JP2020152677A - Composition for inhibiting decrease in muscle mass - Google Patents
Composition for inhibiting decrease in muscle mass Download PDFInfo
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Images
Abstract
Description
本発明は筋肉量の低下抑制のための組成物に関する。 The present invention relates to a composition for suppressing a decrease in muscle mass.
我が国では高齢化が急速に進展しており、２０２５年の高齢化率（６５歳以上人口割合）は３０．０％、７５歳以上の人口割合は１８％となると予測されている。高齢期において自立した生活を営むためには、生活機能の低下を早期に発見し、予防、維持および向上にむけた介入を行うことが重要である。加齢に伴う身体組成の変化は、高齢者の生活機能の障害に深く関わっていることが知られている。とりわけ、加齢に伴う筋肉量の減少はサルコペニアと呼ばれ、疾病として注目されている。筋肉の減少は、一般的に７０歳までに２０歳代に比較すると骨格筋面積は２５〜３０％、筋力は３０〜４０％減少し、５０歳以降は毎年１〜２％程度が減少すると言われている。サルコペニアは、高齢者の「ふらつき」、「転倒」、さらには「フレイル」に密接に関連し、その先には要介護状態が待ち受けているとして問題となっている（非特許文献１）。また、ロコモティブシンドロームは、運動器の障害のため移動機能の低下をきたした状態で、進行すると介護の必要となるリスクが高まるものと定義され、その原因疾患にサルコぺニアがあるとされる（非特許文献２）。 In Japan, the aging of the population is progressing rapidly, and it is predicted that the aging rate (population ratio of people aged 65 and over) will be 30.0% and the population ratio of people aged 75 and over will be 18% in 2025. In order to lead an independent life in old age, it is important to detect the deterioration of living function at an early stage and to take interventions for prevention, maintenance and improvement. It is known that changes in body composition with aging are deeply involved in impaired living functions of the elderly. In particular, age-related loss of muscle mass is called sarcopenia and is drawing attention as a disease. It is said that muscle loss generally decreases by 25 to 30% in skeletal muscle area and 30 to 40% in muscle strength compared to those in their 20s by the age of 70, and decreases by about 1 to 2% every year after the age of 50. It has been. Sarcopenia is closely related to "staggering", "falling", and even "flail" in the elderly, and there is a problem that a state requiring long-term care awaits beyond that (Non-Patent Document 1). In addition, locomotive syndrome is defined as an increase in the risk of needing long-term care as it progresses in a state where locomotive function is impaired due to a disorder of the locomotive organ, and sarcopenia is said to be the causative disease (sarcopenia). Non-Patent Document 2).
本発明は、筋肉量の低下を抑制することができる新規素材およびそれを含む組成物を提供することを目的とする。 An object of the present invention is to provide a novel material capable of suppressing a decrease in muscle mass and a composition containing the same.
本発明者らは今般、老齢マウスでは、若齢マウスと比較して、筋肉量の低下が生じるところ、ＷＹペプチドを摂取させた老齢マウスでは、筋肉量の低下が抑制されることを見出した。本発明は、これらの知見に基づくものである。 The present inventors have recently found that an aged mouse causes a decrease in muscle mass as compared with a young mouse, whereas an aged mouse fed with the WY peptide suppresses the decrease in muscle mass. The present invention is based on these findings.
本発明によれば以下の発明が提供される。
［１］ＷＹのアミノ酸配列を有するペプチドまたはその薬学上許容される塩もしくは溶媒和物を有効成分として含んでなる、筋肉量の低下抑制用組成物および筋肉量の低下抑制剤。
［２］筋肉量の低下が、骨格筋において生ずるものである、上記［１］に記載の組成物および用剤。
［３］筋肉量の低下が、不十分な運動に起因するものである、上記［１］または［２］に記載の組成物および用剤。
［４］筋肉量の低下が、加齢に起因するものである、上記［１］〜［３］のいずれかに記載の組成物および用剤。
［５］運動療法を実施していない対象に摂取させるための、上記［１］〜［３］のいずれかに記載の組成物および用剤。
［６］中高年者に摂取させるための、上記［１］〜［５］のいずれかに記載の組成物および用剤。
［７］筋肉量の低下抑制により治療、予防または改善しうる疾患または症状の治療、予防または改善に用いるための、上記［１］〜［６］のいずれかに記載の組成物および用剤。
［８］前記疾患または症状が、サルコペニアまたはロコモティブシンドロームである、上記［７］に記載の組成物および用剤。
［９］ＷＹのアミノ酸配列を有するペプチドまたはその薬学上許容される塩もしくは溶媒和物を有効成分として含んでなる、筋肉量の低下抑制により治療、予防または改善しうる疾患または症状の治療、予防または改善用組成物および該疾患または症状の治療剤、予防剤および改善剤。
According to the present invention, the following inventions are provided.
[1] A composition for suppressing muscle loss and an agent for suppressing muscle mass loss, which comprises a peptide having the amino acid sequence of WY or a pharmaceutically acceptable salt or solvate thereof as an active ingredient.
[2] The composition and agent according to the above [1], wherein the decrease in muscle mass occurs in skeletal muscle.
[3] The composition and agent according to the above [1] or [2], wherein the decrease in muscle mass is due to insufficient exercise.
[4] The composition and agent according to any one of the above [1] to [3], wherein the decrease in muscle mass is due to aging.
[5] The composition and preparation according to any one of the above [1] to [3], which are to be ingested by a subject who has not undergone exercise therapy.
[6] The composition and preparation according to any one of the above [1] to [5] for ingestion by middle-aged and elderly people.
[7] The composition and agent according to any one of the above [1] to [6], which is used for treating, preventing or ameliorating a disease or symptom that can be treated, prevented or ameliorated by suppressing the decrease in muscle mass.
[8] The composition and agent according to the above [7], wherein the disease or symptom is sarcopenia or locomotive syndrome.
[9] Treatment and prevention of diseases or symptoms that can be treated, prevented or ameliorated by suppressing the loss of muscle mass, which comprises a peptide having the amino acid sequence of WY or a pharmaceutically acceptable salt or solvent product thereof as an active ingredient. Alternatively, an improving composition and a therapeutic, prophylactic and improving agent for the disease or symptom.
