Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
  • A61K9/0029—Parenteral nutrition; Parenteral nutrition compositions as drug carriers
• • 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 semi-solidified nutrient for gastrostoma.
• Enteral nutrition is a physiological route of nutrition via the gastrointestinal tract that can solve the problems associated with high-calorie infusion methods. It is an important nutritional method for difficult patients.
• Tube feeding methods include nasal tube feeding and gastrostomy tube feeding.
• the enteral nutrient is administered through a thin and long tube inserted into the stomach via the nasal cavity, it is necessary to use a liquid enteral nutrient. Therefore, as a result, administration takes a long time of about several hours, and the burden on patients and their caregivers is great.
• the gastrostomy tube feeding method is a method in which percutaneous endoscopic gastrostomy (PEG) is performed and nutrition is supplied directly from outside the body through a tube connected to the stomach (administration). ) Nutrition management method. Compared with the conventional nasal tube feeding method, it is easier to manage, less painful for patients, and easier to eat and swallow rehabilitation. It is attracting attention as one.
• PEG percutaneous endoscopic gastrostomy
• Gastroesophageal reflux is caused by rapid administration of liquid enteral nutrient to the stomach, preventing aspiration pneumonia from developing.
• the enteral nutrient falls from the stomach into the intestine at a stroke (dumping), and the sugar is rapidly absorbed, resulting in unstable blood sugar levels. Prevent it from causing diarrhea symptoms.
• liquid enteral nutrients need to be administered to the patient in the same position for a long time, but they give viscosity and shape retention to enteral nutrients. In this case, administration can be performed in a short time. As a result, pressure ulcer can be prevented, the burden on the patient can be reduced, and the patient's QOL can be improved.
• Patent Document 1 discloses a method of adding agar to an enteral nutrient.
• Patent Document 2 a gel-like liquid food containing agar, xanthan gum and carrageenan (Patent Document 2), a gel-like composition suitable for a dysphagia person comprising a composite gel of a protein isoelectric point gel and a gelling agent gel such as pectin or xanthan gum A thing (patent document 3) etc. are indicated.
• An object of the present invention is to provide a semi-solidified nutrient that has high shape retention even when extruded from a syringe or the like, has low adhesion to the tube, and has low resistance when extruded from the tube. To do.
• the present inventors have found that the above problem can be solved by using agar and modified starch in combination, and further using agar with different jelly strength as agar. Completed the invention.
• the present invention relates to the following semi-solidified nutrient for gastrostoma.
• a semi-solid nutrient for gastric fistula containing nutrients agar having a jelly strength of 10 kPa or less, agar having a jelly strength of 30 kPa or more, and modified starch, wherein the agar content has a jelly strength of 10 kPa or less
• the content of agar having a jelly strength of 30 kPa or more is 0.1 to 1% by mass relative to the total amount of the semi-solidified nutrient for gastrostoma and the total amount of the semi-solidified nutrient for gastrostoma 0.01 to 0.2% by mass
• the content of the modified starch is 0.5 to 3% by mass with respect to the total amount in the semi-solidified nutrient for gastrostoma. Nutrient.
• the semi-solidified nutrient for gastrostoma of the present invention is a semi-solid nutrient with high shape retention even when extruded from a syringe or the like, low adhesion to the tube, and low resistance when extruded from the tube It is. Therefore, the administered patient can surely and easily take nutrition without causing gastroesophageal reflux.
• the semi-solidified nutrient suitable for gastrostomy patients according to the present invention is characterized by containing agar and modified starch in the nutrient, and further using agar with different jelly strength in combination.
• semi-solidified nutrient for gastrostoma of the present invention (hereinafter also simply referred to as semi-solidified nutrient) will be described in further detail.
• the gastrosemi-solidified nutrient comprises nutrients, two or more agars with different jelly strength, and modified starch.
• Agar is a product obtained by freezing and drying mucus of red algae such as agaric and crabs and contains polysaccharides such as agarose and agaropectin as a main component.
• the agarose and agaropectin have a structure in which galactose and 3,6-andehydrogalactose are alternately polymerized.
• Agar may have different properties depending on the degree of polymerization and molecular weight of agarose and agaropectin, the content of sulfate groups and pyruvate groups in the agar, etc., but it is not particularly limited in the semi-solidified nutrient according to this embodiment. Any of these may be used.
• the semi-solidified nutrient tends to be in a jelly shape close to a solid.
• the semi-solidified nutrient tends to be a paste that is close to a liquid.
• an agar having a jelly strength of 10 kPa or less (hereinafter also referred to as a low jelly strength agar) and an agar having a jelly strength of 30 kPa or more (hereinafter also referred to as a high jelly strength agar) are used.
• agars with different jelly strengths in this way, the detailed mechanism is unknown, but it has the effect that adhesion to the tube is suppressed compared to when agars with different jelly strengths are not used together.
• the lower limit of the jelly strength of the low jelly strength agar is not particularly limited, but is usually 0.1 kPa or more.
• the jelly strength of the low jelly strength agar is preferably 0.1 to 10 kPa from the viewpoint of the combined effect with the high jelly strength agar.
• the upper limit of the jelly strength of the high jelly strength agar is not particularly limited, but is usually 300 kPa or less.
• the jelly strength of the high jelly strength agar is preferably 30 to 200 kPa from the viewpoint of suppressing injection resistance.
