一清软胶囊HPLC指纹图谱研究

HPLC Fingerprint Analysis of Yiqing Soft Capsule

摘要:

目的: 建立一清软胶囊的高效液相指纹图谱,为一清软胶囊的内在质量评价提供依据。 方法: 采用Xtimate-C₁₈色谱柱,0.2%磷酸水(A)和乙腈(B)梯度洗脱,流速:0.6 mL·min^-1;检测波长280 nm,柱温30 ℃;测定5个厂家共15个批号的一清软胶囊指纹图谱并做相似度分析,通过和9个对照品、3个单味药材的色谱图进行对照,确定了各个色谱峰的归属。 结果: 建立了一清软胶囊的HPLC标准指纹图谱,标定了18个共有峰,与对照品对比分析,确定了8个特征峰。相似度分析结果说明各个厂家的样品差别较大,同一个厂家不同批次样品的相似度较好。不同厂家和批次的一清软胶囊中,大黄中的蒽醌类成分存在较大差异,黄连和黄芩中的主要成分相对稳定。 结论: 该方法准确可靠、重复性好,可用于一清软胶囊的质量控制。

Abstract:

Objective:To establish a method of fingerprint analysis on Yiqing soft capsule by HPLC and provide a reference for inner quality evaluation of Yiqing soft capsule. Method: The separation was performed on Xtimate-C₁₈ chromatographic column with mobile phase consisted of water (contains 0.2% phosphoric acid)-acetonitrile (gradient elution) at a flow rate of 0.6 mL·min^-1. Detecting wavelength was set at 280 nm and the column temperature was set at 30 ℃. About fifteen samples of Yiqing soft capsule from five manufacturers were determined and the similarity of each chromatogram was analyzed. The adscription of each peak was by comparing nine standard sample and three single herb preparation with Yiqing soft capsule. Result: HPLC-fingerprint of Yiqing soft capsule was established, which contained 18 common peaks, and eight peaks in the fingerprint were identified. The different batch samples made by the same producer had good similarity, but there were great differences among different manufacturers. There was great variability in the content of anthraquinones in individual crude drugs Rhubarb from different manufacturers and batches, but the main component in coptis root and scutellaria is relatively stable. Conclusion: The method with good reproducibility is accurate and reliable, it can be used in quality control of Yiqing soft capsule.