JP2022173374A - oral composition - Google Patents
oral composition Download PDFInfo
- Publication number
- JP2022173374A JP2022173374A JP2022153423A JP2022153423A JP2022173374A JP 2022173374 A JP2022173374 A JP 2022173374A JP 2022153423 A JP2022153423 A JP 2022153423A JP 2022153423 A JP2022153423 A JP 2022153423A JP 2022173374 A JP2022173374 A JP 2022173374A
- Authority
- JP
- Japan
- Prior art keywords
- present
- salt
- hesperidin
- hihatsu
- muscle
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Images
Abstract
Description
本発明は、3-ヒドロキシ-3-メチル酪酸又はその塩を含有する経口組成物に関する。 The present invention relates to oral compositions containing 3-hydroxy-3-methylbutyric acid or salts thereof.
3-ヒドロキシ-3-メチル酪酸(HMB)は、必須アミノ酸であるロイシンの代謝生成物であり、筋肉の合成促進や分解抑制にかかわっていることが知られている。しかしながら、体内でのHMB生成量は非常に少ないため、このHMBをサプリメント等として摂取する試みがなされている(例えば、特許文献1、2参照)。 3-Hydroxy-3-methylbutyric acid (HMB) is a metabolite of leucine, an essential amino acid, and is known to be involved in promoting muscle synthesis and inhibiting muscle breakdown. However, since the amount of HMB produced in the body is very small, attempts have been made to ingest this HMB as a supplement or the like (see, for example, Patent Documents 1 and 2).
サプリメントとして一般的に用いられる3-ヒドロキシ-3-メチル酪酸カルシウムは、粉末であるが、粘度が高いことから、ダマになりやすく、そのため、食感が悪い。また、粉末を溶かして飲む場合、ダマになりやすいため溶けにくく、かつ、食感が悪い。さらに、製品の製造工程においても、ダマになりやすいため均一に混合しにくい等の問題があり、特に顆粒や錠剤に加工する場合には、粘度が高いため機械に付着したり、打錠性が悪化したりして、製造効率が低下するという問題がある。 Calcium 3-hydroxy-3-methylbutyrate, which is commonly used as a supplement, is in the form of a powder, but has a high viscosity and tends to form lumps, resulting in a poor texture. In addition, when the powder is dissolved and drunk, it tends to form lumps, making it difficult to dissolve and has a poor texture. Furthermore, in the manufacturing process of the product, there are problems such as being difficult to mix uniformly because it tends to clump together. There is a problem that the manufacturing efficiency is lowered due to deterioration.
本発明の課題は、3-ヒドロキシ-3-メチル酪酸又はその塩を含む、ダマの形成が抑制された分散性の高い経口組成物を提供することにある。 An object of the present invention is to provide a highly dispersible oral composition containing 3-hydroxy-3-methylbutyric acid or a salt thereof, in which formation of lumps is suppressed.
本発明者らは、上記課題を解決すべく鋭意検討した結果、3-ヒドロキシ-3-メチル酪酸又はその塩と共に、ヒハツ及びヘスペリジンから選ばれる少なくとも1種の素材を用いることにより、ダマの形成が抑えられ、これにより、食感がよくなり、製造効率が向上することを見いだし、本発明を完成するに至った。 As a result of intensive studies aimed at solving the above problems, the present inventors have found that the use of 3-hydroxy-3-methylbutyric acid or a salt thereof and at least one material selected from hihatsu and hesperidin inhibits the formation of lumps. As a result, the inventors have found that the food texture is improved and the production efficiency is improved, leading to the completion of the present invention.
すなわち、本発明は、以下のとおりのものである。
[1]3-ヒドロキシ-3-メチル酪酸又はその塩と、ヒハツ及びヘスペリジンから選ばれる少なくとも1種の素材とを含有することを特徴とする経口組成物。
[2]さらに、ブドウ及びトウガラシから選ばれる少なくとも1種の素材を含有することを特徴とする上記[1]記載の経口組成物。
That is, the present invention is as follows.
[1] An oral composition comprising 3-hydroxy-3-methylbutyric acid or a salt thereof, and at least one material selected from hihatsu and hesperidin.
[2] The oral composition according to [1] above, which further contains at least one material selected from grapes and hot peppers.
本発明によれば、3-ヒドロキシ-3-メチル酪酸の高い粘度に起因するダマの形成が抑制された分散性の高い経口組成物を提供することができる。 According to the present invention, it is possible to provide a highly dispersible oral composition in which the formation of lumps due to the high viscosity of 3-hydroxy-3-methylbutyric acid is suppressed.
本発明の経口組成物は、3-ヒドロキシ-3-メチル酪酸又はその塩と、ヒハツ及びヘスペリジンから選ばれる少なくとも1種の素材とを含有することを特徴とする。 The oral composition of the present invention is characterized by containing 3-hydroxy-3-methylbutyric acid or a salt thereof and at least one material selected from hihatsu and hesperidin.
3-ヒドロキシ-3-メチル酪酸又はその塩と共に、ヒハツ及びヘスペリジンから選ばれる少なくとも1種の素材を用いることにより、ダマの形成(凝集)を抑制することができる。したがって、粉体のまま摂取する際も、食感がよい。また、水やお湯等の液体に溶かして摂取する場合も、液体に溶けやすく、簡単に混合することができ、また、食感がよい。さらに、製品の製造工程では、粉末の混合工程において粉末同士の付着を抑制し、ダマの形成を抑制して均一な混合が可能となる。すなわち、本発明の経口組成物は、単に混合するだけで調製できるものであり、その調製も容易である。例えば、凝集性が強く、ダマを形成しやすい原料を混合する際には、その原料について粉砕機を用いた解砕等の前処理を行い、原料の流動性を確保したうえで仕込み、さらに、仕込み後は、再凝集しないようできるだけ速やかに給気し、流動を開始する必要があることが知られているが、このような煩雑な操作も行う必要がない。また、顆粒や錠剤を製造する場合には、機械に原料が付着することなく、また、打錠性の悪化を抑制できることから、製造効率の低下を抑制することができる。 Formation (aggregation) of lumps can be suppressed by using at least one material selected from Hihatsu and hesperidin together with 3-hydroxy-3-methylbutyric acid or a salt thereof. Therefore, even when ingested as powder, it has a good texture. Also, when dissolved in a liquid such as water or hot water and ingested, it dissolves easily in the liquid, can be easily mixed, and has a good texture. Furthermore, in the manufacturing process of the product, it is possible to suppress the adhesion of the powders in the powder mixing process, suppress the formation of lumps, and achieve uniform mixing. That is, the oral composition of the present invention can be prepared simply by mixing, and the preparation is also easy. For example, when mixing raw materials that are highly agglomerated and tend to form lumps, the raw materials are pre-treated by crushing them with a crusher to ensure the fluidity of the raw materials before being charged. After preparation, it is known that it is necessary to supply air and start flowing as soon as possible to prevent reaggregation, but such complicated operations are not necessary. In addition, when producing granules or tablets, it is possible to prevent the raw materials from adhering to the machine and to suppress deterioration of the tableting properties, thereby suppressing a decrease in production efficiency.
