JP5010026B2 - 中空繊維毛細管膜ならびにその製造方法 - Google Patents
中空繊維毛細管膜ならびにその製造方法 Download PDFInfo
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Description
外側の層Aはその大きな質量密度によって、特に以下に詳細に記述する本発明に係る方法による膜の製造に際して、本発明に係る中空繊維膜に機械的な強度を付加する。加えてこの層は、膜全体中において最も小さな平均細孔大(200nm超)を有する帯域を成すものであり、従って濾過に際して選択性を決定する層となる。従って層Aの機能は本発明に係る膜に安定性と選択性を提供することにある。
(a)2つの紡糸材料溶液AおよびBを生成して、その際に紡糸材料溶液Aの粘度が紡糸材料溶液Bの粘度よりも高くなるようにし、
(b)沈殿槽の温度を70℃超に設定し、
(c)中空繊維ノズルを介して両方の紡糸材料溶液AおよびBを内部沈殿剤と接触させ、
(d)中空繊維膜を沈殿させる、
ステップからなる本発明に係る中空繊維膜の製造方法によって解決される。
粘度測定に際して被検物質は同心上に配置されたシリンダ、“回転体”と“測定容器”の間の環状隙間内に存在した。予め回転数を設定しその際有効圧力(剪断応力)を測定した。まず温度調節容器と回転体MV−DINを基礎枠材にネジ固定した。続いてゼロ点を検査あるいは調節した。回転モータを停止し、回転トルク表示をそのために設けられたボタンを使用して0に調節した。実質的な測定のために、測定容器に被検溶液を気泡が発生しないようにして充填マークの位置まで充填し、ロックネジによって温度調節容器内に固定した。その後回転数レベルを事前設定した。プログラムを設定して測定時間の経過後に粘度を読み取った。
本発明に係る中空繊維膜の水性の限外濾過速度は次の式:
UF=(V濾過液×3600)/t×((pein+paus)/2)×0.75)
に従い従来の技術において知られている透析チューブシステムを使用して判定され、ここでUFは(ml/h×mm Hg)で示した限外濾過速度、V濾過液はml(本実施例においては:1000ml)で示した濾過液容量、tは(1000mlを濾過するための)時間(秒)、peinは装置上の血液側の流入圧力(mbar)、pausは血液側の流出圧力(mbar)を示す。
0.6m2の面積を有するモジュールに対して、200ないし300mg/dlのトリグリセリド含有率を有する高脂血性の全血を1000ml使用する。この血液を1時間200ml/分の流速で繊維の管腔を介して循環させる。その間同時に60ml/分の濾過液流が繊維壁を介して外側に濾過して排出される。この条件下においてLDL(低密度リポタンパク)に対するふるいわけ係数は少なくとも90%、特に95ないし100%、殆どの場合は99%超となる。LDLに対するふるいわけ係数は、一般的な血漿濾過の血液処理時間に少なくとも相当する時間間隔にわたって一定となる。
最終製品からの抽出後の本発明に係る膜のポリビニルピロリドン残留量は1mg未満であった。この数値は、特にそれによって本発明に係る中空繊維膜を極めて長時間にわたって実施される透析処置に使用することができるため極めて好適である。特に本発明に係る膜は膜血漿交換治療に使用することができ、それは後述する方法に従って判定して0.6m2の膜面積のフィルタ当たりで5mgまでのポリビニルピロリドンの放出の限界値が好適なためである。本発明に係る膜はその限界値を大幅に下回る。
抽出に際して同じロットからの2つの血漿フィルタを使用した。
Claims (20)
- 共有押出し成形された2つの層AおよびBからなり、血液接触側を形成する層Bが0.1ないし10μmの網目幅をもったフリース状の構造を有し、層Aは細孔構造を有してなる中空繊維膜であって、
層Aおよび層Bの原料がポリスルホン(PSU)とポリビニルピロリドン(PVP)の混合物であることを特徴とする血漿分離用中空繊維膜。 - 層Aがそれぞれ異なった多孔度を有する少なくとも3つの帯域A1、A2、A3から形成されることを特徴とする請求項1記載の血漿分離用中空繊維膜。
- 帯域A1が層Aの表面を形成するとともに0.7ないし2μmの平均細孔大からなる細孔を有することを特徴とする請求項2記載の血漿分離用中空繊維膜。
