复方盐酸二甲双胍片人体生物等效性研究

Study on Bioequivalence of Compound Fluamine Tablets in Healthy Volunteers

目的 :评价复方盐酸二甲双胍片与盐酸二甲双胍片和格列苯脲片的生物等效性。方法 :采用高效液相色谱法分别测定盐酸二甲双胍和格列苯脲经 -时血药浓度 ,计算药动学参数 ,并进行方差分析和双单侧t检验。结果 :复方盐酸二甲双胍片和盐酸二甲双胍片T1/2 分别为 (7 969±0 713)、(8 103±0 596)h ,Tmax 分别为 (1 889±0 214)、(1 876±0 207)h,Cmax 分别为 (2 001±0 368)、(1 962±0 416) μg/ml,AUC0～24 分别为 (10 706±1 424)、(10 624±1 317) (μg·h)/ml,F为 (100 97±7 73) % ;复方盐酸二甲双胍片和格列苯脲片T1/2 分别为 (6 536±0 890)、(6 629±0 563)h,Tmax 分别为 (4 038±0 309)、(4 056±0 338)h ,Cmax 分别为 (98 026±22 790)、(97 507±20 529)ng/ml,AUC0～24 分别为 (510 702±135 818)、(499 452±111 328) (ng·h)/ml,F为 (102 066±12 405) %。结论 :复方盐酸二甲双胍片与盐酸二甲双胍片和格列苯脲片具有生物等效性。

OBJECTIVE:To evaluate the bioequivalence of compound fluamine tablets with commercial fluamine tablets and glibenclamide tablets(R).METHODS:HPLC method was used to determine the plasma drug time-concentrations of fluˉamine and glibenclamide separately.The pharmacokinetic parameters were calculated and analysed with variance and two-one side t-test.RESULTS:The T 1/2 ,T max ,C max and AUC 0～24 for fluamine of test and reference formulation were(7.969±0.713)h and(8.103±0.596)h;(1.889±0.214)h and(1.876±0.207)h;(2.001±0.368)μg/ml and(1.962±0.416)μg/ml;(10.706±1.424)(μg·h)/ml and(10.624±1.317)(μg·h)/ml respectively.F was(100.97±7.73)%.The T 1/2 ,T max ,and AUC 0～24 for glibenclamide of test and reference formulation were(6.536±0.890)h and(6.629±0.563)h;(4.038±0.309)h and(4.056±0.338)h;(98.026±22.790)ng/ml and(97.507±20.529)ng/ml;(510.702±135.818)(ng·h)/ml and(499.452±111.328)(ng·h)/ml,respectively,and F was(102.066±12.405)%.CONCLUSION:The statistical analysis showed that comˉpound fluamine tablets and commercial fluamine tablets and glibenclamide tablets were bioequivalent.