关于《中国药典》2020年版四部贴剂规格中引入释药速率概念的介绍与浅析

Introduction and a Brief Analysis of the Concept of Drug Release Rate in Transdermal Patch Specifications in Chinese Pharmacopeia 2020 Edition Volume Ⅳ

《中国药典》2020版四部贴剂中,根据透皮贴剂的特点,首次引入释药速率概念。本文将通过对透皮贴剂的定义、特点、各国药典及品种现状等进行分析,针对该增修订内容做系统介绍,旨在进一步使广大《中国药典》的使用者更好的理解和执行2020版药典,并为我国透皮贴剂仿制药的研发和监管提供参考。

According to the characteristics of transdermal patches, the concept of drug release rate was introduced for the first time in the fourth volume of Chinese Pharmacopoeia 2020 edition. This article will analyze transdermal patches on their definition, characteristics, varieties and current status in pharmacopoeias of various countries. A systematic introduction on this addition and revision is made to further enable the Chinese pharmacopoeia users to better understand and implement the 2020 version, and to provide a reference for the development and supervision of generic drugs of transdermal patches in China.