国产注射用盐酸头孢甲肟质量评价

Quality assessment of domestic cefmenoxime hydrochloride for injection

目的 评价国内不同企业生产的注射用盐酸头孢甲肟的质量及存在问题。方法 根据国家评价性抽验计划要求,采用法定标准检验结合探索性研究对样品进行检验,并统计分析检验结果。结果 共抽取130批次样品,按法定标准检验,合格率100%。探索性研究结果表明杂质的含量、聚合物的量与溶液的颜色有一定的相关性;研究了主要杂质的来源和结构;建议现行标准修订有关物质和残留溶剂方法,增加碳酸钠含量测定。结论 目前国内的注射用头孢甲肟的总体质量一般;为提升药物的有效性和安全性,现行标准应进一步提高。

Objective To evaluate the suitability of statutory standard and the quality of cefmenoxime hydrochloride for injection of different domestic manufacturers.Methods According to the general requirements of national assessment programs,the standard methods combined with exploratory researches were used to test the quality of cefmenoxime hydrochloride for injection.The results were analyzed by using the statistical method.Results According to the statutory standards for the examination of the 130 batches of samples,the qualified rate was 100%.The result of exploratory research showed that the content of impurities and the amount of polymer were correlated with the color of the solution.This paper also researched the sources and structures of major impurities.It is recommended that the statutory standard revise related substances and residual solvents and add the determination of sodium carbonate contents.Conclusion The overall quality of domestic cefmenoxime hydrochloride for injection is average presently.The current standard needs to be further improved to ensure the efficacy and safety of products.