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目的测定人血浆中泮托拉唑的浓度,并评价国产和进口泮托拉唑钠肠溶片的生物等效性。方法采用LC-MS/MS测定人血浆中泮托拉唑的浓度,以DAS2.0计算药动学参数考察其生物等效性。结果受试制剂和参比制剂的泮托拉唑t1/2分别为(1.96±0.66)和(1.98±0.59)h,tmax分别为(3.17±0.84)和(3.09±0.81)h,ρmax分别为(3.53±0.78)和(3.41±0.79)μg.mL-1,AUC0-∞分别为(10.12±4.09)和(10.86±3.99)μg.h.mL-1。生物利用度为(97.9±22.3)%。结论该方法重复性好,灵敏度高,泮托拉唑钠肠溶片受试制剂和参比制剂具有生物等效性。
Objective To determine the concentration of pantoprazole in human plasma and evaluate the bioequivalence of domestic and imported pantoprazole sodium enteric-coated tablets. Methods The concentration of pantoprazole in human plasma was determined by LC-MS / MS. The bioequivalence of pantoprazole was calculated by DAS2.0. Results The t1 / 2 of pantoprazole was (1.96 ± 0.66) and (1.98 ± 0.59) h, and the tmax was (3.17 ± 0.84) and (3.09 ± 0.81) h, (3.53 ± 0.78) and (3.41 ± 0.79) μg.mL-1, and the AUC0-∞ were (10.12 ± 4.09) and (10.86 ± 3.99) μg.h.mL-1, respectively. Bioavailability was (97.9 ± 22.3)%. Conclusion The method is reproducible and sensitive. The pantoprazole sodium enteric-coated enteric-coated tablets are bioequivalent.