Special medical purpose formula food for liver diseases and preparation method of special medical purpose formula food

By carefully selecting the ratio of protein and fatty acids in formula foods for special medical purposes and adding functional ingredients, the problem of insufficient nutritional needs for patients with liver disease is solved, comprehensive nutritional support and liver protection are achieved, and patients' quality of life is significantly improved.

CN119214299AInactive Publication Date: 2024-12-31SICHUAN SHUIYUANDAO BIOTECHNOLOGY CO LTD
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Patent Information

Application Number
CN202411755225.8
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-03
Publication Date
2024-12-31
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

Existing special medical-purpose formula foods fail to fully consider the special needs of patients with liver disease, such as specific protein selection, fatty acid ratio optimization and the fortification of key micronutrients, resulting in insufficient metabolism, nutrient absorption and immune function in patients with liver disease.

Method used

Provide a special medical formula for liver disease, through refined protein selection, fatty acid ratio optimization and functional ingredient addition, including high bioavailability whey protein isolate, milk whey protein concentrated, L-carnitine, taurine Acids and inositol, combined with low glycemic index carbohydrates and important micronutrients, have designed a comprehensive nutritional formula.

Benefits of technology

This formula not only provides comprehensive nutritional support for patients with liver disease, reduces the liver metabolic burden, supports liver repair and regeneration, improves nutritional status, regulates blood sugar and lipid metabolism, enhances immune function, and significantly improves patients' quality of life and disease management. Effect.

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Abstract

The invention relates to formula food for special medical purposes for liver diseases and a preparation method of the formula food, and relates to the technical field of formula food for special medical purposes. The formula food for the special medical purpose for the hepatopathy is prepared from the following components in parts by weight: 44 to 48 parts of maltodextrin, 16 to 20 parts of whey protein hydrolysate, 15 to 18 parts of edible vegetable oil microcapsule powder, 4 to 6 parts of a first nutrient supplement, 4 to 6 parts of resistant dextrin, 1.5 to 3.5 parts of fructo-oligosaccharide, 0.8 to 1.3 parts of fish oil powder, 0.35 to 0.70 part of L-leucine and the like. The full-nutrition formula food for special medical purposes is provided for the patients with the hepatopathy, comprehensive nutrition support is provided for the patients with the hepatopathy, and the clinical nutrition status of the patients is greatly improved; in addition, the traditional Chinese medicine composition has remarkable beneficial effects in the aspects of relieving the liver metabolism burden, supporting liver repair and the like, so that the life quality and disease management effect of patients are remarkably improved.
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Description

Technical Field

[0001] The invention relates to the technical field of special medical formula foods, in particular to a special medical formula food for liver diseases and a preparation method thereof. Background Art

[0002] Liver disease is a widespread disease worldwide, and there are many types of it, including but not limited to hepatitis, cirrhosis, fatty liver, etc. These diseases seriously affect the quality of life of patients. For example, in cirrhosis, the liver's utilization of fat decreases, and the mobilization and decomposition of fat is enhanced, resulting in an increase in plasma free fatty acids. At the same time, due to the decrease in bile secretion in the liver, the digestion and absorption of fat in the small intestine is impaired, which in turn affects the absorption of fat-soluble vitamins and easily leads to fat-soluble vitamin deficiency. Therefore, as an important metabolic organ of the human body, when the liver is impaired, it will lead to a variety of nutritional metabolic disorders, which in turn will cause a series of problems such as protein-energy malnutrition (PEM).

[0003] Foods for special medical purposes (FSMP) are special nutritional supplements that meet the special needs of special groups of people for nutrients or diets by providing comprehensive and balanced nutritional support. In recent years, there are some products on the market that are widely used as complete nutritional formulas for special medical purposes for patients with liver disease. These products are mainly produced by internationally renowned brands such as Nestlé and Abbott. Although these products are not completely specifically for patients with liver disease, some of their ingredients and design concepts can be applied to this group of people. The following is the current application status of the existing technologies that are closest to this patent technology on the market: 1. Nestle Peptamen; Nestlé Peptamen is a highly hydrolyzed whey protein formula that is mainly used for enteral nutrition support, especially for patients with gastrointestinal insufficiency. Its design concept is to provide easily digestible and quickly absorbed protein and fat, especially medium-chain triglycerides (MCT), to reduce the digestive burden and meet the nutritional needs of patients with intestinal damage. Although Nestlé Peptamen is not specifically for patients with liver disease, it is also used in patients with liver disease due to its highly hydrolyzed protein and MCT formula design, especially those with digestive and absorption disorders.

[0004] Its defects include: 1) Not specifically designed for liver disease: Nestlé Peptamen was not originally designed for patients with liver disease. Although its easy digestibility is beneficial to some patients with liver disease, it fails to fully consider the special needs of patients with liver disease, such as protein type selection and optimization of fatty acid ratios; 2) Lack of key micronutrient fortification: Nestlé Peptamen does not specifically fortify trace elements such as vitamin D, zinc, and selenium that are often lacking in patients with liver disease, which are essential for the recovery of patients with liver disease; 3) Insufficient control of the glycemic index (GI): The carbohydrate design of this product does not take into account the low GI needs of patients with liver disease and may not be suitable for patients with liver disease with disorders of glucose metabolism.

[0005] 2. Abbott Ensure; Abbott Ensure is a comprehensive, complete nutritional formula suitable for a variety of people who need comprehensive nutritional support, including the elderly, patients recovering from surgery, and patients with chronic diseases. It contains balanced protein, carbohydrates and fats, as well as rich vitamins and minerals. Although Abbott Ensure is not designed specifically for patients with liver disease, its comprehensive nutritional formula can provide basic nutritional support for patients with liver disease in certain circumstances.

[0006] Its defects include: 1) The protein selection is not specific enough: Abbott Ensure's protein sources include whey protein and soy protein. Although they are balanced, the degree of hydrolysis of whey protein is not enough to reduce the ammonia burden for patients with liver disease, and the aromatic amino acid content of soy protein is relatively high, which may not be suitable for patients with impaired liver function; 2) The fatty acid ratio is not ideal: Abbott Ensure mainly uses vegetable oils. Although it is beneficial to health, it lacks a reasonable ratio of MCT and omega-3 fatty acids and cannot effectively reduce the metabolic burden on the liver; 3) Lack of targeted functional ingredients: Abbott Ensure does not add functional ingredients for patients with liver disease, such as L-carnitine and taurine, which are very important for liver protection and fat metabolism.

[0009] In summary, although some special medical formula foods that can be applied to patients with liver disease have been reported in the prior art, most of the existing complete nutritional formula foods were not originally designed for patients with liver disease, and therefore fail to fully consider the special needs of patients with liver disease, such as the selection of specific proteins, the optimized ratio of fatty acids, and the fortification of key micronutrients. Liver disease patients face specific challenges in metabolism, nutrient absorption, and immune function. Existing technologies are difficult to provide comprehensive nutritional support, resulting in the lack of functional ingredients such as L-carnitine, taurine, and inositol. In addition, the type of protein and the selection of fatty acids in existing special medical formula foods are usually not refined, which may bring additional protein and fat metabolic burdens, insufficient control of glycemic index (GI), and other problems to patients with liver disease. Summary of the invention

[0010] In order to solve the above problems, the present invention provides a special medical formula food for liver disease and a preparation method thereof.

