JP2021120358A - Oral skin barrier function improver - Google Patents
Oral skin barrier function improver Download PDFInfo
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- JP2021120358A JP2021120358A JP2020013725A JP2020013725A JP2021120358A JP 2021120358 A JP2021120358 A JP 2021120358A JP 2020013725 A JP2020013725 A JP 2020013725A JP 2020013725 A JP2020013725 A JP 2020013725A JP 2021120358 A JP2021120358 A JP 2021120358A
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- barrier function
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- ferulic acid
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- KSEBMYQBYZTDHS-HWKANZROSA-N ferulic acid Chemical compound COC1=CC(\C=C\C(O)=O)=CC=C1O KSEBMYQBYZTDHS-HWKANZROSA-N 0.000 claims abstract description 50
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Abstract
Description
本発明は、経口皮膚バリア機能強化剤に関する。 The present invention relates to an oral skin barrier function enhancer.
ヒトの身体の最外層を構成する臓器である皮膚は、体温調節、過剰な水分損失の防止、機械受容体を介した感覚入力、免疫防御、及び内分泌(ビタミンDの生成)などの重要な生理機能を担っている。そのなかでも皮膚の重要な機能は、病原体、化学物質、及び太陽紫外線から身体を保護するための物理的バリアである。皮膚のバリアを担うのは、表皮の最外層にある糸状ケラチンを含む15〜20層の角質細胞からなる角質層である。角質層は、乾燥性の外部環境で経皮蒸発水分損失を遅らせる透過性バリアとしての役割を有する。角質層は平坦な無核角質細胞からなる多層組織であり、セラミド、遊離脂肪酸、及びコレステロールで構成される高度に秩序化された脂質ラメラに埋め込まれた角質細胞で構成されている。角質層の細胞外ドメイン内におけるこれら高度疎水性の脂質の局在化は、水の外側への移動を抑制する。さらに、角質層内には、有機酸、遊離アミノ酸、無機イオンなどの天然保湿因子が存在する。表皮分化及び脂質組成の変化に伴う角質層の異常は、アトピー性皮膚炎における環境アレルゲンの侵入、免疫反応、及び炎症に繋がるような皮膚バリアの破綻をもたらす。したがって、皮膚バリアを健常に維持することは非常に重要である。
皮膚バリアを維持する方法としては、化粧品や薬用化粧品を経皮的に塗布することが一般的であるが、近年では適切な栄養素を経口的に摂取することの重要性も指摘されている(非特許文献1)。
The skin, the outermost organ of the human body, has important physiology such as thermoregulation, prevention of excessive water loss, sensory input via mechanoreceptors, immune defense, and endocrine (production of vitamin D). It has a function. Among them, an important function of the skin is a physical barrier to protect the body from pathogens, chemicals, and solar UV rays. The barrier of the skin is the stratum corneum, which is the outermost layer of the epidermis and consists of 15 to 20 layers of corneocytes containing filamentous keratin. The stratum corneum serves as a permeable barrier that delays transdermal evaporation moisture loss in a dry external environment. The stratum corneum is a multi-layered tissue of flat, non-nucleated corneocytes, composed of corneocytes embedded in a highly ordered lipid lamella composed of ceramide, free fatty acids, and cholesterol. Localization of these highly hydrophobic lipids within the extracellular domain of the stratum corneum suppresses the outward migration of water. Furthermore, natural moisturizing factors such as organic acids, free amino acids, and inorganic ions are present in the stratum corneum. Abnormalities of the stratum corneum associated with epidermal differentiation and changes in lipid composition result in the invasion of environmental allergens in atopic dermatitis, immune response, and disruption of the skin barrier leading to inflammation. Therefore, maintaining a healthy skin barrier is very important.
Percutaneous application of cosmetics and medicated cosmetics is a common method for maintaining the skin barrier, but in recent years it has been pointed out that it is important to take appropriate nutrients orally (non-patents). Patent Document 1).
