摘要
目的:研究单剂量口服布洛芬颗粒的药动学特征,并评价两种制剂的生物等效性。方法:采用双周期交叉试验,18名健康志愿者分别单剂量口服受试试剂或参比制剂布洛芬颗粒600mg,用HPLC法测定血药浓度,计算药动学参数,并进行统计分析。结果:布洛芬颗粒受试制剂和参比制剂的主要药动学参数分别为tmax(2.56±0.51)和(2.56±0.51)h,fmax(42.81±8.00)和(42.76±7.84)μg/mL,t1/2(1.79±0.17)和(1.75±0.21)h,AUC0~15(105.10±12.90)和(105.67±10.32)μg·h·mL^-1,AUC0-∞(105.99±12.94)和(106.60±10.33)μg·h·mL^-1。结论:受试制剂的相对生物利用度为(99.29±4.66)%,两种制剂具有生物等效性。
Objective: To study the pharmacokinetics of ibuprofen granules and evaluate the bioequivalence of test and reference formulations. Methyls: Eighteen healthy volunteers were given a single oral dose of 600 mg ibuprofen granules of test and reference formulations respectively in a two-period cross-over test. Plasma concentration of ibuprofen was determined by HPLC method. Pharmacokinetic parameters of the two formulations were calculated and statistically analyzed. Results: The main pharmacokinetic parameters of test and reference formulations of ibuprofen granules were as follows, tmax (2.56±0.51 ) and (2.56 ±0. 51) h,cmax(42. 81±8. 00) and (42.76±7.84) μg/mL,t1/2 (1. 79±0.17) and (1.75±0.21) h,AUC0-15 (105.10±12.90) and (105.67±10.32) μg·h·mL^-1 ,AUC0-∞ (105.99±12.94) and (106.60±10.33) μg·h·mL^-1. Conclusion:Relative bioavailability of the test formulation is (99.29±4.66) %. The two preparations are bioequivalent.
出处
《药学服务与研究》
CAS
CSCD
2009年第6期436-439,共4页
Pharmaceutical Care and Research
关键词
布洛芬
药代动力学
生物等效性
色谱法
高压液相
颗粒剂
ibuprofen
pharmacokinetics
bioequivalence
chromatography, high pressure liquid
granules