屈螺酮炔雌醇片在中国健康女性的生物等效性研究
发布时间：2018-07-27 20:56
【摘要】：目的研究屈螺酮炔雌醇片的生物利用度,评价其生物等效性。方法用两药物、两周期、交叉试验设计。34名健康女性受试者随机分为2组,单剂量口服试验药物或参比药物2片。用HPLC-MS/MS法分别测定血浆中屈螺酮及炔雌醇的浓度,用Phoenix Win Nonlin 6.1软件计算屈螺酮及炔雌醇的药代动力学参数,并进行生物等效性评价。结果试验药物和参比药物中屈螺酮的主要药代动力学参数:Cmax分别为(69.6±16.6),(71.6±15.9)μg·L-1,tmax分别为(1.6±0.7),(1.5±0.7)h,AUClast分别为(845.2±229.1),(831.3±217.8)μg·L-1·h,AUCinf分别为(968.6±233.3),(965.5±243.1)μg·L-1·h,t1/2分别为(30.8±5.9),(31.8±7.2)h,试验药物对参比药物的相对生物利用度Flast为(102.4±14.0)%,Finf为(101.6±13.2)%。试验药物和参比药物中炔雌醇的主要药代动力学参数:Cmax分别为(139.6±49.7),(131.0±45.1)ng·L-1,tmax分别为(1.6±0.4),(1.7±0.5)h,AUClast分别为(1256.3±408.3),(1205.6±440.7)ng·L-1·h,AUCinf为(1420.9±429.8),(1403.3±495.3)ng·L-1·h,t1/2分别为(12.4±3.1),(13.5±5.6)h,试验药物对参比药物的相对生物利用度Flast为(110.3±34.0)%,Finf为(107.2±31.7)%。结论试验药物和参比药物在中国健康女性体内具有生物等效性。
[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. 缁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，
本文编号：2149113
[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. 缁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，
本文编号：2149113
本文链接：https://www.wllwen.com/yixuelunwen/yiyaoxuelunwen/2149113.html
最近更新
教材专著
