【摘 要】目的：建立辅料甘露醇的细菌内毒素检验方法。方法：按照中国药典2015年版四部通则1143细菌内毒素检查方法和中国药典2015年版四部通则9301注射剂安全性检查法应用指导原则[2-4]进行试验，内毒素限值设定为L=1.0EU/g。结果：甘露醇稀释浓度为0.03g/ml时，对鲎试剂与内毒素反应不产生干扰。结论：辅料甘露醇可以建立细菌内毒素检查法质量标准。

    【关键词】：甘露醇;注射制剂;细菌内毒素;干扰试验

    Abstract： OBJECTIVE To establish a bacterial endotoxin test(BET) for mannitol. METHODS According to Ch.P 2015 Vol Ⅳ general principles 1143 and Ch.P 2015 Vol Ⅳ general principles 9301. Set the endotoxin limit： L = 1.0 EU/g. RESULTS There was no interference in the agglutinate reaction between the sample and relative TAL with the ethylenediamine concentration of 0.03g/ml. Need to use the sensitivity of 0.03 EU/ml or higher sensitivity TAL. CONCLUSION Mannitol as the excipient of injection preparation can establish the quality standard of bacterial endotoxin test.

    Key words： Mannitol; Injection preparation; Bacterial endotoxin; Interference test

    【中图分类号】R927 【文献标识码】A 【文章编号】1672-3783(2020)07-21--01

    甘露醇 ......