WO2014003116A1 - Nutritional composition - Google Patents

Nutritional composition Download PDF

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Publication number
WO2014003116A1
WO2014003116A1 PCT/JP2013/067651 JP2013067651W WO2014003116A1 WO 2014003116 A1 WO2014003116 A1 WO 2014003116A1 JP 2013067651 W JP2013067651 W JP 2013067651W WO 2014003116 A1 WO2014003116 A1 WO 2014003116A1
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WO
WIPO (PCT)
Prior art keywords
nutritional composition
water
amount
kcal
moisture
Prior art date
Application number
PCT/JP2013/067651
Other languages
French (fr)
Japanese (ja)
Inventor
佐伯吾郎
中島綾子
Original Assignee
株式会社明治
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社明治 filed Critical 株式会社明治
Priority to JP2014522678A priority Critical patent/JP6449648B2/en
Priority to CN201380031291.4A priority patent/CN104379172B/en
Priority to SG11201408601PA priority patent/SG11201408601PA/en
Publication of WO2014003116A1 publication Critical patent/WO2014003116A1/en
Priority to HK15105991.1A priority patent/HK1205001A1/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
    • A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
    • 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
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
    • 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
    • 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
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • 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
    • A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
    • 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
    • A23L33/16—Inorganic salts, minerals or trace elements
    • 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
    • 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
    • A23L33/30—Dietetic or nutritional methods, e.g. for losing weight
    • 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
    • A23L5/00—Preparation or treatment of foods or foodstuffs, in general; Food or foodstuffs obtained thereby; Materials therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals

Definitions

  • the present invention relates to a nutritional composition that allows easy adjustment of water content, and particularly to a nutritional composition that is suitable for patients requiring strict water management such as chronic renal failure.
  • Such a patient's diet may be provided by a liquid diet, for which commercially available packed nutritional compositions (liquid diet) are often used.
  • Conventional nutritional compositions with packs are designed mainly by adding (compounding) necessary reinforcing ingredients, such as 1 kcal / ml, based on the amount of heat (energy amount) per unit volume. .
  • conventional nutritional compositions with packs are also commercially available, such as 1.5 kcal / ml, which are designed to have a relatively high concentration that allows intake of a large amount of heat (energy) component.
  • it is designed with a composition that makes it possible to ingest the necessary amount of heat (energy amount) and the necessary fortifying component on the premise that the entire amount is used up as it is.
  • the conventional packed nutritional composition is premised on ingestion as it is or on the premise that it is ingested in combination with several patients at best. Designed. This is rather natural because the benefit of designing a high-concentration liquid food on the premise of dilution at the time of use is not normal.
  • the present inventors have recognized that there is a problem that it is extremely difficult to adjust the amount of water when trying to use such packed nutritional composition for patients who require strict moisture management.
  • Nutritional compositions in packs are designed with the appropriate amount of calorie components and fortifying components (nutrients) added to the amount of water normally required for the general patient. As a result, we have obtained knowledge that it is not assumed that the amount of water may be excessively administered to patients who need proper water management.
  • the subject of this invention is providing the nutrition composition which can adjust a water
  • the present inventors have conducted intensive research, and patients who require strict moisture management do not contain excessive amounts of moisture relative to the necessary amount of calorific component and reinforcing component.
  • the present inventors have found that a nutritional composition having a composition ratio can solve the above-mentioned problems all at once, and as a result of further research, the present invention has been completed.
  • the present invention relates to the following nutritional composition, nutritional composition product, and method for preparing the nutritional composition.
  • a nutritional composition for use in a subject requiring moisture management wherein the composition of the calorie component, the reinforcing component and the moisture in the nutritional composition is less than the calorie and the necessary amount of the reinforcing component for the subject.
  • the nutritional composition having a composition ratio that does not contain an excessive amount of water.
  • the nutritional composition according to the above [1], wherein the subject requiring water management is a dialysis patient.
  • the nutritional composition according to [2] wherein the dialysis patient is a patient with chronic renal failure.
  • the calorific component according to any one of [1] to [3], wherein the calorific component is one or more selected from the group consisting of lipids, proteins, carbohydrates, and hydrolysates thereof.
  • Nutritional composition [5] Any of [1] to [4], wherein the reinforcing component is one or more selected from the group consisting of n-3 fatty acids, palatinose, fructooligosaccharides, dietary fiber, carnitine, and selenium.
  • the nutritional composition according to the present invention is prepared at a higher concentration than the conventional nutritional composition, with the necessary amount of calorie component (energy component) and the amount of water required for strengthening component. Since there is no possibility of excessive water supply, the amount of water required by the patient can be adjusted strictly and simply by adding (mixing and adding) the amount of water that is insufficient in the nutritional composition. can do.
  • the moisture content is excessive in a packed nutrition composition, it is almost impossible to remove and use only the moisture, and conversely, the nutritional composition is reduced so that the moisture content is appropriate.
  • the caloric component and / or the reinforcing component is insufficient, so that it becomes necessary to administer the product separately, for example, as a supplement.
  • supplements are usually administered together with water, which impedes strict water management. It will cause problems such as.
  • the amount of water does not become excessive, and the composition can be used as it is or simply by adding water until the required amount is reached. The necessary amount of water can always be easily and accurately administered together with the reinforcing ingredients.
  • the amount of water contained in the nutritional composition a quantity suitable for calculation and measurement such as a unit of 10 ml, the calculation and measurement of the amount of water added to the nutritional composition is facilitated, and strict moisture management is performed. It can be streamlined even more.
  • the nutritional composition of the present invention is used for patients who require strict moisture management in various medical sites and nursing care sites, etc., but is typically used for enteral nutrition.
  • the enteral nutrition method includes an oral intake method in which nutritional components and the like are replenished from the mouth, and a tube feeding method in which the nutritional components and the like are administered through a tube.
  • tube feeding methods include oral, nasal and vaginal methods.
  • the nutritional composition of the present invention is in the form of a liquid, fluid, jelly or paste, and is typically a liquid or fluid.
  • the classification of the nutritional composition includes ingredient nutrients, digested liquid foods or digestive nutrients, semi-digested liquid foods or semi-digested nutrients, or natural concentrated liquid foods. A liquid diet or digestive nutrient, or a semi-digestible fluid or semi-digestible nutrient.
  • the nutritional composition of the present invention has a water content of 10 to 55 ml, preferably 20 to 50 ml, particularly preferably 30 to 50 ml per 100 kcal of calorie, and has a calorie per unit water content as compared with conventional nutritional compositions. Concentrations of nutrients (nutrients) are high. Examples of the water used in the nutritional composition of the present invention include pure water, purified water, and ion exchange water.
  • the nutritional composition of the present invention is used to administer to a subject in need of strict water management, such as a dialysis patient, a patient with heart disease or anti-diuretic hormone secretion syndrome (SIADH).
  • a subject in need of strict water management such as a dialysis patient, a patient with heart disease or anti-diuretic hormone secretion syndrome (SIADH).
  • SIADH anti-diuretic hormone secretion syndrome
  • Examples include patients.
  • the nutritional composition of the present invention is extremely useful in water management.
  • Examples of patients who need dialysis chronically include patients with chronic renal failure.
  • the nutritional composition of the present invention is used for patients with chronic renal failure.
  • the water content cannot be removed from the body due to the decrease or lack of the renal function of the patient, causing swelling or edema due to overdose. Therefore, limit the daily water intake to about 750 to 1500 ml / day. Is preferred.
  • the calorie intake per day is preferably set to 1000 to 1600 kcal / day (35 kcal / kg / day or more). Therefore, excessive amount of water can be avoided by reducing the amount of water per pack of the nutritional composition in advance, and such shortage can be compensated for when insufficient water is obtained by single administration of the nutritional composition. It is preferable to design the composition as described above, and the nutritional composition of the present invention has a lower moisture content per 100 kcal of heat than the conventional nutritional composition (about 80 to 90 ml).
  • the calorific component is one or more selected from the group consisting of lipids, proteins, carbohydrates, and hydrolysates thereof.
  • Lipids to be blended in the nutritional composition of the present invention include vegetable oils such as soybean oil, palm oil, palm fractionation oil and olive oil, animal fats such as milk fat, pork fat and fish oil, oleic acid, linolenic acid and Examples include free fatty acids such as ⁇ -linolenic acid, and preferable examples include soybean oil and palm oil.
  • the amount of lipid blended is preferably in the range of 0 to 4%, more preferably in the range of 2.2 to 3.3%, preferably from the viewpoint of the average intake of healthy Japanese It is in the range of 0 to 30%, more preferably in the range of 20 to 25% of the total calorie (energy amount) of the nutritional composition.
  • the protein to be blended in the nutritional composition of the present invention includes vegetable proteins such as soybean protein, animal proteins such as casein and whey protein, preferably soybean protein, casein and whey protein. In addition, hydrolysates of these proteins may be used, and these proteins and hydrolysates thereof may be used alone or in combination.
  • the amount of protein blended is preferably in the range of 2 to 10%, more preferably in the range of 3 to 6.5%. From the viewpoint of the average intake of healthy Japanese, preferably the nutritional composition It is in the range of 12 to 40%, more preferably in the range of 16 to 25% of the total heat amount (energy amount) of the product.
  • the carbohydrate to be blended in the nutritional composition of the present invention includes dextrin, sucrose, lactose and oligosaccharide, preferably dextrin, sucrose and palatinose. Moreover, hydrolysates of these carbohydrates may be used, and these carbohydrates and hydrolysates may be used alone or in combination of two or more.
  • the amount of the carbohydrate is preferably in the range of 5 to 20%, more preferably in the range of 10 to 15%. From the viewpoint of the average intake of healthy Japanese, the nutritional composition is preferably It is in the range of 20 to 80% of the total heat amount (energy amount), more preferably in the range of 40 to 60%.
  • the nutritional composition of the present invention may contain ingredients that are useful in patients with chronic renal failure, and such useful ingredients may be enriched, that is, included in an amount greater than that contained in normal nutritional compositions. .
  • a component is also referred to as a “strengthening component”.
  • the reinforcing component is blended so as to be contained in the nutritional composition of the present invention at a high concentration of, for example, about 1.5 to 5 times, preferably about 2 to 3 times, as compared with a normal nutritional composition. Is done.
  • the nutritional composition of the present invention is enriched with one or more components selected from the group consisting of n-3 fatty acids, palatinose, fructooligosaccharides, dietary fiber, carnitine and selenium. Particularly preferably, carnitine and / or selenium is used as the reinforcing component.
  • the risk of myocardial infarction and arteriosclerotic renal artery stenosis can be reduced.
  • DHA docosahexaenoic acid
  • EPA eicosapentaenoic acid
  • the content thereof is preferably 10 to 40 mg / 100 kcal, preferably 10 to 30 mg / 100 kcal, particularly preferably 20 to 30 mg / 100 kcal.
