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以多孔二氧化硅为载体制备丹参酮固体分散体,比较喷雾干燥法和溶剂法对药物体外溶出度的影响。采用差示扫描量热法(DSC)、扫描电镜法(SEM)、X-射线粉末衍射法(XRD)和傅立叶红外光谱法(FTIR)等技术对固体分散体的结构特征进行分析研究,并考察其体外溶出度。表征结果显示在2种方法制备的固体分散体中药物均以非晶形式高度分散。体外溶出度测定结果表明,溶剂法制备的丹参酮固体分散体在45,60 min时,丹参酮I,II A的累积溶出度分别为80.9%,84.6%和86.2%,88.7%;喷雾干燥法制备的固体分散体45,60 min时,丹参酮I,II A的累积溶出度分别为92.7%,95.3%和95.8%,97.1%。喷雾干燥法和溶剂法均能成功制备丹参酮固体分散体,喷雾干燥法制备的固体分散体更利于提高溶出度。
Preparation of tanshinone solid dispersion using porous silica as carrier, compared with spray drying method and solvent method on drug dissolution in vitro. The structural characteristics of the solid dispersions were analyzed by DSC, SEM, XRD and FTIR. Its in vitro dissolution. The characterization results show that the drugs are highly dispersed in amorphous form in the solid dispersions prepared by both methods. The results of in vitro dissolution showed that the cumulative dissolution of tanshinone I and II A were 80.9%, 84.6% and 86.2%, 88.7% respectively at 45 and 60 min when the solid dispersion of tanshinone was prepared by the solvent method. At 45 min and 60 min, the cumulative dissolution of tanshinone I and II A were 92.7%, 95.3% and 95.8%, 97.1%, respectively. Tanshinone solid dispersion can be successfully prepared by spray drying and solvent methods. The solid dispersion prepared by spray drying is more conducive to the improvement of dissolution rate.