JP6463776B2 - 変性眼疾患の予防および/または治療のための、サフランをベースとする組成物 - Google Patents
変性眼疾患の予防および/または治療のための、サフランをベースとする組成物 Download PDFInfo
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- JP6463776B2 JP6463776B2 JP2016558313A JP2016558313A JP6463776B2 JP 6463776 B2 JP6463776 B2 JP 6463776B2 JP 2016558313 A JP2016558313 A JP 2016558313A JP 2016558313 A JP2016558313 A JP 2016558313A JP 6463776 B2 JP6463776 B2 JP 6463776B2
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Description
<網膜のモルホロジー分析>
サフランの投与に付随する、神経保護の活性における有効性プロファイルを、網膜変性症のモデルにおける光損傷にさらしたSDアルビノラットの網膜のモルホロジー分析を実施し、損傷を定量化し、サフランのあり得べき保護活性を評価することによって検証した。
本発明にしたがうサフランおよびクルクミンの組み合わせの効果を実験的に検証するために、錠剤状の組成物を調製した。それぞれの錠剤は、活性成分が固体粉末形態である固体組成物の普通の賦形剤ともに、10mgのサフランクロッカス(Crocus sativus)および50mgの秋ウコン(Curcuma longa)を含んだ。
投与の3ヶ月後に、fERG振幅は、開始時の値に比較して増加し、変調の最小深さの減少によって示されるように応答閾値の減少をもたらし、バックグラウンド強度よりも著しく高い応答を起こす。さらに、fERGデータは、試験および再試験の順序において限定的な変動を示した。
投与の最初の3ヶ月後には、既に、平均視力は、2つのスネレン列の改善を示し、いずれにせよ、観察の全期間の間、視力の増大は安定なままであった。
全ての患者に対して定期的に実施されるこの試験は、ドルーゼンの数および大きさにも、網膜色素上皮(RPE)の異常の拡張に関係する事象にも、有意の変化を示さなかった。
<網膜のモルホロジー分析>
サフランの投与に付随する、神経保護の活性における有効性プロファイルを、網膜変性症のモデルにおける光損傷にさらしたSDアルビノラットの網膜のモルホロジー分析を実施し、損傷を定量化し、サフランのあり得べき保護活性を評価することによって検証した。
第1群:16.9%以上のトランス−クロシン−4−ゲンチオビオース−ゲンチオビオース(T1)含有量および8%以上のトランス−クロシン−3−ゲンチオビオース−グルコース(T2)含有量を有するサフラン(サフランB)で処理されたラット;
第2群:12%に等しいトランス−クロシン−4−ゲンチオビオース−ゲンチオビオース(T1)含有量および6%に等しいトランス−クロシン−3−ゲンチオビオース−グルコース(T2)含有量を有するサフラン(サフランA)で処理されたラット;
第3群:非処理であるが、光損傷にさらされたラット(病的な網膜);
第4群:健康な動物(健康な網膜)。
<網膜のモルホロジー分析>
本発明にしたがうサフランおよびクルクミンの組み合わせの投与に付随する、神経保護の活性における有効性プロファイルを、網膜変性症のモデルにおける光損傷にさらしたSDアルビノラットの網膜のモルホロジー分析を実施し、損傷を定量化し、サフラン単独の場合およびクルクミン単独の場合と比較した、サフランおよびクルクミンの組み合わせのあり得べき保護活性を評価することによって検証した。
第1群:16.9%以上のトランス−クロシン−4−ゲンチオビオース−ゲンチオビオース(T1)含有量および8%以上のトランス−クロシン−3−ゲンチオビオース−グルコース(T2)含有量を有するサフランで処理されたラット(サフラン);
第2群:16.9%以上のトランス−クロシン−4−ゲンチオビオース−ゲンチオビオース(T1)含有量、8%以上のトランス−クロシン−3−ゲンチオビオース−グルコース(T2)含有量およびクルクミンを有するサフランの組み合わせで処理されたラット(クルクミン+サフラン);
第3群:クルクミン単独で処理されたラット(クルクミン);
第4群:非処理であるが、光損傷にさらされたラット(対照群−LD);
第5群:健康な動物(対照群)。
Claims (12)
- 有効量のサフランを含み、トランス−クロシン−4−ゲンチオビオース−ゲンチオビオースが、サフランの総質量を基準として16.9質量%以上の量で存在し、トランス−クロシン−3−ゲンチオビオース−グルコースが、サフランの総質量を基準として8質量%以上の量で存在することを特徴とする、変性眼疾患の治療に用いるための薬剤組成物、食餌組成物および/または食品組成物、好ましくは補助食品。
