JP2023102714A - oral composition - Google Patents

Abstract

To provide an oral composition capable of inhibiting an unpleasant symptom such as heartburn incurred when ingesting orally a ferritin iron donating material.SOLUTION: An oral composition contains a ferritin iron donating material and a hardly digestible polysaccharide donating material. A heartburn inhibiting agent, the heartburn being incurred by the ferritin iron donating material, includes a hardly digestible polysaccharide as an active principle. A quality improvement method of the ferritin iron donating material includes blending the hardly digestible polysaccharide with the ferritin iron donating material.SELECTED DRAWING: None

Description

TECHNICAL FIELD The present invention relates to an oral composition that enables good intake of iron.

Minerals such as iron, zinc, and copper are known to be essential trace elements that play important roles in the physiological functions of living organisms. For example, iron is a component of hemoglobin and various enzymes, and about 3,500 to 5,000 mg of iron exists in the body of an adult. Deficiency is known to lead to anemia and decreased motor and cognitive function.

In general, it is believed that the absorption and excretion of essential trace elements that play an important role in physiological functions are strictly regulated for maintaining homeostasis in living organisms. However, the balance may be lost due to various factors such as unbalanced diet, pregnancy, aging, postoperative functional decline, and so on. In addition, the intake of drugs that form complexes with iron, zinc, etc., the use of artificial diets and transfusions during hospitalization, etc., may also disrupt the balance of essential trace elements. Therefore, there is a high demand for products such as dietary supplements (supplements) that allow easy intake of such mineral nutritional components. In addition, iron, zinc, copper, etc. are also listed as mineral nutritional ingredients related to nutritional functional foods (food labeling standards).

In recent years, it has been known to use ferritin iron for supplementation of iron. Ferritin iron is a protein-iron complex consisting of a globular protein consisting of 24 subunits and a cage-like structure that holds the iron inside. Ferritin binds to iron in vivo, keeps it water-soluble and non-toxic, and plays a role of concentrating and storing iron. It is also thought to play a role in suppressing excess or deficiency of iron.

Regarding the use of ferritin iron, for example, Patent Document 1 describes preparation of a ferritin iron-containing material from natural raw materials such as animals and plants, and describes its use in nutritional supplements (supplements) and the like.

Japanese Patent Publication No. 2015-504888

However, studies by the present inventors have revealed that when ferritin iron donors are orally ingested, the materials often cause undesirable symptoms such as heartburn.

Therefore, in view of the above circumstances, an object of the present invention is to provide an oral composition capable of suppressing undesirable symptoms such as heartburn caused when orally ingesting a ferritin iron-donating material.

In order to achieve the above objects, the present inventors have made extensive studies and found that the above problems can be solved by using indigestible polysaccharides, and have completed the present invention.

That is, in its first aspect, the present invention provides an oral composition comprising a ferritin iron-donating material and an indigestible polysaccharide-donating material.

In the oral composition according to the present invention, the ferritin iron-donating material is preferably a bean-derived ferritin iron-containing material having an iron content of 3% by mass or more.

In the oral composition according to the present invention, it is preferable that the indigestible polysaccharide-donating material has a molecular weight of 10,000 or less as the indigestible polysaccharide.

In the oral composition according to the present invention, the indigestible polysaccharide in the indigestible polysaccharide-donating material is preferably contained in an amount of 10 to 1000 parts by mass per 1 part by mass of the total amount of free iron and iron salt contained in the ferritin iron-donating material.

The oral composition according to the present invention preferably contains one or more selected from the group consisting of inulin, indigestible dextrin, cyclodextrin, and gum arabic as the indigestible polysaccharide of the indigestible polysaccharide-donating material.

In the oral composition according to the present invention, the ferritin iron-donating material and the indigestible polysaccharide-donating material are preferably contained in the form of granules thereof.

The oral composition according to the present invention preferably further contains a vitamin C donor. In that case, the vitamin C of the vitamin C donating material is preferably coated. Furthermore, in that case, the vitamin C in the vitamin C donating material is preferably contained in an amount of 0.1 to 100 parts by mass per 1 part by mass of the total amount of free iron and iron salt contained in the ferritin iron donating material.

The oral composition according to the present invention is preferably enteric-coated.

