WO2016208641A1 - Composition for increasing hemoglobin in blood - Google Patents

Composition for increasing hemoglobin in blood Download PDF

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Publication number
WO2016208641A1
WO2016208641A1 PCT/JP2016/068566 JP2016068566W WO2016208641A1 WO 2016208641 A1 WO2016208641 A1 WO 2016208641A1 JP 2016068566 W JP2016068566 W JP 2016068566W WO 2016208641 A1 WO2016208641 A1 WO 2016208641A1
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Prior art keywords
composition
zinc
iron
present
concentration
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PCT/JP2016/068566
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French (fr)
Japanese (ja)
Inventor
伊藤　健太郎
欣也 芦田
祐子 後藤
敏弘 大森
伊藤　裕之
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株式会社明治
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Priority to JP2017524953A priority Critical patent/JP6815994B2/en
Publication of WO2016208641A1 publication Critical patent/WO2016208641A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/26—Iron; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/30—Zinc; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Definitions

  • the present invention relates to a novel composition for increasing blood hemoglobin.
  • Non-Patent Documents 1 and 2 It is known that hemoglobin is related to a decrease in motor function / muscular strength, a decrease in cognitive function, and the like (Non-Patent Documents 1 and 2). Therefore, a significant problem associated with QOL arises when the blood hemoglobin concentration decreases. Especially in elderly people, the blood hemoglobin concentration decreases and the prevalence of anemia increases with age.
  • Non-Patent Document 3 In other words, in such anemia of the elderly, even if iron is simply taken, the symptoms may not be improved or treated.
  • Non-patent Document 4 it is known that taking a large amount of iron may cause gastrointestinal symptoms such as nausea, constipation, abdominal discomfort, abdominal pain, diarrhea, and vomiting as side effects. Therefore, in order to improve or treat anemia symptoms, it is preferable to effectively increase the blood hemoglobin concentration while suppressing the iron dose.
  • Patent Document 1 describes a food supplement containing iron, zinc, folic acid and the like for supplementing the nutritional requirements of women before menopause.
  • Patent Document 2 describes a pharmaceutical composition and processed food containing lactoferrin and iron preparation.
  • Patent Document 3 discloses a dairy product containing trace elements such as iron and zinc and folic acid.
  • Patent Document 4 describes a dietary supplement containing inorganic salts such as iron and zinc, and vitamins such as folic acid, together with plant ferritin.
  • Non-Patent Document 5 it is reported that taking (ingestion) of iron and zinc is effective for improving and treating anemia symptoms in middle-aged women.
  • the dose of iron is set at a high level of 100 mg / day.
  • An object of the present invention is to provide a new technical means for effectively increasing the blood hemoglobin concentration in an anemic subject while suppressing the iron dose.
  • the present inventors have found that the combination of iron, zinc, folic acid, and milk protein can effectively increase blood hemoglobin concentration in anemia subjects while suppressing the iron dose.
  • a composition for increasing blood hemoglobin comprising iron, zinc, folic acid, and milk protein.
  • composition according to any one of (1) to (7) for an elderly person.
  • the composition according to any one of (1) to (8) for a human having a serum ferritin concentration of 25 ng / mL or more.
  • the blood hemoglobin concentration can be effectively increased in an anemic subject while suppressing the iron dose.
  • the present invention can increase at least one anemia-related blood parameter selected from the group consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, and folic acid concentration.
  • composition for increasing blood hemoglobin of the present invention contains iron, zinc, folic acid, and milk protein.
  • the form of iron blended into the composition of the present invention is not particularly limited as long as the effects of the present invention are not hindered, and may be contained in the composition in the form of a salt.
  • Specific examples of such iron include iron citrate, iron sulfide, iron sulfate, iron chloride, iron hydrochloride, iron gluconate, iron lactate, iron hydroxide, iron phosphate, iron carbonate, iron pyrophosphate, heme iron Ferrous hydroxide, ferrous phosphate, ferrous pyrophosphate, ferric pyrophosphate or ferrous carbonate, and more preferable.
  • Is ferrous pyrophosphate or ferric pyrophosphate more preferably ferric pyrophosphate.
  • iron that is commercially available and distributed as a food additive, a preparation containing iron, and the like can be used.
  • the iron content in the composition of the present invention is preferably 1 to 50 mg, more preferably 2 in terms of iron content in order to suppress the iron dose to a low level in improving anemia. -20 mg, more preferably 3-8 mg.
  • the iron content in the composition of the present invention can be measured by, for example, the atomic absorption spectrophotometry described in “Food Hygiene Inspection Guidelines, RIKEN” (supervised by the Ministry of Health and Welfare, Health Sanitation Bureau).
  • the form of zinc to be blended in the composition of the present invention is not particularly limited as long as the effect of the present invention is not hindered, and may be contained in the composition in the form of a salt.
  • Specific examples of such zinc include zinc chloride, zinc sulfate, zinc gluconate, and yeast zinc. Preferred are zinc gluconate and yeast zinc, and more preferred is zinc gluconate.
  • zinc that is commercially available and distributed as a food additive, a preparation containing zinc, and the like can be used.
  • the content of zinc in the composition of the present invention is not particularly limited as long as the effects of the present invention are not hindered, but the content of zinc itself is preferably 1 to 30 mg, more preferably 4 to 20 mg. Yes, more preferably 6 to 10 mg.
  • the zinc content in the composition of the present invention can be measured, for example, by the atomic absorption spectrophotometry described in “Food Hygiene Inspection Guidelines, RIKEN” (supervised by the Ministry of Health and Welfare).
  • the form of folic acid blended in the composition of the present invention is not particularly limited as long as the effect of the present invention is not hindered.
  • Specific examples of such folic acid include folic acid, 5-methyltetrahydrofolic acid, methyl 5-methyltetrahydrofolate, and the like, with folic acid being preferred.
  • folic acid that is commercially available and distributed as a food additive, a preparation containing folic acid, and the like can be used.
  • the content of folic acid in the composition of the present invention is not particularly limited as long as the effects of the present invention are not hindered.
  • the content of folic acid itself is preferably 50 to 1000 ⁇ g, more preferably 70 to 500 ⁇ g. More preferably 80 to 200 ⁇ g.
  • the content of folic acid in the composition of the present invention can be measured, for example, by the microorganism quantification method described in “Fiveth Supplement Japanese Food Standard Component Table Analysis Manual” (published by the National Printing Bureau).
  • the form of milk protein to be blended in the composition of the present invention is not particularly limited as long as the effect of the present invention is not hindered.
  • the milk protein may be left as it is, or in the form of milk protein purified from the milk raw material.
  • Specific forms of such milk raw materials include milk, skim milk, butter, unsalted butter, butter oil, cream, cream powder, butter milk, skim milk powder, whole milk powder, spinach milk, concentrated milk, skim milk concentrate, Concentrated whey, whey powder, milk protein concentrate, whey protein concentrate, lactose or a combination thereof may be mentioned.
  • Milk raw materials or milk proteins purified from milk raw materials may be blended singly or in combination of two or more.
  • the milk raw material marketed and distributed as a food raw material or a food additive can be used as milk protein, for example.
  • the milk protein content in the composition of the present invention is not particularly limited as long as the effects of the present invention are not hindered, but the content of the milk protein itself is preferably 1 to 50 g, more preferably 2 to 40. g, and more preferably 3 to 20 g.
  • the milk protein content in the composition of the present invention can be measured by, for example, the Kjeldahl method described in “Food Hygiene Inspection Guidelines, RIKEN” (supervised by the Ministry of Health and Welfare).
  • the mass ratio of iron, zinc and folic acid to iron is preferably 1: 0.06 to 1: 1, more preferably 1: 0.1 to 1: 0.5, More preferably, it is 1: 0.2 to 1: 0.4.
  • the mass ratio of the total of iron, zinc and folic acid to zinc is preferably 1: 0.04 to 1: 1, more preferably 1: 0.5 to 1: 0.9, More preferably, it is 1: 0.6 to 1: 0.8.
  • the mass ratio of iron, zinc and folic acid to folic acid is preferably 1: 0.0007 to 1: 0.2, more preferably 1: 0.005 to 1: 0.1. More preferably, it is 1: 0.006 to 1: 0.01.
  • the mass ratio of the sum of iron, zinc and folic acid to milk protein is preferably 1:60 to 1: 5000, more preferably 1: 100 to 1: 1000. More preferably, it is 1: 400 to 1: 600.
  • composition of the present invention may further contain vitamins such as vitamin D and / or other minerals such as sodium and calcium together with the above components.
  • the composition of the present invention may further comprise at least one selected from the group consisting of vitamin D, sodium and calcium, such as all of them.
  • the composition of the present invention may contain 0.5 to 8 ⁇ g, preferably 1 to 5 ⁇ g of vitamin D.
  • the composition of the present invention may also contain, for example, 26 to 440 mg of sodium, preferably 55 to 220 mg, and 75 to 1400 mg, preferably 150 to 600 mg of calcium.
  • the composition of the present invention may further contain milk lipid, carbohydrate, ash, moisture and the like.
  • the composition of the present invention may further comprise at least one selected from the group consisting of milk lipids, carbohydrates, ash, and moisture, such as all of them.
  • the composition of the present invention may contain 0.5 to 8 g, preferably 1 to 4 g of milk lipid, 2 to 46 g, preferably 5 to 23 g of carbohydrate, 0.5 to 8 g of ash, Preferably it may contain 1-4 g and may contain 45-740 g, preferably 90-370 g of moisture.
  • composition of the present invention can be provided as a composition in which, together with the above-mentioned components, an orally acceptable additive is blended if desired.
