目的 通过分析口服六价重配轮状病毒减毒活疫苗（Vero细胞）单价病毒原液内猪胰蛋白酶残留量、牛血清白蛋白残留量、Vero细胞DNA残留量及片段大小，为该疫苗的杂质质量控制提供依据。方法 采用ELISA分别检测30批单价病毒原液中猪胰蛋白酶残留量和牛血清白蛋白残留量；用磁珠提取法纯化30批单价病毒原液中残留Vero细胞DNA，分别采用荧光染色法和毛细管凝胶电泳法检测Vero细胞DNA含量、DNA片段大小及分布。结果 在已检测的30批单价病毒原液中，猪胰蛋白酶残留量为3.8～7.2 μg/mL，牛血清白蛋白残留量为85～268 ng/mL，Vero细胞DNA残留量为48～115 μg/mL，Vero细胞DNA片段大小分布在201～2 000 bp的占比为73.4%～91.9%。结论 口服六价重配轮状病毒减毒活疫苗（Vero细胞）单价病毒原液的杂质残留可控。

Objective To provide basis for the quality control of impurities in oral hexavalent reassortant live attenuated rotavirus vaccine (Vero cell) by analyzing the residual levels of porcine trypsin, bovine serum albumin（BSA）, Vero cell DNA，and the DNA fragment size in monovalent virus bulk.Methods The residual levels of porcine trypsin and BSA in 30 batches of monovalent virus bulk were detected by ELISA. The residual Vero cell DNA in 30 batches of monovalent virus bulk was purified by magnetic bead extraction method and then quantified by fluorescent staining method, and the size and distribution of Vero cell DNA fragment were detected by capillary gel electrophoresis.Results In 30 batches of monovalent virus bulk tested, the residual levels of porcine trypsin was 3.8-7.2 μg/mL, BSA was 85-268 ng/mL, and Vero cell DNA was 48-115 μg/mL. The DNA fragments of Vero cells in the range of 201- 2 000 bp counted for 73.4%-91.9% of fragments.Conclusion The residual impurities in the monovalent virus bulk of oral hexavalent reassortant live attenuated rotavirus vaccine (Vero cell) are controllable.