發(fā)布時間：2018-09-12 09:25

【摘要】：目的:為生產企業(yè)合理設計外用藥膏說明書提供參考。方法:根據《藥品說明書和標簽管理規(guī)定》和《化學藥品和治療用生物制品說明書規(guī)范細則》對藥品說明書應標注項目,分析我院2016年1-6月使用的51種外用藥膏說明書標注項情況。結果:在51種外用藥膏中,國產品種39種,進口品種12種。在39種國產藥膏說明書中,標注率較低的項目有藥物過量、藥動學、使用指導、藥理毒理,標注率分別為2.6%、5.1%、15.4%、28.2%,而進口品種的標注率分別為16.7%、83.3%、75.0%、100%。與進口藥膏說明書比較,國產藥膏說明書標注內容不夠詳細的項目有成分、用法用量、不良反應、禁忌、注意事項、藥物相互作用、特殊人群用藥。結論:建議生產企業(yè)咨詢醫(yī)藥學專家,按照《藥品說明書和標簽管理規(guī)定》要求列出全部輔料,細化和完善用法用量、不良反應、注意事項、特殊人群用藥、藥理毒理及藥物過量等項的標注內容,同時行政主管部門要加強監(jiān)管審批力度。
[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.
【作者單位】： 慈溪市皮膚病醫(yī)院藥劑科;
【分類號】：R95
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本文編號：2238591