目的 建立芪术胶囊的薄层色谱（TLC）鉴别、指纹图谱以及有效成分葛根素和毛蕊花糖苷的含量测定方 法，为完善芪术胶囊质量标准提供参考依据。方法 采用TLC法对芪术胶囊中的地黄、黄芪和葛根进行鉴别； 采用高效液相色谱（HPLC）法建立指纹图谱，结合相似度软件对15批芪术胶囊进行质量评价；通过HPLC法同 时测定芪术胶囊中葛根素和毛蕊花糖苷两种成分的含量。结果 TLC方法专属性强，斑点清晰；芪术胶囊指纹图 谱标定15个共有峰，鉴定出梓醇、葫芦素B、3-羟基葛根素、苍术素、白术内酯I、葛根素、槲皮素、3-甲氧基 葛根素、葛根素芹菜糖苷、大豆苷、木犀草素等11个特征峰，各峰分离度良好；15批芪术胶囊样品相似度均大 于0.95；芪术胶囊中葛根素和毛蕊花糖苷线性关系良好（R2≥0.999 2），平均加样回收率为 99.31% 和 96.89%， 平均含量分别为13.07 mg·g-1和50.81 μg·g-1。结论 建立的TLC鉴别方法、HPLC指纹图谱和HPLC含量测定方 法稳定可靠，可为芪术胶囊的质量控制提供参考。

Objective To establish the methods of thin-layer chromatography （TLC） identification， HPLC fingerprint and content determination （puerarin and verbascoside），and to provide reference for improving the quality control of Qizhu Capsules. Methods Rehmanniae Radix， Astragali Radix and Puerariae Lobatae Radix in Qizhu Capsules were identified by TLC. The fingerprint was established by HPLC. The quality evaluation of 15 batches of Qizhu Capsules was conducted by the combination of HPLC fingerprint and similarity software. The contents of puerarin and verbascoside in Qizhu Capsules were determined by HPLC. Results TLC has strong specificity and the spots were clear. A total of 15 common peaks in the fingerprint of Qizhu Capsules were calibrated， 11 of which were identified， including catalpol， cucurbitacin B， 3-hydroxypuerarin， atractylodin， atractylenolide I， puerarin， quercetin， 3-methoxypuerarin， mirificin， daidzein and luteolin. Each peak showed good separation. The similarity values of 15 batches of Qizhu Capsules were greater than 0.95. The linear relationship of puerarin and verbascoside was good （R2≥ 0.999 2），the average recoveries were 99.31% and 96.89%，the average content were 13.07 mg·g-1and 50.81 μg·g-1 respectively. Conclusion The established methods of TLC，HPLC fingerprint and content determination are stable and reliable. These methods can provide scientific basis for the quality control of Qizhu Capsules.

R284.1

云南省科技人才与平台计划 （院士专家工作站） 项目（202305AF150141）