JP2018002652A - 慢性角化型湿疹改善剤 - Google Patents
慢性角化型湿疹改善剤 Download PDFInfo
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- JP2018002652A JP2018002652A JP2016131070A JP2016131070A JP2018002652A JP 2018002652 A JP2018002652 A JP 2018002652A JP 2016131070 A JP2016131070 A JP 2016131070A JP 2016131070 A JP2016131070 A JP 2016131070A JP 2018002652 A JP2018002652 A JP 2018002652A
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- chronic
- eczema
- component
- acid
- tocopherol
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Landscapes
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Abstract
Description
項1.(A)尿素、
(B)グリチルリチン酸、グリチルレチン酸、それらの誘導体、及びそれらの塩よりなる群から選択される少なくとも1種、並びに
(C)トコフェロール、レチノール、及びそれらの誘導体よりなる群から選択される少なくとも1種
を含有する慢性角化型湿疹改善剤。
項2. 前記(C)成分として、トコフェロール及び/又はその誘導体を含有する、項1に記載の慢性角化型湿疹改善剤。
項3. 慢性角化型湿疹における角層の肥厚化及び黒ずみの双方の症状を改善するために使用される、項1又は2に記載の慢性角化型湿疹改善剤。
本発明の慢性角化型湿疹改善剤は、尿素を含有する。尿素は、水素結合による水分保持作用と共に、タンパク質変性により不要な角質を除去する効果を併せ持つため、古くから角化症治療薬として知られている成分である。
本発明の慢性角化型湿疹改善剤は、グリチルリチン酸、グリチルレチン酸、それらの誘導体、及び/又はそれらの塩を含有する。これらの成分は、その炭素骨格がステロイドに類似しており、免疫反応を鈍化させ、炎症反応を弱める作用を有することが知られている成分である。
本発明の慢性角化型湿疹改善剤は、更に、トコフェロール、レチノール、及びそれらの誘導体よりなる群から選択される少なくとも1種を含有する。以下、(C)成分の内、トコフェロール及び/又はその誘導体を(C-1)成分と表記することがあり、また、レチノール及び/又はその誘導体を(C-2)成分と表記することがある。
本発明の慢性角化型湿疹改善剤は、前記(A)〜(C)成分に加えて、必要に応じて、γ−オリザノール(以下、(D)成分と表記することもある)を含んでいてもよい。このように(D)成分を含有させることにより、より一層効果的に、慢性角化型湿疹の改善効果を向上させることが可能になる。
本発明の慢性角化型湿疹改善剤には、保湿性の向上等のために、必要に応じて多価アルコールが含まれていてもよい。
また、本発明の外用組成物は、(C)成分、及び必要に応じて添加される(D)成分を可溶化又は乳化させて所望の製剤形態にするために、界面活性剤が含まれていてもよい。界面活性剤としては、薬学的に許容されることを限度として特に制限されず、ノニオン性界面活性剤、アニオン性界面活性剤、カチオン性界面活性剤、両性界面活性剤のいずれを使用してもよいが、好ましくはノニオン性界面活性剤が挙げられる。
