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目的:评价2种不同厂家盐酸美金刚片的生物等效性。方法:采用标准二阶段交叉设计自身对照试验方案,将20名健康男性受试者随机分为2组,分别单剂量口服盐酸美金刚片受试制剂(国产)或参比制剂(进口)10mg后,用液-质联用(LC-MS)法测定血浆中美金刚浓度,以DAS2.0软件计算药动学参数。结果:20名健康受试者单剂量口服受试制剂或参比制剂后,药动学参数分别为:t1/2(69.77±14.61)、(76.06±17.92)h,tmax(5.15±1.18)、(5.05±1.36)h,cmax(13.64±3.28)、(13.34±4.18)μg·mL-1,AUC0～240h(857.73±164.45)、(888.16±316.00)μg·h·mL-1,AUC0～∞(940.00±180.70)、(999.00±346.40)μg·h·mL-1。与参比制剂比较,受试制剂的生物利用度为104.2%。结论:2种盐酸美金刚片生物等效。
OBJECTIVE: To evaluate the bioequivalence of memantine hydrochloride in two different manufacturers. Methods: A standard two-phase crossover design self-control test protocol, 20 healthy male subjects were randomly divided into two groups, respectively, after a single oral administration of memantine hydrochloride test preparation (domestic) or reference preparation (import) 10mg The concentration of memantine in plasma was determined by liquid chromatography-mass spectrometry (LC-MS). The pharmacokinetic parameters were calculated by DAS2.0 software. Results: The pharmacokinetic parameters of 20 healthy volunteers after a single oral dose of test or reference formulation were: t1 / 2 (69.77 ± 14.61), (76.06 ± 17.92) h, tmax (5.15 ± 1.18), (5.05 ± 1.36) h, cmax (13.64 ± 3.28), (13.34 ± 4.18) μg · mL-1, AUC0 ~ 240h (857.73 ± 164.45), (888.16 ± 316.00) μg · h · mL- (940.00 ± 180.70), (999.00 ± 346.40) μg · h · mL-1. The bioavailability of the test formulation was 104.2% compared to the reference formulation. Conclusion: Two kinds of memantine hydrochloride tablets are bioequivalent.