往复架法在药物溶出度研究中的应用进展  

Progress of the reciprocating holder apparatus in dissolution testing of medical products

作　　者：陈天伊 庾莉菊[2] 宁保明[2] 许卉[1] 张军[3] 徐昕怡 张启明[2] CHEN Tian-yi;YU Li-ju;NING Bao-ming;XU Hui;ZHANG Jun;XU Xin-yi;ZHANG Qi-ming(Yantai University,Yantai 264005,China;National Institutes for Food and Drug Control,Key Laboratory of National Medical Products Administration,Key Laboratory of Research and Evaluation of Chemical Drug Quality,Beijing 102629,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]烟台大学,烟台264005 [2]中国食品药品检定研究院,国家药品监督管理局重点实验室,化学药品质量研究与评价重点实验室,北京102629 [3]国家药典委员会,北京100061

出　　处：《药物分析杂志》2023年第3期375-386,共12页Chinese Journal of Pharmaceutical Analysis

基　　金：2021年度国家药品标准制修订研究课题《溶出度与释放度测定法往复支架法的建立研究》(2021Y06)。

摘　　要：通过对国内外文献进行调研,探讨往复架溶出度测定方法的研究进展和应用现状。往复架法可根据剂型选择样品架,能够更好地满足透皮贴剂、缓释制剂、眼用植入剂、阴道环制剂、药物涂层支架等多种特殊剂型或药械组合产品的研发和质量控制需求,有着广阔的应用前景,为相关制剂开展体内外相关性的研究提供有益的技术支持。Based on the published scientific literatures,the research progress and application of reciprocating holder apparatus are described.Reciprocating holder apparatus with flexible and specific holders can meet the re-quirements of research and development for transdermal delivery system,extended-release preparation,ocular implants,intravaginal rings,drug eluting stents and other special dosage forms or combination products.Recipro-cating holder apparatus has a broad application prospect and may provide scientific support for the in vitro-in vivo correlation research.

关 键 词：往复架法 溶出度 透皮贴剂 缓释制剂 眼部植入剂 大分子药物的制剂 阴道环制剂 药物涂层支架 

分 类 号：R917[医药卫生—药物分析学]