目的 建立毛细管区带电泳方法，检测A、C、Y、W135群脑膜炎球菌多糖疫苗的多糖含量和多糖分子大小分布。方法 建立检测4种多糖的毛细管区带电泳方法，并探究最佳分离电压和温度。通过单次实验同时表征4种多糖，分别检测4种多糖含量以及多糖分子大小分布，并验证方法的线性、准确度、重复性和专属性。结果 当4种多糖的含量在0.081 3~0.487 5 μg/μL之间时，毛细管区带电泳方法线性良好，决定系数＞0.98；检测低、中、高3个浓度样品，回收率在95%~110%，6次实验相对标准偏差＜2.0%，在目标峰位置无杂峰出现。结论 毛细管区带电泳法检测4种脑膜炎球菌多糖具有良好的线性、准确度、重复性、专属性，适合A、C、Y、W135群脑膜炎球菌多糖疫苗多糖含量和多糖分子大小分布的检测。

Objective To establish a capillary zone electrophoresis (CZE) method to detect the polysaccharide content and molecular size distribution of group A, C, Y, and W135 meningococcal polysaccharide vaccine.Methods CZE method was developed to detect all 4 polysaccharides, and the optimal separation voltage and temperature were investigated. Four polysaccharides were characterized in a single experiment, and their contents and molecular size distributions were determined. The method’s linearity, repeatability, accuracy, and specificity were validated.Results When contents of all 4 polysaccharides ranged from 0.081 3 to 0.487 5 μg/μL, the CZE method demonstrated good linearity with coefficient of determination > 0.98. For low, medium, and high concentration samples, the recovery rates were between 95% and 110%, and the relative standard deviation for 6 experiments was < 2.0%. No impurity peaks were observed at the target peak positions.Conclusion The CZE method shows good linearity, accuracy, repeatability, and specificity for detecting the four meningococcal polysaccharide, and is suitable for determining the polysaccharide content and molecular size distribution of group A, C, Y, and W135 meningococcal polysaccharide vaccine.