A special medical purpose liquid formula, and a method of preparation and use thereof

Abstract

This invention provides a special medical purpose liquid formula food, its preparation method, and its application, belonging to the field of special medical purpose formula foods. The special medical purpose liquid formula food comprises the following components: protein, carbohydrates, vitamins, macroelements, and trace elements; the vitamins include vitamin C; the protein source includes mung bean peptides; the special medical purpose liquid formula food is fat-free; and corresponding preparation methods and applications are provided. Compared with existing technologies, this invention, through the compounding of various nutrients required by the human body, has developed a special medical purpose liquid formula food suitable for patients with pancreatitis, which can supplement the various nutrients needed by the human body and has a significant promoting effect on disease recovery.

Description

Technical Field

[0001] This invention belongs to the field of special medical purpose formula foods, specifically relating to a special medical purpose liquid formula food, its preparation method, and its application. Background Technology

[0002] Foods for special medical purposes refer to specially processed and formulated foods designed to meet the special nutritional or dietary needs of people with restricted food intake, digestive and absorption disorders, metabolic disorders, or specific disease states.

[0003] Due to the different diseases, the "General Rules for Foods for Special Medical Purposes GB29922-2013" lists thirteen common specific complete nutritional formula foods:

[0004] a. Diabetic complete nutritional formula food;

[0005] b. Complete nutritional formula foods for respiratory diseases;

[0006] c. Complete nutritional formula food for kidney disease;

[0007] d. Complete nutritional formula food for tumors;

[0008] e. Complete nutritional formula food for liver disease;

[0009] f. Complete nutritional formula food for sarcopenia syndrome;

[0010] g. Complete nutritional formula foods for trauma, infection, surgery and other stressful conditions;

[0011] h. Complete nutritional formula food for inflammatory bowel disease;

[0012] i. Complete nutritional formula food for food protein allergies;

[0013] j. Complete nutritional formula food for refractory epilepsy;

[0014] k. Complete nutritional formula food for gastrointestinal malabsorption and pancreatitis;

[0015] l. Complete nutritional formula food for fatty acid metabolism disorders;

[0016] m. Complete nutritional formula food for obesity and fat reduction surgery.

[0017] Currently, there are relatively few types of foods for special medical purposes available, which is insufficient to fully meet the needs of patients with different diseases and conditions. Therefore, developing new foods for special medical purposes is one of the key research topics for those skilled in the art.

[0018] For example, invention patent CN115005287B provides a fat component for a special medical purpose formula food suitable for diabetic patients, belonging to the field of food design. The application uses shea butter as a base oil, combined with other natural oils. This invention, through the synergistic effect of different oils, rationally regulates the fatty acid composition of the oil composition, making the nutrition more balanced and meeting the body's nutritional needs. It provides essential fat nutritional support for diabetic patients, improves their dietary habits and nutritional status, and has significant preventive or alleviating effects on the disease.

[0019] For example, invention patent CN109965031B provides a fat-based food formula for special medical use in patients with inflammatory bowel disease and its preparation method. The fat component of this invention includes the following raw materials by weight percentage: 40% medium-chain triglycerides (the mass ratio of tricaprylic acid glyceride to tricaprylic acid glyceride is 3:1) and a nutritional oil composed of 13% peony seed oil, 14% camellia seed oil, 9% corn oil, 13% rice bran oil and 11% rapeseed oil.

[0020] It is evident that special medical purpose foods need to be developed specifically for different patients. Furthermore, since different diseases have different requirements and contraindications for food ingredients, further improvements to special medical purpose foods applicable to different diseases are of great significance for improving the efficiency of nutritional supplementation and the quality of life of patients.

[0021] Acute pancreatitis is an inflammatory response caused by the activation of pancreatic enzymes within the pancreas, leading to autodigestion, edema, hemorrhage, and even necrosis of pancreatic tissue. In acute cases, fasting is required for 3-10 days, resulting in a significant nutritional deficit. As acute pancreatitis improves or in milder cases, a liquid diet is necessary, while maintaining a low fat intake as much as possible.

[0022] Patients with gastrointestinal malabsorption or other fat digestion disorders, similar to patients with acute pancreatitis, need to maintain a low-fat liquid diet.

[0023] Therefore, developing a special medical-grade liquid formula food for gastrointestinal malabsorption and pancreatitis is of great significance for the nutritional supplementation and physical recovery of patients. Summary of the Invention

[0024] This invention addresses the lack of a more suitable nutritional supplement for the recovery period of patients with gastrointestinal malabsorption and pancreatitis in the existing technology by providing a non-complete nutritional liquid formula for special medical purposes, along with its preparation method and application.

[0025] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0026] In this invention, the amount of vitamin A is measured in retinol equivalents, and the amount of vitamin E is measured in α-tocopherol equivalents.

