WO2022163760A1 - Gel-like nutritional composition - Google Patents

Gel-like nutritional composition 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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French (fr)
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 KR1020237024467A priority Critical patent/KR102618203B1/en
Priority to JP2022510159A priority patent/JP7085704B1/en
Priority to CN202280012228.5A priority patent/CN116744973B/en
Publication of WO2022163760A1 publication Critical patent/WO2022163760A1/en

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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

A gel-like nutritional composition comprising a lipid, a protein component, a carbohydrate, a vitamin component and a mineral component, and having the following configuration: the energy value of the composition is 0.8 to 1.2 kcal/g, inclusive; as the protein component, a whole milk protein and casein are contained in amounts of 1.7 g or more and 0.25 g or more, respectively, relative to 100 g of the composition; the total amount of magnesium derived from the whole milk protein and magnesium derived from 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 calcium derived from casein is 34.9 mg or more per 900 kcal of the composition; 220 mg or more of magnesium and 500 mg or more of calcium are contained per 900 kcal of the composition; as the mineral component, at least one of 30 μg or more of selenium, 10 μg or more of chromium, 30 μg or more of molybdenum, and 130 μg or more of iodine is contained per 900 kcal of the composition; agar is contained in an amount of 0.15 to 0.40% by weight, inclusive, alginic acid or a salt thereof is contained in an amount of 0.125 to 0.40% by weight, inclusive, and the viscosity is 3,000 to 17,000 mPa·s, inclusive; and a chelating agent selected from citric acid or a salt thereof, phosphoric acid or a salt thereof, and EDTA or a salt thereof is contained in a total amount of 2.0 to 5.7 g, inclusive, per 900 kcal of the composition, and phosphoric acid or a salt thereof is contained in an amount of 1.1 g or more and less than 3.7 g per 900 kcal of the composition.

Description

ゲル状栄養組成物gel nutritional composition
　本発明は、ゲル状栄養組成物に関し、特に、必須ビタミン及びミネラルの摂取に適したゲル状栄養組成物に関する。 The present invention relates to a gel nutritional composition, and particularly to a gel nutritional composition suitable for ingesting essential vitamins and minerals.
　外科手術前後の患者や、通常の食事の摂取が困難な高齢者や要介護者が健康な生活を送るためには、十分な栄養摂取が必要である。栄養管理は、栄養組成物の投与により行われ、栄養組成物は、タンパク質、脂質、炭水化物、ビタミン、ミネラル等の栄養成分をバランス良く含むよう調整されている（特許文献１～４）。 Sufficient nutritional intake is necessary for patients before and after surgery, elderly people who have difficulty in eating normal meals, and people requiring nursing care to live a healthy life. 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).
　経腸栄養組成物の長時間の投与は、被投与者にとって大きな苦痛を伴い、また、高齢者や要介護者は胃の容量も大きくない場合が多いところ、エネルギー値が高く、しかも例えば非特許文献１に示されるような、一日に必要なミネラルやビタミンの目安量・推奨量が十分に含まれる栄養組成物であれば、投与量を抑えることができ、被投与者の負担を軽減し、効率的な栄養補給が可能となる。栄養組成物のエネルギー値（カロリー）調整は、一般に脂質、タンパク質、炭水化物の含有量を調整することにより可能である。 Administration of an enteral nutritional composition for a long period of time is accompanied by great pain for the recipient, and in many cases, the elderly and those requiring nursing care do not have large stomach capacity, but the energy value is high, and moreover, for example, non-patented As shown in Document 1, if the nutritional composition contains a sufficient amount of minerals and vitamins necessary for a day, the dosage can be suppressed, and the burden on the recipient can be reduced. , efficient nutritional supplementation becomes possible. Energy value (calorie) adjustment of nutritional compositions is generally possible by adjusting the contents of lipids, proteins and carbohydrates.
　また、ゲル状の経腸栄養組成物であれば、胃が本来有する貯留及び排出という生理機能を発揮することが期待される。その結果、液状栄養組成物と比較して短時間の投与が可能となり、移動や行動の制限が少なくリハビリテーション等の時間確保が可能になることから、早期離床や日常生活動作（ＡＤＬ）向上に貢献できるようになっている。また、液状栄養組成物で認められる誤嚥性肺炎や下痢を予防できる効果も示唆されている。 In addition, if it is a gel-like enteral nutritional composition, it is expected to exhibit the physiological functions of retention and excretion inherent to the stomach. As a result, it can be administered in a short period of time compared to liquid nutritional compositions, and there are fewer restrictions on movement and behavior, making it possible to secure time for rehabilitation, etc., contributing to early getting out of bed and improvement of activities of daily living (ADL). It is possible. It is also suggested that it can prevent aspiration pneumonia and diarrhea observed in liquid nutritional compositions.
ＷＯ２００６／０３３３４９WO2006/033349 特許４０４７３６３号公報Japanese Patent No. 4047363 ＷＯ２０１３／０８５０５９WO2013/085059 ＷＯ２０１４／１１５７６８WO2014/115768
　例えば、１日９００ｋｃａｌ程度の低用量のエネルギー管理の患者においても、１日におけるビタミンとミネラル摂取を不足させない必要があるところ、以上のとおり、９００ｋｃａｌ程度を栄養組成物によって摂取した場合に、非特許文献１に記載されるようなビタミン、ミネラル等の１日摂取量の目安量・推奨量を摂取可能なゲル状の栄養組成物は様々な利点を有するが、これまでにそのような栄養組成物は提供されていない。 For example, even in patients with low dose energy management of about 900 kcal per day, it is necessary not to lack vitamin and mineral intake per day. 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.
　例えば、特許文献１に記載の総合経腸栄養組成物は、ビタミンＢ１及びビタミンＢ２を高含量とした組成物であり、特許文献３に記載の栄養組成物はナトリウム、カリウム、鉄、カルシウム及びマグネシウムから選択される２種以上のミネラルを含むが、これらはゲル状ではなく、また、ビタミン、ミネラル等の１日摂取量を摂取可能な組成物ではない。 For example, 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. However, these are not gel-like compositions and are not compositions capable of ingesting the daily intake of vitamins, minerals, and the like.
　特許文献２に記載のゲル状経腸栄養剤は、ビタミン、ミネラル等の１日摂取量の目安量・推奨量を摂取可能な栄養剤ではない。特許文献４に記載の液状栄養組成物は、ゲル状ではない。 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.
　以上のような背景のもと、本発明は、栄養組成物によって１日のエネルギー摂取量を摂取できるような栄養組成物であって、ビタミン・ミネラル等の１日摂取量の目安量・推奨量を配合可能であり、かつ、摂取が容易で、安定なゲル状栄養組成物を提供することを目的とする。 Based on the above background, 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.
　本発明者らは、上記の課題を解決するために、まず、特許文献２に記載のような半固形状の経腸栄養組成物のビタミン、ミネラル濃度を増加させたところ、局所的なゲル化が起こり、不均一なゲルとなってしまうことを見出した。一方、特許文献４に記載のような、ビタミン・ミネラル量が多く、高濃度の液状栄養組成物をゲル化しようとしたところ、安定なゲル化が妨げられ、不均一なゲルとなることも見出した。 In order to solve the above problems, 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.
　本発明者らは、さらに鋭意検討を重ね、まず、タンパク質原料として全乳タンパク質、カゼイン等の特定の原料を用いた。さらに、高ビタミン・ミネラル配合の栄養組成物では、カルシウムイオンをはじめとしたイオン濃度が高いため、キレート剤を増量したところ、予想外に栄養組成物の安定性が低下することを見出し、キレート剤の適正配合値を見出し、本発明を完成した。 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
　すなわち本発明は以下に関する。
［１］
　脂質、タンパク質、炭水化物、ビタミン及びミネラルを含み、以下の構成を備える、ゲル状栄養組成物。
　１）組成物のエネルギー値が０．８ｋｃａｌ／ｇ以上１．２ｋｃａｌ／ｇ以下である；
　２）タンパク質として組成物１００ｇ当り、全乳タンパク質を１．７ｇ以上、及びカゼインを０．２５ｇ以上含む；
　３）前記全乳タンパク質及びカゼインに由来するマグネシウムの合計量が、組成物９００ｋｃａｌ当り１．３ｍｇ以上、及び、前記全乳タンパク質及びカゼインに由来するカルシウムの合計量が、組成物９００ｋｃａｌ当り３４．９ｍｇ以上である；
　４）組成物９００ｋｃａｌ当り、２２０ｍｇ以上のマグネシウム及び５００ｍｇ以上のカルシウムを含む；
　５）組成物９００ｋｃａｌ当り、ミネラルとして、３０μｇ以上のセレン、１０μｇ以上のクロム、３０μｇ以上のモリブデン及び１３０μｇ以上のヨウ素から選択されるいずれか１以上を含む；
　６）寒天を０．１５重量％以上０．４０重量％以下含み、アルギン酸又はその塩を０．１２５重量％以上０．４０重量％以下含み、粘度が３，０００ｍＰａ・ｓ以上１７，０００ｍＰａ・ｓ以下である；
　７）組成物９００ｋｃａｌ当り、クエン酸又はその塩、リン酸又はその塩、及びＥＤＴＡ又はその塩から選択されるキレート剤を合計２．０ｇ以上５．７ｇ以下含み、且つ、組成物９００ｋｃａｌ当り、１．１ｇ以上３．７ｇ未満の前記リン酸又はその塩を含む。
［２］
　前記カゼインと前記全乳タンパク質との比率が、含有タンパク質の重量比で１：１．１～１：１３である、［１］に記載のゲル状栄養組成物。
［３］
　前記全乳タンパク質が、乳タンパク質濃縮物である、［１］又は［２］に記載のゲル状栄養組成物。
［４］
　動物性タンパク質分解物及び植物性タンパク質分解物を含まない、［１］～［３］のいずれかに記載のゲル状栄養組成物。
［５］
　組成物中の脂質含有量が、エネルギー比で２０％以上３０％以下であり、
　組成物中のタンパク質含有量が、エネルギー比で１３％以上３０％以下であり、
　組成物中の炭水化物含有量が、エネルギー比で５０％以上６５％以下である、［１］～［４］のいずれかに記載のゲル状栄養組成物。
［６］
　組成物９００ｋｃａｌ当り、３１０ｍｇ以上のマグネシウム及び６５０ｍｇ以上のカルシウムを含む、［１］～［５］のいずれかに記載のゲル状栄養組成物。
［７］
　組成物９００ｋｃａｌ当り、少なくとも以下のビタミン及びミネラルを含む、［１］～［６］のいずれかに記載のゲル状栄養組成物。
Figure JPOXMLDOC01-appb-T000002
 ［８］
　ｐＨが５．５より高くｐＨ７．０以下であり、組成物９００ｋｃａｌ当りのマグネシウム及びカルシウムの合計量：キレート剤量の比が１：４．５以下である、［１］～［７］のいずれかに記載のゲル状栄養組成物。 That is, the present invention relates to the following.
