摘要
中药配方颗粒试点工作结束及质量标准制定技术要求实施后,国家及省级中药配方颗粒标准的制定均取得了阶段性成果。梳理了中药配方颗粒国家标准的研究历程及省级标准的探索研究成果,以山东省中药配方颗粒标准制定过程中的标准复核及审评中遇到的问题为切入点,主要包括药材基原、生产工艺、定性/定量指标成分合理性等问题,挖掘了上述问题产生的具体原因,提出了做好中药配方颗粒源头把控、寻求更加专属经济的检验方法、强化生产全过程质量控制,以及构建以企业为核心、相关各方应合作共享的质量标准制定体系等建议,推动中药配方颗粒标准的制定和完善,以期促进中药配方颗粒产业的高质量发展。
After the completion of pilot work of traditional Chinese medicine formula granules(TCMFGs)and the implementation of technical requirements for the formulation of quality standards,the formulation of national and provincial standards have achieved milestones.Research process on national standard of TCMFGs and exploration and research results of the provincial standard are summarized in this paper.The entry point is the standard review and problems encountered in the review during the formulation of standard of TCMFGs in Shandong Province,such as raw material of TCM,production process,rationality of qualitative/quantitative index composition,etc.Specific reasons for above problems are excavated in this article,controlling the source of TCMFGs,seeking more exclusive and economic inspection methods,strengthening quality control throughout the production process are also proposed.The establishment of a quality standard formulation system with enterprises as the core and relevant parties should be cooperated and shared,so as to promote the formulation and improvement of the standard of TCMFGs,with a view to promoting the high-quality development of TCMFGs industry.
作者
于姗姗
刘洪超
郭东晓
郭衍珩
袁炎炎
林永强
张秋红
YU Shan-shan;LIU Hong-chao;GUO Dong-xiao;GUO Yan-heng;YUAN Yan-yan;LIN Yong-qiang;ZHANG Qiu-hong(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;Heze Institute for Food and Drug Control,Heze 274000,China;Zibo Institute for Food and Drug Control,Zibo 255000,China)
出处
《中草药》
CAS
CSCD
北大核心
2022年第14期4243-4248,共6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
标准复核和审评
问题及对策分析
产业发展
traditional Chinese medicine formula granules
standard formulation
standard review and evaluation
problem and countermeasure analysis
industrial development
作者简介
于姗姗,女,副主任药师,研究方向为中药质量控制与研究。Tel:(0531)55515960 E-mail:yssyb@126.com;通信作者:林永强,男,主任药师,博士,研究方向为中药质量控制及评价研究。E-mail:13864067104@163.com;通信作者:张秋红,主任中药师,硕士,研究方向为中药质量控制与研究。E-mail:zhangqh9886@163.com。