[0027] In this invention, unless otherwise specified, the terms "content" and "component" refer to the content of components relative to the final product of the special purpose liquid formula food.

[0028] This invention first provides a liquid formula food for special medical purposes, comprising the following components:

[0029] Protein, carbohydrates, vitamins, macroelements and trace elements;

[0030] The vitamins mentioned include vitamin C;

[0031] The protein sources include mung bean peptides;

[0032] The special medical purpose liquid formula food contains no fat.

[0033] Preferably, the liquid formula food for special medical purposes comprises the following components in parts by weight:

[0034] Protein 1500-3000 parts, carbohydrates 5500-8000 parts, vitamins 15.9-37.1 parts, macro-elements and trace elements 118.5-882.5 parts;

[0035] The vitamins mentioned include 15-30 parts of vitamin C;

[0036] The protein source includes 40-300 parts of mung bean peptide.

[0037] Preferably, the protein source also includes one or more of the following: soy protein isolate, whey protein, casein, milk protein, hydrolyzed whey protein, soy peptides, collagen peptides, and marine fish oligopeptides.

[0038] Preferably, the source of the carbohydrate includes one or more of glucose, fructose, starch, pregelatinized starch, maltodextrin, and glucose syrup.

[0039] Preferably, the source of vitamin C includes one or more of L-ascorbic acid, sodium L-ascorbate, calcium L-ascorbate, potassium L-ascorbate, and ascorbyl palmitate.

[0040] Preferably, the vitamins also include vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, folic acid, pantothenic acid, and biotin.

[0041] More preferably, the source of vitamin A includes one or both of retinyl acetate and retinyl palmitate; the content of vitamin A is 0.019-0.1 parts by weight.

[0042] More preferably, the source of vitamin D includes one or more of ergocalciferol and cholecalciferol; the content of vitamin D is 0.0002-0.0014 parts by weight.

[0043] More preferably, the source of vitamin E includes one or more of d-α-tocopherol, dl-α-tocopherol, d-α-tocopherol acetate, dl-α-tocopherol acetate, mixed tocopherol concentrate, d-α-tocopherol succinate, and dl-α-tocopherol succinate; and the content of vitamin E is 0.5-2.5 parts by weight.

[0044] More preferably, the source of vitamin K includes the plant menaquinone; the content of vitamin K is 0.002-0.007 parts by weight.

[0045] More preferably, the source of vitamin B1 includes one or both of thiamine hydrochloride and thiamine nitrate, and the content of vitamin B1 is 0.04-0.2 parts by weight.

[0046] More preferably, the source of vitamin B2 includes one or both of riboflavin and riboflavin-5'-phosphate sodium; the content of vitamin B2 is 0.04-0.2 parts by weight.

[0047] More preferably, the source of vitamin B6 includes one or both of pyridoxine hydrochloride and pyridoxal 5'-phosphate; the content of vitamin B6 is 0.025-0.210 parts by weight.

[0048] More preferably, the source of vitamin B12 includes one or more of cyanocobalamin, cyanocobalamin hydrochloride, and hydroxycobalamin; the content of vitamin B12 is 0.00006-0.0004 parts by weight.

[0049] More preferably, the source of the nicotinic acid includes one or both of pyridine-3-carboxylic acid and nicotinamide; the content of the nicotinic acid is 0.09-0.6 parts by weight.

[0050] More preferably, the folic acid content is 0.007-0.04 parts by weight.

[0051] More preferably, the source of the pantothenic acid includes one or both of D-calcium pantothenate and D-sodium pantothenate; the content of the pantothenic acid is 0.21-0.91 parts by weight.

[0052] More preferably, the biotin source includes D-biotin; the biotin content is 0.001-0.005 parts by weight.

[0053] Preferably, the macroelements and trace elements include sodium, potassium, copper, magnesium, iron, zinc, manganese, calcium, phosphorus, iodine and selenium.

[0054] More preferably, the source of sodium includes one or more of sodium bicarbonate, sodium dihydrogen phosphate, sodium citrate, sodium chloride, and disodium hydrogen phosphate; the sodium content is 30-200 parts by weight.

[0055] More preferably, the potassium source includes one or more of potassium gluconate, potassium citrate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, and potassium chloride; the potassium content is 40-200 parts by weight.

[0056] More preferably, the source of copper includes one or more of copper sulfate, copper gluconate, copper citrate and copper carbonate; the copper content is 0.022-0.22 parts by weight.

[0057] More preferably, the magnesium source includes one or more of magnesium sulfate, magnesium chloride, magnesium oxide, magnesium carbonate, magnesium hydrogen phosphate, and magnesium gluconate; the magnesium content is 7-82 parts by weight.

