Application of water-soluble tomato concentrate in preparation of products for inhibiting fatty liver

By using drugs or health foods prepared by water-soluble tomato concentrate (WSTC), the problem of lack of effective treatment methods for metabolic-related fatty liver disease (MAFLD) is solved, and the prevention, relief and treatment of metabolic-related fatty liver disease is achieved, which significantly reduces liver fat levels and liver enzyme activity, and is highly efficient and safe.

CN119633059APending Publication Date: 2025-03-18BY HEALTH CO LTD
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Patent Information

Application Number
CN202411818317.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-11
Publication Date
2025-03-18

AI Technical Summary

Technical Problem

There are currently no clear drugs approved for the treatment of metabolic-related fatty liver disease (MAFLD), and the disease has a high incidence worldwide, especially in people with type 2 diabetes and pathological obesity.

Method used

Use water-soluble tomato concentrate (WSTC) as the main ingredient to prepare drugs or health foods for the prevention, relief and/or treatment of metabolic-related fatty liver diseases. WSTC reduces the vitality of AST and ALT in liver tissues by inhibiting liver lipogenesis and promoting fat degradation, thereby improving liver health.

Benefits of technology

Through experimental research on zebrafish, WSTC can reduce the liver fat tissue level of high-sugar and high-fat model zebrafish, reduce the ALT and AST levels of liver tissue, and repair tissue lesions of metabolic-related fatty liver. Its high activity can greatly reduce the dosage of clinical medicine and reduce the burden on patients. It also has a wide range of sources, has small toxic and side effects, and is safe.

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Abstract

The invention relates to a new application of a water-soluble tomato concentrate, and belongs to the technical field of medicines or health foods. The invention discloses a water-soluble tomato concentrate which has the effect of improving metabolism-related fatty liver and can be used for preparing products for preventing, relieving and / or treating metabolism-related fatty liver diseases. The water-soluble tomato concentrate is prepared through tomato extraction, is wide in source, small in toxic and side effects and high in safety, and has a wide application prospect.
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Description

Technical Field

[0001] The present application relates to the field of biomedicine technology, and in particular to the application of a water-soluble tomato concentrate in the preparation of a product for inhibiting fatty liver. Background Art

[0002] Metabolic associated fatty liver disease (MAFLD) refers to a hepatic fatty degeneration disease associated with systemic metabolic dysfunction. The diagnostic criteria for metabolic associated fatty liver disease (MAFLD) are based on histological (liver biopsy), imaging, and blood biomarker evidence of liver fat accumulation (hepatocyte steatosis), the presence of more than 5% hepatocyte steatosis, and one of the following three conditions: overweight / obesity, type 2 diabetes, and metabolic dysfunction (the presence of at least two metabolic abnormality risk factors).

[0003] The incidence of MAFLD is 25%-30% worldwide, while in certain populations, such as patients with type 2 diabetes and morbidly obese people, the prevalence is 70%-90%. At present, the prevalence of MAFLD in my country is about 30% and is still increasing year by year. It is preliminarily estimated that there are more than 200 million MAFLD patients in the country, and it is expected that the number of MAFLD patients will exceed 300 million by 2030. At present, no clear drug has been approved for the treatment of MAFLD.

[0004] Provis Natural Products Co., Ltd. has developed a water-soluble tomato concentrate (WSTC), known as a "natural aspirin". It has a very strong function of inhibiting platelet aggregation and has no adverse reactions such as gastrointestinal bleeding. It is expected to have very good application prospects in the prevention and treatment of cerebral thrombosis. In 2009, EFSA (European Food Safety Authority) approved the health claim study on "water-soluble tomato concentrate helps maintain normal platelet aggregation and contributes to healthy blood flow" for the first time, and this health claim has been approved. Multiple test results have confirmed that water-soluble tomato concentrate contains naturally occurring antiplatelet compounds, which can inhibit the platelet activity of healthy people after ingestion, reduce platelet aggregation, thereby keeping the blood in a fluid and low coagulation state, prevent the formation of microaggregates in the circulatory system, and prevent platelets from adhering to the blood vessel wall or fatty plaques, thereby maintaining healthy blood circulation. At the same time, platelet function is not completely inhibited and is maintained at an appropriate level, so that platelets can aggregate when blood vessels are damaged, but will not disrupt the necessary coagulation process after injury. Water-soluble tomato concentrate has been used as a nutritional supplement in Europe. Brand sales.

