WO2015137387A1 - Médicament d'amélioration musculaire - Google Patents

Médicament d'amélioration musculaire Download PDF

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Publication number
WO2015137387A1
WO2015137387A1 PCT/JP2015/057130 JP2015057130W WO2015137387A1 WO 2015137387 A1 WO2015137387 A1 WO 2015137387A1 JP 2015057130 W JP2015057130 W JP 2015057130W WO 2015137387 A1 WO2015137387 A1 WO 2015137387A1
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Prior art keywords
salt
amino acid
weight
acid composition
citrulline
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PCT/JP2015/057130
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English (en)
Japanese (ja)
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高志 石田
西村　明仁
中野　裕一郎
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協和発酵バイオ株式会社
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Priority to JP2016507786A priority Critical patent/JPWO2015137387A1/ja
Publication of WO2015137387A1 publication Critical patent/WO2015137387A1/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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/01—Hydrolysed proteins; Derivatives thereof
    • A61K38/012—Hydrolysed proteins; Derivatives thereof from animals
    • A61K38/018—Hydrolysed proteins; Derivatives thereof from animals from milk
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/06—Anabolic agents

Definitions

  • the present invention relates to a muscle strengthening agent containing an amino acid composition containing ornithine or a salt thereof, citrulline or a salt thereof and arginine or a salt thereof as an active ingredient.
  • the present invention also relates to a composition comprising as an active ingredient an amino acid composition containing ornithine, citrulline and arginine or a salt thereof.
  • the maintenance and strengthening of muscles are important not only for athletes to exhibit better exercise performance, but also for the daily life of normal healthy people. Specifically, when muscles weaken due to lack of exercise or aging, daily activities such as standing and sitting are also hindered. For this reason, various supplements are used for the purpose of muscular strength training by exercise load and muscle enhancement effect.
  • Non-patent Document 1 Compositions containing ornithine, citrulline and arginine include amino acids such as ornithine, citrulline and arginine, and amino acid food compositions containing tea and tea flavor components (Patent Document 1), and L-ornithine hydrochloride, L An external cream composition containing -citrulline and L-arginine hydrochloride (Patent Document 2) has been reported.
  • “PheNOm” manufactured by Body Plus International
  • Examples of the amino acid-containing composition having a muscle-enhancing action include muscle-enhancing agents containing L-ornithine (Patent Document 3), muscle protein synthesis promoters using L-citrulline (Non-patent Document 2), muscles produced by L-arginine Protein synthesis accelerators (Non-patent Document 3) have been reported.
  • Patent Document 3 muscle-enhancing agents containing L-ornithine
  • Non-patent Document 2 muscle protein synthesis promoters using L-citrulline
  • Non-patent Document 3 muscles produced by L-arginine Protein synthesis accelerators
  • ingestion of a composition containing ornithine, citrulline and arginine increases muscle protein synthesis and increases muscle mass.
  • An object of the present invention is to provide a muscle potentiator containing an amino acid composition comprising ornithine or a salt thereof, citrulline or a salt thereof and arginine or a salt thereof as an active ingredient, and 10 to 80% by weight of ornithine or a salt thereof, citrulline or a salt thereof.
  • an amino acid composition comprising 10 to 80% by weight of a salt and 10 to 80% by weight of arginine or a salt thereof, and a composition containing a protein in a weight ratio of 1 to 20 times the amino acid composition. is there.
  • the present invention relates to the following (1) to (8).
  • a muscle potentiator containing an amino acid composition comprising ornithine or a salt thereof, citrulline or a salt thereof and arginine or a salt thereof as an active ingredient.
  • the amino acid composition is 10 to 80% by weight of ornithine or a salt thereof, 10 to 80% by weight of citrulline or a salt thereof, and 10 to 80% by weight of arginine or a salt thereof based on the total amount of the amino acid composition.
  • the muscle enhancer according to (1) which is an amino acid composition comprising%.
  • the muscle enhancer according to (1) or (2) which contains only the amino acid composition as the amino acid.