[1]
A gel nutritional composition comprising lipids, proteins, carbohydrates, vitamins and minerals and having the following composition.
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, any one or more selected from 30 μg or more of selenium, 10 μg or more of chromium, 30 μg or more of molybdenum, and 130 μg or more of iodine as minerals;
6) Contains 0.15% by weight or more and 0.40% by weight or less of agar, contains 0.125% by weight or more and 0.40% by weight or less of alginic acid or a salt thereof, and has a viscosity of 3,000 mPa s or more and 17,000 mPa s is the following;
7) A total of 2.0 g or more and 5.7 g or less of a chelating agent selected from citric acid or its salts, phosphoric acid or its salts, and EDTA or its salts per 900 kcal of the composition, and 1 per 900 kcal of the composition .1 g or more and less than 3.7 g of the phosphoric acid or its salt.
[2]
The nutritional gel composition according to [1], wherein the ratio of the casein to the whole milk protein is 1:1.1 to 1:13 in terms of weight ratio of the protein contained.
[3]
The gel nutritional composition according to [1] or [2], wherein the whole milk protein is a milk protein concentrate.
[4]
The gel nutritional composition according to any one of [1] to [3], which does not contain an animal protein hydrolyzate or a vegetable protein hydrolyzate.
[5]
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.
Figure JPOXMLDOC01-appb-T000002
 [8]
Any of [1] to [7], wherein the pH is higher than 5.5 and not higher than pH 7.0, and the ratio of the total amount of magnesium and calcium to the amount of chelating agent per 900 kcal of the composition is not higher than 1:4.5 The gel nutritional composition according to .
　本発明によれば、１日のエネルギー摂取量を摂取できるような栄養組成物であって、ビタミン・ミネラル等の１日摂取量の目安量・推奨量を配合可能であり、かつ、ゲル状であるため摂取が容易で、誤嚥性肺炎の要因ともなり得る胃食道逆流を防止することができる、安定なゲル状栄養組成物を提供することができる。 According to the present invention, 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.
　以下、本発明を実施するための形態（以下、「本実施形態」という。）について詳細に説明する。なお、本発明は以下の本実施形態に限定されるものではなく、その要旨の範囲内で種々変形して実施することができる。 Hereinafter, 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.
　本実施形態のゲル状栄養組成物は、脂質、タンパク質、炭水化物、ビタミン及びミネラルを含み、
１）組成物のエネルギー値が０．８ｋｃａｌ／ｇ以上１．２ｋｃａｌ／ｇ以下であり、
２）タンパク質として組成物１００ｇ当り、全乳タンパク質を１．７ｇ以上、及びカゼインを０．２５ｇ以上含み、
３）前記全乳タンパク質及びカゼインに由来するマグネシウムの合計量が、組成物９００ｋｃａｌ当り１．３ｍｇ以上、及び、前記全乳タンパク質及びカゼインに由来するカルシウムの合計量が、組成物９００ｋｃａｌ当り３４．９ｍｇ以上である、
４）組成物９００ｋｃａｌ当り、２２０ｍｇ以上のマグネシウム及び５００ｍｇ以上のカルシウムを含み、
５）組成物９００ｋｃａｌ当り、ミネラルとして、３０μｇ以上のセレン、１０μｇ以上のクロム、３０μｇ以上のモリブデン及び１３０μｇ以上のヨウ素から選択されるいずれか１以上を含み、
６）寒天を０．１５重量％以上０．４０重量％以下含み、アルギン酸又はその塩を０．１２５重量％以上０．４０重量％以下含み、粘度が３，０００ｍＰａ・ｓ以上１７，０００ｍＰａ・ｓ以下であり、
７）組成物９００ｋｃａｌ当り、クエン酸又はその塩、リン酸又はその塩、及びＥＤＴＡ又はその塩から選択されるキレート剤を合計２．０ｇ以上５．７ｇ以下含み、且つ、組成物９００ｋｃａｌ当り、１．１ｇ以上３．７ｇ未満の前記リン酸又はその塩を含む。 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 μg or more of selenium, 10 μg or more of chromium, 30 μg or more of molybdenum, and 130 μg or more of iodine,
6) Contains 0.15% by weight or more and 0.40% by weight or less of agar, contains 0.125% by weight or more and 0.40% by weight or less of alginic acid or a salt thereof, and has a viscosity of 3,000 mPa s or more and 17,000 mPa s and
7) A total of 2.0 g or more and 5.7 g or less of a chelating agent selected from citric acid or its salts, phosphoric acid or its salts, and EDTA or its salts per 900 kcal of the composition, and 1 per 900 kcal of the composition .1 g or more and less than 3.7 g of the phosphoric acid or its salt.
　全乳タンパク質としては、全乳そのもの、全乳の濃縮物、全乳より調製されたタンパク質、スキムミルク、スキムミルク濃縮物、乳タンパク質濃縮物（ＭＰＣということもある。）、脱脂粉乳より乳糖を除いたもの、総合乳タンパク質等が挙げられ、中でも乳タンパク質濃縮物（例えば、含有タンパク質量約８０～８２％）を用いることが好ましい。
　カゼイン（例えば、含有タンパク質量約９０～９２％）としては、常法により牛乳から分離された乳酸カゼイン、塩酸カゼイン、硫酸カゼイン又はこれらの混合物等の酸カゼイン；カゼインナトリウム、カゼインカルシウム等のカゼイン塩からなるカゼイネート等が挙げられる。 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. Among them, it is preferable to use a milk protein concentrate (eg, about 80 to 82% protein content).
Examples of casein (for example, about 90 to 92% protein content) include 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
　本実施形態のゲル状栄養組成物は、タンパク質として、組成物１００ｇ当り、全乳タンパク質を１．７ｇ以上、好ましくは２．０ｇ以上７．５ｇ以下、より好ましくは２．５ｇ以上６．５ｇ以下、さらに好ましくは３．０ｇ以上５．５ｇ以下含む。また、本実施形態のゲル状栄養組成物は、組成物１００ｇ当り、タンパク質としてカゼインを０．２５ｇ以上、好ましくは０．２５ｇ以上３．６ｇ以下、より好ましくは０．５４以上２．０ｇ以下、さらに好ましくは０．８８ｇ以上１．９ｇ以下含む。
　一態様において、本実施形態のゲル状栄養組成物は、タンパク質のうち全乳タンパク質及びカゼインの割合（タンパク質量換算）が、合計で、７５重量％以上であり、好ましくは８２重量％以上であり、より好ましくは９２重量％以上であり、さらに好ましくは９５重量％以上であり、特に好ましくは９８重量％以上であり、最も好ましくは１００重量％である。 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. In addition, 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.
In one aspect, in the gel nutritional composition of the present embodiment, 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.
　一態様において、本実施形態のゲル状栄養組成物は、動物性タンパク質分解物及び植物性タンパク質分解物のいずれかを含まず、一態様において、本実施形態のゲル状栄養組成物は、動物性タンパク質分解物及び植物性タンパク質分解物をいずれも含まない。動物性タンパク質分解物及び植物性タンパク質分解物はタンパク質を酸や酵素により分解したものであり、分散性が良いため栄養組成物にも用いられているが、過剰に添加すると風味が劣化し、曖気（所謂げっぷ）により不快な匂いを感じる場合がある。 In one aspect, 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.
　本実施形態のゲル状栄養組成物は、タンパク質中、カゼインよりも多く、全乳タンパク質を含む。理論に束縛されるものではないが、この構成により、タンパク質に結合した形でカルシウムを配合することができ、またカゼインにて遊離のマグネシウム及びカルシウムを結合させることで高濃度のマグネシウム及びカルシウムを含有させることができる。 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
　前記カゼインと前記全乳タンパク質との比率は、含有タンパク質の重量比で、１：１．１～１：１３であることが好ましく、１：１．１～１：４．３であることがより好ましく、１：１．１～１：２．９がさらに好ましく、１：２．５～１：２．８が特に好ましい。全乳タンパク質がカゼインより多いと、全乳タンパク質としてマグネシウム及びカルシウムを含有させることができるため多量のミネラルを含有しても安定となり、好ましい。また、全乳タンパク質がカゼインの１３重量倍以下であると、栄養組成物のゲル状態の安定化がより容易になるという観点からも好ましい。なお、上記比率の計算において、全乳タンパク質中に含まれるカゼインについては、カゼインとして抜き出した計算はしないものとする。
　一態様において、本実施形態のゲル状栄養組成物は、タンパク質中のホエイ（全乳タンパク質中に含まれるホエイ以外）が２ｇ／１００ｇ未満であり、好ましくは１ｇ／１００ｇ以下、より好ましくは０．７ｇ／１００ｇ以下であり、さらに好ましくはホエイを含まない。 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.
