小儿化毒散微生物限度检查方法验证

Validation of Microbiological Test Method for Xiaoer Huadu Powder

目的建立小儿化毒散微生物限度的检查方法。方法按2010年版《中国药典(一部)》的要求,对细菌、霉菌及酵母菌计数方法和控制菌检查方法进行验证分析。结果小儿化毒散对金黄色葡萄球菌和枯草芽孢杆菌均有很强的抑制作用。结论细菌数测定采用薄膜过滤法(500 m L/膜),霉菌及酵母菌数测定采用平皿法;控制菌大肠埃希菌、大肠菌群、沙门菌及铜绿假单胞菌采用直接接种法,金黄色葡萄球菌采用薄膜过滤法(400 m L/膜)。

Objective To establish a microbial limit test method for Xiaoer Huadu Powder. Methods The counting method of bacteria,mould and yeast,and the control bacteria test method were performed the validation according to the requirement of the Chinese Pharmacopoeia（2010 version,Part 1）. Results Xiaoer Huadu Powder had strong inhibiting effect on Staphylococccus aureus and bacillus subtilis. Conclusion The bacterial counting adopts the membrane filtration method（500 mL/film）,the mold and yeast counting adopt the plate method. The control bacteria escherichia coli,coliform,salmonella and pseudomonas aeruginosa adopt the direct inoculation method,staphylococccus aureus adopts the membrane- filter procedure（400 mL/film）.