摘要
目的:为生产企业合理设计外用药膏说明书提供参考。方法:根据《药品说明书和标签管理规定》和《化学药品和治疗用生物制品说明书规范细则》对药品说明书应标注项目,分析我院2016年1-6月使用的51种外用药膏说明书标注项情况。结果:在51种外用药膏中,国产品种39种,进口品种12种。在39种国产药膏说明书中,标注率较低的项目有药物过量、药动学、使用指导、药理毒理,标注率分别为2.6%、5.1%、15.4%、28.2%,而进口品种的标注率分别为16.7%、83.3%、75.0%、100%。与进口药膏说明书比较,国产药膏说明书标注内容不够详细的项目有成分、用法用量、不良反应、禁忌、注意事项、药物相互作用、特殊人群用药。结论:建议生产企业咨询医药学专家,按照《药品说明书和标签管理规定》要求列出全部辅料,细化和完善用法用量、不良反应、注意事项、特殊人群用药、药理毒理及药物过量等项的标注内容,同时行政主管部门要加强监管审批力度。
OBJECTIVE： To provide reference for reasonably designing package inserts of ointment for manufacturers. METH- ODS ： According to items included in Management Regulation for Package Insert and Label and Specification for Chemicals and Bi- ological Products for Treatment, labeled items in package inserts of 51 kinds of ointment for external use during Jan.-Jun. 2016 in our hospital were analyzed. RESULTS： Among the 51 kinds of ointment, 39 were domestic varieties and 12 were imported variet- ies. In the package inserts of 39 domestic varieties, items with lower labeling rates were overdose, pharmacokinetics, use guid- ance, pharmacology and toxicology, with labeling rates of 2.6%, 5.1%, 15.4%, 28.2% ; while the labeling rates of imported vari- eties were 16.7%, 83.3%, 75.0%, 100%. Compared with package inserts of imported ointment, composition, dosage and usage, adverse reactions, contraindications, precautions, drug interactions, medication for special populations were not enough detailed in domestic ointments. CONCLUSIONS： It is suggested that manufacturers consult medicine experts, list all auxiliary materials through Management Regulation for Drug Description and Label, refine and improve the labeling contents of dosage and usage, ad- verse reactions, precautions, medication for special populations, pharmacology and toxicology, overdose, etc. In addition, admin- istrative departments should strengthen the regulatory approval efforts.
出处
《中国药房》
CAS
北大核心
2017年第16期2286-2288,共3页
China Pharmacy
关键词
外用药膏
药品说明书
标注
Ointment for external use
Package insert
Labeling
