Dissolution Behavior and Influencing Factors Analysis of Alkaloids in Xianglian Pills

Abstract:

Objective: To establish determination method for in vitro dissolution of alkaloids in Xianglian pills,reveal its in vitro dissloution behavior and influence factors. Method: HPLC was used to determine contents of berberine hydrochloride and palmatine hydrochloride with mobile phase of acetonitrile-potassium dihydrogen phosphate buffer (30 : 70) and detection wavelength at 350 nm.Small cup method was used to determine and draw dissloution curves of berberine hydrochloride and palmatine hydrochloride in Xianglian pills under different pH and volume of dissolution medium,rotation speed of stirring paddle.Origin Pro 8.0 was used to fit dissolution curves with Weibull distribution model and calculate dissolution parameters of T₅₀ (the time for dissolution 50%) and T_d (the time for dissolution 63.2%). Result: Dissloution curves of berberine hydrochloride and palmatine hydrochloride all fitted successfully with Weibull equation.These two components dissoved quickly and completely in dissolution medium with pH of 1.0,with increasing of pH of dissolution medium,both dissolution speed and rate decreased.When pH were 6.8 and 7.8,cumulative dissolution rate of these two components was less than 50%.With increasing of stirring speed, T₅₀ and T_dof these two components slightly decreased.In volume range of 100-250 mL,both T₅₀ and T_d of these two components had not significant difference.Under the same conditions, T₅₀ and T_d of palmatine hydrochloride were less than these two parameters of berberine hydrochloride. Conclusion: Dissolution medium pH has significant influence on dissloution of alkaloids in Xianglian pills,rotation speed of stirring paddle has a certain effect on dissolution speed,but dissolution medium volume almost has no effect.Dissloution of palmatine hydrochloride is slightly quicker than berberine hydrochloride.