WO2022163760A1 - Composition nutritionnelle de type gel - Google Patents

Composition nutritionnelle de type gel Download PDF

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Publication number
WO2022163760A1
WO2022163760A1 PCT/JP2022/003104 JP2022003104W WO2022163760A1 WO 2022163760 A1 WO2022163760 A1 WO 2022163760A1 JP 2022003104 W JP2022003104 W JP 2022003104W WO 2022163760 A1 WO2022163760 A1 WO 2022163760A1
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Prior art keywords
composition
kcal
per
gel
nutritional composition
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PCT/JP2022/003104
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English (en)
Japanese (ja)
Inventor
和孝 重見
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イーエヌ大塚製薬株式会社
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Application filed by イーエヌ大塚製薬株式会社 filed Critical イーエヌ大塚製薬株式会社
Priority to CN202280012228.5A priority Critical patent/CN116744973B/zh
Priority to JP2022510159A priority patent/JP7085704B1/ja
Priority to KR1020237024467A priority patent/KR102618203B1/ko
Publication of WO2022163760A1 publication Critical patent/WO2022163760A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/19—Dairy proteins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels

Definitions

  • the present invention relates to a gel nutritional composition, and particularly to a gel nutritional composition suitable for ingesting essential vitamins and minerals.
  • Nutritional management is performed by administering a nutritional composition, which is adjusted to contain nutritional components such as proteins, lipids, carbohydrates, vitamins and minerals in a well-balanced manner (Patent Documents 1 to 4).
  • a gel-like nutritional composition capable of ingesting a recommended daily intake of vitamins, minerals, etc., as described in Document 1, has various advantages. is not provided.
  • the comprehensive enteral nutrition composition described in Patent Document 1 is a composition containing high amounts of vitamin B1 and vitamin B2, and the nutritional composition described in Patent Document 3 contains sodium, potassium, iron, calcium and magnesium.
  • these are not gel-like compositions and are not compositions capable of ingesting the daily intake of vitamins, minerals, and the like.
  • the gel-type enteral nutritional supplement described in Patent Document 2 is not a nutritional supplement that allows intake of the recommended daily amount of vitamins, minerals, and the like.
  • the liquid nutritional composition described in Patent Document 4 is not gel.
  • the present invention provides a nutritional composition that allows the daily intake of energy to be ingested by the nutritional composition, which is a standard amount/recommended amount of the daily intake of vitamins, minerals, etc. and easy to take, and to provide a stable gel nutritional composition.
  • the present inventors first increased the concentration of vitamins and minerals in a semi-solid enteral nutritional composition as described in Patent Document 2, and found that local gelation occurred. occurred, resulting in a non-uniform gel. On the other hand, when attempting to gel a high-concentration liquid nutritional composition with a large amount of vitamins and minerals as described in Patent Document 4, it was found that stable gelation was hindered, resulting in an uneven gel. rice field.
  • the present inventors conducted further extensive studies and first used specific raw materials such as whole milk protein and casein as protein raw materials. Furthermore, in nutritional compositions containing high amounts of vitamins and minerals, the concentration of ions such as calcium ions is high, so when the amount of the chelating agent was increased, it was found that the stability of the nutritional composition unexpectedly decreased.
  • the present invention was completed by finding an appropriate compounding value of
  • a gel nutritional composition comprising lipids, proteins, carbohydrates, vitamins and minerals and having the following composition.
  • the energy value of the composition is 0.8 kcal/g or more and 1.2 kcal/g or less; 2) Contains 1.7 g or more of whole milk protein and 0.25 g or more of casein per 100 g of the composition as protein; 3)
  • the total amount of magnesium derived from the whole milk protein and casein is 1.3 mg or more per 900 kcal of the composition, and the total amount of calcium derived from the whole milk protein and casein is 34.9 mg per 900 kcal of the composition.
  • the lipid content in the composition is 20% or more and 30% or less in energy ratio
  • the protein content in the composition is 13% or more and 30% or less in energy ratio
  • the gel nutritional composition according to any one of [1] to [4], wherein the carbohydrate content in the composition is 50% or more and 65% or less in terms of energy.
  • [6] The gel nutritional composition according to any one of [1] to [5], containing 310 mg or more of magnesium and 650 mg or more of calcium per 900 kcal of the composition.
  • [7] The gel nutritional composition according to any one of [1] to [6], containing at least the following vitamins and minerals per 900 kcal of the composition.
  • the nutritional composition is such that the daily energy intake can be ingested, and it is possible to incorporate the recommended amount and the recommended amount of the daily intake of vitamins, minerals, etc., and it is in the form of a gel. Therefore, it is possible to provide a stable gel-form nutritional composition that is easy to ingest and that can prevent gastroesophageal reflux that can cause aspiration pneumonia.
  • this embodiment the form for carrying out the present invention (hereinafter referred to as "this embodiment") will be described in detail. It should be noted that the present invention is not limited to the present embodiment described below, and various modifications can be made within the scope of the gist of the present invention.
