JP2000119180A - Enteral nutrient - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain the subject nutrient capable of efficiently feeding a required amount of selenium to a human body without causing selenium deficiency arousing a fear in a conventional enteral nutriment by specifying the contents of vitamin C and/or vitamin E. SOLUTION: This enteral nutrient is obtained by making (A) the selenium content to 0.5-10 μg/100 kal, preferably 1-6 μg/100 kcal, (B) the vitamin C content to >=18 mg/100 kcal, preferably >=20 mg/100 kcal and/or (C) the vitamin E content to >=3.3 mg-α-tocopherol equivalents (αToc)/100 kcal, preferably >=3.5 mg-αToc/100 kcal. Furthermore, the ingredient A is preferably in the form of an organoselenium compound derived from an animal or a plant and especially in the form of a selenomethionine and/or a selenocysteine.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an enteral nutrient having excellent selenium absorption in a living body and capable of increasing the concentration of selenium in blood to prevent the onset of selenium deficiency.

[0002]

2. Description of the Related Art Selenium is an essential trace element in the human body. When selenium is deficient, myocardial damage, muscle pain in both lower limbs,
It has been reported to cause diseases such as Keshan disease and osteoarthritis. At present, the nutritional requirement of selenium is not indicated in Japan, but in 1989 the Food and Nutrition Commission of the U.S. Academy of Sciences determined that the American selenium requirement was 70 μg / day for adult males,
It was recommended that the adult female be 55 μg / day. Selenium is contained in foods usually consumed, and it has been reported in Japan that the intake of healthy adults is around 100 μg per day.
It is said that selenium deficiency is less likely to occur during normal eating habits.

On the other hand, enteral nutrition is widely used in recent years for the purpose of supplying nutrition to patients who have difficulty in eating normal food, such as patients who have difficulty swallowing food and patients with chronic bowel disease. And many enteral nutritional agents are commercially available. Although the selenium content of commercially available enteral nutritional products varies considerably depending on the product, for example, “Journal of Japan Society of Nutrition and Food”, Vol. 48, no. 6 p490-4
93 (1995) reports that the selenium content in commercially available enteral nutritional supplements is 0.04 to 5.74 μg / 100 kcal, at most about 6 μg / 100 kcal.
cal, and the selenium content in the enteral nutrition is generally low. Further, selenium is often not efficiently absorbed and used in a living body. For this reason, elderly people whose supply of enteral nutrients is less than 1000 kcal / day due to low energy requirement per day,
Although the enteral nutritional supplement of 00 kcal / day or more is supplied, the amount of selenium consumed is inevitable for patients who have been supplied with the enteral nutritional supplement for a long period of time, unlike those who can take normal foods. It is feared that the selenium deficiency will have an adverse effect.

[0004] In order to improve the selenium deficiency described above associated with the use of enteral nutrition, it is conceivable to increase the selenium content in the enteral nutrition as compared with conventional ones. However,
As described above, even if selenium is administered, it is often absorbed and not efficiently used in the living body, so it is difficult to determine how much the selenium content should be increased or decreased, and if only the selenium content is increased, However, there is a problem that the balance with other nutrients contained in the enteral nutritional supplement is lost. In addition, selenium is known to cause toxic symptoms such as hair loss, deformed nails, vomiting, and weakness when consumed in large amounts.The amount of selenium that causes deficiency and the amount that causes poisoning are relatively narrow. Therefore, it has been required to efficiently absorb and use a necessary amount of selenium in the body.

[0005]

SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide an enteral nutritional agent which efficiently supplies a required amount of selenium to the human body and does not cause selenium deficiency which has been a concern in conventional enteral nutritional agents. It is to provide.

[0006]

Means for Solving the Problems As a result of repeated studies by the present inventors to achieve the above object, the selenium content was 10 μm.
g / 100 kcal or less, even if the enteral nutrition has a low selenium content,
The content of vitamin E is 18 mg / 100 kal or more, or the content of vitamin E is 3.3 mg-αToc / 100 kal.
As described above, the content of vitamin C is particularly reduced to 20 mg / 1.
00kal or more, or the content of vitamin E is 3.5
When the concentration is not less than mg-αToc / 100 kal, the absorption rate of selenium in the human body is improved, the selenium concentration in blood can be increased, and selenium deficiency can be prevented. Since the selenium content is as low as 10 μg / 100 kcal or less as in the case of the conventional enteral nutritional supplement, the present invention has been found to be free from the risk of poisoning due to an excessive supply of selenium and the nutritional balance of the enteral nutritional supplement. Was completed.

