人凝血酶原复合物在制备过程中凝血因子活性的检测和分析  

Detection and analysis of coagulation factor activity in preparation of human prothrombin complex concentrate

作　　者：张璘[1] 刘晓[1] 李青[1] 张廷芬[1] 张安山[1] 张金[1] 何彦林[1] 

机构地区：[1]兰州生物制品研究所有限责任公司甘肃省疫苗工程技术研究中心,甘肃兰州730046

出　　处：《微生物学免疫学进展》2015年第6期22-25,共4页Progress In Microbiology and Immunology

摘　　要：目的：对人凝血酶原复合物在制备工艺中凝血因子效价进行检测和分析。方法对PCC制备过程中的血浆、S／D病毒灭活、冻干工艺、干热病毒灭活前和后分别取样，检测分析凝血因子Ⅱ、Ⅶ、Ⅸ和Ⅹ效价，分别分析S／D病毒灭活、冻干工艺、干热病毒灭活前和后凝血因子效价的变化情况。分析PCC干热病毒灭活后的样品中四种凝血因子的效价比例。结果三批血浆中凝血因子Ⅱ、Ⅶ、Ⅸ和Ⅹ的活性在0．8～1．2 IU／mL之间。 S／D病毒灭活前后PCC 冻干工艺前后PCC中四种凝血因子活性无明显变化，而干热病毒灭活后PCC中四种凝血因子活性均有明显下降。三批PCC中四种凝血因子的比例基本一致，但是凝血因子Ⅶ效价较低，凝血因子Ⅱ效价偏高。结论通过PCC制备工艺中凝血因子效价的检测和分析可实现良好的质量控制。Objective To detect and analyze the coagulation factors in preparation of human prothrombin complex concen-trate （ PCC） .Methods The activity of coagulation factors II, VII, IX, X was measured in three batches of plasma.The differences in activity of coagulation factors II, VII, IX was determined before and after steps, such as solvent/detergent （S/D） inactivation,freeze-drying process,dry-heating viral inactivation.The proportion of coagulation factor in the PCC sample was also assayed.Results Coagulation factors II, VII, IX, X activity are 0.8-1.2 IU/mL in the three batches of plasma.The difference in four coagulation factor activity was not significant before and after freeze-drying and S/D treat-ment, thus coagulation factor activity was significantly decreased after the dry-heating viral inactivation.The propotion of four factors was basically same in the three batches of PCC;the titer of coagulation factor VII was relative low, but that of coagulation factor II was relative high.Conclusion A good quality control appproach could be achieved by using detection and analysis of the coagulation factors in preparation of human prothrombin complex concentrate.

关 键 词：凝血因子活性 人凝血酶原复合物 质量控制 

分 类 号：TQ460.7[化学工程—制药化工]