动态浊度法定量测定碘海醇中细菌内毒素的含量

Detection of Bacterial Endotoxin in Iohexol by the Method of Kinetic Turbidimetric Limulus Test

关键词:  碘海醇  细菌内毒素  动态浊度法

Key words:  iohexol  endotoxin  kinetic turbidmetric limulus test

摘要:

目的应用动态浊度法鲎试验定量测定供注射用的碘海醇原料中的细菌内毒素含量。方法通过干扰试验确定样品检测浓度，并建立标准曲线对精制程度不同的样品进行细菌内毒素的定量测定。结果样品在10 mg·mL-1时，对鲎试验检查无干扰作用，细菌内毒素回收率在50%～200%范围内。样品中的内毒素含量可定量测定。检测结果与热原检测的结果有一定的相关性。结论动态浊度法可用于碘海醇中的细菌内毒素定量检测。

Abstract:

OBJECTIVE To detect the quantity of endotoxin in iohexol for injection by the method of the kinetic turbidmetric limulus test. METHODS The kinetic turbidmetric limulus test was applied to detect the quantity of endotoxin in several samples. The standard endotoxin working curve was set up and the interference test was studied to range the effective concentrations of sample.RESULTS The diluted concentration of sample preparation down to 10 mg·mL-1 was effective to eliminate the interference. The endotoxin recovery was more than 50% and less than 200%. The endotoxin level in samples could be quantified exactly, and the results were accorded with the results of the pyrogen test. CONCLUSION The kinetic turbidmetric limulus test can be used to quantitate the endotoxin level in iohexol.