JP6844857B2 - A skin moisturizing composition containing acacia bark-derived products - Google Patents
A skin moisturizing composition containing acacia bark-derived products Download PDFInfo
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- JP6844857B2 JP6844857B2 JP2018092041A JP2018092041A JP6844857B2 JP 6844857 B2 JP6844857 B2 JP 6844857B2 JP 2018092041 A JP2018092041 A JP 2018092041A JP 2018092041 A JP2018092041 A JP 2018092041A JP 6844857 B2 JP6844857 B2 JP 6844857B2
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- acacia
- bark
- skin
- derived
- extract
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- 229960002663 thioctic acid Drugs 0.000 description 1
- 230000005068 transpiration Effects 0.000 description 1
- 239000013638 trimer Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 238000003809 water extraction Methods 0.000 description 1
- 230000002087 whitening effect Effects 0.000 description 1
- 239000002023 wood Substances 0.000 description 1
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- Fodder In General (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
Description
本発明は、アカシア属(Acacia)に属する樹木に由来する皮膚保湿用組成物、及びその食品及び医薬部外品などとしての用途に関する。 The present invention relates to a skin moisturizing composition derived from a tree belonging to the genus Acacia, and its use as a food or quasi-drug.
アカシア属の樹木については、アカシア蜂蜜やその樹皮から抽出されるタンニンが皮なめし剤や木材用接着剤として利用できることが知られている。最近はアカシア属の抽出物にCOX−2の選択的阻害効果(特許文献1)のあることやアカシア属の樹皮に活性酸素消去効果(特許文献2)やチロシナーゼ活性阻害効果による美白効果(特許文献3)、掻痒の予防や治療効果(特許文献4)のあることが報告されている。 For trees of the genus Acacia, it is known that acacia honey and tannins extracted from its bark can be used as skin tanning agents and wood adhesives. Recently, the extract of Acacia has a selective inhibitory effect on COX-2 (Patent Document 1), and the bark of Acacia has an active oxygen scavenging effect (Patent Document 2) and a whitening effect due to a tyrosinase activity inhibitory effect (Patent Document 1). 3) It has been reported that it has a preventive and therapeutic effect on pruritus (Patent Document 4).
アカシア属の1樹種であるモリシマアカシア(Acacia mearnsii)の樹皮から得られる熱水抽出物については、アトピー性皮膚炎のマウスを用いた試験において、皮脂の水分保持に重要な役割を担うセラミドの低下を抑制し、さらに皮膚のセラミド含量を減少させる皮膚のセラミダーゼのmRNAの発現量を抑制したことが報告されている(非特許文献1)。 For the hot water extract obtained from the bark of Acacia mearnsii, a species of the genus Acacia, a decrease in ceramide, which plays an important role in water retention of sebum in a test using mice with atopic dermatitis. It has been reported that the expression level of mRNA of ceramide in the skin, which suppresses the amount of ceramide in the skin and further reduces the ceramide content in the skin, was suppressed (Non-Patent Document 1).
しかしながら、アカシア属の樹皮由来物が、アトピー性皮膚炎ではない対象に経口摂取させて用いられても、皮膚からの水分蒸散量を抑制して角層水分量を改善するといった保湿効果を発揮することは知られていなかった。 However, even if the bark-derived product of the genus Acacia is orally ingested by a subject who does not have atopic dermatitis, it exerts a moisturizing effect such as suppressing the amount of water evaporation from the skin and improving the amount of water in the stratum corneum. It was not known.
本発明は、アカシア属樹皮由来物の研究過程で知見を得たものであり、経口摂取が可能で、長期に摂取しても、副作用などのおそれがない、アトピー性皮膚炎ではない対象に用いることができる皮膚保湿用組成物、及びその食品及び医薬部外品などとしての用途を提供することを課題とする。 The present invention was obtained in the course of research on quasi-drugs derived from the genus Acacia, and is used for subjects who are not atopic dermatitis and can be taken orally and have no risk of side effects even if taken for a long period of time. An object of the present invention is to provide a skin moisturizing composition that can be used, and its use as a food or quasi-drug.
本発明者らは、上記課題を解決すべく、鋭意研究を重ねた結果、アカシア属樹皮由来物が、経口摂取により、アトピー性皮膚炎ではないヒトに対しても、皮膚からの水分蒸散量を抑制し角層水分量を改善させる保湿効果を発揮することを見出し、本発明を完成させた。
すなわち、本発明は、アカシア属樹皮由来物を含有することを特徴とする、アトピー性皮膚炎ではない対象に経口摂取させて用いられる皮膚保湿用組成物に関する。
また、本発明は、アトピー性皮膚炎ではない対象に経口摂取させて用いられる皮膚保湿用組成物としてのアカシア属樹皮由来物にも関する。
さらに、本発明は、アトピー性皮膚炎ではない対象に経口摂取させて用いられる皮膚保湿用組成物を製造するための、アカシア属樹皮由来物を使用する方法にも関する。
As a result of intensive studies to solve the above problems, the present inventors have obtained the amount of water evaporated from the skin of acacia bark-derived products by oral ingestion even in humans who do not have atopic dermatitis. The present invention has been completed by finding that it exerts a moisturizing effect of suppressing and improving the water content of the stratum corneum.
That is, the present invention relates to a skin moisturizing composition, which is characterized by containing a product derived from the bark of the genus Acacia and is used orally ingested by a subject who does not have atopic dermatitis.
The present invention also relates to a product derived from the bark of the genus Acacia as a skin moisturizing composition used by orally ingesting a subject who does not have atopic dermatitis.
Furthermore, the present invention also relates to a method of using an acacia bark-derived product for producing a skin moisturizing composition used by orally ingesting a subject who does not have atopic dermatitis.
本発明によれば、優れた皮膚保湿効果を有する組成物を提供することができる。本発明の組成物は、経口摂取により、アトピー性皮膚炎ではない対象に対しても、皮膚からの水分蒸散量を抑制して、保湿効果を奏することができる。また、本発明の組成物は、安全で、長期に経口摂取しても副作用などの心配が少ない。 According to the present invention, it is possible to provide a composition having an excellent skin moisturizing effect. By oral ingestion, the composition of the present invention can suppress the amount of water evaporation from the skin and exert a moisturizing effect even on a subject who does not have atopic dermatitis. In addition, the composition of the present invention is safe and there is little concern about side effects even if it is orally ingested for a long period of time.
本発明で使用できるアカシア属樹皮由来物とは、アカシア属(Acacia)に属する樹木(以下、「アカシア」又は「アカシア属」という)の樹皮を原料として得られるものであれば特に制限されず、例えば、アカシア属の樹皮の細片、粉末及びこれらの懸濁液、アカシア属の樹皮の抽出液、濃縮抽出液、及びエキス粉末などの抽出物ならびにこの抽出物を精製して得た精製物が挙げられる。優れた皮膚保湿効果が得られる上で、アカシア属の樹皮の抽出物、特にアカシア樹皮ポリフェノール、例えばアカシア樹皮由来プロアントシアニジンが好ましい。
本発明では、これらアカシア属樹皮由来物を1種のみ使用してもよいし、2種以上併用してもよい。
The product derived from the bark of the genus Acacia that can be used in the present invention is not particularly limited as long as it is obtained from the bark of a tree belonging to the genus Acacia (hereinafter referred to as "Acacia" or "genus Acacia"). For example, extracts such as acacia bark debris, powder and suspensions thereof, acacia bark extract, concentrated extract, and extract powder, as well as purified products obtained by purifying this extract. Can be mentioned. An extract of the bark of the genus Acacia, particularly an acacia bark polyphenol, for example, acacia bark-derived proanthocyanidins, is preferable in order to obtain an excellent skin moisturizing effect.
In the present invention, only one kind of these acacia bark-derived products may be used, or two or more kinds may be used in combination.