また、本発明の組成物は分散性が高いことから、さらに本発明の成分以外の素材を混合して本発明の経口組成物とする場合にも、上記のような煩雑な操作を行う必要がなく、単に混合するだけで調製することができる。 In addition, since the composition of the present invention has high dispersibility, even when materials other than the components of the present invention are mixed to form the oral composition of the present invention, it is not necessary to perform the above-described complicated operations. can be prepared by simply mixing.
[3-ヒドロキシ-3-メチル酪酸又はその塩]
3-ヒドロキシ-3-メチル酪酸(HMB)とは、必須アミノ酸であるロイシンの代謝産物であり、ヒトの体内で合成される。本発明においては、HMB又はその塩が使用できる。HMBの塩としては、特に制限されないが、カルシウム塩、ナトリウム塩、カリウム塩、マグネシウム塩が挙げられ、筋肉増強効果やダイエット効果の観点から、カルシウム塩(HMBCa)が好ましい。本発明の経口組成物におけるHMB又はその塩は、公知の方法により合成したものや、市販品を用いることができる。市販品としては、食品に適用可能なものであれば限定されない。また、本発明においてHMB又はその塩は1種類のみを使用してもよいし、2種類以上を使用してもよい。
[3-hydroxy-3-methylbutyric acid or a salt thereof]
3-Hydroxy-3-methylbutyric acid (HMB) is a metabolite of the essential amino acid leucine and is synthesized in the human body. HMB or a salt thereof can be used in the present invention. The salt of HMB is not particularly limited, but includes calcium salt, sodium salt, potassium salt, and magnesium salt. From the viewpoint of muscle strengthening effect and diet effect, calcium salt (HMBCa) is preferable. As HMB or a salt thereof in the oral composition of the present invention, those synthesized by a known method or commercially available products can be used. Commercial products are not limited as long as they are applicable to foods. Moreover, in the present invention, only one type of HMB or a salt thereof may be used, or two or more types may be used.
3-ヒドロキシ-3-メチル酪酸又はその塩の含有量は、筋肉増強効果及び/又はダイエット効果が認められる量であれば特に限定されないが、例えば、組成物全量に対して0.1~99質量%であり、好ましくは1~98質量%であり、より好ましくは5~97質量%である。 The content of 3-hydroxy-3-methylbutyric acid or a salt thereof is not particularly limited as long as the muscle-building effect and/or diet effect are observed, but for example, 0.1 to 99 masses relative to the total amount of the composition. %, preferably 1 to 98% by mass, more preferably 5 to 97% by mass.
[ヒハツ]
ヒハツとは、コショウ科コショウ属で、学名がPiper longum L.の植物で、別名のインドナガコショウで称されることもある。本発明で使用するヒハツとしては、成熟又は未成熟の果穂(実)、葉、葉柄、枝、根等が挙げられ、成熟又は未成熟の果穂が好ましい。ヒハツとしては、ヒハツを加工した加工物を用いてもよく、例えば、収穫したヒハツを乾燥させて粉砕し粉末にしたものや、水、低級アルコール又はそれらの混合溶媒等で抽出した抽出物(エキス末)や、発酵物(発酵粉末)を使用でき、エキス末を使用することが好ましい。本発明で使用するヒハツとしては、むくみ抑制効果やむくみ改善効果、身体の冷えの改善効果の観点から、成熟又は未成熟の果穂のエキス末が望ましい。
[Hihatsu]
Hihatsu belongs to the genus Pepper of the pepper family, and its scientific name is Piper longum L. It is also known as Indian long pepper. Hihatsu used in the present invention includes mature or immature spikes (fruits), leaves, petioles, branches, roots, etc. Mature or immature spikes are preferred. As the hihatsu, a processed product obtained by processing the hihatsu may be used, for example, the harvested hihatsu is dried and pulverized into a powder, or an extract extracted with water, a lower alcohol, or a mixed solvent thereof (extract powder) or a fermented product (fermented powder) can be used, and it is preferable to use an extract powder. The extract used in the present invention is desirably mature or immature ear extract powder from the viewpoint of swelling-suppressing effect, swelling-relieving effect, and body cold-relieving effect.
[ヘスペリジン]
本発明で使用するヘスペリジンとしては、ヘスペリジン、又はこれを豊富に含む食品素材(例えば、みかん、グレープフルーツなどの柑橘類の果皮、果汁、種子の抽出物(エキス末))を挙げることができる。また、メチルヘスペリジン、酵素処理ヘスペリジン、糖転移ヘスペリジンなどのヘスペリジンの誘導体であってもよく、むくみ抑制効果やむくみ改善効果、血管の強化効果、血流改善効果の観点から、糖転移ヘスペリジンが好ましい。
[Hesperidin]
Examples of hesperidin used in the present invention include hesperidin and food materials rich in it (for example, citrus peels such as mandarins and grapefruits, fruit juices, and seed extracts (extract powder)). Hesperidin derivatives such as methylhesperidin, enzyme-treated hesperidin, transglycosylated hesperidin, and the like may also be used, and transglycosylated hesperidin is preferable from the viewpoint of swelling-suppressing effect, swelling-improving effect, blood vessel-strengthening effect, and blood flow-improving effect.
