摘要
目的研究布洛芬口腔崩解片与普通片的相对生物利用度和生物等效性。方法20名成年男性健康受试者采用随机交叉自身对照分别口服布洛芬口腔崩解片和普通片200mg。用HPLC法测定血药浓度,用3P97软件计算药动学参数和相对生物利用度,评价生物等效性。结果布洛芬口腔崩解片与普通片的主要药动学参数分别为:t1/2(2.22±0.28)、(2.16±0.43)h,tmax(2.04±0.78)、(1.74±0.84)h,ρmax(21.97±5.83)、(22.68±4.41)mg·L-1;AUC0→12(87.88±15.70)、(89.89±16.46)mg·h·L-1;AUC0→∞(90.93±16.40)、(92.62±17.11)mg·h·L-1。口腔崩解片的相对生物利用度F0→12、F0→∞分别为(98.9±12.7)%和(99.2±12.4)%。lnAUC0→12、lnAUC0→∞和lnρmax经方差分析、双单侧t检验及90%置信区间统计结果均符合要求。tmax非参数法检验结果,Z=-1.424,P=0.155,无显著性差异。结论2种制剂呈生物等效。
AIM To investigate the relative bioavailability and bioequivalence of ibuprofen orally disintegrating tablets in 20 healthy volunteers. METHODS A single dose 200 mg of ibuprofen orally disintegrating tablets（test） or conventional ibuprofen tablets（reference）were administered orally to each subject according to an open randomized crossover design. The ibuprofen concentration in plasma was determined by HPLC, the computation of pharmacokinetic parameters and statistical analysis were performed with 3P97 softwere. RESULTS The main pharmacokinetic parameters of test formulation and reference formulation were as follows： t1/2 were （2.22 ± 0.28）h and （2.16 ± 0.43） h; tmax were（2.04 ± 0.78） h and （ 1.74 ± 0.84） h; ρmax were （ 21.97 ± 5.83 ） mg· L^- 1 and （ 22.68 ± 4.41 ） mg· L^- 1 ; AUC0→12 were （87.88 ± 15.70）mg·h· L^-1 and （89.89 ± 16.46）mg·h· L^-1; AUCo→∞ were （90.93 ± 16.40）mg·h· L^-1 and （92.62± 17.11）mg·h· L^-1.The relative bioavailability F0→12 and F0→∞ were （98.9 ± 12.7）% and （99.2± 12.4） %, respectively. CONCLUSION The result of statistical analysis shows that test and reference formulation are bioequivalent.
出处
《中国临床药学杂志》
CAS
2006年第5期280-283,共4页
Chinese Journal of Clinical Pharmacy