  • Orally acceptable additives include aqueous media such as water, solvents, solubilizers, lubricants, emulsifiers, tonicity agents, stabilizers, preservatives, preservatives, surfactants, regulators, chelates Agents, pH adjusters, buffers, excipients, thickeners, colorants, fragrances or fragrances.
  • composition of the present invention can be prepared by a known method such as mixing, dissolving, dispersing, or suspending the above components. Moreover, in the preparation of the composition of the present invention, a homogenization treatment or a sterilization treatment may be performed on the mixture, solution, dispersion, suspension, etc. of each of the above components unless the effects of the present invention are hindered. Good.
  • the form of the composition of the present invention is not particularly limited as long as the effects of the present invention are not hindered, and may be solid, semi-solid, or liquid, but is preferably liquid.
  • the volume of the composition is not particularly limited as long as the effects of the present invention are not hindered.
  • the volume may be 50 to 5000 mL, preferably 100 to 1000 mL, more preferably 100 to 500 mL. Yes, and more preferably 100 to 200 mL.
  • composition of the present invention is preferably provided as a unit of daily oral intake.
  • the daily oral intake of iron, zinc, folic acid and milk protein in the composition of the present invention can be the same as the content in the composition described above.
  • the composition of the present invention consists of units of daily oral intake, consisting of iron 1 to 50 mg, zinc 1 to 30 mg, folic acid 50 to 1000 mg, milk protein 1 Contains ⁇ 50 g.
  • the content of iron, zinc, folic acid, and milk protein is preferably the content per 100 to 1000 mL of the composition of the present invention, and more preferably per 100 to 500 mL of the composition of the present invention. More preferably, the content per 100 to 200 mL of the composition of the present invention.
  • the composition of the present invention is preferably provided in a package form.
  • the packaging form is not particularly limited, and examples thereof include packs and containers.
  • the container used can be provided in a normal form such as a molded container mainly composed of polyethylene terephthalate, a metal can, or a bottle.
  • the display of a component, the display of a dose, usage, etc. may be attached
  • packaging forms include supplements, drinks, pharmaceutical preparations, foods, beverages and the like.
  • the indication may be affixed to the composition of the present invention itself, or may be affixed to a container, packaging material or package insert containing the composition of the present invention.
  • the display is information related to the composition of the present invention, such as flyers, brochures, pops, catalogs, posters, books, DVDs and other storage media, electronic bulletin boards, advertisements on the Internet, etc. May be displayed / advertised to be effective.
  • the composition for increasing blood hemoglobin of the present invention may be a blood hemoglobin increasing agent.
  • the composition of the present invention can increase blood parameters related to anemia such as hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folic acid concentration. Therefore, according to one preferred embodiment of the composition of the present invention, it is provided as a composition for increasing at least one blood parameter selected from hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration and folate concentration.
  • the composition for increasing blood parameters may be an agent for increasing at least one blood parameter selected from hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration and folic acid concentration.
  • the composition of the present invention is provided as a composition for improving anemia or a composition for reducing the risk of developing anemia.
  • the anemia improving composition or the composition for reducing the risk of becoming anemia may be an anemia improving agent or an agent for reducing the risk of becoming anemia.
  • a method for increasing blood hemoglobin comprising taking (preferably ingesting) an effective amount of iron, zinc, folic acid, and milk protein in a subject.
  • a method comprising ingesting a subject in need thereof is provided. Therefore, according to one preferable aspect of the method of the present invention, it is provided as a method for increasing at least one blood parameter selected from hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration and folate concentration.
  • it is provided as a method for improving anemia.
  • “improvement” not only includes the meaning of “treatment” to improve the established pathological condition, but also means “prevention” to prepare for the expected deterioration in advance and prevent the occurrence of the disease in advance.
  • the “effective amount” can be set in the same manner as the content of iron, zinc, folic acid, milk protein, etc. in the unit of daily oral intake.
  • the medical action with respect to a human is excluded.
  • the medical practice for humans means an act of taking (administering) pharmaceuticals to humans, which requires prescription by a doctor or the like.
  • the method of the present invention may include targeting a healthy person.
  • the method for increasing blood hemoglobin of the present invention can be carried out according to the contents described herein for the composition of the present invention.
  • the method of ingestion of the present invention is not particularly limited as long as the effect of the present invention is not hindered, but preferably is tube ingestion (nasal ingestion, gastric fistula etc.) or oral ingestion, more preferably oral ingestion. is there.
  • composition of the present invention examples include pharmaceuticals, quasi drugs, drinks, supplements, cosmetics, foods or beverages such as foods for specified health use, functional foods including nutritional functional foods or functional foods Offering with food-drinks and feed is mentioned, A drink is preferable from a viewpoint of the simplicity of intake and flavor.
  • iron, zinc, folic acid, milk protein which are components of the composition of the present invention, may be ingested simultaneously by the subject, or may be ingested separately by the subject, preferably It is prepared in the form of the composition of the present invention and simultaneously ingested by the subject.
  • the usage of intake of the present invention can be appropriately set by those skilled in the art according to the type, age, sex, and symptoms of the subject as long as the effects of the present invention are not hindered.
  • the daily intake of the present invention may be ingested by the subject once, or may be ingested by the subject multiple times, but is preferably prepared in the form of the composition of the present invention. Ingesting the subject in a single time. Therefore, the number of daily intakes of the present invention is 1 to 5 times a day, preferably 1 to 3 times a day, and more preferably once a day.
  • the subject of the present invention is preferably a human, more preferably a human with low blood hemoglobin concentration or an anemic human.
  • the blood hemoglobin concentration in the subject of the present invention is not particularly limited, but is preferably low from the viewpoint of the effect of improving anemia due to an increase in blood hemoglobin.
  • a human having a low blood hemoglobin concentration or an anemic human means that, for example, in the case of a human male, the blood hemoglobin concentration is preferably less than 13 ⁇ g / dL. In the case of a human female, the blood hemoglobin concentration preferably means less than 12 g / dL.
  • the age of the subject of the present invention is not particularly limited as long as the effect of the present invention is not hindered, but can be used particularly advantageously in improving the symptoms of elderly people (for example, humans 65 years or older), Preferably, it is an elderly person.
  • the present invention can be used to improve anemia in a subject lacking iron, or to improve anemia in a subject lacking iron.
  • the serum ferritin concentration is preferably 25 ng / mL or more, or the total iron binding capacity (TIBC) is less than 360 ug / dL.
  • a combination of iron, zinc, folic acid and milk protein in the production of a composition for increasing blood hemoglobin. Therefore, according to one preferred embodiment of the use of the present invention, in the production of a composition for increasing at least one blood parameter selected from the group consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folic acid concentration, Provided as the use of a combination of iron, zinc, folic acid, milk protein. Moreover, according to another preferable aspect of the use of the present invention, it is provided as a use of a combination of iron, zinc, folic acid and milk protein in the production of a composition for improving anemia.
  • iron as a composition for increasing blood hemoglobin. Therefore, according to one preferred embodiment of the use of the present invention, iron as a composition for increasing at least one blood parameter selected from the group consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folic acid concentration.
  • a combination of zinc, folic acid and milk protein Provided as the use of a combination of zinc, folic acid and milk protein.
  • it is provided as a use of a combination of iron, zinc, folic acid and milk protein as a composition for improving anemia.
  • iron, zinc, folic acid, and milk protein for increasing blood hemoglobin.
  • iron, zinc for increasing at least one blood parameter selected from the group consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folic acid concentration , Provided as the use of a combination of folic acid and milk protein.
  • it is provided as a use of a combination of iron, zinc, folic acid and milk protein for improving anemia.
  • the above combination is characterized in that the subject is ingested sequentially or simultaneously.
  • a method for producing a composition for increasing blood hemoglobin which comprises blending iron, zinc, folic acid, and milk protein in the composition. Therefore, according to one preferred embodiment of the production method of the present invention, hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folic acid, characterized in that iron, zinc, folic acid, and milk protein are blended in the composition. It is provided as a method for producing a composition for increasing at least one blood parameter selected from the group consisting of concentrations. According to another preferred embodiment of the production method of the present invention, there is provided as a method for producing a composition for improving anemia, wherein iron, zinc, folic acid, and milk protein are blended in the composition.
  • a composition containing iron, zinc, folic acid, and milk protein (as active ingredients) for increasing blood hemoglobin Therefore, according to one preferred embodiment of the composition of the present invention, iron for increasing at least one blood parameter selected from the group consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folate concentration, It is provided as a composition comprising zinc, folic acid, and milk protein (as active ingredients). Moreover, according to another preferable one aspect
  • mode of the composition of this invention it provides as a composition containing iron, zinc, folic acid, and milk protein (as an active ingredient) for improving anemia.
  • a combination of iron, zinc, folic acid, and milk protein for increasing blood hemoglobin.
  • iron for increasing at least one blood parameter selected from the group consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folate concentration Provided as a combination comprising zinc, folic acid, and milk protein.
  • it is provided as a combination comprising iron, zinc, folic acid, and milk protein for improving anemia.
  • the combination is ingested sequentially or simultaneously by the subject.
  • Example 1 Production raw material water of test sample , milk raw material (milk, whole milk powder, skim milk powder, whey powder, unsalted butter), calcium carbonate, ferric pyrophosphate, zinc gluconate, folic acid, vitamin D, baking soda Were blended and mixed thoroughly before homogenization. The obtained aqueous solution was sterilized and then cooled to prepare a liquid test sample (milk base). The composition of the test sample is shown in Table 1.
  • Test example 1 Human test targeting elderly women who are prone to anemia Manufactured in Example 1 for 15 elderly women (mean age: 69.9 ⁇ 3.4 years) who are prone to anemia Each test sample was orally ingested once a day (200 mL). Also, immediately before oral intake and 4 weeks after the first oral intake, hematological anemia index values (hemoglobin concentration, hematocrit value, red blood cell count), serum zinc concentration, folate concentration in the elderly was measured and compared before and after ingestion.
