红斑狼疮青蒿素,新药 分析青蒿素研发环节,探讨新药创制关键点
时间：2019-04-04 03:12:56 来源：雅意学习网 本文已影响 人 
[摘要] 青蒿素（qinghaosu、artemisinin、AT），又名黄花蒿素（artemisine、arteannuin）属过氧缩酮倍半萜内酯类化合物，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。
Analyzing Artemisinin R&D Links, Discussing the Key Points of Development of New drugs
WANG Zhong-lei1，YANG Li-yan2， ZHANG Xiao-hua1*，YUAN Jian-na1，LI Peng-shou1
1(School of Chinese Materia Medica，Beiing University of Chinese Medicine，Beijing 100102)
2(Faculty of Science，China University of Petroleum，Beijing 100084)
Abstract: Qinghaosu (Artemisinin), alternating name 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 and completely independent innovation.As a result 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 (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 identification, 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 analyzed 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 realization 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（WTO）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乱的20世纪6、70年代取得的抗疟史上举世瞩目的成就，并成为中药新药研发典范[4]；另一方面，我国青蒿素的销售量，自20世纪80年代初上市的近30年来，却不足世界抗疟药品市场规模的3%[5]。以上现象为当今的中药新药研发提供了可以借鉴的经验和应当避免的教训。
