中药新药用中药材质量标准的引用及相关问题探讨  

The Quotation of Standards of Chinese Medicinal Materials for New Traditional Chinese Medicine and Relevant Problems

作　　者：李灿 吴晨悦 吴静义 周跃华 Li Can;Wu Chenyue;Wu Jingyi;Zhou Yuehua(Centre for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国药事》2021年第9期991-996,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:分析中药新药用中药材标准引用的相关问题,为准确引用提供参考。方法:对我国中药材标准管理历史、现状进行梳理,分析中药新药研究用中药材标准引用中存在的问题,并提出建议。结果与结论:针对中药材标准基原或药用部位不统一、标准可控性较低等问题,提出中药新药用中药材标准引用的基本原则及相关建议,为中药新药研究、评价、监管提供参考。Objective:To analyze the problems related to the quotation of standards of Chinese medicinal materials for new traditional Chinese medicine,and to provide references for the accuracy of quotation.Methods:The history and current situation of the management of standards for Chinese medicinal materials were reviewed,the related questions of the citation of standards of Chinese medicinal materials for new traditional Chinese medicine research were analysed,and some suggestions were put forward.Results and Conclusion:In view of the problems such as the inconformity of the origin or medicinal parts of Chinese medicinal materials,and the low controllability of the standards,the basic principles and relevant suggestions for the quotation of standards of Chinese medicinal materials for new traditional Chinese medicine are put forward to provide references for the research,evaluation and supervision of new traditional Chinese medicine.

关 键 词：中药材 标准 中药新药 

分 类 号：R95[医药卫生—药学] R288