本発明の経口組成物は、3-ヒドロキシ-3-メチル酪酸又はその塩、並びにヒハツ及びヘスペリジンから選ばれる少なくとも1種の素材と共に、ブドウ及びトウガラシから選ばれる少なくとも1種の素材を含有することが好ましい。これにより、ダマの形成をより抑制することができる。 The oral composition of the present invention may contain 3-hydroxy-3-methylbutyric acid or a salt thereof, and at least one material selected from Hihatsu and hesperidin, and at least one material selected from grape and red pepper. preferable. Thereby, the formation of lumps can be further suppressed.
[ブドウ]
ブドウは、ブドウ科に属する植物で、本発明で使用するブドウとしては、実、皮、種子、葉などを用いることができ、特に限定するものではないが、実、種子、又は葉が好ましい。また、ブドウとしては、欧米種(学名:Vitis. vinifera)、米国種(学名:Vitis. labrusca)など、特に限定するものではなく、いかなる品種を用いてもよいが、欧米種が好ましい。特に、赤色、紫色、青色、紺色又は黒色に近い果皮と赤色の果肉の欧米種である赤ブドウが好ましい。ブドウとしては、ブドウを加工した加工物を用いてもよく、例えば、収穫したブドウを乾燥させて粉砕し粉末にしたものや、水、低級アルコール又はそれらの混合溶媒等で抽出した抽出物(エキス末)や、発酵物(発酵粉末)を使用でき、エキス末を使用することが好ましい。本発明で使用するブドウとしては、むくみ抑制効果やむくみ改善効果、血小板凝集効果、抗炎症効果の観点から、ブドウの実、種子、又は葉のエキス末が好ましく、特に、赤ブドウの葉のエキス末が好ましい。また、3-ヒドロキシ-3-メチル酪酸又はその塩と、ヒハツ及びヘスペリジンから選ばれる少なくとも1種の素材とを含有する経口組成物に、ブドウ、特に、ブドウの実、種子、又は葉のエキス末、さらに好ましくは、赤ブドウの葉のエキス末を加えることで、むくみ抑制効果やむくみ改善効果の向上が期待できる。
[grape]
Grapes are plants belonging to the family Grapeaceae, and the grapes used in the present invention may be berries, skins, seeds, leaves, etc., but are not particularly limited, but berries, seeds, or leaves are preferred. In addition, the grapes are not particularly limited, such as European grapes (scientific name: Vitis. vinifera), American grapes (scientific name: Vitis. labrusca), and any variety may be used, but European grapes are preferable. In particular, red grapes, which are Western varieties with red, purple, blue, navy blue or near-black skins and red flesh, are preferred. As the grapes, processed products of grapes may be used, for example, dried and pulverized harvested grapes, and extracts extracted with water, lower alcohols or their mixed solvents (extract powder) or a fermented product (fermented powder) can be used, and it is preferable to use an extract powder. The grapes used in the present invention are preferably grape, seed, or leaf extract powder from the viewpoint of swelling suppression effect, swelling improvement effect, platelet aggregation effect, and anti-inflammatory effect, especially red grape leaf extract. end is preferred. In addition, an oral composition containing 3-hydroxy-3-methylbutyric acid or a salt thereof and at least one material selected from Hihatsu and hesperidin may be added to grape, especially grape berry, seed, or leaf extract powder. More preferably, by adding red grape leaf extract powder, an improvement in swelling suppressing effect and swelling improving effect can be expected.
[トウガラシ]
トウガラシは、ナス科トウガラシ属で、学名がCapsicum annuumの植物で、本発明で使用するトウガラシとしては、実や葉などを用いることができ、特に限定するものではないが、実が好ましい。また、トウガラシとしては、実が熟し、赤色をした、いわゆる赤トウガラシ、実が未成熟で、緑色をした、いわゆる青トウガラシなどいずれのトウガラシを用いてもよいが、青トウガラシを用いることが好ましい。また、トウガラシとしては、トウガラシを加工した加工物を用いてもよく、例えば、収穫したトウガラシを乾燥させて粉砕し粉末にしたものや、水、低級アルコール又はそれらの混合溶媒等で抽出した抽出物(エキス末)や、発酵物(発酵粉末)を使用でき、発酵粉末を使用することが好ましい。
[Capsicum]
Capsicum is a plant belonging to the genus Capsicum of the Solanaceae family and having the scientific name of Capsicum annuum. As the pepper used in the present invention, fruits, leaves and the like can be used. In addition, as the pepper, any type of pepper may be used, such as so-called red pepper whose fruits are ripe and red, and so-called blue pepper whose fruits are immature and green, but it is preferable to use blue pepper. In addition, as the pepper, a processed product obtained by processing the pepper may be used. For example, the harvested pepper is dried and pulverized into a powder, or an extract extracted with water, a lower alcohol, or a mixed solvent thereof. (extract powder) or fermented material (fermented powder) can be used, and fermented powder is preferably used.
発酵粉末としては、収穫したトウガラシを発酵し、乾燥させて粉末化したものや、収穫したトウガラシから抽出物を得、その抽出物を発酵し、粉末化したものや、収穫したトウガラシを発酵し、その発酵物を抽出して粉末化したもの等を挙げることができる。発酵に用いる菌体としては、麹菌、酵母菌、乳酸菌、酢酸菌、枯草菌等の発酵に通常使用される菌体を用いることができるが、乳酸菌を用いることが好ましい。本発明で使用するトウガラシとしては、むくみ抑制効果やむくみ改善効果、血流改善効果、代謝促進効果の観点から、青トウガラシの発酵物が好ましい。また、3-ヒドロキシ-3-メチル酪酸又はその塩と、ヒハツ及びヘスペリジンから選ばれる少なくとも1種の素材とを含有する経口組成物に、トウガラシ、特に、青トウガラシの発酵物を加えることで、むくみ抑制効果やむくみ改善効果の向上が期待できる。 As the fermented powder, harvested peppers are fermented, dried and powdered, an extract is obtained from the harvested peppers, the extract is fermented and powdered, or the harvested peppers are fermented, Examples include those obtained by extracting and pulverizing the fermented product. As the cells used for fermentation, cells commonly used for fermentation such as koji mold, yeast, lactic acid bacteria, acetic acid bacteria, and bacillus subtilis can be used, but lactic acid bacteria are preferably used. As the hot pepper used in the present invention, fermented green hot pepper is preferable from the viewpoint of swelling suppressing effect, swelling improving effect, blood flow improving effect, and metabolism promoting effect. In addition, edema can be reduced by adding a fermented product of hot pepper, particularly green hot pepper, to an oral composition containing 3-hydroxy-3-methylbutyric acid or a salt thereof and at least one material selected from hihatsu and hesperidin. Improvement of suppression effect and swelling improvement effect can be expected.
