药用辅料油酸钠质量标准的提高研究  

Improvement in quality standards of sodium oleate for pharmaceutical excipients

作　　者：严翠霞 吕晶 胡川梅 邵泓 郑璐侠 陈蕾[2] YAN Cuixia;Lyu Jing;HU Chuanmei;SHAO Hong;ZHENG Luxia;CHEN Lei(Shanghai Institute for Food and Drug Control,National Medical Products Administration Key Laboratory of Quality Control of Therapeutic Monoclonal Antibodies,Shanghai 201203,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]上海市食品药品检验研究院,国家药品监督管理局治疗类单抗质量控制重点实验室,上海201203 [2]国家药典委员会,北京100061

出　　处：《药学前沿》2025年第2期210-217,共8页China Pharmacist

基　　金：国家药品标准制修订研究课题项目(2022Y022)。

摘　　要：目的提升《中国药典(2020年版)》四部中油酸钠的质量标准。方法比较国内外药典标准,聚焦国内外药典标准在脂肪酸组成与含量测定两个项目上的差异,对现行国家标准中的脂肪酸组成项目进行考察,并建立HPLC法对其进行含量测定。结果根据试验结果,对现行国家药典标准中的脂肪酸组成与含量测定项目进行了增修订。HPLC法测定油酸钠在0.30~1.82 mg/mL范围内线性关系良好(r=0.9995);平均加样回收率为100.5%,RSD为1.1%(n=9);15批样品中油酸钠的含量范围在60.4%~101.2%。结论本研究从安全性和规范性上提高并完善了油酸钠的质量标准,旨在为行业提供更精确、可靠的质量控制标准。Objective To improve the quality standard of sodium oleate in the Chinese Pharmacopoeia(2020 Edition)Volume Four.Methods The domestic and international pharmacopoeia standards were compared,the differences in the two items of fatty acid composition and content determination between domestic and international pharmacopoeia standards were focused on,the current national standard for fatty acid composition was examined,and HPLC for its content determination was established.Results Based on the experimental results,the items of fatty acid composition and content determination in the current national pharmacopoeia standards had been revised and improved.The HPLC showed a good linear relationship for the determination of sodium oleate in the range of 0.30 to 1.82 mg/mL(r=0.9995).The average spiked recovery rate was 100.5%,and the RSD was 1.1%(n=9).The content of sodium oleate in 15 batches of samples ranged from 60.4%to 101.2%.Conclusion This study has improved and perfected the quality standards of sodium oleate from the aspects of safety and standardization,with the aim of providing a more accurate and reliable quality control standard for the industry.

关 键 词：油酸钠 脂肪酸组成 含量测定 关键质量属性 质量标准 药用辅料 

分 类 号：R927[医药卫生—药学]