JP7471907B2 - 中空糸膜モジュール - Google Patents
中空糸膜モジュール Download PDFInfo
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- JP7471907B2 JP7471907B2 JP2020083505A JP2020083505A JP7471907B2 JP 7471907 B2 JP7471907 B2 JP 7471907B2 JP 2020083505 A JP2020083505 A JP 2020083505A JP 2020083505 A JP2020083505 A JP 2020083505A JP 7471907 B2 JP7471907 B2 JP 7471907B2
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- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 description 1
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
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Description
(中空糸膜モジュール1の作製)
中空糸膜16の物質吸着に関する物性を評価するために、透過特性の異なる3種類の中空糸膜16を充填した中空糸膜モジュール1を作製した。各中空糸膜16は、上述の手順に準じて作製した。以下では適宜、3つの中空糸膜16をPEPA-A、PEPA-B、PEPA-Cとする。
各中空糸膜16の物質吸着に関する特性を把握するために、デキストランを用いて各中空糸膜16の分画分子量曲線を作成した。分画分子量曲線の作成は、公知の方法に準じて行った。図4は、試験に用いた循環装置の模式図である。
SC=2CF/(CBi+CBo)・・・(3)
各中空糸膜16のエンドトキシン吸着能を評価するために、各中空糸膜16を用いて以下に説明するエンドトキシン吸着試験を実施した。
まず、エンドトキシン(1,000EU/mL)0.02mLをパイロジェンフリー水(pyrogen-free water、型式H20CC0124、Merck社製)20mLで希釈して、エンドトキシン溶液(1EU/mL)を調製した。なお、エンドトキシン(1,000EU/mL)は、エンドトキシン標準品(10,000EU/mL、医薬品医療機器レギュラトリーサイエンス財団製)をパイロジェンフリー水で10倍希釈したものを使用した。調製したエンドトキシン溶液は、乾熱滅菌済みのガラス容器に収容した。また、エンドトキシン溶液20mLを収容したガラス容器を複数用意した。
M=(CB0-CB120)×20・・・(4)
各中空糸膜16のIL-6吸着能を評価するために、各中空糸膜16を用いて以下に説明するIL-6吸着試験を実施した。
まず、PBS(型式045-29795、富士フイルム和光純薬社製)18mL、Blocker(登録商標)BSA(10×)in PBS(型式37525、Thermo Fisher社製)2mL、およびヒト組換え体IL-6(IL-6, Human, Recombinant、10μg/mL、型式206-IL-010、R&D Systems社製)0.02mLを含有するIL-6溶液(10,000pg/mL)を調製した。なお、ヒト組換え体IL-6は、1%Blocker(登録商標)BSA/PBSで10μg/mLに調整したものを使用した。調製したIL-6溶液20mLを収容した容器を複数用意した。
[項目1]
実施の形態に記載の中空糸膜モジュール(1)にエンドトキシンを接触させることを含むエンドトキシンの除去方法。
[項目2]
実施の形態に記載の中空糸膜モジュール(1)を備える血液浄化器。
Claims (4)
- 分子量300000以上1000000以下の範囲全域のデキストランに対するふるい係数が0.12以上0.28以下である第1中空糸膜を備え、
エンドトキシンを含む液が前記第1中空糸膜の膜壁を透過し、前記第1中空糸膜がエンドトキシンを吸着する中空糸膜モジュール。 - 前記第1中空糸膜は、血液中の前記エンドトキシンを吸着する請求項1に記載の中空糸膜モジュール。
- 前記第1中空糸膜は、下記化学式(1)で表される繰り返し単位を有するポリアリレート樹脂、および下記化学式(2)または下記化学式(3)で表される繰り返し単位を有するポリエーテルスルホン樹脂を含有するポリエステル系ポリマアロイ膜で構成される請求項1または2に記載の中空糸膜モジュール。
- 分子量20000以上30000以下のデキストランに対するふるい係数が0.64以上0.80以下である第2中空糸膜を備え、
前記第2中空糸膜がインターロイキン6を吸着する請求項1乃至3のいずれか1項に記載の中空糸膜モジュール。
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2020083505A JP7471907B2 (ja) | 2020-05-11 | 2020-05-11 | 中空糸膜モジュール |
CN202180032609.5A CN115484996A (zh) | 2020-05-11 | 2021-04-28 | 中空纤维膜组件以及内毒素的除去方法 |
PCT/JP2021/016934 WO2021230082A1 (ja) | 2020-05-11 | 2021-04-28 | 中空糸膜モジュールおよびエンドトキシンの除去方法 |
EP21803547.5A EP4151304A4 (en) | 2020-05-11 | 2021-04-28 | HOLLOW FIBER MEMBRANE MODULE AND METHOD FOR REMOVAL OF ENDOTOXINS |
US17/979,451 US20230070035A1 (en) | 2020-05-11 | 2022-11-02 | Hollow fiber membrane module and method for removing endotoxins |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2020083505A JP7471907B2 (ja) | 2020-05-11 | 2020-05-11 | 中空糸膜モジュール |
Publications (3)
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JP2008173163A (ja) | 2007-01-16 | 2008-07-31 | Nikkiso Co Ltd | 血液浄化器、及び、その製造方法 |
JP2017510435A (ja) | 2014-02-06 | 2017-04-13 | ガンブロ ルンディア アー・ベー | 血液浄化のための膜 |
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JPH0611331B2 (ja) | 1984-12-05 | 1994-02-16 | 東レ株式会社 | 固定化ポリミキシン成形品からのエンドトキシン除去方法 |
JPH1057476A (ja) * | 1996-08-26 | 1998-03-03 | Toray Ind Inc | 膜分離装置 |
JP4042876B2 (ja) * | 1998-05-27 | 2008-02-06 | 旭化成クラレメディカル株式会社 | 膜型血液透析器 |
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JP2017510435A (ja) | 2014-02-06 | 2017-04-13 | ガンブロ ルンディア アー・ベー | 血液浄化のための膜 |
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