摘要
目的 :建立人血浆中丙硫氧嘧啶的高效液相色谱测定法 ,以测定志愿者口服丙硫氧嘧啶片剂后的血药浓度 ,并对供试制剂和参比制剂的生物等效性进行评价。方法 :血浆中加入内标磺胺二甲嘧啶后酸化 ,以乙酸乙酯提取 ,进行高效液相色谱法检测。色谱柱为 Kromasil ODS1 5 0× 4 .6 mm,5 μm,流动相为乙腈 -水 -冰醋酸( 1 5∶ 85∶ 1 ) ,流速 1 ml/min,检测波长 2 75 nm。2 0名健康志愿者随机分成两组 ,分别服用供试片和参比片 ,临床实验方案采用双交叉实验设计法。结果 :本测定方法的提取回收率在 97.1 %～ 1 0 2 .1 % ,用本法测定了 2 0名志愿者随机交叉口服单剂量 1 0 0 mg丙硫氧嘧啶后血浆中药物的浓度经时变化过程 ,并对其药动学参数进行估算。结论 :该法简便、准确 ,测得的
AIM A simple HPLC method was developed for the study of pharmacokinetics and bioavailability of propylthiouracil in human body. METHODS Sulfadimidine was used as the internal standard. After adding sulfadimidine and acidification, the plasma samples were extracted with ethyl acetate and determined by HPLC. The mobile phase comprised acetonitrile, water and glacial acetic acid (15∶85∶1, v/v/v). Analyses were run at a flow rate of 1.0 ml/min with the detector operating at a detection wavelength of 275 nm. The plasma concentration of propylthiouracil was determined by this HPLC method following a single oral dose of 100 mg of two formulations given to each 20 volunteers in an open randomized two way crossover design. RESULTS The extraction recovery of this method ranged from 97.07%~102.05%. The assay exhibited a linear range of 0.01~10 μg/ml and gave a correlation(r) of 0.9991. CONCLUSION The method is simple, sensitive and rapid. The bioavailability results of two formulations were similar.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
2001年第5期363-366,共4页
Journal of China Pharmaceutical University