[0005] In addition, other studies have found that the water-soluble tomato concentrate has the effects of reducing hair loss, treating cerebral ischemia-reperfusion injury, and improving memory, but there are no reports on its effects on metabolic-related fatty liver disease. Summary of the invention

[0006] Based on this, the present application provides a new use of a water-soluble tomato concentrate, which relates to the use of the water-soluble tomato concentrate in preparing a product that is beneficial to liver health.

[0007] In a first aspect, the present application provides the use of a water-soluble tomato concentrate in preparing a product for preventing, alleviating, and / or treating metabolism-related fatty liver disease.

[0008] In certain embodiments, the prevention, alleviation, and / or treatment of metabolism-related fatty liver disease refers to inhibiting liver lipogenesis and / or promoting liver fat degradation.

[0009] In certain embodiments, the prevention, alleviation, and / or treatment of metabolic-related fatty liver disease refers to reducing the activity of AST and / or ALT in liver tissue.

[0010] In certain embodiments, the product is a medicine or a nutraceutical.

[0011] In certain embodiments, the medicament further comprises vitamin E, pentoxifylline, and / or a statin.

[0012] In certain embodiments, the health food further comprises milk thistle, artichoke, kudzu root, salvia miltiorrhiza, schisandra chinensis, nattokinase, and / or functional red yeast rice powder.

[0013] In certain embodiments, the dosage form of the medicine or health food is tablets, pills, granules, powders, capsules or liquids.

[0014] In certain embodiments, the medicament further comprises a pharmaceutically acceptable excipient.

[0015] In certain embodiments, the pharmaceutically acceptable excipients include one or more of a filler, a disintegrant, a binder, and a lubricant.

[0016] In certain embodiments, the filler includes one or more of anhydrous powdered sugar, lactose, sucrose, starch, microcrystalline cellulose, and maltodextrin.

[0017] In certain embodiments, the disintegrant comprises one or more of sodium carboxymethyl starch, crospovidone, croscarmellose sodium, ethyl cellulose, methyl cellulose, sodium lauryl sulfate and polyvinyl pyrrolidone.

[0018] In certain embodiments, the binder includes one or more of starch slurry, sodium carboxymethylcellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose and hydroxypropyl methyl cellulose.

[0019] In certain embodiments, the lubricant includes one or more of magnesium stearate, talc, polyethylene glycols, and magnesium laurate sulfate.

[0020] In certain embodiments, the health food further comprises supplementary materials acceptable to health food.

[0021] In certain embodiments, the excipients acceptable to the health food include one or more of a filler, an excipient, a disintegrant, a lubricant and a binder.

[0022] In certain embodiments, the filler includes one or more of anhydrous lactose, microcrystalline cellulose, and maltodextrin.

[0023] In certain embodiments, the excipient comprises maltodextrin.

[0024] In certain embodiments, the disintegrant comprises one or more of croscarmellose sodium, sodium carboxymethyl starch, and crospovidone.

[0025] In certain embodiments, the lubricant includes one or more of magnesium stearate and silicon dioxide.

[0026] In certain embodiments, the binder includes one or more of starch slurry, sodium carboxymethyl cellulose, and hydroxypropyl cellulose.

[0027] Advantageous Effects of the Invention

[0028] The present invention unexpectedly discovered a new use of water-soluble tomato concentrate, which can be used to improve metabolism-related fatty liver, that is, it can be used to prepare medicines or health foods that assist in improving metabolism-related fatty liver. Through zebrafish experimental research, it was found that water-soluble tomato concentrate can reduce the level of liver fat tissue in high-sugar and high-fat model zebrafish, reduce the ALT and AST levels of liver tissue, and repair tissue lesions of metabolism-related fatty liver. Therefore, it is expected that water-soluble tomato concentrate can be used in medicines or health foods that improve metabolism-related fatty liver. It has high activity and can greatly reduce the clinical dosage and reduce the medication burden of patients. In addition, it is extracted and prepared from tomatoes by physical methods, has a wide source, has low toxic and side effects, is highly safe, and has broad application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 A typical graph of fat staining intensity in zebrafish liver after sample treatment is shown, with the yellow dashed line representing the liver area.