In one aspect, 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.
　本実施形態のゲル状栄養組成物におけるタンパク質の含有量は、エネルギー比で１３～３０％であることが好ましく、１３～１９％であることがより好ましい。タンパク質の含有量がエネルギー比で３０％超であると、厚生労働省の食事摂取基準のＰＦＣ比の栄養バランスが悪くなる場合があり、また、１３％未満であると、タンパク質摂取量が不足する場合がある。なお、エネルギー比は、４ｋｃａｌ／ｇとして計算するものとする。 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.
　本実施形態のゲル状栄養組成物に含まれる脂質は、一般に経口投与又は経管投与が可能であれば特に限定されない。例えば、大豆油、エゴマ油、シソ油、ヒマワリ油、サフラワー油、藻油、キャノーラ油、パーム油、コーン油、トウモロコシ油、ココヤシ油、オリーブ油、米油等の植物性油脂；魚油、牛脂等の動物性油脂；ＭＣＴ（中性脂肪、中程度の鎖長の脂肪酸）；エイコサペンタエン酸、ドコサヘキサエン酸、リノレン酸、リノール酸等の高度不飽和脂肪酸；等が挙げられる。脂質は１種を単独で用いてもよく、２種以上を混合して用いてもよい。必須脂肪酸の充足の観点から、複数種の脂質を組み合わせて用いることが好ましい。 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. For example, 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.
　本実施形態のゲル状栄養組成物における脂質の含有量は、エネルギー比で３０％以下であることが好ましく、２０％～３０％であることがより好ましい。脂質の含有量がエネルギー比で３０％以下であると、ＰＦＣ比の栄養バランスが良く好ましい。なお、エネルギー比は、９ｋｃａｌ／ｇとして計算するものとする。脂質の含有量がエネルギー比で２０％以上であると、必須脂肪酸を脂質として補給可能となるため好ましい。 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. In addition, 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.
　本実施形態のゲル状栄養組成物に含まれる炭水化物は、一般に経口投与又は経管投与が可能であれば特に限定はされない。例えば、粉あめ、澱粉、デキストリン、マルトデキストリン、ラクトース、スクロース、グルコース、フラクトース、マルトース等が挙げられる。炭水化物は１種を単独で用いてもよく、２種以上を混合して用いてもよい。特に、甘味を抑え、経済的であるという観点から、粉あめ及び／又はマルトデキストリンが好ましい。 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.
　本実施形態のゲル状栄養組成物における炭水化物の含有量はタンパク質及び脂質の配合量から決まり、配合量は適宜変化するが、エネルギー比で５０％～６５％であることが好ましい。炭水化物の含有量がエネルギー比で５０％～６５％であると、ＰＦＣ比の栄養バランスが良くなるため好ましい。なお、エネルギー比は、炭水化物のエネルギーを４ｋｃａｌ／ｇとして計算するものとする。 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.
　本実施形態のゲル状栄養組成物は、ビタミン及びミネラルを含む。ビタミン及びミネラルとしては、例えば、日本人の食事摂取基準（非特許文献１）に記載のものを上げることができる。ビタミンとしては、例えば、ビタミンＡ、ビタミンＤ、ビタミンＥ、ビタミンＫ、ビタミンＢ１、ビタミンＢ２、ナイアシン、ビタミンＢ６、ビタミンＢ１２、葉酸、パントテン酸、ビオチン及びビタミンＣなどが挙げられ、これらのビタミンのうち１種以上が含まれていればよく、全てを含有させることが好ましい。また、ミネラルとしては、例えば、カルシウム、マグネシウム、リン、鉄、亜鉛、銅、マンガン、ヨウ素、セレン、クロム及びモリブデンなどが挙げられる。本実施形態のゲル状栄養組成物は、少なくともマグネシウム、カルシウム、セレン、クロム、モリブデン及びヨウ素を含み、さらに、リン、鉄、亜鉛、銅及びマンガンのうち１種以上を含むことが好ましく、これらの全てを含むことがより好ましい。一態様において、本実施形態のゲル状栄養組成物は、多様なビタミン及びミネラルを含むことで、１日に必要なビタミン、ミネラルを栄養組成物のみから摂取することができる。 The gel nutritional composition of this embodiment contains vitamins and minerals. Examples of vitamins and minerals include those described in Dietary Reference Intakes for Japanese (Non-Patent Document 1). Examples of 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. In one aspect, 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.
　本実施形態のゲル状栄養組成物は、組成物９００ｋｃａｌ当り、マグネシウムを１８歳以上の年齢別の推定平均必要量を満たす最低値（７５歳以上女性）である２２０ｍｇ以上、好ましくは女性に対する推奨量である２９０ｍｇ以上、より好ましくは３１０ｍｇ以上、さらに好ましくは３７０ｍｇ以上含むことができる。このマグネシウムは、例えば全乳タンパク質及びカゼイン等、他の成分に含まれるものであってもよい。マグネシウムを３１０ｍｇ／９００ｋｃａｌ以上含むと１８歳以上の食事摂取基準の推定平均必要量を満たすため好ましく、３７０ｍｇ／９００ｋｃａｌ以上含むと全年齢に対する食事摂取基準の推奨量を満たすことができるためさらに好ましい。マグネシウムの上限は特に限定されないが、例えば、下記のカルシウムの配合上限と同等とすることができ、一態様において、例えばカルシウム量の半分程度とすることができる。 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. Although 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.
　本実施形態のゲル状栄養組成物は、組成物９００ｋｃａｌ当り、カルシウムを１８歳以上の年齢別の推定平均必要量を満たす最低値（７５歳以上女性）である５００ｍｇ以上、好ましくは６５０ｍｇ以上、より好ましくは８００ｍｇ以上含むことができる。例えば、組成物９００ｋｃａｌ当り、カルシウムを、６５０～２５００ｍｇ、好ましくは７００～２５００ｍｇ、より好ましくは７５０～１３３３ｍｇ、さらに好ましくは８００～１２５０ｍｇ、例えば８１５～１２５０ｍｇの範囲で配合することができる。このカルシウムは、例えば全乳タンパク質及びカゼイン等、他の成分に含まれるものであってもよい。カルシウムを６５０ｍｇ／９００ｋｃａｌ以上配合すると１８歳以上の食事摂取基準の推定平均必要量を満たすため好ましく、８００ｍｇ／９００ｋｃａｌ以上となるように配合すると、１８歳以上の食事摂取基準の推奨量を満たすことができるためさらに好ましい。特に、カルシウムを１２５０ｍｇ／９００ｋｃａｌ以下の範囲で配合した場合は、例えば１日あたり１５００ｋｃａｌのエネルギーを摂取する場合であっても、耐容上限量の２５００ｍｇを超えないため好ましく、８００ｍｇ／９００ｋｃａｌとなるように配合した場合は、９００ｋｃａｌ摂取時に推奨量のカルシウムが摂れ、１５００ｋｃａｌ摂取しても耐容上限まで余裕が存在し、他の食品からの摂取も可能となる。また、一態様において、特に、カルシウムを１２５０ｍｇ／９００ｋｃａｌ以下の範囲で配合した場合は、例えば１日あたり１８００ｋｃａｌのエネルギーを摂取する場合であっても、耐容上限量の２５００ｍｇを超えないため好ましく、８００ｍｇ／９００ｋｃａｌとなるように配合した場合は、９００ｋｃａｌ摂取時に推奨量のカルシウムが摂れ、１８００ｋｃａｌ摂取しても耐容上限まで余裕が存在し、他の食品からの摂取も可能となる。 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. Preferably, it can contain 800 mg or more. For example, 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. In one aspect, in particular, when calcium is blended in the range of 1250 mg/900 kcal or less, even if, for example, 1800 kcal of energy is ingested per day, the tolerable upper limit of 2500 mg is not exceeded, so 800 mg is preferable. /900 kcal, 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.
　本実施形態のゲル状栄養組成物は、安定性の観点から、組成物９００ｋｃａｌ当り、前記全乳タンパク質及びカゼインに由来するマグネシウムの合計量が１．３ｍｇ以上であり、また、その上限は３７０ｍｇ以下であることが好ましく、さらに、１３ｍｇ以上であることが好ましく、２０ｍｇ以上であることがより好ましく、３０ｍｇ以上であることがさらにより好ましい。同様に、組成物９００ｋｃａｌ当り、前記全乳タンパク質及びカゼインに由来するカルシウムの合計量は３４．９ｍｇ以上であり、また、その上限は８８０ｍｇ以下であることが好ましく、さらに、８８ｍｇ以上であることが好ましく、２００ｍｇ以上であることがより好ましく、４００ｍｇ以上であることがさらに好ましく、６４０ｍｇ以上であることがさらにより好ましく、７００ｍｇ以上であることが特に好ましい。 From the viewpoint of stability, 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. Similarly, per 900 kcal of the composition, 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.
　本実施形態のゲル状栄養組成物は、ミネラルを含み、セレン、クロム、モリブデン及びヨウ素から選択される１以上のミネラルを含むことが好ましく、これらを全て含むことがより好ましい。特に、組成物９００ｋｃａｌ当り、ミネラルとして、３０μｇ以上のセレン、１０μｇ以上のクロム、３０μｇ以上のモリブデン及び１３０μｇ以上のヨウ素から選択される１以上を含むことが好ましく、これらを全て含むことがより好ましい。 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. In particular, 900 kcal of the composition preferably contains one or more minerals selected from 30 μg or more of selenium, 10 μg or more of chromium, 30 μg or more of molybdenum, and 130 μg or more of iodine, and more preferably all of these.
