注射剂药品说明书中辅料标注情况调查研究  

Investigation on Declaration of Excipients in Instructions of Injections

作　　者：薛进[1] 陶柏成[1] 蒋云[1] 周丽芳[1] 张先明[1] Xue Jin;Tao Baicheng;Jiang Yun;Zhou Lifang;Zhang Xianming(Children’s Hospital of Soochow University,Jiangsu Suzhou 215003,China)

机构地区：[1]苏州大学附属儿童医院,江苏苏州215003

出　　处：《儿科药学杂志》2020年第5期42-45,共4页Journal of Pediatric Pharmacy

基　　金：苏州市科技项目,编号SYSD2019184。

摘　　要：目的:调查我院静脉用药集中调配中心注射剂药品说明书中有关药用辅料标注情况,为儿科合理用药提供参考。方法:收集我院静脉用药集中调配中心常用注射剂药品说明书,对药品辅料标注情况进行分析。结果:收集注射剂药品说明书191份,其中标注辅料的说明书154份,辅料标注率为80.63%,明确标注辅料使用量仅为4.19%。结论:国家食品药品监督总局应加强药品中辅料的管理及说明书标注规范,尤其是儿童用药的辅料管理,建立完善的药用辅料管理制度,规范药品中辅料使用的种类和用量,规避药用辅料在药物治疗中的风险,提高儿童用药的安全性。Objective:To investigate the declaration of pharmaceutical excipients in instructions of injections in pharmacy intravenous admixture services(PIVAS),so as to provide reference for the rational use of drugs in pediatrics.Methods:Instructions of commonly used injections in PIVAS of our hospital were collected and the declaration of pharmaceutical excipients in instructions was analyzed.Results:Totally 191 pieces of instructions were collected,among which 154 pieces were marked with pharmaceutical excipients,with declaration rate of 80.63%,and the declaration rate of usage amount of pharmaceutical excipients was only 4.19%.Conclusion:The National Medical Products Administration shall strengthen the management of pharmaceutical excipients and the specification of declaration in instructions,especially the excipients for children,establish the management system,regulate the categories and amounts of pharmaceutical excipients,avoid the risks of excipients in drug therapy,and improve the medication safety for children.

关 键 词：药用辅料 儿童 注射剂 安全性 

分 类 号：R95[医药卫生—药学]