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论中药新药临床前研究
引用本文:殷智,郜红利,张怀.论中药新药临床前研究[J].湖北民族学院学报(医学版 ),2001,18(1):29-33.
作者姓名:殷智  郜红利  张怀
作者单位:1. 湖北民族学院中医系,
2. 湖北施南药业有限公司,
摘    要:本文从新药研究机构、科研选题、制备工艺、质量标准、稳定性、药理、毒理几个方面作了系统地论述,旨在帮助中药新药开发工作者了解新药的概念、新药研究的内容、技术、方法以及相应法规和各项管理规则,认识新药研究的科学性、可靠性、实用性,以提高中新药研究的水平,加速新药申报的进程。

关 键 词:中药  新药  临床前研究
文章编号:1008-8164(2001)01-0029-05
修稿时间:2000年12月25

The Study on New Medicine in ChineseTraditional Medicine before Clinical
YIN Zhi,GAO Hong li,ZHANG Huai.The Study on New Medicine in ChineseTraditional Medicine before Clinical[J].Journal of Hubei Institute For Nationalities(Medical Edition),2001,18(1):29-33.
Authors:YIN Zhi  GAO Hong li  ZHANG Huai
Abstract:According to introduce the technical demand which was requested by the nation for the study on New Medicine in Chinese Traditional Medicine,the article expounds some interrelative technology before the clinical study of Chinese Traditional Medicine from the sides of the study organization,the selected topic of scientific research,the technology of preparation,the standard of quality,stabilization,pharmacology,toxicology.The purpose of the article is to help those who are incharge of the New Medicine in Chinese Traditional Medicine to get know the study of scientificability,reliability and practicability on New Medicine correctly,to raise the level of the study on New Medicine,to accelerate the proceeding of modern New Medicine.
Keywords:the new medicine in traditional chinese  medicine  study before clinical
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