关注中药新药研发中潜在的安全性问题  

Pay attention to potential safety problems in the research and development of the new traditional Chinese medicine

作　　者：周刚[1] 王停[2] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038 [2]北京中医药大学中医体质与生殖医学研究中心,北京100029

出　　处：《中国新药杂志》2014年第14期1611-1614,共4页Chinese Journal of New Drugs

基　　金：国家自然科学基金面上项目(81374056)

摘　　要：随着我们对毒性药材研究和认识的不断深入,在近年来的研究和新药审评工作中,发现了一些具有潜在安全性风险的药材,如淫羊藿、白鲜皮等。目前,在中药新药研发工作和临床用药中,人们往往会更多关注已知的毒性药材,对这些潜在毒性药材却关注较少。本文从药材基原、药用部位、产地、炮制、工艺、用量、疗程等多方面探讨了引起中药新药研发中潜在安全性问题的原因,为用药安全,指导临床合理用药,同时也为了指导研发和审评的科学性,以及为药材标准的制定提供依据。Along with deepening of the study,and understanding for toxic herbs in recent research and evaluation of new drugs,we have found out some potential safety risks of medicinal herbs,such as epimedium,cortex dictamni,etc.At present,in the research and development of new drugs of traditional Chinese medicine and clinical medicines,more attention have been paid to the known toxic herbs,but those potentially toxic herbs are less concerned.In this paper,from botanical originals,medicinal part,place of origin,processing,process,dosage and course,the causes of potential safety problems in the research and development of the new traditional Chinese medicine were discussed.We want to guide rational and safe drug use clinically;at the same time to guide the research,development and the scientific nature of the review;and to provide the basis for the standards of Chinese medicinal materials.

关 键 词：中药 安全性 新药研发 

分 类 号：R95[医药卫生—药学]