JP6215821B2 - マルチカロテノイドビーズレット及び関連する方法 - Google Patents
マルチカロテノイドビーズレット及び関連する方法 Download PDFInfo
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- JP6215821B2 JP6215821B2 JP2014520365A JP2014520365A JP6215821B2 JP 6215821 B2 JP6215821 B2 JP 6215821B2 JP 2014520365 A JP2014520365 A JP 2014520365A JP 2014520365 A JP2014520365 A JP 2014520365A JP 6215821 B2 JP6215821 B2 JP 6215821B2
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- carotene
- carotenoid
- gastrointestinal tract
- beadlet
- lutein
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- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
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Description
図1に関連して上記した複数層構造を有するマルチカロテノイドビーズレット、表1に示した構造、又は後述する他の構造を調製し、次に溶解について試験した。図2は、このような逐次的な持続放出ビーズレットの代表的なクロマトグラムを示す。このデータを得るためのプロトコールを表3及びさらに以下に記載する。
この実施例において、即時放出(IR)マルチカロテノイド製剤のカロテノイド組成物、すなわち、個々のカロテノイドが積層されず、または逐次的に放出されないが、代わりに、全てを同時に放出する組成物は、逐次的な持続放出の2つの実施形態と比較された。これらは、放出制御(CR)マルチカロテノイドビーズレットとも呼ばれる。各製剤からの各カロテノイドの正確な量を以下の表5中のミリグラム/グラム(mg/g)で表す。図3〜5は、即時放出(IR)ビーズレット(図3)、及びプロトタイプI(図4)とプロトタイプII(図5)と称される放出制御(CR)ビーズレットの2つの実施形態の溶解プロフィールを示す。図示されるように、プロトタイプIとIIとの間でβ−カロチンとα−カロチンの放出に違いがある。
即時放出マルチカロテノイド製剤及び放出制御マルチカロテノイド製剤を比較した臨床試験が行われる。この臨床研究は、以下に基づいて設計される。腸管内では、カロテノイドは、多重膜脂質小胞を形成し、それらの混合脂質ミセルは、胆汁酸塩、遊離脂肪酸、モノグリセリド及びリン脂質で構成される。一旦ミセルに形成されると、カロテノイドは、一般に、受動拡散によって十二指腸粘膜細胞に吸収されると考えられる。拡散速度は、ミセルと腸細胞との間の濃度勾配によって決定される。カロテノイドは、カイロミクロンによって排他的に、腸粘膜から血流に輸送される。これは、消費後のカロテノイドの取り込みを評価するのに便利なコンパートメントタイプのモデルを提供する。
Claims (19)
- 各々12:6:4:2:1の比率で存在するβ−カロチン、ルテイン、リコピン、α−カロチン、及びゼアキサンチンであるカロテノイドを含む経口投与可能なビーズレット(beadlet)であって、ここで、ビーズレットはコア及び外部を含み、ここで、β−カロチンは、1つの層に配置され、該層は、ルテイン及びゼアキサンチンの少なくとも1つを含む別の層よりもコアに近く、それにより、β−カロチンは、ルテイン及びゼアキサンチンの少なくとも1つがヒトの胃腸管に放出された後に該胃腸管に放出されるように構成された、上記ビーズレット;
を含む逐次的持続放出マルチカロテノイドであって、
ここで、前記ビーズレットは、ヒトへの経口投与の4〜6時間後に、β−カロチンをヒトの胃腸管に放出するように構成され、
ここで、前記ビーズレットは、ヒトへの経口投与の2〜3時間後に、ルテインをヒトの胃腸管に放出するように構成され、
