus is used instead of Acetobacter pasteurianus CGMCC No.12930. The remaining steps and parameters are the same as those of composition 1. The commercial Acetobacter pasteurianus is purchased from Mingzhou Bio, product number: B89645.

[0105] The preparation method of composition ⑩ is different from that of composition 1 in that commercial sporolactobacillus inulinus is used instead of sporolactobacillus inulinus CGMCC No. 2185. The remaining steps and parameters are the same as those of composition 1. The commercial sporolactobacillus inulinus is purchased from Mingzhou Biotechnology, product number: BMZ146281.

[0106] Efficacy trials:

[0107] Animal efficacy verification:

[0108] In the ethanol-induced liver injury model, compositions 1-3 of the present invention showed significant protective effects on ethanol-induced liver injury.

[0109] Preparation of test samples: Deionized water was used to prepare compositions 1-3 and compositions ①-⑩ into a 20 wt % mixed solution.

[0110] Experimental groups: Female KM mice aged 6-7 weeks and weighing 20±2g were randomly divided into 1 normal group, 1 model group, and 13 experimental groups, with 10 mice in each group. Subsequent experiments were conducted after the mice were adaptively raised for 1 week.

[0111] Experimental methods: The normal group and the model group were gavaged with 0.2 mL of sterile deionized water daily, while the test group was gavaged with 0.2 mL of the composition daily for two consecutive weeks. After one week of gavage, the model group and the test group mice were gavaged with 5 mL / kg of a 56 v / v% edible alcohol-water solution daily for one week. After the last gavage, the mice were fasted for 16 hours, and blood was collected from the ocular vein of the mice. The serum was separated and analyzed for the activity or content of ALT (alanine aminotransferase), AST (aspartate aminotransferase), and TG (triglyceride). The test results are expressed as mean ± standard deviation, and the results are shown in Table 1.

[0112] During the experiment, mice in each group were provided with the same feed and drinking water, and were allowed to eat freely with a 12-h circadian rhythm.

[0113] Table 1 Efficacy verification results

[0114]

[0115]

[0116] Note: “*” indicates p < 0.05 compared with the model group; “#” indicates p < 0.05 compared with the normal group.

[0117] The experimental results show that in this experiment, the ALT, AST, and TG activity values ​​of the model group were significantly increased compared with the normal group, indicating that the model was successful.

[0118] Comparison of the model group with compositions 1-3 and compositions ①-⑩ showed that the composition had a significant protective effect on acute alcohol-induced liver injury in mice.

[0119] By comparing the results of composition 1 with compositions ①-④, it can be seen that the effects of milk thistle powder, kudzu root powder, salvia miltiorrhiza powder, aronia berry lyophilized powder, and Hovenia dulcis powder in the substrate of the composition of the present invention are not simply superimposed. Aronia berry lyophilized powder and Hovenia dulcis powder can significantly enhance the liver-protecting effects of milk thistle powder, kudzu root powder, and salvia miltiorrhiza powder.

[0120] Comparison of composition 1 with compositions ⑤-⑥ and ⑧-⑩ shows that the fermentation product produced by the combined use of Acetobacter pasteurianus CGMCC No. 12930 and Sporolactobacillus inulinus CGMCC No. 2185 to ferment the substrate of the present invention has significant liver protection effect.

[0121] Comparison of the results of composition 1 and composition ⑦ shows that the fermentation process of the present invention can effectively enhance the liver-protecting effects of milk thistle powder, kudzu root powder, salvia miltiorrhiza powder, aronia berry freeze-dried powder, and Hovenia dulcis powder.

[0122] The mass fraction, composition and preparation method of the liver protection tablets are as follows:

[0123] Liver protection tablets 1:

[0124] Composition 1: 33 parts; microcrystalline cellulose: 20 parts; lactose: 30 parts; magnesium stearate: 0.5 parts; skimmed milk powder: 20 parts; sodium carboxymethyl starch: 10 parts.