  • the gel nutritional composition of this embodiment contains lipids, proteins, carbohydrates, vitamins and minerals, 1) the energy value of the composition is 0.8 kcal/g or more and 1.2 kcal/g or less; 2) Contains 1.7 g or more of whole milk protein and 0.25 g or more of casein per 100 g of the composition as protein, 3) the total amount of magnesium derived from the whole milk protein and casein is 1.3 mg or more per 900 kcal of the composition, and the total amount of calcium derived from the whole milk protein and casein is 34.9 mg per 900 kcal of the composition; is more than 4) containing 220 mg or more of magnesium and 500 mg or more of calcium per 900 kcal of the composition; 5) Per 900 kcal of the composition, one or more minerals selected from 30 ⁇ g or more of selenium, 10 ⁇ g or more of chromium, 30 ⁇ g or more of molybdenum, and 130 ⁇ g or more of iodine, 6) Contains 0.15% by weight or more
  • Whole milk protein includes whole milk itself, whole milk concentrate, protein prepared from whole milk, skim milk, skim milk concentrate, milk protein concentrate (also referred to as MPC), lactose removed from skimmed milk powder. and total milk protein.
  • a milk protein concentrate eg, about 80 to 82% protein content.
  • casein for example, about 90 to 92% protein content
  • acid casein such as lactic casein, hydrochloride casein, casein sulfate, or mixtures thereof separated from milk by a conventional method
  • caseinates such as sodium caseinate and calcium caseinate. Caseinate and the like consisting of
  • the gel nutritional composition of the present embodiment contains 1.7 g or more, preferably 2.0 g or more and 7.5 g or less, more preferably 2.5 g or more and 6.5 g or less of whole milk protein per 100 g of the composition as protein. , more preferably 3.0 g or more and 5.5 g or less.
  • the gel nutritional composition of the present embodiment contains 0.25 g or more, preferably 0.25 g or more and 3.6 g or less, more preferably 0.54 or more and 2.0 g or less of casein as protein per 100 g of the composition. More preferably, it contains 0.88 g or more and 1.9 g or less.
  • the total ratio of whole milk protein and casein (converted to protein amount) to proteins is 75% by weight or more, preferably 82% by weight or more. , more preferably 92% by weight or more, still more preferably 95% by weight or more, particularly preferably 98% by weight or more, and most preferably 100% by weight.
  • the gel nutritional composition of the present embodiment does not contain either an animal protein hydrolyzate or a vegetable protein hydrolyzate. Contains neither protein hydrolyzate nor vegetable protein hydrolyzate.
  • Animal protein hydrolyzate and vegetable protein hydrolyzate are products obtained by decomposing proteins with acids or enzymes, and are also used in nutritional compositions because of their good dispersibility. (so-called belching) may give off an unpleasant odor.
  • the gel nutritional composition of the present embodiment contains whole milk protein more than casein in protein. Without wishing to be bound by theory, it is believed that this configuration allows calcium to be incorporated in a protein-bound form and also contains high levels of magnesium and calcium by binding free magnesium and calcium in casein. can be made
  • the ratio of the casein to the whole milk protein is preferably 1:1.1 to 1:13, more preferably 1:1.1 to 1:4.3, in terms of weight ratio of the contained protein. 1:1.1 to 1:2.9 is more preferred, and 1:2.5 to 1:2.8 is particularly preferred. If the total milk protein is larger than the casein, magnesium and calcium can be contained as the whole milk protein, so it is stable even if it contains a large amount of minerals, which is preferable. Moreover, it is preferable from the viewpoint that the gel state of the nutritional composition is more easily stabilized when the total milk protein is 13 times or less by weight that of casein. In addition, in the calculation of the above ratio, the casein contained in the whole milk protein shall not be calculated extracted as casein.
  • the gel nutritional composition of the present embodiment has whey in protein (other than whey contained in whole milk protein) of less than 2 g/100 g, preferably 1 g/100 g or less, more preferably 0.1 g/100 g or less. 7 g/100 g or less, more preferably whey-free.
  • the protein content in the gel nutritional composition of the present embodiment is preferably 13-30%, more preferably 13-19% in energy ratio. If the protein content is more than 30% of the energy ratio, the nutritional balance of the PFC ratio of the Dietary Reference Intakes of the Ministry of Health, Labor and Welfare may be poor, and if it is less than 13%, the protein intake may be insufficient. There is In addition, the energy ratio shall be calculated as 4 kcal/g.
  • the lipid contained in the gel nutritional composition of the present embodiment is not particularly limited as long as it can generally be administered orally or through a tube.
  • vegetable oils such as soybean oil, perilla oil, perilla oil, sunflower oil, safflower oil, algae oil, canola oil, palm oil, corn oil, corn oil, coconut oil, olive oil, rice oil; fish oil, beef tallow, etc. animal fats and oils; MCTs (neutral fats, medium chain length fatty acids); highly unsaturated fatty acids such as eicosapentaenoic acid, docosahexaenoic acid, linolenic acid and linoleic acid;
  • One type of lipid may be used alone, or two or more types may be mixed and used. From the viewpoint of sufficiency of essential fatty acids, it is preferable to use a combination of multiple types of lipids.
  • the lipid content in the gel nutritional composition of the present embodiment is preferably 30% or less, more preferably 20% to 30%, in terms of energy ratio.
  • a lipid content of 30% or less in terms of energy is preferable because the nutritional balance of the PFC ratio is good.
