【摘要】 目的:研究载体材料对汉防己甲素(TET)-固体分散体(SD)性质的影响。方法:分别以聚乙烯吡咯烷酮K30(PVPK30)、羟丙基甲基纤维素55(HPMC55)和Soluplus~?为载体材料，按TET-载体材料1∶4的质量比，采用喷雾干燥法制备了TET-SD,并对TET-SD的理化性质及溶出行为进行研究。结果:理化性质研究结果表明，3种TET-SD均为无定形态，药物和载体材料之间存在分子间相互作用，水接触角减小，粉体均为表面光滑的球形，粉体粒径显著减小。统计分析结果表明，TET-PVPK30-SD和TET-HPMC55-SD中TET的溶出行为与相应的物理混合物(PM)相比没有显著差异，TET-Soluplus~?-SD中TET的溶出行为与TET-Soluplus~?-PM相比显著改善。结论:3种无定形状态TET-SD对TET溶出行为的改善存在显著差异，可能是由于TET-PVPK30-SD的表面自由能极性成分含量和铺展系数与相应的TET-PVPK30-PM相近，使TET-PVPK30-SD中TET的溶出行为与TET-PVPK30-PM中TET的溶出行为相比没有显著差异；TET-HPMC55-SD的铺展系数较小，使TET在TET-HPMC55-SD中分散不均匀，可能存在相分离，影响了TET的溶出。更多还原

【Abstract】 Objective: This work aimed to study the effect of carrier materials on the properties of tetrandrine-solid dispersion(TET-SD). Methods: TET-SD was prepared by spray drying method using polyvinylpyrrolidone(PVPK30), hydroxypropyl methylcellulose 55(HPMC55) and Soluplus~? as carrier materials at a mass ratio of 1∶4. The physicochemical properties and dissolution of TET-SD were studied. Results: The results of physicochemical properties showed that all the three TET-SDs were amorphous. Since there was intermolecular interaction between the drug and the carrier materials, the water contact angle was reduced, the powder indicated a smooth spherical surface, and the particle size of the powder significantly reduced. The statistical analysis showed that the dissolution behaviors of TET in TET-PVPK30-SD and TET-HPMC55-SD were not significantly different from that of the corresponding physical mixture(PM), and the dissolution of TET in TET-Soluplus~?-SD was significantly improved compared with that in TET-Soluplus~?-PM. Conclusion: The three amorphous TET-SDs have significant differences in the improvement of TET dissolution, which may be due to the following reasons: the content of surface free energy polar component and spreading coefficient of TET-PVPK30-SD are similar to that of TET-PVPK30-PM, making no significant difference between the dissolution behavior of TET in TET-PVPK30-SD and that in TET-PVPK30-PM. The spread coefficient of TET-HPMC55-SD is small, making the TET in the TET-HPMC55-SD disperse inhomogeneously and phase separation exist, which affects the dissolution of TET.更多还原