  • Test Example 2 Human test for elderly women who tend to be anemic but do not have enough iron content
  • the elderly women who tend to be anemic are immediately before oral intake.
  • 8 elderly who were not deficient in iron (immediately before ingestion, elderly with ferritin of 25 ng / mL or more and total iron binding capacity (TIBC) of less than 360 ⁇ g / dL) were included . Therefore, for the elderly who are not deficient in iron, the hematological anemia index values (hemoglobin concentration, hematocrit value, red blood cell count), serum zinc concentration, and folic acid concentration Compared before and after.
  • the combination of iron, zinc, folic acid, and milk protein can improve blood hemoglobin concentration in anemic subjects while suppressing the iron dose. It was also revealed that anemia-related blood parameters such as hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folic acid concentration can be improved by using a combination of iron, zinc, folic acid, and milk protein. According to the present invention, the blood hemoglobin concentration can be effectively improved in an anemic subject while suppressing the amount of iron used, and in particular, the blood hemoglobin concentration of an elderly person who is not deficient in iron is effectively improved. it can.

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Abstract

The present invention provides a novel composition for increasing the hemoglobin in the blood and a composition for improving anemia. More specifically, the present invention provides a composition for increasing the hemoglobin in the blood and a composition for improving anemia that include iron, zinc, folic acid, and milk protein.

Description

血中ヘモグロビン増加用組成物Composition for increasing blood hemoglobin 関連出願の参照Reference to related applications
　本特許出願は、２０１５年６月２２日に出願された日本国特許出願２０１５－１２５０３８号に基づく優先権の主張を伴うものであり、かかる先の特許出願における全開示内容は、引用することにより本明細書の一部とされる。 This patent application is accompanied by a claim of priority based on Japanese Patent Application No. 2015-125038 filed on June 22, 2015, and the entire disclosure in such earlier patent application is incorporated by reference. It is made a part of this specification.
　本発明は、新規な血中ヘモグロビン増加用組成物に関する。 The present invention relates to a novel composition for increasing blood hemoglobin.
　ヘモグロビンは、運動機能・筋力の低下や、認知機能の低下などに関係していることが知られている（非特許文献１、２）。したがって、血中ヘモグロビン濃度が低下すると、QOLに関連する大きな問題が生じる。特に高齢者では、加齢に伴い、血中ヘモグロビン濃度が低下し、貧血の有病率が増加する。 It is known that hemoglobin is related to a decrease in motor function / muscular strength, a decrease in cognitive function, and the like (Non-Patent Documents 1 and 2). Therefore, a significant problem associated with QOL arises when the blood hemoglobin concentration decreases. Especially in elderly people, the blood hemoglobin concentration decreases and the prevalence of anemia increases with age.
　一般的な貧血では、鉄を服用すると、その症状を改善や治療できる。しかし、高齢者には、鉄分の不足者は少ないことが報告されている（非特許文献３）。つまり、このような高齢者の貧血では、単に鉄を服用しても、その症状を改善や治療できない場合がある。 In general anemia, taking iron can improve or treat the symptoms. However, it has been reported that elderly people have few iron deficiencies (Non-Patent Document 3). In other words, in such anemia of the elderly, even if iron is simply taken, the symptoms may not be improved or treated.
　また、鉄を多量に服用すると、副作用として、悪心、便秘、腹部不快感、腹痛、下痢、嘔吐などの消化器の症状が生じる恐れがあることが知られている（非特許文献４）。したがって、貧血の症状を改善や治療するために、鉄の服用量を抑制しつつ、血中ヘモグロビン濃度を効果的に増加させることが好ましい。 In addition, it is known that taking a large amount of iron may cause gastrointestinal symptoms such as nausea, constipation, abdominal discomfort, abdominal pain, diarrhea, and vomiting as side effects (Non-patent Document 4). Therefore, in order to improve or treat anemia symptoms, it is preferable to effectively increase the blood hemoglobin concentration while suppressing the iron dose.
　一方、近年、種々の健康増進機能を有する、鉄含有経口製品が報告されている。例えば、特許文献１には、閉経付近前の女性の栄養要求の補充用として、鉄、亜鉛、葉酸などを含む食品補充物が記載されている。 On the other hand, in recent years, iron-containing oral products having various health promotion functions have been reported. For example, Patent Document 1 describes a food supplement containing iron, zinc, folic acid and the like for supplementing the nutritional requirements of women before menopause.
　また、特許文献２には、ラクトフェリンや鉄剤などを含む医薬組成物や加工食品が記載されている。 Patent Document 2 describes a pharmaceutical composition and processed food containing lactoferrin and iron preparation.
　また、特許文献３には、鉄、亜鉛などの微量元素や葉酸を含む乳製品が記載されている。 Patent Document 3 discloses a dairy product containing trace elements such as iron and zinc and folic acid.
　また、特許文献４には、植物フェリチンとともに、鉄、亜鉛などの無機塩類、葉酸などのビタミンを含む栄養補助食品が記載されている。 Patent Document 4 describes a dietary supplement containing inorganic salts such as iron and zinc, and vitamins such as folic acid, together with plant ferritin.
　また、非特許文献５には、中年の女性において、貧血の症状を改善や治療するために、鉄と亜鉛の服用（摂取）が有効であることが報告されている。ここで、鉄の服用量は 100 mg／日という高レベルで設定されている。 In Non-Patent Document 5, it is reported that taking (ingestion) of iron and zinc is effective for improving and treating anemia symptoms in middle-aged women. Here, the dose of iron is set at a high level of 100 mg / day.
　しかし、鉄の服用量を抑制しつつ、貧血の対象において血中ヘモグロビン濃度を効果的に増加させうる技術的手段は報告されていない。 However, no technical means has been reported that can effectively increase blood hemoglobin concentration in anemic subjects while suppressing iron dose.
特表２００２－５１４１７０号公報Special table 2002-514170 gazette 特開２００５－０６８０６０号公報Japanese Patent Laying-Open No. 2005-068060 特開平１０－０５２２２２号公報Japanese Patent Laid-Open No. 10-052222 特表２０１３－５３７８０４号公報Special table 2013-537804 gazette
　本発明は、鉄の服用量を抑制しつつ、貧血の対象において血中ヘモグロビン濃度を効果的に増加させる新たな技術的手段を提供することを目的とする。 An object of the present invention is to provide a new technical means for effectively increasing the blood hemoglobin concentration in an anemic subject while suppressing the iron dose.
　本発明者らは、鉄、亜鉛、葉酸、乳タンパク質を組み合わせて服用すると、鉄の服用量を抑制しつつ、貧血の対象において血中ヘモグロビン濃度を効果的に増加させうることを見出した。 The present inventors have found that the combination of iron, zinc, folic acid, and milk protein can effectively increase blood hemoglobin concentration in anemia subjects while suppressing the iron dose.
　本発明によれば、以下の発明が提供される。
（１）鉄、亜鉛、葉酸、および乳タンパク質を含む、血中ヘモグロビン増加用組成物。
（２）鉄の含有量が1～50 mgである、（１）に記載の組成物。
（３）亜鉛の含有量が1～30 mgである、（１）または（２）に記載の組成物。
（４）葉酸の含有量が50～1000 μgである、（１）～（３）のいずれかに記載の組成物。
（５）乳タンパク質の含有量が1～50 gである、（１）～（４）のいずれかに記載の組成物。
（６）１日の経口摂取量の単位の形態である、（１）～（５）のいずれかに記載の組成物。
（７）上記組成物が飲料である、（１）～（６）のいずれか一つに記載の組成物。
（８）高齢者のための、（１）～（７）のいずれかに記載の組成物。
（９）血清中フェリチン濃度が25 ng/mL以上のヒトのための、（１）～（８）のいずれかに記載の組成物。
（１０）ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度、葉酸濃度からなる少なくとも一つの血液パラメーターの増加のための、（１）～（９）のいずれか一つに記載の組成物。
（１１）貧血改善のための、（１）～（１０）のいずれか一つに記載の組成物。
（１２）血中ヘモグロビン増加用組成物の製造における、鉄、亜鉛、葉酸、および乳タンパク質の組み合わせの使用。
（１３）ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度、葉酸濃度からなる少なくとも一つの血液パラメーターの増加のための、（１２）に記載の組み合わせの使用。
（１４）貧血改善のための、（１２）または（１３）に記載の組み合わせの使用。
（１５）鉄、亜鉛、葉酸、および乳タンパク質の有効量を、それを必要とする対象に摂取させることを含んでなる、血中ヘモグロビンの増加方法。
（１６）ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度および葉酸濃度から選択される少なくとも一つの血液パラメーターの増加方法である、（１５）に記載の方法。
（１７）貧血の改善方法である、（１５）または（１６）に記載の方法。 According to the present invention, the following inventions are provided.
(1) A composition for increasing blood hemoglobin, comprising iron, zinc, folic acid, and milk protein.
(2) The composition according to (1), wherein the iron content is 1 to 50 mg.
(3) The composition according to (1) or (2), wherein the zinc content is 1 to 30 mg.
(4) The composition according to any one of (1) to (3), wherein the content of folic acid is 50 to 1000 μg.
(5) The composition according to any one of (1) to (4), wherein the milk protein content is 1 to 50 g.
(6) The composition according to any one of (1) to (5), which is in the form of a unit of daily oral intake.
(7) The composition according to any one of (1) to (6), wherein the composition is a beverage.
(8) The composition according to any one of (1) to (7), for an elderly person.
(9) The composition according to any one of (1) to (8), for a human having a serum ferritin concentration of 25 ng / mL or more.
(10) The composition according to any one of (1) to (9), for increasing at least one blood parameter consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, and folic acid concentration.