本発明の経口組成物は、例えば、医薬品(医薬部外品を含む)や、特定保健用食品、栄養機能食品、機能性表示食品等の所定機関より効能の表示が認められた機能性食品などのいわゆる健康食品や、一般的な食品、食品添加剤、飼料等として用いることができる。 The oral composition of the present invention includes, for example, pharmaceuticals (including quasi-drugs), food for specified health uses, food with nutrient function claims, food with functional claims, etc., whose efficacy has been approved by a predetermined organization. It can be used as so-called health foods, general foods, food additives, feeds, and the like.
本発明の経口組成物は、筋肉の増強のために用いられる筋肉増強用組成物として用いることができる。かかる筋肉増強用組成物としては、HMB又はその塩、並びにヒハツ及び/又はヘスペリジンを含有し、筋肉増強や筋肉疲労回復に用いられる点において、製品として他の製品と区別することができるものであれば特に制限されるものではなく、本発明に係る製品の本体、包装、説明書、宣伝物のいずれかに、例えば、筋肉増強、筋合成の亢進、筋分解の抑制、筋肉量(筋肉重量、筋断面積、筋肉密度)の低下抑制・維持・増加、筋肉の質の低下抑制・維持・向上、筋力(パワー、持久力)の低下抑制・維持・増加、運動能力の低下抑制・維持・向上、代謝(基礎代謝、安静時及び運動時代謝)の低下抑制・維持・向上、除脂肪体重の低下抑制・維持・増加、筋肉疲労の予防・改善、筋肉増強による代謝向上効果、ロコモティブシンドロームの予防・改善効果、サルコペニアの予防・改善効果等の機能がある旨を表示したものが本発明の範囲に含まれる。 The oral composition of the present invention can be used as a muscle building composition for building muscle. Such a muscle-building composition contains HMB or a salt thereof and Hihatsu and/or hesperidin, and can be distinguished from other products in that it is used for muscle building and recovery from muscle fatigue. is not particularly limited, and any of the main body, packaging, instructions, and advertising materials of the product according to the present invention may include, for example, muscle building, muscle synthesis enhancement, muscle breakdown suppression, muscle mass (muscle weight, muscle cross-sectional area, muscle density) decrease/maintenance/increase, muscle quality decrease/maintenance/improvement, muscle strength (power, endurance) decrease/reduction/maintenance/increase, athletic performance decrease/reduction/maintenance/improvement , Suppression/maintenance/improvement of metabolism (basal metabolism, resting and exercise metabolism), Suppression/maintenance/increase of lean body mass, Prevention/improvement of muscle fatigue, Effect of improving metabolism by building muscle, Prevention of locomotive syndrome The scope of the present invention includes those labeled as having functions such as improvement effect, sarcopenia prevention/improvement effect, and the like.
なお、本発明の筋肉増強用組成物は、製品の包装等に、本発明の成分(HMB又はその塩、並びにヒハツ及び/又はヘスペリジン)が筋肉増強の有効成分として表示されているものに限られない。例えば、有効成分を特定していないものであってもよく、HMB又はその塩のみを有効成分として表示したものであってもよい。 The muscle-building composition of the present invention is limited to those in which the ingredients of the present invention (HMB or a salt thereof, and Hihatsu and/or hesperidin) are indicated as active ingredients for muscle-building on the packaging of the product. do not have. For example, the active ingredient may not be specified, or only HMB or a salt thereof may be indicated as the active ingredient.
具体的に、本発明の筋肉増強用組成物としては、医薬品(医薬部外品を含む)やいわゆる健康食品が挙げられ、いわゆる健康食品においては、「筋肉をつくる力をサポートする」、「筋肉の分解を抑える」、「筋力を増強する」、「歩行能力の低下抑制・維持・改善・向上」、「筋肉増強による代謝向上を図る」、「代謝の衰えを抑える」、「筋肉疲労の予防・回復」、「バランス能力の低下抑制・維持」、「シェイプアップ」、「マッチョ」、「細マッチョ」、「美ボディ」、「寝たきり予防」、「転倒予防」、「筋肉増強による代謝向上を図る」、「筋肉量や筋力を維持する」等を表示したものを例示することができる。本発明の経口組成物を摂取する対象としては、通常、筋肉の増強を必要とする人であり、シェイプアップを目的とする人や、スポーツ選手や、足腰の弱った高齢者等を好ましく例示することができる。 Specifically, the muscle building composition of the present invention includes pharmaceuticals (including quasi-drugs) and so-called health foods. Suppress decomposition of muscle", "Increase muscle strength", "Suppress/maintain/improve/enhance walking ability", "Improve metabolism by increasing muscle", "Suppress decline in metabolism", "Prevent muscle fatigue"・Recovery", "Restraining and maintaining balance ability", "Shaping up", "Macho", "Slim macho", "Beauty body", "Prevention of bedridden", "Prevention of falls", "Improvement of metabolism by building muscle" exemplified by displays such as "to work", "to maintain muscle mass and strength", and the like. Subjects to whom the oral composition of the present invention is to be ingested are usually those who need muscle enhancement, and preferred examples include those who aim to shape up, athletes, and elderly people with weak legs. be able to.
