【摘要】 制备具有高度广谱抗菌活性的盐酸左氟沙星注射液以扩大其临床应用。并建立检测方法,以控制其质量。HPLC法检测相关物质,分光光度法测定含量。注射液性质稳定,澄明度高。相关物质检查可靠性高。含量测定在3.68～8.29μg/ml间有良好的线关系,平均回收率为99.08％,RSD为0.90％。盐酸左氟沙星可制成注射液,应用于临床。其检测方法可有效地控制注射液质量。更多还原

【Abstract】 The purpose is to prepare broad-spectrum antibiotic LVFX injection of high activity active for extending its clinical application scope and to establish the methods of identification. The HPLC method was described for determination of related substances and the spectrophotometric method was used in quantitative analysis. The injection has a good stability and high clearity. The related substances determination was highly reliable. Linear regression for LVFX was over the range of 3. 68 - 8. 29 μg/ml. The aveage recovery of LVFX was 99. 08%, and RSD was 0. 90%. LVFX could be prepared into injection for clinical application. Those methods were capable to control effectively the quality of LVFX injection.更多还原