[0011] The technical solution provided by the present invention is as follows: In a first aspect, the present invention provides a special medical formula food for liver disease, which comprises the following components in parts by weight: 44-48 parts of maltodextrin, 16-20 parts of hydrolyzed whey protein, 15-18 parts of edible vegetable oil microcapsule powder, 4-6 parts of a first nutritional enhancer, 4-6 parts of resistant dextrin, 1.5-3.5 parts of oligofructose, 0.8-1.3 parts of fish oil powder, 0.35-0.70 parts of L-leucine, 0.4-0.6 parts of L-valine, 0.3-0.6 parts of edible flavor, 0.2-0.5 parts of inositol, 0.3-0.5 parts of L-carnitine tartrate, 0.2-0.5 parts of calcium hydrogen phosphate, 0.15-0.35 parts of a second nutritional enhancer, 0.1-0.3 parts of sodium dihydrogen phosphate, 0.01-0.05 parts of steviol glycosides, and 0.008-0.015 parts of L-isoleucine; The first nutritional enhancer is prepared by mixing sodium citrate, potassium chloride, magnesium carbonate, potassium dihydrogen phosphate, calcium carbonate, sodium chloride, manganese sulfate, zinc gluconate, ferric pyrophosphate, copper sulfate and sodium selenite in a weight ratio of (1.5-2.0): (0.5-1): (1.2-2.0): (0.2-0.8): (0.5-1): (0.8-1.2): (0.1-0.5): (2.5-3.2): (0.5-1): (0.3-0.6): (1.0-1.5); The second nutritional enhancer is prepared by mixing taurine, L-ascorbic acid, dl-α-tocopherol acetate, niacinamide, potassium iodide, D-calcium pantothenate, vitamin A acetate, cholecalciferol, D-biotin, cyanocobalamin, folic acid, pyridoxine hydrochloride, thiamine hydrochloride, riboflavin and phytonadione in a weight ratio of (0.2-0.5): (1.3-1.6): (1.6-2.0): (0.4-0.7): (2.0-2.4): (1.8-2.2): (0.3-0.5): (1.0-1.5): (0.6-0.9): (0.8-1.5): (0.9-1.4): (2.0-2.5): (3.0-3.5): (2.2-2.5): (1.7-2.3); The preparation method of the whey protein hydrolyzate comprises the following steps: The whey protein raw material is subjected to low-temperature plasma treatment to obtain activated whey protein; The activated whey protein is enzymatically hydrolyzed, and then the enzyme is inactivated, desalted and freeze-dried to obtain the hydrolyzed whey protein.

[0012] Furthermore, the special medical formula food for liver disease comprises the following components in parts by weight: 46.43 parts of maltodextrin, 18.80 parts of hydrolyzed whey protein, 17.00 parts of edible vegetable oil microcapsule powder, 5.40 parts of a first nutritional enhancer, 5.0 parts of resistant dextrin, 2.50 parts of oligofructose, 1.10 parts of fish oil powder, 0.59 parts of L-leucine, 0.51 parts of L-valine, 0.50 parts of edible flavor, 0.40 parts of inositol, 0.42 parts of L-carnitine tartrate, 0.35 parts of calcium hydrogen phosphate, 0.26 parts of a second nutritional enhancer, 0.2 parts of sodium dihydrogen phosphate, 0.03 parts of steviol glycosides and 0.01 parts of L-isoleucine.

[0013] Furthermore, the first nutritional enhancer is prepared by compounding sodium citrate, potassium chloride, magnesium carbonate, potassium dihydrogen phosphate, calcium carbonate, sodium chloride, manganese sulfate, zinc gluconate, ferric pyrophosphate, copper sulfate and sodium selenite in a weight ratio of 1.8:0.6:1.5:0.5:0.8:1.0:0.3:2.7:0.8:0.4:1.2.

[0014] Furthermore, the second nutritional enhancer is prepared by compounding taurine, L-ascorbic acid, dl-α-tocopherol acetate, niacinamide, potassium iodide, D-calcium pantothenate, vitamin A acetate, cholecalciferol, D-biotin, cyanocobalamin, folic acid, pyridoxine hydrochloride, thiamine hydrochloride, riboflavin and phytonadione in a weight ratio of 0.4:1.5:1.8:0.6:2.2:2.0:0.3:1.1:0.7:1.3:1.1:2.4:3.2:2.4:1.9.

[0015] Furthermore, the step of subjecting the whey protein raw material to low-temperature plasma treatment to obtain activated whey protein comprises the following process: The whey protein raw material was placed in the cavity of the low-temperature plasma treatment device and evacuated. When the vacuum degree of the cavity reached below 10 Pa, the gas flow rate was 45-50 cm 3 / min of oxygen as the working medium, and low-temperature plasma treatment for 60 to 120 seconds under the condition of a power supply of 40 to 95 W to obtain activated whey protein; The working condition parameters of the enzymatic hydrolysis include: using papain for enzymatic hydrolysis, the weight of the added papain accounts for 5.2-6.5% of the weight of the activated whey protein substrate, pH is 6.8-7.2, temperature is 52-56° C., and time is 3-5 hours.

[0016] Furthermore, the preparation method of the edible vegetable oil microcapsule powder comprises the following process: High oleic sunflower oil, linseed oil, coconut oil and medium chain triglycerides in a weight ratio of 1:1:0.5:0.5 are stirred uniformly at a temperature of 45-52° C., and then homogenized at a pressure of 15-25 MPa for 10-20 minutes to obtain an oil phase mixture; The oil phase mixture is spray dried with an air inlet temperature of 175-185° C. and an air outlet temperature of 75-85° C. to obtain the edible vegetable oil microcapsule powder.

[0017] In a second aspect, based on the same inventive concept, the present invention provides a method for preparing the special medical formula food for liver disease according to any one of the first aspects, the preparation method comprising the following steps: Stirring and mixing maltodextrin, edible vegetable oil microcapsule powder, hydrolyzed whey protein and water to obtain a first mixture; The first mixture is subjected to low-temperature freezing treatment, and then thawed at room temperature to obtain a second mixture; The remaining components are added to the second mixture, stirred and mixed, and then dried to obtain the special medical formula food for liver disease.

[0018] Furthermore, the working condition parameters of the low-temperature freezing treatment include: the low-temperature freezing temperature is -30~-20°C, and the time is 60 minutes; the drying method is spray drying.

[0019] The above technical solution provided by the embodiment of the present invention has at least the following advantages compared with the prior art: The present invention provides a special medical formula food for liver disease and a preparation method thereof. Based on the existing special medical formula foods, the present invention targets the special needs of liver disease patients and provides a complete nutrition special medical formula food for liver disease patients through innovations in refined protein selection, fatty acid ratio optimization, functional ingredient addition, and GI control. It not only provides comprehensive nutritional support for liver disease patients and greatly improves their clinical nutritional status, but also shows significant beneficial effects in reducing the metabolic burden of the liver, supporting liver repair, and other aspects, thereby significantly improving the patient's quality of life and disease management effect. This innovation fills a market gap and has great clinical application value and commercial potential. Specifically: 1) Accurate ratio of nutrients: According to the special needs of patients with liver disease, scientific ratios of protein, fat, carbohydrates, vitamins and minerals are designed to meet their metabolic and recovery needs.

[0020] 2) Addition of functional ingredients: Introducing specific functional ingredients such as L-carnitine, taurine and inositol into the formula to enhance liver protection and metabolic regulation.

