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目的 :比较奥昔布宁口服液与片剂的生物等效性。方法 :采用双交叉试验设计 ,用HPLC MS法测定血药浓度 ,得药时曲线 ,并计算得各药动学参数。结果 :奥昔布宁口服液与片剂的药动学参数分别为t1/ 2 (h) :3.5 4± 0 .96和 2 .97± 1.0 7;Cmax(ng·ml-1) :2 6 .85± 11.87和 18.33± 7.88;tmax(h) :0 .5± 0 .2和 0 .6± 0 .2 ;MRT (h) :3.71± 0 .91和 3.5 9± 1.2 6 ;AUC0 -12h(ng·h·ml-1) :4 8.2 5± 19.4 2和 4 5 .5 6± 16 .35 ;AUC0→∞(ng·h·ml-1) :5 1.5 1± 2 0 .6 1和 4 8.4 0± 18.6 1。奥昔布宁口服液对奥昔布宁片剂的相对生物利用度 (F % )为 :10 5 .6± 11.7。lnAUC经交叉试验下的方差分析和单双侧t检验证明无显著性差异 (P >0 .0 5 ) ,lnCmax经交叉试验下的方差分析和单双侧t检验证明有显著性差异 (P <0 .0 5 ) ,tmax经非参数检验无显著性差异 (P >0 .0 5 )。结论 :两种制剂的吸收过程具有生物等效性。
OBJECTIVE: To compare the bioequivalence of oxybutynin oral solution with tablets. Methods: The double-crossover design was used to determine the plasma concentration by HPLC-MS. The pharmacokinetic parameters were calculated. Results: The pharmacokinetic parameters of oxybutynin oral solution and tablet were t1 / 2 (h): 3.54 ± 0.96 and 2.97 ± 1.07 respectively; Cmax (ng · ml-1): 2 6 .85 ± 11.87 and 18.33 ± 7.88; tmax (h): 0.5 ± 0.2 and 0.6 ± 0.2; MRT (h): 3.71 ± 0.91 and 3.5 9 ± 1.2 6; AUC0-12h (ng · h · ml-1): 4 8.2 5 ± 19.4 2 and 45.5 ± 16.35; AUC0 → ∞ (ng · h · ml-1): 5 1.5 1 ± 2.06 and 4 8.4 0 ± 18.6 1. The relative bioavailability (F%) of oxybutynin oral solution to oxybutynin tablets was: 105.6 ± 11.7. lnAUC showed no significant difference (P> 0.05) by analysis of variance and single-sided t-test under cross test (P> 0.05), lnCmax was proved by ANOVA and single-sided t-test under cross test (P < 0 .0 5), tmax nonparametric test showed no significant difference (P> 0.05). Conclusion: The absorption of the two preparations is bioequivalent.