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126种外用固体和半固体制剂药品说明书调查分析
引用本文:万正兰,李亚男,倪南珍.126种外用固体和半固体制剂药品说明书调查分析[J].中国药事,2011,0(9):912-913,921.
作者姓名:万正兰  李亚男  倪南珍
作者单位:1. 中山大学附属第五医院,珠海,519000
2. 广东省珠海市金湾区三灶医院
摘    要:目的为改进和完善外用固体和半固体制剂药品说明书提供建议,以促进其安全、合理使用。方法搜集某三级医院药房及2家社会连锁药店外用固体和半固体制剂共126个品种的药品说明书,将西药制剂和中成药制剂说明书分别统计,对其完整性、规范性进行分析。结果在126种西药和中成药说明书中,缺项较多的10个项目分别是:不良反应5.49%和68.57%;禁忌症27.47%和51.43%;注意事项2.20%和17.14%;孕妇及哺乳期妇女用药73.62%和100.00%;儿童用药80.22%和100.00%;老人用药83.52%和100.00%;药物相互作用72.53%和97.14%;药物过量89.01%和100.00%;药理/毒理作用65.93%和94.28%;药代动力学80.22%和100.00%。西药药品说明书的标注项目质量优于中成药制剂。结论外用固体和半固体制剂药品说明书的内容标注仍然存在不规范问题,特别是中成药说明书更需要完善和改进。

关 键 词:外用固体和半固体制剂  说明书  调查分析

Investigation and Analyses on the Instructions of 126 Kinds of Solid and Semi-solid Preparations
Wan Zhenglan,Li Yanan,Ni Nanzhen.Investigation and Analyses on the Instructions of 126 Kinds of Solid and Semi-solid Preparations[J].Chinese Pharmaceutical Affairs,2011,0(9):912-913,921.
Authors:Wan Zhenglan  Li Yanan  Ni Nanzhen
Affiliation:Wan Zhenglan,Li Yanan and Ni Nanzhen1(The Fifth Affiliated Hospital of Sun Yat-sen University,Zhuhai 519000,1Zhuhai Jinwan District Sanzao Hospital)
Abstract:Objective To provide recommendations for improving and perfecting drug instructions of the solid and semi-solid preparations for external use,and to promote the safe and rational use of medicine.Methods Collecting the 126 varieties of drug instructions from tertiary hospital pharmacy and two chain drug stores,and investigating the instructions.Results In the 126 kinds of Western medicine and Chinese traditional medicine instructions,ten items lack at most,such as adverse reactions,contraindications,precauti...
Keywords:solid and semi-solid preparations for external use  drug instructions  investigation and analysis  
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