陳蘭英（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，江西中醫(yī)藥大學(xué)教授，主要從事中藥藥效評(píng)價(jià)及機(jī)制研究。）

由于中醫(yī)藥屬于傳統(tǒng)醫(yī)學(xué)的范疇，從事中醫(yī)藥研究工作者常常會(huì)感覺自己在古代和現(xiàn)代中穿越，盡管按道理來(lái)講，中醫(yī)和中藥是不可分的，但事實(shí)上卻是中醫(yī)還在忙于“望、聞、問(wèn)、切”及辨證論治時(shí)，中藥早已采用現(xiàn)代先進(jìn)技術(shù)，在西醫(yī)理論指導(dǎo)下如火如荼地開展研究，并且還取得了不少可喜的成績(jī)?！続s TCM belongs to the category of tradi?tional medical sciences,practitioners engaged in research of TCM often feel themselves crossing between ancient and modern times.Although traditional Chinese medical treatment and TCM pharmacology are justifiably inseparable,Chinese medicine practitioners are actually still busy with"inspection,listening and smelling examination,inquiry and palpation"and treatment based on syndrome differentiation,while TCM has long used modern advanced technology to carry out research in full swing under the guidance of western medicine theories and has also made a lot of gratifying achievements.】

1 中藥新藥研究的現(xiàn)狀【Status of new drugs in traditional Chinese medicine research】

自從20世紀(jì)20年代，袁淑范研究了何首烏浸膏與蒽醌衍生物對(duì)動(dòng)物腸管運(yùn)動(dòng)的影響、陳克恢研究麻黃堿具有類似腎上腺素樣作用后，中藥的研究形成了一條延續(xù)至今的西醫(yī)理論指導(dǎo)下的化學(xué)藥模式。幾十年來(lái)，已經(jīng)取得了不少驕人的成績(jī)，尤其是一些以有效成分或有效部分入藥的創(chuàng)新中藥，如青蒿素、川芎嗪、麻黃堿素、小檗堿、苦參堿、丹參酮、葛根黃酮和麝香酮等，以其療效確切、質(zhì)量穩(wěn)定、使用方便等優(yōu)勢(shì)成為臨床常用藥，甚至某些方面超越了傳統(tǒng)中藥膏、丹、丸、散等劑型，其中屠呦呦研究的抗瘧疾成分青蒿素成果獲得了諾貝爾獎(jiǎng)?！維ince YUAN Shu-fan studied the effect ofPolygonum multiflorumextract and anthraquinone derivatives on intestine movement and CHEN Ke-hui′s research found that ephedrine had a similar adrenaline-like effect in the 1920 s,the study of TCM has formed a chemical drug model which has continued up to the present under the guidance ofwestern medicine theories.For decades,many impressive achievements have been made.In particular,some innovative Chinese medicines,such as artemisinin,ligustrazine,ephedrine,berberine,matrine,tanshinone,Puer?aria lobataflavonoids and musk ketone,have become clinically commonly used drugs thanks to their strong curative effect,stable quality and user-friendliness,and even surpassed some of the TCM ointments,Dan,pills,powder and other dosage forms.For instance,Professor TU Yo-yo won the Nobel Prize for studying artemisinin,an antimalarial component.】

但很多中藥制劑，尤其是中成藥在臨床的使用和地位仍然令人擔(dān)憂。中成藥是以中草藥為原料，嚴(yán)格按照中醫(yī)復(fù)方標(biāo)準(zhǔn)和中藥制劑要求，經(jīng)現(xiàn)代制藥工藝加工制成的各種劑型的藥物，雖然醫(yī)院（主要是西醫(yī)醫(yī)院）都在使用中成藥，但所用中成藥占全部藥物的比例均比較低，并且存在濫用現(xiàn)象，更談不上中醫(yī)藥理論指導(dǎo)下的合理用藥了。對(duì)于中藥研究者來(lái)說(shuō)，除了中醫(yī)記載內(nèi)容成了研究中藥的來(lái)源依據(jù)，研究?jī)?nèi)容和思路早已與中醫(yī)理論的核心思想脫離。【However,many TCM preparations,especially Chinese patent medicines,remain a cause for concern in clinical use and position.Chinese patentmedicines are made from Chinese herbal medicines in strict accordance with the standards of compound prescriptions and TCM preparations.Although hospitals(mainly western medicine hospitals)are using Chinese patent medicines,their proportion of used in all medicines is relatively low,and there is abuse,not to mention the rational use of medicines under the guidance of TCM theory.For TCM researchers,ancient books and records of TCM have become the resources and basis for the study of TCM,but research content and ideas have long been detached from the core ideas of TCM theory.】