[0030] Figure 2 The intensity of fat staining in zebrafish liver after sample treatment is shown, where **p<0.01, ***p<0.001 compared with the model control group.

[0031] Figure 3 The ALT activity in zebrafish tissues after sample treatment is shown, where **p<0.01, ***p<0.001 compared with the model control group.

[0032] Figure 4 The AST activity in zebrafish tissues after sample treatment is shown, where compared with the model control group, ***p<0.001.

[0033] Figure 5 Shown are histopathological sections of zebrafish liver after sample treatment, where the red area is the liver and the green arrows are vacuolar degeneration. DETAILED DESCRIPTION

[0034] The following is a further detailed description of the use of the water-soluble tomato concentrate of the present application in the preparation of products that are beneficial to liver health in conjunction with specific examples. The present application can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present application more thoroughly and comprehensively understood.

[0035] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0036] The optional scope of the terms "and / or", "or / and", and "and / or" used in this article includes any one of two or more related listed items, and also includes any and all combinations of the related listed items, said any and all combinations include any combination of any two related listed items, any more related listed items, or all related listed items.

[0037] As used herein, "one or more" refers to any one, any two, or any two or more of the listed items.

[0038] In this application, "the first aspect", "the second aspect", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or quantity, nor can they be understood as implicitly indicating the importance or quantity of the indicated technical features. Moreover, "the first", "the second", etc. only serve the purpose of non-exhaustive enumeration and description, and it should be understood that they do not constitute a closed limitation on quantity.

[0039] In this application, when it comes to numerical ranges, unless otherwise specified, the above numerical ranges are deemed to be continuous and include the minimum and maximum values ​​of the range, as well as each value between such minimum and maximum values. Further, when a range refers to an integer, each integer between the minimum and maximum values ​​of the range is included. In addition, when multiple ranges are provided to describe features or characteristics, the ranges can be merged. In other words, unless otherwise specified, all ranges disclosed herein should be understood to include any and all subranges included therein.

[0040] Based on this, some examples of the present application provide the use of water-soluble tomato concentrate in preparing products having liver health benefits.

[0041] Water-soluble tomato concentrate is an extract derived from tomatoes. It is mainly obtained by separating water-soluble components from tomatoes through physical methods (centrifugation, filtration, etc.), and then concentrating and desugaring to obtain water-soluble components. Its main characteristic components are nucleoside compounds, flavonoid compounds and phenolic acid compounds. At present, water-soluble tomato concentrate is managed as a common food in Europe, the United States and my country.

[0042] Water-soluble tomato concentrate (WSTC) is mainly composed of heat-stable water-soluble compounds derived from tomatoes, which are the main biologically active ingredients. The main biologically active ingredients in the water-soluble tomato concentrate may be derived from the pulp of tomato fruits and / or the juice around tomato fruit seeds, and then the solid insoluble components, fat-soluble components and water-soluble sugars from the above sources are further removed, and then concentrated and dried to obtain the water-soluble tomato concentrate. The water-soluble compounds in WSTC include nucleoside compounds, flavonoid compounds and phenolic acid compounds. The nucleoside compounds can be nucleoside compounds themselves or nucleotides formed by phosphorylation, and the nucleoside compounds may include at least one of uridine, cytidine, adenosine and guanosine; the nucleoside compounds are further preferably at least one of adenosine, adenosine-3'-monophosphate and adenosine-5'-monophosphate. The flavonoid compound may be a flavonoid compound itself or a glycosylation product thereof, and the flavonoid compound may be selected from at least one of myricetin, luteolin, kaempferol, and naringenin; the flavonoid compound is further preferably at least one of quercetin-3-O-glucoside, naringin, and rutin. The phenolic acid compound may be a phenolic acid compound itself or a glycosylation product thereof, wherein the phenolic acid compound may be cinnamic acid or a derivative thereof, such as p-coumaric acid, caffeic acid, coumaric acid, ferulic acid, and sinapic acid; wherein the phenolic acid compound may be benzoic acid or a derivative thereof, such as p-hydroxybenzoic acid, chlorogenic acid, gallic acid, vanillic acid, and syringic acid. It is understood that the bioactive components in WSTC are not limited to one or more of the above-mentioned types of substances, and may also contain other substance components.

