阿莫西林胶囊仿制药与原研药溶出行为研究及有区分力溶出方法的建立

Study on the dissolution behaviors of generic and original preparation and establishment of discriminative dissolution method for amoxicillin capsules#br#

Objective To establish a discriminative method for the dissolution curve of amoxicillin capsules. Methods The effects of different stirring device, different stirring speeds, different dissolution media on the dissolution behavior of different manufacturers' amoxicillin capsules (250mg) were investigated by dissolution profile and f2 similarity factor. Results The dissolution test of amoxicillin capsules (250 mg) was carried out by a paddle method (with sinker) with the rotation speed of 100 r/min, temperature of 37 °C, and water as dissolution medium, which could easily and effectively distinguish the dissolution behavior of amoxicillin capsules from various manufacturers. Conclusion This method provides a reference for the further quality consistency evaluation of amoxicillin capsules.