注射用头孢西丁钠的质量评价  

Quality evaluation of cefoxitin sodium for injection

作　　者：王强 李香荷 韩彬 张冬 田兰 高燕霞 Wang Qiang;Li Xiang-he;Han Bin;Zhang Dong;Tian Lan;and Gao Yan-xia(Hebei Institute for Drug and Medical Device Control,Shijiazhuang 050000)

机构地区：[1]河北省药品医疗器械检验研究院,石家庄050000

出　　处：《中国抗生素杂志》2022年第2期134-139,共6页Chinese Journal of Antibiotics

摘　　要：目的 按照国家计划抽验要求,评价国内不同企业生产的注射用头孢西丁钠的质量。方法 按国家标准检验与探索性研究相结合,对全国范围内的202批次抽验样品进行检验,通过对澄清度与颜色、有关物质、聚合物、残氧量等进行考察,分析国内制剂的质量状况。结果 按法定标准检验抽验,合格率为100%;探索性研究发现企业间样品的残氧量差异明显,为0.4%~16.7%,残氧量与头孢西丁钠溶液的颜色呈正相关性,提示企业应严格控制充氮环节。结论 目前国内注射用头孢西丁钠总体质量较好;现行标准有待进一步提高,建议现行标准修订有关物质检查方法,增加聚合物的控制;建议企业对生产工艺中充氮环节进行完善,以提高产品质量。Objective According to the national sampling plan, the quality of cefoxitin sodium for injection produced by different domestic enterprises was evaluated. Methods The 202 batches of samples were tested, and the quality of domestic preparations was analyzed through the investigation of clarity and color, related substances,polymers, residual oxygen content, and other items. Results According to the statutory standards for the examination, the qualified rate of the samples was 100.0%. The exploratory study found that there were significant differences in the residual oxygen of samples from various enterprises, ranging from 0.4% to 16.7%. The residual oxygen was positively correlated with the color of cefoxitin sodium solution, suggesting that enterprises should strictly control the nitrogen filling process. Conclusion Overall, the quality of cefoxitin sodium for injection at present is positive. The statutory standard needs to be further improved. It is suggested that the standard revise the inspection methods of related substances and increase the control of polymers. It is suggested that enterprises improve the nitrogen filling link in the production process to improve the product quality.

关 键 词：注射用头孢西丁钠 有关物质 聚合物 评价性抽验 质量分析 

分 类 号：R978.1[医药卫生—药品]