[0043] In addition, the water-soluble tomato concentrate of the present invention is lycopene-free or substantially lycopene-free. The water-soluble tomato concentrate is substantially free of water-insoluble particulate matter.

[0044] Additionally, the water-soluble tomato concentrate can be formulated with food or pharmaceutically acceptable excipients to improve its commercial attributes, including improved delivery, shelf life and taste.

[0045] The water-soluble tomato concentrate described in the present application can be purchased from Provis Natural Products Co., Ltd. or its authorized sales agency. WO 99 / 55350, WO 2010 / 049707 and CN102271697 also disclose methods for preparing the water-soluble tomato concentrate that can be used in the present application. Therefore, the water-soluble tomato concentrate used in the present application can also be prepared by itself according to WO 99 / 55350, WO 2010 / 049707 or CN102271697. If prepared by itself according to the methods described in WO 99 / 55350, WO 2010 / 049707 or CN102271697, it should be ensured that the ingredients of the prepared water-soluble tomato concentrate meet the above requirements. For example, it can be prepared according to the method of CN102271697. Figure 2 and Figure 4 The process described is a preferred method for producing a water-soluble tomato concentrate.

[0046] Without limitation, the water-soluble tomato concentrate described in the present application can be prepared by the following method, and the effect of the present application on promoting liver health can be achieved. The preparation method of the water-soluble tomato concentrate comprises the following steps:

[0047] (a) preparing an initial mixture of tomato homogenate;

[0048] (b) separating the water-soluble component from the initial mixture, the separation temperature being no higher than 60° C.;

[0049] (c) filtering and concentrating the water-soluble components, wherein the concentration temperature is not higher than 60°C.

[0050] In certain embodiments, the temperature of the initial mixture in step (a) is no higher than 35°C.

[0051] In certain embodiments, the pH of the initial mixture in step (a) does not exceed 5.5.

[0052] In certain embodiments, the browning index of the initial mixture does not exceed 0.4 AU at 4% solids, wherein the browning index is defined as the absorbance of the soluble portion at 420 nm.

[0053] In certain embodiments, in step (b), water-insoluble solids having a particle size greater than 500 μm are separated and removed from mixture A to obtain a water-soluble component.

[0054] In certain embodiments, the separation in step (b) comprises at least one of centrifugal separation and natural sedimentation separation, and the water-soluble component is the supernatant obtained after separation.

[0055] In certain embodiments, in step (c), the filtration is performed using a filter membrane. Without limitation, the pore size of the filter membrane used for filtration is no greater than 1 μm, specifically 0.2 μm.

[0056] In certain embodiments, the concentration in step (c) can be carried out by membrane filtration concentration, low temperature evaporation concentration, freeze drying concentration or spray drying concentration.

[0057] In certain embodiments, the step (c) further comprises a step of removing free sugars from the water-soluble component before filtering.

[0058] In certain embodiments, the prevention, alleviation, and / or treatment of metabolism-related fatty liver disease refers to inhibiting liver lipogenesis and / or promoting liver fat degradation.

[0059] In certain embodiments, the prevention, alleviation, and / or treatment of metabolic-related fatty liver disease refers to reducing the activity of AST and / or ALT in liver tissue.

[0060] In certain embodiments, the product is a medicine or a nutraceutical.

[0061] In some of these examples, the drug or health food is in the form of tablets, pills, granules, powders, capsules or liquids.

[0062] Without limitation, the drug may also include vitamin E, pentoxifylline, and / or statins.

