依达拉奉原料药细菌内毒素检查法的研究

Study on Bacterial Endotoxins Test for Edaravone

目的建立依达拉奉原料药的细菌内毒素检查方法。方法对3批样品,采用不同厂家和不同规格的鲎试剂(TAL),进行了干扰试验和细菌内毒素检查。结果本品在终浓度为0.5mg·mL^(-1)及以下浓度时对TAL与细菌内毒素的凝集反应无干扰作用。结论本品可采用细菌内毒素检查法控制质量。

OBJECTIVE To establish a test method of bacterial endotoxins for Edaravone.METHODS Different products of tachypleus amebocyte lysate(TAL)were used for the investigation of disturb and bacterial endotoxin test on three groups of sample.RESULTS At or below the concentration of 0.5mg·mL-1,there exists no interference of Edaravone in the reaction of TAL and bacterial endotoxin.CONCLUSION Bacterial endotoxin test can be adopted for the quality control of Edaravone.