含细辛中成药说明书安全项信息现状分析及思考

doi:10.19803/j.1672-8629.20230303

摘要/Abstract

摘要： 目的通过对含有细辛及其提取物的中成药说明书中存在的安全性问题现状进行分析,为说明书的修改提供建议。方法收集《中华人民共和国药典》《国家基本药物临床应用指南》和《国家基本药物处方集》中收录含细辛及细辛提取物的中成药组成成分和剂量、主治功效、用法用量及说明书中的安全项信息,录入Excel 2019,对中成药的基本特点、细辛用量和说明书安全项信息进行汇总和统计分析。结果去重后,共纳入40种含细辛及其细辛提取物的中成药。大部分中成药所含细辛剂量符合药典规定,但缺少特殊人群的用法用量信息和“十八反”“十九畏”配伍禁忌。目前收集的药品上市许可持有人说明书安全项信息存在安全性信息缺如、术语不规范的问题。结论建议药品上市许可持有人按照国家药品监督管理局发布的《已上市中药说明书安全信息项内容修订技术指导原则（试行）》等相关法律法规,在中医辨证论治体系和临床用药经验指导下修订和完善说明书的安全项信息,包括【不良反应】【禁忌】【注意事项】【特殊人群用药】和警示语,补充特殊人群的用法用量,为临床安全用药提供法定依据。

关键词: 细辛, 中成药, 说明书, 安全性

Abstract: Objective To analyze the current situation of safety problems in the instructions of Chinese patent medicine containing Asari Radix et Rhizoma and its extracts, and to provide suggestions for the revision of instructions. Methods The Chinese pharmacopoeia 2020, Guidelines for clinical application of national essential drug 2012, Formulary of national essential drug were searched for Chinese patent medicines containing Asari Radix et Rhizoma and its extracts, and the composition and dosage, indications, usage and dosage of the Chinese patent medicine, and the safety information in the drug instructions were collected. Besides, the basic characteristics, dosage of Asari Radix et Rhizoma and safety items of Chinese patent medicine instructions were summarized and statistically analyzed in Excel 2019. Results 40 Chinese patent medicines containing Asari Radix et Rhizoma and its extracts were included after removing duplicates. The dosage of Asari Radix et Rhizoma from most of these Chinese patent medicines meets the regulations of Chinese pharmacopoeia, but there is a lack of the information on usage and dosage for special populations, “eighteen anti” and “nineteen fear”. There were still problems of the safety information of the drug instructions of the marketing authorization holders collected in this study including missing safety information and the nonstandard terminology. Conclusion We suggest the marketing authorization holders to revise the safety information of instructions based on related laws and regulations such as Technical Guiding Principles for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions (Trial) and the guidance of the syndrome differentiation system of traditional Chinese medicine and the clinical medication experience to provide foundation for safe use of clinical drugs. The safety information in the instructions includes adverse events, contraindications, precautions, warnings, application for specific populations, and usage and dosage for specific populations.

Key words: Asari Radix et Rhizoma, Chinese patent medicine, instruction, safety

中图分类号:

乔萌, 雷超, 陈子佳, 张强, 王志飞. 含细辛中成药说明书安全项信息现状分析及思考[J]. 中国药物警戒, 2023, 20(12): 1401-1406.

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.

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