凝血酶原复合物病毒灭活的研究

从Cohn’s组分Ⅲ制备凝血酶原复合物（简称PCC），并经S／D处理灭活病毒。通过加入标志病毒（VSV、Sindbis、仙台及EMC）考察病毒灭活效果。结果显示，因子Ⅱ、Ⅸ活性总回收率分别为52．2％和22．3％，纯化倍数分别为3．5和1．5，均比原制备工艺提高约2倍。对标志病毒的灭活效果分别达107．55TCID50／ml（VSV）、107．27TCID50／ml（Sindbis）、108．25TCID50／ml（仙台），而对非脂膜病毒EMC的灭活小于100．2TCID50／ml，表明S／D对灭活脂膜病毒有效，而对非脂膜病毒无效。TNBP残留量小于10ppm，Tween80残留量小于100ppm。所得制剂的溶解性及外观均比原制备工艺所得制剂有明显改善。

Virus Inactivation in Prothrombin Complex Concentrate

After prothrombin complex concentrate (PCC) was prepared from Cohn'sfraction Ⅲ and S/D method was adopted for virus inactivation. The inactivation effect wasverified with several indictor viruses (VSV, Sindbis, Sendai and EMC). The result showedthat the overall recovery rates of the activities of factor Ⅱ and IX were 52．2％and 22．3％,re-spectively. The virus inactivation effect were found as follawing: 107．55TCID50/ml of VSV,107．27TCID50/ml of Sindbis and 108．25TCID50/ml of Sendai virus. It proved that S/D methodwas effective in the inactivation of lipid-enveloped virus, but was ineffective in that of non-lipid enveloped virus (＜100．2TCID50/ml of EMC). The residual TNBP and Tween80 contentswere＜10ppm and ＜100ppm, respectively. Compared with those prepared by former prece-dure, the solubility and appearance of the PCC were significantly improved.