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目的:比较两种氨基葡萄糖制剂的人体生物等效性。方法:20名健康男性志愿者随机交叉单剂量口服氨基葡萄糖颗粒(受试制剂)与氨基葡萄糖胶囊(参比制剂)0.75 g,采用邻苯二甲醛/3-巯基丙酸衍生化后的LC-MS/MS法测定人血浆中氨基葡萄糖浓度,用DAS 2.1.1软件计算药动学参数和生物利用度。结果:口服氨基葡萄糖受试制剂与参比制剂后的人体药动学参数分别为:C_(max)(1 015±306)和(1 026±470)ng·ml～,t_(max)(2.40±1.20)和(2.80±1.37)h,t_(1/2β)(1.24±0.53)和(1.20±0.32)h,AUC_(0～t)(4 504±1 303)和(4 315±1 410)ng·h·ml～,AUC_(0～∞)(4 579±1 275)和(4 341±1 407)ng·h·ml~(-1)。受试制剂的相对生物利用度为(114.1±44.8)%。受试制剂AUC_(0～1)的90%置信区间在参比制剂的等效范围内。结论:两种氨基葡萄糖制剂生物利用度等效。
OBJECTIVE: To compare the bioequivalence of two glucosamine preparations in humans. Methods: A total of 20 healthy male volunteers were randomized to receive 0.75 g of glucosamine monohydrate (glucosamine monohydrate) and glucosamine capsules (reference formulation) randomly. LC- The concentration of glucosamine in human plasma was determined by MS / MS method. The pharmacokinetic parameters and bioavailability were calculated by DAS 2.1.1 software. Results: The pharmacokinetic parameters of human oral glucose and glucose were respectively: Cmax (1 015 ± 306) and (1026 ± 470) ng · ml ~, t max (2.40 (1.24 ± 0.53) and (1.20 ± 0.32) h, respectively. The AUC_ (0 ~ t) (4 504 ± 1 303) and (4 315 ± 1 410 ) ng · h · ml ~, AUC_ (0 ~ ∞) (4 579 ± 1 275) and (4 341 ± 1 407) ng · h · ml ~ (-1) respectively. The relative bioavailability of the test preparation was (114.1 ± 44.8)%. The 90% confidence interval for the AUC_ (0-1) test formulation was within the equivalent range of the reference formulation. Conclusion: The bioavailability of two glucosamine preparations is equivalent.