汉代经典名方复方制剂开发的用法用量分析与对策  

Usage and Dosage Analysis and Countermeasures for Development of Compound Preparations of Han Dynasty Famous Classical Formulas

作　　者：金艳[1] 李兵[2] 张卫[2] 彭华胜[1] 张华敏[3] 刘晖晖 张林[5] 詹志来 JIN Yan;LI Bing;ZHANG Wei;PENG Huasheng;ZHANG Huamin;LIU Huihui;ZHANG Lin;ZHAN Zhilai(State Key Laboratory for Quality Ensurance and Sustainable Use of Dao-di Herbs,National Resource Center for Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Basic Theory for Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;China Resources Sanjiu Medical&Pharmaceutical Co.Ltd.,Shenzhen 518110,China;Beijing University of Chinese Medicine,Beijing 102488,China)

机构地区：[1]中国中医科学院道地药材品质保障与资源持续利用全国重点实验室,中药资源中心,北京100700 [2]中国中医科学院中药研究所,北京100700 [3]中国中医科学院中医基础理论研究所,北京100700 [4]华润三九医药股份有限公司,广东深圳518110 [5]北京中医药大学,北京102488

出　　处：《中国实验方剂学杂志》2024年第7期1-10,共10页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：中国中医科学院科技创新工程项目(CI2021A03702);中央本级重大增减支项目(2060302);国家重点研发计划项目(2019YFC1711401)。

摘　　要：笔者拟从不同层面对汉代经典名方用法用量进行分析,并在此基础上给出相应对策,以期为此类复方制剂的开发提供参考依据。通过对仲景用药特点、煎煮方式、服法用量分类统计,历代医家度量衡折算方法和已上市汉代经典名方制剂用法用量的综合分析,发现“将息法”为仲景方服法总则,即基于汉代度量衡一两折算今13.8 g的情况下中病即止、灵活用药,达到用药安全有效的目的。梳理后发现,汉代经典名方虽然单味药用量大,但服法灵活,以每服生药量为基础用量,服用次数则根据病情灵活调整,该用法用量成为经典名方复方制剂合理开发的关键。基于考证结论,建议汉代经典名方复方制剂开发时,尊重仲景原方服法用量,以原方每服生药量作为每日基础服用量,服用次数采取区间表述方式,即每日1~N次(N为原文最大日给药次数),具体服用次数可由临床医生根据病情轻重缓急随证加减,灵活选择;毒理学研究时以每服生药量为基础,观察最大次数下的毒理情况,提示临床安全使用范围;药品说明书建议采用区间表述方式,提示毒理风险区间。In order to provide a reference basis for the development of relevant compound preparations,this article takes a comprehensive analysis of the usage and dosage of famous classical formulas in Han dynasty from various perspectives,and gives corresponding countermeasures on this basis.Through the comprehensive analysis of the classification and statistics of Zhongjing's medication characteristics,decoction methods,administration and dosage,and combining conversion methods of weights and measures by ancient medical practitioners,along with the dosage and administration of the listed Han dynasty famous classical formulas,it was found that the "Jiangxi method" served as a general guideline for administration according to Zhongjing's original text.This method allowed for flexible dosing based on the conversion of the ancient measurements to modern equivalents[13.8 g per Liang( 两 )],ensuring the safe and effective medication of these formulas.After combing,it is found that although the dosage of single medicine is large in famous classical formulas from Han dynasty,the administration is flexible.The crude drug amount per administration serves as the foundational dose,with the frequency of administration adjusted flexibly according to the condition.This dosing approach becomes the key for the rational development of compound formulations of famous classical formulas.Based on the conclusions of the study,it is recommended that when developing compound formulations of famous classical formulas in Han dynasty,the original administration method and dosage should be respected.The original crude drug amount per administration should be considered as the daily foundational dose,with the frequency of administration described within a range(1 to N times per day,where N is the maximum number of administrations as per the original text).The specific frequency of administration can be adjusted flexibly by clinical practitioners based on the individual condition.This approach should also be adopted in toxicological studies,where th

关 键 词：经典名方 汉代方剂 用法 用量 中药复方制剂开发 每服生药量 基础服用量 

分 类 号：R289[医药卫生—方剂学] R931[医药卫生—中药学] R28[医药卫生—中医学] G254[文化科学—图书馆学]