WO2016208641A1 - Composition permettant d'augmenter l'hémoglobine dans le sang - Google Patents

Composition permettant d'augmenter l'hémoglobine dans le sang 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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English (en)
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/ja
Publication of WO2016208641A1 publication Critical patent/WO2016208641A1/fr

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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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  • Engineering & Computer Science (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

La présente invention concerne une nouvelle composition permettant d'augmenter l'hémoglobine dans le sang et une composition permettant de soulager l'anémie. Plus spécifiquement, la présente invention concerne une composition permettant d'augmenter l'hémoglobine dans le sang et une composition permettant de soulager l'anémie qui comprennent du fer, du zinc, de l'acide folique, et une protéine du lait.
PCT/JP2016/068566 2015-06-22 2016-06-22 Composition permettant d'augmenter l'hémoglobine dans le sang WO2016208641A1 (fr)

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JP2017524953A JP6815994B2 (ja) 2015-06-22 2016-06-22 血中ヘモグロビン増加用組成物

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JP2015125038 2015-06-22

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Cited By (1)

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JP2018131417A (ja) * 2017-02-16 2018-08-23 株式会社明治 貧血予防または改善用組成物

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Cited By (2)

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JP2018131417A (ja) * 2017-02-16 2018-08-23 株式会社明治 貧血予防または改善用組成物
WO2018151184A1 (fr) * 2017-02-16 2018-08-23 株式会社明治 Composition pour prévenir ou améliorer l'anémie

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