右旋糖酐铁注射液峰位相对分子质量和重均相对分子质量的HPGPC测定  

HPGPC determination of iron dextran peak relative molecular mass and weight mean relative molecular mass in iron dextran injections

作　　者：万丹晶[1] 陈妙芬[2] 陈钢[2] 

机构地区：[1]复旦大学药学院放射药学教研组,上海200032 [2]上海市食品药品检验所,上海201203

出　　处：《药物分析杂志》2007年第5期708-710,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:比较右旋糖酐铁注射液峰位相对分子质量(M_p)和重均相对分子质量(M_w)的测定在质控中的应用。方法:采用凝胶液相色谱法,示差检测器。用 TSKG4000PW(300 mm×7.5 mm)凝胶柱测定右旋糖酐铁的 M_p,流动相是0.1%叠氮钠溶液,流速1.0 mL·min^(-1);用 TSKG3000PW(300 mm×7.5 mm)凝胶柱测定右旋糖酐的 M_w,流动相为0.71%硫酸钠溶液,流速0.5 mL·min^(-1)。采用 GPC 软件计算。结果:进口右旋糖酐铁注射液的 M_p 和 M_w 均符合标准要求,而国产右旋糖酐铁注射液除1个产品的 M_w 符合要求外,其余产品的 M_p 和 M_w 均不符合要求。结论:右旋糖酐铁络合物的 M_p 用于质量控制似乎更合理些。Objective molecular mass（Mw ） ：To compare the test method of peak relative molecular mass for the application in the quality control of several iron dextran （ Mp ） and weight mean relative injections. Methods： High performance gel permeation chromatography（HPGPC） was used along with reflective index detector. The TSKG4000PW （300 mm×7.5 mm） was used to determine the Mp of iron dextran complex with 0. 1% sodium azide solution as mobile phase at flow rate of 1.0 mL· min^-1. The TSKG3000PW（300 mm ×7.5 mm） was used to determine the Mw of dextran with 0. 71% sodium sulfate solution as mobile phase at flow rate of 0. 5 mL·min^-1. Both relative molecular mass were calculated with GPC software. Results：The Mp and Mw of import iron dextran injections were complying with the standard requirement. The Mp and Mw of domestic iron dextran injections were not complying with the standard requirement but the Mw of one domestic product. Conclusion：The Mp of iron dextran complex seems more reasonable in the quality control of iron dextran injections.

关 键 词：右旋糖酐铁注射液 峰位相对分子质量(Mp) 重均相对分子质量(Mw) 高效液相凝胶色谱法 

分 类 号：R917[医药卫生—药物分析学]