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公开(公告)号:US06828155B1
公开(公告)日:2004-12-07
申请号:US09786060
申请日:2001-03-01
申请人: Kazuhiro Kaneko , Tomohiro Watanabe , Yasuyuki Asai , Yoshihisa Sano , Kiyomi Kikuchi , Ikuo Kushida , Kazuhide Ashizawa
发明人: Kazuhiro Kaneko , Tomohiro Watanabe , Yasuyuki Asai , Yoshihisa Sano , Kiyomi Kikuchi , Ikuo Kushida , Kazuhide Ashizawa
IPC分类号: G01N3300
CPC分类号: A61K9/0019 , A61K31/739 , G01N21/19 , G01N21/6445 , G01N33/92
摘要: The present invention provides an evaluation method and preparation process of injection containing a lipid A analog. Specifically, it provides, in an injection preparation containing a lipid A analog or a pharmacologically acceptable salt thereof, forecasting and evaluating methods of the pharmacokinetics of the lipid A analog, and quality evaluating method and preparation process of the injection, which each comprises measuring membrane fluidity and/or circular dichroism.
摘要翻译: 本发明提供含有脂质A类似物的注射液的评价方法和制备方法。 具体而言,在含有脂质A类似物或其药理学上可接受的盐的注射制剂中,提供了脂质A类似物的药代动力学的预测和评估方法以及注射的质量评估方法和制备方法,每种方法包括测量膜 流动性和/或圆二色性。