中文摘要：

目的研制重组HIV-1腺病毒载体活疫苗的冻干保护剂。方法在重组HIV-1腺病毒载体活疫苗中加入不同配比的保护剂，在适宜条件下制备成冻干剂型。根据冻干后外观、病毒滴度和热稳定性试验等结果，筛选出冻干保护剂的最适配方。结果以人血白蛋白、海藻糖、甘露醇、右旋糖苷和蔗糖等成分按比例配伍制备的保护剂，对重组HIV-1腺病毒载体活疫苗显示了较好的保护作用。冻干前后疫苗病毒感染性滴度下降在0．17LogCCID50／ml以内；37℃放置1周，滴度下降0．3LogCCID50／ml左右；37℃放置3周后，滴度下降约为0．6LogcCID50／ml。而无保护剂的液体疫苗对照于37℃放置1周，滴度下降近2．5个LogCCID50／ml。结论以人血白蛋白、海藻糖、甘露醇、右旋糖苷和蔗糖等配伍而制备的保护剂效果较好。

英文摘要：

Objective To prepare the stabilizer of freeze-dried adenovirus-based live HIV vaccine. Methods Add stabilizers with different formula into adenovims-based live HIV vaccine and prepare the vaccine into freeze-dried form under appropriate conditions. Screen the optimal stabilizer according to the appearance, vires titer and thermostability of the freeze-dried vaccine. Results The stabilizer containing human serum albumin, trehalose, mannitol, dextran and sucrose showed good protective effect on freeze-dried adenovirus-based live vaccine. Compared with that before lyophilization, the infectious titer of vaccine after lyophilization decreased by not more than 0. 17 LogCCID50/ml. The titer of freeze-dried vaccine decreased about 0.3 LogCCID50/ml at 37℃ for one week and not more than 0. 6 LogCCID50/ml for 3 weeks. However,the titer of liquid vaccine containing no stabilizer decreased by nearly 2. 5 LngCCID50/ml at 37℃ for one week. Conclusion The stabilizer containing human serum albumin,trehalose,mannitol,dextran and sucrose was suitable for freeze-dried adenovims-based HIV vaccine.