| 240份中成药说明书的调查分析 |
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| 引用本文： | 王建,张桂芬,卢虹,金丹. 240份中成药说明书的调查分析[J]. 中国医院用药评价与分析, 2011, 0(3): 277-280 |
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| 作者姓名： | 王建 张桂芬 卢虹 金丹 |
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| 作者单位： | 苏州大学附属常熟医院药剂科; |
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| 摘 要： | 目的:调查分析中成药说明书记载项目和内容的完整性,为完善药品说明书提供参考依据。方法:收集苏州大学附属常熟医院药房中成药说明书240份,根据国家食品药品监督管理局2006年颁布的《药品说明书和标签的管理规定》及其他参考资料,对说明书的各项内容进行调查,并分析每份说明书应记载的项目和内容的完整性。结果:部分中成药说明书项目未能按国家规定标注,缺项严重,特别是药理毒理、不良反应、禁忌、注意事项和药物相互作用缺项最多。在处方药与非处方药之间、不同使用途径之间和各省份之间说明书项目的完整性存在差异。结论:中成药说明书仍需要不断完善,不规范的药品说明书影响安全、合理用药。
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| 关 键 词： | 中成药说明书 调查 分析 |
Investigation and Analysis of 240 Package Inserts of Chinese Patent Medicine |
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| WANG Jian,ZHANG Gui-fen,LU Hong,JIN Dan. Investigation and Analysis of 240 Package Inserts of Chinese Patent Medicine[J]. Evaluation and Analysis of Drug-Use in Hospital of China, 2011, 0(3): 277-280 |
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| Authors: | WANG Jian ZHANG Gui-fen LU Hong JIN Dan |
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| Affiliation: | WANG Jian,ZHANG Gui-fen,LU Hong,JIN Dan(Dept. of Pharmacy,Soochow University Affiliated Changshu Hospital,Changshu 215500,China) |
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| Abstract: | OBJECTIVE:To investigate and analyze the integrality of the recording items and contents in the package inserts of Chinese patent medicine so as to provide references for improving package inserts.METHODS:240 package inserts of Chinese patent medicines sampled in hospital pharmacy of Soochow University Affiliated Changshu Hospital were investigated regarding each items in accordance with theAdministrative Regulations for Package Inserts and Labels of Drugsannounced by SFDA in 2006 as well as other related r... |
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| Keywords: | Package inserts of Chinese patent medicine Investigation Analysis |
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