国产注射用头孢西丁钠质量评价  

Quality assessment of domestic cefoxitin sodium for injection

作　　者：肖慧[1] 洪建文[1] 彭洁[1] 武建卓[1] 陈冬妮[1] 陆江赢[1] 罗嘉琳 

机构地区：[1]广东省药品检验所,广州510180

出　　处：《中国抗生素杂志》2017年第6期470-475,共6页Chinese Journal of Antibiotics

摘　　要：目的评价国内不同厂家生产的注射用头孢西丁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227批次样品,不合格率为6.6%,主要不合格项目为溶液的澄清度与颜色,不合格项目涉及安全性项目细菌内毒素。探索性研究表明个别杂质的含量、聚合物的量与溶液的颜色有一定的相关性;建议现行标准增加有关物质Ⅱ(聚合物)检查项,修订有关物质限度,修订溶液颜色和含量限度,修订水分测定方法。结论目前国内的注射用头孢西丁钠的总体质量一般,存在不合格产品集中企业;从检验项目的完整性、限度制定的合理性和检测方法的有效性出发,现行标准应进一步提高,以保证该药物的有效和安全。Objective To evaluate the suitability of statutory standard and the quality of cefoxitin sodium 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 evaluate the quality of cefoxitin sodium for injection. Results According to the statutory standards for the examination of the 227 batches of samples, the unqualified rate was 6.6%. The main unqualified items for the solution was the clarity, the color, and bacterial endotoxin. The results showed that the content of the individual impurities was correlated with the color of the solution, and the amount of the polymer was correlated with the color of the solution. It is necessary for the current standard to include the related substances Ⅱ （polymer） inspection items, to revise the related substances limit,the color of the solution and content limit, and the water determination method. Conclusion At present the overall quality of cefoxitin sodium for injection is not satisfactory. Starting from the integrity of the test project, the rationality and validity of the test method, current standards should be further improved to ensure quality control.

关 键 词：注射用头孢西丁钠 杂质谱 有关物质 评价性抽验 质量分析 

分 类 号：R918.1[医药卫生—药学]