论文部分内容阅读
目的:研究国产醋酸甲地孕酮胶囊和进口醋酸甲地孕酮片(美可治片)的药代动力学并比较两者的生物利用度。方法:8名健康受试者自身交叉口服醋酸甲地孕酮胶囊和美可治片(160 mg),采用高效液相色谱法测定血清中醋酸甲地孕酮的浓度。结果:醋酸甲地孕酮胶囊和美可治片(160 mg)的Cmax分别为96.85±34.27μg·L~(-1)和102.78±65.71μg·L~(-1);T_(max)分别为:3.1±0.90 h和3.3±1.2 h;AUC_(0-∞)分别为:1328.36±268.70μg·L~(-1)·h和1475.37±416.70μg·L~(-1)·h。结论:两药各药代动力学参数间均无显著性差异,国产醋酸甲地孕酮胶囊相对生物利用度为90.43±13.12%。
Objective: To study the pharmacokinetics of domestic megestrol acetate capsules and imported megestrol acetate tablets (MEBO tablets) and to compare their bioavailability. Methods: Eight healthy volunteers were given oral administration of megestrol acetate capsules and Meicocrist tablets (160 mg). The concentrations of megestrol acetate in serum were determined by high performance liquid chromatography (HPLC). Results: The C max values of megestrol acetate capsules and megestrol tablets (160 mg) were 96.85 ± 34.27 μg · L -1 and 102.78 ± 65.71 μg · L -1, respectively. The T max values were : 3.1 ± 0.90 h and 3.3 ± 1.2 h; AUC_ (0-∞) were 1328.36 ± 268.70 μg · L -1 · h and 1475.37 ± 416.70 μg · L -1 · h, respectively. Conclusion: There is no significant difference between the pharmacokinetic parameters of the two drugs. The relative bioavailability of domestic megestrol acetate capsules is 90.43 ± 13.12%.