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目的建立复方仙灵骨葆胶囊(XLGB)的超高效液相色谱(UPLC)指纹图谱,结合化学计量学方法对多批次市售制剂进行质量评价。方法采用ACQUITY UPLC BEH Shield RP18色谱柱(2.1 mm×50 mm,1.7μm);以乙腈-水(各含体积分数为0.1%的甲酸)为流动相进行梯度洗脱;流速0.5 m L·min~(-1);柱温30℃;检测波长0~4.6 min,246 nm以及4.6~18 min,270nm;通过对比保留时间和紫外吸收特征,结合峰纯度考察,对建立的指纹图谱中的主要特征峰进行准确指认,并归属组方中药来源;采用相似度软件,结合PCA以及PLS-DA方法,对16批市售产品进行质量评价。结果建立了仙灵骨葆胶囊UPLC指纹图谱,对其中27个峰进行了化学指认和药材归属,相似度在0.959~0.988之间,造成相似度差异的化合物主要为来源于淫羊藿中的朝藿定C和补骨脂中的补骨脂酚、异补骨脂苷和补骨脂苷。结论该方法专属性强,高效快速,可用于市售产品质量评价,为提升仙灵骨葆胶囊整体质量控制方法提供一定实验依据。
OBJECTIVE To establish the ultra-high performance liquid chromatography (UPLC) fingerprint of Compound Xianling Gubao Capsule (XLGB), and evaluate the quality of batches of commercial preparations by chemometric method. Methods The column was eluted with ACQUITY UPLC BEH Shield RP18 (2.1 mm × 50 mm, 1.7 μm). The mobile phase consisted of acetonitrile-water (0.1% formic acid) with a flow rate of 0.5 m L · min ~ (-1) .The column temperature was 30 ℃. The detection wavelength was 0-4.6 min, 246 nm and 4.6-18 min, 270 nm. By comparing the retention time and UV absorption characteristics with peak purity, the main characteristics of the established fingerprint The peak was accurately identified and belongs to the group of traditional Chinese medicine source; using the similarity software, combined with PCA and PLS-DA methods, quality evaluation of 16 batches of commercially available products. Results The UPLC fingerprints of Xianling Gubao Capsule were established, 27 of them were chemically identified and medicated. The similarities ranged from 0.959 to 0.988. The compounds that caused the similarities were mainly from the UPLC fingerprints of Epimedium Ounces C and psoralen in bakuchiol, isopsoralen and psoralen. Conclusion The method is highly specific, efficient and rapid and can be used to evaluate the quality of products marketed, providing some experimental evidence for improving the overall quality control of Xiongsugu capsule.