Method for determining dissolution curve of Rurugolix tablet
The invention belongs to the technical field of drug analysis, and provides a method for determining a dissolution curve of a Rurugolix tablet, which has good durability and reproducibility and distinguishing power, and adopts a phosphate buffer solution with pH of 5.6 as a dissolution medium; the p...
Gespeichert in:
Hauptverfasser: | , , , , , |
---|---|
Format: | Patent |
Sprache: | chi ; eng |
Schlagworte: | |
Online-Zugang: | Volltext bestellen |
Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
Zusammenfassung: | The invention belongs to the technical field of drug analysis, and provides a method for determining a dissolution curve of a Rurugolix tablet, which has good durability and reproducibility and distinguishing power, and adopts a phosphate buffer solution with pH of 5.6 as a dissolution medium; the problem that in the prior art, a dissolution method cannot meet the requirement for comparing the similarity of dissolution curves by adopting a similarity factor (f2) method in the guidance principle of Dissolution Curve Determination and Comparative Guiding Principles of Common Oral Solid Preparation, so that the screening and in-vitro consistency evaluation of a rerugolian tablet imitation medicine process are influenced is solved.
本发明属于药物分析技术领域,提供了一种耐用性和重现性良好、具有区分力的瑞卢戈利片的溶出曲线测定方法,该溶出曲线方法以pH5.6磷酸盐缓冲液为溶出介质,解决了现有技术中溶出方法不能满足《普通口服固体制剂溶出曲线测定与比较指导原则》指导原则中关于采用相似因子(f2)法比较溶出曲线相似性的要求,因而影响瑞卢戈利片仿制药工艺筛选和体外一致性评价的问题。 |
---|