| 徐全华,王羿.无菌药品生产环境微生物的鉴定和种群分析[J].中国药事,2019,33(12):1411-1418 |
| 无菌药品生产环境微生物的鉴定和种群分析 |
| Identification and Population Analysis of Microorganisms in Sterile Drug Manufacturing Environment |
| 投稿时间：2019-04-03 |
| DOI：10.16153/j.1002-7777.2019.12.013 |
| 中文关键词: MIDI脂肪酸鉴定系统 菌种鉴定 微生物种群分析 |
| 英文关键词: MIDI fatty acid identification system identification of bacterial strains microbial population analysis |
| 基金项目: |
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| 摘要点击次数: 1375 |
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| 中文摘要: |
| 目的：对无菌药品洁净区生产环境发现的微生物进行菌种鉴定和种群分析，初步建立环境微生物数据库，为微生物的溯源调查和污染控制提供科学依据，确保药品的安全。方法：对冻干粉针剂生产车间B级洁净区动态监测发现的148株菌株进行分离纯化，通过菌体收获、皂化、甲基化、萃取、碱洗涤提取脂肪酸，采用MIDI Sherlock全自动微生物鉴定系统进行鉴定和种群分析。结果：148株分离菌株分属于15个属31个种，出现频次较高的属依次为葡萄球菌属、微球菌属和节杆菌属，三个属的菌种出现的频次占全部分离菌株的77.7%。在所有分离菌株中，出现频次较高的菌株依次为藤黄微球菌、科氏葡萄球菌、人葡萄球菌、克氏葡萄球菌和变金黄节杆菌，这5种细菌出现的频次占全部分离菌株的69.0%。结论：在洁净区环境监测中，发现较高频次的是以人源性葡萄球菌属、微球菌属等为主的菌株，因此，规范进入洁净区的人员行为规范和采用科学合理的清洁消毒程序，将有助于减少由人员导致的微生物污染。 |
| 英文摘要: |
| Objective: To identify and analyze the population of the microorganisms found in the clean environment for sterile drug production, and establish an environmental microbial database in order to lay a scientific basis for microbial traceability investigation and pollution control and to ensure the safety of drugs. Methods: A total of 148 bacterial strains which were found by dynamic monitoring in grade B clean area of freeze-dried powder injection workshop were separated and purified. Fatty acids were extracted through harvesting bacterial lawn, saponification, methylation, extraction and alkali washing. MIDI Sherlock automatic microbial identification system was used for identification and population analysis. Results: The 148 isolated strains belonged to 15 genera and 31 species. The genera with higher frequency occurred in order as the follows:Staphylococcus, Micrococcus and Arthrobacter, and the occurrence frequency of the three genera accounted for 77.7% of all isolated strains. The strains with high frequency occurred in order as the follows:Micrococcus luteus, Staphylococcus cohnii, Staphylococcus hominis, Staphylococcus kloosii and Arthrobacter aurescens, and the occurrence frequency of the five species accounted for 69.0% of all isolated strains. Conclusion: Human origin Staphylococcus and Micrococcus are found to be the main bacterial strains with higher frequency in clean area's environmental monitoring. Therefore, regulating the behavior of personnel entering clean areas and adopting scientific and reasonable cleaning and disinfecting procedures will help to reduce the microbial contamination caused by personnel. |
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