布洛芬颗粒剂的人体生物等效性研究

Study on Bioequivalence of Ibuprofen Granules in Healthy Volunteers

目的:研究布洛芬颗粒剂的人体生物等效性。方法:HPLC法测定18名男性健康志愿者单剂量口服400 mg布洛芬颗粒剂后的血药浓度,拟合药动学参数并进行统计学评价。结果:单剂量口服布洛芬颗粒剂试验制剂和参比制剂后,血浆中布洛芬的C_(max)分别为(39.35±5.42)μg·ml^(-1)和(40.10±6.33)μg·ml^(-1);t_(max)分别为(1.64±0.41)h和(1.58±0.19)h;AUC_(0-10)分别为(142.70±25.02)μg·ml^(-1)·h和(150.29±18.24)μg·ml^(-1)·h;AUC_(0-inf)分别为(152.93±28.14)μg·ml^(-1)·h和(161.18±19.59)μg·ml^(-1)·h。相对生物利用度为(95.97±18.91)%。结论:经方差分析与双单侧t检验,试验制剂与参比制剂具有生物等效性。

Objective： To study the bioequivalence of ibuprofen granules in healthy volunteers. Method： The concentrations of ibuprofen in plasma were determined by HPLC. A single oral dose （400 mg of tested and reference formulation） were given to 18 healthy volunteers in a randomised crossover study. The pharmacokinetics parameters were calculated and the bioequivalence of two formulations were evaluated by DAS program. Result： After a single dose, the pharmacokinetics parameters for ihuprofen were as follows： Cmax were（39.35±5.42）μg·ml^-1 and （40.10 ±6.33） μg·ml^-1; tmax were （1.64 ±0.41）h and （1.58 ±0.19）h; AUC（0-10） were （142.70 ±25.02） μg·ml^-1·h and （150.29 ± 18.24） μg·ml^-1·h; AUC（0-inf） were （152.93 ±28.14）μg·ml^-1·h and（ 161.18 ± 19.59） μg·ml^-1·h for T and R respectively; the relative bioavailability was （95.97 ± 18.91 ）%. Conclusion： The results of the statistic analysis showed that the two formulations are hioequivalence.