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目的:比较国产与进口替米沙坦片药动学及人体生物等效性。方法:20例健康男性志愿者随机交叉口服替米沙坦片受试制剂或参比制剂80mg,采用HPLC-荧光检测法测定血浆中替米沙坦浓度,经3P97软件统计,进行相对生物利用度与生物等效性分析。结果:受试者口服替米沙坦受试制剂和参比制剂后,血浆中替米沙坦T_(max),C_(max),AUC_(0～1),AUC_(0～∞)和t_(1/2)分别为(0.91±0.19)和(0.86±0.21)h;(672.7±275.1)和(710.2±312.9)μg·L~(-1);(4221.4±2909.0)和(4430.2±3487.9)μg·h·L~(-1);(4568.1±3032.5)和(4742.6±3657.3)μg·h·L~(-1);(30.7±7.0)和(28.0±5.9)h。以AUC_(0～1)计算,替米沙坦片相对生物利用度平均为(98.1±12.1)%。结论:经方差分析和双单侧t检验,两种制剂具有生物等效性。
Objective: To compare the pharmacokinetics and bioequivalence of domestic and imported telmisartan tablets. Methods: Twenty healthy male volunteers were randomized to receive oral telmisartan test or reference formulation 80 mg. Plasma concentrations of telmisartan were determined by HPLC-fluorescence assay. Relative bioavailability was determined by 3P97 software And bioequivalence analysis. RESULTS: After oral administration of telmisartan, the T max, C max, AUC 0 ~ 1, AUC 0 ~ ∞, and t_ (1/2) were (0.91 ± 0.19) and (0.86 ± 0.21) h respectively; (672.7 ± 275.1) and (710.2 ± 312.9) μg · L -1; 4221.4 ± 2909.0 and 4430.2 ± 3487.9 ) μg · h · L -1; (4568.1 ± 3032.5) and (4742.6 ± 3657.3) μg · h · L -1; (30.7 ± 7.0) and (28.0 ± 5.9) h respectively. The relative bioavailability of telmisartan was (98.1 ± 12.1)% on the basis of AUC_ (0 ~ 1). Conclusion: Both formulations were bioequivalent by analysis of variance and double unilateral t-test.