That is, according to the present invention, the selenium content is 0.1.
5-10 μg / 100 kcal and vitamin C
The content is 18 mg / 100 kal or more and / or the vitamin E content is 3.3 mg-αToc / 100 kal.
An enteral nutritional agent characterized by the above.

[0008]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below in detail. Enteral nutrients are generally divided into natural food liquid foods, semi-digestive nutrients, digestive nutrients, component nutrients, and special nutrients for treating liver and kidney diseases, each of which is manufactured and sold as food. Or licensed as a medicinal product. Enteral nutrients are classified into liquid and powdered forms, and powdered forms are ingested in liquid form before use. The enteral nutritional supplement of the present invention may be any type or type of enteral nutritional supplement as long as the selenium content and the content of vitamin C and / or vitamin E are the amounts specified in the present invention. It is not particularly limited. Among them, the enteral nutritional supplement of the present invention is preferably in the form of a semi-digestive nutritional supplement in terms of osmotic pressure, palatability and the like.

The amount of calories per unit volume of the enteral nutritional composition of the present invention is not particularly limited, and may be the same as that of the conventional enteral nutritional composition depending on the type and form of the enteral nutritional supplement. Although it is possible, in general, the amount of calories per 100 ml of the enteral nutrition is set to 50 to 200 kcal,
It is preferable because the required nutritional component can be smoothly supplied to the patient while suppressing the burden on the patient and continuously administering it nasally or percutaneously. Among them, when the amount of calories per 100 ml of the enteral nutrition is set to 100 kcal, the calorie amount can be easily calculated in addition to the above-mentioned characteristics, and the enteral nutritional supplement of the required calorie amount is surely given to the patient. It is very convenient because it has the advantage of being easily supplied.

The enteral nutritional composition of the present invention contains selenium at a rate of 0.5 to 10 μg, preferably 1 to 6 μg, per 100 kcal of the enteral nutritional composition. For example, when the amount of calories per 100 ml of the enteral nutritional agent of the present invention is 100 kcal, selenium may be contained at a ratio of 0.5 to 10 μg in 100 ml of the enteral nutritional supplement. The content of selenium in the enteral nutrition is 0.5
When the amount is less than μg / 100 kcal, the absolute amount of selenium contained in the enteral nutritional supplement is low, so that the amount of selenium supplied to the patient is too small and selenium deficiency is likely to occur. In addition, the selenium content in the enteral nutritional supplement referred to in the present specification refers to the content per 100 kcal of the enteral nutritional supplement in terms of selenium atom, and is a value measured by a fluorescence method after performing a pretreatment. Yes, specific measurements are as described in the section of Examples below.

In the enteral nutritional composition of the present invention, selenium is preferably contained in the form of an organic selenium compound derived from animals and plants, from the viewpoints of selenium absorption by the living body and non-toxicity, among which selenomethionine. And / or more preferably in the form of selenocysteine. These selenomethionine and selenocysteine are contained in soybean protein, egg white hydrolyzate, egg white and the like as constituent amino acids thereof.

Furthermore, the enteral nutrition of the present invention contains 18 mg or more of vitamin C per 100 kcal of the enteral nutrition, or 3.3 mg-αToc of vitamin E.
(Ie, mg α-tocopherol equivalent) or more, or vitamin C at a rate of 18 mg or more and vitamin E at a rate of 3.3 mg-αToc or more. Among them, the enteral nutritional supplement of the present invention contains vitamin C at 20 mg / 100 ka.
1 or more and / or vitamin E3.
It is preferable to contain Vitamin C at a rate of 20 mg / 100 kal or more, because the content of selenium in the living body is improved and the selenium concentration in the blood can be increased. It is more preferable that vitamin E is contained at a rate of 3.5 mg-αToc / 100 kal or more.

When the content of vitamin C in the enteral nutrition is less than 18 mg / 100 kal and / or the content of vitamin E is 3.3 mg-αToc / 100 k
If it is less than al, the absorbability of selenium in the living body will not be improved, and it will be difficult to increase the selenium concentration in blood, and selenium deficiency will easily occur. In this specification, the content of vitamin C and vitamin E in the enteral nutritional supplement is determined according to the method of Japan Food Research Laboratories, and the value of vitamin C is determined by high performance liquid chromatography (HPLC). To tell. Vitamin E is HPLC
The value obtained by measuring according to the
(Fifth revision; supervision of Health Promotion Nutrition Division, Health and Medicine Bureau, Ministry of Health and Welfare)
(Α: β: γ: δ = 100: 25:
5: 0.1), that is, α-tocopherol equivalent (αToc).

