中国输血杂志Issue(10)：978-981,4.
中国市场人凝血因子Ⅷ质量分析
Assessment of human coagulation factor Ⅷ in the Chinese market
张学俊 1叶生亮 1杜晞 1谢亦武 1曹海军 1王宗奎 1李长清1
作者信息
- 1. 中国医学科学院北京协和医学院输血研究所,四川成都610052
- 折叠
摘要
Abstract
Objective To study these human coagulation FⅧ products in China,a preliminary analysis is made on the active ingredients as well as impurity profile. The research on these factor Ⅷ products' efficacy and safety serves to establish new standards for product quality and provide some theoretical basis for applications. Methods A S Corp' s human F Ⅶ .Cross' F Ⅷ.CSL' s Aleviate,L Corp' s F Ⅷ and Bayer' s Kogenate(R) FS are evaluated through the determination of F Ⅲ,F V,F Ⅵ,F Ⅸ,FX and F Ⅷ clotting capability, as well as preliminary evaluation of vWF activity content. Non-reducing and reducing SDS-PAGE electrophoresis is employed to assess purity,while protein content is determined by three different assays. Results The results in the clotting activity,protein concentration and purity indicate that there are qualitative differences among these factor Ⅷ products. Conclusion Preparation by different processes may lead to different product quality Qualitative evaluation of coagulation factor products may be influenced by different methods, equipment and test kits employed. Glycine affect the results of Bradford total protein content determination. The present study show one of the key quality parameters of FⅧ - specific activity in these products to be greater than the WHO requirements for a high-purity FⅧ (10IU/mg) as well as the Chinese Pharmacopoeia 2010 (1IU/mg) requirements.关键词
人凝血因子Ⅷ(FⅧ)/质量分析/评估/比活性Key words
Human coagulation factor Ⅷ/ Quality assessment/analysis/ Specific activity分类
医药卫生引用本文复制引用
张学俊,叶生亮,杜晞,谢亦武,曹海军,王宗奎,李长清..中国市场人凝血因子Ⅷ质量分析[J].中国输血杂志,2012,(10):978-981,4.
