CE-EMMA法测定乙脑灭活疫苗中乙二胺四乙酸二钠残留量  

Determination of residual EDTA-2Na in Japanese encephalitis attenuated live vaccine by capillary electrophoresis with electrophoretically mediated microanalysis

作　　者：吴金凤 白建秋 刘卫 林瑶 姜廷福[2] WU Jinfeng;BAI Jianqiu;LIU Wei;LIN Yao;JIANG Tingfu(Shandong Hengye Biotechnology Co.,Ltd,Qingdao 266114,China;School of Medicine and Pharmacy,Ocean University of China,Qingdao 266003,China)

机构地区：[1]山东恒业生物技术有限公司,山东青岛266114 [2]中国海洋大学医药学院,山东青岛266003

出　　处：《中国药品标准》2024年第1期25-29,共5页Drug Standards of China

基　　金：2018年青岛市自主创新重大专项(18-1-1-91-nsh)。

摘　　要：目的:建立毛细管电泳(CE)结合电泳中介微分析(EMMA)测定乙脑灭活疫苗中乙二胺四乙酸二钠(EDTA-2Na)残留量的方法。方法:运行缓冲液为0.025 mol•L^(-1)磷酸氢二钠缓冲液(pH 2.5),在线络合金属离子为1.5 mg•mL Fe^(3+),孵育时间3 min,分离电压-25 kV,紫外检测波长257 nm,压力进样5000 Pa×5 s,检测温度为25.0℃。结果:EDTA-2Na在0.01~0.5 mg•mL^(-1)的浓度范围内呈现良好的线性关系,r为0.9999,最低检测限为5μg•mL^(-1),测定样品RSD小于2.87%,加样回收率为94.13%~105.56%。结论:该方法操作简便,准确度高,稳定性好,可用于乙脑灭活疫苗中EDTA-2Na残留量的测定。Objective:To establish a capillary electrophoresis(CE)with electrophoretically mediated microanalysis(EMMA)method for the determination of EDTA-2Na in Japanese encephalitis attenuated live vaccine.Methods:The test was performed in disodium hydrogen phosphate buffer with pH 2.5,the online metal ions complexation of 1.5 mg•mL^(-1) Fe^(3+)and incubation time of 3 min.The separation voltage was 25 kV,the detection wavelength was 257 nm,and.the column temperature was 25.0℃.Results:The established method had a good linear relationship in the concentration range of 0.01-0.5 mg•mL^(-1)(r=0.9999),the detection limit was 5μg•mL^(-1),and the relative standard deviation(RSD)of the measured samples was less than 2.87%.The recoveries of spiked samples were between 96.49%-101.02%.Conclusion:The optimized method was applied to the determination of EDTA-2Na in Japanese encephalitis attenuated live vaccine.The satisfactory experimental results were obtained.

关 键 词：毛细管电泳 电泳中介微分析 乙脑灭活疫苗 乙二胺四乙酸二钠 残留量 质量控制 

分 类 号：R921.2[医药卫生—药学]