注射用替加环素细菌内毒素检查法

Investigation of Bacterial Endotoxin Test for Tigecycline injection

目的对注射用替加环素进行凝胶法干扰试验,建立注射用替加环素细菌内毒素检查的试验方法。方法采用2010年版中国药典二部附录细菌内毒素检查法。结果注射用替加环素稀释至浓度为0.0833mg.mL-1时对细菌内毒素检查法无干扰作用。结论使用细菌内毒素检查法检查注射用替加环素中的细菌内毒素是可行的。

OBJECTIVE To establish a method for the determination of bacterial endotoxin of Tigecycline for injection.METHODS According to the method of determination of bacterial endotoxin approved by Chinese Pharmacopoeia 2010 edition. RESULTS The interference on the determination of bacterial endotoxin can be ex cluded when Tigecycline for injection was diluted the concentration of 0.0833mg· mL-1 .CONCLUSION It is feasible to detect the bacterial endotoxin of Tigecycline for injection by the method of determination of bacterial endotoxin.