连栀矾溶液HPLC指纹图谱研究

HPLC Fingerprint of Lianzhifan Solution

目的:建立中药复方制剂连栀矾溶液的HPLC指纹图谱,为该制剂的质量控制提供参考。方法:采用Phenomenex luna C_(18)色谱柱(250 mm×4. 6 mm,5μm),以0. 1%三乙胺0. 2%磷酸水溶液-甲醇-乙腈为流动相进行梯度洗脱,流速为1. 0 ml·min^(-1),检测波长为230 nm,柱温为30℃,建立连栀矾溶液HPLC指纹图谱,运用"中药色谱指纹图谱相似度评价系统"(2012版)软件对10批制剂进行相似度评价,通过对照品保留时间及光谱图的比对,对连栀矾溶液中4种化学成分进行指认,通过连栀矾溶液组方单味药和复方的HPLC比较,初步分析复方中化学成分的来源和归属。结果:建立的连栀矾溶液HPLC指纹图谱专属性、精密度、重复性和稳定性均良好; 10批连栀矾溶液指纹图谱与对照指纹图谱相似度值在0. 994～1. 000,相似度良好;与组方单位药材对比,连栀矾溶液指纹图谱中大部分色谱峰来源于黄连。结论:建立的连栀矾溶液HPLC指纹图谱能全面反映连栀矾溶液中多组分的整体特征,可用于连栀矾溶液的质量控制。

Objective: To establish an HPLC fingerprint of Lianzhifan solution to provide reference for the effective quality control.Methods: The HPLC separation was performed on a Phenomenex luna C18 (250 mm × 4. 6 mm,5 μm) column with the mobile phase consisting of water (0. 1% triethylamine and 0. 2% phosphoric acid)-methanol-acetonitrile with gradient elution at the flow rate of 1. 0ml·min-1. The detection wavelength was set at 230 nm and the column temperature was 30℃. Ten batches of Lianzhifan solution were collected to assess the similarities,the main peaks in the fingerprint were identified by comparing the retention time with that of the reference substances,and the source and attribution of chemical components in the preparation were analyzed by comparing with that in the single herb. Results: The established fingerprint of Lianzhifan solution was specific,precise and stable. Compared with the reference fingerprint,the fingerprint similarities of the 10 batches of Lianzhifan solution were between 0. 994 and 1. 000. A comparative analysis showed that most of the chromatographic peaks in the fingerprint of Lianzhifan solution were derived from Coptis. Conclusion:The analytical method of HPLC fingerprint can reflect overall characteristics of multicomponent and provide evidence for the quality control of Lianzhifan solution.