摘要
Abstract
Objective:To investigate the dissolution curves of levofloxacin hydrochloride tablets from 7 manufacturers and the refer-ence preparation.Methods:The dissolution behaviors were detected using 900 mL of pH 1.2 hydrochloric acid solution,pH 4.5 ace-tate buffer solution,pH 6.8 phosphate buffer solution and water under the slurry method at the rotational speed of 50 r·min-1,HPLC was used for detecting cumulative dissolution,and the consistency was evaluated by the similarity factor(f2).Content,related sub-stances,hardness,crystal form and stability were analyzed to interpret the results.Results:The products from 3 manufacturers were all in line with the reference in the dissolution curve similarities,while the other products showing differences from the reference prepara-tion.The dissolution rate of levofloxacin hydrochloride tablets was lower,the probable cause was crystal form transformation.Conclusion:The production process of levofloxacin hydrochloride was closely related to the crystal form,differences of intrinsic dissolu-tion rate and dissolution rate of tablets between various polymorphic forms were confirmed.Crystal form transformation of the production process should be fully considered.关键词
盐酸左氧氟沙星片/溶出行为/溶出曲线/一致性/转晶Key words
Levofloxacin hydrochloride tablets/Dissolution behavior/Dissolution curve/Consistency/Crystal form transformation分类
医药卫生
