微量热法用于检出药品中污染金黄色葡萄球菌的可行性探讨  

Study on the feasibility of microcalorimetry in the detection of contaminated Staphylococcus aureus in drugs

作　　者：李蕾 黄鹏 阚家义 李玮 LI Lei;HUANG Peng;KAN Jia-yi;LI Wei(Anhui University of Traditional Chinese Medicine,Hefei 230012,China;Anhui Provincial Institute for Food and Drug Control,Hefei 230051,China)

机构地区：[1]安徽中医药大学药学院,合肥230012 [2]安徽省食品药品检验研究院,合肥230051

出　　处：《药物分析杂志》2021年第2期300-305,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：2020年度安徽省药品监督管理局科技创新技术攻关项目(AHYJ-KJ-202005)。

摘　　要：目的:对基于微生物生长热信号的微量热技术快速检出药物中金黄色葡萄球菌污染的可行性进行探讨。方法:测量金黄色葡萄球菌生长热谱图的特征性,通过比较图谱的相似性,设定阳性检出的阈值标准,并进行方法学考察。结果:在一定范围的试验条件下,金黄色葡萄球菌的生长热图谱有特征性和稳定性,成功用于模拟污染的林可霉素利多卡因凝胶样品和质控样品中的金黄色葡萄球菌的检出。结论:建立的微量热检查法具有灵敏、快速、准确、简便的优点,可以作为微生物限度检查中快速检出、确证金黄色葡萄球菌的补充方法。Objective:To discuss the feasibility of rapid detection of Staphylococcus aureus contamination in drugs by microthermal measurement based on microbial growth heat signal.Methods:The characteristics of Staphylococcus aureus growth thermography were measured by referring to the verification guidelines of alternative methods.The threshold of correlation coefficient for positive identification was obtained by comparing the similarity of the maps,and the methodology was investigated.Results:Under certain experimental conditions,the thermal maps of Staphylococcus aureus growth were characterized and stable,which was successfully used in the detection of Staphylococcus aureus in the artificial contaminated lincomycin lidocaine gel and quality control samples.Conclusion:The established microthermal method has the advantages of sensitivity,speed,accuracy and simplicity,and could be used as a supplementary method for rapid detection and confirmation of Staphylococcus aureus in microbial limit tests.

关 键 词：微量热法 金黄色葡萄球菌 微生物污染 生长热 微生物限度检查法 

分 类 号：R917[医药卫生—药物分析学]