WO2011118810A1

WO2011118810A1 - Nutritional composition

Info

Publication number: WO2011118810A1
Application number: PCT/JP2011/057453
Authority: WO
Inventors: 達金; 林　直樹
Original assignee: 味の素株式会社
Priority date: 2010-03-26
Filing date: 2011-03-25
Publication date: 2011-09-29
Also published as: JPWO2011118810A1; CN102811717A

Abstract

Disclosed is a nutritional composition which is suitable for administration by tube feeding such as enteral or gastric administration, or by oral ingestion, and which contains a high concentration of lipids, which are caloric nutrients capable of providing high calorific value. The nutritional composition also exhibits excellent emulsion stability, and excellent utilisation efficiency as a caloric nutrient. The disclosed nutritional composition uses lipids wherein the medium-chain fatty acid inclusion amount is 20-80 weight%, uses an emulsifier such as an organic acid monoglyceride or lecithin which has fatty acids in the structure thereof, and the composition is formed as an oil-in-water type emulsion composition.

Description

Nutritional composition

The present invention relates to a nutritional composition containing, as a main component, a lipid which is a calorie element capable of supplying a high calorie. More specifically, the present invention relates to a nutritional composition that has excellent emulsification stability, is suitable for both oral intake and tube administration, and can be provided as a pharmaceutical or a food or drink.

Currently, most commercially available liquid liquid foods and nutrients used for tube administration are adjusted to a calorific value of 1 kcal / mL (g) to 2 kcal / mL (g). Many of these nutritional compositions have a composition that enables nutritional management (especially for bedridden elderly people). In general, these are administered in several hundreds per day, divided into several times a day.

For example, if administration of 1000 kcal per day is required, if it is administered at a rate of 100 mL / h, the liquid preparation adjusted to 1 kcal / mL requires 10 hours, and the calculation of 2 kcal / mL requires 5 hours. Become. For this reason, it is not difficult to imagine that the time required for nutritional supplementation will be significantly longer than in the case of a normal diet, that is, oral nutrition intake. For this reason, many disadvantages occur. To illustrate, (1) because it is restricted to long-term nutritional administration, the time required for exercise therapy is limited, and (2) it is required to be in a certain position at the time of nutritional administration by tube feeding. (3) Nursing caregivers such as nurses and helpers are often required to check whether the administration status is appropriate at regular intervals, and labor for that is required (4 ) Physiological response such as changes in blood glucose level and gastric acid secretion state may be different from those caused by normal diet. (5) When microbial contamination occurs during tube feeding preparation, There is a possibility that microorganisms may grow and the risk of food poisoning increases. Therefore, as much as possible, it is considered that shortening the time required for administration during nutritional administration will bring about more favorable results.

However, such as elderly people whose stomach has shrunk due to aging, patients whose ability to swallow / chew has decreased due to cerebrovascular disorder, neuromuscular disorder, etc., patients who have difficulty in oral intake due to consciousness disorder, etc. In addition, when the gastrointestinal tract function is attenuated, it may cause side effects such as gastroesophageal reflux or diarrhea, so it is not preferable to administer a large amount of liquid food or nutrients at once.

As a method of solving the above-mentioned problems that occur when a nutritional composition is administered for a long time or in a short time, the composition of the nutritional composition is made higher than the conventional preparation and the dosage of the preparation is made small. Conceivable. By making the concentration high, a sufficient amount of calorie is contained, and by making the volume small, the burden on the patient and caregivers can be reduced. However, since it is difficult to increase the concentration as a general nutrition composition, that is, a preparation containing proteins, carbohydrates, lipids, minerals, and vitamins, from the viewpoint of formulation and ingredient stability, It can be said that it is preferable to use a replenisher-like form mainly containing lipids and specialized for calorific element replenishment.

Microlipid (“Microlipid”; Novartis, registered trademark) is commercially available as such a fat emulsion for oral and enteral nutrition aimed at supplementing calorie with a high concentration and a small volume. This is a 100% fat composition of safflower oil, and it is a liquid emulsion formulation of 4.5 kcal / mL (50 g lipid / 100 mL lipid) in a glass bottle sealed with a screw cap, with a capacity of 89 mL / piece It is. The emulsified preparation is a preferred liquid composition for caloric supplementation, but the fatty acid composition is not particularly considered, and it cannot be said that the utilization efficiency as a caloric element is good. Is not easy to use from the standpoint of hygiene and convenience, does not have sufficient emulsification stability, and can be easily separated during storage at room temperature. However, when it is used in a small volume, it is not a preparation that is sufficiently preferable because it is not hygienic.

On the other hand, as a fat emulsion that can be easily used for tube administration, a technique (Patent Documents 1 and 2) is disclosed in which a prefilled syringe preparation that substantially avoids contact between the liquid surface and oxygen is disclosed. However, these techniques only provide formulation techniques suitable for intravenous administration, and no mention is made of application to gastric or enteral nutrition. Also, the disclosed filling capacity is several mL, which has not been thoroughly examined from the viewpoint of replenishment of calorie. Pharmaceutical formulations such as Intralipid (Termo Co., Ltd., registered trademark) and Intralipos (Otsuka Pharmaceutical Factory, registered trademark), which are commercially available fat emulsions, are also intended for intravenous administration. Although it is good in terms of sexuality, the lipid content is 10% or 20%, and it is mainly composed of long-chain fatty acids. From the viewpoint of “a preparation containing a high concentration of lipid”, it is an ideal transgastric Or it cannot be said to be an enteral nutritional product.

