明胶空心胶囊微生物限度检查法验证试验

Verification test for the microorganism limit inspecting method of vacant gelatin capsules

目的:对明胶空心胶囊微生物限度检查进行方法学验证。方法:《中国药典》2010年版微生物限度检查法验证试验。结果:通过人工5种代表试验菌株测定回收率均超过70%,证明方法是可行的。结论:可用微生物限度检查法中的稀释法检验细菌数,霉菌及酵母菌和控制菌均可用常规法检验。

Objective： To verify the microorganism limit inspecting method of Vacant Gelatin Capsules.Methods：The method of microorganism limit inspection from appendixes in ＂Pharmacopoeia of the People′s Republic of China＂ published in 2010 was adopted.Results：The recovery rates of five diluted trail bacterias were higher than 70%.Conclusion： Dilution method can be used to inspect bacterial count,while mildew,yeast and control bacteria were inspected with conventional methods.