首页|茵莲清肝合剂的HPLC多药效成分定量控制及化学计量学联合加权逼近理想解排序法综合质量评价

茵莲清肝合剂的HPLC多药效成分定量控制及化学计量学联合加权逼近理想解排序法综合质量评价

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目的:建立多指标成分定量测定联合化学计量学及加权逼近理想解排序法(TOPSIS)评价茵莲清肝合剂质量的方法。方法:采用高效液相色谱(HPLC)法,色谱柱为SunFire C18,流动相为乙腈-0。05%磷酸(梯度洗脱),流速为1。0 mL/min。以姜黄素作为内参物,同时采用外标法和一测多评法测定14批茵莲清肝合剂中滨蒿内酯、白绵马素AA、伪绵马素、绵马贯众素ABBA、鸡矢藤次苷甲酯、车叶草苷酸、车叶草苷、双去甲氧基姜黄素、去甲氧基姜黄素、姜黄素、柴胡皂苷a、柴胡皂苷d、去氢土莫酸、去氢茯苓酸、茯苓酸的含量,对比2种方法所得结果,并运用统计软件对14批样品质量进行差异分析,挖掘影响茵莲清肝合剂质量的主要潜在标志物。以化学计量学分析中各成分的VIP值为权重建立加权TOPSIS模型,进一步对含量数据进行处理分析,进而对质量进行排序。结果:15种成分分别在各自范围内线性关系良好(r>0。999),平均加样回收率(n=9)在96。93%~100。14%之间(RSD<2。0%)。建立的相对校正因子耐用性良好,利用相对校正因子计算的各成分含量与外标法所得含量间差异无统计学意义(P>0。05)。化学计量学分析显示14批样品聚为3类,相邻批次聚为一组;滨蒿内酯、柴胡皂苷a、姜黄素、鸡矢藤次苷甲酯、茯苓酸、柴胡皂苷d、车叶草苷和绵马贯众素ABBA是影响茵莲清肝合剂产品质量的主要因子。加权TOPSIS结果显示14批茵莲清肝合剂的最优解的相对贴近度(Ci)为0。113 6~0。792 2,其中S12质量最优(Ci=0。792 2)。结论:本研究建立的茵莲清肝合剂质量评价方法操作便捷、准确,可为科学评价茵莲清肝合剂质量提供参考。
Quantitative Control of Multiple Pharmacodynamic Components in Yinlian Qinggan Mixture(茵莲清肝合剂)by HPLC and Comprehensive Quality Evaluation of Chemometrics Combined with Weighted-Technique for Order Preference by similarity to an Ideal Solution
Objective:To establish a method for evaluating the quality of Yinlian Qinggan mixture by multi-index component quantitative determination combined with chemometrics and weighted-technique for order preference by similarity to an ideal solution(TOPSIS).Methods:HPLC method was used with SunFire C18 column,and the mobile phase was acetonitrile and 0.05%phosphoric acid with gradient elution.The volume flow rate was 1.0 mL/min.Curcumin was used as an internal reference,and the contents of scoparone,albaspidin AA,pseudoaspidin,tetraalbaspidin ABBA,feretoside,asperulosidic acid,asperuloside,bisdemethoxycurcumin,demethoxycurcumin,curcumin,saikosaponin a,saikosaponin d,dehydrotumulosic acid,dehydropachymic acid and pachymic acid in 14 batches of Yinlian Qinggan mixture were determined using external standard method(ESM)and(quantitative analysis of multicomponents by single-marker,QAMS)method.The results obtained from the two methods were compared,and the quality difference of 14 batches of samples was analyzed by statistical software,to find the main potential markers affecting the quality of Yinlian Qinggan mixture.Then,a weighted-TOPSIS model was established based on the VIP value of each component in the stoichiometric analysis and the content data were further processed and analyzed,and then the quality was ranked.Results:The 15 components were well linearly in their respective ranges(r>0.999),and average added sample recovery rate(n=9)was between 96.93%and 100.14%(RSD<2.0%).The established relative correction factor showed good durability,and there was no significant difference between the content of each component calculated by the relative correction factor and the content obtained by the external standard method(P>0.05).The chemometrics method showed that the 14 batches of Yinlian Qinggan mixture could be clustered into three categories,and that adjacent batches were grouped into one group.Scoparone,saikosaponin a,curcumin,feretoside,pachymic acid,saikosaponin d,asperuloside and tetraalbaspidin ABBA were the main factor affecting the quality of Yinlian Qinggan mixture.The weighted-TOPSIS results showed that the euclidean closeness(Ci)of the optimal solution of Yinlian Qinggan mixture in 14 batches ranged from 0.113 6 to 0.792 2,and that the quality of S12 was the best(Ci=0.792 2).Conclusion:The quality evaluation method of Yinlian Qinggan mixture established in this study is convenient and accurate,which can provide reference for scientific evaluation of the quality of Yinlian Qinggan mixture.

Yinlian Qinggan mixtureHPLCchemometricsOPLS-DAweighted-TOPSIS

李晓、马美玲、陈玉洁、许伟

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东营市食品药品检验研究院,山东 东营 257091

山东中医药大学药学院,山东 济南 250355

茵莲清肝合剂 高效液相色谱法 化学计量学 正交偏最小二乘判别分析法 加权逼近理想解排序法

2024

中医药导报
湖南省中医药学会 湖南省中医管理局

中医药导报

CSTPCD
影响因子:0.952
ISSN:1672-951X
年,卷(期):2024.30(12)