【摘要】 目的测定格列吡嗪片在健康人体的药代动力学参数及相对生物利用度。方法18名健康男性志愿者单剂量随机交叉口服10 mg格列吡嗪片后,用高效液相色谱法测定血浆药物浓度。结果口服海南金晓制药有限公司或天津药业集团新郑股份有限公司生产的格列吡嗪片后的药代动力学参数分别为:T1/2(3.239±0.69)h和(3.461±0.59)h,Cmax(675.3±151.7)mg.L-1和(647.1±166.7)mg.L-1,Tmax(2.389±0.50)h和(2.333±0.49)h,AUC0-t(3565.4±733.4)μg.h.L-1和(3304.8±588.4)μg.h.L-1。两种格列吡嗪片主要药代动力学参数间无统计学意义(P>0.05),受试格列吡嗪片的相对生物利用度F为93.204%。结论两种制剂具有生物等效性,可确保临床用药的安全有效。更多还原

【Abstract】 Objective The pharmacokinetics and relative bioavailability of Glipizide tablets were determined after administration of a single oral dose of 10mg to each of 18 Chinese healthy male volunteers in an open,randomized crossover study. Methods The drug concentration in plasma was assayed by HPLC. Results The pharmacokinetic parameters of two brands Glipizi datablet were:T1/2(3.239±0.69)and(3.461±0.59)h,Cmax(675.3±151.7)and(647.1±166.7)mg·L-1,Tmax(2.389±0.50)and(2.333±0.49)h,AUC0-t(3565.4±733.4)and(3304.8±588.4)μg·h·L-1. Conclusion There is no significant difference between the two products.The relative biaovailability of two brands Glipizi is 93.204%.The result demonstrates that the two preparations are bioequivalent.更多还原