安全、有效、可控是药品的3大属性，建立适宜的中药质量评价体系是保证中药质量可控的基本条件，攸关中药临床安全有效使用、新药研发和中药产业发展的关键共性问题，备受中医药领域关注。中药所产生的整体疗效是按中医药理论依法遣药组方对证治疗的结果，因此，要构建适宜中药作用特征的质量评价体系就必须遵循中医药理论去解决“中药有效成分群构成比与药效变化不对等”的科学难题。从中药与人体在自然界生物演化的角度考虑，二者都是生物超分子体，中医药理论本质上是对人体与自然界“分子社会”交流管控规律的揭示，药材的生长、炮制、配伍组方和制剂制备而形成的中药成分群的构成比与药效动态变化规律受控于生物超分子“印迹模板”的印迹作用普遍规律，宜建立以反映“印迹模板”特征的质量标志物（quality marker，Q-Marker）印迹性为指标的质量评价方法。系统梳理单成分化学药和多成分中药质量评价方法的现状，提出建立以Q-Marker为核心的“个体测定，群体分析，印迹表征”的中药新型质量评价体系，解决中药质量控制的关键科学问题和技术难题。

Safety, effectiveness, and controllability are the three main attributes of medicines. The establishment of a suitable quality evaluation system for traditional Chinese medicine (TCM) is the basic condition to ensure controllable quality of TCM. It is related to the key commonality of the clinical safe and effective use of TCM, the development of new drug, and the development of the TCM industry. The problem has attracted much attention in the field of TCM. The overall curative effect of TCM compound prescription is the result of the treatment of syndromes based on the theory of TCM. Therefore, in order to construct a quality evaluation system suitable for the action characteristics of TCM compound prescriptions, it is necessary to follow the theory of TCM to solve the scientific problem of "the composition ratio of the effective component groups of TCM is not equal to the change in efficacy". Considering TCM and the human body from the perspective of biological evolution in nature, both are biological supramolecular bodies. The theory of TCM is essentially to reveal the rules of communication and control between the human body and the natural "molecular society". The composition ratio and the dynamic change rule of the pharmacodynamics of the TCM compound prepared from the growth, processing and compatibility of medicinal materials and the preparation are controlled by the general rule of the imprinting effect of the bio-supramolecular "imprint template", and it is advisable to establish a quality evaluation method using imprintability of quality marker (Q-Marker) reflecting the characteristics of "imprinting template" for the TCM compound prescriptions as an indicator. This article systematically combs the current status of quality evaluation methods for single-component of chemical drugs and multi-component of TCM, and proposes to establish a new quality evaluation system for TCM with Q-Marker as the core, which was composed of "individual determination, group analysis, and imprinting characterization", so as to solve the key scientific and technical problems of the quality control of TCM compound prescriptions.

R282;R284

国家自然科学基金项目（81803729）；长沙市科技计划项目（kq1907137）；湖南省教育厅创新平台开放基金项目（18K071）；湖南省中医药科研项目（2021078）；湖南省药学一流学科开放基金项目（2018YX06，2020YX13）；湖南省自然科学基金青年项目（2019JJ50430）