摘要
中药配方颗粒试点工作结束后,配方颗粒进入了新的历史阶段。以山东省配方颗粒标准制定过程中收到的反馈意见及标准执行中遇到的问题为切入点,主要包括药材基原和饮片使用规范性、与生产工艺相关指标的统一、质量控制项目的修订、特征图谱的结果判定等,提出了促进新技术的推广应用,提高智能制造水平;致力新型标准物质的研究,开发中药配方颗粒对照制剂;构建优质优价体系,基于中药配方颗粒对照制剂进行质量等级评价;推进配方颗粒监管及检验检测人才队伍建设,形成长效监管机制等促进产业高质量发展的建议,以期让配方颗粒能够持续健康的发展。
After the completion of pilot work of traditional Chinese medicine formula granules(TCMFGs),the formula granules have entered a new historical stage.Feedback received during the formulation of standard of TCMFGs in Shandong Province and problems encountered in the implementation of standard are taken as the starting point in this article,mainly including the origin of medicinal materials and standardization of use of decoction pieces,unification of indicators related to the production process,revision of the quality control items,determination of results of the characteristic map,etc.A series of suggestions to promote the high-quality development of the industry,such as promoting the popularization and application of new technologies and improving the level of intelligent manufacturing.Research of new reference materials and development of TCMFGs control preparation are committed.And a high quality and good price system is built,and the quality grade based on control preparation of TCMFGs is evaluated.Construction of talent team for supervision,inspection and testing of TCMFGs are promoted,and long-term regulatory mechanism is formed,in order to make TCMFGs sustain healthy development.
作者
于姗姗
郭东晓
张秋红
王海燕
杨纯国
孟庆廷
刘洪超
林永强
YU Shan-shan;GUO Dong-xiao;ZHANG Qiu-hong;WANG Hai-yan;YANG Chun-guo;MENG Qing-ting;LIU Hong-chao;LIN Yong-qiang(Jinan Supervision and Inspection Center for Food and Drug Control,Jinan 250102,China;Shandong Engineering Research Center for Generic Technologies of Traditional Chinese Medicine Formula Granules,ShandongEngineering Laboratory for Standard Innovation and Quality Evaluation of TCM,NMPA Key Laboratory for Quality Evaluationof Gelatin Product,Shandong Provincial Institute for Food and Drug Control,Jinan 250101,China;Taian Institute for Food and Drug Control,Taian 271000,China;Shandong Yifang Pharmaceutical Co.,Ltd.,Linyi 276000,China;Qingzhou Yaowang Pharmaceutical Co.,Ltd.,Weifang 261000,China)
出处
《中草药》
CAS
CSCD
北大核心
2022年第14期4256-4264,共9页
Chinese Traditional and Herbal Drugs
基金
山东省重点研发计划重大科技创新工程项目(2021CXGC010511)
山东省重点研发计划项目(2020RKB24001)
山东省人文社会科学课题(2021-YYGL-44)
山东省食品药品检验研究院平台课题(SDIFDC-KY-1-2021023,SDIFDC-KY-1-2021026)。
关键词
中药配方颗粒
标准制定
反馈意见
对照制剂
优质优价
等级评价
长效监管机制
traditional Chinese medicine formula granules
standard formulation
feedback
control preparation
high quality and good price
grade evaluation
long-term regulatory mechanism
