亚胺培南首批对照品的研制  

Establishment of the first batch of reference standard of imipenem

作　　者：段宇 田冶[1] 谢晶鑫[1] 朱俐[1] 尹利辉[1] DUAN Yu;TIAN Ye;XIE Jing-xin;ZHU Li;YIN Li-hui(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国新药杂志》2024年第21期2299-2304,共6页Chinese Journal of New Drugs

摘　　要：目的:研制首批对照品亚胺培南,为我国相关制剂质量控制提供保障。方法:采用IR,LC⁃HRMS和NMR对亚胺培南样品进行结构确证;采用质量平衡法测定亚胺培南的含量,并进一步用核磁定量法及外标法对测定结果进行佐证,保证量值的准确性;采用高效液相色谱法对样品的均匀性、稳定性进行了研究,确保亚胺培南对照品均匀稳定。结果:本批亚胺培南对照品按亚胺培南(C_(12)H_(17)N_(3)O_(4)S)计含量为93.2%。结论:研制了首批亚胺培南国家对照品,可用于亚胺培南原料及相关制剂的鉴别和含量测定。Objective:To develop the first batch of reference standard of imipenem in order to provide assurance for the quality control of related preparations in China.Methods:The structure of imipenem was confirmed by IR,LC⁃HRMS and NMR.The content of imipenem was determined by mass balance method,and was further supported by quantitative nuclear magnetic resonance and external standard method to ensure the accuracy of the quantitative value.The uniformity and stability of the sample were studied using HPLC to ensure the uniformity and stability of imipenem reference substance.Results:The content of national reference standard of imipenem was calculated by mass balance method,with the amount of imipenem(C12H17N3O4S)93.2%.Conclusion:The first batch of national reference standard of imipenem was successfully established,which can be used for the identification and content determination of imipenem raw materials and related preparations.

关 键 词：亚胺培南 国家对照品 质量平衡法 含量测定 赋值 

分 类 号：R917[医药卫生—药物分析学]