近年、心理ストレスが皮膚性状に及ぼす影響について注目されている。心理ストレスは、中枢における視床下部-下垂体-副腎(HPA)軸と青斑ノルエピネフリン交感神経副腎髄質系、及び末梢における皮膚内HPA軸と末梢感覚神経及び自律神経からのメディエーターの放出の経路を介して、皮膚バリア機能に影響する可能性が指摘されている(非特許文献2)。皮膚バリア機能の異常は、アトピー性皮膚炎、乾癬、及び他の類似の皮膚状態の患者で顕著であり、健常人との比較では交感神経活動が上昇していることが報告されている(非特許文献3、4)。さらに、健常人において心拍変動解析により得られた副交感神経活動が経表皮水分蒸散量(TEWL)と負の相関を示し、交感神経活動が経表皮水分蒸散量と正の相関を示すことが明らかになっている(非特許文献5)。このことから、自律神経機能と皮膚バリア機能が関連する可能性が考えられている。 In recent years, attention has been paid to the effect of psychological stress on skin properties. Psychological stress is mediated by the hypothalamic-pituitary-adrenal (HPA) axis and the blue-spotted norepinephrine sympathetic adrenal medulla system in the center, and the pathway of mediator release from the intracutaneous HPA axis and peripheral sensory and autonomic nerves in the periphery. Therefore, it has been pointed out that it may affect the skin barrier function (Non-Patent Document 2). Abnormal skin barrier function is prominent in patients with atopic dermatitis, psoriasis, and other similar skin conditions, and sympathetic nerve activity has been reported to be elevated compared to healthy individuals (non-healthy). Patent Documents 3 and 4). Furthermore, it was clarified that the parasympathetic nerve activity obtained by heart rate variability analysis showed a negative correlation with the transepidermal water loss (TEWL) in healthy subjects, and the sympathetic nerve activity showed a positive correlation with the transepidermal water loss. (Non-Patent Document 5). From this, it is considered that the autonomic nerve function and the skin barrier function may be related.
一方、フェルラ酸(FA; 4-hydroxy-3-methoxycinnamic acid)は植物の細胞壁に存在する化合物である。フェルラ酸とジヒドロフェルラ酸は、細胞壁のリグノセルロース中でリグニンと多糖をジョイントする役割を担っている。フェルラ酸は、抗酸化、抗腫瘍、血糖値降下、高血圧改善、脳機能改善、自律神経機能向上などの様々な生理作用を有することが報告されている(例えば、特許文献1)。また、ヒト皮膚に塗布されたフェルラ酸は、UV照射による炎症反応を抑制し、光保護効果を有することが報告されている(非特許文献4)。フェルラ酸はTRPV4の活性化を抑制する(特許文献2)が、一方で、TRPV4の活性化は角化細胞のタイトジャンクション形成を促進し、皮膚バリア機能を高めることが報告されている(特許文献3)。これらの先行文献から、フェルラ酸は皮膚バリア機能を低下させることが推測されており、これまでに当該物質の経口摂取が皮膚バリア機能に及ぼす影響を検討した報告例はなかった。 On the other hand, ferulic acid (FA; 4-hydroxy-3-methoxycinnamic acid) is a compound present in the cell wall of plants. Ferulic acid and dihydroferulic acid play a role in binding lignin and polysaccharide in lignocellulosic cell wall. Ferulic acid has been reported to have various physiological actions such as antioxidant, antitumor, blood glucose lowering, hypertension improvement, brain function improvement, and autonomic nerve function improvement (for example, Patent Document 1). Further, it has been reported that ferulic acid applied to human skin suppresses an inflammatory reaction due to UV irradiation and has a photoprotective effect (Non-Patent Document 4). Ferulic acid suppresses the activation of TRPV4 (Patent Document 2), while the activation of TRPV4 promotes the formation of tight junctions in keratinocytes and enhances the skin barrier function (Patent Document 2). 3). From these previous documents, it is speculated that ferulic acid lowers the skin barrier function, and there have been no reports on the effect of oral ingestion of the substance on the skin barrier function.
本発明は、経口摂取可能な皮膚バリア機能向上剤を提供することに関する。 The present invention relates to providing an orally ingestible skin barrier function improving agent.
本発明者は、上記課題に鑑み鋭意検討したところ、フェルラ酸又はその塩の経口摂取によって皮膚バリア機能が向上することを見出した。 The present inventor has made a diligent study in view of the above problems and found that oral ingestion of ferulic acid or a salt thereof improves the skin barrier function.
