1、研究青蒿素研發(fā)環(huán)節(jié)探析新藥創(chuàng)制關(guān)鍵點摘要 青蒿素(qinghaosu artemisinin at),又名 黃花蒿素(artemisine、arteannuin)屬過氧縮酮倍半菇內(nèi) 酯類化合物，是我國醫(yī)藥學(xué)家于20世紀(jì)70年代初從菊科植 物黃花蒿(artemisia annua . l )中分離獲得的具有顯著臨 床療效的抗瘧藥物。筆者擬以青蒿素為例，一方面對其研究 與開發(fā)(r&d)前期各關(guān)鍵環(huán)節(jié)進(jìn)行總結(jié)論述，另一方面對 其研發(fā)后期市場開發(fā)權(quán)被西方控制的案例加以剖析。進(jìn)而探 討分析中藥新藥研發(fā)過程和保障其創(chuàng)新價值實現(xiàn)這兩大環(huán) 節(jié)所應(yīng)具備的關(guān)鍵要素，以期為今后的中藥新藥研發(fā)提供些 許參考。

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.關(guān)鍵字：青蒿素；新藥研發(fā)；分

8、析探討；關(guān)鍵環(huán)節(jié)key words： qinghaosu； new chinese medicine r&d； analysis； key issues中圖分類號:r917文獻(xiàn)標(biāo)識碼：a文章編號:1004-7484(2012) 10-0240-05具有完全自主知識產(chǎn)權(quán)的創(chuàng)新藥物青蒿素，因其顯著的 臨床療效而被世界衛(wèi)生組織(wt0)評價為治療惡性瘧疾唯 一真正有效的藥物1, 2。其發(fā)明者屠呦呦教授因此于2011 年9月24日登上了國際生物醫(yī)學(xué)大獎“拉斯克獎”的頒獎 臺3。青蒿素的研制，體現(xiàn)了中藥學(xué)界在生命醫(yī)學(xué)領(lǐng)域的 科技創(chuàng)新能力；屠呦呦教授的獲獎，表明了西方國家對中醫(yī) 藥原創(chuàng)性科研成果的極大肯定。再回首，青蒿素研發(fā)歷程中 存有的獨特現(xiàn)象同樣值得深思：一方面，青蒿素是中醫(yī)藥界 在新中國最動