目的 建立香果健消片（Xiangguo Jianxiao Tablets，XJT）HPLC指纹图谱及多成分定量测定方法。方法 采用Infinity Lab Poroshell 120 SB-C₁₈色谱柱（250 mm×4.6 mm，4 μm），流动相为乙腈-0.15%甲酸水，梯度洗脱，体积流量1.0 mL/min，柱温30℃，检测波长254 nm，进样量10 μL；建立XJT指纹图谱，采用层次聚类分析（hierarchical cluster analysis，HCA）和主成分分析（principal component analysis，PCA）评价不同批次XJT质量，采用Hotelliing’s T²和DModX方法设定不同批次XJT质量控制范围；HPLC法测定13批XJT中原儿茶酸、绿原酸、咖啡酸、异绿原酸B、异绿原酸A、橙皮苷、异绿原酸C、木香烃内酯、去氢木香内酯的含量。结果 XJT指纹图谱方法学考察结果符合要求，标记18种共有成分，通过对照品指认鉴定出9种成分，13批样品的相似度均大于0.90；HCA和PCA表明批间一致性良好，Hotelliing’s T²和DModX的控制上限分别为23.58和1.70。13批XJT中原儿茶酸、绿原酸、咖啡酸、异绿原酸B、异绿原酸A、橙皮苷、异绿原酸C、木香烃内酯、去氢木香内酯9种成分的质量分数分别为23.0～68.7、558.7～2 463.9、39.3～109.6、117.1～294.2、228.7～1 001.7、372.2～839.1、151.4～800.6、124.3～1 073.9、589.0～2 229.8 μg/g。结论 所建立的HPLC指纹图谱和多成分定量测定方法准确可靠，可用于XJT的质量评价。

Objective To establish an HPLC fingerprint method and a method for the determination of the multi-component content of Xiangguo Jianxiao Table (XJT). Methods The components were analyzed on an Infinity Lab Poroshell 120 SB-C₁₈ column (250 mm×4.6 mm, 4 μm). The gradient elution was carried out with the mobile phase composed of 0.15% formic acid water and acetonitrile at the flow rate of 1.0 mL/min and the column temperature of 30 ℃. The detecting wavelength was 254 nm and injection volume was 10 μL. Based on the fingerprinting of XJT, hierarchical cluster analysis (HCA) and principal component analysis (PCA) were used to evaluate the quality of different batches of XJT, while Hotelliing’s T² and DModX methods were used to analyze the quality control range of different batches of XJT. HPLC was used to determine the contents of nine components, namely protocatechuic acid, chlorogenic acid, caffeic acid, isochlorogenic acid B, isochlorogenic acid A, hesperidin, isochlorogenic acid C, costunolide and dehydrocostus iactone in 13 batches of XJT. Results The methodological investigation of XJT fingerprints met the requirements, labelled 18 common components, identified nine components by control identification, and the similarity of 13 batches of samples was greater than 0.90. HCA and PCA showed good inter-batch consistency, and the upper control limits of Hotelliing’s T² and DModX were 23.58 and 1.70. The contents of protocatechuic acid, chlorogenic acid, caffeic acid, isochlorogenic acid B, isochlorogenic acid A, hesperidin, isochlorogenic acid C, costunolide and dehydrocostus iactone in 13 batches of XJT ranged from 23.0—68.7, 558.7— 2 463.9, 39.3—109.6, 117.1—294.2, 228.7—1 001.7, 372.2—839.1, 151.4—800.6, 124.3—1 073.9, 589.0—2 229.8 μg/g, respectively. Conclusion The HPLC fingerprinting method and multi-component content determination method were accurate and reliable, and can be used for the quality evaluation of XJT.

R283.6

国家自然科学基金资助项目（82174065）;云南省科技厅重点研发计划（202103AC100005）;云南省科技厅重大科技专项（202102AA310027）;云南省科技厅社会发展专项-重点研发计划项目（202303AC100025）;云南省生物医药专项-重大科技专项计划（202302AA310031）;云南省教育厅科学研究基金项目（2024Y379）;云南省中西医结合慢病防治重点实验室开放基金资助项目（YPKLG2024-016）;云南省傣医药与彝医药重点实验室资助项目（2024SS24074）