摘要
中药配方颗粒经过20多年的发展,由于其剂量小、使用方便等特点,市场规模不断扩大。国家食药总局曾下发《中药配方颗粒管理办法(征求意见稿)》,拟从多个角度对中药配方颗粒的发展提出要求,转变管理方式,中药配方颗粒产业发展将进入新的阶段。标准的建立是中药配方颗粒产业进一步发展的的必要前提,而当前中药配方颗粒生产试点多年仍未能形成统一的标准,标准化成为当前中药配方颗粒产业进一步发展的首要任务。本文结合中药配方颗粒产业发展现状与征求意见稿的相关要求,对进一步开展中药配方颗粒标准化研究的思路进行探讨,为中药配方颗粒相关标准研制提供参考。
With characters of small dose and easy use, Chinese medicine dispensing granule market has been expan- ding constantly in the past two decades. The management of Chinese medicine dispensing granule will be changed referring to the recent documents issued by SFDA, which means that the development of Chinese medicine dispensing granule will enter a new stage. Establishment of the standards becomes a necessary precondition for the further development of Chinese medieine dis- pensing granule, as there is still not a unanimous view after many years of trial production by 6 companies. Combining current situations, this paper discusses the research and exploration of ideas on the standard research of Chinese medicine dispensing granules for providing suggestion to Chinese medicine dispensing granule standards development.
出处
《中国现代中药》
CAS
2017年第6期748-752,共5页
Modern Chinese Medicine
基金
国家自然科学基金项目(81325023
81473307)
财政部中央本级专项(2060302)
发改委标准化项目(ZYBZH-C-HLJ-17
ZYB2H-C-GD-07)
国家科技部重点专项(2016YFF0202802)
关键词
中药配方颗粒
标准化
现状
对策
Chinese medicine dispensing granule
standardization
present situation
strategies
