阿考替胺原料药粒径筛选与阿考替胺片体外溶出行为一致性评价

发布时间：2018-05-05 09:39

  本文选题：阿考替胺 + 粒子大小　； 参考：《中国新药与临床杂志》2015年11期

【摘要】：目的筛选原料药阿考替胺粒径并制备阿考替胺片剂,将自制品与原研上市品溶出行为进行一致性评价。方法研究原料药粒径对阿考替胺溶出速率的影响,筛选适宜的原料药粒径及合适的溶出介质,建立体外溶出度测定方法,对比自制品与原研上市品溶出曲线。结果合适的阿考替胺的粒径为D90≤20μm,用该粒径原料制备的阿考替胺片剂与原研上市品在四种溶出介质中溶出相似因子f2均大于50。结论用该方法制备的阿考替胺片剂与原研上市品体外溶出行为相似。
[Abstract]:Objective to screen the particle size of Acotidine and to prepare Acotidine tablets, and to evaluate the consistency between the self-made drug and the original product. Methods the influence of the particle size of the raw material on the dissolution rate of Acotidine was studied. The suitable particle size and the appropriate dissolution medium were selected. The dissolution rate of the raw material was determined in vitro. The dissolution curves of the self-made and the original product were compared. Results the suitable particle size of acotetylamine was D90 鈮，

本文编号：1847189