(11) The composition according to any one of (1) to (10), for improving anemia.
(12) Use of a combination of iron, zinc, folic acid, and milk protein in the manufacture of a composition for increasing blood hemoglobin.
(13) Use of the combination according to (12) for increasing at least one blood parameter consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, and folic acid concentration.
(14) Use of the combination according to (12) or (13) for improving anemia.
(15) A method for increasing blood hemoglobin, comprising allowing a subject in need thereof to take an effective amount of iron, zinc, folic acid, and milk protein.
(16) The method according to (15), which is a method for increasing at least one blood parameter selected from hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration and folic acid concentration.
(17) The method according to (15) or (16), which is a method for improving anemia.
　本発明によれば、鉄の服用量を抑制しつつ、貧血の対象において血中ヘモグロビン濃度を効果的に増加させることができる。また、本発明は、ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度、葉酸濃度からなる群から選択される少なくとも一つの貧血関連の血液パラメーターを増加させることができる。 According to the present invention, the blood hemoglobin concentration can be effectively increased in an anemic subject while suppressing the iron dose. In addition, the present invention can increase at least one anemia-related blood parameter selected from the group consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, and folic acid concentration.
発明の具体的説明Detailed description of the invention
　本発明の血中ヘモグロビン増加用組成物は、鉄、亜鉛、葉酸および乳タンパク質を含有することを一つの特徴としている。 One feature of the composition for increasing blood hemoglobin of the present invention is that it contains iron, zinc, folic acid, and milk protein.
　本発明の組成物に配合される鉄の形態は、本発明の効果を妨げない限り、特に限定されず、塩の形態で組成物中に含有させてもよい。かかる鉄の具体的な形態としては、クエン酸鉄、硫化鉄、硫酸鉄、塩化鉄、塩酸鉄、グルコン酸鉄、乳酸鉄、水酸化鉄、リン酸鉄、炭酸鉄、ピロリン酸鉄、ヘム鉄などの第１または第２鉄などが挙げられるが、好ましくは、水酸化第一鉄、リン酸第一鉄、ピロリン酸第一鉄、ピロリン酸第二鉄または炭酸第一鉄であり、より好ましくは、ピロリン酸第一鉄またはピロリン酸第二鉄であり、さらに好ましくは、ピロリン酸第二鉄である。本発明では、例えば、食品添加剤として市販されて流通している鉄や、鉄を含む製剤などを用いることができる。 The form of iron blended into the composition of the present invention is not particularly limited as long as the effects of the present invention are not hindered, and may be contained in the composition in the form of a salt. Specific examples of such iron include iron citrate, iron sulfide, iron sulfate, iron chloride, iron hydrochloride, iron gluconate, iron lactate, iron hydroxide, iron phosphate, iron carbonate, iron pyrophosphate, heme iron Ferrous hydroxide, ferrous phosphate, ferrous pyrophosphate, ferric pyrophosphate or ferrous carbonate, and more preferable. Is ferrous pyrophosphate or ferric pyrophosphate, more preferably ferric pyrophosphate. In the present invention, for example, iron that is commercially available and distributed as a food additive, a preparation containing iron, and the like can be used.
　本発明の組成物における鉄の含有量は、貧血の改善において、鉄の服用量を低レベルに抑制するために、鉄そのものの含有量として、好ましくは1～50 mgであり、より好ましくは2～20 mgであり、さらに好ましくは3～8 mgである。本発明の組成物における鉄の含有量は、例えば、「食品衛生検査指針　理化学編」（厚生省生活衛生局監修）に記載の原子吸光光度法で測定することができる。 The iron content in the composition of the present invention is preferably 1 to 50 mg, more preferably 2 in terms of iron content in order to suppress the iron dose to a low level in improving anemia. -20 mg, more preferably 3-8 mg. The iron content in the composition of the present invention can be measured by, for example, the atomic absorption spectrophotometry described in “Food Hygiene Inspection Guidelines, RIKEN” (supervised by the Ministry of Health and Welfare, Health Sanitation Bureau).
　本発明の組成物に配合される亜鉛の形態は、本発明の効果を妨げない限り、特に限定されず、塩の形態で組成物中に含有させてもよい。かかる亜鉛の具体的な形態としては、塩化亜鉛、硫酸亜鉛、グルコン酸亜鉛、酵母亜鉛などが挙げられるが、好ましくは、グルコン酸亜鉛、酵母亜鉛であり、より好ましくは、グルコン酸亜鉛である。本発明では、例えば、食品添加剤として市販されて流通している亜鉛や、亜鉛を含む製剤などを用いることができる。 The form of zinc to be blended in the composition of the present invention is not particularly limited as long as the effect of the present invention is not hindered, and may be contained in the composition in the form of a salt. Specific examples of such zinc include zinc chloride, zinc sulfate, zinc gluconate, and yeast zinc. Preferred are zinc gluconate and yeast zinc, and more preferred is zinc gluconate. In the present invention, for example, zinc that is commercially available and distributed as a food additive, a preparation containing zinc, and the like can be used.
　本発明の組成物における亜鉛の含有量は、本発明の効果を妨げない限り、特に限定されないが、亜鉛そのものの含有量として、好ましくは1～30 mgであり、より好ましくは4～20 mgであり、さらに好ましくは6～10 mgである。本発明の組成物における亜鉛の含有量は、例えば、「食品衛生検査指針　理化学編」（厚生省生活衛生局監修）に記載の原子吸光光度法で測定することができる。 The content of zinc in the composition of the present invention is not particularly limited as long as the effects of the present invention are not hindered, but the content of zinc itself is preferably 1 to 30 mg, more preferably 4 to 20 mg. Yes, more preferably 6 to 10 mg. The zinc content in the composition of the present invention can be measured, for example, by the atomic absorption spectrophotometry described in “Food Hygiene Inspection Guidelines, RIKEN” (supervised by the Ministry of Health and Welfare).
　本発明の組成物に配合される葉酸の形態は、本発明の効果を妨げない限り、特に限定されない。かかる葉酸の具体的な形態としては、葉酸、5-メチルテトラヒドロ葉酸、5-メチルテトラヒドロ葉酸メチル葉酸塩などが挙げられるが、好ましくは、葉酸である。本発明では、例えば、食品添加剤として市販されて流通している葉酸や、葉酸を含む製剤などを用いることができる。 The form of folic acid blended in the composition of the present invention is not particularly limited as long as the effect of the present invention is not hindered. Specific examples of such folic acid include folic acid, 5-methyltetrahydrofolic acid, methyl 5-methyltetrahydrofolate, and the like, with folic acid being preferred. In the present invention, for example, folic acid that is commercially available and distributed as a food additive, a preparation containing folic acid, and the like can be used.
　本発明の組成物における葉酸の含有量は、本発明の効果を妨げない限り、特に限定されないが、葉酸そのものの含有量として、好ましくは50～1000 μgであり、より好ましくは70～500 μgであり、さらに好ましくは80～200 μgである。本発明の組成物における葉酸の含有量は、例えば、「五訂増補日本食品標準成分表分析マニュアル」（国立印刷局発行）に記載の微生物定量法で測定することができる。 The content of folic acid in the composition of the present invention is not particularly limited as long as the effects of the present invention are not hindered. However, the content of folic acid itself is preferably 50 to 1000 μg, more preferably 70 to 500 μg. More preferably 80 to 200 μg. The content of folic acid in the composition of the present invention can be measured, for example, by the microorganism quantification method described in “Fiveth Supplement Japanese Food Standard Component Table Analysis Manual” (published by the National Printing Bureau).
　本発明の組成物に配合される乳タンパク質の形態は、本発明の効果を妨げない限り、特に限定されず、乳原料のままであってもよく、乳原料から精製された乳タンパク質の形態であってもよい。かかる乳原料の具体的な形態としては、牛乳、脱脂乳、バター、無塩バター、バターオイル、クリーム、クリームパウダー、バターミルク、脱脂粉乳、全脂粉乳、れん乳、濃縮乳、脱脂濃縮乳、濃縮ホエイ、ホエイ粉、乳タンパク濃縮物、ホエイタンパク濃縮物、乳糖またはそれらの組み合わせなどが挙げられる。乳原料または乳原料から精製された乳タンパク質は、単独で配合してもよく、２種以上を組み合わせて配合してもよい。本発明では、例えば、食品原料や食品添加剤として市販されて流通している乳原料を、乳タンパク質として用いることができる。 The form of milk protein to be blended in the composition of the present invention is not particularly limited as long as the effect of the present invention is not hindered. The milk protein may be left as it is, or in the form of milk protein purified from the milk raw material. There may be. Specific forms of such milk raw materials include milk, skim milk, butter, unsalted butter, butter oil, cream, cream powder, butter milk, skim milk powder, whole milk powder, spinach milk, concentrated milk, skim milk concentrate, Concentrated whey, whey powder, milk protein concentrate, whey protein concentrate, lactose or a combination thereof may be mentioned. Milk raw materials or milk proteins purified from milk raw materials may be blended singly or in combination of two or more. In this invention, the milk raw material marketed and distributed as a food raw material or a food additive can be used as milk protein, for example.
　本発明の組成物における乳タンパク質の含有量は、本発明の効果を妨げない限り、特に限定されないが、乳タンパク質そのものの含有量として、好ましくは1～50 gであり、より好ましくは2～40 gであり、さらに好ましくは3～20 gである。本発明の組成物における乳タンパク質の含有量は、例えば、「食品衛生検査指針　理化学編」（厚生省生活衛生局監修）に記載のケルダール法で測定することができる。 The milk protein content in the composition of the present invention is not particularly limited as long as the effects of the present invention are not hindered, but the content of the milk protein itself is preferably 1 to 50 g, more preferably 2 to 40. g, and more preferably 3 to 20 g. The milk protein content in the composition of the present invention can be measured by, for example, the Kjeldahl method described in “Food Hygiene Inspection Guidelines, RIKEN” (supervised by the Ministry of Health and Welfare).
