OBJECTIVE: To prepare total flavonoids of Hippophae rhamnoides (TFH)-PVP K30 solid dispersion, and to characterize and study its in vitro dissolution. METHODS: Solvent method was used to prepare TFH-PVP K30 solid dispersion with different drug-loading ratio of 1 ∶ 1, 1 ∶ 2, 1 ∶ 3, 1 ∶ 4, 1 ∶ 5; 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 preparation technology using in vitro dissolution rate as index, and then validated. SEM, DSC and FT-IR were used to characterize solid dispersion. RESULTS: Td of TFH-PVP K30 solid dispersion was the lowest when drug-loading ratio was 1 ∶ 3. Optimal technology was ultrasonic time 10 min, temperature of water bath 60 ℃ and drying time 12 h. 90 min accumulative dissolution rate of prepared 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.
关键词
沙棘总黄酮聚乙烯吡咯烷酮K30固体分散体溶出度正交试验表征
Keywords
Total flavonoids of Hippophae rhamnoidesPVP K30Solid dispersionDissolution rateOrthogonal testCharacterization