[0021] 3) Reduce the metabolic burden on the liver: This patented technology specifically targets the metabolic characteristics of patients with liver disease, and selects highly bioavailable isolated whey protein and concentrated milk whey protein as the main protein source. These proteins are easy to digest and absorb, and can effectively reduce the ammonia produced during amino acid metabolism, thereby reducing the liver's detoxification burden. At the same time, the medium-chain triglycerides (MCTs) contained in this special medical purpose formula food for liver disease are used as a fat source. They do not rely on the participation of bile and pancreatic enzymes, and directly provide energy to the liver through intestinal absorption, effectively reducing the pressure of fat metabolism on the liver.

[0022] 4) Support liver repair and regeneration: The key functional ingredients added to this special medical purpose formula food for liver disease, such as L-carnitine, taurine and inositol, have a significant promoting effect on liver repair and regeneration. L-carnitine can help the liver effectively utilize fatty acids and prevent excessive deposition of fat in the liver, thereby alleviating the symptoms of fatty liver. Taurine improves fat digestion and absorption by promoting the secretion and flow of bile. Inositol plays a key role in lipid metabolism, helps lower blood lipid levels, and further protects the liver.

[0023] 5) Improve the nutritional status of patients: This patented technology can effectively improve the nutritional status of patients with liver disease by precisely controlling the ratio of protein, fat and carbohydrates and adding important micronutrients such as B vitamins, vitamin D, zinc and selenium. B vitamins play an important role in energy metabolism, vitamin D supports bone health, and zinc and selenium enhance immune function and antioxidant defense. Through comprehensive nutritional supplementation, patients can maintain a better nutritional balance, reduce the incidence of malnutrition, and improve the quality of life.

[0024] 6) Regulate blood sugar and lipid metabolism: This patented technology uses carbohydrates with a low glycemic index (GI), such as resistant dextrin and oligofructose. These ingredients can slowly release energy, stabilize blood sugar levels, and avoid postprandial hyperglycemia. For patients with liver disease who have glucose metabolism disorders, this design can significantly reduce the risk of hyperglycemia and help stabilize blood sugar control. At the same time, the ω-3 fatty acids in the product can regulate blood lipids, reduce the levels of triglycerides and low-density lipoprotein cholesterol, improve lipid metabolism, and further reduce the burden on the liver.

[0025] 7) Enhanced immune function and antioxidant protection: Liver disease patients are often accompanied by low immune function and oxidative stress. Vitamin E, vitamin C and functional ingredients such as taurine in this patented technology have strong antioxidant effects, which can effectively remove free radicals and reduce damage to liver cells. At the same time, the supplementation of trace elements such as zinc and selenium helps to enhance the patient's immune defense ability, reduce the risk of infection, and improve the patient's overall resistance.

[0026] In summary, the present invention provides a special medical purpose formula food for liver disease and a preparation method thereof, the beneficial effects of which are reflected in many aspects, including reducing the metabolic burden of the liver, supporting liver repair, improving nutritional status, regulating blood sugar and lipid metabolism, enhancing immune function, etc. These effects not only provide comprehensive and effective nutritional support for patients with liver disease, but also significantly improve the patients' quality of life and disease management effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0028] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0029] Figure 1 The present invention is a flow chart of a method for preparing a special medical formula food for liver disease provided by the present invention. DETAILED DESCRIPTION

[0030] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0031] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in the present invention can be purchased from the market or prepared by existing methods.

[0032] In a first aspect, the present invention provides a special medical formula food for liver disease, which comprises the following components in parts by weight: 44-48 parts of maltodextrin, 16-20 parts of hydrolyzed whey protein, 15-18 parts of edible vegetable oil microcapsule powder, 4-6 parts of a first nutritional enhancer, 4-6 parts of resistant dextrin, 1.5-3.5 parts of oligofructose, 0.8-1.3 parts of fish oil powder, 0.35-0.70 parts of L-leucine, 0.4-0.6 parts of L-valine, 0.3-0.6 parts of edible flavor, 0.2-0.5 parts of inositol, 0.3-0.5 parts of L-carnitine tartrate, 0.2-0.5 parts of calcium hydrogen phosphate, 0.15-0.35 parts of a second nutritional enhancer, 0.1-0.3 parts of sodium dihydrogen phosphate, 0.01-0.05 parts of steviol glycosides, and 0.008-0.015 parts of L-isoleucine; The first nutritional enhancer is prepared by mixing sodium citrate, potassium chloride, magnesium carbonate, potassium dihydrogen phosphate, calcium carbonate, sodium chloride, manganese sulfate, zinc gluconate, ferric pyrophosphate, copper sulfate and sodium selenite in a weight ratio of (1.5-2.0): (0.5-1): (1.2-2.0): (0.2-0.8): (0.5-1): (0.8-1.2): (0.1-0.5): (2.5-3.2): (0.5-1): (0.3-0.6): (1.0-1.5); The second nutritional enhancer is prepared by mixing taurine, L-ascorbic acid, dl-α-tocopherol acetate, niacinamide, potassium iodide, D-calcium pantothenate, vitamin A acetate, cholecalciferol, D-biotin, cyanocobalamin, folic acid, pyridoxine hydrochloride, thiamine hydrochloride, riboflavin and phytonadione in a weight ratio of (0.2-0.5): (1.3-1.6): (1.6-2.0): (0.4-0.7): (2.0-2.4): (1.8-2.2): (0.3-0.5): (1.0-1.5): (0.6-0.9): (0.8-1.5): (0.9-1.4): (2.0-2.5): (3.0-3.5): (2.2-2.5): (1.7-2.3); The preparation method of the whey protein hydrolyzate comprises the following steps: The whey protein raw material is subjected to low-temperature plasma treatment to obtain activated whey protein; Adding activated whey protein into water for stirring and hydration, then heating to 90-100° C. and maintaining for 5-10 minutes, and then cooling to 52-56° C. to obtain a whey protein aqueous solution with a weight percentage of 5-8%; The whey protein aqueous solution is subjected to enzymatic hydrolysis, followed by enzyme inactivation, desalination and drying to obtain the hydrolyzed whey protein.

[0033] The present invention provides a special medical formula food for liver disease. Based on the existing special medical formula food, the present invention provides a full nutrition special medical formula food for liver disease patients through innovations in refined protein selection, fatty acid ratio optimization, functional ingredient addition, and GI control, etc., which not only provides comprehensive nutritional support for liver disease patients and greatly improves their clinical nutritional status, but also shows significant beneficial effects in reducing the metabolic burden of the liver, supporting liver repair, and other aspects, thereby significantly improving the quality of life of patients and the effect of disease management. This innovation fills a market gap and has great clinical application value and commercial potential.

[0034] In some specific embodiments, the total weight parts of each component in the special medical purpose formula food for liver disease is 100 parts.

[0035] In some specific embodiments, the special medical formula food for liver disease comprises the following components in parts by weight: 46.43 parts of maltodextrin, 18.80 parts of hydrolyzed whey protein, 17.00 parts of edible vegetable oil microcapsule powder, 5.40 parts of a first nutritional enhancer, 5.0 parts of resistant dextrin, 2.50 parts of oligofructose, 1.10 parts of fish oil powder, 0.59 parts of L-leucine, 0.51 parts of L-valine, 0.50 parts of edible flavor, 0.40 parts of inositol, 0.42 parts of L-carnitine tartrate, 0.35 parts of calcium hydrogen phosphate, 0.26 parts of a second nutritional enhancer, 0.2 parts of sodium dihydrogen phosphate, 0.03 parts of steviol glycosides and 0.01 parts of L-isoleucine.

