抗生素类药品无菌检查方法研究进展  

Development on sterility testing methods for antibiotic drugs

作　　者：王静 王振波 戴翚[1] 肖璜[1] 王似锦[1] 周发友[1] 马仕洪[1] Wang Jing;Wang Zhenbo;Dai Hui;Xiao Huang;Wang Sijin;Zhou Fayou;Ma Shihong(National Institutes for Food and Drug Control,Beijing 100050;Ningxia Hui Autonomous Region Institute of Drug Inspection,Yinchuan 750002)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]宁夏回族自治区药品检验研究院,银川750002

出　　处：《中国抗生素杂志》2024年第4期404-414,共11页Chinese Journal of Antibiotics

基　　金：中国食品药品检定研究院中青年发展研究基金(No.2023A7)。

摘　　要：无菌检查法是无菌药品检查的法定检验方法,其中薄膜过滤法因易操作、风险低和准确度高等优点比直接接种法应用更广泛。无菌药品剂型种类繁多,其中抗生素类药品因品种结构多变、抑菌性强和抗菌谱广等因素,一直以来是建立无菌检查方法的难点。本文就薄膜过滤法中的溶解、过滤、冲洗和培养等4个关键步骤展开讨论,通过对已建立的13类47个品种共61个抗生素药品无菌检查方法的综述,探讨建立无菌检查方法的基本策略,并对无菌检查方法和结果的局限性进行讨论,以期为建立抗生素类无菌药品无菌检查方法及正确认识无菌检查结果提供思路和参考。Sterility testing is a statutory inspection method for sterile drugs,among which the membrane filtration method is more widely used compared to the direct inoculation of culture medium due to its advantages of easy operation,low risk,and high accuracy.There are various types of sterile drug formulations,among which antibiotic drugs have been a challenge in establishing sterility testing methods due to their diverse variety,structure,strong antibacterial properties,and wide antibacterial spectrum.This article discussed the four key steps of dissolution,filtration,rinsing,and cultivation in the membrane filtration method.Through a review of 61 established sterility testing methods for 13 categories and 47 varieties of antibiotics,the basic strategies for establishing sterility testing methods were discussed,and the limitations of sterility testing methods and results were also discussed in order to provide ideas and references for the establishment of sterility testing methods for antibiotics and the correct understanding of sterility testing results.

关 键 词：抗生素 无菌药品 无菌检查 薄膜过滤法 局限性 

分 类 号：R978.1[医药卫生—药品]