目的 建立HPLC法同時(shí)測定注射用益氣復(fù)脈（凍干）（YQFM）中五味子醇甲、五味子醇乙、當(dāng)歸酰戈米辛Q和當(dāng)歸酰戈米辛H 4種木脂素類成分的含量。方法 采用Phenomenex Luna 5u C₁₈（2） 100A柱（250 mm×4.6 mm，5 μm），以乙腈-0.05%磷酸水梯度洗脫，體積流量1.0 mL/min，柱溫30℃，檢測波長220 nm。進(jìn)行專屬性、線性關(guān)系、加樣回收率、重復(fù)性、穩(wěn)定性、耐用性、方法適用性考察。結(jié)果 4種木脂素成分在各自濃度范圍內(nèi)線性關(guān)系良好（r>0.999）；加樣回收率為93.09%、88.25%、90.69%、91.08%，RSD均小于2%；重復(fù)性、穩(wěn)定性、耐用性結(jié)果均符合要求；選取21批YQFM樣品進(jìn)行含量測定，方法適用性良好。結(jié)論 所建立的方法準(zhǔn)確可靠，可用于YQFM中五味子醇甲、五味子醇乙、當(dāng)歸酰戈米辛Q和當(dāng)歸酰戈米辛H 4種木脂素類成分的含量測定。

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