羟苯磺酸钙胶囊微生物限度检查方法学验证研究

Method Validation for Microbial Limit Test of Calcium Dobesilate Capsules

目的:建立羟苯磺酸钙胶囊微生物限度检查法并进行验证。方法:采用常规法测定霉菌和酵母菌数;用薄膜过滤法,pH7.0氯化钠-蛋白胨缓冲液200mL,每次50mL进行冲洗,测定细菌数;用常规法进行控制菌(大肠埃希菌)的检查。结果:样品对白色念珠菌和黑曲霉无抑制作用;薄膜过滤法可消除该药物对金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌的抑制作用,回收率均大于70%;控制菌检查符合要求。结论:羟苯磺酸钙胶囊微生物限度检查时采用薄膜过滤法进行细菌计数,采用常规法进行霉菌、酵母菌和控制菌计数,方法准确可靠。

OBJECTIVE：To establish microbial limit test of Calcium dobesilate capsules and conduct experiment verification.METHODS：The amount of mould and saccharomycete were determined by routine method.The membrane filtration method was used to examine bacterium count by pH 7.0 sodium chloride-peptone buffer solution 200 mL with 50 mL each time.The routine method was used to examine control bacteria Escherichia coli.RESULTS：Calcium dobesilate capsules had no antimicrobial effect on Candida albicans and Aspergillus niger.The membrane filtration method can eliminate inhibition effect of Calcium dobesilate capsules against Staphylococcus aureus,Escherichia coli,Bacillus subtilis.The recovery rates were more than 70%.The examination of Escherichia coli control was up to the standard.CONCLUSION：Membrane filtration method is reliable and accurate for bacterial count and routine method for count of mould,saccharomycete and control bacteria.