本文選題：托拉塞米　切入點(diǎn)：生物等效性　出處：《中國(guó)藥學(xué)雜志》2017年16期

【摘要】：目的用高效液相色譜-質(zhì)譜法測(cè)定健康男性受試者單次空腹口服受試及參比托拉塞米片后的血藥濃度,計(jì)算受試制劑和參比制劑的藥動(dòng)學(xué)參數(shù),評(píng)價(jià)兩種制劑是否生物等效。方法采取兩制劑、雙周期、交叉的設(shè)計(jì)試驗(yàn),24例男性健康受試者單劑量口服受試制劑和參比制劑的托拉塞米片,以HPLC-MS測(cè)定血漿中的托拉塞米濃度。采用SPSS及BAPP2.2軟件處理計(jì)算主要藥動(dòng)學(xué)參數(shù)。結(jié)果受試制劑與參比制劑中托拉塞米的ρ_(max)分別為(1 408.29±337.27)和(1 487.86±360.24)ng·mL~(-1),t_(max)分別為(0.90±0.42)和(1.03±0.50)h,t_(1/2)分別為(4.43±0.57)和(4.43±0.60)h,MRT分別為(3.90±0.60)和(4.01±0.72)h,AUC_(0-24 h)分別為(3 886.86±865.99)和(3 906.06±761.72)ng·h·mL~(-1),AUC_(0-∞)分別為(3 936.57±903.93)和(3 956.96±789.98)ng·h·mL~(-1)。按AUC_(0-24 h)和AUC_(0-∞)計(jì)算,受試制劑的相對(duì)生物利用度分別為(99.8±11.7)%和(99.7±12.0)%。結(jié)論兩種制劑在健康人體內(nèi)具有生物等效性。
[Abstract]:Objective to determine the plasma concentrations of healthy male volunteers after single fasting oral administration and reference Tora Semie tablets, and to calculate the pharmacokinetic parameters of the tested and reference preparations by high performance liquid chromatography-mass spectrometry (HPLC / MS). Methods to evaluate the bioequivalence of the two preparations. Methods two preparation, two cycle, cross design trial and 24 male healthy volunteers were given single dose of Tora Semide tablets. The main pharmacokinetic parameters were calculated by SPSS and BAPP2.2 software. Results the 蟻 max of Tora Semi in the tested preparation and reference preparation were 1 408.29 鹵337.27) and 1 487.86 鹵360.24)ng mLL- 1 + 0. 42), respectively, and 1.03 鹵0. 50 ht / 2) were 4.43 鹵0. 57). The MRT was 3.90 鹵0.60) and 4.01 鹵0.72 hmol / h respectively (3 886.86 鹵865.99) and 3 906.06 鹵906.06 鹵761.72)ng / h / mL-1 respectively (3 936.57 鹵903.93) and 3 956.96 鹵789.98)ng / mLL / 1 / 鈭，

本文編號(hào)：1671787