S/D病毒灭活方法对人凝血酶活性影响及其S/D去除的试验研究

INFLUENCE OF S/D VIRUS INACTIVATION METHOD ON HUMAN THROMBIN ACTIVITY AND EXPERIMENTAL STUDY ON REMOVAL OF S/D

为了验证病毒灭活剂(S/D)对血液制品中人凝血酶活性的影响及其去除的方法。采用层析和液相色谱法对S/D影响人凝血酶活性及其残留物的去除效果进行了研究。结果,纯化的凝血酶加入S/D进行病毒灭活对活性无影响,离子交换层析分离工艺几乎可全部除去S/D残留物,使产品达到了对人体无害的标准要求。结论,S/D对人凝血酶活性无影响,采用离子交换层析法能去除血液制品中的S/D,使产品达到安全可靠。

In order to test the influence of virus inactivator (S / D) in blood products on human thrombin activity and the method for removing it from the blood products, the influence of S / D on human thrombin activity and the efficacy of removing its residue were studied using chromatography and liquid chromatography. The results showed that addition of S / D to purified thrombin for inactivating virus did not influence its activity. Ion-exchange chromatographic separation technology could remove almost all S / D residue and made the product fulfil the standard requirement of no harm to man. Conclusion: S / D does not influence human thrombin activity and ion-exchange chromatography can remove S / D in blood products to make the products safe and reliable.