加强中医理念的宣传，扩大中医药理论的国际交流，坚持不懈，才能真正地实现中医药国际化

康永（中国药理学会中药与天然药物药理专业委员会委员，山西省中医药研究院研究员，主要从事中药药理学研究和中药新药开发。

中药和天然药物尽管均来源于天然产物，针对二者的新药研发还是有很大区别的。国家药品注册管理体制中对二者的界定也不同，以中医药理论为指导进行研发的归为中药新药管理，以现代医药学为指导的归为天然药物管理。中药新药的应用形式以贴近中医传统为主，贯穿整体观念，强调辨证论治等。如复方配伍应用和成分综合利用，以粗制剂为主（如水提的粗制剂，主要是由汤剂来体现，还有丸、散等全粉入药）。中药的应用在现代以纯化的单一成分入药也是比较少见的，如组分或者有效部位而被称为组分中药，以及不同组分配伍形成的复方，这些新型的用法如果不按中医思维进行研发，那也是应该归为天然药物的范畴。但国际上的天然药物主要还是以来源于天然产物的单一成分入药。【Despite the fact that both TCM and natural medicine are derived from naturalproducts,there is huge difference between their research and development of new drugs.And their defini⁃tions are also different in the National Drug Reg⁃istration and Management System.Research that is guided by the theory of TCM are classified into the administration of new TCM and others guided by modern medicine is classified into admin⁃istration of natural medicine.The form in which new drugs of TCM are applied is mainly close to traditions,and it is consistent with the idea of holism which emphasizes syndrome differentiation and treatment.For example,the compound compati⁃bility and comprehensive utilization of ingredients mainly involve crude preparations(such as the crude preparation extracted by water,mainly presented in the form of decoction,as well as pill powder and other whole powder used as medi⁃cine).In modern times,it is rarely seen that TCM is used in a purified single component.The compo⁃nents or those that are called the effective parts are called the components of TCM,as well as the combination of different components of the compound.These new uses,if not researched or developed in accordance with TCM,should be classified into the category of natural drugs.However,the internationally used natural drugs are mainly a single component derived from natural products.】

中药新药研发强调中医理论的指导，并不是可有可无的，因为中医药经过了大量的实践验证。中药粗制剂和复方应用的特点与中医整体观念、辨证论治的思维相结合，在临床应用时更容易发挥其特色和优势。离开了中医理论的指导，或者纯化程度很高的药物，临床效果往往会大打折扣，这与中医对疾病分类和归纳的独特性有直接关系。大量的事实说明，中药这种成分整体综合应用的形式更适合用中医整体观念的理论指导应用，化学药物这样的成分单一纯度高的形式更适合用具体、直观、数据化的西医理论指导应用，二者结合在一起可能会在多方面取长补短，但根本的理论指导不能互换，那样的话二者的应用不可能“得心应手”，中药和西药各自特点的发挥都会受到很大的影响。【The research and development of TCM emphasizes the guidance of theory of TCM and it is not dispens⁃able,because TCM has been proved by a large amount of practice.When crude preparations of TCM and characteristics of applications of combi⁃nation regimens are combined with the overall concept and the thinking of syndrome differentia⁃tion,it is easier to show the features and advan⁃tages in clinical practice.Without the guidance of TCM theory,even a high degree of purification can also greatly reduce the clinical effects,which is directly related to the uniqueness of TCM classifi⁃cation and induction of disease.A large number of facts show that the overall and comprehensive application of TCM is more suited to the guid⁃ance of the overall concept.Drugs like chemicals that are composed of such a single high purity form can be better guided by specific,intuitive,data-based western medicine theory.When the two are combined,they may learn from each other in many ways.But the fundamental theoretical guidance cannot be interchanged,so that the application of the two cannot be"easy"and char⁃acteristics of both TCM and western medicine are to be greatly affected.】

