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采用溶剂法或熔融法制备以Soluplus为主要载体材料的硝苯地平固体分散体。通过X-射线衍射(XRD)、差示扫描量热分析(DSC)及扫描电镜(SEM)表征了固体分散体的结构,并测定了原药及不同固体分散体的溶解度和体外溶出特性。结果表明,两种方法制得的固体分散体均显著增加了原药的溶解度及体外溶出,且随载体用量增加,增加幅度增大。溶剂法制得的固体分散体中药物2 h溶出率比熔融法制品更高;处方中加入适量泊洛沙姆188可增大熔融法制品的溶出率。
Solid solution of nifedipine with Soluplus as carrier material was prepared by solvent method or melt method. The structure of the solid dispersion was characterized by X-ray diffraction (XRD), differential scanning calorimetry (DSC) and scanning electron microscopy (SEM). The solubility and in vitro dissolution characteristics of the original drug and different solid dispersions were determined. The results showed that both the solid dispersions obtained by the two methods significantly increased the solubility of the original drug and dissolution in vitro. With the increase of the amount of the carrier, the increase range increased. The dissolution rate of the drug in the solid dispersion prepared by solvent method was higher than that of the melting method in 2 h. Adding poloxamer 188 in the prescription could increase the dissolution rate of the melting method.