JP6211220B1 - カプセル用アントシアニン含有組成物及びカプセル剤 - Google Patents
カプセル用アントシアニン含有組成物及びカプセル剤 Download PDFInfo
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- JP6211220B1 JP6211220B1 JP2017012490A JP2017012490A JP6211220B1 JP 6211220 B1 JP6211220 B1 JP 6211220B1 JP 2017012490 A JP2017012490 A JP 2017012490A JP 2017012490 A JP2017012490 A JP 2017012490A JP 6211220 B1 JP6211220 B1 JP 6211220B1
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Abstract
Description
ビルベリー果実を酸性水溶液で抽出処理し、濾過して粗抽出液を得た。次に、該粗抽出液を多孔質合成吸着樹脂に吸着させ、不要な成分を洗い流し、アントシアニン成分をエタノールで溶出させた。そして、溶出物を噴霧乾燥後、粉砕した物をビルベリーエキス末とした。ビルベリーエキス末は、アントシアニン含量36%以上(アントシアニジン含量25%以上)であった。
上記で調製した微細化ビルベリーエキス末をアントシアニン含有素材として用いて、そのアントシアニン含有素材を50質量%と、更に植物ステロール(粉末状、商品名「理研植物ステロール」、理研ビタミン株式会社製)4質量%、サフラワー油43質量%、及びリゾレシチン(ペースト状リゾレシチン、商品名「SLPペーストリゾ」、辻製油社製)3質量%の配合割合となるように、それらを加熱溶解したうえ混合し、除熱後、コロイドミル機構を備えたマスコロイダー(砥石粉砕機)にかけて微細分散化の処理(コロイドミル処理)を行なって、実施例1のアントシアニン含有組成物を調製した。
実施例1の配合において、植物ステロール及びリゾレシチンを配合せず、サフラワー油の配合割合を50質量%に変更した以外は、同様の方法により、比較例1のアントシアニン含有組成物を調製した。
比較例1の配合において、ミツロウを4質量%配合し、サフラワー油の配合割合を46質量%に変更した以外は、同様の方法により、比較例2のアントシアニン含有組成物を調製した。
比較例1の配合において、リゾレシチンを3質量%配合し、サフラワー油の配合割合を47質量%に変更した以外は、同様の方法により、比較例3のアントシアニン含有組成物を調製した。
比較例1の配合において、ミツロウ4質量%とリゾレシチン3質量%を配合し、サフラワー油の配合割合を43質量%に変更した以外は、同様の方法により、比較例4のアントシアニン含有組成物を調製した。
比較例1の配合において、植物ステロールを4質量%配合し、サフラワー油の配合割合を46質量%に変更した以外は、同様の方法により、比較例5のアントシアニン含有組成物を調製した。
実施例1の配合において、リゾレシチンを10質量%配合し、サフラワー油の配合割合を36質量%に変更した以外は、同様の方法により、実施例2のアントシアニン含有組成物を調製した。
実施例1の配合において、リゾレシチンを20質量%配合し、サフラワー油の配合割合を26質量%に変更した以外は、同様の方法により、実施例3のアントシアニン含有組成物を調製した。
実施例1の配合において、植物ステロールを0.5質量%配合し、サフラワー油の配合割合を46.5質量%に変更した以外は、同様の方法により、実施例4のアントシアニン含有組成物を調製した。
実施例1の配合において、植物ステロールを10質量%配合し、サフラワー油の配合割合を37質量%に変更した以外は、同様の方法により、実施例5のアントシアニン含有組成物を調製した。
上記で調製した、実施例1、比較例1〜5のアントシアニン含有組成物を用いて、常法に従い、ソフトカプセルを調製した。具体的には、ソフトカプセルの皮膜としてゼラチン及びグリセリン等の各成分を混合してなるソフトカプセル用皮膜を使用し、金型としてOVAL−6を使用して、ロータリーダイ式カプセル充填機(三協社製)を用いて、300mgを内包しながら膜厚0.9mmのソフトカプセルを作製した。