中医和西医对疾病认识的角度有很大的不同。西医以形态学和生理生化指标的变化来分类，中医以“望、闻、问、切”四诊合参获得的信息进行综合分析。当然现代中医也会结合现代西医手段进行更深入的探究，但最终应归到辨证论治的总体思维来制定根本的治疗原则。按照西医标准诊断出的不同的“病”，中医则按照属性找出其共性即“证”而“异病同治”；按照西医标准诊断出的同一个“病”，中医会对其进行辨“证”而“同病异治”。中医治病是标本兼顾，根据疾病的缓急，会采用“急则治标、缓则治本”的措施，但“急则治标”是为了缓解症状、迅速控制病情发展，减轻患者痛苦，最终目的还是要“治病求本”，“本”就是针对疾病的根本原因直指“证”的核心。由于中医的原则是透过“病”的现象去看“证”的本质，所以才总是突出强调“辨证论治”。这不是守旧，不是远离科学。科学的手段、方法完全可以用在中医的诊断和治疗之中。现代中医也不是只认阴阳五行，现代中医也大量应用现代技术，如现代指标的检测和观察到的形态的改变，再结合“望、闻、问、切”等获取到的各类信息，在此基础上进行另一种的分析和归纳，并采取相应措施。因此，掌握基本的中医理论，理解中医的概念和理念，对研发中药新药至关重要。【TCM and western medicine have many different points of views on diseases.Western medicine requires classification according to the changes of physio⁃logicalandbiochemicalindexeswhileTCM makes comprehensive analysis of the informa⁃tion obtained using the four diagnostic methods:"inspection,auscultation and olfaction,inquiry and palpation".Of course,modern TCM will be combined with modern western medicine to conduct a more in-depth exploration,but it should go back to the overall thinking of treatment based on syndrome differentiation and treatment to formulate fundamental treatment principles ulti⁃mately.When western medicine diagnoses different"diseases"according to diagnostic criteria of western medicine,TCM finds its common"syn⁃drome"in accordance with the characteristic,that is,"treating different disease with the same method".While western medicine diagnoses the same"disease"according to diagnostic criteria of western medicine,TCM will diagnose its"syn⁃drome"and"treating the same disease with different methods".The treatment by TCM is both superficial and radical,based on the belief that"symptomatic treatment in emergency cases,root cause treatment in non-emergency cases"according to the urgency of the disease.However,the"emergency rule"is to relieve symptoms,take rapid control of disease progression and reduce patient suffering.The ultimate goal is to"cure the disease".And to"cure the disease"is to the uproot the cause of the disease,which is clearly focused on the core of the"syndrome".Therefore,the principle of TCM is to look at the nature of the"syndrome"through the phenomena of the"disease",so"syndrome differentiation and treatment"are always emphasized.This is not conservative,not far from science,and the scientific method can be used in the diagnosis and treatment with TCM.Modern TCM not only distinguishesYinfromYangand the "Five Elements",but also make extensive use of mod⁃ern technology,such as modern index tests and observations of morphological changes,combined with"inspection,auscultation and olfaction,inquiry and palpation"and other accessible information.On this basis,a second analysis and induction are undertaken before taking appropriate measures.Therefore are undertaken before,mastering the basictheoryofTCM andunderstandingits concepts are of crucial importance for the devel⁃opment of new Chinese medicine.】

天然药物的研发模式和现代医学更吻合，似乎这是一个实现中药国际化比较快的途径。但这只是使中药的发展一部分走向了天然药物的方向，这样的模式并不能使中医药的精华、特色和优势发扬光大，不利于中医药传承！因此，要想按照中医药自身的规律去实现中药的国际化，我们需要进行不懈的努力，加强中医理念的宣传，扩大中医药理论的国际交流，以此作为一个长期目标，才能真正地实现中医药国际化，让全人类受益。【The research and development model of natural medicine is more consistent with that of modern medicine,which seems to be a faster approach to the inter⁃nationalization of TCM.Despite the fact that this model steers part of the development of TCM into the direction of natural medicine,such a model fails to highlight the essence,features and advan⁃tages of TCM,so it is not conducive to the future development of TCM.Therefore,in order to achieve the internationalization of TCM in accor⁃dance with the internal rule,we need to make uncompromising efforts,make the concepts of TCM better-known,expand the international exchange of TCM theories and take these as a long-term goal so that we can truly achieve the internationalization of TCM and benefit all mankind.】