Hib多糖衍生物中残余CDAP检测方法的建立  

Establishment of the Method to Detect the Residual Content of CDAP in Hib Polysaccharide Derivative

作　　者：朱文勇 管娇琼 朱喆 李双丽 徐倩 魏茂琪 杨增福 杨晓蕾 陈洪波 廖国阳 

机构地区：[1]中国医学科学院医学生物学研究所,昆明650000 [2]昆明医科大学 [3]昆明疾控中心

出　　处：《医学研究杂志》2017年第1期31-34,共4页Journal of Medical Research

基　　金：国家自然科学基金青年科学基金资助项目(109008002);云南省科技计划项目(2015BC009);北京协和医学院协和青年基金资助项目(3332015150)

摘　　要：目的在b型流感嗜血杆菌结合疫苗生产过程中有效监控1-氰基-4-二甲基氨基-吡啶四氟化硼(CDAP)的残留量。方法在已有针对流脑多糖衍生物的基于强阳离子交换层析检测法的基础上进行改进。结果该法具有良好的专属性、准确度、精密度,最低检出限为6μg/L,且在20~100μg/L的范围内线性良好。结论建立了一种针对b型流感嗜血杆菌多糖衍生物中CDAP的检测方法。Objective To monitor the residual of polysaccharide activating agent 1 - cyano - 4 - dimethylamino pyridinium tetraflu- orborate （CDAP） effectively in the process of preparing Hib conjugate vaccine. Methods The method was improved based on high per- formance cation exchange chromatography for meningococcus polysaccharide derivative. Results The validation results showed that this method had good specificity, accuracy and precision. The limit of detection was 6μg/L. There was a good linearity between 20μg/L and 100μg/L. Conclusion A method to detect the residual content of CDAP in Hib polysaccharide derivzdl/ve was successfully established.

关 键 词：B型流感嗜血杆菌 结合疫苗 1-氰基-4-二甲基氨基-吡啶四氟化硼 检测 HAEMOPHILUS influenzae type b (Hib) 1-cyano-4-dimethylamino PYRIDINIUM tetrafluorborate (CDAP) 

分 类 号：R1[医药卫生—公共卫生与预防医学]