环境分离菌在药品微生物检验中的应用研究  

Research on the Application of Environmental Isolation Bacteria in Drug Microbial Testing

作　　者：董航岐 DONG Hangqi(Hanan Center For Drug Evaluation and Inspection,Zhengzhou 450000,China)

机构地区：[1]河南省药品审评查验中心,河南郑州450000

出　　处：《工业微生物》2024年第2期30-32,共3页Industrial Microbiology

摘　　要：文章探讨了环境分离菌在药品微生物检验中的使用情况,通过查阅国内外有关药品微生物检验的资料,对其中存在的问题进行了探讨,并对环境分离菌的适用领域作了简要阐述。目前,各国药典和行业指南都对消毒剂效能验证、抑菌效力检查以及对培养基方法的适用性进行了明确的规定,要求在这些环节中使用环境分离菌。相对于标准菌株,环境分离菌更能真实地反映样本或环境中的微生物的真实状态,并将其应用于药品微生物检验,为人们提供更为客观、科学的评估。同时,也可结合检验的项目、药品生产技术和药品特性进行风险评估,以明确适用于药品微生物检验的环境分离菌。The paper explores the use of environmental isolated bacteria in drug microbiological testing.By consulting relevant information on drug microbiological testing at home and abroad,this paper explores the existing problems and briefly elaborates on its applicable fields.At present,pharmacopoeias and industry guidelines in various countries have clearly stipulated the validation of disinfectant efficacy,antibacterial efficacy testing,and suitability of culture medium methods,requiring the use of environmental isolated bacteria in these processes.Compared to standard strains,environmental isolated bacteria can more accurately reflect the true state of microorganisms in the sample or environment.Using them for drug microbiological testing can provide a more objective and scientific evaluation.At the same time,risk assessments can be conducted by combining the testing items,drug production technology,and drug characteristics in the study to determine the environmental isolation bacteria suitable for drug microbiological testing.

关 键 词：环境分离菌 药品 微生物检验 质量控制 

分 类 号：R446.5[医药卫生—诊断学]