本発明の慢性角化型湿疹改善剤は、前述する成分の他に、必要に応じて、他の薬理成分を含有していてもよい。このような薬理成分としては、例えば、抗ヒスタミン剤(ジフェンヒドラミン、塩酸ジフェンヒドラミン等)、局所麻酔剤(プロカイン、テトラカイン、ブピパカイン、メピパカイン、クロロプロカイン、プロパラカイン、メプリルカイン又はこれらの塩、オルソカイン、オキセサゼイン、オキシポリエントキシデカン、ロートエキス、ペルカミンパーゼ、テシットデシチン等)、抗炎症剤(インドメタシン、フェルビナク、ジクロフェナクナトリウム、ロキソプロフェンナトリウム等)、皮膚保護剤(コロジオン、ヒマシ油等)、血行促進成分(ノニル酸ワニリルアミド、ニコチン酸ベンジルエステル、カプサイシン、トウガラシエキス等)、清涼化剤(メントール、カンフル、ボルネオール、ハッカ水、ハッカ油等)、ムコ多糖類(コンドロイチン硫酸ナトリウム、グルコサミン等)等が挙げられる。
本発明の慢性角化型湿疹改善剤は、(A)〜(C)成分、及び必要に応じて(D)成分及びその他の成分を、その製剤形態に応じた手法で、所望量混合することにより調製される。
本発明の慢性角化型湿疹改善剤は、経皮適用できる剤型である限り、その製剤形態については、特に制限されず、液状、固形状、半固形状(ゲル状、軟膏状、ペースト状)等のいずれであってもよい。
1.評価方法
表1に示す条件に従い、50mM リン酸バッファー(pH6.5)に、5mM L−DOPA(dihydroxy−L−phenylalanine)水溶液を加えた。次いで、各成分(L−アスコルビン酸、グリチルリチン酸モノアンモニウム、γ−オリザノール(フェルラ酸シクロアルテニル(C40H58O4)含有量:99.4重量%)、ビタミンA油(レチノールパルミチン酸エステル100万I.U./g)又はトコフェロール酢酸エステル)のDMSO(dimethyl sulfoxide)溶液を加え撹拌した後、チロシナーゼ水溶液(チロシナーゼ含有量:3.91 unit)を加えることで酵素反応を開始した(反応温度:37℃)。酵素反応開始から15分後、マイクロプレートリーダーを用いて吸光度(475nm)を測定した。各成分について段階希釈により複数濃度のチロシナーゼ活性阻害率を測定し、50%阻害濃度(IC50、w/v%)を算出した。なお、チロシナーゼ活性阻害率(%)は、以下の式により算出した。
得られた結果を表2に示す。この結果、L−アスコルビン酸及びグリチルリチン酸モノアンモニウムはより低濃度でチロシナーゼ活性を阻害できることが確認された。また、γ−オリザノール、トコフェロール酢酸エステル及びビタミンA油については、一定のチロシナーゼ活性阻害効果を有していたが、L−アスコルビン酸及びグリチルリチン酸モノアンモニウムに比べると低い結果であった。
1.評価方法
<試験試料の作製>
表3に示す組成のクリーム剤(水中油型乳化状のクリーム剤)を調製した(実施例1〜5、比較例1〜3、及び参考例1〜2)。具体的には、水性成分と油性成分をそれぞれ混合し、必要に応じて加熱し、溶解させ、それらを撹拌した後に冷却を行うことでクリーム剤を得た。なお、ビタミンA油には1g当たりレチノールパルミチン酸エステルを100万I.U.含有するものを使用し、また、γ−オリザノールにはフェルラ酸シクロアルテニル(C40H58O4)を99.4重量%含有するものを使用した。得られた各クリーム剤を試験試料として使用して以下の試験を行った。
「保湿・美白・抗シワ・抗酸化評価・実験法マニュアル」(フレグランスジャーナル社、2012年2月発行)に収載の「再構築表皮モデルを用いたメラニン産生抑制剤評価法」の試験方法に従って試験を行った。
メラニン細胞をチューブに移し、PBS(−)を用いて洗浄した。更に、5%トリクロロ酢酸、エタノール/ジエチルエーテル溶液、ジエチルエーテルの順で洗浄した後、1mol/L水酸化ナトリウム水溶液を添加して、メラニン細胞に含まれるメラニンを加温溶解(100℃、10分間)した。マイクロプレートリーダーを用いて405nmの吸光度を測定した。合成メラニン(シグマアルドリッチジャパン株式会社)を用いて作成した検量線に基づき、測定値から「メラニン産生量」を算出した。次いで、比較例1のメラニン産生量を「100」とした場合の相対値を「メラニン産生率」(%)として算出した(小数点第1位を四捨五入した)。
メラニン細胞の明度(L値)を、底部側から分光測色計(CR−13(コニカミノルタホールディング株式会社)にて測定した。測定を5回行い、その平均値を求めた。次いで、比較例1の明度を「100」とした場合の相対値を「明度改善率」(%)として算出した(小数点第1位を四捨五入した)。
