外用药物制剂体外透皮试验技术要求概况  

Overview on the technical requirement of in vitro permeation test studies for topical drug products

作　　者：潘宪伟 苏梅 刘新 李慧敏 殷连珍 PAN Xianwei;SU Mei;LIU Xin;LI Huimin;YIN Lianzhen(Jiangsu Carephar Pharmaceutical Co.,Ltd.,Nanjing 210016,China;Nanjing Chia Tai Tianqing Pharmaceutical Co.,Ltd.,Nanjing 210046,China)

机构地区：[1]江苏柯菲平医药股份有限公司,江苏南京210016 [2]南京正大天晴制药有限公司,江苏南京210046

出　　处：《沈阳药科大学学报》2024年第11期1426-1436,共11页Journal of Shenyang Pharmaceutical University

摘　　要：外用药物制剂具有复杂的药物递送途径,通常局部起效,辅料成分复杂,处方组成和制备工艺参数的微小差异就有可能导致产品出现不同的质量特性,从而影响药物的安全性和有效性。近年来,体外透皮试验(in vitro permeation test,IVPT)被广泛用于外用药物制剂的开发及其生物等效性评价。但该试验操作复杂,影响因素较多,操作不当,就有可能导致不同试验之间的结果无法比较,进而影响此类制剂的安全性和有效性评价。本文参考国内外相关技术指导原则及文献,对外用药物制剂IVPT研究的技术要求进行综述,期望为业内人士提供参考。Because of the complex route of delivery associated with topical drug products,which are typically locally acting,and the potential complexity of certain formulations,small differences in prescription composition and preparation process parameters may lead to different quality characteristics of products,thus affecting the safety and effectiveness of drugs.In recent years,in vitro permeation test(IVPT)has been widely used in the development and bioequivalence evaluation of dermatological products.However,the operations of IVPT are complicated and there are many influencing factors,which make unreliable results as well as affect the evaluation of effectiveness and safety for topical and transdermal preparations.This paper reviews the technical requirement of IVPT studies for topical drug products by referring to the relevant technical guidelines and literatures,so as to provide some references for peers.

关 键 词：外用药物制剂 经皮给药 体外透皮试验 一致性评价 

分 类 号：R94[医药卫生—药剂学]