[0063] Without limitation, the health food may also include milk thistle, artichoke, kudzu root, salvia miltiorrhiza, schisandra chinensis, nattokinase, and / or functional red yeast rice powder. For experimental parameters not specified in the following specific embodiments, reference is made to the instructions given in the present application document, and reference may also be made to experimental manuals in the art or other experimental methods known in the art, or to experimental conditions recommended by manufacturers.

[0064] The raw materials and reagents involved in the following specific examples can be obtained from commercial sources, or can be prepared by those skilled in the art according to known methods.

[0065] The water-soluble tomato concentrate used in the examples of this application was purchased from Provis Natural Products Co., Ltd. Make sales.

[0066] Example 1 Study on the effect of water-soluble tomato concentrate on liver health

[0067] 1. Experimental Materials

[0068] Water-soluble tomato concentrate (sample ①), the solvent is ultrapure water.

[0069] Positive control: Atorvastatin calcium tablets (hereinafter referred to as atorvastatin calcium), white tablets, batch number 8154200, Pfizer Pharmaceuticals Co., Ltd., solvent is DMSO.

[0070] 2. Experimental Animals

[0071] Zebrafish were raised in fish farming water at 28°C (water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, the conductivity was 450-550 μS / cm; pH was 6.5-8.5; hardness was 50-100 mg / L CaCO3), bred and provided by Huante Biological Fish Farming Center, the experimental animal use license number is: SYXK (Zhejiang) 2022-0004, and the breeding management complies with the requirements of the international AAALAC certification (certification number: 001458), IACUC ethics review number: IACUC-2024-8434-01.

[0072] 3. Instruments, consumables and reagents

[0073] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); precision electronic balance (CP214, OHAUS, USA); multifunctional microplate reader (SPARK, TECAN, Austria); ultrasonic cleaner (JP-010T, Shenzhen Jiemeng Cleaning Equipment Co., Ltd., China); fully automatic sample rapid grinding instrument (JXFSTPRP-24L, Shanghai Jingxin Laboratory Equipment Technology Department, China); high-speed refrigerated centrifuge (Heraeus Fresco17, ThermoFisher, Germany); 96-well plate (Nest Biotech, China); slicer (KD2258, Jinhua Kedi Medical Equipment Co., Ltd., China); electronic constant temperature stainless steel water bath (HHS-2S, Shanghai Kanglu Instrument Equipment Co., Ltd., China); intelligent electric heating plate (400X280, Tianjin Leyue Nag Laboratory Instrument Sales Co., Ltd., China).

[0074] Egg yolk powder (batch number 20230203, Zhejiang Aiger Biotechnology Co., Ltd., China); anhydrous glucose (batch number C15778026, Shanghai McLean Biochemical Technology Co., Ltd., China); dimethyl sulfoxide (DMSO, batch number I2229063, Shanghai Aladdin Biochemical Technology Co., Ltd., China); GPT kit (enzyme reader method) (i.e. ALT kit, batch number 20231118, Nanjing Jiancheng Bioengineering Institute, China); GOT kit (enzyme reader method) (i.e. AST kit, batch number 20240229, Nanjing Jiancheng Bioengineering Institute, China); 4% tissue cell fixative (batch number 20210828, Beijing Solebaugh Technology Co., Ltd., China); anhydrous ethanol (batch number 20220414, Shanghai Aladdin Biochemical Technology Co., Ltd. Co., Ltd., China); xylene (batch number C14165111, Shanghai McLean Biochemical Technology Co., Ltd., China); PBS phosphate buffer (catalog number BL601A, Biosharp, China); Mayer hematoxylin staining solution (batch number 20220120, Shanghai Yihe Biotechnology Co., Ltd., China); eosin staining solution (batch number 20220120, Shanghai Yihe Biotechnology Co., Ltd., China); neutral gum (batch number 330A021, Solarbio, China); high-efficiency section paraffin (melting point 54-56℃, batch number 20201020, Shanghai Huayong Paraffin Co., Ltd., China); high-efficiency section paraffin (melting point 62-64℃, batch number 20210828, Shanghai Huayong Paraffin Co., Ltd., China); Oil Red O (Oid Red O, batch number SHBN4926, Sigma, USA); 1,2-propylene glycol (batch number 20230817, Sinopharm Chemical Reagent Co., Ltd., China).

