高效液相色谱法研究人体内苯扎贝特片的药动学和生物等效性  

Determination of Bezafibrate Tablets in Human Plasma by HPLC Application to Bioequivalent and Pharmacokinetic Studies

作　　者：姚文[1] 王晓波[1] 石焱[1] 李忠亮[1] 隋淼[1] 宋晓楠[1] 袭荣刚[1] 

机构地区：[1]解放军第210医院国家药物临床试验机构,辽宁大连116021

出　　处：《解放军药学学报》2009年第1期37-40,共4页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的研究健康人口服苯扎贝特片后的药动学和生物等效性。方法20名健康受试者采用随机分组自身交叉对照试验设计,口服苯扎贝特片400mg后用HPLC法测定血浆中苯扎贝特浓度,以DAS软件计算其药动学参数和评价生物等效性。结果在选定的色谱条件下苯扎贝特与内标及血浆杂质分离良好,在0.1～20.0μg.mL-1范围内线性良好。相对回收率>92.47%,日内和日间RSD<11.1%。苯扎贝特片受试制剂(T)和参比制剂(R)的主要药动学参数:Tmax分别为(1.85±0.49)h和(1.65±0.46)h,Cmax分别为(11.107±3.184)μg.mL-1和(11.439±3.388)μg.mL-1;t1/2分别为(1.63±0.28)h和(1.57±0.42)h;AUC0→12分别为(38.9±9.6)μg.h.mL-1和(37.4±10.4)μg.h.mL-1;用面积法(AUC0→t)估算的苯扎贝特片相对生物利用度为(105.7±12.8)%。结论用HPLC法测定血浆中苯扎贝特浓度,杂质无干扰,定量限低,重复性好,准确度高。受试的苯扎贝特片与参比的苯扎贝特片(阿贝他)生物等效。Aim To study the pharmacokinetics of bezafibrate tablets in human plasma. Methods Twenty volunteers were given bezafibrate tablets by oral administration with 2-way crossover design. The concentration of bezafibrate in plasma was determined by HPLC. The pharmacokinetic parameters were calculated by DAS software. Results The calibration curve was linear in the range from 0.11μg·mL^-1 to 20.0μg·mL^-1. The relative recovery exceeded 92.47%. The intra and inter-day RSD was less than 11. 1%. The main pharmacokinetic parameters t 1/2, Cmax, Tmax and AUC0→t, for the test capsules were （ 1.63 ± 0.28 ） h, （ 11. 107 ± 3. 184 ） μg·mL^-1, （ 1.85 ± 0.49 ） h and （ 38.9 ± 9.6 ）μg·h·mL^-1, respectively, while those for the reference preparations were（ 1.57 ± 0.42） h, （ 11. 439 ± 3. 388 ）μg·mL^-1, （ 1.65 ± 0.46 ） h and （ 37.4 ± 10.4 ）μg·h·mL^-1, respectively. The relative bioavalability of the test preparations was （ 105.7 ± 12.8 ） %. Conclusion The HPLC method for determination of bezafibrate in plasma was proved to be sensitive,accurate and convenient. The reference and test preparations are bioequivalent.

关 键 词：苯扎贝特片 HPLC 药动学 生物等效性 

分 类 号：R944.1[医药卫生—药剂学]