他克莫司微生物限度方法学的研究  

Study on the methodology of microbiological limit of tacrolimus

作　　者：傅钰 覃存轩 FU Yu;QIN Cun-xuan(Sinopharm Chuankang Pharmaceutical Co.,Ltd.,Chengdu 611731,China)

机构地区：[1]国药集团川抗制药有限公司,成都611731

出　　处：《药物分析杂志》2019年第8期1527-1532,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立他克莫司原料微生物限度检验方法,探讨如何使用联合检验方法检测他克莫司的微生物限度。方法:选取5种用于适用性检查的标准菌株制备菌液[1],用常规法、培养基稀释法、萃取法、薄膜过滤法制备供试液,对他克莫司进行微生物计数方法进行适用性试验,选取大肠埃希菌制备菌液,通过以上各种方法制备供试液对他克莫司进行控制菌检查试验。结果:他克莫司需氧菌总数、霉菌和酵母菌总数试验用每种菌落回收比值均在0.5~2范围内,控制菌应未检出,均达到药典要求。结论:他克莫司对用于适用性检查与控制菌检查的菌株有很强抗菌活性,可以联合使用培养基稀释法、萃取法、薄膜过滤法,并添加无菌表面活性剂[2]去除抗菌活性,进行微生物限度检测。Objective:To establish a microbiological limit test method for tacrolimus raw materials,and investigate the microbiological limit of tacrolimus using a combination of test methods. Methods:5 standard bacterial strain preparations were selected for the suitability test[1],while conventional method,culture medium dilution method,extraction method and membrane filtration method were used to prepare test solutions in determing the suitability of microbiological counting methods for Tacrolimus. Escherichia coli preparation was used to prepare a test solution in the control bacteria test for Tacrolimus. Results:The recovery ratios of Tacrolimus total aerobic bacteria,mold and yeast were between 0.5-2,and the control bacteria was undetected,which met the requirements of the pharmacopoeia. Conclusion:Tacrolimus has strong antibacterial activity against strains used in suitability test and control bacteria test. Culture medium dilution method,extraction method and membrane filtration method can be combined in addition with the sterile surfactant[2] to remove its antibacterial activity in determing the microbiological limit of Tacrolimus. [2]

关 键 词：微生物方法验证 计数方法适用性试验 检验方法联合使用 回收比值 控制菌检查法 萃取法 薄膜过滤法 培养基稀释法 

分 类 号：R917[医药卫生—药物分析学]