[0075] 4. Detection Methods

[0076] 4.1 Evaluation of auxiliary protective efficacy against metabolic-related fatty liver disease (liver fat staining intensity)

[0077] 5dpf wild-type AB strain zebrafish were randomly selected in beakers, and 30 zebrafish were treated in each beaker (experimental group). The samples were given water-soluble (concentrations are shown in Table 1), the positive control atorvastatin calcium concentration was 11.6μg / mL, and the normal control group and model control group were set up at the same time, with a capacity of 25mL per cup. Except for the normal control group, the other experimental groups were given water-soluble high-sugar and high-fat diets to establish zebrafish fatty liver (food-induced) models. After 2 days of treatment at 28℃, Oil Red O was given for overall fat staining. After decolorization and bleaching, 10 zebrafish were randomly selected from each experimental group and photographed under a dissecting microscope. The data were analyzed and collected using NIS-Elements D 3.20 advanced image processing software, and the zebrafish liver fat staining intensity was analyzed. The statistical analysis results of this indicator were used to evaluate the auxiliary protection efficacy of the sample metabolic fatty liver. The statistical analysis results are expressed as mean±SE. SPSS26.0 software was used for statistical analysis, and p<0.05 indicated that the difference was statistically significant.

[0078] 4.2 Evaluation of auxiliary protective efficacy of metabolic-related fatty liver disease (ALT and AST)

[0079] 5dpf wild-type AB strain zebrafish were randomly selected in beakers, and 30 zebrafish were treated in each beaker (experimental group). The samples were given water-soluble (concentrations are shown in Tables 2 and 3), and the positive control atorvastatin calcium was 11.6μg / mL. At the same time, a normal control group and a model control group were set up, and the capacity of each cup was 25mL. Except for the normal control group, the remaining experimental groups were given water-soluble high-sugar and high-fat feed to establish a zebrafish fatty liver (food-induced) model. Six experiments were set up in parallel. After 2 days of treatment at 28℃, zebrafish samples were collected, and ALT and AST determination kits were used. The data were collected using a multifunctional microplate reader to analyze the ALT activity and AST activity in zebrafish tissues. The statistical analysis results of the above indicators were used to evaluate the auxiliary protection efficacy of the sample metabolic fatty liver. The statistical analysis results are expressed as mean±SE. SPSS26.0 software was used for statistical analysis, and p<0.05 indicated that the difference was statistically significant.

[0080] 4.3 Evaluation of auxiliary protective efficacy in metabolic-related fatty liver disease (histopathology)

[0081] 5dpf wild-type AB strain zebrafish were randomly selected and placed in beakers, with 30 zebrafish in each beaker (experimental group). Samples (concentrations see Figure 5), positive control atorvastatin calcium 11.6μg / mL, normal control group and model control group were set up at the same time, and the capacity of each cup was 25mL. Except for the normal control group, the other experimental groups were given high-sugar and high-fat feed in water to establish a zebrafish fatty liver (food-induced) model. After 2 days of treatment at 28°C, the zebrafish were fixed with 4% tissue cell fixative, and after a series of dehydration-embedding-sectioning-staining steps, the zebrafish were subjected to histopathological H&E staining analysis. The effects of the samples on the liver tissue structure of zebrafish were evaluated by liver histopathological analysis.

[0082] 5. Test results

[0083] 5.1 Evaluation of auxiliary protective efficacy against metabolic-related fatty liver disease (liver fat staining intensity)

[0084] Table 1 Results of the evaluation experiment on the auxiliary protection effect (liver fat staining intensity) of samples on metabolic fatty liver (n=10)

[0085]

[0086] Note: Compared with the model control group, **p<0.01, ***p<0.001;

[0087] See Table 1 and Figure 1-2 Under the experimental conditions, the liver fat staining intensity of the model group was enhanced after high-sugar and high-fat diet modeling, and there was a statistical difference compared with the normal control group, indicating that the model was successfully established. The liver fat staining intensity of the positive drug atorvastatin calcium and the sample groups at each dose was reduced, indicating that the sample has the effect of improving the liver fat staining intensity and assisting in the protection of metabolic fatty liver.

