摘要
建立了高效液相色谱法测定西罗莫司及其药物支架的体内释放度.以0.01 mol/L磷酸钠缓冲液（pH 6.0）∶0.02％BHT乙腈溶液（65∶35）作为药物洗脱支架的萃取液,采用Symmetry ShiledTM RP 18色谱柱,流动相为甲醇∶乙腈∶水（17∶50∶33）,检测波长278 nm.西罗莫司在0.5～16.0 μg/ml范围内线性关系良好,平均回收率为（100.7±0.7）％,RSD为0.7％.西罗莫司药物支架的体内释放度研究结果表明,该支架体内放置7d后累积释放率可达49.8％,放置90 d后累积释放率为82.8％.
An HPLC method was established for the determination of sirolimus and its release rate in drugeluting stents.It was extracted from stents by the addition of 0.01 mol/L phosphate buffer （pH 6.0） ∶ 0.02％ BHT acetonitrile solution （65 ∶ 35）.A Symmetry ShiledTM RPl8 column was used,with the mobile phase of methanol ∶acetonitrile ∶ water （17 ∶ 50 ∶ 33） at the detection wavelength of 278 nm.The calibration curve was linear in the range of 0.5-16.0 μg/ml.The average recovery was （100.7±0.7） ％,with RSD of 0.7％.The results showed that in vivo cumulative drug-release rate ofdrug-eluting stents were 49.8 ％ at 7 days and 82.8 ％ at 90 days.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2014年第6期567-569,共3页
Chinese Journal of Pharmaceuticals
