中成药说明书剂量标示问题的思考及建议  

Consideration and Suggestions on Dosage Labeling Issues in Chinese Patent Medicines Instructions

作　　者：徐娟 王改平 张昱 董玲君 王君飞 刘红风 陈维红 XU Juan;WANG Gaiping;ZHANG Yu;DONG Lingjun;WANG Junfei;LIU Hongfeng;CHEN Weihong(Department of Pharmacy,Shanxi Bethune Hospital(Shanxi Academy of Medical Sciences),the Third Hospital of Shanxi Medical University,Tongji Shanxi Hospital,Taiyuan 030032,China;School of Pharmacy,Shanxi Medical University,Taiyuan 030001,China)

机构地区：[1]山西白求恩医院(山西医学科学院)、山西医科大学第三医院、同济山西医院药学部,太原030032 [2]山西医科大学药学院,太原030001

出　　处：《医药导报》2025年第5期720-726,共7页Herald of Medicine

基　　金：山西省科技厅基础研究计划青年项目(202203021212109);山西省中医药管理局课题项目(2022ZYYC061);山西省科技战略研究专项(202304031401140);国家中医药管理局中西医协同旗舰科室建设项目(晋卫中医药函[2024]14号);山西省卫健委“十四五”省级中医优势专科建设项目(晋卫中医药函[2023]13号);山西省名中医魏孟玲传承工作室建设项目(晋卫中医药函[2022]17号)。

摘　　要：目的探讨中成药说明书剂量标示的标准化方案。方法查阅《中华人民共和国药典》(简称《中国药典》)2020年版收载的成方制剂1378种,从超剂量、不同剂型、含毒性饮片3方面入手,共列举了约50个典型品种,通过推算成方制剂的日服饮片总量和组成药味的日服饮片剂量,与《中国药典》所载的饮片剂量对比分析。结果①超剂量:1378种成方制剂涉及超剂量的品种共146个,占10.60%;超剂量3~5倍的品种共8个,如断血流片、止血复脉合剂等。②不同剂型的剂量差异:银翘散古籍剂量按照明清时期1两换算为36 g,推算单味药的日服饮片剂量与《中国药典》剂量上限接近,日服饮片总量(75.60 g)约为《中国药典》银翘散(15 g)的5倍,约为日本汉方银翘散(23.868 g)的3倍;《中国药典》中不同剂型的银翘解毒制剂之间剂量差异较大,日服饮片总量比较结果显示,颗粒剂(52.50 g)最大,为片剂/胶囊剂(11.20 g)、软胶囊(13.44 g)、散剂(15.00 g)的3~5倍,但仍比古籍原方剂量(75.6 g)小30%。单味药的日服饮片剂量比较,颗粒剂在《中国药典》剂量范围内,片剂、胶囊、软胶囊、散剂均小于《中国药典》剂量;③含毒性饮片:《中国药典》收载的20种含马钱子的口服制剂,7种制剂中马钱子日服剂量超出《中国药典》剂量0.3~0.6 g,其中伸筋活络丸、疏风定痛丸超出1.5~2倍。伸筋活络丸中士的宁日服剂量为21.3 mg,大于中毒剂量5~10 mg。结论中成药说明书的剂量标示必须统一格式,在[用法用量]项下标注每味药的日服饮片剂量、日服饮片总量,并且加注服用总次数。例如:银翘解毒颗粒,每日服用4次的总剂量相当于饮片60 g(其中金银花、连翘各10.71 g,桔梗、薄荷、牛蒡子各6.43 g,淡豆豉、甘草各5.36 g,淡竹叶、荆芥各4.29 g);含毒性饮片的中成药更加需要标注剂量,例如马钱子制剂需标注马钱子粉/制马钱子的日服剂量、士的Objective To explore a standardized approach for indicating dosages in Chinese patent medicines(CPM)instructions.Methods A review of 1378 classic formulas of traditional Chinese medicine in the 2020 edition of the Pharmacopoeia of the People's Republic of China(Chinese Pharmacopoeia)was conducted,focusing on three aspects:overdose,different dosage forms,and inclusion of toxic herbs.Approximately 50 representative formulas were selected,and their daily dosage of herbal pieces and the corresponding dosage of individual herbs were calculated.These results were then compared and analyzed against the dosages stipulated in the Chinese Pharmacopoeia.Results①Overdose:Among the 1378 reviewed formulas,146(10.60%)were found to involve overdose.Specifically,eight formulas were identified as having an overdose of approximately 3 to 5 times the recommended dose,including Duanxueliu tablets and Zhixue Fumai mixture.②Dosage variations across dosage forms:Based on the conversion of the Ming-Qing dynasty dosage of one liang(Chinese traditional weight unit)to 36 g,the estimated daily dose per component of crude herbs in Yinqiao powder was close to the upper limit specified in the Chinese Pharmacopoeia.The total daily dose of crude herbs(75.60 g)was approximately five times that of the Yinqiao powder(15 g)listed in the Chinese Pharmacopoeia and three times that of the Japanese Kampo Yinqiao powder(23.868 g).Significant differences in dosage were observed among Yinqiao Jiedu preparations of different dosage forms.In terms of total daily dose of crude herbs,granules(52.50 g)had the highest dose,approximately 3-5 times that of tablets/capsules(11.20 g),soft capsules(13.44 g),and powders(15.00 g),but still 30%lower than the original prescription from ancient texts(75.6 g).Comparing the daily dose per component,granules fell within the Chinese Pharmacopoeia dose range,while tablets,capsules,soft capsules,and powders were all below the Chinese Pharmacopoeia dose.③Inclusion of toxic herbs:Among the 20 oral formulations containing Str

关 键 词：中成药说明书 标准化 剂量标示 

分 类 号：R286[医药卫生—中药学] R288[医药卫生—中医学]