阴道黏膜给药系统的研究进展

Research Progress of Vaginal Mucosal Drug Delivery System

由于不仅可直达病灶部位而发挥局部治疗作用,还可避免肝脏首过效应而发挥全身治疗作用,阴道黏膜给药在阴道炎、宫颈炎等疾病的治疗和避孕等方面越来越受到国内外学者的关注。本文介绍了阴道的生理特点,探讨了影响药物吸收的因素;以美国食品药品监督管理局(FDA),国家食品药品监督管理局(CFDA)药品数据库和2015年版《中国药典》收载的阴道黏膜给药上市制剂为研究对象,对其剂型、适应症等方面的应用情况进行了梳理和分析;查阅了近年来国内外有关阴道黏膜给药系统的相关文献,对其剂型和体内外评价进行了综述;指出了阴道黏膜给药制剂研究中存在的问题:(1)以西药制剂为主,相关的中药制剂开发较少,(2)剂型以片剂、栓剂、胶囊剂等常规剂型居多,(3)开展体内外评价的研究较少。提出阴道黏膜给药系统今后发展可在多种药物联合给药、高黏附性的辅料、脂质体等新技术、新方法的应用方面进行有益的尝试,以期为阴道黏膜给药系统的应用与完善提供参考。

Because it can not only directly reach the lesion site to play a local therapeutic effect,but also avoid the liver first pass effect and play a systemic therapeutic effect,vaginal mucosal administration has attracted more and more attention from domestic and foreign scholars in the treatment of vaginitis,cervicitis and other diseases.This article introduces the physiological characteristics of the vagina and discusses the factors affecting drug absorption.The vaginal mucosal drug-administered preparations,which are contained in the drug database of U.S.Food and Drug Administration(FDA)and China Food and Drug Administration(CFDA),and listed in the 2015 edition of Chinese Pharmacopoeia,are taken as the research objects.And the application of their dosage forms,indications and other aspects were sorted out and analyzed.The related literature on vaginal mucosal drug delivery systems in recent years was reviewed,and the dosages forms and in vitro and in vivo evaluation were summarized.Some problems in the study of vaginal mucosal drug preparations have been pointed out:(1)the western medicine preparations are widely used,and the related Chinese medicine preparations have been developed less;(2)the majority of dosage forms are tablets,suppositories and other conventional dosage forms;(3)there are few studies on the evaluation of vaginal mucosal preparations in vitro and in vivo.It is suggested that the future development of vaginal mucosal drug delivery system can be a useful attempt in the application of new technologies and methods,such as combination of drugs,high adhesion excipients,liposomes,etc;so as to provide reference for the application and improvement of vaginal mucosal drug delivery system.