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目的:采用高效液相色谱法测定散结镇痛胶囊中黄酮类成分的指纹图谱。方法:采用50%甲醇超声提取黄酮类成分进行分析检测。色谱条件为Waters Symmetry@C18(4.6 mm×250 mm,5μm)色谱柱;流动相为乙腈-水,梯度洗脱;检测波长275 nm;流速1.0 mL.min-1;柱温30℃。采用国家药典委员会出版的《中药色谱指纹图谱相似度评价》(2004年A版)软件,对10批不同批次的散结镇痛胶囊中黄酮类成分指纹图谱进行相似度计算。结果:指纹图谱中标记了15个共有峰,共有峰面积之和大于总峰面积的95%,利用指纹图谱相似度测试软件,测定10批散结镇痛胶囊中黄酮类成分指纹图谱相似度均在0.99以上。结论:方法具有良好的精密度、重复性、稳定性,各共有峰间分离度高,可用于散结镇痛胶囊质量的综合评价。
Objective: To determine the fingerprint of flavonoids in Sanjiezhitong capsule by HPLC. Methods: Ultrasonic extraction of flavonoids with 50% methanol for analysis and detection. The chromatographic conditions were Waters Symmetry @ C18 (4.6 mm × 250 mm, 5 μm) column. The mobile phase consisted of acetonitrile-water with gradient elution. The detection wavelength was 275 nm. The flow rate was 1.0 mL.min-1. Using the “Pharmacopoeia of Similarity Evaluation of Chromatographic Fingerprints of Traditional Chinese Medicines” (Version A, 2004) published by the State Pharmacopoeia Commission, similarity of flavonoid fingerprints in 10 batches of Sanjie analgesic capsules was calculated. RESULTS: Fifteen common peaks were marked in the fingerprint, and the sum of the total peak areas was more than 95% of the total peak area. Fingerprint similarity test software was used to determine the fingerprint similarity of flavonoids in 10 batches of Sanjie analgesic capsules Above 0.99. Conclusion: The method has good precision, repeatability, stability, high separation between the common peak, which can be used for the comprehensive evaluation of Sanjie analgesic capsule quality.