雷帕霉素洗脱支架体外药物释放方法的研究
首发时间:2018-04-02
摘要:本文建立了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、流动相流速以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/水体积比为65/35,流动相流速为1.0mL/min,柱温为50℃,雷帕霉素和其异构峰之间能完全分离。当体外释放介质为0.1%Brij58的PBS(PH=7.4)溶液时,雷帕霉素的稳定性比较好。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℃、75rpm,能更好地模拟体内的环境。采用本文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: 药物洗脱支架 雷帕霉素 体外释放 高效液相色谱 稳定性
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Study on the method for in vitro drug release from sirolimus-eluting stents
Abstract:In this paper, a method for detecting the in vitro release of sirolimusfrom drug-eluting stents was established. The content of sirolimus was quantitatively analyzed byhigh 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 stablity ofsirolimus were compared.The results showed that the main peak and isomeric peak of sirolimuswere completely separatedwhen the volume ratio of acetonitrile/water was 65/35, the mobile phase flow rate was1.0 mL/min, and the column temperature was 50 C.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 shaker condition was 37 C and 75 rpm. The profiles of sirolimus release from coatings prepared with the same coating preparation processand 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 sirolimusfrom drug-eluting stents.
Keywords: drug eluting stent sirolimus in vitro release high performance liquid chromatography stability
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