[0088] 5.2 Evaluation of auxiliary protective efficacy of metabolic-related fatty liver disease (ALT and AST)

[0089] Table 2 Results of the evaluation experiment on the auxiliary protective efficacy (ALT activity) of sample metabolism-related fatty liver disease (n=3)

[0090]

[0091] Note: Compared with the model control group, **p<0.01, ***p<0.001;

[0092] Table 3 Results of the evaluation experiment on the auxiliary protective efficacy (AST activity) of sample metabolism-related fatty liver disease (n=3)

[0093]

[0094] Note: Compared with the model control group, ***p<0.001;

[0095] Under normal circumstances, the levels of ALT and AST in serum are very low. When liver cells are damaged, the permeability of liver cell membrane increases, and ALT and AST in the cytoplasm are released into the blood, causing ALT and AST in the blood to increase. See Table 1-2 and Figure 3-4 Under the experimental conditions, compared with the blank group, the ALT and AST in the model group increased, indicating that the model was successfully established. The ALT activity and AST activity in the tissues of the positive drug group and each dose group of the sample decreased, indicating that the sample has an auxiliary protective effect on metabolism-related fatty liver disease.

[0096] 5.3 Evaluation of auxiliary protective efficacy in metabolic-related fatty liver disease (histopathology)

[0097] See Figure 5 , under the experimental conditions, the liver structure of the normal control group was normal, with clear edges and tight arrangement. The liver of the model control group was enlarged, with loose structure and a large amount of vacuolar degeneration, indicating that the model was successfully established. The liver structure of the atorvastatin calcium 11.6μg / mL group was similar to that of the normal control group, indicating that atorvastatin calcium has an auxiliary protective effect on metabolism-related fatty liver disease. Compared with the model control group, each dose group of the sample had a tight arrangement, clear edges, reduced vacuolar degeneration, and was concentration-dependent, indicating that the sample had an auxiliary protective effect on metabolism-related fatty liver disease.

Claims

1. The present application provides the use of a water-soluble tomato concentrate in the preparation of a product for preventing, alleviating, and / or treating metabolic-related fatty liver disease.

2. The use according to claim 1, characterized in that: The prevention, alleviation, and / or treatment of metabolism-related fatty liver disease refers to inhibiting liver fat production and / or promoting liver fat degradation.

3. The use according to claim 1, characterized in that: The prevention, alleviation, and / or treatment of metabolism-related fatty liver disease refers to reducing the activity of AST and / or ALT in liver tissue.

4. The use according to claim 1, characterized in that: The product is a medicine or a health food.

5. The use according to claim 4, characterized in that: The drug also includes vitamin E, pentoxifylline, and / or statins.

6. The use according to claim 4, characterized in that: The health food also includes milk thistle, artichoke, kudzu root, salvia miltiorrhiza, schisandra chinensis, nattokinase, and / or functional red yeast rice powder.

7. The use according to claim 4, characterized in that: The dosage form of the medicine or health food is tablet, pill, granule, powder, capsule or liquid.

8. The use according to claim 7, characterized in that: The medicine or health food also includes excipients acceptable to the preparation.

9. The use according to claim 8, characterized in that: The acceptable excipients for the preparation include one or more of fillers, excipients, disintegrants, binders and lubricants.

10. The application according to claim 9, having one or more of the following features: (1) The filler comprises one or more of anhydrous lactose, microcrystalline cellulose and maltodextrin; (2) The excipient includes maltodextrin; (3) the disintegrant comprises one or more of sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, ethyl cellulose, methyl cellulose, sodium lauryl sulfate and polyvinyl pyrrolidone; (4) The binder comprises one or more of starch slurry, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose and hydroxypropyl methyl cellulose; (5) The lubricant includes one or more of magnesium stearate, talc, polyethylene glycols and magnesium sulfate.

Citation Information

Patent Citations

  • Antithrombotic agents

    WO1999055350A1

  • Fruit extracts

    WO2010049707A2