ここで、前記ビーズレットは、ヒトへの経口投与の3〜4時間後に、リコピンをヒトの胃腸管に放出するように構成され、
ここで、前記ビーズレットは、ヒトへの経口投与の4〜6時間後に、α−カロチンをヒトの胃腸管に放出するように構成され、及び
ここで、前記ビーズレットは、ヒトへの経口投与の2〜3時間後に、ゼアキサンチンをヒトの胃腸管に放出するように構成され、
ここで、ビーズレットからのカロテノイドの逐次放出に起因して、胃腸管における吸収に対して互いに実質的に競合することなしに、カロテノイドはヒトの飲食物を補足する方法ように構成されている、上記逐次的持続放出マルチカロテノイド。 - カロテノイドがアスタキサンチンを含む、請求項1に記載の逐次的持続放出マルチカロテノイド。
- β−カロチン、ルテイン、リコピン、α−カロチン、ゼアキサンチン、及びアスタキサンチンが各々12:6:4:2:1:1の比率で存在する、請求項2に記載の逐次的持続放出マルチカロテノイド。
- β−カロチンが胃腸管に曝露され、ビーズレットから胃腸管に最初に放出される前に、ルテイン及びゼアキサンチンが胃腸管に曝露され、ビーズレットから胃腸管に最初に放出されるように、カロテノイドがコアから外部に積層され、構成される、請求項1に記載の逐次的持続放出マルチカロテノイド。
- 前記ビーズレットは、α−カロチンが胃腸管に曝露され、ビーズレットから胃腸管に最初に放出される前に、ルテイン及びゼアキサンチンが胃腸管に暴露され、ビーズレットから最初に胃腸管に放出されるように構成される、請求項4に記載の逐次的持続放出マルチカロテノイド。
- 前記ビーズレットは、β−カロチンが胃腸管に曝露され、ビーズレットから胃腸管に最初に放出される前に、リコピンが胃腸管に暴露され、ビーズレットから最初に胃腸管に放出されるように構成され、そして、ルテイン及びゼアキサンチンが胃腸管に曝露され、ビーズレットから胃腸管に最初に放出された後に、リコピンが胃腸管に暴露され、ビーズレットから最初に胃腸管に放出されるように構成される、請求項5に記載の逐次的持続放出マルチカロテノイド。
- 前記ビーズレットは、カロテノイドがアスタキサンチンを含むように構成され、ここで、ヒトへの経口投与の1〜2時間後に、アスタキサンチンがヒトの胃腸管から放出される、請求項1に記載の逐次的持続放出マルチカロテノイド。
- カロテノイドが不足しているヒトに投与するものである、請求項1に記載の逐次的持続放出マルチカロテノイド。
- β−カロチン、ルテイン、リコピン、α−カロチン、及びゼアキサンチンであるカロテノイドを含む経口投与可能な製剤を含む逐次的持続放出マルチカロテノイド栄養補助食品であって、
ここで、前記製剤は、ビーズレット又はカプセルに含まれ、ヒトの胃腸管内にカロテノイドを連続して放出するように構成され、それにより、ルテイン及びゼアキサンチンがヒトの胃腸管に放出された後に、β−カロチン及びα−カロチンの少なくとも1つがヒトの胃腸管に放出される、上記逐次的持続放出マルチカロテノイド栄養補助食品。 - 前記製剤がビーズレットの形態であり、該ビーズレットが、コアと外部を含み、ここで、β−カロチン及びα−カロチンの少なくとも1つは、1つの層に配置され、該層は、ルテイン及びゼアキサンチンの少なくとも1つを含む、分離され、区別される別の層よりもコアに近い、請求項9に記載の逐次的持続放出マルチカロテノイド栄養補助食品。
- β−カロチン、ルテイン、リコピン、α−カロチン及びゼアキサンチンが各々12:6:4:2:1の比率で存在する、請求項9に記載の逐次的持続放出マルチカロテノイド栄養補助食品。
- カロテノイドがアスタキサンチンを含む、請求項9に記載の逐次的持続放出マルチカロテノイド栄養補助食品。
- β−カロチン、ルテイン、リコピン、α−カロチン、ゼアキサンチン、及びアスタキサンチンが各々12:6:4:2:1:1の比率で存在する、請求項12に記載の逐次的持続放出マルチカロテノイド栄養補助食品。
- 前記カロテノイドがアスタキサンチンを含み、ここで、アスタキサンチンは、ルテイン及びゼアキサンチンの前にヒトの胃腸管に前記製剤から放出するように構成される、請求項9に記載の逐次的持続放出マルチカロテノイド栄養補助食品。
- β−カロチン及びα−カロチンが、製剤が経口投与されてから4〜6時間後にヒトの胃腸管に前記製剤から放出するように構成される、請求項9に記載の逐次的持続放出マルチカロテノイド栄養補助食品。
