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目的:建立注射用益气复脉(冻干)总木脂素的含量测定方法。方法:采用Phenomenex luna C18色谱柱(250mm×4.6mm,5μm);流动相:乙腈-水梯度洗脱;柱温30℃;检测波长218nm;进样量10μL;流速1mL/min。结果:五味子醇甲进样量在0.096～0.578μg范围内线性关系良好,其回归方程为:Y=404589x-9426.4,r=0.9998,精密度RSD1.88%,稳定性RSD2.29%,重复性试验RSD1.49%,平均回收率为99.84%、RSD 2.08%。结论:实验结果表明该方法简便,灵敏,专属性强,重复性好,可作为注射用益气复脉(冻干)的质量控制方法。
Objective: To establish a method for the determination of total lignans in Yiqi Fumai (freeze-dried) injection. METHODS: Phenomenex luna C18 column (250 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase was acetonitrile-water gradient. The column temperature was 30 ℃. The detection wavelength was 218 nm. The injection volume was 10 μL. The flow rate was 1 mL / min. Results: The calibration curve was linear in the range of 0.096-0.578μg. The regression equation was: Y = 404589x-9426.4, r = 0.9998, the precision RSD was 1.88%, the stability RSD was 2.29%, the repeatability Test RSD1.49%, the average recovery was 99.84%, RSD 2.08%. Conclusion: The experimental results show that the method is simple, sensitive, specific and reproducible, and can be used as a quality control method for injection of Yiqi Fumai (lyophilized).