国产与进口低分子肝素相对分子质量及其分布比较研究  

Comparison of relative molecular mass and distribution of domestic and imported low-molecular-weight heparins

作　　者：李京[1] 范慧红[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2006年第2期254-256,共3页Chinese Journal of Pharmaceutical Analysis

基　　金：北京市自然基金(7032041)

摘　　要：目的:考察国产低分子肝素的相对分子质量及其分布情况,并与进口低分子肝素比较,为制订该品种国家标准提供依据。方法:高效凝胶渗透色谱(HPGPC)法,色谱柱:TSK-GEL G3000SW(7.5mm×30cm,10μm);柱温:35℃;流动相:2.84%硫酸钠水溶液(pH5.0);检测波长:234nm;流速:0.5mL·min^(-1)。结果:测得国内外15个厂家共124批低分子肝素样品的相对分子质量及其分布情况。结论:大部分国内产品能符合 BP2003版对低分子肝素的相对分子质量的要求,但国内产品的相对分子质量分布整体较国外产品宽。Objective： To investigate the quality of local low - molecular - weight heparins （LMWH） and compare with similar imported products, so as to provide the basis for the national specification. Method：Relative molect, lar mass and relative molecular mass distribution of LMWH was determined by high performance gel permeation chromatography（ HPGPC）on TSK - GEL G3000SW（7.5 mm ×30 cm,10μm） column at 35 ℃ with 2.84% （pH 5.0） sodium sulfate as mobile phase, with RI and UV detector at 234 nm, The flow rate of mobile phase was 0. 5 mL · min^-1 Results： Relative molecular mass and relative molecular mass distribution of 124 LMWH samples of 15 domestic and overseas factories were analyzed. Conclusion： Almost all local products comply with the general rules of BP 2003, except two factories. In general, the relative molecular mass distribution of local products is wider than that of imported products.

关 键 词：低分子肝素 相对分子质量 相对分子质量分布 高效凝胶渗透色谱 

分 类 号：R917[医药卫生—药物分析学]