摘要
目的建立利尿消炎合剂微生物限度检查方法。方法采用《中国药典》2010年版一部附录微生物限度检查法项下方法进行验证。结果利尿消炎合剂有一定抑菌作用,对平皿法和培养基稀释法的细菌计数结果有影响,薄膜过滤法可有效消除此影响。控制菌用常规法检出。结论霉菌及酵母菌计数可用平皿法,细菌计数可用薄膜过滤法,控制菌检查可用常规法。
OBJECTIVE To establish a method of microbial limit test for liniaoxiaoyan mixture.METHODS The microbial limit test was carried out according to the methods and instructions described in the appendix of Chi-nese Pharmacopoeia(2010 Edition,Volume 1).RESULTS Antibacterial components existing in liniaoxiaoyan mix-ture affected the microbial examination result when using plating method or medium dilution method.The method of membrane filtration can effectively eliminate the antimicrobial activity.When routine method was used,validation test of control bacteria was positive.CONCLUSION The plating method can be used formold and yeast count.The membrane filtration method can be used for bacteria count.The routine method can be used for the detection of Esch-erichia coli.
出处
《海峡药学》
2015年第8期61-63,共3页
Strait Pharmaceutical Journal
基金
中山市医学科研基金项目(项目编号:2013A020048)
关键词
利尿消炎合剂
微生物限度检查
薄膜过滤法
验证
Liniaoxiaoyan mixture
Microbial limit test
Membrane filtration method
Validation