本発明で使用できるアカシアは、アカシア属に属する樹木であれば特に制限されないが、優れた皮膚保湿効果があるアカシア属樹皮由来物が得られる点で、マメ科アカシア属、好ましくはマメ科アカシア属Phyllodineae亜属の樹皮が使用される。なかでも学名:Acacia mearnsii De Wild.(一般名ブラックワトル)、学名:Acacia mangium Willd.(一般名アカシアマンギュウム)、学名:Acacia dealbata Link、学名:Acacia decurrens Willd.、及び学名:Acacia pycnantha Benth.からなる群より選ばれるアカシア属の樹皮が好ましく、特にAcacia mearnsii De Wild.及びAcacia mangium Willd.、とりわけAcacia mearnsii De Wild.が好ましい。
本発明では、これらアカシア属の樹皮を1種のみ使用してもよいし、2種以上併用してもよい。
The acacia that can be used in the present invention is not particularly limited as long as it is a tree belonging to the genus Acacia, but the genus Acacia of the leguminous family, preferably the genus Acacia of the leguminous family, is obtained in that a bark-derived product of the genus Acacia having an excellent skin moisturizing effect can be obtained. The bark of the subgenus Phyllodineae is used. Among them, scientific name: Acacia mearnsii De Wild. (generic name Black Wattle), scientific name: Acacia mangium Willd. (generic name Acacia mangium), scientific name: Acacia dealbata Link, scientific name: Acacia decurrens Willd., And scientific name: Acacia pycnantha Benth The bark of the genus Acacia selected from the group consisting of. Is preferable, and Acacia mearnsii De Wild. And Acacia mangium Willd., Especially Acacia mearnsii De Wild. Are preferable.
In the present invention, only one kind of these Acacia bark may be used, or two or more kinds may be used in combination.
上記アカシア属の樹皮は、通常、樹木として伐採したのち、樹皮だけを剥がして、乾燥することなく用いてもよいし、採取後に乾燥して用いてもよい。
上記アカシア属の樹皮を乾燥することなく用いる場合、木部から剥がした樹皮を、そのまま利用してもよいし、粉砕して利用してもよい。なお、剥がされた樹皮はすぐに利用してもよいし、数日放置してから利用してもよい。
上記アカシア属の樹皮を採取後に乾燥して用いる場合、木部から剥がした樹皮を、そのまま乾燥してもよいし、粉砕して乾燥してもよい。なお、剥がされた樹皮はすぐに乾燥してもよいし、数日放置してから乾燥してもよい。乾燥した樹皮から効率よく樹皮抽出物を得るためには、天日、又は熱風、電子線、若しくは加熱などの人工的作業で乾燥させた樹皮を用いてもよい。
なお、アカシア属の樹皮は、外皮とやや繊維質の内皮とからなり、含水率20%程度以下に乾燥するとハンマーミルなどの粉砕機で容易に微粉化する。
本発明では、アカシア属の樹皮として、このアカシア属の内皮と外皮の両方を一緒に用いてもよいし、いずれか一方のみを用いてもよい。
The bark of the genus Acacia is usually used after being cut down as a tree, and then only the bark is peeled off and used without drying, or it may be used after being collected and dried.
When the bark of the genus Acacia is used without drying, the bark peeled from the xylem may be used as it is or may be crushed and used. The peeled bark may be used immediately or may be left for several days before use.
When the bark of the genus Acacia is collected and then dried and used, the bark peeled from the xylem may be dried as it is, or may be crushed and dried. The peeled bark may be dried immediately or left for several days before being dried. In order to efficiently obtain the bark extract from the dried bark, the bark dried in the sun or by artificial work such as hot air, electron beam, or heating may be used.
The bark of the genus Acacia is composed of an exodermis and a slightly fibrous endothelium, and when it is dried to a water content of about 20% or less, it is easily pulverized by a crusher such as a hammer mill.
In the present invention, as the bark of the genus Acacia, both the endodermis and the exodermis of the genus Acacia may be used together, or only one of them may be used.
前記アカシア属の樹皮の細片は、慣用の方法に従って、アカシア属の樹皮を適当な大きさに粉砕して得ることができる。
また、前記アカシア属の樹皮の粉末は、アカシア属の樹皮を慣用の方法で粉砕し粉末化して得ることができるが、特に、粒径が100μm以下、特に50〜70μmである粉末が好ましい。粉末の分画は、含水率20%以下に乾燥した樹皮を適当な大きさ、例えば粒径1.6mm以下程度に粉砕し、得られた粉末を振動ふるい機などで分級して所要の粉末を得ることができる。
The Acacia bark strips can be obtained by pulverizing the Acacia bark to an appropriate size according to a conventional method.
The powder of the bark of the genus Acacia can be obtained by pulverizing the bark of the genus Acacia by a conventional method and pulverizing it, and a powder having a particle size of 100 μm or less, particularly 50 to 70 μm is particularly preferable. For powder fractionation, bark dried to a moisture content of 20% or less is crushed to an appropriate size, for example, a particle size of about 1.6 mm or less, and the obtained powder is classified by a vibrating sieve or the like to obtain the required powder. Obtainable.
上記アカシア属の樹皮の抽出物は、アカシア属の樹皮を慣用の方法に従って抽出して得ることができる。優れた皮膚保湿効果を有するアカシア属の樹皮の抽出物を得るために、アカシア属の樹皮をアルコールや極性溶媒で抽出することが好ましい。
このようなアルコールとしてエタノールが、極性溶媒として水などが使用できるが、水、エタノール以外にも、食品あるいは薬剤の製造に許容される有機溶媒、例えば、メタノール、1−プロパノール、2−プロパノール、1−ブタノール、2−ブタノール、ブタン、アセトン、ヘキサン、シクロヘキサン、プロピレングリコール、含水エタノール、含水プロピレングリコール、エチルメチルケトン、グリセリン、酢酸メチル、酢酸エチル、ジエチルエーテル、ジクロロメタン、食用油脂、1,1,1,2−テトラフルオロエタン、及び1,1,2−トリクロロエテンを用いることができる。水、エタノール、及びこれらの有機溶媒は単独で用いてもよいし、組み合わせて用いてもよい。例えば、水とエチルアルコールなどのアルコールとの混合溶媒が使用できる。
さらに、同一又は異なる溶媒によって複数回抽出操作を行ってもよい。
優れた皮膚保湿効果を有する抽出物を得る上で、アカシア属の樹皮からの水又は熱水による抽出物をさらにエタノールなどの上記溶媒で抽出して得た抽出物を使用してもよい。
The above-mentioned extract of the bark of the genus Acacia can be obtained by extracting the bark of the genus Acacia according to a conventional method. In order to obtain an extract of the bark of the genus Acacia having an excellent skin moisturizing effect, it is preferable to extract the bark of the genus Acacia with alcohol or a polar solvent.
Ethanol can be used as such an alcohol, and water or the like can be used as a polar solvent. In addition to water and ethanol, organic solvents permitted for the production of foods or drugs, such as methanol, 1-propanol, 2-propanol, 1 -Butanol, 2-butanol, butane, acetone, hexane, cyclohexane, propylene glycol, hydrous ethanol, hydrous propylene glycol, ethylmethylketone, glycerin, methyl acetate, ethyl acetate, diethyl ether, dichloromethane, edible fats and oils, 1,1,1 , 2-Tetrafluoroethane, and 1,1,2-trichloroethane can be used. Water, ethanol, and these organic solvents may be used alone or in combination. For example, a mixed solvent of water and an alcohol such as ethyl alcohol can be used.
Further, the extraction operation may be performed a plurality of times with the same or different solvents.
In order to obtain an extract having an excellent skin moisturizing effect, an extract obtained by further extracting an extract from the bark of the genus Acacia with water or hot water with the above solvent such as ethanol may be used.
