摘要
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 。
Bacterial endotoxin test (GEL CLOT method) was employed expansively to control the quality and to detect endotoxin of Japanese Encephalitis Inactivated vaccine. The sensitivity of Tachypleus Amegocyte Lysate (TAL) was rechecked, the L value of vaccine was determined, the MVD was calculated to carry out the interfering test and endotoxin detection according to the requirements defined in Chinese Pharmacpoeis and Chinese Biological Products. The results showed that the L value was determined at 300 EU/mL; MVD was 1 200 times. When using TAL at 0.25 EU/mL of sensitivity, the dilution of maximum non interfering concentration was 30 times. When the vaccine was diluted 120 times to carry out interfering test, no interfering action of endotoxin was detected. This method appeared negative to 15 batches of vaccine in endotoxin detection. Therefore, this method is feasible for endotoxin detection of Japanese Encephalitis inactivated vaccine.
出处
《微生物学杂志》
CAS
CSCD
2001年第4期43-45,共3页
Journal of Microbiology
关键词
细菌内毒素
检查法
鲎试剂
乙脑灭活疫苗
Bacterial endotoxin test, Tachypleus Amebocyte Lysate (TAL), Japanese encephalitis inactivated vaccine.
