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

作　　者：张颖[1] 安秀华[1] 王建平[1] 曹凤兰[1] 

机构地区：[1]天士力制药集团股份有限公司,天津300410

出　　处：《中国药房》2013年第21期2002-2004,共3页China Pharmacy

摘　　要：目的:规范药品微生物限度检查用5种培养基的配制和灭菌过程,使培养基的整个配制和灭菌过程受控,同时确定培养基的贮存条件和贮存效期。方法:对贮存0、15、30、45d的5种常用培养基(营养琼脂、玫瑰红钠琼脂、胆盐乳糖琼脂、曙红亚甲蓝琼脂、MUG培养基)进行相应菌液适用性检查(包括促生长能力、抑制能力、指示能力和无菌性)验证试验。结果:培养基在贮存45d后的适用性检查结果均满足2010年版《中国药典》对培养基质量控制的要求。结论:通过该验证试验,确立了培养基的配制及适用性检查频次(每个批号1次)、灭菌参数(121℃,15min)、贮存条件(洁净度为C级的环境)及贮存效期(30d)。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 

分 类 号：R446.5[医药卫生—诊断学]