对照提取物在人参配方颗粒质量分析中的应用

Application of Extract Reference Substance in Quality Analysis of Ginseng Formula Granules

目的以人参水提对照提取物(GWERS)为参照,对11个不同厂家的19批人参配方颗粒进行质量分析。方法根据国家药品监督管理局颁布的人参配方颗粒标准(YBZ-PFKL-2021186)鉴别和特征图谱方法进行薄层色谱(TLC)鉴别,以及特征图检测。结果TLC分析结果表明,19批人参配方颗粒样品可以分成3类,第1类样品整体图谱与GWERS一致,相似度高;第2类样品检出西洋参特有成分伪人参皂苷F11;第3类样品图谱比GWERS多4个蓝色荧光斑点。HPLC分析结果表明,19批人参配方颗粒均呈现与GWERS色谱中保留时间相对应的8个特征峰。其中一厂家的3批样品图谱比其他样品图谱多出两个色谱峰,与GWERS图谱相似度低于0.65,其余16批样品图谱与GWERS图谱相似度高于0.94。结论目前市售的人参配方颗粒质量差异较大,疑存在混有西洋参投料的情况。应用GWERS分析人参配方颗粒的质量比对照药材具有更好的适用性。

Objective To analyze the quality of 19 batches of Ginseng Formula Granules from 11 different manufacturers by using Ginseng water Extract reference substance(GWERS)as references.Methods Thin layer chromatography(TLC)identification and feature map detection were carried out according to the identification items and characteristic maps of Ginseng Formula Granules standard(YBZ-PFKL-2021186)issued by the National Medical Products Administration.Results The results of TLC analysis showed that the 19 batches of Ginseng Formula Granules-labeled samples could be divided into three categories.The overall pattern of the first type of samples was consistent with that of GWERS,and the similarity was high.Pseudoginsenoside F11,a unique component of American ginseng,was detected in the second type of samples.Four blue fluorescent spots were observed in the third type of samples compared to GWERS.HPLC results indicated that all 19 batches of Ginseng Formula Granules showed eight characteristic peaks at the same retention time as that of GWERS chromatogram.Two more chromatographic peaks were found in the chromatogram of three batches of samples from one manufacturer compared to the chromatogram of other samples,whose similarity to the GWERS chromatogram was less than 0.65.The similarity between the chromatogram of the remaining 16 sample and GWERS chromatogram was higher than 0.94.Conclusion At present,the quality of Ginseng Formula Granules on the market varies greatly.It was suspected that American ginseng might appear among them.The application of GWERS for quality analysis of Ginseng Formula Granules has better applicability to the control medicinal materials.