FFP经亚甲蓝光化学法灭活病毒并直接冻干于血袋的冻干血浆研制  

Preparation of lyophilized plasma by methylene blue/light treatment and blood bag lyophilization

作　　者：马平[1] 周锡鹏[1] 闫舫[1] 张艳宇[1] 吕丽萍[1] 许金波[1] 

机构地区：[1]军事医学科学院野战输血研究所,北京100850

出　　处：《中国输血杂志》2010年第5期335-338,共4页Chinese Journal of Blood Transfusion

摘　　要：目的探索制备冻干血浆的新工艺,研制适合在艰苦环境下储运和方便使用的新型冻干血浆。方法采用亚甲蓝光化学技术对新鲜冰冻血浆(FFP)做病毒灭活处理,再将FFP直接冻干于血袋中,观察不同条件下的保存效果。结果亚甲蓝光化学技术(终浓度为1μmol/L)能有效灭活血浆中的Sindbis病毒、PRV和VSV等指示病毒,处理30min后灭活效果>4.75LgTCID50,经细胞3代盲传证明灭活病毒效果可靠。新型冻干血浆外观成淡黄色疏松体,残水量为2.2%—2.5%,室温下<2min完全溶解;储存稳定性试验表明,新型冻干血浆中的FⅡ、FⅤ、FⅧ、FⅨ和FⅪ在25℃和4℃比较稳定,高温(40℃)保存对其活性有一定影响。结论采用亚甲蓝光化学灭活病毒技术和袋装血浆冻干技术制备新型冻干血浆是可行的。Objective To investigate a new technology for the preparation of lyophilized plasma which is suitable for the storage, transport and easy use in the conflagration events.Methods Fresh frozen plasma （FFP） was treated with methylene blue /light method for virus inactivation and then lyophilized directly in the PVC blood bag. The freeze dried plasma was kept in different conditions for a period of time and some protein functions in the plasma were analyzed. Results Methylene blue （with a final concentration 1 μmol/L） reduced Sindbis virus, pseudorabies virus and vesicular stomatitis virus in the plasma for more than 4.75 LgTCID50, and no cytopathic effect was found in the cell line which was inoculated with treated samples after blind passage for three generations. The new freeze dried plasma had a puffy and pallide-flavens appearance with residual water content between 2.2% to 2.5% and could be dissolved completely in 2 minutes at room temperature. The results of storing stability test showed that the activities of clotting factor Ⅱ, Ⅴ, Ⅷ, Ⅸ and Ⅺ in the new freeze dried plasma had little change under the holding conditions of 4 ℃ and 25 ℃,but holding temperature over 40 ℃ had some influences to them. Conclusion It is possible to produce the freeze dried plasma with the techniques of methylene blue /light treatment and blood bag lyophilization.

关 键 词：冻干血浆 亚甲蓝 光化学 病毒灭活 指示病毒 

分 类 号：R457.14[医药卫生—治疗学] Q664.1[医药卫生—临床医学]