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    注射剂中非离子表面活性剂色谱分析方法的研究进展

    Research Progress in Chromatographic Analysis Methods of Nonionic Surfactants in Injections

    • 摘要: 作为注射剂中关键增溶辅料,聚山梨酯80等非离子表面活性剂已被证实是引发制剂不良反应的重要风险源,建立其精准分析方法体系已成为注射剂质量控制的关键环节。为了对注射剂中非离子表面活性剂进行有效控制和监测,综述了非离子表面活性剂的色谱分析方法,包括反相液相色谱法、高效液相色谱-质谱联用法、凝胶色谱法、混合模式色谱法、二维液相色谱法等,以期为生物医药领域的非离子表面活性剂的控制和监测提供参考(引用文献58篇)。

       

      Abstract: As key solubilising excipients in injections, nonionic surfactants such as polysorbate 80 are an important source of risk for triggering adverse reactions in preparations, and the establishment of the accurate analysis method system for them has become a key link in the quality control of injections. In order to effectively control and monitor nonionic surfactants in injections, the chromatographic analysis methods, including reversed-phase liquid chromatography, high performance liquid chromatography-mass spectrometry, gel chromatography, mixed-mode chromatography and two-dimensional liquid chromatography, were reviewed, aiming to provide references for the control and monitoring of nonionic surfactants in the biomedical field (58 ref. cited).

       

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