摘要
目的探讨丹参酮ⅡA(TSA)固体分散体制备、表征和体外溶出情况,分析其体外溶出特性。方法利用固体分散技术制备丹参酮ⅡA-PVP固体分散体(TSA-PVP SD),建立TSA的HPLC质量分数测定方法,采用显微观察、溶解度实验及体外溶出度测定对TSA-PVP SD进行物相鉴别,采用X射线粉末衍射(XRD)、差示扫描量热(DSC)及红外光谱研究(FTIR)进行结构鉴定。结果 TSA-PVP SD能显著增强TSA溶解性能及体外溶出度,80 min体外累积溶出率即达到90%以上;物相鉴别结果显示TSA以非结晶状态均匀分散于PVP载体中形成固体分散体。结论TSA-PVP SD具有较好的溶出度,溶出适应性较高,为丹参酮ⅡA制剂研究提供了参考。
Objective To investigate the preparation and characterization of tanshinone Ⅱ A(TSN) and its dissolution in vitro,and to analyze its dissolution characteristics.Methods The solid dispersion technology was used to prepare tanshinone Ⅱ A-PVP solid dispersion(TSA-PVP SD).A method for determination of TSA by high-performance liquid chromatography(HPLC) was established.The phase of TSA-PVP SD was identified by microscopic observation,solubility test and dissolution test in vitro.The structure of TSA-PVP SD was identified by X-ray powder diffraction(XRD),differential scanning calorimetry(DSC) and infrared spectroscopy(FTIR).Results TSA-PVP SD could significantly enhance the solubility and dissolution of TSA in vitro,and the cumulative dissolution rate in vitro was more than 90% after 80 min.The results of phase identification showed that TSA was uniformly dispersed in PVP carrier in an amorphous state to form solid dispersion.Conclusion Tanshinone Ⅱ A solid dispersion has good dissolution,higher dissolution adaptability,and it significantly improves the bioavailability,which provides an effective experimental reference for the study of tanshinone Ⅱ A preparation.
作者
王慧婷
赵必鑫
詹燕珊
郭思旖
何杰滢
时军
WANG Huiting;ZHAO Bixin;ZHAN Yanshan;GUO Siyi;HE Jieying;SHI Jun(School of Traditional Chinese Medicine,Guangdong Pharmaceutical University,Guangzhou 510006,China;Guangdong Engineering&Technology Research Center of Precise Drug Delivery System,Guangzhou 510006,China)
出处
《广东药科大学学报》
CAS
2021年第2期7-10,共4页
Journal of Guangdong Pharmaceutical University
基金
国家大学生创新训练项目(201810573016)
广东药科大学大学生“专创融合”项目(19zcrh01)。