上記［１］と上記［９］の組成物を本明細書において「本発明の組成物」と、上記［１］と上記［９］の用剤を本明細書において「本発明の用剤」と、それぞれいうことがある。 The composition of the above [1] and the above [9] is referred to as "the composition of the present invention" in the present specification, and the above-mentioned [1] and the above-mentioned [9] are referred to as "the preparation of the present invention" in the present specification. There are things to say.
本発明の組成物および用剤が有効成分とするジペプチド：ＷＹは、筋肉量の低下を抑制する機能を発揮する機能性素材として利用できるとともに、ヒトを含む哺乳類に安全な機能性素材として利用できる点で有利である。 The dipeptide contained in the composition and preparation of the present invention: WY can be used as a functional material that exerts a function of suppressing a decrease in muscle mass, and can be used as a functional material that is safe for mammals including humans. It is advantageous in that.
本発明の組成物および用剤は、ＷＹのアミノ酸配列を有するペプチド（以下、「本発明のペプチド」ということがある）を有効成分として含有してなるものである。ここで、「アミノ酸配列を有するペプチド」とは、該アミノ酸配列により配列が特定されたペプチドを意味する。 The composition and preparation of the present invention contain a peptide having an amino acid sequence of WY (hereinafter, may be referred to as "peptide of the present invention") as an active ingredient. Here, the "peptide having an amino acid sequence" means a peptide whose sequence is specified by the amino acid sequence.
本発明のペプチドは、化学合成によって得られたものを用いてもよく、乳、大豆、小麦、卵、畜肉、魚肉、魚介などに由来するタンパク質やポリペプチド原料等から化学的もしくは酵素的に分解して得られたものを用いてもよい。具体的には、例えば、本発明のペプチドの配列は、少なくとも、乳のホエイやカゼイン、牛血清アルブミン（ＢＳＡ）、大豆のグリシニン、小麦のグルテニン、卵黄のリボビテリン、卵白のオボアルブミン、オボトランスフェリン、リゾチウム、チキン蛋白のコラーゲンなどに含まれているから、これら食品もしくは食品素材を酸加水分解やプロテアーゼによる酵素処理または微生物発酵等に供して、上記ペプチドを生成させることができる。本発明の組成物および用剤としては上記食品もしくは食品素材の調製物をそのまま用いてもよいし、濃縮物として、あるいはスプレードライや凍結乾燥等により乾燥粉末として用いてもよい。また、必要に応じて不純物、塩、酵素等の除去など、任意の程度の精製を施して用いてもよい。 The peptide of the present invention may be obtained by chemical synthesis, and is chemically or enzymatically decomposed from a protein derived from milk, soybean, wheat, egg, livestock meat, fish meat, seafood, etc., a polypeptide raw material, or the like. You may use the obtained product. Specifically, for example, the sequences of the peptides of the invention include at least milk whey and casein, bovine serum albumin (BSA), soybean glycinin, wheat glutenin, egg yolk riboviterin, egg white ovalbumin, ovotransferase, Since it is contained in lysodium, collagen of chicken protein, etc., these foods or food materials can be subjected to acid hydrolysis, enzymatic treatment with protease, microbial fermentation, or the like to produce the above peptides. As the composition and the preparation of the present invention, the above-mentioned food or food material preparation may be used as it is, or may be used as a concentrate, or as a dry powder by spray-drying or freeze-drying. Further, if necessary, it may be used after being purified to any degree such as removal of impurities, salts, enzymes and the like.
本発明のペプチドを構成するアミノ酸は、Ｌ型のアミノ酸のみから構成されていてもよいし、Ｄ型のアミノ酸のみから構成されていてもよいし、あるいは両者が混在したペプチドのいずれであってもよい。また、天然に存在するアミノ酸のみから構成されていてもよいし、アミノ酸にリン酸化やグリコシル化等、任意の官能基が結合した修飾アミノ酸のみから構成されていてもよいし、あるいは両者が混在したペプチドのいずれであってもよい。また、ペプチドが２以上の不斉炭素を含む場合には、エナンチオマー、ジアステレオマー、あるいは両者が混在したペプチドのいずれであってもよい。 The amino acids constituting the peptide of the present invention may be composed of only L-type amino acids, may be composed of only D-type amino acids, or may be a peptide in which both are mixed. Good. Further, it may be composed of only naturally occurring amino acids, may be composed of only modified amino acids in which arbitrary functional groups such as phosphorylation and glycosylation are bonded to amino acids, or both may be mixed. It may be any of the peptides. When the peptide contains two or more asymmetric carbons, it may be an enantiomer, a diastereomer, or a peptide in which both are mixed.
さらに、本発明のペプチドは、遊離塩の形態であっても、その薬学上許容される塩または溶媒和物の形態であってもよく、本発明の組成物および用剤はこれらのいずれか、あるいはこれら全部または一部の混合物を含むものである。薬学上許容される塩としては酸付加塩、金属塩、アンモニウム塩および有機アミン付加塩が挙げられる。薬学上許容される酸付加塩としては、塩酸塩、硫酸塩、リン酸塩等の無機酸塩、酢酸塩、マレイン酸塩、フマル酸塩、クエン酸塩、メタンスルホン酸塩等の有機酸塩等が挙げられる。また、薬学上許容される金属塩としては、ナトリウム塩、カリウム塩等のアルカリ金属塩、マグネシウム塩、カルシウム塩等のアルカリ土類金属塩、アルミニウム塩、亜鉛塩等が挙げられる。また、薬学上許容されるアンモニウム塩としては、アンモニウム、テトラメチルアンモニウム等の塩が挙げられる。また、薬学上許容される有機アミン付加塩としては、モルホリン、ピペリジン等の付加塩が挙げられる。 Furthermore, the peptides of the invention may be in the form of free salts or in the form of pharmaceutically acceptable salts or solvates thereof, and the compositions and solvates of the invention are any of these. Alternatively, it may contain a mixture of all or a part of these. Pharmaceutically acceptable salts include acid addition salts, metal salts, ammonium salts and organic amine addition salts. Pharmaceutically acceptable acid addition salts include inorganic acid salts such as hydrochlorides, sulfates and phosphates, and organic acid salts such as acetates, maleates, fumarates, citrates and methanesulfonates. And so on. Examples of pharmaceutically acceptable metal salts include alkali metal salts such as sodium salt and potassium salt, alkaline earth metal salts such as magnesium salt and calcium salt, aluminum salts and zinc salts. Examples of the pharmaceutically acceptable ammonium salt include salts of ammonium, tetramethylammonium and the like. Examples of the pharmaceutically acceptable organic amine addition salt include addition salts such as morpholine and piperidine.