また、本発明の経口組成物は、ダイエットのために用いられるダイエット用組成物として用いることができる。かかるダイエット用組成物としては、HMB又はその塩、並びにヒハツ及び/又はヘスペリジンを含有し、ダイエット(肥満抑制、肥満改善)に用いられる点において、製品として他の製品と区別することができるものであれば特に制限されるものではなく、例えば、本発明に係る製品の本体、包装、説明書、宣伝物のいずれかに、ダイエット(体脂肪低減、体脂肪蓄積抑制、メタボリックシンドローム改善、痩身などを含む)の機能がある旨を表示したものが本発明の範囲に含まれる。なお、本発明のダイエット用組成物は、製品の包装等に、本発明の成分(HMB又はその塩、並びにヒハツ及び/又はヘスペリジン)がダイエットの有効成分として表示されているものに限られない。例えば、有効成分を特定していないものであってもよく、HMB又はその塩のみを有効成分として表示したものであってもよい。 Moreover, the oral composition of the present invention can be used as a diet composition for dieting. Such a diet composition contains HMB or a salt thereof and Hihatsu and/or hesperidin, and can be distinguished from other products as a product in that it is used for diet (obesity suppression, obesity improvement). There is no particular limitation, and for example, diet (body fat reduction, body fat accumulation suppression, metabolic syndrome improvement, slimming, etc.) included) is included in the scope of the present invention. The diet composition of the present invention is not limited to one in which the ingredients of the present invention (HMB or a salt thereof, and hihatsu and/or hesperidin) are indicated as active diet ingredients on the packaging of the product. For example, the active ingredient may not be specified, or only HMB or a salt thereof may be indicated as the active ingredient.
具体的に、本発明のダイエット用組成物としては、医薬品(医薬部外品を含む)やいわゆる健康食品が挙げられ、いわゆる健康食品においては、「体脂肪が気になる方へ」、「肥満気味な方へ」、「体重(BMI)が気になる方へ」、「体重やお腹の脂肪(内臓脂肪と皮下脂肪)を減らす」、「ウエスト周囲長を減らす」等を表示したものを例示することができる。 Specifically, the diet composition of the present invention includes pharmaceuticals (including quasi-drugs) and so-called health foods. For those who are concerned about their weight (BMI)", "Reduce weight and abdominal fat (visceral fat and subcutaneous fat)", "Reduce waist circumference", etc. can do.
本発明の経口組成物による筋肉増強効果、ダイエット効果は、日常生活と共に本発明の組成物を摂取すれば得られるものであるが、運動と併用することで、より優れた効果を得ることができる。運動とは、例えば、有酸素運動、レジスタンス運動(筋力トレーニング、ウェイトトレーニング)を挙げることができる。特に、筋肉増強効果を得る場合、レジスタンス運動を併用することが好ましく、運動量としては、1日あたり10分以上であることが好ましく、20分以上であることがより好ましく、30分以上であることがさらに好ましい。 The muscle building effect and diet effect of the oral composition of the present invention can be obtained by ingesting the composition of the present invention along with daily life, but more excellent effects can be obtained by using the composition in combination with exercise. . Exercise includes, for example, aerobic exercise and resistance exercise (strength training, weight training). In particular, when obtaining a muscle strengthening effect, it is preferable to use resistance exercise in combination, and the amount of exercise is preferably 10 minutes or more, more preferably 20 minutes or more, and 30 minutes or more per day. is more preferred.
また、本発明の経口組成物は、むくみの抑制のために用いられるむくみ抑制用組成物や、むくみの改善のために用いられるむくみ改善用組成物として用いることができる。かかるむくみ抑制及び/又は改善用組成物としては、HMB又はその塩、並びにヒハツ及び/又はヘスペリジンを含有し、むくみの抑制及び/又はむくみの改善に用いられる点において、製品として他の製品と区別することができるものであれば特に制限されるものではなく、例えば、本発明に係る製品の本体、包装、説明書、宣伝物のいずれかに、例えば、むくみの抑制、むくみの改善、むくみの予防、むくみの低減、むくみの解消、足首・ふくらはぎ・下腿部・大腿部・腿などの脚部や上腕・前腕などの腕部の周囲長の減少・面積の減少・体積の減少、顔の面積の減少・体積の減少等の機能がある旨を表示したものが本発明の範囲に含まれる。なお、本発明のダイエット用組成物は、製品の包装等に、本発明の成分(HMB又はその塩、並びにヒハツ及び/又はヘスペリジン)がむくみの抑制及び/又はむくみの解消の有効成分として表示されているものに限られない。例えば、有効成分を特定していないものであってもよく、ヒハツ及び/又はスペリジンを有効成分として表示したものであってもよい。 In addition, the oral composition of the present invention can be used as a swelling-suppressing composition for suppressing swelling and a swelling-improving composition for improving swelling. Such a composition for suppressing and/or improving swelling contains HMB or a salt thereof and Hihatsu and/or hesperidin, and is distinguished from other products in that it is used for suppressing and/or improving swelling. It is not particularly limited as long as it can be used. Prevention, reduction of swelling, elimination of swelling, reduction in circumference, area, and volume of legs such as ankles, calves, lower legs, thighs, thighs, and arms such as upper arms and forearms, face The scope of the present invention includes those indicating that they have functions such as reduction of area and reduction of volume. In the diet composition of the present invention, the ingredients of the present invention (HMB or a salt thereof, and Hihatsu and/or hesperidin) are indicated on the packaging of the product as active ingredients for suppressing and/or relieving swelling. is not limited to For example, the active ingredient may not be specified, or Hihatsu and/or Speridin may be indicated as the active ingredient.
具体的に、本発明のむくみの抑制及び/又は改善用組成物としては、医薬品(医薬部外品を含む)やいわゆる健康食品が挙げられ、いわゆる健康食品においては、「むくみが気になる方へ」、「むくみを防ぐ」、「むくみを減らす」、「むくみをなくす」、「足首の周囲長を減らす」、「ふくらはぎの周囲長を減らす」、「大腿部の周囲長を減らす」、「上腕の周囲長を減らす」、「前腕の周囲長を減らす」等を表示したものを例示することができる。 Specifically, the composition for suppressing and/or improving swelling of the present invention includes pharmaceuticals (including quasi-drugs) and so-called health foods. "To", "Prevent swelling", "Reduce swelling", "Eliminate swelling", "Reduce ankle circumference", "Reduce calf circumference", "Reduce thigh circumference", For example, "reduce the circumference of the upper arm", "reduce the circumference of the forearm", or the like.
