血漿分画製剤に関する品質試験 : 第VIII因子製剤の性状分析

概要

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Three factor VIII concentrate products (Hemofil-M, Hemate-P, and Confact-F) were examined to characterize the quality of activity. The factor VIII activity of Hemate-P was confirmed to be 6,500% by comparison with normal serum from humans factor VIII, and the specific activity of this product was about 4,600%/mg of protein, Hemofil-M had likewise 3,750% as the activity of factor VIII, and 12,500%/mg of protein as the specific activity. The factor VIII activity of Confact-F was 4,250%, and the specific activity was 1,250%/mg of protein. While Hemate-P and Confact-F were contaminated by impurities such as fibrinogen, fibronectin or IgG, Hemofil-M purified by the monoclonal technique took no notice of those impurities. The light and heavy chains of factor VIII in three products were evaluated as bands by Western blotting, and the molecular weight of factor VIII were observed to be in the range of 90 to 200 KD. The von Willebrand factor involved in Hemate-P and Confact-F on a par level corresponded to 100 times as much as that in Hemofil-M.
日本医療薬学会の論文
1992-08-20