• Ultra Agar Ena manufactured by Ina Food Industry Co., Ltd., jelly strength: 0.2 kPa
• Ultra Agar UX-30 manufactured by Ina Food Industry Co., Ltd., jelly strength: 0.6 kPa
• Ultra Agar AX-30 Ina Food Industry Co., Ltd., jelly strength: 0.7 kPa
• Ultra Agar BX-30 Ina Food Industry Co., Ltd., jelly strength: 0.6 kPa
• Ultra Agar UX-100 Ina Food Industry Co., Ltd.
• Jelly strength: 3 kPa Ultra Agar AX-100 (Ina Food Industry Co., Ltd., jelly strength: 3.5 kPa)
• Ultra Agar BX-100 Ina Food Industry Co., Ltd., jelly strength: 3 kPa
• Ultra Agar UX-200 Ina Food Industry Co., Ltd., jelly strength: 5 kPa
• Ultra Agar AX-200 Ina Food Industry Co., Ltd., jelly strength: 5 kPa
• High jelly strength agar and low jelly strength agar may be used alone or in combination of two or more.
• the jelly strength a value measured by the following method is adopted.
• Agar is dissolved in 90 ° C hot water to prepare a 1.0 mass% solution, cooled at 4 ° C for 24 hours, and then allowed to stand at 25 ° C for 2 hours.
• the measurement conditions were such that a jelly strength was calculated by dividing the maximum load value when measured at a compression speed of 60 mm / min by a plunger area using a resinous plunger having a diameter of 15 mm. The measurement is performed three times under the above measurement conditions, and the jelly strength is the average value.
• the content of agar having a jelly strength of 10 kPa or less is 0.1 to 1% by mass, preferably 0.2 to 1% by mass, based on the total amount of the semi-solidified nutrient for gastrostoma.
• the content of agar having a jelly strength of 30 kPa or more is 0.01 to 0.2% by mass, preferably 0.02 to 0.1% by mass, based on the total amount of the semi-solidified nutrient for gastrostoma. .
• the blending amount of the low jelly strength agar is less than 0.1% by mass, the above effect of using in combination with the high jelly strength agar may not be exhibited.
• pouring resistance at the time of administering a nutrient from a tube will become high when the compounding quantity of low jelly strength agar exceeds 1 mass%, it is unpreferable.
• the blending amount of the high jelly strength agar is less than 0.01% by mass, the above effect of using in combination with the low jelly strength agar may not be exhibited. Problems may arise. Also, if high jelly strength agar exceeds 0.2% by mass, the nutrient will cause gelation, causing coagulation unevenness in the nutrient or increasing the adhesion of the nutrient to the tube This is not preferable.
• Modified starch By using modified starch, when combined with agar, the shape is maintained even when extruded from a syringe or the like, and the injection resistance from the tube is suppressed. Moreover, the adhesiveness to the tube of a nutrient is suppressed.
• Processed starch is obtained by subjecting starch to physical, enzymatic or chemical treatment. By performing the treatment, physical properties such as solubility in water, gelatinization temperature, viscosity stability at the time of heat dissolution, and physical property stability are changed.
• Examples of the physical treatment include wet heat treatment, high-frequency treatment, radiation treatment, bleaching treatment, acid treatment, and base treatment.
• Examples of the enzymatic treatment include treatment with enzymes such as ⁇ -amylase, ⁇ -amylase, glucoamylase 7, isoamylase, and pullulanase.
• Examples of the chemical treatment include oxidation treatment, esterification treatment, acetylation treatment, etherification treatment, and crosslinking treatment.
• the modified starch obtained by the above treatment is not particularly limited, but roasted dextrin, acid-treated starch, alkali-treated starch, bleached starch, enzyme-treated starch, starch glycolate sodium, starch phosphate sodium, acetylated adipic acid Cross-linked starch, acetylated oxidized starch, acetylated phosphate cross-linked starch, starch sodium octenyl succinate, starch acetate, oxidized starch, hydroxypropylated phosphate cross-linked starch, hydroxypropyl starch, phosphate cross-linked starch, phosphorylated starch, monophosphate Examples include esterified phosphoric acid crosslinked starch.
• acetylated phosphate-crosslinked starch, hydroxypropylated phosphate-crosslinked starch, hydroxypropyl starch and phosphate-crosslinked starch are preferably used, and acetylated phosphate-crosslinked starch, hydroxypropylated phosphate-crosslinked starch, hydroxypropyl More preferably, starch is used.
• Processed starch may be prepared by itself or a commercially available product may be used.
• a modified starch can be prepared by subjecting a known starch, for example, the above-mentioned starch, to at least one or more of the above physical treatment, enzymatic treatment, and chemical treatment.
• WMS acetylated phosphoric acid crosslinked starch: Matsutani Chemical Industry Co., Ltd.
• Matsutani Suisen acetylated phosphoric acid crosslinked starch: Matsutani Chemical Industry Co., Ltd.
• Farinex VA70WM hydroxypropylated phosphorus Acid-crosslinked starch: manufactured by Matsutani Chemical Co., Ltd.
• Farinex VA70X hydroxypropylated phosphoric acid-crosslinked starch: manufactured by Matsutani Chemical Industry Co., Ltd.
• Farinex VA70C hydroxypropylated phosphoric acid-crosslinked starch: manufactured by Matsutani Chemical Industry Co., Ltd.
• Select Amir XF hydroxypropylated phosphate cross-linked starch: made by Matsutani Chemical Co., Ltd.
