目的 建立以对照药材为基准物质的定性和不依赖多种对照品定量的甘草Glycyrrhiza uralensis药材“质-量”双标控制方法。方法 采用HPLC技术，以对照药材为基准物质建立甘草特征图谱，通过Q-TOF-MS技术，鉴定共有峰的化学成分，以对照药材和供试药材特征峰的相似度，明确药材真伪，即“质”；对内标成分“甘草酸”进行准确定量，以内标成分计，计算不同批次供试品中各特征峰的相对含量，取“平均数－标准差”作为特征峰化学成分相对于内标物质化学成分的相对含量下限，依据特征峰相对含量下限明确甘草药材优劣，即“量”。结果 建立的特征图谱及含量测定方法符合方法学考察要求；确定了10个共有色谱峰，鉴定出了5个化学成分，分别为芹糖甘草苷、甘草苷、芹糖异甘草苷、异甘草苷、甘草酸，各甘草供试药材与甘草对照药材的相似度均大于0.90；规定了甘草药材特征峰化学成分相对含量下限。结论 该方法不依赖多种对照品，能清晰、快速地判断药材的真伪优劣，为甘草的质量控制方法提供参考。

Objective To establish a "quality-quantity" double standard control method of Glycyrrhiza uralensis, which is qualitative based on the reference traditional Chinese medicinal materials (TCMM) as standard substances and quantitative without relying on multiple reference substances. Methods HPLC technology was used to establish the characteristic chromatogram of G. uralensis based on the reference TCMM as standard substances. The chemical constituents of common peaks were identified by Q-TOF-MS technology, and the authenticity of G. uralensis was determined by the similarity of characteristic peaks of the reference TCMM and the tested TCMM. The above statement is "quality". The relative content of each characteristic peak in different batches of the tested TCMM was calculated by accurate quantition of internal standard component glycyrrhizic acid. The "average value-standard deviation" was taken as the lower limit of the relative content of characteristic peak chemical components relative to chemical composition of internal standard substance, and the quality of G. uralensis was determined according to the lower limit of the relative content of characteristic peak. The above statement is "quantity".Results The characteristic chromatogram and content determination method met the requirements of methodology investigation. A total of ten common chromatographic peaks were determined, and five chemical components were identified, which were liquiritin apioside, liquiritin, isoliquiritin apioside, isoliquiritin, glycyrrhizic acid. The similarity between the tested TCMM and reference TCMM was greater than 0.90. The lower limit of relative content of chemical components of G. uralensis characteristic peak was defined. Conclusion The method can judge the authenticity of medicinal materials clearly and quickly without many reference substances, and provide reference for quality control of G. uralensis.

R286.2

辽宁省科技创新领军人才（XLYC1902116）