すなわち、本発明は以下の1)〜2)に係るものである。
1)フェルラ酸又はその塩を有効成分とする経口皮膚バリア機能向上剤。
2)フェルラ酸又はその塩を有効成分とする経口皮膚バリア機能向上用食品。
That is, the present invention relates to the following 1) and 2).
1) An oral skin barrier function improving agent containing ferulic acid or a salt thereof as an active ingredient.
2) A food for improving the oral skin barrier function containing ferulic acid or a salt thereof as an active ingredient.
本発明によれば、フェルラ酸又はその塩を経口摂取することにより、皮膚バリア機能を高めることができ、角質層のバリア機能の異常による皮膚疾患などを予防又は改善することができる。 According to the present invention, by ingesting ferulic acid or a salt thereof orally, the skin barrier function can be enhanced, and skin diseases and the like due to abnormalities in the barrier function of the stratum corneum can be prevented or ameliorated.
本発明においてフェルラ酸(4-ヒドロキシ-3-メトキシケイ皮酸)は、分子式C10H10O4を有するケイ皮酸誘導体であり、以下の構造を有する。 In the present invention, ferulic acid (4-hydroxy-3-methoxycinnamic acid) is a cinnamic acid derivative having the molecular formula C 10 H 10 O 4 and has the following structure.
フェルラ酸は、化学合成すること、或いはフェルラ酸を含有する天然物、例えば、米(米糠、米胚芽)、小麦、ライ麦、大麦、コーヒー、リンゴ、アーティチョーク、ピーナッツ、オレンジ、パイナップルなどの植物から抽出・精製することにより取得することができる。また、試薬として市販されているものを用いることができる。
フェルラ酸又はその塩には、立体異性体が存在し、本発明では、純粋な立体異性体又はそれらの混合物を用いることができる。
Ferulic acid can be chemically synthesized or extracted from natural products containing ferulic acid, such as rice (rice bran, rice germ), wheat, rye, barley, coffee, apples, artichokes, peanuts, oranges, pineapples, etc. -It can be obtained by purifying. In addition, commercially available reagents can be used.
There are stereoisomers in ferulic acid or salts thereof, and in the present invention, pure stereoisomers or mixtures thereof can be used.
フェルラ酸の塩は、薬学的に許容される塩が好ましい。当該塩としては、例えば、ナトリウム、カリウムなどのアルカリ金属との塩;カルシウム、マグネシウムなどのアルカリ土類金属との塩、アンモニウム塩などの無機塩基の塩;アルギニン、リジン、ヒスチジン、オルニチンなどの塩基性アミノ酸との塩;モノエタノールアミン、ジエタノールアミン、トリエタノールアミンなどの有機塩基との塩などが用いられる。このうち、アルカリ金属又はアルカリ土類金属との塩が好ましい。 The salt of ferulic acid is preferably a pharmaceutically acceptable salt. Examples of the salt include salts with alkali metals such as sodium and potassium; salts with alkaline earth metals such as calcium and magnesium, and salts with inorganic bases such as ammonium salts; bases such as arginine, lysine, histidine, and ornithine. Salts with sex amino acids; Salts with organic bases such as monoethanolamine, diethanolamine, triethanolamine and the like are used. Of these, salts with alkali metals or alkaline earth metals are preferable.
後記実施例に示すように、フェルラ酸の経口摂取によって、経表皮水分蒸散量が減少した。すなわち、フェルラ酸又はその塩は、皮膚バリア機能を向上する作用を有する。
従って、フェルラ酸又はその塩は、皮膚バリア機能向上剤となり得、皮膚バリア機能の向上のために使用することができ、また、皮膚バリア機能向上剤を製造するために使用することができる。
ここで、前者の「使用」は、ヒト若しくは非ヒト動物への投与又は摂取であり得、また治療的使用であっても非治療的使用であってもよい。尚、「非治療的」とは、医療行為を含まない概念、すなわち人間を手術、治療又は診断する方法を含まない概念、より具体的には医師又は医師の指示を受けた者が人間に対して手術、治療又は診断を実施する方法を含まない概念である。
As shown in Examples below, oral ingestion of ferulic acid reduced transepidermal water loss. That is, ferulic acid or a salt thereof has an action of improving the skin barrier function.