本発明の組成物および用剤は、本発明のペプチド単独で、あるいは本発明のペプチドを含む素材（例えば、食品原料）として提供することができる。本発明の組成物および用剤はまた、本発明のペプチドまたは本発明のペプチドを含む素材と、他の成分（例えば、食品原料、食品添加物、製剤添加物）とを混合して提供することもできる。本発明の組成物および用剤における本発明のペプチドの含有量は、その目的、用途、形態、剤型、症状、体重等に応じて任意に定めることができ、本発明はこれに限定されないが、その含有量としては、全体量に対して、０．００００１〜５０質量％（固形分換算）の割合で含有させることができ、さらに好ましくは０．０００１〜１０質量％（固形分換算）の割合で含有させることができる。本発明においては、本発明の用剤を本発明のペプチドからなるものとし、本発明の組成物を本発明のペプチドと他の成分とを含んでなるものとすることができる。 The composition and preparation of the present invention can be provided alone or as a material containing the peptide of the present invention (for example, a food raw material). The compositions and preparations of the present invention are also provided by mixing the peptide of the present invention or a material containing the peptide of the present invention with other components (for example, food raw materials, food additives, preparation additives). You can also. The content of the peptide of the present invention in the composition and the preparation of the present invention can be arbitrarily determined according to the purpose, use, form, dosage form, symptom, body weight, etc., and the present invention is not limited thereto. As the content thereof, it can be contained at a ratio of 0.00001 to 50% by mass (solid content equivalent) with respect to the total amount, and more preferably 0.0001 to 10% by mass (solid content equivalent). It can be contained in proportion. In the present invention, the agent of the present invention may consist of the peptide of the present invention, and the composition of the present invention may contain the peptide of the present invention and other components.
本発明のペプチドの含有量の測定は、液体クロマトグラフィータンデム質量分析法（ＬＣ／ＭＳ／ＭＳ）により実施することができる。当業者であればその条件設定は容易に行うことができ、測定の際に標準ペプチドとしてＬＣ／ＭＳ／ＭＳ測定用の純度のものを使用することはいうまでもないが、例えば、ＳＩＧＭＡ ＡＬＤＲＩＣＨ社製ＡＱＵＡペプチドを使用することができる。 The peptide content of the present invention can be measured by liquid chromatography tandem mass spectrometry (LC / MS / MS). Those skilled in the art can easily set the conditions, and it goes without saying that a standard peptide having a purity for LC / MS / MS measurement is used for the measurement. For example, SIGMA ALDRICH AQUA peptide manufactured by AQUA Peptide can be used.
本発明のペプチドを含む食品素材としては、タンパク質の酵素分解物が挙げられ、好ましくはホエイタンパク質の酵素分解物（以下、「ホエイ分解物」ということがある）である。本発明のペプチドが含まれるホエイ分解物の製造方法は公知であり、例えば、国際公開公報第２０１７／０８６３０３号の記載に従って製造することができる。あるいは、本発明のペプチドを含有する市販のホエイ酵素分解物を用いてもよく、例えば、ＬＥ８０ＧＦ−ＵＳ（ＤＭＶ社製）を本発明のペプチドとして用いてもよい。 Examples of the food material containing the peptide of the present invention include an enzymatic decomposition product of a protein, and an enzymatic decomposition product of a whey protein (hereinafter, may be referred to as a “whey decomposition product”). A method for producing a whey decomposition product containing the peptide of the present invention is known, and for example, it can be produced according to the description of International Publication No. 2017/086303. Alternatively, a commercially available whey enzymatic decomposition product containing the peptide of the present invention may be used, and for example, LE80GF-US (manufactured by DMV) may be used as the peptide of the present invention.
本発明のペプチドをホエイタンパク質分解物として本発明の組成物および用剤に含有させる場合、本発明のペプチドをホエイタンパク質分解物に対して、０．００１〜１０質量％（固形分換算）の割合で含有させることができ、さらに好ましくは０．０１〜５質量％（固形分換算）の割合で含有させることができる。また、本発明の組成物および用剤に対して、ホエイタンパク質分解物は、０．００１〜９５質量％（固形分換算）の割合で含有させることができ、好ましくは０．０１〜５０質量％（固形分換算）の割合で含有させることができる。 When the peptide of the present invention is contained as a whey proteolytic product in the composition and preparation of the present invention, the ratio of the peptide of the present invention to the whey proteolytic product is 0.001 to 10% by mass (in terms of solid content). It can be contained in a proportion of 0.01 to 5% by mass (in terms of solid content), more preferably 0.01 to 5% by mass. Further, the whey proteolytic product can be contained in a proportion of 0.001 to 95% by mass (in terms of solid content) with respect to the composition and the preparation of the present invention, preferably 0.01 to 50% by mass. It can be contained in a ratio (in terms of solid content).
後記実施例に示されるように、本発明のペプチドは、筋肉量の低下抑制作用を有する。従って、本発明のペプチドは筋肉量の低下抑制に用いるための組成物および筋肉量の低下抑制剤の有効成分として使用することができる。本発明において筋肉量の低下は、横紋筋（特に骨格筋）において生ずるものとすることができ、好ましくは遅筋（より好ましくはヒラメ筋）において生ずるものとすることができる。 As shown in Examples below, the peptides of the present invention have an inhibitory effect on muscle mass loss. Therefore, the peptide of the present invention can be used as an active ingredient of a composition for use in suppressing muscle loss and an agent for suppressing muscle loss. In the present invention, the decrease in muscle mass can occur in the striated muscle (particularly skeletal muscle), preferably in the slow muscle (more preferably in the soleus muscle).
本発明において筋肉量の測定は、特に限定されるものではなく、例えば、コンピュータ断層撮影（ＣＴスキャン）、磁気共鳴画像法（ＭＲＩ）、二重エネルギーＸ線吸収測定法（ＤＸＡ）、生体インピーダンス解析（ＢＩＡ）法、体内総カリウム量測定／部位別カリウム量測定（ＴＢＫ／ＰＢＫ）等を用いて行うことができる。また、ＳＭＩ推定式を用いて推定してもよい。なお、筋肉量は四肢の筋肉量の合計である骨格筋量（ＡＬＭ）やそれを身長の２乗で除した値（骨格筋量指数）で評価することができる。 In the present invention, the measurement of muscle mass is not particularly limited, and for example, computed tomography (CT scan), magnetic resonance imaging (MRI), dual energy X-ray absorption measurement method (DXA), bioimpedance analysis. It can be carried out by using the (BIA) method, total body potassium amount measurement / site-specific potassium amount measurement (TBK / PBK), or the like. Moreover, you may estimate using the SMI estimation formula. The muscle mass can be evaluated by the skeletal muscle mass (ALM), which is the total muscle mass of the limbs, or the value obtained by dividing it by the square of the height (skeletal muscle mass index).