[0058] More preferably, the source of the iron includes one or more of ferrous sulfate, ferrous gluconate, ferric ammonium citrate, ferrous fumarate, ferric citrate, ferrous succinate, and ferric pyrophosphate; and the iron content is 0.3-1 parts by weight.

[0059] More preferably, the zinc source includes one or more of zinc sulfate, zinc gluconate, zinc oxide, zinc lactate, zinc citrate, zinc chloride, and zinc acetate; the zinc content is 0.2-1 parts by weight.

[0060] More preferably, the source of manganese includes one or more of manganese sulfate, manganese chloride, manganese carbonate, manganese citrate, and manganese gluconate; the content of manganese is 0.025-0.25 parts by weight.

[0061] More preferably, the source of calcium includes one or more of calcium carbonate, calcium gluconate, calcium citrate, calcium hydrogen phosphate, calcium chloride, tricalcium phosphate, calcium oxide, calcium sulfate, and L-calcium lactate; the calcium content is 20-155 parts by weight.

[0062] More preferably, the source of phosphorus includes one or both of tricalcium phosphate and dicalcium phosphate; the phosphorus content is 15-150 parts by weight.

[0063] More preferably, the source of the iodine includes one or more of potassium iodate, potassium iodide and sodium iodide; and the iodine content is 0.003-0.01 parts by weight.

[0064] More preferably, the source of chlorine includes one or both of sodium chloride and potassium chloride; the chlorine content is 6-100 parts by weight.

[0065] More preferably, the source of selenium includes one or both of sodium selenate and sodium selenite; the content of selenium is 0.0016-0.01 parts by weight.

[0066] Preferably, the liquid formula food for special medical purposes further includes nutritional fortifiers, reconstitution stabilizers, and taste improvers.

[0067] More preferably, the nutritional fortifier is selected from one or more of dietary fiber, choline, inositol, molybdenum, chromium, taurine and L-carnitine.

[0068] More preferably, the mixing stabilizer is selected from one or more of xanthan gum, carrageenan, guar gum, sodium alginate, gellan gum, and pectin.

[0069] More preferably, the taste improver is selected from one or more of citric acid, malic acid, sucralose, acesulfame potassium, aspartame, and cyclamate.

[0070] Most preferably, the dietary fiber source includes one or more of polydextrose, fructooligosaccharides, and inulin; the dietary fiber content is 0-1000 parts by weight.

[0071] The choline is selected from one or both of choline chloride and choline tartrate; the choline content is 0-77 parts by weight.

[0072] The content of taurine is 0-10 parts by weight;

[0073] The content of L-carnitine is 0.3-1 parts by weight;

[0074] The inositol content is 0-40 parts by weight;

[0075] The source of molybdenum includes one or both of sodium molybdate and ammonium molybdate; the content of molybdenum is 0-0.02 parts by weight.

[0076] The chromium source includes one or both of chromium sulfate and chromium chloride; the chromium content is 0-0.025 parts by weight.

[0077] Preferably, the liquid formula food for special medical purposes comprises the following components in parts by weight:

[0078] Protein 1500-3000 parts, carbohydrates 5800-7600 parts, vitamins 21.2-31.2 parts, macro-elements and trace elements 423.2-712.3 parts;

[0079] The vitamins mentioned include 15-30 parts of vitamin C;

[0080] The protein sources include 43-292 parts of mung bean peptide.

[0081] More preferably, the vitamins also include vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, folic acid, pantothenic acid, and biotin;

[0082] The vitamin A content is 0.0184-0.0513 parts by weight;

[0083] The vitamin D content is 0.0002-0.0014 parts by weight;

[0084] The content of vitamin E is 0.5-2.5 parts by weight;

[0085] The vitamin K content is 0.002-0.007 parts by weight;

[0086] The content of vitamin B1 is 0.037-0.191 parts by weight;

[0087] The content of vitamin B2 is 0.044-0.198 parts by weight;

[0088] The content of vitamin B6 is 0.028-0.206 parts by weight;

[0089] The content of vitamin B12 is 0.000063-0.000396 parts by weight;

[0090] The content of nicotinic acid is 0.099-0.591 parts by weight;

[0091] The folic acid content is 0.00781-0.03954 parts by weight;

[0092] The content of pantothenic acid is 0.217-0.910 parts by weight;

[0093] The biotin content is 0.001-0.005 parts by weight.

[0094] More preferably, the macroelements and microelements include sodium, potassium, copper, magnesium, iron, zinc, manganese, calcium, phosphorus, iodine and selenium;

[0095] The sodium content is 31.2-197.2 parts by weight;

[0096] The potassium content is 43.5-198.1 parts by weight;

[0097] The copper content is 0.021-0.216 parts by weight;

[0098] The magnesium content is 7.3-81.5 parts by weight;

[0099] The iron content is 0.280-0.945 parts by weight;

[0100] The zinc content is 0.22-0.97 parts by weight;

[0101] The manganese content is 0.0266-0.2468 parts;

[0102] The calcium content is 20.8-153.1 parts by weight;

[0103] The phosphorus content is 15.5-147.6 parts by weight;

[0104] The iodine content is 0.00279-0.00971 parts by weight;

[0105] The chlorine content is 6.2-99.4 parts by weight;

[0106] The selenium content is 0.0016-0.0099 parts by weight.