　また、本発明の組成物において、鉄、亜鉛および葉酸の合計と、鉄との質量比は、好ましくは1：0.06～1：1であり、より好ましくは1：0.1～1：0.5であり、さらに好ましくは1：0.2～1：0.4である。 In the composition of the present invention, the mass ratio of iron, zinc and folic acid to iron is preferably 1: 0.06 to 1: 1, more preferably 1: 0.1 to 1: 0.5, More preferably, it is 1: 0.2 to 1: 0.4.
　また、本発明の組成物において、鉄、亜鉛および葉酸の合計と、亜鉛との質量比は、好ましくは1：0.04～1：1であり、より好ましくは1：0.5～1：0.9であり、さらに好ましくは1：0.6～1：0.8である。 In the composition of the present invention, the mass ratio of the total of iron, zinc and folic acid to zinc is preferably 1: 0.04 to 1: 1, more preferably 1: 0.5 to 1: 0.9, More preferably, it is 1: 0.6 to 1: 0.8.
　また、本発明の組成物において、鉄、亜鉛および葉酸の合計と、葉酸との質量比は、好ましくは1：0.0007～1：0.2であり、より好ましくは1：0.005～1：0.1であり、さらに好ましくは1：0.006～1：0.01である。 In the composition of the present invention, the mass ratio of iron, zinc and folic acid to folic acid is preferably 1: 0.0007 to 1: 0.2, more preferably 1: 0.005 to 1: 0.1. More preferably, it is 1: 0.006 to 1: 0.01.
　また、本発明の組成物において、鉄、亜鉛および葉酸の合計と、乳タンパク質との質量比は、好ましくは1：60～1：5000であり、より好ましくは1：100～1：1000であり、さらに好ましくは1：400～1：600である。 In the composition of the present invention, the mass ratio of the sum of iron, zinc and folic acid to milk protein is preferably 1:60 to 1: 5000, more preferably 1: 100 to 1: 1000. More preferably, it is 1: 400 to 1: 600.
　また、本発明の組成物は、上記成分と共に、ビタミン、例えば、ビタミンＤなど、および／または他のミネラル、例えば、ナトリウム、カルシウムなどをさらに含んでもよい。例えば、本発明の組成物は、ビタミンＤ、ナトリウムおよびカルシウムからなる群から選択される少なくとも１つ、例えばその全て、をさらに含んでもよい。例えば、本発明の組成物は、ビタミンＤを０．５～８μｇ、好ましくは１～５μｇ含んでもよい。本発明の組成物はまた、例えば、ナトリウムを２６～４４０ｍｇ、好ましくは５５～２２０ｍｇ含んでもよく、カルシウムを７５～１４００ｍｇ、好ましくは１５０～６００ｍｇ含んでもよい。 The composition of the present invention may further contain vitamins such as vitamin D and / or other minerals such as sodium and calcium together with the above components. For example, the composition of the present invention may further comprise at least one selected from the group consisting of vitamin D, sodium and calcium, such as all of them. For example, the composition of the present invention may contain 0.5 to 8 μg, preferably 1 to 5 μg of vitamin D. The composition of the present invention may also contain, for example, 26 to 440 mg of sodium, preferably 55 to 220 mg, and 75 to 1400 mg, preferably 150 to 600 mg of calcium.
　また、本発明の組成物は、乳脂質、炭水化物、灰分、水分などをさらに含んでもよい。例えば、本発明の組成物は、乳脂質、炭水化物、灰分および水分からなる群から選択される少なくとも１つ、例えばその全て、をさらに含んでもよい。例えば、本発明の組成物は、乳脂質を０．５～８ｇ、好ましくは１～４ｇ含んでもよく、炭水化物を２～４６ｇ、好ましくは５～２３ｇ含んでもよく、灰分を０．５～８ｇ、好ましくは１～４ｇ含んでもよく、および水分を４５～７４０ｇ、好ましくは９０～３７０ｇ含んでもよい。 The composition of the present invention may further contain milk lipid, carbohydrate, ash, moisture and the like. For example, the composition of the present invention may further comprise at least one selected from the group consisting of milk lipids, carbohydrates, ash, and moisture, such as all of them. For example, the composition of the present invention may contain 0.5 to 8 g, preferably 1 to 4 g of milk lipid, 2 to 46 g, preferably 5 to 23 g of carbohydrate, 0.5 to 8 g of ash, Preferably it may contain 1-4 g and may contain 45-740 g, preferably 90-370 g of moisture.
　また、本発明の組成物は、上記成分と共に、所望により経口上許容可能な添加剤を配合した組成物として提供することができる。経口上許容可能な添加剤として、水などの水性媒体、溶剤、溶解補助剤、滑沢剤、乳化剤、等張化剤、安定化剤、保存剤、防腐剤、界面活性剤、調整剤、キレート剤、ｐＨ調整剤、緩衝剤、賦形剤、増粘剤、着色剤、芳香剤または香料などが挙げられる。 In addition, the composition of the present invention can be provided as a composition in which, together with the above-mentioned components, an orally acceptable additive is blended if desired. Orally acceptable additives include aqueous media such as water, solvents, solubilizers, lubricants, emulsifiers, tonicity agents, stabilizers, preservatives, preservatives, surfactants, regulators, chelates Agents, pH adjusters, buffers, excipients, thickeners, colorants, fragrances or fragrances.
　本発明の組成物は、上記の各成分を混合、溶解、分散、懸濁するなどの公知の手法により、調製することができる。また、本発明の組成物の調製においては、本発明の効果を妨げない限り、上記の各成分の混合物、溶解物、分散物、懸濁物などに、均質化処理や殺菌処理を施してもよい。 The composition of the present invention can be prepared by a known method such as mixing, dissolving, dispersing, or suspending the above components. Moreover, in the preparation of the composition of the present invention, a homogenization treatment or a sterilization treatment may be performed on the mixture, solution, dispersion, suspension, etc. of each of the above components unless the effects of the present invention are hindered. Good.
　また、本発明の組成物の形態は、本発明の効果を妨げない限り、特に制限されず、固形状、半固形状や液状であってもよいが、液状であることが好ましい。この場合、組成物の容量は、本発明の効果を妨げない限り、特に限定されず、例えば、50～5000 mLとしてもよく、好ましくは100～1000 mLであり、より好ましくは100～500 mLであり、さらに好ましくは100～200 mLである。 The form of the composition of the present invention is not particularly limited as long as the effects of the present invention are not hindered, and may be solid, semi-solid, or liquid, but is preferably liquid. In this case, the volume of the composition is not particularly limited as long as the effects of the present invention are not hindered. For example, the volume may be 50 to 5000 mL, preferably 100 to 1000 mL, more preferably 100 to 500 mL. Yes, and more preferably 100 to 200 mL.
　また、本発明の組成物は、１日の経口摂取量の単位として提供することが好ましい。本発明の組成物における鉄、亜鉛、葉酸および乳タンパク質の１日の経口摂取量は、上述した組成物中の含有量と同様とすることができる。 In addition, the composition of the present invention is preferably provided as a unit of daily oral intake. The daily oral intake of iron, zinc, folic acid and milk protein in the composition of the present invention can be the same as the content in the composition described above.
　したがって、本発明の好ましい態様によれば、本発明の組成物は、１日の経口摂取量の単位からなり、鉄1～50 mg、亜鉛1～30 mg、葉酸50～1000 μg、乳タンパク質1～50 gを含んでなる。また、上記の鉄、亜鉛、葉酸、乳タンパク質の含有量は、好ましくは、本発明の組成物100～1000 mL当たりの含有量であり、より好ましくは、本発明の組成物100～500 mL当たりの含有量であり、さらに好ましくは、本発明の組成物100～200 mL当たりの含有量である。 Therefore, according to a preferred embodiment of the present invention, the composition of the present invention consists of units of daily oral intake, consisting of iron 1 to 50 mg, zinc 1 to 30 mg, folic acid 50 to 1000 mg, milk protein 1 Contains ~ 50 g. The content of iron, zinc, folic acid, and milk protein is preferably the content per 100 to 1000 mL of the composition of the present invention, and more preferably per 100 to 500 mL of the composition of the present invention. More preferably, the content per 100 to 200 mL of the composition of the present invention.
　また、本発明の組成物は、包装形態で提供することが好ましい。包装形態としては、特に限定されず、パックや容器などが挙げられる。この場合、使用される容器は、例えば、ポリエチレンテレフタレートを主成分とする成形容器や金属缶、瓶などの通常の形態で提供することができる。ここで、本発明の組成物が液状の場合、容器詰とすることにより、例えば、希釈せずに飲用できる。また、包装の表面には、成分の表示、用量や用法の表示などを付していてもよいし、血中ヘモグロビンを増加させるなどの具体的な機能の表示などを付していてもよい。かかる包装形態の好適な例としては、サプリメント、ドリンク剤、医薬製剤、食品、飲料などが挙げられる。ここで、表示は、本発明の組成物自体に付したものであってもよいし、本発明の組成物を含有する容器、包装材または添付文書に付したものであってもよい。また、表示は、本発明の組成物の関連する情報として、チラシ、パンフレット、ポップ、カタログ、ポスター、書籍、ＤＶＤなどの記憶媒体、電子掲示板やインターネットなどでの広告などで、本発明の組成物が効果的であることを表示・広告するものであってもよい。 In addition, the composition of the present invention is preferably provided in a package form. The packaging form is not particularly limited, and examples thereof include packs and containers. In this case, the container used can be provided in a normal form such as a molded container mainly composed of polyethylene terephthalate, a metal can, or a bottle. Here, when the composition of the present invention is in a liquid state, it can be drunk without dilution, for example, by filling the container. Moreover, the display of a component, the display of a dose, usage, etc. may be attached | subjected to the surface of a package, and the display of the concrete function, such as increasing blood hemoglobin, may be attached | subjected. Preferable examples of such packaging forms include supplements, drinks, pharmaceutical preparations, foods, beverages and the like. Here, the indication may be affixed to the composition of the present invention itself, or may be affixed to a container, packaging material or package insert containing the composition of the present invention. In addition, the display is information related to the composition of the present invention, such as flyers, brochures, pops, catalogs, posters, books, DVDs and other storage media, electronic bulletin boards, advertisements on the Internet, etc. May be displayed / advertised to be effective.
