芪黄益气浓缩丸HPLC指纹图谱研究

目的：建立芪黄益气浓缩丸HPLC指纹图谱为评价其质量提供科学依据。方法：采用Venusil XBP C₁₈（L）（250 mm×4.6 mm，5 μm）色谱柱；检测波长为0~15 min 280 nm；15~70 min 250 nm；流速1.0 mL·min^-1；柱温25℃；流动相为甲醇（A）-水（B）梯度洗脱；使用指纹图谱相似度评价软件，对10批样品进行相似度评价；将芪黄益气浓缩丸HPLC指纹图谱与各单味药代表成分的HPLC指纹图谱进行比较分析，利用色谱峰的相对保留时间，对主要色谱峰进行归属和定性。结果：得到分离度、稳定性、重复性均良好的芪黄益气浓缩丸HPLC指纹图谱，标定22个共有指纹峰，并归属到各药材，确定5个峰的化学成分。对10批样品指纹图谱进行相似度评价，相似度均大于0.9。结论：该方法操作简单、重复性好、准确可靠，为完善芪黄益气缩丸的质量控制提供了依据。

Study on HPLC fingerprint of Qihuang Yiqi concentrated pills

OBJECTIVE To establish HPLC fingerprint spectrum of Qihuang Yiqi concentrated pills and provide the scientific basis for its quality evaluation.METHODS HPLC equipped with Venusil XBP C₁₈ (L) (250 mm×4.6 mm, 5 μm) column,was used and the detection wavelength was 280 nm within 0-15 min and 250 nm from 15 min to 70 min.The flow rate was 1.0 mL·min^-1 and column temperature was 25℃; methanol (A)-water(B) was used as mobile phase in gradient elution was selected. In addition,fingerprint similarity evaluation software was used to evaluate 10 batches of samples for similarity. The comparison of the HPLC fingerprints of Qihuang Yiqi concentrated pills and the representative components of each single drug in the pills were examined and analyzed. The main chromatographic peaks were assigned and characterized by their relative retention time.RESULTS The HPLC fingerprints of Qihuang Yiqi concentrated pills with good resolution, stability and repeatability were obtained. 22 common fingerprint peaks were interpreted and assigned to the corresponding medicinal material, and the chemical constituents of the five peaks were identified. The similarity was more than 0.9 in the analysis of 10 batches.CONCLUSION The method is simple, reproducible, accurate and reliable, which provides a basis for improving the quality control method of Qihuang Yiqi concentrated pills.