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目的:研究匹多莫德糖浆的人体相对生物利用度和生物等效性。方法:健康志愿者20名,随机双交叉单剂量口服匹多莫德糖浆(受试制剂)和溶液(参比制剂),剂量分别为20 ml(800 mg)和14 ml(800 mg),采用HPLC法测定血浆中匹多莫德的浓度,用DAS2.1药动学程序计算药动学参数和生物利用度,并进行生物等效性评价。结果:单剂量口服匹多莫德受试和参比制剂后,血浆匹多莫德的C_(max)分别为(4.45±1.80)μg·ml~(-1)和(5.17±1.57)μg·ml~(-1),t_(max)分别为(2.28±0.550)h和(2.18±0.61)h,t_(1/2)分别为(2.27±1.07)h和(1.98±0.77)h,AUC_(0-14)分别为(21.77±6.48)μg·h·ml~(-1)和(21.13±5.30)μg·h·ml~(-1),AUC_(0-∞)分别为(22.28±6.48)μg·h·ml~(-1)和(21.56±5.36)μg·h·ml~(-1)。AUC_(0-14)、AUC_(0-∞)和C_(max)的90%可信区间分别为89.2%～116.4%,89.8%～116.9%和74.8%～94.2%。受试制剂的相对生物利用度F_(0-14)和F_(0-∞)分别为(107.69±37.25)%和(108.20±37.13)%。结论:匹多莫德受试制剂和参比制剂具有生物等效性。
Objective: To study the relative bioavailability and bioequivalence of pidotimode syrup. METHODS: Twenty healthy volunteers were randomized to receive double crossover doses of pidotimod (test formulation) and solution (reference formulation) in doses of 20 ml (800 mg) and 14 ml (800 mg), respectively. The concentration of pidotimod in plasma was determined by HPLC. The pharmacokinetic parameters and bioavailability were calculated by DAS2.1 pharmacokinetic program and bioequivalence was evaluated. RESULTS: After single-dose oral pidotimod test and reference formulation, the C max of plasma podolamide were (4.45 ± 1.80) μg · ml -1 and (5.17 ± 1.57) μg · (2.28 ± 0.550) h and (2.18 ± 0.61) h respectively, t 1/2 was (2.27 ± 1.07) h and (1.98 ± 0.77) h respectively, AUC_ (0-14) were (21.77 ± 6.48) μg · h · ml -1 and 21.13 ± 5.30 μg · h · ml -1, respectively, and the AUC 0- ∞ were (22.28 ± 6.48) μg · h · ml ~ (-1) and (21.56 ± 5.36) μg · h · ml ~ (-1) respectively. The 90% confidence intervals of AUC_ (0-14), AUC_ (0-∞) and C_max were 89.2% -116.4%, 89.8% -116.9% and 74.8% -94.2%, respectively. The relative bioavailability of the tested formulations was (107.69 ± 37.25)% and (108.20 ± 37.13)%, respectively, for F_ (0-14) and F_ (0-∞). Conclusion: Pidotimod formulations and reference formulations are bioequivalent.