女贞子“一测多评”法测定

Quantitative Analysis of Multi-components in Ligustri Lucidi Fructus with Single Marker Method

目的：建立女贞子＂一测多评＂（QAMS）法,以实现女贞子中多指标成分控制。方法：采用HPLC法,以建立女贞子中红景天苷、女贞苷、特女贞苷、橄榄苦苷和oleonuezhenide含量测定方法为基础,以特女贞苷为参照物,统计其他成分的相对校正因子（fi,s）作为定量参数,同时统计其他组分与特女贞苷的相对保留时间（γi,s）作为定性参数。结果：各成分分离良好,系统适应性与方法学考察结果符合含量测定要求,在测定浓度范围内线性关系良好,相关系数均〉0.999 5,平均回收率为96.8%-105.0%（RSD≤3%）,在系统适应性范围内各fi,s的RSD均〈5%,各γi,s的RSD均〈2%,比较校正因子法与外标法的测定值,显示无显著差异。结论：建立的QAMS法准确、快速,结果可靠,具有可操作性,可用于女贞子多指标成分质量控制。

Objective： To establish a quantitative analysis of multi-components by single marker（ QAMS） method and realize quality control of Ligustri Lucidi Fructus. Method： HPLC method was used in this paper for determining the contents of specnuezhenide,nuezhenoside,oleuropein,salidroside and oleonuezhenide.With specnuezhenide as a reference,the relative correction factors（ fi,s） of other four constituents were used as a quantitative parameter and the values of relative retention time（ γi,s） were used as a qualitative parameter. Result：All five components were well separated. The results of system suitability test and methodology met the requirement of content determination. All the calibration curves showed good linearity in corresponding concentration ranges,with the correlation coefficients ≥ 0. 999 5. The recoveries of these target compounds were in the range of 96. 8%-105. 0%（ RSD ≤ 3%）. RSD of fi,sand γi,swere respectively less than 5% and 2% within the determination range. The results calculated with the proposed single marker method were consistent with those obtained by the external standard method, showing no significant differences between these two methods. Conclusion： The proposed QAMS method was proven to be operable and rapid with reliable results,which can be used for quality control of Ligustri Lucidi Fructus with multi-target ingredients.