乳酸左氧氟沙星注射液内控质量标准的制定

目的：建立乳酸左氧氟沙星注射液内控质量标准。方法：依据该制剂法定质量标准，选择性状、鉴别、pH、颜色、左氧氟沙星含量作为内控质量检验项目，并同时采用紫外分光光度法和HPLC法对左氧氟沙星含量测定进行比较性试验。结果：制剂中左氧氟沙星的2种含量测定结果差异无统计学意义，可用紫外分光光度法代替HPLC法测定左氧氟沙星含量。结论：内控质量标准简单、快速、准确，适合于注射液中间品检验。

Study on Quality Control of Levofloxacin Lactate Injection

Objective： To establish the quality control method of levofloxacin lactate injection. Method： The characteristics, identification, pH, color and contents were adopted as items of the quality control. The contents of levfloxcin was determined by HPLC and UV spectrophotometry. Result： No significant differences were noted in the contents in the two methods. The content of levofloxacin could be determined by UV sectrophotometry. Conclusion： The quality control method of the products is simple, quick, accurate, and can be adapted to the quality control of half finished product of the injection.