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雷帕霉素洗脱支架体外药物释放方法研究

发表时间:2018-06-15  浏览量:968  下载量:170
全部作者: 顾益庆,李凤芹,田原,赵古田
作者单位: 东南大学机械工程学院
摘 要: 建立一种适用于检测药物洗脱支架中雷帕霉素体外释放的方法。采用高效液相色谱定量分析雷帕霉素的含量,研究不同流动相成分、流动相流速及柱温对雷帕霉素出峰效果的影响,比较不同表面活性剂和摇床条件对雷帕霉素稳定性的影响。结果表明,当流动相乙腈/水的体积比为65/35、流动相流速为1.0 mL/min、柱温为50℃时,雷帕霉素主峰及其异构峰之间能完全分离。当体外释放介质为0.1%聚氧乙烯醚58(Brij58)的PBS(pH=7.4)时,雷帕霉素的稳定性较好。不同的摇床条件对雷帕霉素的稳定性影响不大,设定摇床条件为37℃、75 r/min,能更好地模拟体内环境。采用本研究建立的方法比较不同批次、相同涂层制备工艺下制备的雷帕霉素载药涂层和不同涂层制备工艺下制备的雷帕霉素载药涂层的释放曲线,验证了所提方法的稳定性和灵敏性,为有效检测药物洗脱支架中雷帕霉素的体外释放提供了依据。
关 键 词: 药物化学;药物洗脱支架;雷帕霉素;体外释放;高效液相色谱;稳定性
Title: Study on the method for in vitro drug release from sirolimus-eluting stents
Author: GU Yiqing, LI Fengqin, TIAN Yuan, ZHAO Gutian
Organization: School of Mechanical Engineering, Southeast University
Abstract: In this paper, a method for detecting the in vitro release of sirolimus from drug-eluting stents was established. The content of sirolimus was quantitatively analyzed by high performance liquid chromatography (HPLC). The effects of different mobile phase components, mobile phase flow rates, and column temperatures on the peak of sirolimus were studied. The effects of different surfactants and shaking conditions on the stability of sirolimus were compared. The results showed that the main peak and isomeric peak of sirolimus were completely separated when the volume ratio of acetonitrile/water was 65/35, the mobile phase flow rate was 1.0 mL/min, and the column temperature was 50℃. When the PBS (pH=7.4) solution containing 0.1% Brij58 as the in vitro release medium, the stability of sirolimus was better. Different shaking conditions had little effect on the stability of sirolimus. In order to simulate the environment in vivo better, the shaking condition was 37℃ and 75 r/min. The profiles of sirolimus release from coatings prepared with the same coating preparation process in different batches and with different coating preparation processes were compared using the method established in this paper. The results showed that the method was stable and sensitive, which provided a basis for the effective detection of in vitro release of sirolimus from drug-eluting stents.
Key words: medicinal chemistry; drug-eluting stent; sirolimus; in vitro release; high performance liquid chromatography; stability
发表期数: 2018年6月第11期
引用格式: 顾益庆,李凤芹,田原,等. 雷帕霉素洗脱支架体外药物释放方法研究[J]. 中国科技论文在线精品论文,2018,11(11):1093-1103.
 
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