本発明の組成物の形態としては、例えば、錠状、カプセル状(ハードカプセル状やソフトカプセル状など)、粉末状、顆粒状、液状、粒状、棒状、板状、ブロック状、固形状、丸状、ペースト状、クリーム状、カプレット状、ゲル状、チュアブル錠状、スティック状等を挙げることができる。これらの中でも、錠状、ハードカプセル状、粉末状、顆粒状、丸状、チュアブル錠状の形態が好ましい。 Examples of the form of the composition of the present invention include tablets, capsules (hard capsules, soft capsules, etc.), powders, granules, liquids, granules, rods, plates, blocks, solids, rounds, Paste, cream, caplet, gel, chewable tablet, stick and the like can be mentioned. Among these, tablets, hard capsules, powders, granules, rounds, and chewable tablets are preferred.
本発明の組成物を錠状、丸状、チュアブル錠状とする場合、賦形剤、滑沢剤、流動化剤のいずれか1種以上を添加することにより、成型性を高めるとともに得られた錠剤、丸剤又はチュアブル錠剤の保存安定性を向上するため、好ましい。特に、賦形剤及び滑沢剤を使用することで保存安定性をより高めることができる。 When the composition of the present invention is in the form of a tablet, a round tablet, or a chewable tablet, by adding one or more of excipients, lubricants, and fluidizing agents, moldability is improved and obtained. It is preferable because it improves the storage stability of tablets, pills or chewable tablets. In particular, storage stability can be further enhanced by using excipients and lubricants.
賦形剤とは、組成物の取扱いあるいは成形の向上や服用を便利にするために加えるものである。本発明に使用できる賦形剤としては特に制限はなく、例えば、デンプン、アルファー化デンプン、部分アルファー化デンプン、デンプン分解物等のデンプン又はその誘導体、結晶セルロース、糖アルコール、乳糖、ビール酵母、低置換度ヒドロキシプロピルセルロース、ヒドロキシプロピルセルロース、精製白糖、軽質無水ケイ酸、ケイ酸カルシウム、酸化チタン、沈降炭酸カルシウム等を挙げることができる。これらは、1種単独で使用してもよいし、2種以上を併用してもよい。 Excipients are added to improve the handling or molding of the composition, or to facilitate administration. Excipients that can be used in the present invention are not particularly limited. Substituted hydroxypropyl cellulose, hydroxypropyl cellulose, refined sucrose, light anhydrous silicic acid, calcium silicate, titanium oxide, precipitated calcium carbonate and the like can be mentioned. These may be used individually by 1 type, and may use 2 or more types together.
滑沢剤とは、錠剤用の粉末を圧縮する際に打錠機杵臼と錠剤間の摩擦を緩和し、スティッキングなどの打錠障害を防ぐために使用するものである。本発明に使用できる滑沢剤としては、上記目的を達成することが可能な成分であれば特に制限はなく、例えば、ステアリン酸、ステアリン酸カルシウム、ステアリン酸マグネシウム等のステアリン酸又はその塩、フマル酸ステアリルナトリウム、ショ糖脂肪酸エステル、タルク、ポリエチレングリコール、植物油脂、硬化油等を挙げることができる。これらは、1種単独で使用してもよく、2種以上を併用してもよい。 Lubricants are used to reduce friction between the punches of a tableting machine and tablets when compressing powder for tablets, and to prevent tableting failures such as sticking. The lubricant that can be used in the present invention is not particularly limited as long as it is a component that can achieve the above purpose. Stearyl sodium, sucrose fatty acid ester, talc, polyethylene glycol, vegetable oil, hardened oil and the like can be mentioned. These may be used individually by 1 type, and may use 2 or more types together.
流動化剤とは、混合末や顆粒の流動性を改善するために使用するものである。本発明に使用できる流動化剤としては特に制限はなく、例えば、二酸化ケイ素、ケイ酸アルミニウム、ケイ酸アルミン酸マグネシウム、リン酸カルシウム、炭酸マグネシウム、酸化マグネシウム等を挙げることができる。これらは、1種単独で使用してもよいし、2種以上を併用してもよい。本発明において、賦形剤、滑沢剤、流動化剤はいずれも市販品を使用することができる。 A fluidizer is used to improve the fluidity of mixed powder and granules. The fluidizing agent that can be used in the present invention is not particularly limited, and examples thereof include silicon dioxide, aluminum silicate, magnesium aluminosilicate, calcium phosphate, magnesium carbonate, and magnesium oxide. These may be used individually by 1 type, and may use 2 or more types together. In the present invention, commercial products can be used as excipients, lubricants, and fluidizers.
本発明の成分(HMB又はその塩、並びにヒハツ及び/又はヘスペリジン)の含有量としては、その効果の奏する範囲で適宜含有させればよい。 The content of the components of the present invention (HMB or a salt thereof, and hihatsu and/or hesperidin) may be appropriately contained within a range in which the effect is exhibited.
具体的には、本発明の経口組成物が錠状、丸状、カプセル状のサプリメントや医薬品の場合には、本発明の成分が乾燥質量換算で全体の5~99質量%含まれていることが好ましく、8~98質量%含まれていることがより好ましく、10~97質量%含まれていることが特に好ましい。また、本発明の経口組成物がチュアブル錠状のサプリメントや医薬品の場合には、本発明の成分が乾燥質量換算で全体の0.1~70質量%含まれていることが好ましく、0.5~60質量%含まれていることがより好ましく、1~50質量%含まれていることが特に好ましい。粉末状、顆粒状のサプリメントや医薬品の場合、本発明の成分が乾燥質量換算で全体の0.1~90質量%含まれていることが好ましく、0.5~80質量%含まれていることがより好ましく、1~70質量%含まれていることが特に好ましい。液状のサプリメントや医薬品の場合、本発明の成分が乾燥質量換算で全体の5~99質量%含まれていることが好ましく、8~98質量%含まれていることがより好ましく、10~97質量%含まれていることが特に好ましい。 Specifically, when the oral composition of the present invention is a tablet, round, capsule-shaped supplement or drug, the component of the present invention should be contained in an amount of 5 to 99% by mass in terms of dry mass. is preferred, more preferably 8 to 98% by mass, and particularly preferably 10 to 97% by mass. In addition, when the oral composition of the present invention is a chewable tablet supplement or pharmaceutical, it is preferable that the component of the present invention is contained in an amount of 0.1 to 70% by mass in terms of dry mass of the whole, and 0.5% by mass. It is more preferably contained in an amount of up to 60% by mass, and particularly preferably contained in an amount of 1 to 50% by mass. In the case of powdery or granular supplements and pharmaceuticals, the component of the present invention preferably contains 0.1 to 90% by mass of the total in terms of dry mass, and 0.5 to 80% by mass. is more preferable, and it is particularly preferable that it is contained in an amount of 1 to 70% by mass. In the case of liquid supplements and pharmaceuticals, the component of the present invention preferably contains 5 to 99% by weight of the total dry weight, more preferably 8 to 98% by weight, and 10 to 97% by weight. % is particularly preferred.
