目的 建立苓甘五味姜辛汤基准样品的指纹图谱及其5个关键指标性成分定量测定方法，研究其基准样品量质传递规律。方法 采用HPLC法建立苓甘五味姜辛汤指纹图谱，通过基准样品与各单味中药饮片的相关性分析进行共有峰归属，以对照品进行共有峰指认，通过各批次间相似度评价，分析15批苓甘五味姜辛汤基准样品的质量差异。同时建立指标性成分甘草苷、甘草酸铵、6-姜酚、五味子醇甲和细辛脂素定量测定方法，结合定量分析结果及各指标成分的转移率进行量值传递研究。结果 建立了15批苓甘五味姜辛汤基准样品的HPLC指纹图谱，共标定28个共有峰，各批次间相似度均≥0.950，经与对照品比对，确定峰7为甘草苷，峰17为甘草酸铵，峰20为6-姜酚，峰22为五味子醇甲，峰26为细辛脂素。15批苓甘五味姜辛汤基准样品中甘草苷、甘草酸铵、6-姜酚、五味子醇甲、细辛脂素的质量分数分别为2.75～4.20、4.38～7.18、0.94～1.69、0.28～0.47、0.21～0.33 mg·g^-1；中药饮片至基准样品的平均转移率分别为21.57%～35.11%、16.83%～31.00%、7.45%～13.64%、3.13%～5.47%、3.15%～5.40%。结论 建立的指纹图谱及多指标成分定量测定方法，可用于经典名方苓甘五味姜辛汤基准样品的量值传递分析，为该方剂基准样品的质量控制及复方制剂的开发提供了科学依据。

Objective To establish fingerprint chromatogram of the benchmark sample of Linggan Wuwei Jiangxin Decoction and the quantitative determination methods of five key index components, and to study the law of quantity and quality transfer of its benchmark sample. Methods The HPLC fingerprint chromatogram of Linggan Wuwei Jiangxin Decoction was established. The common peaks were attributed through the correlation analysis between the benchmark sample and each single Chinese herbal decoction piece, and identified by reference substances. The quality differences of 15 batches of benchmark samples of Linggan Wuwei Jiangxin Decoction were evaluated by similarity analysis among batches. Meanwhile, the quantitative determination methods of index components such as liquiritin, ammonium glycyrrhetate, 6-gingerol, schizandrin and asarinin were established. The quantity and quality transfer were studied based on the quantitative analysis results and the transfer rates of each index component. Results The HPLC fingerprint chromatograms of 15 batches of benchmark samples of Linggan Wuwei Jiangxin Decoction were established, with a total of 28 common peaks. The similarity among batches was all ≥ 0.950. Through comparison with reference substances, peak 7 was identified as liquiritin, peak 17 as ammonium glycyrrhetate, peak 20 as 6-gingerol, peak 22 as schizandrin, and peak 26 as asarinin. The mass fractions of liquiritin, ammonium glycyrrhetate, 6-gingerol, schizandrin and asarinin in 15 batches of benchmark samples of Linggan Wuwei Jiangxin Decoction were 2.75－4.20, 4.38－7.18, 0.94－1.69, 0.28－0.47, 0.21－0.33 mg·g^-1, respectively. The average transfer rates from Chinese herbal decoction pieces to benchmark samples were 21.57%－35.11%, 16.83%－31.00%, 7.45%－13.64%, 3.13%－5.47%, and 3.15%－5.40%, respectively. Conclusion The established fingerprint chromatogram and multi-index component quantitative determination methods can be used for the quantity and quality transfer analysis of the benchmark sample of the classic prescription Linggan Wuwei Jiangxin Decoction, providing a scientific basis for the quality control of the benchmark sample and the development of compound preparations of this prescription.

R283.6

黑龙江省自然科学基金资助项目（PL2024H246）；哈尔滨市科学技术局科技人才应用技术研究与开发（青年储备 A 类）项目（2017RAQXJ127）