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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 explore a new process for the preparation of lyophilized plasma and to develop a novel freeze-dried plasma suitable for storage and transport in harsh environments and for ease of use. Methods Methylene blue photochemical technique was used to inactivate fresh frozen plasma (FFP). The FFP was directly lyophilized into blood bags and the preservation effect under different conditions was observed. Results Methylene blue photochemical technique (final concentration of 1μmol / L) effectively inactivated Sindbis virus, PRV and VSV and other indicator viruses in plasma. After inactivation for 30min, the inactivation effect was> 4.75LgTCID50. Inactivated by 3 generations of cells The virus is reliable. The appearance of the new freeze-dried plasma into pale yellow loose body, residual volume of 2.2% -2.5%, <2min at room temperature completely dissolved; storage stability test showed that the new lyophilized plasma F Ⅱ, FⅤ, FⅧ, FⅨ and FXI in 25 ℃ and 4 ℃ relatively stable, high temperature (40 ℃) preservation of its activity have a certain impact. Conclusion It is feasible to prepare new freeze-dried plasma using methylene blue photochemical inactivated virus technology and bagged plasma freeze-drying technology.