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将细菌内毒素检查法 (凝胶法 )扩大应用于乙脑灭活疫苗的质量控制及其内毒素的检测。按《中国药典》及《中国生物制品规程方法》方法 ,复核鲎试剂灵敏度、确定疫苗的L值、计算MVD、进行干扰试验及内毒素的检测。疫苗L值确定为 30 0EU/mL ,MVD为 12 0 0倍。用灵敏度 0 .2 5EU/mL的鲎试剂 ,疫苗的最大非干扰浓度为将其稀释 30倍 ,将此疫苗稀释 12 0倍进行干扰试验 ,对内毒素的检测无干扰作用。以此法对 15批疫苗进行内毒素检查均呈阴性反应。结果显示 ,此法用于乙脑灭活疫苗质量控制及其内毒素检查是可行的
Bacterial endotoxin test (gel method) to expand the JE inactivated vaccine quality control and detection of endotoxin. According to the methods of “Chinese Pharmacopoeia” and “China Biological Products Procedures Method”, the sensitivity of reagent was checked, L value of vaccine was determined, MVD was calculated, interference test and endotoxin test were performed. Vaccine L value was determined as 30 0EU / mL, MVD was 1200 times. With a sensitivity of 0.25EU / mL of the limulus reagent, the maximum non-interferon concentration of the vaccine was 30-fold diluted and the vaccine was diluted 12-fold for interference testing without any interference with endotoxin testing. This method of 15 batches of vaccine endotoxin tests were negative. The results showed that this method is feasible for the quality control of JE inactivated vaccine and its endotoxin test