  • the energy ratio shall be calculated as 9 kcal/g.
  • a lipid content of 20% or more in terms of energy is preferable because essential fatty acids can be supplied as lipid.
  • the carbohydrate contained in the gel nutritional composition of this embodiment is not particularly limited as long as it can be administered orally or through a tube.
  • Examples include powdered candy, starch, dextrin, maltodextrin, lactose, sucrose, glucose, fructose and maltose.
  • Carbohydrate may be used individually by 1 type, and may mix and use 2 or more types. In particular, powdered candy and/or maltodextrin are preferred from the viewpoint of suppressing sweetness and being economical.
  • the carbohydrate content in the gel nutritional composition of the present embodiment is determined by the amount of protein and lipid blended, and although the blended amount varies as appropriate, it is preferably 50% to 65% in terms of energy. When the carbohydrate content is 50% to 65% in terms of energy, it is preferable because the nutritional balance in terms of PFC ratio is improved. The energy ratio is calculated assuming that the carbohydrate energy is 4 kcal/g.
  • the gel nutritional composition of this embodiment contains vitamins and minerals.
  • vitamins and minerals include those described in Dietary Reference Intakes for Japanese (Non-Patent Document 1).
  • vitamins include vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, niacin, vitamin B6, vitamin B12, folic acid, pantothenic acid, biotin and vitamin C. It suffices if at least one of them is contained, and it is preferable to contain all of them.
  • Minerals include, for example, calcium, magnesium, phosphorus, iron, zinc, copper, manganese, iodine, selenium, chromium and molybdenum.
  • the gel nutritional composition of the present embodiment contains at least magnesium, calcium, selenium, chromium, molybdenum and iodine, and preferably contains one or more of phosphorus, iron, zinc, copper and manganese. All inclusive is more preferred.
  • the gel nutritional composition of the present embodiment contains various vitamins and minerals, so that the daily necessary vitamins and minerals can be ingested only from the nutritional composition.
  • the gel nutritional composition of the present embodiment contains 220 mg or more of magnesium per 900 kcal of the composition, which is the minimum value (women aged 75 and over) that satisfies the estimated average requirement for each age group of 18 years and over, preferably the recommended amount for women. 290 mg or more, more preferably 310 mg or more, and still more preferably 370 mg or more. This magnesium may also be present in other ingredients such as whole milk protein and casein.
  • a magnesium content of 310 mg/900 kcal or more is preferable because it satisfies the estimated average requirement of the Dietary Reference Intakes for those aged 18 and over, and a magnesium content of 370 mg/900 kcal or more is more preferable because it can satisfy the recommended amounts of the Dietary Reference Intakes for all ages.
  • the upper limit of magnesium is not particularly limited, it can be, for example, equivalent to the upper limit of calcium blended below, and in one embodiment, can be, for example, about half the amount of calcium.
  • the gel nutritional composition of the present embodiment contains 500 mg or more, preferably 650 mg or more, which is the minimum value (women aged 75 or over) that satisfies the estimated average calcium requirement for each age group of 18 years or over, per 900 kcal of the composition.
  • it can contain 800 mg or more.
  • 650 to 2500 mg, preferably 700 to 2500 mg, more preferably 750 to 1333 mg, even more preferably 800 to 1250 mg, for example 815 to 1250 mg of calcium can be added per 900 kcal of the composition.
  • This calcium may also be present in other ingredients such as whole milk protein and casein.
  • Calcium of 650 mg/900 kcal or more is preferable because it satisfies the estimated average requirement of the Dietary Reference Intakes for those aged 18 and over. It is more preferable because it can In particular, when calcium is blended in the range of 1250 mg / 900 kcal or less, even if, for example, 1500 kcal of energy is ingested per day, it does not exceed the tolerable upper limit of 2500 mg. When mixed, the recommended amount of calcium can be ingested when 900 kcal is ingested, and even when 1500 kcal is ingested, there is a margin up to the upper tolerable limit, and ingestion from other foods is also possible.
  • the tolerable upper limit of 2500 mg is not exceeded, so 800 mg is preferable.
  • the recommended amount of calcium can be ingested when 900 kcal is ingested, and even if 1800 kcal is ingested, there is room for the upper limit of tolerance, and ingestion from other foods is also possible.
  • the gel nutritional composition of the present embodiment has a total amount of magnesium derived from the whole milk protein and casein of 1.3 mg or more per 900 kcal of the composition, and the upper limit is 370 mg or less. is preferably 13 mg or more, more preferably 20 mg or more, and even more preferably 30 mg or more.
  • the total amount of calcium derived from the whole milk protein and casein is 34.9 mg or more, and the upper limit is preferably 880 mg or less, and further preferably 88 mg or more. It is preferably 200 mg or more, still more preferably 400 mg or more, even more preferably 640 mg or more, and particularly preferably 700 mg or more.
  • the gel nutritional composition of the present embodiment contains minerals, preferably one or more minerals selected from selenium, chromium, molybdenum and iodine, more preferably all of them.
  • 900 kcal of the composition preferably contains one or more minerals selected from 30 ⁇ g or more of selenium, 10 ⁇ g or more of chromium, 30 ⁇ g or more of molybdenum, and 130 ⁇ g or more of iodine, and more preferably all of these.
