疫苗中硫柳汞含量测定及其降解产物分析  

Study on the assayof thiomersal and the analysis of degradation products in vaccine

作　　者：焦旭雯[1] 陈龙少 梁蔚阳[1] JIAO Xu-wen;CHEN Long-shao;LIANG Wei-yang(Guangdong Institute for Drug Control,NMPA Key Laboratory of Quality Control of Blood Product,Guanghou,510663,Guangdong,China)

机构地区：[1]广东省药品检验所国家药品监督管理局血液制品质量控制重点实验室,广州510663

出　　处：《药物分析杂志》2022年第6期1045-1053,共9页Chinese Journal of Pharmaceutical Analysis

基　　金：广东省医学科学技术研究基金项目(B2021371)。

摘　　要：目的:建立HPLC法测定疫苗中硫柳汞的含量,与2020年版《中华人民共和国药典》收载的测定法进行比较。方法:采用C色谱柱(4.6 mm×250 mm, 5μm),以甲醇-0.05%三氟醋酸溶液(60∶40)为流动相;检测波长为222 nm,柱温为30℃。结果:本法测定样品中硫柳汞的含量,与2020年版《中华人民共和国药典》测定无机汞离子含量结果存在一定差异。结论:硫柳汞在疫苗生产过程中易降解,本法专属性好,可以更准确地测定疫苗中硫柳汞的含量。Objective:To establish an HPLC method for the detection the assay of thiomersal in vaccine,and compare the result with the content determined by ChP 2020 method.Methods:The analysis was carried out on C_(18) column(4.6 mm×250 mm,5μm)with mobile phase of methanol and 0.05%trifluoroacetic acid solution(60∶40).The experimentwas carried out at 30℃with the UV detection at 222 nm.Results:There was a certain difference between the content of thiomersal calculated by external standard and ChP 2020.Conclusions:Thiomersal can be degraded in the production process.The method has good specificity and can be used to determine the content of thiomersal in vaccine.

关 键 词：疫苗 硫柳汞 高效液相色谱法 含量测定 降解产物 

分 类 号：R917[医药卫生—药物分析学]