摘要
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.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
1999年第5期332-334,共3页
Chinese Pharmaceutical Journal
关键词
低分子肝素
分子量
分布
HPGPC
low molecular weight heparin, HPGPC, molecular weight , molecular weight distribution