关键词: font-size:medium, ">盐酸乙胺丁醇； 高效液相色谱法； 溶出曲线； f2

Abstract: Objective： To compare the dissolution profiles of self-prepared and original Ethambutol Hydrochloride Tablets in 4 kinds of mediums， and that as a reference for improving the quality evaluation Ethambutol Hydrochloride Tablets. Methods： According to the second dissolution method (paddle method) stated in general rule 0931 of Chinese Pharmacopeia (2015 edition Part 4)， the rotation speed was 50 r·min-1(250 r·min-1 in 45 min to 60 min) with dissolution medium volume of 900 mL. HPLC was adopted to determine the content of Ethambutol Hydrochloride in water， pH 1.2 hydrochloride acid， pH 4.0 phosphoric acid and pH 6.8 phosphate buffer solution， calculate the cumulative dissolution and draw dissolution profiles， then similarity factor (f2) was used to evaluate the similarity of dissolution profiles. Results： In four different pH solvents， self-prepared Ethambutol Hydrochloride Tablets dissolve behavior was similar to original drug and the f2 was higher than 50 for both self-prepared and original. Conclusion： Self-prepared Ethambutol Hydrochloride Tablets could release completely in four solvents and the dissolve behavior was similar to original. That could guarantee the consistency for both qualities.
 

Key words: font-size:medium, ">Ethambutol Hydrochloride； HPLC； Dissolution Curves； f2