　上記以外のビタミン及びミネラルの含有量は、好ましくは、食事摂取基準に記載の摂取の推奨量又は目安量を充足するよう設定することができる。以下は、非特許文献１から算出した、各ビタミン及びミネラルの１日当りの食事摂取基準であり、一態様において、組成物９００ｋｃａｌ当り、以下のいずれか１以上、好ましくは５以上、より好ましくは１０以上、さらに好ましくは１５以上、特に好ましくは全てを満たす量を含むことが好ましい。さらには、以下に記載のないビタミン及びミネラルを含んでもよい。 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. In one aspect, 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.
Figure JPOXMLDOC01-appb-T000003
Figure JPOXMLDOC01-appb-T000003
　例えば、１８歳以上の成人の場合、一日の摂取時における各成分の摂取の推奨量・目安量は、以下のとおり設定されている（非特許文献１参照）。
　ビタミンＡ（レチノールパルミチン酸エステル）９００～２７００μｇＲＥ（レチノール当量）、ビタミンＤ（コレカルシフェロール）８．５～１００μｇ、ビタミンＥ（トコフェロール酢酸エステル）７．０～６５０ｍｇ（αトコフェロール換算）、ビタミンＫ１５０μｇ以上、ビタミンＢ１（チアミン塩化物塩酸塩）１．４ｍｇ以上（チアミン換算で１１０１μｇ以上）、ビタミンＢ２（リボフラビン）１．６ｍｇ以上、ナイアシン（ニコチン酸アミド）１５～２５０ｍｇ、ビタミンＢ６（ピリドキシン）１．４～４０ｍｇ、ビタミンＢ１２（シアノコバラミン）２．４μｇ以上、葉酸２４０～９００μｇ、パントテン酸６ｍｇ以上、ビオチン５０μｇ以上、ビタミンＣ（アスコルビン酸）１００ｍｇ以上、リン１０００～３０００ｍｇ、鉄１１～４０ｍｇ、亜鉛１１～３０ｍｇ、マンガン４．０～１１ｍｇ、銅０．９～７ｍｇ、ヨウ素１３０～３０００μｇ、セレン３０～３５０μｇ、クロム１０～５００μｇ、モリブデン３０～５００μｇ。
　これを考慮し、本実施形態のゲル状栄養組成物にビタミン及びミネラルを配合する場合、１日１５００ｋｃａｌ分摂取し得ることを念頭に、組成物９００ｋｃａｌ当り、以下を満たすよう配合することが好ましい。
　ビタミンＡ（レチノールパルミチン酸エステル）９００～１３５０μｇＲＥ、ビタミンＤ（コレカルシフェロール）８．５～５０μｇ、ビタミンＥ（トコフェロール酢酸エステル）７．０～３２５ｍｇ、ビタミンＫ７５μｇ以上、ビタミンＢ１（チアミン塩化物塩酸塩）１．４ｍｇ以上、ビタミンＢ２（リボフラビン）１．６ｍｇ以上、ナイアシン（ニコチン酸アミド）１５～１２５ｍｇ、ビタミンＢ６（ピリドキシン）１．４～２０ｍｇ、ビタミンＢ１２（シアノコバラミン）２．４μｇ以上、葉酸２４０～４５０μｇ、パントテン酸６ｍｇ以上、ビオチン５０μｇ以上、ビタミンＣ（アスコルビン酸）１００ｍｇ以上、リン１０００～１５００ｍｇ、鉄１１～２０ｍｇ、亜鉛１１～１５ｍｇ、マンガン４．０～５．５ｍｇ、銅０．９～３．５ｍｇ、ヨウ素１３０～１５００μｇ、セレン３０～１７５μｇ、クロム１０～２５０μｇ、モリブデン３０～２５０μｇ。
　一態様において、本実施形態のゲル状栄養組成物は、組成物９００ｋｃａｌ当り、ビタミンＢ１を２．７ｍｇ未満含む。 For example, in the case of adults aged 18 years or older, the recommended intake/standard intake of each component in a day is set as follows (see Non-Patent Document 1).
Vitamin A (retinol palmitate) 900-2700 μg RE (retinol equivalent), vitamin D (cholecalciferol) 8.5-100 μg, vitamin E (tocopherol acetate) 7.0-650 mg (alpha tocopherol conversion), vitamin K 150 μg or more , vitamin B 1 (thiamine chloride hydrochloride) 1.4 mg or more (1101 μg or more in terms of thiamine), vitamin B 2 (riboflavin) 1.6 mg or more, niacin (nicotinamide) 15-250 mg, vitamin B 6 (pyridoxine) 1.4-40 mg, vitamin B 12 (cyanocobalamin) 2.4 μg or more, folic acid 240-900 μg, pantothenic acid 6 mg or more, biotin 50 μg or more, vitamin C (ascorbic acid) 100 mg or more, phosphorus 1000-3000 mg, iron 11-40 mg, 11-30 mg zinc, 4.0-11 mg manganese, 0.9-7 mg copper, 130-3000 μg iodine, 30-350 μg selenium, 10-500 μg chromium, 30-500 μg molybdenum.
Considering this, when adding vitamins and minerals to the gel nutritional composition of the present embodiment, it is preferable to add vitamins and minerals so as to satisfy the following per 900 kcal of the composition, keeping in mind that 1500 kcal can be ingested per day.
Vitamin A (retinol palmitate) 900-1350 μg RE, vitamin D (cholecalciferol) 8.5-50 μg, vitamin E (tocopherol acetate) 7.0-325 mg, vitamin K 75 μg or more, vitamin B 1 (thiamine chloride hydrochloride) salt) 1.4 mg or more, vitamin B 2 (riboflavin) 1.6 mg or more, niacin (nicotinamide) 15-125 mg, vitamin B 6 (pyridoxine) 1.4-20 mg, vitamin B 12 (cyanocobalamin) 2.4 μg or more , folic acid 240-450 μg, pantothenic acid 6 mg or more, biotin 50 μg or more, vitamin C (ascorbic acid) 100 mg or more, phosphorus 1000-1500 mg, iron 11-20 mg, zinc 11-15 mg, manganese 4.0-5.5 mg, copper 0 .9-3.5 mg, 130-1500 μg iodine, 30-175 μg selenium, 10-250 μg chromium, 30-250 μg molybdenum.
In one aspect, the gel nutritional composition of this embodiment contains less than 2.7 mg of vitamin B 1 per 900 kcal of composition.
　なお、カリウムは血中濃度上昇傾向がみられる可能性があるため、食事摂取基準よりも低くすることが安全性の面からも好ましい（ＪＪＰＥＮ．　Ｖｏｌ．１９　Ｎｏ．６，１９９７，ｐ５６７－６３３）。
　ナトリウムの濃度は、食塩換算で最低必要量が１．５ｇであり、高血圧で食塩制限がある場合６ｇ未満であることから、想定最大摂取量の１５００ｋｃａｌ摂取時でも食塩相当量にて最大５ｇ以下となるように設定することが好ましい（高血圧治療ガイドライン２００９年版）。
　フィトナジオンは、ワルファリンの相互作用による医療事故を防止する観点から食事摂取基準よりも低くすることが安全性の面からも好ましい。ビタミンＫについても同様の理由により、食事摂取基準である１５０μｇより少なく配合することが好ましい。 Since there is a possibility that the blood concentration of potassium tends to increase, it is preferable to make it lower than the dietary intake standard from the viewpoint of safety (JJPEN. Vol. 19 No. 6, 1997, p567-633). .
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. For the same reason, vitamin K should preferably be blended below the dietary intake standard of 150 μg.
　本実施形態のゲル状栄養組成物において、カルシウムとリンとの質量比（Ｃａ／Ｐ）は、０．７４以上であることが好ましい。Ｃａ／Ｐが０．７４以上であれば、０．７４未満を配合した場合と比較して骨密度が有意に高くなるので好ましい（日本人の食事摂取基準［２０１０年版］、Ｐ２０２）。 In the gel nutritional composition of the present embodiment, the mass ratio of calcium to phosphorus (Ca/P) 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).
　本実施形態のゲル状栄養組成物は、エネルギー値が好ましくは０．８～１．２ｋｃａｌ／ｇ、より好ましくは０．９～１．２ｋｃａｌ／ｇ、さらに好ましくは０．９５～１．１ｋｃａｌ／ｇである。エネルギー値は、上記した各種成分のエネルギー比の範囲内において調整することができる。エネルギー値が０．９ｋｃａｌ／ｇ以上に調整されることで、摂取量を少なくすることができ、投与時間を短縮できるため、被投与者の負担を低減することができる。 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.
　本実施形態のゲル状栄養組成物は、増粘剤として、寒天と、アルギン酸又はその塩を含む。より詳細には、後述する粘度範囲の組成物が得られるよう、寒天を０．１５重量％以上０．４０重量％以下、好ましくは０．２０重量％以上０．４０重量％以下含み、より好ましくは０．３５重量％以下、さらに好ましくは０．３０重量％以下含み、また、アルギン酸又はその塩を（アルギン酸及びその塩類を含む場合は合計、また、アルギン酸の塩の場合、アルギン酸の量に換算する。）０．１２５重量％以上０．４０重量％以下、好ましくは０．１５重量％以上０．４０重量％以下、より好ましくは０．１５重量％以上０．３５重量％以下、さらに好ましくは０．２０重量％以上０．３０重量％以下、含むことができる。添加量が少ないとダマのない均一で状態の良いゲル状とならず、また多量ではゲルが硬くチューブ通過性に問題が生じる。ゲル状（半固形状）とすることで、エネルギー摂取の時間を削減することができ、リハビリ等にその分の時間を用いて回復を早めることも可能となる。本実施形態のゲル状栄養組成物は、寒天とアルギン酸又はその塩を上記の範囲で含み、後述する所定の粘度が得られる限り、他の増粘剤を含むことができるが、一態様において、本実施形態のゲル状栄養組成物は、後述する観点から、増粘剤として寒天とアルギン酸又はその塩のみを含む。 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. contains 0.35% by weight or less, more preferably 0.30% by weight or less, and 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. By making it gel-like (semi-solid), it is possible to reduce the time for energy intake, and it is also possible to use the time for rehabilitation or the like to hasten recovery. 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.
