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目的:研究盐酸依匹斯汀片的药动学与生物利用度,并进行生物等效性评价。方法:20名健康男性志愿者单剂量口服盐酸依匹斯汀试验或参比制剂各40mg;采用反相高效液相色谱法测定其血药浓度。结果:人体药动学研究表明,口服盐酸依匹斯汀片的药-时曲线符合二室开放模型。受试制剂与参比制剂的主要药动学参数:tmax分别为(2.2±0.5)和(2.0±0.4)h;Cmax分别为(66±16)和(68±13)μg/L;t1/2分别为(10.1±1.3)和(10.4±2.4)h;AUC0-36分别为(592±88)和(601±94)μg.h.L-1;相对生物利用度为(99±13)%。结论:盐酸依匹斯汀片两种制剂具有生物等效性。
Objective: To study the pharmacokinetics and bioavailability of epinastine hydrochloride tablets and evaluate its bioequivalence. Methods: Twenty healthy male volunteers were given a single oral dose of 40 mg of epinastine hydrochloride test or reference formulation respectively. The plasma concentration was determined by RP-HPLC. Results: Human pharmacokinetic studies showed that the drug-time curve of oral epinastine hydrochloride tablets in line with the two-compartment open model. The main pharmacokinetic parameters of test preparation and reference preparation were: tmax (2.2 ± 0.5) and (2.0 ± 0.4) h respectively; Cmax were (66 ± 16) and (68 ± 13) μg / 2 were (10.1 ± 1.3) and (10.4 ± 2.4) h respectively; AUC0-36 was (592 ± 88) and (601 ± 94) μg.hL-1, respectively; relative bioavailability was (99 ± 13)%. Conclusion: Both formulations of epinastine hydrochloride tablets are bioequivalent.