HPSEC法检测注射用双黄连（冻干）中的高分子量物质

摘要

目的：建立注射用双黄连（冻干）中高分子量物质的检测方法。方法：采用凝胶色谱柱（ TSK-G2000SWxl，5μm，7．8mm ×300mm）；以三氟乙酸-乙腈-水（0．05：20：80）为流动相；蒸发光散射检测器检测；流速为0．7 mL/min。结果：注射用双黄连（冻干）中未检出高分子量物质。结论：所建立的方法简便、准确、灵敏度好，适合检测注射用双黄连（冻干）中的高分子量物质。%Objective:To establish a method for the determination of high molecular weight substances in Shuanghuanglian injection (freeze-drying).Methods:TSK-G2000 SWxl(5μm,7.8mm ×300mm)column was used.The mobile phase was a mixed solution of trifluoracetic -CH3 CN-Water(0.05:20:80) with the flow rate of 0.7mL/min.ELSD detector was used .Results:The high molecular weight substances were not detected in Shuanghuanglian injection ( freeze-dr-ying).Conclusion:The method is simple,accurate,sensitive and reliable for the determination of high molecular weight substances in Shuanghuanglian injection (freeze-drying).