JP6556720B2 - 皮膚症の治療におけるダフネ・ラウレオラ抽出物 - Google Patents
皮膚症の治療におけるダフネ・ラウレオラ抽出物Info
- Publication number
- JP6556720B2 JP6556720B2 JP2016535157A JP2016535157A JP6556720B2 JP 6556720 B2 JP6556720 B2 JP 6556720B2 JP 2016535157 A JP2016535157 A JP 2016535157A JP 2016535157 A JP2016535157 A JP 2016535157A JP 6556720 B2 JP6556720 B2 JP 6556720B2
- Authority
- JP
- Japan
- Prior art keywords
- psoriasis
- dermatitis
- extract
- daphne
- skin
- 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.)
- Active
Links
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Description
アトピー性皮膚炎:通常、心身に起因する。
接触皮膚炎:特定のアレルゲンへの接触に対する身体の反応である。皮膚の赤み、かさぶたおよび落屑となって現れる。
脂漏性皮膚炎:このタイプは、たとえば、頭皮のような皮脂分泌を起こしやすい身体の領域に主に関与する。
慢性皮膚炎:皮膚に関与し、異なる身体の部分に広がる刺激として最初に現れ、再発型で、慢性的に進行する免疫系の活性化による炎症反応である。
非特異的皮膚炎:時折起こり、正確な病理学的原因に関連付けることができず、赤味および/または落屑、また、かゆみがある場合もある。
尋常性乾癬:臨床的観点から最も一般的なタイプ;典型的な病変は、雲母に似た銀色の落屑薄片で覆われた、くっきりとした紅斑性プラークである。1つのプラークは、さまざまな直径を有することができ、全身の領域を覆うように融合することができる。
滴状乾癬:連鎖球菌扁桃感染後の若い患者に起こる。1 mm〜1 cmの丘疹が、雨滴の外観を有して、主として体幹の皮膚上に現れる。
膿疱性乾癬:このタイプは、局所性または全身性の特徴をもって生じうる;特に、前者は、主として手のひらおよび足の裏に生じる。この場合、小さい角層下小胞が表面および落屑に到達するように見える。
紅皮性乾癬:これは、すべての皮膚表面が、紅斑になり、落屑する重篤なタイプの乾癬である。このタイプは、薬物、ストレス、併発症によって引き起こされうる。
脂漏性乾癬:「sebopsoriasis」または「seboriasis」とも呼ばれる非常に一般的なタイプ。脂漏性皮膚炎に非常に類似しているが、通常、該皮膚炎が関与しない領域を含みうる病変を特徴とする。
石綿状癬(Psoriasis amiantacea):頭皮のみに関与するタイプである。通常、若年性疾患である。
本発明は、一般的皮膚症、特に乾癬の治療のためのDL抽出物の局所適用を提案する。DL抽出物を、フジモドキ(DG)の抽出物とインビトロで比較した。これらの2種類の植物は、異なる起源および地理的分布を有し、さまざまな特徴によって区別され、DLは常緑性植物であり、DGは落葉性植物であり、DGは、また珍しいアメジストの色相をもつライラックブルーの花によってもDLと区別される。
本発明のDLフィトコンプレックスを含む抽出物を、植物、好ましくは開花していない植物から得る。抽出物を葉から得るのが好ましいが、いずれにせよ植物のすべての部分を用いることができる:花、果実、葉、茎および根の生ものおよび乾燥物の両方。収穫後、サンプルを濯いだ後、生の状態で用いることができるが、あるいは、ストーブで乾燥させることができる(たとえば、完全に脱水されるまで22度の換気ストーブで)。
-0.1〜5%の無水抽出物を含有するクレンジングミルク;
-0.5〜10%の無水抽出物を含有するエマルション;
-5〜20%の無水抽出物を含有する水系ゲル;
-0.5〜20%の無水抽出物を含有する水性ローション;
-5〜2%の無水抽出物を含有する薬用パッチ;
-0.5〜10%の無水抽出物を含有するシャンプー。
煎出液調製
DLおよび煎出液を、生の植物の葉を5% w/vで水に浸漬(50 gの生の葉を1000 mlの水に浸漬)することによって調製し、体積が半分になるまで約2時間沸騰させた。煎出液を放冷し、次いで、ろ過した。
生の植物を室温にて24-48時間、96%エタノール中で冷浸(200 gの生の植物を1リットルの溶媒に冷浸) (極性および非極性化合物用の広範囲可溶化溶媒)し、植物材料を3回抽出し(完全抽出)し、抽出溶媒を除去した後、抽出物を1つの抽出物にてプールすることにより抽出物を得た。植物材料中に存在するすべての二次成分を抽出するための溶媒として96%エタノールを選んだ。
