A complete nutritional emulsion for special medical purposes and its preparation method and application

Abstract

The present invention relates to a complete nutritional emulsion for special medical purposes and a preparation method and application thereof, wherein the complete nutritional emulsion comprises protein, fat, carbohydrate, vitamin, trace element, oxide, magnesium salt, emulsifier and water, and the fat comprises low-erucic acid rapeseed oil, ordinary sunflower oil and high-oleic acid sunflower oil. The complete nutritional emulsion provided by the present invention has the advantages of small droplet size, uniform dispersion and high stability, can improve its bioavailability, and better exert its nutritional value in clinical practice.

Description

Technical Field

[0001] The invention belongs to the technical field of food, and relates to a complete nutritional emulsion for special medical purposes, and a preparation method and application thereof. Background Art

[0002] my country's GB29922 stipulates that special medical purpose formula foods refer to formula foods specially processed and prepared to meet the special needs of people with limited food intake, digestion and absorption disorders, metabolic disorders or specific disease states for nutrients or diets. This type of product must be consumed alone or with other foods under the guidance of a doctor or clinical nutritionist. Specifically, it includes complete nutritional formula foods, specific complete nutritional formula foods and non-complete nutritional formula foods. Emulsion-type special medical purpose formula foods (special medical foods) are a type of liquid formula food that is specially processed and prepared. It belongs to the water-in-oil emulsion system and is easy to digest and absorb.

[0003] Nanoemulsion is a colloidal delivery system with unparalleled advantages over other nanocarriers, such as: 1) small droplet size, uniform dispersion and high stability; 2) improved solubility and bioavailability of bioactive substances. Nanoemulsion food will be more helpful for the target population to absorb nutrients in the case of restricted food intake, digestive and absorption disorders, metabolic disorders or specific disease states.

[0004] The ingredients of nanoemulsion special medical purpose formula foods are complex, including large molecular proteins, carbohydrate components, water-insoluble fats, soluble and insoluble minerals, etc., all of which will affect the stability of the complete nutritional emulsion: proteins are very sensitive to changes in the system environment and are prone to coagulation and precipitation; unstable vitamins decompose due to changes in internal and external conditions of the system or react with other ingredients, causing the product stability system to collapse; soluble and insoluble minerals combine with proteins or precipitate, leading to the precipitation of proteins and other substances, and fat aggregation and floating, etc., which can easily lead to the destruction of the stability system of special medical emulsions.

[0005] High energy density refers to a nutritional emulsion with a higher calorie content in the same volume. Studies have shown that the same volume can provide a higher energy supply, which is of great significance in improving malnutrition in critically ill patients, reducing mortality, reducing complications, shortening the course of the disease and hospitalization time, and reducing economic costs. Compared with conventional nutritional emulsions (energy density 1.0kcal / mL), the same dose of high energy density nutritional emulsion treatment has the advantage that although the volume of the emulsion consumed is smaller, the nutrition and calories provided are not reduced. However, in actual production, emulsion special medical products with an energy density of >1.0kcal / mL are very likely to cause gelatinization and blockage of pipes due to poor emulsification and heat instability of protein.

[0006] In clinical use, emulsions do not require preparation and can be used immediately after opening the lid. They have the advantages of high safety, convenient use, and low medical operation intensity, and have therefore received increasing attention in recent years. How to combine modern process technology to minimize the loss of nutrients, establish a stable special medical emulsion product system, and improve the bioavailability of such products has become an imminent technical difficulty. Summary of the invention

[0007] In view of the deficiencies in the prior art, the object of the present invention is to provide a complete nutritional emulsion for special medical purposes and a preparation method and application thereof.

[0008] In order to achieve the purpose of the invention, the present invention adopts the following technical solutions:

[0009] In a first aspect, the present invention provides a complete nutritional emulsion for special medical purposes, wherein the complete nutritional emulsion comprises protein, fat, carbohydrate, vitamins, trace elements, oxides, magnesium salts, emulsifiers and water, wherein the fat comprises low-erucic acid rapeseed oil, ordinary sunflower oil and high-oleic acid sunflower oil.

[0010] The ordinary sunflower seed oil refers to sunflower seed oil with an oleic acid content of 14-40%.

[0011] The high oleic sunflower oil refers to sunflower oil with an oleic acid content of 75-91%.

[0012] Preferably, the complete nutritional emulsion comprises, by mass, 60-100 parts of protein, 25-56 parts of fat, 145-256 parts of carbohydrates, 0.5-1.5 parts of vitamins, 0.5-1.5 parts of trace elements, 0.2-0.4 parts of oxides, 1-3 parts of magnesium salts, 2-4 parts of emulsifiers and 600-900 parts of water.