[0107] The present invention further provides a method for preparing the above-mentioned liquid formula food for special medical purposes, comprising the following steps:

[0108] (1) Weigh the amount of protein in the formula as premixed raw material a; weigh the amount of carbohydrates in the formula as premixed raw material b; weigh the amount of vitamins in the formula as premixed raw material c; weigh the amount of macro-elements and micro-elements in the formula as premixed raw material d;

[0109] (2) Premix the premixed raw materials a, b, c and d in step (1) to obtain premixed materials a, b, c and d.

[0110] (3) Mix the premix c and premix d obtained in step (2) to obtain mixture 1;

[0111] (4) Mix the mixture 1 obtained in step (3) with the premix a obtained in step (2) to obtain mixture 2;

[0112] (5) Mix the mixture 2 obtained in step (4) with the premix b obtained in step (2) to obtain the finished product.

[0113] Preferably, the premixing device mentioned in step (2) is a three-dimensional motion mixer;

[0114] The premixing time is 15-25 min; the premixing speed is 24-28 rpm.

[0115] Preferably, the mixing device in step (3) is a three-dimensional motion mixer;

[0116] The mixing time is 38-52 minutes; the mixing speed is 24-28 rpm.

[0117] Preferably, the mixing device in step (4) is a three-dimensional motion mixer;

[0118] The mixing time is 42-56 min; the mixing speed is 30-34 rpm.

[0119] Preferably, the mixing device in step (5) is a three-dimensional motion mixer;

[0120] The mixing time is 26-35 min; the mixing speed is 30-34 rpm.

[0121] Preferably, when the premixed raw material c is premixed in step (2), the above-mentioned reconstituted stabilizer is added together.

[0122] More preferably, when the premixed raw material c in step (2) is premixed, one or two of the following are added: a nutrient fortifier and a taste improver.

[0123] This invention also provides the application of the above-mentioned special medical purpose liquid formula food or the special medical purpose liquid formula food prepared by the above-mentioned special medical purpose liquid formula food preparation method in the preparation of special medical purpose complete nutritional formula food for nutritional supplementation during the recovery period of pancreatitis.

[0124] Compared with the prior art, the present invention has the following beneficial effects:

[0125] This invention develops a special medical purpose liquid formula food suitable for patients with pancreatitis by compounding various nutrients required by the human body. It can supplement the various nutrients needed by the human body, significantly improve the therapeutic effect of drug treatment, and have a significant promoting effect on the recovery of the condition. Detailed Implementation

[0126] Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly used in the field to which this invention pertains. For the purposes of interpreting this specification, the following definitions will apply, and where appropriate, terms used in the singular will also include the plural forms, and vice versa.

[0127] Unless the context clearly indicates otherwise, the terms “a” and “an” as used herein include plural references.

[0128] As used herein, the term "about" indicates a range of ±20% of the following value. In some embodiments, the term "about" indicates a range of ±10% of the following value. In some embodiments, the term "about" indicates a range of ±5% of the following value.

[0129] The numerical ranges used in this article should be understood as including all numbers within that range. For example, the range 1 to 20 should be understood to include any number, combination of numbers, or subrange from the following group: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20.

[0130] As used herein, the terms “comprises” or “comprising” mean “including, but not limited to”. This term is intended to be open-ended to specify the presence of any of the stated features, elements, integers, steps, or components, but does not exclude the presence or addition of one or more other features, elements, integers, steps, components, or groups thereof. Therefore, the term “comprising” includes the more restrictive terms “consisting of” and “substantially consisting of”. In one embodiment, the term “comprising” as used throughout the application, particularly in the claims, may be replaced by the term “consisting of”.

[0131] As used herein, the terms “optional,” “any,” “arbitrary,” or “any one” mean that the event or situation described below may, but does not have to, occur, including the circumstances in which the event or situation occurs or does not occur. As used herein, “an” and “a” refer to one or more grammatical objects.

[0132] The term “and / or” as used herein should be understood to mean any one of the options or any combination of two or more of the options.

[0133] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. Unless otherwise specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. All reagents or instruments without a specified manufacturer are commercially available conventional products. Numerous specific details are provided in the following detailed embodiments to better illustrate the invention. The specific embodiments described herein are for illustrative purposes only and are not intended to constitute any limitation on the invention. Furthermore, descriptions of well-known structures and techniques are omitted in the following description to avoid unnecessarily obscuring the concept of the invention. Such structures and techniques have also been described in many publications.

