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高效液相色谱-紫外检测法测定人血浆中法罗培南的浓度及其生物等效性研究
引用本文:梁雁,诸兰振,贺春晖.高效液相色谱-紫外检测法测定人血浆中法罗培南的浓度及其生物等效性研究[J].中南药学,2009,7(8):593-595.
作者姓名:梁雁  诸兰振  贺春晖
作者单位:1. 湖南省常德市澧县人民医院药剂科,湖南,常德,415500
2. 湖南省常德市第四人民医院药剂科,湖南,常德,415003
3. 南京医科大学药学院,南京,210029
摘    要:目的建立高效液相色谱-紫外检测法(HPLC-UV)测定人血浆中法罗培南浓度的方法,用于人体生物等效性研究。方法采用随机双交叉实验设计,20名健康受试者口服受试制剂和参比制剂400mg,用HPLGUV法测定血浆中的法罗培南浓度。结果受试制剂和参比制剂的AUC0~8分别为(9.82±4.62)和(9.56±4.53)mg·h·L^-1;Cmax分别为(4.82±2.53)和(4.76±2.46)mg·L^-1;Cmax分别为(0.86±0.35)和(0.91±0.32)h;t1/2分别为(1.O士0.2)和(0.9±0.2)h。受试制剂的相对生物利用度为102.7%±10.7%。结论经统计学分析,2种法罗培南片剂具有生物等效性。

关 键 词:法罗培南  药物动力学  生物等效性  高效液相色谱法

HPLC determination of faropenem in human plasma and its bioequivalence
LIANG Yan,ZHU Lan-zhen,HE Chun-hui.HPLC determination of faropenem in human plasma and its bioequivalence[J].Central South Pharmacy,2009,7(8):593-595.
Authors:LIANG Yan  ZHU Lan-zhen  HE Chun-hui
Institution:1. Department of Pharmacy, Lixian People's Hospital, Changde Hunan 415500; 2. Department of Pharmacy, Changde Fourth Hospital, Changde Hunan 415003; 3. School of Pharmacy, Nanjing Medical University, Nanjing , 210029)
Abstract:Objective To establish an HPLC-UV method and to determine the pharmacokinetics and relative bioavailability of faropenem tablets in Chinese healthy volunteers. Methods Twenty healthy male volunteers received 400 mg faropenem tablets orally in a random crossover design. Drug concentrations in the plasma were determined by HPLCUV. Results The main pharmacokinetic parameters of the test tablet and reference tablet were as follows : AUC0-8: (9.82±4. 62) vs (9.56±4.53) mg. h. L^-1 ; Cmax : (4.82±2.53) vs (4.76±2.46) mg. L^-1 ; tmax (0. 86±0.35) vs (0. 91±0.32) h; t1/2 . (1.0±0.2) vs (0. 9±0. 2) h, respectively. The relative bioavailability o{ the test tablet was 102.7 %±10.7%. Conclusion The test and reference faropenem tablets are bioequivodent by statistics analysis.
Keywords:faropenem  pharmacokinetics  bioequivalence  HPLC
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