Résumé
OBJECTIVE:To study the preparation method of ranolazine sustained release tablets and to optimize the preparation technology conditions for these preparations. METHODS: The preparation technology conditions were optimized by orthogonal design with the amounts of HPMCP, MC, PH101 and the hardness of ranolazine sustained release tablets as indexes. The optimized results were verified and the in vitro release of ranolazine sustained release tablets was determined. RESULTS: The optimum preparation technology conditions of ranolazine sustained release tablets were as follows: the amounts of HPMCP, MC, PH101 and the hardness were 150mg, 75mg, 30mg, and 10kg, respectively; and the in vitro release rates at 2, 6, and 12h were (29.33?1.05)%, (59.9?1.53)% and (95.60?1.31)%, respectively. CONCLUSION: The delayed release effect of ranolazine sustained release tablets coincided with the predictive value on the whole, and the preparation technology was reproducible. The in vitro accumulated drug release was in conformity with the requirements.