In addition, Patent Documents 3 to 5 are disclosed as techniques relating to the preparation of fat emulsion. However, these are techniques disclosed mainly for the stability of the formulation, especially the effect of suppressing the phase separation by controlling the particle size, and no consideration has been given to the lipid concentration from the viewpoint of caloric administration. It does not disclose a more preferable technique regarding nutrient administration. In the fat emulsion, glucose and glycerin are blended as an emulsion stabilizer, and there is a risk that diarrhea becomes a problem during oral and enteral administration depending on the blending amount and the condition of the recipient. Therefore, information disclosure is insufficient as a technique for performing ideal gastric or enteral nutrition. Furthermore, since the fat emulsion is assumed to be administered intravenously, in order to avoid clogging of the filter during administration, in order to reduce the average particle size of the emulsified particles, high-pressure or multiple emulsification treatments are performed during production. is necessary.

In addition, Patent Documents 6 to 8 are disclosed as techniques relating to a kit for a liquid nutritional composition. These technologies are characterized by manufacturing and storing each nutrient separately, but they are not kits focused on calorimetric supplementation, but can be administered in a small volume and high concentration, especially calorie Improvement of utilization efficiency of elementary lipids has not been studied. Further, in such a kit, it is necessary to mix a plurality of liquid agents in use, but this operation may be complicated.

That is, a single-component nutritional composition containing a high concentration and high utilization efficiency lipid as a calorie and excellent in emulsion stability has not been disclosed so far.

Japanese Patent Laid-Open No. 2004-210688 JP 2006-239048 A JP-A-5-9111 Japanese Patent Laid-Open No. 9-67246 Japanese Patent Laid-Open No. 10-310517 Japanese Patent Laid-Open No. 6-141819 JP 2004-283117 A JP 2007-262088 A

Accordingly, an object of the present invention is to provide a nutritional composition containing a high concentration of lipid, which is a calorie that supplies a high calorie, and suitable for both oral intake and tube administration such as gastric or enteral administration. An object of the present invention is to provide a nutritional composition having excellent emulsification stability and excellent utilization efficiency as a calorimetric element.

As a result of intensive studies to solve the above problems, the present inventors use a lipid containing a predetermined amount of medium-chain fatty acid, and use an emulsifier having a fatty acid in its structure, such as lecithin and organic acid monoglyceride, as an emulsifier. Thus, it has been found that a nutritional composition having excellent emulsification stability can be obtained while containing a lipid having good utilization efficiency as a calorie in a high concentration, and the present invention has been completed.

That is, the present invention relates to the following [1] to [18].
[1] An oil-in-water emulsion composition comprising a lipid having a medium chain fatty acid content of 20 wt% to 80 wt% in the lipid and an emulsifier having a fatty acid in its structure, A nutritional composition, wherein the total content of the emulsifier is 25 (w / v)% to 65 (w / v)% based on the total amount of the composition.
[2] The nutritional composition according to [1], wherein the emulsifier having a fatty acid in its structure is one or more selected from the group consisting of lecithin and organic acid monoglycerides.
[3] The nutritional composition according to the above [2], wherein the organic acid monoglyceride is citric acid monoglyceride.
[4] The nutritional composition according to [1] or [2] above, wherein the medium chain fatty acid in the lipid is contained in the form of a medium chain fatty acid triglyceride.
[5] The nutritional composition according to [1] or [2] above, further comprising one or more selected from the group consisting of sugars and glycerin.
[6] The nutritional composition according to [5] above, wherein the content of one or more selected from the group consisting of saccharides and glycerin is 35 (w / v)% or less based on the total amount of the composition .
[7] The nutritional composition according to the above [6], which is for diabetic patients.
[8] The nutritional composition according to [1] or [2] above, comprising a lipid having a weight ratio of ω-3 fatty acid to ω-6 fatty acid in the lipid of 1:10 to 10: 1.
[9] The nutritional composition according to [1] or [2] above, wherein the phosphorus content is 20 mg or less per 100 kcal of the nutritional composition.
[10] The nutritional composition according to the above [9], which is for patients with kidney disease.
[11] The nutritional composition according to [1] or [2] above, further comprising one or more selected from the group consisting of proteins, dietary fiber, vitamins and minerals.
[12] The nutritional composition according to [1] or [2] above, wherein a volume of 10 mL to 100 mL is used as one packaging unit.
[13] The nutritional composition according to [1] or [2], which is filled in a sterile state.
[14] The nutritional composition according to [1] or [2], which is for oral consumption.
[15] The nutritional composition according to the above [1] or [2], which is for gastric or enteral administration.
[16] A pharmaceutical comprising the nutritional composition according to any one of [1] to [11] above.
[17] A food or drink containing the nutritional composition according to any one of [1] to [11].
[18] A nutritional kit for oral intake or for gastric or enteral administration, comprising a comprehensive nutritional composition and the nutritional composition according to any one of [1] to [10] above.