  • the content of vitamins and minerals other than the above can preferably be set so as to satisfy the recommended amount or guideline amount of intake described in the Dietary Reference Intakes.
  • the following are the daily dietary intake standards for each vitamin and mineral calculated from Non-Patent Document 1.
  • any one or more, preferably 5 or more, more preferably 10 of the following per 900 kcal of the composition It is preferable to include an amount that satisfies the above, more preferably 15 or more, and particularly preferably all. Additionally, vitamins and minerals not listed below may be included.
  • Vitamin A retinol palmitate
  • Vitamin D cholecalciferol
  • vitamin E tocopherol acetate
  • vitamin K 150 ⁇ g or more
  • vitamin B 1 thiamine chloride hydrochloride
  • vitamin B 2 riboflavin
  • niacin nicotinamide
  • vitamin B 6 pyridoxine
  • vitamin B 12 cyanocobalamin
  • Vitamin A retinol palmitate
  • vitamin D cholesterol calcium
  • vitamin E tocopherol acetate
  • vitamin K 75 ⁇ g or more
  • vitamin B 1 thiamine chloride hydrochloride
  • vitamin B 2 riboflavin
  • niacin tonicotinamide
  • vitamin B 6 pyridoxine
  • vitamin B 12 cyanocobalamin
  • the minimum required amount of sodium is 1.5 g in terms of salt, and less than 6 g in the case of high blood pressure and salt restriction. (High blood pressure treatment guideline 2009 edition).
  • Phytonadione is preferably lower than the dietary intake standard from the viewpoint of safety from the viewpoint of preventing medical accidents due to interactions with warfarin.
  • vitamin K should preferably be blended below the dietary intake standard of 150 ⁇ g.
  • the mass ratio of calcium to phosphorus is preferably 0.74 or more.
  • a Ca/P ratio of 0.74 or more is preferable because bone density is significantly higher than when Ca/P ratio is less than 0.74 (Dietary Reference Intakes for Japanese [2010 edition], P202).
  • the gel nutritional composition of the present embodiment preferably has an energy value of 0.8 to 1.2 kcal/g, more preferably 0.9 to 1.2 kcal/g, still more preferably 0.95 to 1.1 kcal/g. is g.
  • the energy value can be adjusted within the range of the energy ratio of the various components described above. By adjusting the energy value to 0.9 kcal/g or more, the intake amount can be reduced and the administration time can be shortened, so that the burden on the recipient can be reduced.
  • the gel nutritional composition of this embodiment contains agar and alginic acid or a salt thereof as thickeners. More specifically, it contains 0.15% by weight or more and 0.40% by weight or less, preferably 0.20% by weight or more and 0.40% by weight or less, more preferably agar so that a composition with a viscosity range described later can be obtained.
  • alginic acid or a salt thereof when alginic acid and its salts are included, the total amount is converted to the amount of alginic acid in the case of a salt of alginic acid ) 0.125 wt% or more and 0.40 wt% or less, preferably 0.15 wt% or more and 0.40 wt% or less, more preferably 0.15 wt% or more and 0.35 wt% or less, still more preferably 0.20% by weight or more and 0.30% by weight or less. If the amount added is too small, a homogeneous gel with no lumps will not be obtained.
  • the gel nutritional composition of the present embodiment contains agar and alginic acid or a salt thereof within the ranges described above, and may contain other thickening agents as long as a predetermined viscosity described later is obtained.
  • the gel nutritional composition of the present embodiment contains only agar and alginic acid or a salt thereof as thickening agents from the viewpoint described later.
  • the type of agar is not particularly limited, and agar and agar powder listed in the Japanese Pharmacopoeia, agar powder as a food material, bar agar, quick-dissolving agar, and the like can be used.
  • the types of alginic acid and its salts are not particularly limited, either, and those meeting pharmaceutical additive standards or those meeting food additive standards can be used.
  • the type of alginate is also not particularly limited, and sodium salt, calcium salt, and the like can be used.
  • the viscosity of the gel nutritional composition of the present embodiment is 3,000 to 17,000 mPa ⁇ s, preferably 4,000 to 16,000 mPa ⁇ s, more preferably 4,500 to 15,000 mPa ⁇ s, still more preferably 5,000 to 14,000 mPa ⁇ s. It is about 5000 to 13000 mPa ⁇ s.
  • Viscosity means the value measured by the method specified in the 17th revision Japanese Pharmacopoeia General Test Methods ⁇ 2.53> Viscosity Measurement Method. If the viscosity is too low, syneresis tends to occur, and the shape-retaining power in the stomach is weak, which tends to cause reflux esophagitis and the like. If the viscosity is too high, the gel will be hard and will likely cause problems with tube passage.
  • the gel nutritional composition of the present embodiment is produced by filling about 30 g of the gel nutritional composition sample into a 50 ml catheter tip syringe and adding 20 Fr. After attaching the PEG tube to the syringe, the extrusion force when discharged from the syringe at a speed of 65% using a compression tester (SV-55C-20H: Imada Seisakusho Co., Ltd.) was measured (measurement temperature: 20 ° C.) , preferably 45N or less, more preferably 40N or less.
