JPWO2009148058A1 - 固体脂を使ったマイクロカプセルの製造方法 - Google Patents
固体脂を使ったマイクロカプセルの製造方法 Download PDFInfo
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- JPWO2009148058A1 JPWO2009148058A1 JP2010515878A JP2010515878A JPWO2009148058A1 JP WO2009148058 A1 JPWO2009148058 A1 JP WO2009148058A1 JP 2010515878 A JP2010515878 A JP 2010515878A JP 2010515878 A JP2010515878 A JP 2010515878A JP WO2009148058 A1 JPWO2009148058 A1 JP WO2009148058A1
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- Prior art keywords
- solid fat
- physiologically active
- active substance
- surfactant
- suspension
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Abstract
Description
(1)親水性生理活性物質と界面活性剤(A)の複合体を調製又は入手する。
(2)上記親水性生理活性物質と界面活性剤(A)の複合体を、固体脂の融点以上の温度で固体脂中に分散させ、S/Oサスペンションを得る。
(3)上記S/Oサスペンションを液滴分散させ、該S/Oサスペンション液滴を固体脂の融点未満に冷却して固体脂を固化させて固体粒子を得る。
(1’)親水性生理活性物質、界面活性剤(A)及び分散媒の混合液から、液体成分を除去して、親水性生理活性物質と界面活性剤(A)の複合体を調製する、
(2)上記親水性生理活性物質と界面活性剤(A)の複合体を、固体脂の融点以上の温度で固体脂中に分散させ、S/Oサスペンションを得る、
(3)上記S/Oサスペンションを液滴分散させ、該S/Oサスペンション液滴を固体脂の融点未満に冷却して固体脂を固化させて固体粒子を得る、
という3つの工程の操作を行うことを特徴とする、S/O型マイクロカプセルの製造方法も本発明の製造方法の一態様である。ここで工程(1’)は前記工程(1)の好ましい態様である。以下、親水性生理活性物質と界面活性剤(A)の複合体を得る好ましい方法(工程(1’))について説明する。
粒子径測定装置(堀場製作所 LA−950)を使用して測定した。
得られたマイクロカプセルを、使用した固体脂の融点以上の温度に加温して液状化した上で、水と混合し、マイクロカプセル内に封入した親水性生理活性物質を水相中に抽出した。抽出した水相中の親水性生理活性物質濃度をHPLCにより測定し、マイクロカプセル中の正味の親水性生理活性物質の含量を算出した。
工程(1)で仕込んだ親水性生理活性物質の重量と、上記方法により算出したマイクロカプセル中の親水性生理活性物質の含量より、下記式を用いて封入収率を算出した。
実施例1で得られたラクトフェリン含有マイクロカプセルの人工胃液中での安定性をSDS-PAGEにて解析した。人工胃液は、ブタ胃粘膜由来のペプシン(和光純薬工業株式会社製)をpH1.2の崩壊試験第1液(関東化学株式会社製)に溶解させて調製した。実施例1で得られたラクトフェリン含有マイクロカプセルを人工胃液で120分間処理した後、マイクロカプセルを回収し、中鎖脂肪酸トリグリセリド(商品名「アクターM2」、理研ビタミン株式会社製)を用いて、カプセル基材である油脂を溶解させ、溶解後の溶液からラクトフェリンを水相に抽出した。抽出したラクトフェリン水溶液をSDS-PAGEにて確認した。対照としてラクトフェリン水溶液を人工胃液中で5、20、40、60および120分間処理した後、SDS-PAGEにてラクトフェリンマイクロカプセルと同様の条件で確認した。
ICR系マウス(日本クレア製;雄、6週齢)を、表2に示すように、対照群(A群)、ラクトフェリン粉末投与群(市販のラクトフェリン粉末(和光純薬製)を投与:B群)、ラクトフェリン含有マイクロカプセル投与群(実施例1で得られたラクトフェリン含有マイクロカプセルを投与:C群)のそれぞれ3群構成(各群9匹)に分け、高脂肪粉末精製飼料(オリエンタル酵母社製、配合組成は表3)を基本飼料とした各飼料を自由摂取させて、4週間飼育した。なお、ラクトフェリン粉末投与群、ラクトフェリン含有マイクロカプセル投与群におけるラクトフェリンの投与量は飼料に対してラクトフェリン濃度換算で1wt%となるように調整した。
Claims (25)
- 下記(1)〜(3)の工程を含有する、固体脂のマトリクス中に親水性生理活性物質が多分散したS/O型マイクロカプセルの製造方法。
(1) 親水性生理活性物質と界面活性剤(A)の複合体を調製又は入手する
(2) 上記親水性生理活性物質と界面活性剤(A)の複合体を、固体脂の融点以上の温度で固体脂中に分散させ、S/Oサスペンションを得る
(3) 上記S/Oサスペンションを液滴分散させ、該S/Oサスペンション液滴を固体脂の融点未満に冷却して固体脂を固化させて固体粒子を得る - 固体脂の融点が40℃以上であることを特徴とする請求項1に記載の製造方法。
- 工程(1)において、親水性生理活性物質、界面活性剤(A)及び分散媒の混合液から、液体成分を除去して親水性生理活性物質と界面活性剤(A)の複合体を調製することを特徴とする請求項1または2に記載の製造方法。
- 工程(1)における分散媒が、水、ケトン類、アルコール類、ニトリル類、エーテル類、炭化水素類、脂肪酸エステル類、および液体油脂からなる群より選択される少なくとも1種類の分散媒であることを特徴とする請求項3に記載の製造方法。
- 分散媒が、親水性生理活性物質を完全に溶解しないものである、請求項4に記載の製造方法。
