【摘要】：目的:為生產(chǎn)企業(yè)合理設(shè)計(jì)外用藥膏說(shuō)明書(shū)提供參考。方法:根據(jù)《藥品說(shuō)明書(shū)和標(biāo)簽管理規(guī)定》和《化學(xué)藥品和治療用生物制品說(shuō)明書(shū)規(guī)范細(xì)則》對(duì)藥品說(shuō)明書(shū)應(yīng)標(biāo)注項(xiàng)目,分析我院2016年1-6月使用的51種外用藥膏說(shuō)明書(shū)標(biāo)注項(xiàng)情況。結(jié)果:在51種外用藥膏中,國(guó)產(chǎn)品種39種,進(jìn)口品種12種。在39種國(guó)產(chǎn)藥膏說(shuō)明書(shū)中,標(biāo)注率較低的項(xiàng)目有藥物過(guò)量、藥動(dòng)學(xué)、使用指導(dǎo)、藥理毒理,標(biāo)注率分別為2.6%、5.1%、15.4%、28.2%,而進(jìn)口品種的標(biāo)注率分別為16.7%、83.3%、75.0%、100%。與進(jìn)口藥膏說(shuō)明書(shū)比較,國(guó)產(chǎn)藥膏說(shuō)明書(shū)標(biāo)注內(nèi)容不夠詳細(xì)的項(xiàng)目有成分、用法用量、不良反應(yīng)、禁忌、注意事項(xiàng)、藥物相互作用、特殊人群用藥。結(jié)論:建議生產(chǎn)企業(yè)咨詢醫(yī)藥學(xué)專(zhuān)家,按照《藥品說(shuō)明書(shū)和標(biāo)簽管理規(guī)定》要求列出全部輔料,細(xì)化和完善用法用量、不良反應(yīng)、注意事項(xiàng)、特殊人群用藥、藥理毒理及藥物過(guò)量等項(xiàng)的標(biāo)注內(nèi)容,同時(shí)行政主管部門(mén)要加強(qiáng)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(lèi)號(hào)】：R95
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本文編號(hào)：2238591