对实施批准文号管理的中药饮片和提取物的现状分析  

Administration Status Quo Analysis of Implementing Approval Document of Decoction Pieces and Extracts of Chinese Medicine

作　　者：张永文[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《世界科学技术-中医药现代化》2014年第5期940-946,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

摘　　要：《中华人民共和国药品管理法实施条例》对集中规模化栽培养殖、质量可以控制并符合国务院药品监督管理部门规定条件的中药材品种,实行批准文号管理。本文对目前我国中药饮片和提取物实行批准文号管理的品种进行了梳理,并对实施批准文号管理的中药提取物与按化学药批准文号管理的植物提取物之间混乱的现象进行分析,为进一步实施并改进中药饮片和提取物批准文号管理的方式提出建议。Regulations for the Implementation of the Drug A dministration Law of the People＆#39;s Republic of China made status quo administration centralized large-scale cultivation farming, quality controls and complied with the provisions of herbal variety conditions of departments of the State Drug Administration. This article summarized the current implementation of approval number on decoction pieces and extracts of Chinese medicine. It also analyzed the faint classification between extracts of Chinese medicine of implementing approval document with those of imple-menting approval document for chemical drugs. Further details of implementing and improving approval document for decoction pieces and extracts of Chinese medicine were also discussed.

关 键 词：中药饮片 提取物 批准文号 管理 

分 类 号：R95[医药卫生—药学]