本文選題：皮膚科 + 外用藥物��； 參考：《中國(guó)新藥雜志》2017年18期

【摘要】：皮膚外用制劑多為半固體制劑,具有多相、熱力學(xué)不穩(wěn)定等特點(diǎn),輔料多樣且篩選過(guò)程復(fù)雜,多需進(jìn)行體外透皮吸收試驗(yàn)加以評(píng)價(jià),與常規(guī)注射、固體制劑的評(píng)價(jià)有顯著差異。本文結(jié)合實(shí)際審評(píng)經(jīng)驗(yàn),對(duì)局部外用皮膚科藥物的科學(xué)處方開發(fā)、原輔料的來(lái)源和控制、雜質(zhì)分析的特點(diǎn)和技術(shù)要求、透皮吸收試驗(yàn)的設(shè)計(jì)與評(píng)價(jià)、穩(wěn)定性研究的特點(diǎn)等技術(shù)關(guān)鍵點(diǎn)進(jìn)行匯總和分析,希望有助于當(dāng)前皮膚科藥物的研發(fā)和評(píng)價(jià)。
[Abstract]:The skin preparations for external use are mostly semisolid preparations with the characteristics of multiphase thermodynamics instability and so on. The excipients are various and the screening process is complex. It needs to be evaluated by in vitro transdermal absorption test and there is a significant difference from the conventional injection and the evaluation of solid preparations.In this paper, the scientific prescription development of local external dermatologic drugs, the source and control of raw materials, the characteristics and technical requirements of impurity analysis, the design and evaluation of transdermal absorption test are discussed.The characteristics of stability research and other technical key points are summarized and analyzed in order to contribute to the current research and evaluation of dermatologic drugs.
【作者單位】： 國(guó)家食品藥品監(jiān)督管理總局藥品審評(píng)中心;
【分類號(hào)】：R986

【相似文獻(xiàn)】

相關(guān)期刊論文 前1條

1 顧有守;;喜讀“最新皮膚科藥物手冊(cè)(第2版)”[J];嶺南皮膚性病科雜志;2008年05期

，

本文編號(hào)：1752571