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。 The plate settlement method was used to collect the micro-organisms in the scene of the pharmaceutical enterprise workshop to understand the pollution degree and potential risks of micro-organisms in the production environment. After the API biochemical identification method, automatic microbial identification instrument and 16S rRNA gene sequence analysis technology, the isolated microorganisms were identified. This time a total of 106 strains of microorganisms were collected, divided into 16 genera and 19 species. Among them, 16S rRNA gene sequence identification results showed that the genus accuracy rate was 100% (19/19), 68.4% (13/19) of the microbial strains can be directly identified species. According to the homology of bacterial 16S rRNA gene, it was initially determined that there was a high homology of Micrococcus luteus detected from sampling points between the ingredients to be isolated and the bottle-washing in the plant 10,000-level environment. The environment may be cross-contaminated with the same strain of microorganism as either people or logistics.