中国药物评价2016，Vol.33Issue(3)：139-143,5.
复方蒿甲醚片人体药动学及生物等效性研究
Study on Pharmacokinetics and Bioequivalence of Compound Artemether Tablets
丁百莲 1王彦君 2林长旭1
作者信息
- 1. 沈阳双鼎制药有限公司，辽宁沈阳110179
- 2. 沈阳达善医药科技有限公司，辽宁沈阳110179
- 折叠
摘要
Abstract
Objective: To develop a liquid chromatographic-mass spectrometric( LC-MS/MS) method for the de-termination of lumefantrine Artemether、dihydroartemisinin、lumefantrine in human plasma and evaluate the bioequivalence of Compound Ar-temether Tablets.Methods: In a ran-domized,double-period,self-crossover study,subjects received a single oral dose of test or reference formulation.The main pharmacokinetic parameters were calculated by software Phoenix WinNonlin 6.0 and the bioequiva-lence of two formulations was evaluated.Results:The linear calibration curve was obtained over the con-centration range of 2.0 ~199.2 ng・mL -1(Artemether)、2.0 ~204.2ng・ mL -1(dihydroartemisinin), 0.0200 ~14.964 μg・ mL -1(lumefantrine).The main pharmacokinetic parameters of test formulation and reference formulation were as following:AUC0-t were (193.3 ±25.5) and (184.3 ±30.5) ng・ h・ mL -1 ( Artemether), (328.7 ±103.3) and (320.5 ±62.1) ng・ h・ mL -1 ( dihydroartemisinin), (180.2 ±70.5) and 173.8 ±51.4) ng・h・mL -1(lumefantrine); By calculation of AUC 0-t the relative bioavailability of test for-mulation was (106.1% ±12.9%) Artemether, (101.2% ±18.9%) dihydroartemisinin, 103.3% ±19.7%) lumefantrine. Conclusion: The method was simple,sensitive,accurate and suitable for the bioequivalence study of Compound Artemether Tablets in human.The statistic data showed that the test formulation and reference formulation had the similar rate and extent of absorption, and they were bioequivalent.关键词
复方蒿甲醚片/人血浆样本/液相色谱-串联质谱法/药代动力学/生物等效性Key words
Compound artemether tablets/Plasma samples/LC-MS/MS/Pharmacokinetics/Bioequivalence分类
医药卫生引用本文复制引用
丁百莲,王彦君,林长旭..复方蒿甲醚片人体药动学及生物等效性研究[J].中国药物评价,2016,33(3):139-143,5.
