目的  研究微量鲎试剂动态显色法定量检测肠道病毒71型灭活疫苗（inactivated enterovirus 71 vaccine, iEV71）内毒素含量的可行性。方法  使用微量鲎试剂动态显色法，进行标准曲线可靠性验证、干扰试验及3批成品测定，同时与凝胶法检测结果比对。结果  标准曲线可靠性验证线性范围为0.005 0~5.000 0内毒素单位（endotoxin unit，EU）/ml，标准曲线决定系数为0.999，线性良好；干扰试验结果显示，供试品稀释10倍加入0.5 EU/ml标准内毒素测定回收率，回收率为94.4%，满足回收率50%~200%的要求。说明该稀释倍数下供试品对反应无干扰。另外，3批成品检测结果均符合标准限要求，且与凝胶法检测结果一致。结论  微量鲎试剂动态显色法可用于iEV71成品内毒素含量的定量检测。

Objective  To study the feasibility of quantitative detection of endotoxin content in inactivated enterovirus 71 vaccine (iEV71) by micro-dynamic chromogenic assay. Methods  The reliability verification of standard curve, interference test and detection of 3 batches of final product were carried out by micro-dynamic chromogenic assay. The results were compared with those of gel method. Results  In the reliability verification of the standard curve, the linear range was 0.005 0-5.000 0 endotoxin unit (EU)/ml, and the standard curve had good linearity with coefficient of determination at 0.999. The interference test result showed that the recovery rate was 94.4% when the test sample was diluted 10 times and 0.5 EU/ml standard endotoxin was added. The recovery rate met the requirement of 50%-200% indicating that the test sample did not interfere with the reaction at this dilution ratio. In addition, the results for 3 batches of final product met the requirements of the standard limit and were consistent with the gel method test results. Conclusion  The micro-dynamic chromogenic assay can be used for quantitative detection of endotoxin in the final product of iEV71.