复方甘草口服溶液的应用现状及思考

doi:10.19803/j.1672-8629.20230558

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (5): 529-534.
DOI: 10.19803/j.1672-8629.20230558

• 阿片类药物合理使用专栏 • 上一篇下一篇

复方甘草口服溶液的应用现状及思考

曹颖¹, 周虎子威¹, 朱兰², 王胜锋^1*

¹北京大学公共卫生学院，重大疾病流行病学教育部重点实验室（北京大学），北京 100191；
²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

收稿日期:2023-09-05 出版日期:2024-05-15 发布日期:2024-05-13
通讯作者: ^*王胜锋,男,博士,研究员,药物流行病、真实世界数据分析和大数据建模。E-mail: shengfeng1984@126.com
作者简介:曹颖,女,在读本科,预防医学。
基金资助:
国家自然科学基金资助项目（82173616）

Management of compound glycyrrhiza oral solution and recommendations

CAO Ying¹, ZHOU Huziwei¹, ZHU Lan², WANG Shengfeng^1,*

¹Peking University School of Public Health, Key Laboratory of Epidemiology of Major Diseases (Peking University), Beijing 100191, China;
²Center for Drug Reevaluation, NMPA/ NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China

Received:2023-09-05 Online:2024-05-15 Published:2024-05-13

摘要/Abstract

摘要： 目的梳理复方甘草口服溶液监管现状并提出建议。方法检索中国知网、万方数据、维普网、美国食品药品监督管理局、我国国家药品监督管理局及省级药品监督管理局网站有关文件,对纳入文献进行汇总和分析。结果当前我国复方甘草口服溶液存在生产制备过程部分不稳定、含量测定标准相对不全面、说明书记载相对不全、药品不良反应临床表现多样等状况。结论建议参考国内外对类似药物的监管办法优化对复方甘草口服溶液的监管措施;企业规范销售对象与流程;加强医务人员培训、开展科普活动。

关键词: 复方甘草口服溶液, 阿片类物质, 药物成瘾, 药物滥用, 药物安全, 监管措施

Abstract: Objective To investigate the current management level of compound glycyrrhiza oral solution, and to offer recommendations for improvement. Methods Related literature was retrieved from CNKI, Wanfang, VIP, the website of the FDA of the United States, and the official websites of NMPA and provincial drug regulatory agencies of China before being summarized and analyzed. Results There were some problems with this solution, such as unstable preparation processes, incomplete standards for content determination, ambiguous instructions, and complicated ADRs during the use of compound glycyrrhiza oral solution in China. Conclusion It is recommended that ways to regulate similar drugs at home and abroad be referred to to optimize the regulations of CGOS, the targets of marketing and processes be standardized for enterprises, health care providers be better trained and related knowledge be made more accessible.

Key words: compound glycyrrhiza oral solution, opioids, drug addiction, drug abuse, drug safety, regulatory measures

中图分类号:

R974
R954

曹颖, 周虎子威, 朱兰, 王胜锋. 复方甘草口服溶液的应用现状及思考[J]. 中国药物警戒, 2024, 21(5): 529-534.

CAO Ying, ZHOU Huziwei, ZHU Lan, WANG Shengfeng. Management of compound glycyrrhiza oral solution and recommendations[J]. Chinese Journal of Pharmacovigilance, 2024, 21(5): 529-534.