The type, content, composition, caloric content, etc., of the nutritional components in the enteral nutritional composition of the present invention are not particularly limited, and may be the same as conventional ones according to the type and form of the enteral nutritional supplement. be able to. For example, proteins include milk proteins (whey protein, low-lactose milk protein, whole milk protein, casein, etc.) and their hydrolysates, skim milk powder, milk, egg white hydrolysates, egg white powder, whole eggs, soy protein, etc. Vegetable protein, soy protein hydrolyzate, gelatin hydrolyzate,
It can be appropriately selected from low molecular peptides, amino acids and the like. As the lipid, for example, a vegetable oil such as corn oil, soybean oil, canola oil, olive oil, fish oil, or the like can be appropriately selected and used. In addition, as the saccharide, for example, dextrin, glucose, sucrose, or the like can be appropriately selected and used.

Further, the enteral nutritional supplement of the present invention contains vitamin C
And / or may contain one or more other vitamins and vitamin precursors together with vitamin E, and may contain one or more other minerals together with selenium. Good. The enteral nutritional supplement of the present invention may contain dietary fiber, germ extract, emulsifier, stabilizer, flavor, seasoning, animal and plant extract, and the like.

The method for preparing the enteral nutrition of the present invention is not particularly limited, and it can be prepared in the same manner as a conventional enteral nutrition, depending on the type and form of the enteral nutrition. It can be produced by adding necessary nutrients to pure water, emulsifying and subjecting to heat sterilization and the like.

In supplying the enteral nutritional supplement of the present invention to a patient, the amount of calories per unit volume of the enteral nutritional supplement,
The supply amount is determined according to the patient's symptoms, the content of the disease, the nutritional status, the age, the weight, the sex, etc., and generally 800 to 2400 kca for adults depending on the symptoms and the like.
It is supplied in an amount in the range of 1 / day.

[0018]

EXAMPLES The present invention will be specifically described below with reference to examples and the like, but the present invention is not limited to the following examples. In the following examples, the caloric content of the enteral nutrition, the selenium content in the enteral nutrition, the vitamin C content and the vitamin E content, and the selenium concentration in the blood of the subject (patient) are determined by the following methods. Measured or calculated.

[Calories of Enteral Nutrition] The weight of protein, lipid and carbohydrate contained in a given weight of enteral nutrition is determined. The coefficient of 4 kcal / g for protein and carbohydrate and 9 kcal for lipid are calculated. / G was multiplied to calculate the calorie amount (energy amount).

[Selenium Content in Enteral Nutrition] 20 ml of nitric acid and 10 ml of perchloric acid were added to 5 g of the enteral nutrition, and the mixture was heated and decomposed in a Kjeldahl flask. After cooling, 2 ml of 10% hydrochloric acid was added, and the mixture was heated in a boiling water bath for 30 minutes. This was transferred to a tall beaker, 4 ml of 0.1 M ethylenediaminetetraacetic acid and 2 ml of 20% hydroxylamine hydrochloride were added, and then the pH was adjusted to 1.0 to 1.5 using 10% hydrochloric acid or 10% aqueous ammonia, Add water to about 50ml
And 5 ml of a 0.1% 2,3-diaminonaphthalene solution was added thereto, and the mixture was heated in a water bath at 50 ° C. for 30 minutes, transferred to a separatory funnel, added with 10 ml of cyclohexane, and shaken for 5 minutes. After standing, the cyclohexane layer was removed, and a fluorescence spectrophotometer (excitation wavelength 378 nm, measurement wavelength 5
20 nm), and the selenium content was determined by referring to a previously prepared calibration curve. The selenium content per unit weight was calculated by dividing the obtained selenium content per unit weight by the specific gravity of the enteral nutrient, and the selenium content per 100 kcal of the enteral nutrient was calculated.

[Vitamin C content in enteral nutrition] 3 g of enteral nutrition was added to a 5% metaphosphoric acid solution, homogenized to 50 ml, and insoluble materials were removed by centrifugation and filtration (5C filter paper). 1 ml of this solution was taken, and 1 ml of 5% metaphosphoric acid, 3 drops of 0.5% dichlorophenol indophenol solution and 2 ml of 2% thiourea / 5% metaphosphoric acid solution were added thereto. Further, 0.5 ml of 2,4-dinitrophenylhydrazine / 4.5 M sulfuric acid solution was added, and the mixture was heated at 50 ° C. for 1 hour in a water bath. 2m of ethyl acetate
l was added and shaken for 60 minutes to perform extraction, and the vitamin C content was measured by HPLC. Based on this vitamin C content, the vitamin C content per 100 kcal of the enteral nutrition was calculated in the same manner as in the case of the selenium content in the enteral nutrition.