On the other hand, in its second aspect, the present invention provides a heartburn suppressing agent using a ferritin iron-donating material, characterized by containing an indigestible polysaccharide as an active ingredient.

Furthermore, in its third aspect, the present invention provides a method for improving the quality of the ferritin iron-donating material, comprising mixing an indigestible polysaccharide with the ferritin iron-donating material.

According to the present invention, by using the indigestible polysaccharide, it is possible to suppress undesirable symptoms such as heartburn caused by the ferritin-iron-containing donor material when orally ingested.

In the present invention, ferritin iron is used in order to allow iron to be well absorbed into the body. Ferritin iron is reported to have absorbability and bioavailability comparable to iron sulfate used in pharmaceuticals. In addition, in the present invention, an indigestible polysaccharide-donating material is used together with the ferritin iron-donating material in order to ameliorate the problem of heartburn symptoms associated with the ferritin iron-donating material.

The ferritin iron-donating material used in the present invention is not particularly limited as long as it is a material capable of donating ferritin iron, but a material containing a predetermined amount of ferritin iron prepared from natural raw materials such as animals and plants may be used. Preparation of a ferritin-iron-containing material using natural products such as animals and plants as a raw material is described, for example, in Japanese Patent Publication No. 2015-504888, etc., and is a well-known technique for those skilled in the art. Therefore, in the present invention, a ferritin-iron-containing material prepared by such well-known means can be used.

The ferritin iron-donating material used in the present invention may be a bean-derived ferritin iron-containing material prepared from a leguminous plant. Examples of leguminous plants include soybeans, lentils, kidney beans, chickpeas, fava beans, adzuki beans, peas, peanuts, flower beans, mung beans, tree beans, cowpeas (large horn beans), and lupine. In addition, as the parts of leguminous plants used as raw materials, parts other than legumes such as leaves, stems, vines, sheaths, roots, seeds, flowers, etc. may be used as raw materials in addition to legumes, and a plurality of such parts may be combined. Furthermore, sprouts may be used as a raw material. In addition, since "Mame iron" (manufactured by SloIron) is commercially available as a soybean-derived ferritin iron-containing material, such a commercially available product may be used.

In general, a bean-derived ferritin iron-containing material may contain bean-derived phospholipids and isoflavone compounds as subcomponents. For use in the present invention, the iron content is typically 3% by mass or more, more typically 3.5% by mass or more and 6.5% by mass or less, and even more typically 4% by mass or more and 6% by mass or less. In that case, the lipid content is typically 5 mass % or less, more typically 0.5 mass % or more and 3.5 mass % or less. Also, the isoflavone compound content is typically 2% by mass or less, more typically 0.5% by mass or less.

The bean-derived ferritin iron-containing material having the above composition is not particularly limited, but can be prepared, for example, by subjecting a water-soluble extract of soybean raw material to a process of concentrating the protein fraction by salting out, or a process of decomposing carbohydrates with one or more types of glycosidase enzymes, and then subjecting it to molecular weight fractionation means such as ultrafiltration. In this case, both the salting-out treatment and the enzymatic treatment may be applied to the water-soluble extract of the soybean raw material, and the treatment order may be either the salting-out treatment or the enzymatic treatment first. Glycosidase enzymes include, for example, α-amylase, β-amylase, α-galactosidase, β-galactosidase, β-glucosidase, xylanase, cellulase, cellobiohydrolase, xylosidase, mannanase, glucuronidase, arabinanase, arabinofuranosidase, galactanase, pectin lyase, and the like.

On the other hand, the indigestible polysaccharide-providing material used in the present invention is not particularly limited as long as it can provide indigestible polysaccharides. Examples of indigestible polysaccharides include inulin, cyclodextrin (which may be α-type, β-type, or γ-type), polydextrose, indigestible dextrin, guar gum decomposition products, gum arabic, cellulose derivatives, arabinose-containing polysaccharides, and the like. At this time, it is preferable to use one with a molecular weight of 10,000 or less, more preferably with a molecular weight of 6,000 or less, and even more preferably with a molecular weight of 1,500 or more and 5,500 or less. When a non-digestible polysaccharide having a molecular weight within this range is used, it is water-soluble and facilitates operations such as mixing with a ferritin iron-donating agent or other raw materials. In addition, in the case of granulation processing, the indigestible polysaccharide plays a role of an excipient and a binder, facilitating the formation of granules with the ferritin iron donor and other raw materials.

