右旋糖酐铁相对分子质量及其分布的探析

目的：对右旋糖酐铁原料及其制剂的相对分子质量与相对分子质量分布进行研究。方法：采用凝胶液相色谱法，示差检测器，Shodex SB-806M HQ（7.8 mm×300 mm）凝胶柱，以0.1%叠氮化钠溶液为流动相对7个厂家生产的12批样品进行分析。结果：各企业生产的右旋糖酐铁原料及其制剂的右旋糖酐铁相对分子质量与相对分子质量分布测定结果差异较大，且同一企业的原料与制剂测定结果也不一致。结论：各企业产品质量有待进一步提高，建议对现行质量标准增加右旋糖酐铁相对分子质量与相对分子质量分布的测定。本文为全面评价右旋糖酐铁的质量和完善其质量标准提供借鉴和参考。

Objective: To study relative molecular mass and relative molecular mass distribution of iron dextran and its preparation.Methods: The 12 samples from 7 different manufacturers were analyzed by high performance gel permeation chromatography(HPGPC) with reflective index detector and Shodex SB-806M HQ(7.8 mm×300 mm) column,and 0.1% sodium azide solution as mobile phase.Results: There were significant differences in the determination of relative molecular mass and relative molecular mass distribution among different products,and the relative molecular mass and relative molecular mass distribution of iron dextran and its preparation even from the same manufacturer differs a lot.Conclusion: The quality in different enterprises remains to be improved and the determination of relative molecular mass and relative molecular mass distribution should be involved in the quality standard.We provide useful reference for complete evaluation and the improvement of the quality standard of iron dextran.

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