不同厂家注射用哌拉西林钠/舒巴坦钠的质量考察

Evaluation the quality of piperacillin sodium and sulbactam sodium for injection from different manufacturers

目的考察不同厂家注射用哌拉西林钠(青霉素类广谱抗生素)/舒巴坦钠(β内酰胺酶抑制剂)的质量。方法按性状、水分、溶液的颜色、哌拉西林的有关物质、哌拉西林高分子杂质5个项目,分别对4个不同厂家的产品进行质量考察。结果上述项目在各厂家之间存在一些差异。结论不同厂家的产品质量略有区别,A厂优于另3个厂家的产品。

Objective To evaluate the quality of piperacillin sodium and sulbactam sodium for injection from different manufacturers. Methotis The determination of product from four different manufactures was performed from five aspects ： description, water, color of solution, relat- ed substances of piperacillin, and high moleeular weight impurities of piperacillin. Results There are some differences in the quality of product from different manufacturers. Conclusion The results suggest that the quality of product from manufacturer A is better.