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Component-based biocompatibility and safety evaluation of polysorbate 80

机译：基于组分的生物相容性和聚山梨醇酯80的安全评估

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摘要

Polysorbate 80 is a complicatedmixture 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：聚山梨醇酯80是由一系列酯和通过油酸和环氧乙烷分别合成的酯和醚酯的复杂混合物，其与山梨糖醇和异山梨醇的两核基质分别合成。其组件的极端复杂性使其难以确定其安全性。在该研究中，我们提供了使用UPLC-Q-TOF-MS的定量方法来鉴定其组分，并进一步使用体外溶血研究进一步探讨其主要成分的副作用，LO2细胞细胞毒性测定和体内急性毒性测定斑马鱼。我们分开了含有355种化学物质的九种主要成分，确认其结构并准确确定其内容。体外和体内研究表明，聚氧乙烯脱水山梨糖醇Diolate（PSD）可以诱导最高的溶血率，最高的细胞毒性，即斑马鱼的最高死亡率，尽管其在聚山梨醇酯80中的含量相对较低。穷举成分 - 基于对多电阻物80的研究提供了风险控制和安全改进的基础，为重新评估和应用任何复杂的药物赋形剂带来了新的思路。

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  • 来源
    《RSC Advances》 |2017年第25期|共12页
  • 作者

    Sun Huimin; Yang Rui; Wang Jue; Yang Xia; Tu Jiasheng; Xie Langui; Li Chunqi; Lao Qiaocong; Sun Chunmeng;

  • 作者单位

    China Pharmaceut Univ Dept Pharmaceut State Key Lab Nat Med 24 Tong Jia Xiang Nanjing 210009 Jiangsu Peoples R China;

    Natl Inst Food &

    Drug Control 2 Tiantan Xili Beijing 100050 Peoples R China;

    Natl Inst Food &

    Drug Control 2 Tiantan Xili Beijing 100050 Peoples R China;

    Yuncheng Univ 1155 Fudan West St Yuncheng 044000 Peoples R China;

    China Pharmaceut Univ Dept Pharmaceut State Key Lab Nat Med 24 Tong Jia Xiang Nanjing 210009 Jiangsu Peoples R China;

    Natl Inst Food &

    Drug Control 2 Tiantan Xili Beijing 100050 Peoples R China;

    Hunter Biotechnol Inc Transfarland Xiaoshan Econ &

    Technol Hangzhou 311231 Zhejiang Peoples R China;

    Hunter Biotechnol Inc Transfarland Xiaoshan Econ &

    Technol Hangzhou 311231 Zhejiang Peoples R China;

    China Pharmaceut Univ Dept Pharmaceut State Key Lab Nat Med 24 Tong Jia Xiang Nanjing 210009 Jiangsu Peoples R China;

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  • 正文语种 eng
  • 中图分类 化学;
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