中国药业2025，Vol.34Issue(4)：88-91,4.DOI:10.3969/j.issn.1006-4931.2025.04.021
制药用水环境分离菌用于荧光染色快检技术的专属性研究
Study on the Specificity of Bacteria Isolated from Pharmaceutical Water for Fluorescence Staining Rapid Detection Technology
摘要
Abstract
Objective To study the specificity of bacteria isolated from pharmaceutical water for fluorescence staining rapid detection technology.Methods According to the requirements of relevant domestic and foreign regulations for the verification of alternative microbial testing methods,Burkholderia,Bradyrhizobium and Aquabacterium(concentration≤1 000 cfu/mL)suspensions were taken and stained at different culture time points based on the traditional staining times(3,7,5 d)to determine the optimal staining time for microorganisms.The strains were divided into the rapid detection method group(cultured to the optimal staining time),the re-culture group(cultured to the traditional staining time after the optimal staining time),the traditional culture group(cultured to the traditional staining time),and the negative control group(rapid detection method and traditional culture).After staining and cultivation,the bacterial colony was counted in each group,the ratio of average counts of rapid detection method to traditional culture,the ratio of average counts of rapid detection method to re-culture after staining,the ratio of average counts of re-culture after staining to rapid detection method were calculated(recorded as average recovery rates 1,2,3,respectively)to verify the specificity of fluorescence staining rapid detection technology.Results The optimal staining time for the three bacteria was 26,72,40 h,respectively.Compared with the pharmacopoeia method,the average recovery rates of the three bacteria were all greater than 0.7(Aquabacterium had no recovery rate due to its special colony morphology and no counting results),which met the validation requirements of alternative methods.Conclusion Fluorescence staining rapid detection technology is suitable for the detection of Burkholderia,Bradyrhizobium and Aquabacterium introduced in pharmaceutical water.关键词
伯克霍尔德菌/慢生根瘤菌/水杆状菌/荧光染色法/快检技术/制药用水/专属性/回收率Key words
Burkholderia/Bradyrhizobium/Aquabacterium/fluorescence staining method/quick detection technology/pharmaceutical water/specificity/recovery rate分类
医药卫生引用本文复制引用
任凤姣,王杠杠,马仕洪..制药用水环境分离菌用于荧光染色快检技术的专属性研究[J].中国药业,2025,34(4):88-91,4.基金项目
国家药典委员会药品标准制修订研究课题[2022Y29]. （）
