沙棘总黄酮-聚乙烯吡咯烷酮K30固体分散体的制备、表征及体外溶出研究
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篇名: 沙棘总黄酮-聚乙烯吡咯烷酮K30固体分散体的制备、表征及体外溶出研究
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摘要: 目的:制备沙棘总黄酮(TFH)-聚乙烯吡咯烷酮K30(PVP K30)固体分散体,并对其进行表征及体外溶出研究。方法:采用溶剂法制备不同药载比(1 ∶ 1、1 ∶ 2、1 ∶ 3、1 ∶ 4、1 ∶ 5)的TFH-PVP K30固体分散体,以溶出参数Td为指标设计单因素试验筛选药载比,以体外溶出度为指标设计正交试验优选制备工艺中的超声时间、水浴温度和干燥时间,并进行验证。采用扫描电镜法(SEM)、差示扫描量热法(DSC)和傅里叶红外光谱法(FT-IR)对固体分散体进行表征。结果:药载比为1 ∶ 3时TFH-PVP K30固体分散体的Td最小;最优工艺为超声时间10 min、水浴温度60 ℃、干燥时间12 h。以此工艺制备的TFH-PVP K30固体分散体90 min的累积溶出度平均值为90.22%(RSD=1.74%,n=3)。SEM、DSC与FT-IR结果表明,TFH以无定形分散在PVP K30载体中,二者之间形成氢键。结论:成功制得TFH-PVP K30固体分散体,其体外溶出度明显提高。
ABSTRACT: 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.
期刊: 2017年第28卷第1期
作者: 田茜,何晨,贺敬霞,尹蓉莉,杨军宣,张礼
AUTHORS: TIAN Qian,HE Chen,HE Jingxia,YIN Rongli,YANG Junxuan,ZHANG Li
关键字: 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 rhamnoides; PVP K30; Solid dispersion; Dissolution rate; Orthogonal test; Characterization
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