新型抗凝药磺达肝癸钠人血浓度测定方法的建立

目的建立人血浆中磺达肝癸钠浓度的检测方法。方法使用肝素试剂盒拟合标准曲线，测定其检测限、精密度、回收率和稳定性，并检测开胸术后使用磺达肝癸钠进行预防血栓治疗的患者血样156份。结果磺达肝癸钠质量浓度在0．1-1．5mg·L^-1时线性良好（r^2=0．996），方法回收率99．5％-102％，日内和日间RSD分别为4．2％-8．44％和2．73％-9．51％。结论肝素试剂盒用于检测磺达肝癸钠的血浆浓度简便、快捷，可用于临床药动学研究。

Establishment of method for determination of concentration of fondaparinux sodium in human plasma

AIM To establish a method to detect the concentration of fondaparinux sodium in human plasma. METHODS The heparin kit was used to fit the standard curve, measure the limit of detection, precision, reeovery rate and stability. A total of 156 samples were detected by this assay in postthoracic surgery patients. RESULTS The linearity of the standard curve was preferable ranged from 0.1 to 1.5 mg· L^- 1. The limit of detection was 0.1 mg· L^- 1. Theintra- and inter-assay relative standard deviations （RSDs） were 4.2% - 8.44% and 2.73% - 9.51%, respeetively. The method recovery rate was 99.5% - 102%. CONCLUSION The method to detect the plasma concentrations of fondaparinux sodium by using heparin kit is fast, simple and convenient, and can be applied to study pharmacokinetics.