基于大数据科技的中药质量控制技术创新战略  

The technological innovation strategy for quality control of Chinese medicine based on Big Data

作　　者：李振皓[1] 钱忠直[2] 程翼宇[1] 

机构地区：[1]浙江大学中药科学与工程学系,浙江杭州310058 [2]国家药典委员会,北京100061

出　　处：《中国中药杂志》2015年第17期3374-3378,共5页China Journal of Chinese Materia Medica

摘　　要：该文简述国际上药品质量控制理念及中药质量控制技术发展历程,并针对我国药品监管及中药质量控制领域难点问题,倡议采用大数据科技应对中药产业所面临的重大挑战,进而提出中药质量控制技术创新发展策略及方法学。围绕显著提升中药标准和实现国际化的战略目标,论述了其关键核心技术研发方向。The evolution of the quality control concepts of medical products within the global context and the development of the quality control technology of Chinese medicine are briefly described. Aimed at the bottlenecks in the regulation and quality control of Chinese medicine,using Big Data technology to address the significant challenges in Chinese medicine industry is proposed. For quality standard refinements and internationalization of Chinese medicine,a technological innovation strategy encompassing its methodology,and the RD direction of the subsequent core technology are also presented.

关 键 词：中药质量控制 监管科学 制药过程控制 制药工业大数据 药品质量检验 

分 类 号：R288[医药卫生—中药学]