病毒灭活血浆中亚甲蓝残留量的质量控制

The Quality Control of the Residual Quantity of Methylene Blue in Virus Inactivation Plasma

目的探讨如何在提高病毒灭活血浆制备效率的基础上,尽可能减少血浆中的亚甲蓝残留量/率。方法将30份200 m l新鲜血浆,平均分为3组,对照组使用旧型病毒灭活过滤器,实验1组和2组使用新型过滤器,对照组和实验1组对血浆中的亚甲蓝只进行1次滤除,实验2组对亚甲蓝进行2次滤除,留样测定每组滤过前、后的亚甲蓝含量,以及总蛋白和Ⅷ因子的回收率。结果实验1组、2组与对照组的亚甲蓝释放量的差异均无统计学意义(P>0.05)。实验2组与对照组的亚甲蓝残留量/率的差异无统计学意义(P>0.05),实验1组与对照组,以及实验1和实验2组的亚甲蓝残留量/率的差异有统计学意义(P<0.01),三组的总蛋白和Ⅷ因子回收率的差异无统计学意义(P>0.05)。结论对亚甲蓝进行2次滤除可大大降低血浆中的亚甲蓝残留量/率,该方法简单、高效,能够在血站推广应用。

Objective To explore how to decrease the residual quantity/ratio of methylene blue(MB) on the basis of improving efficiency of preparation for the virus inactivation plasma.Methods 30 bags(200 ml/bag) of the fresh plasma were divided equally into 3 groups.The comparison group used the old-style virus-inactived filter.The first and the second experimental groups used the new-style filter.Plasma with MB was filtered only once in the comparison group and the first experimental group,but twice in the second experimental group.The samples of each group were kept to quantify MB before and after filtered,and to calculate the recovery rate of total protein and factor Ⅷ.Results About the released quantity of MB,the difference between the first experimental group and the comparison group was insignificant(P>0.05),the difference between the second experimental group and the comparison group was insignificant as well.And about the residual quantity/ratio of MB,the difference between the second experimental group and the comparison group was insignificant(P>0.05),but difference between the first experimental group and the comparison group,the first and the second exprimented group,was significant(P<0.01).The difference of the recovery rate of total protein and factor Ⅷ in the three groups was insignificant(P>0.05).Conclusion The method to filter plasma twice could reduce the residual quantity/ratio of MB greatly;and it is simple and effective.This method could be popularly applied to the blood station.