目的 建立HPLC法同时测定注射用益气复脉（冻干）（YQFM）中五味子醇甲、五味子醇乙、当归酰戈米辛Q和当归酰戈米辛H 4种木脂素类成分的含量。方法 采用Phenomenex Luna 5u C₁₈（2） 100A柱（250 mm×4.6 mm，5 μm），以乙腈-0.05%磷酸水梯度洗脱，体积流量1.0 mL/min，柱温30℃，检测波长220 nm。进行专属性、线性关系、加样回收率、重复性、稳定性、耐用性、方法适用性考察。结果 4种木脂素成分在各自浓度范围内线性关系良好（r>0.999）；加样回收率为93.09%、88.25%、90.69%、91.08%，RSD均小于2%；重复性、稳定性、耐用性结果均符合要求；选取21批YQFM样品进行含量测定，方法适用性良好。结论 所建立的方法准确可靠，可用于YQFM中五味子醇甲、五味子醇乙、当归酰戈米辛Q和当归酰戈米辛H 4种木脂素类成分的含量测定。

Objective To establish a method for the content determination of schizandrol A, gomisin A, angeloylgomisin Q, angeloylgomisin H of Yiqi Fumai Lyophilized Injection (YQFM) and to investigate the stability ofmethods. Methods The chromatographic separation was achieved on the Phenomenex Luna 5u C₁₈ column using acetonitrile-0.05% phosphoric acid water as mobile phase gradient elution, the flow rate was 1.0 mL/min, the column temperature was 30℃, and the detection wavelength was 220 nm.Specificity, linear relationship, sample recovery, repeatability, stability, durability and applicability of the method were investigated. Results The linear range of the four lignans were good in their own ranges (r>0.999). The average recovery of the four lignans was 93.09%, 88.25%, 90.69% and 91.08%, RSD was less than 2%. The results of repeatability, stability and durability all meet the requirements. Select 21 batches of YQFM samples for content determination, and the applicability of method was good. Conclusion The established method was accurate and reliable and can be used for the determination of the four lignans in YQFM.

R284.1