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左炔诺孕酮片的人体生物等效性 被引量:3

Bioequivalence of Levonorgestrel Tablets in Human
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摘要 20名女性健康志愿者随机分成两组,采用自身对照交叉给药的方式,单剂量口服两种左炔诺孕酮片,采用放射免疫分析法测定血药浓度。20名志愿者口服左炔诺孕酮受试和参比制剂后的药动学参数分别为:tmax(1.9±0.2)和(2.0±0.1)h,cmax(6.34±1.16)和(6.86±1.07)ng/ml,MRT(30.48±4.85)和(29.26±4.71)h,t1/2(24.60±4.28)和(24.12±4.61)h,AUC0→72 h(92.43±24.24)和(101.09±31.21)h.ng.ml-1,AUC0→∞(104.41±29.25)和(113.06±36.07)h.ng.ml-1。受试制剂的相对生物利用度为(93.5±16.2)%。 Twenty healthy female volunteers were given a single oral dose of levonorgestrel tablets in a randomized crossover study. Serum levels of the drug were determined by radioimmunoassay method. The pharmacokinetics of test and reference preparation were as follows: tmax (1.9±0.2) and (2.0±0.1) h, em,x (6.34±1.16) and (6.86±1.07) ng/ml, MRT (30.48±4.85) and (29.26±4.71) h, tta (24.60±4.28) and (24.12±4.61) h, AUCo-72h (92.43±24.24) and (101.09±31.21) h.ng.ml-l, AUCo (104.41±29.25) and (113.06±36.07) h.ng.ml^-1, respectively. The relative bioavailabilitv of the test r}reDaration was (93.5+16.2) %.
出处 《中国医药工业杂志》 CAS CSCD 北大核心 2012年第3期197-200,共4页 Chinese Journal of Pharmaceuticals
关键词 左炔诺孕酮 放射免疫分析法 药物动力学 生物等效性 levonorgestrel radioimmunoassay pharmacokinetics bioequivalence
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