中成药说明书存在的问题分析  

Analysis on problems in directions of Chinese patent medicine

作　　者：邓敏[1] 赵捷[1] 李一丹[1] 

机构地区：[1]广东海洋大学医院药剂科,湛江524008

出　　处：《国际医药卫生导报》2009年第12期83-84,共2页International Medicine and Health Guidance News

摘　　要：目的探讨中成药说明书存在的问题，促进药品说明书的规范化。方法收集2007年1月-2008年1月间使用的中成药176种，并对其说明书存在的问题进行统计分析。结果本组收集176份中成药，其中有18份（10．23％）无说明书，158份有说明书的中成药中缺乏项目，依次为禁忌（74．68％）、不良反应（73．24％）、药理作用（53．80％）、注意事项（39．24％）、药品名称（17．72％）、性状（15．82％）等。结论中成药说明书存在的严重的缺项和书写不规范问题，药品监督管理部门应进一步加强监督管理。Objective To investigate the problems in directions of Chinese patent medicine in order to promote the normalization of drug directions. Methods 176 kinds of Chinese patent medicine used in our hospital from January 2007 to January 2008 were gathered, and the problems in directions of Chinese patent medicine were analyzed. Results A total of 176 Chinese patent medicines, 18 were no directions, and 158 were short of items that include taboo （74.68%）, untoward reaction （73.24%）, pharmacologic action （53.80%）, announcements （39.24%）, drug name （17.72%）, characteristics （15.82%） and so on. Conclusions The seriously incomplete items and nonstandard writings existed in the drug directions. So the drug surveillance and managements must strengthen.

关 键 词：中成药 说明书 管理 

分 类 号：R28[医药卫生—中药学]