医院制剂鞣酸软膏微生物限度检查方法研究  

Study on microbial limit of detection method for hospital preparation of ellagic acid ointment

作　　者：谢巍 李萍 杨妮 韦祖巧 XIE Wei;LI Ping;YANG Ni;WEI Zuqiao(Liuzhou Hospital,Guangzhou Women and Children’s Medical Center,Liuzhou Guangxi 545616)

机构地区：[1]广州市妇女儿童医疗中心柳州医院,广西柳州545616

出　　处：《天津化工》2025年第1期47-50,共4页Tianjin Chemical Industry

基　　金：广西壮族自治区中医药管理局自筹经费科研课题GXZYB20230789。

摘　　要：目的:建立鞣酸软膏微生物限度控制方法,并验证该方法的适用性。方法:根据《中国药典》2020年版四部通则1105、1106和1107要求,考察鞣酸软膏的微生物计数法和控制菌检查方法的适用性。需氧菌计算方法采用稀释平板法1∶100,霉菌和酵母总数采用常规平板法1∶10,金黄色葡萄球菌采用1000 mL增菌液接种,铜绿假单胞菌采用100 mL增菌液接种检测。结果:5种实验细菌的回收率研究结果在0.5~2.0之间,实验组中检测到金黄色葡萄球菌和铜绿假单胞菌。结论:该方法科学可靠,可用于鞣酸软膏的微生物限度检查,有效控制了鞣酸软膏内部质量。Objective:To establish a method for microbial limit checking of ellagic acid ointment and to check the applica-bility of the method.Methods:A pilot study on the applicability of microbial enumeration method and controlled bacteria inspection method for ellagic acid ointment in accordance with the requirements of four general rules 1105,1106 and 1107 of the 2020 edition of the Chinese Pharmacopoeia.Aerobic bacterial enumeration was performed using the 1∶100 dilution dish pouring method.The total number of molds and yeasts was determined by the conventional 1∶10 flat dish decanting meth-od.Staphylococcus aureus was inoculated by the enriched liquid method and Pseudomonas aeruginosa was examined as a routine method for microbiological limits.Results:The recovery test results of the five test organisms were in the range of 0.5~2.0,Staphylococcus aureus and Pseudomonas aeruginosa were detected in the check test group.Conclusion:This method is scientific and reliable for the microbial limit check of ellagic acid ointment and can effectively control the intrinsic quality of ellagic acid ointment.

关 键 词：鞣酸软膏 微生物限度检查 方法学验证 

分 类 号：G642.0[文化科学—高等教育学]