後記実施例に示されるように、本発明のペプチドは、老齢モデルマウスにおいて筋肉量の低下抑制作用を有するところ、加齢に伴って筋肉量が低下することが知られている（非特許文献１）。従って本発明の組成物および用剤は、好ましくは中高年者（例えば、４５歳以上の者、５５歳以上の者、６５以上の者）に摂取させるためのものとすることができる。 As shown in Examples below, it is known that the peptide of the present invention has an effect of suppressing the decrease in muscle mass in an old model mouse, and the muscle mass decreases with aging (Non-Patent Document 1). ). Therefore, the compositions and preparations of the present invention can preferably be ingested by middle-aged and elderly people (for example, persons aged 45 and over, persons aged 55 and over, persons aged 65 and over).
後記実施例に示されるように、本発明のペプチドは、摂取対象に強制的に運動させない状況下において、筋肉量（特に骨格筋重量）の低下を抑制することができる。従って、本発明において筋肉量の低下は、不十分な運動に起因するものとすることができる。また本発明の組成物および用剤は、運動療法を実施していない対象に摂取させるためのものとすることができる。 As shown in Examples below, the peptide of the present invention can suppress a decrease in muscle mass (particularly skeletal muscle weight) in a situation where the ingested subject is not forcibly exercised. Therefore, in the present invention, the loss of muscle mass can be attributed to inadequate exercise. In addition, the compositions and preparations of the present invention can be ingested by subjects who have not undergone exercise therapy.
後記実施例に示されるように、本発明のペプチドは、老齢マウスの筋肉量（特に骨格筋重量）の低下を抑制することができる。従って、本発明の組成物および用剤は、筋肉量の低下抑制により治療、予防または改善しうる疾患または症状の治療、予防または改善に用いるためのものとすることができる。 As shown in Examples below, the peptides of the present invention can suppress a decrease in muscle mass (particularly skeletal muscle weight) in aged mice. Therefore, the compositions and preparations of the present invention can be used for the treatment, prevention or amelioration of diseases or symptoms that can be treated, prevented or ameliorated by suppressing the loss of muscle mass.
ここで、サルコペニアは骨格筋量の低下を必然的に伴い、それ以外に筋力低下や身体能力の低下も伴うとされているところ、その要因としては、複数の因子が提案され、多因子により複合的な要因が重なり合って誘発されると考えられ、加齢はサルコペニアの要因の一つと考えられている（非特許文献１）。また、ロコモティブシンドロームは加齢による筋力低下や疾患による運動器の機能低下を伴う疾患として知られている（非特許文献２）。従って、筋肉量の低下抑制により治療、予防または改善しうる疾患または症状の治療、予防または改善としてはサルコペニアおよびロコモティブシンドロームが挙げられる。 Here, it is said that sarcopenia is inevitably accompanied by a decrease in skeletal muscle mass, and is also accompanied by a decrease in muscle strength and physical ability. As the factors, multiple factors have been proposed, and multiple factors are combined. It is considered that the factors are overlapped and induced, and aging is considered to be one of the factors of sarcopenia (Non-Patent Document 1). Locomotive syndrome is known as a disease associated with age-related muscle weakness and musculoskeletal function deterioration due to the disease (Non-Patent Document 2). Therefore, treatment, prevention or amelioration of diseases or symptoms that can be treated, prevented or ameliorated by suppressing muscle loss includes sarcopenia and locomotive syndrome.
本発明の組成物および用剤は、医薬品（例えば、医薬組成物）、医薬部外品、食品（例えば、食品組成物）、飼料（ペットフード含む）等の形態で提供することができ、下記の記載に従って実施することができる。 The compositions and preparations of the present invention can be provided in the form of pharmaceuticals (for example, pharmaceutical compositions), quasi-drugs, foods (for example, food compositions), feeds (including pet food), etc. It can be carried out according to the description of.
本発明のペプチドは、ヒトおよび非ヒト動物に経口投与することができる。経口剤としては、顆粒剤、散剤、錠剤（糖衣錠を含む）、丸剤、カプセル剤、シロップ剤、乳剤、懸濁剤が挙げられる。これらの製剤は、当分野で通常行われている手法により、薬学上許容される担体を用いて製剤化することができる。薬学上許容される担体としては、賦形剤、結合剤、希釈剤、添加剤、香料、緩衝剤、増粘剤、着色剤、安定剤、乳化剤、分散剤、懸濁化剤、防腐剤等が挙げられる。 The peptides of the invention can be orally administered to humans and non-human animals. Examples of oral preparations include granules, powders, tablets (including sugar-coated tablets), pills, capsules, syrups, emulsions, and suspensions. These formulations can be formulated using pharmaceutically acceptable carriers by methods commonly practiced in the art. Pharmaceutically acceptable carriers include excipients, binders, diluents, additives, fragrances, buffers, thickeners, colorants, stabilizers, emulsifiers, dispersants, suspending agents, preservatives, etc. Can be mentioned.
