亲水凝胶骨架片凝胶强度的研究进展  

Research Advances in Gel Strength of Hydrophilic Matrix Tablets

作　　者：高谐 刘怡 GAO Xie;LIU Yi(Shanghai Ashland Chemical Technology Development Co.,Ltd.,Shanghai 200233)

机构地区：[1]上海亚什兰化工技术开发有限公司,上海200233

出　　处：《中国医药工业杂志》2022年第8期1121-1132,共12页Chinese Journal of Pharmaceuticals

摘　　要：亲水凝胶骨架片由于缺少合适的凝胶形成行为考察方法,在体内评价中往往存在不必要的风险。近年来,随着体外模拟检测手段的发展,已有研究通过穿刺负荷、流变学测试、质量和体积检测、透射成像等手段量化凝胶层骨架的强度和稳健性。这些方法逐渐在凝胶骨架片的早期研究中被开发和应用。本综述就亲水凝胶骨架片的体内外相关性、凝胶强度检测方法及处方和工艺参数的关键影响进行阐述,以期为凝胶骨架片的相关研究与产业化提供参考。Due to the lack of methods for investigating gel-forming behaviors,hydrophilic matrix tablets always face unnecessary risks in in vivo evaluation.In recent years,with the development of in vitro simulated detection methods,studies have been conducted to quantify the strength and robustness of the gel layer of hydrophilic matrix tablets by puncturing,rheological testing,mass and volume measurement,and transmission imaging.These gel strength detection methods are continuously developed and applied in early research and development.In this review,in vitro-in vivo correlation of hydrophilic matrix tablets,gel strength detection methods,and critical influences of formulation and process parameters,are summarized to provide a brief reference for the relevant studies and manufacturing on gel matrix tablets.

关 键 词：亲水凝胶骨架片 凝胶强度 体内外相关性 体外模拟 影响因素 

分 类 号：R917[医药卫生—药物分析学]