　本発明の血中ヘモグロビン増加用組成物は、血中ヘモグロビン増加剤であってもよい。また、本発明の組成物は、ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度、葉酸濃度などの貧血に関連した血液パラメーターを増加させることができる。したがって、本発明の組成物の好ましい一つの態様によれば、ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度および葉酸濃度から選択される少なくとも一つの血液パラメーターの増加用組成物として提供される。また、上記血液パラメーターの増加用組成物は、ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度および葉酸濃度から選択される少なくとも一つの血液パラメーターの増加剤であってもよい。また、本発明の組成物の好ましい別の一つの態様によれば、本発明の組成物は、貧血改善用組成物または貧血となるリスクの低減用組成物として提供される。また、上記貧血改善用組成物または貧血となるリスクの低減用組成物は、貧血改善剤または貧血となるリスクの低減剤であってもよい。 The composition for increasing blood hemoglobin of the present invention may be a blood hemoglobin increasing agent. In addition, the composition of the present invention can increase blood parameters related to anemia such as hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folic acid concentration. Therefore, according to one preferred embodiment of the composition of the present invention, it is provided as a composition for increasing at least one blood parameter selected from hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration and folate concentration. The composition for increasing blood parameters may be an agent for increasing at least one blood parameter selected from hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration and folic acid concentration. According to another preferred embodiment of the composition of the present invention, the composition of the present invention is provided as a composition for improving anemia or a composition for reducing the risk of developing anemia. In addition, the anemia improving composition or the composition for reducing the risk of becoming anemia may be an anemia improving agent or an agent for reducing the risk of becoming anemia.
　また、本発明の別の態様によれば、血中ヘモグロビンの増加方法であって、鉄、亜鉛、葉酸、乳タンパク質の有効量を対象に服用（好ましくは、摂取）させることを含んでなる方法が提供され、それを必要とする対象に摂取させることを含んでなる方法が提供される。したがって、本発明の方法の好ましい一つの態様によれば、ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度および葉酸濃度から選択される少なくとも一つの血液パラメーターの増加方法として提供される。また、本発明の方法の好ましい別の一つの態様によれば、貧血の改善方法として提供される。ここで、「改善」とは、確立された病態の改善という「治療」の意味を含むだけでなく、想定される悪化に対して事前に備え、疾患の発生を未然に防ぐ「予防」の意味も含む。また、「有効量」とは、１日の経口摂取量の単位における、鉄、亜鉛、葉酸、乳タンパク質の含有量などと同様に設定することができる。そして、本発明の方法では、一つの態様によれば、ヒトに対する医療行為を除くものである。ここで、ヒトに対する医療行為とは、医師等の処方を必要として、ヒトに対して医薬品を摂取させる（投与する）行為などを意味する。また、本発明の方法は健常者を対象とすることを含んでもよい。本発明の血中ヘモグロビンの増加方法は、本発明の組成物について、本明細書に記載された内容に従って実施することができる。 According to another aspect of the present invention, there is provided a method for increasing blood hemoglobin, the method comprising taking (preferably ingesting) an effective amount of iron, zinc, folic acid, and milk protein in a subject. Is provided, and a method comprising ingesting a subject in need thereof is provided. Therefore, according to one preferable aspect of the method of the present invention, it is provided as a method for increasing at least one blood parameter selected from hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration and folate concentration. Moreover, according to another preferable aspect of the method of the present invention, it is provided as a method for improving anemia. Here, “improvement” not only includes the meaning of “treatment” to improve the established pathological condition, but also means “prevention” to prepare for the expected deterioration in advance and prevent the occurrence of the disease in advance. Including. The “effective amount” can be set in the same manner as the content of iron, zinc, folic acid, milk protein, etc. in the unit of daily oral intake. And in the method of this invention, according to one aspect, the medical action with respect to a human is excluded. Here, the medical practice for humans means an act of taking (administering) pharmaceuticals to humans, which requires prescription by a doctor or the like. In addition, the method of the present invention may include targeting a healthy person. The method for increasing blood hemoglobin of the present invention can be carried out according to the contents described herein for the composition of the present invention.
　本発明の摂取の方法は、本発明の効果を妨げない限り、特に限定されないが、好ましくは、経管摂取（経鼻摂取、胃ろうなど）、経口摂取であり、より好ましくは、経口摂取である。 The method of ingestion of the present invention is not particularly limited as long as the effect of the present invention is not hindered, but preferably is tube ingestion (nasal ingestion, gastric fistula etc.) or oral ingestion, more preferably oral ingestion. is there.
　本発明の組成物としては、医薬品、医薬部外品、ドリンク剤、サプリメント、化粧料、または、特定保健用食品、栄養機能食品もしくは機能性表示食品を含む機能性食品等の食品もしくは飲料等の飲食品、飼料での提供が挙げられ、摂取の簡便性、風味の観点から飲料が好ましい。 Examples of the composition of the present invention include pharmaceuticals, quasi drugs, drinks, supplements, cosmetics, foods or beverages such as foods for specified health use, functional foods including nutritional functional foods or functional foods Offering with food-drinks and feed is mentioned, A drink is preferable from a viewpoint of the simplicity of intake and flavor.
　また、本発明の方法では、本発明の組成物の構成成分である、鉄、亜鉛、葉酸、乳タンパク質を同時に対象に摂取させてもよく、別々に対象に摂取させてもよいが、好ましくは、本発明の組成物の形態に調製して同時に対象に摂取させることである。 Further, in the method of the present invention, iron, zinc, folic acid, milk protein, which are components of the composition of the present invention, may be ingested simultaneously by the subject, or may be ingested separately by the subject, preferably It is prepared in the form of the composition of the present invention and simultaneously ingested by the subject.
　本発明の摂取の用法は、本発明の効果を妨げない限り、対象の種類、年齢、性別、症状に応じて、当業者が適宜設定することができる。また、本発明の１日の摂取量は、１回で対象に摂取させてもよく、複数回で対象に摂取させてもよいが、好ましくは、本発明の組成物の形態に調製して１回で対象に摂取させることである。したがって、本発明の１日の摂取回数は、１日に１～５回であり、好ましくは、１日に１～３回であり、より好ましくは、１日に１回である。 The usage of intake of the present invention can be appropriately set by those skilled in the art according to the type, age, sex, and symptoms of the subject as long as the effects of the present invention are not hindered. In addition, the daily intake of the present invention may be ingested by the subject once, or may be ingested by the subject multiple times, but is preferably prepared in the form of the composition of the present invention. Ingesting the subject in a single time. Therefore, the number of daily intakes of the present invention is 1 to 5 times a day, preferably 1 to 3 times a day, and more preferably once a day.
　本発明の対象は、好ましくは、ヒトであり、より好ましくは、血中ヘモグロビン濃度が低いヒトや貧血のヒトである。本発明の対象における血中ヘモグロビン濃度は、特に限定されないが、血中ヘモグロビンの増加による貧血の改善効果の観点から、低いことが好ましい。ここで、血中ヘモグロビン濃度が低いヒトや貧血のヒトとは、例えば、ヒトの男性の場合、血中ヘモグロビン濃度は、好ましくは13 g/dL未満を意味する。また、ヒトの女性の場合、血中ヘモグロビン濃度は、好ましくは12 g/dL未満を意味する。 The subject of the present invention is preferably a human, more preferably a human with low blood hemoglobin concentration or an anemic human. The blood hemoglobin concentration in the subject of the present invention is not particularly limited, but is preferably low from the viewpoint of the effect of improving anemia due to an increase in blood hemoglobin. Here, a human having a low blood hemoglobin concentration or an anemic human means that, for example, in the case of a human male, the blood hemoglobin concentration is preferably less than 13 μg / dL. In the case of a human female, the blood hemoglobin concentration preferably means less than 12 g / dL.
　また、本発明の対象の年齢は、本発明の効果を妨げない限り、特に限定されないが、高齢者（例えば、65歳以上のヒト）の症状の改善において特に有利に利用することができることから、好ましくは、高齢者である。 In addition, the age of the subject of the present invention is not particularly limited as long as the effect of the present invention is not hindered, but can be used particularly advantageously in improving the symptoms of elderly people (for example, humans 65 years or older), Preferably, it is an elderly person.
　本発明は、鉄が不足している対象における貧血の改善にも、鉄が不足していない対象における貧血の改善にも用いることができる。例えば、鉄が不足していない対象の場合、好ましくは、血清フェリチン濃度が25 ng/mL以上であるか、または総鉄結合能（Total Iron Binding Capacity；TIBC）が360 μg/dL未満である。 The present invention can be used to improve anemia in a subject lacking iron, or to improve anemia in a subject lacking iron. For example, in the case of a subject not deficient in iron, the serum ferritin concentration is preferably 25 ng / mL or more, or the total iron binding capacity (TIBC) is less than 360 ug / dL.