The indigestible polysaccharide donating material used in the present invention is not particularly limited, but a material containing a predetermined amount of indigestible polysaccharide prepared from natural raw materials such as animals and plants may be used. In that case, it is preferable to use a material containing a certain amount or more of the indigestible polysaccharide, preferably a material containing 10% by mass or more and 100% by mass or less, more preferably a material containing 20% by mass or more and 90% by mass or less, and even more preferably a material containing 30% by mass or more and 80% by mass or less. For example, inulin includes those derived from Jerusalem artichoke, agave, and chicory. Moreover, indigestible dextrins include those derived from corn and sugarcane.

The oral composition provided by the present invention contains the ferritin iron-donating material and the indigestible polysaccharide-donating material described above to form a single agent. By ingesting this composition, the iron content can be well absorbed into the body mainly due to the effect of the ferritin iron, and symptoms such as heartburn can be avoided mainly due to the effect of the indigestible polysaccharide. Therefore, from another point of view, the present invention can be said to use an indigestible polysaccharide as an active ingredient of a heartburn suppressing agent based on a ferritin iron-donating material. From still another aspect, the present invention can be said to be a method for improving the quality of a ferritin iron-donating material by mixing an indigestible polysaccharide with the ferritin iron-donating material.

The oral composition provided by the present invention may contain a ferritin iron-donating material in the composition, and the content thereof can be appropriately set according to the desired iron absorption effect. Typically, for example, the lower limit of the dry matter content of ferritin iron donated by the ferritin iron donating material in the composition may be 0.1% by mass or more, 0.2% by mass or more, 0.3% by mass or more, 0.4% by mass or more, 0.5% by mass or more, or 1% by mass or more. The upper limit may be 10% by mass or less, 9% by mass or less, 8% by mass or less, 7% by mass or less, 6% by mass or less, or 5% by mass or less.

The oral composition provided by the present invention may contain an indigestible polysaccharide-donating material in the composition, and the content thereof can be appropriately set according to the desired effect of suppressing heartburn. Typically, for example, the lower limit of the content of the indigestible polysaccharide provided by the indigestible polysaccharide-providing material in the composition in terms of dry matter may be 1% by mass or more, 2% by mass or more, 3% by mass or more, 4% by mass or more, 5% by mass or more, or 10% by mass or more. Moreover, the upper limit may be 30% by mass or less, 25% by mass or less, 20% by mass or less, 15% by mass or less, or 10% by mass or less.

In addition, it is preferable that the indigestible polysaccharide provided by the indigestible polysaccharide-providing material is contained in an amount of 10 to 1000 parts by weight per 1 part by weight of the total amount of free iron and iron salt contained in the ferritin iron-providing material. According to this, free iron and iron salts, which cause heartburn, can be more effectively detoxified by the action of the indigestible polysaccharide. The lower limit of the content per 1 part by mass of the total amount of free iron and iron salt contained in the ferritin iron-donating material may be 10 parts by mass or more, 20 parts by mass or more, 30 parts by mass or more, 40 parts by mass or more, 50 parts by mass or more, or 100 parts by mass or more. The upper limit may be 1000 parts by mass or less, 900 parts by mass or less, 800 parts by mass or less, 700 parts by mass or less, 600 parts by mass or less, or 500 parts by mass or less.

In any non-limiting embodiment of the present invention, the oral composition may further contain a vitamin C donor. In this case, the lower limit of the content of vitamin C in terms of dry matter may be 1% by mass or more, 2% by mass or more, 3% by mass or more, 4% by mass or more, 5% by mass or more, 6% by mass or more, 7% by mass or more, 8% by mass or more, 9% by mass or more, 10% by mass or more. In addition, the upper limit of the content of vitamin C in terms of dry matter may be 20% by mass or less, 19% by mass or less, 18% by mass or less, 17% by mass or less, 16% by mass or less, 15% by mass or less, 14% by mass or less, 13% by mass or less, 12% by mass or less, 11% by mass or less.