Therefore, ferulic acid or a salt thereof can be a skin barrier function improving agent, can be used for improving the skin barrier function, and can be used for producing a skin barrier function improving agent.
Here, the former "use" can be administration or ingestion to humans or non-human animals, and may be therapeutic or non-therapeutic use. The term "non-therapeutic" means a concept that does not include medical practice, that is, a concept that does not include a method of surgery, treatment, or diagnosis of a human being, and more specifically, a doctor or a person who has been instructed by a doctor to treat a human being. It is a concept that does not include a method of performing surgery, treatment, or diagnosis.
本発明において、「皮膚バリア機能」とは、皮膚の内側からの水分の蒸散を防ぐ機能及び外界から皮膚への物質の侵入を防ぐ機能を意味する。本発明においては、皮膚の内側からの水分の蒸散を防ぐ機能(水分透過バリア機能)の向上に適する。
「皮膚バリア機能向上」は、皮膚バリア機能の強化、低下、破壊又は崩壊の防止又は抑制、維持の概念も含む。
フェルラ酸又はその塩の経口摂取によって皮膚バリア機能が向上することにより、角質層のバリア機能の異常による皮膚疾患などを予防又は改善することができる。ここで、「予防」とは、個体における疾患若しくは症状の発症の防止若しくは遅延、或いは個体の疾患若しくは症状の発症の危険性を低下させることをいう。「改善」とは、症状若しくは状態の好転、症状若しくは状態の悪化の防止、抑制若しくは遅延、或いは症状若しくは状態の進行の逆転、防止、抑制若しくは遅延をいう。
In the present invention, the "skin barrier function" means a function of preventing the evaporation of water from the inside of the skin and a function of preventing the invasion of substances from the outside into the skin. In the present invention, it is suitable for improving the function of preventing the evaporation of water from the inside of the skin (moisture permeation barrier function).
"Improvement of skin barrier function" also includes the concept of strengthening, lowering, destroying or collapsing skin barrier function, preventing or suppressing it, and maintaining it.
By improving the skin barrier function by oral ingestion of ferulic acid or a salt thereof, it is possible to prevent or improve skin diseases and the like due to abnormalities in the barrier function of the stratum corneum. Here, "prevention" means preventing or delaying the onset of a disease or symptom in an individual, or reducing the risk of developing a disease or symptom in an individual. "Improvement" means improvement of a symptom or condition, prevention, suppression or delay of deterioration of the symptom or condition, or reversal, prevention, suppression or delay of progression of the symptom or condition.
本発明の経口皮膚バリア機能向上剤は、それ自体、皮膚バリア機能を向上するための医薬品、医薬部外品、サプリメント又は食品であってもよく、或いは当該医薬品、医薬部外品、又は食品に配合して使用される素材又は製剤であってもよい。
当該食品には、皮膚バリア機能の向上をコンセプトとし、必要に応じてその旨を表示した機能性表示食品、特定保健用食品、サプリメントなどが包含される。これらの食品は機能表示が許可された食品であるため、一般の食品と区別することができる。
The oral skin barrier function improving agent of the present invention may itself be a drug, a quasi drug, a supplement or a food for improving the skin barrier function, or the drug, the quasi drug, or the food. It may be a material or a preparation used in combination.
The foods include foods with functional claims, foods for specified health use, supplements, etc., which have the concept of improving the skin barrier function and are labeled to that effect as necessary. Since these foods are foods for which functional labeling is permitted, they can be distinguished from general foods.
当該医薬品(医薬部外品も含む)は、皮膚バリア機能の向上のための医薬品であり、フェルラ酸又はその塩を当該皮膚バリア機能向上のための有効成分として含有する。さらに、該医薬品は、該有効成分の機能が失われない限りにおいて、必要に応じて薬学的に許容される担体、又は他の有効成分、薬理成分などを含有していてもよい。 The drug (including quasi-drugs) is a drug for improving the skin barrier function, and contains ferulic acid or a salt thereof as an active ingredient for improving the skin barrier function. Further, the pharmaceutical product may contain a pharmaceutically acceptable carrier, other active ingredient, pharmacological ingredient and the like, if necessary, as long as the function of the active ingredient is not lost.