　寒天の種類は、特に限定されるものではなく、日本薬局方収載のカンテンやカンテン末、食品素材としての寒天末、棒寒天、即溶性寒天などを使用することができる。アルギン酸及びその塩類の種類も特に限定されるものではなく、医薬品添加物規格のものや、食品添加物規格のものが使用できる。アルギン酸塩の種類も特に限定されず、ナトリウム塩、カルシウム塩などが使用できる。 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.
　本実施形態のゲル状栄養組成物の粘度は、３０００～１７０００ｍＰａ・ｓであり、好ましくは４０００～１６０００ｍＰａ・ｓであり、より好ましくは４５００～１５０００ｍＰａ・ｓ、さらに好ましくは５０００～１４０００ｍＰａ・ｓ、例えば５０００～１３０００ｍＰａ・ｓ程度である。粘度は、第十七改正　日本薬局方一般試験法　＜２．５３＞　粘度測定法に規定された方法により測定された値を意味する。粘度が低すぎると、離水が生じやすく、また、胃内で形状保持力が弱く、逆流性食道炎等を引き起こしやすくなる。粘度が高すぎると、ゲルが硬く、チューブ通過性に問題が生じやすくなる。 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.
　一態様において、本実施形態のゲル状栄養組成物は、後述の実施例の方法で、ゲル状栄養組成物試料約３０ｇを５０ｍｌカテーテルチップシリンジに充填し、２０Ｆｒ．のＰＥＧチューブをシリンジに装着後、圧縮試験機（ＳＶ－５５Ｃ－２０Ｈ：今田製作所社）を用いて速度６５％でシリンジから排出した際の押し出し力を測定した場合に（測定温度：２０℃）、好ましくは４５Ｎ以下、より好ましくは４０Ｎ以下の押し出し力を有する。 In one aspect, 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.
　寒天と、アルギン酸又はその塩との組合せは、胃内などの酸性条件下でもゲルが崩壊しにくく、食道への逆流を低下させるが、ゲル状栄養組成物の濃度が高く、ミネラル等に由来するイオンが多く含まれる場合、単にこの組み合わせを用いても長期間安定なゲル状組成物は得られないことが判明した。この点、キレート剤を添加又は増量することで、かかる欠点を解消することができると考えていたが、検討したところ、逆に不安定化することがわかった。キレート剤としては、クエン酸又はその塩、リン酸又はその塩、及びＥＤＴＡ又はその塩から選択されるものを用いることができ、例えば、クエン酸ナトリウム（クエン酸二水素ナトリウム、クエン酸二ナトリウム、クエン酸三ナトリウム等）、クエン酸カリウム（クエン酸二水素カリウム、クエン酸二カリウム、クエン酸三カリウム等）のようなクエン酸塩、クエン酸、リン酸カリウム（リン酸二水素カリウム、リン酸二カリウム、リン酸三カリウム等）、リン酸ナトリウム（リン酸二水素ナトリウム、リン酸二ナトリウム、リン酸三ナトリウム等）のようなリン酸塩、ＥＤＴＡを用いることができる。一態様において、好ましくは、クエン酸ナトリウム（クエン酸二水素ナトリウム、クエン酸二ナトリウム、クエン酸三ナトリウム等）、クエン酸カリウム（クエン酸二水素カリウム、クエン酸二カリウム、クエン酸三カリウム等）、クエン酸、リン酸カリウム（リン酸二水素カリウム、リン酸二カリウム、リン酸三カリウム等）、ＥＤＴＡをキレート剤として用いることができ、より好ましくは、クエン酸三ナトリウム、クエン酸三カリウム及びリン酸二カリウムから選択されるキレート剤を用いることができる。 The combination of 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. As the chelating agent, one selected from citric acid or its salts, phosphoric acid or its salts, and EDTA or its salts can be used. trisodium citrate, etc.), 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. In one embodiment, preferably 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.
　キレート剤は、１種を用いることもでき、２種、３種又はそれ以上を用いることもできる。一態様において、クエン酸塩とリン酸塩とを組み合わせて用いることができ、例えば、クエン酸ナトリウム（クエン酸三ナトリウム）及び／又はクエン酸カリウムと、リン酸二カリウムとを組み合わせて用いることができる。 One kind of chelating agent can be used, or two kinds, three kinds or more can be used. In one aspect, 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.
　キレート剤の添加量は、組成物９００ｋｃａｌ当り、非水和物換算で、２．０ｇ以上５．７ｇ以下であり、好ましくは３．０ｇ以上５．７ｇ以下、より好ましくは３．２ｇ以上５．５ｇ以下、さらに好ましくは３．４ｇ以上５．３ｇ以下、特に好ましくは３．６ｇ以上５．１ｇ以下、例えば、５．０ｇ以下とすることができる。キレート剤の量が不足すると、タンパク質溶解が不十分となり得る。また、キレート剤の量が多すぎると組成物（ゲル）が不均一になりうる。 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.
　また、本実施形態の栄養組成物においては、キレート剤中のリン酸又はその塩（例えば、リン酸二カリウム）の含有量が製造性に与える影響が大きい。例えば、組成物９００ｋｃａｌ当り、２．３ｇのリン酸又はその塩が用いられている場合、他のキレート剤（例えば、クエン酸ナトリウム（クエン酸三ナトリウム）及び／又はクエン酸カリウム）が含まれていなくても製造性に問題はなく良好に栄養組成物を作製することができる。このように、キレート剤がリン酸又はその塩が単独である場合、製造性の点で、その含有量は組成物９００ｋｃａｌ当り、２．３ｇ以上であることが好ましい。一方、リン酸又はその塩と他のキレート剤（例えば、クエン酸ナトリウム及び／又はクエン酸カリウム）とを組み合わせる場合には、製造性の点で、その含有量は組成物９００ｋｃａｌ当り、１．１ｇ以上が好ましく、２．３ｇ以上がさらに好ましい。これに対し、リン酸又はその塩の含有量の上限は、ゲルの安定性の観点から、組成物９００ｋｃａｌ当り、３．７ｇ未満であることが好ましい。以上から、組成物の安定性及び製造性の観点から、リン酸又はその塩の含有量は、組成物９００ｋｃａｌ当り、１．１ｇ以上３．７ｇ未満である。 In addition, in the nutritional composition of the present embodiment, the content of phosphoric acid or a salt thereof (eg, dipotassium phosphate) in the chelating agent has a large effect on productivity. For example, if 2.3 g of phosphoric acid or a salt thereof is used per 900 kcal of the composition, other chelating agents (e.g., sodium citrate (trisodium citrate) and/or potassium citrate) are included. Even without it, the nutritional composition can be produced satisfactorily without any problem in productivity. Thus, when 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. On the other hand, 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. The above is preferable, and 2.3 g or more is more preferable. On the other hand, 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. As described above, 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.
　本実施形態のゲル状栄養組成物は、多量のミネラル等を含むため、これに応じた量のキレート剤が必要と考えられたが、予想に反して、キレート剤の量を一定範囲とすることで、長期間安定なゲル状組成物が得られた。上記の観点から、本実施形態のゲル状栄養組成物９００ｋｃａｌ当りのマグネシウム及びカルシウムの合計量（マグネシウム及びカルシウム換算）：キレート剤（非水和物換算）量の重量比は、例えば、１：４．５以下とすることができ、好ましくは１：４．４以下であり、より好ましくは１：４．３以下であり、特に好ましくは１：４．２以下である。また、下限値は、好ましくは１：１以上、さらに好ましくは１：２．４以上である。また、一態様において、本実施形態のゲル状栄養組成物９００ｋｃａｌ又は１００ｇ当りのカルシウム量：キレート剤（非水和物換算）量の重量比は、１：７．０以下とすることができ、好ましくは１：６．５以下であり、より好ましくは１：６．０以下である。下限値は、１：１以上、好ましくは１：３．４以上である。 Since 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. From the above viewpoint, 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. Also, the lower limit is preferably 1:1 or more, more preferably 1:2.4 or more. In one aspect, 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.
　一態様において、本実施形態のゲル状栄養組成物は、ｐＨが５．５より高くｐＨ７．０以下であることが好ましい。この範囲外であると不均一なゲルになりやすく、また、保存時の各種ビタミンの減少が加速し得る。 In one aspect, 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.
　なお、本実施形態のゲル状栄養組成物は、必要に応じて、乳化剤、キレート剤とは異なる塩類、果汁、香料、懸濁化剤、安定化剤などを添加してもよい。例えば、乳化剤としては、レシチン、グリセリン脂肪酸エステル、酵素分解レシチン、ソルビタン脂肪酸エステル、プロピレングリコール脂肪酸エステル、ショ糖脂肪酸エステル等を単独又は組み合わせて用いることができる。 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. For example, 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.
