三七药材-三七二醇皂苷指纹图谱及其物质群量值传递分析

Analysis of Fingerprint of Notoginseng Radix et Rhizoma-panaxadiol Saponins and Their Quality Transmitting of Components Group

目的：建立同时适用于三七药材及其乙醇提取液、树脂洗脱液、三七二醇皂苷（PDS）的HPLC指纹图谱方法，分析PDS制备的主要工艺环节物质群量值传递情况。方法：采用HPLC，以乙腈-水为流动相进行梯度洗脱，建立了三七药材及其中间产物，PDS的指纹图谱检测方法；采用“中药色谱指纹图谱相似度评价系统”（2012版）软件对制备过程各关键工艺环节多批次样品进行相似度评价，同时进行物质群的量值传递分析。结果：建立的HPLC指纹图谱方法精密度、重复性和稳定性良好，能有效分离三七药材、中间产物及PDS各组分，标定了12批三七药材的16个共有峰，指认了其中5个主要色谱峰；各批次样品与其相应的对照指纹图谱的相似度均≥O．9；工艺过程较好地去除了药材中三七三醇皂苷类成分，而三七二醇皂苷类药效成分完整传递至PDS。结论：建立的指纹图谱方法稳定可靠，能充分展示三七药材、中间产物及PDS物质群变化及其量值传递情况，为中药新药的开发与应用提供了精准工艺及质量控制研究新模式；现有PDS主要工艺流程科学合理。

Objective： To provide an effective way for processing evaluation and quality control of panaxadiol saponins （PDS）, Notoginseng Radix et Rhizoma and its ethanol extract, resin eluent by establishing the fingerprint of them. Method： HPLC was adopted to establish fingerprint of Notoginseng Radix et Rhizoma, PDS and their intermediates. The similarity evaluation was analyzed with similarity evaluation system for chromatograhic fingerprint of traditional Chinese medicine （2012 version）. The processing of quality transmitting of components group was analyzed. Result： The components of PDS, Notoginseng Radix et Rhizoma and its ethanol extract, resin eluent could be well separated by the established HPLC. The developed method was precise, reproducible and stable. The similarities of the samples with their corresponding control fingerprint were~〉0.9. Sixteen common peaks were selected from 12 batches of Notoginseng Radix et Rhizoma, and 5 main peaks were identified. In the process, the panaxatriol saponins in the medicinal material was removed, while the PDS was transferred to PDS. Conclusion： The fingerprint method is stable and reliable, and it can fully demonstrate the changes of active materials of Notoginseng Radix et Rhizoma, panaxadiol saponins and their intermediate in the key production processes.