目的 研究非諾貝特雙層滲透泵片在犬體內(nèi)的藥動學(xué)特征，并評價受試制劑和參比制劑的生物等效性。方法 采用LC-MS測定比格犬體內(nèi)的血藥濃度，采用DAS 2.1.1軟件計算藥動學(xué)參數(shù)。結(jié)果 受試制劑和參比制劑血漿中非諾貝特酸的C_max分別為（1 100.0±771.2）、（924.3±564.0）ng/mL，t_max分別為（6.7±8.5)、（2.5±0.5）h，AUC0-t分別為（17 841.1±12 220.7）、（17 615.5±12 870.2）ng·h/mL；t_1/2分別為（17.7±8.2）、（16.4±3.3）h，MRT_0-t分別為（24.7±4.0）、（24.5±5.2）h，受試制劑中非諾貝特酸的平均相對生物利用度為（104.7±12.4）%。結(jié)論 受試制劑非諾貝特滲透泵片和參比制劑非諾貝特緩釋膠囊具有生物等效性。

Objective To study the pharmacokinetics of Fenofibrate Double-layer Osmotic Pump Tablets and evaluate the bioequivalence between tested preparation and reference preparation in Beagle's dogs. Methods The concentration of fenofibric acid in plasma was determined by LC-MS. Also, the pharmacokinetic parameters of Fenofibrate Double-layer Osmotic Pump Tablets in vivo were calculated by pharmacokinetic software DAS 2.1.1. Results The main pharmacokinetic parameters of the tested preparation and reference preparation were as follows. The C_max were (1 100.0 ± 771.2) and (924.3 ± 564.0) ng/L, t_max were (6.7 ± 8.5) and (2.5 ± 0.5) h, AUC_0-t were (17 841.1 ± 12 220.7) and (17 615.5 ± 12 870.2) ng·h/mL, t_1/2 were (17.7 ± 8.2) and (16.4 ± 3.3) h, MRT_0-t were (24.7 ± 4.0) and (24.5 ± 5.2) h, the relative bioavailability of fenofibric acid in the tested preparation was (104.7 ± 12.4)%. Conclusion The test preparation and reference preparations are bioequivalent.

國家重點基礎(chǔ)研究發(fā)展計劃（973計劃）項目（2012CB724001）