摘要
为评价三七总皂苷提取物和不同厂家血塞通注射液整体质量及成分组成差异,建立超高效液相色谱与三重四级杆飞行时间质谱联用技术UPLC-QTOF MS^E分析方法,进行数据采集,借助多元统计的主成分分析方法(PCA)及偏最小二乘法(OPLS-DA)比较分析组分差异,筛选特征成分。结果显示PCA图上三七总皂苷提取物和不同厂家血塞通注射液样品明显分为3部分,特别是He与YB厂家血塞通注射液样品分在两组,只有Hu厂家样品与提取物分为一组,表明血塞通注射液样品厂家间及厂家内部质量均一性都不好,且成药的质量与提取物的质量密切相关。运用统计学方法,筛选出造成质量差异的特征成分,分别为人参皂苷Rd、Rg_1、Re、Rb_1、Rh_1、Rg_2、Rh_4、Rk_1 or Rg_5、Rg_3、F_2、绞股蓝皂苷Ⅶ、三七皂苷Fc、原人参二醇。其中人参皂苷Rd、Rg_1、Re、Rb_1及绞股蓝皂苷Ⅶ被认为是控制三七总皂苷提取物和血塞通注射液质量的指标成分,通过对这些特征成分的有效控制,可以保证三七提取物原料及注射液质量的均一稳定。
In the present study, we established an UPLC-QTOF-MSE based metabolomic approach in order to evaluate the holistic qualities and compare the quality difference by finding characteristic components of Panax notoginseng extracts （PNE） and Xuesaitong （XST） injection samples from different manufacturers. The data were processed through unsupervised principal component analysis （PCA） and supervised orthogonal partial least squared discrimination analysis （OPLS-DA） to compare the quality differences. Two-dimensional PCA score plots showed a tendency to separate the XST injections and extracts, and most XST injection samples were clearly clustered into two groups. Especially, the injections from He and YB companies were distinguished into two groups. In addition, only injection samples of Hu company were near the cluster of PNE. To explore the potential chemical components contributing most to the differences between XST injection samples from different manufacturers and PNE, an S-plot was constructed following the OPLS-DA. Ginsenoside Rd, ginsenoside Rgl, ginsenoside Re, ginsenoside Rbl, 20（S）-ginsenoside Rhl, gypenoside VII, ginsenoside Rg2, ginsenoside Rh4, ginsenoside Rkl or Rgs, notoginsenoside Fc, 20（R）-ginsenoside Rg3, ginsenoside F2 and protopanaxadiol were recognized as characteristic chemical markers that contributed most to reflect the difference between XST injections and PNE. Ginsenoside Rd, ginsenoside Rgl, ginsenoside Re, ginsenoside Rbl and gypenoside VII were revealed as index components contributing most to the differences of PNE and XST injections, and quantitative analysis of these components could ensure the consistent quality of XST injections. Based on the fact that the injections should be standardized with the characteristic components as quality control chemical markers, it is most important to keep the quality of extracts of raw materials stable and reliable.
