国产注射用硫酸头孢匹罗质量评价

Quality assessment of cefpirome sulfate for injection

目的评价国产注射用硫酸头孢匹罗的质量现状并分析存在的问题。方法按照2017年国家评价性抽验计划总体要求,采用法定检验方法进行样品检验,并结合探索性研究进行统计分析,对国产注射用硫酸头孢匹罗的质量现状进行评价。结果本次抽验中涉及4家生产企业的12批样品,按法定标准检验结果均符合规定,合格率100%。标准检验发现4个现行标准均为局颁注册标准,存在限度不统一、安全性项目(如聚合物、碳酸钠含量、硫酸盐含量等)缺失或方法不完善等问题。探索性研究显示,由于处方中含有碳酸钠,导致本品有较强的引湿性,引湿后杂质含量明显增加。结论目前国产注射用硫酸头孢匹罗总体质量较好,质量标准有待统一提高。建议优化有关物质Ⅰ的检查方法,并增加碳酸钠含量和有关物质Ⅱ等安全性项目。

Objective To evaluate the suitability of the standard and the quality condition of domestic cefpirome sulfate for injection. Methods According to the general requirements of national assessment programs in 2017, statutory testing methods combined with the exploratory research were used to evaluate the quality of domestic cefpirome sulfate for injection, and the results were analyzed statistically. Results Twelve batches of samples from four manufacturing enterprises were tested. The pass rate was 100%. The standard test found that the four current standards were all registered standards. However, the limits were not uniform, and safety items (such as polymer content, sodium carbonate, and sulfate content) were missing or methods were not perfect. Exploratory studies showed that the sample had hygroscopicity because of sodium carbonate, and the impurity content increased significantly after moisture absorption. Conclusion At present, the quality of domestic cefpirome sulfate for injection is good, but the quality standards need to be improved. It is suggested to optimize the methods of related substances Ⅰ and increased the safety items such as the sodium carbonate content and related substances Ⅱ.