注射用盐酸米托蒽醌细菌内毒素检查方法学研究

目的 研究注射用盐酸米托蒽醌对细菌内毒素检查试验的干扰情况，建立其细菌内毒素限量检查的方法。方法 采用细菌内毒素凝胶法，用两个厂家的鲎试剂对提供的注射用盐酸米托蒽醌连续3批样品进行了干扰试验。结果 注射用盐酸米托蒽醌最大非干扰浓度为0．25mg／ml。结论 注射用盐酸米托蒽醌用细菌内毒素检查法进行细菌内毒素检测是可行的，其内毒素限值为每1mg米托蒽醌含内毒素量应小于5EU。

Study on bacterial endotoxin test in mitoxantrone hydrochloride injection

Objective To study the interference of mitoxantrone hydrochloride injection in bacterial endotoxin test,and to find a method of endotoxin limit test in this drug.Methods The gel-clot method was used to determine the interference of mitoxantrone hydrochloride injection with tachypleus amebocyte lysate(TAL) made by two manufacturers. Results The maximum concentration of mitoxantrone hydrochloride injection without interfering effect was 0.25 mg/ml.Conclusion Bacterial endotoxin test could be used for mitoxantrone hydrochloride injection.The bacterial endotoxin limit of mitoxantrone hydrochloride injection should be less than 5 EU/mg.