  • a compression tester SV-55C-20H: Imada Seisakusho Co., Ltd.
  • agar and alginic acid or its salt does not easily disintegrate the gel even under acidic conditions such as in the stomach and reduces reflux into the esophagus, but the gel nutritional composition has a high concentration and is derived from minerals. It has been found that when a large amount of ions is contained, a gel composition that is stable for a long period of time cannot be obtained simply by using this combination. In this respect, it was thought that adding or increasing the amount of the chelating agent would solve this drawback, but upon examination, it was found that the chelating agent was instead destabilized.
  • the chelating agent one selected from citric acid or its salts, phosphoric acid or its salts, and EDTA or its salts can be used.
  • citrates such as potassium citrate (potassium dihydrogen citrate, dipotassium citrate, tripotassium citrate, etc.), citric acid, potassium phosphate (potassium dihydrogen phosphate, phosphoric acid Dipotassium phosphate, tripotassium phosphate, etc.), phosphates such as sodium phosphate (sodium dihydrogen phosphate, disodium phosphate, trisodium phosphate, etc.), EDTA can be used.
  • sodium citrate sodium dihydrogen citrate, disodium citrate, trisodium citrate, etc.
  • potassium citrate potassium dihydrogen citrate, dipotassium citrate, tripotassium citrate, etc.
  • citric acid potassium phosphate (potassium dihydrogen phosphate, dipotassium phosphate, tripotassium phosphate, etc.)
  • EDTA can be used as a chelating agent, more preferably trisodium citrate, tripotassium citrate and A chelating agent selected from dipotassium phosphate can be used.
  • citrate and phosphate can be used in combination, for example, sodium citrate (trisodium citrate) and/or potassium citrate can be used in combination with dipotassium phosphate. can.
  • the amount of the chelating agent to be added is 2.0 g or more and 5.7 g or less, preferably 3.0 g or more and 5.7 g or less, more preferably 3.2 g or more and 5.7 g or less, per 900 kcal of the composition, in terms of non-hydrate. 5 g or less, more preferably 3.4 g or more and 5.3 g or less, particularly preferably 3.6 g or more and 5.1 g or less, for example, 5.0 g or less. Insufficient amounts of chelating agent can result in insufficient protein dissolution. Also, if the amount of chelating agent is too high, the composition (gel) may become non-uniform.
  • the content of phosphoric acid or a salt thereof (eg, dipotassium phosphate) in the chelating agent has a large effect on productivity.
  • phosphoric acid or a salt thereof e.g, dipotassium phosphate
  • other chelating agents e.g., sodium citrate (trisodium citrate) and/or potassium citrate
  • the nutritional composition can be produced satisfactorily without any problem in productivity.
  • the chelating agent is phosphoric acid or a salt thereof alone, the content thereof is preferably 2.3 g or more per 900 kcal of the composition from the viewpoint of productivity.
  • the content when combining phosphoric acid or a salt thereof with another chelating agent (e.g., sodium citrate and/or potassium citrate), the content is 1.1 g per 900 kcal of the composition in terms of productivity.
  • another chelating agent e.g., sodium citrate and/or potassium citrate
  • the upper limit of the content of phosphoric acid or a salt thereof is preferably less than 3.7 g per 900 kcal of the composition from the viewpoint of gel stability.
  • the content of phosphoric acid or a salt thereof is 1.1 g or more and less than 3.7 g per 900 kcal of the composition, from the viewpoint of the stability and manufacturability of the composition.
  • the gel nutritional composition of the present embodiment contains a large amount of minerals and the like, it was thought that a corresponding amount of chelating agent would be required. , a gel composition that was stable for a long period of time was obtained.
  • the weight ratio of the total amount of magnesium and calcium (in terms of magnesium and calcium) to the amount of chelating agent (in terms of non-hydrate) per 900 kcal of the gel nutritional composition of the present embodiment is, for example, 1:4. 0.5 or less, preferably 1:4.4 or less, more preferably 1:4.3 or less, and particularly preferably 1:4.2 or less.
  • the lower limit is preferably 1:1 or more, more preferably 1:2.4 or more.
  • the weight ratio of the amount of calcium per 900 kcal or 100 g of the gel nutritional composition of the present embodiment: the amount of chelating agent (in terms of non-hydrate) can be 1:7.0 or less, It is preferably 1:6.5 or less, more preferably 1:6.0 or less.
  • the lower limit is 1:1 or more, preferably 1:3.4 or more.
  • the gel nutritional composition of the present embodiment preferably has a pH higher than 5.5 and pH 7.0 or lower. If it is out of this range, the gel tends to be non-uniform, and the reduction of various vitamins during storage may be accelerated.
  • the gel nutritional composition of the present embodiment may optionally contain emulsifiers, salts other than chelating agents, fruit juices, flavors, suspending agents, stabilizers, and the like.
  • emulsifiers that can be used include lecithin, glycerin fatty acid ester, enzymatically decomposed lecithin, sorbitan fatty acid ester, propylene glycol fatty acid ester, sucrose fatty acid ester, and the like, either alone or in combination.
  • the gel nutritional composition of the present embodiment contains water in addition to the ingredients such as proteins, lipids, carbohydrates, vitamins and minerals.