[0134] The component detection methods involved in this invention are all in accordance with the corresponding component testing methods in the "National Food Safety Standard for Foods for Special Medical Purposes (General Rules) GB 29922-2013".

[0135] The mouse feed used in this invention was purchased from the laboratory SPF-grade rat feed for maintaining reproduction of mice and rats at Liaoning Changsheng Biotechnology Co., Ltd.

[0136] It should be noted that, according to the "General Rules for Nutrition Labelling of Prepackaged Foods" (GB 28050—2011), the permissible error range for energy and nutrient content is as follows:

[0137] ① Protein, polyunsaturated and monounsaturated fats (acids), carbohydrates, sugars (lactose only), total, soluble or insoluble dietary fiber and its monomers, vitamins (excluding vitamin D and vitamin A), minerals (excluding sodium), and other fortified nutrients in food: ≥80% of the labeled value.

[0138] ② Energy, fat, saturated fat (acid), trans fat (acid), cholesterol, sodium, and sugar (excluding lactose) in food: ≤120% of the labeled value.

[0139] Therefore, when comparing the nutritional components of the embodiments and comparative examples of the present invention, differences within 10% are considered to be insignificant.

[0140] Examples 1-3: A liquid formula food for special medical purposes and its preparation method

[0141] The raw materials used in Examples 1-3 are shown in Table 1 below, and the components are shown in Table 3 below:

[0142] Table 1. Nutritional components and sources used in Examples 1-3

[0143]

[0144]

[0145] Note: Mung bean peptide (99% purity) was purchased from Shaanxi Jinkangtai Biotechnology Co., Ltd.

[0146] Pregelatinized starch (medical grade, 99% purity), Xi'an Tianzheng Pharmaceutical Excipients Co., Ltd.

[0147] Maltodextrin (pharmaceutical grade, 99% purity), Xi'an Tianzheng Pharmaceutical Excipients Co., Ltd.

[0148] Starch (medical grade corn starch, 99% purity), Ganzhou Luohua Pharmaceutical Co., Ltd.

[0149] Whey protein (food grade, 99% purity), Shaanxi Chenming Biotechnology Co., Ltd.

[0150] Soy protein isolate (food grade, 99% purity), Xi'an Tianzhixiang Biotechnology Co., Ltd.

[0151] Soybean peptides (500Da, 99% purity), Shaanxi Yunqi Biotechnology Co., Ltd.

[0152] Xanthan gum (medical grade, 99% purity), Xi'an Tianzheng Pharmaceutical Excipients Co., Ltd.

[0153] Sodium alginate (pharmaceutical grade, 99% purity), Shanxi Jinyang Pharmaceutical Excipients Co., Ltd.

[0154] Carrageenan (food grade, 99% purity), Guangzhou Jianke Biotechnology Co., Ltd.

[0155] Guar gum (food grade, 99% purity), Beijing Guarrun Technology Co., Ltd.

[0156] Pectin (food grade, 99% purity), Zhejiang Fuxuan Biotechnology Co., Ltd.

[0157] The preparation method of the special medical purpose liquid formula food described in Examples 1-3 includes the following steps:

[0158] (1) Weigh the amount of protein in the formula as premixed raw material a; weigh the amount of carbohydrates in the formula as premixed raw material b; weigh the amount of vitamins in the formula as premixed raw material c; weigh the amount of macro-elements and micro-elements in the formula as premixed raw material d;

[0159] (2) Premix the premixed raw materials a, b, c and d in step (1) to obtain premixed materials a, b, c and d.

[0160] (3) Mix the premix c and premix d obtained in step (2) to obtain mixture 1;

[0161] (4) Mix the mixture 1 obtained in step (3) with the premix a obtained in step (2) to obtain mixture 2;

[0162] (5) Mix the mixture 2 obtained in step (4) with the premix b obtained in step (2) to obtain the finished product;

[0163] In step (2) of the preparation methods in Examples 1-3, 0.3wt%, 0.4wt%, and 0.2wt% of the total mass of all other raw materials were added sequentially as a reconstitution stabilizer.