• Food Starch HR-7 hydroxypropylated phosphate cross-linked starch: made by Matsutani Chemical Co., Ltd.
• Pine Ace # 1 hydroxypropylated
• the content of the modified starch is 0.5 to 3% by mass, preferably 0.7 to 2% by mass, based on the total amount in the semi-solidified nutrient for gastrostoma. If the blended amount of the modified starch is less than 0.5% by mass, the effect of maintaining the retention of nutrients when discharged from the container may be reduced. Moreover, when the compounding quantity of modified starch exceeds 3 mass%, it will become a stickiness and the adhesiveness to a tube will increase in connection with this.
• modified starch may be used alone or in combination of two or more.
• the semi-solid nutrient for gastrostoma contains nutrients for the purpose of nutritional supplementation.
• Nutrients preferably include carbohydrates and protein sources.
• the nutrient may further contain at least one selected from the group consisting of lipids, vitamins, minerals, and dietary fiber as an optional component.
• the total amount of nutrients in the semi-solidified nutrient is preferably 8 to 65% by mass, and more preferably 15 to 40% by mass.
• Carbohydrates are also called carbohydrates and serve as energy sources.
• the carbohydrate that can be used is not particularly limited as long as it is absorbed into a living body and becomes an energy source, and examples thereof include monosaccharides, disaccharides, and polysaccharides.
• monosaccharides include glucose (glucose), fructose (fructose), galactose and the like.
• disaccharide include sucrose (sucrose), lactose (lactose), maltose (malt sugar), isomaltose, trehalose and the like.
• Specific examples of the polysaccharide include starch (amylose, amylopectin), dextrin and the like. Of these, dextrin is preferably used.
• Dextrin is a general term for substances in which several ⁇ -glucoses are polymerized by glycosidic bonds, and can be obtained by hydrolysis of starch. Since dextrin has a slow degradation rate in the small intestine and is slowly absorbed, it can prevent a rapid increase in blood sugar. Moreover, by using dextrin, the osmotic pressure of the semi-solidified nutrient can be reduced, and osmotic diarrhea can be prevented.
• the dextrin either a high molecular dextrin having a high degree of polymerization of ⁇ -glucose or a low molecular dextrin having a low degree of polymerization of ⁇ -glucose may be used, but a high molecular dextrin capable of further reducing the osmotic pressure should be used. Is preferred.
• the low molecular dextrin is also called maltodextrin and is usually a polymer of 3 to 5 ⁇ -glucose.
• Dextrin may be prepared by itself or a commercially available product may be used.
• known starches such as corn, waxy corn, wheat, rice, waxy rice, waxy miro, beans (broad beans, mung beans, red beans, etc.), potatoes, sweet potatoes, tapioca, etc. It can be prepared by hydrolysis by a known method.
• examples of commercially available dextrin include TK-16 (manufactured by Matsutani Chemical Industry Co., Ltd.) and the like, which can be preferably used.
• the above carbohydrates may be used alone or in combination of two or more.
• the content of the saccharide in the semi-solidified nutrient can be appropriately adjusted depending on the subject to be applied, but is preferably 5 to 30% by mass with respect to the total amount of the semi-solidified nutrient.
• the said modified starch is also saccharide
• the protein source is not particularly limited, and known ones can be used.
• Amino acids include essential amino acids such as valine, leucine, isoleucine, lysine, methionine, phenylalanine, threonine, tryptophan, histidine; and glycine, alanine, serine, cysteine, asparagine, glutamine, proline, tyrosine, aspartic acid, glutamic acid, arginine, etc.
• essential amino acids such as valine, leucine, isoleucine, lysine, methionine, phenylalanine, threonine, tryptophan, histidine
• glycine alanine, serine, cysteine, asparagine, glutamine, proline, tyrosine, aspartic acid, glutamic acid, arginine, etc.
• modified amino acids such as 4-hydroxyproline, 5-hydroxylysine, ⁇ -carboxyglutamic acid, O-phosphoserine, O-phosphotyrosine, N-acetylserine, N ⁇ -methylarginine, pyroglutamic acid, M-formylmethionine; Special amino acids such as ornithine, citrulline, ⁇ -aminobutyric acid (GABA), thyroxine, S-adenylmethionine can also be included.
• the amino acids may be stereoisomers (enantiomers, diastereomers), positional isomers, or a mixture thereof.
• the amino acid may be in the form of an inorganic acid salt (hydrochloride, etc.), an organic acid salt (acetate, etc.), or an ester body (methyl ester, etc.) that can be hydrolyzed in vivo.
• the peptide one obtained by polymerizing two or more of the above amino acids via a peptide bond (amide bond) can be used.
• the peptide may be a dipeptide, a tripeptide, an oligopeptide (having about 10 amino acids), or a polypeptide (having several tens to several hundred amino acids).
• the polypeptide includes proteins such as plant proteins and animal proteins. Some oligopeptides such as lactotripeptides, casein decapeptides, valyltyrosine-containing sadden peptides and the like may have health functions such as antihypertensive action.
• plant proteins examples include proteins contained in grains such as rice and beans such as soybeans and tofu.
• soy protein it can have health functions, such as combining with a bile acid and promoting the excretion of cholesterol.
• animal proteins examples include proteins contained in eggs, meat, seafood, milk and the like.
• whey protein made from milk (whey) as a raw material, casein protein contained in milk, and soybean protein are preferably used, and whey protein is more preferably used.