本発明の経口組成物の摂取量としては特に制限はないが、本発明の効果をより顕著に発揮させる観点から、成人の1日当たり、HMB又はその塩の摂取量が、100mg/日以上となるように摂取することが好ましく、200mg/日以上となるように摂取することがより好ましく、300mg/日以上となるように摂取することが特に好ましい。その上限は、例えば、10000mg/日であり、好ましくは8000mg/日であり、より好ましくは5000mg/日である。本発明の経口組成物は、1日の摂取量が前記摂取量となるように適宜設計すればよく、1回で摂取してもよいし、複数回に分けて摂取してもよい。例えば、錠剤、カプセル剤、粉末剤、顆粒剤、丸剤又はチュアブル錠剤の場合は1日あたり1~4回の摂取回数とし、合計量として前記摂取量が摂取できればよく、飲料の場合、1日の摂取量に前記摂取量が配合されていればよい。本発明の経口組成物は、1日の摂取量が前記摂取量となるように、1つの容器に、又は例えば2~3の複数の容器に分けて、1日分として収容することができる。 The intake of the oral composition of the present invention is not particularly limited, but from the viewpoint of exhibiting the effects of the present invention more remarkably, the daily intake of HMB or a salt thereof for adults should be 100 mg/day or more. more preferably 200 mg/day or more, and particularly preferably 300 mg/day or more. The upper limit is, for example, 10000 mg/day, preferably 8000 mg/day, more preferably 5000 mg/day. The oral composition of the present invention may be appropriately designed so that the daily intake is the above-mentioned intake, and may be taken in one dose or in multiple doses. For example, in the case of tablets, capsules, powders, granules, pills, or chewable tablets, the number of intakes is 1 to 4 times per day, and the total amount of intake should be ingested. It is sufficient that the above-mentioned intake amount is blended with the intake amount of . The oral composition of the present invention can be contained in one container or divided into a plurality of containers, for example 2 to 3, so that the daily intake is equal to the above-mentioned intake for one day.
HMB又はその塩と、ヒハツ及びヘスペリジンの合計量との配合質量比としては、乾燥質量換算で、1:0.00001~10の範囲であることが好ましく、1:0.00005~5の範囲であることがより好ましく、1:0.0001~1の範囲であることが特に好ましい。 The blending mass ratio of HMB or a salt thereof to the total amount of Hihatsu and hesperidin is preferably in the range of 1:0.00001 to 10, more preferably in the range of 1:0.00005 to 5, in terms of dry mass. 1:0.0001 to 1 is particularly preferred.
本発明の経口組成物は、必要に応じて、本発明の成分以外の他の成分を添加して、公知の方法によって製造することができる。本発明の成分以外の他の成分としては、例えば、水溶性ビタミン(ビタミンB1、B2、B3、B5、B6、B12、B13、B15、B17、ビオチン、コリン、葉酸、イノシトール、PABA、ビタミンC、ビタミンP)、油溶性ビタミン(ビタミンA、D、E、K)等のビタミン類;マグネシウム、リン、亜鉛、鉄等のミネラル類;タウリン、ニンニク等に含まれる含硫化合物;ヘスペリジン、ケルセチン等のフラバノイド或いはフラボノイド類;コラーゲン等のタンパク質;ペプチド;アミノ酸;動物性油脂;植物性油脂;動物・植物の粉砕物又は抽出物等を挙げることができる。特に、糖質を筋肉に運ぶことが可能なグルカゴン様ペプチド-1(GLP-1)ホルモンの分泌を亢進する成分が好ましく、例えば、スピルリナ、甘藷茎葉、マジョラム、カワラヨモギが挙げられる。 The oral composition of the present invention can be produced by a known method by adding other ingredients other than the ingredients of the present invention, if necessary. Other ingredients other than the ingredients of the present invention include, for example, water-soluble vitamins (vitamin B1, B2, B3, B5, B6, B12, B13, B15, B17, biotin, choline, folic acid, inositol, PABA, vitamin C, vitamin P), oil-soluble vitamins (vitamins A, D, E, K); minerals such as magnesium, phosphorus, zinc, and iron; sulfur-containing compounds contained in taurine, garlic, etc.; hesperidin, quercetin, etc. proteins such as collagen; peptides; amino acids; animal oils and fats; vegetable oils and fats; In particular, a component that enhances the secretion of glucagon-like peptide-1 (GLP-1) hormone capable of transporting carbohydrates to muscle is preferred, and examples thereof include spirulina, sweet potato stems and leaves, marjoram, and kawara mugwort.
以下、本発明を実施例に基づき説明する。なお、本発明は、実施例に限定されるものではない。 EXAMPLES The present invention will be described below based on examples. In addition, the present invention is not limited to the examples.
(サンプルの調製)
3-ヒドロキシ-3-メチル酪酸又はその塩としては、HMBCa(粉末)を用いた。
ヒハツとしては、ヒハツの果穂を熱水で抽出したものを乾燥し、粉砕したエキス末を用いた。
ヘスペリジンとしては、糖転移ヘスペリジンを用いた。
ブドウとしては、赤ブドウの葉を30%エタノール水溶液で抽出したものを乾燥し、粉砕したエキス末を用いた。
トウガラシとしては、青トウガラシの実を、乳酸菌を用いて発酵し、固液分離によって液体を得て、デキストリンを添加・混合し、スプレードライして粉末にした発酵抽出物(粉末)を用いた。
(Sample preparation)
HMBCa (powder) was used as 3-hydroxy-3-methylbutyric acid or a salt thereof.
