布洛芬缓释胶囊相对生物利用度研究

目的:研究布洛芬缓释胶囊在健康人体内的药代动力学与相对生物利用度,以评价其生物等效性。方法:采用高效液相色谱法测定20名健康志愿者随机交叉口服单剂量（600mg）布洛芬缓释胶囊与参比制剂芬必得胶囊后血浆中布洛芬的药-时数据,用3p87药代动力学程序拟合,计算药代动力学参数并评价其生物等效性。结果:布洛芬缓释胶囊与芬必得胶囊的主要药代动力学参数分别为T1-2=（2.88±0.25）h、（2.91±0.33）h;Cmax=（30.66±4.21）mg/L、（29.09±3.54）mg/L;Tmax=（4.4±0.52）h、（43±0.48）h;AUC0-1=（174.26±13.95）mg/（h·L）、（165.80±11.89）mg/（h·L）;Css=（16.25±1.47）mg/L、（15.63±1.83）mg/L;Cmin=（1.36±0.56）mg/L、（1.24±0.46）mg/L;FI=（1.83±0.07）、（1.84±0.06）。布洛芬缓释胶囊的相对生物利用度为（105.10±7.77）％。结论:布洛芬缓释胶囊与参比制剂芬必得胶囊为生物等效制剂。

Relative Bioavailability of Ibuprofen Sustained Release Capsules in Healthy Volunteers

OBJECTIVE:To study the pharmacokinetics and relative bioavailability of ibuprofen sustained release capsules in healthy volunteers for evaluating the bioequi valency .METHODS: 20 healthy volunteers took a single dose(600mg) of ibuprofen sustained release capsules and fenbid capsules(as reference drug) alternatively, then the plasma concentrations of ibuprofen were determined by HPLC.The pharmacokinetic parameters were calculated with 3p87 pharmacokinetic program and the bioequivalence was calculated .RESULTS: The pharmacokinetic parameters of ibuprofen sustained release capsule and fenbid capsule wereT1/2= (2.88+ 0.25)h, (2.91 + 0.33)h;Cmax = (30.66+ 4.21)mg/L, (29.09+3.54)mg/L;Tmax = (4.4 + 0.52)h, (4.3+0.48)h;AUCo-1, = (174.26+13.95)mg/(h . L), (165.80+ 11.89)mg/(h ?L) ;C = (16.25+ 1.47)mg/L, (15.63+1.83) mg/L; Cmin= (1.36 + 0.56) mg/L, (1.24 + 0.46) mg/ L; FI = (1.83 + 0.07), (1.84 + 0.06) .The relative bioavailability of ibuprofen sustained release capsule was( 105.10 + 7.77) % .CONCLUSION: Ibuprofen sustained release capsule and fenbid (reference drug) were bioequivalent.