基于有效基准特征图谱质量表征的甜叶菊饮片质量评价研究

Study on quality evaluation of Stevia Rebaudiana decoction pieces based on quality criterion model of effective reference characteristic spectrum

目的建立甜叶菊有效基准特征图谱质量表征模式、方法与质量评价应用,以精准、有效地评价甜叶菊饮片质量。方法以确定具有降血糖药效的甜叶菊饮片(实验样品编号T2)作为有效饮片基准,以有效特征指标性成分绿原酸及其含量作为质量表征基准点,采用HPLC-PDA法建立甜叶菊有效基准特征图谱,基于绿原酸对照品模拟基准点的有效基准特征图谱质量表征信息,建立评价甜叶菊饮片的质量标尺,并对其准确性进行佐证及质量评价应用与验证。结果以甜叶菊有效饮片基准(T2)中的绿原酸为质量表征基准点(保留时间:23.027分钟;检测溶液中含量:0.0438 mg/mL),并以绿原酸对照品准确模拟基准点,分别对甜叶菊有效饮片基准(T2)进行表征,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甜叶菊有效基准特征图谱质量信息(质量标尺)为:21个特征峰的保留时间、峰面积、相对保留时间、相对峰面积、9个特征指标性成分(TYJ-10、TYJ-14、红景天苷、绿原酸、异绿原酸A、异绿原酸B、异绿原酸C、槲皮苷、木犀草苷)含量、相对含量、换算系数,其涵盖了甜叶菊药学架构中苯乙醇类、酚酸类及黄酮类三种主要化学类型。采用所构建的甜叶菊质量评价模式及质量标尺对14批甜叶菊饮片的质量进行评价得出:T3、T6、T5、T1、T7、T15、T12质量较优,且基于换算系数得到的9个代表性成分的含量皆与实测值基本一致。结论建立的基于甜叶菊有效基准特征图谱的质量表征模式、方法能整体、准确地对甜叶菊饮片进行质量表征,且可有效、精准、经济地评价甜叶菊饮片质量。

Objective To establish the quality criterion model of effective reference characteristic spectrum,method and quality evaluation application of Stevia Rebaudiana so as to accurately and effectively evaluate the quality of Stevia Rebaudiana.Methods Taking Stevia Rebaudiana decoction pieces(T2)with hypoglycemic effect as effective decoction piece benchmark,taking the effective characteristic index component chlorogenic acid and its content as the quality characterization reference point,accepting the HPLC-PDA method to establish the effective reference characteristic atlas of Stevia Rebaudiana,combing with quality criterion information of effective reference characteristic spectrum based on chlorogenic acid reference substance simulation reference point,to establish a quality scale for evaluating Stevia Rebaudiana decoction pieces,and to verify its accuracy and the application of quality evaluation.Results Taking the chlorogenic acid in effective tablet(T2)decoction pieces of Stevia Rebaudiana as the quality criterion reference point(retention time:23.027;The content of the test solution was 0.0438 mg/mL),and using the chlorogenic acid reference to simulate the reference point accurately,the effective decoction pieces(T2)of Stevia Rebaudiana were characterized respectively,the results proved the feasibility of the method and the accuracy of the test results.The quality information(quality scale)of effective reference characteristic spectrum of Stevia Rebaudiana obtained based on the simulated reference point were,the retention time,peak area,relative retention time and relative peak area of the 21 characteristic peaks,contents and relative contents and conversion factors of 9 characteristic index components(TYJ-10,TYJ-14,salidroside,chlorogenic acid,isochlorogenic acid A,isochlorogenic acid B,isochlorogenic acid C,quercitrin,luteolin),they include phenylethanol phenolic acids and flavonoids in stevia pharmaceutical structure.Using the established quality evaluation model and quality scale of Stevia Rebaudiana,to evaluate the quality of 14 batches of Stevia Rebaudiana,the results showed that T3,T6,T5,T1,T7,T15,T12 were superior in quality,and the contents of 9 representative components obtained based on conversion factors were basically consistent with the measured values.Conclusion The established quality criterion model and method based on effective reference characteristic spectrum of Stevia Rebaudiana,can comprehensively and accurately characterize the quality of Stevia Rebaudiana decoction pieces,and can evaluate the quality of Stevia Rebaudiana decoction pieces effectively,accurately and economically.