  • the method for producing the gel nutritional composition of the present invention is not particularly limited as long as the desired gel nutritional composition can be obtained. For example, it can be produced as follows. (1) A liquid nutritional composition is prepared by adding the above protein, carbohydrates, vitamins, minerals, oils and fats and, if necessary, an emulsifier to water or warm water, and emulsifying with a homogenizer. (2) Add and mix a solution of agar previously heated and dissolved and alginic acid or a salt thereof.
  • the chelating agent also functions as a solubilizing agent when added during dissolution of alginic acid or a salt thereof, but the order of administration is not particularly limited as long as a uniform composition can be obtained.
  • the product is packed in a pouch such as an aluminum pouch or a container such as a soft bag, and is sterilized by heating in a retort pouch.
  • the heat sterilization method may follow a conventional method, and a known soft synthetic resin, a laminate of paper and metal foil, or the like can be appropriately used as the container.
  • the order of administration of each component is not particularly limited as long as a desired uniform gel nutritional composition can be obtained, and a high-pressure homogenizer may be used as appropriate at each administration step, if necessary.
  • the gel nutritional composition of the present embodiment thus prepared does not aggregate or precipitate, and is stable without becoming uneven even when stored at room temperature for a long period of time, such as 2 weeks or 4 weeks. be.
  • the term "gel nutritional composition is stable" means that there is no aggregation or sedimentation and no unevenness after storage at room temperature for 2 weeks or 4 weeks after heat sterilization.
  • the gel nutritional composition of the present embodiment is stable without becoming uneven even when stored at 25° C. and 65% RH for 13 months.
  • the gel nutritional composition of the present embodiment is in gel form, it can suppress gastroesophageal reflux and is also suitable as an enteral nutritional composition.
  • the present invention will be further described below with examples and comparative examples, but the present invention is not limited to the following examples.
  • the nutritional composition is "heterogeneous" it means that stratification of gelation, local gel of agar is observed by visual inspection, and / or hardness is uneven. means that In addition, nutritional compositions in which such "non-uniformity" was not observed were evaluated as “stable” (excellent in stability).
  • an agar solution dissolved by heating and an alginic acid solution prepared by dissolving potassium carbonate in water as a dissolution aid were added, and a mixture containing 0.25 g each of agar and alginic acid per 100 g was added after dissolution.
  • the obtained composition was filled in an aluminum pouch container and sterilized by heat treatment. After production, a uniform gel was obtained as compared with Comparative Example 1, but partial unevenness was observed.
  • the amount of whole milk protein per 100 g was 3.58 g and the amount of casein was 1.19 g.
  • the amount of sodium citrate (trisodium citrate dihydrate) was 2662 mg per 900 kcal. When gelation was attempted without dilution, the properties were even worse.
  • Comparative Example 3 Increase in amount of sodium citrate 1 Since the gel nutritional composition of Comparative Example 2 has a high ion concentration including calcium ions, sodium citrate as a chelating agent was increased by 1.25 times for the purpose of further stabilizing the gel nutritional composition. The resulting composition was prepared in the same manner as in Comparative Example 2 except for the amount of sodium citrate. However, deterioration of the property and stability equivalent to or slightly worse than in Comparative Example 2 was observed.
  • Comparative Example 4 Increased amount of sodium citrate 2
  • a gel nutritional composition was prepared in the same manner as in Comparative Example 3, except that the amount of sodium citrate was further increased (1.56 times that of Comparative Example 2) based on the Dietary Reference Intakes and the amount of sodium citrate was not used. Compared with Comparative Example 3, the properties and stability were further deteriorated. Also, slight scorching was observed during the heat treatment.
  • Example 7.5 L of warm water at 40-60°C, 800 g of milk protein concentrate (protein content: about 80%) as whole milk protein, 260 g of sodium caseinate (protein content: about 90%) as casein, 540 g of emulsifier-containing oil as lipid, dextrin as carbohydrate 2800 g, using a vitamin and mineral mixture having the following composition as vitamins and minerals, so that the final concentrations are the PFC ratio, casein:whole milk protein ratio, Ca/P ratio, Mg concentration, Ca concentration, and energy amount shown in Table 3 mixed into There was 4 g of milk protein concentrate and 1.3 g of casein per 100 g of the final nutritional composition.
  • the vitamin and mineral mixture contains, per 900 kcal, vitamin A (retinol palmitate): 900 ⁇ g RE, vitamin B 1 (thiamine chloride hydrochloride): 1.4 mg, vitamin B 2 (riboflavin): 1.6 mg, vitamin B 6 ( pyridoxine): 1.4 mg, vitamin B 12 (cyanocobalamin): 4.5 ⁇ g, vitamin D (cholecalciferol): 15 ⁇ g, vitamin E (tocopherol acetate): 22.5 mg, vitamin C (ascorbic acid): 200 mg, niacin (nicotinamide): 15.0 mg, pantothenic acid: 6.0 mg, folic acid: 240 ⁇ g, vitamin K: 75 ⁇ g, biotin: 50.0 ⁇ g, phosphorus: 1000 mg, iron: 11.0 mg, zinc: 11.0 mg, copper: A mixture of 0.9 mg, manganese: 4.0 mg, iodine: 130 ⁇ g, selenium: 50.0 ⁇ g,
  • Calcium and magnesium were added as calcium lactate hydrate and magnesium chloride so that the amounts shown in Table 1 were obtained in total with the amount contained in other ingredients such as whole milk protein.
