6厂家左氧氟沙星片质量评价

Quality Evaluation of Levofloxacin Tablets Produced by Six Different Pharmaceutical Factories

目的 :考察6厂家左氧氟沙星片的质量。方法 :参照相关标准考察6厂家17个批号左氧氟沙星片质量 ,并采用同一溶出条件考察各样品溶出曲线。结果 :6厂家左氧氟沙星片质量均符合规定 ,但溶出特性、治疗费用均有显著性差异 (P<0 01)。结论 :不同厂家生产的左氧氟沙星片质量有差异 ,拥有专利的原研发厂家药品价格较高 ,但质量较稳定。

OBJECTIVE:To evaluate the quality of levofloxacin tablets produced by 6 different factories.METHODS:To investigate the quality of 17 batches of levofloxacin tablets produced by 6 factories according to related standards and to evaluate the drug dissolubilities using paddle method.RESULTS:17 products from six factories were all proved qualified.Significant differences of dissolution parameters and treatment costs were found among the different products.CONCLUSION:There are difference in quality of levofloxacin tablets.The tablets produced by the factory holding the patent right are more expensive,however the qualiity is more stable.