  • the content is preferably 5 to 50 mg / 100 kcal, preferably 10 to 40 mg / 100 kcal, particularly preferably 20 to 40 mg / 100 kcal.
  • the energy ratio of palatinose in the saccharide contained in the nutritional composition of the present invention is preferably 40-60 kcal / 100 kcal, more preferably 45-55 kcal / 100 kcal, and 45-50 kcal / 100 kcal. Is particularly preferred.
  • fructooligosaccharide By strengthening fructooligosaccharide and / or dietary fiber, it is possible to improve a decrease in stool properties due to water restriction and disturbance of the intestinal flora.
  • its content is preferably 0.1 to 0.5 g / 100 kcal, and preferably 0.2 to 0.4 g / 100 kcal. Particularly preferred.
  • the dietary fiber content is preferably 1.0 to 3.0 g / 100 kcal, preferably 1.0 to 2.0 g / 100 kcal since the daily intake is preferably 20 to 25 g / day. Is particularly preferred.
  • the carnitine content may be 5 to 100 mg / 100 kcal, preferably 15 to 100 mg / 100 kcal, more preferably 20 to 50 mg / 100 kcal, and still more preferably 20 to 30 mg / 100 kcal.
  • the selenium content is preferably 2 to 15 ⁇ g / 100 kcal, preferably 5 to 15 ⁇ g / 100 kcal, more preferably 5 to 10 ⁇ g / 100 kcal, still more preferably 7 to 10 ⁇ g / 100 kcal.
  • the nutritional composition of the present invention does not contain various minerals or is mixed in a manner that is lower than conventional ones. That is, various minerals are blended so as to be included in the nutritional composition of the present invention in a small amount as compared with a normal nutritional composition.
  • one or more mineral components selected from the group consisting of potassium, phosphorus and calcium are reduced.
  • the potassium content since the daily intake is preferably 40 to 70 mEq / day, it is preferably 30 to 100 mg / 100 kcal, preferably 30 to 80 mg / 100 kcal, particularly preferably 30 to 60 mg. / 100 kcal.
  • the phosphorus content is preferably from 30 to 80 mg / 100 kcal, more preferably from 30 to 60 mg / 100 kcal since the daily intake is preferably 8 to 17 mEq / day.
  • the calcium content is preferably 30 to 80 mg / 100 kcal, more preferably 30 to 60 mg / 100 kcal since the daily intake is preferably 1400 to 1600 mEq / day.
  • the nutritional composition of the present invention typically has a protein amount of 3.0 to 5.0 g / 100 kcal, preferably 3.0 to 4.0 g / 100 kcal, particularly preferably 3.5. -4.0 g / 100 kcal.
  • a protein amount of 3.0 to 5.0 g / 100 kcal, preferably 3.0 to 4.0 g / 100 kcal, particularly preferably 3.5. -4.0 g / 100 kcal.
  • the protein energy ratio is 12 to 20 kcal / 100 kcal, preferably 12 to 16 kcal / 100 kcal, particularly preferably 14 to 16 kcal / 100 kcal, and the lipid energy ratio is 20 to 40 kcal / 100 kcal, preferably 25 -40 kcal / 100 kcal, particularly preferably 30-40 kcal / 100 kcal.
  • the remaining necessary energy is mainly supplemented with carbohydrates.
  • the nutritional composition of the present invention is typically housed in a sealed container and can be a nutritional composition product.
  • the sealed container means a sealed container (closed pack) for shutting off the nutritional composition as the contents and the outside world, and the form of the container is typically a pack, a retort pouch, a soft A bag, a fixed container, a can, etc. are mentioned, Preferably, they are a pack, a retort pouch, and a soft bag.
  • Typical examples of the material of the container include paper, plastic, glass and metal, and preferably paper, plastic and metal.
  • the container may be provided with one or two or more narrow mouth portions for spilling and / or mixing, and the narrow mouth portion is sealed before use, and in use, the nutrition composition It may be provided with a mechanism capable of being directly connected to a tube or other narrow mouth portion of a container of other nutritional composition.
  • the nutritional composition of the present invention By making the container filled with the nutritional composition of the present invention into the above-mentioned sealed container, the nutritional composition is not greatly opened to the patient or added with water, or only the minimum narrow mouth part is opened. This makes it possible to prevent contamination by minimizing contact with outside air.
  • the present invention is a pack of nutritional composition product containing the nutritional composition of the present invention, wherein the nutritional composition has a carnitine content of 5 to 100 mg per 100 kcal of calorie and a selenium content of 2 to
  • the present invention relates to the nutritional composition product, which has a composition of 15 ⁇ g, a water content of 10 ml to 55 ml, and one or more packs of the product required for use, but does not require removal of water.
  • the content of carnitine and / or selenium can be changed as appropriate, but when administered for the purpose of strengthening these components, there is no excess of water, that is, the amount of water is appropriate or insufficient. It is contained in such a composition ratio.
  • this invention is a preparation method of the nutritional composition for using for the object which needs water management in one aspect
  • the nutritional composition of this invention uses 1 or 2 packs or more of quantity required for object.
  • the present invention relates to the preparation method, comprising a step of calculating a water amount when a calorie component and a strengthening component are administered, and a step of adding a deficient amount of water when the calculated water amount is insufficient for a target amount. Even when a calorie component and a strengthening component are administered to an object requiring moisture management such as a patient using a plurality of packs, the composition ratio is such that the moisture does not become excessive. When preparing a composition, the moisture can only be in an appropriate amount or in a state where the moisture is insufficient.
  • the water added when using the nutritional composition of the present invention includes pure water, purified water, ion-exchanged water, and the like.
  • the term “in use” as used herein means when the nutritional composition is administered, that is, not only immediately before and during administration but also immediately after administration. Therefore, the moisture of the nutritional composition is increased by the moisture added at the time of use, and the nutritional composition adhering to the inner wall of the container is washed with water (flushing), and the moisture is given to the patient together with the nutritional composition. It means to include administration.
  • the moisture added at the time of use may be measured in advance and may be stored in a container different from the nutritional composition, and may be measured and used when added.
  • the water added during use is also preferably an integral multiple of the same unit water content.
  • the unit moisture amount can be measured and calculated more easily.
  • the amount of water used by doctors is usually 30 ml or 50 ml per kg of body weight per day. In some cases, 15 ml / kg ⁇ DW * / day ( * : standard body weight with proper body water content) may be used.
  • the amount of water contained in one pack of the nutritional composition product of the present invention is not particularly limited. For example, for dialysis patients, it should be an integer multiple of 5 ml, an integer multiple of 10 ml, an integer multiple of 50 ml, or an integer multiple of 100 ml. Thus, the calculation of the amount of water to be added is simplified, and it is preferable that 50 ml, 100 ml, 150 ml or 200 ml of water is typically contained in one pack.
  • Sodium, lipids, proteins, carbohydrates, vitamins, minerals and the like to be blended in the nutritional composition of the present invention are not particularly limited as long as they are normally used in the fields of foods and beverages and pharmaceuticals. It is preferable to use those approved by the Ministry of Labor as raw materials and additives for foods and pharmaceuticals.
  • Lipids to be blended in the nutritional composition of the present invention include vegetable oils such as soybean oil, palm oil, palm fractionation oil and olive oil, animal fats such as milk fat, pork fat and fish oil, and oleic acid, linolenic acid and Examples include free fatty acids such as ⁇ -linolenic acid, preferably soybean oil and palm oil. Moreover, you may use these lipids by 1 type (s) or 2 or more types.
  • Examples of the protein blended in the nutritional composition of the present invention include vegetable proteins such as soybean protein, animal proteins such as casein and whey protein, and preferably soybean protein, casein and whey protein.
  • hydrolysates of these proteins may be used, and these proteins and hydrolysates thereof may be used alone or in combination.
  • Examples of the carbohydrate to be blended in the nutritional composition of the present invention include dextrin, sucrose, lactose and oligosaccharide, preferably dextrin, sucrose and palatinose.
  • hydrolysates of these carbohydrates may be used, and these carbohydrates and hydrolysates may be used alone or in combination of two or more.
  • Vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, pantothenic acid, vitamin C and the like are preferable as vitamins to be blended in the nutritional composition of the present invention, preferably examples thereof include vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, pantothenic acid and vitamin C. Moreover, you may use these vitamins by 1 type (s) or 2 or more types.
  • Sodium sources of the nutritional composition of the present invention include sodium acetate, sodium chloride, sodium citrate, sodium hydroxide, sodium carbonate, sodium bicarbonate, monosodium hydrogen phosphate, disodium hydrogen phosphate, sodium metaphosphate, Examples include sodium pyrophosphate and sodium tripolyphosphate, preferably sodium chloride and sodium citrate. Moreover, you may use these sodium supply sources by 1 type, or 2 or more types.
  • Examples of minerals other than sodium to be blended in the nutritional composition of the present invention include calcium, iron, phosphorus, magnesium, potassium, copper and zinc, and preferably calcium, phosphorus, magnesium, potassium and the like. Moreover, you may use these minerals by 1 type (s) or 2 or more types.
  • the nutritional composition of the present invention may contain dietary fiber, examples of water-soluble dietary fiber include indigestible dextrin and reduced indigestible dextrin, and examples of water-insoluble dietary fiber include cellulose. Etc. Furthermore, the nutritional composition of the present invention can contain various flavors, sweeteners and other additives.
  • the pH of the nutritional composition of the present invention is preferably in the range of pH 3 to 11, more preferably in the range of 4 to 10, still more preferably in the range of 5 to 9, from the viewpoint of flavor and physical properties. , Substantially seven. Moreover, in order to adjust pH, you may contain pH adjusters, such as a citric acid.
  • the osmotic pressure of the nutritional composition of the present invention is preferably in the range of 200 to 800 mOsm / L, more preferably 300 to 750 mOsm / L, from the viewpoint of preventing digestive symptoms such as diarrhea and abdominal pain due to high osmotic pressure. Range.
  • the nutritional composition of the present invention can be prepared according to conventional methods known in the art.
  • each component is weighed, mixed well with water, and then emulsified, and the nutritional composition is preliminarily heat sterilized and then aseptically filled into a container (for example, UHT sterilization method and aseptic packaging method) Or a method in which the nutritional composition is filled in a container and then sterilized with heat (for example, a retort sterilization method).
  • a container for example, UHT sterilization method and aseptic packaging method
  • a method in which the nutritional composition is filled in a container and then sterilized with heat (for example, a retort sterilization method).
  • the nutritive composition in a container of the present invention can be commercialized as a kit with, for example, moisture for addition that has been measured in advance and stored in another container.
  • a kit with, for example, moisture for addition that has been measured in advance and stored in another container.
