目的 建立同時測定茵梔黃顆粒中梔子苷、山梔苷、去乙酰車葉草苷酸甲酯和京尼平-1-β-D-龍膽二糖苷的一測多評法，驗證該方法在茵梔黃顆粒質(zhì)量控制應用中的科學性和可行性。方法 采用高效液相色譜法，以梔子苷為內(nèi)參物，建立該成分與山梔苷、去乙酰車葉草苷酸甲酯和京尼平-1-β-D-龍膽二糖苷的相對校正因子，利用相對校正因子來計算各成分的質(zhì)量分數(shù)，同時用外標法測定茵梔黃顆粒中梔子苷等4個成分的質(zhì)量分數(shù)，對一測多評的計算值和外標法實測值進行比較，驗證一測多評法在茵梔黃顆粒中應用的科學性和準確性。結果 各相對校正因子重復性良好，一測多評法測定結果與外標法測定結果無顯著差異。結論 在缺少對照品的情況下，以梔子苷為內(nèi)標同時測定梔子苷、山梔苷、去乙酰車葉草苷酸甲酯和京尼平-1-β-D-龍膽二糖苷的一測多評法可用于茵梔黃顆粒的定量分析。

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.

山東省重點研發(fā)計劃（重大關鍵技術）項目（2016ZDJS07B09）；臨沂市自主創(chuàng)新重大專項（2016ZX020）