摘要
介绍了以质量标志物(Q-marker)为目标开展的注射用益气复脉(冻干)(YQFM)质量评价与监测技术研究进展,为开展全面的YQFM质量评价与控制创造了必要条件,也为中药Q-marker理论成果向制药工业质量控制实践转化提供参考。包括在药品全生命周期内构建基于Q-marker的质量评价及监测体系技术路线,针对不同组方药材、生产工艺中间体以及成品中Q-marker的分析技术研究结果;基于近红外光谱技术的生产过程分析技术体系,在生产过程中对Q-marker实施监控,为药品生产全过程的质量评价提供技术支撑。
The development for the researches of quality evaluation and monitoring technologies for Yiqi Fumai Lyophilized Injection(YQFM)targeting on quality marker(Q-marker)were presented,created the condition for the overall quality evaluation and control of YQFM,and provided inference for the transformation from Q-marker theory achievement to traditional Chinese medicine industrial quality control.The technical chart for the construction of quality evaluation and monitoring system in product lifecycle based on Q-marker was showed.The analytical methods of Q-markers in raw materials,intermediates,and products were introduced,which provided technical tools for quality evaluation in manufacturing process.The process quality monitoring system using near infrared spectroscopy technology was established,and quality models for determining Q-markers in critical process were developed,which were applied to monitor Q-markers in manufacture.
作者
张磊
苏小琴
陈昊喆
尚献召
李莉
郭晓彤
李德坤
刘昌孝
张铁军
鞠爱春
ZHANG Lei;SU Xiaoqin;CHEN Haozhe;SHANG Xianzhao;LI Li;GUO Xiaotong;LI Dekun;LIU Changxiao;ZHANG Tiejun;JU Aichun(Tianjin Tasly Pride Pharmaceutical Co.,Ltd.,Tianjin 300410,China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections,Tianjin 300410,China;Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Tianjin Institute of Pharmaceutical Research,Tianjin 300462,China)
出处
《药物评价研究》
CAS
2023年第8期1778-1786,共9页
Drug Evaluation Research
关键词
注射用益气复脉(冻干)
质量标志物
质量评价
近红外光谱技术
质量控制
Yiqi Fumai Lyophilized Injection
quality marker
quality evaluation
near infrared spectroscopy technology
quality control
