摘要
目的:测定肝素钠及其类似物的dn/dc值及绝对分子质量,以便对该类药品进行更好的质控。方法:高效凝胶渗透色谱和激光光散射联用(SEC-MALLS)法,采用TSK G3000SW_(XL)色谱柱(300 mm×7.8 mm,10μm),流动相为2.84%硫酸钠溶液(含0.2%叠氮化钠),流速为0.5 mL·min^(-1),检测器为18角激光光散射器(MALLS)和示差折光检测器(DNDC)联用。结果:测得5个样品的dn/dc值,12个厂家共32批肝素及类似物的绝对分子质量及其分布情况。结论:该方法可用于该类产品的分子质量测定,并能初步判定样品是否含有其类似物。
Objective：To determine the dn/dc value and absolute molecular weight of heparin and it＇s similarities, so as to control the quality of this kind of drugs better.Methods：SEC - MALLS method,TSK - G3000PW column was used with mobile phases of 2.84%sodium sulfate（with 0.2%sodium azide）,at 35℃with a flow rate 0.5 mL·min^-1 by DNDC with laser light scattering detection.Results：dn/dc values of 5 samples were got,so as to the absolute molecular weight and absolute molecular weight distribution of 32 samples from 12 factories.Conclusion： The method can be used for determination of molecular weight of samples above,and assessment whether its similarities were incorporated.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2010年第4期677-679,共3页
Chinese Journal of Pharmaceutical Analysis
