Study on the Application of Flow Cytometry in Drug Sterility Test / 中国药师

ABSTRACT

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 examina-tion method recorded in Chinese Pharmacopoeia and those from the flow cytometry were compared. Results:The detection limit of in-jection and injection of sterile powder using flow cytometry was less than 10 cfu. It could be directly detected when the microbial con-tamination of the test samples was greater than 105cfu. When the amount of pollution was <10 cfu-104cfu, the detection time was shortened by 40%-70% when compared with that of the routine method. Conclusion:Flow cytometry used for the detection of microbi-ological contamination can shorten the time for positive result,which can be an effective supplement to the routine method.