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目的:进行A、B、C、D 4厂家米非司酮片健康女性受试者体内的药动学比较研究。方法:40名健康女性受试者随机分为4组,每组10人,分别服用4个不同厂家生产的米非司酮片75mg,于不同时间抽取肘静脉血,经液液萃取,采用高效液相色谱法测定米非司酮经时血浓度,DAS 2.0计算米非司酮药动学参数。结果:A、B、C、D 4厂家米非司酮片的Cmax分别为(1.57±0.36)μg.mL-1、(1.7±0.7)μg.mL-1、(1.4±0.4)μg.mL-1和(1.6±0.5)μg.mL-1;tmax分别为(0.70±0.26)h、(1.0±0.6)h、(1.0±0.6)h和(0.80±0.35)h;t1/2分别为(26.1±7.6)h、(26.7±5.2)h、(27.1±6.4)h和(28.9±7.4)h;AUC0-96分别为(20.3±5.1)μg.mL-1.h、(20.5±6.4)μg.mL-1.h、(18.1±8.7)μg.mL-1.h和(20.7±7.4)μg.mL-1.h。以A厂家米非司酮片为参比,B、C、D厂家米非司酮片相对生物利用度分别为101.1%、89.4%和101.8%。结论:所选择A、B、C、D 4厂家米非司酮片人体药动学过程差异无显著性。
OBJECTIVE: To compare the pharmacokinetics of mifepristone tablets in healthy female subjects A, B, C, D 4. Methods: Forty healthy female subjects were randomly divided into 4 groups with 10 in each. They took 75 mg of mifepristone tablets produced by 4 different manufacturers, elbow venous blood was drawn at different times, extracted by liquid-liquid extraction, Chronic plasma concentrations of mifepristone were determined by liquid chromatography and kinetic parameters of mifepristone were calculated using DAS 2.0. Results: The Cmax of mifepristone tablets of A, B, C and D 4 were (1.57 ± 0.36) μg.mL-1, (1.7 ± 0.7) μg.mL-1 and (1.4 ± 0.4) μg.mL (1.0 ± 0.6) h, (1.0 ± 0.6) h and (0.80 ± 0.35) h, respectively; t1 / 2 was (-1.6 ± 0.5) μg.mL-1 and (26.1 ± 7.6) h, (26.7 ± 5.2) h, (27.1 ± 6.4) h and (28.9 ± 7.4) h, respectively; AUC0-96 were (20.3 ± 5.1) μg.mL- ) μg.mL-1.h, (18.1 ± 8.7) μg.mL-1.h and (20.7 ± 7.4) μg.mL-1.h. The relative bioavailability of mifepristone tablets from manufacturers B, C and D was 101.1%, 89.4% and 101.8%, respectively. Conclusion: The pharmacokinetics of mifepristone tablets of A, B, C, D 4 manufacturers were not significantly different.