抽出は、通常、アカシア属の樹皮の粉砕物、あるいは樹皮の細片や粉末などに溶媒を加えて必要に応じて攪拌して行うが、温度や時間あるいは固液比については特に限定されない。抽出方法は、特に制限されず、例えば、加温抽出法、超臨界流体抽出法などが用いられ、また圧力を加えた条件のもと、常温又は加熱しながら抽出を行ってもよい。
溶媒に水を用いる場合には、熱水で抽出してもよい。得られた抽出液は、そのまま凍結乾燥あるいは噴霧乾燥してもよいし、あるいは減圧濃縮してから凍結乾燥又は噴霧乾燥してもよい。得られる抽出物は、抽出液、溶液、粉末、濃縮液、ペースト状物などの種々の形態とすることができ、広く必要に応じて使用できる。
さらに、これらの形態で得られた本発明のアカシア属の樹皮抽出物はそのまま本発明の組成物として使用できるほか、さらに必要に応じて精製し、その精製物も本発明の組成物として使用することができる。
Extraction is usually carried out by adding a solvent to crushed acacia bark, bark fragments or powder, and stirring as necessary, but the temperature, time, or solid-liquid ratio is not particularly limited. The extraction method is not particularly limited, and for example, a heating extraction method, a supercritical fluid extraction method, or the like may be used, and extraction may be performed at room temperature or while heating under pressure.
When water is used as the solvent, it may be extracted with hot water. The obtained extract may be freeze-dried or spray-dried as it is, or may be freeze-dried or spray-dried after being concentrated under reduced pressure. The obtained extract can be in various forms such as an extract, a solution, a powder, a concentrate, and a paste, and can be widely used as needed.
Further, the bark extract of the genus Acacia of the present invention obtained in these forms can be used as it is as the composition of the present invention, and further purified as necessary, and the purified product is also used as the composition of the present invention. be able to.
本発明では、アカシア属樹皮由来物として、アカシア属の樹皮に含有されている成分も例示される。このような成分として、アカシア樹皮ポリフェノールなどが例示される。特にアカシア樹皮ポリフェノール、とりわけアカシア樹皮由来プロアントシアニジンは、優れた皮膚保湿効果を示すので好ましい成分である。
本発明のアカシア樹皮由来プロアントシアニジンとは、例えば、(−)−フィセチニドール、(−)−ロビネチニドール、(+)−カテキン、及び(+)−ガロカテキンなどのフラバン−3−オール;ならびにこれらフラバン−3−オール及び/又はフラバン−3,4−オールを基本骨格とするフラバノール類がC4−C8、C4−C6結合した重合体である縮合型タンニン、例えば、プロロビネチニジン及びプロフィセチニジンなどの2量体の縮合型タンニン、及び主にロビネチニドール骨格を伸張単位とする3量体以上の縮合型タンニンなどを意味する。ここで、このような縮合型タンニンとして分子量280〜5000、とりわけ300〜3000のものが好ましい。本発明で用いるアカシア樹皮由来プロアントシアニジンは、上記アカシア属の樹皮の粉末などを熱水抽出することにより得ることができる。
また、アカシア樹皮由来プロアントシアニジンを含むアカシア樹皮由来物製品としてはMIMOSA Central Co-operative Ltd.製の登録商標MIMOSA ME POWDER、MIMOSA MS POWDER、MIMOSA GS POWDER、MIMOSA FS POWDER、MIMOSA WS POWDER、MIMOSA RG POWDER、MIMOSA RN POWDER、MIMOSA DK POWDER、MIMOSA AL POWDER、MIMOSA CR POWDER、GOLDEN MIMOSA POWDER、あるいはUCL製のMimosa Me Food Grade Powderなどが例示される。
In the present invention, as a product derived from the bark of the genus Acacia, a component contained in the bark of the genus Acacia is also exemplified. Examples of such components include acacia bark polyphenols. In particular, acacia bark polyphenols, particularly acacia bark-derived proanthocyanidins, are preferable components because they exhibit excellent skin moisturizing effects.
The acacia bark-derived proanthocyanidins of the present invention include, for example, flavan-3-ols such as (-)-fisetinidol, (-)-robinetinidol, (+)-catechin, and (+)-galocatechin; and these flavan-3s. -Ol and / or flavan-3,4-ol Condensed tannin, which is a polymer in which flavanols having a basic skeleton of C4-C8 and C4-C6 are bonded, for example, 2 such as proanthocyanidins and profisetinidines. It means condensed tannins of quanta, and condensed tannins of trimers or more having a flavanetinidol skeleton as an extension unit. Here, as such condensed tannins, those having a molecular weight of 280 to 5000, particularly preferably 300 to 3000. The acacia bark-derived proanthocyanidin used in the present invention can be obtained by hot water extraction of the above-mentioned powder of the bark of the genus Acacia.
In addition, as acacia bark-derived products containing acacia bark-derived proanthocyanidins, registered trademarks MIMOSA ME POWDER, MIMOSA MS POWDER, MIMOSA GS POWDER, MIMOSA FS POWDER, MIMOSA WS POWDER, MIMOSA RG POWDER manufactured by MIMOSA Central Co-operative Ltd. , MIMOSA RN POWDER, MIMOSA DK POWDER, MIMOSA AL POWDER, MIMOSA CR POWDER, GOLDEN MIMOSA POWDER, or UCL's Mimosa Me Food Grade Powder.
本発明の組成物は、アカシア属樹皮由来物、例えば、アカシア属の樹皮、その抽出物、その精製物、又はアカシア樹皮ポリフェノール、例えばアカシア樹皮由来プロアントシアニジンそのものであってもよいし、それらのみを有効成分として含んでいてもよい。
また、本発明の組成物は、本発明の効果を損なわない限り、他の皮膚保湿効果を有する物質、例えばヒアルロン酸、コラーゲン、α-リポ酸、コエンザイムQ10、プラセンタ、セラミド、ムコ多糖、プロテオグリカン、ビタミン類、ポリフェノール類(カテキン類、イソフラボン、リンゴポリフェノール、松樹皮抽出物、及びアントシアニンなど)、米麹、酒麹、及び天然保湿因子などを含んでいてもよい。
The composition of the present invention may be an acacia bark-derived product, for example, an acacia bark, an extract thereof, a purified product thereof, or an acacia bark polyphenol, for example, an acacia bark-derived proanthocyanidin itself, or only them. It may be contained as an active ingredient.
In addition, the composition of the present invention contains other substances having a skin moisturizing effect such as hyaluronic acid, collagen, α-lipoic acid, coenzyme Q10, placenta, ceramide, mucopolysaccharide, proteoglycan, as long as the effects of the present invention are not impaired. It may contain vitamins, polyphenols (catechins, isoflavones, apple polyphenols, pine bark extracts, and anthocyanins, etc.), rice koji, sake koji, and natural moisturizing factors.
本発明の組成物は、本発明の効果を損なわない限り、賦形剤、甘味料、酸味料、増粘剤、香料、色素、乳化剤及びその他に医薬品や食品で一般に利用されている素材を含んでいてもよい。 The composition of the present invention contains excipients, sweeteners, acidulants, thickeners, flavors, pigments, emulsifiers and other materials commonly used in pharmaceuticals and foods, as long as the effects of the present invention are not impaired. You may be.
本発明の組成物を経口摂取させる対象は、アトピー性皮膚炎でなければ、特に制限されないが、例えば、肌が乾燥しているヒト、例えば顔や手などの皮膚が乾燥しているヒト、あるいは、肌の乾燥により、肌に不快感、例えばムズムズ感を感じているヒトなどが挙げられる。 The subject to which the composition of the present invention is orally ingested is not particularly limited as long as it is not atopic dermatitis, but for example, a person with dry skin, for example, a person with dry skin such as face or hands, or a person with dry skin, or , Humans who feel discomfort in their skin due to dry skin, for example, a feeling of muzzle.
