高压液相色谱法测定联苯双酯制剂的生物利用度

DETERMINATION OF BIOAVAILABILITY OF BIFENDATE PREPARATIONS BY HPLC

改进了测定联苯双酯血药浓度的高效液相色谱法。本法检测很为0.02μg,最低检测浓度为0.1μg/ml血浆,日内cv为2.03％,日间cv为2.64％,回收率96.67％。测定了由同一原料制成的三种联苯双酯制剂的生物利用度,片剂Ⅰ及片剂Ⅱ相对于滴丸的生物利用度分别为65.05％及16.73％。

Bifendate (4,4'-dimethoxy-5, 6, 5', 6'-bi (methylenedioxy)-2, 2'-bicabomethoxybiphenyl is effective in lowering SGPT in patients with chronichepatitis and very little toxic effects were observed. Modified RP-HPLC methodwith UV-278nm detector was adopted for the determination of the plasma levelof this drug. It was separated completely from other impurities with methanol-water (65:35) as mobile phase and diazepam as an internal standard. The re-coveries from plasma samples by extraction were 96.67% for itself and 97.14%for diazepam, respectively. The relative bioavailabilities of bifendate from thetablets I, II were estimated as 65.05% and 16.73% retative to the pills, respec-tively.