[0013] The mass proportion of protein can be selected as 60, 65, 70, 75, 80, 85, 90, 95, 100, etc., the mass proportion of fat can be selected as 25, 28, 30, 32, 35, 38, 40, 42, 45, 48, 50, 52, 55, 56, etc., and the mass proportion of carbohydrates can be selected as 145, 150, 155, 160, 165, 170, 175, 180 , 185 parts, 190 parts, 195 parts, 200 parts, 205 parts, 210 parts, 215 parts, 220 parts, 225 parts, 230 parts, 235 parts, 240 parts, 245 parts, 250 parts, 256 parts, etc. The mass proportions of vitamins can be selected as 0.5 parts, 0.6 parts, 0.7 parts, 0.8 parts, 0.9 parts, 1 part, 1.1 parts, 1.2 parts, 1.3 parts, 1.4 parts, 1.5 parts, etc. The mass proportions of trace elements can be selected as 0.5 parts, 0.6 parts, 0.7 parts, 0.8 parts, 0.9 parts, 1 parts, 1.1 parts, 1.2 parts, 1.3 parts, 1.4 parts, 1.5 parts, etc. The mass parts of oxides can be selected as 0.2 parts, 0.22 parts, 0.24 parts, 0.26 parts, 0.28 parts, 0.3 parts, 0.32 parts, 0.34 parts, 0.36 parts, 0.38 parts, 0.4 parts, etc. The mass parts of magnesium salts can be selected as 1 part, 1.2 parts, 1.4 parts, 1.6 parts, 1.8 parts, 2 parts, 2.2 parts, 2.4 parts, 2.6 parts, 2.8 parts , 3 parts, etc., the mass parts of emulsifier can be selected as 2 parts, 2.2 parts, 2.4 parts, 2.6 parts, 2.8 parts, 3 parts, 3.2 parts, 3.4 parts, 3.6 parts, 3.8 parts, 4 parts, etc., the mass parts of water can be selected as 600 parts, 620 parts, 650 parts, 680 parts, 700 parts, 720 parts, 750 parts, 780 parts, 800 parts, 820 parts, 850 parts, 880 parts, 900 parts, etc. Other specific points within the above numerical range can be selected, so they will not be elaborated here.

[0014] Preferably, the protein comprises any one of casein, calcium caseinate or sodium caseinate, or a combination of at least two of them.

[0015] Preferably, the protein comprises, by mass, any one of 4-5 parts of casein, 2-3 parts of calcium caseinate or 1-2 parts of sodium caseinate, or a combination of at least two of them.

[0016] The mass proportion of casein can be selected as 4 parts, 4.1 parts, 4.2 parts, 4.3 parts, 4.4 parts, 4.5 parts, 4.6 parts, 4.7 parts, 4.8 parts, 4.9 parts, 5 parts, etc., the mass proportion of calcium caseinate can be selected as 2 parts, 2.1 parts, 2.2 parts, 2.3 parts, 2.4 parts, 2.5 parts, 2.6 parts, 2.7 parts, 2.8 parts, 2.9 parts, 3 parts, etc., the mass proportion of sodium caseinate can be selected as 1 part, 1.1 parts, 1.2 parts, 1.3 parts, 1.4 parts, 1.5 parts, 1.6 parts, 1.7 parts, 1.8 parts, 1.9 parts, 2 parts, etc. Other specific point values ​​within the above numerical range can be selected, so they will not be elaborated here one by one.

[0017] Preferably, the oxide comprises magnesium oxide.

[0018] Preferably, the magnesium salt comprises magnesium sulfate and / or magnesium chloride.

[0019] Preferably, the fat comprises, by mass, 20-40 parts of low-erucic acid rapeseed oil, 5-15 parts of ordinary sunflower oil and 10-25 parts of high oleic acid sunflower oil.

[0020] The mass proportion of low erucic acid rapeseed oil can be selected from 20 parts, 22 parts, 24 parts, 26 parts, 28 parts, 30 parts, 32 parts, 34 parts, 36 parts, 38 parts, 40 parts, etc.; the mass proportion of ordinary sunflower oil can be selected from 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, etc.; the mass proportion of high oleic acid sunflower oil can be selected from 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, etc. Other specific point values ​​within the above numerical range can be selected, so they will not be described one by one here.

[0021] Preferably, the vitamins include any one of vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, niacin, pantothenic acid or folic acid, or a combination of at least two thereof.

[0022] Preferably, the trace elements include any one of iron, zinc, selenium, copper, iodine or manganese, or a combination of at least two of them.

[0023] Preferably, the carbohydrates include maltodextrin and / or sucrose.

[0024] Preferably, the emulsifier comprises a phospholipid.

[0025] Preferably, the nutritional emulsion further comprises any one of flavors, potassium salts, calcium salts, sodium salts, nucleotides, amino acids, choline or dietary fiber, or a combination of at least two thereof.

[0026] Preferably, the energy density of the complete nutritional emulsion is 1.2-2.0 kcal / mL, for example 1.2 kcal / mL, 1.3 kcal / mL, 1.4 kcal / mL, 1.5 kcal / mL, 1.6 kcal / mL, 1.7 kcal / mL, 1.8 kcal / mL, 1.9 kcal / mL, 2.0 kcal / mL, etc. Other specific point values ​​within the above numerical range can be selected, which will not be described one by one here.

[0027] Preferably, the average particle size of the complete nutritional emulsion is 20-100 nm, for example, 20 nm, 30 nm, 40 nm, 50 nm, 60 nm, 70 nm, 80 nm, 90 nm, 100 nm, etc. Other specific point values ​​within the above numerical range can be selected and will not be described one by one here.

[0028] Preferably, the multiple light scattering stability index of the complete nutritional emulsion is ≤0.3, for example 0.05, 0.08, 0.1, 0.12, 0.15, 0.18, 0.2, 0.22, 0.25, 0.28, 0.3, etc. Other specific points within the above numerical range can be selected and will not be described one by one here.