本発明のペプチドを食品として提供する場合には、それをそのまま食品として提供することができ、あるいはそれを食品に含有させて提供することができる。例えば、本発明のペプチドを食品として提供する場合には、本発明のペプチドを含有する、ホエイ分解物等のタンパク質の酵素分解物等を、そのまま食品として提供することができ、あるいはそれを食品に含有させて提供することができる。このようにして提供された食品は本発明のペプチドを有効量含有した食品である。本明細書において、本発明のペプチドを「有効量含有した」とは、個々の食品において通常喫食される量を摂取した場合に後述するような範囲で本発明のペプチドが摂取されるような含有量をいう。また「食品」とは、健康食品、機能性食品、栄養補助食品、保健機能食品（例えば、特定保健用食品、栄養機能食品、機能性表示食品）、特別用途食品（例えば、幼児用食品、妊産婦用食品、病者用食品）およびサプリメントを含む意味で用いられる。なお、本発明のペプチドをヒト以外の動物に摂取させる場合には、本発明でいう食品が飼料として使用されることはいうまでもない。 When the peptide of the present invention is provided as a food, it can be provided as it is as a food, or it can be provided by being contained in the food. For example, when the peptide of the present invention is provided as a food, an enzymatically decomposed product of a protein such as a whey decomposition product containing the peptide of the present invention can be provided as it is as a food, or it can be provided as a food. It can be contained and provided. The food provided in this manner is a food containing an effective amount of the peptide of the present invention. In the present specification, "containing an effective amount" of the peptide of the present invention means that the peptide of the present invention is ingested in the range described later when the amount normally eaten in each food is ingested. The amount. "Foods" are health foods, functional foods, nutritional supplements, health functional foods (for example, foods for specified health use, nutritional functional foods, foods with functional claims), special purpose foods (for example, infant foods, pregnant women). It is used to include foods for food, foods for the sick) and supplements. Needless to say, when the peptide of the present invention is ingested by an animal other than human, the food of the present invention is used as feed.
本発明のペプチドは、上記のような筋肉量の低下抑制効果を有するため、日常摂取する食品に含有させることができ、あるいは、サプリメントとして提供することができる。すなわち、本発明の組成物および用剤は食品の形態で提供することができる。この場合、本発明の組成物および用剤は１食当たりに摂取する量が予め定められた単位包装形態で提供することができる。１食当たりの単位包装形態としては、例えば、パック、包装、缶、ボトル等で一定量を規定する形態が挙げられる。本発明の組成物および用剤の各種作用をよりよく発揮させるためには、後述する、本発明のペプチドの１回当たりの摂取量に従って１食当たりの摂取量を決定できる。本発明の食品は、摂取量に関する説明事項が包装に表示されるか、あるいは説明事項が記載された文書等と一緒に提供されてもよい。 Since the peptide of the present invention has the above-mentioned effect of suppressing the decrease in muscle mass, it can be contained in daily foods or can be provided as a supplement. That is, the composition and preparation of the present invention can be provided in the form of food. In this case, the composition and the preparation of the present invention can be provided in a unit packaging form in which the amount to be ingested per meal is predetermined. Examples of the unit packaging form per meal include a form in which a fixed amount is specified for packs, packages, cans, bottles, and the like. In order to better exert various actions of the composition and the preparation of the present invention, the intake amount per meal can be determined according to the intake amount of the peptide of the present invention described later. The food product of the present invention may be provided with an explanation regarding the amount of intake displayed on the package or together with a document or the like containing the explanation.
単位包装形態においてあらかじめ定められた１食当たりの摂取量は、１日当たりの有効摂取量であっても、１日当たりの有効摂取量を２回またはそれ以上（好ましくは２または３回）に分けた摂取量であってもよい。従って、本発明の組成物および用剤の単位包装形態には、後述のヒト１日当たりの摂取量で本発明のペプチドを含有させることができ、あるいは、後述のヒト１日当たりの摂取量の２分の１から６分の１の量で本発明のペプチドを含有させることができる。本発明の組成物および用剤は、摂取の便宜上、１食当たりの摂取量が１日当たりの有効摂取量である、「１食当たりの単位包装形態」で提供することが好ましい。 The predetermined intake per meal in the unit packaging form is the effective intake per day divided into two or more times (preferably two or three times). It may be the amount of intake. Therefore, the unit packaging form of the composition and the preparation of the present invention can contain the peptide of the present invention at the daily intake of humans described below, or 2 minutes of the daily intake of humans described below. The peptide of the present invention can be contained in an amount of 1 to 1/6 of that of the above. For convenience of ingestion, the compositions and preparations of the present invention are preferably provided in a "unit packaging form per meal" in which the intake per meal is the effective intake per day.
「食品」の形態は特に限定されるものではなく、例えば、飲料の形態であっても、半液体やゲル状の形態であっても、固形体や粉末状の形態であってもよい。また、「サプリメント」としては、本発明のペプチドに賦形剤、結合剤等を加え練り合わせた後に打錠することにより製造された錠剤や、カプセル等に封入されたカプセル剤が挙げられる。 The form of the "food" is not particularly limited, and may be, for example, a beverage form, a semi-liquid or gel form, or a solid form or a powder form. In addition, examples of the "supplement" include tablets produced by adding excipients, binders and the like to the peptides of the present invention, kneading them, and then tableting them, and capsules encapsulated in capsules and the like.
本発明で提供される食品は、本発明のペプチドを含有する限り、特に限定されるものではないが、例えば、清涼飲料水、炭酸飲料、果汁入り飲料、野菜汁入り飲料、果汁および野菜汁入り飲料、牛乳等の畜乳、豆乳、乳飲料、ドリンクタイプのヨーグルト、ドリンクタイプやスティックタイプのゼリー、コーヒー、ココア、茶飲料、栄養ドリンク、エナジー飲料、スポーツドリンク、ミネラルウォーター、ニア・ウォーター、ノンアルコールのビールテイスト飲料等の非アルコール飲料；飯類、麺類、パン類およびパスタ類等炭水化物含有飲食品；チーズ類、ハードタイプまたはソフトタイプのヨーグルト、畜乳その他の油脂原料による生クリーム、アイスクリーム等の乳製品；クッキー、ケーキ、チョコレート等の洋菓子類、饅頭や羊羹等の和菓子類、ラムネ等のタブレット菓子（清涼菓子）、キャンディー類、ガム類、ゼリーやプリン等の冷菓や氷菓、スナック菓子等の各種菓子類；ウイスキー、バーボン、スピリッツ、リキュール、ワイン、果実酒、日本酒、中国酒、焼酎、ビール、アルコール度数１％以下のノンアルコールビール、発泡酒、その他雑酒、酎ハイ等のアルコール飲料；卵を用いた加工品、魚介類や畜肉（レバー等の臓物を含む）の加工品（珍味を含む）、味噌汁等のスープ類等の加工食品、みそ、しょうゆ、ふりかけ、その他シーズニング調味料等の調味料、濃厚流動食等の流動食等を例示することができる。なお、ミネラルウォーターは、発泡性および非発泡性のミネラルウォーターのいずれもが包含される。また、本発明で提供される食品には、食品製造原料および食品添加物のいずれもが含まれる。 The food provided in the present invention is not particularly limited as long as it contains the peptide of the present invention, and is, for example, a soft drink, a carbonated beverage, a beverage containing fruit juice, a beverage containing vegetable juice, a beverage containing fruit juice and vegetable juice. Beverages, milk and other livestock milk, soy milk, milk beverages, drink-type yogurt, drink-type and stick-type jelly, coffee, cocoa, tea beverages, nutritional drinks, energy beverages, sports drinks, mineral water, near water, non- Non-alcoholic beverages such as alcoholic beer-taste beverages; carbohydrate-containing foods and drinks such as rice, noodles, breads and pasta; cheeses, hard or soft yogurt, fresh cream from livestock milk and other fats and oils, ice cream Dairy products such as cookie, cake, Western confectionery such as chocolate, Japanese confectionery such as bun and sheep, tablet confectionery such as ramune (cool confectionery), candy, gum, cold confectionery such as jelly and pudding, ice confectionery, snack confectionery, etc. Various confectionery; whiskey, bourbon, spirits, liqueur, wine, fruit liquor, Japanese liquor, Chinese liquor, shochu, beer, non-alcoholic beer with alcohol content of 1% or less, sparkling liquor, other miscellaneous liquor, alcoholic beverages such as liquor high Processed products using eggs, processed products of seafood and livestock meat (including guts such as liver) (including delicacies), processed foods such as soups such as miso soup, miso, soy sauce, sprinkles, other seasoning seasonings, etc. Examples of liquid foods such as seasonings and concentrated liquid foods can be used. The mineral water includes both effervescent and non-effervescent mineral water. In addition, the food provided in the present invention includes both food manufacturing raw materials and food additives.
