1/2分別為(7.16±2.34)和(6.95±1.57) h、Cmax分別為(522.89±201.12)和(515.22±159.29)ng/mL、Tmax分別為(10.38±1.69)和(10.50±2.07)h、AUC0-t分別為(8 398.64±3332.86)和(8 050.71±2103.15)ng·h/mL、AUC0-∞分別為(8 701.60±3303.29)和(8 450.01±2273.45)ng·h/mL;以參比制劑為參考,受試制劑AUC0-∞相對(duì)生物利用度為(101.0±13.1)%。結(jié)論 鹽酸文拉法辛緩釋片受試制劑與參比制劑在Beagle犬體內(nèi)具有生物等效性。;Objective To investigate the pharmacokinetic profiles and bioequivalence of Venlafaxine hydrochloride sustained release tablets.Methods Eight healthy Beagle dogs were ig given Venlafaxine hydrochloride sustained-release tablets or reference tablets of 75 mg in two-cycle, double-crossover and single-dose respectively. A method for the determination of Venlafaxine hydrochloride in plasma by LC-MS/MS was established. The method was validated for precision, accuracy, recovery, matrix effect and stability. The blood concentration of Venlafaxine hydrochloride in plasma was determined before (0 h) and 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72 h after administration. The pharmacokinetic parameters were calculated by DAS 2.1.1 and its bioequivalence was evaluated. Results LC-MS/MS methodologies were verified to meet the detection requirements. The main pharmacokinetic parameters of Venlafaxine test and reference preparations were as follows:T1/2, (7.16±2.34) and (6.95±1.57) h; Cmax, (522.89±201.12) and (515.22±159.29) ng/mL; Tmax, (10.38±1.69) and (10.50±2.07) h; AUC0-t, (8 398.64±3 332.86) and (8 050.71±2 103.15) ng·h/mL;AUC0-∞,(8 701.60±3 303.29) and (8 450.01±2 273.45) ng·h/mL, respectively. The relative bioavailability of Venlafaxinewas (101.0±13.1)%。Conclusion Venlafaxine hydrochloride sustained-release tablets have bioequivalence with reference tablets in Beagle dogs."/>

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首頁(yè) > 過(guò)刊瀏覽>2019年第42卷第7期 >2019,42(7):1314-1317. DOI:10.7501/j.issn.1674-6376.2019.07.010
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鹽酸文拉法辛緩釋片Beagle犬體內(nèi)藥動(dòng)學(xué)及生物等效性研究

Pharmacokinetics and bioequivalence of Venlafaxine hydrochloride sustained release tablets in Beagle dogs

發(fā)布日期:2019-07-08
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