家兔经皮给药安全性评价研究方法的探讨

Discussion of research methods based on transdermal administration safety evaluation in rabbits

近年来,经皮给药因具有避免肝脏的“首关效应”、保护胃肠道免受药物损伤、血药浓度持久恒定等优势而备受青睐。而药物临床前安全性评价研究对新药临床研究,以及上市前审批过程中均起重要的作用。以《药物非临床安全性评价指导原则》为依据,结合多年的研究经验,从实验动物、剂量设置、给药量的换算、皮肤去毛及破损模型制备、指标评价等多个方面对家兔经皮给药的安全性评价研究方法进行探讨,为经皮给药的受试药物安全性评价研究提供方法参考。

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.