摘要
目的:测定不同生产厂家生脉注射液中大分子物质含量.方法:采用色谱柱为G4000PWXL 7.8×300 mm,10μm;色谱条件为柱温35℃,内部温度35℃,流速0.6 mL·min-1;流动相为0.01%硫酸钠溶液(内含0.02%叠氮钠).结果:8家企业生脉注射液,均有分子量2700(右旋糖酐D1)到分子量64650(右旋糖酐D6)范围内的大分子物质,且每个厂家内各批次的数据较平行.结论:本方法重复性良好,可用于生脉注射液中大分子物质相对分子质量及其分布的测定,测定结果可为生脉注射液质量标准制定提供参考.
Objective:Study on the determination of macromolecular substances of Shengmai injection.Methods:Separation was performed on a G4000PWXL 7.8×300 mm,10μm.The chromatographic column temperature is 35℃,the internal temperature is 35℃,and the mobile phase is 0.01%Na 2 SO 4(Containing 0.02%NaN 3)at a flow rate of 0.6 mL·min-1.Results:The products of 8 companies all have the 2700(Dextran D1)-64650(Dextran D6)polysaccharide macromolecules,and the data of each batch in each manufacturer is relatively parallel.Conclusion:This method has a good repeatability and can be used to determine the relative molecular weight and distribution of macromolecules in Shengmai injection.The results can be used to improve the quality standard of Shengmai injection.
作者
刘斯亮
姜范成
鄢长余
LIU Si-liang;JIANG Fan-cheng;YAN Chang-yu(Dalian Inspection and Certification Technical Service Center,Liaoning Dalian 116021,China)
出处
《中国药物评价》
2020年第1期38-40,共3页
Chinese Journal of Drug Evaluation
关键词
高效凝胶渗透色谱
生脉注射液
大分子物质
重均分子量
High performance gel permeation chromatography
Shengmai injection
Macromolecular substances
Weight-average molecular weight
