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目的建立银杏二萜内酯提取物中大分子物质的高效液相体积排阻色谱(HPSEC-RI)检测方法。方法色谱柱为Phenomenex Biosep-SEC-S2000(300 mm×7.8 mm,5μm);以0.05 mol/L硫酸钠为流动相;体积流量为0.7 m L/min;柱温30℃;示差检测器,按面积归一化法计算大分子物质的质量分数。结果相对分子质量在2 500~84 400的物质,其相对分子质量对数-保留时间呈现良好的线性关系(r=0.998 3);平均回收率为96.8%,RSD为1.5%;5批银杏二萜内酯提取物和14批银杏二萜内酯葡胺注射液均未检出大分子物质。结论本方法简便易行,结果准确可靠,可作为银杏二萜内酯提取物及银杏二萜内酯葡胺注射液质量控制方法。
Objective To establish a method for the determination of macromolecular substances in diterpene lactone extract of Ginkgo biloba by high performance liquid chromatography with size exclusion chromatography (HPSEC-RI). Methods The chromatographic column was Phenomenex Biosep-SEC-S2000 (300 mm × 7.8 mm, 5 μm) with 0.05 mol / L sodium sulfate as mobile phase. The volume flow rate was 0.7 m L / min and the column temperature was 30 ℃. Area normalization method to calculate the mass fraction of macromolecules. Results The relative molecular mass logarithm-retention time showed a good linear relationship (r = 0.998 3) with an average molecular weight of 2 500-84 400; the average recovery was 96.8% and the RSD was 1.5%. Five batches of Ginkgo biloba No macromolecular substances were detected in the terpene lactones and 14 batches of diterpene lactone meglumine injection. Conclusion The method is simple and easy to operate with accurate and reliable results. It can be used as a quality control method for diterpene lactone extract and ginkgo diterpene lactone meglumine injection.