目的 建立银杏达莫注射液定量测定方法。方法 黄酮类成分(槲皮素、山柰素和异鼠李素)采用Agela C₁₈柱(150 mm×4.6 mm,5 μm),乙腈-0.4%磷酸水溶液为流动相,梯度洗脱,体积流量1.0 mL/min,检测波长360 nm,柱温35 ℃。内酯类成分(银杏内酯A、B、C及白果内酯)采用Agela C₁₈柱(150 mm×4.6 mm,5 μm),甲醇-四氢呋喃水溶液(10:75)为流动相,梯度洗脱,体积流量0.8 mL/min,用蒸发光散射检测器检测,柱温30 ℃。结果 分别取10个批次的银杏达莫注射液,测定7个主要成分的量,槲皮素12.4 μg/mL、山柰素20.8 μg/mL、异鼠李素5.5 μg/mL、银杏内酯A 7.2 μg/mL、银杏内酯B 2.6 μg/mL、银杏内酯C 4.7 μg/mL、白果内酯102.0 μg/mL。结论 建立的方法稳定性、重复性、精密度等方面考察均符合要求,可作为银杏达莫注射液质量控制方法。

Objective To establish a method for quantitative determination of Dipyridamole Injection. Methods The flavonoids were determined using Agela C₁₈ column (150 mm × 4.6 mm, 5μm), acetonitrile-0.4% phosphoric acid (gradient) as the mobile phase with flow rate 1.0 mL/min, detection wavelength of 360 nm, column temperature of 35 ℃. The lactones were determined using Agela C₁₈ column (150 mm × 4.6 mm, 5 μm), methanol-tetrahydrofuran and water (10:75) solution (gradient) as the mobile phase with flow rate 0.8 mL/min, with evaporative light scattering detector, and column temperature of 30 ℃. Results Respectively taking 10 batches of Dipyridamole Injection, the contents of seven major components such as quercetin, kaempferide, isorhamnetin, ginkgolide A, ginkgolide B, ginkgolide C, and bilobalide were determined as 12.4, 20.8, 5.5, 7.2, 2.6, 4.7, and 102.0 μg/mL. Conclusion The established method is with good stability, repeatability, and precision, which conforms to the requirements and can be used for the quality control of Dipyridamole Injection.

贵州省科技基金(黔中合重大专项字[2011]6019-06号)