JP5318625B2 - Semi-solidifying agent for enteral nutrition for gastrostomy patients - Google Patents

Description

  The present invention relates to a semi-solidifying agent for enteral nutrition used for gastrostomy patients and a semi-solid enteral nutrition for gastrostomy patients containing the semi-solidifying agent. Specifically, even if the tube used for enteral administration is a thin tube with an inner diameter of about 4 mm, an enteral nutritional agent that has little adhesion to the inner wall of the tube and has an appropriate shape retention after passing through the tube is prepared. Relates to possible semi-solidifying agents. Furthermore, the present invention relates to a semi-solid enteral nutritional agent in which the occurrence of water separation after tube administration and during long-term storage is also suppressed.

  Nasal / oral tube feeding methods and gastrostomy / gastroenteral tube feeding methods are used for patients who have difficulty in ingesting food, such as significant reductions in mastication / swallowing function and disturbance of consciousness. Nasal / oral tube feeding is a continuous administration of nutrients such as enteral nutrients through a tube inserted through the nose or mouth to reach any part of the esophagus, stomach, duodenum, or jejunum. It is a method to do. However, since such a nasal / oral tube feeding method administers the enteral nutrient through a thin and long tube inserted from the nose or mouth, 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.

  On the other hand, gastrostomy tube feeding method (PEG) inserts a tube from an external fistula (fistula) constructed surgically or endoscopically in the stomach and directly enters the stomach through the tube into the stomach. A method of administering nutrients. Unlike conventional nasal tube feeding methods, this method is not an uncomfortable feeling in the nose and is easy to care at home, so it is an effective tube feeding method with less burden on patients and their caregivers. It is attracting attention as a kind.

  In such gastrostomy tube feeding method (PEG), a method for imparting shape retention to enteral nutrients has been studied for the reasons shown in (1) to (4) below. (1) To prevent the enteral nutrient from leaking from the tube mouth of the outer cage constructed in the stomach during or after administration of the enteral nutrient. (2) By direct administration of liquid enteral nutrients to the stomach, enteral nutrients fall into the intestine from the stomach (dumping), carbohydrates are rapidly absorbed, resulting in hyperglycemia, diarrhea To prevent causing symptoms. (3) In order to prevent the symptoms described in (2), the liquid enteral nutrient must be administered to the patient in the same position for a long time, but the enteral nutrient is given shape retention The symptoms of (2) can be suppressed and administration in a short time becomes possible. As a result, pressure ulcers can be prevented, the burden on the patient can be reduced, and the patient's QOL (Quality of Life) can be improved. (4) Elderly patients and patients to whom tube feeding is applied may have a markedly reduced function of the cardia in the upper stomach, and liquid enteral nutrients may cause gastroesophageal reflux For.

  For example, a method of adding agar or whole egg as a semi-solidifying agent to a enteral nutrient (Patent Document 1), or a gel enteral nutrient containing agar and alginic acid and / or a salt thereof (Patent Document 2) ), Gel-like liquid food containing 20 to 120 parts by mass of xanthan gum and 20 to 60 parts by mass of iota-type carrageenan with respect to 100 parts by mass of agar (patent document 3), stomach containing guar gum enzymatic degradation product, agar and gellan gum A nutritional composition for patients with hemorrhoids (Patent Document 4) is disclosed. In addition, as a technique using LM pectin (low methoxyl pectin), a solution containing low methoxyl pectin and condensed phosphate (first liquid), a solution containing divalent or polyvalent metal salt (second liquid), and And a technique for mixing or gelling or solidifying with a nutrient before administration (Patent Document 5), and a technique for administering low-methoxyl pectin by tube administration before and after liquid tube administration (Patent Document 6). ing.

