中国药业2026，Vol.35Issue(7)：40-44,5.DOI:10.3969/j.issn.1006-4931.2026.07.007
高风险制药企业环境菌库构建与风险分析
Construction and Risk Analysis of Environmental Microbiota Repository in High-Risk Pharmaceutical Enterprises
摘要
Abstract
Objective To establish an environmental microbial repository for high-risk pharmaceutical enterprises,and to conduct pollution risk analysis based on multidimensional data.Methods A high-risk drug production enterprise was selected as the research object,and microbial samples were collected from six sources including air,personnel,water system,surface,raw materials,and finished products from January to August 2023 according to the enterprise environmental monitoring plan.Bacterial 16S rRNA gene and fungal internal transcribed spacer(ITS)sequencing were used for strain identification,and the species,variation trends,and detection frequencies were analyzed.Results A total of 671 strains were isolated.The microbiota repository was predominantly composed of gram-positive bacteria(63.79%),with Staphylococcus(29.96%)and Micrococcus(14.75%)as the dominant genera.Rhodotorula was detected in the grade A,B,and C zones.Personnel-associated bacterial communities were observed in grade B and C zones.Water system-associated gram-negative bacteria were enriched in the grade U zone.The microbial community structure and quantity showed significant changes from May to August.Conclusion The environmental microbiota repository based on gene sequencing identification can be used to identify pollution sources and potential transmission pathways in pharmaceutical environments,which can provide data support for disinfection efficacy evaluation and process control,and improve the quality of products.关键词
高风险制药企业/环境菌库/微生物鉴定/16S rRNA基因测序/真菌转录间隔区测序/风险分析Key words
high-risk pharmaceutical enterprises/environmental bacterial repository/microbial identification/16S rRNA gene sequencing/fungal internal transcribed spacer sequencing/risk analysis分类
医药卫生引用本文复制引用
徐玲笑,郑晓琴,方芳,周勇,黄华,胡佳晨..高风险制药企业环境菌库构建与风险分析[J].中国药业,2026,35(7):40-44,5.基金项目
浙江省药品监督管理局2023年科技计划项目[2023024] （）
浙江省衢州市科技攻关项目[2022K134]. （）