　本実施形態のゲル状栄養組成物は、上記タンパク質、脂質、炭水化物、ビタミン及びミネラルなどの成分に加えて水を含む。本発明のゲル状栄養組成物の製造方法は、所望のゲル状栄養組成物が得られる限り特に限定されず、例えば、以下のとおり製造することができる。
（１）水又は温水に、上記のタンパク質、炭水化物、ビタミン、ミネラル、油脂及び必要に応じて乳化剤を添加し、ホモジナイザーで乳化するなどの方法により液状栄養組成物を調製する。
（２）予め加熱溶解した寒天とアルギン酸又はその塩の溶液を添加混合する。キレート剤は、アルギン酸又はその塩の溶解時に添加すると、溶解補助剤としても機能するが、均一の組成物が得られる限り投与順序等は特に限定されない。
（３）必要に応じて、アルミパウチなどのパウチやソフトバッグなどの容器に充填し、レトルトなどで加熱滅菌して製造する。加熱殺菌方法は、常法に従えばよく、容器も公知の軟質合成樹脂、紙と金属箔との積層体等を適宜用いることができる。
　各成分の投与順序は均一の所望のゲル状栄養組成物が得られる限り特に限定されず、必要に応じて各投与段階で適宜高圧ホモジナイザーを用いてもよい。 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.
(3) If necessary, 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.
　このようにして調製された本実施形態のゲル状栄養組成物は、凝集や沈殿がなく、かつ、例えば２週間、４週間等、長期間室温で保存しても、不均一にならず安定である。本実施形態において、ゲル状栄養組成物が安定であるとは、加熱殺菌してから２週間、又は４週間室温保存後、凝集や沈殿がなく、不均一にならないことをいう。一態様において、本実施形態のゲル状栄養組成物は、２５℃、６５％ＲＨで１３カ月間保存しても不均一にならず安定である。 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. In the present embodiment, 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. In one aspect, 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.
　本実施形態のゲル状栄養組成物は、ゲル状であるため、胃食道逆流を抑制することができ、経腸栄養組成物にも適する。 Since 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.
　以下、本発明を実施例及び比較例によりさらに説明するが、本発明は下記例に制限されるものではない。なお、以下において、栄養組成物（製剤）が「不均一」とは、目視により、ゲル化の層状化、寒天の局所的ゲルが認められた場合、及び／又は、硬さが不均一であったことを意味する。また、このような「不均一」な点が認められなかった栄養組成物を「安定」している（安定性に優れる）と評価した。 The present invention will be further described below with examples and comparative examples, but the present invention is not limited to the following examples. In the following, when the nutritional composition (formulation) 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).
（比較例１：ゲル状栄養組成物に対するビタミン、ミネラルの添加）
　大豆タンパク質をタンパク質として用いたゲル状栄養組成物である、ラコールＮＦ配合経腸用半固形剤（イーエヌ大塚製薬株式会社製造販売）を調製する際に、９００ｋｃａｌ相当量に対して日本人の食事摂取基準（非特許文献１）に基づき、セレン、クロム、モリブデン、コリン、カルニチンを含む、１日分のビタミン及びミネラルの目安量を添加し、混合したところ、局所的なゲル化が発生し、製剤が不均一になった。特に、カルシウム濃度、マグネシウム濃度が高まったことで、局所的なゲル化が発生したと考えられた。 (Comparative Example 1: Addition of vitamins and minerals to gel nutritional composition)
When preparing a semi-solid preparation for enteral use containing Lacol NF (manufactured and sold by EN Otsuka Pharmaceutical Co., Ltd.), which is a gel nutritional composition using soy protein as a protein, Japanese dietary intake for an amount equivalent to 900 kcal Based on the standard (Non-Patent Document 1), a daily recommended amount of vitamins and minerals including selenium, chromium, molybdenum, choline, and carnitine was added and mixed. became uneven. In particular, it was considered that local gelation occurred due to the increase in calcium concentration and magnesium concentration.
（比較例２：液状栄養組成物のゲル化）
　液状栄養組成物であるイノラス配合経腸用液（イーエヌ大塚製薬株式会社製造販売）は１．６ｋｃａｌ／ｍＬ（１００ｍＬ当りの全乳タンパク質量は５．７３ｇであり、同カゼイン量は１．９１ｇ）であるところ、これを製造する際に、１．０ｋｃａｌ／ｇに希釈し、１日分のビタミン及びミネラルを含有する栄養組成物とし、高圧ホモジナイザーで乳化した。その後、加熱溶解した寒天溶液と炭酸カリウムを溶解補助剤として水に溶解したアルギン酸溶液を添加し、１００ｇ当り、寒天及びアルギン酸をそれぞれ０．２５ｇ含む混合物を溶解後添加した。得られた組成物をアルミパウチ容器に充填し、加熱処理して殺菌した。製造後、比較例１と比較して均一なゲルが得られたが部分的に不均一な箇所を認めた。１００ｇ当りの全乳タンパク質量は３．５８ｇであり、同カゼイン量は１．１９ｇであった。クエン酸ナトリウム（クエン酸三ナトリウム二水和物）の量は、９００ｋｃａｌ当り２６６２ｍｇであった。なお、希釈せずにゲル化を試みた場合、性状はより悪化した。 (Comparative Example 2: Gelation of liquid nutritional composition)
The liquid nutritional composition, Inorasu-blended enteral liquid (manufactured and sold by EN Otsuka Pharmaceutical Co., Ltd.), has 1.6 kcal/mL (per 100 mL, the amount of whole milk protein is 5.73 g, and the amount of casein is 1.91 g). However, during production, it was diluted to 1.0 kcal/g, made into a nutritional composition containing vitamins and minerals for one day, and emulsified with a high-pressure homogenizer. Thereafter, 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.
　比較例１及び２の結果から、従来のゲル状栄養組成物に単にビタミン及びミネラルを添加する手法や、従来の液状栄養組成物をゲル化剤でゲル化する手法では、安定で、経管投与にも適した、ビタミン、ミネラルを十分に含むゲル状栄養組成物は得られないことが明らかになった。 From the results of Comparative Examples 1 and 2, the method of simply adding vitamins and minerals to a conventional gel nutritional composition and the method of gelling a conventional liquid nutritional composition with a gelling agent are stable and can be administered through a tube. It has become clear that a gel nutritional composition containing a sufficient amount of vitamins and minerals, which is suitable also for
（比較例３：クエン酸ナトリウムの増量１）
　比較例２のゲル状栄養組成物は、カルシウムイオンをはじめとするイオン濃度が高いため、ゲル状栄養組成物のさらなる安定化を目的として、キレート剤であるクエン酸ナトリウムを１．２５倍に増加した組成物を、クエン酸ナトリウムの量以外は比較例２と同様の手法で作成した。しかしながら、比較例２と同等又は若干の性状及び安定性の悪化がみられた。 (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.
（比較例４：クエン酸ナトリウムの増量２）
　食事摂取基準に基づく、クエン酸ナトリウム量をさらに増やし（比較例２の１．５６倍）、クエン酸ナトリウムの量以外は比較例３と同様の手法でゲル状栄養組成物を作成した。比較例３と比べて、性状及び安定性がさらに悪化した。また、加熱処理時に若干の焦げがみられた。 (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.
（実施例）
　４０～６０℃の温水７．５Ｌ、全乳タンパク質として乳タンパク質濃縮物（タンパク質含量約８０％）８００ｇ、カゼインとしてカゼインナトリウム（タンパク質含量約９０％）２６０ｇ、脂質として乳化剤含有油脂５４０ｇ、炭水化物としてデキストリン２８００ｇ、ビタミン及びミネラルとして下記組成のビタミン及びミネラル混合物を用いて、最終濃度が表３に示すＰＦＣ比、カゼイン：全乳タンパク質比、Ｃａ／Ｐ比、Ｍｇ濃度、Ｃａ濃度、エネルギー量となるように混合した。最終的な栄養組成物１００ｇ当りの乳タンパク質濃縮物は４ｇ、カゼインは１．３ｇであった。 (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.
　ビタミン及びミネラル混合物は、９００ｋｃａｌ当り、ビタミンＡ（レチノールパルミチン酸エステル）：９００μｇＲＥ、ビタミンＢ１（チアミン塩化物塩酸塩）：１．４ｍｇ、ビタミンＢ２（リボフラビン）：１．６ｍｇ、ビタミンＢ６（ピリドキシン）：１．４ｍｇ、ビタミンＢ１２（シアノコバラミン）：４．５μｇ、ビタミンＤ（コレカルシフェロール）：１５μｇ、ビタミンＥ（トコフェロール酢酸エステル）：２２．５ｍｇ、ビタミンＣ（アスコルビン酸）：２００ｍｇ、ナイアシン（ニコチン酸アミド）：１５．０ｍｇ、パントテン酸：６．０ｍｇ、葉酸：２４０μｇ、ビタミンＫ：７５μｇ、ビオチン：５０．０μｇ、リン：１０００ｍｇ、鉄：１１．０ｍｇ、亜鉛：１１．０ｍｇ、銅：０．９ｍｇ、マンガン：４．０ｍｇ、ヨウ素：１３０μｇ、セレン：５０．０μｇ、クロム：４０．０μｇ、モリブデン：３０．０μｇ、の混合物を用いた。
　カルシウム及びマグネシウムについては、全乳タンパク質等他の成分に含まれる分との合計で、表１に記載の量となるよう、乳酸カルシウム水和物及び塩化マグネシウムとして添加した。一例として、実施例２の場合、乳酸カルシウム水和物として９９８ｍｇ、塩化マグネシウムとして２８２８．９ｍｇを添加した。 The vitamin and mineral mixture contains, per 900 kcal, vitamin A (retinol palmitate): 900 μg 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 μg, vitamin D (cholecalciferol): 15 μg, 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 μg, vitamin K: 75 μg, biotin: 50.0 μg, phosphorus: 1000 mg, iron: 11.0 mg, zinc: 11.0 mg, copper: A mixture of 0.9 mg, manganese: 4.0 mg, iodine: 130 μg, selenium: 50.0 μg, chromium: 40.0 μg, molybdenum: 30.0 μg, was used.
