中药质量标志物（Q-Marker）研究发展的5年回顾

被引：184

作者：

刘昌孝 ^{[1
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,3
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机构：

[1] 天津药物研究院

[2] 天津市中药质量标志物重点实验室

[3] 释药技术与药代动力学国家重点实验室

来源：

中草药 | 2021年 / 52卷 / 09期

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;

D O I：

暂无

中图分类号：

R284 [中药化学];

学科分类号：

100804 [中药化学];

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。

引用

页码：2511 / 2518

页数：8

共 45 条

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