脑膜炎球菌多糖疫苗分子质量及其分子质量分布研究  

Determination of Molecular Weight and Molecular Weight Distribution of Meningococcal Polysaccharide Vaccines

作　　者：焦旭雯[1] 古月丽 梁蔚阳[1] 陈龙少 JIAO Xu-wen;GU Yue-li;LIANG Wei-yang;CHEN Long-shao(Guangdong Institute for Drug Control,NMPA Key Laboratory of for Quality Control of Blood Products,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所,国家药品监督管理局血液制品质量控制重点实验室,广州510663

出　　处：《中国药学杂志》2021年第18期1459-1465,共7页Chinese Pharmaceutical Journal

摘　　要：目的建立分子排阻色谱-多角度激光散射-示差折光检测器(SEC-MALLS-RI)联用测定A、C、Y、W135群脑膜炎球菌多糖疫苗(MPV)的相对分子质量与相对分子质量分布的方法。方法采用TSK Gel G5000 PWxl色谱柱,以0.2 mol·L^(-1)氯化钠为流动相,流速为0.5 mL·min^(-1),柱温为25℃,多角度激光散射器和示差折光检测器联用测定脑膜炎球菌多糖疫苗分子质量,并与2020年版《中国药典》通则3419测定法进行比较。结果 A群、C群、Y群、W135群重均分子质量分别约为20万、30万、15万、30万。结论 SEC-MALLS-RI法可直接测定样品的分子质量与分子质量分布,方法更简便、快速。OBJECTIVE To establish a method for determination of molecular weight and molecular weight distribution of group A, C, Y and W135 meningococcal polysaccharide vaccines by SEC-MALLS-RI. METHODS A gel size exclusion chromatography in conjunction with refractive index detector and multi-angle laser light scattering detector was performed on a TSK Gel G5000 PWxl column, using 0.2 mol·L^(-1) NaCl solution as mobile phase, the flow rate was 0.5 mL·min^(-1), and the column temperature was maintained at 25 ℃. And the method was compared with that in General Rule 3419 of ChP 2020. RESULTS The molecular weights of group A, C, Y, W135 were about 200 000, 300 000, 150 000 and 300 000, respectively. CONCLUSION The method is simple and rapid, suitable for the determination of molecular weight and molecular weight distribution of group A, C, Y and W135 meningococcal polysaccharide vaccines.

关 键 词：脑膜炎球菌多糖疫苗 分子排阻色谱 多角度激光散射检测器 分子质量 分子质量分布 

分 类 号：R917[医药卫生—药物分析学]