青蒿琥酯细菌内毒素检查法研究

Study on the Test Method of Bacterial Endotoxin in Artesunate

目的:建立青蒿琥酯的细菌内毒素检查方法。方法:采用凝胶法,参照《中国药典》2010年版附录ⅪE对青蒿琥酯进行细菌内毒素的方法学研究。结果:样品溶液稀释为0.4mg/ml、0.2mg/ml、0.1mg/ml、0.05mg/ml、0.025mg/ml,通过试验最终判定青蒿琥酯稀释为0.4mg/ml时对细菌内毒素无干扰作用,用灵敏度为0.25EU/ml的鲎试剂进行试验,供试品不干扰细菌内毒素检查。结论:建立的青蒿琥酯的细菌内毒素检查法可行。

Objective：To establish a method for testing the bacterial endotoxin in Artesunate.Methods：By gelation assay and referencing appendix of China Pharmacopoeia 2010 edition,the methodology for the bacterial endotoxinstest for Artesunate was researched. Resuhs：h was diluted at 0.4mg/ml,0.2mg/ml,0.1mg/ml,0.05mg/ml,0.025mg/ml,and it had proved that the product did not interfere endotoxin if it was diluted at 0.4mg/ml. It was feasibly done through 0.25EU/ml Tachypleus Amebocyte Lysate reagents for bacterial endotoxin test.Conclusion：h can be used for the bacterial endotoxins test.