[0029] Preferably, the complete nutritional emulsion further comprises, by weight, any one of 0.1-5 parts of flavors, 1-5 parts of potassium salts, 0.1-2 parts of calcium salts, 1-5 parts of sodium salts, 1-5 parts of nucleotides, 12-20 parts of amino acids, 0.5-1.5 parts of choline or 10-20 parts of dietary fiber, or a combination of at least two of them.

[0030] The mass fraction of the flavor can be selected from 0.1 parts, 0.5 parts, 1 parts, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts, etc., and the mass fraction of potassium salt can be selected from 1 part, 1.2 parts, 1.5 parts, 1.8 parts, 2 parts, 2.2 parts, 2.5 parts, 2.8 parts, 3 parts, 3.2 parts, 3.5 parts, 3.8 parts, 4 parts, 4.2 parts, 4 The mass proportions of calcium salt can be selected as 0.1 part, 0.2 part, 0.5 part, 0.8 part, 1 part, 1.2 part, 1.5 part, 1.8 part, 2 parts, etc. The mass proportions of sodium salt can be selected as 1 part, 1.2 parts, 1.5 parts, 1.8 parts, 2 parts, 2.2 parts, 2.5 parts, 2.8 parts, 3 parts, 3.2 parts, 3.5 parts, 3.8 parts, 4 parts, The mass fractions of nucleotides can be selected from 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts, etc. The mass fractions of amino acids can be selected from 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, etc. The mass fractions of choline can be selected from 0.5 parts, 0.6 parts, 0.7 parts, 0.8 parts, 0.9 parts, 1 part, 1.1 parts, 1.2 parts, 1.3 parts, 1.4 parts, 1.5 parts, etc. The mass fractions of dietary fiber can be selected from 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, etc. Other specific point values ​​within the above numerical range can be selected, so they will not be repeated here one by one.

[0031] Preferably, the potassium salt includes any one of potassium chloride, dipotassium hydrogen phosphate or potassium citrate, or a combination of at least two thereof.

[0032] Preferably, the calcium salt comprises calcium carbonate and / or calcium hydrogen phosphate.

[0033] Preferably, the sodium salt comprises sodium chloride and / or sodium citrate.

[0034] In a second aspect, the present invention provides a method for preparing the complete nutritional emulsion for special medical purposes according to the first aspect, the preparation method comprising:

[0035] (1) mixing water, protein, and carbohydrate, and shearing them to obtain a first mixture;

[0036] (2) mixing the first mixture, oxide, emulsifier, fat and trace elements, and then mixing with magnesium salt to obtain a second mixture;

[0037] (3) homogenizing the second mixture and performing pre-sterilization;

[0038] (4) The product obtained in step (3) is mixed with vitamins and then sterilized at ultra-high temperature to obtain the product.

[0039] Preferably, the temperature of the mixture of water, protein and carbohydrates is 55-65°C, for example 55°C, 56°C, 57°C, 58°C, 59°C, 60°C, 61°C, 62°C, 63°C, 64°C, 65°C, etc. Other specific points within the above numerical range can be selected and will not be described here one by one.

[0040] Preferably, the shearing speed is 1000-3000 rpm and the shearing time is 5-20 min.

[0041] The speed can be selected as 1000 rpm, 1200 rpm, 1500 rpm, 1800 rpm, 2000 rpm, 2200 rpm, 2500 rpm, 2800 rpm, 3000 rpm, etc. The time can be selected as 5 min, 6 min, 7 min, 8 min, 9 min, 10min, 11 min, 12 min, 13 min, 14 min, 15 min, 16 min, 17 min, 18 min, 19 min, 20 min, etc. Other specific point values ​​within the above numerical range can be selected, so they will not be elaborated here.

[0042] Preferably, the first mixture, oxide, emulsifier, fat and trace elements are mixed at a temperature of 45-65° C. and a time of 30-80 min.

[0043] The temperature can be selected from 45°C, 48°C, 50°C, 52°C, 55°C, 58°C, 60°C, 62°C, 65°C, etc., and the time can be selected from 30 min, 35 min, 40 min, 45 min, 50 min, 55 min, 60min, 65 min, 70 min, 75min, 80min, etc. Other specific point values ​​within the above numerical range can be selected, and they will not be elaborated here.

[0044] Preferably, the temperature for mixing with the magnesium salt is 45-65° C. and the time is 5-15 min.

[0045] The temperature can be selected as 45°C, 48°C, 50°C, 52°C, 55°C, 58°C, 60°C, 62°C, 65°C, etc., and the time can be selected as 5 min, 6 min, 7 min, 8 min, 9 min, 10 min, 11 min, 12 min, 13 min, 14 min, 15 min, etc. Other specific point values ​​within the above numerical range can be selected, and they will not be elaborated here.

[0046] Preferably, the homogenization includes a first homogenization and a second homogenization, the pressure of the first homogenization is 300-600 bar, and the pressure of the second homogenization is 100-300 bar.

