不同对照品对右旋糖酐铁分子量测定的影响

Influence of Different Reference Substance on the Molecular Weight and Weight Distribution of Iron Dextran

目的研究不同对照品对高效凝胶色谱法(HPGPC)测定右旋糖酐铁原料及制剂分子量的影响。方法分别采用右旋糖酐和普鲁兰为对照品,以Shodex SB-806M HQ(7.8 mm×300 mm)凝胶柱,对7个不同厂家生产的12批样品进行分析。结果以普鲁兰对照品测得的右旋糖酐铁峰位分子量比用右旋糖酐对照品测得的结果低。结论不同对照品对HPGPC测定右旋糖酐铁分子量的影响较大,对照品的选择直接影响测定结果的准确性。

OBJECTIVE To study the influence of different reference substance on HPGPC used in the determine the molecular weight of raw materials and the domestic preparation of iron dextran. METHODS The 12 iron dextran samples from 7 different manufactures were analyzed by Shodex SB-806M HQ （ 7.8 mm× 300 mm） column with dextran and pullulan as reference substance. RESULTS The peak molecular weight obtained by pullulan as reference substance was lower than those obtained by dextran as reference substance. CONCLUSION The calibration may be influenced greatly on detemaining molecular weight of iron dextran by different reference substances. The selection of appropriate reference substance directly affects the accuracy of the results of the determination of molecular weight.