The nutritional composition of the present invention has excellent emulsification stability, and when stored for a long period of time, changes in the emulsified state such as water separation and phase separation such as creaming are not observed for at least one month. In addition, since it can be made into a small volume while containing a high concentration of lipid that is highly efficient as a calorie, it is suitable for both oral intake, gastric or enteral administration such as enteral administration, and heat supply Useful for patients who need it.

The nutritional composition of the present invention is an oil-in-water emulsified composition containing a high concentration of lipid having a high medium chain fatty acid content and emulsified with an emulsifier having a fatty acid in its structure, such as lecithin and organic acid monoglyceride.

The “lipid” contained in the nutritional composition of the present invention refers to fat used as a calorie, that is, fats and oils. Such fats and oils can be used without particular limitation as long as they are provided for pharmaceuticals or foods and drinks. For example, avocado oil, linseed oil, almond oil, egoma oil, olive oil, cacao butter, grape Seed oil, sesame oil, rice oil, safflower oil, perilla oil, soybean oil, camellia oil, evening primrose oil, corn oil, rapeseed oil, nuka oil, palm oil, palm kernel oil, peanut oil, sunflower oil, hazelnut oil, cottonseed oil Vegetable oils such as coconut oil and lettuce oil; animal oils such as fish oil, chicken oil, beef tallow, pork tallow and sheep fat; milk fats such as butter oil, butter and margarine and processed fats and oils. In the present invention, one or more of these are selected and used.

In the present invention, those having a medium chain fatty acid content in the lipid of 20 wt% to 80 wt% are used. In the present invention, the “medium chain fatty acid” means a fatty acid having 8 to 12 carbon atoms such as caprylic acid, capric acid, lauric acid, etc., and these are preferably contained in the form of medium chain fatty acid triglyceride in the lipid. . Medium-chain fatty acids are generally about 4 times faster in digestion and absorption than long-chain fatty acids present in fats and oils, and after absorption, they are transported to the liver via the portal vein without passing through the lymph vessels, and are rapidly metabolized. Therefore, it can be suitably used as a calorimetric element. Therefore, it is not preferable that the content of the medium chain fatty acid in the lipid is less than 20% by weight because the utilization efficiency as a calorimetric element is not sufficient. On the other hand, if it exceeds 80% by weight, there is a risk of developing acidosis accompanying an increase in blood ketone bodies. For the purpose of the present invention, “Coconard MT”, “Coconard RK”, “Coconard ML” (manufactured by Kao Chemical), “Derios SJ”, “Derios VJ” (manufactured by Cognis), “Actor M-1”, “ Products commercially available as “medium chain fatty acid triglycerides” such as Actor M-107FR (manufactured by Riken Vitamin Co., Ltd.) can be used. Moreover, you may use fats and oils containing a comparatively large amount of medium chain fatty acids, such as palm oil, palm oil, palm kernel oil, butter oil, butter. As coconut oil, palm oil, etc., those extracted and purified from natural plants such as coconut may be used, but it is convenient to use commercially available products.

Next, in the present invention, an emulsifier having a fatty acid in its structure is used. Fatty acids contained in the structure of the emulsifier include fatty acids derived from vegetable oils and fats such as coconut oil, palm oil, soybean oil, and rapeseed oil, particularly 12 to 18 carbon atoms such as lauric acid, myristic acid, palmitic acid, and stearic acid. Examples thereof include unsaturated fatty acids having about 18 carbon atoms such as about saturated fatty acids, oleic acid, linoleic acid, and linolenic acid. Examples of the emulsifier include glycerin fatty acid ester (fatty acid monoglyceride, fatty acid diglyceride), organic acid monoglyceride which is a derivative of the glycerin fatty acid ester, polyglycerin fatty acid ester, polyglycerin condensed ricinoleic acid ester, sorbitan fatty acid ester, sucrose fatty acid ester, lecithin Etc., and one or more of these can be selected and used. In particular, by containing at least one selected from the group consisting of lecithin and organic acid monoglycerides in an emulsifier, a composition that has excellent emulsion stability and does not cause separation of an aqueous phase and an oil phase for at least one month during storage. Obtainable.

Lecithin refers to a lipid product containing phospholipid, but as lecithin that can be used as an emulsifier in the present invention, soy lecithin obtained from soybean and mainly composed of phosphatidylcholine; plant lecithin obtained from seeds such as rape; egg yolk Egg yolk lecithin obtained by enzymatic degradation of soybean lecithin, plant lecithin or egg yolk lecithin, and enzymatic degradation lecithin mainly composed of phosphatidic acid and / or lysolecithin; mainly sphingomyelin, phosphatidylinositol, phosphatidylethanolamine and phosphatidylcholine Fractionated lecithin as component; partial hydrolyzed lecithin obtained by partially hydrolyzing lecithin, hydrogenated lecithin obtained by hydrogenating lecithin, hydroxylated lecithin obtained by introducing hydroxyl group into lecithin, etc. Such as modified lecithin, and the like. In the present invention, one or more of soybean lecithin, enzyme-decomposed lecithin, and fractionated lecithin are preferably used.

The organic acid monoglyceride is a derivative of the monoglyceride in which an organic acid is bonded to the remaining hydroxyl group of the fatty acid monoglyceride. Examples of the organic acid monoglyceride that can be used as an emulsifier in the present invention include acetic acid monoglyceride, citric acid monoglyceride, succinic acid monoglyceride, diacetyltartaric acid monoglyceride, and lactic acid monoglyceride. In the present invention, citric acid monoglyceride is most preferably used since it is excellent in acid-resistant emulsification and is also used as an auxiliary for fat and oil antioxidants.

