多糖类辅料分子质量及分子质量分布的研究方法进展  

Research progress of determination methods for molecular mass and molecular mass distribution of polysaccharides excipients

作　　者：刘海涛 张朝阳[1] 杨锐[1] 王珏[1] 汤龙[1] 孙会敏[1] LIU Hai-tao1,2 ,ZHANG Zhao-yang1, YANG Rui1 ,WANG Jue1 , TANG Long1, SUN Hui-min1(1. National Institutes for Food and Drug Control, Beijing 100050, China; 2. China Pharmaceutical University, Nanjing 211198, China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]中国药科大学,南京211198

出　　处：《药物分析杂志》2018年第3期376-384,共9页Chinese Journal of Pharmaceutical Analysis

基　　金：中国食品药品检定研究院中青年课题:多糖类大分子药用辅料分子量测定方法比较(2015C04);国家药典委员会课题-辅料功能性评价及大分子药用辅料分子量分布测定

摘　　要：药用辅料的功能性指标会影响药物制剂的稳定性和一致性,在药用辅料的质量研究中日益引起人们的重视,多糖属于药用辅料中的一种,其应用日趋广泛。因多糖类辅料的分子质量及其分布是影响其功能性的关键指标,需对其分子质量及其分布进行准确测定。本文对多糖类辅料的分子质量及其分布测定方法进行归纳总结,主要包括黏度法、凝胶渗透色谱法、凝胶渗透色谱与光散射法联用、场流分离法等。黏度法只能得到黏均分子质量,凝胶渗透色谱法可得到相对分子质量及其分布,当其联用光散射法时,可测定绝对分子质量及其分布,场流分离法也可得到绝对分子质量及其分布,但在药用辅料测定中应用有限。Functionality related characteristics （ FRCs ） of pharmaceutical excipients will affect the stability and consistency of the pharmaceutical preparations, and have attracted much attention to the quality control of pharmaceutical excipients. Polysaccharides is one kind of pharmaceutical excipients. Its application has become increasingly popular. Molecular mass and its distribution of polysaccharide excipients are the key factors that affect FRCs. Thus these key factors should be measured accurately. In this review, the determination methods for molecular mass and molecular mass distribution of polysaccharide excipients were summarized, including viscosity method, gel permeation chromatography （ GPC ）, GPC combined with laser light scattering method and field flow separation method etc. Viscosity method can only generate viscosity-average molecular mass, molecular mass values and their distribution can be obtained by GPC, the absolute molecular mass and molecular mass distribution can be obtained by GPC combined with laser light scattering method or field flow fractionation （ FFF ） method while FFF method is not widely used in pharmaceutical excipients.

关 键 词：药用辅料 多糖检测 分子质量 相对分子质量分布 凝胶渗透色谱法 光散射法 场流分离法 

分 类 号：R917[医药卫生—药物分析学]