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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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药品企业生产车间洁净环境沉降菌的鉴定分析

Identification and analysis of sedimentary bacteria of clean environment of production workshop in pharmaceutical manufacturers

 

分类号:R917
出版年·卷·期(页码):2020,40 (5):795-802
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:采集鉴定药品企业生产车间的沉降菌,以了解药品生产环境微生物的污染程度和潜在风险。方法:采用MALDI-TOF-MS和16Sr RNA基因测序方法,对分离到的微生物进行鉴定分析。结果:共采集鉴定沉降微生物1396株,分为89个属271个种,主要以革兰阳性菌为主,其中比重较高的为葡萄球菌属、芽孢杆菌属、微球菌属和库克氏菌属。同一区域间分离到的同一种菌(如藤黄微球菌或溶血葡萄球菌)具有高度同源性,它们之间存在交叉污染的可能。结论:逐步构建药品生产企业微生物污染信息库,了解跟踪企业微生物污染重点环节并进行风险控制,加强对生产车间洁净区的环境控制和管理。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To collect and identify sedimentary bacteria in production workshop of pharmaceutical manufacturers in order to find out the pollution degree and potential risk of microorganism in the pharmaceutical production environment. Methods: MALDI-TOF-MS and 16Sr RNA gene sequencing were used to identify and analyze the isolated microorganisms. Results: A total of 1396 strains of sedimentary microorganisms were collected and identified with the distribution of 89 genera and 271 species, and mainly Gram-positive bacteria. Staphylococcus, Bacillus, Micrococcus and Kocuria were the dominated microorganisms. There was high homology between the same species of bacteria, such as Micrococcus luteus or Staphylococcus haemolyticus, isolated from the same region, demonstrating the possibility of cross contamination. Conclusion: It is important to build microbial pollution information database in pharmaceutical manufacturers gradually, to understand and track the key links of microbial pollution in manufacturersfor the risk control, to strengthen environmental control and management of clean area in production workshop.

-----参考文献:---------------------------------------------------------------------------------------

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