ヒト角化細胞(NCTC2544)、(Emilia and Lombardia Experimental Zooprophylactic Institute)において、抗乾癬活性のインビトロ評価を行なった。NCTC2544をペトリ皿(直径100 mm)に播種し、ペニシリン(50 U/ml)、ストレプトマイシン(50 μg /ml)、非必須アミノ酸、アンホテリシンB(50 μg /ml)およびウシ胎児血清(FBS)(10% v/v)を補足したD-MEM培養培地(GIBCO、Invitrogen Corporation、U.K.)を用いてインキュベートした。インキュベーションを、細胞インキュベーター中、5% CO2下、37℃にて行なった。細胞を3日間培養して、細胞モデルを集密度80%に到達させた。3日間のインキュベーション後、1 mlのトリプシン/EDTAを用いて細胞をペトリ皿から剥がし、15 mlの遠心管に移した。2 mlの培養培地を用いて、ヒト角化細胞を中和した。カルシウムおよびマグセシウムを含まない2 mlのリン酸緩衝液(PBS)を用いてペトリ皿を洗浄し、次いで、遠心管に移した。このようにして得た細胞懸濁液を、Megafuge 1.0遠心分離機(Heraeus Sepatech、Osterode/Harz、ドイツ)を用いて、1000 rpmで室温にて10分間遠心分離した。得られた細胞ペレットを6 mlの培養培地に再懸濁して、最終濃度1x106細胞/mlにて細胞懸濁液を得た。次いで、懸濁液200 μlを2500細胞/ウェルで96ウェルプレートに播種し、5% CO2下、37℃にて24時間インキュベーショトして、接着させた。
減少%=(AbsT/AbsU)×100
[式中、AbsTは、処置細胞の吸光度であり、AbsUは、非処置細胞の吸光度である。]
を用いて決定した。得られた細胞増殖の増加パーセントは、3回の別の評価±標準偏差の平均である。
24、48および72時間のインキュベーション後に、使用した生成物v/vパーセントの関数として、DL煎出液毒性を評価した。予め凍結乾燥した煎出液の濃度の増加(0.01、0.1、1、10% w/v)を、上述のMTTアッセイを用いて評価した。化合物毒性を生存率パーセントの関数として評価した。得られた値は、6回の異なる実験±標準偏差の平均である。
試験プロトコルを説明され、インフォームドコンセントを与えた30人の患者(試験が行われる医療行為において記録された)においてDL煎出液を用いて試験を行った。4人の患者を、グリセリンと混合した、乾燥およびみじん切りした葉の混合物(グリセリン混合物)で処置した。
ベースライン病変の記録として、提案する処理の有効性を評価するために、患者の承諾を得て処置前に写真を撮った(図5)。
1日2回のグリセリン混合物を用いて、先の試験と同じ試験を繰り返した。
煎出液で処置された患者とは異なって、乾燥葉で処置された患者は、1ヶ月間の処置の後でも有意な改善を示さなかった(図7)。
本発明で記載したDL煎出液は、局所的に使用されることを意味し、皮膚に適用されるさまざまな製品(水系ゲル、エマルション、界面活性剤製品、ローション)のための出発点である。
ゲル-1
水中のDL抽出物 0.5-5%
ヒドロキシプロピルセルロース 2.5%
保存剤 0.2%
水 100への適量
ゲル-2
水中のDL抽出物 0.5-5%
カルボマー 1.5%
保存剤 0.2%
トリエタノールアミン pH 4.5への適量
水 100への適量
O/Wエマルション
油相
カプリル酸/カプリン酸トリグリセリド 7.5%
PEG 15 ステアリルエーテル 7.5%
イソヘキサデカン 15%
シリコンオイル 5%
PEG-10 グリセリルオレイン酸イソヘキサデカンコハク酸塩 4%
水相
水中のDL抽出物 0.5-5%
蒸留水 100への適量
カルボマー 2%
保存剤 0.2%
1. H. Fleisch、A. Reszka、G.A. Rodan、M. Rogers、Bisphosphonates-mechanism of action、in:J.P. Bilezikian、L.G. Raisz、G.A. Rodan (Eds.)、Principles of Bone Biology、2nd ed.、Academic Press、San Diego、2002、pp. 1361-1385.
2. M.D. Fancis、I. Fogelman、99mTc diphosphonate uptake mechanism on bone、in:I. Fogelman (Ed.)、Bone Scanning in Clinical Pactice、Springer-Verlag、New York、1987、pp. 7-17.
