摘要
本文对近几年来申报的含有毒中药村的中药新药进行了分析,归纳了有毒中药材的类型,提出了对含各类毒性成分中药新药的药学、药效学、毒理学和临床研究的要求及新药审评中应掌握的原则,对中药新药的研制和开发具有一定的指导意义。
This paper analyzes the new drugs containing toxic Chinese medicinal materials, which have been sent for registration in recent years, sums up the patterns of toxic Chinese medicinal materials, and makes requirements for the studies of pharmacy, pharmacodynamics, toxicology and clinics of new drugs containing contents of toxic Chinese medicinal materials, and the principles for the evaluation of new drugs. It is of guiding significance in the research and development of new drugs in traditional Chinese medicine.
出处
《世界科学技术-中药现代化》
2002年第3期22-25,共4页
World Science and Technology(Modernization of Traditional Chinese Medicine)
关键词
有毒中药材
中药新药
技术审评
雷公藤
马兜铃
toxic traditional Chinese medicine, drug safety, evaluation of new drugs
