注射用头孢尼西钠残留溶剂质量分析  

Quality analysis of residual solvents in cefonicid sodium for injection

作　　者：李佩 李雪[1] 洪建文[1] 田洁 Li Pei;Li Xue;Hong Jian-wen;Tian Jie(Guangdong Institute for drug control,Guangzhou 510663;Center for Drug Reevaluation,NMPA,Beijing 100022)

机构地区：[1]广东省药品检验所,广州510663 [2]国家药品监督管理局药品评价中心,北京100022

出　　处：《中国抗生素杂志》2022年第2期196-202,共7页Chinese Journal of Antibiotics

摘　　要：目的 通过比较不同企业生产的注射用头孢尼西钠中残留溶剂的种类和量,对该类产品的质量状况进行评价。方法在《中国药典》2020年版二部头孢尼西钠残留溶剂检测方法的基础上,新建头孢尼西钠中2-乙基己酸检测方法,均采用气相色谱法对各样品中残留溶剂的种类和量进行测定。结果 在《中国药典》质控要求的基础上,在13个生产企业的注射用头孢尼西钠中共发现3个需关注的溶剂,分别为异丙醇、异亚丙基丙酮和2-乙基己酸。结论 注射用头孢尼西钠中残留溶剂种类和量的差异揭示了该品种存在不同的原料合成工艺,而部分工艺中使用了毒性需关注的有机溶剂,提示生产企业需关注合成中溶剂的选择并加强对残留溶剂的控制,以保证药品的安全和质量。Objective To evaluate the quality of cefonicid sodium for injection by comparing the residual solvents in different manufacturers. Methods Based on the method of residual solvents in cefonicid sodium in ChP 2020, a new method for the determination of 2-ethylhexanoic acid in cefonicid sodium was established. The type and amount of residual solvents in each sample were determined by gas chromatography. Results Based on the quality control requirements of ChP, three solvents were found in 13 manufacturers of cefonicid sodium for injection,which were isopropanol, isopropylidene acetone, and 2-ethylhexanoic acid. Conclusion The differences of residual solvents in cefonicid sodium for injection revealed that there were different API synthesis processes, and some organic solvents with toxicity were used in some processes, which suggested that manufacturers should pay attention to the selection of solvents in synthesis and strengthen the control of residual solvents, so as to ensure the safety and quality of drugs.

关 键 词：头孢尼西钠 残留溶剂 质量分析 

分 类 号：R978.1[医药卫生—药品]