首页|CE-EMMA法测定乙脑灭活疫苗中乙二胺四乙酸二钠残留量

CE-EMMA法测定乙脑灭活疫苗中乙二胺四乙酸二钠残留量

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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 Fe3+,孵育时间3 min,分离电压-25 kV,紫外检测波长257 nm,压力进样5 000 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。999 9,最低检测限为5 μg·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。
Determination of residual EDTA-2Na in Japanese encephalitis attenuated live vaccine by capillary electrophoresis with electrophoretically mediated microanalysis
Objective:To establish a capillary electrophoresis(CE)with electrophoretically mediated microanaly-sis(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 com-plexation of 1.5 mg·mL-1 Fe3+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=0.999 9),the detection limit was 5 μg·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.

capillary electrophoresiselectrophoretically mediated microanalysisJapanese encephalitis attenuated live vaccineEDTA-2Naresidual quantityquality control

吴金凤、白建秋、刘卫、林瑶、姜廷福

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山东恒业生物技术有限公司,山东青岛 266114

中国海洋大学医药学院,山东青岛 266003

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

2018年青岛市自主创新重大专项

18-1-1-91-nsh

2024

中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
年,卷(期):2024.25(1)
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