动态浊度法测定阿奇霉素中细菌内毒素含量

Content Determination of Bacterial Endotoxin in Azithromycin by Kinetic Turbidimetric Limulus Method

目的建立测定阿奇霉素中细菌内毒素含量的方法。方法采用动态浊度法，通过测定供试液中外加内毒素的回收率进行干扰试验，确定样品检测质量浓度线性范围，并定量测定样品中的细菌内毒素。结果内毒素检测质量浓度线性范围为0．03125～2．0EU／mL（r=-0．9989）；样品在2．5g／L及以下质量浓度时，对试验无干扰，细菌内毒素回收率在50％～200％范围内，样品中内毒素的含量可定量测定。结论动态浊度法可用于阿奇霉素中细菌内毒素的定量检测。

Objective To establish a method for determining the content of bacterial endotoxin in azithromycin. Methods The kinetic turbidimetric limulus method was adopted to generate the standard curve of bacterial endotoxin. The interference test was performed by determining the recovery rate of additional bacterial endotoxin in the test sample solution. Furthermore the bacterial endotoxin content in samples was quantitatively determined. Results The linear range of bacterial endotoxin detection concentration was 0. 031 52-2.0 EU/mL （r=-0. 998 9）;the sample under the concentration ≤2.5 g/L had no interference to test. The recovery rate of bacterial endotoxin was within the range of 50%-200%. The bacterial endotoxin content in the sample could be quantitatively determined. Conclusion The kinetic turbidimetric linmlus method can be used to the quantitative determination of bacterial endotoxin in azithromycin.