近年來(lái)，經(jīng)皮給藥因具有避免肝臟的“首關(guān)效應(yīng)”、保護(hù)胃腸道免受藥物損傷、血藥濃度持久恒定等優(yōu)勢(shì)而備受青睞。而藥物臨床前安全性評(píng)價(jià)研究對(duì)新藥臨床研究，以及上市前審批過(guò)程中均起重要的作用。以《藥物非臨床安全性評(píng)價(jià)指導(dǎo)原則》為依據(jù)，結(jié)合多年的研究經(jīng)驗(yàn)，從實(shí)驗(yàn)動(dòng)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(píng)價(jià)等多個(gè)方面對(duì)家兔經(jīng)皮給藥的安全性評(píng)價(jià)研究方法進(jìn)行探討，為經(jīng)皮給藥的受試藥物安全性評(píng)價(jià)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(xiàng)計(jì)劃資助項(xiàng)目（2017ZF011）