药用辅料明胶相对分子量及其分布测定方法的建立  

Establishment of a method for determination of relative molecular weight and distribution of pharmaceutical excipients gelatin*

作　　者：吴福海 康肖梦 孙钰林 邢宇 WU Fu-hai;KANG Xiao-meng;SUN Yu-lin;XING Yu(CAEA Center of Excellence on Nuclear Technology Applications for Engineering and Industrialization of Radiopharmaceuticals,CNNC Engineering Research Center of Radiopharmaceuticals,HTA Co.,Ltd.,Beijing 102413,China)

机构地区：[1]原子高科股份有限公司,国家原子能机构核技术(放射性药物工程转化)研发中心,中核集团放射性药物工程技术研究中心,北京102413

出　　处：《化学工程师》2025年第4期34-38,共5页Chemical Engineer

基　　金：中核集团青年英才项目(YZGK-KY23-06)。

摘　　要：建立了测定药用辅料明胶相对分子量及其分布的凝胶渗透色谱法。色谱柱为Agilent PL aquagel-OH MIXED-H(300×7.5mm,8μm),3根串联,示差折光检测器温度为40℃,流动相为含0.2mol·L^(-1)NaNO3的混合盐溶液(等度洗脱),流速为1.0m L·min^(-1),柱温为30℃,进样量为20μL。建立的聚乙二醇/聚环氧乙烷分子量分布标准曲线线性关系良好(r≥0.999);在2.0~20.0mg·m L^(-1)浓度范围内明胶浓度和其峰面积有良好的线性关系(r≥0.999);方法的精密度良好。建立的凝胶渗透色谱法操作简便、准确度高,可用于测定药用辅料明胶的相对分子量及其分布,为药用辅料明胶的生产、质量控制及药品辅料的选择提供了依据。A gel permeation chromatography method was established for the determination of relative molecular weight and distribution of pharmaceutical excipients gelatin.The chromatography was performed on Agilent PL aquagel-OH MIXED-H(300×7.5mm,8μm)column with three columns in series.The temperature of differential refraction detector was 40℃,and the mobile phase was mixed salt solution containing 0.2mol·L^(-1) sodium nitrate(iso-elution)at the flow rate of 1.0mL·min^(-1).The column temperature was 30℃,and the injecting volume was 20μL.The standard curve of molecular weight distribution of polyethylene glycol/polyethylene oxide had a good linear relationship(r≥0.999).In the range of 2.0~20.0mg·mL^(-1),the concentration of gelatin had a good linear relationship with its peak area(r≥0.999).The precision of the method is good.The established gel permeation chromatography method is simple and accurate,and can be used to determine the relative molecular weight and distribution of pharmaceutical excipient gelatin.It provides a basis for the production,quality control and selection of pharmaceutical excipient gelatin.

关 键 词：凝胶渗透色谱法 明胶 分子量及其分布 药用辅料 

分 类 号：O657.72[理学—分析化学] R917[理学—化学]