目的 将壳聚糖（CS）应用于丹参酮II_A（Tan II_A）固体分散体的制备，考察并比较以不同相对分子质量（M_W）的CS为载体的Tan II_A固体分散体的溶出度。方法 以CS为载体，采用溶剂法制备Tan II_A固体分散体，对不同M_W的CS以及药物与载体的不同比例所制备固体分散体的溶出行为进行比较研究，并进行物相分析。结果 Tan II_A-CS（M_W 3 000～5 000）按1∶9比例制备的固体分散体的体外溶出效果最好，60 min时药物的体外累积溶出率达到90%以上；经差示扫描量热（DSC）和扫描电镜（SEM）分析，固体分散体中药物以非晶形形式存在于载体中。结论 以CS为载体制备的Tan II_A固体分散体能显著改善Tan II_A的溶出；CS作为Tan II_A一种新型的固体分散体载体，具有实际应用价值。

Objective To prepare and characterize the solid dispersion of tanshinone II_A (Tan II_A) using chitosan (CS) and compare the dissolution of solid dispersion using CS with different molecular weight (M_W). Methods Tan II_A solid dispersion was prepared by the solvent method with CS as the carrier. The physical characteristics and in vitro dissolution of solid dispersion prepared by different M_W of CS and different proportions of drug and carrier were further evaluated. Results The ideal Tan II_A solid dispersion was prepared under the condition as follows: the weight ratio of Tan II_A-CS (M_W 3 000—5 000) was 1∶9. The in vitro dissolution of Tan II_A solid dispersion reached up to 90% at 60 min. The differential scanning calorimetry (DSC) and scanning electron microscopy (SEM) demonstrated that Tan II_A existed as amorphous state in carriers. Conclusion The results indicate that in vitro dissolution of Tan II_A is improved greatly by the solid dispersion with CS as the carrier. As a new type of solid dispersion carrier of Tan II_A, CS has its practical value.

江苏省中医药领军人才项目（2006）；“国家中医药管理局中药口服制剂释药系统重点研究室”开放基金课题（2011NDDCM01002）