[0164] The process equipment involved in Examples 1-3 is a three-dimensional motion mixer, and the process parameters involved are shown in the table below:

[0165] Table 2. Process parameters involved in Examples 1-3

[0166]

[0167]

[0168] Note: All times in the table above are in minutes (min), and all rotation speeds are in revolutions per minute (rpm). The composition of Examples 1-3 prepared using the above method was analyzed, and the results are shown in the table below:

[0169] Table 3. Ingredients of the liquid formula foods for special medical purposes prepared in Examples 1-3 (per 100g)

[0170]

[0171] In some embodiments, a nutrient fortifier is added during the premixing of premixed raw material c;

[0172] The nutritional fortifier is selected from one or more of dietary fiber, choline, inositol, molybdenum, chromium, taurine and L-carnitine;

[0173] The dosage of the nutrient fortifier can be determined according to:

[0174] The choline content is 0-77 parts by weight;

[0175] The content of taurine is 0-10 parts by weight;

[0176] The content of L-carnitine is 0.3-1 parts by weight;

[0177] The inositol content is 0-40 parts by weight;

[0178] The molybdenum content is 0-0.02 parts by weight;

[0179] The chromium content is 0-0.025 parts by weight.

[0180] Comparative Example 1

[0181] The only difference between this comparative example and Example 1 is that the proportion of mung bean peptides in the protein raw material is increased to 15 wt%, and the amount of vitamin C is reduced by 50%.

[0182] Comparative Example 2

[0183] The only difference between this comparative example and Example 1 is that all the mung bean peptides in the raw materials were replaced with an equal mass of ginseng oligopeptides with a purity of 98%, purchased from Shaanxi Jinkangtai Biotechnology Co., Ltd.

[0184] Comparative Example 3

[0185] The only difference between this comparative example and Example 1 is that, while the proportion of each component remains unchanged (e.g., in Example 1, mung bean peptide still accounts for 4 wt% of the protein source), the components of the special medical purpose liquid formula food are different.

[0186] The specific component contents of Comparative Examples 1-3 are shown in the table below:

[0187] Table 4. Ingredients of Special Medical Purpose Liquid Formula Foods Prepared in Comparative Examples 1-3 (per 100g)

[0188]

[0189]

[0190] Experimental Example: The Promoting Effect of Special Medical Purpose Liquid Formula Food on Rats with Mild to Moderate Acute Pancreatitis Treated with Positive Drugs

[0191] 1. Laboratory animals

[0192] Ninety-seven male SD rats, SPF grade, 7-8 weeks old, weighing 230-280g, were purchased from Chengdu Dashuo Experimental Animal Co., Ltd.

[0193] They were separated into different cages and allowed to adapt for 7 days at a room temperature of 21-25℃ and a humidity of 40%-70%. They were fed regular feed, had normal access to water, and followed a 12-hour diurnal rhythm.

[0194] 2. Experimental Grouping

[0195] The adaptively fed rats were randomly divided into 9 experimental groups: control group (n=9), model group (n=11), positive drug group (n=11), Example 1-Example 3 group and Comparative Example 1-Comparative Example 3 group (n=11 each).

[0196] 3. Animal modeling

[0197] Before modeling, rats in each group were kept from eating for 24 hours, but their water intake was not restricted.

[0198] The specific process of model making is as follows:

[0199] Except for the control group, all other groups were diluted with saline and injected intraperitoneally at a rate of 1 mL once per hour. Finally, the rats in the experimental group were injected subcutaneously with a total dose of 300 μg / kg of saline to induce acute pancreatitis (AP) 6 times.

[0200] The control group was injected with the same volume of saline solution without hygroscopic ...

[0201] When the model rats exhibit symptoms such as rapid breathing, ruffled fur, frequent writhing, difficulty crawling, and abdominal distension, two rats from each experimental group participating in the modeling process are randomly selected and sacrificed 12 hours after the onset of symptoms for pancreatic histological scoring. If the pancreatic tissue shows hemorrhage, edema, necrosis, and inflammation, and the pancreatic histological score is higher than 4, it indicates that the modeling is successful. The experiment is conducted 12 hours after successful modeling.

[0202] 4. Experiment Content

[0203] 4.1 Evaluation Methods

[0204] At the time of rat sacrifice, pancreatic head tissue was collected. The pancreatic edema, hemorrhage, necrosis, and inflammatory cell infiltration were assessed using the Kusske scoring method for pancreatic histology. The total score was the sum of four scoring indicators. A blind selection method was used, with three researchers simultaneously reading the slides and scoring the pancreatic tissue according to the scoring criteria in Table 5. The score for each pancreatic tissue pathological slide was the average of the researchers' readings.

[0205] The specific scoring criteria are as follows:

[0206] Table 5. Pancreatic Histopathological Scoring Criteria - Kusske Scoring Method

[0207]

[0208] Data Analysis:

[0209] SPSS 25.0 software was used for analysis. The measurement data of each group are represented in this way. 's' represents the mean, and 's' represents the standard deviation.

[0210] Test method:

[0211] For each group of data, a normality test is first performed. If the data in each group follows a normal distribution, a homogeneity of variance test is performed using the Levene test to determine whether the variances of the data in each group are equal.

[0212] If the homogeneity of variance test shows homogeneity of variance (i.e., the variances of all groups are equal), then one-way ANOVA is used to compare the differences between the group means. After one-way ANOVA, if the ANOVA results show that at least one group is significantly different from the other groups, then pairwise comparisons are needed to specifically determine which groups have differences.

