氟罗沙星葡萄糖注射液细菌内毒素检测方法的探讨

Detection of Bacterial Endotoxin in Fleroxacin Glucose Injection

目的:建立氟罗沙星葡萄糖注射液细菌内毒素的检测方法,制定细菌内毒素限值(L)。方法:氟罗沙星葡萄糖注射液按有效浓度范围稀释后,进行干扰试验考察。结果:氟罗沙星葡萄糖注射液经1倍稀释后对细菌内毒素检查法无干扰作用。结论:时氟罗沙星葡萄糖注射液进行热原检查及细菌内毒素检查对比试验,两法符合率为100％。

Objective: To establish a detecting method for the bacterial endotoxin in the fleroxacin glucose injection and the bacterial endotoxin limited value (L). Method: After the fleroxacin glucose injection was diluted within the range of effective concentration, the interfere experimentation was made. Result: There was no interfere effect in the detection for the bacterial endotoxin in the fleroxacin glucose injection, which was diluted one time. Conclusion: The according rate is 100% in comparison of two methods.