Study on Correlation Dissolution Method of Nifedipine Controlled-release Tablets In Vitro and In Vivo

OBJECTIVE To develop corresponding dissolution methods that can distinguish and reflect the release difference between the reference preparation and the self-developed preparation, so as to maximize the matching of the in vitro release of the self-developed preparation and the reference preparation, thus to provide more relevant research in vivo and in vitro for bioequivalence test METHODS USP(United States Pharmacopoeia) dissolution method 2(paddle method) was used as the quality control method; In addition, the flow cell method was used as the dissolution differentiation method to evaluate the dissolution results under different experimental parameters. RESULTS the method was determined as an open-loop system with a flow rate of 3.0 mL·min^-1 and 1/2 spoon of glass beads. This method could effectively distinguish the influence of prescription and production process changes on product dissolution. The dissolution rate and dissolution rate obtained based on this method were consistent with the results of pharmacokinetics study in vivo. CONCLUSION The established flow-through cell method is suitable for discriminatory testing of the nifedipine controlled-release tablets.