鲎试剂检查丹红注射液细菌内毒素的探讨

Establishment a method for detection of bacterial endotoxin in Danhong injection with tachypleus amebocyte lysate

目的研究丹红注射液细菌内毒素检查方法。方法按中国药典2005年版附录细菌内毒素检查法要求进行试验。结果鲎试剂浓度在0.25EU.ml-时,丹红注射液经5倍稀释对细菌内毒素测定无干扰。结论鲎试剂细菌内毒素检查法具有准确性、可靠性,适用于丹红注射液中的内毒素检测。

Aim For the safe clinic application of Danhong Injection,and ensure the quality of it,we tried to establish a method that using tachypleus amebocyte lysate（TAL）for testing the bacterial endotoxin in Danhong Injection.Methods The tests were conducted according to appendix IX E of Chp 2005.Result Noninterference was determinated as the injection was diluted 5 times,as the same time,the TAL concentration was 0.25EU.ml-1.Conclusion Bacterial endotoxin test is suitable for the detection of bacterial endotoxin in Potassium Sodium pehydroandroandrographolide Succinate for Danhong Injection.