呋喃西林片2015年版微生物限度检查标准及探索性研究

Inspection Standard and Exploratory Research of Microbial Limit in 2015 With Nitrofurazone

目的为了适应《中国药典》2015年版的出版,新版药典中微生物限度检查法中对部分培养基和试验菌株进行了改动,需要对呋喃西林片重新建立微生物限度检查方法。方法采用薄膜过滤法作为需氧菌总数测定及霉菌和酵母菌总数的测定(总冲洗量均为1 000 ml);薄膜过滤法作为控制菌检查方法。结果需氧菌总数测定可采用薄膜过滤法,霉菌和酵母菌总数的测定可采用薄膜过滤法,控制菌检查金黄色葡萄球菌可采用薄膜过滤法(总冲洗量为1 000 ml)、铜绿假单胞菌可采用培养基稀释法(总冲洗量为1 000 ml)。结论经多次试验方法准确精密度强、重复性好,可用于该制剂的微生物限度检查。

Objective In order to adapt to the chinese pharmacopoeia 2015 edition of the publication,the new pharmacopoeia in microbial limit test on the part of the culture medium and test strains in the changes,need of nitrofurazone piece to establish microbial limit inspection method.Methods The membrane filtration method is adopted as the determination of the total number of aerobe and determination of the total number of mold and yeast（always flush volumes are 1 000 ml）. Membrane filtration method as the control bacteria checking method.Results Determination of the total number of aerobe membrane filtration method can be used,the total number of mold and yeast can be used for determination of the membrane filtration method,control check bacteria staphylococcus aureus can use membrane filtration method（total capacity of 1 000 ml）flushing、pseudomonas aeruginosa culture medium dilution method can be used（total capacity of 1 000 ml）flushing.Conclusion After repeated strong test method for accurate precision, good repeatability,can be used for the preparation of microbial limit examination.