JP6166480B2 - カロテノイドの医薬組成物 - Google Patents
カロテノイドの医薬組成物 Download PDFInfo
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- JP6166480B2 JP6166480B2 JP2016536837A JP2016536837A JP6166480B2 JP 6166480 B2 JP6166480 B2 JP 6166480B2 JP 2016536837 A JP2016536837 A JP 2016536837A JP 2016536837 A JP2016536837 A JP 2016536837A JP 6166480 B2 JP6166480 B2 JP 6166480B2
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Description
本出願は、2013年12月11日出願の米国特許出願第61/914879号の優先権を主張し、その全開示を参照により本明細書に組み入れることとする。
[医薬組成物]
一実施形態では、本発明に係る医薬組成物は、(a)一つ又は複数のカイロミクロンと、(b)1または2以上のカロテノイドとを含む。カイロミクロンに封入されるカロテノイドのバイオアベイラビリティは、カイロミクロンに封入されていないカロテノイドのバイオアベイラビリティより相対的に高いである。一実施形態では、医薬組成物の封入効率が50、60、70、80%を超えた。
本発明の一実施例は下記ステップにより調製された。
(1)高粘度のカロテノイド混合物(MCS(登録商標)、Health Ever Biotech株式会社(台湾)から購入可能)は、15mgのソラノルビン(カロテノイド)と、1.5mgの八水素ソラノルビン(カロテノイド)と、1.25mgの六水素ソラノルビン(カロテノイド)と、25mgのレシチン(リン脂質)と、1.5mgのフィトステロールと、5mgのトコフェロールと、0.5mgのβ−カロチンとを含み、且つ300.25mgの大豆油(トリグリセリド)と十分に混合した。
(2)ステップ(1)で得られた混合物を30分の超音波処理によって、油中水型(W/O)の乳液(MCS(登録商標)カロテノイド混合物の粘度より低い)を得た。
例2:ミセル及びカロテノイドを含む医薬組成物の調製
本発明の一実施例は下記ステップにより調製された。
(1)50mgの高粘度のカロテノイド混合物は、(a)2.2mgのソラノルビン(カロテノイド)と、(b)0.21mgの八水素ソラノルビン(カロテノイド)と、(c)0.18mgの六水素ソラノルビン(カロテノイド)と、(d)3.28mgのレシチン(リン脂質)と、(e)0.71mgのトコフェロールと、(f)0.07mgのβ−カロチンと、(g)42.9mgの油とを含み、且つガラス管に600mgのTween80(界面活性剤)と十分に混合する。混合物を均質となるように攪拌した。
(2)ステップ(1)で得られた混合物を5.4mL(5.4gに相当)の脱イオン水と混合して、超音波により30分処理した。
(3)ステップ(1)で得られた混合物を室温で24時間保存することにより、ミセル(O/W乳液)を得た。その中、ソラノルビンの濃度が約0.37mg/mLであった。
例3:医薬(Pharmaceutical)及び医薬組成物の薬物動態学の研究
例1及び例2で調製された医薬組成物の薬物動態学的特性を、雄スプラーグドーリーラット(Sprague−Dawley rat)を用いて評価した。
経口投与による医薬組成物のバイオアベイラビリティを表2に示す。
Claims (15)
- 医薬組成物であって、
(a)トリグリセリドと、リン脂質と、フィトステロールとを含み、前記医薬組成物に対してトリグリセリドは75〜95重量%であり、リン脂質は1〜15重量%であり、フィトステロールは0.1〜1.5重量%である混合物と、
(b)前記混合物に封入されたカロテノイドと、
を含むことを特徴とする、医薬組成物。 - フィトステロールの比率が、0.7(w/w)であることを特徴とする、請求項1に記載の医薬組成物。
- 前記医薬組成物は、薬学的に許容される担体又は薬学的に許容される賦形剤をさらに含むことを特徴とする、請求項1に記載の医薬組成物。
- 前記薬学的に許容される賦形剤が、トコフェロールであることを特徴とする、請求項3に記載の医薬組成物。
- 前記トリグリセリドが、大豆油、パンプキンシード油、亜麻仁油、グレープシード油、オリーブ油、ひまわり油、及びそれらの組合せから選択されることを特徴とする、請求項1に記載の医薬組成物。
- 前記リン脂質が、レシチン及びホスファチジルコリンから選択されることを特徴とする、請求項1に記載の医薬組成物。
- 前記カロテノイドが、カロチンであることを特徴とする、請求項1に記載の医薬組成物。
- 前記カロテノイドが、ソラノルビン、八水素ソラノルビン、六水素ソラノルビン及びそれらの組合せから選択されることを特徴とする、請求項1に記載の医薬組成物。
- 前記医薬組成物に対してソラノルビン:八水素ソラノルビン:六水素ソラノルビンの重量比が、4〜5:0.1〜1:0.1〜1であることを特徴とする、請求項8に記載の医薬組成物。
- 前記医薬組成物に対してソラノルビン:八水素ソラノルビン:六水素ソラノルビンの重量比が、4.2〜4.5:0.3〜0.5:0.3〜0.5であることを特徴とする、請求項9に記載の医薬組成物。
- ソラノルビンの薬物濃度−時間曲線下面積が、450〜580分・μg/mlであることを特徴とする、請求項1に記載の医薬組成物。
- 八水素ソラノルビンの薬物濃度−時間曲線下面積が、150〜200分・μg/mlであることを特徴とする、請求項1に記載の医薬組成物。
- 六水素ソラノルビンの薬物濃度−時間曲線下面積が、65〜120分・μg/mlであることを特徴とする、請求項1に記載の医薬組成物。
- 前記医薬組成物は、β−カロチンをさらに含むことを特徴とする、請求項1に記載の医薬組成物。
- 前記医薬組成物は、使用前に水及びリン脂質で構成されることを特徴とする、請求項1に記載の医薬組成物。
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