[0036] In some specific embodiments, the hydrolysis degree (expressed as DE value) of maltodextrin in the present invention is about 10; specifically, commercially available products such as MD10 produced by China Resources Company can be selected.

[0037] In some specific embodiments, the hydrolyzed whey protein in the present invention refers to whey protein that has been hydrolyzed. Whey protein is a high-quality protein extracted from dairy products, with good amino acid composition and biological activity. During the hydrolysis process, whey protein is broken down into smaller peptide chains or single amino acids by enzymes or acids; commercial products such as those of FrieslandCampina can be directly used, or they can be made by themselves according to the existing hydrolyzed whey protein preparation process. Specifically, the whey protein raw material of the hydrolyzed whey protein is preferably isolated whey protein (commercial products such as FrieslandCampina, product model WPI-90, etc.) and concentrated milk whey protein (commercial products such as Fonterra, product model WPC80, etc.) with a weight ratio of 1:1.

[0038] In some specific embodiments, the resistant dextrin in the present invention can be selected from products of Matsutani Co., Ltd. of Japan, such as commercially available products such as Fibersol-2.

[0039] In some specific embodiments, the oligofructose in the present invention can be selected from commercial products such as FOS-95 produced by Benesse.

[0040] In some specific embodiments, the first nutritional enhancer is a compound of sodium citrate, potassium chloride, magnesium carbonate, potassium dihydrogen phosphate, calcium carbonate, sodium chloride, manganese sulfate, zinc gluconate, ferric pyrophosphate, copper sulfate and sodium selenite in a weight ratio of 1.8:0.6:1.5:0.5:0.8:1.0:0.3:2.7:0.8:0.4:1.2.

[0041] In some specific embodiments, the preparation method of the first nutritional enhancer includes the following process: sodium citrate, potassium chloride, and magnesium carbonate are mixed in proportion, the temperature is controlled at 30°C, and stirred evenly, and then the remaining components are added and stirred at 25°C for 20 minutes to obtain the first nutritional enhancer.

[0042] In some specific embodiments, the second nutritional enhancer is a compound of taurine, L-ascorbic acid, dl-α-tocopherol acetate, niacinamide, potassium iodide, D-calcium pantothenate, vitamin A acetate, cholecalciferol, D-biotin, cyanocobalamin, folic acid, pyridoxine hydrochloride, thiamine hydrochloride, riboflavin and phytonadione in a weight ratio of 0.4:1.5:1.8:0.6:2.2:2.0:0.3:1.1:0.7:1.3:1.1:2.4:3.2:2.4:1.9.

[0043] In some specific embodiments, the preparation method of the second nutritional enhancer includes the following process: taurine, L-ascorbic acid, and dl-α-tocopherol acetate are mixed in proportion, the temperature is controlled at 25° C., and stirred evenly, and then the remaining components are added and stirred for 15 minutes to obtain the second nutritional enhancer.

[0044] In some specific embodiments, the step of subjecting the whey protein raw material to low-temperature plasma treatment to obtain activated whey protein comprises the following process: The whey protein raw material was placed in the cavity of the low-temperature plasma treatment device and evacuated. When the vacuum degree of the cavity reached below 10 Pa, the gas flow rate was 45-50 cm 3 / min of oxygen is used as the working medium, and low-temperature plasma treatment is carried out for 60 to 120 seconds under the condition of a power supply of 40-95W to obtain activated whey protein.

[0045] When the low-temperature plasma treatment is controlled to the above-mentioned condition parameters, the present invention is more conducive to changing the protein conformation of whey protein, so that the whey protein exposes more allergenic key positions, which is conducive to the subsequent hydrolysis reaction and has a better activation effect, thereby effectively reducing the β-lactoglobulin allergenicity of the obtained hydrolyzed whey protein.

[0046] In some specific embodiments, the working condition parameters of the enzymatic hydrolysis include: using papain for enzymatic hydrolysis, the weight of the added papain accounts for 5.2-6.5% of the weight of the activated whey protein substrate, the pH is 6.8-7.2, the temperature is 52-56° C., and the time is 3-5 hours.

[0047] In some specific embodiments, the preparation method of hydrolyzed whey protein in the present invention, unless otherwise specified or specifically described, can be directly carried out using the process parameters disclosed in the existing preparation method of hydrolyzed whey protein. For example, enzyme inactivation can be carried out using existing methods such as inactivation at a high temperature of 105°C for 1 min; desalination can be carried out using existing methods such as desalting the whey protein hydrolyzate solution after enzyme inactivation using a beverage cation exchange resin, and the present invention document will not repeat them one by one.

[0048] In some specific embodiments, the method for preparing the edible vegetable oil microcapsule powder comprises the following process: High oleic sunflower oil, linseed oil, coconut oil and medium chain triglycerides in a weight ratio of 1:1:0.5:0.5 are stirred uniformly at a temperature of 45-52° C., and then homogenized at a pressure of 15-25 MPa for 10-20 minutes to obtain an oil phase mixture; The oil phase mixture is spray dried with an air inlet temperature of 175-185° C. and an air outlet temperature of 75-85° C. to obtain the edible vegetable oil microcapsule powder.

[0049] In some specific embodiments, high oleic sunflower oil can be selected from the product of Golden Dragon Fish Company, model GXH-02; flaxseed oil can be selected from the product of Omega Company, model OM-03; coconut oil can be selected from the product of Coco Island Company, model CYO-04; medium chain triglycerides can be selected from the product of Esdy Company, model MCT-100.

[0050] In some specific embodiments, the fish oil powder can be directly a food-grade commercial product, or can be prepared in-house according to the following preparation method: Add the purified fish oil to a carrier material such as maltodextrin, the weight of the carrier material added being 0.8 to 1.2 times of the purified fish oil, stir evenly for 10 minutes, and keep the temperature at 40°C; then spray dry it in a spray dryer, with an inlet air temperature of 170°C and an outlet air temperature of 60°C, to obtain fish oil powder.

[0051] In a second aspect, based on the same inventive concept, the present invention provides a method for preparing the special medical formula food for liver disease according to any one of the first aspects, such as Figure 1 As shown, the preparation method comprises the following steps: Stirring and mixing maltodextrin, edible vegetable oil microcapsule powder, hydrolyzed whey protein and water to obtain a first mixture; The first mixture is subjected to low-temperature freezing treatment, and then thawed at room temperature to obtain a second mixture; The remaining components are added to the second mixture, stirred and mixed, and then dried to obtain the special medical formula food for liver disease.

[0052] The present invention provides a method for preparing a special medical formula food for liver disease, which is simple to operate, does not require additional specific equipment, and is suitable for batch industrial production. At the same time, the preparation method is based on the special medical formula food for liver disease described in any one of the first aspects, and therefore has at least the beneficial effects of the special medical formula food for liver disease described in any one of the first aspects, which will not be repeated here.

[0053] In some specific embodiments, the working condition parameters of the low-temperature freezing treatment include: the low-temperature freezing temperature is -30~-20°C, and the time is 60 minutes; the drying method is spray drying, the drying temperature is 180°C, and the air outlet temperature is 80°C.

[0054] In some specific embodiments, the weight of the added water is 1.5 times the weight of the maltodextrin.

