双氢青蒿素哌喹片微生物限度检查方法的建立

Estaboishment of method for microbial limit test of Dihydroartemisinin and Piperaquine Tablets

目的:完善双氢青蒿素哌喹片微生物限度检查方法。方法:采用薄膜过滤法去除磷酸哌喹的抗菌活性。结果:本方法满足中国药典2005版验证试验的基本要求。结论:该方法可作为双氢青蒿素哌喹片的常规微生物限度检查方法。

Objective ： To establish a method for mixrobial limit test of Dihydroartemisinin and Piperaquine Tablets. Method：The filtration method was used to inhibit the residual antimicrobial activity of Piperaquine phosphate.Result：The method passed the validation test of Chinese pharmacopoeia 2005 version. Conclusion： The method has been used in microbial limit test control for Dihydroartemisinin and Piperaquine Tablets oral preparation.