右旋糖酐铁注射液中右旋糖酐铁峰位相对分子质量的测定

目的:建立测定右旋糖酐铁注射液中右旋糖酐铁峰位相对分子质量(Mp)的方法,以评价2种注射液的质量差异。方法:色谱柱为TSKG4000SW凝胶柱(7.5mm×30.0cm),保护柱为TSKgelSWguardcolumn(7.5mm×7.5cm);流动相为0.1%叠氮化钠水溶液,流速为1.0mL·min-1;柱温和检测器温度为30℃。以已知Mp的右旋糖酐为标样,拟合计算右旋糖酐的Mp工作曲线,并经已知Mp的右旋糖酐铁对照品校正,进一步拟合计算右旋糖酐铁的Mp。结果:注射液A右旋糖酐铁Mp较小,平均为1.53×105;注射液B右旋糖酐铁Mp较大,平均为4.26×105。结论:建立了右旋糖酐铁的峰位Mp的测定方法,2种注射液中右旋糖酐铁的Mp相差较大,反映了注射液的质量差异。

Iron dextran peak molecular weight comparison determination in iron dextran injections

AIM: To establish a method for iron dextran peak molecular weight de termination in order to evaluate the quality of the two iron dextran inje ctions. METHODS: High performance gel permeation chromatography (HPGPC) was us ed to determine the peak molecular weight in the two injections. The TSK G4000SW g el column (7.5 mm×30.0 cm) and TSKgel SW guard column (7.5 mm×7.5 cm) were uti lized with 0.1 % NaN_3 as mobile phase taking known peak molecular weights of dextra ns a s the calibration standards and known peak molecular weights of iron dextrans as corrected standards. The flow rate was (1.0 mL·min~(-1)) with 30 ℃ as th e te m peratur e for the column and the reflective index detector. RESULTS: A method for pea k molecular weig ht determination of iron dextran was established. The peak molecular weight for injection A was determined as 1.5×10~5 and for injection B as 4.2×10~5. CONCLUSIO N: A method for determination of iron dextran peak molecular weight was establi shed and the values of peak molecular weight were varied greatly between the two injections suggesting different quality between them.