注射用头孢哌酮钠舒巴坦钠的质量评价

Quality Evaluation of Cefoperazone Sodium and Sulbactam Sodium for Injection

目的对注射用头孢哌酮钠舒巴坦钠的质量现状进行评价。方法按《中国药典》及有关标准进行检验,利用统计学方法对检验结果进行分析,并对溶液澄清度、贮存条件等进行了考察。结果合格率为97.9%,不合格产品涉及6个厂家,不合格项目主要为溶液澄清度、可见异物与含量测定项。结论注射用头孢哌酮钠舒巴坦钠的总体质量较好。

Objective To evaluate the quality of Cefoperazone Sodium and Sulbactam Sodium for Injection at present.Methods All the samples were experimented according to Chinese Pharmacopoeia and other approved criteria.The data were analyzed by statistic methods.Results The qualification rate was 97.9%.The unqualified products related to 6 pharmaceutical factories.The major items of unqualification were solutions clarify,visible foreign matter and content.Conclusion The Cefoperazone Sodium and Sulbactam Sodium for Injection is superior in quality.