论文部分内容阅读
９名男性健康志愿者，自身交叉口服单剂量（２ｍｇ）国产和进口格拉司琼片剂，用高效液相色谱荧光检测法测定血浆中格拉司琼浓度，进行药代动力学和相对生物利用度研究。试验结果表明，口服国产和进口格拉司琼的血药浓度－时间曲线均符合一房室模型，Ｔｍａｘ分别为１．２９±０．５２ｈ和１．４５±０．９８ｈ；Ｃｍａｘ为７．２３±１．９４μｇ·Ｌ－１和６．７８±２．８６μｇ·Ｌ－１；Ｔ１／２为５．３３±２．６５ｈ和５．４３±２．３２ｈ；ＡＵＣ为６８．０９±４２．６８μｇ·ｈ·Ｌ－１和７０．５５±５０．１９μｇ·ｈ·Ｌ－１；国产格拉司琼的相对生物利用度为１０２．４５±１６．９１％，其ＡＵＣ和Ｃｍａｘ值经对数转换后作方差分析，双单侧Ｔ检验证明两种制剂为生物等效制剂。
Nine male healthy volunteers, taking a single dose (2mg) of homemade and imported granisetron tablets at their own intersections, measured the concentration of granisetron in plasma by high performance liquid chromatography (HPLC) fluorescence detection, and carried out pharmacokinetics and relative bioavailability the study. The results showed that oral concentration of domestic and imported granisetron - time curve in line with a one-compartment model, Tmax were 1.29 ± 0.52h and 1.45 ± 0.98h; Cmax was 7.23 ± 1.94 μg · L -1 and 6.78 ± 2.86 μg · L -1; T1 / 2 was 5.33 ± 2.65 h and 5.43 ± 2.32 h; AUC was 68.09 ± 42.68 μg · h · L-1 and 70.55 ± 50.19 μg · h · L-1 respectively. The relative bioavailability of domestic granisetron was 102.45 ± 16.91%. The AUC and Cmax values were logarithmically converted Analysis of variance, two-sided one-sided T-test showed that the two preparations were bioequivalent.