Also, the vitamin C provided by the vitamin C donating material is preferably contained in an amount of 0.1 to 100 parts by weight per 1 part by weight of the total amount of free iron and iron salt contained in the ferritin iron donating material. By including the vitamin C donor in the above range, trivalent iron is reduced to divalent iron by the reducing power of vitamin C, and is easily absorbed via divalent metal transporter (DMT1) in the intestinal epithelium. The lower limit of the content per 1 part by mass of the total amount of free iron and iron salt contained in the ferritin iron-donating material may be 0.1 parts by mass or more, 0.5 parts by mass or more, 1 part by mass or more, 2 parts by mass or more, 3 parts by mass or more, 4 parts by mass or more, or 5 parts by mass or more. The upper limit may be 100 parts by mass or less, 90 parts by mass or less, 80 parts by mass or less, 70 parts by mass or less, 60 parts by mass or less, or 50 parts by mass or less.

In any non-limiting aspect of the present invention, the vitamin C of the vitamin C donating material may be coated. According to this, the reaction with gastric contents is suppressed, so that the reduction rate of iron ions in the intestinal tract is further increased. As a coating process of vitamin C, it may be according to the usual means well-known to those skilled in the art. For example, rapeseed oil, stearic acid and salts thereof may be added to vitamin C at the time of formulation and stirred and granulated, or rapeseed oil or corn protein may be sprayed on vitamin C to form microcapsules. More specifically, examples of vitamin C coating materials include rapeseed oil, corn protein, stearic acid and salts thereof (calcium stearate and magnesium stearate).

In any non-limiting embodiment of the invention, the oral composition may further contain minerals. Examples of minerals include, but are not limited to, zinc, copper, manganese, iron other than ferritin iron, and the like.

As zinc-containing materials applicable for oral use, zinc gluconate, zinc sulfate, papaya extract, oyster meat extract, zinc-containing lactic acid bacteria, zinc-containing yeast, etc. are known, and these may be used. Among them, zinc-containing yeast is preferable. Yeast-containing minerals, in which zinc is taken in by yeast as a nutrient, are thought to be due to the fact that zinc is in a protein-bound form, and have excellent bioabsorbability.

Copper gluconate, copper-containing lactic acid bacteria, copper-containing yeast, and the like are known as copper-containing materials applicable for oral use, and these may be used, but among them, copper-containing yeast is preferable. Yeast-containing minerals, in which yeast incorporates copper as a nutrient, are thought to be due to the fact that copper is in a protein-bound form, and have excellent bioabsorbability.

Manganese-containing lactic acid bacteria, manganese-containing yeast, and the like are known as manganese-containing materials that can be orally applied, and these may be used, but among these, manganese-containing yeast is preferable. Yeast-containing minerals, in which manganese is incorporated into yeast as a nutrient, are thought to be due to the fact that manganese is in a protein-bound form, and have excellent bioabsorbability.

As iron-containing materials other than ferritin iron that can be orally applied, iron citrate, iron pyrophosphate, iron-containing lactic acid bacteria, iron-containing yeast, heme iron, etc. are known, and these may be used, but among them, heme iron is preferable. Heme iron is absorbed by a mechanism other than the mechanism mediated by DMT1 (Divalent Metal Transporter 1), which is a transporter of metal ions, and the mechanism mediated by endocytosis used by ferritin iron. As for the heme iron, for example, JP-A-5-244899 discloses a method for producing heme iron with improved water solubility. From the viewpoint of absorbability, it is preferable to use such water-soluble heme iron.

Specifically, when the mineral contained in the oral composition is zinc, the content of zinc is preferably 0.1 to 5 parts by mass, more preferably 1 to 3 parts by mass, relative to 1 part by mass of iron contained in the ferritin iron donor.

Further, when the mineral contained in the oral composition is copper, the content of copper is preferably 0.1 parts by mass or more and 5 parts by mass or less, more preferably 0.5 parts by mass or more and 2.5 parts by mass or less with respect to 1 part by mass of the iron content contained in the ferritin iron donor.

When the mineral contained in the oral composition is manganese, the content of manganese is preferably 0.1 to 5 parts by mass, more preferably 0.5 to 2.5 parts by mass, based on 1 part by mass of iron contained in the ferritin iron donor.

