压敏胶在透皮贴剂中的应用及其药学研究探讨一刘孟斯乖2021.1.

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压敏胶在透皮贴剂中的应用及其药学研究探讨


刘孟斯1 ，姜典卓1 ，罗华菲2 ，袁利佳1
(1. 国家药品监督管理局药品审评中心，北京 100022；2. 中国医药工业研究总院药物制剂国家工程研究中心，上海 201203) 摘要：压敏胶是透皮贴剂的关键辅料，并对最终产品的疗效、安全性及质量属性起重要作用，通常分为丙烯酸类压敏 胶、聚异丁烯压敏胶、硅酮压敏胶及热熔压敏胶。本文探讨了压敏胶对透皮贴剂关键质量属性(如体外透皮、体外释放、 黏附力、析晶及稳定性)的影响。同时梳理了国内外监管机构对于压敏胶质量控制的考虑，特别是对于流变性能与安全性 指标的相关要求。
关键词：透皮贴剂；压敏胶；药学研究；质量控制
中图分类号：R944.9 文献标志码：A 文章编号：1001-8255(2021)07-0863-08 DOI：10.16522/j.cnki.cjph.2021.07.001 收稿日期：2021-01-12


作者简介：刘孟斯(1986—)，女，中级工程师，从事药品审评工作。
Tel：010-85242574 E-mail：liums@cde.org.cn Application of Pressure Sensitive Adhesive in Transdermal Patch and Discussion on Its Pharmaceutical Research LIU Mengsi1 , JIANG Dianzhuo1 , LUO Huafei2 , YUAN Lijia1 (1. Center for Drug Evaluation, National Medical Products Administration, Beijing 100022; 2. National Pharmaceutical Engineering Research Center, China State Institute of Pharmaceutical Industry, Shanghai 201203) ABSTRACT: Pressure sensitive adhesive(PSA) is the key auxiliary material of transdermal patches, which is important to the efficacy, safety and quality properties of the final product. It is usually divided into acrylic PSA, polyisobutylene PSA, silicone-type PSA and thermoplastic elastomer adhesive. This paper discusses the effect of PSA on the critical quality attributes of transdermal patches, including in vitro skin permeation, in vitro release, adhesion, recrystallization and stability. At the same time, the considerations on quality control of PSA by domestic and foreign regulatory agencies were sorted out, especially the related requirements for rheological properties and safety indicators. Key Words: transdermal patch; pressure sensitive adhesive; pharmaceutical research; quality control

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