医药导报Issue(8)：1014-1018,5.DOI:10.3870/yydb.2015.08.007
乙酰半胱氨酸颗粒在健康人体的生物等效性研究
Study on Bioequivalence of Acetylcysteine Granules in Chinese Healthy Volunteers
李杰 1刘明周 2黎维勇 1贾萌萌 1周颖 1李虎群1
作者信息
- 1. 华中科技大学同济医学院附属协和医院药剂科，武汉 430022
- 2. 武汉大学基础医学院，武汉 430071
- 折叠
摘要
Abstract
Objective To establish an analytical method for assessing acetylcysteine in human plasma and study the relative bioavailability and bioequivalence of acetylcysteine granules in Chinese healthy volunteers. Methods In the randomized crossover study, 24 healthy male volunteers received a single oral dose of 0. 6 g test acetylcysteine granules, reference acetylcysteine granules or no medication. The plasma concentration of acetylcysteine was determined by LC-MS/MS. Pharmacokinetic parameters were calculated and bioequivalence of two preparations were evaluated by DAS3. 0 software. Results The main pharmacokinetic parameters of the test and reference preparations were as follows:AUC0→t was (8 547. 64± 2 860.04) and (8 783.07±4 042. 10) μg·h·L-1, respectively; AUC0→∞ was (9 481. 64±3 444. 76) and (9 540. 51± 4 239. 30) μg·h·L-1, respectively;Cmax was (1 994. 39±726. 42) and (2 090. 27±885. 46) μg·L-1, respectively;tmax was (1.18±0. 60) and (1. 13±0. 53) h, respectively; t1/2 was (8. 60±3. 76) and (7. 75±5. 01) h, respectively. The relative bioavailability F0→t and F0→∞ was ( 107. 0 ± 43. 3 )% and ( 106. 5 ± 40. 1 )%, respectively. Conclusion The results of statistical analysis indicate that the test and reference formulations are bioequivalent.关键词
乙酰半胱氨酸颗粒/生物利用度,相对/生物等效性/液相色谱串联质谱法Key words
Acetylcysteine granules/Bioavailability, relative/Bioequivalence/Liquid chromatography-tandem mass spectrometry分类
医药卫生引用本文复制引用
李杰,刘明周,黎维勇,贾萌萌,周颖,李虎群..乙酰半胱氨酸颗粒在健康人体的生物等效性研究[J].医药导报,2015,(8):1014-1018,5.
