关键词: font-size:medium, ">盐酸左氧氟沙星片；溶出行为；溶出曲线；一致性；转晶

Abstract: Objective： To investigate the dissolution curves of levofloxacin hydrochloride tablets from 7 manufacturers and the reference preparation. Methods： The dissolution behaviors were detected using 900 mL of pH 1.2 hydrochloric acid solution， pH 4.5 acetate 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 substances， 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 preparation. 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 dissolution rate and dissolution rate of tablets between various polymorphic forms were confirmed. Crystal form transformation of the production process should be fully considered.

Key words: font-size:medium, ">Levofloxacin hydrochloride tablets； Dissolution behavior； Dissolution curve； Consistency； Crystal form transformation