Abstract: Objective To provide effective means for daily drug quality control and market supervision by establishing a bio-relevance dissolution method for lansoprazole enteric-soluble capsules. Methods According to the correlation model of lansoprazole enteric dissolved formulations constructed in previous studies, the biorelevant dissolution conditions was further developed by combining with in vitro dissolution data, formulations of enteric dissolved capsules, in vitro dissolution model and other information. Results The dissolution model was established successfully, and the possible biorelevant dissolution method was speculated: basket method using USP I method. Set the rotating speed of the instrument at 150 rpm; before 45 minutes, phosphate buffer with pH 5.8 was used. From 45 min to 90 min, the pH of the dissolved medium was adjusted to form a buffer with a pH of 7.5. After 90 minutes, the pH of the dissolution medium was adjusted to 10.0. The method was confirmed by in vitro dissolution experiments, which indicated that the dissolution method predicted by the model had good accuracy. Conclusion The biorelated dissolution method established in this study truly reflects the inherent quality of generic drugs, provides a simple and convenient means for drug quality control and consistency evaluation, and provides a new idea for scientific supervision.

Key words: lansoprazole, enteric capsule, in vivo - in vitro correlation, dissolution model, bio-relevance