胰酪胨大豆肉汤培养基和改良马丁培养基在药品无菌检查中的比较研究  

Comparative study on sterility testing of pharmaceuticals with TSB and MM medium

作　　者：蔡芷荷[1] 严纪文[2] 卢勉飞[1] 杨宁[1] 吴清平[3] 李艳嫦[1] 

机构地区：[1]广东环凯微生物科技有限公司,广州510663 [2]广东省疾病预防控制中心,广州510300 [3]广东省微生物研究所,广州510070

出　　处：《药物分析杂志》2014年第10期1847-1852,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：药典附录药品微生物限度检查方法的修订-无菌检查用培养基研究(NO.957);广东省饮用水安全应急技术研究中心(粤科社字【2010】164号)

摘　　要：目的:观察胰酪胨大豆肉汤培养基(TSB)和改良马丁培养基(MM)对真菌和需氧菌检测效果的差异。方法:选用3株细菌和3株霉菌试验菌株,用定性和定量2种方法分别测试培养基对试验菌株的促生长能力和检测灵敏度;定性方法参照现行中国药典;定量方法采用平板计数法。结果:定性和定量2种检测方法所得的实验结果基本一致,除腊叶芽枝霉外,在规定的条件下TSB和MM培养基对试验菌株的促生长能力比较,经统计学分析,差异无显著性(P>0.05);TSB培养基对所有试验菌株的检测灵敏度均可达到<1 CFU,下限可达到<0.1 CFU,与MM培养基比较,差异无显著性(P>0.05)。结论:在现行中国药典规定的接种和培养条件下,TSB培养基对试验菌株的促生长能力和检测灵敏度与MM培养基基本等同,能满足我国现行药典的检测要求。Objective：To examine the testing ability of trypticase soy broth medium（TSB）and modified Martin medium （MM） in detecting fungi and aerobic bacteria. Methods：The productivity ability and detection sensitivity of the two media were separately examined with 3 strains of bacteria and fungi by quantitative and qualitative methods. The qualitative method was based on the current Pharmacopeia of China ,while the quantitative method was used with plate enumeration. Results ：Qualitative and quantitative methods produced similar results, except for Cladosporium herbarum, no statistical significance was found between the TSB and the MM media in productivity ability under given culturing conditions（P 〉 0. 05）. The sensitivity of TSB medium was 〈 1 CFU for all tested strains with the lower limit of 〈 0. 1 CFU and was not statistically different from MM medium（ P 〉 0. 05 ）. Conclusion ：TSB and MM media performed similarly in productivity ability and detection sensitivity, both of which could meet the requirements of the current Pharmacopeia of China.

关 键 词：胰酪胨大豆肉汤培养基 改良马丁培养基 无菌检查 真菌检测 需氧菌检测 促生长能力 灵敏度 

分 类 号：R917[医药卫生—药物分析学]