Study on Preparation of Fluvastatin Sodium Extended-release Tablet and Its Pharmacokinetics in Beagle Dogs

OBJECTIVE To prepare the fluvastatin extended-release tablet and investigate its pharmacokinetics in Beagle dogs and in vitro release. METHODS Hydroxypropyl methyl cellulose was used as a sustained release material to prepare fluvastatin sodium extended release tablet. The release degree in vitro and the concentration of blood drug after single and multi dose oral administration of Beagle dogs were measured. The pharmacokinetic parameters were calculated. RESULTS The release behavior of fluvastatin extended-release tablets were similar in vitro, C_max in Beagle dogs after single dose and multi dose oral administration were (3 304.23±1 043.30)μg·L^-1 and (3 760.86±754.77)μg·L^-1, T_1/2 were (7.37±4.09)h and (6.04±2.63)h, AUC_(0-t) were (15 052.91±3 878.01)μg·L^-1 and (15 374.91±2 712.20)μg·h·L^-1. CONCLUSION The fluvastatin extended-release tablet shows a significant sustained release effect, and good security but not obvious accumulation phenomenon during repeated administration.