口服脊髓灰质炎减毒活疫苗中庆大霉素残留量检测方法的验证

目的  验证口服脊髓灰质炎减毒活疫苗（人二倍体细胞）中庆大霉素残留量的检测方法。方法  应用庆大霉素ELISA试剂盒建立庆大霉素残留量的检测方法。对该方法标准曲线的线性、线性范围内的准确度、精密度、专属性、耐用性、检测限及定量限进行验证。结果  验证的标准曲线线性良好，相关系数>0.98。该法检测高、中、低浓度的庆大霉素标准品的回收率为92.7%～123.6%；检测同一批次的供试品的相对标准偏差为8%；不同试验人员检测同一批次供试品和不同批次试剂盒检测同一批次供试品，相对标准偏差均<15%；庆大霉素加样回收率为95.9%～121.3%；该法在（37±1） ℃温度范围内耐用性良好；该法测定庆大霉素的检测限为0.040 ng/ml，定量限为0.135 ng/ml。结论  用于检测口服脊髓灰质炎减毒活疫苗（人二倍体细胞）中庆大霉素残留量的方法是有效的。

The validation ofresidual gentamicin detection method in liveattenuated oral poliovirus vaccine

Objective  To verify the detection method of residual gentamicin  in the live attenuated oral poliovirus vaccine (human diploid cells). Method  Gentamicin ELISA kit was used to establish a method for the determination of gentamicin residues. The linearity of the standard curve of the method and the accuracy, precision, specificity, durability, detection and quantitative limit of the linear range are verified. Results  The standard curve of the test was linear, with correlation coefficient >0.98. The recovery rate of the high, medium and low concentrations of gentamicin was 92.7%-123.6%. The relative standard deviation of same batch samples tested for the same batch was 8%. The relative standard deviations of same batch samples tested by different test personnel and different batches of  test kit were all <15%. The recovery rates of gentamicin was 95.9%-121.3%. The method had good durability in the temperature range of  (37±1) ℃. The detection limit of gentamicin was 0.040 ng/ml and the quantitative limit was 0.135 ng/ml. Conclusion  The method is effective for the detection of gentamycin in live attenuated oral poliovirus vaccine(human diploid cells).