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

作　　者：卓晓琴 慕艳红 周亚辉 吴起鹏 傅元欣 冯潇 冯德杰 ZHUO Xiao-qin;MU Yan-hong;ZHOU Ya-hui;WU Qi-peng;FU Yuan-xin;FENG Xiao;FENG De-jie(The Quality Control Department,Lanzhou Institute of Biological Products Co.,Ltd.,Center for Gansu Provincial Vaccine Engineering Research,Lanzhou 730046,Gansu Province,China)

机构地区：[1]兰州生物制品研究所有限责任公司质量检定室甘肃省疫苗工程技术研究中心,甘肃兰州730046

出　　处：《微生物学免疫学进展》2021年第1期31-37,共7页Progress In Microbiology and Immunology

摘　　要：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.

关 键 词：冻干疫苗 水分 容量滴定法 库伦滴定法 

分 类 号：TQ460.6[化学工程—制药化工]