2010年北京地区市售注射用哌拉西林钠/舒巴坦钠质量评价  

Quality Evaluation of Piperacillin Sodium/Sulbactam Sodium for Injection in Beijing Area in 2010

作　　者：寇晋萍[1] 方颖[1] 余立[1] 王俊秋[1] 

机构地区：[1]北京市药品检验所,北京市100035

出　　处：《中国药房》2011年第45期4273-4275,共3页China Pharmacy

摘　　要：目的:考察北京地区市售注射用哌拉西林钠/舒巴坦钠的药品质量。方法:采用现行标准方法对来自4个生产企业的21批次市售样品进行质量检验,采用非标文献方法检查其中高分子杂质含量。结果:按现行标准检验,各企业样品质量略有差异但均符合规定;非标文献方法考察结果表明不同企业样品中高分子杂质含量不同,样品质量存在明显差异。结论:注射用哌拉西林钠/舒巴坦钠中高分子杂质值得关注,建议在其检验标准中增加此检查项。OBJECTIVE ： To evaluate the quality of Piperacillin sodium/sulbactam sodium for injection in Beijing Area. METHODS： The qualities of 21 batches of samples from 4 manufacturers were detected using current specifications, and the content of impurity was inspected by non-standard literature method. RESULTS： According to the current required specifications, there were some differences in the quality of product from different manufacturers but the samples all conformed to specification; non-standard method indicated that the contents of high molecular impurities in samples from different manufacturers were different and the quality of samples had significant difference. CONCLUSION： Great importance should be paid attention to the high molecular impurities of Piperacillin sodium/sulbactam sodium for injection. It is suggested to add the item into the specification standard.

关 键 词：注射用哌拉西林钠/舒巴坦钠 北京地区 质量评价 高分子杂质 

分 类 号：R978.11[医药卫生—药品] R927.11[医药卫生—药学]