• whey protein examples include whey protein concentrate (WPC), whey protein isolate (WPI), hydrolyzed whey peptide (WPH) and the like.
• WPC whey protein concentrate
• WPI whey protein isolate
• WPH hydrolyzed whey peptide
• Commercially available products such as WPC, WPI, and soy protein may be used.
• WPI18855 (manufactured by Fontara), WPI18822 (manufactured by Fontera), WPI1895 (manufactured by Fontera), WPC392 (manufactured by Fontera) ), WPC80 (manufactured by Fontera), WPC7009 (manufactured by Fontera), WPC164 (manufactured by Fontera), WPC162 (manufactured by Fontera), WPC132 (manufactured by Fontera), WPC472 (manufactured by Fontera), Prolina 900 (Fuji Oil) New Fuji Pro 3000 (Fuji Oil Co., Ltd.), New Fuji Pro 1700N (Fuji Oil Co., Ltd.) and the like.
• the above proteins, amino acids or peptides may be used alone or in combination of two or more.
• the content of the protein source in the semi-solidified nutrient can be appropriately adjusted depending on the subject to be applied, but is preferably 2 to 18% by mass with respect to the total amount of the semi-solidified nutrient.
• Lipids can be a source of energy, biomembrane constituents, steroid hormones and bile acids.
• the lipid that can be used is not particularly limited as long as it can be ingested by humans, and examples thereof include saturated fatty acids, unsaturated fatty acids, vegetable oils, animal fats, and fish oils.
• saturated fatty acids examples include caprylic acid, capric acid, lauric acid, palmitic acid, stearic acid and the like.
• unsaturated fatty acids include oleic acid, palmitoleic acid, linoleic acid, arachidonic acid, ⁇ -linolenic acid, eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA).
• EPA and DHA it can have health functions, such as a blood cholesterol raise inhibitory effect and a neutral fat rise inhibitory effect.
• Vegetable oils include coconut oil, corn oil, cottonseed oil, olive oil, palm oil, palm kernel oil, peanut oil, rapeseed oil, safflower oil (safflower oil), sesame oil, soybean oil, sunflower oil, almond oil, cashew oil, hazelnut Oil, macadamia nut oil, mongolian oil, pecan oil, pine nut oil, pistachio oil, walnut oil, gourd seed oil, buffalo pumpkin oil, pumpkin seed oil, watermelon seed oil, amaranth oil, apricot oil, apple oil, argan oil , avocado oil, babas oil, moringa oil, borneo oil, cape chestnut oil, cocoa butter, carob oil, kofne palm oil, coriander seed oil, dica oil, flaxseed oil, grape seed oil, hemp oil, kapok seed oil, lale mantia oil , Marula oil, Meadow foam oil, mustard oil, Tsumug butter, okra oil, papaya oil, perilla oil
• Animal fats include lard (pig fat), head (tallow), milk fat, and the like.
• Fish oil includes fish oil such as mackerel, salmon, yellowtail, sardine, saury.
• linoleic acid and ⁇ -linolenic acid that cannot be synthesized in vivo by humans, or lipids containing these.
• lipids may be used alone or in combination of two or more.
• the lipid content in the semi-solidified nutrient can be appropriately adjusted depending on the subject to be applied, but is preferably 1 to 8% by mass with respect to the total amount of the semi-solidified nutrient.
• vitamin Vitamins are a general term for organic compounds other than carbohydrates, amino acids or peptides, and lipids that are necessary for maintaining the nutritional state of organisms.
• Vitamin A retinol
• vitamin D ergocalciferol, cholecalciferol
• vitamin E tocopherol, tocotrienol
• vitamin K phytoquinone, menaquinone
• vitamin B1 thiamine
• vitamin B2 Roboflavin
• vitamin B3 niacin
• vitamin B5 pantothenic acid
• vitamin B6 pyridoxal, pyridoxamine, pyridoxine
• vitamin B7 biotin
• vitamin B9 folic acid
• vitamin B12 cyanocobalamin, hydroxocobalamin
• vitamin C water-soluble vitamins such as (ascorbic acid).
• the content of vitamins in the semi-solidified nutrient can be adjusted as appropriate by the subject to be applied. Normally, fat-soluble vitamins are added in an amount that does not cause excess disease, and water-soluble vitamins are not limited in the amount added.
• the preferable content of each vitamin per 100 g of the semi-solidified nutrient is as follows.
• Vitamin A preferably 0 to 3000 ⁇ g, more preferably 20 to 200 ⁇ g Vitamin D: preferably 0.1-50 ⁇ g, more preferably 0.1-5.0 ⁇ g Vitamin E: preferably 0.2 to 800 mg, more preferably 1 to 10 mg Vitamin K: preferably 0.5 to 1000 ⁇ g, more preferably 2 to 50 ⁇ g Water-soluble vitamins; Vitamin B1: preferably 0.01 to 40 mg, more preferably 0.1 to 10 mg Vitamin B2: preferably 0.01-20 mg, more preferably 0.05-10 mg Niacin: preferably 0.1 to 300 mg NE, more preferably 0.5 to 60 mg NE Pantothenic acid: preferably 0.1 to 55 mg, more preferably 0.2 to 30 mg Vitamin B6: preferably 0.01-60 mg, more preferably 0.1-30 mg Biotin: preferably 0.1 to 1000 ⁇ g, more preferably 1 to 100 ⁇ g Folic acid: preferably 1-1000 ⁇ g, more preferably 10-200 ⁇ g Vitamin B12: preferably 0.01-100 ⁇ g, more
• Minerals include quasi-major elements such as sodium, potassium, calcium, phosphorus and magnesium; essential trace elements such as iron, zinc, copper, iodine, manganese, selenium, chromium and molybdenum. These minerals may be used alone or in combination of two or more.