[0055] It should be noted that the raw materials involved in the special medical purpose formula food for liver disease and the preparation method thereof provided by the present invention, unless otherwise specified or specified, can be directly commercially available products or homemade according to the preparation process disclosed in the prior art; at the same time, the operating steps and condition parameters involved, unless otherwise specified or specified, can be carried out according to the existing special medical purpose formula food preparation process or using existing equipment, and the present invention document will not describe them one by one.

[0056] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are intended only to illustrate the present invention and are not intended to limit the scope of the present invention. The experimental methods in the following examples that do not specify specific conditions are usually measured according to national standards. If there is no corresponding national standard, then the conditions recommended by the manufacturer are followed.

[0057] Example 1 This example provides a whey protein hydrolyzate, and the preparation method of the whey protein hydrolyzate comprises the following steps: Step (1): Place whey protein isolate and concentrated milk whey protein in a weight ratio of 1:1 as whey protein raw materials in a chamber of a low-temperature plasma treatment device, evacuate the chamber, and when the vacuum degree of the chamber reaches below 10 Pa, introduce a gas flow rate of 48 cm 3 / min of oxygen as the working medium, and low-temperature plasma treatment for 90 seconds under the condition of a power supply of 65W to obtain activated whey protein; Step (2): adding the activated whey protein obtained in step (1) into water for stirring and hydration, then heating to 95° C. and maintaining for 8 minutes, and then cooling to 55° C. to obtain a whey protein aqueous solution with a weight percentage of 6%; Step (3): enzymatically hydrolyzing the whey protein aqueous solution obtained in step (2), followed by enzyme inactivation, desalting and drying to obtain the hydrolyzed whey protein; wherein the working condition parameters of the enzymatic hydrolysis include: enzymatic hydrolysis using papain, the added weight of the papain accounting for 6% of the weight of the activated whey protein substrate, pH 7.0, temperature 55°C, and time 4 hours.

[0058] Example 2 This example provides a whey protein hydrolyzate, and the preparation method of the whey protein hydrolyzate comprises the following steps: Step (1): Place whey protein isolate and concentrated milk whey protein in a weight ratio of 1:1 as whey protein raw materials in a low-temperature plasma treatment device, evacuate the chamber, and when the vacuum degree of the chamber reaches below 10 Pa, introduce a gas flow rate of 45 cm 3 / min of oxygen as the working medium, and low-temperature plasma treatment for 60 seconds under the condition of a power supply of 95W to obtain activated whey protein; Step (2): adding the activated whey protein obtained in step (1) into water for stirring and hydration, then heating to 100° C. and maintaining for 5 minutes, and then cooling to 56° C. to obtain a whey protein aqueous solution with a weight percentage of 8%; Step (3): enzymatically hydrolyzing the whey protein aqueous solution obtained in step (2), followed by enzyme inactivation, desalting and drying to obtain the hydrolyzed whey protein; wherein the working condition parameters of the enzymatic hydrolysis include: enzymatic hydrolysis using papain, the added weight of the papain accounting for 6.5% of the weight of the activated whey protein substrate, pH 7.0, temperature 56°C, and time 4 hours.

[0059] Example 3 This example provides a whey protein hydrolyzate, and the preparation method of the whey protein hydrolyzate comprises the following steps: Step (1): Place whey protein isolate and concentrated milk whey protein in a weight ratio of 1:1 as whey protein raw materials in a chamber of a low-temperature plasma treatment device, evacuate the chamber, and when the vacuum degree of the chamber reaches below 10 Pa, introduce a gas flow rate of 50 cm 3 / min of oxygen as the working medium, and low-temperature plasma treatment for 120 seconds under the condition of a power supply of 40W to obtain activated whey protein; Step (2): adding the activated whey protein obtained in step (1) into water for stirring and hydration, then heating to 90° C. and maintaining for 10 minutes, and then cooling to 52° C. to obtain a whey protein aqueous solution with a weight percentage of 5%; Step (3): enzymatically hydrolyzing the whey protein aqueous solution obtained in step (2), followed by enzyme inactivation, desalting and drying to obtain the hydrolyzed whey protein; wherein the working condition parameters of the enzymatic hydrolysis include: enzymatic hydrolysis using papain, the added weight of the papain accounting for 5.2% of the weight of the activated whey protein substrate, pH 7.0, temperature 52°C, and time 4 hours.

[0060] Example 4 This example provides a special medical formula food for liver disease, which includes the following components by weight: 44 parts of maltodextrin, 20 parts of hydrolyzed whey protein, 18 parts of edible vegetable oil microcapsule powder, 6 parts of a first nutritional enhancer, 6 parts of resistant dextrin, 3.5 parts of oligofructose, 0.8 parts of fish oil powder, 0.70 parts of L-leucine, 0.4 parts of L-valine, 0.6 parts of edible flavor, 0.2 parts of inositol, 0.3 parts of L-carnitine tartrate, 0.5 parts of calcium hydrogen phosphate, 0.15 parts of a second nutritional enhancer, 0.3 parts of sodium dihydrogen phosphate, 0.05 parts of steviol glycosides and 0.008 parts of L-isoleucine; The first nutritional enhancer is prepared by compounding sodium citrate, potassium chloride, magnesium carbonate, potassium dihydrogen phosphate, calcium carbonate, sodium chloride, manganese sulfate, zinc gluconate, ferric pyrophosphate, copper sulfate and sodium selenite in a weight ratio of 1.5:1:1.2:0.8:1:0.8:0.5:2.5:0.5:0.3:1.0; The second nutritional enhancer is prepared by mixing taurine, L-ascorbic acid, dl-α-tocopherol acetate, niacinamide, potassium iodide, D-calcium pantothenate, vitamin A acetate, cholecalciferol, D-biotin, cyanocobalamin, folic acid, pyridoxine hydrochloride, thiamine hydrochloride, riboflavin and phytonadione in a weight ratio of 0.5:1.6:2.0:0.4:2.0:2.2:0.5:1.0:0.6:0.8:0.9:2.0:3.5:2.2:1.7; The hydrolyzed whey protein is obtained in Example 3; The preparation method of the edible vegetable oil microcapsule powder comprises the following steps: High oleic sunflower oil, linseed oil, coconut oil and medium chain triglycerides in a weight ratio of 1:1:0.5:0.5 were stirred uniformly at 50° C., and then homogenized at a pressure of 20 MPa for 15 minutes to obtain an oil phase mixture; The oil phase mixture is spray-dried at an air inlet temperature of 180° C. and an air outlet temperature of 80° C. to obtain the edible vegetable oil microcapsule powder; The preparation method of the fish oil powder comprises the following processes: Add the purified fish oil to maltodextrin, the weight of maltodextrin added is 0.8 times of the purified fish oil, stir evenly, the stirring time is 10 minutes, and the temperature is maintained at 40°C; then spray dry it through a spray dryer, the inlet air temperature is 170°C, and the outlet air temperature is 60°C, to obtain fish oil powder.

[0061] The preparation method of the above-mentioned special medical purpose formula food for liver disease comprises the following steps: The maltodextrin, edible vegetable oil microcapsule powder, hydrolyzed whey protein and water are stirred and mixed at a stirring speed of 400 rpm for 25 minutes to obtain a first mixture; wherein the weight of the added water is 1.5 times the weight of the maltodextrin; The first mixture is subjected to a low-temperature freezing treatment at a low-temperature temperature of -25°C for 60 minutes, and then thawed at room temperature for 120 minutes to obtain a second mixture; The remaining components are added to the second mixture and stirred for mixing at a stirring speed of 300 rpm for 20 minutes; then spray drying is performed at an air inlet temperature of 175° C. and an air outlet temperature of 75° C. to obtain the special medical formula food for liver disease.

