研究青蒿素研发环节探析新药创制关键点

1、研究青蒿素研发环节探析新药创制关键点摘要 青蒿素(qinghaosu artemisinin at),又名 黄花蒿素(artemisine、arteannuin)属过氧缩酮倍半菇内 酯类化合物，是我国医药学家于20世纪70年代初从菊科植 物黄花蒿(artemisia annua . l )中分离获得的具有显著临 床疗效的抗疟药物。笔者拟以青蒿素为例，一方面对其研究 与开发(r&d)前期各关键环节进行总结论述，另一方面对 其研发后期市场开发权被西方控制的案例加以剖析。进而探 讨分析中药新药研发过程和保障其创新价值实现这两大环 节所应具备的关键要素，以期为今后的中药新药研发提供些 许参考。

2、analyzing artemisinin r&d links, discussing the key points of development of new drugswang zhong-leil, yang li-yan2, zhang xiao-hual*, yuan jian-nal, li peng-shoul1 (school of chinese materia medica , beiing university of chinese medicine, beijing 100102)2(faculty of science , china university o

3、f petroleum, beijing 100084)abstract： qinghaosu (artemisinin), alternatingname is arteannuin, belongs to times within a. half sesquiterpanes ester compounds qinghaosu is separated from artemisia. annua l. of compositae by chinese medical experts in the early 1970， ' s, which is a epoch-making an

4、d completely independent innovation. as a resuit of its significant clinical curative effect in curing malaria, it not only gains the international community， ' s wide recognition, but also is assessed as the only really effective drugs for malignant malaria drug by the world health organization

5、 (wto). the following two questions were talked about in this paper with the example of qinghaosu. on the one hand, the key elements were explored in r&d process of new medicine through summary discussion and systematic analysis of the choice of topic, isolation and purification, structure ident

6、ification, activity validation in its earlier stage of research and development (r&d). on the other hand, the case of its marketing rights, being controlled by western medicine company which is resulted from weak intellectual property rights consciousness in its later stage of r&d, was analy

7、zed so as to pay more attention to its later work. in conclusion, the following two key issues were discussed in this article, that is, the r&d process of new medicine and the insurance of the realiza.tion of innovation value, so as to provide reference for r&d of new medicine.关键字：青蒿素；新药研发；分

8、析探讨；关键环节key words： qinghaosu； new chinese medicine r&d； analysis； key issues中图分类号:r917文献标识码：a文章编号:1004-7484(2012) 10-0240-05具有完全自主知识产权的创新药物青蒿素，因其显著的 临床疗效而被世界卫生组织(wt0)评价为治疗恶性疟疾唯 一真正有效的药物1, 2。其发明者屠呦呦教授因此于2011 年9月24日登上了国际生物医学大奖“拉斯克奖”的颁奖 台3。青蒿素的研制，体现了中药学界在生命医学领域的 科技创新能力；屠呦呦教授的获奖，表明了西方国家对中医 药原创性科研成果的极大肯定。再回首，青蒿素研发历程中 存有的独特现象同样值得深思：一方面，青蒿素是中医药界 在新中国最动