导出引用管理器 EndNote|Ris|BibTeX

链接本文: https://www.zgywjj.com/CN/10.19803/j.1672-8629.20230558

https://www.zgywjj.com/CN/Y2024/V21/I5/529

参考文献

[1] NMPA. Notice on the Announcement of the Second Batch of National OTC Drug Catalogues[EB/OL].(2001-05-18)[2023-10-30]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20010518010101130.html.
[2] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China, Volume I(中华人民共和国药典一部)[M]. Beijing: China Medical Science Press, 2020: 992-993.
[3] QIAO D, LI QY, SUN YF, et al.Segmental determination of seven components in compound glycyrrhiza oral solution by UPLC-MS/MS combined with lon switching technology[J]. Chinese Journal of Pharmaceuticals(中国医药工业杂志), 2014, 45(5): 470-473.
[4] XIE JX, DENG YP, SHI LW.The opioids crisis in the U.S. and the utilization and supervision of Analgesics in China[J]. Chinese Journal of Drug Abuse Prevention and Treatment(中国药物滥用防治杂志), 2020, 26(4): 192-197.
[5] ZHANG CW, SUN YL.A case of allergic shock caused by compound licorice oral liquid[J]. Chinese Journal of Pharmacoepidemiology(药物流行病学杂志), 2005, 14(6): 374-374.
[6] ZHANG L.Literature Analysis of 27 cases of adverse drug reactions induced by compound glycyrrhiza mixture/oral solution[J]. China Pharmacy(中国药房), 2015, 26(24): 3361-3363.
[7] YI CH, YAN J, SONG XN.A case of allergic reaction caused by compound licorice oral solution[J]. Chinese Medicine(中国医药), 2011, 6(10): 1172.
[8] WANG SH, CUI XL.Combined use of cefoxitin and compound licorice oral solution to induce disulfiram reaction[J]. Adverse Drug Reactions Journal(药物不良反应杂志), 2017, 19(2): 149-150.
[9] LIU WQ, LI MM, SU G, et al.A case of facial edema caused by compound licorice oral solution[J]. Chinese Medicine(中国医药), 2014, 9(11): 1720.
[10] SUN Y.A case of ethanol allergy caused by compound licorice oral solution[J]. The Medical Forum(基层医学论坛), 2020, 24(10): 1468-1469.
[11] XU L, CAI Y, ZHANG KH.Disulfilamide like reaction induced by the combination of laxocephalosporin and compound licorice oral solution[J]. Chinese Journal of Hospital Pharmacy(中国医院药学杂志), 2015, 35(6): 564.
[12] SHI FH.A case report of allergic reaction to infant oral compound licorice mixture[J]. Qinghai Medical Journal(青海医药杂志), 2017, 47(7): 22.
[13] LU H, SHI QZ, LIU FQ.One case of disulfiram like reaction induced by the combination of cefoperazone sodium and sulbactam sodium for injection with compound licorice oral solution[J]. Central South Pharmacy(中南药学), 2017, 15(12): 1802.
[14] WANG JP, LI CM, LIU ZF, et al.Analysis of 25 cases of allergic reactions caused by compound liquorice tablet/mixture/oral solution[J].Chinese Journal of Clinical Rational Drug Use(临床合理用药杂志), 2021, 14(11): 3-5.
[15] LI YB, ZHANG ZC, SONG ZL.Pareto diagram analysis of adverse reactions by compound glycyrrhiza oral solution[J]. Chinese Journal of Clinical Rational Drug Use(临床合理用药杂志), 2023, 16(32): 29-33.
[16] XU YJ, ZHANG J, GUO DH, et al.Analysis of 1230 cases of anaphylactic shock induced by drugs[J].Chinese Journal of Drug Application and Monitoring(中国药物应用与监测), 2020, 17(2): 99-103.
[17] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China, Volume Ⅱ(中华人民共和国药典二部)[M]. Beijing: China Medical Science Press, 2020: 959.
[18] QIN QF, LIN H, LIAO Y.Investigation of Quality of 31 batches of compound glycyrrhiza oral solutions[J]. China Pharmacy(中国药房), 2008, 207(9): 689-691.
[19] LI HB, XIE YB, XIAO HB, et al.Improvement of preparing technique for compound glycyrrhiza oral solution[J]. Journal of International Pharmaceutical Research(国际药学研究杂志), 2017, 44(6): 660-662.
[20] Shaanxi Provincial Food and Drug Administration. Shaanxi Provincial Food and Drug Quality Announcement(No. 16 of2016)[EB/OL].(2016-04-16)[2023-10-30]. https://www.cqn.com.cn/ms/content/2016-04/26/content_2854164.htm.
[21] Fujian Provincial Food and Drug Administration. Fujian Province Drug Quality Announcement(Issue 3 of 2019, Total Issue 77)[EB/OL].(2019-11-28)[2023-10-30]. http://yjj.scjgj.fujian.gov.cn/yp/gstg/201911/t20191128_5140881.htm.
[22] NMPA. Announcement of the State Food and Drug Administration on 7 batches of drugs that do not comply with regulations (No. 78 of2021)[EB/OL].(2021-10-12)[2023-10-30]. https://www.nmpa.gov.cn/xxgk/ggtg/ypchj/ypgjjgg/20211012150748176.html.
[23] KE YJ, ZHANG Y, CAI B, et al.Process quality review analysis in hospital preparation compound glycyrrhiza oral solution[J]. Anhui Medical and Pharmaceutical Journal(安徽医药), 2022, 26(1): 205-208.
[24] NMPA. Announcement on Revising the Instructions for Cold Medicines Containing Codeine[EB/OL].(2018-09-06)[2023-10-30]. https://www.nmpa.gov.cn/xxgk/ggtg/ypshmshxdgg/ 20180906165801678.html.
[25] FDA. FDA Warns Consumers Not to Use Licorice Coughing Liquid[EB/OL].[2023-10-30]. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-licorice-coughing-liquid.
[26] Guangxi Stitute for Food and Drug Control. Guangxi Food and Drug Inspection Institute officially opens personal entrusted inspection services in response to public expectations[EB/OL].(2021-07-15)[2023-10-30]. http://yjj.gxzf.gov.cn/xwdt/bjdt/t9533452.shtml.
[27] WebMD. Drugs & Medications.Acetaminophen W/Codeine 300Mg-30Mg Tablet-Uses, Side Effects, and More[EB/OL]. [2023-10-30]. https://www.webmd.com/drugs/2/drug-63338/acetaminophen-w-codeine-oral/details.
[28] FDA. Approved Drug Products with therapeutic equivalence evalutions 43re Edition[EB/OL].[2023-10-30]. https://www.fda.gov/media/72973/download.
[29] Natinal Library of Medicine. Dailymed.Acetaminophen and Codeine Phosphate solution[EB/OL].[2023-10-30]. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=83a536d8-385d-46ed-9cd2-47b7efe96ccf.
[30] HUO YF, XIE YJ, XU LL, et al.1160 cases of adverse reactions caused by compound liquorice tablets and risk factor[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 18(12): 1176-1180.
[31] ZHUANG CY.Analysis of current situation of abuse monitoring of compound licorice tablets[J]. Strait Pharmaceutical Journal(海峡药学), 2022, 34(4): 169-171.
[32] NMPA. Announcement on Revising the Instructions for compound Glycyrrhiza Tablets[EB/OL].(2020-03-03)[2023-10-30]. https://www.nmpa.gov.cn/xxgk/ggtg/ypshmshxdgg/20200303171701693.html.

