不同厂家盐酸左氧氟沙星片的质量考察

摘要

Objective To compare the quality of Levofloxacin Hydrochloride Tablets from different manufactories. Methods The determination of Levofloxacin Hydrochloride 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 Pharmacopoeia , 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.%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.