JP2009513641A - ドコサヘキサエン酸およびルテインを含有する乳児用製剤 - Google Patents
ドコサヘキサエン酸およびルテインを含有する乳児用製剤 Download PDFInfo
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- JP2009513641A JP2009513641A JP2008537844A JP2008537844A JP2009513641A JP 2009513641 A JP2009513641 A JP 2009513641A JP 2008537844 A JP2008537844 A JP 2008537844A JP 2008537844 A JP2008537844 A JP 2008537844A JP 2009513641 A JP2009513641 A JP 2009513641A
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- Prior art keywords
- lutein
- infant
- formulation
- mcg
- liter
- 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.)
- Granted
Links
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- KBPHJBAIARWVSC-RGZFRNHPSA-N lutein Chemical compound C([C@H](O)CC=1C)C(C)(C)C=1\C=C\C(\C)=C\C=C\C(\C)=C\C=C\C=C(/C)\C=C\C=C(/C)\C=C\[C@H]1C(C)=C[C@H](O)CC1(C)C KBPHJBAIARWVSC-RGZFRNHPSA-N 0.000 title claims abstract description 141
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Abstract
Description
本発明は、ルテイン(mcg)対ドコサヘキサエン酸(mg)の重量比が約1:2から約10:1である、ドコサヘキサエン酸および少なくとも約50mcg/リットルのルテインを含む、脂肪、タンパク質、炭水化物、ビタミンおよびミネラルを含む乳児用製剤に関する。本発明はまた、乳児における未熟児網膜症のリスクを軽減すること、および乳児の眼への過剰な自然光または人工光の損傷効果に対して保護することを含む、乳児における網膜の健康および視覚の発達を促進するための、該製剤の使用方法に関する。
本発明の乳児用製剤は、脂肪、タンパク質、炭水化物、ミネラルおよびビタミンを含み、ルテインとドコサヘキサエン酸との新規組合せを含む。本発明の乳児用製剤および対応方法のこれらの及び他の必須要素または限定を以下に詳細に説明する。
本発明の乳児用製剤はルテインを含み、その濃度は少なくともルテイン約50mcg/リットルでなければならない。乳児用製剤において使用されることが公知であるか又は乳児用製剤における使用に適しており、該製剤中のその他の選択された成分に適合性である限り、任意のルテイン源が本発明における使用に適しており、ここで、該製剤におけるルテイン(mcg/リットル)対ドコサヘキサエン酸(mg/リットル)の重量比は約1:2から約10:1の範囲である。
本発明の乳児用製剤は、メチル末端から3番目の炭素から始まる6個の二重結合を伴う炭素数22の鎖長を有する有機カルボン酸(22:6 n−3)であるドコサヘキサエン酸を含む。乳児用製剤において使用されることが公知であり、該製剤中のその他の選択された成分に適合性である限り、任意のドコサヘキサエン酸源が本発明における使用に適している。
本発明の乳児用製剤は脂肪、タンパク質、炭水化物、ミネラルおよびビタミンを含み、これらの全ては、種類および量において、意図される乳児集団の食事要求を満たすように選択される。
本発明の乳児用製剤は更に、該組成物の物理的、化学的、美的または加工特性を修飾しうる又は対象乳児集団において使用された場合に医薬的または追加的栄養成分として働きうる他の随意的成分を含みうる。多数のそのような随意的成分が公知であるか、または栄養製品における使用に適しており、本発明の乳児用製剤においても使用されうる。ただし、そのような随意的物質は、本明細書に記載されている必須物質に適合しうるものでり、それ以外の点で乳児製剤における使用に適したものでなければならない。
本発明の乳児用製剤は、乳児における使用に適した任意の製品形態、還元可能な粉末、そのまま摂取される液体および希釈可能な液体濃縮物として製造されることが可能であり、これらの製品形態は全て、栄養および乳児製剤の分野においてよく知られている。