  • Example 1 Each raw material shown in Table 1 below was put into pure water at about 60 ° C. and mixed, and then the mixed solution was put into a homomixer and rough emulsified at about 5000 rpm for 10 minutes. Subsequently, after heating to 90 degreeC and leaving still for 5 minutes, fine emulsification (20 kgf / cm ⁇ 2 >) was performed with the high pressure emulsifier. The obtained emulsified liquid was cooled to about 20 ° C., vitamins, minerals and flavors were added, and the volume was increased to obtain the nutritional composition (AD type) of the present invention. Table 2 shows each component of the obtained nutritional composition.
  • Example 2 Each of the A to D type nutritional compositions obtained in Example 1 above was filled into a sealed plastic container having a connection port for enteral nutrition, and then retort sterilized (preheated at 80 ° C., sterilized. 121 ° C., 9 minutes and 30 seconds) to prepare nutritional compositions A to D in containers.
  • Each physical property value of the obtained nutritional composition in a container satisfied the product specification value, and no significant changes such as thickening, precipitation formation and fat separation were observed even after long-term storage.
  • (2) Prepare 25 ml of water.
  • the nutritive composition A in a container is connected to a tube and administered by tube.
  • the nutrient composition A remaining on the inner wall of the container after administration is poured with 25 ml of water prepared in the above (2).
  • a dialysis patient is administered by tube with a calorie of 400 kcal and a water content of 300 ml as a serving.
  • the nutritive composition B in a container is connected to a tube and administered by tube. (4) Pour the nutrient composition B remaining on the inner wall of the container after administration with 100 ml of water prepared in (2) above.
  • the nutritional composition of the present invention can administer a small amount of water relative to the amount of heat, such as “heat amount 300 kcal, water amount 100 ml” or “heat amount 400 kcal, water amount 300 ml”.
  • a conventional nutritional composition adjusted to 1 kcal / ml cannot be used for administration with a small amount of water such as “heat amount 300 kcal, water amount 100 ml” or “heat amount 400 kcal, water amount 300 ml” in the first place.
  • the amount of water is a fraction, even when administering a large amount of water (for example, “300 ml of heat, 350 ml of water”, etc.), the calculation of the amount of water is complicated. Strict moisture management is difficult.
  • the nutritional composition of the present invention can easily calculate the amount of water, and can eliminate an error in dosage due to a calculation error.
  • a nutritional composition suitable for administration to a patient requiring strict water management, particularly in chronic dialysis patients such as renal insufficiency patients. Errors such as administration of excessive water can be reduced or avoided.

Abstract

The problem of the present invention is to provide a nutritional composition with which a health care provider or a patient can easily and precisely perform strict water content management, which is difficult with conventional nutritional compositions. The present invention relates to a nutritional composition for use in a subject requiring water content management, wherein the composition ratio of the caloric ingredients, fortifying ingredients, and water in the nutritional composition is such that the composition does not contain excess water in relationship to the caloric and fortifying ingredients required by a subject. The present invention also relates to a nutritional composition product in packet form containing the nutritional composition and a method for producing the nutritional composition.

Description

栄養組成物Nutritional composition
　本発明は、水分調整が容易な栄養組成物、とくに慢性腎不全などの厳格な水分管理を必要とする患者用として好適な栄養組成物に関する。 The present invention relates to a nutritional composition that allows easy adjustment of water content, and particularly to a nutritional composition that is suitable for patients requiring strict water management such as chronic renal failure.
　慢性腎不全の患者では、塩分や水分を排泄できないため、体内に水分が貯留しやすく、高血圧、心不全などの症状がしばしば生じる。このため、水分の貯留を抑えられるよう、他の病態の患者より特に厳しい水分管理が必要とされている。このような患者の食事は、流動食により与えられることがあるが、それには、市販のパック入り栄養組成物（流動食）がしばしば用いられている。 In patients with chronic renal failure, salt and water cannot be excreted, so water tends to accumulate in the body, and symptoms such as hypertension and heart failure often occur. For this reason, especially severe water management is needed compared with the patient of another disease state so that accumulation of water can be controlled. Such a patient's diet may be provided by a liquid diet, for which commercially available packed nutritional compositions (liquid diet) are often used.
　従来のパック入り栄養組成物では、主として、１ｋｃａｌ／ｍｌなどのように、単位容量当たりの熱量（エネルギー量）を基準にして、必要な強化成分などを添加（配合）することで設計されている。また、従来のパック入り栄養組成物では、１．５ｋｃａｌ／ｍｌなどのように、熱量（エネルギー量）成分を多量に摂取可能にした比較的に高濃度に設計されたタイプも市販されているが、一般に、そのままの濃度で全量を使い切ることを前提として、必要な熱量（エネルギー量）と必要な強化成分を摂取可能にした組成で設計されている。 Conventional nutritional compositions with packs are designed mainly by adding (compounding) necessary reinforcing ingredients, such as 1 kcal / ml, based on the amount of heat (energy amount) per unit volume. . In addition, conventional nutritional compositions with packs are also commercially available, such as 1.5 kcal / ml, which are designed to have a relatively high concentration that allows intake of a large amount of heat (energy) component. In general, it is designed with a composition that makes it possible to ingest the necessary amount of heat (energy amount) and the necessary fortifying component on the premise that the entire amount is used up as it is.
　一方、一般の患者や要介護者などの多種多様な対象者に投与する栄養組成物において、栄養組成物同士を組み合わせて、熱量（エネルギー量）、水分量、食塩換算量（ナトリウム量）などを簡便に調節することができる栄養組成物について検討されているが（特許文献１）、厳格な水分管理を要する患者用の栄養組成物としては、その水分量の調整などの点で必ずしも十分とはいえない。 On the other hand, in nutritional compositions to be administered to a wide variety of subjects such as general patients and care recipients, combining nutritional compositions together, the amount of heat (amount of energy), the amount of water, the amount in terms of salt (amount of sodium), etc. Although a nutritional composition that can be easily adjusted has been studied (Patent Document 1), as a nutritional composition for patients requiring strict moisture management, it is not necessarily sufficient in terms of adjustment of the amount of water. I can't say that.
国際公開第２００９／１３９１６７号International Publication No. 2009/139167
　上記の通り、従来のパック入り栄養組成物では、そのままの状態で摂取させることを前提にするか、または、せいぜい様々な患者などを対象に、いくつかをそのまま組み合わせて摂取させることを前提にして設計されている。このことは、使用時の希釈を前提としてわざわざ高濃度の流動食を設計する利益は、通常ではあり得ないことからすればむしろ当然のことといえる。本発明者らは、かかるパック入り栄養組成物を厳格な水分管理を要する患者を対象に用いようとすると、水分量の調整が極めて困難であるという問題が所在することを認識したところ、従来のパック入り栄養組成物では、一般の患者などを対象に通常で必要とされる水分量に対し、必要な熱量成分や強化成分（栄養成分）などの適量を配合して設計されているため、厳格な水分管理を要する患者を対象に、水分量が過剰に投与される場合があり得ることを想定していないという知見を得るに至った。より具体的には、従来の栄養組成物をそのままの組成比で用いる場合には、熱量成分および／または強化成分を必要量で投与すると、水分の投与量が過剰となり、逆に水分量が適量となるように、栄養組成物を減量制御して投与すると、熱量成分および／または強化成分が不足するため、別途、熱量成分および／または強化成分を用意する必要があるなどのように、実用性に乏しいという、全く新たな問題に直面した。
　したがって、本発明の課題は、従来の問題点を解決して、熱量成分および／または強化成分を投与する際、より容易に水分を調整できる栄養組成物を提供することにある。 As mentioned above, the conventional packed nutritional composition is premised on ingestion as it is or on the premise that it is ingested in combination with several patients at best. Designed. This is rather natural because the benefit of designing a high-concentration liquid food on the premise of dilution at the time of use is not normal. The present inventors have recognized that there is a problem that it is extremely difficult to adjust the amount of water when trying to use such packed nutritional composition for patients who require strict moisture management. Nutritional compositions in packs are designed with the appropriate amount of calorie components and fortifying components (nutrients) added to the amount of water normally required for the general patient. As a result, we have obtained knowledge that it is not assumed that the amount of water may be excessively administered to patients who need proper water management. More specifically, when the conventional nutritional composition is used in the composition ratio as it is, if the calorie component and / or the fortifying component are administered in the required amount, the amount of water will be excessive, and conversely the amount of water will be appropriate. Therefore, if the nutritional composition is administered while controlling the weight reduction, the calorie component and / or the strengthening component are insufficient, so that it is necessary to prepare the calorie component and / or the strengthening component separately. I was faced with a completely new problem.
Therefore, the subject of this invention is providing the nutrition composition which can adjust a water | moisture content more easily when solving a conventional problem and administering a calorie | heat amount component and / or a reinforcement | strengthening component.
　本発明者らは、上記の問題を解決すべく、鋭意研究を重ねる中で、厳格な水分管理を要する患者などには、熱量成分および強化成分の必要量に対し、水分量を過剰に含まない組成比とする栄養組成物であれば、上記の問題を一挙に解決できることを見出し、さらに研究を進めた結果、本発明を完成するに至った。 In order to solve the above-mentioned problems, the present inventors have conducted intensive research, and patients who require strict moisture management do not contain excessive amounts of moisture relative to the necessary amount of calorific component and reinforcing component. The present inventors have found that a nutritional composition having a composition ratio can solve the above-mentioned problems all at once, and as a result of further research, the present invention has been completed.
　すなわち本発明は、以下の栄養組成物、栄養組成物製品および栄養組成物の調製方法に関する。
［１］　水分管理の必要な対象に用いるための栄養組成物であって、該栄養組成物中の熱量成分、強化成分および水分の組成が、該対象にとっての熱量および強化成分の必要量に対し、水分量を過剰に含まない組成比である、前記栄養組成物。
［２］　水分管理の必要な対象が、透析患者である、前記［１］に記載の栄養組成物。
［３］　透析患者が、慢性腎不全患者である、前記［２］に記載の栄養組成物。
［４］　熱量成分が、脂質、タンパク質、炭水化物、およびそれらの加水分解物からなる群より選ばれる１種または２種以上である、前記［１］～［３］のいずれか一項に記載の栄養組成物。
［５］　強化成分が、ｎ－３系脂肪酸、パラチノース、フラクトオリゴ糖、食物繊維、カルニチンおよびセレンからなる群から選択される１種または２種以上である、前記［１］～［４］のいずれか一項に記載の栄養組成物。 That is, the present invention relates to the following nutritional composition, nutritional composition product, and method for preparing the nutritional composition.
[1] A nutritional composition for use in a subject requiring moisture management, wherein the composition of the calorie component, the reinforcing component and the moisture in the nutritional composition is less than the calorie and the necessary amount of the reinforcing component for the subject. The nutritional composition having a composition ratio that does not contain an excessive amount of water.