  • 998 mg of calcium lactate hydrate and 2828.9 mg of magnesium chloride were added.
  • compositions were measured for viscosity and extrusion force using the following methods. Viscosity measurements after 2 and 4 weeks of room temperature storage were also performed for some compositions.
  • Viscosity measurement After storing the nutritional composition at 20 ° C. for 10 minutes, 20 mL was collected and measured using a single cylindrical rotational viscometer (17th revision Japanese Pharmacopoeia general test method ⁇ 2.53> Viscosity measurement method) . The viscosities shown in Tables 3 and 4 were measured with a Brookfield viscometer at 12 rpm and 20°C.
  • Extrusion force measurement About 30 g of the gel nutritional composition sample was filled into a 50 ml catheter tip syringe (Terumo Corporation), and 20 Fr.
  • the gel nutritional composition of the obtained example contains a recommended amount of vitamins and minerals for one day in an amount equivalent to 900 kcal, and the viscosity does not decrease even after storage for 4 weeks to 13 months, Neither extreme syneresis nor uneven properties were observed, and the composition was stable.
  • Table 3 also shows various compositions with different PFC ratios and different amounts of agar and alginic acid. Viscosity, extrusion force and pH in Table 3 show the results of measurements, and Examples 10-1 to 10-3 are examples prepared in different production lots.
  • the amount of whole milk protein per 100 g of Example 2 was 3.58 g and the amount of casein was 1.19 g. All amounts of chelating agents in Table 3 are expressed in terms of mg/100 g and are converted to hydrates.
  • Sodium citrate is trisodium citrate dihydrate (written as sodium citrate hydrate in the Japanese Pharmacopoeia), potassium citrate is tripotassium citrate monohydrate, and dipotassium phosphate is anhydrous. used.
  • Table 3 shows an example in which up to 370 mg was blended per 900 kcal, but a larger amount could be easily blended.
  • the raw materials are of natural origin and the viscosity of the final composition differs depending on the lot, the maximum and minimum viscosity values are shown. Lot differences had little effect on stability.
  • Table 4 shows the results of measuring the viscosity of the gel nutritional composition described in Example 16 in Table 3 while varying the amounts of agar and alginic acid. Viscosity is the average value of three measurements.
  • the gel-like nutritional composition of Comparative Example 1 contained soybean protein as the main protein, and even if vitamins and minerals were added to it, a uniform composition could not be obtained.
  • milk protein concentrate and casein are used as main proteins, and the amount of chelating agent is adjusted to obtain a stable gel nutritional composition containing a large amount of minerals such as calcium. It was thought that
  • Comparative Example 2 Although the liquid nutritional composition of Comparative Example 2 originally contained a large amount of vitamins and minerals, even if it was gelled, a stable gelled nutritional composition could not be obtained. Since the mineral content was high, the amount of the chelating agent was increased as in Comparative Examples 3 and 4, but compared with Comparative Example 2, the stability was not improved and deteriorated. On the other hand, in the examples, the amount and type of protein added and the amount of minerals added were adjusted, and the amounts of gelling agent and chelating agent optimal for gelation were found, resulting in a large amount of minerals and the like. Nevertheless, it was considered that a stable gel-like nutritional composition could be obtained.
  • the amounts of magnesium, calcium and chelating agent in representative examples and comparative examples are shown below.
  • the total amount of chelating agent is shown without hydrate.
  • the contents of dipotassium phosphate nonhydrate were 2749.5 mg/900 kcal (Inolas-blended enteral solution) and 2753.4 mg/900 kcal (Comparative Example 2).
  • Example 2 nutritional compositions of each Example and Comparative Example were prepared. Specifically, 7.5 L of warm water at 40 to 60 ° C., 800 g of milk protein concentrate (protein content of about 80%) as whole milk protein, 260 g of sodium caseinate (protein content of about 90%) as casein, 540 g of emulsifier-containing fat as lipid. , using 2800 g of dextrin as a carbohydrate and a vitamin and mineral mixture having the following composition as vitamins and minerals, the final concentrations are shown in Table 6: PFC ratio, casein:whole milk protein ratio, Ca/P ratio, Mg concentration, Ca concentration, energy Mix to volume. There was 4 g of milk protein concentrate and 1.3 g of casein per 100 g of the final nutritional composition.
  • the vitamin and mineral mixture contains, per 900 kcal, vitamin A (retinol palmitate): 900 ⁇ g RE, vitamin B 1 (thiamine chloride hydrochloride): 1.4 mg, vitamin B 2 (riboflavin): 1.6 mg, vitamin B 6 ( pyridoxine): 1.4 mg, vitamin B 12 (cyanocobalamin): 4.5 ⁇ g, vitamin D (cholecalciferol): 15 ⁇ g, vitamin E (tocopherol acetate): 22.5 mg, vitamin C (ascorbic acid): 200 mg, niacin (nicotinamide): 15.0 mg, pantothenic acid: 6.0 mg, folic acid: 240 ⁇ g, vitamin K: 75 ⁇ g, biotin: 50.0 ⁇ g, phosphorus: 1000 mg, iron: 11.0 mg, zinc: 11.0 mg, copper: A mixture of 0.9 mg, manganese: 4.0 mg, iodine: 130 ⁇ g, selenium: 50.0 ⁇ g,
  • Table 6 also shows the amount of magnesium, calcium, chelating agent, and dipotassium phosphate derived from MPC/casein in Examples and Comparative Examples. The total amount of the chelating agent and the amount of dipotassium phosphate are shown without hydrate.