Japanese Patent No. 3516673 JP 2008-69090 A JP 2008-237186 A JP 2007-176848 A JP 2006-248981 A International Publication No. 00/013529 Pamphlet

  However, gels prepared using agar have the property of being difficult to reattach after being crushed once. For this reason, semi-solid enteral nutrients prepared using agar are in the form of a crash gel at the stage of injection into a gastrostomy tube with a syringe or the like (the gel breaks down and a collection of crumbly small gel-like fragments. The gel piece remains in the tube. In addition, semi-solid enteral nutrients prepared using agar will cause water separation during distribution, long-term storage, or when the gel is crushed. Although the generated water separation can improve the fluidity in the tube, on the other hand, when a semi-solid enteral nutrient is administered to a gastrostomy patient, water leaks from the tube and the workability is deteriorated. In addition, due to the generated water separation, the stomach contents are likely to flow, which may cause gastroesophageal reflux. Similarly, conventional enteral nutrients containing agar and alginic acid, gelled liquid foods containing agar, xanthan gum and iota carrageenan, guar gum enzymatic degradation products, agar and gellan gum However, it is not sufficient to solve the problems of semi-solid enteral nutrients prepared using agar. Specifically, the gel-like enteral nutrient containing agar and alginic acid (Patent Document 2) prepares a uniform gel because calcium ions and alginic acid in the nutrient cause a rapid gelation reaction in the preparation stage. Difficult to do. Even if a uniform gel can be prepared, both the agar and alginic acid are brittle and easily gelled. Gelled liquid food containing agar, xanthan gum and iota carrageenan (Patent Document 3) has excellent points such as high shape retention and low water separation, but it has high adhesion, so it remains in the tube at the time of administration. Many remain. Similarly, enteral nutrient containing guar gum enzyme degradation product, agar, and gellan gum (Patent Document 4) is also effective as an enteral nutrient for gastrostomy, although it has an effect of reducing water separation but has high adhesion. It wasn't.

  On the other hand, in the technique disclosed in Patent Document 5 using LM pectin, shape retention is not sufficient with LM pectin alone, and there are many residues in the tube. In the case of using alginic acid, sodium alginate, and kappa carrageenan as materials used in combination with LM pectin in Patent Document 6, calcium ions and alginic acid in the nutrient cause a rapid gelation reaction during preparation. It was difficult to prepare a uniform gel. On the other hand, when iota carrageenan was used as a combined material, the adhesion was high, and when lambda carrageenan was used, problems such as the inability to reinforce shape retention, which was not sufficient with LM pectin alone, remained. .

  An object of this invention is to provide the semi-solidifying agent which can provide the physical property suitable for the enteral nutrient for gastrostomy patients in view of this problem. In detail, even a thin tube with an inner diameter of about 4 mm provides a semi-solidifying agent that can be used to prepare enteral nutrients that have low adhesion to the tube and have adequate shape retention even after passing through the tube. The purpose is to do. Furthermore, it aims at providing the semi-solidified enteral nutrient which suppressed generation | occurrence | production of water separation after tube administration and the time of long-term storage.

  The present inventor has conducted extensive research in view of the above problems, and as a semi-solidifying agent for enteral nutrients for gastrostomy patients, the use of agar in combination with LM pectin provides sufficient shape retention. In spite of the fact that LM pectin, which has a large amount of residue adhered to the tube, is used, on the contrary, there is little adhesion to the inner wall of the tube and it has moderate shape retention after passing through the tube. It has been found that enteral nutrition can be provided. Furthermore, the present invention has been completed by finding that by using the semi-solidifying agent, it is possible to prepare an enteral nutrient in which the occurrence of water separation is suppressed even after tube administration and during long-term storage.

The present invention relates to a semi-solidifying agent for enteral nutrition used for a gastrostomy patient and a semi-solid enteral nutrition for gastrostomy patients having the following aspects;
Item 1. A semi-solidifying agent for enteral nutrition for gastrostomy patients, comprising agar and LM pectin.
Item 2. A semi-solid enteral nutrient for gastric fistula patients, comprising the semi-solid agent according to Item 1.

  According to the present invention, it is possible to provide an enteral nutrient that has low adhesion to the inner wall of the tube and that has an appropriate shape retention even after passing through the tube. Furthermore, it is possible to provide an enteral nutrient in which the generation of water separation is suppressed even during long-term storage. Thereby, the workability at the time of tube administration to a gastrostomy patient is improved, and gastroesophageal reflux after tube administration can be suppressed preferentially.

  The semi-solidifying agent for enteral nutrient used for gastrostomy patients of the present invention is characterized by containing agar and LM pectin.