上記で調製した、実施例1、比較例1〜5のアントシアニン含有組成物を内包するカプセル剤について、その溶出性、製剤性(内容液)、製剤性(カプセル)、及び内容液の保存安定性を評価した。具体的には、以下に示す試験方法又は評価基準により評価を行なった。
溶出試験は、日本薬局方第16改正の一般試験法記載の6.09崩壊試験法に準じて行った。具体的には、試験液として溶出試験第1液(塩化ナトリウム2gを塩酸7mL及び水に溶かして1Lに調製(pH1.2))を使用し、また、崩壊試験機として富山産業社製NT−20HSを使用し、各例のカプセル剤1粒を試験液(900mL)に投入して、ガラス管内に補助盤を入れて試験を行った。所定時間経過後において、アントシアニンの最大吸収波長(513.5nm)における試験液の吸光度を測定し、全てのアントシアニンが試験液に溶解した場合の吸光度を溶出率100%として、溶出率(%)求めた。なお、各例において試験開始から6分後にカプセル皮膜が崩壊し、内容物の溶出が開始されたことを目視にて確認した。また、下記表には、内容物の溶出開始からの経過時間(分)も併せて記載した。
溶解試験の試験結果について、下記の基準で評価した。
◎・・・溶出性がかなり優れている
○・・・溶出性が優れている
△・・・溶出性があまりよくない
×・・・溶出性が悪い
コロイドミル処理時の熱発生について、下記の基準で評価した。
○・・・ 45℃以下
△・・・ 45〜55℃
×・・・ 55℃以上
カプセル充填機による連続生産性について、下記の基準で評価した。
○・・・ 連続生産可能
△・・・ 充填不良率が高いが連続生産可能
×・・・ カプセル化は可能だが連続生産不可
各例のアントシアニン含有組成物を透明なバイアル瓶に適量充填し、40℃で48時間保存した。保存期間終了後、バイアル瓶の外観より、アントシアニン含有組成物の分離の有無を目視にて観察し、下記の基準で評価した。
○・・・分離・沈殿なし
△・・・若干の油浮きみられる
×・・・強く分離している
上記で調製した、実施例2、3のアントシアニン含有組成物を内包するカプセル剤について、試験例1と同様にして、その溶出性、製剤性(内容液)、製剤性(カプセル)、及び内容液の保存安定性を評価した。
上記で調製した、実施例4、5のアントシアニン含有組成物を内包するカプセル剤について、試験例1と同様にして、その溶出性、製剤性(内容液)、製剤性(カプセル)、及び内容液の保存安定性を評価した。
Claims (7)
- アントシアニン含有素材と、油脂と、リゾレシチンと、植物ステロールとを含有し、前記植物ステロールの含有量が0.5〜10質量%であることを特徴とするカプセル用アントシアニン含有組成物。
- 前記アントシアニン含有素材は、ビルベリー、ブルーベリー、クランベリー、コケモモ、リンゴンベリー、ハックルベリー、ラズベリー、ブラックベリー、ローガンベリー、サーモンベリー、ボイセンベリー、イチゴ、クワ、エルダベリー、ハスカップ、ニワトコ、ハイビスカス、スグリ、クズベリー、アサイー、プルーン、サクランボ、リンゴ、マンゴー、シソ、有色イモ、赤キャベツ、赤ダイコン、ブドウ、紫トウモロコシ、紫タマネギ、ナス、有色米、黒豆、黒ゴマ、及び椿からなる群から選ばれる1種又は2種以上である、請求項1に記載のカプセル用アントシアニン含有組成物。
- 前記油脂は、魚油、植物油、及び中鎖脂肪酸からなる群から選ばれる1種又は2種以上である、請求項1又は2に記載のカプセル用アントシアニン含有組成物。
- 前記植物ステロールは、β−シトステロ−ル、スチグマステロ−ル、カンペステロ−ル、ブラシカステロ−ル、7-エルゴステノール、イソフコステロール、7-スチグマステノール、及びアベナステロールからなる群から選ばれる1種又は2種以上である、請求項1〜3のいずれか一項に記載のカプセル用アントシアニン含有組成物。
- 前記リゾレシチンの含有量が0.1〜20質量%である、請求項1〜4のいずれか一項に記載のカプセル用アントシアニン含有組成物。
- 請求項1〜5のいずれか一項に記載のカプセル用アントシアニン含有組成物を内包することを特徴とするカプセル剤。
- 日本薬局方第16改正に記載されている崩壊試験法において、溶出試験第1液を用いて試験を行った場合、内容物の溶出開始から30分後のアントシアニンの溶出率が90%以上となるよう構成されたものである、請求項6に記載のカプセル剤。
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