When the minerals contained in the oral composition are iron other than ferritin iron, the iron content is preferably 0.1 parts by mass or more and 5 parts by mass or less, more preferably 0.5 parts by mass or more and 2.5 parts by mass or less, relative to 1 part by mass of the iron content contained in the ferritin iron donor.

Moreover, the minerals contained in the oral composition may be of a plurality of types, and may be one or more selected from the group consisting of zinc, copper, manganese, and iron other than ferritin iron. In a more preferred embodiment, it is two or more selected from the group consisting of zinc, copper and manganese. In these cases, the preferred ranges of the amounts of zinc, copper, manganese, and iron other than ferritin iron relative to the iron content in the ferritin iron-donating material are the same as the ranges individually shown for the above mineral species. However, when the minerals contained in the oral composition are two or more selected from the group consisting of zinc, copper and manganese, the total content of the two or more selected from the group consisting of zinc, copper and manganese is more preferably 1 part by mass or more, and even more preferably 2 parts by mass or more with respect to 1 part by mass of the iron content in the ferritin iron donor.

The oral composition provided by the present invention is arbitrary in form without any particular limitation. Typically, it may be in various dosage forms such as tablets, granules, liquids, jelly, troches, powders, capsules, bars, and pastes. In that case, excipients, disintegrants, binders, lubricants, coating agents, coloring agents, coloring agents, corrigents, flavoring agents, antioxidants, preservatives, flavoring agents, acidulants, sweeteners, nutritional enhancers, vitamins, swelling agents, thickeners, surfactants, and other various materials may be added. The preparation and manufacture of these various forms can be appropriately carried out by means well known to those skilled in the art.

In any non-limiting aspect of the invention, oral compositions provided by the invention are preferably enteric coated. According to this, the iron content can be better absorbed into the body. The enteric coating may be carried out by ordinary means well known to those skilled in the art. For example, it may be enclosed in an enteric hard capsule, or may be prepared as a tablet coated with an enteric material. More specifically, enteric materials include corn protein, HPMC (hydroxypropyl methylcellulose), shellac, and the like.

The oral composition provided by the present invention can be used, for example, in various product forms such as health foods, supplements, dietary supplements, functional foods, pharmaceuticals, quasi-drugs, animal health foods, animal supplements, animal nutritional supplements, animal functional foods, veterinary drugs, or in combination with these products. Moreover, it can be used as general food and drink or animal feed, or in combination with general food and drink or animal feed.

Common foods include, for example, chocolates, biscuits, gums, candies, cookies, gummies, confectionery such as tablet confectionery, frozen desserts such as ice cream and sherbet, cereals, protein bars, pastes, and canned foods.

The amounts of iron, zinc, copper, or manganese described in this specification can be measured by well-known analytical methods, such as atomic absorption spectrophotometry or ICP mass spectrometry.

In analyzing the ferritin iron-donating material, the ferritin iron-donating material is subjected to molecular weight fractionation means such as an ultrafiltration membrane to separate it into a high-molecular layer and a low-molecular-weight layer, and then the iron content is analyzed by the above-described analysis method, whereby the iron content contained as ferritin iron can be obtained from the analysis of the high-molecular layer. Also, from the analysis of the low-molecular-weight layer, the total iron content of free iron and iron salts can be determined.

Also, the amount of lipids can be measured by well-known analytical methods of food analysis, such as acidolysis.

Also, the amount of isoflavone compounds can be measured by HPLC analysis using a standard product of isoflavone compounds prepared at a specific concentration as an indicator.

Moreover, the indigestible polysaccharide can be measured by a well-known analysis method in the field of food analysis. For example, indigestible polysaccharides can be quantified by the Prosky method (enzyme-weight method), HPLC method, or the like. Also, for example, the molecular weight of the indigestible polysaccharide can be measured by GPC method (HPLC method using a GPC column) or the like.

EXAMPLES The present invention will be described more specifically with reference to examples below. However, these examples are not intended to limit the scope of the present invention.

