磷酸左奥硝唑酯二钠微生物限度检查方法的适用性研究  

Study on the applicability of the microbial limit test method for(s)-Ornidazol disodium phosphate

作　　者：杨晓东 毛晖[2] 李宏铎 李亚楠 任文鑫 沙淼 窦建卫[3] YANG Xiaodong;MAO Hui;LI Hongduo;LI Yanan;REN Wenxin;SHA Miao;DOU Jianwei(Xi'an Institute for Food and Drug Control,Xi'an,Shaanxi,710054 P.R.China;Shaanxi Research Design Institute of Petroleum and Chemical Industry ,Xi 'an,Shaanxi ,710054 P.R.China;College of Pharmacy,Xi 'an Jiaotong University,Xi ' an,Shaanxi,710061 P.R.China)

机构地区：[1]西安市食品药品检验所,陕西西安710054 [2]陕西省石油化工研究设计院,陕西西安710054 [3]西安交通大学药学院,陕西西安710061

出　　处：《华西药学杂志》2019年第1期104-106,共3页West China Journal of Pharmaceutical Sciences

基　　金：国家自然科学基金资助项目(批准号:30300444);陕西省重点研发计划项目(2017ZDXM-NY-052)

摘　　要：按2015年版《中国药典》四部中的微生物限度检查法对磷酸左奥硝唑酯二钠进行方法适用性验证。采用平皿法测定需氧菌、霉菌和酵母菌总数,采用常规法检查控制菌。所用方法可用于磷酸左奥硝唑酯二钠的微生物限度检查。According to the Chinese Pharmacopeia( 2015 Edition the forth version),the methods of microbial limit test for(s)-Ornidazol disodium phosphate were verified. A plate method was used in the total aerobic microbial,yeast and mouldcount,and the direct inoculation method was used for the detection of the( s)-Ornidazol disodium phosphate. The verifiedmethods in this study can be used to detect the microbial limit of( s)-Ornidazol disodium phosphate.

关 键 词：磷酸左奥硝唑酯二钠 微生物限度 方法适用性验证 需氧菌 霉菌 酵母菌 平皿法 常规法 

分 类 号：R917[医药卫生—药物分析学]