茶飲料としては、発酵茶、半発酵茶および不発酵茶のいずれもが包含され、例えば、紅茶、緑茶、麦茶、玄米茶、煎茶、玉露茶、ほうじ茶、ウーロン茶、ウコン茶、プーアル茶、ルイボスティー、ローズ茶、キク茶、イチョウ葉茶、ハーブ茶（例えば、ミント茶、ジャスミン茶）が挙げられる。 Tea beverages include fermented tea, semi-fermented tea and non-fermented tea, for example, tea, green tea, barley tea, brown rice tea, roasted tea, tamaro tea, roasted tea, oolong tea, corn tea, puer tea, and louis bostee. , Rose tea, Kiku tea, Ginkgo biloba tea, Herb tea (eg, mint tea, jasmine tea).
果汁入り飲料や果汁および野菜汁入り飲料に用いられる果物としては、例えば、リンゴ、ミカン、ブドウ、バナナ、ナシ、モモ、マンゴー、アサイー、ブルーベリーおよびウメが挙げられる。また、野菜汁入り飲料や果汁および野菜汁入り飲料に用いられる野菜としては、例えば、トマト、ニンジン、セロリ、カボチャ、キュウリおよびスイカが挙げられる。 Fruits used in beverages containing fruit juice and beverages containing fruit juice and vegetable juice include, for example, apples, oranges, grapes, bananas, pears, peaches, mangoes, acai, blueberries and ume. Examples of vegetables used in beverages containing vegetable juice and beverages containing fruit juice and vegetable juice include tomatoes, carrots, celery, pumpkins, cucumbers and watermelons.
本発明のペプチドの摂取量は、受容者の性別、年齢および体重、症状、摂取時間、剤形、摂取経路並びに組み合わせる薬剤等に依存して決定できる。筋肉量の低下抑制を目的とした本発明のペプチドの成人１日当たりの摂取量（乾燥質量換算）は、例えば、０．００１〜１００００ｍｇ（好ましくは１〜１０００ｍｇ）である。上記の本発明のペプチドの摂取量および下記摂取タイミングおよび摂取期間は、本発明のペプチドを非治療目的および治療目的のいずれで使用する場合にも適用があり、治療目的の場合には摂取は投与に読み替えることができる。なお、本発明のペプチドはヒト以外の哺乳動物（例えば、マウス、ラット、ウサギ、イヌ、ネコ、ウシ、ウマ、ブタ、サル、イルカ、アシカ等）に対しても摂取させることができ、摂取量、摂取タイミングおよび摂取期間はヒトに関する記載を参考にして決定することができる。 The intake amount of the peptide of the present invention can be determined depending on the sex, age and weight of the recipient, symptoms, intake time, dosage form, intake route, drugs to be combined, and the like. The daily intake (dry mass equivalent) of the peptide of the present invention for the purpose of suppressing the decrease in muscle mass is, for example, 0.001 to 10000 mg (preferably 1 to 1000 mg). The above-mentioned intake amount of the peptide of the present invention and the following intake timing and intake period are applicable when the peptide of the present invention is used for both non-therapeutic purpose and therapeutic purpose, and in the case of therapeutic purpose, the intake is administered. Can be read as. The peptide of the present invention can also be ingested by mammals other than humans (for example, mice, rats, rabbits, dogs, cats, cows, horses, pigs, monkeys, dolphins, sea lions, etc.). , Ingestion timing and ingestion period can be determined with reference to the description regarding humans.
本発明のペプチドの摂取期間は、上記１日量での摂取を少なくとも３日間（好ましくは１週間または２週間、より好ましくは１か月間、３か月間または５か月間）とすることができる。本発明のペプチドの摂取間隔は、上記１日量での摂取を３日に１回、２日に１回または１日１回とすることができる。 The ingestion period of the peptide of the present invention can be at least 3 days (preferably 1 week or 2 weeks, more preferably 1 month, 3 months or 5 months) in the above daily dose. The ingestion interval of the peptide of the present invention can be such that the daily intake is once every three days, once every two days, or once a day.
本発明の組成物および用剤並びに食品には、筋肉量の低下抑制効果を有する旨の表示が付されてもよい。この場合、消費者に理解しやすい表示とするため本発明の組成物および用剤並びに食品には以下の一部または全部の表示が付されてもよい。なお、本発明において「筋肉量の低下抑制」が以下の表示を含む意味で用いられることはいうまでもない。
・筋肉の減少が気になる方に
・筋肉のアンチエージングのために
・筋肉の衰えが気になる方に
・加齢によるふらつき、転倒、つまずきが気になる方に
・加齢によるフレイルが気になる方に
・筋力の衰えで疲れを感じやすい方へ
・筋力の衰えで長時間の歩行が難しくなってきた方
・筋力低下でふらつき、転倒、つまずきが増えた方へ
・踏み出す力が衰えてきた方へ
・歩行能力が気になる方へ
The composition, the preparation, and the food of the present invention may be labeled to have an effect of suppressing the decrease in muscle mass. In this case, the compositions, preparations and foods of the present invention may be labeled in part or in whole as follows in order to make the labeling easy for consumers to understand. Needless to say, in the present invention, "suppression of decrease in muscle mass" is used to include the following indications.
