近年來，經(jīng)皮給藥因具有避免肝臟的“首關(guān)效應(yīng)”、保護胃腸道免受藥物損傷、血藥濃度持久恒定等優(yōu)勢而備受青睞。而藥物臨床前安全性評價研究對新藥臨床研究，以及上市前審批過程中均起重要的作用。以《藥物非臨床安全性評價指導(dǎo)原則》為依據(jù)，結(jié)合多年的研究經(jīng)驗，從實驗動物、劑量設(shè)置、給藥量的換算、皮膚去毛及破損模型制備、指標(biāo)評價等多個方面對家兔經(jīng)皮給藥的安全性評價研究方法進行探討，為經(jīng)皮給藥的受試藥物安全性評價研究提供方法參考。

In recent years, transdermal drug delivery system (TDDS) is attractive because of its avoiding liver metabolism, protecting gastrointestinal tract mucosa from drug, stable blood concentration, etc. Nevertheless, drug non-clinical safety evaluation study play an important role in clinical study and NDA. In order to provide reference for research methods of transdermal administration safety evaluation, research methods based on transdermal administration safety evaluation in rabbits were discussed from experimental animal, dose setting, conversion of total dose, depilation and animal model preparation of damage skin, evaluation index and so on, which is according to 'guideline on non-clinical safety evaluation of drug' and many years research experience of ours GLP.

R965.3

云南省重大科技專項計劃資助項目（2017ZF011）