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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 mass of heparin sodium and its analogs for better quality control of such drugs. Methods: High performance gel permeation chromatography coupled with laser light scattering (SEC-MALLS) was performed on a TSK G3000SW XL column (300 mm × 7.8 mm, 10 μm) with a mobile phase of 2.84% sodium sulfate solution containing 0.2% Sodium azide) at a flow rate of 0.5 mL · min ~ (-1). The detector was equipped with a 18-angle laser light diffuser (MALLS) and a differential refractive index detector (DNDC). Results: The dn / dc values of 5 samples were measured, and the absolute molecular mass and distribution of 32 batches of heparin and the like from 12 manufacturers were measured. Conclusion: This method can be used to determine the molecular weight of these products, and can determine whether the sample contains its analogues.