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本文研究了１２名男性健康志愿者单剂口服国产和进口盐酸索他洛尔片剂１６０ｍｇ的药代动力学和相对生物利用度。按照随机、交叉试验设计，采集服药后０．５，１．０，１．５，２，３，４，６，８，１２，２４，３６，４８ｈ的血样本。ＨＰＬＣ方法测定索他洛尔的血药浓度。两种制剂的药－时曲线符合口服吸收有滞后时间的二房室模型及一级动力学吸收、消除过程。国产索他洛尔的主要药代动力学参数：Ｃｍａｘ１．４５±０．３６ｍｇ／ｌ，Ｔｐｅａｋ２．５±０．９８ｈ，Ｔ１／２β９．６７±１．６７ｈ，ＡＵＣ０－ｔ１４．９２±２．８５ｍｇ·ｈ·Ｌ－１。国产索他洛尔相对于进口制剂的生物利用度为９９．７±１７．８％，国产索他洛尔与进口制剂生物等效。
This study investigated the pharmacokinetics and relative bioavailability of 160 mg single dose domestic and imported Sotalol Hydrochloride tablets in 12 male healthy volunteers. According to a randomized, crossover design, blood samples of 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 h after taking the drug were collected. HPLC method for the determination of sotalol blood concentration. The drug-time curves for both formulations are in line with the two-compartment model of oral absorption with lag time and the first-order kinetics of absorption and elimination. The main pharmacokinetic parameters of domestic sotalol: Cmax 1.45 ± 0.36mg / l, Tpeak 2.5 ± 0.98h, T1 / 2β 9.67 ± 1.67h, AUC0-t 14.92 ± 2.85mg · H · L-1. The bioavailability of domestic sotalol relative to imported preparations was 99.7 ± 17.8%. Domestic sotalol was bioequivalent to imported preparations.