动态浊度法检测冻干甲型肝炎减毒活疫苗细菌内毒素含量的研究

Detection of Bacterial Endotoxin Content in Freeze-Dried Attenuated Hepatitis A Live Vaccine by Dynamic Turbidity Method

探讨动态浊度法检测冻干甲型肝炎减毒活疫苗细菌内毒素含量的可行性。参照《中国药典》2015年版通则1143细菌内毒素检测法中动态浊度法,对甲肝疫苗进行标准曲线可靠性试验、干扰初筛试验、干扰验证试验及内毒素含量的测定,同时与经凝胶法检定合格的同批疫苗进行比较。标准曲线可靠性试验结果符合规定。干扰初筛试验疫苗稀释160、320及640倍,回收率在50%~200%之间,均无干扰,符合要求。干扰验证试验结果进一步表明：疫苗稀释160倍对试验无干扰作用。采用动态浊度法检测的10批甲肝疫苗细菌内毒素含量均小于该疫苗的限值L=20 EU/m L,且与经凝胶法检定的同批疫苗结果一致。采用动态浊度法检测甲肝疫苗细菌内毒素含量是可行的,值得推广应用。

The feasibility of dynamic turbidity method to detect bacterial endotoxin content in freeze dried attenuated hepatitis A live vaccine was investigated.According to Incoterms 1143 on Bacterial Endotoxin Detection Method in Chinese Pharmacopoeia Ver.2015,and the freeze-dried attenuated hepatitis A live vaccine for standard curve reliability test,interference initial screening test,interference verification test and the endotoxin content was determined,and compared with the results by gel method for verification of the same batch of vaccine.The reliability test results of standard curves accord with the regulations.Interference of early screening test,160 times and 320 times as well as640 times dilution of the vaccine,the recovery rate was between 50% and 200%,all without interference,and accord with the requirement.Interference verification test has further proved that vaccine dilution 160 times had no interference effect on the test,the kinetic turbidimetric assay of 10 batches of hepatitis A vaccine bacterial endotoxin content were all less than the vaccine limits value of L = 20 EU / m L,and verification by gel method for the same batch of vaccine results are consistent with.Therefore,it is feasible to detect the content of bacterial endotoxin in freeze-dried attenuated hepatitis A live vaccine by dynamic turbidity method,and it is worth the popularization and application.