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目的:研究盐酸多奈哌齐口腔崩解片与盐酸多奈哌齐片人体的生物等效性。方法:20名男性健康志愿者随机交叉单剂量口服盐酸多奈哌齐口腔崩解片(受试制剂)与盐酸多奈哌齐片(参比制剂)5 mg,用液质联用法测定人血浆中多奈哌齐的浓度,用DAS 2.1软件计算药动学参数,并评价两制剂的生物等效性。结果:口服受试制剂和参比制剂药动学参数分别为C_(max)(8.56±2.10)和(8.08±1.78)ng·ml~(-1),t_(max)(2.65±0.74)和(3.05±0.83)h,t_(1/2)(70.31±19.54)和(71.15±18.47)h,AUC_(0～216)(373.76±94.15)和(353.04±81.42)ng·h·ml~(-1),AUC_(0-∞)(420.30±110.99)和(399.80±108.56)ng·h·ml~(-1)。受试制剂AUC_(0～216)的90%置信区间在参比制剂的等效范围内。结论:两种盐酸多奈哌齐制剂生物等效。
Objective: To study the bioequivalence of donepezil hydrochloride orally disintegrating tablets and donepezil hydrochloride tablets. Methods: Twenty male healthy volunteers were randomized to receive a single oral dose of donepezil hydrochloride orally disintegrating tablets (test preparation) and donepezil hydrochloride tablets (reference preparation) 5 mg. Plasma concentrations of donepezil were determined by liquid chromatography-mass spectrometry The DAS 2.1 software calculates pharmacokinetic parameters and evaluates the bioequivalence of the two formulations. Results: The pharmacokinetic parameters of oral preparation and reference preparation were C max (8.56 ± 2.10) and (8.08 ± 1.78) ng · ml -1, t max (2.65 ± 0.74) and (3.05 ± 0.83) h, t 1/2 (70.31 ± 19.54) and (71.15 ± 18.47) h, AUC 0 ~ 216 (373.76 ± 94.15) and (353.04 ± 81.42) ng · h · ml ~ -1), AUC 0-∞ (420.30 ± 110.99) and (399.80 ± 108.56) ng · h · ml -1, respectively. The 90% confidence interval for the AUC_ (0-216) of the test formulation was within the equivalent range of the reference formulation. Conclusion: Two donepezil hydrochloride formulations are bioequivalent.