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分别以Soluplus~?、聚乙二醇(PEG)6000和泊洛沙姆188为载体,采用熔融淬冷技术制备了药物-载体质量比为1∶3的非诺贝特固体分散体,并以扫描电镜(SEM)、粉末X-射线衍射(PXRD)和差示扫描量热(DSC)技术进行表征。PXRD和DSC数据表明,非诺贝特在3种固体分散体中均主要以无定形状态存在。以Soluplus~?为载体时,水中固体分散体中非诺贝特的溶出率(60 min时)及溶解度(25℃)显著高于其他两种固体分散体及物理混合物(P<0.05)。在非诺贝特超饱和的状态下,含有Soluplus~?的水溶液中非诺贝特1 h时的溶解度为20.4mg/ml,显著高于含有另两种聚合物的水溶液(P<0.05),表现出更好的结晶抑制效应。
Solofugate solid dispersions with drug-carrier mass ratio of 1: 3 were prepared by melt quenching technique using Soluplus®, PEG 6000 and poloxamer 188 as carriers respectively. Electron microscopy (SEM), powder X-ray diffraction (PXRD) and differential scanning calorimetry (DSC) techniques were used for characterization. PXRD and DSC data showed that fenofibrate was predominantly amorphous in all three solid dispersions. When Soluplus® was used as carrier, the dissolution rate (at 60 min) and solubility (25 ℃) of fenofibrate in water were significantly higher than those of the other two solid dispersions and physical mixtures (P <0.05). In the case of fenofibrate over-saturation, the solubility of fenofibrate in aqueous solutions containing Soluplus® was 20.4 mg / ml at 1 h, significantly higher than that of the aqueous solutions containing the other two polymers (P <0.05) Show better crystallization inhibitory effect.