胰酪胨大豆培养基和改良马丁培养基药品无菌检查效果的比对研究

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(MMB)对细菌和真菌的检测灵敏度和促生长能力。方法: 选用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检查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,分别测试培养基对试验菌株的促生长能力和检测灵敏度。结果: 6株试验菌株在不同生产厂家的受试TSB和MMB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 < 0.1 cfu·mL^-1;不同生产厂家间两受试培养基对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: 在一定的接种和培养条件下,TSB可替代MMB用于药品无菌检查中的需氧菌和真菌检测。

Comparison of the Effects in PharmaceuticalSterility Test for Tryptic Soy Medium and Modified Martin Medium

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 < 0.1 cfu·mL^-1.The capacity of promoting bacteria growth between any two medium manufacturers was not statistically different(P>0.05).Conclusion: TSB medium can readily replace MMB medium in detecting aerobic bacteria and fungi in pharmaceutical sterility test with inoculation and cultivation conditions.