10%アラマーブルー試薬を含むEPI−100LLMM長期維持培地を24穴プレートに分注した。MEL−300をこのプレートへ移し、2時間培養した。培養上清の蛍光強度(Ex./Em.=544nm/590nm)を測定した。細胞生存率は、比較例1の蛍光強度を「100」とした場合のIndex(%)として算出した。結果はいずれも99〜105%であった。この細胞生存率に基づいて、「メラニン産生量」と「明度」の値を補正した。
得られた結果を表3に示す。尿素のみを含む比較例2は、メラニン産生量及び明度において、コントロール(比較例3)と大きな差は見られなかった。また、チロシナーゼ活性阻害効果を有するグリチルリチン酸モノアンモニウムを尿素との組合せた比較例1については、メラニン産生量及び明度において十分な効果を奏さなかった。一方、尿素とグリチルリチン酸モノアンモニウムと共に、ビタミンA油を含む実施例1では、メラニン産生量を抑制し、かつ明度を向上させることができていた。また、尿素、グリチルリチン酸モノアンモニウム、及びトコフェロール酢酸エステルを含む実施例2では、メラニン産生量が著しく低下しており、かつ明度の顕著な向上も認められた。更に、尿素、グリチルリチン酸モノアンモニウム、並びにビタミンA油及び/又はトコフェロール酢酸エステルに加えて、γ−オリザノールを含む実施例3〜5では、メラニン産生量が格段顕著に低下しており、更に明度の著しい向上が認められた。
1.評価方法
表4に示す組成のクリーム剤(水中油型乳化状のクリーム剤)を、前記試験例1と同様の方法で調製した(実施例2、4、5、比較例1、2、4〜7)。なお、ビタミンA油には1g当たりレチノールパルミチン酸エステルを100万I.U.含有するものを使用し、また、γ−オリザノールにはフェルラ酸シクロアルテニル(C40H58O4)を99.4重量%含有するものを使用した。
得られた結果を表4に示す。また、実施例5の塗布前と塗布1カ月後の肘の状態を撮影した写真を図1に示す。尿素を単独で含有する比較例2では、角層の肥厚化及び黒ずみを十分に改善できず、慢性角化型湿疹の改善効果は満足できるものではなかった。また、尿素とグリチルリチン酸モノアンモニウムを組み合わせた比較例1、尿素とビタミンA油を組み合わせた比較例5、及び尿素とトコフェロール酢酸エステルを組み合わせた比較例6でも、尿素単独の比較例1と同程度の効果しか認められなかった。更に、グリチルリチン酸モノアンモニウムとトコフェロール酢酸エステルを組み合わせた比較例4、並びにグリチルリチン酸モノアンモニウムとビタミンA油を組み合わせた比較例7では、尿素単独の比較例2に比べて、慢性角化型湿疹の改善効果は劣っていた。これに対して、尿素、グリチルリチン酸モノアンモニウム、及びトコフェロール酢酸エステルを含む実施例2では、優れた慢性角化型湿疹の改善効果が認められた。更に、これらの成分に加えて、ビタミンA油及び/又はγ−オリザノールを含む実施例4及び5では、慢性角化型湿疹の改善効果が顕著に優れており、とりわけ、実施例5では、慢性角化型湿疹の改善効果が格段顕著に高まっていた。
表5〜7に示す慢性角化型湿疹改善剤を調製した。表5に示す慢性角化型湿疹改善剤はクリーム剤(水中油型乳液状クリーム剤)、表6に示す慢性角化型湿疹改善剤は液剤、表5に示す慢性角化型湿疹改善剤はゲル剤である。得られた各慢性角化型湿疹改善剤を前記試験例2と同様の方法で慢性角化型湿疹の改善効果を評価したところ、優れた慢性角化型湿疹の改善効果が認められた。
Claims (3)
- (A)尿素、
(B)グリチルリチン酸、グリチルレチン酸、それらの誘導体、及びそれらの塩よりなる群から選択される少なくとも1種、
(C)トコフェロール、レチノール、及びそれらの誘導体よりなる群から選択される少なくとも1種、
を含有する慢性角化型湿疹改善剤。 - 前記(C)成分として、トコフェロール及び/又はその誘導体を含有する、請求項1に記載の慢性角化型湿疹改善剤。
- 慢性角化型湿疹における角層の肥厚化及び黒ずみの双方の症状を改善するために使用される、請求項1又は2に記載の慢性角化型湿疹改善剤。
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