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

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-Ⅱ 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.