中国药房2013，Vol.24Issue(21)：2002-2004,3.DOI:10.6039/j.issn.1001-0408.2013.21.29
药品微生物限度检查用培养基的配制、灭菌和贮存效期验证
Verification of the Preparation, Sterilization and Storage Life of the Medium Used in Drug Microbial Limit Tests
张颖 1安秀华 1王建平 1曹凤兰1
作者信息
- 1. 天士力制药集团股份有限公司,天津300410
- 折叠
摘要
Abstract
OBJECTIVE:To standardize the preparation and sterilization procedures of 5 kinds of medium used in drug microbial limit test and determine its storage condition and life.METHODS:The applicability of the 5 kinds of common medium including NA,RBA,BL,EMB,and MUG medium stored for 0,15,30 and 45 days were checked (including growth promotion,inhibitory property,indicative ability and sterilization).RESULTS:The applicability test results of the medium stored for 45 days were in line with the requirements for quality control of medium in Chinese Pharmacopoeia (2010 edition).CONCLUSIONS:The preparation and the frequency of applicability (one times per batch),sterilization parameters (121 ℃,15 min),storage condition (cleanliness environment for class C) and life of the 30 days of prepared medium are confirmed through the verification test.关键词
微生物限度检查/培养基/适用性检查/配制方法/灭菌参数/贮存效期Key words
Microbiological limit test/ Medium/ Applicability test/ Preparation methods/ Sterilization parameters/ Storage life分类
医药卫生引用本文复制引用
张颖,安秀华,王建平,曹凤兰..药品微生物限度检查用培养基的配制、灭菌和贮存效期验证[J].中国药房,2013,24(21):2002-2004,3.
