80份中成药说明书的调查研究.pdfVIP

目 录 摘要 ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙I-II 1 前言∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙1 2 参考资料∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙2 2.1 我国相关法律规定∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙2 2.2 初步调查发现的问 ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙3 3 调查结果与分析∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙4 3.1 调查结果∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙4 3.2 分析∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙6 4 讨论 ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙12 4.1 药品说明书修改建议 ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙12 4.2 药品说明书修改动力 ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙12 参考文献 ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙14 综述 ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙15 致谢 ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙20 80份中成药说明书的调查分析 摘要: 目的 分析目前非处方中成药说明书存在的问题，为规范中成药说明书提供依据；方法 随机抽取80份非处方中成药说明书,参照中国的药品相关法规，进行内容项目规 范性调查，并与10种现存比较规范的药品说明书进行对比分析；结果 中成药说明书普遍缺少不良反应、注意事项、孕妇及哺乳期妇女用药、儿童用药 、老年患者用药、药物相互作用、药理毒理、药代动力学等重要的项目的描述；结 论 中成药说明书需要尽快加强规范。 关键词:中成药；非处方药；说明书；调查：分析 I Survey and analysis of 80 package inserts of traditional Chinese medicine Abstract: Objective To analyze the problems existing in the package inserts of traditional Chinese medicine(TCM)so as to provide reference for standardization of the package inserts of TCM．Methods 80 package inserts of TCM which were randomly refer to the law for medicine management in China，and compared with 10 package inserts of medicines which are normative ．Results The common problems existing in the package inserts of TCM were characterized by absence of important items such as pharmacokinetics ，ADR ，contraindication，precautions ，medication of pregnant and lactation women ，medication of children and elderly patients ，drug interaction，pharmacy toxicology ．Conclusions It is urgent to standardize the package inserts of TCM． Key words: Traditional Chinese medicine;OTC drugs;instructions;survey;analysis I 1 前言 近年来中药行业成长趋势明显，中成药以其在预防、治疗和保健方面的独特 优势，在当前社会条件下将有望释放出更大的需求。我国正进行的医疗体制改革 和国家对中医药产业的扶持政策，为中药行业发展提供了难得的发展机遇。近年 来，中国中成药产业保持快速增长的良好发展态势，2013年中成药制造业工业总 产值约占整个中药制造行