[关键词]
[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。
[Key word]
[Abstract]
Regulations for the Implementation of the Drug Administration Law of the People'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 implementing approval document for chemical drugs. Further details of implementing and improving approval document for decoction pieces and extracts of Chinese medicine were also discussed.
[中图分类号]
[基金项目]