本文選題：阿考替胺 + 粒子大小��； 參考：《中國新藥與臨床雜志》2015年11期

【摘要】：目的篩選原料藥阿考替胺粒徑并制備阿考替胺片劑,將自制品與原研上市品溶出行為進行一致性評價。方法研究原料藥粒徑對阿考替胺溶出速率的影響,篩選適宜的原料藥粒徑及合適的溶出介質,建立體外溶出度測定方法,對比自制品與原研上市品溶出曲線。結果合適的阿考替胺的粒徑為D90≤20μm,用該粒徑原料制備的阿考替胺片劑與原研上市品在四種溶出介質中溶出相似因子f2均大于50。結論用該方法制備的阿考替胺片劑與原研上市品體外溶出行為相似。
[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，

本文編號：1847189