[0062] Example 5 This example provides a special medical formula food for liver disease, which includes the following components by weight: 48 parts of maltodextrin, 16 parts of hydrolyzed whey protein, 15 parts of edible vegetable oil microcapsule powder, 4 parts of a first nutritional enhancer, 4 parts of resistant dextrin, 1.5 parts of oligofructose, 1.3 parts of fish oil powder, 0.35 parts of L-leucine, 0.6 parts of L-valine, 0.3 parts of edible flavor, 0.5 parts of inositol, 0.5 parts of L-carnitine tartrate, 0.2 parts of calcium hydrogen phosphate, 0.35 parts of a second nutritional enhancer, 0.1 parts of sodium dihydrogen phosphate, 0.01 parts of steviol glycosides and 0.015 parts of L-isoleucine; The first nutritional enhancer is prepared by compounding sodium citrate, potassium chloride, magnesium carbonate, potassium dihydrogen phosphate, calcium carbonate, sodium chloride, manganese sulfate, zinc gluconate, ferric pyrophosphate, copper sulfate and sodium selenite in a weight ratio of 2.0:0.5:2.0:0.2:0.5:1.2:0.1:3.2:1:0.6:1.5; the specific preparation method is the same as that in Example 4; The second nutritional enhancer is prepared by mixing taurine, L-ascorbic acid, dl-α-tocopherol acetate, nicotinamide, potassium iodide, D-calcium pantothenate, vitamin A acetate, cholecalciferol, D-biotin, cyanocobalamin, folic acid, pyridoxine hydrochloride, thiamine hydrochloride, riboflavin and phytonadione in a weight ratio of 0.2:1.3:1.6:0.7:2.4:1.8:0.3:1.5:0.9:1.5:1.4:2.5:3.0:2.5:2.3; the specific preparation method is the same as that in Example 4; The hydrolyzed whey protein is obtained in Example 2; The preparation method of the edible vegetable oil microcapsule powder is the same as that of Example 4; The preparation method of the fish oil powder is the same as that of Example 4.

[0063] The preparation method of the special medical purpose formula food for liver disease provided in this example is the same as that in Example 4.

[0064] Example 6 This example provides a special medical formula food for liver disease, which includes the following components by weight: 46.43 parts of maltodextrin, 18.80 parts of hydrolyzed whey protein, 17.00 parts of edible vegetable oil microcapsule powder, 5.40 parts of a first nutritional enhancer, 5.0 parts of resistant dextrin, 2.50 parts of oligofructose, 1.10 parts of fish oil powder, 0.59 parts of L-leucine, 0.51 parts of L-valine, 0.50 parts of edible flavor, 0.40 parts of inositol, 0.42 parts of L-carnitine tartrate, 0.35 parts of calcium hydrogen phosphate, 0.26 parts of a second nutritional enhancer, 0.2 parts of sodium dihydrogen phosphate, 0.03 parts of steviol glycosides and 0.01 parts of L-isoleucine; The first nutritional enhancer is prepared by compounding sodium citrate, potassium chloride, magnesium carbonate, potassium dihydrogen phosphate, calcium carbonate, sodium chloride, manganese sulfate, zinc gluconate, ferric pyrophosphate, copper sulfate and sodium selenite in a weight ratio of 1.8:0.6:1.5:0.5:0.8:1.0:0.3:2.7:0.8:0.4:1.2; the specific preparation method is the same as that of Example 4; The second nutritional enhancer is prepared by compounding taurine, L-ascorbic acid, dl-α-tocopherol acetate, nicotinamide, potassium iodide, D-calcium pantothenate, vitamin A acetate, cholecalciferol, D-biotin, cyanocobalamin, folic acid, pyridoxine hydrochloride, thiamine hydrochloride, riboflavin and phytonadione in a weight ratio of 0.4:1.5:1.8:0.6:2.2:2.0:0.3:1.1:0.7:1.3:1.1:2.4:3.2:2.4:1.9; the specific preparation method is the same as that in Example 4; The hydrolyzed whey protein is obtained in Example 1; The preparation method of the edible vegetable oil microcapsule powder is the same as that of Example 4; The preparation method of the fish oil powder is the same as that of Example 4.

[0065] The preparation method of the special medical purpose formula food for liver disease provided in this example is the same as that in Example 4.

[0066] Example 7 This example provides a special medical purpose formula food for liver disease and a preparation method thereof, which is different from Example 6 only in that the hydrolyzed whey protein is adjusted to commercially available hydrolyzed whey protein; the remaining steps and parameters are the same.

[0067] Comparative Example 1 This example provides a whey protein hydrolyzate and a preparation method thereof, which is different from Example 1 only in that no low-temperature plasma treatment is performed; the remaining steps and parameters are the same.

[0068] The preparation method of the above-mentioned whey protein hydrolyzate comprises the following steps: Step (1): adding isolated whey protein and concentrated milk whey protein in a weight ratio of 1:1 as whey protein raw materials into water for stirring and hydration, then heating to 95° C. and maintaining for 8 minutes, and then cooling to 55° C. to obtain a whey protein aqueous solution with a weight percentage of 6%; Step (2): enzymatically hydrolyzing the whey protein aqueous solution obtained in step (1), followed by enzyme inactivation, desalting and drying to obtain the hydrolyzed whey protein; wherein the working condition parameters of the enzymatic hydrolysis include: using papain for enzymatic hydrolysis, the weight of the papain added accounts for 6% of the weight of the activated whey protein substrate, the pH is 7.0, the temperature is 55° C., and the time is 4 hours.

[0069] Comparative Example 2 This example provides a special medical purpose formula food for liver disease and a preparation method thereof, which is different from Example 7 only in that: the second nutritional enhancer is obtained by compounding taurine, L-ascorbic acid, dl-α-tocopherol acetate, niacinamide, potassium iodide, D-calcium pantothenate, vitamin A acetate, cholecalciferol, D-biotin, cyanocobalamin, folic acid, pyridoxine hydrochloride, thiamine hydrochloride, riboflavin and phytonadione in a weight ratio of 1:1:1:1:1:1:1:1:1:1:1:1:1:1; the other steps and parameters are the same.

[0070] Comparative Example 3 This example provides a special medical purpose formula food for liver disease and a preparation method thereof, which is different from Example 7 only in that: the first nutritional enhancer is obtained by compounding sodium citrate, potassium chloride, magnesium carbonate, potassium dihydrogen phosphate, calcium carbonate, sodium chloride, manganese sulfate, zinc gluconate, ferric pyrophosphate, copper sulfate and sodium selenite in a weight ratio of 1:1:1:1:1:1:1:1:1:1:1; the remaining steps and parameters are the same.

[0071] Test Example 1 This example aims to evaluate the allergenicity properties of the hydrolyzed whey proteins provided by Examples 1 to 3 and Comparative Example 1.

[0072] 1. Material preparation: 1.1 Cell culture: Select and thaw frozen KU812 cells and perform necessary subculture to ensure that the cells are in good condition and sufficient in number.

