动态浊度法测定硫酸异帕米星注射液中细菌内毒素的含量

Quantitative Determination of Bacterial Endotoxin in Isepamicin Sulfate Injection by Kinetic Turbidimetric Assay

目的:建立测定硫酸异帕米星注射液中细菌内毒素含量的方法。方法:采用动态浊度法,将样品作系列稀释,通过干扰试验确定样品检测浓度,并建立标准曲线对样品进行细菌内毒素的定量检测。结果:硫酸异帕米星注射液稀释至6.25mg·mL-1时对鲎试剂检查无干扰作用,细菌内毒素的回收率均在50%～200%范围内。结论:本方法可用于测定硫酸异帕米星注射液中细菌内毒素的含量。

OBJECTIVE： To establish a method for the determination of the bacterial endotoxin content in isepamicin sulfate injection. METHODS： By using tinetic turbidimetric assay in which the sample was subjected to a serial dilution and the detection concentration of the sample was established by interference tests, meanwhile the standard endotoxin working curve was established for quantitative determination of the bacterial endotoxin in samples. RESULTS： The results showed that at a concentration of 6.25 mg·mL^-1, isepamicin sulfate injection did no interference on tachypleus amebocyte lysate test. The bacterial endotoxin recovery ranged form 50% to 200%. CONCLUSIONS： It is feasible to use kinetic turbidimetry assay for the determination of bacterial endotoxin in isepamicin sulfate injection.