Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (12): 1401-1406.
DOI: 10.19803/j.1672-8629.20230303
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QIAO Meng, LEI Chao, CHEN Zijia, ZHANG Qiang, WANG Zhifei*
Received:
2023-05-12
Online:
2023-12-15
Published:
2023-12-15
CLC Number:
QIAO Meng, LEI Chao, CHEN Zijia, ZHANG Qiang, WANG Zhifei. Analysis and thinking on the status quo of safety item information in the instructions of traditional Chinese patent medicines containing Asari Radix et Rhizoma and its extracts[J]. Chinese Journal of Pharmacovigilance, 2023, 20(12): 1401-1406.
[1] WANG ZS, XUE H. Shennong’s Herb(神农本草经)[M]. Chengdu: Sichuan Science and Technology Press, 2008: 2,62. [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. [3] LIU MT, WANG LM, MENG J, et al.Chemical constituents, pharmacology, and toxicology of Asari Radix et Rhizoma: a review[J]. Chinese Journal of Experimental Traditional Medical Formulae(中国实验方剂学杂志), 2023, 29(10): 224-234. [4] HU ZX,FU YL.Literature research on the clinical dosage of Asarum sieboldi before Bencao Bieshuo[J]. Jiangsu Journal of Traditional Chinese Medicine(江苏中医药), 2019, 51(4): 69-71. [5] LI SZ.Compendium of materia medica(本草纲目)[M]. Beijing: China Federation of Literary and Art Circles Publishing Corporation, 2016: 333-335. [6] LI M, ZHOU Q, YANG LN, et al.Literature study on common doses of Xixin [Asari Radix Et Rhizoma] in Xixin-containing decoction formulae during past dynasties[J]. Journal of Traditional Chinese Medicine(中医杂志), 2017, 58(20): 1783-1786. [7] LI RL.Discussion on the dosage of Asari Radix et Rhizoma[J]. Xinjiang Journal of Traditional Chinese Medicine(新疆中医药), 2021, 39(2): 62-64. [8] LIU JW.Study on the mechanisms of Asarum in pulmonary-liver-kidney toxicity based on network pharmacology and metabonomics of 1H NMR[D]. Wuhan: Hubei Universitity of Chinese Medicine(湖北中医药大学), 2022. [9] ZHANG LY, SU L.Study on renal toxicity of Xixin (Asari Radix Et Rhizoma) on basis of symptom-based prescription theory[J]. Chinese Archives of Traditional Chinese(中华中医药学刊), 2021, 39(10): 78-81,269. [10] NIE AZ, BIAN M, ZHU CS. Effects of different doses of asarum decoction on liver,kidney and lung toxicity in rats[J/OL]. Information on Traditional Chinese Medicine. [2023-06-27]. http://kns.cnki.net/kcms/detail/23.1194.R.20230317.0958.006.html. [11] ZHU WJ, ZHANG LD, ZHOU Y, et al.Risk difference between aristolochic acid and clinical use of traditional Chinese medicines in aristolochiaceae[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2022, 19(11): 1213-1217. [12] ZHANG XM, SA RN, ZHANG B, et al.Technical specification for instructions for clinical application of chinese patent medicines in China Association of Chinese medicine[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2021, 46(17): 4563-4568. [13] National Medical Products Administration. Notice on printing and distributing requirements for writing format and guidelines for formulating instructions for Traditional Chinese Medicines and natural medicines[EB/OL]. (2006-06-22)[2023-05-01]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20060622010101502.html. [14] National Medical Products Administration. Notice on the issuance of specifications and rules for the instructions for over the counter drug[EB/OL].(2006-10-20)[2023-05-01]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20061020010101266.html. [15] Editorial Board of Guidelines for Clinical Application of National Essential Drug and Formulary. Guidelines for clinical application of national essential drug 2012 (Chinese patent drug)[国家基本药物临床应用指南(中成药 2012年版)][M] drug)[国家基本药物临床应用指南(中成药 2012年版)][M]. Beijing: The Peoples Medical Publishing House, 2013. [16] ZHANG B, ZHANG XM, LIN ZJ, et al.Series of group standards of technical specifications for revision of safety information in marketed chinese patent medicine instructions[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2022, 47(2): 285-294. [17] National Medical Products Administration. Announcement of National Medical Products Administration on the release of Good Quality Management Practice for Pharmacovigilance (No.65 of2021)[EB/OL].