| 米非司酮片在健康人体的生物等效性研究 |
| |
| 引用本文： | 潘澄,徐海燕,刘春玲,徐萍蔚,王玲兰,袁波.米非司酮片在健康人体的生物等效性研究[J].药物分析杂志,2011(3). |
| |
| 作者姓名： | 潘澄 徐海燕 刘春玲 徐萍蔚 王玲兰 袁波 |
| |
| 作者单位： | 沈阳药科大学药学院; |
| |
| 摘 要： | 目的:建立测定人血浆中米非司酮浓度的HPLC法,以评价2种制剂在健康人体内的生物等效性。方法:18名健康女性受试者双周期随机交叉单剂量口服2种米非司酮片剂(受试制剂和参比制剂)25 mg,采用HPLC法测定米非司酮的血药浓度,计算两者药代动力学参数及相对生物利用度。结果:受试制剂与参比制剂的主要药动学参数:Tmax分别为(0.81±0.23)和(0.81±0.23)h;Cmax分别为(849.91±257.77)和(852.01±258.26)ng.mL-1;t1/2分别为(29.72±11.06)和(27.96±13.35)h;AUC0～120分别为(7259.49±2256.93)和(7802.63±4049.20)ng.h.mL-1;AUC0～!分别为(8635.35±2696.45)和(9354.08±4469.31)ng.h.mL-1。受试制剂相对生物利用度为(104.91±36.45)%。结论:该方法选择性好,灵敏度高,适于米非司酮的体内过程研究;2种片剂具有生物等效性。
|
| 关 键 词： | 米非司酮 高效液相色谱法 生物等效性 |
Bioequivalence of mifepristone tablets in healthy volunteers |
| |
| PAN Cheng,XU Hai-yan,LIU Chun-ling,XU Ping-wei,WANG Ling-lan,YUAN Bo.Bioequivalence of mifepristone tablets in healthy volunteers[J].Chinese Journal of Pharmaceutical Analysis,2011(3). |
| |
| Authors: | PAN Cheng XU Hai-yan LIU Chun-ling XU Ping-wei WANG Ling-lan YUAN Bo |
| |
| Institution: | PAN Cheng,XU Hai-yan,LIU Chun-ling,XU Ping-wei,WANG Ling-lan,YUAN Bo*(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China) |
| |
| Abstract: | Objective:To establish an HPLC method for determination of pharmacokinetic of mifepristone in human plasma and to evaluate the bioequivalence of two mifepristone tablets in healthy volunteers.Method:In a randomized,crossover and self-control study,18 healthy female volunteers were orally administrated with mifepristone tablets(test sample and reference sample)25 mg.The plasma concentration of mifepristone was determined by HPLC detection.The pharmacokinetic parameters and relative bioavailability were calcu... |
| |
| Keywords: | mifepristone HPLC bioequivalence |
| 本文献已被 CNKI 等数据库收录！ |
|
