内毒素工作标准品的效价测定及标示方法

Methods of potency determination and labeling of endotoxin refenrence standard

目的:介绍内毒素工作标准品(CSE)效价的测定方法和标示方法。方法:以实例介绍美国 FDA 测定 CSE 的方法及要求,介绍现行标示 CSE 效价的两种方法——固定效价标示法和浮动效价标示法,对2种 CSE 效价标示方法的利弊进行分析。结果:用固定效价法标示 CSE,忽略了 RSE/CSE 比率差异的影响因率,影响 BET 实验的精密度和可信度。结论:应采用浮动法标示 CSE 效价。

Objective： To introduce the methods for potency determination and labeling of control standard endotoxin（CSE）. Method：Introduce the method for potency determination of CSE and requirements adopted by US FDA and the current two methods for potency labeling of CSE - fixed potency labeling and floating potency labeling meth- od. Analyze the advantages and disadvantages of these two labeling methods for CSE potency. Results：Provided fixed CSE potency labeling method is adopted,the impact of RSE/CSE ratio difference is ignored ,which will affect the preciseness and reliability of bacterial endotoxin test（BET）. Conclusion：Floating CSE potency labeling method should be adopted.