[2] The nutritional composition according to the above [1], wherein the subject requiring water management is a dialysis patient.
[3] The nutritional composition according to [2], wherein the dialysis patient is a patient with chronic renal failure.
[4] The calorific component according to any one of [1] to [3], wherein the calorific component is one or more selected from the group consisting of lipids, proteins, carbohydrates, and hydrolysates thereof. Nutritional composition.
[5] Any of [1] to [4], wherein the reinforcing component is one or more selected from the group consisting of n-3 fatty acids, palatinose, fructooligosaccharides, dietary fiber, carnitine, and selenium. A nutritional composition according to claim 1.
［６］　前記［１］～［５］のいずれか一項に記載の栄養組成物を含有するパック入り栄養組成物製品であって、該栄養組成物が、熱量１００ｋｃａｌあたりの水分量が１０ｍｌ～５５ｍｌであり、かつ使用時に前記製品が1または２パック以上で必要とされるが、水分の除去を必要としない組成である、前記栄養組成物製品。
［７］　強化成分として、カルニチンを含み、熱量１００ｋｃａｌあたりのカルニチン含量が１５～１００ｍｇである、前記［６］に記載の栄養組成物製品。
［８］　強化成分として、セレンを含み、熱量１００ｋｃａｌあたりのセレン含量が５～１５μｇである、前記［６］または［７］に記載の栄養組成物製品。
［９］　１パックに含まれる水分量が、５ｍｌ、１０ｍｌ、５０ｍｌまたは１００ｍｌの整数倍である、前記［６］～［８］のいずれか一項に記載の栄養組成物製品。
［１０］　水分管理の必要な対象に用いるための栄養組成物の調製方法であって、
前記［６］～［９］のいずれか一項に記載の栄養組成物製品を１または２パック以上を用いて対象に必要量の熱量成分および強化成分を投与した場合の水分量を算出する工程、
算出した水分量が、対象の必要量に不足する場合に不足分の水分を添加する工程
を含む、前記調製方法。 [6] A packaged nutritional composition product containing the nutritional composition according to any one of [1] to [5], wherein the nutritional composition has a water content per 10 calories of heat of 10 ml or more. 55. The nutritional composition product of 55 ml and a composition that requires one or more packs of the product when used but does not require moisture removal.
[7] The nutritional composition product according to [6] above, which contains carnitine as a reinforcing component and has a carnitine content of 15 to 100 mg per 100 calories.
[8] The nutritional composition product according to [6] or [7] above, which contains selenium as a reinforcing component and has a selenium content of 5 to 15 μg per 100 kcal of heat.
[9] The nutritional composition product according to any one of [6] to [8], wherein the amount of water contained in one pack is an integer multiple of 5 ml, 10 ml, 50 ml, or 100 ml.
[10] A method for preparing a nutritional composition for use in a subject requiring moisture management,
A step of calculating the amount of water when the necessary amount of caloric component and reinforcing component are administered to a subject using one or more packs of the nutritional composition product according to any one of [6] to [9] above ,
The said preparation method including the process of adding the water | moisture content of a shortage, when the calculated water | moisture content is inadequate to the required amount of object.
　本発明にかかる栄養組成物は、上記の構成のとおり、従来の栄養組成物よりも必要な熱量成分（エネルギー量成分）量および強化成分量が必要な水分量に対し、高濃度に調製してあるので、水分が過剰に供給されるということがあり得ないため、栄養組成物において不足する水分量を添加（配合、追加）するだけで、患者に必要な水分量を厳格にかつ簡便に調整することができる。 As described above, the nutritional composition according to the present invention is prepared at a higher concentration than the conventional nutritional composition, with the necessary amount of calorie component (energy component) and the amount of water required for strengthening component. Since there is no possibility of excessive water supply, the amount of water required by the patient can be adjusted strictly and simply by adding (mixing and adding) the amount of water that is insufficient in the nutritional composition. can do.
　パック入り栄養組成物において、水分量が過剰な場合には、水分のみを除去して用いることは凡そ不可能であるし、また逆に、水分量が適量となるように、栄養組成物を減量制御して投与すると、熱量成分および／または強化成分が不足するため、別途、例えばサプリメントとして投与する必要性が生じてしまうところ、サプリメントは通常水分とともに投与するため、厳格な水分管理に支障をきたすといった問題をも生じてしまう。これに対して、本発明にかかる栄養組成物においては、水分量が過剰となることはなく、そのままの組成で、または水分を必要量となるまで単に添加して用いることができるので、必要量の強化成分と共に、必要量の水分を常に簡単かつ正確に投与することができる。 When the moisture content is excessive in a packed nutrition composition, it is almost impossible to remove and use only the moisture, and conversely, the nutritional composition is reduced so that the moisture content is appropriate. When administered in a controlled manner, the caloric component and / or the reinforcing component is insufficient, so that it becomes necessary to administer the product separately, for example, as a supplement. However, supplements are usually administered together with water, which impedes strict water management. It will cause problems such as. On the other hand, in the nutritional composition according to the present invention, the amount of water does not become excessive, and the composition can be used as it is or simply by adding water until the required amount is reached. The necessary amount of water can always be easily and accurately administered together with the reinforcing ingredients.
　さらにまた、栄養組成物に含まれる水分量を１０ｍｌ単位のような計算や計量に適した数量とすることにより、栄養組成物に添加する水分量の計算や計量を容易にし、厳格な水分管理をより一層合理化することができる。 Furthermore, by making the amount of water contained in the nutritional composition a quantity suitable for calculation and measurement such as a unit of 10 ml, the calculation and measurement of the amount of water added to the nutritional composition is facilitated, and strict moisture management is performed. It can be streamlined even more.
　本発明の栄養組成物は、様々な医療現場や介護現場等において厳格な水分管理が要求される患者などに用いられるが、典型的には、経腸栄養法に用いられる。ここで、経腸栄養法は、栄養成分などを口から補給する経口摂取法と、栄養成分などをチューブにより投与する経管栄養法とを含む。さらに、経管栄養法は、経口法、経鼻法および経瘻法を含む。
　本発明の栄養組成物の性状は、液体、流動体、ゼリー状またはペースト状などであり、典型的には、液体または流動体である。
　また、栄養組成物の分類は、成分栄養剤、消化態流動食もしくは消化態栄養剤、半消化態流動食もしくは半消化態栄養剤、または天然濃厚流動食などであり、典型的には、消化態流動食もしくは消化態栄養剤、または半消化態流動食もしくは半消化態栄養剤である。 The nutritional composition of the present invention is used for patients who require strict moisture management in various medical sites and nursing care sites, etc., but is typically used for enteral nutrition. Here, the enteral nutrition method includes an oral intake method in which nutritional components and the like are replenished from the mouth, and a tube feeding method in which the nutritional components and the like are administered through a tube. In addition, tube feeding methods include oral, nasal and vaginal methods.
The nutritional composition of the present invention is in the form of a liquid, fluid, jelly or paste, and is typically a liquid or fluid.
The classification of the nutritional composition includes ingredient nutrients, digested liquid foods or digestive nutrients, semi-digested liquid foods or semi-digested nutrients, or natural concentrated liquid foods. A liquid diet or digestive nutrient, or a semi-digestible fluid or semi-digestible nutrient.
　本発明の栄養組成物は、熱量１００ｋｃａｌあたりの水分量が１０～５５ｍｌ、好ましくは、２０～５０ｍｌ、とくに好ましくは、３０～５０ｍｌであり、従来の栄養組成物に比べて、単位水分量に対する熱量に関する栄養成分（栄養素）の濃度が高い。
　本発明の栄養組成物に用いる水は、純水、精製水およびイオン交換水などが挙げられる。 The nutritional composition of the present invention has a water content of 10 to 55 ml, preferably 20 to 50 ml, particularly preferably 30 to 50 ml per 100 kcal of calorie, and has a calorie per unit water content as compared with conventional nutritional compositions. Concentrations of nutrients (nutrients) are high.
Examples of the water used in the nutritional composition of the present invention include pure water, purified water, and ion exchange water.
　本発明の栄養組成物は、厳格な水分管理の必要な対象へ投与するのに用いられるところ、かかる対象として、例えば、透析患者、心疾患を有する患者または抗利尿ホルモン分泌異常症候群（ＳＩＡＤＨ）の患者などが挙げられる。とくに慢性的に透析を必要とする透析患者に対し、本発明の栄養組成物は水分管理において極めて有用である。慢性的に透析を必要とする患者の例として慢性腎不全患者などが挙げられる。 The nutritional composition of the present invention is used to administer to a subject in need of strict water management, such as a dialysis patient, a patient with heart disease or anti-diuretic hormone secretion syndrome (SIADH). Examples include patients. Especially for dialysis patients who need dialysis chronically, the nutritional composition of the present invention is extremely useful in water management. Examples of patients who need dialysis chronically include patients with chronic renal failure.
　本発明の栄養組成物は、一態様において慢性腎不全患者に用いる。
　かかる用途の場合、患者の腎機能の低下や欠如により水分が身体から抜けず、過量摂取によるむくみや浮腫の原因となるため、一日当たりの摂取水分量を７５０～１５００ｍｌ／ｄａｙ程度に制限することが好ましい。また、透析患者には栄養障害が多く、より多くの摂取熱量が必要とされているため、一日当たりの摂取熱量を１０００～１６００ｋｃａｌ／ｄａｙ（３５ｋｃａｌ／ｋｇ／ｄａｙ以上）とすることが好ましい。
　したがって、栄養組成物の１パック当たりの水分量を予め少なくすることによって水分の過剰な投与を回避し、栄養組成物の単独投与で水分が不足する場合には、かかる不足分を補うことができるように組成を設計することが好ましく、本発明の栄養組成物は、熱量１００ｋｃａｌあたりの水分量が従来の栄養組成物（約８０～９０ｍｌ程度）よりも少ない。 In one aspect, the nutritional composition of the present invention is used for patients with chronic renal failure.
In such a case, the water content cannot be removed from the body due to the decrease or lack of the renal function of the patient, causing swelling or edema due to overdose. Therefore, limit the daily water intake to about 750 to 1500 ml / day. Is preferred. In addition, since dialysis patients have many malnutrition and more calorie intake is required, the calorie intake per day is preferably set to 1000 to 1600 kcal / day (35 kcal / kg / day or more).
Therefore, excessive amount of water can be avoided by reducing the amount of water per pack of the nutritional composition in advance, and such shortage can be compensated for when insufficient water is obtained by single administration of the nutritional composition. It is preferable to design the composition as described above, and the nutritional composition of the present invention has a lower moisture content per 100 kcal of heat than the conventional nutritional composition (about 80 to 90 ml).
