日本汉方制剂及其特点与中药新药研究的思考  

Characteristics of Japanese Kampo preparations and thoughts on studies of new Chinese materia medica

作　　者：杨平 林丹 宋菊 阳长明[1] YANG Ping;LIN Dan;SONG Ju;YANG Chang-ming(Center for Drug Evaluation, China Food and Drug Administration, Beijing 100022, China)

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100022

出　　处：《中草药》2018年第9期1985-1989,共5页Chinese Traditional and Herbal Drugs

摘　　要：通过对日本汉方制剂目录、分类、审批、生产销售等基本情况的介绍,以及对其药材、剂型、工艺和质量控制等方面特点的分析,提出我国经典名方制剂研究应注意结合临床应用遴选经典名方,尊重中医药理论指导和中医临床应用特点,重视上市后再研究,加强质量控制研究,积极关注已上市"经典名方"制剂的再评价;中药新药研究应加强药材/饮片源头质量控制,基于人用历史开展中药复方新药研究,以"质量源于设计"的思路和理念开展中药新药的质量控制,加强工艺过程控制和质量标准研究。This paper introduces the general information of Japanese Kampo preparations, including the catalogue, classification, approval, production and so on, and summarizes their quality characteristics on medicinal materials, formulation, productive process, and quality control. It is suggested that classical representative prescriptions should be selected in combination with clinical application, and the research of classical prescription preparations should follow the guidance of traditional Chinese medicine（TCM） theories and the characteristics of clinical application of TCM, attach important to the research after listed, and strengthen studies on the quality control. Moreover, the reassessment of post-marketed ＂classical representative famous prescription＂ preparations should be paid more attention to. The research of new Chinese materia medica（CMM） should strengthen quality control of medicinal materials/pieces source, and new CMM compound preparation research should base on the history of human use. Quality control study of new CMM should base on ＂quality by design＂ ideas and concepts, and strengthen process control research and quality standard research.

关 键 词：日本汉方制剂 经典名方 中药新药 质量设计 质量控制 

分 类 号：R28[医药卫生—中药学]