佐米曲普坦片的人体生物等效性研究

Study on the Bioequiavailability of Zolmitriptan Tablets in Human Body

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。

OBJECTIVE： To study the bioavailability of the domestic and the imported zolmitriptan tablets in human body。METHODS： The plasma concentration of zolmitriptan in 24 healthy male volunteers were determined by HPLC - FI after orally administered with single dose of 5mg 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 imported tablets were described as follows, Cmax（8.273 ±3. 379） ng/ml and（7. 756± 2.623） ng/ml, tmax（2.341±1.169） h and （2.644±1.121） h, AUC0-t（47.95±15.75） （ng· h）/ml and （46.27± 13.71） （ng·h）/ml, the relative bioavailability of domestic zolmitriptan tablets and the imported tablets was（ 106.72± 32.03）%, CONCLUSION： The domestic and the imported zomitriptan tablets is bioequivalent。