　本発明の栄養組成物において、熱量成分は、脂質、タンパク質、炭水化物、およびそれらの加水分解物からなる群より選ばれる１種または２種以上である。
　本発明の栄養組成物に配合する脂質としては、大豆油、パーム油、パーム分別油およびオリーブ油などの植物性油脂、乳脂肪、豚脂および魚油などの動物性油脂、ならびにオレイン酸、リノレン酸およびγ-リノレン酸などの遊離脂肪酸などが挙げられ、好ましくは、大豆油およびパーム油などが挙げられる。また、これらの脂質を１種または２種以上で用いてもよい。脂質の配合量としては、好ましくは０～４％の範囲であり、より好ましくは２．２～３．３％の範囲であり、健常な日本人の平均的な摂取量の観点から、好ましくは栄養組成物の全熱量（エネルギー量）の０～３０％の範囲であり、より好ましくは２０～２５％の範囲である。 In the nutritional composition of the present invention, the calorific component is one or more selected from the group consisting of lipids, proteins, carbohydrates, and hydrolysates thereof.
Lipids to be blended in the nutritional composition of the present invention include vegetable oils such as soybean oil, palm oil, palm fractionation oil and olive oil, animal fats such as milk fat, pork fat and fish oil, oleic acid, linolenic acid and Examples include free fatty acids such as γ-linolenic acid, and preferable examples include soybean oil and palm oil. Moreover, you may use these lipids by 1 type (s) or 2 or more types. The amount of lipid blended is preferably in the range of 0 to 4%, more preferably in the range of 2.2 to 3.3%, preferably from the viewpoint of the average intake of healthy Japanese It is in the range of 0 to 30%, more preferably in the range of 20 to 25% of the total calorie (energy amount) of the nutritional composition.
　本発明の栄養組成物に配合するタンパク質としては、大豆タンパク質などの植物性タンパク質、カゼインおよびホエイタンパク質などの動物性タンパク質などが挙げられ、好ましくは、大豆タンパク質、カゼインおよびホエイタンパク質などが挙げられる。また、これらのタンパク質の加水分解物などを用いてもよく、これらのタンパク質およびその加水分解物などを１種または２種以上で用いてもよい。タンパク質の配合量としては、好ましくは２～１０％の範囲であり、より好ましくは３～６．５％の範囲であり、健常な日本人の平均的な摂取量の観点から、好ましくは栄養組成物の全熱量（エネルギー量）の１２～４０％の範囲であり、より好ましくは１６～２５％の範囲である。 The protein to be blended in the nutritional composition of the present invention includes vegetable proteins such as soybean protein, animal proteins such as casein and whey protein, preferably soybean protein, casein and whey protein. In addition, hydrolysates of these proteins may be used, and these proteins and hydrolysates thereof may be used alone or in combination. The amount of protein blended is preferably in the range of 2 to 10%, more preferably in the range of 3 to 6.5%. From the viewpoint of the average intake of healthy Japanese, preferably the nutritional composition It is in the range of 12 to 40%, more preferably in the range of 16 to 25% of the total heat amount (energy amount) of the product.
　本発明の栄養組成物に配合する炭水化物としては、デキストリン、ショ糖、乳糖およびオリゴ糖などが挙げられ、好ましくは、デキストリン、ショ糖およびパラチノースなどが挙げられる。また、これらの炭水化物の加水分解物などを用いてもよく、これらの炭水化物および加水分解物などを１種または２種以上で用いてもよい。炭水化物の配合量としては、好ましくは５～２０％の範囲であり、より好ましくは１０～１５％の範囲であり、健常な日本人の平均的な摂取量の観点から、好ましくは栄養組成物の全熱量（エネルギー量）の２０～８０％の範囲であり、より好ましくは４０～６０％の範囲である。 The carbohydrate to be blended in the nutritional composition of the present invention includes dextrin, sucrose, lactose and oligosaccharide, preferably dextrin, sucrose and palatinose. Moreover, hydrolysates of these carbohydrates may be used, and these carbohydrates and hydrolysates may be used alone or in combination of two or more. The amount of the carbohydrate is preferably in the range of 5 to 20%, more preferably in the range of 10 to 15%. From the viewpoint of the average intake of healthy Japanese, the nutritional composition is preferably It is in the range of 20 to 80% of the total heat amount (energy amount), more preferably in the range of 40 to 60%.
　本発明の栄養組成物は、慢性腎不全患者において有用な成分を含んでいてもよく、かかる有用な成分が強化、すなわち、通常の栄養組成物において含まれる量よりも多く含まれていてもよい。本明細書においては、かかる成分を「強化成分」ともいう。ここで、強化成分は、通常の栄養組成物と比べて、例えば、１．５～５倍程度、好ましくは、２～３倍程度の高濃度で本発明の栄養組成物に含まれるように配合される。
　本発明の栄養組成物は、一態様において、ｎ－３系脂肪酸、パラチノース、フラクトオリゴ糖、食物繊維、カルニチンおよびセレンからなる群から選択される１種または２種以上の成分が強化されている。とくに好ましくは、カルニチンおよび／またはセレンを強化成分とする。 The nutritional composition of the present invention may contain ingredients that are useful in patients with chronic renal failure, and such useful ingredients may be enriched, that is, included in an amount greater than that contained in normal nutritional compositions. . In this specification, such a component is also referred to as a “strengthening component”. Here, the reinforcing component is blended so as to be contained in the nutritional composition of the present invention at a high concentration of, for example, about 1.5 to 5 times, preferably about 2 to 3 times, as compared with a normal nutritional composition. Is done.
In one aspect, the nutritional composition of the present invention is enriched with one or more components selected from the group consisting of n-3 fatty acids, palatinose, fructooligosaccharides, dietary fiber, carnitine and selenium. Particularly preferably, carnitine and / or selenium is used as the reinforcing component.
　ＤＨＡ（ドコサヘキサエン酸）やＥＰＡ（エイコサペンタエン酸）などのｎ－３系脂肪酸を強化することによって、心筋梗塞、動脈硬化性腎動脈狭窄症のリスクを低減することができる。本発明の栄養組成物において、ＤＨＡを含む場合には、その含量としては、１０～４０ｍｇ／１００ｋｃａｌとするのがよく、好ましくは１０～３０ｍｇ／１００ｋｃａｌ、とくに好ましくは２０～３０ｍｇ／１００ｋｃａｌである。また、ＥＰＡを含む場合には、その含量としては、５～５０ｍｇ／１００ｋｃａｌとするのがよく、好ましくは１０～４０ｍｇ／１００ｋｃａｌ、とくに好ましくは２０～４０ｍｇ／１００ｋｃａｌである。 By strengthening n-3 fatty acids such as DHA (docosahexaenoic acid) and EPA (eicosapentaenoic acid), the risk of myocardial infarction and arteriosclerotic renal artery stenosis can be reduced. When the DHA is contained in the nutritional composition of the present invention, the content thereof is preferably 10 to 40 mg / 100 kcal, preferably 10 to 30 mg / 100 kcal, particularly preferably 20 to 30 mg / 100 kcal. When EPA is contained, the content is preferably 5 to 50 mg / 100 kcal, preferably 10 to 40 mg / 100 kcal, particularly preferably 20 to 40 mg / 100 kcal.
　パラチノースを強化することによって、慢性的透析患者に多くみられる糖尿病性腎症を改善することができる。本発明の栄養組成物に含まれる糖質中のパラチノースのエネルギー比率を、４０～６０ｋｃａｌ／１００ｋｃａｌとするのが好ましく、４５～５５ｋｃａｌ／１００ｋｃａｌとするのがより好ましく、４５～５０ｋｃａｌ／１００ｋｃａｌとするのがとくに好ましい。 強化 By strengthening palatinose, diabetic nephropathy often seen in chronic dialysis patients can be improved. The energy ratio of palatinose in the saccharide contained in the nutritional composition of the present invention is preferably 40-60 kcal / 100 kcal, more preferably 45-55 kcal / 100 kcal, and 45-50 kcal / 100 kcal. Is particularly preferred.
　フラクトオリゴ糖および／または食物繊維を強化することによって、水分制限や腸内菌叢の乱れに伴う便性の低下を改善することができる。本発明の栄養組成物において、フラクトオリゴ糖を添加する場合には、その含量としては、０．１～０．５ｇ／１００ｋｃａｌであることが好ましく、０．２～０．４ｇ／１００ｋｃａｌであることがとくに好ましい。また、食物繊維含量としては、一日摂取量を２０～２５ｇ／ｄａｙにすることが好ましいことから、１．０～３．０ｇ／１００ｋｃａｌとすることが好ましく、１．０～２．０ｇ／１００ｋｃａｌであることがとくに好ましい。 By strengthening fructooligosaccharide and / or dietary fiber, it is possible to improve a decrease in stool properties due to water restriction and disturbance of the intestinal flora. In the nutritional composition of the present invention, when fructooligosaccharide is added, its content is preferably 0.1 to 0.5 g / 100 kcal, and preferably 0.2 to 0.4 g / 100 kcal. Particularly preferred. Further, the dietary fiber content is preferably 1.0 to 3.0 g / 100 kcal, preferably 1.0 to 2.0 g / 100 kcal since the daily intake is preferably 20 to 25 g / day. Is particularly preferred.
　カルニチンを強化することによって、透析患者に不足しがちなカルニチンを補い、さらに透析患者で発生しやすい脂質代謝異常を改善することができる。本発明の栄養組成物において、カルニチン含量としては、５～１００ｍｇ／１００ｋｃａｌとするのがよく、好ましくは１５～１００ｍｇ／１００ｋｃａｌであり、より好ましくは２０～５０ｍｇ／１００ｋｃａｌ、さらに好ましくは２０～３０ｍｇ／１００ｋｃａｌである。 By strengthening carnitine, it is possible to supplement carnitine, which tends to be deficient in dialysis patients, and to improve lipid metabolism abnormalities that tend to occur in dialysis patients. In the nutritional composition of the present invention, the carnitine content may be 5 to 100 mg / 100 kcal, preferably 15 to 100 mg / 100 kcal, more preferably 20 to 50 mg / 100 kcal, and still more preferably 20 to 30 mg / 100 kcal.
　セレンを強化することによって、透析に伴う酸化ストレスを軽減することができる。本発明の栄養組成物において、セレン含量としては、２～１５μｇ／１００ｋｃａｌとするのがよく、好ましくは５～１５μｇ／１００ｋｃａｌであり、より好ましくは５～１０μｇ／１００ｋｃａｌ、さらに好ましくは７～１０μｇ／１００ｋｃａｌである。 ¡By strengthening selenium, oxidative stress associated with dialysis can be reduced. In the nutritional composition of the present invention, the selenium content is preferably 2 to 15 μg / 100 kcal, preferably 5 to 15 μg / 100 kcal, more preferably 5 to 10 μg / 100 kcal, still more preferably 7 to 10 μg / 100 kcal.
