摘要
目的:建立流式细胞技术在药品中无菌快速检测方法。方法:选用荧光染料SYTO9对药品中微生物进行荧光标定,采用流式细胞仪对标定微生物进行检查,同时与中国药典2015年版<1101>无菌检查法进行比较研究。结果:溶液型注射液和注射用无菌粉末两种类型的药品采用流式细胞技术检测检出限均<10 cfu,当规定检验量的样品中微生物污染量>10~5cfu时采用流式细胞技术可直接检出,当污染量在<10cfu^10~4cfu范围时检出时间比常规方法缩短40%~70%。结论:流式细胞技术用于药品无菌检查可以缩短检出时间,可作为法定检查法的有效补充。
Objective： To establish a method for the rapid detection of sterile preparations. Methods： Microbes in the sterile preparations were labeled by fluorescent dye SYTO9,and detected by flow cytometry. Meanwhile,the results from the routine examination method recorded in Chinese Pharmacopoeia and those from the flow cytometry were compared. Results： The detection limit of injection and injection of sterile powder using flow cytometry was less than 10 cfu. It could be directly detected when the microbial contamination of the test samples was greater than 10~5 cfu. When the amount of pollution was 10 cfu-10~4 cfu,the detection time was shortened by 40%-70% when compared with that of the routine method. Conclusion： Flow cytometry used for the detection of microbiological contamination can shorten the time for positive result,which can be an effective supplement to the routine method.
出处
《中国药师》
CAS
2018年第2期342-345,共4页
China Pharmacist
关键词
无菌制剂
无菌检查
流式细胞技术
荧光染料
Sterile preparation
Sterility test
Flow cytometry
Fluorescent dye
作者简介
通讯作者：刘浩Tel：（021）50798183E-mail：liuhao1968@hotmail．com
