摘要
本文概述了透皮贴剂的特性,汇总分析了国内外已上市化学药品透皮贴剂规格表述的现状,梳理了国内外药品监管机构对透皮贴剂规格表示的要求,论述了递送速率的含义、影响因素和测定/计算方法,讨论了透皮贴剂规格表示需关注的问题。
This paper summarizes the characteristics of transdermal patch.The present situation of the dosage strength expression of transdermal patches is analyzed.Based on the requirements of drug regulatory agencies domestic and abroad for specification of transdermal patches,this paper discusses the issues on the dosage strength expression of transdermal patches that should be concerned about.The meaning and contributing factors of the rate of delivery are discussed,so is the measurement/calculation method.
作者
袭辰辰
姜典卓
XI Chen-chen;JIANG Dian-zhuo(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2022年第8期878-882,共5页
The Chinese Journal of Clinical Pharmacology
关键词
透皮贴剂
规格
递送速率
测定/计算方法
transdermal patches
dosage strength
the rate of delivery
measurement/calculation method