- 変性眼疾患が、遺伝性網膜変性症および誘発性網膜変性症を含む群から選択されることを特徴とする、請求項1に記載の用途のための組成物。
- 前記遺伝性網膜変性症が色素性網膜炎およびシュタルガルト病であり、誘発性網膜変性症が加齢黄斑変性症であることを特徴とする、請求項2に記載の用途のための組成物。
- 組成物が、5mgと50mgとの間で変動する量のサフランクロッカス(Crocus sativus)を含有することを特徴とする、請求項1から3のいずれかに記載の用途のための組成物。
- 前記サフランが20mg/日の一日当たりの投与量で投与されることを特徴とする、請求項1から4のいずれかに記載の用途のための組成物。
- 有効量のクルクミンをさらに含有することを特徴とする、請求項1から5のいずれかに記載の用途のための組成物。
- 組成物が、30mgと200mgとの間で変動する量の秋ウコン(Curcuma longa)と、5mgと50mgとの間で変動する量のサフランクロッカス(Crocus sativus)を含有することを特徴とする、請求項6に記載の用途のための組成物。
- 前記サフランが20mg/日の一日当たりの投与量で投与され、前記クルクミンが100mg/日の一日当たりの投与量で投与されることを特徴とする、請求項6または7に記載の用途のための組成物。
- 哺乳類、特にヒトに投与されることを特徴とする、請求項1から8のいずれかに記載の用途のための組成物。
- 少なくとも1種の生理学的に許容可能な賦形剤をさらに含むことを特徴とする、請求項1から9のいずれかに記載の用途のための組成物。
- 錠剤、顆粒、糖衣錠またはカプセル、好ましくは錠剤の形態にあることを特徴とする、請求項1から10のいずれかに記載の用途のための組成物。
- 前記サフランが、アブルッツイ地域、ウンブリア地域、またはトスカナ地域の産出であることを特徴とする、請求項1から11のいずれかに記載の用途のための組成物。
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PCT/IB2015/052053 WO2015145316A1 (en) | 2014-03-28 | 2015-03-20 | Compositions based on saffron for the prevention and/or treatment of degenerative eye disorders. |
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CN106659698A (zh) | 2014-09-19 | 2017-05-10 | 霍图斯诺伟司有限责任公司 | 基于藏红花的用于预防和/或治疗角膜营养不良的组合物 |
ES2573542B1 (es) * | 2016-04-18 | 2017-03-13 | Pharmactive Biotech Products, S.L. | Empleo de un nuevo extracto de azafrán para la prevención de trastornos del estado de ánimo relacionados con la depresión |
IT201600126405A1 (it) * | 2016-12-14 | 2018-06-14 | Raffaella Bertoglio | Composizione farmaceutica per la prevenzione e il trattamento della degenerazione maculare senile |
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US20040076691A1 (en) | 2002-01-16 | 2004-04-22 | David Haines | Anti-inflammatory formulations |
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ES2428665B1 (es) | 2012-05-04 | 2014-10-01 | Universidad De Valladolid | Composición para su uso en el tratamiento y/o prevención de la inflamación, el estrés oxidativo y la neovascularización ocular |
US9211298B2 (en) * | 2012-11-16 | 2015-12-15 | Song Gao | Compositions containing enriched natural crocin and/or crocetin, and their therapeutic or nutraceutical uses |
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