丹参酮Ⅱ_A喷雾干燥粉体药剂学性质的研究

Micromeritic properties of tanshinone Ⅱ_A spray drying powder

目的探索丹参酮IIA喷雾干燥粉体的药剂学性质。方法采用喷雾干燥法处理丹参酮IIA,并运用比表面积测定法(BET)、扫描电镜法(SEM)、差示扫描量热法(DSC)和X射线粉末衍射法(XRD)等方法对丹参酮IIA粉体进行分析,考察其体外溶出度和稳定性。结果 BET结果显示经喷雾干燥处理后的丹参酮IIA具有较窄的粒径分布范围及较大的比表面积;XRD和DSC分析结果显示部分丹参酮IIA已转变为非晶形式;在8 h丹参酮IIA的累积溶出度为85.2%。结论喷雾干燥方法处理丹参酮IIA有利于提高药物体外溶出度,为难溶性药物口服给药制剂的设计提供参考。

Objective To explore a method to improving the in vitro dissolution oftanshinone IIA spray drying powder and to study its pharmceutieal properties. Methods Tanshinone IIA was processed with spray drying method and analyzed by determination of the specific surface area （BET）, scanning electron microscopy （SEM）, differential scanning calorimetry （DSC）, and X-ray powder diffraction （XRPD）. And in vitro dissolution and drug stability were also investigated. Results The BET results showed that tanshinone IIg powder after spray drying had narrow particle size distribution range and large specific surface area; XRD and DSC analyses showed that most drug was transformed into amorphous form. The in vitro dissolution achieved 85.2% within 8 h. Accelerating experiment showed that the in vitro dissolution of tanshinone IIA decreased by approximately 21% stored for 6 months. Conclusion The drug dissolution is improved by spray-drying method. It provides a reference for the research and development of poorly soluble pharmaceutical preparations for oral administration.