103份滴眼液说明书内容分析  

An Analysis on Package Inserts of 103 Samples of Eye Drops

作　　者：孙超[1] 崔潇[1] 何志一[1] 尹燕杰[1] 

机构地区：[1]哈尔滨市食品药品检验检测中心,哈尔滨150525

出　　处：《中国药事》2015年第11期1216-1218,共3页Chinese Pharmaceutical Affairs

摘　　要：目的:对103份滴眼液说明书内容进行分析,探讨说明书中存在的问题,为规范、完善滴眼液说明书内容提供参考。方法:收集33类103份滴眼液的说明书,参考相关法律、法规及规范对其内容进行分析。结果:说明书中成分、用法用量、药物相互作用、孕妇及哺乳期妇女用药、儿童用药、老年患者用药、使用期限等项目,存在内容不完整和模糊描述的现象。结论:滴眼液说明书存在一些不规范问题,有关部门需加强对药品说明书的科学管理,使医师、药师、患者获得更多、更详细的药品知识,以利于安全、有效用药。Objective： To analyze the contents of package inserts of 103 samples of eye drops, and discuss the problems existing in the package inserts, so as to provide references for regulating and improving the contents of package inserts of eye drops. Methods： Package inserts of 103 samples of eye drops in 33 categories were collected to analyze their contents according to the relevant laws, regulations and rules. Results： There was a phenomenon of incomplete and fuzzy descriptions of items such as ingredients, dosage, drug interactions, medication for pregnant and lactating women, medication for children, medication for the elderly and shelf life in package inserts.Conclusion： There were problems of irregularity in package inserts of eye drops. It is suggested that relevant authorities should strengthen the scientific management of package inserts, making more detailed drug information available for physicians, pharmacists and patients, which is conducive to safe and effective use of drugs.

关 键 词：滴眼液 说明书 内容分析 

分 类 号：R95[医药卫生—药学]