摘要
放射性药品多为效期短、非终端灭菌的注射剂,该类药品的微生物检测周期宜控制在较短的时间内,传统微生物检测方法在应对具有快速检测需求的放射性药品时往往力有不逮。近年来出现的快速微生物检测技术具有检测效率高、自动化程度强、即时监控等特点,不但可以填补传统检测方法的不足,而且在药品微生物检验数据的可靠性评价、药品生产过程控制方式改进等方面具有重要的参考价值。本文阐述了快速微生物检测技术的原理和近年相关机构和各国药典中所报道的研究进展,并对该技术应用于放射性药品检测的前景进行了展望。
Radiopharmaceuticals are commonly non-terminal sterilization injection with short period of validity that require short detection duration,making traditional methods uncompetitive for radiopharmaceuticals.The rapid microbiological methods(RMM)developed in recent years are highly efficient as automated,and real-time monitoring technologies,which could not only compensate traditional detection methods but also provide significant insights for the evaluation of the data reliability of the microbiological detection and the control of the manufacturing process of the pharmaceuticals.In this review,we summarized the principle and recent progress of rapid microbiological methods reported by relevant organizations and the pharmacopeias of different countries,as well as the prospect of this technology in radiopharmaceuticals.
作者
邵长芳
孔浩
孙祥敏
杜建冬
张云
SHAO Changfang;KONG Hao;SUN Xiangmin;DU Jiandong;ZHANG Yun(HTA Co.,Ltd.,Beijing 102413,China)
出处
《标记免疫分析与临床》
CAS
2023年第3期536-540,共5页
Labeled Immunoassays and Clinical Medicine
关键词
快速微生物检测技术
研究进展
放射性药品
过程控制
Rapid microbiological methods(RMM)
Research progress
Radiopharmaceuticals
Control of the manufacturing process
