S/D法灭活病毒后凝血酶原复合物的生物活性及S/D残留量的分析

Analysis of the Biological Activity of and the Residual SD in the Prothrombin Complex Concentrate after Inactivation of Virus by SD

考察了6批经S/D(solvent/detergent)灭活病毒后的凝血酶原复合物(PCC)的生物活性回收率及S/D(磷酸三丁酯/吐温80)残留量,PCC的PE效价活性平均回收率为87.83％,吐温80残留量<40μg/ml,磷酸三丁酯(TNBP)<10μg/ml;并着重探讨了TNBP的气相色谱法,建立了以正十八烷为内标、测定PCC中TNBP残留量的方法,浓度在(2～70)μg/ml范围内线性关系良好,最低检测浓度为0.5μg/ml,回收率为92.6％～95.5％,方法准确可靠。

The biological activity recovery rate of and the residual SD in the 6 batches of prothrombin complex concentrate after inactivation of virus by solvent-detergent was investigated. The average recovery rate of PE activity of prothrombin compound was 87. 83%,the residual Tween 80 was < 40μg/ml and TNBP Was < 10μg/ml. The TNBP in prothrombin complex concentrate was emphatically approached by gas chromatography,and the method of determination of TNBP in prothrombin complex concentrate using n-octadecane as internal standard,was set up. The linear relationship was good at the concentration ranging from 2 to 70μg/ml. The minimal concentration which could be detected was 1μg/ml. The recovery rate was 92. 6%-95. 5%.