托拉塞米片人体生物等效性研究

发布时间：2018-03-27 13:51

  本文选题：托拉塞米　切入点：生物等效性　出处：《中国药学杂志》2017年16期

【摘要】：目的用高效液相色谱-质谱法测定健康男性受试者单次空腹口服受试及参比托拉塞米片后的血药浓度,计算受试制剂和参比制剂的药动学参数,评价两种制剂是否生物等效。方法采取两制剂、双周期、交叉的设计试验,24例男性健康受试者单剂量口服受试制剂和参比制剂的托拉塞米片,以HPLC-MS测定血浆中的托拉塞米浓度。采用SPSS及BAPP2.2软件处理计算主要药动学参数。结果受试制剂与参比制剂中托拉塞米的ρ_(max)分别为(1 408.29±337.27)和(1 487.86±360.24)ng·mL~(-1),t_(max)分别为(0.90±0.42)和(1.03±0.50)h,t_(1/2)分别为(4.43±0.57)和(4.43±0.60)h,MRT分别为(3.90±0.60)和(4.01±0.72)h,AUC_(0-24 h)分别为(3 886.86±865.99)和(3 906.06±761.72)ng·h·mL~(-1),AUC_(0-∞)分别为(3 936.57±903.93)和(3 956.96±789.98)ng·h·mL~(-1)。按AUC_(0-24 h)和AUC_(0-∞)计算,受试制剂的相对生物利用度分别为(99.8±11.7)%和(99.7±12.0)%。结论两种制剂在健康人体内具有生物等效性。
[Abstract]:Objective to determine the plasma concentrations of healthy male volunteers after single fasting oral administration and reference Tora Semie tablets, and to calculate the pharmacokinetic parameters of the tested and reference preparations by high performance liquid chromatography-mass spectrometry (HPLC / MS). Methods to evaluate the bioequivalence of the two preparations. Methods two preparation, two cycle, cross design trial and 24 male healthy volunteers were given single dose of Tora Semide tablets. The main pharmacokinetic parameters were calculated by SPSS and BAPP2.2 software. Results the 蟻 max of Tora Semi in the tested preparation and reference preparation were 1 408.29 卤337.27) and 1 487.86 卤360.24)ng mLL- 1 + 0. 42), respectively, and 1.03 卤0. 50 ht / 2) were 4.43 卤0. 57). The MRT was 3.90 卤0.60) and 4.01 卤0.72 hmol / h respectively (3 886.86 卤865.99) and 3 906.06 卤906.06 卤761.72)ng / h / mL-1 respectively (3 936.57 卤903.93) and 3 956.96 卤789.98)ng / mLL / 1 / 鈭，

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