摘要
目的考察了5种、11个批次的中国市场人凝血因子Ⅷ(FⅧ)制品,分析相关制品的成份。研究对国内制品的有效性和安全性做出评估,为建立新的制品质量标准提供理论依据。方法选用S公司人FⅧ、CSL Alevi-ate、+公司人FⅧ、L公司人FⅧ和Bayer KogenateFS,通过FⅧ测定进行制品活性评估,通过FⅡ、FⅤ、FⅦ、FⅨ、FⅩ分析杂质蛋白含量,用3种不同蛋白测定方法测定制品总蛋白含量;初步评价von Willebrand Factor(vWF)活性,并用非还原和还原SDS-PAGE电泳分析纯度。结果不同制品在活性检测、蛋白含量测定和电泳纯度评估中均有不同的表现差异。结论不同的工艺制备流程导致不同的制品质量;凝血因子类制品测定不同的方法、设备和检测试剂盒都对数值造成不确定性;甘氨酸影响Bradford法总蛋白含量测定,目前考察的几种FⅧ的关键性质量参数-比活性均大于WHO高纯度(10 IU/mg)和2010版中国药典(1IU/mg)的要求。
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 estab- lish new standards for product quality and provide some theoretical basis for applications. Methods A S Corp＇ s human F Ⅷ ,Cross＇ F ⅧCSL＇ s Aleviate,L Corp＇ s F Ⅷ and Bayer＇s Kogenate~ FS are evaluated through the determination of F 11 , F V, F V~, F IX, F X and F Ⅷ clotting capability, as well as preliminary evaluation of vWF activity content. Non-re- ducing 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 qualita- tive differences among these factor Ⅷ products. Conclusion Preparation by different processes may lead to different prod- uct 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（101U/mg） as well as the Chinese Pharmacopoeia 2010 （1IU/mg） requirements.
出处
《中国输血杂志》
CAS
CSCD
北大核心
2012年第10期978-981,共4页
Chinese Journal of Blood Transfusion
