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中药配方颗粒国家标准研究要求与实践浅析

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2016年,国家药典委员会公开征求《中药配方颗粒质量控制与标准研究技术要求》(征求意见稿)的意见,鼓励全社会研究机构、生产企业以政府为主导,以企业为主体,共同参与配方颗粒的制定工作。至此,国家药典委员会公示的配方颗粒国家标准已有300余个品种。为了更好地推进标准建立工作,结合《中药配方颗粒质量控制与标准研究技术要求》(征求意见稿)的内容,本文从药材、炮制、标准汤剂、工艺、量值传递等方面,对前期研究工作进行了回顾,对配方颗粒国家标准的建立做了浅要的分析。
Analysis on the research requirements and practice of national standards of Chinese medicine formula granules
In 2016,the draft of Quality control and technical requirements of standards establishment of Chinese medicine formula granules was released,and scientific research institutes and enterprises began to study the nation-al standards of formula granules.So far,there are more than 300 national standards of formula granules.In order to better promote the standard establishment,combined with the main content of"Quality control and technical re-quirements of standards establishment of Chinese medicine formula granules",retrospective analysis on medicinal materials,processing,standard decoction,technology,quantity and value transmission and so on was carried out,and the establishment of national standards for formula granules was briefly analyzed.

Chinese medicine formula granulesnational standardtechnical requirementsidentification of herbsidentification of processingdissemination

周永康、张志强、吉艳慧、程立伟、孙海涛、闫晓鑫

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北京康仁堂药业有限公司

北京市中药配方颗粒工程技术研究中心,中药配方颗粒关键技术国家地方联合工程研究中心,北京 101399

中药配方颗粒 国家标准 技术要求 药材鉴别 炮制鉴别 量值传递

2024

中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
年,卷(期):2024.25(4)