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采用单剂量随机交叉试验设计,评价10只Beagle犬口服盐酸鲁拉西酮片受试和参比制剂的相对生物利用度。用UPLC-MS/MS法测定血浆中的鲁拉西酮。鲁拉西酮在0.1~300.0 ng/ml范围内线性关系良好,最低定量限(LLOQ)为0.1 ng/ml。10只Beagle犬口服盐酸鲁拉西酮片,受试和参比制剂的主要药动学参数为:t_(max)(0.8±0.2)和(0.8±0.5)h;c_(max)(51.1±50.1)和(66.4±75.5)ng/ml,AUC_(0→t)(162.9±97.2)和(175.9±123.7)ng·h·ml~(-1),AUC_(0→∞)(178.0±99.1)和(183.9±124.3)ng·h·ml~(-1),t_(1/2)(16.6±8.8)和(15.7±4.4)h。受试制剂中盐酸鲁拉西酮的相对生物利用度为(92.6±43.8)%。两制剂的平均药动学参数没有统计学差异。
A single dose randomized crossover design was used to evaluate the relative bioavailability of 10 beagle dogs orally with both losalicone hydrochloride tablets and reference formulations. Determination of Lubaraclone in Plasma by UPLC-MS / MS. The calibration curve of lurasidone was linear in the range of 0.1-300.0 ng / ml with the lowest limit of quantitation (LLOQ) of 0.1 ng / ml. The main pharmacokinetic parameters of test and reference preparations were as follows: t max (0.8 ± 0.2) and (0.8 ± 0.5) h; c max (51.1 ± 50.1) and (66.4 ± 75.5) ng / ml, AUC 0 ± t 162.9 ± 97.2 and 175.9 ± 123.7 ng · h · ml -1, AUC 0 ~ ∞ 178.0 ± 99.1 ) And (183.9 ± 124.3) ng · h · ml -1, t 1/2 (16.6 ± 8.8) and (15.7 ± 4.4) h, respectively. The relative bioavailability of lusalone hydrochloride in the test preparation was (92.6 ± 43.8)%. The average pharmacokinetic parameters of the two formulations were not statistically different.