目的 建立香果健消片（Xiangguo Jianxiao Tablets，XJT）HPLC指紋圖譜及多成分定量測定方法。方法 采用Infinity Lab Poroshell 120 SB-C₁₈色譜柱（250 mm×4.6 mm，4 μm），流動(dòng)相為乙腈-0.15%甲酸水，梯度洗脫，體積流量1.0 mL/min，柱溫30℃，檢測波長254 nm，進(jìn)樣量10 μL；建立XJT指紋圖譜，采用層次聚類分析（hierarchical cluster analysis，HCA）和主成分分析（principal component analysis，PCA）評價(jià)不同批次XJT質(zhì)量，采用Hotelliing’s T²和DModX方法設(shè)定不同批次XJT質(zhì)量控制范圍；HPLC法測定13批XJT中原兒茶酸、綠原酸、咖啡酸、異綠原酸B、異綠原酸A、橙皮苷、異綠原酸C、木香烴內(nèi)酯、去氫木香內(nèi)酯的含量。結(jié)果 XJT指紋圖譜方法學(xué)考察結(jié)果符合要求，標(biāo)記18種共有成分，通過對照品指認(rèn)鑒定出9種成分，13批樣品的相似度均大于0.90；HCA和PCA表明批間一致性良好，Hotelliing’s T²和DModX的控制上限分別為23.58和1.70。13批XJT中原兒茶酸、綠原酸、咖啡酸、異綠原酸B、異綠原酸A、橙皮苷、異綠原酸C、木香烴內(nèi)酯、去氫木香內(nèi)酯9種成分的質(zhì)量分?jǐn)?shù)分別為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。結(jié)論 所建立的HPLC指紋圖譜和多成分定量測定方法準(zhǔn)確可靠，可用于XJT的質(zhì)量評價(jià)。

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

國家自然科學(xué)基金資助項(xiàng)目（82174065）;云南省科技廳重點(diǎn)研發(fā)計(jì)劃（202103AC100005）;云南省科技廳重大科技專項(xiàng)（202102AA310027）;云南省科技廳社會(huì)發(fā)展專項(xiàng)-重點(diǎn)研發(fā)計(jì)劃項(xiàng)目（202303AC100025）;云南省生物醫(yī)藥專項(xiàng)-重大科技專項(xiàng)計(jì)劃（202302AA310031）;云南省教育廳科學(xué)研究基金項(xiàng)目（2024Y379）;云南省中西醫(yī)結(jié)合慢病防治重點(diǎn)實(shí)驗(yàn)室開放基金資助項(xiàng)目（YPKLG2024-016）;云南省傣醫(yī)藥與彝醫(yī)藥重點(diǎn)實(shí)驗(yàn)室資助項(xiàng)目（2024SS24074）