动态浊度法定量检测磺达肝癸钠注射液细菌内毒素含量的研究

目的:建立动态浊度法定量检测磺达肝癸钠注射液中细菌内毒素的含量。方法:使用两个厂家的动态浊度法鲎试剂建立细菌内毒素标准曲线,对3批供试品进行干扰试验,分析不同稀释倍数下细菌内毒素的回收率并进行验证,完成供试品溶液中内毒素含量的定量检测。结果:两个厂家鲎试剂的标准曲线均符合标准要求,3批供试品在稀释10、100、800、1 600倍时细菌内毒素回收率均在50%~200%范围内,均无干扰,符合药典要求。结论:采用动态浊度法检测磺达肝癸钠注射液中细菌内毒素含量是可行的。

Quantification of bacterial endotoxin in fondaparinux sodium injection by kinetic turbidimetric assay

Objective: To establish a kinetic turbidimetric method for the quantification of bacterial endotoxin in fondaparinux sodium injection.Methods: The standard curve of bacterial endotoxin was established by kinetic turbidimetric limulus amebocyte lysate. The interference test was carried out using three batches of test samples. The recovery rate of bacterial endotoxin at different dilution times was analyzed and verified, and the endotoxin content in test sample solution was quantified.Results: The standard curve of limulus amebocyte lysate from two manufacturers met the standard requirements. The recoveries of bacterial endotoxin were in the range of 50%-200% at 10, 100, 800 and 1 600 dilution times, and the endotoxin content of three batches of test samples met the standard requirements.Conclusion: This method can be used for the quantification of bacterial endotoxin in fondaparinux sodium injection.