低分子肝素分子量及其分布的测定

Measurement of molecular weight and molecular weight distribution of low molecular weight heparin

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 develop a method for the quality control of low molecular weight heparin.METHODS:Molecular weight and molecular weight distribution of LMWH was determined by high performance gel permeation chromatography(HPGPC)on Shodex Asahipak GF-510HQ column or TSK G3000SWxl column at 35℃with 2.84%(pH5.0)sodium sulfate as the mobile phase,It was detecled by RI and UV detector at 234nm.The flow rate of the mobile phase was 0.5ml·min -1 .RESULTS:The molecular weight and molecular weight distribution of two LMWH samples were obtained. RSD was less than 1%.CONCLUSION:The method is simple with good reproducibility(RSD <1%)and practicible for the control of the medicine.