本発明の組成物は、アトピー性皮膚炎を除く、皮膚の保湿効果が有効な疾患や症状の予防又は治療に使用することできる。このような疾患や症状として、皮脂欠乏症、皮膚掻痒症、老人性乾皮症、及び乾癬などが例示される。 The composition of the present invention can be used for the prevention or treatment of diseases and symptoms for which the moisturizing effect of the skin is effective, except for atopic dermatitis. Examples of such diseases and symptoms include sebum deficiency, pruritus cutaneous, senile xerosis, and psoriasis.
本発明に係る組成物は、皮膚保湿を目的とする食品又は動物用飼料として、例えば、健康食品、保健機能食品(例えば、特定保健用食品、栄養機能食品、及び機能性表示食品)、健康補助食品、美容食品、又は栄養補助食品(サプリメント)、特に機能性表示食品として使用することができる。これら食品及び動物用飼料は、例えば、お茶及びジュースなどの飲料水;アイスクリーム、ゼリー、あめ、チョコレート、及びチューインガムなどの形態であってもよい。また、液剤、粉剤、粒剤、カプセル剤、又は錠剤の形態であってもよい。ここで、動物用飼料の動物には、ペット動物、畜産動物、又は動物園等で飼育されている動物を含む、皮膚保湿を必要とする全ての動物を含む。 The composition according to the present invention is, for example, a health food, a health functional food (for example, a specified health food, a nutritionally functional food, and a food with a functional claim), a health supplement, as a food for the purpose of moisturizing the skin or a feed for animals. It can be used as a food, beauty food, or nutritional supplement (supplement), especially as a food with functional claims. These foods and animal feeds may be in the form of drinking water such as tea and juice; ice cream, jelly, candy, chocolate, chewing gum and the like. It may also be in the form of a liquid, a powder, a granule, a capsule, or a tablet. Here, the animals for animal feed include all animals that require skin moisturization, including pet animals, livestock animals, and animals bred in zoos and the like.
また、本発明に係る組成物は、前述の疾患若しくは症状の予防若しくは治療を目的とする医薬品として、又は皮膚の保湿を目的とする医薬部外品として使用することができる。これら医薬品や医薬部外品は、例えば、錠剤、コーティング錠、糖衣錠、硬若しくは軟ゼラチンカプセル剤、液剤、乳濁剤、又は懸濁剤の形態で経口的に投与する。 In addition, the composition according to the present invention can be used as a pharmaceutical product for the purpose of preventing or treating the above-mentioned diseases or symptoms, or as a quasi-drug for the purpose of moisturizing the skin. These drugs and quasi-drugs are orally administered in the form of tablets, coated tablets, sugar-coated tablets, hard or soft gelatin capsules, liquids, emulsions, or suspensions, for example.
本発明に係る組成物の摂取量は、特に制限されないが、剤型、ならびに使用者若しくは患者などの摂取者又は摂取動物の年齢、体重及び症状に応じて適宜選択することができる。例えば、有効成分量として1日あたり摂取者又は摂取動物の体重1kgにつきアカシア樹皮由来プロアントシアニジン量で0.0001〜1g、好ましくは0.0001〜0.5g、より好ましくは0.001〜0.05gを経口摂取することが、優れた皮膚保湿効果が得られるので、望ましい。
摂取期間は、使用者又は患者の年齢、症状に応じて任意に定めることができる。
The ingestion amount of the composition according to the present invention is not particularly limited, but can be appropriately selected depending on the dosage form and the age, weight and symptom of the ingestor such as the user or the patient or the ingesting animal. For example, the amount of proanthocyanidin derived from acacia bark per day as the amount of active ingredient per 1 kg of body weight of the ingestor or the ingested animal is 0.0001 to 1 g, preferably 0.0001 to 0.5 g, and more preferably 0.001 to 0. Oral ingestion of 05 g is desirable because it provides an excellent skin moisturizing effect.
The ingestion period can be arbitrarily determined according to the age and symptoms of the user or patient.
以下、実施例を挙げて本発明をさらに詳しく具体的に説明するが、本発明はこれらに限定されるものではない。 Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited thereto.
以下、製造例、配合例、試験例を挙げて本発明を更に詳しく具体的に説明するが、本発明はこれらに限定されるものではない。特に、ここでは本発明のアカシア属の樹皮を外皮と内皮とに分けないで実施例を示しているが、外皮を内皮から分離してそれぞれ使用することもできる。
以下の製造例、試験例等において、本発明の各アカシアをそれぞれの学名の後の括弧内に示した番号で示す。例えば、学名:Acacia mearnsii De Wild.のアカシアをアカシアNo.1と記す。
学名:Acacia mearnsii De Wild.(No.1)、学名:Acacia mangium Willd.(No.2)、学名:Acacia dealbata Link(No.3)、学名:Acacia decurrens Willd.(No.4)、学名:Acacia pycnantha Benth.(No.5)。
また、%は特に示さない限り重量%を意味する。
Hereinafter, the present invention will be described in more detail with reference to production examples, compounding examples, and test examples, but the present invention is not limited thereto. In particular, although examples are shown here without dividing the bark of the genus Acacia of the present invention into an exodermis and an endothelium, the exodermis can be separated from the endothelium and used respectively.
In the following production examples, test examples, etc., each acacia of the present invention is indicated by the number shown in parentheses after each scientific name. For example, the scientific name: Acacia mearnsii De Wild. Acacia is referred to as Acacia No.1.
Scientific name: Acacia mearnsii De Wild. (No.1), Scientific name: Acacia mangium Willd. (No.2), Scientific name: Acacia dealbata Link (No.3), Scientific name: Acacia decurrens Willd. (No.4), Scientific name: Acacia pycnantha Benth. (No.5).
Further,% means% by weight unless otherwise specified.
アカシア樹皮粉末の製造例1
アカシアNo.1の樹皮を含水率20%以下まで乾燥し、その乾燥樹皮をハンマーミルで1.6mm以下(10メッシュ篩(タイラー:Tyler)通過)の粉末に粉砕した後、更に振動ふるい機で分級し、63μm以下(250メッシュ篩下)の微粉末を得た。
同様にして、残り4種のアカシアNo.2〜5の樹皮を粉砕してそれぞれ63μm以下の微粉末を得た。種類によって250メッシュ篩通過の微粉末の収率に多少の差はあるが、目的とする微粉末が得られた。
Production example of acacia bark powder 1
The bark of Acacia No. 1 is dried to a water content of 20% or less, and the dried bark is crushed into a powder of 1.6 mm or less (passed through a 10-mesh sieve (Tyler)) with a hammer mill, and then further with a vibrating sieve. The classification was performed to obtain a fine powder having a size of 63 μm or less (under a 250 mesh sieve).
In the same manner, the barks of the remaining four types of acacia Nos. 2 to 5 were crushed to obtain fine powders of 63 μm or less, respectively. Although there are some differences in the yield of the fine powder passing through the 250 mesh sieve depending on the type, the desired fine powder was obtained.
アカシア樹皮抽出物の製造例2
本発明の各アカシアNo.1〜5の樹皮をそれぞれ乾燥することなく、そのまま、ハンマーミルで1.6mm以下の粉末に粉砕した後、この粉砕樹皮100gに対して5倍量の熱水を加え、沸騰してから15分間抽出し、10〜20μmのフィルターを用いて濾過した。得られた濾液をスプレードライヤで噴霧乾燥し、各樹皮の熱水抽出物を16g得た。
以下、各樹皮の熱水抽出物はアカシアNo.1〜5熱水抽出物と記す。
Production example 2 of acacia bark extract
The bark of each acacia No. 1 to 5 of the present invention is crushed into a powder of 1.6 mm or less with a hammer mill as it is without being dried, and then 5 times the amount of hot water is added to 100 g of the crushed bark. After boiling, the mixture was extracted for 15 minutes and filtered using a 10 to 20 μm filter. The obtained filtrate was spray-dried with a spray dryer to obtain 16 g of a hot water extract of each bark.
