摘要
目的应用细菌内毒素检查法(凝胶法)检测肠道病毒71型灭活疫苗中细菌内毒素,并对该方法进行验证。方法用凝胶法检测肠道病毒71型灭活疫苗的细菌内毒素,并验证检测方法的可行性。结果灵敏度复核试验中,博康海洋鲎试剂λc为0.125 EU/ml,福州新北鲎试剂λc为0.0866 EU/ml,均在标示灵敏度的0.5λ~2λ(0.0625~0.25),符合要求。供试品干扰试验中,博康海洋鲎试剂的Es为0.125 EU/ml,且3批供试品的Et分别为0.105 EU/ml、0.0625 EU/ml及0.0625 EU/ml,均在0.5 Es~2 Es(0.0625~0.25),符合要求;福州新北的Es为0.0866 EU/ml,且3批供试品的Et分别为0.149 EU/ml、0.149 EU/ml及0.125 EU/ml,均在0.5 Es~2 Es(0.0433~0.1732),符合要求。且对10批肠道病毒71型灭活疫苗进行细菌内毒素检测,结果均符合要求。结论凝胶法检测肠道病毒71型灭活疫苗中细菌内毒素,结果稳定,符合方法验证的要求,可为该疫苗的质量控制提供稳定可靠的检测方法。
Objective This paper aims to detect bacterial endotoxin in inactivated enterovirus 71 vaccine by bacterial endotoxin test(gel method)and verify the method.Methods The bacterial endotoxin of enterovirus 71 inactivated vaccine was detected by the gel method,and the feasibility of the detection method was verified.Results In the sensitivity recheck test,Bokang Marine Tachypleus Amebocyte Lysate λC is 0.125 EU/ml,and the Et values of the three batches were 0.105 EU/ml,0.0625 EU/ml and 0.0625 EU/ml,respectively,in the range of 0.5 Es-2 Es(0.0625-0.25),which met the requirements.Fuzhou New North Limulus Amebocyte Lysate Reagent λC is 0.0866 EU/ml.The Et values of the three batches were 0.149 EU/ml,0.149 EU/ml and 0.125 EU/ml,respectively,in the range of 0.5 Es-2 Es(0.0433-0.1732),which met the requirements.Bacterial endotoxin tests were performed on 10 batches of enterovirus 71 inactivated vaccines,and the results all met the requirements.Conclusion The gel method for the detection of bacterial endotoxin in the inactivated enterovirus 71 vaccine is stable and meets the requirements of the method validation.It can provide a stable and reliable detection method for the quality control of the vaccine.
作者
苏雯
吴凡
SU Wen;WU Fan(Yunnan Institute of Supervision and Inspection for Food and Drug,Kunming,Yunnan 650106,China)
出处
《中国卫生检验杂志》
CAS
2023年第16期1928-1930,共3页
Chinese Journal of Health Laboratory Technology
基金
云南省科技厅重大科技专项计划(202002AA100008)。
