注射用头孢曲松钠的质量对比研究  

Comparative studies on the quality of ceftriaxone sodium for injection from two companies

作　　者：贾国慧[1] 呼海涛[1] 

机构地区：[1]上海医药集团股份有限公司中央研究院,上海201203

出　　处：《上海医药》2013年第13期45-49,共5页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的:对比上海新亚药业与原研企业生产的两注射用头孢曲松钠产品质量的异同。方法:采用反相高效液相色谱、液质联用、手性分析、粒度分布等多种方法,对两企业产品进行检测分析。结果:两企业终产品在含量、有关物质、手性及异构体杂质、聚合物杂质上无明显差异,临床用药稳定性及输液器截留等用药环节测定结果无差异。粒度分布测定显示原研品粒径95%小于9.82μm,新亚样品95%粒径小于51.84μm。结论:在本实验范围内,影响产品安全与疗效的关键质量项无明显差异。临床用药稳定性及输液器截留等用药环节对产品有效量的影响无差异。Objective： To compare the quality of ceftriaxone sodium for injection made by the original company and Shanghai Xinyapharm company so as to get the breakthrough points to improve the product quality. Methods： Two products were analyzed by RP-HPLC, LC-MS, chiral analysis, particle size distribution and so on. Results： There is no significant difference in content, related substances, chiral isomer impurities and so on between two products and the stability in clinical use and the interception of infusion apparatus are almost same. However, there is a little difference in the appearance and the particle size distribution. Conclusion： There is no significant difference in the key quality items.

关 键 词：注射用头孢曲松钠 质量对比 含量 杂质 理化性质 

分 类 号：R927.11[医药卫生—药学] R978.11