Furthermore, as an emulsifier, one or more fatty acid glycerin esters, particularly preferably fatty acid monoglycerides, and one or more selected from the group consisting of lecithin and organic acid monoglycerides are used in combination. Emulsification stability is obtained.

In the nutritional composition of the present invention, in order to maintain stable emulsification, the total amount of the emulsifier having a fatty acid in the structure thereof is 5% by weight to 40% by weight, preferably 10% by weight with respect to the total amount of lipid used. % To 30 wt. In addition, one or more selected from the group consisting of lecithin and organic acid monoglyceride is 2 (w / v)% to 26 (w / v)% of the total amount of these, It is preferably contained in an amount of 30 to 100% by weight based on the total amount of the emulsifier having a fatty acid in the structure.

In the nutritional composition of the present invention, the total content of the lipid and the emulsifier having a fatty acid in its structure is 25 (w / v)% to 65 (w / v)% with respect to the total amount of the composition. 25 (w / v)% to 55 (w / v)%, preferably 30 (w / v)% to 50 (w / v)%.

Also, emulsifiers that do not contain fatty acids in the structure, and other raw materials that have an emulsion stabilizing action, such as gelling agents such as agar and carrageenan, thickening polysaccharides; chelating action such as phosphates and citrates Salts and the like may be used. Among these, in consideration of storage stability, heat resistance, absorbability, production cost, etc., one or more kinds can be selected, and the blending amount and blending ratio can be determined.

From the viewpoint of replenishing calorie in a preferable form, one or two or more selected from the group consisting of carbohydrates and glycerin have problems with digestive disorders (such as diarrhea) caused by elevated blood glucose levels or high osmotic pressure. If it does not become a grade, it can be contained. However, since the nutritional composition of the present invention contains lipids at a high concentration, the water content is relatively reduced by further containing a large amount of carbohydrates and the like, and the sterilization is caused by a decrease in production suitability, flavor, and viscosity. And convenience during administration may be impaired. Therefore, in the present invention, when one or more selected from the group consisting of carbohydrate and glycerin is contained, it is 35 (w / v)% or less, preferably 10 (w / v) based on the total amount of the composition. v) It should be less than%. In the present invention, the carbohydrate is not necessarily contained. If it is in a situation where carbohydrates are supplied into the recipient's body as a separate nutritional composition including intravenous nutrition, blood sugar levels can be controlled by using a composition that does not contain carbohydrates. It becomes possible. That is, by considering the saccharide content, it can be an appropriate calorie supplement source for diabetic patients. In addition, for lung diseases such as chronic obstructive respiratory disease, it is possible to reduce the generation of metabolic carbon dioxide by administration of carbohydrates, and to reduce the ventilation load on the lungs. Have.

Sugars that can be used in the present invention include monosaccharides such as glucose and fructose; disaccharides such as sucrose and maltose; oligosaccharides such as fructooligosaccharides, galactooligosaccharides, mannan oligosaccharides, and dairy oligosaccharides; dextrin, dextran, Examples thereof include polysaccharides such as starch and glycogen; sugar alcohols such as xylitol, sorbitol and reduced dextrin.

When essential fatty acids are required, the weight ratio of omega-3 fatty acids to omega-6 fatty acids in the lipid is preferably 1:10 to 10: 1, and 1: 4 to 4: 1. More preferably. “Ω-3 fatty acid” is also expressed as “n-3 fatty acid”, and examples include α-linolenic acid, eicosapentaenoic acid, docosapentaenoic acid, and docosahexaenoic acid. Since eicosapentaenoic acid is known to have an effect of improving insulin resistance, it can be more suitably used in the case of diabetic nephropathy. In the present invention, one or more of these are selected and used. “Ω-6 fatty acid” is also expressed as “n-6 fatty acid”, and examples thereof include linoleic acid, γ-linolenic acid, arachidonic acid and the like. In the present invention, one or more of these are selected and used.

The ω-3 fatty acid is abundant in perilla oil, linseed oil, fish oil, etc., and the ω-6 fatty acid is abundant in safflower oil, sunflower oil, soybean oil, rapeseed oil, evening primrose oil, etc. Can be extracted and purified from these oils and fats. Moreover, what was manufactured by the chemical synthesis method, the fermentation method, etc. can also be used, and the commercial item marketed for food-drinks can also be used. Furthermore, the fats and oils rich in ω-3 fatty acids or ω-6 fatty acids can be used as they are as a lipid source. Furthermore, the above fatty acid composition can be achieved by using an emulsifier having such a ω-3 fatty acid or ω-6 fatty acid in its structure. In the present invention, it is particularly preferable that the omega-3 fatty acid contains either or both of eicosapentaenoic acid and docosahexaenoic acid from the viewpoint of the effect on various inflammatory diseases. Regarding the weight ratio of omega-3 fatty acid to omega-6 fatty acid, the nutritional state of the patient expected to be used, and the amount of essential fatty acid contained in the composition when other nutritional compositions are used together, nutritional composition It is determined in consideration of the administration route of the product, the price and grade of the oil and fat.

