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目的探讨多潘立酮片生物等效性及相对生物利用度。方法选取30例男性健康志愿受试者,单剂量口服多潘立酮受试制剂及耳参比制剂,以高效液相色谱—质谱连用法(LC-MS/MS)测定血浆多潘立酮浓度,计算主要药动学参数。结果受试制剂血浆多潘立酮半衰期为(10.2±1.9)h,达峰浓度(Cmax)为(26.0±11.0)μg/L,达峰时间(Tmax)为(0.7±0.5)h,药—时曲线下面积(AUC)0~36h为(75.0±24.0)μg·h~(-1)·L~(-1);参比制剂血浆多潘立酮半衰期为(10.2±2.2)h,达峰浓度为(25.0±12.0)μg/L,达峰时间为(0.6±0.3)h,药—时曲线下面积AUC 0~36h为(70.0±27.0)μg·h~(-1)·L~(-1)。结论受试试剂与参比试剂均存在生物学等效性。
Objective To investigate the bioequivalence and relative bioavailability of domperidone tablets. Methods Thirty male healthy volunteers, single oral dose of domperidone and ototoxic reference formulation were selected for determination of plasma domperidone concentration by high performance liquid chromatography-mass spectrometry (LC-MS / MS), and the main pharmacokinetics parameter. Results The plasma half-life of plasma domperidone was (10.2 ± 1.9) h, the peak concentration (Cmax) was (26.0 ± 11.0) μg / L and the peak time (Tmax) was (0.7 ± 0.5) The half-life of domperidone in reference plasma was (10.2 ± 2.2) h and the peak concentration was (25.0 ± 0.0) μg · h -1 12.0) μg / L, peak time was (0.6 ± 0.3) h, and the area under the drug-time curve was (70.0 ± 27.0) μg · h -1 · L -1. Conclusions There is biological equivalence between test and reference reagents.