国产注射用头孢地嗪钠质量分析

目的评价国内不同厂家生产的注射用头孢地嗪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研究,统计分析检验结果。结果按法定标准检验抽取的152批次样品,不合格率4%,不合格项目均为溶液的澄清度。通过"注射用粉针剂中痕量胶塞迁移物检测平台",推断出溶液澄清度不合格的影响因素为胶塞中残留的二硫化碳,样品溶液的浊度值与通过GC-MS试验测得样品中二硫化碳的峰面积值呈良好的线性关系(r=0.9956);探索性研究表明,头孢地嗪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地嗪钠的产品质量基本能符合现行标准要求,而探索性研究提示现行标准有关物质Ⅰ检测方法存在缺陷,未能检出所有杂质,需进一步完善检验标准;建议企业控制所用胶塞的品质,以确保产品质量。

Quality assessment of cefodizime sodium for injection

Objective To evaluate the suitability of the statutory standard and the quality of cefodizime 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 were used to evaluate the quality of cefodizime sodium for injection. Results According to the statutory standards for the examination of the 152 batches, the unqualified rate was 4%, and the unqualified items were the clarification of the solution. Using the detection platform for the trace of rubber plugs in powders for injection, the exploratory research showed the factors affecting the nonconformity was CS2 in the rubber plugs. The results conclude that the turbidity value of the sample solution has a good linear relationship with the peak area of the CS2 by GC-MS (r=0.9956). The current method ofthe standard with isocratic elution was difficult to elute the strongly retained impurities. Therefore, gradient elution chromatography should be chosen to achieve high efficiency and sensitivity. Conclusions On the one hand, the quality of domestic cefodizime sodium for injection generally met the requirement of the current statutory standard. On the other hand, exploratory research results suggested that the current standard had defects and could not detect all the impurities. The current standard should be further improved. The quality of the rubber plugs used in the industry should be improved to ensure the product