中藥新藥研發(fā)國(guó)際化的困難和希望

王月華（中國(guó)藥理學(xué)會(huì)中藥與天然藥物藥理專業(yè)委員會(huì)委員兼副秘書長(zhǎng)，中國(guó)醫(yī)學(xué)科學(xué)院藥物研究所副研究員，主要從事新藥發(fā)現(xiàn)及心腦血管藥理學(xué)研究。）

中醫(yī)藥是世界傳統(tǒng)醫(yī)藥的重要組成部分，但中藥新藥研發(fā)國(guó)際化仍存在一定的困難和挑戰(zhàn)。隨著青蒿素的研究榮獲2015年諾貝爾獎(jiǎng)，以及國(guó)家“一帶一路”戰(zhàn)略布局的推動(dòng)，借鑒現(xiàn)代醫(yī)學(xué)詮釋中醫(yī)藥國(guó)際化時(shí)代已經(jīng)到來(lái)，但任務(wù)也極其艱巨?！綝espite 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.】

中醫(yī)是在古代樸素的唯物論和辯證法思想指導(dǎo)下，通過(guò)長(zhǎng)期醫(yī)療實(shí)踐逐步形成并發(fā)展形成的醫(yī)學(xué)理論體系。整體觀和辨證論治是中醫(yī)的兩大特點(diǎn)：整體是指人體的統(tǒng)一性和完整性；辨證論治是中醫(yī)學(xué)認(rèn)識(shí)疾病和治療疾病的過(guò)程。中醫(yī)是在幾千年應(yīng)用的基礎(chǔ)上總結(jié)出的中醫(yī)應(yīng)用的科學(xué)結(jié)果，是一種經(jīng)驗(yàn)性總結(jié)。因此，應(yīng)用現(xiàn)代科技手段闡明中醫(yī)的理論和應(yīng)用是一項(xiàng)艱巨任務(wù)?！綯CM 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.】

中藥藥理學(xué)是在中醫(yī)藥理論指導(dǎo)下，運(yùn)用現(xiàn)代科學(xué)技術(shù)，研究中藥與機(jī)體相互作用及其作用規(guī)律的科學(xué)。目前，很多人把中藥藥理學(xué)當(dāng)作天然藥物藥理學(xué)，認(rèn)為是用藥理學(xué)方法研究中藥，而忽視了中醫(yī)藥理論的指導(dǎo)。應(yīng)用中醫(yī)理論指導(dǎo)中藥藥理研究和中藥新藥研發(fā)面臨的很多問(wèn)題有待解決：如何以西醫(yī)的標(biāo)準(zhǔn)建立“證”的模型來(lái)模擬疾病的不同狀態(tài)？如何建立評(píng)價(jià)標(biāo)準(zhǔn)和檢測(cè)體系來(lái)反映疾病的狀態(tài)？中藥藥理如何解釋中醫(yī)表述的中藥的功效？如何以定量的手段詮釋“辨證論治”？【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，針對(duì)中藥新藥研究開發(fā)遇到的問(wèn)題，我國(guó)已經(jīng)建立了一系列政策法規(guī)和技術(shù)標(biāo)準(zhǔn)，并不斷在實(shí)踐中完善、補(bǔ)充和提高，逐步實(shí)現(xiàn)科學(xué)化、規(guī)范化、標(biāo)準(zhǔn)化和法制化。雖然近年來(lái)中醫(yī)藥國(guó)際化發(fā)展遇到一些困難和挑戰(zhàn)，但中醫(yī)藥在世界范圍內(nèi)認(rèn)可度仍然得到較大的提升。隨著中醫(yī)藥“走出去”力度不斷加大，隨著全球中醫(yī)藥專家交流平臺(tái)的搭建，中醫(yī)藥國(guó)際化發(fā)展將迎來(lái)新的機(jī)遇，具備良好的傳播與發(fā)展前景?！続t 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.】