动态浊度法测定注射用比阿培南细菌内毒素的含量

Content Determination of the Bacterial Endotoxin of Biapenem for Injection by Kinetic Turbidimetric Limulus Test

目的：建立测定注射用比阿培南细菌内毒素含量的方法。方法：采用动态浊度法,确定细菌内毒素检查的标准曲线及稀释倍数,通过干扰试验确定样品质量浓度测定范围,并对样品的细菌内毒素进行定量测定。结果：比阿培南质量浓度在0.062 5-0.25 mg/ml范围内对试验无干扰,细菌内毒素的回收率在50%-200%之间,比阿培南中的内毒素含量可定量测定。结论：动态浊度法可用于注射用比阿培南细菌内毒素的定量检测。

OBJECTIVE： To establish a method for determining the content of bacterial endotoxin of Biapenem for injection. METHODS： Kinetic turbidimetric method was adopted to determine the standard curve and dilution of test sample. The interference test was used to determine the testing range of samples＇ concentration and the quantification. RESULTS： There was no interference when the concentration of biapenem was in the range of 0.062 5-0.25 mg/ml, the recovery of endotoxin was 50%-200% and the content of endotoxin could be quantitatively determined. CONCLUSIONS： Kinetic turbidimetric limulus test can be used for the quantitative determination of bacterial endotoxin of Biapenem for injection.