  • a muscle enhancer wherein the muscle enhancer according to any one of (1) to (3) contains a protein having a weight of 1 to 20 times that of the amino acid composition.
  • An amino acid composition comprising ornithine or a salt thereof at 10 to 80% by weight, citrulline or a salt thereof at 10 to 80% by weight and arginine or a salt thereof at 10 to 80% by weight, and the amino acid composition, A composition containing a protein having a weight ratio of 1 to 20 times.
  • the composition according to (6), wherein the protein is whey protein.
  • the composition according to (6) or (7), wherein the amino acid contains only the amino acid composition as a component.
  • a muscle strengthening agent containing as an active ingredient an amino acid composition comprising ornithine or a salt thereof, citrulline or a salt thereof and arginine or a salt thereof, and ornithine or a salt thereof is 10 to 80% by weight, citrulline or a salt thereof It is possible to provide an amino acid composition comprising 10 to 80% by weight and 10 to 80% by weight of arginine or a salt thereof, and a composition containing a protein having a weight ratio of 1 to 20 times the amino acid composition.
  • the vertical axis represents muscle protein synthesis rate, and the unit is% / hour.
  • “Cont.” Represents a basal feed administration group
  • “WP10” represents a 10 wt% whey protein administration group
  • “WP10 + AA5” represents a 10 wt% whey protein and 5 wt% amino acid composition administration group
  • “AA5” represents a 5 wt% amino acid composition administration group.
  • * Indicates that there is a significant difference (p ⁇ 0.05, n 6) ⁇ ⁇ ⁇ by Tukey HSD test compared to the basic feed administration group.
  • the vertical axis represents muscle mass and the unit is g / kg body weight.
  • Cont Represents the basic feed administration group
  • WP10 represents the 10 wt% whey protein administration group
  • WP10 + AA2 represents the 10 wt% whey protein and 2 wt% amino acid composition administration. Represents a group.
  • any of L-form, D-form, and a mixture of L-form and D-form may be used, but L-form is preferably used.
  • Ornithine can be obtained by a known method such as chemical synthesis or fermentation. Ornithine can also be obtained by purchasing commercial products from various companies such as Kyowa Hakko Bio Co., Ltd.
  • Examples of the method for chemically synthesizing ornithine include the method described in Coll.Czechoslov.Chem.Commun, 24, 1993 (1959). Examples of the method for fermentative production of ornithine include the methods described in JP-A Nos. 53-24096 and 61-119194. L-ornithine and D-ornithine can also be purchased from Sigma-Aldrich.
  • Citrulline can be obtained by a known method of chemically synthesizing or fermentative production. Citrulline can also be obtained by purchasing commercial products from various companies such as Kyowa Hakko Bio Co., Ltd. Examples of methods for chemically synthesizing citrulline include the methods described in J. Biol. Chem. 122, 477 (1938) and J. Org. Chem. 6, 410 (1941).
  • L-citrulline and D-citrulline can also be purchased from Sigma-Aldrich.
  • Arginine can be obtained by a known method such as chemical synthesis or fermentation production. Arginine can also be obtained by purchasing commercial products from various companies such as Kyowa Hakko Bio Co., Ltd.
  • L-arginine and D-arginine can also be purchased from Sigma-Aldrich.
  • the salts of ornithine, citrulline and arginine are the same or different and include, for example, acid addition salts, metal salts, ammonium salts, organic amine addition salts, amino acid addition salts and the like.
  • acid addition salts include inorganic acid salts such as hydrochloride, sulfate, nitrate, and phosphate, acetate, maleate, fumarate, citrate, malate, lactate, ⁇ -ketoglutar Organic acid salts such as acid salts, gluconates and caprylates can be mentioned.
  • metal salt include alkali metal salts such as sodium salt and potassium salt, alkaline earth metal salts such as magnesium salt and calcium salt, aluminum salt, zinc salt and the like.
  • ammonium salts include ammonium and tetramethylammonium salts.
