建立我国现代中药质量标准体系的研究

建立创新并具有独立知识产权的中药质量标准体系是开展我国自主医药研究和生产的关键之一。创建中药质量标准体系应遵循以下原则:应能体现中医药理论的特性;应能体现中药的物质基础是有效化合物群;要有利于中药专利的申请;应能体现与时俱进。通过中药指纹图谱的信息获取、信息处理和信息挖掘三方面内容的研究,开展指纹图谱信息与药效活性信息相关性研究,可实现中药化学指纹图谱向中药药效组分指纹图谱的转化,形成中药组效学研究体系。以中药药效组分指纹图谱结合指标成分定量为核心技术和基础的中药质量标准体系的建立,必将增强我国中药领域的自主创新能力。

Studies on Establishment of Modern Quality Standards System of Traditional Chinese Medicine in China

The establish ment of the modern quality standards system of TCM,which owns Chinese innovative intellectual property right,is one of the key factors in the research and production of medicines in China.In this endeavor the following principles should be kept:1.It should embody the characteristics of TCM theory;2.It should reflect that the material foundation of TCM is groups of effective compounds;3.It should be helpful to the application for patent;4.It should show that the development of TCM is abreast with the times.Therefore,through the study of the acquirement of fingerprint information,the information processing and the exploration of information of TCM and via the information and the information of medicine effectivness and its activities,the transformation from the chemical fingerprint of TCM into the fingerprint of composition and effectiveness of TCM may be accomplished and thus the stystem of the study on the relationship between the composition and effectiveness of TCM may also be formed.With the establishment of the fingerprint of the composition and effectiveness of TCM,which is taken as the key technology,and of the system of basic quality standards of TCM,the indipendent ability of innovation in the are a of TCM will be enhanced in China.