建立中药提取生产质量管理规范,促进我国植物提取物质量标准化

目的:加强植物提取物质量控制,促进我国植物药及中药走向国际市场。方法:阐述植物提取物市场概况,分析目前我国植物提取物质量控制中出现的问题,探讨建立中药提取生产质量管理规范(GEP)的意义和关键点。结果与结论:必须加强我国植物提取物的质量控制,即确立适宜的质量标准;优化生产工艺,制订相应的“标准操作规程”;采用先进技术和设备,提高科技含量,严格控制有毒物质;把好原材料关,加强与《中药材生产质量管理规范》的衔接。

Establishing of Good Extracting Practice of the Traditional Chinese Medicine and Facilitating the Standardization of Chinese Botanical Extracts

OBJECTIVE:In order to enhance the quality control of Chinese botanical extracts and to facilitate the entry of Chinese botanical drugs and traditional Chinese medicine into the international market.METHODS:The market overview of the botanical extracts was expounded,problems existed in the quality control of the Chinese botanical extracts were analyzed,and the significance and key points in establishing Good Extracting Practice(GEP)of the traditional Chinese medicine were discussed.RESULTS&CONCLUSION:The quality control of the Chinese botanical extracts must be emphasized,which means to establish the feasible quality standard;the production process should be optimized and the corresponding‘Standard Operating Procedure’should be formed;advanced technology and facilities should be adopted to improve the content of hi-tech,the toxic substances should be strictly controlled;the quality of the raw material should be guaranteed,the connection between which and the‘Good Agricultural Practice for Chinese Crude Drugs'should be strengthened.