Hereinafter, the hot water extract of each bark is referred to as Acacia No. 1 to 5 hot water extract.
アカシア樹皮抽出物の製造例3
本発明の各アカシアNo.1〜5の樹皮をそれぞれ含水率20%以下まで乾燥し、その乾燥樹皮をハンマーミルで1.6mm以下の粉末に粉砕した後、この乾燥粉砕樹皮100gに対して5倍量の熱水を加え、沸騰してから15分間抽出し、10〜20μmのフィルターを用いて濾過した。得られた濾液をスプレードライヤで噴霧乾燥し、各樹皮の熱水抽出物を40g得た。
Production Example 3 of Acacia Bark Extract
The bark of each acacia No. 1 to 5 of the present invention is dried to a moisture content of 20% or less, the dried bark is crushed into a powder of 1.6 mm or less with a hammer mill, and then 5 per 100 g of the dry crushed bark. Double the amount of hot water was added, the mixture was boiled, extracted for 15 minutes, and filtered using a 10 to 20 μm filter. The obtained filtrate was spray-dried with a spray dryer to obtain 40 g of a hot water extract of each bark.
アカシア樹皮抽出物の製造例4
本発明のアカシアNo.1の樹皮をそのまま乾燥することなく、ハンマーミルで1.6mm以下の粉末に粉砕した後、この粉砕樹皮100gに対して5倍量のエタノールを加え、沸騰させて還流させながら15分間抽出し、10〜20μmのフィルターを用いて濾過した。得られた濾液からエタノールを蒸発させた後、濃縮液をクローズドスプレードライヤで噴霧乾燥し、樹皮のエタノール抽出物(以下、アカシアNo.1エタノール抽出物の如く記す)16gを得た。
同様にして、アカシアNo.2〜5エタノール抽出物を得た。
Production Example 4 of Acacia Bark Extract
The bark of Acacia No. 1 of the present invention is crushed into a powder of 1.6 mm or less with a hammer mill without being dried as it is, and then 5 times the amount of ethanol is added to 100 g of the crushed bark, and the mixture is boiled and refluxed. Extraction was carried out for 15 minutes, and the mixture was filtered using a filter of 10 to 20 μm. After evaporating ethanol from the obtained filtrate, the concentrated solution was spray-dried with a closed spray dryer to obtain 16 g of an ethanol extract of bark (hereinafter referred to as Acacia No. 1 ethanol extract).
Similarly, acacia No. 2-5 ethanol extracts were obtained.
アカシア樹皮抽出物の製造例5
本発明のアカシアNo.1の樹皮を含水率20%以下まで乾燥し、その乾燥樹皮をハンマーミルで1.6mm以下の粉末に粉砕した後、この乾燥粉砕樹皮100gに対して5倍量のエタノールを加え、沸騰させて還流させながら15分間抽出し、10〜20μmのフィルターを用いて濾過した。得られた濾液からエタノールを蒸発させた後、濃縮液をクローズドスプレードライヤで噴霧乾燥し、樹皮のエタノール抽出物40gを得た。
同様にして、アカシアNo.2〜5のエタノール抽出物を得た。
Production Example 5 of Acacia Bark Extract
The bark of Acacia No. 1 of the present invention is dried to a water content of 20% or less, the dried bark is crushed into a powder of 1.6 mm or less with a hammer mill, and then 5 times the amount of ethanol is added to 100 g of the dried crushed bark. Was added, and the mixture was boiled and refluxed for 15 minutes, and filtered using a 10 to 20 μm filter. After evaporating ethanol from the obtained filtrate, the concentrate was spray-dried with a closed spray dryer to obtain 40 g of an ethanol extract of bark.
Similarly, ethanol extracts of Acacia Nos. 2 to 5 were obtained.
アカシア樹皮抽出物の製造例6
製造例2で得られたアカシアNo.1熱水抽出物10gに3倍量のエタノールを加え、沸騰させて還流させながら15分間抽出し、10〜20μmのフィルターを用いて濾過した。得られた濾液からエタノールを蒸発させて、それに水を加えてから凍結乾燥させて9gの抽出物(以下、アカシアNo.1熱水抽出物エタノール画分の如く記す)を得た。
同様にして、アカシアNo.2〜5の熱水抽出物エタノール画分を得た。
Production Example 6 of Acacia Bark Extract
To 10 g of the Acacia No. 1 hot water extract obtained in Production Example 2, 3 times the amount of ethanol was added, and the mixture was extracted for 15 minutes while boiling and refluxing, and filtered using a 10 to 20 μm filter. Ethanol was evaporated from the obtained filtrate, water was added thereto, and then freeze-dried to obtain 9 g of an extract (hereinafter referred to as Acacia No. 1 hot water extract ethanol fraction).
In the same manner, the ethanol fraction of the hot water extract of Acacia Nos. 2 to 5 was obtained.
アカシア樹皮抽出物の製造例7
製造例3で得られたアカシアNo.1の熱水抽出物10gに3倍量のエタノールを加え、沸騰させて還流させながら15分間抽出し、10〜20μmのフィルターを用いて濾過した。得られた濾液からエタノールを蒸発させて、それに水を加えてから凍結乾燥させて9gの抽出物を得た。
同様にして、アカシアNo.2〜5の熱水抽出物エタノール画分を得た。
Production example of acacia bark extract 7
To 10 g of the hot water extract of Acacia No. 1 obtained in Production Example 3, 3 times the amount of ethanol was added, and the mixture was extracted for 15 minutes while boiling and refluxing, and filtered using a filter of 10 to 20 μm. Ethanol was evaporated from the obtained filtrate, water was added thereto, and the mixture was freeze-dried to obtain 9 g of an extract.
In the same manner, the ethanol fraction of the hot water extract of Acacia Nos. 2 to 5 was obtained.
配合例1 内服剤の調製
製造例6のアカシア樹皮熱水抽出物エタノール画分を用い、下記に示す組成にて内服剤を調製した。
製造例6の抽出物画分 1.0(重量%)
乳糖 30.0
コーンスターチ 60.0
結晶セルロース 8.0
ポリビニールピロリドン 1.0
計 100.0
Formulation Example 1 Preparation of Oral Preparation An internal preparation was prepared using the ethanol fraction of the acacia bark hot water extract of Production Example 6 with the composition shown below.
Extract fraction of Production Example 6 1.0 (% by weight)
Lactose 30.0
Cornstarch 60.0
Crystalline cellulose 8.0
Polyvinyl pyrrolidone 1.0
100.0 in total
配合例2 ペットフードの調製
製造例2のアカシア樹皮熱水抽出物を用い、下記に示す組成にてペットフードを調製した。
製造例2の抽出物 1.0(重量%)
オートミール 88.0
でんぷん 5.0
食塩 2.5
全卵 3.0
調味料 0.5
計 100.0
Formulation Example 2 Preparation of Pet Food Using the acacia bark hot water extract of Production Example 2, a pet food was prepared with the composition shown below.
Extract of Production Example 2 1.0 (% by weight)
Oatmeal 88.0
Starch 5.0
Salt 2.5
Whole egg 3.0
Seasoning 0.5
100.0 in total
配合例3 錠剤(菓子)の調製
製造例6のアカシア樹皮熱水抽出物エタノール画分を用い、下記に示す組成にて錠剤(菓子)を調製した。
製造例6の抽出物画分 1.0(重量%)
クエン酸 1.0
脱脂粉乳 15.0
ショ糖エステル 1.0
フレーバー 0.5
粉糖 20.0
乳糖 61.5
計 100.0
Formulation Example 3 Preparation of Tablets (Confectionery) Using the ethanol fraction of the acacia bark hot water extract of Production Example 6, tablets (confectionery) were prepared with the composition shown below.
