注射用头孢唑肟钠的质量评价  

Quality assessment of cefazole sodium for injection

作　　者：王小亮 梁亚伟 席志芳 牛龙青 邓玉龙 张伊榕 张秉华 Wang Xiaoliang;Liang Yawei;Xi Zhifang;Niu Longqing;Deng Yulong;Zhang Yirong;Zhang Binghua(Shanxi Institute for Food and Drug Control,Xi'an 710065)

机构地区：[1]陕西省食品药品检验研究院,西安710065

出　　处：《中国抗生素杂志》2024年第3期289-296,共8页Chinese Journal of Antibiotics

摘　　要：目的 评价国内上市的注射用头孢唑钠整体的质量状况。方法 按照法定标准检验结合探索性研究,包括对产品的有关物质、聚合物、残留溶剂、2-巯基苯并噻唑、成盐率等关键质量属性的考察,综合评价产品的质量及现行质量标准对产品质量的可控性。结果 抽取的238批样品,按法定标准检验,合格率为100.0%。探索性研究结果表明,法定标准在杂质控制、聚合物测定等方面存在一定不足;个别企业样品醋酸残留超出限度;部分企业样品检出基因毒性杂质2-巯基苯并噻唑;不同企业样品成盐率无明显差异。结论 国内上市的注射用头孢唑肟钠总体质量较好;现行标准需进一步统一和提高,建议完善有关物质等检测方法;建议生产企业关注工艺中“醋酸”的残留及2-巯基苯并噻唑的潜在风险。Objective This study evaluated the quality of cefazole sodium for injection in China.Methods The quality of cefazole sodium injection was assessed,along with its current specifications,in accordance with the legal standard determination and exploratory research.This included looking into related substances,polymer impurities,residual solvents,2-mercaptobenzothiazole,salt formation rate,and other important product quality attributes.Results The qualified rate of 238 batches of samples was 100.0% according to the legal specifications.The results of exploratory research showed that the legal specifications had some deficiencies in impurity control and polymer determination.The acetic acid residue of individual samples exceeded the limit;the genotoxic impurity 2-mercaptobenzothiazole was detected in some samples.There was no significant difference in the salt formation rate of samples from different manufacturers.Conclusion The quality of cefazoxime sodium for injection in China was good.The current specifications should be further unified and improved.It was proposed to improve the control of polymer impurities and related substances.It is suggested that manufacturers should pay attention to the residue of “acetic acid” in the process and the potential risk of 2-mercaptobenzothiazole.

关 键 词：注射用头孢唑肟钠 评价性抽验 质量评价 聚合物 二巯基苯并噻唑 

分 类 号：R917[医药卫生—药物分析学]