不同厂家盐酸左氧氟沙星片的质量考察

Investigation on Quality of Levofloxacin Hydrochloride Tablets from Different Manufacturers

目的比较不同厂家盐酸左氧氟沙星片的质量。方法对国内、外4个厂家盐酸左氧氟沙星片产品的主要检测项目如有关物质、溶出度、异构体及含量等进行测定。结果所有被测产品各项指标均符合国家标准要求,但不同厂家之间各指标结果存在差异。结论测定结果可为产品质量标准提高提供参考。

Objective To compare the quality of Levofloxacin Hydrochloride Tablets from different manufactories. Methods The determi- nation of Levofloxacin Hydroehloride Tablets produced by 4 different manufacturers from inland and abroad was performed on several aspects：the related substance, dissolution, isomer content and content of levofloxacin. Results The determined indexes of all products of Levofloxacin Hydrochloride Tablets produced by 4 different manufacturers were all in line with the specification of the China Pharma- copoeia, but the differences existed in the detection results of various indexes among different manufacturers. Conclusion The detection results can provide the reference for increasing the quality of this product.