  • organic amine addition salts include morpholine and piperidine salts.
  • amino acid addition salts include salts of glycine, phenylalanine, lysine, aspartic acid, glutamic acid, and the like.
  • amino acid composition in the present invention represents a mixture comprising ornithine or a salt thereof, citrulline or a salt thereof, and arginine or a salt thereof other than the protein in the entire composition of the present invention.
  • the amino acid composition is 0.1 to 99% by weight, preferably 1 to 10% by weight, more preferably 2 to 5% by weight, based on the total weight of the composition of the present invention.
  • each amino acid with respect to the amino acid composition is ornithine or a salt thereof from 10 to 80% by weight, citrulline or a salt thereof from 10 to 80% by weight, and arginine or a salt thereof from 10 to 80% by weight.
  • the salt is 25-50% by weight
  • citrulline or a salt thereof is 25-50% by weight
  • arginine or a salt thereof is 25-50% by weight.
  • the “protein” in the present invention examples include casein protein, soybean protein, egg protein, wheat protein, whey protein and the like, and whey protein is preferable.
  • the “protein” in the present invention is 1 to 99% by weight, preferably 5 to 95% by weight, more preferably 10 to 90% by weight, based on the weight of the entire composition.
  • the composition of the present invention can be used as a pharmaceutical or food additive (hereinafter also referred to as the pharmaceutical or food additive of the present invention).
  • an amino acid composition containing ornithine or a salt thereof, citrulline or a salt thereof and arginine or a salt thereof can be administered as it is, but is usually provided as various preparations. desirable.
  • the preparation contains an amino acid composition containing ornithine or a salt thereof, citrulline or a salt thereof and arginine or a salt thereof as active ingredients, but may further contain any other active ingredient for treatment.
  • These pharmaceutical preparations are produced by any method well known in the technical field of pharmaceutics by mixing the active ingredient with one or more pharmacologically acceptable carriers.
  • dosage form of the preparation it is desirable to use the most effective form in treatment, and oral administration or parenteral administration such as intravenous, intraperitoneal or subcutaneous administration can be mentioned, but oral administration is preferred.
  • dosage forms to be administered include tablets, powders, granules, pills, suspensions, emulsions, soaking and decoction, capsules, syrups, solutions, elixirs, extracts, tinctures, fluid extracts, etc.
  • parenteral preparations such as oral preparations, injection preparations, instillation preparations, cream preparations, and suppositories may be used, but they are preferably used as oral preparations.
  • Liquid preparations such as syrups, suitable for oral administration include saccharides such as water, sucrose, sorbitol, fructose, glycols such as polyethylene glycol, propylene glycol, oils such as sesame oil, olive oil, soybean oil, p -Preservatives such as -hydroxybenzoic acid esters, paraoxybenzoic acid derivatives such as methyl paraoxybenzoate, preservatives such as sodium benzoate, and flavors such as strawberry flavor and peppermint can be added to prepare a preparation.
  • saccharides such as water, sucrose, sorbitol, fructose, glycols such as polyethylene glycol, propylene glycol, oils such as sesame oil, olive oil, soybean oil, p -Preservatives such as -hydroxybenzoic acid esters, paraoxybenzoic acid derivatives such as methyl paraoxybenzoate, preservatives such as sodium benzoate, and flavors such as strawberry flavor and peppermint can be added to prepare a preparation
  • Also suitable for oral administration are lactose, sucrose, glucose, sucrose, mannitol, sorbitol and other sugars, potato, wheat, corn and other starches, calcium carbonate, calcium sulfate, hydrogen carbonate Inorganic substances such as sodium and sodium chloride, excipients such as crystalline cellulose, licorice powder and gentian powder, etc., starch, agar, gelatin powder, crystalline cellulose, carmellose sodium, carmellose calcium, calcium carbonate, sodium bicarbonate , Disintegrants such as sodium alginate, magnesium stearate, talc, hydrogenated vegetable oil, macrogol, silicone oil and other lubricants, polyvinyl alcohol, hydroxypropylcellulose, methylcellulose, ethylcellulose, carmellose, gelatin, starch Binders glue solution and the like, surfactants such as fatty acid esters can be formulated by adding a plasticizer such as glycerin.
