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目的:比较两种盐酸氟桂利嗪胶囊的人体生物等效性。方法:20名健康男性志愿者随机交叉单剂量口服盐酸氟桂利嗪胶囊(受试制剂)与盐酸氟桂利嗪胶囊(参比制剂)20 mg,采用LC-MS/MS法测定人血浆中氟桂利嗪浓度,用BAPP 2.2软件和DAS 2.1软件计算药动学参数和生物利用度。结果:口服盐酸氟桂利嗪受试制剂与参比制剂后的人体药动学参数分别为C_(max)(73.34±10.87)和(70.54±10.27)ng·ml~(-1),t_(max)(4.2±1.2)和(3.8±1.1)h,t_(1/2β)(6.1±1.4)和(6.4±1.8)h,AUC_(n～30)(736.7±116.1)和(696.4±134.8)ng·h·ml~(-1),AUC_(0～∞)(767.1±123.4)和(731.3±150.5)ng·h·ml~(-1)。受试制剂的相对生物利用度为(107.2±13.3)%。受试制剂AUC_(0～30)的90%置信区间在在参比制剂的等效范围内。结论:两种氟桂利嗪制剂生物利用度等效。
OBJECTIVE: To compare the bioequivalence of two flunarizine hydrochloride capsules. Methods: Twenty healthy male volunteers were randomized to receive a single dose of flunarizine hydrochloride capsules (test preparation) and flunarizine hydrochloride capsules (reference preparation) 20 mg, the determination of the content in human plasma by LC-MS / MS Flunarizine concentrations, pharmacokinetic parameters and bioavailability were calculated using BAPP 2.2 software and DAS 2.1 software. Results: The pharmacokinetic parameters of Flunarizine hydrochloride after oral administration and reference formulation were C max (73.34 ± 10.87) and (70.54 ± 10.27) ng · ml -1, t_ ( max (4.2 ± 1.2) and (3.8 ± 1.1) h, t 1/2 (6.1 ± 1.4) and (6.4 ± 1.8) h, AUC n30 (736.7 ± 116.1) and (696.4 ± 134.8) ) ng · h · ml ~ (-1), AUC_ (0 ~ ∞) (767.1 ± 123.4) and (731.3 ± 150.5) ng · h · ml ~ (-1) respectively. The relative bioavailability of the test preparation was (107.2 ± 13.3)%. The 90% confidence interval for the AUC_ (0-30) of the test formulation was within the equivalent range of the reference formulation. Conclusion: The bioavailability of two flunarizine formulations is equivalent.