[0073] 1.2 Serum from allergic patients: Serum from a serum pool of patients with confirmed allergies containing 2% bovine milk β-lactoglobulin was prepared as the allergen (the blank control group was replaced with sterile buffer).

[0074] 1.3 Sample preparation: The hydrolyzed whey protein samples provided in Examples 1 to 3 and Comparative Example 1 were prepared into solutions with a protein concentration of 10 mg / mL.

[0075] 1.4 Kit: β-HEX detection kit, used for the subsequent determination of β-HEX release rate.

[0076] 2. Experimental steps: 2.1 Cell sensitization: The revived and passaged KU812 cells were inoculated into the culture medium; 2% serum from the serum pool of patients allergic to bovine milk β-lactoglobulin was added to the culture medium and incubated for 12 hours to fully sensitize the cells (sterile buffer was added to the blank control group).

[0077] 2.2 Sample treatment: Add 1% by volume of a sample solution with a protein concentration of 10 mg / mL to the sensitized cell culture medium (add sterile buffer to the negative control group); continue incubation for 6 hours to allow the sample to fully interact with the cells.

[0078] 2.3 Cell lysis and detection: TritonX-100 was used to lyse the cells to release intracellular β-HEX; according to the instructions of the kit, the content of β-HEX in each group of samples was detected and determined.

[0079] 2.4 Data calculation and analysis: Calculate the β-HEX release rate according to the measured OD value. The calculation formula is: β-HEX release rate (100%) = (OD value of sample group - OD value of negative group) / (OD value of positive group - OD value of negative group) × 100%; Statistical analysis was performed on the experimental results to compare the differences in β-HEX release rates between the embodiments and the comparative examples to evaluate the allergenicity of hydrolyzed whey protein; the test results are shown in Table 1.

[0080] Table 1 Allergenicity test results of hydrolyzed whey protein

[0081] As can be seen from Table 1, compared with Comparative Example 1, in Examples 1 to 3 of the present invention, by subjecting the whey protein raw material to low-temperature plasma pretreatment, the β-HEX release rate of the obtained hydrolyzed whey protein is significantly reduced, the hydrolysis is deeper, and its allergenicity is reduced.

[0082] Test Example 2 This example aims to evaluate in detail the efficacy of the special medical formula foods for liver disease in Example 6, Example 7, Comparative Example 2 and Comparative Example 3 on the rat model of liver cirrhosis induced by carbon tetrachloride (CCl4). Through systematic monitoring of rat body weight, liver function, plasma protein level, and oxidative stress-related indicators, the specific effects and mechanisms of the complete nutritional formula emulsion for liver disease in terms of liver function protection, nutritional improvement, and anti-oxidative stress were comprehensively evaluated.

[0083] 1. Experimental Materials 1.1 Experimental animals: Type: Wistar rats, number: 50 (half male and half female, randomly divided into 5 groups, 4 experimental groups and 1 control group), body weight: 250±50g; Treatment method: All rats were induced with CCl4 to establish a cirrhosis model.

[0084] 1.2 Induction reagent: Carbon tetrachloride (CCl4) was injected intraperitoneally with a mixture of CCl4 and olive oil (1:1) 3 times a week for 4 weeks to induce cirrhosis in rats.

[0085] 1.3 Sample preparation: The special medical purpose formula foods for liver disease provided in Example 6, Example 7, Comparative Example 2 and Comparative Example 3 were respectively prepared with warm water at a ratio of 1.3 kcal / mL to obtain a complete nutritional formula emulsion for liver disease; the daily energy intake was 35-40 kcal / (kg·d).

[0086] 2. Experimental design: 2.1 Experimental groups: Control group: standard diet group, without intervention of complete nutritional formula emulsion for liver disease; Experimental group: fed with complete nutritional formula emulsion for liver disease obtained from special medical purpose formula food for liver disease provided by Example 6, Example 7, Comparative Example 2 and Comparative Example 3, once a day for 14 consecutive days.

[0087] 2.2 Experimental cycle: Induction phase: CCl4 was injected continuously for 4 weeks to form a stable cirrhosis model; Experimental phase: After basic data collection on day 0, a 14-day experimental intervention (feeding a complete nutritional formula emulsion for liver disease) was started.

[0088] 2.3 Monitoring indicators and methods: The following indicators were measured and analyzed on the 0th day of the experiment (before the start of the experimental intervention) and the 14th day (after the end of the experimental intervention): 1) Weight change; Measurement method: Use an electronic balance to measure the weight of each rat and record to two decimal places to ensure the accuracy of the data; Data processing: Calculate the weight gain of each rat during the experiment (weight gain = weight on day 14 - weight on day 0), and analyze the differences in weight changes between groups; 2) Liver function index - alanine aminotransferase (ALT); Measurement method: Collect blood samples from the rat tail vein and use a biochemical analyzer to measure the ALT activity in the serum, the unit is U / L; Analysis: The level of ALT directly reflects the degree of liver cell damage. The higher the value, the more serious the liver cell damage. Compare the changes in ALT of rats in each group on the 0th day and the 14th day to evaluate the effect of the liver disease complete nutrition formula emulsion on liver disease protection; 3) Plasma protein levels - total protein (TP) and transferrin (TRF); Measurement method: ELISA or biochemical analyzer was used to measure the concentrations of TP and TRF, respectively, in g / dL; Analysis: TP reflects the protein synthesis function of the liver, while TRF is closely related to nutritional status. By comparing the changes in protein levels of rats in each group on day 0 and day 14, the effect of the complete nutritional formula emulsion for liver disease in improving malnutrition caused by liver cirrhosis was evaluated.

[0089] 4) Oxidative stress related index - superoxide dismutase (SOD); Measurement method: Use SOD activity assay kit to measure the activity of SOD in liver tissue, the unit is U / mg protein; Analysis: SOD activity reflects the antioxidant capacity of the liver. By comparing the changes in SOD activity in liver tissue of rats in each group on day 0 and day 14, the effect of the complete nutritional formula emulsion for liver disease in enhancing the antioxidant capacity of the liver was evaluated.

[0090] The test results are shown in Tables 2, 3, 4 and 5; Note: The “-” in the test results of the control group in Tables 3, 4 and 5 should be understood as there is no significant difference in the test results of the index changes before and after the test.

[0091] Table 2 Weight change test results

[0092] Table 3 Test results of changes in liver function indicators

[0093] Table 4 Test results of changes in plasma protein levels

[0094] Table 5 Test results of changes in oxidative stress related indicators

[0095] It can be seen from Tables 2, 3, 4 and 5 above that the special medical purpose formula food for liver disease provided by the embodiments of the present invention has shown significant therapeutic effects in many aspects, including: 1) significantly increasing the body weight of cirrhotic rats and improving the overall nutritional status; 2) effectively reducing liver function damage indicators (AST, ALT, TBIL) and protecting liver cells; 3) significantly increasing plasma protein levels and improving malnutrition symptoms; 4) significantly enhancing the antioxidant capacity of the liver and reducing the damage to the liver caused by oxidative stress, etc.

[0096] To sum up, the present invention provides a special medical purpose formula food for liver disease and a preparation method thereof, the beneficial effects of which are reflected in many aspects, including reducing the metabolic burden of the liver, supporting liver repair, improving nutritional status, regulating blood sugar and lipid metabolism, enhancing immune function, etc. These effects not only provide comprehensive and effective nutritional support for patients with liver disease, but also significantly improve the patients' quality of life and disease management effect.

