多基原甘草质量标准探讨  

Quality standard for licorice of different sources

作　　者：杨乐 单莲莲 王亚丽 闫顺华 周钢 陈佳[3] 魏锋[3] YANG Le;SHAN Lianlian;WANG Yali;YAN Shunhua;ZHOU Gang;CHEN Jia;WEI Feng(Center for Drug Reevaluation of NMPA/NMPA,Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100076,China;Xinjiang Uygur Autonomous Region Institute for Drug Control,Urumqi Xinjiang 830054,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京100076 [2]新疆维吾尔自治区药品检验研究院,国家药品监督管理局中药(维药)质量控制重点实验室,新疆乌鲁木齐830054 [3]中国食品药品检定研究院,北京102629

出　　处：《中国药物警戒》2024年第9期1025-1028,1033,共5页Chinese Journal of Pharmacovigilance

基　　金：国家药品监督管理局药品监管科学体系建设重点项目(RS2024Z006);2024年度新疆维吾尔自治区重点研发任务专项项目(2024B02024)。

摘　　要：目的分析多基原甘草质量现状及存在的问题,探索制约因素并提出解决方案。方法通过和企业座谈、实地调研、文献查询及甘草质量标准研究工作,分析当前甘草产业现状、药用标准问题及发展契机。结果以《中华人民共和国药典》(2020年版)含量测定标准,我国胀果甘草、光果甘草中甘草苷含量不合格率偏高,但3种基原的甘草存在其他具有药理作用的黄酮类化学成分,仅以甘草苷作为质量控制指标评价不够全面。结论建议进一步提高和完善《中华人民共和国药典》中胀果甘草和光果甘草质量标准,采用多种黄酮类成分作为甘草质量评价指标,进而推进我国甘草种植业发展。Objective To analyze the problems with the quality of Glycyrrhiza inflata Bat.and Glycyrrhiza glabra L.,identify obstacles to development and offer solutions.Methods Through talks with enterprises,field investigation,literature research and studies on the quality standard for Glycyrrhiza inflata Bat.and Glycyrrhiza glabra L.,the status quo of the Glycyrrhiza inflata Bat.and Glycyrrhiza glabra L.industry in Xinjiang,the problems with pharmaceutical standards and opportunities of development were analyzed.Results The rate of defective Glycyrrhiza inflata Bat.and Glycyrrhiza glabra L.in the medicinal field was high by the content determination standard specified in the Pharmacopoeia of the People’s Republic of China(2020 edition).However,the licorice of three sources contained flavonoids with pharmacological action,so liquiritin alone could not be used as an indicator of quality control.Conclusion It is recommended that the quality standard for Glycyrrhiza inflata Bat.and Glycyrrhiza glabra L.be revised to adopt various flavonoid components as the quality evaluation indexes of licorice so as to promote its cultivation in China.

关 键 词：甘草 胀果甘草 光果甘草 甘草苷 质量 标准 基原 

分 类 号：R932[医药卫生—生药学] R954[医药卫生—药学] R926