【摘要】 目的:建立一种雷帕霉素冠脉药物支架体外释放度测定的方法。方法:根据美国药典释放度测定第7法的仪器装置,改装了药物溶出度仪。释放介质为4%牛血清和0.1%叠氮化钠溶解在PBS(pH=7.4,0.01 M)的缓冲液;以ODS为固定相,乙腈∶水(65∶35)为流动相,柱温为60℃,检测波长为280 nm。结果:雷帕霉素在0.5~100μg.mL-1浓度范围内线性关系良好,相关系数0.9999,回收率99.7%,最低检测限为0.025μg;雷帕霉素在0~28 d的释放曲线与USP释放度测定第7法测定结果一致。结论:本法改装后的仪器简便,适合国情,符合USP7的要求,检测结果较为满意。更多还原

【Abstract】 Objective:To establish a method for the analysis of release of rapamycin in drug eluting stents(DES).Methods:Chp dissolution test method(modify USP7)was adopted and used 250 mL the mixture of 4% BSA and 0.1%NaN3 in PBS buffer(pH=7.4,0.01 M)as the release media.Agilent Ecilpse C18(150 mm×4.6 mm,5 μm)was adopted,The mobile phase consisted of acetonitrile and methanol solution(65∶35)at a flow rate of 1.0 mL·min-1.Keep the detective wave length at 280 nm.Results:The linear correlation of rapamycin in acetonitrile is observed over the range of 1-100 μg· mL-1(r=0.9999).The recoveries of rapamycin is 99.7%.The LOD is 0.025 μg.The release of rapamycin using improved method is identical to which using USP method Ⅶ.Conclusion:The method is fastness and convenience.更多还原