[0097] Various embodiments of the present invention may be presented in the form of a range; it should be understood that the description in the form of a range is only for convenience and brevity, and should not be understood as a rigid limitation on the scope of the present invention; therefore, the range description should be considered to have specifically disclosed all possible sub-ranges and single numerical values ​​within the range. For example, the range description from 1 to 6 should be considered to have specifically disclosed sub-ranges, such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as single numbers within the range, such as 1, 2, 3, 4, 5 and 6, which are applicable regardless of the range. In addition, whenever a numerical range is indicated herein, it is intended to include any cited number (fractional or integer) within the indicated range.

[0098] The foregoing is merely a specific embodiment of the present invention, which enables those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A special medical formula food for liver disease, characterized in that: The special medical formula food for liver disease comprises the following components in parts by weight: 44-48 parts of maltodextrin, 16-20 parts of hydrolyzed whey protein, 15-18 parts of edible vegetable oil microcapsule powder, 4-6 parts of a first nutritional enhancer, 4-6 parts of resistant dextrin, 1.5-3.5 parts of oligofructose, 0.8-1.3 parts of fish oil powder, 0.35-0.70 parts of L-leucine, 0.4-0.6 parts of L-valine, 0.3-0.6 parts of edible flavor, 0.2-0.5 parts of inositol, 0.3-0.5 parts of L-carnitine tartrate, 0.2-0.5 parts of calcium hydrogen phosphate, 0.15-0.35 parts of a second nutritional enhancer, 0.1-0.3 parts of sodium dihydrogen phosphate, 0.01-0.05 parts of steviol glycosides, and 0.008-0.015 parts of L-isoleucine; The first nutritional enhancer is prepared by mixing sodium citrate, potassium chloride, magnesium carbonate, potassium dihydrogen phosphate, calcium carbonate, sodium chloride, manganese sulfate, zinc gluconate, ferric pyrophosphate, copper sulfate and sodium selenite in a weight ratio of (1.5-2.0): (0.5-1): (1.2-2.0): (0.2-0.8): (0.5-1): (0.8-1.2): (0.1-0.5): (2.5-3.2): (0.5-1): (0.3-0.6): (1.0-1.5); The second nutritional enhancer is prepared by mixing taurine, L-ascorbic acid, dl-α-tocopherol acetate, niacinamide, potassium iodide, D-calcium pantothenate, vitamin A acetate, cholecalciferol, D-biotin, cyanocobalamin, folic acid, pyridoxine hydrochloride, thiamine hydrochloride, riboflavin and phytonadione in a weight ratio of (0.2-0.5): (1.3-1.6): (1.6-2.0): (0.4-0.7): (2.0-2.4): (1.8-2.2): (0.3-0.5): (1.0-1.5): (0.6-0.9): (0.8-1.5): (0.9-1.4): (2.0-2.5): (3.0-3.5): (2.2-2.5): (1.7-2.3); The preparation method of the whey protein hydrolyzate comprises the following steps: The whey protein raw material is subjected to low-temperature plasma treatment to obtain activated whey protein; Adding activated whey protein into water for stirring and hydration, then heating to 90-100° C. and maintaining for 5-10 minutes, and then cooling to 52-56° C. to obtain a whey protein aqueous solution with a weight percentage of 5-8%; The whey protein aqueous solution is subjected to enzymatic hydrolysis, followed by enzyme inactivation, desalination and drying to obtain the hydrolyzed whey protein.

2. The special medical formula food for liver disease according to claim 1, characterized in that: The special medical formula food for liver disease comprises the following components in parts by weight: 46.43 parts of maltodextrin, 18.80 parts of hydrolyzed whey protein, 17.00 parts of edible vegetable oil microcapsule powder, 5.40 parts of a first nutritional enhancer, 5.0 parts of resistant dextrin, 2.50 parts of oligofructose, 1.10 parts of fish oil powder, 0.59 parts of L-leucine, 0.51 parts of L-valine, 0.50 parts of edible flavor, 0.40 parts of inositol, 0.42 parts of L-carnitine tartrate, 0.35 parts of calcium hydrogen phosphate, 0.26 parts of a second nutritional enhancer, 0.2 parts of sodium dihydrogen phosphate, 0.03 parts of steviol glycosides and 0.01 parts of L-isoleucine.

3. The special medical formula food for liver disease according to claim 1, characterized in that: The first nutritional enhancer is prepared by mixing sodium citrate, potassium chloride, magnesium carbonate, potassium dihydrogen phosphate, calcium carbonate, sodium chloride, manganese sulfate, zinc gluconate, ferric pyrophosphate, copper sulfate and sodium selenite in a weight ratio of 1.8:0.6:1.5:0.5:0.8:1.0:0.3:2.7:0.8:0.4:1.

2.

4. The special medical formula food for liver disease according to claim 1, characterized in that: The second nutritional enhancer is prepared by mixing taurine, L-ascorbic acid, dl-α-tocopherol acetate, niacinamide, potassium iodide, D-calcium pantothenate, vitamin A acetate, cholecalciferol, D-biotin, cyanocobalamin, folic acid, pyridoxine hydrochloride, thiamine hydrochloride, riboflavin and phytonadione in a weight ratio of 0.4:1.5:1.8:0.6:2.2:2.0:0.3:1.1:0.7:1.3:1.1:2.4:3.2:2.4:1.

9.

5. The special medical formula food for liver disease according to claim 1, characterized in that: The step of subjecting the whey protein raw material to low-temperature plasma treatment to obtain activated whey protein comprises the following process: The whey protein raw material is placed in the cavity of the low-temperature plasma treatment device and evacuated. When the vacuum degree of the cavity reaches below 10Pa, the gas flow rate is 45~50cm 3 / min of oxygen as the working medium, and low-temperature plasma treatment for 60 to 120 seconds under the condition of a power supply of 40 to 95 W to obtain activated whey protein; The working condition parameters of the enzymatic hydrolysis include: using papain for enzymatic hydrolysis, the weight of the added papain accounts for 5.2-6.5% of the weight of the activated whey protein substrate, pH is 6.8-7.2, temperature is 52-56° C., and time is 3-5 hours.

6. The special medical formula food for liver disease according to claim 1, characterized in that: Preparation method of edible vegetable oil microcapsule powder The process includes: High oleic sunflower oil, linseed oil, coconut oil and medium chain triglycerides in a weight ratio of 1:1:0.5:0.5 are stirred uniformly at a temperature of 45-52° C., and then homogenized at a pressure of 15-25 MPa for 10-20 minutes to obtain an oil phase mixture; The oil phase mixture is spray dried with an air inlet temperature of 175-185° C. and an air outlet temperature of 75-85° C. to obtain the edible vegetable oil microcapsule powder.

7. A method for preparing the special medical formula food for liver disease according to any one of claims 1 to 6, characterized in that: The preparation method comprises the following steps: Stirring and mixing maltodextrin, edible vegetable oil microcapsule powder, hydrolyzed whey protein and water to obtain a first mixture; The first mixture is subjected to low-temperature freezing treatment, and then thawed at room temperature to obtain a second mixture; The remaining components are added to the second mixture, stirred and mixed, and then dried to obtain the special medical formula food for liver disease.

8. The method for preparing the special medical formula food for liver disease according to claim 7, characterized in that: The working condition parameters of the low-temperature freezing treatment include: the low-temperature freezing temperature is -30~-20°C, and the time is 60 minutes; the drying method is spray drying.

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