张晓朦;林志健;李凡;张冰;郭晓昕;杨乐;
ZHANG Xiao-meng;LIN Zhi-jian;LI Fan;ZHANG Bing;GUO Xiao-xin;YANG Le;Beijing University of Chinese Medicine;Center for Drug Evaluation,State Food and Drug Administration;

• 1:北京中医药大学
• 2:国家食品药品监督管理总局药品评价中心

摘要(Abstract)：

基于毒性中药的效-毒关系认识,梳理东汉至清朝48部传统中医药古籍中含乌头类中药内治方的应用剂量规律与特点,为临床用药风险警戒提供依据。检索纳入每日剂量明确的处方4 521首,建立乌头类中药内治处方数据表,采用SPSS20.0软件对乌头类中药每日剂量与入药种类、适应证、剂型、炮制、特殊人群用药等的关系进行统计分析。在4 521首处方中,67%处方以附子入药,且90%处方用量小于14.87 g·d~(-1);乌头(川乌、草乌)90%处方用量小于3.14 g·d~(-1)。在治疗伤寒、时疫、水肿痰饮的处方中,乌头用药剂量较大。在汤剂、酒剂中用量明显高于丸散剂型。且随朝代演变,乌头类中药处方剂量、叠加用药情况均有所降低。特殊人群用乌头类中药比例相对较少,剂量较轻。因此,在现代临床应用中,乌头类中药内治方用量不宜超过现行《中国药典》规定剂量上限,并结合多方面因素严格控制用量,保障效-毒关系平衡。
Based on the relation of efficacy and toxicity,this study mined the dosage rules and characteristics of Aconitum herbs in oral prescriptions from 48 traditional ancient books from Eastern Han dynasty to Qing dynasty,to provide the basis for strengthening the clinical risk pharmacovigilance. In the 48 traditional ancient books,4 521 prescriptions with clear daily oral dosage were included to establish a database. SPSS 20. 0 software was used for statistics and analysis of the daily dosage characteristics with different kinds of herbs,indications,dose forms,processing,use in special population,and other aspects. The results showed that 67% prescriptions contained Aconitum carmichaeli( Fuzi),and 90% of them was less than 14. 87 g·d~(-1); The dosage of A. carmichaeli(Chuanwu) and A. kusnezoffii( Caowu) were less than 3. 14 g·d~(-1). In the prescriptions for treating typhoid,epidemic,edema and phlegm,the dosage of Aconitum was larger. There dosage in the decoction and vinum was significantly higher than that in the pill and powder. With the dynastic evolution,the dosage of Aconitum herbal medicines prescriptions and the application percentage of superposition drug also had decreased. For the special populations that with different metabolism process,such as old people,children,pregnant and lactating women,the application of Aconitum was not only with relatively small ratio,but also with lower dose. Therefore,based on the data-mining of ancient books,the dosage of Aconitum should not exceed the limit prescribed by the current China Pharmacopoeia,and also should be strictly controlled by considering various factors,which will ensure the balance of efficacy and toxicity.

关键词(KeyWords)： 乌头类中药;剂量规律;效-毒关系;合理用药
Aconitum herbs;dosage regulation;efficacy-toxicity relation;rational drug use

Abstract:

Keywords:

基金项目(Foundation): 北京中医药大学研究生创新项目(2016-JYB-XS123);; 国家食品药品监督管理总局药品评价中心项目(2020071420118);; 中央高校建设世界一流大学(学科)和特色发展引导专项(1000061020002/016)

作者(Author): 张晓朦;林志健;李凡;张冰;郭晓昕;杨乐;
ZHANG Xiao-meng;LIN Zhi-jian;LI Fan;ZHANG Bing;GUO Xiao-xin;YANG Le;Beijing University of Chinese Medicine;Center for Drug Evaluation,State Food and Drug Administration;

Email:

DOI: 10.19540/j.cnki.cjcmm.20171106.009

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