　また、本発明の別の態様によれば、血中ヘモグロビン増加用組成物の製造における、鉄、亜鉛、葉酸、乳タンパク質の組み合わせの使用が提供される。したがって、本発明の使用の好ましい一つの態様によれば、ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度、葉酸濃度からなる群から選択される少なくとも一つの血液パラメーターの増加用組成物の製造における、鉄、亜鉛、葉酸、乳タンパク質の組み合わせの使用として提供される。また、本発明の使用の好ましい別の一つの態様によれば、貧血改善用組成物の製造における、鉄、亜鉛、葉酸、乳タンパク質の組み合わせの使用として提供される。 Also, according to another aspect of the present invention, there is provided use of a combination of iron, zinc, folic acid and milk protein in the production of a composition for increasing blood hemoglobin. Therefore, according to one preferred embodiment of the use of the present invention, in the production of a composition for increasing at least one blood parameter selected from the group consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folic acid concentration, Provided as the use of a combination of iron, zinc, folic acid, milk protein. Moreover, according to another preferable aspect of the use of the present invention, it is provided as a use of a combination of iron, zinc, folic acid and milk protein in the production of a composition for improving anemia.
　また、本発明の別の態様によれば、血中ヘモグロビン増加用組成物としての、鉄、亜鉛、葉酸、乳タンパク質の組み合わせの使用が提供される。したがって、本発明の使用の好ましい一つの態様によれば、ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度、葉酸濃度からなる群から選択される少なくとも一つの血液パラメーターの増加用組成物としての、鉄、亜鉛、葉酸、乳タンパク質の組み合わせの使用として提供される。また、本発明の使用の好ましい別の一つの態様によれば、貧血改善用組成物としての、鉄、亜鉛、葉酸、乳タンパク質の組み合わせの使用として提供される。 Also, according to another aspect of the present invention, there is provided use of a combination of iron, zinc, folic acid, and milk protein as a composition for increasing blood hemoglobin. Therefore, according to one preferred embodiment of the use of the present invention, iron as a composition for increasing at least one blood parameter selected from the group consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folic acid concentration. Provided as the use of a combination of zinc, folic acid and milk protein. Moreover, according to another preferable aspect of the use of the present invention, it is provided as a use of a combination of iron, zinc, folic acid and milk protein as a composition for improving anemia.
　また、本発明の別の態様によれば、血中ヘモグロビン増加のための、鉄、亜鉛、葉酸、乳タンパク質の組み合わせの使用が提供される。また、本発明の使用の好ましい一つの態様によれば、ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度、葉酸濃度からなる群から選択される少なくとも一つの血液パラメーターの増加のための、鉄、亜鉛、葉酸、乳タンパク質の組み合わせの使用として提供される。また、本発明の使用の好ましい別の一つの態様によれば、貧血改善のための、鉄、亜鉛、葉酸、乳タンパク質の組み合わせの使用として提供される。本発明の好ましい態様によれば、上記組み合わせは逐次または同時に対象に摂取させることを特徴とする。 Also, according to another aspect of the present invention, there is provided use of a combination of iron, zinc, folic acid, and milk protein for increasing blood hemoglobin. According to one preferred embodiment of the use of the present invention, iron, zinc for increasing at least one blood parameter selected from the group consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folic acid concentration , Provided as the use of a combination of folic acid and milk protein. According to another preferred embodiment of the use of the present invention, it is provided as a use of a combination of iron, zinc, folic acid and milk protein for improving anemia. According to a preferred aspect of the present invention, the above combination is characterized in that the subject is ingested sequentially or simultaneously.
　また、本発明の別の態様によれば、鉄、亜鉛、葉酸、乳タンパク質を組成物中に配合することを特徴とする、血中ヘモグロビン増加用組成物の製造方法が提供される。したがって、本発明の製造方法の好ましい一つの態様によれば、鉄、亜鉛、葉酸、乳タンパク質を組成物中に配合することを特徴とする、ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度、葉酸濃度からなる群から選択される少なくとも一つの血液パラメーターの増加用組成物の製造方法として提供される。また、本発明の製造方法の好ましい別の一つの態様によれば、鉄、亜鉛、葉酸、乳タンパク質を組成物中に配合することを特徴とする、貧血改善用組成物の製造方法として提供される。 Also, according to another aspect of the present invention, there is provided a method for producing a composition for increasing blood hemoglobin, which comprises blending iron, zinc, folic acid, and milk protein in the composition. Therefore, according to one preferred embodiment of the production method of the present invention, hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folic acid, characterized in that iron, zinc, folic acid, and milk protein are blended in the composition. It is provided as a method for producing a composition for increasing at least one blood parameter selected from the group consisting of concentrations. According to another preferred embodiment of the production method of the present invention, there is provided as a method for producing a composition for improving anemia, wherein iron, zinc, folic acid, and milk protein are blended in the composition. The
　また、本発明の別の態様によれば、血中ヘモグロビンの増加のための、鉄、亜鉛、葉酸、乳タンパク質を（有効成分として）含む組成物が提供される。したがって、本発明の組成物の好ましい一つの態様によれば、ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度、葉酸濃度からなる群から選択される少なくとも一つの血液パラメーターの増加のための、鉄、亜鉛、葉酸、乳タンパク質を（有効成分として）含む組成物として提供される。また、本発明の組成物の好ましい別の一つの態様によれば、貧血を改善するための、鉄、亜鉛、葉酸、乳タンパク質を（有効成分として）含む組成物として提供される。 Also, according to another aspect of the present invention, there is provided a composition containing iron, zinc, folic acid, and milk protein (as active ingredients) for increasing blood hemoglobin. Therefore, according to one preferred embodiment of the composition of the present invention, iron for increasing at least one blood parameter selected from the group consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folate concentration, It is provided as a composition comprising zinc, folic acid, and milk protein (as active ingredients). Moreover, according to another preferable one aspect | mode of the composition of this invention, it provides as a composition containing iron, zinc, folic acid, and milk protein (as an active ingredient) for improving anemia.
　また、本発明の別の態様によれば、血中ヘモグロビンの増加のための、鉄、亜鉛、葉酸、および乳タンパク質の組み合わせ物が提供される。また、本発明の組み合わせ物の好ましい一つの態様によれば、ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度、葉酸濃度からなる群から選択される少なくとも一つの血液パラメーターの増加のための、鉄、亜鉛、葉酸、および乳タンパク質を含む組み合わせ物として提供される。また、本発明の組み合わせ物の好ましい別の一つの態様によれば、貧血を改善するための、鉄、亜鉛、葉酸、および乳タンパク質を含む組み合わせ物として提供される。本発明の好ましい態様によれば、上記組み合わせ物は逐次または同時に対象に摂取させることを特徴とする。 Also, according to another aspect of the present invention, there is provided a combination of iron, zinc, folic acid, and milk protein for increasing blood hemoglobin. According to a preferred embodiment of the combination of the present invention, iron for increasing at least one blood parameter selected from the group consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folate concentration, Provided as a combination comprising zinc, folic acid, and milk protein. Moreover, according to another preferable aspect of the combination of the present invention, it is provided as a combination comprising iron, zinc, folic acid, and milk protein for improving anemia. According to a preferred embodiment of the present invention, the combination is ingested sequentially or simultaneously by the subject.
　上記の使用、製造方法、組成物（組み合わせ物）の態様はいずれも、本発明の組成物や方法に関する記載に準じて実施することができる。 Any of the above-described uses, production methods, and compositions (combinations) can be carried out in accordance with the description of the composition and method of the present invention.
　以下、実施例により、本発明をより具体的に説明するが、本発明の技術範囲は、これらの例示に限定されるものではない。なお、特に記載しない限り、本発明で用いられる全部のパーセンテージや比率は質量による。また、特に記載しない限り、本明細書に記載の単位や測定方法はJIS規格による。 Hereinafter, the present invention will be described more specifically by way of examples. However, the technical scope of the present invention is not limited to these examples. Unless otherwise specified, all percentages and ratios used in the present invention are based on mass. Unless otherwise specified, the units and measurement methods described in this specification are based on JIS standards.
例１：試験サンプルの製造
　原料水に、乳原料（牛乳、全脂粉乳、脱脂粉乳、ホエイ粉、無塩バター）、炭酸カルシウム、ピロリン酸第二鉄、グルコン酸亜鉛、葉酸、ビタミンD、重曹を配合して十分に混合してから均質化した。この得られた水溶液を殺菌してから冷却して、液状の試験サンプル（乳ベース）を調製した。試験サンプルの組成を表１に示した。 Example 1: Production raw material water of test sample , milk raw material (milk, whole milk powder, skim milk powder, whey powder, unsalted butter), calcium carbonate, ferric pyrophosphate, zinc gluconate, folic acid, vitamin D, baking soda Were blended and mixed thoroughly before homogenization. The obtained aqueous solution was sterilized and then cooled to prepare a liquid test sample (milk base). The composition of the test sample is shown in Table 1.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
試験例１：貧血の傾向にある女性の高齢者を対象としたヒト試験
　貧血の傾向にある女性の高齢者（平均年齢： 69.9±3.4歳）の15名を対象にして、実施例１で製造した試験サンプルを１日に１本（200 mL）ずつで経口摂取させた。また、経口摂取の直前と、最初の経口摂取から４週間後に、上記の高齢者における血液学的な貧血の指標値（ヘモグロビン濃度、ヘマトクリット値、赤血球数）と、血清中の亜鉛濃度、葉酸濃度を測定し、経口摂取の前後で比較した。なお、ヘモグロビン濃度では、SLS-Hb法、ヘマトクリット値では、赤血球パルス波高値検出法、赤血球数では、電気抵抗検出法、血清中の亜鉛濃度では、原子吸光光度法、葉酸濃度では、CLIA法によって測定した。 Test example 1: Human test targeting elderly women who are prone to anemia Manufactured in Example 1 for 15 elderly women (mean age: 69.9 ± 3.4 years) who are prone to anemia Each test sample was orally ingested once a day (200 mL). Also, immediately before oral intake and 4 weeks after the first oral intake, hematological anemia index values (hemoglobin concentration, hematocrit value, red blood cell count), serum zinc concentration, folate concentration in the elderly Was measured and compared before and after ingestion. For hemoglobin concentration, SLS-Hb method, for hematocrit value, red blood cell pulse peak detection method, for red blood cell count, electrical resistance detection method, for zinc concentration in serum, atomic absorption spectrophotometry, for folate concentration, CLIA method It was measured.