当該医薬品(医薬部外品も含む)の剤形としては、経口投与可能な剤形、例えば、錠剤(チュアブル錠などを含む)、カプセル剤、顆粒剤、散剤、トローチ剤などの経口固形製剤、及び内服液剤、シロップ剤などの経口液状製剤が挙げられる。これらの剤形の製剤は、フェルラ酸又はその塩を、薬学的に許容される担体(例えば賦形剤、結合剤、増量剤、崩壊剤、界面活性剤、滑沢剤、分散剤、緩衝剤、保存剤、嬌味剤、香料、被膜剤、希釈剤など)、他の薬効成分などなどと適宜組み合わせて、定法に従って調製することができる。 Dosage forms of the drug (including non-pharmaceutical products) include dosage forms that can be orally administered, for example, oral solid preparations such as tablets (including chewable tablets), capsules, granules, powders, and troches. And oral liquid preparations such as oral liquids and syrups. Formulations of these dosage forms use ferulic acid or salts thereof as pharmaceutically acceptable carriers (eg, excipients, binders, bulking agents, disintegrants, surfactants, lubricants, dispersants, buffers). , Preservatives, flavoring agents, fragrances, coating agents, diluents, etc.), and other medicinal ingredients, etc., can be appropriately combined and prepared according to a conventional method.
当該食品は、皮膚バリア機能の向上のための食品であり、フェルラ酸又はその塩を当該皮膚バリア機能向上のための有効成分として含有する。食品の形態は、固形、半固形又は液状(例えば飲料)であり得る。該食品の例としては、例えば、清涼飲料水、茶系飲料、コーヒー飲料、果汁飲料、炭酸飲料、ゼリー状飲料、ニアウォーターなどの飲料、ゼリー、ウエハース、ビスケット、パン、麺、ソーセージなどの飲食品や栄養食などの各種食品、ならびにそれらの原料が挙げられる。あるいは、該食品は、錠剤、カプセル、顆粒、粉末、液剤、シロップなどの経口投与製剤の形態を有するサプリメントであってもよい。 The food is a food for improving the skin barrier function, and contains ferulic acid or a salt thereof as an active ingredient for improving the skin barrier function. The form of the food can be solid, semi-solid or liquid (eg beverage). Examples of the food include soft drinks, tea-based beverages, coffee beverages, fruit juice beverages, carbonated beverages, jelly-like beverages, near-water beverages, and foods and drinks such as jelly, wafers, biscuits, bread, noodles, and sausages. Various foods such as goods and nutritional foods, and their raw materials can be mentioned. Alternatively, the food product may be a supplement in the form of an orally administered preparation such as tablets, capsules, granules, powders, liquids and syrups.
当該食品は、フェルラ酸又はその塩を、任意の食品材料、もしくは他の有効成分、又は食品に許容される添加物(例えば、溶剤、軟化剤、油、乳化剤、防腐剤、酸味料、甘味料、苦味料、pH調整剤、安定剤、着色剤、紫外線吸収剤、酸化防止剤、保湿剤、増粘剤、固着剤、分散剤、流動性改善剤、湿潤剤、香科、調味料、風味調整剤)などと適宜組み合わせて、定法に従って調製することができる。 The food is ferulic acid or a salt thereof, any food material, or other active ingredient, or food-acceptable additives (eg, solvents, softeners, oils, emulsifiers, preservatives, acidity agents, sweeteners). , Bitterness, pH regulator, stabilizer, colorant, UV absorber, antioxidant, moisturizer, thickener, sticker, dispersant, fluidity improver, wetting agent, fragrance, seasoning, flavor It can be prepared according to a conventional method by appropriately combining it with a regulator) or the like.
上記医薬品、医薬部外品又は食品におけるフェルラ酸又はその塩の含有量は、それらの剤型や形態により異なり得る。例えば、フェルラ酸換算量で、好ましくは0.01質量%以上、より好ましくは1質量%以上、さらに好ましくは5質量%以上であり、また、好ましくは90質量%以下、より好ましくは70%質量%以下、さらに好ましくは30質量%以下である。 The content of ferulic acid or a salt thereof in the above-mentioned pharmaceutical products, quasi-drugs or foods may vary depending on their dosage forms and forms. For example, in terms of ferulic acid equivalent, it is preferably 0.01% by mass or more, more preferably 1% by mass or more, further preferably 5% by mass or more, and preferably 90% by mass or less, more preferably 70% by mass. % Or less, more preferably 30% by mass or less.
