伤寒Vi多糖疫苗细菌内毒素检测  

Determination of Bacterial Endotoxin in Typhoid Vi Polysaccharide Vaccine

作　　者：梁昊宇[1] 蔡彤[1] 裴宇盛[1] 曾明[1] 王斌[1] Liang Haoyu Cai Tong Pei Yusheng Zeng Ming Wang Bin(National Institutes for Food and Drug Control, Beijing 100050, China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2017年第7期780-784,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:建立动态浊度法检测伤寒Vi多糖疫苗的细菌内毒素。方法:参考《中国药典》三部(2010版),采用动态浊度法对伤寒Vi多糖疫苗中细菌内毒素进行检测,并对标准曲线的可靠性和干扰试验进行验证。结果:本次试验内毒素浓度在0.03125~1.0 EU·mL^(-1),r=-0.9972,具有良好线性关系。干扰试验样品回收率在50%~200%。伤寒Vi疫苗细菌内毒素限值确定为600 EU·mL^(-1)。样品的内毒素值从低于检测限到125.7 EU·mL^(-1)。结论:采用动态浊度法监控伤寒Vi多糖疫苗中的细菌内毒素是可行的。Objective： To establish a method for determination of bacterial endotoxin in typhoid Vi polysaccharide vaccine. Methods： A dynamic turbidimetric method for determination of bacterial endotoxin in the typhoid Vi polysaccharide vaccine was developed according to the requirements in appendix XIIE of Chinese Pharmacopoeia（Volume Ⅲ, 2010 edition）. Moreover, the reliability of standard curve and interference test was verified. Results： There was good linear relationship within the bacterial endotoxin concentration range of 0.03125-1.0 EU·mL^（-1）（r=-0.9972）. The recovery rate of samples in the interference test was 50%-200%. The bacterial endotoxin limit in typhoid Vi polysaccharide vaccine was 600 EU·mL^（-1）. The endotoxin content in samples ranged from being below detection limit to 125.7 EU·mL^（-1）. Conclusion： It is feasible to control bacterial endotoxin in typhoid Vi polysaccharide vaccine using the dynamic turbidimetric method.

关 键 词：伤寒Vi疫苗 细菌内毒素 动态浊度法 疫苗质量控制 

分 类 号：Q539[生物学—生物化学] R927.1[医药卫生—药学]