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目的制备丹参酮组分缓释固体分散体,以提高其体外溶出,并控制药物的释放。方法以单硬脂酸甘油酯(GMS)和高相对分子质量的聚氧乙烯(PEO)为复合载体,用溶剂熔融法制备缓释固体分散体,考察其体外释药性能,并利用SEM、DSC、XRD、FTIR等表征手段对固体分散体的结构特征进行分析研究。结果药物与复合载体(GMS-PEO 2∶1)比例为1∶8时所制备的固体分散体取得了较好的缓释效果,指标成分的12 h体外累积溶出度均达90%以上;物相分析结果表明药物以非晶型状态高度分散于载体中。结论以GMS和PEO为载体制备的丹参酮组分固体分散体能显著改善药物的溶出,且缓释效果良好,具有实际应用价值。
Objective To prepare the tanshinone sustained-release solid dispersion to improve the in vitro dissolution and to control the drug release. Methods The sustained-release solid dispersion was prepared by solvent melting method with glycerol monostearate (GMS) and polyoxyethylene (PEO) with high relative molecular weight as the composite carrier. The in vitro drug release properties were investigated. SEM, DSC , XRD, FTIR and other characterization methods to analyze the structural characteristics of the solid dispersion. Results The solid dispersion prepared with GMS-PEO 2:1 ratio of 1: 8 had a good sustained-release effect. The cumulative dissolution of the indicator components in vitro reached over 90% The phase analysis showed that the drug was highly dispersed in the carrier in an amorphous state. Conclusion The solid dispersions of tanshinone prepared with GMS and PEO can significantly improve the dissolution of the drug and have good sustained-release effect, which is of practical value.