  The agar used in the present invention can be any of various types obtained by drying and coagulating hot water extracted from red algae such as Amakusa, Ogonori, Obakusa, and Cyprinus. Various shapes of agar such as agar, flake agar and powder agar can be used. When gelling concentrated liquid foods or nutrients for the purpose of tube administration, it has been conventionally known that agar is used as a gelling agent. However, agar gel tends to cause water separation during storage. Further, when the gel is broken by pressurization during the tube administration to form a crush gel, the surface area of the gel increases and water separation further increases. The generated water separation becomes a smoothing agent that makes the enteral nutrient easy to slip in the tube at the time of tube administration, and has the advantage that the enteral nutrient can be administered without excessive burden even in a thin tube. When intestinal nutrients are injected into a tube, water separation generated from a fistula of a gastrostomy patient (tube connection part added to the stomach) leaks, and the workability at the time of tube administration is reduced. In addition, when the generated water separation flows back to the gastroesophageal tract, it may cause secondary aspiration and the accompanying aspiration pneumonia. In addition, enteral nutrients prepared using agar become crush gel after passing through the tube, which may reduce the shape retention of enteral nutrients in the stomach and prevent gastroesophageal reflux sufficiently There is sex. However, the present invention has a feature that even agar having such properties can provide a semi-solid enteral nutrient capable of solving the above-mentioned problems when used together with LM pectin.

  Pectin is an acidic polysaccharide having α-D-galacturonic acid as a main chain component, which exists as a cell wall component in vegetables and fruits. Galacturonic acid constituting pectin is partially methyl esterified, and is divided into LM (low methoxyl) pectin and HM (high methoxyl) pectin depending on the degree of esterification. The present invention is characterized by using LM pectin having an esterification degree of 50% or less that causes sufficient reaction with calcium ions when mixed with a concentrated liquid food. Among them, it is preferable to use those having an esterification degree of 10 to 40% that can be easily prepared. Commercially available LM pectin products include “Bistop [trademark] D-402”, “Bistop [trademark] D-1382” manufactured by San-Ei Gen FFI Co., Ltd., and the like.

  By using this LM pectin in combination with agar as a semi-solidifying agent for enteral nutrients for gastrostomy patients, enteral nutrients are prevented from crashing into a gel gel and shape retention is reduced. It is possible to prepare a semi-solid enteral nutrient having good shape retention (after passing through the tube). In addition, water separation that occurs when agar is used as a semi-solidifying agent for enteral nutrients can be remarkably suppressed, and the enteral nutrients are not excessively burdened even though water separation is suppressed. It is possible to inject into a tube. Furthermore, it has become possible to prepare enteral nutrients that are less likely to adhere to the inner wall of the tube used for tube administration.

  The amount of agar and LM pectin added in the enteral nutrient for gastrostomy patients of the present invention can be adjusted as appropriate depending on the composition of the enteral nutrient to be used and the required shape retention, The amount of agar added to the enteral nutrient is 0.05 to 2% by mass, preferably 0.1 to 1% by mass, more preferably 0.1 to 0.5% by mass, and the amount of LM pectin added is 0.00. It is preferable to contain it so that it may become 01-5 mass%, Preferably it is 0.05-2 mass%, More preferably, it is 0.05-1 mass%.

  The semi-solidifying agent for enteral nutrient for gastrostomy patients of the present invention is LM pectin 0.5 to 10000 parts by mass, preferably 1 to 2000 parts by mass, more preferably 10 to 100 parts by mass of agar. It is preferable to contain agar and LM pectin so that it may become 1000 mass parts.

  The enteral nutrient to which the semi-solidifying agent for gastrostomy patients of the present invention is added is a liquid general nutrition currently marketed in addition to a nutrient intended to be injected through a fistula built in the stomach. Liquid foods such as foods, paste foods, and milk that are administered to gastrostomy patients using gastrostomy tube feeding (PEG) are also widely included. Particularly preferred is the enteral nutrient (nutrient intended to be injected through the fistula). By adding the semi-solidifying agent of the present invention to such enteral nutrient, it has become possible to provide a semi-solid enteral nutrient suitable for administration to gastrostomy patients.

  Hereinafter, the content of the present invention will be specifically described with reference to the following examples and comparative examples, but the present invention is not limited thereto. Unless otherwise specified, “parts” means “parts by mass” and “%” means “% by mass”. Those marked with “*” in the text indicate that they are registered trademarks of San-Ei Gen FFI Co., Ltd., and “*” marks in the text indicate that they are registered trademarks of San-Ei Gen FFI Co., Ltd.

