国产与原研注射用头孢曲松钠药品说明书对比分析  

Comparison and Analysis of the Instructions of Domestic and Original Ceftriaxone Sodium for Injection

作　　者：夏旭东[1] 张雨[2] 杨雪[1] 夏明[1] 刘伟[3] 李文武[1] 

机构地区：[1]河南省食品药品评价中心,郑州450004 [2]郑州铁路职业技术学院药学系,郑州450052 [3]郑州大学药学院,郑州450001

出　　处：《中国药房》2016年第28期4025-4027,共3页China Pharmacy

基　　金：河南省科技攻关计划项目(No.142102310075)

摘　　要：目的:探讨国产注射用头孢曲松钠药品说明书的问题和不足,为药品监管部门、药品生产企业完善说明书内容管理提供参考。方法:选取齐鲁制药有限公司官方网站的英派琦说明书作为国产注射用头孢曲松钠药品说明书的代表,选取上海罗氏制药有限公司官方网站的罗氏芬说明书作为原研注射用头孢曲松钠药品说明书,对二者的结构和内容进行对比分析。结果:二者在说明书修订日期、成分、适应证、用法用量、不良反应、禁忌、注意事项、药物相互作用、警告等的结构基本一致,但内容上国产药说明书在特殊人群用药、不良反应描述、药物相互作用等方面没有原研药说明书描述的全面和详细。结论:建议药品监督管理部门及时督促相关制药企业修订药品说明书,落实相关法律规定,进一步规范、完善注射用头孢曲松钠说明书,特别是安全性信息;制药企业应强化第一责任人意识,承担相应法律规定和社会责任,主动收集药品上市后安全性信息,及时更新完善说明书内容,加强管理国产药说明书在不良反应、注意事项、药物相互作用、禁忌等方面的内容。OBJECTIVE： To provide reference for improving instruction contents by drug administration departments and pharmaceutical production enterprises through finding the problems and deficiencies of the instructions for domestic Ceftriaxone sodium for injection. METHODS： The instructions of Yingpaiqi were selected from Qilu Pharmaceutical Co., Ltd. website as the representative of domestic Ceftriaxone sodium for injection; the instructions of Rocephin were selected from Shanghai Roche Pharmaceutical Co., Ltd. website as the representative of original drugs. They were analyzed comparatively in terms of structure and content. RESULTS ： The structure of domestic instruction was similar to that of original one in respects of revision date, components, indication, usage and dosage, ADR, eontraindication, precautions, drug interaction, warning, etc. ; but in content, some aspects of the domestic instruction, such as drug use of special population, ADR, drug interaction, were not provided a rather complete description. CONCLUSIONS： It is suggested that drug administration departments should timely urge relevant pharmaceutical enterprises to revise drug instructions and implement relevant laws and regulations and further standardize and improve the instructions of Ceftriaxone sodium for injection, especially the relevant safety information; pharmaceutical enterprises should strengthen the awareness of first responsibility and undertake relevant legal liability and social responsibility, collect drug safety information actively, update the content of instruction and strengthen the content management in terms of ADR, precaution, drug interactions, contraindication and so on.

关 键 词：注射用头孢曲松钠 药品说明书 国产药 原研药 对比 

分 类 号：R954[医药卫生—药学]