2010年版《中国药典》中10种培养基灭菌参数的研究  

Study on the Sterilization Parameters for 10 kinds of Culture Media Stated in Chinese Pharmacopoeia(2010 Edition)

作　　者：李艳嫦[1] 蔡芷荷[1] 卢勉飞[1] 田亮[1] 吴清平[2] 李兴[1] 

机构地区：[1]广东环凯微生物科技有限公司,广州510663 [2]广东省微生物研究所,广州510070

出　　处：《中国药房》2015年第31期4371-4374,共4页China Pharmacy

基　　金：2011年度国家药品标准提高工作科研立项(No.957)

摘　　要：目的:研究2010年版《中国药典》中10种微生物限度检查用培养基的高压蒸汽灭菌参数统一调整为121℃、15 min的可行性。方法:依据GB4789.28-2013标准中培养基性能测试方法和2010年版《中国药典》中培养基适用性检查方法,对采用121℃高压蒸汽灭菌15 min和按产品说明书提供的灭菌参数进行灭菌处理的包括改良马丁培养基等10种培养基进行性能测试(色泽、p H、无菌性、促生长能力、抑菌能力和指示能力),比较2种参数灭菌处理后培养基的质量差异。结果:各培养基经2种参数灭菌后培养基的质量水平相当,且均可满足2010年版《中国药典》对微生物限度检查用培养基质量控制的要求。结论:2010年版《中国药典》中10种培养基均可采用121℃、15 min参数进行高压蒸汽灭菌,且灭菌后培养基的性能保持稳定。OBJECTIVE：To study the feasibility of 10 kinds of culture media used in pharmaceutical microbial limit test stated in Chinese Pharmacopoeia（2010 edition）autoclaving at 121 ℃ for 15 min. METHODS：The performance（color,p H,sterility,the growth-promoting activity,antibacterial ability,indication）of 10 kinds of culture media including Modified Martin Broth medium were tested after autoclaving at 121 ℃ for 15 min or in the parameters from the product instructions according to GB4789.28-2013 and the requirements for quality control of culture media in Chinese Pharmacopoeia（2010 edition）. The quality of the media were compared after autoclaved by different parameters. RESULTS：The quality of the media which were autoclaved at 121 ℃ for 15 min were equivalent with the media which were autoclaved by the parameters from the product instructions,and their quality met the requirements for quality control of media in Chinese Pharmacopoeia（2010 edition）. CONCLUSIONS：The sterilization parameters of 10 kinds of media in Chinese Pharmacopoeia（2010 edition）can be adjusted to be autoclaved at 121 ℃ for 15 min,the quality of the media remain stable after autoclaving.

关 键 词：中国药典 培养基 灭菌参数 性能测试 

分 类 号：R954[医药卫生—药学]