[Vitamin E content in enteral nutritional supplement] To 1 g of enteral nutritional supplement were added 2 ml of 1% aqueous sodium chloride solution, 10 ml of 3% pyrogallol / ethanol solution and 2 ml of 60% aqueous sodium hydroxide solution, and the mixture was added at 70 ° C. Heated for 30 minutes. Next, 21 ml of a 1% aqueous sodium chloride solution was added, and a mixed solvent 1 of n-hexane: ethyl acetate = 9: 1 was added.
Extraction was performed three times with 5 ml. The organic layer was dehydrated and dried under reduced pressure. This was redissolved in 4 ml of n-hexane, and the vitamin E content was measured by HPLC. Based on the vitamin E content, the vitamin E content per 100 kcal of the enteral nutrition was calculated in the same manner as in the case of the selenium content in the enteral nutrition.

[Selenium Concentration in Blood of Subject] Serum was separated from the blood, and the diluted serum was measured with a graphite furnace atomic absorption spectrometer to determine the selenium concentration in the serum.

Example 1 [Preparation of Enteral Nutrition] (1) The components shown in Table 1 below were added in the proportions shown in Table 1, mixed uniformly with a mixer, and powdered. Enteral nutritional supplements were prepared.

[0025]

[Table 1]

The vitamin mix used above contains dextrin as an excipient in 1 g of the vitamins shown in Table 2 below.

[0027]

[Table 2] [Vitamin mix composition]  Vitamin A 100 IU Vitamin B1 0.07 mg Vitamin B2 0.09 mg Vitamin B6 0.10 mg Vitamin B12 0.07 μg Vitamin C 25.0 mg Vitamin D 5 IU Vitamin E 3.75 mg-αToc Niacin 1.00 μg Folic acid 10 μg Pantothenic acid .20mg

The mineral mix used above contains the minerals shown in Table 3 below in 1 g using dextrin as an excipient.

[0029]

[Table 3] [Mineral Mix Composition] Sodium 25mg Potassium 100mg Calcium 30mg Magnesium 15mg Phosphorus 30mg Iron 0.7mg

The powdery enteral nutritional product obtained above has a uniform appearance, good powder properties, and maintains a good powder state without solidification even after being sealed and stored for 12 months. I was keeping it.

(2) For 236 g (1000 kcal) of the powdery enteral nutrient obtained in the above (1), 40
C. Water was added and the mixture was stirred and mixed at a ratio such that the total amount was 1000 ml. The mixture was dissolved well without causing aggregation, sedimentation, suspension, or adhesion to the wall. (Hereinafter referred to as “enteral nutritional supplement”). The specific gravity of this enteral nutrient was measured using a standard hydrometer (a glass float), and was found to be 1.074.
The selenium content of the enteral nutritional product thus obtained was 2.2 μg / 100 k as measured by the method described above.
cal. The content of vitamin C in the enteral nutritional supplement was 25.0 mg / 100 kcal and the content of vitamin E was 3.75 mg-αToc / 100 kal. (3) Further, when the enteral nutrition was brought to a temperature of 37 ° C. and the tube was allowed to flow naturally at a head of 50 cm using a polytetrafluoroethylene supply tube (ED tube) (inner diameter 0.7 mm), The whole amount dropped within one hour without clogging the tube. Further, the enteral nutrient was placed in a plastic beaker and allowed to stand at room temperature (25 ° C.) for 2 hours, but no discoloration, aggregation, sedimentation, flotation, and adhesion to the wall occurred.

<< Control Example 1 >> [Preparation of Enteral Nutrition] (1) Employing the ingredients shown in Table 1 above, a vitamin mix having the composition shown in Table 4 below was used. A powdered enteral nutritional supplement was prepared in the same manner as in Example 1 except for the difference. The powdery enteral nutritional product thus obtained had a uniform appearance, had good powder properties, and kept a good powder state without solidification even after being sealed and stored for 12 months. .

[0033]

[Table 4] [Composition of vitamin mix] ¹⁾ Vitamin A 100 IU Vitamin B1 0.07 mg Vitamin B2 0.09 mg Vitamin B6 0.10 mg Vitamin B12 0.07 μg Vitamin C 16.0 mg Vitamin D 5 IU Vitamin E 3.0 mg-αToc Niacin 1.00 μg Folic acid 10 μg Pantothenate .20mg 1) Dextrin used as excipient.