• the content of mineral in the semi-solidified nutrient can be adjusted as appropriate by the subject to be applied.
• the preferable content of each mineral per 100 g of the semi-solidified nutrient is as follows.
• Dietary fiber can have functions such as reduced nutrient utilization, reduced plasma cholesterol, improved blood glucose response, improved colon function, and prevention of colon cancer.
• dietary fiber may be fermented by intestinal bacteria and converted to short chain fatty acids, carbon dioxide gas, hydrogen gas, methane gas, and the like. Among these, since short chain fatty acids are absorbed in the large intestine, dietary fiber may be an energy source.
• the dietary fiber is not particularly limited, but insoluble dietary fiber such as cellulose, hemicellulose, lignin, insoluble pectin, chitin, chitosan, psyllium seed, low molecular weight sodium alginate; water-soluble pectin, guar gum, konjac mannan, glucomannan, alginic acid , Agar, chemically modified polysaccharide, polydextrose, indigestible oligosaccharide, maltitol, inulin, carrageenan, wheat bran, indigestible dextrin (eg, Pine Fiber C (manufactured by Matsutani Chemical Co., Ltd.), polydextrose, guar gum decomposition Water-soluble dietary fibers such as foods, etc. These dietary fibers may be used alone or in admixture of two or more.
• the content of dietary fiber in the semi-solidified nutrient can be adjusted as appropriate by the subject to be applied.
• the semi-solidified nutrient according to the present invention preferably contains moisture.
• the water content in the semi-solidified nutrient can be appropriately adjusted depending on the subject to be applied, the desired viscosity, etc., but is preferably 30 to 90% by mass with respect to the total amount of the semi-solidified nutrient, From the viewpoint of moisture management, the content is more preferably 50 to 90% by mass.
• the semi-solidified nutrient according to this embodiment may further contain other known components such as functional additives, food additives, thickeners and the like.
• a health function component is a component that exhibits a certain function for a living body when ingested.
• resistant oligosaccharide sugar alcohol, calcium citrate malate (CCM) and casein phosphopeptide (CPP), chitosan, L-arabinose, guava leaf polyphenol, wheat albumin, bean extract, diacylglycerol, diacylglycerol plant Sterols, soy isoflavones, milk basic proteins and the like.
• Indigestible oligosaccharides are saccharides that are not as large in molecular weight as polysaccharides (about 300 to 3000) among compounds in which monosaccharides are linked by glycosidic bonds.
• the indigestible oligosaccharides are not degraded by human digestive enzymes, but those digested by human digestive enzymes can be included in the aforementioned carbohydrates. Ingestion of indigestible oligosaccharides can provide a bowel regulation effect.
• the indigestible oligosaccharide is not particularly limited, and examples thereof include xylooligosaccharide, fructooligosaccharide, soybean oligosaccharide, isomaltooligosaccharide, dairy oligosaccharide, lactulose, and galactooligosaccharide. These indigestible oligosaccharides may be used alone or in combination of two or more.
• the content of indigestible oligosaccharides in the semi-solidified nutrient can be appropriately adjusted depending on the subject to be applied.
• Sugar alcohol is a kind of sugar produced by reduction of the carbonyl group of aldose or ketose, and it is not easily absorbed from the small intestine into the body and does not easily become calories. Sugar alcohol is difficult to be metabolized to acid by oral bacteria and can prevent plaque formation. The sugar alcohol can be used as a low calorie sweetener.
• sugar alcohols examples include erythritol, maltitol, palatinose and the like. These sugar alcohols may be used alone or in admixture of two or more.
• the content of sugar alcohol in the semi-solidified nutrient can be adjusted as appropriate by the subject to be applied.
• CCM and CPP can promote calcium absorption and promote bone formation.
• the CCM and CPP may be used alone or in combination.
• CCM and CPP are preferably used in combination with calcium.
• the contents of CCM and CPP in the semi-solidified nutrient can be appropriately adjusted depending on the subject to be applied.
• Food additive The food additive is used for the purpose of processing or storing the food by adding, mixing, moistening or other methods to the food.
• food additives for example, zinc gluconate and copper gluconate, ascorbic acid 2-glucoside, cyclodextrin, preservatives, fungicides, antioxidants, coloring agents, sweeteners, A pH adjuster, a sour agent, an emulsifier, a fragrance
• Zinc gluconate and copper gluconate are gluconates that utilize high chelating ability of gluconate with heavy metal ions. Since it becomes easy to be absorbed when it is made into the form of gluconate, zinc and copper can be absorbed effectively.
• the zinc gluconate and copper gluconate may be used alone or in combination.
• the content of zinc gluconate and copper gluconate in the semi-solidified nutrient can be adjusted as appropriate by the subject to be applied.
• Ascorbic acid 2-glucoside is a compound in which glucose is bonded to the hydroxyl group at the 2-position of vitamin C (ascorbic acid) in an ⁇ -coordination, and is not subject to oxygen attack. It is a vitamin C derivative with high stability. Vitamin C can be efficiently absorbed by ascorbic acid 2-glucoside.