本発明はまた、乳児における網膜の健康および視覚の発達を促進するために該製剤を投与する方法に関する。この特定の方法においては、該乳児製剤は、唯一の栄養源、主要な栄養源または補助的な栄養源として正期産児または早期産児に投与され、この場合、該製剤は、ドコサヘキサエン酸および少なくとも約50mcg/リットルのルテインを含む、脂肪、タンパク質、炭水化物、ビタミンおよびミネラルを含み、ルテイン(mcg)対ドコサヘキサエン酸(mg)の重量比は約1:2から約10:1である。そのような方法は、本明細書中に記載または示唆されている任意の製剤実施形態に適用されうる。
本発明の乳児用製剤は、未熟児網膜症のリスクを軽減するために早期産児に投与された場合に特に有用である。そのような方法においては、該製剤は、唯一の栄養源、主要な栄養源または補助的な栄養源として投与され、この場合、該製剤は、ドコサヘキサエン酸および少なくとも約50mcg/リットルのルテインを含む、脂肪、タンパク質、炭水化物、ビタミンおよびミネラルを含み、ルテイン(mcg)対ドコサヘキサエン酸(mg)の重量比は約1:2から約10:1である。そのような方法は、本明細書中に記載または示唆されている任意の製剤実施形態に適用されうる。
本発明の乳児用製剤は、乳児用製剤または同様の他の製剤を製造し製剤化するのに適した任意の公知または有効な技術により製造されうる。それらの変更は、所望の乳児用製剤のための選択された製品形態、成分の組合せ、パッケージング(包装)および容器の選択などのような変数に左右されうる。任意の与えられた製剤に関するそのような技術および変法は、乳児用栄養製剤または製造の分野の当業者により容易に決定され、適用される
したがって、以下に記載され例示される製剤を含む本発明の乳児用製剤は、種々の公知または有効な製剤化または製造方法のいずれかにより製造されうる。これらの方法は、最も典型的には、炭水化物、タンパク質、脂質、安定剤または他の製剤化補助剤、ビタミン、ミネラルまたはそれらの組合せを含有する水性スラリーの初期形成を含む。該スラリーを乳化し、低温殺菌し、ホモジナイズし、冷却する。更なる加工の前、途中または後に、得られたエマルションに種々の他の溶液、混合物または他の物質を添加することが可能である。ついでこのエマルションを更に希釈し、加熱処理し、パッケージングして、そのまま摂取される又は濃縮された液体を得ることが可能であり、あるいはそれを加熱処理し、ついで加工し、還元可能な粉末(例えば、噴霧乾燥物、乾燥混合物、凝集物)としてパッケージングすることが可能である。
この実験の目的は、DHAまたは添加ルテインを伴うDHAのいずれかを含む乳児用製剤が給餌された動物における視力の変化を評価することである。16頭のサルに、出生後の最初の12週の間に、2つの定められた乳児用製剤の1つを給餌する。一方は対照製剤、すなわち、Abbott Laboratories,Columbus Ohioから入手可能なSimilac(登録商標)Advance(登録商標)乳児用製剤であり、もう一方は、Similac(登録商標)Advance(登録商標)乳児用製剤を基礎製剤として含み、ルテインを含むカロテノイドがそれに添加された実験用製剤である。該製剤は以下のものを含む。
ルテイン、リコペンおよびベータ−カロテンの血漿中濃度は、出生時(0週齢)には、該対照製剤を与えたサルと該実験用製剤を与えたサルとの間で有意な差はない。血漿中ルテイン濃度は、4週齢(p<0.001)、8週齢(p<0.001)および12週齢(p<0.001)では、該実験用製剤を与えたサルにおいては、該対照製剤を与えたサルの場合より有意に高い。同様に、血漿中リコペン濃度は、4週齢(p<0.001)、8週齢(p<0.001)および12週齢(p<0.001)で、実験群においては、対照群の場合より有意に高い。血漿中ベータ−カロテン濃度は、4週齢(p=0.005)および8週齢(p=0.010)では、実験群製剤群において、対照製剤群の場合より有意に高いが、12週齢(p<0.001)ではそうではない。
該サルを、4、8および12週齢において、視力の変化に関して評価する。視力は、乳児における視覚誘発電位を測定するための当技術分野でよく知られた方法であるスイープ視覚誘発電位(VEP)により測定する。視力は、視皮質からの測定可能な応答を誘発する最小空間周波数高コントラスト格子を決定することにより測定する。一次皮質視覚野からのVEPを、水溶性電極ペーストで頭皮上に配置された小さな銀円盤EEG電極を使用して記録する。該乳児は実験者のひざにかかえられながら、黒および白の位相反転格子を表示するビデオモニターを凝視する。必要に応じて、小さなぶら下がり玩具を使用して、該乳児の注意を該スクリーンの中央に引きつける。各「スイープ(sweep)」中、格子の空間周波数を、数秒の記録時間中に被験者の視力閾値の上から下へ段階的に減少させる。刺激反転速度に関連した応答を反映する、VEP応答の第2調波の振幅を、空間周波数の関数としてプロットして、被験者の視力閾値を決定する(Neuringer M,Jeffrey BG:Visual development:neural basis and new assessment methods.J Pediatr 2003;143:S87−S95)。
