硫酸氢氯吡格雷片的人体生物等效性

硫酸氢氯吡格雷片的人体生物等效性

舒成仁;卫乐乐;黄露;黎维勇

【期刊名称】《中国医院药学杂志》

【年(卷),期】2012(032)006

【摘要】OBJECTIVE To study the bioequivalence of clopidogrel hydrogen sulfate tablets. METHODS 30 healthy male volunteers were administered 150 mg clopidogrel hydrogen shlfate tablets orally in a randomized crossover design. The drug concentrations in the plasma samples were determined by an HPLC-MS/MS method. With use of DAS software the pharmaco-kinetic parameters were calculated and the bioequivalence of the two preparations was evaluated. RESULTS The main pharma-cokinetic parameters of the test and reference preparations were as follows;/?, were(0. 98 ± 0. 34) h and(0. 86 ± 0. 36) h;Cmax were(8 994. 7 + 3 515. 6) ng·mL-1 and(9 677. 0±3 838. 1) ng·mL-1 ;t1/t2 were(7. ()± 2. 4) h an d(7. 0+1. 8) h; AUG41-24 were (31 670. 1 ± 13 545. 7) ng·h·mL-1 and(32 887. 4 ± 14 907. 5) ng·h·mL-1; AUG were(34 096. 8 + 14 482. 3) ng·h·mL-1 and(35 550. 4+16 455.5) ng·h·mL-1. The relative bioavailability of the test tablet was(97. 7 + 16.

6)%. CONCLUSION The two preparations are bioequivalent.%目的:研究硫酸氢氯吡格雷片受试制剂与参比制剂的人体生物等效性.方法:30名健康男性志愿者随机交叉单剂量口服硫酸氢氯吡格雷试验片或对照片1 50 mg,采用高效液相色谱-串联质谱(HPLC-MS/MS)法测定血浆中氯吡格雷羧酸代谢产物浓度.用