论文部分内容阅读
目的评价国产西尼地平胶囊与国产上市西尼地平片剂在中国健康人体内的生物等效性。方法入选20名男性健康志愿者,随机交叉单剂量口服西尼地平胶囊或西尼地平片剂10mg,液质联用测定血浆中西尼地平浓度。结果西尼地平胶囊及片剂的药动学参数分别如下:ρmax分别为(11.08±4.42)和(2.94±3.44)μg.L-1;tmax分别为(1.30±0.56)和(2.21±1.25)h;t1/2分别为(3.99±1.90)和(4.55±1.75)h,AUC0-t分别为(35.28±14.63)和(13.22±12.44)μg.h.L-1,AUC0-∞分别为(38.05±16.49)和(15.43±13.59)μg.h.L-1。2种制剂的ρmax、tmax、AUC0-t、AUC0-∞均存在显著差异(P<0.01)。结论国产西尼地平胶囊与国产上市西尼地平片剂生物不等效。
Objective To evaluate the bioequivalence of domestic cilnidipine capsules and domestic cilnidipine tablets in Chinese healthy volunteers. Methods Twenty healthy volunteers were enrolled in this study. 10 mg of cilnidipine capsules or cilnidipine tablets were randomly given at a single crossover dose. The concentrations of cilnidipine in plasma were determined by LC / MS. Results The pharmacokinetic parameters of cilnidipine capsules and tablets were as follows: ρmax were (11.08 ± 4.42) and (2.94 ± 3.44) μg.L-1, respectively; tmax was 1.30 ± 0.56 and 2.21 ± 1.25, h and t1 / 2 were (3.99 ± 1.90) and (4.55 ± 1.75) h, AUC0-t were (35.28 ± 14.63) and (13.22 ± 12.44) μg.hL- 16.49) and (15.43 ± 13.59) μg.hL-1.2, respectively. There was a significant difference (P <0.01) in pmax, tmax, AUC0-t and AUC0-∞. Conclusion domestic cilnidipine capsules and domestic listing cilnidipine tablet organism is not equivalent.