Preparation,Characterization and in vitro Dissolution Study of Total Flavonoids of Hippophae rhamnoi-des-PVP K30 Solid Dispersion / 中国药房

ABSTRACT

OBJECTIVE:To prepare total flavonoids of Hippophae rhamnoides(TFH)-PVP K30 solid dispersion,and to char-acterize and study its in vitro dissolution. METHODS:Solvent method was used to prepare TFH-PVP K30 solid dispersion with dif-ferent drug-loading ratio of 11,12,13,14,15;single factor test was designed to screen drug-loading ratio using dissolution parameter Td as index;orthogonal test was designed to optimize ultrasonic time,temperature of water bath and drying time for prep-aration technology using in vitro dissolution rate as index,and then validated. SEM,DSC and FT-IR were used to characterize sol-id dispersion. RESULTS:Td of TFH-PVP K30 solid dispersion was the lowest when drug-loading ratio was 13. Optimal technolo-gy was ultrasonic time 10 min,temperature of water bath 60 ℃ and drying time 12 h. 90 min accumulative dissolution rate of pre-pared TFH-PVP K30 solid dispersion was 90.22% in average(RSD=1.74%,n=3). The results of SEM,DSC and FT-IR showed that the drug as amorphous form dispersed in the PVP K30,the formation of hydrogen bond of the both. CONCLUSIONS:TFH-PVP K30 solid dispersion is prepared successfully,and in vitro dissolution rate of it is improved significantly.