・ For those who are worried about muscle loss ・ For muscle anti-aging ・ For those who are worried about muscle weakness ・ For those who are worried about wobbling, falling, and tripping due to aging ・ Frail due to aging・ For those who tend to feel tired due to weakness ・ For those who have difficulty walking for a long time due to weakness ・ For those who stagger, fall, or trip over due to weakness ・ The ability to step on is weakening For those who are concerned about walking ability
本発明の別の面によれば、有効量の本発明のペプチドまたはその薬学上許容される塩もしくは溶媒和物あるいはそれを含む組成物を、それを必要としている対象に摂取させるか、あるいは投与することを含んでなる、筋肉量の低下抑制方法が提供される。本発明によればまた、有効量の本発明のペプチドまたはその薬学上許容される塩もしくは溶媒和物あるいはそれを含む組成物を、それを必要としている対象に摂取させるか、あるいは投与することを含んでなる、サルコペニアの治療、予防または改善方法が提供される。本発明の方法は、本発明の組成物および用剤に関する記載に従って実施することができる。 According to another aspect of the invention, an effective amount of the peptide of the invention or a pharmaceutically acceptable salt or solvate thereof or a composition containing the same is ingested or administered to a subject in need thereof. A method of suppressing the loss of muscle mass, which comprises doing so, is provided. According to the present invention, an effective amount of the peptide of the present invention or a pharmaceutically acceptable salt or solvate thereof or a composition containing the same is ingested or administered to a subject in need thereof. A method of treating, preventing or ameliorating sarcopenia, which comprises, is provided. The method of the present invention can be carried out in accordance with the description regarding the composition and the preparation of the present invention.
本発明のさらに別の面によれば、筋肉量の低下抑制剤の製造のための、筋肉量の低下抑制剤としての、あるいは本発明の筋肉量の低下抑制方法における、本発明のペプチドまたはその薬学上許容される塩もしくは溶媒和物の使用が提供される。本発明によればまた、サルコペニアの治療、予防または改善剤の製造のための、サルコペニアの治療、予防または改善剤としての、あるいは本発明の治療、予防または改善方法における、本発明のペプチドまたはその薬学上許容される塩もしくは溶媒和物の使用が提供される。本発明の使用は、本発明の組成物および用剤に関する記載に従って実施することができる。 According to yet another aspect of the present invention, the peptide of the present invention or a peptide thereof for producing a muscle mass loss inhibitor, as a muscle mass loss inhibitor, or in the muscle mass loss inhibitory method of the present invention. The use of pharmaceutically acceptable salts or solvates is provided. According to the present invention, the peptide of the present invention or a peptide thereof for the treatment, prevention or improvement of sarcopenia, as a treatment, prevention or ameliorating agent for sarcopenia, or in the treatment, prevention or improvement method of the present invention. The use of sarcopenic salts or solvates is provided. The use of the present invention can be carried out in accordance with the description regarding the compositions and agents of the present invention.
本発明のさらにまた別の面によれば、筋肉量の低下抑制に用いるためのＷＹのアミノ酸配列を有するペプチドまたはその薬学上許容される塩もしくは溶媒和物が提供される。本発明によればまた、サルコペニアの治療、予防または改善に用いるためのＷＹのアミノ酸配列を有するペプチドまたはその薬学上許容される塩もしくは溶媒和物が提供される。上記のＷＹのアミノ酸配列を有するペプチド並びにその薬学上許容される塩および溶媒和物は、本発明の組成物および用剤に関する記載に従って実施することができる。 According to yet another aspect of the present invention, there is provided a peptide having the amino acid sequence of WY or a pharmaceutically acceptable salt or solvate thereof for use in suppressing the loss of muscle mass. The present invention also provides peptides having the amino acid sequence of WY or pharmaceutically acceptable salts or solvates thereof for use in the treatment, prevention or amelioration of sarcopenia. The peptides having the amino acid sequence of WY and the pharmaceutically acceptable salts and solvates thereof can be carried out according to the description regarding the compositions and solvates of the present invention.
本発明の方法および本発明の使用はヒトを含む哺乳動物における使用であってもよく、治療的使用と非治療的使用のいずれもが意図される。本明細書において、「非治療的」とはヒトを手術、治療または診断する行為（すなわち、ヒトに対する医療行為）を含まないことを意味し、具体的には、医師または医師の指示を受けた者がヒトに対して手術、治療または診断を行う方法を含まないことを意味する。 The methods of the invention and the use of the invention may be in mammals, including humans, and are intended for both therapeutic and non-therapeutic use. As used herein, "non-therapeutic" means does not include the act of operating, treating or diagnosing a human (ie, medical practice for a human), specifically under the direction of a physician or physician. It means that a person does not include a method of performing surgery, treatment or diagnosis on a human.
以下の例に基づき本発明をより具体的に説明するが、本発明はこれらの例に限定されるものではない。 The present invention will be described in more detail based on the following examples, but the present invention is not limited to these examples.
例１：加齢による筋肉減少に対するＷＹペプチドの抑制効果
（１）試験の概要
老齢マウスについて、被験食品摂取群と非摂取群の筋肉量を比較検討した。また、若齢マウスの被験食品非摂取群と比較検討した。被験食品として、ＷＹペプチドを用いた。
Example 1: Suppressive effect of WY peptide on muscle loss due to aging (1) Outline of the test For aged mice, the muscle mass of the test food intake group and the non-intake group was compared and examined. In addition, we compared it with the test food non-ingestion group of young mice. WY peptide was used as a test food.
