中药与天然药物研发途径的选择

齐云（中国药理学会中药与天然药物药理专业委员会委员，中国医学科学院药用植物研究所研究员，主要从事植物药的抗炎免疫及中药注射剂速发性毒性分子机制研究。）

中药新药及健康产品研发当然应当在国家的政策法规之下运行。刚刚颁布的中药、天然药物注册分类对中药及天然药物有明确的限定。中药是指在我国中医药理论指导下使用的天然药物及其制剂，而天然药物则为在现代医药理论指导下使用的天然药用物质及其制剂。具体分了5类，分别为创新药、改良型新药、古代经典名方、同方类似药及进口药。在创新药中又包括单方与复方制剂2种。研究开发的途径从注册分类的角度，不外就2种，即在中医药理论指导下的中药新药（及健康产品）的研发，及在现代医药理论指导下的天然药物新药（及健康产品）的研发。客观上讲，2种完全不同的研发途径长期并存且常有孰优孰劣、甚至孰正孰邪的争议。其实，从国家的层面及患者的角度看，无论是从哪条途径开发出来的产品，只要符合安全、有效及质量可控的三大条件，均是有益于社会的，是应当受到欢迎的。不存在什么途径优（或正）或什么途径劣（或邪）的问题。因此，跳出小行业局限，从更高层级去考虑这个问题，会发现纠结于是在中医药理论指导还是现代医药理论指导下进行研究，其实是没有任何实际意义的。对国家而言，关注的是是否能促进社会的进步；对患者而言，关注的是是否对疾病确有疗效；对研究者而言，选择什么样的途径进行产品的研发，往往与其自身知识结构、遇到的实际问题等密切相关，并非完全由主观意愿所决定。以屠呦呦教授发现青蒿素而言，可能在研发阶段更多的采用的是现代医药理论指导，具有更多的天然药物研发的特征，诺奖委员会在颁奖中特别申明这不是针对中医药的奖项。但从屠呦呦教授实际研发过程，我们又能清楚地看到，屠教授在提取抗疟有效成分时，明显受到了传统用药经验的影响，甚至对获得青蒿素起到了决定性作用。因此，任何一个务实的研究者，都应当把如何才能研发出优良的产品［而真正优良的产品为世界所接受（即国际化）只是一个时间问题］放到考量的第一位，能够达成这个目标的途径就是好的途径。其实，在青蒿素的研究中，屠呦呦教授既采用现代医药理论指导，又充分重视传统中医的临床经验。行业与学会将来应当把关注重点与途径转向关注产品，好产品不问出身。只有这样，才能在行业形成一个百花齐放、产品层出不穷的局面。希望我们一起为这个局面而努力。【The research and development of new drugs and health products of TCM should of course proceed under the policies and regula⁃tions of the country.In the Guidelines for Regis⁃tration and Classification of TCM and Nature Drugs which were published recently,there are clear definitions of TCM and natural drugs.TCM refers to natural medicines and their prepara⁃tions under the guidance of TCM theory,while natural drugs are natural medicinal substances and their preparations under the guidance of modern medicine theory.These medicines are divided into five categories,namely innovative drugs,modified new drugs,historic classic recipes and their analogues and imported drugs.Besides,innovative drugs include single and compound preparations.Seen from the perspective of regis⁃tration and classification,there are no more than two ways to research and develop,namely the research and development of new drugs(and health products)under the guidance of TCM theory,or modern medicine theory.Objectively speaking,the two absolutely different ways will coexist for a long time and a dispute persists about which is superior.In fact,from both the country′s and patients′points of view,whatever the way products are developed,society will benefit as long as the products meet the top three requirements of safety,effectiveness and quality control,and they should be welcomed.There is no telling which is superior or inferior.Therefore,breaking the limitations of small industries and considering this problem at a higher level,we will find that it makes no sense to be entangled with the problem of which guidance to follow,the TCM or the modern medicine theory.The country is concerned with whether it can promote social progress;for patients,the concern is whether there is a curative effect on diseases;for the researchers,which research approach to take is closely related to their own knowledge structure and the practical problems encountered rather than being completely determined by subjective intention.Take Professor TU′s discovery of arte⁃misinin as an instance,she may have applied more modern medicine theory in the course of development which is more characterized by the natural drugs development,so the Nobel Prize Committee stated in the awards that it was not an award for TCM.But from the actual process of development,we can see clearly that Professor TU′s extraction of antimalarial active ingredients was obviously influenced by the traditional expe⁃rience of drug use,which even played a decisive role in the obtainment of artemisinin.Therefore,any pragmatic researchers should give top priority to how to develop excellent products[the world⁃wide recognition of which is only a matter of time].Any way to achieve the goal is a good one.In fact,in the study of artemisinin,Professor TU not only applied modern medical theory but gave much weight to clinical experience of TCM.Both the practitioners in industries and the researchers in the society should switch atten⁃tion to products in the future,since the true good product will never be stopped by its origin.Only in this way can all flowers blossom together and products emerge in an endless stream in the industry,to which I hope we will work together and make a difference.】