毕业论文 常用中药注射剂说明书内容的对比分析与研究.docVIP

目 录 摘要 Ⅰ-Ⅱ 1前言 1 2资料与方法 1 3结果与分析 2 3.1核准日期和修改日期项 3 3.2药品名称、拼音项 3 3.3成分项 3 3.4性状项 4 3.5功能主治项 4 3.6规格项 5 3.7用法用量项 5 3.8不良反应项 6 3.9禁忌项和注意事项 8 3.10贮藏项 8 3.11包装项 8 3.12有效期项 9 3.13特殊人群和药物基础研究 9 3.13.1特殊人群用药 9 3.13.2药物基础研究 10 4讨论 10 参考文献 12 综述 14 致谢 19 常用中药注射剂说明书内容的对比分析与研究 摘要：目的 对中山市中医院门诊30份中药注射剂说明书进行调查分析，了解中药注射剂说明书现状，为规范完善说明书提供参考；方法 以国家食品药品监督管理局颁布的《药品管理法》、《中药、天然药物处方药说明书格式》、《中药、天然药物处方药说明书内容书写要求》、《中药、天然药物处方药说明书撰写指导原则》为标准，对中山市中医院30份中药注射剂说明书的内容进行统计分析；结果 调查的30份中药注射剂药品说明书必备项目齐全，标注率100%,但对用药安全有重要影响的项目,如特殊人群和药学相关基础研究鲜见标注；结论 中药注射剂说明书对用药安全有重要影响的项目如特殊人群和药学相关基础研究标注率极低,不能充分发挥指导临床合理用药的作用。应规范中药注射剂药品说明书，企业要积极进行有关研究， 完善相关标注，不断提高中药注射剂药品说明书的技术标准，同时药品监督管理部门应进一步加强监督管理，保证中药注射剂更加安全、有效、合理地使用。 关键词：中药注射剂；说明书；调查分析 Analyze Frequentiy-used Directions Of Traditional Chinese Medicine lnjection lnstruction Abstract：Objective To investigate and analyze 30 directions of traditional Chinese medicine injections in zhongshan Chinese medicine hospital. to understand current traditional Chinese medicine injection in order to provide reference for Standarded and perfected the instruction. methods according “Pharmaceutical affairs law”“traditional Chinese medicine，natural medicine，prescription drugs instructionl format,”“traditional Chinese medicine，natural medicine，prescription drug guide content writing requirements，”“traditional Chinese medicine，natural medicine，prescription instructions written guidelines”instruction of 30 directions of traditional Chinese medicine injection Were analyzed in zhongshan Chinese medicine hospital.Results In 30 traditional Chinese medicine injections specification specified items marked rate reached 100% ,but other items were labeled in a low recovery rate such as medication in women during pregnancy and lactation，children and the aged patients and special groups of people,pharmacology and toxicology，and drug interactions. Conclusion Drug instructions project tagging such as medication in women during pregnancy and lactation，children and the aged patients and sp