中药新药研发国际化的困难和希望

王月华（中国药理学会中药与天然药物药理专业委员会委员兼副秘书长，中国医学科学院药物研究所副研究员，主要从事新药发现及心脑血管药理学研究。）

中医药是世界传统医药的重要组成部分，但中药新药研发国际化仍存在一定的困难和挑战。随着青蒿素的研究荣获2015年诺贝尔奖，以及国家“一带一路”战略布局的推动，借鉴现代医学诠释中医药国际化时代已经到来，但任务也极其艰巨。【Despite the fact that TCM is an important part of the traditional medicine in the world,there are still some difficulties and challenges in the inter⁃nationalization of the research and development of new drugs of TCM.In the wake of the study of artemisinin which was awarded the 2015 Nobel Prize,and the promotion of national"Belt and Road Initiative"strategic layout,the age has come when the internationalization of TCM can be interpreted via modern medicine,which is also extremely hard.】

中医是在古代朴素的唯物论和辩证法思想指导下，通过长期医疗实践逐步形成并发展形成的医学理论体系。整体观和辨证论治是中医的两大特点：整体是指人体的统一性和完整性；辨证论治是中医学认识疾病和治疗疾病的过程。中医是在几千年应用的基础上总结出的中医应用的科学结果，是一种经验性总结。因此，应用现代科技手段阐明中医的理论和应用是一项艰巨任务。【TCM is a medical theory system which has been formed and devel⁃oped gradually through long-term medical prac⁃tice under the guidance of ancient simple materi⁃alism and dialectical thought.Holism and treat⁃ment based on differentiation of syndrome mainly characterize TCM:the former refers to the unity and integration of the human body and the latter is the process of understanding and treating diseases in TCM,which is the scientific result of applica⁃tion for thousands of years,hence an empirical summary.Therefore,it is an arduous task to clarify the theory and application of TCM by modern scientific and technological means.】

中药药理学是在中医药理论指导下，运用现代科学技术，研究中药与机体相互作用及其作用规律的科学。目前，很多人把中药药理学当作天然药物药理学，认为是用药理学方法研究中药，而忽视了中医药理论的指导。应用中医理论指导中药药理研究和中药新药研发面临的很多问题有待解决：如何以西医的标准建立“证”的模型来模拟疾病的不同状态？如何建立评价标准和检测体系来反映疾病的状态？中药药理如何解释中医表述的中药的功效？如何以定量的手段诠释“辨证论治”？【TCM pharmacology is a science that utilizes modern science and technology to study the interactions between TCM and the human body.At present,many people who take TCM pharmacology as natural product pharmacology consider that phar⁃macological methods are to be used to study TCM,only to ignore the guidance of the theory of TCM.Many problems are facing the application of the theory of TCM to guide the study of phar⁃macology of TCM and to guide the research and development of new Chinese medicine:How to simulate different states of diseases by establishing"manifestation"models up to the standard of western medicine?How to establish the evalua⁃tion criteria and detection system to reflect the condition of the disease?How does the pharma⁃cology of TCM explain the efficacy of TCM?How to interpret"treatment based on differentiation of syndrome"by quantitative means?】

目前，针对中药新药研究开发遇到的问题，我国已经建立了一系列政策法规和技术标准，并不断在实践中完善、补充和提高，逐步实现科学化、规范化、标准化和法制化。虽然近年来中医药国际化发展遇到一些困难和挑战，但中医药在世界范围内认可度仍然得到较大的提升。随着中医药“走出去”力度不断加大，随着全球中医药专家交流平台的搭建，中医药国际化发展将迎来新的机遇，具备良好的传播与发展前景。【At present,aiming at the problems encountered in the research and devel⁃opment of new drugs of TCM,China has estab⁃lished a series of policies,regulations and technical standards,which are constantly perfected,comple⁃mented and improved in practice so as to gradu⁃ally realize scientific validity,standardization and legalization.Despite some difficulties and chal⁃lenges encountered in the international develop⁃ment of TCM in recent years,the recognition of TCM has been improved greatly in the world.With the increasing development of"going global"in TCM and the establishment of global communi⁃cation platforms for TCM experts, the internationalization of TCM will usher in new opportunities and have good prospects for communication and development.】