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目的:考察2种硝苯地平缓释胶囊的生物等效性,同时检测其药动学参数。方法:采用单剂量交叉试验,口服2种缓释胶囊,测定血药浓度。结果:单剂量时受试制剂和参比制剂的体内药动学参数如下:ρmax分别为1246.2±30.6(μg/L)和1468.2±32.8(μg/L);tmax分别为4.5±0.7(H)和2.6±0.8(H);t1/2分别为7.6±2.8(H)和4.6±2.9(H);AUC0～36分别为5886.6±124.8(μg/L)和3724.6±101.9(μg/L)。受试制剂的相对生物利用度为101±21%()。结论:两种制剂在健康人体中的处置过程基本一致,具有生物等效性。
OBJECTIVE: To investigate the bioequivalence of two nifedipine sustained-release capsules and determine the pharmacokinetic parameters. Methods: A single-dose crossover test was used to orally inoculate 2 kinds of sustained-release capsules to determine the plasma concentration. RESULTS: In vivo pharmacokinetic parameters of the test and reference preparations were as follows: ρmax 1246.2 ± 30.6 (μg / L) and 1468.2 ± 32.8 (μg / L) respectively; tmax was 4.5 ± 0.7 (H) And 2.6 ± 0.8 (H); t1 / 2 was 7.6 ± 2.8 (H) and 4.6 ± 2.9 (H), respectively; AUC0-36 were 5886.6 ± 124.8 (μg / L) and 3724.6 ± 101.9 (μg / L), respectively. The relative bioavailability of the test preparation was 101 ± 21% (). Conclusion: The two preparations are basically the same in the treatment of healthy people, with bioequivalence.