• the content of ascorbic acid 2-glucoside in the semi-solidified nutrient can be appropriately adjusted depending on the subject to be applied.
• Cyclodextrin is a cyclic oligosaccharide having a cyclic structure in which glucose is bound by a glucoside bond. Those consisting of 6 glucoses are called ⁇ -cyclodextrin, those consisting of 7 glucoses are called ⁇ -cyclodextrin, and those consisting of 8 glucoses are called ⁇ -cyclodextrin. Cyclodextrins can have functions such as an allergy suppressing effect, a blood sugar level increase suppressing effect, and an emulsifying action. The said cyclodextrin may be used independently or may be used in mixture of 2 or more types.
• the content of cyclodextrin in the semi-solidified nutrient can be appropriately adjusted depending on the subject to be applied.
• Antioxidant has the function of preventing alteration of semi-solidified nutrient due to oxidation.
• the antioxidant is not particularly limited, but ascorbic acid and its sodium salt, erythorbic acid and its sodium salt, and the like can be used. These antioxidants may be used alone or in combination of two or more.
• Colorant has a function of beautifying the semi-solidified nutrient.
• dye Edible red No. 2, No. 3, No. 40, No. 102, No. 104, No. 105, and No. 106, Edible blue No. 1 and No. 2, Edible yellow No. 4 And No. 5, Edible Green No.
• ⁇ -carotene water-soluble anato, chlorophyll derivatives (chlorophyll a, chlorphyll b, copper chlorophyll, copper chlorophyllin sodium, iron chlorophyllin sodium, etc.), riboflavin, iron sesquioxide, titanium dioxide Safflower yellow pigment, cochineal pigment, gardenia yellow pigment, turmeric pigment, red cabbage pigment, beet red, grape skin pigment, paprika pigment, caramel and the like can be used. These colorants may be used alone or in admixture of two or more.
• Sweetener The sweetener has a function of imparting sweetness to the semi-solidified nutrient.
• the sweetener is not particularly limited, but saccharin and its sodium salt, xylitol, aspartame, sucralose, acesulfame potassium, dulcin, cyclamate, neotame, trehalose, erythritol, maltose, para-north, sorbitol, licorice extract
• saccharin and its sodium salt xylitol, aspartame, sucralose, acesulfame potassium, dulcin, cyclamate, neotame, trehalose, erythritol, maltose, para-north, sorbitol, licorice extract
• Stevia processed sweeteners thaumatin, curculin, disodium lithyrrhizinate and the like can be used. These sweeteners may be used alone or in combination of two or more.
• the pH adjuster has a function of adjusting the pH of the semi-solidified nutrient.
• the pH adjuster is not particularly limited, and citric acid, gluconic acid, succinic acid, potassium carbonate, sodium hydrogen carbonate, carbon dioxide, lactic acid, sodium lactate, sodium citrate, adipic acid and the like can be used. These pH adjusters may be used alone or in combination of two or more.
• Acidulant has functions such as imparting acidity to the nutrient, preventing oxidation of the food, and adjusting the pH.
• the acidulant is not particularly limited, but acetic acid, citric acid, succinic acid, lactic acid, malic acid, tartaric acid, gluconic acid, phosphoric acid and the like can be used. These acidulants may be used alone or in combination of two or more.
• Emulsifier has functions such as improving the solubility of oil-soluble components such as lipids in water.
• the emulsifier is not particularly limited, and examples include natural emulsifiers such as lecithin, saponin, and casein sodium; and synthetic emulsifiers such as glycerin fatty acid ester, sorbitan fatty acid ester, propylene glycol fatty acid ester, and sucrose fatty acid ester. These emulsifiers may be used alone or in combination of two or more.
• the fragrance has a function of flavoring and smelling the semi-solidified nutrient.
• the fragrance is not particularly limited, but acetophenone, ⁇ -amylcinnamaldehyde, anisaldehyde, benzaldehyde, benzyl acetate, benzyl alcohol, cinnamaldehyde, cinnamic acid, citral, citronellal, citronellol, decanal, decanol, ethyl acetoacetate, Ethyl cinnamate, ethyl decanoate, ethyl vanillin, eugenol, geraniol, isoamyl acetate, isoamyl butyrate, isoamyl phenyl acetate, dl-menthol, l-menthol, methyl salicylate, piperonal, propionic acid, terpineol, vanillin, d-borneol, etc. Can be mentioned. These fragrances may be used alone or in combination of two or more.
• enzymes such as ⁇ -amylase, ⁇ -amylase, glucoamylase, glucose isomerase, trehalose producing enzyme, trehalose releasing enzyme, glutaminase, yeast and the like can be used.
• the content of the food additive in the semi-solidified nutrient can be appropriately adjusted depending on the subject to be applied.
• the thickener has a function of imparting viscosity to the semi-solidified nutrient.
• Thickeners other than agar and modified starch can also be combined as appropriate.
• the thickener is not particularly limited, but gelatin, pectin, guar gum, locust bean gum, konjac mannan, xanthan gum, tamarind gum, carrageenan, propylene glycol, carboxymethylcellulose gellan gum, gellan gum, tara gum, tamarind seed gum, psyllium seed gum, Gum arabic, curdlan, pullulan, sodium alginate, tragacanth gum, karaya gum, veegum and the like can be used.
• These thickeners may be used alone or in admixture of two or more.
• the content of the thickener in the semi-solidified nutrient is appropriately adjusted in consideration of viscosity and the like.
