论文部分内容阅读
目的：本文对进口和国产索他洛尔片剂在１２名男性健康志愿者中的药物动力学和相对生物利用度进行了研究。方法：建立了一个检测血清中索他洛尔浓度的反相高效液相色谱－荧光检测法。结果：单剂量口服索他洛尔１６０ｍｇ后的血药浓度数据用３Ｐ８７药物动力学程序进行模型拟合，国产片剂ＡＵＣ、Ｃｍａｘ、Ｔｍａｘ、Ｔ１／２分别为１６．２±３．６ｈ·μｇ·ｍｌ－１，１．２±０．２μｇ·ｍｌ－１，２．１±０．７ｈ，１７．０±７．２ｈ；进口片剂ＡＵＣ、Ｃｍａｘ、Ｔｍａｘ、Ｔ１／２分别为１５．９±３．５ｈ·μｇ·ｍｌ－１，１．２±０．４μｇ·ｍｌ－１，２．１±０．６ｈ，１８．６±９．４ｈ。国产片剂的相对生物利用度为１０３．５％。结论：两种片剂的所有药动学参数经统计学（ＳＰＳＳ软件）处理差异均无显著性（Ｐ＞０．０５）。
OBJECTIVE: In this paper, the pharmacokinetics and relative bioavailability of imported and domestic sotalol tablets in 12 male healthy volunteers were studied. Methods: A reversed-phase high performance liquid chromatography-fluorescence method was developed for the determination of sotalol in serum. Results: The single-dose oral sotalol 160mg plasma concentration data using 3P87 pharmacokinetic program model fitting, domestic tablets AUC, Cmax, Tmax, T1 / 2 were 16.2 ± 3.6h · μg · Ml -1,1.2 ± 0.2μg · ml-1, 2.1 ± 0.7h, 17.0 ± 7.2h. The AUC, Cmax, Tmax and T1 / 2 of imported tablets were 15.9 ± 3.5 h · μg · ml-1, 1.2 ± 0.4 μg · ml-1, 2.1 ± 0.6 h, 18.6 ± 9.4 h. The relative bioavailability of domestic tablets was 103.5%. CONCLUSION: All pharmacokinetic parameters of the two tablets showed no statistical difference (SPSS software) (P> 0.05).