(2) For 236 g (1000 kcal) of the powdery enteral nutritional agent obtained in the above (1), 40
C. Water was added and the mixture was stirred and mixed at a ratio such that the total amount was 1000 ml. The mixture was dissolved well without causing aggregation, sedimentation, suspension, or adhesion to the wall. (Hereinafter referred to as “enteral nutritional supplement”). The specific gravity of this enteral nutrient was measured by the same method as described above, and was 1.074. The selenium content in the enteral nutrient thus obtained was 2.2 μg / 100 kcal as measured by the method described above. In addition, the vitamin C content in the enteral nutrition is 1
The content of 6.0 mg / 100 kcal and vitamin E was 3.0 mg-αToc / 100 kal. (3) The enteral nutrient was brought to a temperature of 37 ° C. and allowed to flow naturally in the tube at a drop of 50 cm using a polytetrafluoroethylene supply tube (ED tube) (inner diameter 0.7 mm). The whole amount dropped within one hour without clogging. Further, the enteral nutrient was placed in a plastic beaker and allowed to stand at room temperature (25 ° C.) for 2 hours, but no discoloration, aggregation, sedimentation, flotation, and adhesion to the wall occurred.

<< Test Example 1 >> (i) Control test: Six patients A to F (subjects) shown in Table 5 below were tested according to the type and symptoms of the disease.
The enteral nutritional supplement obtained in Control Example 1 was administered daily for one month in the amounts shown in Table 5, and the selenium concentration in the blood before administration and the blood (serum) one month after administration were obtained. The selenium concentration was measured by the method described above, and was as shown in Table 5. (Ii) Implementation test: a stage in which the one-month administration test of the enteral nutritional product obtained in Control Example 1 above was completed for the six patients A to F who had administered the above (i). Then, switching to the enteral nutrient obtained in Example 1, the same dose as in the above (i) was administered daily for one month, and the selenium concentration in blood before administration of the enteral nutrient and one month after administration After blood (serum)
The selenium concentration in the medium was measured by the method described above, and was as shown in Table 5 below.

[0036]

[Table 5]

From the results shown in Table 5, the selenium content was 2.2 μg / 100 kcal and the vitamin C content was 1
When the enteral nutritional supplement obtained in Control Example 1 having 6.0 mg / 100 kal and vitamin E content of 3.0 mg-αToc / 100 kal was administered, the selenium concentration in the blood of the patient even after one month of administration Has little change and may cause selenium deficiency, whereas selenium content is 2.2 μg / 100 kcal and vitamin C
Content of 25.0mg / 100kal and vitamin E
When the enteral nutritional supplement obtained in Example 1 having a content of 3.75 mg-αToc / 100 kal was administered,
The selenium concentration in the patient's blood increased significantly after one month, indicating that the patient was effective in improving selenium deficiency.

[0038]

The enteral nutritional supplement of the present invention is excellent in the absorption of selenium in a living body. Therefore, when the enteral nutritional supplement of the present invention is supplied to a patient, the selenium concentration in blood can be increased. It can prevent the onset of myocardial damage, muscular pain in both lower limbs, Keshan disease, osteoarthritis, etc. due to selenium deficiency. The enteral nutritional supplement of the present invention has a selenium content of 0.5 to 10 μg / 1.
Since the value is as low as 00 kcal, there is no concern about the occurrence of poisoning due to excessive selenium intake even if it is given to the patient for a long time.

──────────────────────────────────────────────────続 き Continued on the front page (51) Int.Cl. ⁷ Identification symbol FI theme coat ゛ (reference) // A61K 9/08 A61K 9/08 EF term (reference) 4C076 AA17 AA29 BB05 CC21 CC22 4C086 AA01 AA02 BA09 BA18 HA08 MA03 MA04 MA52 NA11 ZC21 ZC28 ZC29 4C206 AA01 AA02 JA27 JA58 MA03 MA04 MA13 MA72 ZC21 ZC28 ZC29

Claims (4)

[Claims] 1. A selenium content of 0.5 to 10 μg / 10
0 kcal and a vitamin C content of 18 mg /
An enteral nutritional supplement characterized by having a content of 100 kal or more and / or a vitamin E content of 3.3 mg-αToc / 100 kal or more. 2. The selenium content is 1 to 6 μg / 100 kc.
al and has a vitamin C content of 20 mg / 100 ka.
l or more and / or the vitamin E content is 3.5 mg-
The enteral nutritional product according to claim 1, which is αToc / 100 kal or more. 3. The enteral nutrition according to claim 1, wherein the selenium is in the form of an organic selenium compound derived from animals and plants. 4. The enteral nutritional composition according to claim 1, wherein selenium is in the form of selenomethionine and / or selenocysteine.