  • a plasticizer such as glycerin.
  • an injection preferably comprises a sterile aqueous preparation containing an amino acid composition comprising ornithine or a salt thereof, citrulline or a salt thereof and arginine or a salt thereof that is isotonic with the blood of the recipient.
  • a solution for injection is prepared using a carrier such as a salt solution, a glucose solution, or a mixture of a salt solution and a glucose solution.
  • a carrier such as a salt solution, a glucose solution, or a mixture of a salt solution and a glucose solution.
  • the concentration of the amino acid composition containing ornithine or a salt thereof, citrulline or a salt thereof and arginine or a salt thereof in the medicament of the present invention is appropriately selected according to the type of the preparation, the effect expected by administration of the preparation, etc.
  • the amino acid composition containing ornithine or a salt thereof, citrulline or a salt thereof and arginine or a salt thereof is usually 0.1 to 100% by weight, preferably 0.5 to 80% by weight, particularly preferably 1 to 70% by weight.
  • the dose and frequency of administration of the medicament of the present invention vary depending on the administration form, patient age, body weight, nature or severity of the symptoms to be treated, and are usually per day for adults ornithine or a salt thereof, citrulline or a salt thereof.
  • the amino acid composition comprising arginine or a salt thereof is usually administered once to several times a day so as to be 100 to 5 mg, preferably 150 to 4 mg, more preferably 200 to 3 mg.
  • the administration period is not particularly limited, but is usually 1 day to 1 year, preferably 1 week to 3 months.
  • the composition of the present invention is used as a food additive, ornithine or a salt thereof, citrulline or a salt thereof and an amino acid composition containing arginine or a salt thereof can be used as they are, but the same method as the above preparation
  • a food additive containing an amino acid composition containing ornithine or a salt thereof, citrulline or a salt thereof and arginine or a salt thereof as an active ingredient may be prepared.
  • the food additive of the present invention is processed or manufactured by mixing or dissolving other food additives as required, for example, in the form of powder, granules, pellets, tablets, or various liquids.
  • the food / beverage products containing the food additive of the present invention (hereinafter also referred to as the food / beverage product of the present invention) use a general method for producing a food / beverage product, except that the food additive of the present invention is added to the food / beverage product. Thus, it can be processed and manufactured.
  • the food and drink of the present invention are, for example, fluidized bed granulation, stirring granulation, extrusion granulation, rolling granulation, airflow granulation, compression molding granulation, pulverization granulation, spray granulation, spray granulation, etc.
  • Granulation method coating method such as pan coating, fluidized bed coating, dry coating, puff drying, excess steam method, foam mat method, expansion method such as microwave heating method, extrusion method such as extrusion granulator and extruder etc. It can also be manufactured using.
  • Examples of the food and drink of the present invention include juices, soft drinks, teas, lactic acid bacteria beverages, fermented milk, frozen desserts, butter, cheese, yogurt, processed milk, skim milk and other dairy products, ham, sausage, hamburger Livestock meat products, fish paste products such as bamboo shoots, bamboo rings, fried fish balls, egg products such as sushi rolls, egg tofu, cookies, jelly, chewing gum, candy, snacks and other confectionery, breads, noodles, pickles, salmon products, dried fish, It may be in any form such as boiled salmon, salted products, soups, seasonings and the like.
  • the food and drink of the present invention may be in the form of, for example, powdered food, sheet food, bottled food, canned food, retort food, capsule food, tablet food, liquid food, and drink.
  • the food / beverage products of the present invention can be used as food / beverage products such as health foods, functional foods, dietary supplements, foods for specified health use, etc. for strengthening muscles.
