皮肤外用制剂生物利用度及生物等效性研究进展  

Upate of bioavailability and bioequivalence of topical dermatological drugs

作　　者：吴黎莉[1] 陈沄[1] WU Lili; CHEN Yun(Department of Pharmacology, Institute of Dermatology, Chinese Academy of Medical Sciences ＆ Peking Union Medical College, Nanjing 210042, China)

机构地区：[1]中国医学科学院北京协和医学院皮肤病研究所,南京210042

出　　处：《中国麻风皮肤病杂志》2018年第9期573-576,共4页China Journal of Leprosy and Skin Diseases

基　　金：杨森科学研究委员会中国分会研究基金资助项目(编号:2012JRCC皮科01)

摘　　要：皮肤外用制剂要求在皮肤局部发挥药效,口服给药药物的生物利用度研究方法对于皮肤外用制剂并不适用。目前血管收缩测定法已被FDA认可,但该法只适用于糖皮质激素类药物,其他外用制剂仍需通过临床对比试验来评价其生物等效性。FDA仍在努力寻找其他的研究方法,如胶带粘贴法、皮肤微透析法、开流微量灌注及体外研究方法。本文对以上方法的研究进展进行综述。Topical dermatologic drugs take effect at the target skin and the bioequivalence study methods for orally administrated drugs may not be applicable to topical dermatologic drug. Currently,vasoconstrictor assay（ VCA） has been approved by FDA,but which is only applied to glucocorticoid drugs. The bioequivalence of other topical preparations is evaluated through clinical end-point trials. FDA is still trying to explore other methods for bioavailability,such as tape stripping,dermal microdialysis,open flow perfusion and in vitro studies. The update of above methods is reviewed in this article.

关 键 词：外用制剂 生物利用度 生物等效性 

分 类 号：R96[医药卫生—药理学]