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目的分析酶联免疫法测定重组乙型肝炎疫苗中庆大霉素残留量的相关影响因素。方法使用庆大霉素酶联免疫试剂盒对3种表达系统的重组乙型肝炎疫苗(酿酒酵母、汉逊酵母、CHO细胞)成品和原液进行庆大霉素回收率测定,同时对不同来源庆大霉素标准品绘制的标准曲线进行对比,对铝佐剂和标准品对庆大霉素残留量检测的影响进行分析。结果含铝佐剂的乙型肝炎疫苗成品中庆大霉素回收率差异较大,疫苗原液中测定庆大霉素的回收率较稳定,在85.1%~101.5%之间,波动性较小;试剂盒自带标准品与庆大霉素国家标准品绘制的标准曲线存在差异。结论不同制备工艺的铝佐剂会影响乙型肝炎疫苗中庆大霉素的回收率,在原液中测定庆大霉素残留量稳定性良好,标准品来源及批次会影响庆大霉素残留量的测定。
Objective To analyze the influential factors of determination of gentamicin residues in recombinant hepatitis B vaccine by enzyme-linked immunosorbent assay. Methods The gentamicin recovery of three recombinant hepatitis B vaccines (Saccharomyces cerevisiae, Hansenula polymorpha, CHO cells) from three kinds of expression systems was determined by using gentamycin enzyme-linked immunosorbent assay (ELISA kit) The calibration curve of gentamicin standard was compared and the influence of aluminum adjuvant and standard on the detection of gentamicin residues was analyzed. Results The recoveries of gentamicin in finished vaccine containing aluminum adjuvant were quite different. The recovery of gentamycin in the vaccine liquid was stable, with a small fluctuation between 85.1% and 101.5%. There is a difference between the standard curve of the standard kit and the national standard of gentamycin. Conclusion Aluminum adjuvant with different preparation process will affect the recovery rate of gentamicin in hepatitis B vaccine. The stability of gentamycin residues in the stock solution is good. The origin and batch of standard product will affect the gentamycin residues Determination of the amount.