中药注射剂说明书存在问题及分析  

Analysis of the Problems of Package Inserts of Traditional Chinese Medicine Injection

作　　者：孟菲[1] 李学林[1] 

机构地区：[1]河南中医学院第一附属医院,郑州市450000

出　　处：《中国药房》2011年第27期2587-2589,共3页China Pharmacy

基　　金："重大新药创制"科技重大专项子课题(2009ZX09502-030);国家科技支撑计划课题(2006038086056);河南省科技发展计划项目(102102310077)

摘　　要：目的: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:以我院现有的及医院PASS系统信息中心检索到的120种中药注射剂说明书为研究对象,根据《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》的格式项目及内容要求对说明书内容进行分析判断。结果与结论:部分中药注射剂说明书内容缺失、描述不规范现象严重,应不断完善和提高说明书质量,药品监督管理部门应进一步加强监督管理。OBJECTIVE：To investigate the status quo of package inserts of traditional Chinese medicine（TCM） injection,and to provide reference for standardize and perfect package inserts.METHODS：Using the package inserts of 120 TCM injection in our hospital and PASS information center as research objects,the contents of package inserts were analyzed according to format and content requirements of Package Inserts Format of Traditional Chinese Medicine and Natural Medicine Prescription Drugs,Package Inserts Writing Requirements of Traditional Chinese Medicine and Natural Medicine Prescription Drugs,Package Inserts Writing Guidelines of Traditional Chinese Medicine and Natural Medicine Prescription Drugs.RESULTSCONCLUSION：Some package inserts of TCM injection exist content missing and description irregularities.It is necessary to improve and enhance the quality of prescription,and drug regulatory departments should further strengthen the supervision and management.

关 键 词：中药注射剂 说明书 调查分析 

分 类 号：R926[医药卫生—药学] R283.611