摘要
采用平板沉降法收集制药企业车间生产现场环境微生物,以了解药品生产环境微生物的污染程度和潜在风险。经过API生化鉴定方法、全自动微生物鉴定仪和16S rRNA基因序列分析技术,对分离到的微生物进行鉴定。本次共收集沉降微生物106株,分为16个属19个种。其中,16S rRNA基因序列鉴定结果显示,属的准确率为100%(19/19),有68.4%(13/19)的微生物菌株可直接鉴定到种。根据细菌16S rRNA基因同源性,初步判断在工厂万级环境中,从应隔离的配料间和洗瓶间的采样点监测到的藤黄微球菌同源性较高,分析该工厂十万级环境可能随人流或物流受到同一株微生物交叉污染。
This study was designed to discover biological contaminations and potential risks in critical processing procedures and controlled areas at a pharmaceutical plant.Bacteria were collected by settle plate method and identified by API system,VITEK 2 compact system and 16S rRNA gene sequencing technique.Total 106 bacteria were identified and characterized into 16 genus and 19 species.The identification accuracy of genus given by 16S rRNA gene sequencing was 100%,68.4%（13/19） of which could be conveniently characterized to the species level.According to the results of 16S rRNA gene sequencing,the phylogenetic trees were developed for the analysis of the relationship between species.The homologous Micrococcus luteus strains were found from the weighing procedure area and washing procedure area,which showed that cross contaminations of Micrococcus luteus strains occurred through people activities and materiel channels at the class 100 000 clean areas.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2010年第11期810-817,822,共9页
Chinese Journal of Pharmaceuticals
关键词
微生物
鉴定
分型
污染源调查
microorganism
identifi cation
characterization
biological contamination survey
作者简介
范一灵（1983-），男，微生物检验师，从事食品药品安全及微生物检测。Tel：13512104684E—mail：tcfyl@163．com
