摘要
在近30年,通过较系统、全面、深入的研究,在发现药效物质基础,建立导向明确、路线清晰、方案合理的研究框架体系,为解读作用机制,明晰组方的合理性、用药的科学性,防病治病的科学内涵,中药及其复方研究获得较大进展。在从药材到成药、从研发到产业、从产品到临床,从工厂到市场的全过程的质量控制体系的研究中,亟需建立新理论、新方法、新体系进行广泛的探索研究、应用研究和产业转化研究。弘扬"传承精华,守正创新"的科学精神,需要具有前沿性的领引力、创新性的想象力、跨界性的融合力、务实性的执行力和人文性的涵养力的发展观,才能提出中药质量标志物(quality marker,Q-Marker)的新概念、新理论。2016年以来,中药Q-Marker重点开展"指纹成分-工艺过程可重现性""生物学-有效性、安全性""中药功效-作用机制关联性""质量物质可测性"和"质量标准稳定性"五要素研究,使其贯穿中药及其制剂开发的全过程中,形成质量和风险控制的"药材-饮片-成药"全过程质量追溯系统。为确立"中药Q-Marker"为抓手的策略,为建立全新的质量管理体系提供科学依据。在总结近5年研究的基本思路和获得的主要研究成果基础上,还分析了国内国际学术期刊公开发表该理论和应用情况和学术影响。相信中药Q-Marker研究,一定会对促进中药标准化和国际学术交流产生积极影响。
In the past 30 years,through systematic,comprehensive and in-depth research,a research framework system with clear orientation,clear route and reasonable scheme has been established based on the discovery and its active material basis.In order to interpret the mechanism of action,clarify the rationality of prescription,the scientific nature of medication,and the scientific connotation of disease prevention and treatment,the great progress has been made in the research of traditional Chinese medicines(TCMs)and compound TCM formulas.In the research of quality control system in the whole process from medicinal materials to Chinese patent medicines(CPMs),from research to industry,from product to clinic,from factory to market,it is urgent for us to establish new theories,new methods and new systems for extensive exploration,application and industrial transformation.To carry forward the scientific spirit of"inheriting the essence,keeping the integrity and innovating",we need the development concept of leading gravity,innovative imagination,cross-border integration,practical execution and humanistic conservation to put forward the new concept and theory of quality-marker.Since 2016,we have focused on the study of five elements of quality markers such as"fingerprint composition-reproducibility of technological process","biology-effectiveness and safety","correlation between efficacy and action mechanism of TCM","testability of quality substances"and"stability of quality standards",so that it runs through the whole process of development of TCMs and its preparations,forming a traceability system for whole process of"medicinal material-decoction piece-CPM"with quality and risk control.It provides a scientific basis for establishing the strategy of"TCM quality markers"and establishing a brand-new quality management system.On the basis of summarizing the basic ideas of our researches and the main research results obtained,this paper also analyzes the theory published in domestic and international academic journals and its application and academic influence.We believe that the research on TCM quality markers will have positive effect on promoting the development of TCM standardization and international academic exchange.
作者
刘昌孝
LIU Chang-xiao(Tianjin Key Laboratory of Chinese Medicine Quality Markers,State Key Laboratory of Drug Release Technology and Pharmacokinetics,Tianjin Pharmaceutical Research Institute,Tianjin 300462,China)
出处
《中草药》
CAS
CSCD
北大核心
2021年第9期2511-2518,共8页
Chinese Traditional and Herbal Drugs
关键词
中药
质量标志物
生产过程质量控制
发展战略
发展策略
traditional Chinese medicine
quality markers
production process quality control
development strategy
development tactics
