容量滴定法和库伦滴定法测定冻干疫苗水分含量的比较

Comparison of volumetric titration and coulometric titration in determination of water content in freeze-dried vaccine

目的在适宜的温度和湿度条件下,评价容量滴定法和库伦滴定法测定冻干疫苗水分是否具有差异性。方法确定冻干疫苗水分测定的适宜温度和湿度条件,在此条件下,分别从水分含量区间、冻干疫苗类型和进样量三个主要影响方面,对容量滴定法(volumetric titration)和库伦滴定法(coulometric titration)进行比较。结果冻干疫苗水分测定的适宜条件为:温度<25℃、湿度<45%。冻干疫苗水分的质量分数为1.0%~2.0%时,容量滴定法和库伦滴定法的检测结果差异有统计学意义(P<0.05);水分的质量分数在2.0%~3.0%时,两种滴定法的检测结果差异无统计学意义(P>0.05)。对于不同类型冻干疫苗和不同进样量的冻干疫苗,两种滴定法检测结果差异均无统计学意义(P均>0.05)。结论在适宜的温度和湿度条件下,库伦滴定法更适用于低水分含量冻干疫苗的水分测定;其他情况下两种滴定法无明显差异。

Objective To evaluate the differences of water content in freeze-dried vaccine determined by volumetric titration and coulometric titration under appropriate temperature and humidity conditions.Methods To determine an appropriate temperature and humidity conditions for detection of water content in freeze-dried vaccine under this condition,the volumetric titration and coulometric titration were compared from three main aspects:water content range,freeze-dried vaccine type and injection amount.Results The suitable conditions for the water content determination of freeze-dried vaccine were:temperature<25℃,humidity<45%.When the water content of freeze-dried vaccine was 1.0%~2.0%,the difference between volumetric titration and coulometric titration was statistically significant(P<0.05).When the water content of the same batch freeze-dried vaccine was 2.0%~3.0%,there was no statistically significant difference in the two titration methods(P>0.05).For different types and injection amount of freeze-dried vaccines,there was no significant difference between the two methods(P>0.05).Conclusion Under appropriate temperature and humidity conditions,coulometric titration is more suitable for water content determination of freeze-dried vaccine with low water content;in other cases,there is no significant difference between the two methods.