HPLC-MS测定褪黑素缓释片的家犬体内药动学和相对生物利用度

 目的 比较褪黑素缓释片与已上市的褪黑素片在家犬体内的药动学及相对生物利用度。方法 6只家犬随机交叉口服 褪黑素缓释片(制剂A)和市售褪黑素片(制剂B)6mg,采用液相色谱-质谱联用技术测定血浆样品中的药物浓度。结果 制剂 A和制剂B的t_max分别为(2．08±0．20)和(1．13±0．59)h,ρ_max分别为(4．66±6．87)和(6．54±6．16)μg·L^-1,AUC分别为(13．21± 17．21)和(11．48±5．37)μg·h·L^-1。结论 以制剂B为参比,制剂A的相对生物利用度为(87．79±72．68)％。

Pharmacokinetics and bioavailability of sustained release melatonin tablets in healthy dogs by HPLC-MS

OBJECTIVE To compare data of pharmacokinetics and bioavailability between sustained release melatonin tablets and commercial tablets.METHODS A single oral dose of 6 mg test or reference preparations was given to 6 healthy dogs in a randomized crossover study. The serum concentrations of melatonin were determined by HPLC-MS method. RESULTS The pharmacokinetic parameters of two kinds of tablets were as Mows:t_max(2.08±0.20),(1.13±0.59) h;ρ_max(4.66±6.87),(6.54±6.16)μg·L^-1;AUC(13.21±17.21),(11.48± 5.37)μg·h·L^-1.CONCLUSION The relative bioavailability of sustained release tablets is(87.79±72.68)% compared with the commercial tablets.The two formulations are bioequivalent.