胶束电动毛细管色谱同时快速测定疫苗制品中不同防腐剂  

Rapid Detection of Different Preservatives in Various Vaccines by Micel⁃lar Electrokinetic Capillary Electrophoresis

作　　者：赵崑荔 刘梦媛 石蓓佳 陆益红 史清水 赵述强 ZHAO Kunli;LIU Mengyuan;SHI Beijia;LU Yihong;SHI Qingshui;ZHAO Shuqiang(Jiangsu Institute for Food and Drug Control,Nanjing 210019,China)

机构地区：[1]江苏省食品药品监督检验研究院,南京210019

出　　处：《药学与临床研究》2025年第1期42-44,共3页Pharmaceutical and Clinical Research

基　　金：江苏省市场监督管理局科技计划项目(KJ21125067)。

摘　　要：目的:建立胶束电动毛细管色谱(MEKC)法同时快速测定多种疫苗中不同防腐剂。方法:采用MEKC法,无涂层毛细管(52 cm有效长度,60 cm总长,内径50μm),50 mmol·L^(-1)硼酸与20 mmol·L^(-1)十二烷基硫酸钠缓冲液(pH9.0),柱温20℃,分离电压20 kV,于214 nm检测,同时与药典推荐方法的结果进行比较。结果:在优化的电泳条件下,10 min内苯酚、2-苯氧乙醇、硫柳汞达到完全分离,MECK法与药典推荐方法所得含量测定结果无显著性差异。结论:本方法能快速、准确有效地检测疫苗中的防腐剂含量,为相关产品质量控制提供方法参考。Objective:A micellar electrokinetic capillary electrophoresis(MEKC)method was estab-lished for simultaneous and rapidly determination of different preservatives in various vaccines.Methods:The MECK method was applied using an uncoated fused-silica capillary(52 cm effective length,60 cm total length,50μm inner diameter)with a buffer solution 50 mmol·L^(-1) boric acid and 20 mmol·L^(-1) sodium dodecyl sulfate(pH9.0).The column temperature was maintained at 20℃,the separation voltage was 20 kV,and the detection wavelength was at 214 nm.Finally,the preservatives in three vaccines were determined by MEKC comparing with the results of the method recommended by the Chinese Pharmaco-poeia.Results:Under the optimized electrophoresis condition,phenol,2-phenoxyethanol,and thiomersal were completely separated within 10 minutes.The results between MEKC and Chinese Pharmacopoeia rec-ommended method showed no significant difference.Conclusion:This method is simple,rapid and repro-ducible for analysis of preservatives in vaccines,providing a reference method for quality control of related products.

关 键 词：胶束电动毛细管色谱 防腐剂 质量控制 

分 类 号：R917[医药卫生—药物分析学]