对中成药质量标准研究现状的思考与建议  

Reflection and Suggestion to Quality Standard of Chinese Patent Medicine

作　　者：祝军委[1] 冯泳[1] 

机构地区：[1]贵阳中医学院,贵阳550002

出　　处：《中国实验方剂学杂志》2013年第11期333-336,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：贵州省中药现代化专项(黔科合社字[2008]5025号)

摘　　要：研究方剂理论在中成药质量标准研究中的指导意义,从而确保中成药的研究始终在中医理论的指导下进行。通过查阅历版《中国药典》以及已经发表的关于中成药质量标准研究的大量文献资料进行总结。从中成药的发展概况、中成药现行质量标准研究存在的局限性和相关问题、方剂理论在中成药质量标准研究中的指导意义进行探讨。结果显示当前中成药质量标准研究由于仪器、人才学科背景交叉的欠缺、中成药成分的复杂性以及研究的艰巨性等原因,导致现行中成药质量标准的研究存在指标成分的选取不科学性、质量标准研究中功能主治不规范的问题。方剂理论在指导中成药药效物质基础的筛选、药效学验证实验的设计及指导中成药功效主治的规范撰写方面起着重要作用。目前在中成药质量标准的研究中对方剂理论的重视度不够,值得进一步推动中成药质量标准的研究在方剂理论的指导下进行。To study prescription significance of the theory in the guide of proprietary Chinese medicine quality standards, in order to ensure this research are always under the guidance of the Chinese medicine theory. Published papers on the research about Chinese medicine quality standards and a series of Pharmacopoeia of the People＇s Republic of China and literature were inspected to summary. Investigation was made from the overview of development of Chinese medicines, the existing limitations and related issues in Chinese medicine quality research, prescription significance of the theory in the guide of proprietary Chinese medicine quality standards. Due to lack of equipment, personnel and interdisciplinary background, the complexity of proprietary Chinese medicine ingredients, as well as the study of the arduous nature, led to the existence of index components selected unscientific and non-standard function and indications problem in Chinese medicine quality standards research. Prescription significance of the theory in the guide of proprietary Chinese medicine effective substances, the verification experiment design and guidance of proprietary Chinese medicines effects indications specification writing plays an important role. The current study of Chinese medicine quality does not pay enough attention on prescription theory, a prescription theory under the theoretical guidance should be always ensured.

关 键 词：方剂理论 中成药 质量标准 内容分析 

分 类 号：R284.1[医药卫生—中药学]