中国药物评价2023，Vol.40Issue(6)：480-484,5.
基于流池法的氨糖美辛肠溶片体外溶出行为研究
Study on the in vitro Dissolution Behavior of Glucosamine Indometacin Enteric-coated Tablets Based on Flow-through Cell Method
摘要
Abstract
Objective:To establish a flow-through cell method for the dissolution test of Glucosamine Indomethacin Entric-coated Tab-lets(GIETs),and compare the in vitro dissolution behavior of products from different manufacturers,in order to provide reference for the evaluation of quality consistency.Methods:The dissolution profiles of seven manufacturers were determined using the open loop system with flow-through cell and the flow rate was 8 mL·min-1.After being released for 2 hours in 0.1 mol·L-1 hydrochloric acid solution,the dissolution medium was changed to pH6.8 phosphate buffer solution for another 2 hours.The dissolution amount of indomethacin at prescribed time points was determined by HPLC.The release rate curve in vitro was fitted by Weibull function and dissolution parameters were extracted for statistical analysis to evaluate the differences in dissolution behavior in vitro.Results:Statistically significant differences in parts of dissolution parameters were observed among the dissolution curve of GIETs from senen manufacturers.The quality homogeneity of partial preparation were poor.Conclusion:This method can provide reference for quality consistency evaluation of GIETs.关键词
氨糖美辛肠溶片/流池法/溶出曲线/Weibull方程Key words
Glucosamine Indomethacin Entric-coated tablets/Flow-through cell method/Dissolution curve/Weibull equation分类
医药卫生引用本文复制引用
甘加明,邹瑜,黄丹,陈冬华,严全鸿..基于流池法的氨糖美辛肠溶片体外溶出行为研究[J].中国药物评价,2023,40(6):480-484,5.基金项目
广东省医学科学技术研究基金项目(课题名称:流通池法在肠溶制剂体外溶出中的应用 （）
项目编号:B202298) （）
广东省医学科学技术研究基金项目(课题名称:流通池法在复杂口服缓释制剂中体外释放评价的应用研究 （）
项目编号:B2023313) （）