[0125] Liver protection tablets 2:

[0126] Composition 1: 35 parts; microcrystalline cellulose: 30 parts; lactose: 20 parts; magnesium stearate: 1 part; skimmed milk powder: 10 parts; sodium carboxymethyl starch: 5 parts.

[0127] Liver protection tablets 3:

[0128] Composition 1: 30 parts; microcrystalline cellulose: 10 parts; lactose: 40 parts; magnesium stearate: 0.01 parts; skimmed milk powder: 30 parts; sodium carboxymethyl starch: 15 parts.

[0129] Liver protection tablets 4:

[0130] Composition 2: 33 parts; microcrystalline cellulose: 20 parts; lactose: 30 parts; magnesium stearate: 0.5 parts; skimmed milk powder: 20 parts; sodium carboxymethyl starch: 10 parts.

[0131] Liver protection tablets 5:

[0132] Composition 3: 33 parts; microcrystalline cellulose: 20 parts; lactose: 30 parts; magnesium stearate: 0.5 parts; skimmed milk powder: 20 parts; sodium carboxymethyl starch: 10 parts.

[0133] Preparation method of liver protection tablets 1-5:

[0134] Step 1: Mix the microcrystalline cellulose, lactose, skimmed milk powder, and sodium carboxymethyl starch, add the mixture to a dry granulator, and collect 80-mesh granules;

[0135] Step 2: mixing the composition having liver protection effect, the particles collected in step 1, and magnesium stearate to obtain a mixture;

[0136] Step 3: Put the mixture into the tablet press and adjust the pressure to 40kN to obtain liver protection tablets.

[0137] Acute oral toxicity test:

[0138] Test sample, liver protection tablets 1-5.

[0139] Using the limited dose method, 20 SPF-grade ICR mice weighing 18-22g (half male and half female) were selected. 20.00g of Liver Protection Tablets were ground and diluted with water to 60mL, achieving the maximum permissible gavage concentration. The mice were orally gavaged twice daily, 4 hours apart, at a volume of 0.3mL / 10g·bw, equivalent to a dose of 20.00g / kg·bw. The mice were fasted for 6 hours before the first gavage. Following gavage, they were observed for two weeks, and any signs of poisoning and mortality were recorded.

[0140] Table 2 Results of acute oral toxicity test on samples in mice

[0141] gender Number of animals way Dosage (g / kg bw) Number of deaths (individuals) LD50 (g / kg bw) male 10 Oral 20 0 >20 female 10 Oral 20 0 >20

[0142] As shown in the experimental results in Table 2, oral administration of 20.00 g / kg·bw of the Liver Protection Tablet to ICR mice of both sexes showed no obvious symptoms of toxicity, and no mortality was observed over the 14-day observation period. At the end of the observation period, the animals were sacrificed and autopsied, revealing no significant abnormalities in major organs, including the liver, spleen, kidneys, intestines, heart, and lungs. The LD50 of the Liver Protection Tablet in both male and female ICR mice was greater than 20.00 g / kg·bw. This is considered practically non-toxic according to the acute toxicity dose grading standard in GB 15193.3-2014.

[0143] The embodiments described above are some embodiments of the present invention, rather than all embodiments. The detailed description of the embodiments of the present invention is not intended to limit the scope of the invention as claimed, but merely represents selected embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

