一测多评法结合面积归一化法测定西红花中西红花苷类成分

Determination of crocins in Croci Stigma by quantitative analysis of multi-components with single marker and area normalization method

目的:采用一测多评法结合面积归一化法,对西红花药材中西红花总苷进行质量控制,解决HPLC法测定含量时对照品不易获得的问题。方法:以西红花苷-Ⅰ为内参物,建立西红花苷-Ⅰ对西红花苷-Ⅱ的相对校正因子,利用相对校正因子计算西红花苷-Ⅱ的含量,实现一测多评;并与中国药典采用的外标法测定的32批西红花中西红花苷-Ⅰ和苷-Ⅱ含量进行比较,以验证一测多评法的可行性。同时以西红花苷-Ⅰ为对照,面积归一化法检测西红花中总西红花苷的含量。结果:西红花苷-Ⅰ相对西红花苷-Ⅱ的相对校正因子重复性好,一测多评法测定的32批西红花中西红花苷-Ⅱ的含量范围为1.2%~8.2%,与外标法测定的结果基本一致。面积归一化法测定的总西红花苷含量范围为7.1%~28.7%,与UV法测定的总西红花苷含量无显著性差异。结论:一测多评法结合面积归一化法测定西红花苷含量,该方法准确可靠,简便可行,能更合理地反映西红花的内在质量,可用于西红花中西红花苷类成分的质量控制。

Objective： To establish a method for determination of total crocins in Croci Stigma so as to overcome difficulties in the obtainment of reference compound. Methods： Crocin- I was used as reference to establish its relative correction factor （ RCF ） to crocin- II in order to perform quantitative analysis of multi-components with single marker（ QAMS ）. The contents of crocin- II in 32 batches of Croci Stigma were determined with RCF and external standard method （ ESM ） , respectively. The accuracy and feasibility of quantitative analysis of QAMS were evaluated by comparison of the data based on ESM and QAMS. Meanwhile, crocin- I was also used as the reference for determining the contents of total crocins by using area normalization method （ ANM ）. Results： RCF had a good repeatability. The contents of crocin- 11 in 32 batches of Croci Stigma, determined by QAMS, were 1.2%-8.2%. and they were of no significant differences compared with determined by ESM. The contents of total crocins determined by ANM were 7.1%-28.7%, and they were consistent with those determined by UV. Conclusion： The presented method, QAMS combined with ANM, is accurate, simple and feasible, which can be used as a quality control method for Croci Stigma as crocins.