[0213] When variances are homogeneous, pairwise comparisons are performed using the Least Significant Difference (LSD) method.

[0214] When variances are unequal, Welch’s ANOVA is used for analysis of variance, and Dunnett’s T3 test is used for pairwise comparisons.

[0215] For all statistical tests, the significance level was set at P<0.05.

[0216] 4.2 Experimental Procedure

[0217] After the experiment began, rats in all groups except the control group and the model group were injected subcutaneously with octreotide acetate at a daily dose of 0.03 mg / kg and a volume of 0.5 mL. The control group and the model group were injected with the same volume of physiological saline. All groups were injected for seven days.

[0218] During the seven days following the injection of octreotide acetate or saline, rats in the control group, model group, and positive control group were fed with Haiweishu special medical purpose complete nutritional formula food (Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd., National Food Registration Number TY20230010) (50 mL by gavage daily). Groups 1-3 of Examples and Comparative Examples 1-3 were fed with the special medical purpose liquid formula food prepared in the corresponding examples / comparative examples (100 g was prepared into 500 mL of liquid food, 50 mL by gavage daily).

[0219] All experimental groups started the experiment at the same time. Three mice from each group were sacrificed at 12h, 72h and 7 days after the start of the experiment, and the evaluation was carried out according to the above evaluation method.

[0220] 4.3 Experimental Results

[0221] The experimental results of the aforementioned experiment are shown below:

[0222] Table 6. Experimental Results and Kusske Scoring Data for Experimental Examples

[0223] experimental group 12h 72h 7d control group 0.56±0.53 0.78±0.67 0.67±0.50 Model group <![CDATA[8.56±1.13 * ]]> <![CDATA[11.1±1.05 * ]]> <![CDATA[12.22±1.79 * ]]> Positive drug group <![CDATA[8.55±0.88 * ]]> <![CDATA[6.89±1.76 * ]]> <![CDATA[4.67±1.00 * ]]> Example 1 Group <![CDATA[8.78±1.72 * ]]> <![CDATA[5.44±0.88 * ]]> <![CDATA[2.44±0.73 *# ]]> Example 2 group <![CDATA[8.67±1.58 * ]]> <![CDATA[5.56±1.13 * ]]> <![CDATA[2.78±0.83 *# ]]> Example 3 Group <![CDATA[8.44±1.51 * ]]> <![CDATA[5.78±1.20 * ]]> <![CDATA[2.67±0.50 *# ]]> Comparative Example 1 <![CDATA[8.56±0.73 * ]]> <![CDATA[6.56±1.42 * ]]> <![CDATA[4.00±1.22 * ]]> Comparative Example 2 <![CDATA[8.78±1.48 * ]]> <![CDATA[6.89±1.27 * ]]> <![CDATA[4.11±0.93 * ]]> Comparative Example 3 Groups <![CDATA[8.33±1.80 * ]]> <![CDATA[6.22±1.09 * ]]> <![CDATA[4.00±1.12 * ]]>

[0224] Compared with the control group, * P < 0.05; compared with the positive drug group, # P < 0.05;

[0225] Based on the above experimental results, it can be seen that the Kusske scores of each experimental group in this invention showed significant differences compared with the control group 12 hours after the experiment, further confirming the successful establishment of the experimental rat model.

[0226] Mice that received nutritional supplementation with the special medical purpose liquid formula food provided by this invention showed faster recovery from acute pancreatitis during the treatment with the positive drug. On the 7th day of treatment, the Kusske score was significantly different from that of the positive drug group, indicating that the special medical purpose liquid formula food provided by this invention has a significant effect on promoting the recovery of mild to moderate pancreatitis.

[0227] In contrast, comparative examples 1-3, although their Kusske scores were slightly lower than those of the positive drug group, may have a certain effect in promoting the treatment of pancreatitis. However, since their components are not within the preferred range of this invention, the promoting effect is not significant and the technical effect of this invention cannot be achieved.

[0228] Since the nutritional requirements of gastrointestinal malabsorption are similar to those of pancreatitis, and the General Rules for Foods for Special Medical Purposes GB29922-2013 classifies foods for gastrointestinal malabsorption and pancreatitis as a single category, it is reasonable to believe that the liquid formula food for special medical purposes provided by this invention has a significant promoting effect on the recovery of gastrointestinal malabsorption.

[0229] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A liquid formula food for special medical purposes, characterized in that, Composed of the following components in parts by weight: Protein 1500-3000 parts, carbohydrates 5500-8000 parts, vitamins 15.9-37.1 parts, macro-elements and trace elements 118.5-882.5 parts; The vitamins mentioned include 15-30 parts of vitamin C; The protein source includes mung bean peptides, which account for 2.86 wt%, 4 wt%, and 9.6 wt% of the protein. The special medical purpose liquid formula food contains no fat.

