ZHANG Xiao-meng;LIN Zhi-jian;LI Fan;ZHANG Bing;GUO Xiao-xin;YANG Le;

• 1:Beijing University of Chinese Medicine
• 2:Center for Drug Evaluation
• 3:State Food and Drug Administration

Abstract：

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.

Key Words： Aconitum herbs;dosage regulation;efficacy-toxicity relation;rational drug use

Abstract:

Keywords:

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)

Authors: ZHANG Xiao-meng;LIN Zhi-jian;LI Fan;ZHANG Bing;GUO Xiao-xin;YANG Le;

DOI: 10.19540/j.cnki.cjcmm.20171106.009

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