羟乙基淀粉130/0.4氯化钠注射液相对分子质量及分布的测定___

目的：建立凝胶色谱法由多角度激光光散射检测器和示差折光检测器联用测定羟乙基淀粉130/0.4氯化钠注射液相对分子质量及分布的方法。方法：以醋酸盐缓冲液（醋酸钠18.7 g，冰醋酸34.5 mL，加水溶解并稀释至5 L）为流动相，流速0.5 mL•min-1，TSK-GEL G4000 PWXL色谱柱，多角度激光光散射检测器和示差折光检测器联用；SPSS软件进行系统聚类分析。结果：获得了样品的重均相对分子质量、数均相对分子质量、相对分子质量分布、聚集态等数据；分析了17个不同来源样品，所分析样品大致可分为2类。结论：本方法快速、简便，结果准确，适于该产品相对分子质量及分布的测定；目前，市售的羟乙基淀粉130注射液的相对分子质量及相对分子质量分布差异较大，有待于进一步规范。

Objective:To establish a method to determine relative molecular mass and distribution of hydroxyethyl starch 130/0.4 and sodium chloride injection by size exclusion chromatography.Methods:A gel size-exclusion chromatography in conjunction with refractive index detector and multi-angle laser light scattering detection-line,was performed on a TSK-GEL G4000 PWXL column,using acetate buffer(sodium acetate 18.7 g,glacial acetic acid 34.5 mL,dissolved and diluted to 5 L with water) as mobile phase.The flow rate is 0.5 mL•min-1.Hierachical cluster analysis was executed by SPSS software.Results:The weight-average relative molecular mass,relative molecular mass distribution and conformational information were obtained.All of the 17 samples coming from different factories were determined,and the samples can be clustered into two groups.Conclusion:This method is convenient,accurate and rapid for the quantitative determination of molecular substitution of hydroxyethyl starch 130/0.4 and sodium chloride injection.It is demonstrated that weight-average relative molecular mass and distribution in the samples vary greatly from different factories,and need for further standardizing.