目的 建立同時(shí)測(cè)定茵梔黃顆粒中梔子苷、山梔苷、去乙酰車(chē)葉草苷酸甲酯和京尼平-1-β-D-龍膽二糖苷的一測(cè)多評(píng)法，驗(yàn)證該方法在茵梔黃顆粒質(zhì)量控制應(yīng)用中的科學(xué)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(chē)葉草苷酸甲酯和京尼平-1-β-D-龍膽二糖苷的相對(duì)校正因子，利用相對(duì)校正因子來(lái)計(jì)算各成分的質(zhì)量分?jǐn)?shù)，同時(shí)用外標(biāo)法測(cè)定茵梔黃顆粒中梔子苷等4個(gè)成分的質(zhì)量分?jǐn)?shù)，對(duì)一測(cè)多評(píng)的計(jì)算值和外標(biāo)法實(shí)測(cè)值進(jìn)行比較，驗(yàn)證一測(cè)多評(píng)法在茵梔黃顆粒中應(yīng)用的科學(xué)性和準(zhǔn)確性。結(jié)果 各相對(duì)校正因子重復(fù)性良好，一測(cè)多評(píng)法測(cè)定結(jié)果與外標(biāo)法測(cè)定結(jié)果無(wú)顯著差異。結(jié)論 在缺少對(duì)照品的情況下，以梔子苷為內(nèi)標(biāo)同時(shí)測(cè)定梔子苷、山梔苷、去乙酰車(chē)葉草苷酸甲酯和京尼平-1-β-D-龍膽二糖苷的一測(cè)多評(píng)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(diǎn)研發(fā)計(jì)劃（重大關(guān)鍵技術(shù)）項(xiàng)目（2016ZDJS07B09）；臨沂市自主創(chuàng)新重大專(zhuān)項(xiàng)（2016ZX020）