动态浊度法测定注射用阿奇霉素中细菌内毒素的含量

Detection of Bacterial Endotoxin in Azithromycin for Injection by Kinetic Turbidimetric Limulus Test

目的应用动态浊度法定量测定注射用阿奇霉素中的细菌内毒素含量。方法建立动态浊度法测定细菌内毒素标准曲线,通过干扰试验确定样品浓度检测范围,并对样品的细菌内毒素定量测定。结果样品在0.208 3 mg.mL-1以下浓度时,对试验无干扰作用,细菌内毒素回收率在50%-200%内,样品中的内毒素含量可定量测定。结论动态浊度法可用于定量检测注射用阿奇霉素中的细菌内毒素。

OBJECTIVE To detect the quantity of endotoxin in Azithromycin for injection by the method of the kinetic turbidimetric limulus test. METHODS Four endotoxin concentrations were prepared to generate the standard curve by kinetic turbidimetric limulus test. The interfering factors test was studied to range the effective concentration of samples and basing on standard curve the sample was measured. RESULTS The diluted concentration of sample preparation down to 0.208 3 mg.mL？1 can be effective measured and recovery of endotoxin is within 50% to 200%. CONCLUSION The kinetic turbidimetric limulus test can be used to quantitate the endotoxin level in Azithromycin for injection.