3. H.M. Lamb、D. Faulds. Samarium 153Sm lexidronam、Drugs Aging 1997、11、413-418.
4. USA Patent Application 20090123383、Frangioni、Jhon、“Non isotopic detection of osteoblastic activity in vivo using modified bisphosphonates”.
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Claims (14)
- ダフネ・ラウレオラ抽出物を含む、皮膚への適用のための、細胞の過剰増殖を特徴とする皮膚疾患の治療薬であって、
皮膚疾患が、乾癬、慢性皮膚炎、アトピー性皮膚炎、接触性皮膚炎、脂漏性皮膚炎、非特異的皮膚炎、時折の皮膚炎、およびふけ症から選択される、治療薬。 - 乾癬が、尋常性乾癬、滴状乾癬、膿疱性乾癬、紅皮症乾癬、脂漏性乾癬、石綿状癬から選ばれる、請求項1に記載の治療薬。
- 生ものおよび乾燥物の両方の、ダフネ・ラウレオラ植物の花、果実、葉、茎および根のからの液体、半固体または無水形態である、請求項1または2に記載の治療薬。
- ダフネ・ラウレオラの抽出物ならびに1種以上の医薬的、化粧品的および薬用化粧品的に許容しうる成分を含む、皮膚への適用のための、医薬、化粧品および薬用化粧品組成物。
- 医薬的、化粧品的および薬用化粧品的に許容しうる成分が、皮膚軟化剤、保湿剤、増粘剤、乳化剤、着色剤、界面活性剤、消毒剤、抗酸化剤、緩衝剤、艶消し剤、剥離剤、芳香剤など、精油、ビタミン、UVフィルター、コラーゲン、エラスチンおよびその混合物から選ばれる、請求項4に記載の医薬品、化粧品および薬用化粧品組成物。
- たとえば、ゲル、ローション、ミルク、エマルション、フォームなどの液体製剤;クリーム、軟膏、スティックなどなどの固体または半固体製剤として製剤された、請求項4または5に記載の組成物。
- シャンプー、クレンジングミルク、トニックウォーター、水性溶液、アルコール溶液、含水アルコール溶液、マスク、エマルション、水系ゲル、リポゲル、フェイスおよびボディオイル、薬用パッチとして製剤された、請求項4〜6のいずれかに記載の組成物。
- 細胞の過剰増殖を特徴とする皮膚疾患を治療するための、ダフネ・ラウレオラ抽出物を含む、皮膚への適用のための、医薬、化粧品および薬用化粧品組成物であって、
皮膚疾患が、乾癬、慢性皮膚炎、アトピー性皮膚炎、接触性皮膚炎、脂漏性皮膚炎、非特異的皮膚炎、時折の皮膚炎、およびふけ症から選択される、医薬、化粧品および薬用化粧品組成物。 - 乾癬が、尋常性乾癬、滴状乾癬、膿疱性乾癬、紅皮症乾癬、脂漏性乾癬、石綿状癬から選ばれる、請求項8に記載の組成物。
- 浸出液、煎出液、冷浸、パーコレーション、超音波および/またはマイクロウェーブによって補助された継続的攪拌下での抽出、超臨界流体を用いる抽出から選ばれる、ダフネ・ラウレオラから、請求項1に記載の抽出物を得る方法。
- 抽出が、水、エタノール、グリセロール、プロパノール、ブタノール、アセトン、エチレン-,プロピレン-およびブチレン-グリコールなどのグリコール、酢酸エチル、ヘキサン、塩化メチレン、メタノール、エーテルおよびその混合物から選ばれる極性溶媒の存在下で行なわれる、請求項10に記載の方法。
- 抽出に続いて、液体、半固体または無水抽出物が得られるまで、蒸発または凍結乾燥による濃縮が行なわれる、請求項10または11に記載の方法。
- 抽出が、生ものおよび乾燥物の両方の、ダフネ・ラウレオラ植物の花、果実、葉、茎および根から行なわれる、請求項10〜12のいずれかに記載の方法。
- ヒトにおける皮膚への適用による細胞の過剰増殖を特徴とする皮膚疾患の治療のための、医薬、化粧品または薬用化粧品の製造における、ダフネ・ラウレオラのフィトコンプレックスまたは抽出物の使用であって、
皮膚疾患が、乾癬、慢性皮膚炎、アトピー性皮膚炎、接触性皮膚炎、脂漏性皮膚炎、非特異的皮膚炎、時折の皮膚炎、およびふけ症から選択される、使用。
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