动态比浊法鲎试验定量分析催化剂的细菌内毒素

Quantitative analysis of kinetic turbidimetric limulus testfor bacterial endotoxin in catalyst

目的通过定量检测催化剂的细菌内毒素含量,为控制药品质量及筛选最佳生产工艺提供参考。方法应用动态比浊法及凝胶法鲎试验对催化剂的细菌内毒素进行定量和半定量检测。结果动态比浊法鲎试验定量检测了4批催化剂,其原液(原瓶加5.0mL水)细菌内毒素含量依次为20EumL-1-50EumL-1不等,样品在256倍稀释时其添加内毒素(2.0EumL-1)的回收率在75%-125%之间,此时对鲎试验反应无干扰作用,与凝胶法的检查结果一致。结论动态比浊法鲎试验可用来定量检测催化剂的细菌内毒素含量。

Objective To determine bacterial endotoxin in catalyst quantitatively,and provide methods for drugcontrol and sieve the best industrial technic. Methods Kinetic turbidimetric and gel-clot limulus tests were applied todetect bacterial endotoxin in catalyst quantitatively or semi-quantitatively. Results The bacterial endotoxin in 4 batchof samples(5.0 mL water added to one bottle as primary sample) ranged from 20EumL-1-500 EumL-1, the amount ofendotoxin (2.0 EumL-1)spiked in a 256-fold dilution of catalyst were recovered between 75%-125%.ConclusionKinetic turbidimetric limulus test provided a new quantitative way to determine bacterial endotoxin in catalyst.