多基原甘草质量标准探讨

doi:10.19803/j.1672-8629.20240286

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

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 Gang^2#, CHEN Jia^3,*, WEI Feng³

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

摘要/Abstract

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

中图分类号:

杨乐, 单莲莲, 王亚丽, 闫顺华, 周钢, 陈佳, 魏锋. 多基原甘草质量标准探讨[J]. 中国药物警戒, 2024, 21(9): 1025-1028.

YANG Le, SHAN Lianlian, WANG Yali, YAN Shunhua, ZHOU Gang, CHEN Jia, WEI Feng. Quality standard for licorice of different sources[J]. Chinese Journal of Pharmacovigilance, 2024, 21(9): 1025-1028.

导出引用管理器 EndNote|Ris|BibTeX

链接本文: https://zgywjj.magtechjournal.com/CN/10.19803/j.1672-8629.20240286

https://zgywjj.magtechjournal.com/CN/Y2024/V21/I9/1025

参考文献

[1] ZHOU DL, WANG M, FENG JL, et al.Study on differential metabolites of Glycyrrhiza uralensis Fisch. in different years based on extensive targeted metabonomics[J]. Journal of Pharmaceutical Analysis, 2024, 44(1): 144-157.
[2] BIAN YH, WANG L, ZHANG XY, et al.Current situation and technology improvement of licorice industry chain[J]. Journal of Tianjin University of Traditional Chinese Medicine(天津中医药大学学报), 2020, 39(1): 19.
[3] LI WB, LUO L, CUI J, et al.Research progress on genetic diversity of 3 medicinal glycyrrhiza[J]. Journal of Chinese Medicinal Materials(中药材), 2019, 42(2): 463-469.
[4] XU K, LU JH, LI X, et al.Composition and functions of soil bacterial communities of wild Glycyrrhiza uralensis Fisch. in habitats with different degrees of salinization[J]. Acta Microbiologica Sinica, 2024, 65(5): 1550-1556.
[5] ZHOU G, SHAN LL, WANG YL, et al.Present Situation and prospect of study on quality standard of ethnic medicine in Xinjiang[J]. Chinese Pharmaceutical Affairs(中国药事), 2024, 38(1): 28-34.
[6] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People’s Republic of China: VolumeⅠ(中华人民共和国药典一部)[S]. Beijing: China Medical Science Press, 2020: 88-89.
[7] CHEN J, NIE LX, CHENG XL, et al.Qualitative and quantitative analysis of main characteristic components of Glycyrrhiza inflate Bat. with chemometrics[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 18(9): 826-830.
[8] CHEN J, NIE LX, DAI SY, et al.Multivariate statistical analysis of the difference in chemical components between glycyrrhizae radix et rhizoma derived from Glycyrrhiza glabra L. and G. inflata Bat. from Xinjiang[J]. Modern Chinese Medicine(中国现代中药), 2021, 23(12): 2088-2095.
[9] CHEN J, NIE LX, HU XR, et al.Differences of chemical compounds between Glycyrrhiza uralensis Fisch. and Glycyrrhiza glabra L. by UHPLC-Q-TOF-MS/MS[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2022, 19(9): 954-958.
[10] HAN WW, ZHONG Q, ZHANG R, et al.Research progress of active constituents and their mechanism of action in Glycyrrhiza uralensis Fisch.[J]. Chemistry of Life(生命的化学), 2023, 43(12): 1956-1962.

[1]	申晨, 周娴, 刘建平. 中草药-药物相互作用数据库的建立与评价方法探讨[J]. 中国药物警戒, 2025, 22(8): 902-908.
[2]	刘疆, 陈洁, 邱思鸿, 李娜, 周莹, 陈永刚, 罗季. 基于美国FAERS数据库的奥马环素和莫西沙星不良事件分析[J]. 中国药物警戒, 2025, 22(8): 933-936.
[3]	杨怡帆, 杨艳伟, 张頔, 谢寅, 张勇, 陈旭林, 高苏涛, 耿兴超, 屈哲. 人类诱导多能干细胞质量控制及测试方法[J]. 中国药物警戒, 2025, 22(7): 728-734.
[4]	刘维婷, 魏巍, 杨彦彪. 华法林钠片与迈之灵片联用致国际标准化比值异常升高1例分析[J]. 中国药物警戒, 2025, 22(5): 586-588.
[5]	刘颖, 熊舜禹, 熊慧瑜, 蔡飞, 徐梦丹, 王青, 任韡, 许燕. 《药物警戒质量管理规范》的药品上市许可持有人符合性评估方法研究[J]. 中国药物警戒, 2025, 22(3): 282-285.
[6]	郑长辉, 马丽娜, 何婷, 顾媛媛, 赵薇, 汪红斌, 牛源菲, 富尧, 陈彦君, 曹俊岭. 基于“性状-化学-生物”序贯检测的柴胡饮片质量评控[J]. 中国药物警戒, 2025, 22(2): 197-205.
[7]	刘博, 袁亚楠, 王悦, 程舒倩, 卢治国, 范慧红, 孙会敏. 寡核苷酸药物的质控关键技术研究[J]. 中国药物警戒, 2025, 22(1): 1-9.
[8]	李文龙, 贾娟娟, 黄海伟, 姚静, 张春青, 王岩, 张辉. 我国放射性药品发展现状与展望[J]. 中国药物警戒, 2025, 22(1): 37-42.
[9]	孙得洋, 孙葭北, 李文龙, 贾娟娟, 张文在, 刘燕, 黄海伟, 姚静. 氟[¹⁸F]脱氧葡糖注射液质控关键杂质氨基聚醚对照品的定值研究[J]. 中国药物警戒, 2025, 22(1): 43-46.
[10]	贾娟娟, 孙葭北, 张文在, 孙得洋, 施亚琴, 黄海伟. 锝[^99mTc]二巯丁二酸盐注射液的生物分布测定方法研究[J]. 中国药物警戒, 2025, 22(1): 47-52.
[11]	裴宇盛, 徐琳, 赵雨歆, 蔡彤, 华晓东. 低细菌内毒素回收现象及其缓解方式研究[J]. 中国药物警戒, 2025, 22(1): 72-75.
[12]	陈霙仁, 薛泽宇, 黄天驰, 梁懿洪, 林子淇, 修琳琳. 海藻-甘草配伍毒效关系可视化分析[J]. 中国药物警戒, 2025, 22(1): 93-98.
[13]	陆德, 许文艳, 刘瑾欣, 裴宇盛. 美国食品药品监督管理局警告信中细菌内毒素问题探讨[J]. 中国药物警戒, 2024, 21(8): 857-862.
[14]	孙莉, 谢彬, 徐艳琴. 中药缓控释制剂研究进展[J]. 中国药物警戒, 2024, 21(8): 949-954.
[15]	叶岸平, 魏雪, 黄明月, 张娴勰, 马增春, 高月. 养胃安神方对慢性不可预知应激失眠模型小鼠睡眠质量的改善作用及机制研究[J]. 中国药物警戒, 2024, 21(7): 771-775.

多基原甘草质量标准探讨

Quality standard for licorice of different sources

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics