【摘要】：目的研究屈螺酮炔雌醇片的生物利用度,評價(jià)其生物等效性。方法用兩藥物、兩周期、交叉試驗(yàn)設(shè)計(jì)。34名健康女性受試者隨機(jī)分為2組,單劑量口服試驗(yàn)藥物或參比藥物2片。用HPLC-MS/MS法分別測定血漿中屈螺酮及炔雌醇的濃度,用Phoenix Win Nonlin 6.1軟件計(jì)算屈螺酮及炔雌醇的藥代動力學(xué)參數(shù),并進(jìn)行生物等效性評價(jià)。結(jié)果試驗(yàn)藥物和參比藥物中屈螺酮的主要藥代動力學(xué)參數(shù):Cmax分別為(69.6±16.6),(71.6±15.9)μg·L-1,tmax分別為(1.6±0.7),(1.5±0.7)h,AUClast分別為(845.2±229.1),(831.3±217.8)μg·L-1·h,AUCinf分別為(968.6±233.3),(965.5±243.1)μg·L-1·h,t1/2分別為(30.8±5.9),(31.8±7.2)h,試驗(yàn)藥物對參比藥物的相對生物利用度Flast為(102.4±14.0)%,Finf為(101.6±13.2)%。試驗(yàn)藥物和參比藥物中炔雌醇的主要藥代動力學(xué)參數(shù):Cmax分別為(139.6±49.7),(131.0±45.1)ng·L-1,tmax分別為(1.6±0.4),(1.7±0.5)h,AUClast分別為(1256.3±408.3),(1205.6±440.7)ng·L-1·h,AUCinf為(1420.9±429.8),(1403.3±495.3)ng·L-1·h,t1/2分別為(12.4±3.1),(13.5±5.6)h,試驗(yàn)藥物對參比藥物的相對生物利用度Flast為(110.3±34.0)%,Finf為(107.2±31.7)%。結(jié)論試驗(yàn)藥物和參比藥物在中國健康女性體內(nèi)具有生物等效性。
[Abstract]:Objective to study the bioavailability and bioequivalence of droparonne estradiol tablets. Methods Thirty-four healthy female subjects were randomly divided into two groups with two drugs, two cycles and two cycles. The plasma concentrations of dipirone and ethylestradiol in plasma were determined by HPLC-MS/MS method. The pharmacokinetic parameters of drapone and ethylestradiol were calculated by Phoenix Win Nonlin 6.1 software, and the bioequivalence was evaluated. 緇撴灉璇曢獙鑽墿鍜屽弬姣旇嵂鐗╀腑灞堣灪閰殑涓昏鑽唬鍔ㄥ姏瀛﹀弬鏁，

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