目的 建立热毒宁注射液中高分子物质的测定方法。方法 采用体积排阻色谱法，色谱柱为TSK G2000SWxl凝胶色谱柱（300 mm×7.8 mm，5 μm）；以乙腈-0.1%三氟乙酸水溶液（30∶70）为流动相；体积流量0.7 mL/min；检测波长214 nm；柱温30 ℃。结果 相对分子质量在3 108～66 446的物质，其相对分子质量对数与保留时间呈现良好的线性关系（r＝0.992 0）；11批热毒宁注射液均未检出高分子物质。结论 本方法简便易行，结果准确可靠，可作为热毒宁注射液质量内控方法。

Objective To establish a high performance size exclusion chromatography for the determination of high molecular weight substance in Reduning Injection. Methods The chromatography on TSK G2000 SWxl column (300 mm × 7.8 mm, 5 μm) was used with 0.1% trifluoroacetic acid aqueous solution-acetonitrile (70∶30) as the mobile phase at a flow rate of 0.7 mL/min, and the detection wavelength was at 214 nm at column temperature of 30 ℃. Results In the range of 3 108—66 446, the molecular weight was linear with retention time (r = 0.992 0). The high molecular weight substances were not detected in 11 batches of Reduning Injection. Conclusion This method is simple, quick, and accurate, and suitable for the quality control of Reduning Injection.

“973”计划项目（中药制药过程控制技术模式和方式研究，2010CB735604）