In the present invention, a nutritional composition capable of appropriate nutritional management can be provided as a nutritional supplement preparation for patients with kidney disease by adjusting the phosphorus content. In this case, the phosphorus content is preferably 20 mg or less per 100 kcal of the nutritional composition, more preferably 10 mg or less. In order to adjust the compounding amount of phosphorus, it is necessary to adjust the compounding amount of the phosphorus source components such as phosphates and phosphates, and appropriately use the amount of lecithin and lysolecithin used as emulsifiers. It is necessary to specify. When reducing the amount of phospholipid used, it is preferable to use organic acid monoglyceride instead of phospholipid.

In the nutritional composition of the present invention, proteins can be added as other calorimetric elements. Examples of protein include casein and its salts, milk protein such as whey, soy protein, wheat protein, corn protein, potato protein, fish meat protein, animal meat protein, egg protein and the like. Those processed into flakes or pellets can also be used. These hydrolysates can also be used, and one or more of them may be selected from amino acids and salts thereof. Moreover, these can also be mix | blended for the purpose of an emulsion stability improvement as needed.

Also, other nutritional components can be added to the nutritional composition of the present invention. Such nutritional components include dietary fiber, vitamins and minerals.

Examples of dietary fiber include pectin, agarose, glucomannan, cellulose, indigestible dextrin, and the like, and one or more of these can be selected and used. For the purpose of the present invention, the dietary fiber preferably has an energy conversion factor other than 0 kcal / g as indicated by the Ministry of Health, Labor and Welfare notification (Shokushin No. 0217001, Shokushin No. 0217002). Examples of such dietary fiber include guar gum and its hydrolyzate, indigestible dextrin, wheat germ, and water-soluble soybean dietary fiber.

As vitamins, vitamin A such as retinol, retinal, retinoic acid; carotenoid such as β-carotene; vitamin D such as ergocalciferol and cholecalciferol; vitamin E such as α-tocopherol and γ-tocopherol; phylloquinone, menaquinone Such as vitamin K such as vitamin K, vitamin B ₁ such as thiamine, vitamin B ₂ such as riboflavin, vitamin B ₆ such as pyridoxine, pyridoxal, pyridoxamine, vitamin B ₁₂ such as cyanocobalamin, nicotinic acid, nicotinamide, etc. Examples include vitamin B groups such as niacin, pantothenic acid, biotin, and folic acid; and water-soluble vitamins such as vitamin C.

Examples of minerals include common minerals such as sodium, potassium, magnesium, calcium, phosphorus, iodine, iron, copper, manganese, selenium, zinc, chromium and molybdenum. In addition, when setting it as the nutrition composition for kidney disease patients, as above-mentioned, it is preferable that the phosphorus content per 100 kcal of nutrition composition shall be 20 mg or less.

Note that the nutritional composition of the present invention preferably has a high calorific value and a small volume within the range where there is no problem in the stability of the composition, and specifically 2.5 kcal / mL to 6 kcal / mL. It is preferably 3 kcal / mL to 5 kcal / mL.

∙ Other pharmaceutical or food additives can be added to the nutritional composition of the present invention as necessary. Examples of such additives include pH adjusters such as citric acid, sodium citrate, acetic acid, sodium acetate, gluconic acid, sodium hydroxide; antioxidants such as erythorbic acid, butylhydroxyanisole, propyl gallate; aspartame, liquorice extract , Saccharin, etc .; acidulants such as lactic acid, succinic acid, tartaric acid, malic acid; sodium benzoate, sodium edetate, sorbic acid, sodium sorbate, methyl parahydroxybenzoate, butyl paraoxybenzoate, etc. Colorants such as Bengala, yellow iron oxide, black iron oxide, carmine, edible blue No. 1, edible yellow No. 4, edible red No. 2 and the like.

The nutritional composition of the present invention can be provided as a pharmaceutical or a food or drink as it is or with a carrier for a pharmaceutical or a food or drink. The pharmaceutical can be a preparation for oral intake or a preparation for tube administration such as a gastric and enteral nutrient. In addition, the food and drink may be a milky or creamy general food, but is preferably a health food such as a food for specified health use, a nutritional functional food, a nutritional supplement, or other health food.

In such a case, as the nutritional composition of the present invention, the content of one or more selected from the group consisting of carbohydrates and glycerin is 35 (w / v)% or less with respect to the total amount of the composition. By using the composition controlled to become, it can be set as the pharmaceutical or food-drinks for diabetics. Moreover, it can be set as the pharmaceutical or food-drinks for patients with a kidney disease by using the composition which controlled phosphorus content to 20 mg or less per 100 kcal of nutritional composition.

The capacity of the nutritional composition of the present invention per package should be small as long as there is no hindrance in replenishing the necessary amount of heat from the viewpoints of consumption per use, suppression of microbial contamination, handling, etc. Is preferred. Specifically, preferably 10 mL to 100 mL, more preferably 10 mL to 50 mL is used as one packaging unit. When one package unit is the above-mentioned volume, when the whole amount is administered by tube at one time, there is almost no need to pay attention to the injection rate, and it is easy to supply sufficient calorie.

