传统药物产业化是中药创新发展的重要途径

杜冠华（中国药理学会原理事长，中国药理学会中药与天然药物药理专业委员会副主任委员，中国医学科学院药物研究所研究员，主要从事药物发现、高通量药物筛选、神经药理学和心脑血管药理学研究。）

我国的传统药物有着悠久的临床应用历史，并积累了丰富的临床应用经验和资料，形成了比较完整的药学科学理论体系和科学的应用方式。我们目前认识的中药即传统药物在应用的历史过程中，主要有2种应用方式。第一种是由医生根据病情进行遣药组方，经煎煮或一定的处理方法使用，并在治疗过程中不断对处方进行调整，以达到最佳治疗效果；第二种方式是经过特定工艺制成固定处方的成药，在临床上给适合的患者使用，并根据患者的疾病情况进行适当的剂量调整。这2种应用方式互相补充，形成了传统医药学的治疗模式和系统。【TCM has a long history of clinical application,and has accumulated a wealth of clinical experi⁃ence and information enough to form a relatively complete theoretical system of pharmaceutical science and scientific application.The TCM that we currently know has mainly two application modes in the process of application.The first is to prescribe TCM prescriptions by the doctor,which are used after boiling or after some processing and continue to be adjusted in order to achieve the best treatment effect according to the disease.The second way is a specific process formulated into a Chinese patent drug,which used for the right patients,followed by the appropriate dose adjustment according to the patient′s condition.These two application methods complement each other,forming a traditional medical treatment model and system.】

1 传统药物的现代产业化是传统成药的提升【Modern industrialization of traditional medi⁃cines contribute to improvement of Chinese traditional patent medicines】

中药有大量的传统成药应用于临床，在防治人类疾病中发挥着积极作用。现代工业化的技术引进，实现这些成药的产业化和规模化生产，不仅可以提高产量，更重要的是提高了产品的均一度，有效控制药物的质量。这些药物可以按照传统的方法使用，保持了全部传统药物的特点，在生产技术提升的基础上实现规模化。但是，传统成药的产业化对于药物本身来说，仅仅是对这些传统药物的传承，并不能在根本上实现传统药物的提升和创新。【TCM has a large number of Chinese traditional patent medicines used in clinical practice,which are playing positive roles in prevention and treat⁃ment of human diseases.Due to the introduction of modern industrial technology,the industrializa⁃tion and large-scale production of Chinese tradi⁃tional patent medicines have been made possible,which not only improves the output but also,more importantly,increases the uniformity of products and effectively controls the quality of medicines.These drugs can be used in accordance with the traditional methods and maintain all the properties of TCM,based on the upgrading of production technology to remain large-scale.However,for medicine itself,the industrialization of TCM is merely the inheritance of traditional drugs,which cannot fundamentally bring about the promotion and innovation of TCM.】

2 传统药物的现代产业化发展推动了传统成药的提升和改造【Modern industrialization of tradi⁃tional medicines has promoted upgrading and reform of Chinese traditional patent medi⁃cines】

长期以来，人们已经认识到传统的成药，包括丸、散、膏和丹等各种剂型，与现代药物相比具有极大的差异。为了改变这种现状，科研人员进行了改进。经过多年的努力，在中药成药的剂型方面取得了突破性进步和发展。在剂型改造的同时，更重要的是通过研究，在药物成分及有效性方面进行了大量的确证性研究，也提升了这些药物内涵的水平。如传统的六味地黄丸，现在已有六味地黄软胶囊和六味地黄胶囊等。【For a long time,people have realized that the forms of TCM,including pills,powders,ointments and Dan,are considerably different from modern medicines.In order to change the status quo,scientists have made improvements.After years of efforts,we have made breakthroughs and development in the formu⁃lation of TCM.Along with formulation modifica⁃tion,more importantly,a large number of confir⁃matory studies have been conducted on the compo⁃sition and effectiveness of drugs through research,and the level of connotation of these drugs has also been raised.For example,Liuwei Dihuang Wanhas improved soft capsules and capsules dosage forms.】

3 中药现代产业化是推动传统医药学进步和创新的动力【Modern industrialization of traditional Chinese medicine promotes progress and inno⁃vation of traditional medicine】

在中药新药研发的长期努力中，我们始终在探讨创新的内容和创新的目标。除了已有中成药的升级改造之外，对传统有效方剂的开发成为中药研究的主要内容。也就是说，实现中药方剂的产业化，就是推动了传统药物的创新。对于方剂的产业化研究，不仅是对药物的物质基础、有效成分、药理作用和有效性进行系统的研究，更重要的是对这些方剂在治疗过程中使用的特点进行研究，毕竟产业化的产品不仅固定了处方，也固定了剂量，这样与传统中药应用方剂就有了显著的差异。在这种情况下，如何保证产业化的产品能够实现临床应用的治疗效果，不仅要研究药物的作用，更要研究对疾病的精确的选择性，这样才有可能达到比较理想的治疗效果。【In the long-term efforts devoted to new Chinese medicine research and development,we are always exploring innovative content and goals.In addition to the upgrading of TCM,the development of traditional and effective prescrip⁃tions has become a priority for TCM research.In other words,to achieve the industrialization of TCM prescriptions is to promote the innovation of TCM.For the industrialization of prescription research,not only is it necessary to make a systematic study of the material basis,active ingredients,pharmacological effects and effec⁃tiveness of drugs,but more importantly,the charac⁃teristics of these prescriptions used in the treat⁃ment process need to be studied.After all,indus⁃trialized products make not only the prescription fixed,but also the dose fixed,hence the great differ⁃ence compared with the TCM prescription.Under such circumstances,how to ensure that the industri⁃alized products can achieve the therapeutic effect in clinical application requires studies not only on the effect of the drug,but also on the exact selec⁃tivity of the disease so as to achieve the ideal therapeutic effect.】

4 中药现代产业化是促进中药走向国际的重要渠道【Modern industrialization of traditional Chinese medicine is an important channel to promote traditional Chinese medicine to the world】

中药现代研究的过程中，我们一直纠结于促进中药的国际化，这不仅是让中药造福于人类，更希望国际社会认可或认识中药内涵的科学性和先进性。但是，让中药走向国际，现代产业化是必然的选择。首先，现代产业化的中药产品实现了技术规范、质量稳定、产品先进，具备了国际社会接受的基本条件。没有产业化的产品形式，实现国际化是不可能的。但是，仅有产业化的产品并不能走向国际，还需要这些产品具有可以被国际认可的治疗效果。因此，促进中药产业化发展，提升产品质量水平，确保产品治疗疾病的优势作用，将有效推动中药的产品和中药的理论传播到全世界。【In the process of modern TCM research,we have been committed to promoting the internationalization of TCM.It not only benefits TCM to the mankind,but shows our hope that the international community will accept and recognize the scientific validity and advance⁃ment of TCM.However,to make TCM globally used,modern industrialization is an inevitable choice.First of all,the modern industrialized TCM products have achieved technical specifications,stable quality and advanced products,which have met the basic requirements on the part of the inter⁃national community.Without industrialized product forms,it is impossible to achieve internationaliza⁃tion.Nevertheless,industrialized products alone cannot go globally,and they need the internationally recognized therapeutic benefits of these products.Therefore,to promote the industrialization of TCM,we have to improve the quality of products and ensure the superiority of products in the treatment of diseases.The products and theory of TCM need to be effectively promoted to the whole world.】