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.
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