[Test Example 1]
[1-1. material〕
The materials shown below were prepared for the preparation of test samples.
・ Soybean extract (containing 10 % by mass as ferritin iron, 5 % by mass as iron): Anti -aging -professional company -Inulin (Agave -derived) (average molecular quantity) (about 5000): Made in Armatella, Indigestible Dexplyline (Average molecular weight of about 2000): Matsutani Chemical Industries Made in α Cyclodextrin Co., Ltd. (molecular weight 973): Cyclokeem Arabia Gum Co., Ltd. (Average molecular weight approx.

[1-2. test group]
The following test groups were set for each test sample.
・Test group 1-1: 200 mg of soybean extract (10 mg as iron)
・Test group 1-2: 200 mg of soybean extract (10 mg as iron) and 1000 mg of inulin were mixed ・Test group 1-3: 200 mg of soybean extract (10 mg as iron) and 1000 mg of inulin were mixed and granulated ・Test group 1-4: 200 mg of soybean extract (10 mg as iron) and 1000 mg of indigestible dextrin were mixed ・Test group 1-5: 200 mg of soybean extract (10 mg as iron) and 1000 mg α-cyclodextrin Test group 1-6: 200 mg soybean extract (10 mg as iron) and 1000 mg gum arabic were mixed Test group 1-7: 200 mg soybean extract (10 mg as iron) + 1000 mg gum arabic were mixed and granulated (fluid bed granulation)

[1-3. evaluation〕
Sixteen women (aged 20 to 39) who were not good at taking iron preparations were asked to change the test sample to correspond to each test group and ingest it on an empty stomach before breakfast for 6 days, and then evaluate the symptoms of heartburn after ingestion. The evaluation was carried out by conducting a questionnaire in which each point was scored on a 10-point scale based on the heartburn score criteria shown below.
(heartburn score)
0 points: no heartburn, 10 points: very strong heartburn

Table 1 summarizes the composition of the test samples for each test group and the evaluation results (mean values) based on heartburn scores.

As a result, the following facts were clarified.
(1) In test group 1-1, in which only soybean extract was ingested, the average heartburn score was 4.5, whereas inulin, indigestible dextrin, α-cyclodextrin, gum arabic, and other indigestible polysaccharides were used in combination to alleviate the symptoms of heartburn (test groups 1-2 to 1-7).
(2) From the comparison between Test Group 1-6 and Test Group 1-1, the effect of gum arabic in alleviating the symptoms of heartburn was limited, and the effect was shown only when heated during granulation processing (Test Group 1-7).
(3) It should be noted that the subjects who took only the soybean extract evaluated that the symptoms of heartburn were less than those of other iron preparations. In addition, no symptoms of constipation peculiar to iron preparations were observed throughout this test example.

[Test Example 2]
For the soybean extract used in Test Example 1, in order to measure the ratio of the amount of iron derived from ferritin iron and the amount of iron present as free iron and iron salts, the soybean extract was dissolved in an aqueous solution containing 0.1 w/v% vitamin C, and the high-molecular layer and low-molecular-weight layer were separated and recovered using a centrifugal ultrafiltration filter unit (molecular weight cutoff: 10,000). The iron content of each of the high-molecular layer and the low-molecular layer was quantified by ICP-MS (Japan Food Research Laboratories). Also, the iron content of the sample before being applied to the filter unit was measured in the same manner.

Table 2 shows the results.

As a result, the measured iron content of the polymer layer was 4.99 g/100 g, whereas the measured iron content of the low molecular layer was 0.68 g/100 g. Therefore, it was revealed that the soybean extract contained 11.7 to 12.0% of low-molecular-weight iron (free iron and iron salts) relative to the total iron content. The total iron content of the high-molecular-weight layer and the low-molecular-weight layer did not match the iron content of the sample before being subjected to the ultrafiltration filter unit.