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. As an example, in the case of Example 2, 998 mg of calcium lactate hydrate and 2828.9 mg of magnesium chloride were added.
　高圧ホモジナイザーで乳化し、次いで、加熱溶解した寒天溶液と、炭酸カリウムを溶解補助剤として水に溶解したアルギン酸溶液を添加後、加熱処理して殺菌し、ゲル状栄養組成物を得た。寒天濃度及びアルギン酸濃度は、最終濃度が表３の濃度となるように添加した。最終的な栄養組成物９００ｋｃａｌ当りのキレート剤は、表３に示すとおりである。 It was emulsified with a high-pressure homogenizer, then an agar solution dissolved by heating and an alginic acid solution prepared by dissolving potassium carbonate in water as a dissolution aid were added, followed by heat treatment and sterilization to obtain a gel nutritional composition. Agar concentration and alginic acid concentration were added so that the final concentration was as shown in Table 3. The chelating agent per 900 kcal of the final nutritional composition is as shown in Table 3.
　得られた組成物について、以下の方法を用いて粘度及び押し出し力を測定した。一部の組成物については、２週間及び４週間の室温保存後の粘度測定も実施した。
［粘度測定］
　栄養組成物を２０℃で１０分間保存後、２０ｍＬを採取して単一円筒形回転粘度計を用いて、測定した（第十七改正　日本薬局方一般試験法　＜２．５３＞　粘度測定法）。表３、表４に示す粘度はＢ型粘度計、回転数１２ｒｐｍ、２０℃で測定した。
［押し出し力測定］
　ゲル状栄養組成物試料約３０ｇを５０ｍｌカテーテルチップシリンジ（テルモ社）充填し、２０Ｆｒ．のＰＥＧチューブ（バードポンスキーＮ．Ｂ．Ｒ．カテーテル：メディコン社）をシリンジに装着後、圧縮試験機（ＳＶ－５５Ｃ－２０Ｈ：今田製作所社）を用いて速度６５％でシリンジから排出した際の押し出し力を測定した（測定温度：２０℃）。
［ｐＨ測定］
　ｐＨ計を用いて、第十七改正　日本薬局方　ｐＨ測定法＜２．５４＞に基づき測定した。 The resulting 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. After attaching the PEG tube (Bird Pomsky NBR catheter: Medicon) to the syringe, using a compression tester (SV-55C-20H: Imada Seisakusho) when ejecting from the syringe at a speed of 65% was measured (measurement temperature: 20°C).
[pH measurement]
Using a pH meter, it was measured based on the Japanese Pharmacopoeia 17th edition pH measurement method <2.54>.
　得られた実施例のゲル状栄養組成物は、９００ｋｃａｌ相当量に１日分のビタミン及びミネラルの目安量を含み、かつ、４週間保存後～１３カ月間保存後も粘度が低下することなく、極端な離水や不均一な性状も確認されず、安定な組成物であった。 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.
　ＰＦＣ比、寒天・アルギン酸量の異なる様々な組成についても、表３に示す。表３中、粘度、押し出し力及びｐＨは、測定したものについての結果を示し、また、実施例１０－１～１０－３は、異なる製造ロットで作成した例である。実施例２の、１００ｇ当りの全乳タンパク質量は３．５８ｇであり、同カゼイン量は１．１９ｇであった。表３中のキレート剤の量は、いずれもｍｇ／１００ｇの量で表し、水和物換算値である。クエン酸ナトリウムはクエン酸三ナトリウム二水和物（日本薬局方でクエン酸ナトリウム水和物と表記される）、クエン酸カリウムはクエン酸三カリウム一水和物、リン酸二カリウムは無水物を使用した。 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.
　なお、マグネシウム量については、９００ｋｃａｌ当り３７０ｍｇまで配合した例を表３に示しているが、より多い量も容易に配合可能であった。また、原料が天然由来であり、ロットの違いによって最終組成物の粘度が異なるため、粘度は測定値のうち最大値及び最小値を記載した。安定性については、ロットの違いによる影響は少なかった。 Regarding the amount of magnesium, Table 3 shows an example in which up to 370 mg was blended per 900 kcal, but a larger amount could be easily blended. In addition, since 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.
Figure JPOXMLDOC01-appb-T000004
Figure JPOXMLDOC01-appb-T000004
　表３中の実施例１６に記載のゲル状栄養組成物について、寒天とアルギン酸の量を変化させ、粘度を測定した結果を表４に示す。粘度は、３回の測定結果の平均値である。
Figure JPOXMLDOC01-appb-T000005
 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.
Figure JPOXMLDOC01-appb-T000005
　比較例１のゲル状栄養組成物は、主要タンパク質として大豆タンパク質を含むものであり、これにビタミン及びミネラルを添加しても均一な組成物が得られなかった。一方、実施例においては、乳タンパク質濃縮物及びカゼインを主要タンパク質とし、かつ、キレート剤の量を調整することで、カルシウム等のミネラルを多量に含み、かつ安定なゲル状栄養組成物を得ることができたと考えられた。 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. On the other hand, in the examples, 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
　比較例２の液状栄養組成物は、ビタミン、ミネラルがもともと多く含まれているところ、これをゲル化しても、安定なゲル状栄養組成物は得られなかった。ミネラル含量が多いことから、比較例３及び４のとおり、キレート剤の量を増加したが、比較例２と比較して安定性は改善せず悪化した。一方、実施例においては、タンパク質の添加量・種類とともに、ミネラルの添加量を調整し、また、ゲル化に最適なゲル化剤、キレート剤の量を見出したことで、ミネラル等を多量に含むにもかかわらず安定なゲル状栄養組成物を得ることができたと考えられた。 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.
　以下に、代表的な実施例及び比較例におけるマグネシウム量、カルシウム量及びキレート剤量を示す。キレート剤の合計量は、水和物を含まない量で示した。なお、表５に示す実施例及び比較例において、リン酸２カリウムの非水和物の含有量は、２７４９．５ｍｇ／９００ｋｃａｌ（イノラス配合経腸溶液）、２７５３．４ｍｇ／９００ｋｃａｌ（比較例２）、２３２０．２ｍｇ／９００ｋｃａｌ（実施例２６）、２６６３．４ｍｇ／９００ｋｃａｌ（実施例２）であった。
Figure JPOXMLDOC01-appb-T000006
 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. In the examples and comparative examples shown in Table 5, 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). , 2320.2 mg/900 kcal (Example 26) and 2663.4 mg/900 kcal (Example 2).
Figure JPOXMLDOC01-appb-T000006
　さらに、実施例１と同様にして、各実施例及び比較例の栄養組成物を調製した。具体的に、４０～６０℃の温水７．５Ｌ、全乳タンパク質として乳タンパク質濃縮物（タンパク質含量約８０％）８００ｇ、カゼインとしてカゼインナトリウム（タンパク質含量約９０％）２６０ｇ、脂質として乳化剤含有油脂５４０ｇ、炭水化物としてデキストリン２８００ｇ、ビタミン及びミネラルとして下記組成のビタミン及びミネラル混合物を用いて、最終濃度が表６に示すＰＦＣ比、カゼイン：全乳タンパク質比、Ｃａ／Ｐ比、Ｍｇ濃度、Ｃａ濃度、エネルギー量となるように混合した。最終的な栄養組成物１００ｇ当りの乳タンパク質濃縮物は４ｇ、カゼインは１．３ｇであった。 Furthermore, in the same manner as in Example 1, 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.
　ビタミン及びミネラル混合物は、９００ｋｃａｌ当り、ビタミンＡ（レチノールパルミチン酸エステル）：９００μｇＲＥ、ビタミンＢ１（チアミン塩化物塩酸塩）：１．４ｍｇ、ビタミンＢ２（リボフラビン）：１．６ｍｇ、ビタミンＢ６（ピリドキシン）：１．４ｍｇ、ビタミンＢ１２（シアノコバラミン）：４．５μｇ、ビタミンＤ（コレカルシフェロール）：１５μｇ、ビタミンＥ（トコフェロール酢酸エステル）：２２．５ｍｇ、ビタミンＣ（アスコルビン酸）：２００ｍｇ、ナイアシン（ニコチン酸アミド）：１５．０ｍｇ、パントテン酸：６．０ｍｇ、葉酸：２４０μｇ、ビタミンＫ：７５μｇ、ビオチン：５０．０μｇ、リン：１０００ｍｇ、鉄：１１．０ｍｇ、亜鉛：１１．０ｍｇ、銅：０．９ｍｇ、マンガン：４．０ｍｇ、ヨウ素：１３０μｇ、セレン：５０．０μｇ、クロム：４０．０μｇ、モリブデン：３０．０μｇ、の混合物を用いた。
　カルシウム及びマグネシウムについては、全乳タンパク質等他の成分に含まれる分との合計で、表６に記載の量となるよう、乳酸カルシウム水和物及び塩化マグネシウムとして添加した。 The vitamin and mineral mixture contains, per 900 kcal, vitamin A (retinol palmitate): 900 μg 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 μg, vitamin D (cholecalciferol): 15 μg, 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 μg, vitamin K: 75 μg, biotin: 50.0 μg, phosphorus: 1000 mg, iron: 11.0 mg, zinc: 11.0 mg, copper: A mixture of 0.9 mg, manganese: 4.0 mg, iodine: 130 μg, selenium: 50.0 μg, chromium: 40.0 μg, molybdenum: 30.0 μg, was used.