Favorable for tube administration to a patient with a gastrostomy or intestinal fistula by making the volume of one packaging unit of the nutritional composition of the present invention small. Tube feeding via gastrostomy and intestinal fistula is rapidly spreading, because it is easier than conventional nasogastric feeding and can improve the quality of life for patients. It is said that there is. If the nutritional composition of the present invention is used for gastrostomy or enteral fistula administration, the time required for administration is expected to be several minutes, and while administering the necessary calorie according to the patient's condition, while watching the state The implementation time can be shortened. In addition, it is hygienic and has little waste, and the administration operation is simpler, which may further improve the quality of life. Furthermore, since the osmotic pressure can be easily adjusted, the risk of diarrhea can be reduced. Furthermore, in elderly people, the stomach is often shrinking with age, and the amount of food that can be consumed is extremely small, so the nutritional composition of the present invention containing a small amount of high-concentration lipids Is useful. It is more effective especially when gastroesophageal reflux occurs frequently or when the gastric volume is reduced and the administration volume is limited. In addition, since it is not preferable to administer an acidic liquid substance through the intestinal fistula, the pH of the nutritional composition of the present invention is preferably 5 to 7.5, and 5.5 to 6.8. More preferably. By adjusting the pH to near neutrality, it is possible to reduce the occurrence of side effects even when used for patients with gastric wall disorders.

As a container filled with a small-volume nutritional composition, it is used via a tube administration tube such as a tube for enteral stomach or enteral nutrition, and has a portion that can be connected to the tube and can be injected at the same time. A container having a mechanism capable of flushing the inside of the tube with air, water, or gel is preferable. When it is not used directly through a tube tube because it has such a form and the content liquid is kept sterile, for example, it is used by adding the nutritional composition of the present invention to a comprehensive nutrient liquid food Even when the nutritional composition of the present invention is used as a kit preparation, microbial contamination can be avoided as much as possible. Specific examples of such containers include disposable containers such as prefilled syringes, drop-shaped containers made by blow molding or multilayer film, and pouches with stoppers.

The material of the container such as a prefilled syringe may be either glass or plastic, but is preferably plastic from the viewpoint of safety during transportation and use and waste disposal. Moreover, transparency, light-shielding property and heat resistance are favorable, and those that can be recycled and are stable with respect to the filler are more preferable. Plastic resins include polysulfone resin, polyethersulfone resin, polyamide resin, polycarbonate resin, polyvinyl chloride resin, acrylic resin, cyclic polyolefin resin, cyclic polyolefin copolymer resin, polymethylpentene resin, polyester resin, polypropylene resin, polyethylene Examples thereof include resins and resins made of a crosslinked polymer such as polyethylene terephthalate resin. In addition to plastic, an elastic polymer material such as rubber or elastomer can be used for the gasket portion, but rubber having good sliding property coated with silicone or fluororesin is preferable. In addition, the portion connected to the tube for tube administration should be tapered so as to be gradually reduced in diameter from the tip so as to adapt to various shapes. It is maintained by making it a shape that can be opened by closing the plug, fitting with a screw cap and a spout shape, and cutting off a part of the connecting portion.

In this specification, “sterile” means that no microorganism is present in the substance, and in the case of a pharmaceutical preparation, it means that the conditions prescribed by the Japanese Pharmacopoeia are satisfied. In the case of food and drink, there are no food poisoning bacteria, infectious disease pathogens, or microorganisms that cause spoilage, and so-called retort foods that do not contain microorganisms that cause infection, spoilage, or economic loss under normal temperature distribution. Means commercial sterility. Such sterilization is achieved by aseptic filling or high-temperature high-pressure sterilization after filling. In the nutritional composition of the present invention, sterility is maintained until immediately before use, and microbial contamination may occur by filling a container suitable for connection with a tube tube, administration of the composition, and washing of the tube tube. Is extremely reduced, and it becomes possible to administer easily.

The nutritional composition of the present invention can be provided in combination with other nutritional compositions as a nutritional kit for oral intake or for tube administration such as gastric or enteral administration. In such a kit, when used in combination with a comprehensive nutrition composition such as a comprehensive nutrition liquid food, a higher calorie can be supplied. Since the nutritional composition of the present invention has a small volume while containing a high concentration of lipid, the increase in volume with respect to the heat supply amount is kept to a minimum amount. Therefore, it is more effective when the volume of the composition to be administered is limited. In addition, when administration to a diabetic patient is a problem such as an increase in blood glucose level, the nutritional composition of the present invention efficiently supplies heat by using a composition in which the amount of carbohydrate added is considered. In addition, the risk of fluctuations in blood glucose level is low, and patient nutrition management is facilitated.

The nutritional composition according to the present invention can be obtained by preparing an oil-in-water emulsion composition by a normal emulsification method. For example, when adding a water-soluble component, heat the aqueous phase in which the component is mixed with water, and when adding a lipid and an emulsifier, and further adding an oil-soluble component, add the mixed oil-phase component. The mixture can be prepared by mixing and homogenizing using a homomixer, a colloid mill, a high-pressure homogenizer, a microfluidizer, or the like. Depending on the type and properties of the emulsifier used, the emulsifier can be added to the aqueous phase. Moreover, when adding a thermally unstable component like some vitamins etc., it can add and mix, after emulsifying and cooling.

The particle size of the emulsion particles of the obtained nutritional composition can be measured by a general particle size measurement method for emulsions and micelles, for example, dynamic light scattering method, laser diffraction method and the like. About the nutritional composition which concerns on this invention, the average particle diameter was measured using the laser diffraction scattering method.