　ヘモグロビン濃度、ヘマトクリット値、赤血球数の測定結果（平均値±標準偏差（n=15））を表２に示した。表２より、経口摂取の直前と比較して、最初の経口摂取から４週間後では、ヘモグロビン濃度とヘマトクリット値は、それぞれ有意に高かった（t検定）。一方、経口摂取の直前と比べて、最初の経口摂取から４週間後では、赤血球数は変わらなかった。 Table 2 shows the measurement results (mean value ± standard deviation (n = 15)) of hemoglobin concentration, hematocrit value, and red blood cell count. From Table 2, the hemoglobin concentration and the hematocrit value were significantly higher at 4 weeks after the first oral intake compared to immediately before oral intake (t test). On the other hand, the red blood cell count did not change 4 weeks after the first oral intake compared to immediately before oral intake.
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000002
　血清中の亜鉛濃度と葉酸濃度の測定結果（平均値±標準偏差（n=15））を表３に示した。表３より、経口摂取の直前と比較して、最初の経口摂取から４週間後では、亜鉛濃度と葉酸濃度は、それぞれ有意に高かった（t検定）。 The measurement results of zinc concentration and folic acid concentration in serum (average value ± standard deviation (n = 15)) are shown in Table 3. From Table 3, the zinc concentration and the folic acid concentration were significantly higher 4 weeks after the first oral intake compared to immediately before oral intake (t test).
Figure JPOXMLDOC01-appb-T000003
Figure JPOXMLDOC01-appb-T000003
試験例２：貧血の傾向にあるものの、鉄分が不足していない女性の高齢者を対象としたヒト試験
　上記の試験例１で、貧血の傾向にある女性の高齢者には、経口摂取の直前で鉄分が不足していない高齢者（経口摂取の直前で、フェリチンが25 ng/mL以上、総鉄結合能（TIBC）が360 μg/dL未満である高齢者）が8名で含まれていた。そこで、上記の鉄分が不足していない高齢者のみを対象にして、血液学的な貧血の指標値（ヘモグロビン濃度、ヘマトクリット値、赤血球数）と、血清中の亜鉛濃度、葉酸濃度を経口摂取の前後で比較した。 Test Example 2: Human test for elderly women who tend to be anemic but do not have enough iron content In Test Example 1 above, the elderly women who tend to be anemic are immediately before oral intake. And 8 elderly who were not deficient in iron (immediately before ingestion, elderly with ferritin of 25 ng / mL or more and total iron binding capacity (TIBC) of less than 360 μg / dL) were included . Therefore, for the elderly who are not deficient in iron, the hematological anemia index values (hemoglobin concentration, hematocrit value, red blood cell count), serum zinc concentration, and folic acid concentration Compared before and after.
　鉄分が不足していない高齢者におけるヘモグロビン濃度、ヘマトクリット値、赤血球数の測定結果（平均値±標準偏差（n=8））を表４に示した。表４より、経口摂取の直前と比較して、最初の経口摂取から４週間後では、ヘモグロビン濃度、ヘマトクリット値、赤血球数は、それぞれ有意に高かった（t検定）。 Table 4 shows the measurement results (average value ± standard deviation (n = 8)) of hemoglobin concentration, hematocrit value, and red blood cell count in elderly people who are not deficient in iron. From Table 4, the hemoglobin concentration, hematocrit value, and red blood cell count were significantly higher after 4 weeks from the first oral intake compared to immediately before oral intake (t test).
Figure JPOXMLDOC01-appb-T000004
Figure JPOXMLDOC01-appb-T000004
　血清中の亜鉛濃度と葉酸濃度の測定結果（平均値±標準偏差（n=8））を表５に示した。表５より、経口摂取の直前と比較して、最初の経口摂取から４週間後では、葉酸濃度は有意に高かった（t検定）。また、経口摂取の直前と比較して、最初の経口摂取から４週間後では、亜鉛濃度は高かった。 Table 5 shows the measurement results of zinc concentration and folate concentration in serum (average value ± standard deviation (n = 8)). From Table 5, the folic acid concentration was significantly higher 4 weeks after the first oral intake compared to immediately before oral intake (t test). In addition, the zinc concentration was higher 4 weeks after the first oral intake compared to immediately before the oral intake.
Figure JPOXMLDOC01-appb-T000005
Figure JPOXMLDOC01-appb-T000005
　鉄、亜鉛、葉酸、乳タンパク質を組み合わせて用いることで、鉄の服用量を抑制しつつ、貧血の対象において血中ヘモグロビン濃度を向上できることが明らかとなった。また、鉄、亜鉛、葉酸、乳タンパク質を組み合わせて用いることで、ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度、葉酸濃度などの貧血関連血液パラメーターを向上できることが明らかとなった。本発明によれば、鉄の使用量を抑制しつつ、貧血の対象において血中ヘモグロビン濃度を効果的に向上でき、特に、鉄分が不足していない高齢者の血中ヘモグロビン濃度を効果的に向上できる。 It has been clarified that the combination of iron, zinc, folic acid, and milk protein can improve blood hemoglobin concentration in anemic subjects while suppressing the iron dose. It was also revealed that anemia-related blood parameters such as hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folic acid concentration can be improved by using a combination of iron, zinc, folic acid, and milk protein. According to the present invention, the blood hemoglobin concentration can be effectively improved in an anemic subject while suppressing the amount of iron used, and in particular, the blood hemoglobin concentration of an elderly person who is not deficient in iron is effectively improved. it can.

Claims (17)

  1. 　鉄、亜鉛、葉酸、および乳タンパク質を含む、血中ヘモグロビン増加用組成物。 A composition for increasing blood hemoglobin containing iron, zinc, folic acid, and milk protein.
  2. 　鉄の含有量が１～５０ｍｇである、請求項１に記載の組成物。 The composition according to claim 1, wherein the iron content is 1 to 50 mg.
  3. 　亜鉛の含有量が１～３０ｍｇである、請求項１または２に記載の組成物。 The composition according to claim 1 or 2, wherein the zinc content is 1 to 30 mg.
  4. 　葉酸の含有量が５０～１０００μｇである、請求項１～３のいずれか一項に記載の組成物。 The composition according to any one of claims 1 to 3, wherein the content of folic acid is 50 to 1000 µg.
  5. 　乳タンパク質の含有量が１～５０ｇである、請求項１～４のいずれか一項に記載の組成物。 The composition according to any one of claims 1 to 4, wherein the milk protein content is 1 to 50 g.
  6. 　１日の経口摂取量の単位の形態である、請求項１～５のいずれか一項に記載の組成物。 The composition according to any one of claims 1 to 5, which is in the form of a unit of daily oral intake.
  7. 　前記組成物が飲料である、請求項１～６のいずれか一項に記載の組成物。 The composition according to any one of claims 1 to 6, wherein the composition is a beverage.
  8. 　高齢者のための、請求項１～７のいずれか一項に記載の組成物。 The composition according to any one of claims 1 to 7, for elderly people.
  9. 　血清中フェリチン濃度が２５ｎｇ／ｍＬ以上のヒトのための、請求項１～８のいずれか一項に記載の組成物。 The composition according to any one of claims 1 to 8, which is for human having a serum ferritin concentration of 25 ng / mL or more.
  10. 　ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度、葉酸濃度からなる群から選択される少なくとも一つの血液パラメーターの増加のための、請求項１～９のいずれか一項に記載の組成物。 The composition according to any one of claims 1 to 9, for increasing at least one blood parameter selected from the group consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, and folic acid concentration.
  11. 　貧血改善のための、請求項１～１０のいずれか一項に記載の組成物。 The composition according to any one of claims 1 to 10, for improving anemia.
  12. 　血中ヘモグロビン増加用組成物の製造における、鉄、亜鉛、葉酸、および乳タンパク質の組み合わせの使用。 Use of a combination of iron, zinc, folic acid, and milk protein in the manufacture of a composition for increasing blood hemoglobin.
  13. 　ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度、葉酸濃度からなる少なくとも一つの血液パラメーターの増加のための、請求項１２に記載の組み合わせの使用。 Use of the combination according to claim 12 for increasing at least one blood parameter consisting of hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration, folic acid concentration.
  14. 　貧血改善のための、請求項１２または１３に記載の組み合わせの使用。 Use of the combination according to claim 12 or 13 for improving anemia.
  15. 　鉄、亜鉛、葉酸、および乳タンパク質の有効量を、それを必要とする対象に摂取させることを含んでなる、血中ヘモグロビンの増加方法。 A method for increasing blood hemoglobin, comprising ingesting an effective amount of iron, zinc, folic acid, and milk protein to a subject in need thereof.
  16. 　ヘモグロビン濃度、ヘマトクリット値、赤血球数、亜鉛濃度および葉酸濃度から選択される少なくとも一つの血液パラメーターの増加方法である、請求項１５に記載の方法。 The method according to claim 15, which is a method for increasing at least one blood parameter selected from hemoglobin concentration, hematocrit value, red blood cell count, zinc concentration and folic acid concentration.
  17. 　貧血の改善方法である、請求項１５または１６に記載の方法。 The method according to claim 15 or 16, which is a method for improving anemia.
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