玻璃酸钠dn/dc值测定方法研究  

Determination Method of the dn/dc of Sodium Hyaluronate

作　　者：张丽容 宋玉娟[2] 李京[2] 范慧红[2] 王悦[2] 刘博[2] ZHANG Lirong;SONG Yujuan;LI Jing;FAN Huihong;WANG Yue;LIU Bo(School of Pharmacy,Yantai University,Yantai 264003,China;NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]烟台大学药学院,山东烟台264003 [2]中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京102629

出　　处：《中国药学杂志》2025年第4期407-411,共5页Chinese Pharmaceutical Journal

基　　金：国家药典会标准提高课题资助(65号)。

摘　　要：目的 建立玻璃酸钠(sodium hyaluronate, SH)折光指数增量(dn/dc值)的通用测定方法,为实现SH相对分子质量与相对分子质量分布的准确测定奠定基础。方法 采用不同仪器、流动相和样品对SH的dn/dc值进行研究。结果 SH在0.1 mol·L^(-1)硝酸钠溶液中更稳定,dn/dc值的相对标准偏差(RSD)均小于1.0%(n=3),建立了dn/dc值的准确测定方法。结论 新建测定方法简便、快速、准确,解决了SH的dn/dc值测定困难的问题,也为其他高分子物质相对分子质量与相对分子质量分布的精准测定提供了新的方法。OBJECTIVE To establish a universal method for determining the refractive index increment(dn/dc)of sodium hyaluronate(SH),laying the foundation for achieving accurate determination of SH molecular weight and molecular weight distribution.METHODS Various instruments,mobile phases,and samples were used to study the dn/dc of SH.RESULTS SH was more stable in 0.1 mol·L^(-1) sodium nitrate solution,and the relative standard deviation(RSD)of dn/dc was less than 1.0%(n=3).CONCLUSION The newly established determination method is simple,fast,and accurate,solving the problem of difficult determination of SH dn/dc both domestically and internationally for many years.It also provides new methods and ideas for determining the dn/dc of other polymer substances.

关 键 词：玻璃酸钠 相对分子质量 分子排阻色谱-多角度激光光散射联用法 折光指数增量 CalypsoⅡ梯度混合仪 

分 类 号：R917[医药卫生—药物分析学]