国产尼扎替丁胶囊剂人体药动学及生物等效性

 目的 研究两种尼扎替丁胶囊的人体相对生物利用度。方法 采用高效液相色谱紫外检测法测定20名健康受试者单剂量 po 300 mg尼扎替丁国产或进口胶囊剂后的药动学数据。结果 po 国产与进口制剂后AUC_0～12均值分别为(6.66±1.54)和(6.79±1.56)μg·h·mL^-1,实测c_max均值分别为(2.10±0.64)和(2.06±0.74)μg·mL^-1,实测t_max均值分别为(1.32±0.59)和(1.67±1.04)h,国产尼扎替丁胶囊的相对生物利用度为(98.40±10.50)％。结论 经统计学分析,两种制剂具有生物等效性。

Studies on the pharmacokinetics and bioequivalence of domestic nizatidine cap-sules in healthy volunteers

OBJECTIVE To study the relative bioavailability of two nizatidine capsules in human. METHODS A single oral dose of 300 mg domestic or imported capsules were administered to 20 healthy volunteers in a randomized crossover study. RESULTS The pnarmacokinet-ic parameters included:AUC_0～12(6.66 ±1.54)and(6.79±1.56μg·h·mL^-1,c_max(2.10±0.64)and (2.06±0.74)μg·mL_-1, t_max(1.32 ±0.59) and(1.67±1.04) h, respectively. The relative bioavailability of domestic capsules to imported capsules was(98.40±10.50)% .CONCLUSION The two kinds of capsules were bioequivalent.