After preparing the nutritional composition of the present invention, it is filled in a container such as the syringe or pouch described above and sterilized. The sterilization method is selected in consideration of the components contained in the nutritional composition and the heat and pressure stability of the container to be filled. For example, the high-pressure steam sterilization method, filter filtration method, gas sterilization method using ethylene oxide gas, etc. Etc. can be used. It is also preferable to aseptically fill the nutritional composition by acceptive filling.

Hereinafter, the present invention will be described in detail by way of examples.

[Example 1] Nutritional composition (1) According to the composition shown in Table 1, 740 g of prepared water was weighed in a 3 L stainless steel bucket (hereinafter referred to as A) and heated to 70 ° C to 80 ° C in a hot water bath. Subsequently, dextrin was added and dissolved under high-speed stirring conditions of 3000 rpm with TK Robotics (manufactured by PRIMIX Corporation).
(2) Soybean oil and medium chain fatty acid triglyceride as edible fats and oils, powdered lecithin (enzymatically decomposed lecithin) and fatty acid monoglyceride as emulsifiers were added to A. Next, the volume was increased to 2000 mL, and then dissolved and dispersed until a uniform state was obtained, and then treated twice with a high-pressure homogenizer at a homogeneous pressure of 70 MPa.
(3) An aluminum pouch was filled so that the weight per piece was 150 g, and a retort sterilization treatment was performed at 123 ° C. for 10 minutes to obtain a nutritional composition.

The above composition was stored at 25 ° C., and the day after sterilization, the rotor No. was measured with a rotary viscometer (“BH-80”, manufactured by Toki Sangyo Co., Ltd.). It was about 300 cP when measured at 25 ° C. under conditions of 1, 12 rpm. Moreover, it was 0.19 micrometer when the average particle diameter was measured using the laser diffraction scattering method particle size distribution measuring apparatus (LS13 ~ 320; Beckman Coulter company make). The pH was 5.8.

[Example 2] Nutritional composition (1) According to the composition shown in Table 1, 740 g of prepared water was weighed in a 3 L stainless steel bucket (hereinafter referred to as B), and heated to 70 to 80 ° C in a hot water bath. Subsequently, dextrin was added and dissolved under high-speed stirring conditions of 3000 rpm with TK Robotics (manufactured by PRIMIX Corporation).
(2) Soybean oil and medium chain fatty acid triglyceride as edible fats and oils, powdered lecithin (enzymatically decomposed lecithin), citric acid monoglyceride and fatty acid monoglyceride as B were added to B. Next, the volume was increased to 2000 mL, and then dissolved and dispersed until a uniform state was obtained, and then treated twice with a high-pressure homogenizer at a homogeneous pressure of 70 MPa.
(3) An aluminum pouch was filled so that the weight per piece was 150 g and subjected to retort sterilization at 123 ° C. for 10 minutes.

The above composition was stored at 25 ° C., and the day after sterilization, the rotor No. was measured with a rotary viscometer (“BH-80”, manufactured by Toki Sangyo Co., Ltd.). It was about 180 cP when measured at 25 ° C. under conditions of 1, 12 rpm. Moreover, it was 0.19 micrometer when the average particle diameter was measured using the laser diffraction scattering method particle size distribution measuring apparatus (LS13 ~ 320; Beckman Coulter company make). The pH was 4.0.

In addition, about the nutritional composition of Example 1 and 2, the calculated value of the phosphorus content per 100 kcal and the calorie | heat amount per mL was shown together in Table 1.

[Example 3] Nutritional composition (1) In accordance with the composition shown in Table 2, 900 g of prepared water was weighed in a 3 L stainless steel bucket (hereinafter referred to as C) and heated to 70 ° C to 80 ° C in a hot water bath.
(2) Powder lecithin (enzymatically decomposed lecithin), which is an emulsifier, was added to C under high-speed stirring conditions at 3000 rpm using TK Robotics (manufactured by PRIMIX Corporation). In addition, soybean oil, which is an edible oil and fat, medium chain fatty acid triglyceride, rapeseed oil and refined fish oil, and pasty lecithin (soybean lecithin) and fatty acid monoglyceride, which are emulsifiers, were mixed in advance and then added to C. The blending amounts of various edible fats and oils were adjusted so that the ω-3 fatty acid: ω-6 fatty acid = 1: 2.7 (weight ratio) in the lipid composition. Next, the volume was increased to 2000 mL, and then dissolved and dispersed until a uniform state was obtained, and then treated twice with a high-pressure homogenizer at a homogeneous pressure of 70 MPa.
(3) An aluminum pouch was filled so that the weight per piece became 150 g, and retort sterilization treatment was performed at 123 ° C. for 10 minutes.

The above composition was stored at 25 ° C., and the day after sterilization, the rotor No. was measured with a rotary viscometer (“BH-80”, manufactured by Toki Sangyo Co., Ltd.). It was about 30 cP when measured at 25 ° C. under conditions of 1, 12 rpm. Moreover, it was 0.29 micrometer when the average particle diameter was measured using the laser diffraction scattering method particle size distribution measuring apparatus (LS13 * 320; Beckman Coulter company make). The pH was 6.0.

