中药新药研发现状及国际化的思考

陈兰英（中国药理学会中药与天然药物药理专业委员会委员，江西中医药大学教授，主要从事中药药效评价及机制研究。）

由于中医药属于传统医学的范畴，从事中医药研究工作者常常会感觉自己在古代和现代中穿越，尽管按道理来讲，中医和中药是不可分的，但事实上却是中医还在忙于“望、闻、问、切”及辨证论治时，中药早已采用现代先进技术，在西医理论指导下如火如荼地开展研究，并且还取得了不少可喜的成绩。【As 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 中药新药研究的现状【Status of new drugs in traditional Chinese medicine research】

自从20世纪20年代，袁淑范研究了何首乌浸膏与蒽醌衍生物对动物肠管运动的影响、陈克恢研究麻黄碱具有类似肾上腺素样作用后，中药的研究形成了一条延续至今的西医理论指导下的化学药模式。几十年来，已经取得了不少骄人的成绩，尤其是一些以有效成分或有效部分入药的创新中药，如青蒿素、川芎嗪、麻黄碱素、小檗碱、苦参碱、丹参酮、葛根黄酮和麝香酮等，以其疗效确切、质量稳定、使用方便等优势成为临床常用药，甚至某些方面超越了传统中药膏、丹、丸、散等剂型，其中屠呦呦研究的抗疟疾成分青蒿素成果获得了诺贝尔奖。【Since 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.】

但很多中药制剂，尤其是中成药在临床的使用和地位仍然令人担忧。中成药是以中草药为原料，严格按照中医复方标准和中药制剂要求，经现代制药工艺加工制成的各种剂型的药物，虽然医院（主要是西医医院）都在使用中成药，但所用中成药占全部药物的比例均比较低，并且存在滥用现象，更谈不上中医药理论指导下的合理用药了。对于中药研究者来说，除了中医记载内容成了研究中药的来源依据，研究内容和思路早已与中医理论的核心思想脱离。【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 中药新药国际化的思考【Reflection on new drugs in traditional Chinese medicine global⁃ization】

中药新药国际化就是中药新药研究、开发、管理和生产均必须具有“被国际社会认可”的特征，中药新药能够成为具有国际竞争力的产业。然而，目前中医药在大部分国家仍然处于补充和替代地位，尚未完全纳入主流医学体系，严重制约了中医药国际化发展。究其根源，在于中医的科学性在国际上始终未得到真正认可，中医药学独立的学术地位始终没有得到正视和承认。【The 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.】

由于中医药在科研领域尚未与国际完全接轨，国际社会对中医药科研成果的认可度不高，中药新药有可能为了迎合国际化市场而导致西药化。中药新药应该是继承了五千年中医传统的现代化和国际化，而不是中药的西药化。无论是中药国际化还是中药创新，都必须与中医药理论紧密相连，中药新药的国际化才是真正意义上的国际化创新中药。【As 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.】

中药国际化的关键是要在国际上传扬中医药文化，建立文化自信。同时，在中药现代化研究的过程中，也应加强对中医理论的认识和研究，对中医药理论的相关研究抱以开放、包容和鼓励的心态，而不是以SCI论文的发表来衡量中医药的研究成果。由于文化背景的差异，在相当长的时期内，西方国家不可能完全接受中医药，而与中国历史文化背景相似的广大东南亚地区，可能是中医药走向世界主流医药市场的最佳方式。习总书记分别提出建设“新丝绸之路经济带”和“21世纪海上丝绸之路”的战略构想。“一带一路”是中医药事业发展的新契机，该战略正在助推中医药事业走向世界。【The 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.】