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目的:评价两种复方厄贝沙坦片中氢氯噻嗪的生物等效性。方法:20名健康男性志愿者分别单剂量po受试制剂和参比制剂,采用高效液相色谱-质谱联用法测定血浆中氢氯噻嗪的浓度并拟合药动学参数。结果:受试制剂和参比制剂在受试者体内的药动学参数如下:血浆中氢氯噻嗪的C_(max)(72.6±33.8)和(74.7±31.9)ng·ml~(-1),t_(max)(2.0±0.5)和(1.8±0.4)h,t_(1/2)(2.9±1.2)和(2.5±1.0)h,AUC_(0-48h)(372.3±168.7)和(377.5±210.4)ng·h·ml~(-1),AUC_(0-∞)(398.3±191.2)和(396.5±223.5)ng·h·ml~(-1)。与参比制剂相比,受试制剂中氢氯噻嗪的平均相对生物利用度为(106.7±26.1)%。结论:两种制剂中氢氯噻嗪具生物等效性。
Objective: To evaluate the bioequivalence of hydrochlorothiazide in two compound irbesartan tablets. Methods: Twenty healthy male volunteers were given a single dose of po test preparation and reference preparation. The plasma hydrochlorothiazide concentration was determined by HPLC-MS method and the pharmacokinetic parameters were fitted. Results: The pharmacokinetic parameters of test and reference preparations in subjects were as follows: C max (72.6 ± 33.8) and (74.7 ± 31.9) ng · ml -1, (2.9 ± 1.2) and (2.5 ± 1.0) h, AUC_ (0-48h) (372.3 ± 168.7) and (377.5 ± 210.4 ng · h · ml -1, AUC 0 -∞ (398.3 ± 191.2) and (396.5 ± 223.5) ng · h · ml -1, respectively. The mean relative bioavailability of hydrochlorothiazide in the test formulation was (106.7 ± 26.1)% compared to the reference formulation. Conclusions: Hydrochlorothiazide is bioequivalent in both formulations.