浓维磷糖浆质量评价及质量研究  

Quality Evaluation and Quality Research of Concentrated Divitamins and SodiumPhosphate Syrup

作　　者：石笑弋 郑金凤 彭飞城 李昭 刘轶 刘雁鸣 廖彬 SHI Xiaoyi;ZHENG Jinfeng;PENG Feicheng;LI Zhao;LIU Yi;LIU Yanming;LIAO Bin(Hunan Institute for Drug Control,Changsha 410001,China;NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Changsha 410001,China;Hunan Drug Inspection Center,Changsha 410001,China)

机构地区：[1]湖南省药品检验检测研究院,湖南长沙410001 [2]国家药品监督管理局药用辅料工程技术研究重点实验室,湖南长沙410001 [3]湖南省药品审核查验中心,湖南长沙410001

出　　处：《工业微生物》2023年第5期45-50,共6页Industrial Microbiology

基　　金：湖南省自然科学基金科药联合基金项目(2021JJ80038)。

摘　　要：现阶段浓维磷糖浆的整体质量状况较差,现行质量标准有待完善。基于此,文章根据国家食品药品监督管理局国家药品标准WS-10001-(HD-1215)-2002-2013,对现行标准中的全部检验项目进行考察,建立了多种检测方法来充分分析其质量,还结合试验结果及其存在的问题提出了改进方案。试验结果显示,按照现行质量标准进行检验,20家生产企业的170批次样品中有7批样品不合格,不合格率为4.1%,不合格项目为维生素B_(1)的含量,探索性研究检验的不合格率为38.2%。文章希望通过评价浓维磷糖浆的质量及现存的问题,为该品种国家标准的修订提供参考依据,同时为药品监管提供技术支持。The paper evaluates the quality and existing problems of concentrated vitamin phosphate syrup,providing reference basis for the revision of national standards for this variety,and providing technical support for drug supervision.According to the national drug standard WS-10001-(HD-1215)-2002-2013 of the National Food and Drug Administration,all inspection items in the current standard were inspected,and improvement plans were proposed based on the test results.Multiple detection methods were established to fully analyze its quality.According to the current quality standards,170 batches of samples from 20 production enterprises were inspected,and 7 batches of samples were found to be unqualified,with a failure rate of 4.1%.The unqualified item was the content of vitamin B_(1).The failure rate of exploratory research inspection is 38.2%.This paper proposes improvement suggestions for these issues.The overall quality status of concentrated vitamin phosphate syrup is“poor”,and the current quality standards need to be improved.

关 键 词：浓维磷糖浆 质量评价 质量标准 修订建议 

分 类 号：R95[医药卫生—药学]