2 中藥新藥國(guó)際化的思考【Reflection on new drugs in traditional Chinese medicine global?ization】

中藥新藥國(guó)際化就是中藥新藥研究、開發(fā)、管理和生產(chǎn)均必須具有“被國(guó)際社會(huì)認(rèn)可”的特征，中藥新藥能夠成為具有國(guó)際競(jìng)爭(zhēng)力的產(chǎn)業(yè)。然而，目前中醫(yī)藥在大部分國(guó)家仍然處于補(bǔ)充和替代地位，尚未完全納入主流醫(yī)學(xué)體系，嚴(yán)重制約了中醫(yī)藥國(guó)際化發(fā)展。究其根源，在于中醫(yī)的科學(xué)性在國(guó)際上始終未得到真正認(rèn)可，中醫(yī)藥學(xué)獨(dú)立的學(xué)術(shù)地位始終沒(méi)有得到正視和承認(rèn)?！綯he globalization of TCM means that the new drug research,development,management and production must be"recog?nized by the international community",and that new drugs of TCM can become an internationally competitive industry.However,at present,TCM is still supplementary and alternative,far from fully integrated into the mainstream medical system in the most countries,which poses a huge obstacle to the internationalization of TCM.The root of the problem lies in the fact that the scientific validity of TCM has not really been confirmed worldwide.WhetherTCM has independent academic status has not been directly addressed or recognized.】

由于中醫(yī)藥在科研領(lǐng)域尚未與國(guó)際完全接軌，國(guó)際社會(huì)對(duì)中醫(yī)藥科研成果的認(rèn)可度不高，中藥新藥有可能為了迎合國(guó)際化市場(chǎng)而導(dǎo)致西藥化。中藥新藥應(yīng)該是繼承了五千年中醫(yī)傳統(tǒng)的現(xiàn)代化和國(guó)際化，而不是中藥的西藥化。無(wú)論是中藥國(guó)際化還是中藥創(chuàng)新，都必須與中醫(yī)藥理論緊密相連，中藥新藥的國(guó)際化才是真正意義上的國(guó)際化創(chuàng)新中藥?！続s TCM has not yet been fully integrated into the international community in the field of scientific research,the achievements made by TCM research are not well-known to the interna?tional community.New drugs of TCM may become westernized in order to cater to the international market.New drugs of TCM should be modernized and globalized by inheriting the fruits of five thou?sand years of TCM rather than becoming western?ized.Both globalization and innovation of TCM must be closely linked to the theory of TCM.Only in this way can the internationalization of new drugs of TCM lead to truly international innova?tive TCM.】

中藥國(guó)際化的關(guān)鍵是要在國(guó)際上傳揚(yáng)中醫(yī)藥文化，建立文化自信。同時(shí)，在中藥現(xiàn)代化研究的過(guò)程中，也應(yīng)加強(qiáng)對(duì)中醫(yī)理論的認(rèn)識(shí)和研究，對(duì)中醫(yī)藥理論的相關(guān)研究抱以開放、包容和鼓勵(lì)的心態(tài)，而不是以SCI論文的發(fā)表來(lái)衡量中醫(yī)藥的研究成果。由于文化背景的差異，在相當(dāng)長(zhǎng)的時(shí)期內(nèi)，西方國(guó)家不可能完全接受中醫(yī)藥，而與中國(guó)歷史文化背景相似的廣大東南亞地區(qū)，可能是中醫(yī)藥走向世界主流醫(yī)藥市場(chǎng)的最佳方式。習(xí)總書記分別提出建設(shè)“新絲綢之路經(jīng)濟(jì)帶”和“21世紀(jì)海上絲綢之路”的戰(zhàn)略構(gòu)想?！耙粠б宦贰笔侵嗅t(yī)藥事業(yè)發(fā)展的新契機(jī)，該戰(zhàn)略正在助推中醫(yī)藥事業(yè)走向世界?！綯he key to internationalizing TCM is to promote the culture of TCM and establish cultural confi?dence in the international community.Mean?while,in the process of modernizing TCM,we should also strengthen our understanding and research of TCM theory,and make relevant studies on TCM theory with the mindset of being open,inclusive and hortative,rather than adopting the publication of"SCIpapers"as a measurement of the research results of TCM.Due to differences in cultural backgrounds,it is impossible for western countries to fully accept TCM for a long period of time.The vast majority of Southeast Asian coun?tries with similar historical and cultural back?grounds to China may be the best way for TCM to enter the mainstream pharmaceutical market in the world.General Secretary XI Jin-ping proposed the strategic concept of building the"New Silk Road Economic Belt"and ″the 21stCentury Mari?time Silk Road"."Belt and Road"is a new oppor?tunity for the development of TCM.This strategy is boosting the cause of TCM to the world.】