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瞿麦(石竹)配方颗粒质量与饮片特征图谱的相关性

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为了建立基于饮片特征图谱预测瞿麦(石竹)配方颗粒质量指标的方法,探究瞿麦(石竹)配方颗粒质量与饮片特征图谱的相关性.利用特征图谱对瞿麦(石竹)原料中不同药用部位的化学成分进行表征,明确差异峰,统计 15 批饮片特征图谱中差异峰占总特征峰的峰面积比值(α值);同时依据国药瞿麦(石竹)配方颗粒标准对制备的 15 批饮片瞿麦(石竹)配方颗粒总黄酮含量、出膏率、浸出物含量等指标进行测定;采用Pearson相关性分析方法对饮片特征图谱中的α值与配方颗粒的总黄酮含量、出膏率、浸出物含量进行相关性分析,建立回归模型,并采用具有生产规模的 6 批瞿麦(石竹)原料、配方颗粒质量参数进行验证.结果表明:王不留行黄酮苷峰和皂草苷峰在饮片中不同药用部位的特征图谱存在相对峰面积差异,15 批饮片中二者峰面积总和的α值为 0.45~0.83;通过Pearson相关性分析发现,瞿麦(石竹)配方颗粒的总黄酮含量、出膏率、浸出物含量与α值呈显著正相关(P<0.01),总黄酮含量与α值极强相关,出膏率、浸出物含量与α值强相关;依据相关性建立的 3 个回归模型,所得R2 均大于 0.7,模型拟合度较高,通过 6 批数据的验证发现预测值和实测值的相对标准偏差均小于 15%,说明模型有较好的准确性.研究利用原料特征图谱中的α值能够初步预测所得瞿麦(石竹)配方颗粒的各指标范围,并可实现源头控制瞿麦(石竹)配方颗粒质量,保证所得配方颗粒质量的可控性.
Correlation between the quality of Dianthi Herb(Dianthus chinensis L.)formula granule and characteristic map of decoction pieces
In order to establish the method of predicting the quality index of Dianthi Herb(Dianthus chinensis L.)formula granules based on the characteristic map of decoction pieces,the correlation between the quality of Dianthi Herb(Dianthus chinensis L.)formula granules and the characteristic map of decoction pieces was investigated.The chemical components of different medicinal parts in Dianthi Herb(Dianthus chinensis L.)raw materials were characterized by the characteristic atlas,the difference peak was defined,and the peak area ratio(α)of the difference peak to the total characteristic peak in the characteristic atlas of 15 batches of decoction pieces was calculated;At the same time,according to the national standard of Dianthi Herb(Dianthus chinensis L.)formula granules,the total flavonoids content,paste yield,extract and other indexes of Dianthi Herb(Dianthus chinensis L.)formula granules prepared by using the above 15 batches of decoction pieces were determined;Pearson correlation analysis method was used to analyze the correlation between α value in the characteristics of decoction pieces and the total flavonol content,paste yield and extract of formula granules,the corresponding regression model was established,and the quality parameters of six batches of Dianthi Herb(Dianthus chinensis L.)raw materials and formula particles with production scale were used for verification.The result shows that the relative peak area of vaccarin and saponarin in different medicinal parts in decoction pieces was different,and the α ratio of the total peak area of the two peaks was 0.45~0.83 in 15 batches of decoction pieces;Through Pearson correlation analysis,it is found that the total flavonoids content,paste yield and extract are significantly positively correlated with α value(P<0.01),total flavonoids content is strongly correlated with α value,and paste rate and extract are strongly correlated with α value;According to the three regression models established according to the correlation,the R2 obtained is all greater than 0.7,and the model has a high degree of fitting.Through the verification of six batches of data,it is found that the relative standard deviation of the predicted value and the measured value is less than 15%,indicating that the model has a good accuracy.In this study,the α value in the characteristic map of raw materials can be used to preliminarily predict the index range of Dianthi Herb(Dianthus chinensis L.)formula granules,and can achieve source control of the quality of Dianthi Herb(Dianthus chinensis L.)formula granules,ensuring the controllability of the obtained formula granules quality.

chemistry of Chinese material medicaldecoction piecesformula granulecharacteristic mappeak area ratiocorrelationcontrollability

杜微波、陈敬然、万莹莹、李雪、马智玲、张志强、沈建梅

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北京康仁堂药业有限公司,北京 101301

中药配方颗粒关键技术国家地方联合工程研究中心,北京 101301

北京市中药配方颗粒工程技术研究中心,北京 101301

中药化学 饮片 配方颗粒 特征图谱 峰面积比值 相关性 可控性

2024

河北工业科技
河北科技大学

河北工业科技

CSTPCD
影响因子:0.694
ISSN:1008-1534
年,卷(期):2024.41(3)