(2021-05-13)[2023-06-16]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210513151827179.html. [18] ZHOU S, YANG HJ, JING ZW, et al.Safety information in oral Chinese patent medicine instructions for big brand Traditional Chinese Medicine[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2021, 18(10): 981-985. [19] WU LD, SHEN JF.Risk factors of safety and countermeasures in clinical application of Chinese patent medicine[J]. Journal of Traditional Chinese Medicine Management(中医药管理杂志), 2022, 30(2): 148-150. [20] HONG YL, WANG YJ, SHEN L, et al.Application,problems,and development strategies of personalized traditional Chinese medicine preparations[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2021, 46(15): 3739-3745. [21] LUO ED, LI LG, BIAN Y.Analysis of outpatients’ prescriptions utilization of Chinese Patent Medicines in primary health institutions from rural western China[J]. Chinese Journal of Health Policy(中国卫生政策研究), 2017, 10(7): 59-64. [22] National Medical Products Administration. Regulations on Drug Instructions and Labels (No.24 of CFDA)[EB/OL].(2006-03-16)[2023-05-24]. http://www.gov.cn/ziliao/flfg/2006-03/16/content_228465.htm. [23] National Medical Products Administration. Drug Administration Law of the People’s Republic of China[EB/OL].(2019-08-27)[2023-06-16]. https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html. [24] National Medical Products Administration. Announcement of National Medical Products Administration on the release of Technical Guiding Principles for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions (Trial)(No.1 of2022)[EB/OL].(2022-01-07)[2023-05-24]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20220107145808154.html. [25] ZHANG XM, LIN ZJ, ZHANG B, et al.Interpretation of technical specifications for revision of safety information in marketed Chinese patent medicine instructions[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2022, 47(2): 295-300. [26] GUAN G, LI CX, RONG CL, et al.System evaluation of Kuanxiong Aerosol in the treatment of coronary heart disease and angina pectoris[J]. Journal of Community Medicine(社区医学杂志), 2020, 18(9): 692-696. [27] ZHENG SK, LU YH, CHEN ZX.Efficacy and safety of Xinqin granules combined with H1 receptor antagonist in the treatment of allergic rhinitis:a meta-analysis[J]. New Chinese Medicine(新中医), 2023, 55(7): 48-52. [28] WANG RJ, ZHANG GJ, PANG WT, et al.Xinqin granule in the treatment of allergic rhinitis:a systematic review of randomized clinical trials[J]. Tianjin Journal of Traditional Chinese Medicine(天津中医药), 2022, 39(2): 205-210. [29] ZHAO NN.A systematic review and meta-analysis: XinQin granules for allergic rhinitis[D]. Chengde: Chengde Medical University(承德医学院), 2021. [30] GAO Y, JIN JJ.Clinical study of Zhennaoning capsules combined with Shuxuening injection in the treatment of cerebral arteriosclerosis[J]. China Pharmaceuticals(中国药业), 2023, 32(2): 93-96. [31] LIN ZJ, HUANG ZK, ZHANG XM, et al.Strategies for clinical pharmaceutical care based on the improvement of “adverse drug reactions” in Chinese patent medicine instructions[J]. Journal of Beijing University of Traditional Chinese Medicine(北京中医药大学学报), 2022, 45(10): 985-989. [32] ZHANG B, LI YL, ZHANG XM, et al.Strategies for clinical pharmaceutical care based on the improvement of “contraindications” in Chinese patent medicine instructions[J]. Journal of Beijing University of Traditional Chinese Medicine(北京中医药大学学报), 2022, 45(10): 990-993. [33] SA RN, ZHANG XM, ZHANG B, et al.Strategies for clinical pharmaceutical care based on improvement of “precautions” in Chinese patent medicine instructions[J]. Journal of Beijing University of Traditional Chinese Medicine(北京中医药大学学报), 2022, 45(10): 994-998. [34] ZHANG B, LYU JT, ZHANG XM, et al.Strategies for clinical pharmaceutical care based on improvement of “application for special populations” in Chinese patent medicine instructions[J]. Journal of Beijing University of Traditional Chinese Medicine(北京中医药大学学报), 2022, 45(10): 999-1004. [35] ZHANG B, WU H, ZHANG XM, et al.Strategies for clinical pharmaceutical care based on the improvement of “warnings” in Chinese patent medicine instructions[J]. Journal of Beijing University of Traditional Chinese Medicine(北京中医药大学学报), 2022, 45(10): 979-984. |
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