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目的：建立一种低分子肝素分子量及其分布测定的质量控制方法。方法：采用高效凝胶渗透色谱法（ＨＰＧＰＣ），色谱柱为ＳｈｏｄｅｘＡｓａｈｉｐａｋＧＦ－５１０ＨＱ（７．６ｍｍ×３００ｍｍ）或ＴＳＫＧ３０００ＳＷｘｌ（７．８ｍｍ×３００ｍｍ），理论塔板数以葡萄糖峰计算分别为１５２０６和１５７３１；柱温３５℃；流速０．５ｍｌ·ｍｉｎ－１；示差折光检测器和二极管阵列检测器联用，检测波长为２３４ｎｍ。结果：测得两个低分子肝素样品的重均分子量和分子量分布。结论：ＨＰＧＰＣ具有简便、快速和重现性好等特点，适合于该类药物的质量控制。
Objective: To establish a quality control method for molecular weight and distribution determination of low molecular weight heparin. Methods: High performance gel permeation chromatography (HPGPC) was used. The number of theoretical plates was 15206 and 15731 respectively for ShodexAsahipakGF-510HQ (7.6mm × 300mm) or TSKG3000SWxl (7.8mm × 300mm) Column temperature 35 ℃; flow rate 0.5ml · min-1; refractive index detector and diode array detector combined detection wavelength of 234nm. Results: The weight average molecular weights and molecular weight distributions of two low molecular weight heparin samples were measured. Conclusion: HPGPC is simple, rapid and reproducible. It is suitable for the quality control of these drugs.