歸納聚山梨酯80在質(zhì)量標準、組分分析、雜質(zhì)檢查方面的研究概況，總結(jié)制劑中聚山梨酯80的含量測定方法，探討了現(xiàn)有技術(shù)的特點。聚山梨酯80的成分可以通過分光光度法、分子排阻–蒸發(fā)光散射檢測法（SEC-ELSD）、液質(zhì)聯(lián)用法（LC-MS）直接測定，也可以水解后法經(jīng)液相色譜–紫外檢測法（HPLC-UV）或氣相色譜法（GC）間接測定。近年來有關(guān)聚山梨酯80的組分分析和雜質(zhì)檢查的研究已經(jīng)取得了長足的進步。但由于聚山梨酯80原料純度差異較大，相關(guān)制劑中該輔料的含量測定方法還有待深入研究。

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.

國家自然科學(xué)基金（81303194）；國家中醫(yī)藥管理局“中藥標準化建設(shè)”項目（ZYBZH-C-JS-32）