归纳聚山梨酯80在质量标准、组分分析、杂质检查方面的研究概况，总结制剂中聚山梨酯80的含量测定方法，探讨了现有技术的特点。聚山梨酯80的成分可以通过分光光度法、分子排阻–蒸发光散射检测法（SEC-ELSD）、液质联用法（LC-MS）直接测定，也可以水解后法经液相色谱–紫外检测法（HPLC-UV）或气相色谱法（GC）间接测定。近年来有关聚山梨酯80的组分分析和杂质检查的研究已经取得了长足的进步。但由于聚山梨酯80原料纯度差异较大，相关制剂中该辅料的含量测定方法还有待深入研究。

Research progress of polysorbate 80 was summarized, including standards, chemical composition and impurity test. Assay methods of polysorbate 80 in preparations were also summarized. In addition, characteristics of the current technologies were discussed. Compositions of polysorbate 80 could be detected directly by spectrophotometry, SEC-ELSD or LC-MS methods. In addition, they could be analyzed indirectly by determing the hydrolysates with HPLC-UV or GC methods. In recent years, remarkable progress has been achieved in chemical composition determination and impurity test of polysorbate 80. But assay method of the excipient in related drugs need further study, due to large difference between purities of polysorbate 80 raw materials.

国家自然科学基金（81303194）；国家中医药管理局“中药标准化建设”项目（ZYBZH-C-JS-32）