丹参酮组分缓释固体分散体的研究  

Studies on sustained release solid dispersion of tanshione composition

作　　者：陈小云[1,2] 张振海[1] 郁丹红[1,2] 刘丹[1] 金慧芬[1] 杨世林 贾晓斌[1,2] 

机构地区：[1]江苏省中医药研究院国家中医药管理局中药释药系统重点研究室,江苏南京210028 [2]南京中医药大学,江苏南京210046 [3]江西本草天工科技有限责任公司,江西南昌330006

出　　处：《中草药》2013年第17期2391-2396,共6页Chinese Traditional and Herbal Drugs

基　　金：国家“十一五”科技支撑计划“基于中药有效成分群的中药组方设计技术研究”课题(2008BAI51B03);江苏省高等学校大学生创新训练计划项目(011042004000);江苏省中医药领军人才专项(2006)

摘　　要：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 sustained release solid dispersions of tanshinone composition with the intention of improvingdrug dissolution and controlling drug release. Methods The glycerin monostearate （GMS） and polyethylene oxide （PEO） were used as composite carriers to prepare tanshinone solid dispersions by solvent melting method and the in vitro dissolution oftanshinone solid dispersions was performed. The structure of solid dispersions was characterized by SEM, DSC, XRD, and FTIR. Results When the ratio of drug to composite carriers （GMS-PEO 2 ： 1） was 1 ： 8, the solid dispersions had a better sustained release effect, the accumulative drug-release percent in vitro at 12 h was over 90%, and the results from the phase analysis indicated that the tanshinone composition existed in carriers as amorphous state. Conclusion The in vitro dissolution oftanshinone is greatly improved by the solid dispersions with GMS-PEO as its carriers. And it exhibits excellent release characteristics in vitro with the actual applied value.

关 键 词：丹参酮组分 固体分散体 缓释 复合载体 体外释放 溶出 单硬脂酸甘油脂 聚氧乙烯 

分 类 号：R283.6[医药卫生—中药学]