• the viscosity of the semi-solidified nutrient according to the present embodiment is preferably 10,000 to 50,000 mPa ⁇ s, more preferably 14,000 to 30,000 mPa ⁇ s at 25 ° C. It is preferable that the semi-solidified nutrient has a viscosity of 10,000 mPa ⁇ s or more because gastroesophageal reflux, aspiration pneumonia, and the like can be less likely to occur. On the other hand, it is preferable that the viscosity of the semi-solidified nutrient is 50000 mPa ⁇ s or less because digestion can be facilitated. The viscosity can be adjusted mainly by appropriately setting the contents of agar and modified starch in the semi-solidified nutrient. In this specification, “viscosity” is a value measured by the method described in the examples.
• the calorific value of the semi-solidified nutrient according to this embodiment varies depending on the use of the semi-solidified nutrient, but is preferably 0.5 to 2.5 kcal / g, and is 0 from the viewpoint of water management safety. More preferably, it is 0.5 to 1.0 kcal / g, but more preferably 1.0 to 2.5 kcal / g when it is administered to a patient with water restriction or a burn patient.
• heat amount can be adjusted by setting suitably addition amount, such as saccharide
• the pH of the semi-solidified nutrient according to this embodiment is preferably 3.0 to 4.5, and more preferably 3.5 to 4.0. If pH is in the said range, since the proliferation of bacteria can be suppressed and a refreshing feeling can be obtained, it is preferable.
• the said pH can be adjusted by setting suitably addition amount, such as a pH adjuster and a sour agent.
• pH is a value measured by the method described in the examples.
• the semi-solid enteral nutrient according to this embodiment preferably has a discharge pressure of 15 kPa or less, more preferably 10 kPa or less, when discharged from a syringe at a rate of 60 mm / min.
• a discharge pressure 15 kPa or less, more preferably 10 kPa or less, when discharged from a syringe at a rate of 60 mm / min.
• the semi-solidified nutrient of the present invention is for gastrostoma.
• the gastrostoma nutrient refers to a nutrient administered via the gastrostomy in the tube feeding method. Administration using gastrostomy is difficult to take orally, and can be targeted for the elderly and patients with intestinal function.
• the semi-solidified nutrient according to the present embodiment preferably contains nutrients (preferably carbohydrate and protein sources), moisture, a predetermined amount of agar, and a predetermined amount of modified starch.
• nutrients preferably carbohydrate and protein sources
• limit especially as content of the said nutrient
• Other components that can be added are not particularly limited, and can be appropriately set according to the administration method, the state of the elderly or patient to which the semi-solid enteral nutrient is applied, and the like. Moreover, it is preferable that the patient who needs whole body management contains the vitamin and mineral required in order to maintain a nutritional state. It is preferable to add dietary fiber to elderly people with reduced digestive function in order to improve constipation due to the administration of a semi-solid enteral nutrient.
• the semi-solidified nutrient of this form is adjusted to an appropriate viscosity with modified starch and agar, and contains a necessary nutrient source in a balanced manner, so that the elderly whose stomach has shrunk with aging, cerebrovascular disorder, For patients with impaired swallowing / mastication due to neuromuscular disorders, patients who have difficulty in oral intake due to disturbance of consciousness, etc., for the treatment of gastrointestinal tract function, for patients with undernutrition, reflux esophagitis, etc. Suitable for prevention / treatment and aspiration pneumonia prevention / treatment.
• the semi-solidified nutrient according to this embodiment can be produced by a known method. For example, it can be produced by adding nutrients, agar, modified starch, and other desired components to warm water and stirring. Also, prepare a solution in which agar is dissolved in warm water and a solution in which modified starch is dissolved in water, add nutrients and other desired ingredients to one, and mix and stir the two solutions Can be manufactured.
• the obtained semi-solidified nutrient can be commercialized by, for example, filling a container after continuous sterilization. Although it does not restrict
• UHT Ultra high temperature short time
• the sterilization is preferably performed in a short time. By performing sterilization in a short time, deterioration of components contained in the semi-solidified nutrient can be suppressed.
• the container for filling the semi-solidified nutrient is not particularly limited, and a known container can be used.
• the container include a tetrapack, a cart can, a glass container, a metal can, an aluminum pouch, and a plastic container. Of these, it is preferable to use a plastic container.
• polyethylene polyethylene
• PP polypropylene
• PVC polyvinyl chloride
• PVAc polyvinyl acetate
• PC polycarbonate
• PBT polybutylene terephthalate
• PET polyethylene terephthalate
• PEN Polyethylene naphthalate
• EVA ethylene-vinyl acetate copolymer
• EVA ethylene- ⁇ -olefin copolymer
• polyfluorocarbon polyimide and the like
• the plastic container further includes polyethylene terephthalate (PET), polyethylene naphthalate (PEN), ethylene-vinyl alcohol copolymer (EVOH), polyvinylidene chloride (PVDC), polyacrylonitrile, polyvinyl alcohol, polyamide, polyester, and the like.
• Gas barrier resin layer Gas barrier inorganic layers such as an aluminum foil, an aluminum vapor deposition film, a silicon oxide film, and an aluminum oxide film may be used in appropriate combination. By providing the gas barrier layer, deterioration of the semi-solidified nutrient due to oxygen, water vapor, or the like can be prevented.
• the container may be further shielded from light.
• the light shielding for example, deterioration due to light such as vitamin A, vitamin B2, vitamin C, and vitamin K that can be contained in the semi-solidified nutrient can be suppressed.
