【摘要】 目的评价枸橼酸喷托维林口腔崩解片在健康男性受试者体内的生物等效性。方法健康志愿者20名,随机双周期交叉试验设计,单剂量口服25mg枸橼酸喷托维林受试制剂和参比制剂。用HPLC-MS/ESI+法测定人血浆中枸橼酸喷托维林的浓度。用DAS程序计算药动学参数并评价两种制剂的生物等效性。结果受试制剂与参比制剂的Tmax分别为(1.62±0.75)h和(2.52±1.21)h;Cmax分别为62.28±33.06μg·L-1和59.72±33.25μg·L-1;AUC015分别为234.44±130.01μg·h·L-1和228.77±129.24μg·h·L-1;AUC0∞分别为246.80±136.19μg·h·L-1和244.11±140.73μg·h·L-1。Cmax、AUC015和AUC0∞的90%可信区间分别为81.4%～138.4%、86.0%～123.3%和86.5%～121.2%。结论受试制剂与参比制剂具有生物学等效性。更多还原

【Abstract】 Objective To evaluate the bioequivalence of orally disintegrating tablets of pentoxyverine citrate (tested preparation) in healthy male volunteers. Methods A single oral dose of the tested and reference preparations at 25 mg were given to 20 healthy volunteers in a randomized two-period cross-over design. Plasma pentoxyverine citrate concentrations were determined by HPLC-MS/ESI+ method. The pharmacokinetic parameters were calculated and the bioequivalence of the two preparations were evaluated using DAS program. Results The Tmax, Cmax, AUC0 15 and AUC0∞ of tested and reference preparations were 1.62±0.75 h and 2.52±1.21 h, 62.28±33.06 μg/L and 59.72±33.25 μg/L, 234.44±130.01 μg·h·L-1 and 228.77±129.24 μg·h·L-1, 246.80±136.19 μg·h·L-1 and 244.11±140.73 μg·h·L-1, respectively. The 90% confidence interval of Cmax, AUC0 15 and AUC0∞of tested preparations were 81.4%-138.4%, 86.0%-123.3% and 86.5%-121.2%, respectively. Conclusion The tested and reference preparations are bioequivalent.更多还原