奥昔布宁口服液与片剂人体生物等效性研究  

Study on Bioequivalence Between Liquid Tablet vs Oral of Oxybutynin

作　　者：汤震[1] 吴帼华 胡健勇[1] 梁小宁 黄仲义[1] 

机构地区：[1]上海市静安区中心医院药科临床药学与临床药理部,上海200040 [2]深圳市罗湖区中心医院 [3]珠海联邦制剂厂

出　　处：《中国药师》2003年第8期457-459,共3页China Pharmacist

摘　　要：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 campare a bioequivalence between tablet and oral liquid of oxybutynin. Method: A double-cross experimental design was used, the plasma drug concentration versus time curve was obtained by HPLC-MS.Result: The parameters of oral liquid and tablet of oxybutinin, such as t 1/2, C max, t max, MRT, AUC 0～12 h and AUC 0→∞ were ( 3.54± 0.96) h and ( 2.97± 1.07)h, ( 26.85± 11.87)ng·ml -1 and ( 18.33± 7.88)mg·ml -1,( 0.5± 0.2)h and ( 0.6± 0.2)h,( 3.71± 0.91)h and ( 3.59± 1.26) h,( 48.25± 19.42)ng·h·ml -1 and ( 45.56± 16.35)ng·h·ml -1, ( 51.51± 20.61)ng·h·ml -1 and ( 48.40± 18.61)ng·h·ml -1, respectively. The relative bioequivalence(F%) of oral liquid vs tablet was 105± 11.7. There was no a significant difference(P> 0.05) evidenced by the analysis of variance with a cross experiment and by single two-sided verify for lnAUC, but there was a significant difference for lnC max. There was no a sinificant difference (P> 0.05) by non-parameter verify for t max.Conclusion: There was a bioequivalence in absorption process of two preparations.

关 键 词：奥昔布宁 生物等效性 口服液 片剂 

分 类 号：R969.1[医药卫生—药理学]