论文部分内容阅读
目的:建立测定人血浆中地奥司明苷元浓度的液相色谱-串连质谱检测法,并研究地奥司明片在健康人体内的药物动力学特征。方法:用LC/MS/MS法测定,色谱柱为CAPCELL PAK UG120柱,流动相为乙腈-0.1%甲酸溶液(80:20,v/v),流速0.6 ml·min~(-1),柱温为24℃,对12名健康志愿者口服地奥司明片后不同时间点的血药浓度进行测定,并用统计矩法计算药动学参数。结果:地奥司明片中地奥司明苷元在健康受试者体内的主要药动学参数t_(max)为(12.1±0.9)h,C_(max)为(8.88±2.69)ng·ml~(-1),t_(1/2)为(11.9±2.5)h,AUC_(0-48h)为(183±55)ng·h·ml~(-1),AUC_(0-∞)为(200±61)ng·h·ml~(-1)。结论:本方法具有良好的准确性、精密度和较高的灵敏度、简便快速,能满足地奥司明的血药浓度测定和药动学研究。
OBJECTIVE: To establish a liquid chromatography-tandem mass spectrometry (HPLC-MS / MS) method for the determination of des osidin in human plasma and to study the pharmacokinetics of desogestrel in healthy volunteers. Methods: The chromatographic column was CAPCELL PAK UG120 column with a mobile phase of acetonitrile-0.1% formic acid (80:20, v / v) at a flow rate of 0.6 ml · min -1 The temperature was 24 ℃. The plasma concentrations of oral administration of oseltamivir in 12 healthy volunteers were measured at different time points, and the pharmacokinetic parameters were calculated by statistical moment method. Results: The main pharmacokinetic parameters of desigenin in desfluoside tablets were (12.1 ± 0.9) h and (8.88 ± 2.69) ng · (-1), t 1/2 (11.9 ± 2.5) h and AUC 0-48h were (183 ± 55) ng · h · ml -1, AUC 0-0, (200 ± 61) ng · h · ml -1. Conclusion: The method has good accuracy, precision and high sensitivity, simple and quick, and can meet the oseltamivudine concentration determination and pharmacokinetic studies.