日本汉方制剂说明书与我国中成药说明书对比浅析  

Basic Contrastive Analysis of Drug Instruction of Ethical kampo extract product in Japan and Ethical New TCMs in China

作　　者：薛斐然[1] 刘炳林[1] 周贝[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国现代中药》2017年第6期877-879,共3页Modern Chinese Medicine

基　　金：2012年度中医药行业科研专项(201207009)

摘　　要：本文分析了日本医用汉方制剂说明书并与我国现行中成药处方药说明书撰写要求进行了对比,发现我国中成药处方药说明书在不同生产企业同品种说明书功能主治的表述上较日本汉方制剂更为规范统一,日本医用汉方制剂在不同生产企业同品种说明书的安全性信息表述上更为完整和统一。因此,在我国经典名方制剂说明书【功能主治】项不应参考日本医用汉方制剂的表述和管理方式,但是对于说明书中安全性信息的撰写和更新上可借鉴日本汉方制剂的相关经验。This paper analyzed the drug instruction of Ethical kampo extract product in Japan and contrasted with the writing requirement of the drug instruction of Ethical New TCMs in China, the functions and indications in the drug instruction for the some prescription produced by different drug manufacturers are of more standard and uniform in China, but the safety information are more completed and unified in Japan. So in fact, it should not refer the functions and indications in the drug instruction of Kampo formulation for prescription in Japan but it is necessary to imitate the writing and updating experience of safety information for the classical representative famous prescriptions in China.

关 键 词：日本汉方制剂 说明书 注册监管 

分 类 号：R289[医药卫生—方剂学]