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

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。

Application of 16S rRNA/ITS Sequencing and Analysis in the Identification, Classification of Microbial and Drug Quality Control

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.