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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18.7g,冰醋酸34.5mL,加水溶解并稀释至5L)为流动相,流速0.5mL·min-1,TSK-GELG4000PWXL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 for the determination of relative molecular mass and distribution of hydroxyethyl starch 130 / 0.4 sodium chloride injection by multi-angle laser light scattering detector and differential refractometer with gel chromatography. Methods: The mobile phase consisted of acetate buffer solution (sodium acetate, 18.7g, acetic acid, 34.5mL, dissolved in water and diluted to 5L) with a flow rate of 0.5mL · min-1 and TSK-GELG4000PWXL column with multi-angle laser light scattering And refractive index detector combined; SPSS software cluster analysis. Results: The weight average molecular weight, number average molecular weight, relative molecular mass distribution and aggregation state of the samples were obtained. Seventeen samples from different sources were analyzed. The samples analyzed could be divided into two groups. Conclusion: The method is rapid, simple and accurate. It is suitable for the determination of relative molecular mass and distribution of the product. At present, the relative molecular mass and relative molecular mass distribution of hydroxyethyl starch 130 injection on the market are quite different. Further regulate.