关键词: 吲达帕胺, 溶出度, 溶出曲线, 参比制剂, 仿制药

Abstract: Objective To compare the dissolution curves of indapamide tablets from different manufacturers and its reference formulation. Methods The dissolution of 13 types of generics of indapamide tablets and its reference formulation in different pH media was determined via a dissolution tester and HPLC before the dissolution curve was drawn. The column was Agilent Poroshell 120 SB-C₁₈, the mobile phase was methanol-water-glacial acetic acid (45：55：0.1) at a flow rate of 1 mL·min^-1, the detection wavelength was 240 nm, the column temperature was 40℃, and the injection volume was 5 μL. The stirring paddle method was adopted, with the volume of the dissolution medium at 900 mL at the rotating rate of 50 r·min^-1. The dissolution media were water, hydrochloric acid solution (pH 1.2), acetic acid-sodium acetate buffer solution (pH 4.0) and phosphate buffer solution (pH 6.8). The similarity of dissolution profiles was evaluated by calculating the similar factor (f₂). Results In different dissolution media, the dissolution curves of generic drugs from only a few manufacturers were similar to those of the reference formulation, but most of the dissolution curves of generic drugs from different manufacturers were not similar to those of the reference formulation. Conclusion There are differences in the dissolution of indapamide tablets produced by different manufacturers. It is recommended that relevant manufacturers improve the excipients and production processes that affect the dissolution of the preparation to improve the quality of generic drugs.

Key words: indapamide, dissolution, dissolution profile, reference formulation, generic drug