高效毛细管电泳检测脑膜炎球菌结合疫苗原液中二甲亚砜残余量  

Determination of residual content of dimethyl sulfoxide in bulk of meningococcal conjugate vaccine by high performance capillary chromatography

作　　者：朱衍志 马路萍 吕玉婷 崔保峰 赵一欢 杨淼 刘晓凡 罗树权 ZHU Yan-zhi;MA Lu-ping;LU Yu-ting;CUI Bao-feng;ZHAO Yi-huan;YANG Miao;LIU Xiao-fan;LUO Shu-quan(Department of Quality Assurance, Lanzhou Institute of Biological Products Co., Ltd., Center for Gansu Provincial Vaccine Engineering Research, Lanzhou 730046, Gansu Province, Chin)

机构地区：[1]兰州生物制品研究所有限责任公司质量保证部甘肃省疫苗工程技术研究中心,甘肃兰州730046

出　　处：《微生物学免疫学进展》2018年第3期13-17,共5页Progress In Microbiology and Immunology

基　　金：重大新药创制(2013ZX09402302)

摘　　要：目的采用毛细管区带电泳法(capillary zone electrophoresis,CZE)测定脑膜炎球菌结合疫苗原液中二甲亚砜(dimethyl sulfoxide,DMSO)的含量。方法以25 mmol/L四硼酸钠(p H 8.0)为背景电解质,以20 cm×50μm I.D.未涂层的毛细管为色谱分离柱,于200 nm波长检测脑膜炎球菌结合疫苗原液中二甲亚砜的残余量。结果DMSO在不同溶液中质量浓度为1~100 mg/L的线性范围内线性关系良好,R2≥0.998 9。加标回收率为98.07%~103.13%,变异系数为0.38%~2.57%。结论该方法简单、快速、经济、环保,不受混合物组分中其他物质的干扰,适用于快速检测结合疫苗中DMSO的残余量。Objective Residual content of dimethyl sulfoxide（ DMSO） in bulk of meningococcal conjugate vaccine was determined by a capillary zone electrophoresis（ CZE）. Methods The samples could be tested on the condition of 25 mmol/L sodium borate（ p H 8.0） as running buffer,capillary of 20 cm × 50 μm I.D. as chromatographic column,200 nm as detection wavelength. Results The results showed that a good liner correlation was obtained for DMSO at 1—100 mg/L in different solutions,with R2≥0. 998 9. The recovery range for DMSO was 98.07%—103.13%,and the variation coefficient range was 0.38%—2.57%. Conclusion The method is simple,fast,economical and environmental protection,and is not disturbed by other substances in the components of mixture. It is suitable to the rapid detection of residual content of DMSO in bulk of meningococcal conjugate vaccine.

关 键 词：毛细管区带电泳 二甲亚砜 脑膜炎球菌结合疫苗 残余含量 

分 类 号：R392-33[医药卫生—免疫学]