Extract fraction of Production Example 6 1.0 (% by weight)
Citric acid 1.0
Skim milk powder 15.0
Sucrose ester 1.0
Flavor 0.5
Powdered sugar 20.0
Lactose 61.5
100.0 in total
配合例4 錠剤の調製
製造例2のアカシアNo.1熱水抽出物を用い、下記に示す一粒あたりの組成にて錠剤を調製した。
製造例2のアカシアNo.1熱水抽出物 125(mg)
ショ糖エステル 9
乳糖 166
計 300
Formulation Example 4 Preparation of Tablets Using the Acacia No. 1 hot water extract of Production Example 2, tablets were prepared with the composition per tablet shown below.
Acacia No. 1 hot water extract of Production Example 2 125 (mg)
Sucrose ester 9
Lactose 166
300 in total
配合例5 錠剤の調製
製造例2のアカシアNo.1熱水抽出物を用い、下記に示す一粒あたりの組成にて錠剤を調製した。
製造例2のアカシアNo.1熱水抽出物 62.52(mg)
デキストリン 126.48
還元麦芽糖 45
セルロース 60
ステアリン酸カルシウム 6
計 300
Formulation Example 5 Preparation of Tablets Using the Acacia No. 1 hot water extract of Production Example 2, tablets were prepared with the composition per tablet shown below.
Acacia No. 1 hot water extract of Production Example 2 62.52 (mg)
Dextrin 126.48
Reduced maltose 45
Cellulose 60
Calcium stearate 6
300 in total
試験例
(1) 試験デザイン
ランダム化プラセボ対照二重盲検並行群間比較試験とした。
Test example
(1) Study design This was a randomized, placebo-controlled, double-blind, parallel-group comparative study.
(2) 被験者
次の登録基準及び選抜基準に該当し、かつ除外基準に該当しない者を被験者として選択した。
[登録基準]
a. 肌(顔や手)の乾燥により、肌に不快感(ムズムズ感)を感じている日本人成人男女
[除外基準]
a. 悪性腫瘍、心不全、心筋梗塞の治療中若しくは既往歴がある者
b. 以下の慢性疾患で治療中の者
不整脈、肝障害、腎障害、脳血管障害、リウマチ、糖尿病、脂質異常症、高血圧、その他の慢性疾患
c. 特定保健用食品、機能性表示食品を日頃から摂取している者
d. むずむず脚症候群と診断されている者
e. アトピー性皮膚炎と診断されたことがある者
f. 日常的なスキンケアとして、クリーム・美容液・オールインワン製品・パック等化粧水・乳液・日焼け止め以外を使用している者
g. 日常的にスキンケアの施術(エステ等)を受ける、若しくは美容器具(美顔器等)を使用している者。
h. 同意書取得日から過去1カ月間に過度の日焼けをしている者、若しくは試験期間中(同意書取得日から最終検査まで)に過度の日焼けをする予定のある者。
i. 医薬品(漢方薬を含む)・サプリメントを常用している者
j. アレルギー(医薬品・試験用食品関連食品・肌)がある者
k. 妊娠中、授乳中、あるいは試験期間中に妊娠する意思のある者
l. 同意書取得日以前の3か月間において他の臨床試験に参加していた者
m. その他、試験責任医師が本試験の対象として不適切と判断した者
[選抜基準]
a. 試験責任医師が肌に疾患(アトピー等)がなく、かつ、試験参加に問題ないと判断した者
b. a.の内、TARCが450pg/mL未満及び、非特異的IgEが170IU/mL未満の者
c. b.の内、経皮水分蒸散量が相対的に高い者
(2) Subjects We selected subjects who met the following registration criteria and selection criteria and did not meet the exclusion criteria.
[Registration criteria]
a. Japanese adult men and women who feel discomfort (mushy feeling) on their skin due to dry skin (face and hands) [Exclusion criteria]
Those who are undergoing treatment or have a history of malignant tumor, heart failure, or myocardial infarction
b. Those who are being treated for the following chronic diseases: Arrhythmia, liver disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, and other chronic diseases
c. Persons who regularly consume foods for specified health use and foods with functional claims
d. Those who have been diagnosed with restless legs syndrome
e. Those who have been diagnosed with atopic dermatitis
f. Those who use creams, serums, all-in-one products, packs, etc. other than lotion, milky lotion, and sunscreen as daily skin care
g. Those who receive skin care treatments (esthetics, etc.) on a daily basis or use beauty equipment (facial equipment, etc.).
h. Those who have had excessive sunburn in the past month from the date of obtaining the consent form, or who plan to have excessive sunburn during the test period (from the date of obtaining the consent form to the final inspection).
i. Those who regularly use medicines (including Chinese herbs) and supplements
j. Persons with allergies (pharmaceutical products, test foods, skin)
k. Those who are pregnant, breastfeeding, or willing to become pregnant during the study period
l. Those who participated in other clinical trials in the 3 months prior to the date of obtaining the consent form
m. Others who are judged by the investigator to be inappropriate for this study [Selection criteria]
a. Those who the investigator has determined that there is no skin disease (atopy, etc.) and that there is no problem in participating in the study.
Among ba, those with TARC less than 450 pg / mL and non-specific IgE less than 170 IU / mL
Among cb, those with relatively high transepidermal water loss
なお、被験者には、試験参加中の遵守事項として、以下の点を徹底するよう求めた。
a. 試験用食品を定められた用法・用量の通り摂取する。
b. 試験期間中は、暴飲暴食を避け、それまでの生活習慣を変えない。
c. 試験期間中は、化粧習慣を変えない。(化粧水や乳液などのスキンケアを含む)
d. 試験期間中は、過度の日焼けをなるべくしない。
e. 試験期間中は、なるべくハンドクリームを使用しない。
f. 検査前日から当日の検査終了までは飲酒と過度の運動を行わない。
g. 検査の当日は検査終了まで、入浴・シャワー及び、洗顔シートやボディシート、制汗スプレー等の使用を禁止する。
h. 採血を行う6時間前から飲食を禁止する。試験用食品の摂取も禁止とする。ただし、水のみ摂取可能とする。機能水、お茶は不可とする。
i. 試験期間中に体調の変化が生じた場合は、直ちに試験運営機関に連絡し、以後の対応の指示を仰ぐ。
j. 試験期間中は、特定保健用食品、機能性表示食品、その他の機能性が考えられる食品/飲料をなるべく摂取しない。
The subjects were asked to thoroughly observe the following points as compliance items during the test participation.
Ingest the test food according to the prescribed dosage and administration.
b. During the test period, avoid binge eating and do not change your lifestyle.
c. Do not change your makeup habits during the test period. (Including skin care such as lotion and milky lotion)
d. Avoid excessive sunburn during the test period.
e. If possible, avoid using hand cream during the test period.
f. Do not drink alcohol or exercise excessively from the day before the test until the end of the test on the day.
g. On the day of the test, bathing / showering and the use of face wash sheets, body sheets, antiperspirant sprays, etc. are prohibited until the end of the test.
h. Eating and drinking is prohibited from 6 hours before blood collection. Ingestion of test foods is also prohibited. However, only water can be ingested. Fuctioned water and tea are not allowed.
i. If you experience any changes in your physical condition during the test period, immediately contact the test administration and ask for further instructions.
j. During the test period, avoid eating foods for specified health use, foods with functional claims, and other foods / beverages with possible functionality as much as possible.