以下は、乳に基づくそのまま摂取される本発明の乳児用製剤の実施例であり、該製剤の使用および製造方法を含む。各バッチの製剤成分を以下の表に示す。
以下は、ダイズに基づく本発明の粉末乳児用製剤の実施例であり、該製剤の使用および製造方法を含む。各バッチの製剤成分を以下の表に示す。
以下は、乳に基づく本発明の粉末乳児用製剤の実施例であり、該製剤の使用および製造方法を含む。各バッチの製剤成分を以下の表に示す。
以下は本発明の濃縮人乳強化液の実施例であり、該製剤の使用および製造方法を含む。各バッチの製剤成分を以下の表に示す。
この実施例は、本発明のそのまま摂取される早期産児用製剤の実施形態を例示する。この製剤は、ルテイン濃度が増加していること及びそれに伴いルテイン対ドコサヘキサエン酸の比が増加していること以外は、Abbott Laboratories,Columbus,Ohioから入手可能な早期産児用製剤である、早期産児用鉄製剤を伴うSimilac(登録商標)Special Care(登録商標)Advance(登録商標)に類似している。
母乳栄養児における血漿中ルテイン濃度と製剤摂取乳児における血漿中ルテイン濃度とを比較するために、研究を行う。後者には、32.6mcg/リットル(L1)、52.6mcg/リットル(L2)または14.6mcg/リットル(CTRL)のルテイン濃度により特徴づけられる3つの製剤のうちの1つを与えた。該研究群および得られた血漿中ルテイン濃度を以下の表に要約する。
Claims (17)
- ドコサヘキサエン酸、およびそのまま摂取される形態に基づき少なくとも約50mcg/リットルのルテインを含む、脂肪、タンパク質、炭水化物、ビタミンおよびミネラルを含んでなる乳児用製剤であって、ルテイン(mcg)対ドコサヘキサエン酸(mg)の重量比が約1:2から約10:1であり、該製剤が卵リン脂質を含有しない、乳児用製剤。
- 組成物が約50から約1150mcg/リットルの添加ルテインを含む、請求項1の乳児用製剤。
- 製剤が約100から約200mcg/リットルのルテインを含む、請求項1の乳児用製剤。
- 製剤が約100から約200mcg/リットルのルテインを含む、請求項1の乳児用製剤。
- ルテイン(mcg)対ドコサヘキサエン酸(mg)の重量比が約1.5:1から約10:1である、請求項1の乳児用製剤。
- ルテイン(mcg)対ドコサヘキサエン酸(mg)の重量比が約2:1から約5:1である、請求項1の乳児用製剤。
- 製剤が約20から30kcal/流体オンスのカロリー密度を有する、請求項1の乳児用製剤。
- 製剤が単一源からの遊離ルテインとゼアキサンチンとの組合せを含み、該源がタゲテス・エレクタ(Tagetes erecta)の結晶抽出物であり、該遊離ルテインが該組合せの85重量%から95重量%に相当し、該遊離ゼアキサンチンが該組合せの約5重量%から約15重量%に相当する、請求項1の乳児用製剤。
- 製剤が粉末である、請求項1の乳児用製剤。
- 製剤が液体である、請求項1の乳児用製剤。
- ルテインが少なくとも25重量%の添加ルテインを含む、請求項1の乳児用製剤。
- そのまま摂取される形態に基づき、
(a)約54から約108gm/リットルの炭水化物、
(b)約20から約54gm/リットルの脂肪、
(c)約7から約24gm/リットルのタンパク質、
(d)約100から約200mcg/リットルのルテイン、および
(e)ドコサヘキサエン酸
を含んでなる乳児用製剤であって、ルテイン(mcg)対ドコサヘキサエン酸(mg)の重量比が約2:1から約5:1であり、該製剤が卵リン脂質を含有しない、乳児用製剤。 - 製剤が単一源からの遊離ルテインとゼアキサンチンとの組合せを含み、該源がタゲテス・エレクタ(Tagetes erecta)の結晶抽出物であり、該遊離ルテインが該組合せの85重量%から95重量%に相当し、該遊離ゼアキサンチンが該組合せの約5重量%から約15重量%に相当する、請求項12の乳児用製剤。
- 早期産児における未熟児網膜症のリスクを軽減するための方法であって、未熟児網膜症のリスクの軽減を要する早期産児に請求項1記載の製剤を投与して約7から約300mcg/kg/日のルテインを該乳児に供給することを含んでなる方法。
- 早期産児における未熟児網膜症のリスクを軽減するための方法であって、未熟児網膜症のリスクの軽減を要する早期産児に請求項1記載の製剤を投与して約14から約220mcg/kg/日のルテインを該乳児に供給することを含んでなる方法。
- 乳児における網膜の健康および視覚の発達を促進するための方法であって、網膜の健康および視覚の発達の促進を要する乳児に請求項1記載の製剤を投与して約7から約300mcg/kg/日のルテインを該乳児に供給することを含んでなる方法。
- 乳児における網膜の健康および視覚の発達を促進するための方法であって、網膜の健康および視覚の発達の促進を要する乳児に請求項1記載の製剤を投与して約7から約300mcg/kg/日のルテインを該乳児に供給することを含んでなる方法。
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