| 黄家乐,王玥,何睿,裘畅,徐雪娥,董铸雄.制药企业微生物鉴定技术和监测数据库的建立[J].中国药事,2018,32(10):1393-1399 |
| 制药企业微生物鉴定技术和监测数据库的建立 |
| Establishment of Microbial Identification Technology and Monitoring Database in Pharmaceutical Company |
| 投稿时间：2017-03-08 |
| DOI：10.16153/j.1002-7777.2018.10.013 |
| 中文关键词: 微生物定向鉴定法 数值分类鉴定法 微生物污染调查 污染菌库 |
| 英文关键词: microbial orientation identification numerical classification identification microbial contamination investigation library of contaminating bacteria |
| 基金项目: |
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| 摘要点击次数: 1395 |
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| 中文摘要: |
| 目的：建立制药企业微生物鉴定技术和监测数据库，以达到微生物溯源调查、回顾分析和法规符合性的要求。方法：建立微生物定向和数值分类鉴定方法，通过对标准菌株的分析鉴定，以确认鉴定方法的适用性，并将污染菌的来源、菌落、细菌形态和鉴定信息以图片形式保存于Word、Excel文档中。结果：微生物定向和数值分类鉴定法经确认后均符合要求，可用于微生物的鉴定。制药企业污染菌库、鉴定电子菌库和药品生产过程中微生物监测电子数据库，可用于污染菌的测试、鉴定信息确认和分析调查。结论：所述的微生物定向和数值分类鉴定法，以及污染菌库、鉴定电子菌库和监测电子数据库为同行提供一套简单、应用性强、成本低的微生物鉴定技术和建立污染菌库的指导方法及技术平台。 |
| 英文摘要: |
| Objective: To establish microbial identification technology and monitoring database in the pharmaceutical company, so as to meet the requirements of microbial traceability investigation, analysis review and regulation compliance. Methods: Microbial orientation and numerical classification identification methods were established and the applicability of the methods was verified by analysis and identification of standard strains. Moreover, the following information of the identified bacterial, including source, colony, morphology and API identification information were stored in Word or Excel files in the format of pictures. Results: Both the microbial orientation identification and numerical classification identification methods met the requirements, which could be used for microbial identification. A library of contaminating bacteria of pharmaceutical company, electronic database of microbial identification and microbial monitoring database during the drug production could be used for testing, confirming the identification information and analyzing the contaminating bacteria. Conclusion: The microbial orientation identification and numerical classification identification methods, library of contaminating bacteria, electronic database of microbial identification and microbial monitoring database in this article could provide a simple, practical and low-cost microbial identification technology, guidance and platform for establishment of library of contaminating bacteria. |
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