  • the food additive or food / beverage product of the present invention includes additives generally used in food / beverage products, for example, sweeteners described in the Food Additives Display Handbook (Japan Food Additives Association, issued on January 6, 1997) , Coloring agent, Preservative, Thickening stabilizer, Antioxidant, Coloring agent, Bleaching agent, Antifungal agent, Gum base, Bittering agent, Enzyme, Brightener, Acidulant, Seasoning, Emulsifier, Strengthening agent, Production agent A fragrance, a spice extract, etc. may be added.
  • sweeteners described in the Food Additives Display Handbook (Japan Food Additives Association, issued on January 6, 1997) , Coloring agent, Preservative, Thickening stabilizer, Antioxidant, Coloring agent, Bleaching agent, Antifungal agent, Gum base, Bittering agent, Enzyme, Brightener, Acidulant, Seasoning, Emulsifier, Strengthening agent, Production agent A fragrance, a spice extract, etc. may be added.
  • the amount of the food additive of the present invention added to the food or drink of the present invention is appropriately selected according to the type of food or drink, the effect expected from the intake of the food or drink, ornithine or a salt thereof, citrulline or
  • the salt and arginine or an amino acid composition containing the salt are usually added in an amount of 0.1 to 90% by weight, preferably 0.5 to 80% by weight, particularly preferably 1 to 70% by weight.
  • the intake of the food and drink according to the present invention varies depending on the intake form, the age of the user, the body weight, etc., but usually an ornithine or a salt thereof, citrulline or a salt thereof and an amino acid composition containing arginine or a salt thereof per adult day As a product, it is taken once to several times a day so as to be 100 mg to 5 g, preferably 150 mg to 4 g, more preferably 200 mg to 3 g.
  • the intake period is not particularly limited, but is usually 1 day to 1 year, preferably 1 day to 3 months, and more preferably 1 day to 1 month.
  • the muscle strengthening action of the present invention means an action for increasing muscle mass and an accompanying action for increasing muscle strength.
  • the increase in muscle mass can be broadly divided into three categories: increase in muscle fiber, increase in connective tissue, and increase in interstitial fluid, and it is known that the main part of the increase in muscle mass accompanying the increase in muscle strength is the increase in muscle fiber. It has been.
  • the increase in muscle fiber is thought to be due to an increase in muscle protein synthesis rate, a decrease in degradation rate, or both.
  • Science of exercise and muscle 2000, p84-85
  • the following is a test example in which the muscle protein synthesis promoting action and the muscle wet weight increasing action of the muscle enhancer were examined. Test Example 1.
  • Muscle protein synthesis promoting effect Using an amino acid composition comprising L-ornithine, L-citrulline and L-arginine in a 1: 1: 1 weight ratio, the basic feed (Cont.), 10 at the composition ratio shown in Table 1 below. Each feed was prepared by weight% whey protein (WP10), 10 weight% whey protein and 5 weight% amino acid composition (WP10 + AA5) and 5 weight% amino acid composition (AA5).
  • WP10 weight% whey protein
  • WP10 + AA5 weight% amino acid composition
  • the test group consists of a basic feed group (Cont.), 10 wt% whey protein group (WP10), 10 wt% whey protein and 5 wt% amino acid composition group (WP10 + AA5) and 5 wt% amino acids corresponding to each feed.
  • a total of 4 groups of composition groups (AA5) were provided.
  • test groups consisted of 3 groups: basic feed group (Cont.), 10 wt% whey protein group (WP10) and 10 wt% whey protein and 2 wt% amino acid composition group (WP10 + AA2) Provided.
  • FIG. 2 shows the result of determining the muscle wet weight per body weight.
  • WP10 + AA2 group which is the muscle potentiator or composition of the present invention, it was found that the muscle wet weight increased compared to the Cont. Group and the WP10 group, and showed a muscle strengthening action.
  • WP10 + AA2 Composition Weigh the amino acid composition of Example 1 and whey protein (Nippon Shinyaku Co., Ltd.) and each feed ingredient (Nippon Claire Co., Ltd.) according to the composition of WP10 + AA2 in Table 2. Used to mix uniformly to obtain a test feed.
