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目的:制备类似WHO的附带一宽分布标样表的低分子肝素(low molecular weight heparin,LMWH)相对分子质量测定用对照品。方法:采用肝素酶Ι控制降解肝素得到宽分布低分子的肝素片段混合物,并以WHO LMWH相对分子质量对照品为对照,采用高效分子排阻色谱法绘制自制相对分子质量与累积面积百分比的量表。分别利用该自制对照品与WHO对照品检测4种不同工艺制备的LMWH相对分子质量。结果:自制LMWH相对分子质量对照品与WHO相对分子质量对照品的校正曲线基本重合在一起,2种对照品测定的4种LMWH相对分子质量结果十分接近。结论:自制的LMWH相对分子质量测定用对照品可以用于LMWH相对分子质量的测定,为LMWH相对分子质量测定用对照品国产化奠定了基础。
OBJECTIVE: To prepare a reference substance for the determination of relative molecular mass of low molecular weight heparin (LMWH) with a wide distribution standard table similar to WHO. Methods: Heparin was treated with heparanase Ι to obtain a mixture of heparin fragments with wide distribution and low molecular weight. The WHO LMWH relative molecular weight reference substance was used as a control, and the relative molecular mass and cumulative area percentage were plotted by high performance size exclusion chromatography table. The relative molecular mass of LMWH prepared by four different processes of the homemade reference substance and the WHO reference substance were respectively used. Results: The calibration curves of LMWH relative molecular weight reference substance and WHO relative molecular weight reference substance basically coincide, and the relative molecular mass results of the four LMWH determined by the two reference substances are very similar. Conclusion: The homemade LMWH molecular weight determination reference substance can be used for LMWH molecular weight determination, LMWH relative molecular mass determination with the reference substance laid the foundation.