β-内酰胺类抗生素聚合物检测中的质控方法分析探讨  

Analysis and Discussion of Quality Control Methods in the Detection ofβ-lactam Antibiotic Polymers

作　　者：黄财顺 陆璐璐 贺凡珍 王乾蕾 Huang Caishun;Lu Lulu;He Fanzhen;Wang Qianlei(Zhongshan Institue for Food and Drug Control,Zhongshan 528437,China)

机构地区：[1]中山市食品药品检验所,广东中山528437

出　　处：《化工与医药工程》2022年第3期20-24,共5页Chemical and Pharmaceutical Engineering

基　　金：广东省市场监督管理局科技项目(2021CS10)。

摘　　要：聚合物是β-内酰胺类抗生素产生不良反应的主要诱因,其对照品难以制备,自身对照法是较为理想的测定方法。目前《中国药典》采用基于葡聚糖凝胶Sephadex G-10的自身对照外标法作为主要的质控方法,而后衍生的替代对照品法弥补了自身对照法的不足。近几年发展的高效凝胶色谱法和柱切换技术,也是基于自身对照法,有效地将凝胶色谱法的优势与指针性聚合物杂质的定位结合起来。对相关文献报道的聚合物测定结果进行统计,为相关质控方法的应用提出建议。Polymer is the main cause of adverse reactions ofβ-lactam antibiotics,and its reference substance is difficult to prepare,so self-reference method is an ideal method for determination.At present,The Chinese Pharmacopoeia adopts the self-reference external standard method based on Sephadex G-10 as the main quality control method,and the derivative substitute reference method makes up for the deficiency of the self-reference method.The high performance gel chromatography and column switching techniques developed in recent years are also based on their own comparison methods,which effectively combine the advantages of gel chromatography with the localization of pointer polymer impurities.In this paper,the results of polymer determination reported in related literature were analyzed and some suggestions were put forward for the application of related quality control methods.

关 键 词：Β-内酰胺类抗生素 聚合物 自身对照法 

分 类 号：R927.1[医药卫生—药学]