炉甘石粉原料药微生物限度检查法适用性研究

Applicability Test of Microbiological Limit Method for Calamine Powder

目的:建立炉甘石粉微生物限度检查方法,并对方法进行适用性研究。方法:采用薄膜过滤法对需氧菌计数(1∶100供试液),冲洗量为400 mL/筒;霉菌、酵母菌计数法为平皿法;控制菌检查(金黄色葡萄球菌和铜绿假单胞菌)为薄膜过滤法,冲洗量均为400 mL/筒。结果:5种试验菌回收试验结果均在0.5~2.0间,符合《中国药典》规定。结论:该方法科学可靠,可用于炉甘石粉原料药的微生物限度检查,可有效控制该品种质量。

Objective:To establish microbiological limit test method of Calamine powder and testt heapplicability of the method.Methods:Membrane filtration method was used for aerobic bacteria count,rinse volume was 400mL/cartridge(1∶100).Plate method was used for mold and yeast count.And control bacteria was checked by Membrane filtration method,rinse volume was 400 mL/cartridge.Results:There covery ratio of 5 bacteria were between 0.5~2.0,and the results were in accordance with the provisions of pharmacopoeia.Conclusion:The method is reasonable and reliable,and can effectively control the product quality.