• the above-mentioned container may use what is marketed, for example, a soft pouch (made by Fuji Seal Co., Ltd.), a bottled pouch (made by Toppan Printing Co., Ltd.), a spouch (made by Dai Nippon Printing Co., Ltd.), a cheer pack (Co., Ltd.) Hosokawa Yoko) etc. can be used.
• a soft pouch made by Fuji Seal Co., Ltd.
• a bottled pouch made by Toppan Printing Co., Ltd.
• a spouch made by Dai Nippon Printing Co., Ltd.
• a cheer pack Co., Ltd. Hosokawa Yoko
• Example 1 The preparation method when 4000 g is charged is described below.
• the amount of each raw material is as shown in Table 1. 1200 g of prepared water was weighed in a 5 L stainless steel bucket and heated to 80 ° C. or higher in a hot water bath. Next, agar (Inagar Kari Korikan (made by Ina Food Industry Co., Ltd.) as high jelly strength agar and Ultra Agar Ena (made by Ina Food Industry Co., Ltd.) as low jelly strength agar was dissolved sufficiently, and then heated to 50-60 ° C.
• the obtained solution was continuously sterilized, filled in an aluminum pouch with a stopper so as to be 200 parts per piece, and subjected to container sterilization at 90 ° C. for 10 minutes. After the container sterilization treatment, a semi-solidified nutrient containing a pouch was produced by cooling.
• Total energy was calculated as (4 Kcal ⁇ sugar content) + (9 Kcal ⁇ lipid content) + (4 Kcal ⁇ amino acid or peptide content) + (2 kcal ⁇ dietary fiber content), and the calorie was shown as Kcal per g of sample.
• pH measured the pH of the semi-solidified nutrient using pH meter METTLER TOLEDO MP220 (METTLER TOLEDO company).
• WPI WPI1895 (whey protein isolate: manufactured by Fonterra)
• TK-16 manufactured by Matsutani Chemical Industry Co., Ltd.
• WMS acetylated phosphate cross-linked starch: Matsutani Chemical
• vitamins water-soluble vitamin mix, fat-soluble vitamin mix; as minerals, calcium gluconate, magnesium chloride, potassium chloride, sodium chloride, Sodium dihydrogen phosphate and tripotassium citrate; as dietary fiber, gua Yeast mix; citric acid, malic acid, and lactic acid as acidulants; ascorbic acid diglucoside; zinc gluconate; copper gluconate; Water was added until it became, and it was dissolved and dispersed until it became uniform.
• the obtained solution was continuously sterilized, filled in an aluminum pouch with a stopper so as to be 200 parts per piece, and subjected to container sterilization at 90 ° C. for 10 minutes. After the container sterilization treatment, a semi-solidified nutrient containing a pouch was produced by cooling.
• Viscosity After allowing the semi-solidified nutrient to stand at 25 ° C. for 24 hours, a B-type rotational viscometer (manufacturer: BROOKFIELD, model: DV-II + Pro, measurement conditions: rotational speed 6 rpm, measurement time 1 min, rotor No. 64, measurement temperature room temperature (25 ° C.)).
• Injection resistance (kPa) (discharge pressure when discharging from the syringe at a speed of 60 mm / min): About 50 g of a sample was filled in a 50 ml catheter tip syringe (manufactured by Terumo Corporation), and the outer diameter was 20 Fr. When a gastrostomy tube (CR Bard) with an inner diameter of 4 mm is attached to the syringe, the autograph (AGS-J: manufactured by Shimadzu Corporation) is used to discharge from the syringe at a rate of 60 mm / min. The extrusion force was measured (measurement temperature: room temperature 25 ° C.).
• Shape retention A 50 mL catheter tip syringe filled with a semi-solidified nutrient is connected to a tube with an inner diameter of 4 mm, and the shape after extrusion of the semi-solid nutrient is visually confirmed from the syringe. Judged. The shape retention was judged according to the following evaluation criteria.
• Adhesiveness About 50 g of a sample was filled in a 50 ml catheter tip syringe (manufactured by Terumo Corporation), and the outer diameter was 20 Fr. After installing a 4 mm inner diameter Bird Gastrotomy tube (CR Bard) to the syringe, fill the tube with the sample and let stand for 3 minutes. Thereafter, 10 mL of water was allowed to pass through 1, 2, 3, 4, 5 times, and the adhesion state of the sample in the tube after the water had passed was visually confirmed and evaluated by the following evaluation.
• CR Bard Bird Gastrotomy tube
• A The surface of the nutrient solution discharged from the container in a straight line of about 20 cm has a smooth appearance.
• X The appearance of the nutrient solution discharged from the container in a straight line of about 20 cm has a rough appearance and partial aggregation.
• the nutrients of Examples 1 to 10 had low viscosity in injection from a syringe and excellent shape retention, despite having the same viscosity as that of Comparative Examples 3 to 6. From this, it can be understood that the control of the injection resistance is not simply caused by the viscosity of the nutrient, but it is important to use a combination of high jelly strength agar, low jelly strength agar and modified starch. Further, it can be seen that the adhesion of the nutrient to the tube is suppressed as compared with the nutrient using other gelling agents (Comparative Examples 3 to 6).
• the nutrients of Examples 1 to 10 had low injection resistance from the syringe. Moreover, it was a nutrient with excellent shape retention, little aggregation unevenness, and little adhesion to the tube.

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