一测多评法测定茵栀黄颗粒中4个环烯醚萜苷类成分

Determination of four iridoid glycosides in Yinzhihuang Granules by QAMS

目的建立同时测定茵栀黄颗粒中栀子苷、山栀苷、去乙酰车叶草苷酸甲酯和京尼平-1-β-D-龙胆二糖苷的一测多评法,验证该方法在茵栀黄颗粒质量控制应用中的科学性和可行性。方法采用高效液相色谱法,以栀子苷为内参物,建立该成分与山栀苷、去乙酰车叶草苷酸甲酯和京尼平-1-β-D-龙胆二糖苷的相对校正因子,利用相对校正因子来计算各成分的质量分数,同时用外标法测定茵栀黄颗粒中栀子苷等4个成分的质量分数,对一测多评的计算值和外标法实测值进行比较,验证一测多评法在茵栀黄颗粒中应用的科学性和准确性。结果各相对校正因子重复性良好,一测多评法测定结果与外标法测定结果无显著差异。结论在缺少对照品的情况下,以栀子苷为内标同时测定栀子苷、山栀苷、去乙酰车叶草苷酸甲酯和京尼平-1-β-D-龙胆二糖苷的一测多评法可用于茵栀黄颗粒的定量分析。

Objective To establish a quantitative analysis method of multi-components with single marker（QAMS） for the simultaneous determination of geniposide, shanzhiside, deacetyl asperulosidic acid methyl ester and genipin-1-β-D-gentiobioside in Yinzhihuang granules, which is proved to be a scientific and feasible method for the quality control in Yinzhihuang granules. Methods Geniposide was chosen as the internal reference substance in the HPLC method, and three relative correction factors（RCFs） of geniposide to shanzhiside, deacetyl asperulosidic acid methyl ester and genipin-1-β-D-gentiobioside were established, which were adopted to calculate the mass fraction of each. Meanwhile, the mass factions of four iridoid glycosides in Yinzhihuang granules were also calculated by the external standard method（ESM）, and the scientificalness and feasibility of QAMS was verified by comparing the quantitative results between the two methods. Results The three relative correction factors（RCFs） were perfact. The detection calculated by QAMS was consistent with the results by ESM. Conclusion The established QAMS method can be used for quality control of Yinzhihuang granules to improve its quality standard, especially when some authentic standard substances were unavailable.