  • the obtained mixture is compression-molded at a compression molding pressure of 10 kN using a rotary compression molding machine (VIRGO524SS1AY, manufactured by Kikusui Seisakusho Co., Ltd.) to produce tablets with a diameter of 8 mm and 250 mg.
  • VIRGO524SS1AY manufactured by Kikusui Seisakusho Co., Ltd.
  • enteric capsule containing ornithine, citrulline and arginine 120 kg of amino acid composition prepared in Example 1, 19 kg of cyclic oligosaccharide, 57 kg of cellulose, 3 kg of calcium stearate and 1 kg of pullulan are mixed in a conical blender. . A mixture obtained by mixing and stirring 20 kg of the obtained mixture and 0.2 kg of silicon dioxide is put into a capsule filling machine and filled into hard capsules to obtain hard capsules. The surface of the resulting hard capsule is coated with a zein solution to produce an enteric capsule.
  • a 190 mL beverage is prepared by blending 3000 mg of the amino acid composition prepared in Example 1, an appropriate amount of sucrose, trehalose, acidulant, flavor, baking soda, thickener (pectin), and sweetener (stevia).
  • jelly type beverage containing ornithine, citrulline and arginine 1800 mg of the amino acid composition prepared in Example 1, erythritol, sucrose in an appropriate amount, gelling agent (thickening polysaccharide (including apple origin), citric acid, A 180 g jelly type beverage is produced by blending flavoring, calcium lactate, sodium citrate and sweeteners (sucralose, stevia).
  • a safe muscle enhancer or composition comprising specific amino acids and proteins as active ingredients is provided.

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Abstract

L'invention porte sur les éléments suivants : un médicament d'amélioration musculaire contenant, en tant que composant efficace, une composition d'acides aminés constituée par de l'ornithine ou un sel correspondant, de la citrulline ou un sel correspondant et de l'arginine ou un sel correspondant ; et une composition contenant une composition d'acides aminés constituée de 10 à 80 % en poids d'ornithine ou d'un sel correspondant, de 10 à 80 % en poids de citrulline ou d'un sel correspondant et de 10 à 80 % en poids d'arginine ou d'un sel correspondant et des protéines à un rapport pondéral de 1 à 20 fois par rapport à la composition d'acides aminés.
PCT/JP2015/057130 2014-03-11 2015-03-11 Médicament d'amélioration musculaire WO2015137387A1 (fr)

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Cited By (4)

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JP2018090504A (ja) * 2016-11-30 2018-06-14 株式会社東洋新薬 筋肉増強用組成物
WO2018181621A1 (fr) * 2017-03-28 2018-10-04 味の素株式会社 Composition d'aliment pour améliorer le milieu intraintestinal
WO2019022216A1 (fr) * 2017-07-28 2019-01-31 株式会社明治 Composition d'acides aminés destinée à l'amélioration de la force musculaire
JP2019507727A (ja) * 2016-01-13 2019-03-22 メタボリック・テクノロジーズ，インコーポレーテッド 関節安定性のためのβ−ヒドロキシ−β−メチルブチレート（ＨＭＢ）の組成物および使用方法

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JP2004256513A (ja) * 2003-02-04 2004-09-16 Ezaki Glico Co Ltd 筋肉量増加剤
JP2010506887A (ja) * 2006-10-17 2010-03-04 ユニヴェルシテ パリ デカルト 栄養不足状態の治療のためのシトルリンの使用
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WO2018181621A1 (fr) * 2017-03-28 2018-10-04 味の素株式会社 Composition d'aliment pour améliorer le milieu intraintestinal
WO2018181619A1 (fr) * 2017-03-28 2018-10-04 味の素株式会社 Aliment pour améliorer le milieu intraintestinal
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EP3603420A4 (fr) * 2017-03-28 2021-04-14 Ajinomoto Co., Inc. Aliment pour améliorer le milieu intraintestinal
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