文章摘要
刘亚茹,余萌,肖璜,王似锦,马仕洪.五家制药企业洁净区微生物群落分析[J].中国药事,2019,33(7):796-802
五家制药企业洁净区微生物群落分析
Analysis of Microflora in Clean Areas of Five Pharmaceutical Enterprises
投稿时间:2019-04-17  
DOI:10.16153/j.1002-7777.2019.07.012
中文关键词: 洁净区  微生物群落  16S rRNA序列分析  dnaJ序列分析  ITS序列分析
英文关键词: clean areas  microflora  16S rRNA gene sequence analysis  dnaJ gene sequence analysis  ITS gene sequence analysis
基金项目:国家药典委员会药品标准制修订研究课题(编号2018H002)
作者单位E-mail
刘亚茹 烟台大学, 烟台 264000  
余萌 中国食品药品检定研究院, 北京 100050  
肖璜 中国食品药品检定研究院, 北京 100050  
王似锦 中国食品药品检定研究院, 北京 100050  
马仕洪 中国食品药品检定研究院, 北京 100050 mash@nifdc.org.cn 
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中文摘要:
      目的:研究制药企业洁净区微生物群落的组成及分布规律,为制药企业良好的微生物控制提供依据。同时,也为超标调查分析、药品检出菌溯源分析及洁净环境菌数据库的建立与分析提供数据支持。方法:在A、B、C、D、E五家制药企业的生产洁净车间、洁净实验室、操作人员等监控点采集沉降菌,运用16S rRNA序列分析、ITS序列分析、看家基因序列分析,将收集获得的细菌、真菌鉴定到属或种。结果:本研究共收集获得细菌139株,真菌5株。16S rRNA序列分析结果判定葡萄球菌属40株,占比27.8%;微球菌属27株,占比18.8%;芽孢杆菌属16株,占比11.1%;微杆菌属9株,占比6.3%;不动杆菌属8株,占比5.6%;假单胞菌属6株,占比4.2%;真菌5株,占比3.5%;其他分属于10个属的菌株共33株,占比22.9%。结论:制药洁净环境微生物的组成主要为革兰氏阳性球菌包括葡萄球菌、微球菌;革兰氏阳性杆菌包括芽孢杆菌、微杆菌;少量的革兰氏阴性杆菌如假单胞菌、不动杆菌;还包括少量真菌。建议制药企业要控制洁净区人员数量,规范人员更衣进场程序和洁净区行为,制定有效的清洁消毒程序,加强环境监控,定期分析监控数据,研究数据变化趋势,出现异常数据,应及时采取措施,使洁净区处于良好的受控状态。
英文摘要:
      Objective:To study composition and distribution of microflora in clean areas of pharmaceutical enterprises, lay a basis for good microbiological control of pharmaceutical enterprises and to provide data for the investigation and analysis of standard exceeding, traceability analysis of drug-detecting bacteria and establishment and analysis of clean environmental microorganism database. Methods:Airborne environmental microorganisms in manufacturing workshops, clean laboratories, personnel and other monitoring points of five pharmaceutical enterprises marked A, B, C, D and E were collected. 16S rRNA sequence analysis, ITS sequence analysis, and housekeeping gene sequence analysis were used to identify genus or species of the bacteria or fungi collected. Results:A total of 139 bacteria and 5 fungi were collected in the study. The results of 16S rRNA sequence analysis determined 40 strains of Staphylococci, accounting for 27.8%; 27 strains of Micrococci, accounting for 18.8%; 16 strains of Bacilli, accounting for 11.1%; 9 strains of Microbacteria, accounting for 6.3%; 8 strains of Acinetobacters, accounting for 5.6%; 6 strains of Pseudomonades, accounting for 4.2%; 5 strains of fungi, accounting for 3.5% and other 33 strains belonging to 10 different genera, accounting for 22.9%. Conclusion:The composition of microorganisms in pharmaceutical clean areas is mainly Gram-positive cocci including Staphylococci and Micrococci; Gram-positive bacilli (Bacilli and Microbacteria included); a small number of Gram-negative bacilli such as Pseudomonades, Acinetobacters, as well as a few fungi. It is suggested that pharmaceutical enterprises should control the number of personnel in the clean areas, standardize the personnel's dressing procedures and clean area behavior, formulate effective cleaning and disinfection procedures, strengthen environmental monitoring, regularly analyze monitoring data, study datum trends and take measures in time to deal with abnormal data so as to keep the clean areas in a good state of control.
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