[0047] The pressure of the first homogenization can be selected as 300 bar, 320 bar, 350 bar, 380 bar, 400 bar, 420bar, 450 bar, 480 bar, 500 bar, 520 bar, 550 bar, 580 bar, 600 bar, etc. The pressure of the second homogenization can be selected as 100 bar, 120 bar, 150 bar, 180 bar, 200 bar, 220 bar, 250 bar, 280 bar, 300 bar, etc. Other specific points within the above numerical range can be selected, so they will not be described here one by one.

[0048] Preferably, the temperature of the first homogenization is 55-65°C, and the time is 10-40 min; the temperature of the second homogenization is 75-81°C, and the time is 10-40 min.

[0049] The temperature for the first homogenization can be selected as 55℃, 56℃, 57℃, 58℃, 59℃, 60℃, 61℃, 62℃, 63℃, 64℃, 65℃, etc. The temperature for the second homogenization can be selected as 75℃, 76℃, 77℃, 78℃, 79℃, 80℃, 81℃, etc. The time can be selected as 10 min, 12 min, 15 min, 18 min, 20 min, 22 min, 25 min, 28 min, 30 min, 32min, 35 min, 38 min, 40 min, etc. Other specific point values ​​within the above numerical range can be selected, so they will not be elaborated here.

[0050] Preferably, the first mixture, oxide, emulsifier, fat and trace elements are mixed together with any one or at least two of choline, potassium salt, calcium salt or sodium salt.

[0051] Preferably, the mixture with vitamins also includes mixing with any one or at least two of flavors, nucleotides, amino acids or dietary fibers.

[0052] Preferably, the temperature for mixing with vitamins is 20-40°C and the time is 5-25 min.

[0053] The temperature can be selected at 20°C, 22°C, 25°C, 28°C, 30°C, 32°C, 35°C, 38°C, 40°C, etc., and the time can be selected at 5 min, 8 min, 10 min, 12 min, 15 min, 18 min, 20 min, 22 min, 25 min, etc. Other specific point values ​​within the above numerical range can be selected, and they will not be described here one by one.

[0054] Preferably, the pre-sterilization temperature is 80-110° C. and the time is 25-35 s.

[0055] The temperature can be selected from 80°C, 82°C, 85°C, 88°C, 90°C, 92°C, 95°C, 98°C, 100°C, 102°C, 105°C, 108°C, 110°C, etc., and the time can be selected from 25 s, 26 s, 27 s, 28 s, 29 s, 30 s, 31 s, 32 s, 33 s, 34 s, 35 s, etc. Other specific point values ​​within the above numerical range can be selected, and they will not be described one by one here.

[0056] Preferably, the ultra-high temperature sterilization temperature is 135-145° C. and the time is 2-10 s.

[0057] The temperature can be selected from 135°C, 136°C, 137°C, 138°C, 139°C, 140°C, 141°C, 142°C, 143°C, 144°C, 145°C, etc., and the time can be selected from 2 s, 3 s, 4 s, 5 s, 6 s, 7 s, 8 s, 9 s, 10 s, etc. Other specific point values ​​within the above numerical range can be selected, and they will not be described here one by one.

[0058] Ultra-high temperature sterilization uses direct steam injection heating.

[0059] In a third aspect, the present invention provides a use of the complete nutritional emulsion for special medical purposes according to the first aspect in the preparation of special medical purpose formula foods.

[0060] Preferably, the food comprises nutritionally complete formula food and specific nutritionally complete formula food.

[0061] The obtained special medical purpose formula food can be used for people who need nutritional supplements, including those with limited food intake, digestive and absorption disorders, metabolic disorders, etc. The general population for application is people who need nutritional supplements in the early stage such as severe illness and surgery, people who need nutritional supplements due to limited fluid intake or high energy requirements, malnourished people or people who need enhanced nutritional supplements. The specific population for application is tumors, diabetes, kidney disease, sarcopenia syndrome, inflammatory bowel disease, liver disease, respiratory diseases, trauma, infection, surgery and other stress states, gastrointestinal absorption disorders, pancreatitis, abnormal fatty acid metabolism, obesity, fat reduction surgery complete nutritional formula food and others.

[0062] Compared with the prior art, the present invention has the following beneficial effects:

[0063] 1. The preparation method of the high energy density nanoemulsion special medical formula food provided by the present invention has a high degree of automation and high commercial value;

[0064] 2. The high-energy-density nanoemulsion special medical purpose formula food provided by the present invention has the advantages of small droplet size, uniform dispersion and high stability, which can improve its bioavailability and better exert its nutritional value in clinical practice. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Figure 1 It is the ΔBS test result of the nutritional emulsion prepared in Example 1.

[0066] Figure 2 This is the ΔBS test result of the nutritional emulsion prepared in Example 2.

[0067] Figure 3 This is the ΔBS test result of the nutritional emulsion prepared in Example 3.

[0068] Figure 4 It is the TSI test result of the nutritional emulsion prepared in Example 1.

[0069] Figure 5 It is the TSI test result of the nutritional emulsion prepared in Example 2.

[0070] Figure 6 It is the TSI test result of the nutritional emulsion prepared in Example 3. DETAILED DESCRIPTION

[0071] The technical solution of the present invention is further described below by specific implementation methods. It should be understood by those skilled in the art that the embodiments are only to help understand the present invention and should not be regarded as specific limitations of the present invention.

