首页|基于HPLC指纹图谱结合化学计量学及多成分定量测定的香果健消片质量评价

基于HPLC指纹图谱结合化学计量学及多成分定量测定的香果健消片质量评价

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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。0mL/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,PC A)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。8μg/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。
Quality evaluation of Xiangguo Jianxiao Tablets based on HPLC fingerprint combined with chemometrics and multi-component content determination
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 DModXwere 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.

Xiangguo Jianxiao Tabletsfingerprintchemometricsprotocatechuic acidchlorogenic acidcaffeic acidisochlorogenic acid Bisochlorogenic acid Ahesperidinisochlorogenic acid Ccostunolidedehydrocostus iactone

梅佳华、郝佳旭、程欣、张权、张占尧、李姓喜、张海亮、马云淑

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云南中医药大学,云南 昆明 650500

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云南省药食同源饮片工程中心,云南 昆明 650500

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香果健消片 指纹图谱 化学计量学 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

2025

中草药
天津药物研究院,中国药学会

中草药

北大核心
影响因子:1.632
ISSN:0253-2670
年,卷(期):2025.56(2)