摘要
目的考察分析市售鱼肝油乳的微生物负载,评估产品污染微生物风险,为规范鱼肝油乳的微生物检测方法提供依据。方法采用2020年版《中国药典》四部中的方法测定鱼肝油乳需氧菌总数、霉菌和酵母菌总数及大肠埃希菌,并对检出的污染菌进行菌株鉴定分型。结果2个生产企业27个批次样品微生物限度检查有26个批次样品合格,1个批次样品霉菌和酵母菌超标,经鉴定超标样品污染微生物为葡糖醋杆菌。样品中分离的微生物经鉴定为共15种微生物,包括芽孢杆菌属、葡萄球菌属、微球菌属和微杆菌属。结论鱼肝油乳的生产和储存过程中存在微生物污染的风险,应关注来自原辅料、生产环境以及人员的微生物控制风险。
Objective To analyze the microbial contamination and provide a basis for standardizing microbial test method of non-sterile drug cod liver oil emulsion in the market.Methods The total aerobic microbial count,the total combined yeasts and molds count,and specified microorganisms were tested by the methods in the 2020 edition of Chinese Pharmacopoeia(VolⅣ).Microbes isolated from drug samples were identified and characterized by Gram staining,microscope examination,and 16S rDNA sequencing.Results A total of 27 batches samples obtained from two manufacturers of cod liver oil emulsion were detected in this report.One of them was exceeded because gluconacetobacter aggeris were detected in the yeasts and molds count,while 26 batches samples were qualified.Results of strain identification revealed that 15 kinds of strains were detected including bacillus,staphylococcus,micrococcus and gluconacetobacter.Conclusion The research work showed that the microbial contaminants were found in cod liver oil emulsion during manufacturing and over product shelf life.Increased focus on should be placed on controlling of microbial populations from excipients,manufacturing environment and personnel,and refining microbiological examination and acceptance criteria for non-sterile products.
作者
郑孝贤
王海龙
詹清
周阿容
林梦丹
揭小玲
ZHENG Xiaoxian;WANG Hailong;ZHAN Qing;ZHOU Arong;LIN Mengdan;JIE Xiaoling(Fujian Institute of Microbiology,Fuzhou Fujian 350007,China)
出处
《药品评价》
CAS
2023年第10期1185-1189,共5页
Drug Evaluation
基金
福建省科技计划项目(2021R1005008)。
关键词
鱼肝油乳
微生物限度检查
方法验证
质量分析
Cod liver oil emulsion
Microbial test method
Validation of method
Quality assessment