[0072] The sources of the functional ingredients contained in the products involved in the following embodiments and comparative examples are as follows (only the functional ingredients are reflected, and the necessary auxiliary ingredients contained in other commercially available raw materials are not repeated):

[0073] Sodium caseinate is a product purchased from Friesland Campina DMV under the trade name of Sodium Caseinate S;

[0074] Calcium caseinate is a product purchased from Friesland Campina DMV under the trade name Calcium Caseinate S;

[0075] Membrane separated casein was purchased from INGREDIA with the trade name Membrane separated casein 87 B;

[0076] The rapeseed oil was purchased from Yihai Kerry Company under the trade name Shaniya Rapeseed Oil;

[0077] Ordinary sunflower seed oil was purchased from Yihai Kerry Company under the trade name of Shaniya Sunflower Seed Oil;

[0078] High oleic sunflower oil was purchased from Yihai Kerry Company under the trade name Shaniya high oleic sunflower oil;

[0079] Maltodextrin was purchased from Roquette (China) Nutrition Food Co., Ltd. under the trade name of GLUCIDEX;

[0080] The compound trace elements were purchased from DSM Vitamins (Shanghai) Co., Ltd. under the trade name of Rovira Compound Trace Elements;

[0081] The multivitamins were purchased from DSM Vitamins (Shanghai) Co., Ltd. under the trade name of Rovirid multivitamins;

[0082] Oligofructose was purchased from Quantum Hi-Tech (Guangdong) Biological Co., Ltd. under the trade name of P95s;

[0083] Phospholipids were purchased from Yihai Kerry Company under the trade name N100;

[0084] The edible flavor is a product purchased from Guangzhou Kaihong Flavors & Fragrances Co., Ltd. under the trade name of vanilla flavor;

[0085] The compound stabilizer is a product purchased from Danisco (China) Co., Ltd. under the trade name of Novagel GP;

[0086] Medium chain triglycerides were purchased from Qingdao Haizhiyuan Life Science Co., Ltd. under the trade name of MCT80;

[0087] The fish oil extract was purchased from EPAX NORWAY under the trade name EPAX 6620 TGN;

[0088] Nucleotides were purchased from Dalian Zhenao Biotechnology Co., Ltd. under the trade names of adenosine 5′ monophosphate, cytidine 5′ monophosphate, disodium 5′-guanylate, and disodium 5′-uridylate;

[0089] The mono- and di-glycerol fatty acid esters are commercially available from RIKEVITA under the trade name PVS.

[0090] Example 1

[0091] The present embodiment provides a nutritional emulsion, which includes, by weight, 30 parts of membrane separated casein, 20 parts of calcium caseinate, 15 parts of sodium caseinate, 20 parts of low-erucic acid rapeseed oil, 10 parts of ordinary sunflower oil, 10 parts of high oleic sunflower oil, 160 parts of maltodextrin, 25 parts of white sugar, 1 part of complex vitamins, 0.5 parts of complex trace elements, 10 parts of oligofructose, 3 parts of phospholipids, 3 parts of sodium citrate, 1.5 parts of dipotassium hydrogen phosphate, 1.2 parts of potassium chloride, 1.2 parts of sodium chloride, 2 parts of magnesium sulfate, 1.2 parts of anhydrous citric acid, 1.2 parts of choline chloride, 0.3 parts of calcium carbonate, 0.3 parts of magnesium oxide, 0.3 parts of potassium hydroxide, 0.3 parts of calcium hydroxide, and 700 parts of water.

[0092] Its preparation method is:

[0093] (1) mixing membrane separated casein, calcium caseinate, sodium caseinate, white sugar, maltodextrin and water at 60° C., shearing under a vacuum condition of 0.5 bar at a speed of 1500 rpm for 10 min to obtain a first mixture;

[0094] (2) Mixing the composite trace elements, sodium citrate, dipotassium hydrogen phosphate, potassium chloride, sodium chloride, anhydrous citric acid, choline chloride, calcium carbonate, magnesium oxide, potassium hydroxide, calcium hydroxide, low-erucic acid rapeseed oil, ordinary sunflower oil, high-oleic acid sunflower oil, and phospholipids with the first mixture at 55° C. for 35 min, then mixing with magnesium sulfate for 10 min, and pre-sterilizing at 110° C. for 25 s to obtain a second mixture;

[0095] (3) homogenizing the second mixture at 400 bar and 60°C for 20 min, and then homogenizing the second mixture at 200 bar and 78°C for 20 min;

[0096] (4) Mix the homogenized raw materials with vitamins and oligofructose at 30°C for 15 min and sterilize at 140°C for 8 seconds.

[0097] Example 2

[0098] The present embodiment provides a nutritional emulsion, which includes, by mass, 600 parts of water, 30 parts of calcium caseinate, 30 parts of sodium caseinate, 10 parts of low-erucic acid rapeseed oil, 10 parts of ordinary sunflower oil, 10 parts of high oleic sunflower oil, 160 parts of maltodextrin, 0.5 parts of complex vitamins, 1 part of complex trace elements, 2 parts of phospholipids, 3 parts of sodium citrate, 1.8 parts of dipotassium hydrogen phosphate, 1.5 parts of potassium chloride, 1 part of magnesium chloride, 0.5 parts of anhydrous citric acid, 0.5 parts of choline chloride, 0.5 parts of calcium carbonate, 0.5 parts of calcium hydrogen phosphate, 0.1 parts of sodium chloride, 0.2 parts of magnesium oxide, 0.1 parts of potassium hydroxide, 0.1 parts of calcium hydroxide, and 0.1 parts of edible flavor.