- 帯域A3が層Bに隣接するとともに層Bに向かって細孔大が漸増するような細孔大階調を層Bに向かって有することを特徴とする請求項3記載の血漿分離用中空繊維膜。
- 帯域A2は帯域A1と帯域A3の間に配置され200nm超の細孔大を有することを特徴とする請求項4記載の血漿分離用中空繊維膜。
- 中空繊維膜の内径が280ないし400μmであることを特徴とする請求項5記載の血漿分離用中空繊維膜。
- 中空繊維膜の総壁厚が40ないし80μmであることを特徴とする請求項6記載の血漿分離用中空繊維膜。
- 層A対層Bの層厚比が4:1ないし6:1であることを特徴とする請求項7記載の血漿分離用中空繊維膜。
- 完成した膜中の自由な残留ポリビニルピロリドンの溶出性成分比率が5mg/膜面積0.6m2未満であることを特徴とする請求項8記載の血漿分離用中空繊維膜。
- 中空繊維膜のLDLふるいわけ係数が0.9超であることを特徴とする請求項9記載の血漿分離用中空繊維膜。
- (a)紡糸材料溶液Aおよび血液接触側を形成する紡糸材料溶液Bを生成して、溶液AおよびBはポリスルホン(PSU)とポリビニルピロリドン(PVP)の混合物を含み、その際に紡糸材料溶液Aの粘度が紡糸材料溶液Bの粘度よりも高くなるようにし、
(b)沈殿槽の温度を70℃超に設定し、
(c)中空繊維ノズルを介して両方の紡糸材料溶液AおよびBを内部沈殿剤と接触させ、
(d)中空繊維膜を沈殿させる、
ステップからなる請求項1ないし10のいずれかに記載の血漿分離用中空繊維膜の製造方法。 - 紡糸材料溶液Aの粘度が8000ないし15000mPa・sの範囲にあることを特徴とする請求項11記載の方法。
- 紡糸材料溶液Aが15ないし35%のポリスルホンと4ないし8%のポリビニルピロリドンと残りの成分としての沈殿剤を含有することを特徴とする請求項12記載の方法。
- 紡糸材料溶液Bの粘度が1000mPa・s未満であることを特徴とする請求項11ないし13のいずれかに記載の方法。
- 紡糸材料溶液Bが8ないし14%のポリスルホンと3ないし6%のポリビニルピロリドンと残りの成分としての溶媒を含有することを特徴とする請求項14記載の方法。
- 紡糸速度が200ないし400mm/sとなることを特徴とする請求項11ないし15のいずれかに記載の方法。
- 紡糸ブロックの温度を50ないし90℃に設定することを特徴とする請求項16記載の方法。
- 沈殿剤はジメチルアセトアミドと水の混合物であることを特徴とする請求項17記載の方法。
- ナノ濾過ならびに限外濾過分野における分離プロセスのための請求項1ないし10のいずれかに記載の中空繊維膜の適用。
- 血液透析、血液透析濾過、ならびに血液濾過のための請求項1ないし10のいずれかに記載の膜の適用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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DE102007019051.6 | 2007-04-23 | ||
DE102007019051A DE102007019051B3 (de) | 2007-04-23 | 2007-04-23 | Hohlfaserkapillarmembran und Verfahren zu deren Herstellung |
PCT/EP2008/003195 WO2008128749A1 (de) | 2007-04-23 | 2008-04-21 | Hohlfaserkapillarmembran und verfahren zu deren herstellung |
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US20100326915A2 (en) | 2010-12-30 |
US20100163488A1 (en) | 2010-07-01 |
CN101626821A (zh) | 2010-01-13 |
WO2008128749A1 (de) | 2008-10-30 |
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