摘要
目的:建立测定人血浆中多潘立酮浓度的高效液相色谱-荧光测定方法,并对多潘立酮片的生物等效性进行评价。方法:以普萘洛尔为内标,血浆样品经两次萃取,采用C_(18)色谱柱、磷酸二氢钠缓冲液(0.02 mol·L^(-1),pH=3.5):乙腈=70:30为流动相,用HPLC-FLD法测定多潘立酮的浓度。20名健康男性志愿者随机自身交叉单次口服受试制剂和参比制剂后测血药浓度,计算各药动学参数和相对生物利用度。结果:在1.0～50.0 ng·ml^(-1)范围内峰比值与浓度线性关系良好(r= 0.992 3),最低定量浓度为1.0 ng·ml^(-1)。绝对回收率为68.6%～77.0%。多潘立酮片的相对生物利用度为(100.5±25.1)%。结论:统计学结果表明两种制剂生物等效。
Objective： To develop a reversed phase HPLC- fluorescence assay for determination of domperidone in human plasma and to investigate the pharmacokinetics and bioequivalence of testing tablets and reference tablets in human. Method： After adding internal standard （ propranolol）, the plasma samples were extracted twice and separated by HPLC on a reversed-phase Cl8 column with a mobile phase consisted of acetonitrile-0.02 mol·L^-l sodium dihydrogen phosphate with pH 3, 5 （30： 70）, HPLC-FLD was performed in the determination of the concentration of domperidone. Plasma concentrations of 20 healthy male volunteers received a single dose of the test tablets and reference tablets were determined. All the data was gained for studying the pharmacokinetic parameters and relative bioavailability. Result： Domperidone was linear in the range of 1.0 -50.0 ng·ml^-1. The limit detection concentration was 1.0ng·ml^-1 and the recovery was 68.6% -77.0%. Conclusion： The results show that the two formulations are bioequivalent.
出处
《中国药师》
CAS
2008年第5期513-515,共3页
China Pharmacist
关键词
多潘立酮片
高效液相色谱-荧光法
生物等效性
Domperidone tablets
High performance liquid chromatography-fluorescence
Bioequivalent
作者简介
柯徐，男，硕士，研究方向：临床药理学。Tel：13545079660 E-mail：kexu2006@sina．com
陈汇，女，教授，主研方向：临床药理学。Tel：（027）83692628 E-mail：chenhui_tj@126．com
