盐酸氨基葡萄糖片的相对生物利用度及其生物等效性评价

目的研究盐酸氨基葡萄糖片在健康人体内的药物动力学及相对生物利用度。方法采用液相色谱质谱质谱联用法测定了18名健康男性受试者口服盐酸氨基葡萄糖片和盐酸氨基葡萄糖胶囊后不同时间血浆中氨基葡萄糖的质量浓度,并求出主要药物动力学参数。结果血浆中氨基葡萄糖的tmax分别为(3.1±0.7)和(2.9±0.8)h,ρmax分别为(636.5±310.1)和(666.0±371.3)μg.L-1,t1/2分别为(0.9±0.2)和(1.1±0.4)h,AUC0-12分别为(1 896±809.7)和(1 967±858.2)μg.h.L-1。氨基葡萄糖的相对生物利用度为(96.8±9.7)%。结论根据双单侧检验表明两种制剂具有生物等效性。

Assessment of relative bioavailability and bioequivalence of the glucosamine hydrochloride tablets

Objective To study the pharmacokinetics and relative bioavailability of glucosamine hydrochloride tablets.Method A LC-MS-MS method was developed to determine the plasma concentrations of glucosamine in 18 heathy Chinese male volunteers following a(480 mg) single dose of glucosamine hydrochloride tablets(test formulation) and glucosamine hydrochloride capsules(reference formulation) and the main pharmacokinetics parameters were calculated.Result The main pharmacokinetic parameters of glucosamine in plasma sample were:t_(max)=(3.1±0.7)and(2.9±0.8)h,ρ_(max)=(636.5±310.1)and(666.0±371.3)μg·L~(-1),t_(1/2)=(0.9±0.2) and(1.1±0.4)h,AUC_(0-12)=((1 896)±809.7)and((1 967)±858.2)μg·h·L~(-1).The value of relative bioavailability is(96.8±9.7)%.Conclusion According to the two one sided t-tests,the two formulations are bioequivalent.