　本発明の栄養組成物は、一態様において、各種のミネラルを配合しないか、従来よりも低減して配合する。すなわち、各種のミネラルは、通常の栄養組成物と比べて、少量で本発明の栄養組成物に含まれるように配合される。典型的には、カリウム、リンおよびカルシウムからなる群から選択される１種または２種以上のミネラル成分が低減されている。
　カリウム含量としては、一日摂取量を４０～７０ｍＥｑ／ｄａｙとするのが好ましいことから、３０～１００ｍｇ／１００ｋｃａｌとするのがよく、好ましくは３０～８０ｍｇ／１００ｋｃａｌであり、とくに好ましくは３０～６０ｍｇ／１００ｋｃａｌである。 In one embodiment, the nutritional composition of the present invention does not contain various minerals or is mixed in a manner that is lower than conventional ones. That is, various minerals are blended so as to be included in the nutritional composition of the present invention in a small amount as compared with a normal nutritional composition. Typically, one or more mineral components selected from the group consisting of potassium, phosphorus and calcium are reduced.
As the potassium content, since the daily intake is preferably 40 to 70 mEq / day, it is preferably 30 to 100 mg / 100 kcal, preferably 30 to 80 mg / 100 kcal, particularly preferably 30 to 60 mg. / 100 kcal.
　リン含量としては、一日摂取量を８～１７ｍＥｑ／ｄａｙとするのが好ましいことから、３０～８０ｍｇ／１００ｋｃａｌとするのがよく、好ましくは３０～６０ｍｇ／１００ｋｃａｌである。
　カルシウム含量としては、一日摂取量を１４００～１６００ｍＥｑ／ｄａｙとするのが好ましいことから、３０～８０ｍｇ／１００ｋｃａｌとするのがよく、好ましくは３０～６０ｍｇ／１００ｋｃａｌである。 The phosphorus content is preferably from 30 to 80 mg / 100 kcal, more preferably from 30 to 60 mg / 100 kcal since the daily intake is preferably 8 to 17 mEq / day.
The calcium content is preferably 30 to 80 mg / 100 kcal, more preferably 30 to 60 mg / 100 kcal since the daily intake is preferably 1400 to 1600 mEq / day.
　本発明の栄養組成物は、タンパク質量としては、典型的には、３．０～５．０ｇ／１００ｋｃａｌでよく、好ましくは３．０～４．０ｇ／１００ｋｃａｌであり、とくに好ましくは３．５～４．０ｇ／１００ｋｃａｌである。透析患者の場合には、透析によって、タンパク質やアミノ酸の喪失があるので、十分な摂取が必要であるが、一方で、過剰摂取による血清尿素窒素やリン濃度の上昇を防ぐ必要がある。
　また、タンパク質のエネルギー比率は、１２～２０ｋｃａｌ／１００ｋｃａｌ、好ましくは１２～１６ｋｃａｌ／１００ｋｃａｌであり、とくに好ましくは１４～１６ｋｃａｌ／１００ｋｃａｌであり、脂質のエネルギー比率は、２０～４０ｋｃａｌ／１００ｋｃａｌ、好ましくは２５～４０ｋｃａｌ／１００ｋｃａｌであり、とくに好ましくは３０～４０ｋｃａｌ／１００ｋｃａｌである。残りの必要なエネルギーは、主に糖質で補う。 The nutritional composition of the present invention typically has a protein amount of 3.0 to 5.0 g / 100 kcal, preferably 3.0 to 4.0 g / 100 kcal, particularly preferably 3.5. -4.0 g / 100 kcal. In the case of dialysis patients, protein and amino acids are lost due to dialysis, so sufficient intake is necessary. On the other hand, it is necessary to prevent an increase in serum urea nitrogen and phosphorus concentrations due to excessive intake.
The protein energy ratio is 12 to 20 kcal / 100 kcal, preferably 12 to 16 kcal / 100 kcal, particularly preferably 14 to 16 kcal / 100 kcal, and the lipid energy ratio is 20 to 40 kcal / 100 kcal, preferably 25 -40 kcal / 100 kcal, particularly preferably 30-40 kcal / 100 kcal. The remaining necessary energy is mainly supplemented with carbohydrates.
　本発明の栄養組成物は、典型的には、密閉式容器に収容され、栄養組成物製品とすることができる。密閉式容器とは、内容物である栄養組成物と外界とを遮断するための密閉された容器（クローズドパック）を意味し、容器の形態としては、典型的には、パック、レトルトパウチ、ソフトバッグ、定形の容器および缶などが挙げられ、好ましくは、パック、レトルトパウチ、ソフトバッグである。容器の材質としては、典型的には、紙、プラスチック、ガラスおよび金属などが挙げられ、好ましくは、紙、プラスチックおよび金属などである。
　また、容器としては、流出用および／または混合用の細口部を１つまたは２つ以上で備えていてもよく、該細口部としては、使用前にはシールされており、使用時には栄養組成物を投与するチューブまたは他の栄養組成物の容器の細口部などに直接に接続できる機構を備えていてもよい。 The nutritional composition of the present invention is typically housed in a sealed container and can be a nutritional composition product. The sealed container means a sealed container (closed pack) for shutting off the nutritional composition as the contents and the outside world, and the form of the container is typically a pack, a retort pouch, a soft A bag, a fixed container, a can, etc. are mentioned, Preferably, they are a pack, a retort pouch, and a soft bag. Typical examples of the material of the container include paper, plastic, glass and metal, and preferably paper, plastic and metal.
Further, the container may be provided with one or two or more narrow mouth portions for spilling and / or mixing, and the narrow mouth portion is sealed before use, and in use, the nutrition composition It may be provided with a mechanism capable of being directly connected to a tube or other narrow mouth portion of a container of other nutritional composition.
　本発明の栄養組成物を充填する容器を上記の密閉式容器とすることにより、栄養組成物の患者への投与や水分の添加などを大きく開封せずに、または最小限の細口部のみを開封することにより行うことが可能となり、外気との接触を最小限に抑えて汚染を防止することができる。 By making the container filled with the nutritional composition of the present invention into the above-mentioned sealed container, the nutritional composition is not greatly opened to the patient or added with water, or only the minimum narrow mouth part is opened. This makes it possible to prevent contamination by minimizing contact with outside air.
　本発明は、一態様において、本発明の栄養組成物を含有する１パックの栄養組成物製品であって、該栄養組成物が、熱量１００ｋｃａｌあたりのカルニチン含量が５～１００ｍｇ、セレン含量が２～１５μｇ、水分量が１０ｍｌ～５５ｍｌであり、かつ使用時に前記製品が1また２パック以上必要とされるが、水分の除去を必要としない組成である、前記栄養組成物製品に関する。前記のカルニチンおよび／またはセレンの含量は、適宜、変更することができるが、これらの成分を強化する目的で投与した際、水分が過剰であることがなく、すなわち、水分は適量か、不足するような組成比で含まれている。 In one aspect, the present invention is a pack of nutritional composition product containing the nutritional composition of the present invention, wherein the nutritional composition has a carnitine content of 5 to 100 mg per 100 kcal of calorie and a selenium content of 2 to The present invention relates to the nutritional composition product, which has a composition of 15 μg, a water content of 10 ml to 55 ml, and one or more packs of the product required for use, but does not require removal of water. The content of carnitine and / or selenium can be changed as appropriate, but when administered for the purpose of strengthening these components, there is no excess of water, that is, the amount of water is appropriate or insufficient. It is contained in such a composition ratio.
　また、本発明は、一態様において、水分管理の必要な対象に用いるための栄養組成物の調製方法であって、本発明の栄養組成物を１または２パック以上を用いて対象に必要量の熱量成分および強化成分を投与した場合の水分量を算出する工程、算出した水分量が、対象の必要量に不足する場合に不足分の水分を添加する工程を含む、前記調製方法に関する。
　複数のパックを用いて、患者等の水分管理の必要な対象に熱量成分および強化成分を投与した場合においても、水分は過剰となることがない組成比になっていることから、本発明の栄養組成物を調製する場合には、水分は適量か、水分が不足する状態しか起こり得ない。 Moreover, this invention is a preparation method of the nutritional composition for using for the object which needs water management in one aspect | mode, Comprising: The nutritional composition of this invention uses 1 or 2 packs or more of quantity required for object. The present invention relates to the preparation method, comprising a step of calculating a water amount when a calorie component and a strengthening component are administered, and a step of adding a deficient amount of water when the calculated water amount is insufficient for a target amount.
Even when a calorie component and a strengthening component are administered to an object requiring moisture management such as a patient using a plurality of packs, the composition ratio is such that the moisture does not become excessive. When preparing a composition, the moisture can only be in an appropriate amount or in a state where the moisture is insufficient.
　本発明の栄養組成物の使用時に添加する水分としては、純水、精製水およびイオン交換水などが挙げられる。ここで、使用時とは、栄養組成物を投与する際、すなわち投与の直前および投与中のみならず投与の直後も意味する。したがって、使用時に添加する水分によって、栄養組成物の水分を増加させることや、容器の内壁に付着した栄養組成物を水で洗い込む（フラッシング）ことを行い、その水分を栄養組成物と共に患者に投与することを包含する意味である。 The water added when using the nutritional composition of the present invention includes pure water, purified water, ion-exchanged water, and the like. The term “in use” as used herein means when the nutritional composition is administered, that is, not only immediately before and during administration but also immediately after administration. Therefore, the moisture of the nutritional composition is increased by the moisture added at the time of use, and the nutritional composition adhering to the inner wall of the container is washed with water (flushing), and the moisture is given to the patient together with the nutritional composition. It means to include administration.
　使用時に添加する水分は、予め計量され、栄養組成物とは異なる容器に収容されていてもよく、添加する際に計量して用いることも可能である。本発明の栄養組成物が単位水分量の整数倍の水分量を有する場合には、使用時に添加する水分もまた、同じ単位水分量の整数倍であることが好ましい。また、かかる単位水分量を、例えば、１０ｍｌ、５０ｍｌ、１００ｍｌなどのように一般的な計量カップなどで簡便に計測できる数量としておくことによって、さらに容易に水分量を計測し、計算することができる。 The moisture added at the time of use may be measured in advance and may be stored in a container different from the nutritional composition, and may be measured and used when added. When the nutritional composition of the present invention has a water content that is an integral multiple of the unit water content, the water added during use is also preferably an integral multiple of the same unit water content. Further, by setting the unit moisture amount to a quantity that can be easily measured with a general measuring cup such as 10 ml, 50 ml, 100 ml, etc., the moisture amount can be measured and calculated more easily. .
