乙型脑炎减毒活疫苗细菌内毒素检查方法及质量标准的建立

Establishment of the inspection methods and quality criteria for bacterial endotoxin of live-attenuated vaccine of encephalitis B virus

目的建立乙型脑炎减毒活疫苗细菌内毒素检测的方法及质量标准。方法参照《中华人民共和国药典》(三部)中细菌内毒素检查法检测,并与家兔热原实验结果进行对比。结果使用凝胶限量法检测乙型脑炎减毒活疫苗细菌内毒素,限值为40 EU/mL,即将样品稀释至160倍,在该稀释度下样品对试验没有干扰。结论该方法简便、灵敏、结果可靠,可用于乙型脑炎减毒活疫苗中间产品的细菌内毒素检查。

Objective To establish the inspection methods and quality criteria for bacterial endotoxin of live-attenuated vaccine of encephalitis B virus. Methods The inspecting method for bacterial endotoxin from Pharmacopoeia of the People＇s Republic of China （3 ed） was employed and the results were compared with the results of rabbit pyrogen test. Results Bacterial endotoxin of live-attenuated vaccine of encephalitis B virus was detected by gel-clot limit test, the detection limit was 40 EU/mL, namely, 160-fold dilution of the sample. In this dilution, no interference of samples to the endotoxin test was observed. Conclusion The method is convenient, sensitive and reliable and may be used for bacterial endotoxin inspection of intermediate products of live-attenuated vaccine of encephalitis B virus.