[0099] Its preparation method is:

[0100] (1) mixing calcium caseinate, sodium caseinate, maltodextrin and water at 55° C., shearing under a vacuum condition of 0.5 bar at a rotation speed of 2000 rpm for 8 minutes to obtain a first mixture;

[0101] (2) Mixing the composite trace elements, sodium citrate, dipotassium hydrogen phosphate, potassium chloride, magnesium oxide, choline chloride, anhydrous citric acid, calcium carbonate, calcium bicarbonate, sodium chloride, potassium hydroxide, calcium hydroxide, low-erucic acid rapeseed oil, ordinary sunflower oil, high-oleic acid sunflower oil, and phospholipids with the first mixture at 45° C. for 60 min, then mixing with magnesium chloride for 15 min, and sterilizing at 85° C. for 35 s to obtain a second mixture;

[0102] (3) homogenizing the second mixture for the first time at 350 bar and 65 °C for 10 min, and then homogenizing for the second time at 180 bar and 80 °C for 10 min;

[0103] (4) Mix the homogenized raw materials with vitamins and edible flavors at 20°C for 25 min and sterilize at 135°C for 10 s.

[0104] Example 3

[0105] The present embodiment provides a nutritional emulsion, which comprises, by weight, 800 parts of water, 50 parts of calcium caseinate, 50 parts of sodium caseinate, 10 parts of low-erucic acid rapeseed oil, 10 parts of ordinary sunflower oil, 16 parts of high-oleic acid sunflower oil, 15 parts of medium-chain triglycerides, 5 parts of fish oil extract, 100 parts of maltodextrin, 25 parts of white sugar, 20 parts of oligofructose, 15 parts of L-arginine, 3 parts of nucleotides, 1.5 parts of complex vitamins, and 1 part of complex 1.5 parts of trace elements, 2 parts of phospholipids, 3 parts of sodium citrate, 1 part of potassium citrate, 1 part of dipotassium hydrogen phosphate, 2 parts of potassium chloride, 2 parts of magnesium chloride, 10 parts of anhydrous citric acid, 1.5 parts of choline chloride, 1 part of calcium carbonate, 0.5 parts of calcium hydrogen phosphate, 1.5 parts of sodium chloride, 0.4 parts of magnesium oxide, 1 part of beta-carotene, 0.5 parts of potassium hydroxide, 0.5 parts of calcium hydroxide, 2 parts of mono- and di-glycerol fatty acid esters, 5 parts of compound stabilizer, and 3 parts of edible flavors.

[0106] Its preparation method is:

[0107] (1) mixing calcium caseinate, sodium caseinate, maltodextrin, white sugar and water at 65° C., shearing under a vacuum condition of 0.5 bar at a speed of 1200 rpm for 12 min to obtain a first mixture;

[0108] (2) Mixing the composite trace elements, sodium citrate, potassium citrate, dipotassium hydrogen phosphate, potassium chloride, sodium chloride, anhydrous citric acid, choline chloride, calcium carbonate, calcium hydrogen phosphate, magnesium oxide, potassium hydroxide, calcium hydroxide, low-erucic acid rapeseed oil, sunflower oil, high-oleic acid sunflower oil, medium-chain triglycerides, fish oil extract, phospholipids, mono- and di-glycerol fatty acid esters, and a composite stabilizer with the first mixture at 65° C. for 30 min, then mixing with magnesium chloride for 5 min, and sterilizing at 90° C. for 30 s to obtain a second mixture;

[0109] (3) homogenizing the second mixture for the first time at 420 bar and 55°C for 40 min, and then homogenizing for the second time at 150 bar and 75°C for 40 min;

[0110] (4) Mix the homogenized raw materials with vitamins, β-carotene, nucleotides, L-arginine, oligofructose and flavors at 40°C for 5 min and sterilize at 145°C for 3 s.

[0111] Example 4

[0112] This embodiment provides a nutritional emulsion, which differs from Embodiment 1 only in that step (2) in the preparation method is "mixing composite trace elements, sodium citrate, dipotassium hydrogen phosphate, potassium chloride, sodium chloride, anhydrous citric acid, choline chloride, calcium carbonate, magnesium oxide, potassium hydroxide, calcium hydroxide, low-erucic acid rapeseed oil, ordinary sunflower oil, high-oleic acid sunflower oil, magnesium sulfate, phospholipids and the first mixture at 55° C. for 45 min, and pre-sterilizing at 110° C. for 25 s to obtain a second mixture", and the other ingredients and contents remain unchanged, and the other operations remain unchanged.

[0113] Example 5

[0114] This embodiment provides a nutritional emulsion, which differs from Embodiment 1 only in that step (3) is "homogenizing the second mixture at 400 bar and 60° C. for 40 min", and other ingredients and contents remain unchanged, and other operations in the preparation method remain unchanged.

[0115] Example 6

[0116] This embodiment provides a nutritional emulsion, which differs from Embodiment 1 only in that step (3) is "homogenizing the second mixture at 200 bar and 78° C. for 40 min", and the other ingredients and contents remain unchanged, and the other operations in the preparation method remain unchanged.