复方甘草口服溶液的应用现状及思考

Management of compound glycyrrhiza oral solution and recommendations

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

[1]	李文鹏, 刘明煜, 曹颖, 周虎子威, 王胜锋. 阿片类药物全球滥用的监管现状及研究进展[J]. 中国药物警戒, 2024, 21(5): 513-518.
[2]	刘翠丽, 吴晨, 王涛. 吡拉西坦制剂安全性风险分析及思考[J]. 中国药物警戒, 2024, 21(5): 563-566.
[3]	杨乐, 夏东胜, 王涛. 维生素B₆注射剂安全性风险分析[J]. 中国药物警戒, 2023, 20(7): 791-794.
[4]	孟康康, 刘赛月. 辅酶Q10注射剂上市后安全性分析[J]. 中国药物警戒, 2023, 20(7): 795-798.
[5]	梁士兵, 余泽宇, 孔令垚, 晏利姣, 韩梅, 吴嘉瑞, 刘兆兰, 刘建平. 文献计量法在中药药物警戒领域中的应用价值及展望[J]. 中国药物警戒, 2023, 20(5): 591-594.
[6]	朱兰, 金哲, 刘丽红, 钟露苗, 刘小军. 康妇消炎栓给药途径相关安全风险分析及思考[J]. 中国药物警戒, 2023, 20(3): 306-310.
[7]	杨乐, 夏东胜, 王涛. 维生素B₂注射剂安全性风险分析[J]. 中国药物警戒, 2023, 20(11): 1256-1258.
[8]	刘翠丽, 吴晨, 王涛. 妇产科用米索前列醇片安全性风险分析及思考[J]. 中国药物警戒, 2022, 19(9): 999-1001.
[9]	孟康康, 王春婷, 熊玮仪. 普萘洛尔片剂治疗婴幼儿血管瘤的安全性分析[J]. 中国药物警戒, 2022, 19(7): 749-751.
[10]	黄丽婷, 汤在祥, 白璐, 时贯宏, 江翊国. 基于FAERS数据库的苯二氮窧类药物的不良反应分析[J]. 中国药物警戒, 2022, 19(11): 1223-1227.
[11]	王丹, 吴晨, 任经天. 右美沙芬滥用风险分析[J]. 中国药物警戒, 2022, 19(10): 1097-1099.
[12]	吴晨, 刘翠丽, 王涛. 氟哌啶醇制剂心血管系统安全性风险的分析及思考[J]. 中国药物警戒, 2022, 19(10): 1100-1102.
[13]	于一, 黄倩倩, 肖爱丽. 银杏叶片等口服制剂安全性风险的分析及思考[J]. 中国药物警戒, 2021, 18(7): 678-682.
[14]	于一, 王慧, 刘红亮, 王春婷. 注射用七叶皂苷钠安全性风险分析及思考[J]. 中国药物警戒, 2021, 18(2): 174-177.
[15]	刘翠丽, 朱兰, 王涛, 吴晨. 注射用鼠神经生长因子安全性风险的分析及思考[J]. 中国药物警戒, 2021, 18(10): 953-955.