重庆医学2013，Vol.42Issue(12)：1380-1381,1384,3.DOI:10.3969/j.issn.1671-8348.2013.12.023
自制左炔诺孕酮片溶出度、生物利用度与国外制剂比较研究
Comparative study on the dissolution and bioavailability between self-made levonorgestrel tablets and foreign preparation
余春梅 1陈兰 1徐洁 1杨秀丽 1周成林 1陈仲祥1
作者信息
摘要
Abstract
Objective To compare the dissolution and bioavailability with foreign preparation, and to imitate better quality of levonorgestrel tablets with equal to foreign preparation. Methods The dissolution was investigated with paddle method. In an open randomized controlled crossover design,20 healthy volunteers received reference and tested tablets. The plasma concentration of levonorgestrel was determined by HPLC MS/MS detection. Results The peak areas and concentrations of levonorgestrel presented a good linear relationship within the range of 0～13. 2μg·mL-1 ;the linear equation was A= —0. 90+65. 33C,the average recov ery rate of levonorgestrel was (101. 7±1. 5) % ,the similarity factor(f2) of the dissolution curves for our levonorgestrel tablets and the reference preparations(made by Hungary Gedeon Richter Plc) was 83. 0,the relative bioavailability of the test to the reference was 103. 5 ±30. 1. Conclusion The dissolution cruves of the tested tablets(made by our company) and reference preparation(made in Hungary) were similar,and two preparations were bioequivalent in healthy volunteers.关键词
左炔诺孕酮片/溶出度/生物利用度Key words
levonorgestrel tablets/ dissolution/ bioavailability引用本文复制引用
余春梅,陈兰,徐洁,杨秀丽,周成林,陈仲祥..自制左炔诺孕酮片溶出度、生物利用度与国外制剂比较研究[J].重庆医学,2013,42(12):1380-1381,1384,3.