- ルテイン及びゼアキサンチンが、リコピンの前にヒトの胃腸管に前記製剤から放出するように構成される、請求項15に記載の逐次的持続放出マルチカロテノイド栄養補助食品。
- β−カロチン、
ルテイン、
リコピン、
α−カロチン、及び
ゼアキサンチン
を含む逐次的持続放出マルチカロテノイドビーズレットであって、
ここで、β−カロチン、ルテイン、リコピン、α−カロチン、及びゼアキサンチンはビーズレットに12:6:4:2:1の比率で存在し、
ここで、ビーズレットはコア及び外部を含み、β−カロチン及びα−カロチンの少なくとも1つは、1つの層に配置され、該層は、ルテイン及びゼアキサンチンの少なくとも1つを含む、分離され、区別される別の層よりもコアに近く、それにより、β−カロチン及びα−カロチンの少なくとも1つは、胃腸管にビーズレットを投与後、ルテイン及びゼアキサンチンの少なくとも1つがヒトの胃腸管に放出された後に胃腸管に放出される前記ビーズレット。 - β−カロチン、ルテイン、リコピン、α−カロチン、ゼアキサンチン、及びアスタキサンチンが各々12:6:4:2:1:1の比率でビーズレットに存在する、アスタキサンチンを含む、請求項17に記載の逐次的持続放出マルチカロテノイドビーズレット。
- β−カロチン、ルテイン、リコピン、α−カロチン及びゼアキサンチンがビーズレットに積層され、それにより、ビーズレットが投与された胃腸管に、各々4〜6時間、2〜3時間、3〜4時間、4〜6時間及び2〜3時間で放出する、請求項17に記載の逐次的持続放出マルチカロテノイドビーズレット。
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WO2005065669A1 (en) * | 2003-12-19 | 2005-07-21 | Alcon, Inc. | Composition and methods for inhibiting the progression macular degeneration and promoting healthy vision |
US9247765B2 (en) | 2004-01-14 | 2016-02-02 | Omniactive Health Technologies Limited | Stable beadlets of lipophilic nutrients |
TW200738227A (en) | 2006-04-03 | 2007-10-16 | Panatoz Corp | One kind of multi-carotenoids and its administration |
CN101292965B (zh) * | 2007-04-24 | 2011-12-07 | 沈阳皓天万嘉医药科技有限公司 | 一种类β-胡萝卜素微囊及其制备方法 |
CN201719567U (zh) * | 2010-01-25 | 2011-01-26 | 中国人民解放军第四军医大学 | 一种抗结核药物梯度缓释结构 |
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US20130017292A1 (en) | 2013-01-17 |
KR101840086B1 (ko) | 2018-03-19 |
TR201807481T4 (tr) | 2018-06-21 |
KR20140057267A (ko) | 2014-05-12 |
WO2013012716A2 (en) | 2013-01-24 |
JP2014520556A (ja) | 2014-08-25 |
WO2013012716A3 (en) | 2013-03-21 |
HK1197004A1 (en) | 2015-01-02 |
EP2731461A2 (en) | 2014-05-21 |
US9265277B2 (en) | 2016-02-23 |
CN103841839A (zh) | 2014-06-04 |
CN103841839B (zh) | 2017-10-10 |
EP2731461B1 (en) | 2018-05-16 |
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