康永（中國藥理學(xué)會中藥與天然藥物藥理專業(yè)委員會委員，山西省中醫(yī)藥研究院研究員，主要從事中藥藥理學(xué)研究和中藥新藥開發(fā)。

中藥和天然藥物盡管均來源于天然產(chǎn)物，針對二者的新藥研發(fā)還是有很大區(qū)別的。國家藥品注冊管理體制中對二者的界定也不同，以中醫(yī)藥理論為指導(dǎo)進行研發(fā)的歸為中藥新藥管理，以現(xiàn)代醫(yī)藥學(xué)為指導(dǎo)的歸為天然藥物管理。中藥新藥的應(yīng)用形式以貼近中醫(yī)傳統(tǒng)為主，貫穿整體觀念，強調(diào)辨證論治等。如復(fù)方配伍應(yīng)用和成分綜合利用，以粗制劑為主（如水提的粗制劑，主要是由湯劑來體現(xiàn)，還有丸、散等全粉入藥）。中藥的應(yīng)用在現(xiàn)代以純化的單一成分入藥也是比較少見的，如組分或者有效部位而被稱為組分中藥，以及不同組分配伍形成的復(fù)方，這些新型的用法如果不按中醫(yī)思維進行研發(fā)，那也是應(yīng)該歸為天然藥物的范疇。但國際上的天然藥物主要還是以來源于天然產(chǎn)物的單一成分入藥?！綝espite 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.】

中藥新藥研發(fā)強調(diào)中醫(yī)理論的指導(dǎo)，并不是可有可無的，因為中醫(yī)藥經(jīng)過了大量的實踐驗證。中藥粗制劑和復(fù)方應(yīng)用的特點與中醫(yī)整體觀念、辨證論治的思維相結(jié)合，在臨床應(yīng)用時更容易發(fā)揮其特色和優(yōu)勢。離開了中醫(yī)理論的指導(dǎo)，或者純化程度很高的藥物，臨床效果往往會大打折扣，這與中醫(yī)對疾病分類和歸納的獨特性有直接關(guān)系。大量的事實說明，中藥這種成分整體綜合應(yīng)用的形式更適合用中醫(yī)整體觀念的理論指導(dǎo)應(yīng)用，化學(xué)藥物這樣的成分單一純度高的形式更適合用具體、直觀、數(shù)據(jù)化的西醫(yī)理論指導(dǎo)應(yīng)用，二者結(jié)合在一起可能會在多方面取長補短，但根本的理論指導(dǎo)不能互換，那樣的話二者的應(yīng)用不可能“得心應(yīng)手”，中藥和西藥各自特點的發(fā)揮都會受到很大的影響?！綯he 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.】

中醫(yī)和西醫(yī)對疾病認識的角度有很大的不同。西醫(yī)以形態(tài)學(xué)和生理生化指標(biāo)的變化來分類，中醫(yī)以“望、聞、問、切”四診合參獲得的信息進行綜合分析。當(dāng)然現(xiàn)代中醫(yī)也會結(jié)合現(xiàn)代西醫(yī)手段進行更深入的探究，但最終應(yīng)歸到辨證論治的總體思維來制定根本的治療原則。按照西醫(yī)標(biāo)準(zhǔn)診斷出的不同的“病”，中醫(yī)則按照屬性找出其共性即“證”而“異病同治”；按照西醫(yī)標(biāo)準(zhǔn)診斷出的同一個“病”，中醫(yī)會對其進行辨“證”而“同病異治”。中醫(yī)治病是標(biāo)本兼顧，根據(jù)疾病的緩急，會采用“急則治標(biāo)、緩則治本”的措施，但“急則治標(biāo)”是為了緩解癥狀、迅速控制病情發(fā)展，減輕患者痛苦，最終目的還是要“治病求本”，“本”就是針對疾病的根本原因直指“證”的核心。由于中醫(yī)的原則是透過“病”的現(xiàn)象去看“證”的本質(zhì)，所以才總是突出強調(diào)“辨證論治”。這不是守舊，不是遠離科學(xué)?？茖W(xué)的手段、方法完全可以用在中醫(yī)的診斷和治療之中?，F(xiàn)代中醫(yī)也不是只認陰陽五行，現(xiàn)代中醫(yī)也大量應(yīng)用現(xiàn)代技術(shù)，如現(xiàn)代指標(biāo)的檢測和觀察到的形態(tài)的改變，再結(jié)合“望、聞、問、切”等獲取到的各類信息，在此基礎(chǔ)上進行另一種的分析和歸納，并采取相應(yīng)措施。因此，掌握基本的中醫(yī)理論，理解中醫(yī)的概念和理念，對研發(fā)中藥新藥至關(guān)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.】

天然藥物的研發(fā)模式和現(xiàn)代醫(yī)學(xué)更吻合，似乎這是一個實現(xiàn)中藥國際化比較快的途徑。但這只是使中藥的發(fā)展一部分走向了天然藥物的方向，這樣的模式并不能使中醫(yī)藥的精華、特色和優(yōu)勢發(fā)揚光大，不利于中醫(yī)藥傳承！因此，要想按照中醫(yī)藥自身的規(guī)律去實現(xiàn)中藥的國際化，我們需要進行不懈的努力，加強中醫(yī)理念的宣傳，擴大中醫(yī)藥理論的國際交流，以此作為一個長期目標(biāo)，才能真正地實現(xiàn)中醫(yī)藥國際化，讓全人類受益?！綯he 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.】