摘要
作为非侵入型药物递送系统,透皮贴剂可通过皮肤以固定剂量和可调节的速率递送药物,从而产生全身或局部的治疗作用。本文聚焦透皮贴剂关键质量属性,阐述其检测方法及试验中的关键点,同时参考国内外药典及现行政策法规,简述部分其他特性质量的检测方法及控制标准,以期为企业及相关部门完善质量检测体系及控制标准提供参考。
As non-invasive drug delivery systems,transdermal patches can deliver drugs through the intact skin at a fixed dose and a adjustable rate in order to product a systemic or local therapeutic effect.Focused on the key quality attributes of transdermal patches,the article illustrated the testing methods and how to control key points.It also briefly described the testing methods and standards of some other characteristics referring to pharmacopoeia,current policies and regulations in various countries,which provided a reference for pharmaceutical industries and relevant departments to improve the quality control methods and standards.
作者
全丹毅
赵慧芳
刘羽恩
杨广强
陈华
QUAN Danyi;ZHAO Huifang;LIU Yuen;YANG Guangqiang;CHEN Hua(Institute of Advanced Drug Delivery Technology,Nanjing 210032,China;National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国药品标准》
CAS
2024年第2期126-133,共8页
Drug Standards of China
关键词
经皮给药
透皮贴剂
体外释放
检测方法
质量标准
transdermal drug delivery system
transdermal patch
testing method
quality standard
