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目的测定低分子肝素的分子量及其分布。方法高效体积排阻色谱,以0.2mol·L-1硫酸钠水溶液(pH5.0)为流动相,TSK-GELG2000SWxl凝胶色谱柱,示差折光检测器与多角激光光散射仪联用。结果获得了供试品的分子量与分子量分布,并与《欧洲药典》中规定的高效体积排阻色谱法的测定结果比较,结果一致。结论本法不需要分子量对照品,可以直接测定低分子肝素分子量及其分布,快速简便,结果该确。
Objective To determine the molecular weight and distribution of LMWH. Methods High performance size exclusion chromatography (HPLC-MS) was performed with a 0.2 mol·L-1 sodium sulfate aqueous solution (pH 5.0) as the mobile phase and a TSK-GELG2000SWxl gel column with a refractive index detector and a polygon laser light scattering instrument. Results The molecular weight and molecular weight distribution of the test samples were obtained and compared with the results of high performance size exclusion chromatography as defined in the European Pharmacopoeia. The results were consistent. Conclusion This method does not require molecular weight reference substance, you can directly determine the molecular weight of low molecular weight heparin and its distribution, quick and easy, the results indeed.