(3) 試験用食品の調製
被験食品及びプラセボ食品(本明細書では総称して「試験用食品」ともいう)を用意した。被験食品として、配合例5で調製した錠剤を用いた。また、プラセボ食品として、下記に示す一粒あたりの組成にて調製した錠剤を用いた。
デキストリン 175.5(mg)
還元麦芽糖 60
セルロース 60
ステアリン酸カルシウム 4.5
計 300
(3) Preparation of test foods Test foods and placebo foods (collectively referred to as “test foods” in the present specification) were prepared. As the test food, the tablets prepared in Formulation Example 5 were used. In addition, as a placebo food, tablets prepared with the composition per grain shown below were used.
Dextrin 175.5 (mg)
Reduced maltose 60
Cellulose 60
Calcium Stearate 4.5
300 in total
(4) 試験スケジュール及び検査内容
ア 試験スケジュール
前記の選択された被験者の経皮水分蒸散量(TEWL)を測定して、以下の割付基準に従い、被験者を、Microsoft Excel用アドインStatlight #11(ユックムス株式会社)を用いて、完全無作為法により、被験食品群とプラセボ群の2群に分けた。
[割付基準]
a. 経皮水分蒸散量の平均値と標準偏差が、群間で大きく異ならないこと。
b. 男女比及び年齢が群間で大きく異ならないこと。
(4) Test schedule and test contents a. Test schedule Measure the transepidermal water loss (TEWL) of the selected subject, and subject the subject to Microsoft Excel add-in Statlight # 11 (Yukmus Co., Ltd.) according to the following allocation criteria. The company) was used to divide the group into two groups, a test food group and a placebo group, by a completely random method.
[Assignment criteria]
The mean and standard deviation of transepidermal water loss should not differ significantly between groups.
b. The gender ratio and age should not differ significantly between groups.
被験食品群の被験者には被験食品を、プラセボ群の被験者にはプラセボ食品を、それぞれ配布して、6粒を水またはぬるま湯とともに1日1回8週間摂取させた。
そして、以下の評価項目について、試験用食品の摂取4週間後及び摂取8週間後に検査を行った。
The test food was distributed to the subjects in the test food group, and the placebo food was distributed to the subjects in the placebo group, and 6 tablets were ingested once a day with water or lukewarm water for 8 weeks.
Then, the following evaluation items were inspected 4 weeks after ingestion and 8 weeks after ingestion of the test food.
イ 評価項目
(ア) 主要アウトカム
i. 皮膚表面水分量測定
a. 実施内容:各検査ポイントをコルネオメーターを用いて3回測定した。
b. 調査項目:角層水分量
c. 評価方法:各検査ポイントで3回測定し平均値を算出した。
ii. 経皮水分蒸散量(TEWL)測定
a. 実施内容:テヴァメーターを用いて約60秒間の測定を3回行った。
b. 調査項目:経皮水分蒸散量
c. 評価方法:各検査ポイントで3回測定し平均値を算出した。
(イ) 副次的アウトカム
i. 皮膚表面光沢度測定
a. 実施内容:各検査ポイントを、グロッシーメーターを用いて3回測定した。
b. 調査項目:皮膚表面の光沢度
c. 評価方法:各検査ポイントで3回測定し平均値を算出した。
ii. 皮膚粘弾性測定
a. 実施内容:各検査ポイントをキュートメーターを用いて3回測定した。
b. 調査項目:肌の弾力性
c. 評価方法:各検査ポイントで3回測定し平均値を算出した。
B Evaluation items
(A) Major outcomes
i. Skin surface moisture measurement
Implementation details: Each inspection point was measured 3 times using a corneometer.
b. Survey item: stratum corneum water content
c. Evaluation method: The average value was calculated by measuring 3 times at each inspection point.
ii. Percutaneous transpiration (TEWL) measurement
Implementation details: Measurements were performed 3 times for about 60 seconds using a tevameter.
b. Survey item: Amount of transepidermal water loss
c. Evaluation method: The average value was calculated by measuring 3 times at each inspection point.
(B) Secondary outcome
i. Skin surface gloss measurement
Implementation details: Each inspection point was measured 3 times using a glossy meter.
b. Survey item: Gloss of skin surface
c. Evaluation method: The average value was calculated by measuring 3 times at each inspection point.
ii. Skin viscoelasticity measurement
Implementation details: Each inspection point was measured 3 times using a cute meter.
b. Survey item: Skin elasticity
c. Evaluation method: The average value was calculated by measuring 3 times at each inspection point.
なお、前記の皮膚表面水分量、経皮水分蒸散量、皮膚表面光沢度及び皮膚粘弾性は、被験者を、クレンジング、洗顔、及び手洗い後に、温度23±5度、湿度50±15%の部屋で10分以上馴化させた後、検査ポイント:顔(右目尻から垂直に下した線と鼻中心から地面に平行に伸ばした線との交点)及び手の甲(図1の斜線部)で測定した。但し、経皮水分蒸散量については、顔のみ測定した。 The amount of water on the skin surface, the amount of evapotranspiration on the skin surface, the glossiness of the skin surface, and the elasticity of the skin were determined in a room having a temperature of 23 ± 5 degrees and a humidity of 50 ± 15% after cleansing, washing the face, and washing the hands. After acclimatization for 10 minutes or more, the measurement was performed at the inspection points: the face (the intersection of the line vertically lowered from the outer corner of the right eye and the line extending parallel to the ground from the center of the nose) and the back of the hand (hatched portion in FIG. 1). However, the amount of transepidermal water loss was measured only on the face.
(5) 試験結果
ア 被験者
本試験は、肌(顔や手)の乾燥により、肌に不快感(ムズムズ感)を感じている日本人成人男女を対象とした。試験参加に同意した101名のうち試験責任医師の問診や選抜基準により35名を除外したため、66名を本試験に組み入れた。
試験終了後、試験期間中に追跡不能となったためデータが欠損した1名及び遵守事項を違反した5名を解析対象から除外した。キーオープン後に解析対象から除外された者の内訳を確認したところ、追跡不能となったためデータが欠損した1名は被験食品群、遵守事項を違反した者はプラセボ群3名、被験食品群2名であった。よって、最終的な解析対象者はPer Protocol Setであり、プラセボ群が30名(男性8名、女性22名:44.8±9.1歳)、被験食品群が30名(男性7名、女性23名:44.3±9.8歳)であった。なお、試験用食品の摂取率が90%に満たない被験者はいなかった。
(5) Test Results A Subject This test was conducted on Japanese adult men and women who feel discomfort (feeling of muzzle) on their skin due to dry skin (face and hands). Of the 101 patients who agreed to participate in the study, 35 were excluded due to interviews with the investigator and selection criteria, so 66 were included in the study.
After the end of the test, 1 person whose data was lost due to unfollowability during the test period and 5 people who violated the compliance items were excluded from the analysis. When we checked the breakdown of those who were excluded from the analysis after the key opening, 1 person whose data was missing due to untraceable was the test food group, 3 people in the placebo group and 2 people in the test food group violated the compliance items. Met. Therefore, the final analysis target was the Per Protocol Set, with 30 subjects in the placebo group (8 males, 22 females: 44.8 ± 9.1 years old) and 30 subjects in the test food group (7 males, 7 males). Twenty-three women: 44.3 ± 9.8 years old). There were no subjects whose intake rate of the test food was less than 90%.
イ 検査項目
角層水分量、皮膚表面の光沢度、及び皮膚の弾力性について、摂取前の測定値と各検査時点(摂取4週間後及び摂取8週間後)の測定値とをDunnettの方法を用いて比較した。
経皮水分蒸散量については、摂取前から各検査時点(摂取4週間後及び摂取8週間後)にかけての測定値の変化量で、プラセボ群と被験食品群とをStudentのt検定を用いて比較した。
結果は、表1及び2に示した。
B. Inspection items Regarding the water content of the stratum corneum, the glossiness of the skin surface, and the elasticity of the skin, the measured values before ingestion and the measured values at each inspection time point (4 weeks after ingestion and 8 weeks after ingestion) are measured by Dunnett's method. Used for comparison.
