558份化学药品说明书的调查分析

目的:改进化学药品说明书,以促进化学药品的合理使用。方法:收集我院及附近医院临床常用的558种化学药品说明书,根据《药品说明书规范细则(暂行)》相关要求对其进行统计分析。结果:部分化学药品说明书中药理毒理、用法与用量、药动学等几个最重要的项目均未完全达到国家规定标准,但其中进口化学药品优于国产化学药品;注射剂优于口服制剂,口服制剂优于外用制剂。结论:化学药品说明书还存在一些不规范问题,仍需要不断完善。

Investigation and Analysis on 558 Package Inserts of Chemical Drugs

OBJECTIVE:To improve package inserts of chemical drugs so as to promote safe,rational and effective use of chemical drugs.METHODS:A total of 558 package inserts of different chemical drugs commonly used in the clinic were collected from our hospital and other local hospitals and analyzed statistically based on the regulations stipulated by the "Norms of Package inserts of Drugs(trial)".RESULTS:Some important items such as pharmaco-toxicology,usage and dosage,pharmacokinetics etc in the package inserts of chemical drugs failed to meet the state standards,but the package inserts of the imported chemical drugs superior to those of the domestic ones,those of the injections superior to those of oral preparations,and those of oral preparations superior to those of external preparations.CONCLUSION:The package inserts of chemical drugs are far from perfect,which thus remain to be improved further.