2. The special medical purpose liquid formula food according to claim 1, characterized in that, The protein sources also include one or more of soy protein isolate, whey protein, casein, milk protein, hydrolyzed whey protein, soy peptides, collagen peptides, and marine fish oligopeptides; the vitamins also include vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, folic acid, pantothenic acid, and biotin.

3. The special medical purpose liquid formula food according to claim 1, characterized in that, The macroelements and microelements include sodium, potassium, copper, magnesium, iron, zinc, manganese, calcium, phosphorus, iodine and selenium; The special medical purpose liquid formula foods also include nutritional fortifiers, reconstitution stabilizers and taste improvers; The nutritional fortifier is selected from one or more of dietary fiber, choline, inositol, molybdenum, chromium, taurine and L-carnitine; The mixing stabilizer is selected from one or more of xanthan gum, carrageenan, guar gum, sodium alginate, gellan gum, and pectin; The taste improver is selected from one or more of citric acid, malic acid, sucralose, acesulfame potassium, aspartame, and cyclamate.

4. The special medical purpose liquid formula food according to claim 1, characterized in that, The special medical purpose liquid formula food comprises the following components in parts by weight: Protein 1500-3000 parts, carbohydrates 5800-7600 parts, vitamins 21.2-31.2 parts, macro-elements and trace elements 423.2-712.3 parts; The vitamins mentioned include 15-30 parts of vitamin C.

5. The special medical purpose liquid formula food according to claim 4, characterized in that, The vitamins also include vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, folic acid, pantothenic acid, and biotin; The vitamin A content is 0.0184-0.0513 parts by weight; The vitamin D content is 0.0002-0.0014 parts by weight; The content of vitamin E is 0.5-2.5 parts by weight; The vitamin K content is 0.002-0.007 parts by weight; The content of vitamin B1 is 0.037-0.191 parts by weight; The content of vitamin B2 is 0.044-0.198 parts by weight; The content of vitamin B6 is 0.028-0.206 parts by weight; The content of vitamin B12 is 0.000063-0.000396 parts by weight; The content of nicotinic acid is 0.099-0.591 parts by weight; The folic acid content is 0.00781-0.03954 parts by weight; The content of pantothenic acid is 0.217-0.910 parts by weight; The biotin content is 0.001-0.005 parts by weight.

6. The special medical purpose liquid formula food according to claim 5, characterized in that, The macroelements and microelements include sodium, potassium, copper, magnesium, iron, zinc, manganese, calcium, phosphorus, iodine and selenium; The sodium content is 31.2-197.2 parts by weight; The potassium content is 43.5-198.1 parts by weight; The copper content is 0.021-0.216 parts by weight; The magnesium content is 7.3-81.5 parts by weight; The iron content is 0.280-0.945 parts by weight; The zinc content is 0.22-0.97 parts by weight; The manganese content is 0.0266-0.2468 parts; The calcium content is 20.8-153.1 parts by weight; The phosphorus content is 15.5-147.6 parts by weight; The iodine content is 0.00279-0.00971 parts by weight; The chlorine content is 6.2-99.4 parts by weight; The selenium content is 0.0016-0.0099 parts by weight.

7. A method for preparing a liquid formula food for special medical purposes according to any one of claims 1-6, comprising the following steps: (1) Weigh the amount of protein in the formula as premixed raw material a; Weigh out the amount of carbohydrates in the formula as premixed raw material b; weigh out the amount of vitamins in the formula as premixed raw material c; weigh out the amount of macroelements and microelements in the formula as premixed raw material d; (2) Premix the premixed raw materials a, b, c and d in step (1) to obtain premixed materials a, b, c and d; (3) Mix the premix c and premix d obtained in step (2) to obtain mixture 1; (4) Mix the mixture 1 obtained in step (3) with the premix a obtained in step (2) to obtain mixture 2; (5) Mix the mixture 2 obtained in step (4) with the premix b obtained in step (2) to obtain the finished product.

8. The preparation method according to claim 7, characterized in that, The premixing time in step (2) is 15-25 min; the premixing speed is 24-28 rpm; The mixing time in step (3) is 38-52 min; the mixing speed is 24-28 rpm; The mixing time in step (4) is 42-56 min; the mixing speed is 30-34 rpm; The mixing time in step (5) is 26-35 min; the mixing speed is 30-34 rpm.

9. The use of the special medical purpose liquid formula food according to any one of claims 1-6 or the special medical purpose liquid formula food prepared by the preparation method according to any one of claims 7-8 in the preparation of a special medical purpose complete nutritional formula food for nutritional supplementation during the recovery period of pancreatitis.

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