Regarding the amount of transdermal water evaporation, the change in the measured value from before ingestion to each test time point (4 weeks after ingestion and 8 weeks after ingestion) was used to compare the placebo group and the test food group using Student's t-test. did.
The results are shown in Tables 1 and 2.
表1が示すとおり、被験食品の摂取により、角層水分量、皮膚表面の光沢度、及び皮膚の弾力性は増大しており、特に、摂取4週間後の角層水分量(手)及び皮膚表面の光沢度(手)、摂取8週間後の角層水分量(顔)、角層水分量(手)、皮膚表面の光沢度(手)は有意に増大した。 As shown in Table 1, ingestion of the test food increased the water content of the stratum corneum, the glossiness of the skin surface, and the elasticity of the skin, and in particular, the water content of the stratum corneum (hands) and the skin 4 weeks after ingestion. The glossiness of the surface (hands), the water content of the stratum corneum (face) 8 weeks after ingestion, the water content of the stratum corneum (hands), and the glossiness of the skin surface (hands) were significantly increased.
表2が示すとおり、経皮水分蒸散量(顔)は、被験食品群がプラセボ群よりも有意な低値を示した。 As shown in Table 2, the transepidermal water loss (face) was significantly lower in the test food group than in the placebo group.
前記試験例では、肌(顔や手)の乾燥により、肌に不快感(ムズムズ感)を感じている成人男女を対象とした。その目的は、アカシア樹皮抽出物を含有した被験食品を8週間継続摂取させることによる肌の乾燥及び不快感の改善効果について検証することであった。
角層水分量については、試験期間を通して被験食品によるスコアの有意な増加が認められた(表1)。経皮水分蒸散量について、被験食品群の顔の経皮水分蒸散量は摂取8週間後の変化量(=摂取8週間後の測定値−摂取前の測定値)において、プラセボ群よりも有意に低値を示した(表2)。経皮水分の蒸散防止は皮膚の乾燥の抑制、つまり角層水分量の保持に有効なアプローチのひとつであることから(宍戸吉浩, 鳥居和樹, 藤原敏雄ら. 浴用剤の保湿性に関する研究. 日本温泉気候物理医学会雑誌. 1989;52(2):97-103.)、経皮水分の蒸散を抑制することは、皮膚の乾燥を抑制し、皮膚保湿につながるものと考えられた。
また、データは特に示していないが、主観的な皮膚症状の改善、皮膚状態に関連したQOLの向上、かゆみの改善がみられた。皮膚の乾燥が抑制されたため、皮膚のかゆみや痛みに関する自覚症状が緩和され、肌のQOLが改善されたと考えられた。
以上より、被験食品の摂取は、アカシア樹皮抽出物による水分蒸散量抑制作用を介した保湿効果により、乾燥による皮膚のダメージやかゆみ・炎症反応を軽減し、肌の乾燥や不快感を改善することが期待できる。
最後に、被験食品については、その安全性を、摂取前、摂取4週間後、及び摂取8週間後に身体測定・理学検査、尿検査、末梢血液検査により評価もした。その結果、身体測定・理学検査及び末梢血液検査においては、測定値の平均値に有意な変動が散見されたものの、いずれの項目も正常範囲あるいは基準値内での変動であった。尿検査では、基準値内外の人数は摂取前後及び群間で有意差が認められなかった。これらの安全性試験の結果より、試験用食品は安全であることも確認できた。
In the above test example, adult men and women who feel discomfort (feeling of muzzle) on the skin due to dry skin (face and hands) were targeted. The purpose was to verify the effect of improving the dryness and discomfort of the skin by continuously ingesting the test food containing the acacia bark extract for 8 weeks.
Regarding the water content of the stratum corneum, a significant increase in the score by the test food was observed throughout the test period (Table 1). Regarding the amount of percutaneous water evaporation, the amount of percutaneous water evaporation on the face of the test food group was significantly higher than that of the placebo group in the amount of change after 8 weeks of ingestion (= measured value after 8 weeks of ingestion-measured value before ingestion). It showed a low value (Table 2). Since prevention of transepidermal water loss is one of the effective approaches to suppress skin dryness, that is, to maintain the water content of the stratum corneum (Yoshihiro Shishido, Kazuki Torii, Toshio Fujiwara et al. Journal of the Society of Hot Spring Climate Physics. 1989; 52 (2): 97-103.), It was considered that suppressing the evaporation of transdermal water suppresses the dryness of the skin and leads to moisturizing the skin.
In addition, although the data is not shown in particular, improvement of subjective skin symptoms, improvement of QOL related to skin condition, and improvement of itch were observed. Since the dryness of the skin was suppressed, it was considered that the subjective symptoms related to itching and pain of the skin were alleviated and the QOL of the skin was improved.
Based on the above, ingestion of the test food should reduce skin damage, itchiness and inflammatory reaction due to dryness, and improve dryness and discomfort of the skin by the moisturizing effect of the acacia bark extract through the effect of suppressing the amount of water evaporation. Can be expected.
Finally, the safety of the test food was evaluated by physical measurement / physical examination, urinalysis, and peripheral blood test before, 4 weeks after, and 8 weeks after ingestion. As a result, in the physical measurement / physical examination and the peripheral blood test, although significant fluctuations were found in the average value of the measured values, all the items were fluctuations within the normal range or the standard value. Urinalysis showed no significant difference in the number of people inside and outside the standard value before and after ingestion and between groups. From the results of these safety tests, it was also confirmed that the test food was safe.
本発明によれば、安全で、長期に経口摂取しても副作用などの心配が少ない皮膚保湿用組成物を提供できる。
また、本発明の組成物は、経口摂取により、皮膚からの水分蒸散を抑制して保湿効果を奏することができるので、肌の保湿力を高め、肌の潤い(水分)を逃しにくくして、肌の水分を保持し、潤いを守るのに、特に肌が乾燥しがちなヒトの肌の潤いに有用である。また、本発明の組成物は、肌の乾燥や肌荒れを抑えて、肌の健康維持にも有用である。
本発明の組成物は、皮膚からの水分蒸散量の抑制、皮膚の乾燥の予防若しくは改善、乾燥による肌トラブルの解消、例えば肌荒れの改善などにも有用である。
本発明の組成物は、医薬品又は医薬部外品、あるいは健康食品、保健機能食品(例えば、特定保健用食品、栄養機能食品、及び機能性表示食品)、健康補助食品、美容食品、又は栄養補助食品(サプリメント)などの食品あるいは動物用飼料、特に機能性表示食品として利用できる。
According to the present invention, it is possible to provide a skin moisturizing composition that is safe and has less concern about side effects even when taken orally for a long period of time.
In addition, the composition of the present invention can suppress the evaporation of water from the skin and exert a moisturizing effect by oral ingestion, so that the moisturizing power of the skin is enhanced and the moisture (moisture) of the skin is hard to escape. It is useful for retaining moisture and keeping the skin moisturized, especially for moisturizing human skin, which tends to be dry. In addition, the composition of the present invention is also useful for maintaining the health of the skin by suppressing dryness and rough skin.
The composition of the present invention is also useful for suppressing the amount of water evapotranspiration from the skin, preventing or improving dryness of the skin, eliminating skin troubles due to dryness, for example, improving rough skin.
The composition of the present invention is a pharmaceutical or non-pharmaceutical product, or a health food, a health functional food (for example, a food for specified health use, a nutritionally functional food, and a food with a functional claim), a health supplement, a beauty food, or a nutritional supplement. It can be used as foods such as foods (supplements) or animal feeds, especially foods with functional claims.
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