Experimental Example 1 Preparation of semi-solid enteral nutrient for gastrostomy patients According to the formulation in Table 1, a semi-solid enteral nutrient was prepared. Specifically, agar (Comparative Examples 1 and 2) or a mixture of agar and LM pectin (Example 1) was added to 50 g of water, and the mixture was stirred and dissolved at 90 ° C. for 10 minutes. A commercially available enteral nutrient (100 kcal per 100 ml, 5 g of protein, 2 g of fat, 15 g of carbohydrates, 2 g of carbohydrates, 2 g of dietary fiber, about 500 mg of minerals, about 13 mg of vitamins) added in advance to the above solution and mixed, A semi-solid enteral nutrient was prepared by filling a beaker with a diameter of 40 mm with 25 ml each in a 15 mm and 50 ml catheter tip syringe and cooling in a refrigerator (5 ° C.) overnight. About the prepared semi-solidification enteral agent, shape retention property, water separation, and adhesiveness were evaluated. The results are shown in Table 1.

Shape retention: A 50 ml catheter tip syringe filled with semi-solid enteral nutrient is connected to a tube (inner diameter of about 4 mm), and the shape retention after extruding the semi-solid enteral nutrient from the syringe is maintained. Evaluations were made in five grades from +++>++>+>±> − from the highest type.
Water separation: After extruding a semi-solid enteral nutrient from a syringe in the same manner as the shape retention, the enteral nutrient is low in water in five stages: +++>++>+>±>- evaluated.
Adhesion: TPA (texture profile analysis) measurement was performed on semi-solid enteral nutrients filled in a stainless steel container with a diameter of 40 mm and a height of 15 mm under the following conditions to adhere to a jig (plunger) Was measured. Specifically, the sample was filled in a 40 mm diameter container to a height of 15 mm, and a compression measurement was performed twice with a texture analyzer using a plunger with a diameter of 20 mm at a compression speed of 10 mm / sec and a clearance of 5 mm. In addition, it shows that adhesiveness is so low that a numerical value is small.

  From Table 1, by using agar and LM pectin in combination, the shape retention was improved compared to the semi-solid enteral nutrient using agar alone, and the water separation that occurred during tube administration was significantly suppressed. . Conventionally, semi-solid enteral nutrients containing agar have improved fluidity in the tube due to water separation occurring during tube administration, and even a thin tube can be pushed in without excessive burden. However, the semi-solid enteral nutrient of Example 1 was able to be pushed in without excessive burden even though water separation was remarkably suppressed. Furthermore, by using agar and LM pectin in combination, adhesion to the inner wall of the tube is also reduced, and enteral nutrients having excellent physical properties as semi-solid enteral nutrients for gastrostomy patients can be prepared. (Example 1). In addition, the semi-solidified enteral nutrient of Example 1 was an enteral nutrient suitable for long-term storage because water separation was suppressed even after storage at room temperature for 1 month. On the other hand, Comparative Example 2 in which the amount of agar added was increased as compared with Comparative Example 1, but the shape retention was improved as compared with Comparative Example 1, but the adhesion was also increased. Among these, the semi-solid enteral preparation of the present invention (Example 1) has a small adhesiveness despite having the same shape retention as Comparative Example 2, and enteral nutrition for gastrostomy patients. As an excellent physical property.

  According to the present invention, since there is little adhesion to the inner wall of the tube, there is little tube residue, and an enteral nutrient excellent in bacterial hygiene can be provided. Moreover, since it has moderate shape-retaining property even after passing through the tube, it is possible to suppress gastroesophageal reflux in gastrostomy patients by using the semi-solidified enteral nutrient of the present invention. Furthermore, enteral nutrients can be provided in which the occurrence of water separation is suppressed even during long-term storage, thereby improving the workability during tube administration to gastrostomy patients, and gastroesophageal after tube administration Backflow can also be suppressed preferentially.

Claims (2)

A semi-solidifying agent for enteral nutrition for gastrostomy patients, comprising agar and LM pectin. A semi-solid enteral nutrient for gastric fistula patients, comprising the semi-solidifying agent according to claim 1.