　また、透析患者の水分管理において、医師が目安とする投与水分量は、通常、１日に、体重１ｋｇあたり３０ｍｌや５０ｍｌとなるように行われており、１日の水分量が極めて厳格に管理される場合は、１５ｍｌ／ｋｇ・ＤＷ＊／日（＊：体内水分量等が適正な状態での標準体重）とする場合もある。
　本発明の栄養組成物製品１パックに含まれる水分量は、とくに限定されないが、例えば、透析患者用として、５ｍｌの整数倍、１０ｍｌの整数倍、５０ｍｌの整数倍または１００ｍｌの整数倍とすることにより、添加する水分量の計算が簡便となり好ましく、典型的には１パックに、５０ｍｌ、１００ｍｌ、１５０ｍｌまたは２００ｍｌの水分が含まれることが好ましい。 In addition, in water management for dialysis patients, the amount of water used by doctors is usually 30 ml or 50 ml per kg of body weight per day. In some cases, 15 ml / kg · DW * / day ( * : standard body weight with proper body water content) may be used.
The amount of water contained in one pack of the nutritional composition product of the present invention is not particularly limited. For example, for dialysis patients, it should be an integer multiple of 5 ml, an integer multiple of 10 ml, an integer multiple of 50 ml, or an integer multiple of 100 ml. Thus, the calculation of the amount of water to be added is simplified, and it is preferable that 50 ml, 100 ml, 150 ml or 200 ml of water is typically contained in one pack.
　本発明の栄養組成物に配合する、ナトリウム、脂質、タンパク質、炭水化物、ビタミンおよびミネラルなどは、食品および飲料ならびに医薬品の分野において、通常に用いられているものであれば、特に限定されないが、厚生労働省に、食品および医薬品の原材料および添加剤として認可されているものを用いることが好ましい。
　本発明の栄養組成物に配合する脂質としては、大豆油、パーム油、パーム分別油およびオリーブ油などの植物性油脂、乳脂肪、豚脂および魚油などの動物性油脂、ならびにオレイン酸、リンノレン酸およびγ-リノレン酸などの遊離脂肪酸などが挙げられ、好ましくは、大豆油およびパーム油などである。また、これらの脂質を１種または２種以上で用いてもよい。 Sodium, lipids, proteins, carbohydrates, vitamins, minerals and the like to be blended in the nutritional composition of the present invention are not particularly limited as long as they are normally used in the fields of foods and beverages and pharmaceuticals. It is preferable to use those approved by the Ministry of Labor as raw materials and additives for foods and pharmaceuticals.
Lipids to be blended in the nutritional composition of the present invention include vegetable oils such as soybean oil, palm oil, palm fractionation oil and olive oil, animal fats such as milk fat, pork fat and fish oil, and oleic acid, linolenic acid and Examples include free fatty acids such as γ-linolenic acid, preferably soybean oil and palm oil. Moreover, you may use these lipids by 1 type (s) or 2 or more types.
　本発明の栄養組成物に配合するタンパク質としては、大豆タンパク質などの植物性タンパク質、カゼインおよびホエイタンパク質などの動物性タンパク質などが挙げられ、好ましくは、大豆タンパク質、カゼインおよびホエイタンパク質などである。また、これらのタンパク質の加水分解物などを用いてもよく、これらのタンパク質およびその加水分解物などを１種または２種以上で用いてもよい。
　本発明の栄養組成物に配合する炭水化物としては、デキストリン、ショ糖、乳糖およびオリゴ糖などがあげられ、好ましくは、デキストリン、ショ糖およびパラチノースなどが挙げられる。また、これらの炭水化物の加水分解物などを用いてもよく、これらの炭水化物および加水分解物などを１種または２種以上で用いてもよい。 Examples of the protein blended in the nutritional composition of the present invention include vegetable proteins such as soybean protein, animal proteins such as casein and whey protein, and preferably soybean protein, casein and whey protein. In addition, hydrolysates of these proteins may be used, and these proteins and hydrolysates thereof may be used alone or in combination.
Examples of the carbohydrate to be blended in the nutritional composition of the present invention include dextrin, sucrose, lactose and oligosaccharide, preferably dextrin, sucrose and palatinose. Moreover, hydrolysates of these carbohydrates may be used, and these carbohydrates and hydrolysates may be used alone or in combination of two or more.
　本発明の栄養組成物に配合するビタミンとしては、ビタミンＡ、ビタミンＤ、ビタミンＥ、ビタミンＢ１、ビタミンＢ２、ナイアシン、ビタミンＢ６、葉酸、ビタミンＢ１２、パントテン酸およびビタミンＣなどが挙げられ、好ましくはビタミンＢ１、ビタミンＢ２、ナイアシン、ビタミンＢ６、葉酸、ビタミンＢ１２、パントテン酸およびビタミンＣなどである。また、これらのビタミンを１種または２種以上で用いてもよい。 Vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, pantothenic acid, vitamin C and the like are preferable as vitamins to be blended in the nutritional composition of the present invention, preferably Examples thereof include vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, pantothenic acid and vitamin C. Moreover, you may use these vitamins by 1 type (s) or 2 or more types.
　本発明の栄養組成物のナトリウム供給源としては、酢酸ナトリウム、塩化ナトリウム、クエン酸ナトリウム、水酸化ナトリウム、炭酸ナトリウム、炭酸水素ナトリウム、リン酸水素一ナトリウム、リン酸水素二ナトリウム、メタリン酸ナトリウム、ピロリン酸ナトリウムおよびトリポリリン酸ナトリウムなどが挙げられ、好ましくは塩化ナトリウムおよびクエン酸ナトリウムなどである。また、これらのナトリウム供給源を１種または２種以上で用いてもよい。
　本発明の栄養組成物に配合するナトリウム以外のミネラルとしては、カルシウム、鉄、リン、マグネシウム、カリウム、銅および亜鉛などが挙げられ、好ましくはカルシウム、リン、マグネシウム、カリウムなどである。また、これらのミネラルを１種または２種以上で用いてもよい。 Sodium sources of the nutritional composition of the present invention include sodium acetate, sodium chloride, sodium citrate, sodium hydroxide, sodium carbonate, sodium bicarbonate, monosodium hydrogen phosphate, disodium hydrogen phosphate, sodium metaphosphate, Examples include sodium pyrophosphate and sodium tripolyphosphate, preferably sodium chloride and sodium citrate. Moreover, you may use these sodium supply sources by 1 type, or 2 or more types.
Examples of minerals other than sodium to be blended in the nutritional composition of the present invention include calcium, iron, phosphorus, magnesium, potassium, copper and zinc, and preferably calcium, phosphorus, magnesium, potassium and the like. Moreover, you may use these minerals by 1 type (s) or 2 or more types.
　また、本発明の栄養組成物は、食物繊維を含んでもよく、水溶性食物繊維としては、難消化性デキストリンおよび還元難消化性デキストリンなどが挙げられ、また、非水溶性食物繊維としては、セルロースなどが挙げられる。さらに、本発明の栄養組成物は、各種の香料、甘味料および他の添加物などを含むことができる。
　本発明の栄養組成物のｐＨは、風味面や物性面の観点から、好ましくはｐＨ３～１１の範囲であり、より好ましくは４～１０の範囲であり、さらに好ましくは５～９の範囲であり、実質的に７であってもよい。また、ｐＨを調整するために、クエン酸などのｐＨ調整剤を含んでもよい。 The nutritional composition of the present invention may contain dietary fiber, examples of water-soluble dietary fiber include indigestible dextrin and reduced indigestible dextrin, and examples of water-insoluble dietary fiber include cellulose. Etc. Furthermore, the nutritional composition of the present invention can contain various flavors, sweeteners and other additives.
The pH of the nutritional composition of the present invention is preferably in the range of pH 3 to 11, more preferably in the range of 4 to 10, still more preferably in the range of 5 to 9, from the viewpoint of flavor and physical properties. , Substantially seven. Moreover, in order to adjust pH, you may contain pH adjusters, such as a citric acid.
　また、本発明の栄養組成物の浸透圧は、高浸透圧による下痢、腹痛など消化器症状の防止の観点から、好ましくは２００～８００ｍＯｓｍ／Ｌの範囲であり、より好ましくは３００～７５０ｍＯｓｍ／Ｌの範囲である。
　本発明の栄養組成物は、当該分野において公知の常法に従って調製することができる。例えば、各成分を秤量し、水に加えて十分に混合した後、乳化させ、該栄養組成物を予め加熱滅菌した後、無菌的に容器に充填する方法（例えば、ＵＨＴ滅菌法とアセプティック包装法を併用した方法）、または該栄養組成物を容器に充填した後、容器とともに加熱滅菌する方法（例えば、レトルト滅菌法）などがあげられる。 The osmotic pressure of the nutritional composition of the present invention is preferably in the range of 200 to 800 mOsm / L, more preferably 300 to 750 mOsm / L, from the viewpoint of preventing digestive symptoms such as diarrhea and abdominal pain due to high osmotic pressure. Range.
The nutritional composition of the present invention can be prepared according to conventional methods known in the art. For example, each component is weighed, mixed well with water, and then emulsified, and the nutritional composition is preliminarily heat sterilized and then aseptically filled into a container (for example, UHT sterilization method and aseptic packaging method) Or a method in which the nutritional composition is filled in a container and then sterilized with heat (for example, a retort sterilization method).
　本発明の容器入り栄養組成物は、例えば、予め計量されて別の容器に収容された添加用の水分と共にキットとして製品化することもできる。
　以下、本発明について実施例および使用例に基づいて、更に詳細に説明を加えるが、本発明は、これらの実施例に限定されるものではなく、本発明の技術的思想を逸脱しない範囲で種々の変更が可能である。 The nutritive composition in a container of the present invention can be commercialized as a kit with, for example, moisture for addition that has been measured in advance and stored in another container.
Hereinafter, the present invention will be described in more detail based on examples and use examples. However, the present invention is not limited to these examples, and various modifications can be made without departing from the technical idea of the present invention. Can be changed.