Calcium and magnesium were added as calcium lactate hydrate and magnesium chloride so that the amounts shown in Table 6 were obtained in total with the amounts contained in other ingredients such as whole milk protein.
　高圧ホモジナイザーで乳化し、次いで、加熱溶解した寒天溶液と、炭酸カリウムを溶解補助剤として水に溶解したアルギン酸溶液を添加後、加熱処理して殺菌し、ゲル状栄養組成物を得た。寒天濃度及びアルギン酸濃度は、最終濃度が表６の濃度となるように添加した。最終的な栄養組成物９００ｋｃａｌ当りのキレート剤は、表６に示すとおりである。 It was emulsified with a high-pressure homogenizer, then an agar solution dissolved by heating and an alginic acid solution prepared by dissolving potassium carbonate in water as a dissolution aid were added, followed by heat treatment and sterilization to obtain a gel nutritional composition. Agar concentration and alginic acid concentration were added so that the final concentration was as shown in Table 6. The chelating agent per 900 kcal of the final nutritional composition is as shown in Table 6.
Figure JPOXMLDOC01-appb-T000007
Figure JPOXMLDOC01-appb-T000007
　また、表６中の実施例及び比較例におけるＭＰＣ／カゼイン由来のマグネシウム量、カルシウム量及びキレート剤量、リン酸２カリウム量を示す。キレート剤の合計量及びリン酸２カリウム量は、水和物を含まない量で示した。 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.
Figure JPOXMLDOC01-appb-T000008
Figure JPOXMLDOC01-appb-T000008
　表６及び表７に関し、実施例においては１日のエネルギー摂取量を摂取可能な栄養組成物であって、ビタミン、ミネラルの１日摂取目安量・推奨量を配合可能であり、且つ、ゲル安定性及び均一性に優れたゲル状栄養組成物が得られた。
　一方、比較例１６及び１７においては、一部ゲルが不均一であり、また、製造の際にホモジナイザー通液時に沈殿物による流路の閉塞等が認められ、やや製造性に劣っていた。
　また、比較例７～１５，２０においては、実施例に比して性状及び安定性が低いものであった。また、比較例１８は、製造の際にホモジナイザー通液時に沈殿物による流路の閉塞等が認められ、やや製造性に劣っていた。さらに、比較例１９の栄養組成物は、製造の際にホモジナイザー通液時における沈殿物による流路の閉塞等が頻繁に認められ製造性に劣っていた。 With regard to Tables 6 and 7, in the examples, 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. Thus, a gel nutritional composition having excellent properties and uniformity was obtained.
On the other hand, in 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.
Also, in Comparative Examples 7 to 15 and 20, the properties and stability were lower than those of the Examples. In addition, in 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. Furthermore, 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.
　本発明のゲル状栄養組成物は、１日のエネルギー摂取量を容易に摂取できる安定な栄養組成物であって、しかもビタミン、ミネラルを１日の摂取目安量・推奨量含有しており、さらには、ゲル状であるため摂取や保存が容易で、胃食道逆流を抑止することができ、経腸投与にも適する。本発明のゲル状栄養組成物は、医療、リハビリ、介護等の分野において産業上の利用可能性を有する。 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.

Claims (8)

  1. 　脂質、タンパク質、炭水化物、ビタミン及びミネラルを含み、以下の構成を備える、ゲル状栄養組成物。
    　１）組成物のエネルギー値が０．８ｋｃａｌ／ｇ以上１．２ｋｃａｌ／ｇ以下である；
    　２）タンパク質として組成物１００ｇ当り、全乳タンパク質を１．７ｇ以上、及びカゼインを０．２５ｇ以上含む；
    　３）前記全乳タンパク質及びカゼインに由来するマグネシウムの合計量が、組成物９００ｋｃａｌ当り１．３ｍｇ以上、及び、前記全乳タンパク質及びカゼインに由来するカルシウムの合計量が、組成物９００ｋｃａｌ当り３４．９ｍｇ以上である；
    　４）組成物９００ｋｃａｌ当り、２２０ｍｇ以上のマグネシウム及び５００ｍｇ以上のカルシウムを含む；
    　５）組成物９００ｋｃａｌ当り、ミネラルとして、３０μｇ以上のセレン、１０μｇ以上のクロム、３０μｇ以上のモリブデン及び１３０μｇ以上のヨウ素から選択されるいずれか１以上を含む；
    　６）寒天を０．１５重量％以上０．４０重量％以下含み、アルギン酸又はその塩を０．１２５重量％以上０．４０重量％以下含み、粘度が３，０００ｍＰａ・ｓ以上１７，０００ｍＰａ・ｓ以下である；
    　７）組成物９００ｋｃａｌ当り、クエン酸又はその塩、リン酸又はその塩、及びＥＤＴＡ又はその塩から選択されるキレート剤を合計２．０ｇ以上５．７ｇ以下含み、且つ、組成物９００ｋｃａｌ当り、１．１ｇ以上３．７ｇ未満の前記リン酸又はその塩を含む。     A gel nutritional composition comprising lipids, proteins, carbohydrates, vitamins and minerals and having the following composition.
    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, any one or more selected from 30 μg or more of selenium, 10 μg or more of chromium, 30 μg or more of molybdenum, and 130 μg or more of iodine as minerals;
    6) Contains 0.15% by weight or more and 0.40% by weight or less of agar, contains 0.125% by weight or more and 0.40% by weight or less of alginic acid or a salt thereof, and has a viscosity of 3,000 mPa s or more and 17,000 mPa s is the following;
    7) A total of 2.0 g or more and 5.7 g or less of a chelating agent selected from citric acid or its salts, phosphoric acid or its salts, and EDTA or its salts per 900 kcal of the composition, and 1 per 900 kcal of the composition .1 g or more and less than 3.7 g of the phosphoric acid or its salt.
  2. 　前記カゼインと前記全乳タンパク質との比率が、含有タンパク質の重量比で１：１．１～１：１３である、請求項１に記載のゲル状栄養組成物。 The gel nutritional composition according to claim 1, wherein the ratio of the casein to the whole milk protein is 1:1.1 to 1:13 by weight of the protein contained.
  3. 　前記全乳タンパク質が、乳タンパク質濃縮物である、請求項１又は２に記載のゲル状栄養組成物。 The gel nutritional composition according to claim 1 or 2, wherein the whole milk protein is a milk protein concentrate.
  4. 　動物性タンパク質分解物及び植物性タンパク質分解物を含まない、請求項１～３のいずれか一項に記載のゲル状栄養組成物。 The gel nutritional composition according to any one of claims 1 to 3, which does not contain an animal protein hydrolyzate or a vegetable protein hydrolyzate.
  5. 　組成物中の脂質含有量が、エネルギー比で２０％以上３０％以下であり、
    　組成物中のタンパク質含有量が、エネルギー比で１３％以上３０％以下であり、
    　組成物中の炭水化物含有量が、エネルギー比で５０％以上６５％以下である、請求項１～４のいずれか一項に記載のゲル状栄養組成物。     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 claims 1 to 4, wherein the carbohydrate content in the composition is 50% or more and 65% or less in terms of energy.
  6. 　組成物９００ｋｃａｌ当り、３１０ｍｇ以上のマグネシウム及び６５０ｍｇ以上のカルシウムを含む、請求項１～５のいずれか一項に記載のゲル状栄養組成物。 The gel nutritional composition according to any one of claims 1 to 5, containing 310 mg or more of magnesium and 650 mg or more of calcium per 900 kcal of the composition.
  7. 　組成物９００ｋｃａｌ当り、少なくとも以下のビタミン及びミネラルを含む、請求項１～６のいずれか一項に記載のゲル状栄養組成物。
    Figure JPOXMLDOC01-appb-T000001
         The gel nutritional composition according to any one of claims 1 to 6, which contains at least the following vitamins and minerals per 900 kcal of the composition.
    Figure JPOXMLDOC01-appb-T000001
  8. 　ｐＨが５．５より高くｐＨ７．０以下であり、組成物９００ｋｃａｌ当りのマグネシウム及びカルシウムの合計量：キレート剤量の比が１：４．５以下である、請求項１～７のいずれか一項に記載のゲル状栄養組成物。
          8. The composition according to any one of claims 1 to 7, wherein the pH is higher than 5.5 and not higher than pH 7.0, and the ratio of the total amount of magnesium and calcium to the amount of chelating agent per 900 kcal of the composition is not higher than 1:4.5. The gel nutritional composition according to the item.
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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008069090A (en) * 2006-09-13 2008-03-27 En Otsuka Pharmaceutical Co Ltd Gel-shaped enteral nutrient
JP2010070469A (en) * 2008-09-16 2010-04-02 En Otsuka Pharmaceutical Co Ltd Preservation method of fat-soluble vitamin
JP2010163408A (en) * 2009-01-19 2010-07-29 En Otsuka Pharmaceutical Co Ltd Method for preservation of water-soluble vitamin
WO2019215641A1 (en) * 2018-05-09 2019-11-14 Domalina Pty Ltd ATF the Domalina Unit Trust A consumable gel delivery method for health ingredients

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008069090A (en) * 2006-09-13 2008-03-27 En Otsuka Pharmaceutical Co Ltd Gel-shaped enteral nutrient
JP2010070469A (en) * 2008-09-16 2010-04-02 En Otsuka Pharmaceutical Co Ltd Preservation method of fat-soluble vitamin
JP2010163408A (en) * 2009-01-19 2010-07-29 En Otsuka Pharmaceutical Co Ltd Method for preservation of water-soluble vitamin
WO2019215641A1 (en) * 2018-05-09 2019-11-14 Domalina Pty Ltd ATF the Domalina Unit Trust A consumable gel delivery method for health ingredients

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