田方 李军山 常云凤 高晗 李雪利

摘 要：为实现对车前子配方颗粒多指标成分的质量评价，解决中药化学对照品分离难度大、单体性质不稳定、供应价格高等问题，建立了一测多评法同时测定车前子配方颗粒中的3种有效成分含量。以京尼平苷酸为内标物，建立与芦丁、毛蕊花糖苷的相对校正因子，测定其含量，同时采用外标法测定这3种成分的含量，比较两种方法的结果差异。结果表明：京尼平苷酸、芦丁、毛蕊花糖苷分别在0.804～8.040，0.172～1.720，0.158～1.580 μg范围内线性关系良好（r≥0.999），平均加样回收率分别为102.52%，102.00%和101.86%，RSD值分别为1.64%，1.06%和1.07%。一测多评法所得结果与外标法差异不明显，具有较高的重复性、稳定性及可信度，可为车前子配方颗粒的质量评价提供参考依据。

關键词：中药化学;车前子配方颗粒;京尼平苷酸;芦丁;毛蕊花糖苷;一测多评

中图分类号：R2841   文献标志码：A

Simultaneous determination of three constituents in Plantago

Seed formula granules by QAMS

TIAN Fang1， LI Junshan1，2， CHANG Yunfeng1， GAO Han1， LI Xueli1

（1. Shineway Pharmaceutical Group Company Limited， Shijiazhuang， Hebei 051430， China;2. TCM Formula Granule Engineering Technology Research Center of Hebei， Shijiazhuang， Hebei  050200， China）

Abstract：In order to achieve the quality evaluation of the multi-index components of Plantago Seed Formula Granules and to solve the problem of the difficulty in separating the chemical reference substances of traditional Chinese medicine and the unstable supply price of monomer properties， the quantitative analysis of multi-components by single marker （QAMS） is established to simultaneously determine the content of three effective components in Plantago Seed formula granules.Geniposidic acid is used as the internal reference substance， and the relative correction factor of Rutin and Verbascoside is established respectively， measuring the content， and the three constituents are determined by the relative correction factor. At the same time， the content of the 3 components is determined by external standard method， and the difference between the results of the two methods is compared. Geniposidic acid， Rutin and Verbascoside show good linear relationships within the ranges of 0.804～8.040，0172～1.720，0.158～1.580 μg（r≥0.999），whose average recovery rate is 102.52%，102.00%，101.86%，and the RSD is 164%，1.06%，1.07% correspondingly. The results obtained by QAMS are close to the external standard method. The results turn out that it is no obviously difference between the two Methods and the quantitative analysis of multi-components by single marker （QAMS） is accurate and feasible， which could provide a reference for the quality evaluation of Plantago Seed formula granules.

Keywords：chemistry of Chinese materia medica;Plantago Seed formula granules; Geniposidic acid; Rutin; Verbascoside; quantitative analysis of multi-components by single marker （QAMS）

车前子为车前科植物车前Plantago asiatica L.或平车前Plantago depressa Willd.的干燥成熟种子，性寒，味甘，归肝、肾、肺、小肠经，《神农本草经》将其列为上品，具有清热利尿通淋、渗湿止泻、明目、祛痰的功效，用于治疗热淋涩痛、水肿胀满、暑湿泄泻、目赤肿痛、痰热咳嗽[1]，主产于江西、河南等地。本研究所用样品为车前的干燥成熟种子经水提取、浓缩、喷雾干燥而制成的颗粒，具有免煎易服、携带方便、计量准确、调配方便等优点，受到广大医患人员的欢迎[2]，但关于该制剂的质量控制方法目前尚无统一标准，相关报道也较少。

车前子配方颗粒的临床疗效是其活性成分、药理活性的综合体现，仅以单指标成分评价其质量高低有一定的局限性，难以体现制剂的整体质量。……