药品无菌检查用培养基的比对研究 - 中国药品标准.doc

胰酪胨大豆培养基和改良马丁培养基药品无菌检查的比对研究 1, 蔡芷荷1, 姚华卓1, 严纪文2 , 吴清平3(, 林干1 (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) 摘要目的：比较药品无菌检查用的胰酪胨大豆培养基（TSB）和改良马丁培养基（MM）对细菌和真菌的检测灵敏度和促生长能力。方法：3株细菌和3株霉菌试验菌株，分别采用中国药典无菌检查法规定的培养基适用性中半定量检测方法和以平板菌落计数法为基础计算试验菌株生长率的定量方法。结果：6株试验菌株在不同生产厂家的受试TSB和MM中，其生长管数和生长率经统计学分析，差异均无显著性（P＞0.05），灵敏度可达到＜0.1CFU?；不同生产厂家间受试培养基对6株试验菌株的促生长能力和检测灵敏度差异也无显著性（P＞0.05）。结论： TSB可替代MM用于药品无菌检查中的需氧菌和真菌检测。 关键词：无菌检查 试验菌株 灵敏度 促生长能力 生长率 Comparof the Effects in PharmaceuticalSterility Test for Tryptic Soy Medium and Modified Martin Medium Lu Mianfei 1, Cai Zhihe 1, Yao Huaizhuo1, Yan Jiwen2, Wu Qingping3＊, Lin Gan 1 ( 1.Guangdong Huankai Microbial Sci Tech. Co., Ltd.,Guangzhou 510663；2Center for Disease Control and Prevention of Guangdong Province,Guangzhou 510300；3Guangdong Institute of Microbiology,Guangzhou 510070 ) Abstract Objective: To compare the sensitivity and the capacity to promote the growth of bacteria and fungi of tryptic-soy-broth(TSB) medium and modified martin(MMB) medium (MMB) in pharmaceutical sterility test . Methods: The productivity ability and detection sensitivity of the two media were separately examined by three bacteria and three fungi in semi-quantitative and quantitative methods. The semi- quantitative method was based on Chinese Pharmacopeia, while the quantitative method was plate enumeration method by the productivity of the testing strains. Results: By comparing the number of tubes with bacterial growth and the productivity of the six testing strains on TSB medium and MMB medium provided by different medium manufacturers, no statistically significant difference was observed(P＞0.05). The sensitivity of detection was ＜0.1CFU?. The capacity of promoting bacteria growth between any two medium manufacturers was not statistically different(P＞0.05). Conclusion: TSB medium can readily replace MM medium in detecting aerobic bacteria and fungi in pharmaceutical sterility test with inoculation and cultivation conditions. Key w