HPGPC-RID法测定右旋糖酐20分子量及其分布的可行性研究  

Feasibility study on the determination of molecular mass and its distribution of dextran 20 by HPGPC-RID method

作　　者：梁姗 王爱秀 王靖睿 张锦波 李小娟 黄群惠 朱衍志 LIANG Shan;WANG Aixiu;WANG Jingrui;ZHANG Jinbo;LI Xiaojuan;HUANG Qunhui;ZHU Yanzhi(Lanzhou Biotechnology Development Limited Company,Lanzhou,Gansu 730046,China)

机构地区：[1]兰州生物技术开发有限公司,甘肃兰州730046

出　　处：《现代医药卫生》2024年第12期1981-1985,共5页Journal of Modern Medicine & Health

摘　　要：目的 建立高效凝胶渗透色谱-示差折光检测器(HPGPC-RID)测定右旋糖酐20分子量及其分布的方法,并对该方法进行可行性研究。方法 对新建方法进行专属性、准确度、重复性及耐用性验证,并评价新建方法与《中国药典》2020版(二部)收录方法检测结果的等效性。结果 新建方法专属性、准确度、重复性、耐用性良好,且与药典方法等效,可用于右旋糖酐20分子量及其分布的测定。与此同时,新建方法能避免药典方法中硫酸钠(Na_(2)SO_(4))峰对右旋糖酐20峰的干扰。结论 相比于药典方法,新建方法对右旋糖酐20分子量及其分布测定具有更好的适用性。Objective To establish a method for the determination of molecular mass and distribution of dextran 20 by high performance gel permeation chromatography-refractive index detector(HPGPC-RID)and conducting a feasibility study on this new method.Methods The specificity,accuracy,repeatability and durability of the new method were verified,evaluating the equivalence between the new method and the Chinese Pharmacopoeia 2020 version(PartⅡ)method.Results The specificity,accuracy,repeatability and durability of the new method were good.The results were equivalent to pharmacopoeia methods,and could be used to determine the relative molecular mass and relative molecular mass distribution of dextran 20.At the same time,the new method could avoid the interference of sodium sulfate(Na_(2)SO_(4))peak to dextran 20 peak in the pharmacopoeia method.Conclusion Compared to pharmacopoeia method,the new method has better applicability for the determination of relative molecular mass and relative molecular mass distribution of Dextran 20.

关 键 词：高效凝胶渗透色谱-示差折光检测器 右旋糖酐20 分子量 分子量分布 等效性 

分 类 号：R286.0[医药卫生—中药学]