[0117] Comparative Example 1

[0118] This comparative example provides a nutritional emulsion, which differs from Example 1 only in that it does not contain magnesium oxide, and its reduced mass is distributed to the mass of magnesium sulfate, while other components and contents remain unchanged.

[0119] The preparation method is similar to that of Example 1.

[0120] Comparative Example 2

[0121] This comparative example provides a nutritional emulsion, which differs from Example 1 only in that it does not contain magnesium sulfate, and its reduced mass is distributed to the mass of magnesium oxide, while other components and contents remain unchanged.

[0122] The preparation method is similar to that of Example 1.

[0123] Comparative Example 3

[0124] This comparative example provides a nutritional emulsion, which differs from Example 1 only in that magnesium sulfate is replaced by magnesium carbonate in equal amounts, and other ingredients and contents remain unchanged.

[0125] The preparation method is similar to that of Example 1.

[0126] Test Example 1

[0127] The nutritional components of the nutritional emulsions prepared in Examples 1-3 were tested, and the results are shown in Table 1.

[0128] Testing method: Test according to the national standard method corresponding to each nutrient.

[0129] Table 1

[0130]

[0131] Test Example 2

[0132] Stability test

[0133] The particle size and polydispersity index (PDI) of the high energy density nanoemulsions prepared in the above examples were measured using a Nano-Particle Size Potential Analyzer at 25°C, a refractive index of 1.33, and a laser wavelength of 631 nm; the changes in transmission and backscattering in the emulsion were detected using a Turbiscan stability analyzer, which can reflect the movement of droplets in the emulsion (aggregation or sedimentation) and further evaluate the emulsion stability (Kaombe DD, Lenes M, Toven K, et al. Turbiscan as a tool for studying the phase separation tendency of pyrolysis oil [J]. Energy & Fuels, 2013, 27 (3): 1446-1452.). The physical stability of the emulsion system was reflected by recording the average particle size of the emulsion, the Δ backscattered light value (ΔBS, ΔBS = BSt-BS0) and the multiple light scattering stability (TSI) index.

[0134] In an emulsion system, the average particle size is a key feature that indicates its physical stability and is used to describe the average size of dispersed oil droplets. PDI is the dispersion index, which is another indicator of stability. Generally, a PDI value of less than 1 and a PDI value between 0 and 0.70 indicate that the emulsion is evenly dispersed. The smaller the PDI value, the more concentrated the particle size distribution and the better the particle size uniformity. The change in the backscattered light (BS) curve of the emulsion sample is related to the change in droplet size and the migration process. Generally, a positive ΔBS indicates the migration of oil droplets, while a negative ΔBS indicates the aggregation of oil droplets (Sun Y, Deac A, Zhang GG Z. Assessing physical stability of colloidal dispersions using a turbiscan optical analyzer[J].Molecular Pharmaceutics, 2018,16(2):877-885.). TSI can reflect the movement speed of droplets in the emulsion. A high TSI value (>0.5) indicates that the emulsion droplets move quickly and are more likely to be unstable and phase separate. A low TSI value (<0.5) indicates that the emulsion is less likely to undergo phase separation (Kaombe DD, Lenes M, Toven K, et al. Turbiscan as a tool for studying the phase separation tendency of pyrolysis oil [J]. Energy & Fuels, 2013, 27 (3): 1446-1452.).

[0135] Table 2

[0136]

[0137] As can be seen from Table 2, the product obtained in the present application has high stability and small particle size. The mixing method and homogenization method of magnesium salt and magnesium oxide will affect the stability of the product, and magnesium salt and magnesium oxide are indispensable.

[0138] Figure 1-3 The change of ΔBS value of all high energy density emulsions in the examples for 12 months is shown. The change of ΔBS indicates that the emulsion particles did not settle or move upward during storage and remained near the baseline, indicating that the emulsion particles were more evenly distributed, i.e., had better stability; Figure 4-6 The TSI values ​​of all emulsion products were less than 0.5, indicating that all emulsions had good stability.

[0139] Test Example 3

[0140] Test method: According to the accelerated test method for liquid products in the “Requirements for Stability Studies of Foods for Special Medical Purposes (Trial)” (2017 revised edition).

[0141] Test results: The expected shelf life of the product is 12 months. It is required to undergo a three-month accelerated test. The three-month accelerated test results of Example 1 are shown in Table 3, the three-month accelerated test results of Example 2 are shown in Table 4, and the three-month accelerated test results of Example 3 are shown in Table 5.

[0142] Table 3

[0143]

[0144]

[0145] Table 4

[0146]

[0147]

[0148] Table 5

[0149]

[0150]

[0151] Test Example 4

[0152] The clinical safety, nutritional adequacy and clinical effect of special medical use of the nutritional emulsion obtained in Example 1 were evaluated through a randomized, open, multi-center clinical trial. The subjects took it orally, with a daily recommended amount of 600±100 kcal / d (the nutritional emulsion obtained in Example 1 was 140 kcal / mL, 4±2 days before radiotherapy, reaching more than 50% of the recommended amount; the total intake for 17±3 days did not exceed 120% of the recommended amount), and the evaluation indicators included serum prealbumin, body weight, nutritional assessment scale, etc.

