摘要
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.
出处
《中国药师》
CAS
2008年第5期508-510,共3页
China Pharmacist