Claims

1. A method for preparing a composition having liver-protecting efficacy, characterized in that: The following steps are involved: a) Enzymolysis: Mixing the substrate raw materials of the composition to obtain a raw material powder, using sterile deionized water to prepare the raw material powder into a raw material liquid with a concentration of 11-13wt%, adding a complex enzyme to the raw material liquid for enzymolysis to obtain an enzymatic hydrolysis liquid, wherein the added amount of the complex enzyme is 1-3wt% of the mass of the raw material liquid, and the complex enzyme is composed of cellulase and pectinase in a mass ratio of 1:(0.5-0.7), the enzymatic hydrolysis temperature is 40-55°C, the enzymatic hydrolysis time is 2-4h, and the enzymatic hydrolysis pH is 4.0-5.5; b) Composite fermentation: sterile deionized water is used to prepare the enzymatic hydrolyzate into a mixed solution with a concentration of 10-12 wt%, the mixed solution is sterilized, and a mixed bacterial solution is inoculated, and fermented at 30-37° C. for 48-72 h to obtain a fermentation solution, and the fermentation solution is sterilized, filtered, concentrated, and spray-dried to obtain a liver protection composition, wherein the mass ratio of the mixed bacterial solution to the mixed solution is 1:(11-12), the mixed bacterial solution is composed of an Acetobacter pasteurian culture solution and a Sporobacter inulinus culture solution, the ratio of the number of viable bacteria of the Acetobacter pasteurian culture solution to the Sporobacter inulinus culture solution is 1:(0.5-1.5), and the number of viable bacteria of the Acetobacter pasteurian culture solution is 1×10 8 -1×10 10 CFU / g, the viable bacteria count of the inulin sporolactobacillus culture liquid is 1×10 8 -1×10 10 CFU / g; The Acetobacter pasteurianus deposit number is: CGMCC No.12930; The preservation number of the Sporolactobacillus inulinus is: CGMCC No.2185; The substrate raw materials of the composition include the following raw materials in parts by weight: Milk thistle powder: 10-30 parts; Kudzu root powder: 15-40 parts; Salvia miltiorrhiza powder: 20-35 parts; Aronia berry freeze-dried powder: 5-15 servings; Hovenia dulcis powder: 8-20 parts.

2. The preparation method according to claim 1, characterized in that The substrate raw materials of the composition include the following raw materials in parts by weight: Milk thistle powder: 20-30 parts; Kudzu root powder: 25-40 parts; Salvia miltiorrhiza powder: 30-35 parts; Aronia berry freeze-dried powder: 5-10 servings; Hovenia dulcis powder: 15-20 parts.

3. The preparation method according to claim 2, characterized in that: The substrate raw materials of the composition include the following raw materials in parts by weight: Milk thistle powder: 20 parts; Kudzu root powder: 25 parts; Salvia miltiorrhiza powder: 30 parts; Aronia berry freeze-dried powder: 10 parts; Hovenia dulcis powder: 15 parts.

4. The preparation method according to any one of claims 1 to 3, characterized in that The cellulase activity is 10,000-100,000 U / g, and the pectinase activity is 10,000-100,000 U / g.

5. A composition having liver-protecting effect, characterized in that: The composition is prepared by the preparation method of the composition with liver protection effect according to any one of claims 1 to 4.

6. Use of the composition with liver-protecting efficacy according to claim 5 in the preparation of health products or medicines with liver-protecting efficacy.

7. A liver protection preparation, characterized in that: A composition having liver-protecting effect as claimed in claim 5.

8. The liver protection preparation according to claim 7, characterized in that The preparation is in the form of any one of tablets, capsules, ointments and oral liquids.

9. A liver protection tablet, characterized in that: Contains the following components by mass: The composition with liver-protecting effect according to claim 5: 30-35 parts; Microcrystalline cellulose: 10-30 parts; Lactose: 20-40 parts: Magnesium stearate: 0.01-1 part; Skimmed milk powder: 10-30 parts; Sodium carboxymethyl starch: 5-15 parts.

10. A method for preparing the liver-protecting tablet according to claim 9, characterized in that: The following steps are involved: Step 1: Mix the microcrystalline cellulose, lactose, skimmed milk powder, and sodium carboxymethyl starch, add the mixture to a dry granulator, and collect granules of 10-120 mesh; Step 2: mixing the composition having liver protection effect, the particles collected in step 1, and magnesium stearate to obtain a mixture; Step 3: Put the mixture into the tablet press and adjust the pressure to 10-40kN to obtain liver protection tablets.

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