51种外用药膏说明书标注项情况分析

发布时间：2018-09-12 09:25

【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。
[Abstract]:Objective: to provide reference for the rational design of external ointment instruction in production enterprises. Methods: according to the regulations for the Administration of Drug instructions and labels and the rules of Specification for Chemical and Therapeutic Bio-products, the drug instructions should be marked with items. 51 kinds of external ointment used in our hospital from January to June 2016 were analyzed. Results: of 51 kinds of ointment, 39 were domestic and 12 were imported. In the specification of 39 kinds of domestic ointment, the items with low labeling rate were drug overdose, pharmacokinetics, use guidance, pharmacological toxicology and labeling rate of 2.6and 5.1and 15.4cm, respectively. In comparison with imported ointment instructions, the components, usage dosage, adverse reactions, contraindications, precautions, drug interactions and drug use in special population were not enough detailed in domestic ointment instructions. Conclusion: it is suggested that production enterprises should consult medical experts, list all excipients according to the requirements of Drug description and label Management, refine and perfect usage dosage, adverse reactions, precautions, and use of drugs by special people. Pharmacological toxicology and drug overdose should be labeled, and administrative authorities should strengthen supervision and approval.
【作者单位】： 慈溪市皮肤病医院药剂科;
【分类号】：R95
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本文编号：2238591