磺胺多辛乙胺嘧啶片微生物限度检查方法的建立

Estaboishment of method for microbial limit test of Sulfadoxine and pyrimethamine Tablets

目的:完善磺胺多辛乙胺嘧啶片微生物限度检查方法。方法:采用薄膜过滤并在培养基中加入中和剂(1%的对氨基苯甲酸溶液)的方法,去除磺胺多辛的抗菌活性。结果:本方法满足中国药典2005版验证试验的基本要求。结论:该方法可作为磺胺多辛乙胺嘧啶片的常规微生物限度检查方法。

To establish a method for mixrobial limit test of Sulfadoxine and pyrimethamine Tablets. Method：The filtration method was first used to remove the drug, material and then 1% of 4-Aminobenzoic acid solution as neutralizer was added into the nutrient agar medium to inhibit the residual antimicrobial activity.Result：The method passed the validation test of Chinese pharmacopoeia 2005 version. Conclusion： The method has been used in microbial limit test control for Sulfadoxine andpyrimethamine Tablets oral preparation.