本発明において、フェルラ酸又はその塩の投与量及び投与計画は、対象の種、体重、性別、年齢、状態、又はその他の要因に従って当業者により適宜決定することができる。
本発明によるフェルラ酸又はその塩の投与量(フェルラ酸換算量)は、例えば、成人1人(60kg)に対して1日あたり、好ましくは5mg以上であり、より好ましくは10mg以上、更に好ましくは50mg以上、更に好ましくは100mg以上であり、また、好ましくは1000mg以下であり、より好ましくは500mg以下、更に好ましくは300mg以下である。
本発明では、上記の用量を、例えば、1日に1回、2回又は3回以上に分け、経口投与又は経口摂取することが好ましい。より好ましくは、1日に1回、上記の用量のフェルラ酸又はその塩を経口投与又は経口摂取する。投与又は摂取期間は、特に限定されないが、好ましくは継続的であり、より好ましくは1週間以上、さらに好ましくは2週間以上である。投与又は摂取のタイミングは、夕食後から就寝までの間が好ましく、就寝前1時間以内がより好ましい。
In the present invention, the dose and administration plan of ferulic acid or a salt thereof can be appropriately determined by those skilled in the art according to the species, weight, sex, age, condition, or other factors of the subject.
The dose of ferulic acid or a salt thereof (ferulic acid equivalent amount) according to the present invention is, for example, preferably 5 mg or more, more preferably 10 mg or more, still more preferably 10 mg or more per day for one adult (60 kg). It is 50 mg or more, more preferably 100 mg or more, preferably 1000 mg or less, more preferably 500 mg or less, still more preferably 300 mg or less.
In the present invention, it is preferable that the above dose is orally administered or orally ingested, for example, once, twice or three times or more a day. More preferably, the above dose of ferulic acid or a salt thereof is orally administered or orally ingested once a day. The administration or ingestion period is not particularly limited, but is preferably continuous, more preferably 1 week or longer, still more preferably 2 weeks or longer. The timing of administration or ingestion is preferably from after dinner to bedtime, and more preferably within 1 hour before bedtime.
本発明の好ましい実施形態においては、皮膚バリア機能の向上を必要とするヒトに対して、上記1日用量のフェルラ酸又はその塩を経口投与するか又は経口摂取させる。 In a preferred embodiment of the present invention, the daily dose of ferulic acid or a salt thereof is orally administered or orally ingested to a human who needs to improve the skin barrier function.
試験例1
1.対象者
実験は、臨床研究の倫理ガイドラインとヘルシンキ宣言で定められた倫理原則に従って、花王株式会社の研究倫理審査委員会の承認を得て実施された。被験者として35〜50歳の健康な日本人男性16人が採用された。除外基準は次のとおりであった。
除外基準:喫煙習慣、重度の病気の罹患率(例:高血圧、心臓病、腎臓病、糖尿病など)、体調不良、薬を必要とする継続中の治療、睡眠薬の服用。
Test Example 1
1. 1. Subjects The experiments were conducted with the approval of the Research Ethics Review Board of Kao Corporation in accordance with the ethical guidelines for clinical research and the ethical principles stipulated in the Declaration of Helsinki. Sixteen healthy Japanese men aged 35 to 50 years were selected as subjects. The exclusion criteria were as follows.
Exclusion criteria: Smoking habits, prevalence of severe illness (eg, high blood pressure, heart disease, kidney disease, diabetes, etc.), poor health, ongoing treatment in need of medication, taking sleeping pills.
