ELISA法检测乙型脑炎减毒活疫苗中卡那霉素和庆大霉素的残留量

用ELISA试剂盒检测乙脑减毒活疫苗中卡那霉素和庆大霉素的残留量。以间接竞争ELISA法检测线性范围内加入高、中、低3种浓度的卡那霉素和庆大霉素,测定其在疫苗稳定剂、疫苗稳定剂10倍稀释溶液、试剂盒稀释液中的回收率,以及在10倍稀释乙脑减毒活疫苗中的回收率。高、中、低浓度的卡那霉素在疫苗稳定剂、疫苗稳定剂10倍稀释溶液、试剂盒稀释液中的回收率为101.40%～124.80%之间;原倍疫苗稳定剂对庆大霉素的测定有明显干扰,在原倍疫苗稳定剂中低浓度和中浓度的庆大霉素的回收率高达2280%和575%,但其它测定条件下回收率在90%～125%之间。在10倍稀释的乙脑疫苗中加入一定量的卡那霉素和庆大霉素,回收率分别为124%和103.25%。用10倍稀释法测定1人份规格的乙脑减毒活疫苗17批、5人份规格的乙脑减毒活疫苗19批。乙脑减毒活疫苗10倍稀释后,可用ELISA试剂盒检测卡那霉素和庆大霉素残留量。

Detection of the residual content of kanamycin and gentamicin in live attenuated Japanese encephalitis vaccine with ELISA method

To detect the residual kanamycin and gentamicin containing in live attenuated Japanese encephalitis（JE）vaccine using ELISA method.The recovery rates of high,medium and low concentration of kanamycin and gentamicin containing in vaccine stabilizer,10 times diluted stabilizer and diluent of the ELISA kit were detected with the indirect competitive ELISA method.The recovery rates of these antibiotics containing in 10 times diluted live attenuated JE vaccine were also detected.The results showed that the recovery rates of high,medium and low concentration of kanamycin containing the three above-mentioned preparations are between 101.40% to 124.80%.It was found that vaccine stabilizer has obvious interference to the detection of gentamicin,the recovery rates of medium,low concentration of gentamicin from vaccine stabilizer come up to 575% and 2280% respectively,the gentamicin recovery rates are between 90% to 125% under the other conditions.The gentamicin and kanamycin recovery rates are 124% and 103.25% respectively in 10 times diluted live attenuated JE vaccine,17 batches 0.5ml reconstituted vaccine per container and 19 batches 2.5ml of reconstituted vaccine per container were tested.It was found that the kanamycin and gentamicin residual content in 10 times diluted JE vaccine can be detected by ELISA kit.