234份药品注射剂说明书规范性的研究  

Study on the Specifications of 234 Drug Instructions in injection

作　　者：杨学娟[1] 张传军[1] 

机构地区：[1]邳州市人民医院药剂科,江苏邳州221300

出　　处：《中国药物评价》2012年第5期366-368,380,共4页Chinese Journal of Drug Evaluation

摘　　要：目的:通过研究相关法规,调查目前药品说明书中存在的普遍问题,为临床用药及有关部门制定、修改和审核药品说明书时提供参考。方法:收集整理我院近年在用的部分药品说明书,归纳其项下内容及印刷存在的问题,对不同厂家同一种药品的说明书作内容比对,同时与《中国药典临床用药须知》等权威药学书籍药品说明内容相比较。结果与结论:部分药品说明书内容有缺陷,印刷质量差;建议药品监管部门对《药品说明书与标签管理规定》进行必要的修订。Objective:To provide a reference for clinical drug use,instruction formulation and modification by reviewing laws and regulations and investigating the existing problems in the drug instructions.Methods:Collecting parts of the drug instructions in our hospital in recent years,summarize their contents and printing problems,contrast the same kind of drug instructions from different manufacturers,and compare with'the Clinical Guide to the Chinese Pharmacopoeia'and other authoritative pharmaceutical books.Results and Conclusion:Parts of the drug instruction contents have defects,and the printing quality is poor.It is recommend that drug regulatory department should make the necessary amendments to the Drug Instructions and Label Management Regulations.

关 键 词：注射剂 药品说明书 规范 

分 类 号：R95[医药卫生—药学]