- 界面活性剤(A)が、HLB10以下のショ糖脂肪酸エステル類、グリセリン脂肪酸エステル類、ソルビタン脂肪酸エステル類、ポリオキシエチレンソルビタン脂肪酸エステル類、およびレシチン類等からなる群より選択される少なくとも1種類であることを特徴とする請求項1〜5のいずれか1項に記載の製造方法。
- 親水性生理活性物質と界面活性剤(A)の複合体における、親水性生理活性物質と界面活性剤(A)の重量比が1/99〜99.99/0.01の範囲内であることを特徴とする請求項1〜6のいずれか1項に記載の製造方法。
- 工程(1)において、親水性生理活性物質と界面活性剤(A)の混合液から液体成分を除去する方法が、凍結乾燥、真空乾燥、噴霧乾燥、デカンテーション、遠心分離、加圧濾過、減圧濾過、自然濾過からなる群より選択される1種類であることを特徴とする請求項1〜7のいずれか1項に記載の製造方法。
- 工程(2)における、親水性生理活性物質と界面活性剤(A)の複合体と、固体脂の重量比が0.01/99.99〜70/30の範囲内であることを特徴とする請求項1〜8のいずれか1項に記載の製造方法。
- 工程(3)における液滴分散が、水相中に、工程(2)で得られたS/Oサスペンションを添加し、固体脂の融点以上かつ沸点未満の温度で分散させてS/O/Wエマルションとすることで行われる、請求項1〜9のいずれか1項に記載の製造方法。
- 工程(3)において、水相中に、HLB5以上のショ糖脂肪酸エステル類、グリセリン脂肪酸エステル類、ソルビタン脂肪酸エステル類、ポリオキシエチレンソルビタン脂肪酸エステル、サポニン類、およびレシチン類等からなる群より選択される少なくとも1種類の界面活性剤(B)を含有することを特徴とする請求項10に記載の製造方法。
- 水相中の界面活性剤(B)の濃度が、0.001重量%以上であることを特徴とする請求項11に記載の製造方法。
- 工程(3)において、水相中に、アラビアガム、ゼラチン、寒天、澱粉、カラギーナン、ローカストビーンガム、タラガム、ペクチン、ジェランガム、カードラン、グルコマンナン、カゼイン、アルギン酸類、糖類、プルラン、セルロース類、キサンタンガム、グアーガム、タマリンドガム、およびポリビニルアルコール等からなる群より選択される少なくとも1種類の増粘剤を含有することを特徴とする請求項10〜12のいずれか1項に記載の製造方法。
- 水相中の増粘剤の濃度が、0.001〜10重量%であることを特徴とする請求項13に記載の製造方法。
- 工程(3)において、水相中に、ケトン類、アルコール類、ニトリル類、およびエーテル類からなる群より選択される少なくとも1種類の親水性有機溶媒を含有することを特徴とする請求項10〜14いずれか1項に記載の製造方法。
- 水相中の親水性有機溶媒の濃度が1〜70容量%であることを特徴とする請求項15に記載の製造方法。
- 工程(3)において、水相中でS/Oサスペンションを液滴分散させるための方法が、撹拌、ラインミキサー、多孔板分散、噴流、ポンプからなる群より選択される少なくとも1種類の剪断方法であることを特徴とする請求項10〜16のいずれか1項に記載の製造方法。
- 工程(3)における剪断方法が、単位容積当たりの撹拌所要動力が0.01kW/m3以上の条件で撹拌することである請求項17に記載の製造方法。
- 工程(3)におけるS/Oサスペンション液滴の冷却が、得られたS/O/Wエマルションを、0.01〜0.5℃/minの冷却速度で冷却することによって行われる請求項10〜18のいずれか1項に記載の製造方法。
- 工程(3)におけるS/Oサスペンション液滴の冷却が、得られたS/O/Wエマルションを固体脂の融点未満に冷却した水相に移送して、急冷させることによって行われる請求項10〜18のいずれか1項に記載の製造方法。
- 工程(3)において、工程(2)で得られたS/Oサスペンションを噴霧冷却することによって、S/Oサスペンションを気相中で液滴分散させるとともに、該S/Oサスペンションを固体脂の融点未満まで冷却して固体脂を固化させることを特徴とする請求項1〜9のいずれか1項に記載の製造方法。
- 固体脂のマトリクス中に、親水性生理活性物質と界面活性剤の複合体が多分散していることを特徴とするS/O型マイクロカプセル。
- 固体脂のマトリクス中に、乳タンパク質由来成分が多分散していることを特徴とするS/O型マイクロカプセル。
- 乳タンパク質由来成分がラクトフェリンである請求項23に記載のS/O型マイクロカプセル。
- マイクロカプセル中の乳タンパク質由来成分の含有量が、0.01〜70重量%であることを特徴とする請求項23または24に記載のマイクロカプセル。
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WO2005025609A1 (ja) * | 2003-09-10 | 2005-03-24 | Nrl Pharma, Inc. | ラクトフェリン素材組成物 |
US20090010999A1 (en) * | 2004-03-10 | 2009-01-08 | Kyowa Hakko Kogyo Co., Ltd. | Complex Particles and Coated Complex Particles |
JP4050784B2 (ja) * | 2005-02-03 | 2008-02-20 | 株式会社Nrlファーマ | マトリックス型腸溶性・徐放性組成物 |
-
2009
- 2009-06-02 JP JP2010515878A patent/JP5677086B2/ja not_active Expired - Fee Related
- 2009-06-02 US US12/995,819 patent/US20110091553A1/en not_active Abandoned
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US20110091553A1 (en) | 2011-04-21 |
JP5677086B2 (ja) | 2015-02-25 |
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