凝胶色谱法测定参芪扶正注射液中的高分子物质

Determination of High Molecular Substances in Shenqi Fuzheng Injection by Gel Chromatography

目的:建立测定参芪扶正注射液中高分子物质的方法。方法:采用凝胶色谱法。色谱柱为TSKGEL2000SWxl(300mm×7.8mm,5μm),流动相为乙腈-0.83%三氟乙酸溶液(40∶60),流速为0.7mL·min-1,检测波长为214nm。结果:参芪扶正注射液中高分子物质在分子量1638～13700范围内,分子量对数与出峰时间呈良好线性关系(r=0.9848)。各批样品含高分子物质的量均≤1.0%。结论:该方法操作简便,结果准确、可靠,可以作为参芪扶正注射液的内控质量标准方法。

OBJECTIVE：To establish a method for the determination of high molecular substances in Shenqi fuzheng injection.METHODS：Gel chromatography was adopted.TSK GEL 2000 SWxl（300 mm×7.8 mm,5 μm） column was used with mobile phase consisted of acetonitrile-0.83% trifluoracetic acid（40：60） at flow rate of 0.7 mL·min-1.The detection wavelength was set at 214 nm.RESULTS：The weight of high molecular substances from 1 638 to 13 700 showed a good linear relationship between the logarithm of molecular weight and retention times（r=0.984 8）.The weight of high molecular substances in different batches was lower than 1.0%.CONCLUSION：The method is simple,accurate and reliable for internal quality control of Shenqi fuzheng injection.