采用动态图像分析法考察不同处方组成非诺贝酸胆碱盐凝胶骨架片的溶胀行为,以研究处方组成对溶胀的影响以及溶胀与释药的关联。结果表明,图像法所测得的体积溶胀率、高宽比可以有效评价骨架片的溶胀行为;羟丙基甲基纤维素(hydroxypropyl methylcellulose,HPMC)的用量、K15M与K4M的比例对骨架片的体积溶胀率有较大影响,而溶胀与黏合剂聚乙烯吡咯烷酮(polyvinylpyrrolidone,PVP)几乎无关;3个因素均对骨架片溶胀后的凝胶强度有不同程度的影响;将骨架片体积溶胀率和累积释放度、溶胀速率和释放速率进行比较,结果表明骨架片溶胀行为与释放特性的相关性较强。该研究可对亲水凝胶骨架缓释片的设计提供一定参考。
The purpose of this study is to investigate the effects of formulation on the swelling behavior of choline fenofibrate hydrogel matrix tablets and reveal the relation between swelling property and release profile using dynamic image analysis. The volume swelling ratio (SR) and height/width (k) could evaluate the swelling behavior of matrix tablets well. The mount of hydroxypropyl methylcellulose (HPMC) and the ratio between K15M and K4M affected the volume swelling ratio, while PVP didn't. The three factors all impacted k, which was an indicator of the strength of the gel formed by HPMC. The accumulative release ratio and SR, the rate of swelling and the rate of release were compared. The proper model equations were established for the results with an excellent correlation. The results prove that there is a strong relevance between the swelling behavior and release property. This study provides a guideline in the study design for hydrogel matrix tablets.