[Test Example 3]
[3-1. material〕
The materials shown below were prepared for the preparation of test samples.
・Soybean extract (containing 10% by mass of ferritin iron and 5% by mass of iron): manufactured by Anti-Aging Pro Co., Ltd. ・Vitamin C: manufactured by Tohoku Pharmaceutical Co., Ltd. ・Zein (corn protein): product name “Kobayashi Zein DP-N”, manufactured by Kobayashi Koryo Co., Ltd. ・Enteric hard capsule: product name “DRcaps”, manufactured by Lonza

[3-2. test group]
The following test groups were set for each test sample.
・Test group 3-1: 200 mg of soybean extract (10 mg as iron) coated with zein (enteric-coated tablet)
Test group 3-2: Mix 200 mg of soybean extract (10 mg as iron) and 50 mg of vitamin C and coat with zein (enteric-coated tablet)
Test group 3-3: 200 mg of soybean extract (10 mg as iron) enclosed in an enteric hard capsule (enteric capsule)
Test group 3-4: Enclose 200 mg of soybean extract (10 mg as iron) and 50 mg of vitamin C in an enteric hard capsule (enteric capsule)
Test group 3-5: Enclose 200 mg of soybean extract (10 mg as iron) in a pig gelatin hard capsule (gelatin capsule)
Test group 3-6: Enclose 200 mg of soybean extract (10 mg as iron) and 50 mg of vitamin C in a pig gelatin hard capsule (gelatin capsule)

[3-3. evaluation〕
Blood was collected from 30 women (ages 20 to 39) who experienced iron deficiency at the end of menstruation, and then intake of the test sample was started. Blood was collected again 10 days after the start of intake, and hemoglobin levels were compared before and after intake. The food to be tested was ingested on an empty stomach before breakfast, and 5 people took each test sample.

Table 3 summarizes the composition of test samples and the results of hemoglobin values (mean values) for each test group.

As a result, the following facts were clarified.
(1) From the results of test groups 3-1 to 3-6, intake of soybean extract increased the hemoglobin level at a rate of change of 11.3 to 26.9%.
(2) Comparison between test group 3-2 (change rate 16.4%) and test group 3-1 (change rate 11.3%), comparison between test group 3-4 (change rate 26.9%) and test group 3-3 (change rate 14.4%), and comparison between test group 3-6 (change rate 13.8%) and test group 3-5 (change rate 13.3%) showed that vitamin C in addition to soybean extract increased the It was found that higher increases in robin values were obtained.
(3) Of the above (2), comparison between Test Group 3-2 and Test Group 3-1 (difference in rate of change: 5.1%), comparison between Test Group 3-4 and Test Group 3-3 (difference in rate of change: 12.5%), and comparison between Test Group 3-6 and Test Group 3-5 (difference in rate of change: 0.5%) showed that the effect of obtaining a higher increase in hemoglobin level by ingesting vitamin C in addition to soybean extract was the effect of enteric coating. It was more pronounced at times.
(4) In addition, the subject did not complain of symptoms such as heartburn throughout this test example.

Claims (12)

An oral composition comprising a ferritin iron-donating material and an indigestible polysaccharide-donating material. The oral composition according to claim 1, wherein the ferritin iron-donating material is a bean-derived ferritin iron-containing material having an iron content of 3% by mass or more.
3. The oral composition according to claim 1, wherein the indigestible polysaccharide-donating material has a molecular weight of 10,000 or less. 4. The oral composition according to any one of claims 1 to 3, wherein the indigestible polysaccharide in the indigestible polysaccharide-donating material contains 10 to 1000 parts by mass with respect to 1 part by mass of the total amount of free iron and iron salt contained in the ferritin iron-donating material. The oral composition according to any one of claims 1 to 4, wherein the indigestible polysaccharide of the indigestible polysaccharide-donating material contains one or more selected from the group consisting of inulin, indigestible dextrin, cyclodextrin, and gum arabic. The oral composition according to any one of claims 1 to 5, wherein the ferritin iron-donating material and the indigestible polysaccharide-donating material are contained in the form of granules thereof. The oral composition according to any one of claims 1 to 6, further comprising a vitamin C donating material. The oral composition according to claim 7, wherein the vitamin C of the vitamin C donating material is coated. 9. The oral composition according to claim 7 or 8, wherein said vitamin C in said vitamin C donating material is contained in an amount of 0.1 to 100 parts by mass per 1 part by mass of the total amount of free iron and iron salt contained in said ferritin iron donating material. The oral composition of any one of claims 1-9, which is enteric coated. An inhibitor of heartburn by a ferritin iron donating material, characterized by containing an indigestible polysaccharide as an active ingredient. A method for improving the quality of a ferritin iron-donating material, comprising mixing an indigestible polysaccharide with the ferritin iron-donating material.