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Component-based biocompatibility and safety evaluation of polysorbate 80

机译：聚山梨酯80的基于组分的生物相容性和安全性评估

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Polysorbate 80 is a complicated mixture consisting of a series of esters and etherates synthesized separately by oleic acid and ethylene oxide with a two-core matrix of sorbitan and isosorbide. The extreme complexity of its components makes it difficult to determine its safety. In this study, we provided a quantitative method using UPLC-Q-TOF-MS to identify its components and further explored the side effects of its main constituents using an in vitro hemolysis study, LO2 cells cytotoxicity assay and an in vivo acute toxicity assay to zebrafish. We separated nine major components containing a total of 355 chemicals, confirmed their structures and accurately determined their content. In vitro and in vivo studies revealed that polyoxyethylene sorbitan dioleate (PSD) could induce the highest hemolysis rate, highest cytotoxicity to LO2 cells and highest fatality rate of zebrafish in spite of its relatively low content in polysorbate 80. The results of the exhaustive component-based investigation on polysorbate 80 provide a basis for risk control and safety improvement, and brings new ideas for the re-evaluation and application of any complicated pharmaceutical excipients.
机译：聚山梨酯80是复杂的混合物，由一系列由油酸和环氧乙烷分别合成的酯和醚与脱水山梨糖醇和异山梨醇的双核基质组成。其组件的极端复杂性使得很难确定其安全性。在这项研究中，我们提供了一种使用UPLC-Q-TOF-MS鉴定其成分的定量方法，并通过体外溶血研究，LO2细胞细胞毒性测定和进一步研究了其主要成分的副作用。对斑马鱼的体内急性毒性试验。我们分离了九种主要成分，共包含355种化学物质，确认了其结构并准确确定了其含量。 体外和体内研究表明，聚氧乙烯脱水山梨糖醇二油酸酯（PSD）可以诱导最高的溶血率，对LO2细胞的最高细胞毒性和最高的斑马鱼死亡率，尽管聚山梨酯80中相对较低的含量。基于详尽成分的聚山梨酯80的研究结果为风险控制和安全性改善提供了基础，并为重新评估和应用任何复杂的药物赋形剂带来了新思路。

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