基于有效基准特征图谱质量表征的丁香质量评价研究

Quality-evaluation of Flos Caryophylli based on the representation model of effective characteristic spectrum of reference

目的建立基于丁香有效基准特征图谱的质量表征模式、方法与质量评价应用,以精准、有效地评价丁香饮片质量。方法以确定有促胃动力作用的丁香饮片作为饮片基准,以具有促胃动力功效的代表性成分及其含量作为质量表征基准点,采用HPLC-PDA建立丁香有效基准特征图谱,基于对照品模拟基准点的有效基准特征图谱质量表征信息作为评价丁香饮片质量标尺,并对其准确性进行佐证及质量评价应用与验证。结果以丁香饮片S10(饮片基准)中的丁香酚作为质量表征基准点(保留时间:65.198分钟、检测溶液中含量:1.574 mg/mL),并以丁香酚对照品准确模拟其基准点,分别对丁香有效饮片(基准)进行质量表征,结果佐证了检测方法的可行性及检测结果的准确性。以模拟基准点为基准得到的丁香有效基准特征图谱质量表征信息(质量标尺)为:特征峰数目、相对保留时间、相对峰面积,5个代表性成分(异槲皮苷、没食子酸、丁香酚、山楂酸、齐墩果酸)的相对含量;涵盖了丁香药学架构中黄酮类、酚酸类、苯丙素类、三萜类四种主要的化学类型。采用所构建的丁香质量评价模式及其质量基准标尺对14批丁香饮片的质量进行评价得出:饮片S13,S2,S9,S14,S15,S3和S7质量较优;且基于换算系数得到的5个代表性成分的含量皆与实测值基本一致。结论建立的基于丁香有效基准特征图谱的质量表征模式、方法能够整体、准确地对丁香饮片进行质量表征,且可以有效、精准、简易地评价丁香饮片质量。

Objective To establish the quality criterion model,method and the application of quality evaluation based on the effective benchmark specific chromatogram of Flos Caryophylli,so as to accurately and effectively evaluate the quality of decoction pieces of Flos Caryophylli.Methods Taking the decoction pieces of Flos Caryophylli with gastric stimulating effect as the reference point,and the representative components and their contents with gastric stimulating effect as the reference point of quality criterion,HPLC-PDA was used to establish the effective benchmark specific chromatogram of Flos Caryophylli,and the quality criterion information of the effective benchmark specific chromatogram based on the simulated reference point of reference was used as the quality scale to evaluate the quality of decoction pieces of Flos Caryophylli,and its accuracy was corroborated and applied to verify the quality evaluation.Results Decoction pieces of Flos Caryophylli S10(benchmark)slices of eugenol as quality criterion of datum(retention time:65.198 minutes,content in solution:1.574 mg/mL),and with eugenol reference substance accurate simulation of its benchmark,effective decoction pieces of Flos Caryophylli(benchmark)for quality criterion,the results support the feasibility of detection method and the accuracy of the test results.The quality criterion information(quality scale)of the effective benchmark specific chromatogram of Flos Caryophylli obtained from the simulated reference point was as follows:number of characteristic peaks,relative retention time,relative peak area,and relative contents of five representative components(isoquercitroside,gallic acid,eugenol,maslinic acid and oleanolic acid).It covers 4 main chemical types in the pharmaceutical structure of Flos Caryophylli:flavonoids,phenolic acids,phenylpropanoids,triterpenoids.The quality evaluation model of Flos Caryophylli and its quality reference scale were used to evaluate the quality of 14 batches of Flos Caryophylli decoction pieces.The results showed that decoction pieces of S13,S2,S9,S14,S15,S3 and S7 were better than others,The contents of the 5 representative components obtained based on the conversion factor are basically consistent with the measured values.Conclusion The established quality criterion model and method of Flos Caryophylli based on the effective benchmark specific chromatogram,can be used represent the quality of Flos Caryophylli decoction pieces accurately and integrally,and can be used to analyze the quality of it effectively,accurately and simply.