佐米曲普坦片的人体生物等效性研究

目的:研究国产与进口佐米曲普坦片的人体生物等效性。方法:采用高效液相色谱-荧光法测定24名健康男性志愿者随机交叉单剂量口服佐米曲普坦片5mg后血浆中的药物浓度,计算其药动学参数及相对生物利用度。结果:口服佐米曲普坦片的药-时曲线符合线性动力学一室开放模型,国产及进口佐米曲普坦片的Cmax分别为(8.273±3.379)、(7.756±2.623)ng/ml,tmax分别为(2.341±1.169)、(2.644±1.121)h,AUC0～t分别为(47.95±15.75)、(46.27±13.71)(ng·h)/ml,国产制剂相对于进口制剂的人体生物利用度为(106.72±32.03)%。结论:国产与进口佐米曲普坦片具有生物等效性。

Study on the Bioequiavailability of Zolmitriptan Tablets in Human Body

OBJECTIVE:To study the bioavailability of the domestic and the imported zolmitriptan tablets in human body.METHODS:The plasma concentration of zolmitriptan in24healthy male volunteers were determined by HPLC-FI after oˉrally administered with single dose of5mg zolmitriptan tablets by randomized crossover way,the pharmacokinetics parameters and the relative bioavailability of which were calculated.RESULTS:The plasma concentration-time curves of the oral zolmitriptan tablets fitted one-compartment open model of linear dynamics,the main parameters of domestic tablets and imˉported tablets were described as follows,C max (8.273±3.379)ng/ml and(7.756±2.623)ng/ml,t max (2.341±1.169)h and(2.644±1.121)h,AUC 0～t (47.95±15.75)(ng·h)/ml and(46.27±13.71)(ng·h)/ml,the relative bioavailability of doˉmestic zolmitriptan tablets and the imported tablets was(106.72±32.03)%.CONCLUSION:The domestic and the imported zomitriptan tablets is bioequivalent.