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引用本文:张国林,苏远科,沈海英,顾珉,邢以文.16S rRNA/ITS基因序列分析与微生物分类鉴定及其在药品微生物质量控制中的应用[J].中国现代应用药学,2017,34(10):1489-1495.
ZHANG Guolin,SU Yuanke,SHEN Haiying,GU Min,XING Yiwen.Application of 16S rRNA/ITS Sequencing and Analysis in the Identification, Classification of Microbial and Drug Quality Control[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(10):1489-1495.
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16S rRNA/ITS基因序列分析与微生物分类鉴定及其在药品微生物质量控制中的应用
张国林1,2, 苏远科3, 沈海英1, 顾珉1, 邢以文1
1.苏州市药品检验检测研究中心, 江苏 苏州 215000;2.南京中医药大学, 南京 210000;3.龙口出入境检验检疫局, 山东 龙口 265700
摘要:
经典的微生物鉴定有赖于微生物的纯培养,其在一些难培养、生长缓慢或需要特殊营养的微生物鉴定方面有明显的局限性。全自动细菌鉴定及药敏分析系统和基质辅助激光解离飞行时间质谱对微生物鉴定属表型鉴定,严重依赖仪器生产厂商提供的数据库,对类型多样的环境微生物的鉴定分型有明显缺陷。基于遗传物质的分子生物学鉴定技术为微生物的准确鉴定及分型提供了新的思路。16S rRNA/ITS遗传信息具有相对稳定性和易变异的双重特点,不依赖于微生物的营养及生长状态,在微生物的鉴定、分型中得到广泛应用。微生物是影响药品质量的重要因素,而药品微生物控制是药品质量控制的重要方面。本文对16S rRNA/ITS序列与微生物鉴定、分型及其在药品微生物质量控制领域中的应用进行综述,为相关工作提供参考。
关键词:  微生物鉴定  溯源分析  形态学鉴定  16S rRNA  16S-23S rRNA基因间隔区  分子生物学技术
DOI:10.13748/j.cnki.issn1007-7693.2017.10.030
分类号:
基金项目:苏州市科技发展计划项目(SYS201425);山东省出入境检验检疫局项目(SK201618)
Application of 16S rRNA/ITS Sequencing and Analysis in the Identification, Classification of Microbial and Drug Quality Control
ZHANG Guolin1,2, SU Yuanke3, SHEN Haiying1, GU Min1, XING Yiwen1
1.Suzhou Institute for Drug Control, Suzhou 215000, China;2.Nanjing University of Traditional Chinese Medicine, Nanjing 210000, China;3.Longkou Entry-Exit Inspection and Quarantine Bureau, Longkou 265700, China
Abstract:
Traditional methods for identification and classification of microorganisms have limitations in those of unculturable, slow-growth and special dietary needed bacteria. Fully automatic bacteria identification and drug susceptibility analysis system and MALDI-TOF MS are belonged to phenotype identification which is dependent obviously on the database of equipment. These two methods are defective in the variety kinds of environmental microorganisms. Modern molecular based identification methods supply new idea for the environmental microorganism analysis. 16S rRNA/ITS, a sequence contains conservative and variant region is not related with the culture state is widely used in the identification and classification of microorganisms. Microorganism is a significant factor for drug quality control. The present dissertation tried to explore the structure of 16S rRNA/ITS and its application on drug quality control area.
Key words:  microorganism identification  trace-back investigation  morphological identification  16 Small Subunit Ribosomal RNA  internal transcribed spacer  molecular biological technique
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