As the hihatsu, the extract powder obtained by extracting the spikes of Hihatsu with hot water, drying and pulverizing was used.
Transglycosylated hesperidin was used as hesperidin.
As grapes, red grape leaves were extracted with a 30% aqueous ethanol solution, dried, and crushed to obtain an extract powder.
As the pepper, a fermented extract (powder) was used, which was obtained by fermenting green pepper fruit with lactic acid bacteria, obtaining a liquid by solid-liquid separation, adding and mixing dextrin, and spray-drying to powder.
各サンプルを下記表1(単位:g)に示す分量でよく混合した。そのうちの10gを使って混合物の粒度を測定した。 Each sample was thoroughly mixed in the amount shown in Table 1 (unit: g) below. 10 g of it was used to measure the particle size of the mixture.
具体的には、ミクロ型電磁振動ふるい器M-2型(筒井理化学器械(株)製)を用いて粒度を測定した。測定条件は、各サンプル10gにつき、振動度の目盛りを5に合わせて、振動時間を5分とした。使用した篩は、目開きが150、106μmの2種類で、受け器の上に、下から目開きの小さい順に大きなものを重ねて使用した。5分間の振動後、各篩及び受け器に残った粉末を回収し、当該粉末の重量を測定した。
その結果を表2及び図1に示す。
Specifically, the particle size was measured using a micro-type electromagnetic vibrating sieve M-2 (manufactured by Tsutsui Rikagaku Kikai Co., Ltd.). As for the measurement conditions, the scale of the vibration degree was adjusted to 5 for each 10 g of sample, and the vibration time was set to 5 minutes. Two types of sieves with openings of 150 and 106 μm were used, and the sieves having the largest openings were stacked on top of the receiver from the bottom in ascending order of opening. After 5 minutes of shaking, the remaining powder in each sieve and receiver was collected and weighed.
The results are shown in Table 2 and FIG.
表2及び図1に示すように、HMBと共にヒハツ又はヘスペリジンを用いた混合物(実施例1~3)における150μm未満の粒度の小さい粉末の回収量は、HMB単独の場合(比較例1)よりも増加しており、ダマの形成(凝集)が抑制されたことがわかる。また、実施例1~3の粉末回収量は、HMB、ヒハツ、ヘスペリジンそれぞれ単独の場合(比較例1~3)よりも増加しており、組み合せによる相乗的な凝集抑制効果がみられた。さらに、実施例4~10に示すように、ブドウ及び/又はトウガラシを加えることにより、その凝集抑制効果はさらに顕著なものとなった。 As shown in Table 2 and FIG. 1, the recovery amount of powder with a small particle size of less than 150 μm in the mixture using Hihatsu or hesperidin with HMB (Examples 1 to 3) was higher than that in the case of HMB alone (Comparative Example 1). It can be seen that the formation (aggregation) of lumps was suppressed. In addition, the amount of powder recovered in Examples 1 to 3 was greater than when HMB, Hihatsu, and hesperidin were used alone (Comparative Examples 1 to 3), indicating a synergistic aggregation-inhibiting effect due to the combination. Furthermore, as shown in Examples 4 to 10, the addition of grapes and/or hot peppers made the anticoagulant effect even more remarkable.
<製造例1~6>
下記表3の配合にて、HMB又はその塩と、ヒハツ及び/又はヘスペリジンを含有する顆粒剤を製造した。
<Production Examples 1 to 6>
Granules containing HMB or a salt thereof and Hihatsu and/or hesperidin were produced according to the formulations shown in Table 3 below.
<製造例7~12>
下記表4の配合にて、HMB又はその塩と、ヒハツ及び/又はヘスペリジンを含有する顆粒剤を製造した。
<Production Examples 7 to 12>
Granules containing HMB or a salt thereof and Hihatsu and/or hesperidin were produced according to the formulations shown in Table 4 below.
<製造例13~18>
下記表5の配合にて、HMB又はその塩と、ヒハツ及び/又はヘスペリジンを含有する粉末飲料を製造した。
<Production Examples 13 to 18>
Powdered beverages containing HMB or a salt thereof and Hihatsu and/or hesperidin were produced according to the formulations shown in Table 5 below.
<製造例19~24>
下記表6の配合にて、HMB又はその塩と、ヒハツ及び/又はヘスペリジンを含有するソフトカプセルを製造した。
<Production Examples 19 to 24>
Soft capsules containing HMB or a salt thereof and Hihatsu and/or hesperidin were produced according to the formulations shown in Table 6 below.
<製造例25~30>
下記表7の配合にて、HMB又はその塩と、ヒハツ及び/又はヘスペリジンを含有するハードカプセルを製造した。
<Production Examples 25-30>
Hard capsules containing HMB or a salt thereof and Hihatsu and/or hesperidin were produced according to the formulations shown in Table 7 below.
<製造例31~36>
下記表8の配合にて、HMB又はその塩と、ヒハツ及び/又はヘスペリジンを含有する液体飲料を製造した。
<Production Examples 31 to 36>
Liquid beverages containing HMB or a salt thereof and Hihatsu and/or hesperidin were produced according to the formulations shown in Table 8 below.
<製造例37~42>
下記表9の配合にて、HMB又はその塩と、ヒハツ及び/又はヘスペリジンを含有する錠剤を製造した。
<Production Examples 37 to 42>
Tablets containing HMB or a salt thereof and Hihatsu and/or hesperidin were produced according to the formulations shown in Table 9 below.
本発明の経口組成物は、いわゆる健康食品等として用いることができることから、産業上有用である。特に、錠状、ハードカプセル状、粉末状、顆粒状、丸状、チュアブル錠状の健康食品が有用である。 The oral composition of the present invention is industrially useful because it can be used as a so-called health food or the like. In particular, health foods in the form of tablets, hard capsules, powders, granules, rounds, and chewable tablets are useful.
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