冻干麻疹减毒活疫苗残余水分影响因素的探讨

影响冻干制品残余水分的因素很多,但西林瓶胶塞的含水量是其关键因素。使用经干烤工艺处理和未干烤处理的药用溴丁基胶塞进行麻疹减毒活疫苗冻干试验,结果显示,用未经干烤工艺处理及处理的药用溴丁基胶塞冻干的麻疹减毒活疫苗,存储18个月后,水分上升的平均值分别为2.03%和0.08%,经单一因素的方差分析,两者有统计学意义(P0.01)。证明经处理的药用溴丁基胶塞,对保持麻疹减毒活疫苗在存储期内的残余水分稳定作用效果明显。

Study on the influence factor of residual moisture in freeze-dried attenuated measles live vaccine during storage

Many factors make the impacts on the residual moisture of the freeze-dried products,among them,the moisture content of cilin rubber stopper is a critical factor.The moisture contents of attenuated measles live vaccines were determined in the case of using dry-heat treated and non-treated rubber stopper.The result showed that the average moisture content of freeze-dried products is 2.03% and 0.08% respectively corresponding to use non-treated stoppers and treated ones after storage for 18 months.There is significant difference between two groups by the variance analysis of single factor（P〈0.01）.This experiment proves the evidence that dry-heat treated rubber stopper can play a clear effect for maintaining the stability of the residual moisture in freeze-dried attenuated measles live vaccine during storage.