中国药物警戒 ›› 2024, Vol. 21 ›› Issue (9): 1025-1028.
DOI: 10.19803/j.1672-8629.20240286

• 法规与管理研究 • 上一篇    下一篇

多基原甘草质量标准探讨

杨乐1, 单莲莲2, 王亚丽2, 闫顺华2, 周钢2#, 陈佳3,*, 魏锋3   

  1. 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
  • 收稿日期:2024-03-12 出版日期:2024-09-15 发布日期:2024-09-14
  • 通讯作者: *陈佳,女,博士,研究员,中药质量控制与评价。E-mail: chenjia@nifdc.org.cn。#为共同通信作者。
  • 作者简介:杨乐,男,本科,主任药师,药品不良反应监测与评价。
  • 基金资助:
    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）

Quality standard for licorice of different sources

YANG Le1, SHAN Lianlian2, WANG Yali2, YAN Shunhua2, ZHOU Gang2#, CHEN Jia3,*, WEI Feng3   

  1. 1Center for Drug Reevaluation of NMPA/NMPA, Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
    2Xinjiang Uygur Autonomous Region Institute for Drug Control, Urumqi Xinjiang 830054, China;
    3National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2024-03-12 Online:2024-09-15 Published:2024-09-14

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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。

关键词: 甘草, 胀果甘草, 光果甘草, 甘草苷, 质量, 标准, 基原

Abstract: 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.

Key words: licorice, Glycyrrhiza inflata Bat., Glycyrrhiza glabra L., liquiritin, quality, standard, origin

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