红鹤方制剂HPLC指纹图谱研究?

目的建立红鹤方制剂HPLC指纹图谱,研究红鹤方制剂、各药材有效组分、原药材指纹图谱的相关性,为其质量控制提供依据。方法采用Inertsil ODS-3(5μm,4.6 mm×250 mm)色谱柱;流动相为乙腈(A)-0.01%磷酸水溶液(D),0~125 min内进行梯度洗脱;流速1 m L/min;柱温:25℃;检测波长223 nm;分别对10批样品、各药材有效组分和原药材进行测定。采用阴性对照的方式,通过对比红鹤方制剂、各药材有效组分、原药材及各药材阴性对照制剂指纹图谱,对共有峰进行归属。结果用对照品指认了制剂中6个色谱峰。采用中药指纹图谱相似度评价系统(2004A版)分析,确立了28个分离较好的共有峰,并根据共有峰对10批样品进行相似度分析。相似度结果表明,10批红鹤方制剂指纹图谱之间相似性良好,均大于0.96。红鹤方制剂中各共有峰均能在对应的有效组分及药材中得到归属。结论该方法简便易行,有较好的精密度、重复性及稳定性,可作为红鹤方制剂的质量评价方法。

HPLC fingerprint study of Honghe Fang preparation

Objective To establish the HPLC fingerprint of new preparation of Honghe Fang, a Chinese medicine compound, and to study the correlation of the preparation , effective components, and the fin-gerprint of raw herbal materials, so as to underlie its quality control. Methods The effective compo-nents were separated by HPLC with Inertsil ODS-3 column(5 μm, 4. 6 mm × 250 mm)in a gradient elu-tion of acetonitrile and water with 0. 01 H3 PO4 as the mobile phase at the flow rate of 1 mL/min and tem-perature of 25℃ and detection wavelength of 338 nm for 125 min. Then the common peaks were analyzed and identified by the alignment of HPLC fingerprint of Honghe Fang, effective components of raw herbal medicines, raw herbal medicines and negative control preparation. Results Altogether 28 common peaks separated completely from the 10 batches of Honghe Fang were confirmed by using the software“Similarity Evaluation System for Chromatographic Fingerprint of TCMs ( Version 2004 A )”, and of which six peaks were identified. The similarity based on the information of common peaks were all above 0. 96, a high similarity index. And each common peak could be identified in HPLC chromatograms of ef-fective components and raw herbal medicines. Conclusion This method proved to be simple, accurate and repeatable, could be applied in quality control of Honghe Fang.