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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 method for the detection of bacterial endotoxin in fleroxacin and glucose injection and to develop a limit of bacterial endotoxin (L). Methods: Fleroxacin dextrose injection diluted according to the effective concentration range, the interference test study. Results: Fleroxacin dextran injection did not interfere with bacterial endotoxin test after one-time dilution. Conclusions: The comparison of pyroxoflurate glucose injection with pyrogen test and bacterial endotoxin test shows that the coincidence rate of the two methods is 100%.