  • the nutritional composition is capable of ingesting the daily energy intake, the recommended daily intake amount and recommended amount of vitamins and minerals can be blended, and the gel is stable.
  • a gel nutritional composition having excellent properties and uniformity was obtained.
  • Comparative Examples 16 and 17 the gel was partially non-uniform, and clogging of the flow path due to sediment was observed when the liquid was passed through the homogenizer during production, and the productivity was somewhat inferior.
  • Comparative Examples 7 to 15 and 20 the properties and stability were lower than those of the Examples.
  • Comparative Example 18 clogging of the flow path due to precipitates was observed when the liquid was passed through the homogenizer during production, and the productivity was somewhat inferior.
  • the nutrient composition of Comparative Example 19 was inferior in productivity due to frequent clogging of the flow paths due to sediments during the homogenizer flow during production.
  • the gel nutritional composition of the present invention is a stable nutritional composition that allows easy intake of daily energy intake, contains vitamins and minerals in the recommended daily intake amount, and Since it is gel, it is easy to ingest and store, can inhibit gastroesophageal reflux, and is suitable for enteral administration.
  • the gel nutritional composition of the present invention has industrial applicability in fields such as medical care, rehabilitation, and nursing care.

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Abstract

Une composition nutritionnelle de type gel comprend un lipide, un constituant protéique, un glucide, un constituant vitaminique et un constituant minéral, et présente la configuration suivante : la valeur calorique de la composition est comprise entre 0,8 et 1,2 kcal/g, inclus ; en tant que constituant protéique, une protéine de lait entier et de la caséine sont contenues en des quantités respectivement de 1,7 g ou plus et de 0,25 g ou plus, par rapport à 100 g de la composition ; la quantité totale du magnésium dérivé de la protéine de lait entier et du magnésium dérivé de la caséine est de 1,3 mg ou plus pour 900 kcal de la composition, et la quantité totale du calcium dérivé de la protéine de lait entier et du calcium dérivé de la caséine est de 34,9 mg ou plus pour 900 kcal de la composition ; 220 mg ou plus de magnésium et 500 mg ou plus de calcium sont contenus pour 900 kcal de la composition ; en tant que constituant minéral, au moins l'un de 30 µg ou plus de sélénium, 10 µg ou plus de chrome, 30 µg ou plus de molybdène et 130 µg ou plus d'iode sont contenus pour 900 kcal de la composition ; de l'agar-agar est contenu en une quantité comprise entre 0,15 et 0,40 % en poids, inclus, de l'acide alginique ou un sel de ce dernier est contenu en une quantité comprise entre 0,125 et 0,40 % en poids, inclus, et la viscosité est comprise entre 3 000 et 17 000 mPa·s, inclus ; un agent chélatant choisi parmi l'acide citrique ou un sel de ce dernier, l'acide phosphorique ou un sel de ce dernier et l'EDTA ou un sel de ce dernier est contenu en une quantité totale de 2,0 à 5,7 g, inclus, pour 900 kcal de la composition, de l'acide phosphorique ou un sel de ce dernier est contenu en une quantité de 1,1 g ou plus et moins de 3,7 g pour 900 kcal de la composition.
PCT/JP2022/003104 2021-01-28 2022-01-27 Composition nutritionnelle de type gel WO2022163760A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008069090A (ja) * 2006-09-13 2008-03-27 En Otsuka Pharmaceutical Co Ltd ゲル状経腸栄養剤
JP2010070469A (ja) * 2008-09-16 2010-04-02 En Otsuka Pharmaceutical Co Ltd 脂溶性ビタミンの保存方法
JP2010163408A (ja) * 2009-01-19 2010-07-29 En Otsuka Pharmaceutical Co Ltd 水溶性ビタミンの保存方法
WO2019215641A1 (fr) * 2018-05-09 2019-11-14 Domalina Pty Ltd ATF the Domalina Unit Trust Procédé d'administration par gel consommable pour des ingrédients de santé

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008069090A (ja) * 2006-09-13 2008-03-27 En Otsuka Pharmaceutical Co Ltd ゲル状経腸栄養剤
JP2010070469A (ja) * 2008-09-16 2010-04-02 En Otsuka Pharmaceutical Co Ltd 脂溶性ビタミンの保存方法
JP2010163408A (ja) * 2009-01-19 2010-07-29 En Otsuka Pharmaceutical Co Ltd 水溶性ビタミンの保存方法
WO2019215641A1 (fr) * 2018-05-09 2019-11-14 Domalina Pty Ltd ATF the Domalina Unit Trust Procédé d'administration par gel consommable pour des ingrédients de santé

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