[0153] Inclusion criteria:

[0154] 1. Patients diagnosed with esophageal cancer, oral cancer, or nasopharyngeal cancer by histology or cytology and who require initial radiotherapy;

[0155] 2. Patients who need nutritional therapy according to the researcher's judgment: patients with NRS2002 total score ≥3 points or PG-SGA ≥4 points or patients who need nutritional supplements before and after radiotherapy;

[0156] 3. Age between 18 and 80 (including the limit), regardless of gender;

[0157] 4. Expected survival period ≥ 3 months;

[0158] 5. Those who can tolerate enteral nutrition;

[0159] 6. Those who voluntarily participate in clinical trials and sign informed consent forms.

[0160] Table 6

[0161]

[0162] The normal range of prealbumin for radiotherapy patients is 150-400, and the normal range of prealbumin for patients undergoing concurrent radiotherapy and chemotherapy is 200-400. As of now, the results of prealbumin in the subjects before and after the test show that the prealbumin level of the hematological nutritional evaluation index of the subjects has increased after the test, indicating that the verified product can provide reasonable and effective nutrients for cancer patients and maintain a good metabolic status or quality of life.

[0163] The applicant declares that the present invention illustrates a complete nutritional emulsion for special medical use and its preparation method and application through the above-mentioned embodiments, but the present invention is not limited to the above-mentioned embodiments, that is, it does not mean that the present invention must rely on the above-mentioned embodiments to be implemented. Those skilled in the art should understand that any improvement of the present invention, equivalent replacement of the raw materials of the product of the present invention, addition of auxiliary ingredients, selection of specific methods, etc., all fall within the protection scope and disclosure scope of the present invention.

[0164] The preferred embodiments of the present invention are described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the technical concept of the present invention, a variety of simple modifications can be made to the technical solution of the present invention, and these simple modifications all belong to the protection scope of the present invention.

[0165] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present invention will not further describe various possible combinations.

Claims

1. A complete nutritional emulsion for special medical purposes, characterized in that: The complete nutritional emulsion comprises, by weight, 60-100 parts of protein, 25-56 parts of fat, 145-256 parts of carbohydrates, 0.5-1.5 parts of vitamins, 0.5-1.5 parts of trace elements, 0.2-0.4 parts of oxides, 1-3 parts of magnesium salts, 2-4 parts of emulsifiers and 600-900 parts of water, wherein the fat comprises low-erucic acid rapeseed oil, ordinary sunflower oil and high-oleic acid sunflower oil; The oxide includes magnesium oxide, and the magnesium salt is magnesium sulfate; The complete nutritional emulsion is prepared by a method comprising the following steps: (1) mixing water, protein, and carbohydrate, and shearing them to obtain a first mixture; (2) mixing the first mixture, oxide, emulsifier, fat and trace elements, and then mixing with magnesium salt to obtain a second mixture; (3) homogenizing and pre-sterilizing the second mixture; (4) mixing the product obtained in step (3) with vitamins and sterilizing by ultra-high temperature to obtain; The first mixture, oxide, emulsifier, fat and trace elements are mixed at a temperature of 45-65°C for 30-80 minutes; The temperature of mixing with magnesium salt is 45-65°C and the time is 5-15 minutes; The homogenization includes a first homogenization and a second homogenization. The pressure of the first homogenization is 300-600 bar, the temperature is 55-65°C, and the time is 10-40 min; the pressure of the second homogenization is 100-300 bar, the temperature is 75-81°C, and the time is 10-40 min.

2. The complete nutritional emulsion for special medical purposes according to claim 1, characterized in that: The fat comprises, by weight, 20-40 parts of low-erucic acid rapeseed oil, 5-15 parts of common sunflower oil and 10-25 parts of high-oleic acid sunflower oil.

3. The complete nutritional emulsion for special medical purposes according to claim 1, characterized in that: The energy density of the complete nutritional emulsion is 1.2-2.0 kcal / mL; The average particle size of the complete nutritional emulsion is 20-100 nm; The multiple light scattering stability index of the complete nutritional emulsion is ≤0.

3.

4. The complete nutritional emulsion for special medical purposes according to claim 1, characterized in that: The first mixture, oxide, emulsifier, fat and trace elements are mixed together and further include any one or at least two of choline, potassium salt, calcium salt or sodium salt.

5. The complete nutritional emulsion for special medical purposes according to claim 1, characterized in that: When mixed with vitamins, it also includes mixing with any one or at least two of flavors, nucleotides, amino acids or dietary fibers.

6. The complete nutritional emulsion for special medical purposes according to claim 1, characterized in that: The temperature of the mixture of water, protein and carbohydrate is 55-65°C, the shearing speed is 1000-3000 rpm, and the time is 5-20 min.

7. The complete nutritional emulsion for special medical purposes according to claim 1, characterized in that: The pre-sterilization temperature is 80-110° C. and the time is 25-35 s.

8. The complete nutritional emulsion for special medical purposes according to claim 1, characterized in that: The ultra-high temperature sterilization adopts steam direct injection heating, the temperature is 135-145°C, and the time is 2-10 s.

9. Use of the complete nutritional emulsion for special medical purposes according to any one of claims 1 to 8 in the preparation of special medical purpose formula foods.

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