左氧氟沙星原料药的质量对比研究

目的:比较不同厂家左氧氟沙星原料药的质量。方法:采用《中国药典》和进口注册标准对国内外4个厂家左氧氟沙星原料药的主要检测项目(酸度、溶液的澄清度、溶液的颜色、水分、有关物质、异构体及含量)进行测定。结果:所有被测产品各项指标均符合进口原料药注册标准的要求,但各项指标在结果上存在一定的差异。结论:该测定数据可为左氧氟沙星制剂的原料选择以及制剂的临床用药提供参考。

Investigation on Quality of Bulk Pharmaceutical of Levofloxacin from Different Manufacturers

Objective： To compare the quality of bulk pharmaceutical of levofloxacin from different manufacturers. Methods： Accord- ing to the ChP （2010 edition） and the register standard specified in the drug import registration certificate, the determination of levo- floxacin from 4 different manufacturers was performed from several aspects ： acidity, the clarity of solution, the color of solution, mois- ture content, the related substance and the isomer content. The content of levofloxacin was also determined. Results ： The determined indexes of all levofloxacin products obtained from 4 different manufacturers were all in line with the register standard, with all of the in- dexes showing no difference. Conclusion： The results will provide the reference for choice of bulk pharmaceutical from different manu- facturers and for the clinic use of levofloxacin .