有效性、安全性和可控性是药品的三大基本属性且相互联系与依托。中药“效-毒”二重性不仅是中药药性的有机组成部分，属于中药的根本属性；而且因其“多成分、多效应、多靶点、配伍应用、长期用药”等中医药特点，导致中药的可控性极端复杂，单一或多个化学成分检测无论是从质量专属性、活性与功效关联度还是毒性与安全性控制等方面都难以保证中药的质量，再加上基原、产地、采收、贮藏、提取等中药固有因素和炮制与配伍应用等中医习惯用法等方面的影响，致使中药质量控制也因此成为制约中医药现代化、国际化和中医药产业发展的关键因素和技术瓶颈。根据刘昌孝院士提出的中药质量标志物（Q-marker）的概念，本研究选择有毒中药吴茱萸为模式药物，开展基于“效-毒”关联评价的Q-marker合理辨识与科学控制研究，为临床合理、安全用药提供质量控制保证。

Effectiveness,safety,and controllability are three basic properties of drugs and contact and rely on each other.The “efficacy-toxicity” dual character which is the basic attribute of traditional Chinese medicine(TCM)is not only an organic part of TCM medicinal properties,but makes TCM quality control become the key to the development of modernization and internationalization of TCM and its industry factors and technical bottleneck.Because of its "composition,effect,multiple targets,coordinating,long-term medication" and other characteristics in TCM,the controllability is extremely complicated.Single or multiple chemical composition test whether from the quality specificity,activity and efficacy or toxicity and safety control is difficult to guarantee the quality of TCM,combined with the inherent factors of TCM,such as the original,producing area,collecting,storage and extracting,and the influence of the usage of TCM and some other aspects,such as processing and coordinating.According to the Chinese traditional medicine quality markers(Q-marker)concept proposed by Liu Changxiao academician,we selected Evodia Fructus as a model drug,carried out the research on reasonable identification and scientific control of Q-marker based on efficacy-toxicity correlation,a reasonable guarantee for the quality control of clinical reasonable medication safety.

科学技术部重点基础研究发展计划“973计划”项目（2009CB522802）：有毒中药的毒性与功效、证候的关系基础研究，负责人：孙蓉；科学技术部“重大新药创制”科技重大专项（2009ZX09502-015）：中药复方药理学研究与药效评价关键技术，负责人：孙蓉；山东省科技厅自主创新和成果转化项目（2014ZZCX02104）：药物安全性评价和适宜于抗肿瘤及缺血性脑血管疾病多靶点和复方新药成药性评价关键技术，负责人：孙蓉；山东省泰山学者工程专项经费资助，特聘专家（ts 201511107）：孙蓉。