（２）マウス
Ｃ５７ＢＬ／６Ｊ雄マウス（日本チャールス・リバー社、本明細書において単に「本マウス」ということがある）を使用した。日本チャールス・リバー社の資料によれば（https://www.crj.co.jp/cms/cmsrs/img/usr/top/B6-Aged.pdf）、本マウスはジャクソン研究所により開発され、加齢研究に広く使われているものであり、本マウス３２匹を観察した結果、１００週齢で死亡個体が発生し、１７０週齢までに全ての個体が死亡したことが公開されている（マウス・フェノーム・データベース（https://www.phenome.jax.org/）参照）。本マウスとヒトとの生涯の対応は、ヒト２０〜３０歳が本マウス３〜６月齢（成熟個体）と、ヒト３８〜４７歳が本マウス１０〜１４月齢（中年個体）と、ヒト５６〜６９歳が本マウス１８〜２４月齢（老年個体）とそれぞれ対応する。本試験では、老年マウスとして本マウス６２週齢の個体を、若年マウスとして本マウス７週齢の個体を、それぞれ１ヵ月の馴化飼育の後に使用した。老齢マウスは、被験食品（ＷＹペプチド）を摂取させる「老齢ＷＹ摂取群」（９匹）と、被験食品を摂取させない「老齢非摂取群」（１２匹）とに体重の偏りが無いように群分けした。また、若齢マウスは、被験食品を摂取させない「若齢非摂取群」（１５匹）とした。なお、マウスは、同じ群に分けられた個体とともに５匹以下で同じケージで通常飼育し、特段の運動は強制しなかった。
(2) Mouse A C57BL / 6J male mouse (Charles River Japan, Inc., sometimes referred to simply as "this mouse" in the present specification) was used. According to the materials of Charles River Japan (https://www.crj.co.jp/cms/cmsrs/img/usr/top/B6-Aged.pdf), this mouse was developed by Jackson Laboratory. It is widely used in aging studies, and as a result of observing 32 of these mice, it has been disclosed that dead individuals occurred at 100 weeks of age and all of them died by 170 weeks of age (). Mouse phenome database (see https://www.phenome.jax.org/). The lifelong correspondence between this mouse and human is that humans 20 to 30 years old are 3 to 6 months old (mature individuals), humans 38 to 47 years old are 10 to 14 months old (middle-aged individuals), and humans 56. ~ 69 years old corresponds to 18-24 months old (aged individuals) of this mouse, respectively. In this study, a 62-week-old individual of this mouse was used as an aged mouse, and a 7-week-old individual of this mouse was used as a young mouse after 1 month of acclimatization. The aged mice were grouped so that there was no bias in body weight between the "old-age WY intake group" (9 mice) that received the test food (WY peptide) and the "old-age non-ingestion group" (12 animals) that did not receive the test food. Divided. In addition, the young mice were defined as the "young non-ingestion group" (15 mice) in which the test food was not ingested. In addition, the mice were normally bred in the same cage with 5 or less mice divided into the same group, and no special exercise was forced.
（３）被験食品（ＷＹペプチド）の投与
老齢ＷＹ摂取群には、ＷＹペプチド（Ｂａｃｈｅｍ社製）を乾燥質量換算で０．０５％（ｗ／ｗ）含む精製飼料（ＡＩＮ−９３Ｍ、オリエンタル酵母社製）を自由摂食させた。老齢非摂取群および若齢非摂取群には、ＷＹペプチドを含まないＡＩＮ−９３Ｍを自由摂食させた。摂取期間は５ヵ月とした。
(3) Administration of test food (WY peptide) The aged WY intake group contains a purified feed (AIN-93M, Oriental Yeast Co., Ltd.) containing 0.05% (w / w) of WY peptide (manufactured by Bachem) in terms of dry weight. Made) was fed freely. The old-age non-ingestion group and the young non-ingestion group were allowed to freely feed AIN-93M containing no WY peptide. The intake period was 5 months.
（４）測定
摂取期間終了後、遅筋であるヒラメ筋を摘出し重量を測定した。
(4) Measurement After the end of the ingestion period, the soleus muscle, which is a slow muscle, was removed and the weight was measured.
（５）統計処理
各群の測定値は、平均値±標準偏差で表記した。検定は、Ｔｕｋｅｙ−Ｋｒａｍｅｒにより行い、危険率Ｐ＜０．０５％であった場合に、比較した両群間に有意差ありとした。
(5) Statistical processing The measured values of each group are expressed as mean ± standard deviation. The test was performed by Tukey-Kramer, and when the risk rate P <0.05%, there was a significant difference between the two groups compared.
（６）結果
結果は、図１に示した通りであった。図１の結果から、老齢非摂取群のヒラメ筋の重量は、若齢非摂取群と比較して有意に減少した。一方、老齢ＷＹ摂取群では、老齢非摂取群と比較して、ヒラメ筋の重量が有意に増加し、若齢非摂取群との差は有意でないことが確認された。これらの結果から、ＷＹペプチドの摂取は、加齢に伴い減少する筋肉（特に遅筋）の重量を増加させることが示された。従って、ＷＹペプチドの摂取により、加齢に伴う筋肉量の低下を抑制すること、すなわち、サルコペニアを抑制すること、さらにはサルコペニアを原因とするロコモティブシンドロームを抑制することが確認され、さらに、ふらつき、転倒、フレイルを抑制できることが示唆された。また、特段の運動をさせなくても、ＷＹペプチドの摂取により筋肉量の低下が抑制されたことから、ＷＹペプチドは不十分な運動（運動不足）によって生ずる筋肉量低下を抑制できること、また、運動療法を組み合わせずに筋肉量の低下を抑制することが示唆された。
(6) Results The results were as shown in FIG. From the results shown in FIG. 1, the weight of soleus muscle in the old non-ingestion group was significantly reduced as compared with the young non-ingestion group. On the other hand, in the old WY intake group, the weight of soleus muscle was significantly increased as compared with the old non-intake group, and it was confirmed that the difference from the young non-intake group was not significant. These results indicate that ingestion of WY peptide increases the weight of muscles (especially slow muscles) that decrease with age. Therefore, it was confirmed that ingestion of WY peptide suppresses the decrease in muscle mass associated with aging, that is, suppresses sarcopenia, and further suppresses locomotive syndrome caused by sarcopenia. It was suggested that falls and flails could be suppressed. In addition, since the decrease in muscle mass was suppressed by ingestion of WY peptide without any special exercise, WY peptide can suppress the decrease in muscle mass caused by insufficient exercise (lack of exercise), and exercise. It was suggested to suppress the loss of muscle mass without combining therapies.
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| JP2011184314A (en) * | 2010-03-04 | 2011-09-22 | Snow Brand Milk Products Co Ltd | Muscular atrophy-preventing agent |
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| WO2017086303A1 (en) * | 2015-11-16 | 2017-05-26 | キリン株式会社 | Peptide composition and production method therefor |
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