【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/m L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。更多还原

【Abstract】 Objective To detect and analyze the coagulation factors in preparation of human prothrombin complex concentrate( 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 / m L in the three batches of plasma. The difference in four coagulation factor activity was not significant before and after freeze-drying and S / D treatment,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.更多还原