动态浊度法测定注射用还原型谷胱甘肽的细菌内毒素含量

Quantitative Determination of Bacterial Endotoxin in Reduced Glutathione for Injection by Kinetic Turbidimetric Assay

目的应用动态浊度法定量测定注射用还原型谷胱甘肽中细菌内毒素的含量。方法通过干扰试验确定样品检测浓度,建立标准曲线并对样品进行细菌内毒素的定量检测。结果注射用还原型谷胱甘肽稀释至质量浓度为1mg/mL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。结论用动态浊度法测定注射用还原型谷胱甘肽中的细菌内毒素含量,方法可行。

Objective To establish kinetic turbidimetric assay for detecting endotoxin in Reduced Glutathione for Injection. Methods According to the interfering tests of Reduced Glutathione for Injection,the standard curve of endotoxin was set up. Results The diluted concentration of 1 mg/mL was effective to eliminate the interference, the endotoxin recovery rate was in the range of 50% - 200%. Conclusion It is feasible to use kinetic turbidimetry assay for the determination of bacterial endotoxin in Reduced Glutathione for Injection.