[Example 4] Nutritional composition (1) According to the composition shown in Table 2, 900 g of the prepared water was weighed in a 3 L stainless steel bucket (hereinafter referred to as D) and heated to 70 ° C to 80 ° C in a hot water bath.
(2) Powder lecithin, which is an emulsifier (enzymatically decomposed lecithin), was added to D under high-speed stirring conditions at 3000 rpm using TK Robotics (manufactured by PRIMIX Corporation). In addition, soybean oil, which is an edible fat, medium chain fatty acid triglyceride, rapeseed oil and refined fish oil, and pasty lecithin (soybean lecithin), which are emulsifiers, citric acid monoglyceride and fatty acid monoglyceride were mixed in advance and then added to D. The blending amounts of various edible fats and oils were adjusted so that the ω-3 fatty acid: ω-6 fatty acid = 1: 2.7 (weight ratio) in the lipid composition. Next, the volume was increased to 2000 mL, and then dissolved and dispersed until a uniform state was obtained, and then treated twice with a high-pressure homogenizer at a homogeneous pressure of 70 MPa.
(3) An aluminum pouch was filled so that the weight per piece became 150 g, and retort sterilization treatment was performed at 123 ° C. for 10 minutes.

The above composition was stored at 25 ° C., and the day after sterilization, the rotor No. was measured with a rotary viscometer (“BH-80”, manufactured by Toki Sangyo Co., Ltd.). It was about 16 cP when measured at 25 ° C. under conditions of 1, 12 rpm. Moreover, it was 0.20 micrometer when the average particle diameter was measured using the laser diffraction scattering method particle size distribution measuring apparatus (LS13 * 320; Beckman Coulter company make). The pH was 4.3.

In addition, about the nutritional composition of Example 3 and 4, the calculated value of the phosphorus content per 100 kcal and the calorie | heat amount per mL was shown together in Table 2.

[Test example] Evaluation of emulsification stability during storage The emulsification stability during storage of the nutritional compositions of Examples 1 to 4 was evaluated using Microlipid (Novatis, registered trademark) as a comparative example. That is, each nutritional composition of the example and the composition of the comparative example were stored at room temperature for 6 months, and the emulsified state was observed over time. The emulsified state was evaluated according to the following evaluation criteria, and the results are shown in Table 3.
<Evaluation criteria>
○: No water separation or creaming is observed △: Water separation or creaming is slightly observed ×: Water separation or creaming is remarkably recognized

As is apparent from Table 3, all of the nutritional compositions of Examples 1 to 4 showed good emulsification stability, and although some water separation was observed in the composition of Example 2 at 6 months, 3 months No phase separation such as water separation was observed. On the other hand, in the composition of the comparative example, some phase separation was observed in the first month of storage, and the phase separation became remarkable in the second month.

As described above in detail, according to the present invention, lipids that are excellent in emulsion stability and have high utilization efficiency as a calorie can be contained at a high concentration and can be made into a small volume. A nutritional composition suitable for any tube administration such as enteral administration can be provided. Therefore, the nutritional composition is useful for patients who need a calorie supply.

This application is based on Japanese Patent Application No. 2010-073639 filed in Japan, the contents of which are incorporated in full herein.

Claims

An oil-in-water emulsion composition comprising a lipid having a medium chain fatty acid content of 20 to 80% by weight in a lipid and an emulsifier having a fatty acid in its structure, wherein the lipid and the emulsifier A nutritional composition having a total content of 25 (w / v)% to 65 (w / v)% based on the total amount of the composition.
The nutritional composition according to claim 1, wherein the emulsifier having a fatty acid in its structure is one or more selected from the group consisting of lecithin and organic acid monoglyceride.
The nutritional composition according to claim 2, wherein the organic acid monoglyceride is citric acid monoglyceride.
The nutritional composition according to claim 1 or 2, wherein the medium chain fatty acid in the lipid is contained in the form of a medium chain fatty acid triglyceride.
Furthermore, the nutrition composition of Claim 1 or 2 containing the 1 type (s) or 2 or more types selected from the group which consists of saccharides and glycerol.
The nutritional composition according to claim 5, wherein the content of one or more selected from the group consisting of saccharides and glycerin is 35 (w / v)% or less based on the total amount of the composition.
The nutritional composition according to claim 6, which is for diabetic patients.
The nutritional composition according to claim 1 or 2, comprising a lipid having a weight ratio of ω-3 fatty acid to ω-6 fatty acid in the lipid of 1:10 to 10: 1.
The nutritional composition according to claim 1 or 2, wherein the phosphorus content is 20 mg or less per 100 kcal of the nutritional composition.
The nutritional composition according to claim 9, which is for a kidney disease patient.
The nutritional composition according to claim 1 or 2, further comprising one or more selected from the group consisting of proteins, dietary fiber, vitamins and minerals.
The nutritional composition according to claim 1 or 2, wherein a volume of 10 mL to 100 mL is used as one packaging unit.
The nutritional composition according to claim 1 or 2, which is filled in a sterile state.
The nutritional composition according to claim 1 or 2, which is for oral consumption.
The nutritional composition according to claim 1 or 2, which is for transgastric or enteral administration.
A pharmaceutical comprising the nutritional composition according to claim 1 or 2.
Food or drink containing the nutritional composition according to claim 1 or 2.
A nutritional kit for oral intake or for gastric or enteral administration, comprising a comprehensive nutritional composition and the nutritional composition according to claim 1 or 2.