［実施例１］
　下記表１に示す各原料を、約６０℃の純水に投入して混合した後、混合液をホモミキサーに投入し、約５０００ｒｐｍ、１０分間で粗乳化を行った。ついで、９０℃に加温して５分間で静置した後、高圧乳化機にて精乳化（２０ｋｇｆ／ｃｍ２）を行った。得られた乳化液を約２０℃に冷却し、ビタミン、ミネラルおよび香料を添加した後、メスアップを行い、本発明の栄養組成物（Ａ～Ｄタイプ）を得た。得られた栄養組成物の各成分を表２に示す。 [Example 1]
Each raw material shown in Table 1 below was put into pure water at about 60 ° C. and mixed, and then the mixed solution was put into a homomixer and rough emulsified at about 5000 rpm for 10 minutes. Subsequently, after heating to 90 degreeC and leaving still for 5 minutes, fine emulsification (20 kgf / cm < 2 >) was performed with the high pressure emulsifier. The obtained emulsified liquid was cooled to about 20 ° C., vitamins, minerals and flavors were added, and the volume was increased to obtain the nutritional composition (AD type) of the present invention. Table 2 shows each component of the obtained nutritional composition.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000002
［実施例２］
　上記実施例１で得られたＡ～Ｄタイプの夫々の栄養組成物を、経腸栄養法用の接続口を備えた密閉型のプラスチック容器に充填した後に、レトルト殺菌（予備加熱８０℃、殺菌１２１℃、９分３０秒間）して、容器入り栄養組成物Ａ～Ｄを調製した。得られた容器入り栄養組成物の各物性値は、製品規格値を満たしており、長期の保存でも顕著な増粘、沈殿形成および脂肪分離などの変化は認められなかった。 [Example 2]
Each of the A to D type nutritional compositions obtained in Example 1 above was filled into a sealed plastic container having a connection port for enteral nutrition, and then retort sterilized (preheated at 80 ° C., sterilized. 121 ° C., 9 minutes and 30 seconds) to prepare nutritional compositions A to D in containers. Each physical property value of the obtained nutritional composition in a container satisfied the product specification value, and no significant changes such as thickening, precipitation formation and fat separation were observed even after long-term storage.
［使用例１］
　上記実施例２で得られた容器入り栄養組成物Ａを用い、透析患者に対し、一食分として、熱量３００ｋｃａｌ、水分量１００ｍｌを経管投与する。
（１）投与目標である熱量３００ｋｃａｌ、水分量１００ｍｌに対し、容器入り栄養組成物Ａは１パックが熱量３００ｋｃａｌ、水分量７５ｍｌであることから、不足する水分量を算出する（１００ｍｌ－７５ｍｌ＝２５ｍｌ）。
（２）水２５ｍｌを用意する。
（３）容器入り栄養組成物Ａをチューブに連結し、経管投与する。
（４）投与後の容器の内壁に残った栄養組成物Ａを、前記（２）で用意した水２５ｍｌで流し込む。 [Usage example 1]
Using the nutritional composition A contained in the container obtained in Example 2 above, a heat dose of 300 kcal and a water content of 100 ml are administered by tube to a dialysis patient as a serving.
(1) The nutritional composition A in a container has a calorific value of 300 kcal and a water content of 75 ml, whereas the calorie content in the container is 300 kcal and a water content of 100 ml, which is the administration target, calculate the deficient water content (100 ml-75 ml = 25 ml) ).
(2) Prepare 25 ml of water.
(3) The nutritive composition A in a container is connected to a tube and administered by tube.
(4) The nutrient composition A remaining on the inner wall of the container after administration is poured with 25 ml of water prepared in the above (2).
［使用例２］
　上記実施例２で得られた容器入り栄養組成物Ｂを用い、透析患者に対し、一食分として、熱量４００ｋｃａｌ、水分量３００ｍｌを経管投与する。
（１）投与目標である熱量４００ｋｃａｌ、水分量３００ｍｌに対し、容器入り栄養組成物Ｂは１パックが熱量４００ｋｃａｌ、水分量２００ｍｌであることから、１パックを用い（熱量４００ｋｃａｌ、水分量２００ｍｌ）、不足する水分量を算出する（３００ｍｌ－２００ｍｌ＝１００ｍｌ）。
（２）予め容器に入った水１００ｍｌを用意する。
（３）容器入り栄養組成物Ｂをチューブに連結し、経管投与する。
（４）投与後の容器の内壁に残った栄養組成物Ｂを、前記（２）で用意した水１００ｍｌで流し込む。 [Usage example 2]
Using the nutritional composition B contained in the container obtained in Example 2 above, a dialysis patient is administered by tube with a calorie of 400 kcal and a water content of 300 ml as a serving.
(1) In contrast to the administration target of calorie 400 kcal and water content 300 ml, the nutritional composition B in a container uses 1 pack because the heat content is 400 kcal and water content 200 ml, and one pack is used (heat calorie 400 kcal, water content 200 ml). Calculate the amount of water shortage (300 ml-200 ml = 100 ml).
(2) Prepare 100 ml of water in a container in advance.
(3) The nutritive composition B in a container is connected to a tube and administered by tube.
(4) Pour the nutrient composition B remaining on the inner wall of the container after administration with 100 ml of water prepared in (2) above.
　上記使用例１および２のように、本発明の栄養組成物は、「熱量３００ｋｃａｌ、水分量１００ｍｌ」や「熱量４００ｋｃａｌ、水分量３００ｍｌ」のように熱量に対して少ない水分量を投与することが可能である。例えば、１ｋｃａｌ／ｍｌに調整された従来の栄養組成物では、そもそも一食分として、「熱量３００ｋｃａｌ、水分量１００ｍｌ」や「熱量４００ｋｃａｌ、水分量３００ｍｌ」などの少ない水分量での投与に対応できない。さらに、従来の栄養組成物では、水分量が端数であるため、仮に熱量に対して多い水分量（例えば、「熱量３００ｍｌ、水分量３５０ｍｌ」など）の投与においても、水分量の計算が煩雑で、厳格な水分管理が困難である。本発明の栄養組成物は、かかる水分量の計算も容易に行うことができ、計算ミスによる投与量の錯誤をなくすことができる。 As in the above use examples 1 and 2, the nutritional composition of the present invention can administer a small amount of water relative to the amount of heat, such as “heat amount 300 kcal, water amount 100 ml” or “heat amount 400 kcal, water amount 300 ml”. Is possible. For example, a conventional nutritional composition adjusted to 1 kcal / ml cannot be used for administration with a small amount of water such as “heat amount 300 kcal, water amount 100 ml” or “heat amount 400 kcal, water amount 300 ml” in the first place. Furthermore, in conventional nutritional compositions, since the amount of water is a fraction, even when administering a large amount of water (for example, “300 ml of heat, 350 ml of water”, etc.), the calculation of the amount of water is complicated. Strict moisture management is difficult. The nutritional composition of the present invention can easily calculate the amount of water, and can eliminate an error in dosage due to a calculation error.
　本発明によれば、厳格な水分管理が要求される患者に投与するのに適した栄養組成物が提供でき、とくに腎不全症患者のような慢性的透析患者において水分管理を簡単にし、誤って過剰の水分を投与するなどのミスを低減、回避することができる。 According to the present invention, it is possible to provide a nutritional composition suitable for administration to a patient requiring strict water management, particularly in chronic dialysis patients such as renal insufficiency patients. Errors such as administration of excessive water can be reduced or avoided.

Claims (10)

  1. 　水分管理の必要な対象に用いるための栄養組成物であって、該栄養組成物中の熱量成分、強化成分および水分の組成が、該対象にとっての熱量および強化成分の必要量に対し、水分量を過剰に含まない組成比である、前記栄養組成物。 A nutritional composition for use in a subject in need of moisture management, wherein the composition of the caloric component, the reinforcing component and the moisture in the nutritional composition is the amount of moisture relative to the calorific value and the necessary amount of the reinforcing component for the subject. The nutritional composition, which is a composition ratio that does not contain excessive amounts.
  2. 　水分管理の必要な対象が、透析患者である、請求項１に記載の栄養組成物。 The nutritional composition according to claim 1, wherein the subject requiring water management is a dialysis patient.
  3. 　透析患者が、慢性腎不全患者である、請求項２に記載の栄養組成物。 The nutritional composition according to claim 2, wherein the dialysis patient is a patient with chronic renal failure.
  4. 　熱量成分が、脂質、タンパク質、炭水化物、およびそれらの加水分解物からなる群より選ばれる１種または２種以上である、請求項１～３のいずれか一項に記載の栄養組成物。 The nutritional composition according to any one of claims 1 to 3, wherein the calorific component is one or more selected from the group consisting of lipids, proteins, carbohydrates, and hydrolysates thereof.
  5. 　強化成分が、ｎ－３系脂肪酸、パラチノース、フラクトオリゴ糖、食物繊維、カルニチンおよびセレンからなる群から選択される１種または２種以上である、請求項１～４のいずれか一項に記載の栄養組成物。 The reinforcing component is one or more selected from the group consisting of n-3 fatty acids, palatinose, fructooligosaccharides, dietary fiber, carnitine and selenium, according to any one of claims 1 to 4. Nutritional composition.
  6. 　請求項１～５のいずれか一項に記載の栄養組成物を含有するパック入り栄養組成物製品であって、該栄養組成物が、熱量１００ｋｃａｌあたりの水分量が１０ｍｌ～５０ｍｌであり、かつ使用時に前記製品が1または２パック以上で必要とされるが、水分の除去を必要としない組成である、前記栄養組成物製品。 A packed nutritional composition product containing the nutritional composition according to any one of claims 1 to 5, wherein the nutritional composition has a water content of 10 ml to 50 ml per 100 kcal of heat and is used. The nutritional composition product, which is a composition that is sometimes required in one or more packs, but does not require removal of moisture.
  7. 　強化成分として、カルニチンを含み、熱量１００ｋｃａｌあたりのカルニチン含量が１５～１００ｍｇである、請求項６に記載の栄養組成物製品。 The nutritional composition product according to claim 6, comprising carnitine as a reinforcing component and having a carnitine content per 100 kcal of calorie of 15 to 100 mg.
  8. 　強化成分として、セレンを含み、熱量１００ｋｃａｌあたりのセレン含量が５～１５μｇである、請求項６または７に記載の栄養組成物製品。 The nutritional composition product according to claim 6 or 7, which contains selenium as a reinforcing component and has a selenium content of 5 to 15 µg per 100 kcal of heat.
  9. 　１パックに含まれる水分量が、５ｍｌ、１０ｍｌ、５０ｍｌまたは１００ｍｌの整数倍である、請求項６～８のいずれか一項に記載の栄養組成物製品。 The nutritional composition product according to any one of claims 6 to 8, wherein the amount of water contained in one pack is an integer multiple of 5 ml, 10 ml, 50 ml, or 100 ml.
  10. 　水分管理の必要な対象に用いるための栄養組成物の調製方法であって、
    請求項６～９のいずれか一項に記載の栄養組成物製品を１または２パック以上を用いて対象に必要量の熱量成分および強化成分を投与した場合の水分量を算出する工程、
    算出した水分量が、対象の必要量に不足する場合に不足分の水分を添加する工程
    を含む、前記調製方法。     A method for preparing a nutritional composition for use in a subject in need of moisture management,
    A step of calculating the amount of water when the nutritional composition product according to any one of claims 6 to 9 is administered to a subject with a necessary amount of caloric component and reinforcing component using one or more packs;
    The said preparation method including the process of adding the water | moisture content of a shortage, when the calculated water | moisture content is inadequate to the required amount of object.
PCT/JP2013/067651 2012-06-28 2013-06-27 Nutritional composition WO2014003116A1 (en)

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