首页|期刊导航|中国医院用药评价与分析|基于智能药柜的三位一体临床试验药品信息化管理系统的构建与应用

基于智能药柜的三位一体临床试验药品信息化管理系统的构建与应用OA

Construction and Application of the Three-in-One Information Management System for Clinical Trial Drugs Based on Intelligent Medicine Cabinet

中文摘要英文摘要

该文介绍了该院药物临床试验质量管理规范(GCP)中心药房构建的"信息管理系统-智能药柜-手持移动终端(PDA)"三位一体临床试验药品信息化管理系统的构建与应用.该系统通过集成电子锁控、光电计数、温控模块及药品二维码标识等技术,实现了试验用药从验收入库、存储、精准发放到回收退回的全流程数字化与闭环可追溯管理.与传统的纸质记录模式相比,该智能化管理体系显著提升了管理效率、缩短了药品发放时间,并有效降低了药品发放、记录信息、效期管理及库存盘点等方面的差错率.实践证明,该体系为解决传统管理模式效率低下、差错率高等问题提供了有效的智能化解决方案,为GCP中心药房的规范化建设和质量管理水平的提升提供了重要技术支持,具有广泛的临床推广价值.

This paper introduces the construction and application of the three-in-one information management system for clinical trial drugs that comprising the Information Management System-Intelligent Medicine Cabinet-Personal Digital Assistant(PDA)established by the Good Clinical Practice(GCP)Central Pharmacy of the hospital.By integrating electronic lock mechanisms,photoelectric counting,temperature control modules and drug QRcode identification technologies,the system enables comprehensive digital and closed-loop traceable management of clinical trial drugs throughout inspection,warehousing,storage,precise distribution,recovery,and return.Compared with traditional paper-based record,this intelligent management system significantly improves management efficiency,reduces drug distribution time,and effectively lowers error rates in drug distribution,record keeping,expiration date management and inventory verification.The system has demonstrated effectiveness in addressing inefficiencies and high error rates associated with traditional management models,which provides essential technical support for the standardization and quality improvement of GCP Central Pharmacy operations and exhibits significant potential for broader clinical application.

江莹;左成淳;李艳丽;陈灿;许青;吕迁洲;李晓宇

复旦大学附属中山医院药剂科,上海 200032复旦大学附属中山医院药剂科,上海 200032复旦大学附属中山医院药剂科,上海 200032复旦大学附属中山医院药剂科,上海 200032复旦大学附属中山医院药剂科,上海 200032复旦大学附属中山医院药剂科,上海 200032复旦大学附属中山医院药剂科,上海 200032

医药卫生

智能药柜药物临床试验信息化管理质量控制

Intelligent medicine cabinetDrug clinical trialsInformation managementQuality control

《中国医院用药评价与分析》 2026 (3)

257-260,4

国家卫生健康委医院管理研究所医院药学高质量发展研究课题(智慧药学专项)资助项目(No.NIHAYSZX2512)

10.14009/j.issn.1672-2124.2026.03.001

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