2005年监督抽验的54批国产注射用头孢哌酮钠舒巴坦钠的质量评价  

Results and statistic analysis of domestic Cefoperazone Sodium and Sulbactam Sodium for injections in 2005

作　　者：姚蕾[1] 顾立素[1] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药品评价》2006年第4期282-285,共4页Drug Evaluation

摘　　要：目的对国产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,利用统计手段分析检验结果。结果30个企业生产的54批注射用头孢哌酮舒巴坦钠中,17批不合格,占31.5%,涉及10个厂家。不合格项目主要是溶液的澄清度和头孢哌酮的纯度。结论目前国产注射用头孢哌酮钠舒巴坦钠存在的主要质量问题是头孢哌酮的稳定性和溶液的澄清度,其中头孢哌酮钠的质量是决定制剂质量的关键。Objective To evaluate the quality of cefoperazone sodium and sulbactam sodium for injections at present. Methods All the samples were experimented according to the Chp. and other approved criteria. The data were analyzed by statistic methods. Results Seventeen samples produced by 10 pharmaceutical factories were unqualified, which were found among 54 samples produced by 30 pharmaceutical factories, with the disqualification rate of 31.5%. The major items of disqualification were solution＇s clarify and the purity of cefoperazone in all these preparations.Conclusions The solution＇s clarify and the stability of cefoperazone were the main problems for qualities of these domestic preparations, and cefoperazone sodium was the key factor for the quality of cefoperazone sodium and sulbactam sodium for injections.

关 键 词：注射用头孢哌酮钠舒巴坦钠 监督抽验 质量评价 

分 类 号：R927[医药卫生—药学]