国产注射用头孢替唑钠质量分析

Quality assessment of ceftezole sodium for injection

目的评价国内不同厂家生产的注射用头孢替唑钠的质量现状及存在问题。方法按照国家评价性抽验计划总体要求,采用法定检验方法结合探索性研究进行样品检验,统计分析检验结果。结果按法定标准检验抽取的166批次样品,不合格率4.8%,不合格项目为装量差异。部分样品粒度分布不均匀,造成流动性较差,出现填充不匀的现象。探索性研究表明,头孢替唑主峰后存在多个杂质,现行标准采用等度洗脱很难将强保留的杂质洗脱出来,建议采用更为高效,灵敏的梯度洗脱方式,优化有关物质和聚合物检查的色谱方法,使质量标准更为合理、有效。结论目前国产注射用头孢替唑钠的产品质量能符合现行标准要求,而探索性研究提示现行标准存在缺陷,未能检出所有杂质和高聚物,不能全面反映产品的质量,需进一步完善检验标准。

Objective To evaluate the suitability of statutory standard and the quality condition of ceftezole sodium for injection of different domestic manufacturers. Methods According to the general requirements of national assessment programs, the statutory standard methods combined with exploratory researches are used to evaluate the quality of ceftezole sodium for injection. Results According to the statutory standards for the examination of the 166 batches, the unqualified rate was 4.8%, and the unqualified items were content uniformity. The particle size distributions of some samples were not uniform, which caused the content problem. Exploratory researches showed that many impurities of peaks eluted after the peak of ceftezole. The current method of the standard with isocratic elution is difficult to elute the strongly retained impurities. Therefore, gradient elution chromatography should be chosen to achieve high efficiency and sensitivity. It is also necessary to optimize the method of related substances and polymer inspections to make standard more reasonable and effective. Conclusion On the one hand, the quality of domestic ceftezole sodium for injection met the requirement of current Statutory standard. On the other hand, exploratory research results suggested that the current standard had defects and could not detect all the impurities and polymers. The current standard should be further improved.