罗红霉素缓释颗粒微生物限度检验方法的探讨

目的建立罗红霉素缓释颗粒的微生物限度检查方法。方法采用常规法测定霉菌和酵母菌数；用离心薄膜过滤法，即pH7．0氯化钠-蛋白胨缓冲液300mL，每次100mL进行冲洗，测定细菌数；用pH7．0氯化钠-蛋白胨缓冲液500mL，每次100mL进行冲洗，进行控制菌的检查。结果该药对白色念珠菌和黑曲霉菌无抑制作用；离心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，回收率达80％以上。结论采用离心薄膜过滤法可有效的控制其药物质量，建立的方法准确可靠。

Discussion for Microbial Limits of Roxithromycin Sustained-release Granules

Objective To provide methods of microbial limit tests for Roxithromycin Sustained-release Granules. Methods Determined the number of mould and saccharomycete for Roxithromyein Sustainedrelease Granules by the common method. The centrifuging membrane filtration method was used to examine bacterium number by washing in pH 7.0 sodium chloride-peptone buffer solution 300mL, with 100mL each time, and it was used to control bacteria examined by washing in pH 7.0 sodium chloridepeptone buffer solution 500mL, with 100ml. each time. Results The medicine had no antimicrobial effect with Candida albicansand Aspergillus niger. The centrifuging membrane filtration method can eliminate restraining effect of Staphylococcus aureus, Escherichia coli and Bacillus subtilils. The recovery rates of tests were more than 80%. Conclusions The centrifuging membrane filtration method can control medicine quality effectively and the established method is accurate and reliable.