动态比浊法测定金叶败毒注射液中细菌内毒素含量

Determination of bacterial endotoxin in Jinye Baidu injection by kinetic turbidimetry

目的:建立金叶败毒注射液中细菌内毒素含量测定方法。方法:将金叶败毒注射液作100倍稀释,采用动态比浊法,通过干扰试验和验证试验,测定金叶败毒注射液中细菌内毒素含量。结果:将样品作100倍稀释可以有效地消除对鲎试验的干扰,检测其平均回收率均在50%～200%范围内。结论:动态比浊法鲎试验可以高效地测定金叶败毒注射液中的细菌内毒素含量。

OBJECTIVE To establish a method to determine the content of bacterial endotoxin in Jinye Baidu injection.METHODS The injection was diluted to 100-fold. The content of bacterial endotoxin was determined by kinetic turbidimetry through interference test and verifying test. RESULTS The 100-fold dilution of the injection was effective to eliminate interference in limulus test. The average recovery was in the range of 50%～200%. CONCLUSION The kinetic turbidimetric limulus test provides a new and quick method for the quantitative determination of bacterial endotoxin in Jinye Baidu injection.