食品与药品2024,Vol.26Issue(6) :537-541.DOI:10.3969/j.issn.1672-979X.2024.06.011

药品中白色念珠菌的实时荧光定量PCR快速检测法

Rapid Detection of Candida Albicans in Drugs by Real-time Fluorescence Quantitative PCR

李杰 陈学海 林鹏 李学红 钱云开
食品与药品2024,Vol.26Issue(6) :537-541.DOI:10.3969/j.issn.1672-979X.2024.06.011

药品中白色念珠菌的实时荧光定量PCR快速检测法

Rapid Detection of Candida Albicans in Drugs by Real-time Fluorescence Quantitative PCR

李杰 1陈学海 1林鹏 1李学红 1钱云开2
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作者信息

  • 1. 临沂市检验检测中心,山东临沂 276000
  • 2. 秦皇岛海关技术中心,河北秦皇岛 066004
  • 折叠

摘要

目的 建立一种药品中白色念珠菌的快速检测法.方法 根据白色念珠菌ITS2基因序列,设计特异性引物和探针,通过优化扩增反应体系进行实时荧光定量PCR扩增,达到快速检测药品中白色念珠菌的目的.结果 方法具有良好的重复性和稳定性,能满足试验要求,药品中白色念珠菌的检测灵敏度达2cfu/g(ml),仅需3~5 d即可完成检测,采用该方法检测4批药品,结果与药典方法一致.结论 本方法检测特异性强、所需时间短、灵敏度高,可作为《中国药典》白色念珠菌检查法的补充方法.

Abstract

Objective To establish a real-time fluorescence quantitative PCR method for rapid detection of Candida albicans in drugs.Methods According to the ITS2 gene sequence of Candida albicans,specific primers and probes were designed,and the real-time fluorescence quantitative PCR amplification was carried out by optimizing the amplification reaction system to achieve the purpose of rapid detection of Candida albicans in drugs.Results The method showed good repeatability and stability,and could meet the experimental requirements.The detection sensitivity of Candida albicans in drugs reached 2 cfu/g(ml).The detection could be completed in only 3-5 d.Four batches of drugs were tested by this method,and the results were consistent with the results detected by the method listed in Chinese Pharmacopoeia.Conclusion This method has high detection specificity,short detection time and high sensitivity,and could be used as a supplementary method for the method for detection of Candida albicans listed in Chinese Pharmacopoeia.

关键词

中国药典/药品/白色念珠菌/实时荧光定量PCR/检测

Key words

Chinese Pharmacopoeia/drug/Candida albicans/real-time fluorescence quantitative PCR/detection

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出版年

2024
食品与药品
山东省生物药物研究院

食品与药品

CSTPCD
影响因子:0.537
ISSN:1672-979X
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