注射用盐酸头孢替安质量评价

Quality evaluation of cefotiam hydrochloride for injection

目的:探寻影响注射用盐酸头孢替安产品质量的内在因素。方法:对不同企业的注射用盐酸头孢替安常规质量进行分析,并对其加热稳定性进行了比较。采用柱切换LC-MS方法对降解杂质进行了定性分析,采用粉末X衍射方法对不同企业产品的晶型进行了比较,采用光散射法对产品粒度分布进行了测定,采用热重分析(TGA)结合近红外光谱法对水分结合方式进行了推测。结果:不同企业产品常规质量差异较小,但热稳定性及内在质量存在较大差异。结论:影响注射用盐酸头孢替安稳定性的内在因素主要为晶体粒径分布以及制剂中碳酸钠含量。评价产品的质量应从其内在质量入手,从而评价生产工艺的优劣。

Objective:To explore the internal factors affecting the quality of cefotiam hydrochloride for injection.Methods:The routine quality items of cefotiam hydrochloride for injection products from different manufactures were evaluated,and the thermal stability was compared.The degradation impurities were analyzed using column switching LC-MS,the crystal forms of products with different manufactures were compared by powder X diffraction method,the particle size distribution of the products was determined by light scattering method,and TGA and near infrared spectroscopy were used to predict the binding mode of water.Results:The differences of the routine quality among the products from different manufacturers were small,but the thermal stability and internal quality showed significant differences.Conclusion:The main internal factors affecting the thermal stability of cefotiam hydrochloride for injection were crystal size distribution and sodium carbonate content.The evaluation of product quality should start with its internal quality,so as to evaluate the advantages and disadvantages of the production process.