2.試験デザイン
試験品として、米胚芽由来のフェルラ酸(FA)を含むカプセル(フェルラ酸として67mg/カプセル,質量比11.6%)とプラセボカプセルを用いた。プラセボカプセルにはフェルラ酸が含まれていない。なお、フェルラ酸の分析は、HPLC等の通常知られている測定法のうち測定試料の状況に適した分析法により行うことができる(J. Agric. Food Chem. 2002; 50: 5735-5741、J. Nutr. 2007; 137:2196-2201参照)。
2. Test design As test products, capsules containing ferulic acid (FA) derived from rice germ (67 mg / capsule as ferulic acid, mass ratio 11.6%) and placebo capsules were used. Placebo capsules do not contain ferulic acid. The analysis of ferulic acid can be performed by an analysis method suitable for the condition of the measurement sample among the commonly known measurement methods such as HPLC (J. Agric. Food Chem. 2002; 50: 5735-5741). See J. Nutr. 2007; 137: 2196-2201).
二重盲検プラセボ対照並行試験を実施した。被験者は、それぞれプラセボ及びフェルラ酸を摂取する2つのグループ(n =8/グループ)に分けられた。被験者は、就寝前に、プラセボ群はプラセボカプセル3個を摂取し、フェルラ酸摂取群はフェルラ酸を含むカプセル3個を摂取した。
摂取期間は2週間で、2週間のフェルラ酸摂取期間の開始時と研究終了時に皮膚性状を測定した。被験者は検査する前腕内側を洗浄した後、空調された部屋で20分間馴化した。誘電体媒体の静電容量測定に基づいた経表皮水分蒸散量(TEWL)は、Tewameter(登録商標) TM300(Courage + Khazaka Electronic GmbH、Koln、ドイツ)を使用して測定した。
A double-blind, placebo-controlled, parallel study was conducted. Subjects were divided into two groups (n = 8 / group) receiving placebo and ferulic acid, respectively. Before going to bed, the subjects ingested three placebo capsules in the placebo group and three capsules containing ferulic acid in the ferulic acid intake group.
The intake period was 2 weeks, and skin properties were measured at the beginning of the 2-week ferulic acid intake period and at the end of the study. Subjects cleaned the inside of the forearm to be examined and then acclimatized in an air-conditioned room for 20 minutes. Transepidermal water loss (TEWL) based on capacitance measurement of the dielectric medium was measured using Tewameter® TM300 (Courage + Khazaka Electronic GmbH, Koln, Germany).
3.統計解析
データは平均±標準偏差(SD)として表した。SPSS統計バージョン26(IBM, Armonk, NY, USA)を使用した。一対のt検定を使用して、同じグループ内でベースラインの測定値と2週間の連続摂取時の測定値との比較を行った。また、変化量の比較はスチューデントのt-検定を行った。有意水準は5%に設定された。
3. 3. Statistical analysis data are expressed as mean ± standard deviation (SD). SPSS statistics version 26 (IBM, Armonk, NY, USA) was used. A pair of t-tests was used to compare baseline measurements with those taken during a two-week continuous ingestion within the same group. In addition, Student's t-test was performed to compare the amount of change. The significance level was set to 5%.
4.結果
結果を図1に示す。プラセボ群の経表皮水分蒸散量(g/m2/hr)は、2週間の摂取期間前の4.8±1.9から摂取期間後の5.3±2.4に増加する傾向を示した(p =0.089)が、フェルラ酸摂取群では、経表皮水分蒸散量は6.1±1.1から4.8±1.0へ有意に減少した(p =0.004)。 プラセボ群の経表皮水分蒸散量の変化量は0.5±0.7であり、フェルラ酸摂取群の経表皮水分蒸散量の変化量は−1.3±0.9であった。経表皮水分蒸散量の変化量は、2つのグループ間で有意に異なっていた(p <0.01)。以上の結果から2週間のフェルラ酸連続経口摂取により皮膚バリア機能が改善することが示された。
4. Results The results are shown in FIG. The transepidermal water loss (g / m 2 / hr) of the placebo group tended to increase from 4.8 ± 1.9 before the 2-week intake period to 5.3 ± 2.4 after the intake period. However, in the ferulic acid intake group, transepidermal water loss significantly decreased from 6.1 ± 1.1 to 4.8 ± 1.0 (p = 0.004). The change in transepidermal water loss in the placebo group was 0.5 ± 0.7, and the change in transepidermal water loss in the ferulic acid intake group was -1.3 ± 0.9. The amount of change in transepidermal water loss was significantly different between the two groups (p <0.01). From the above results, it was shown that the skin barrier function was improved by continuous oral intake of ferulic acid for 2 weeks.
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