一测多评法同时测定酒续断配方颗粒中6种成分的含量

The content of 6 components in Jiuxuduan Formula Granules was determined by one test and multiple evaluation method

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维普
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中文摘要：目的采用UPLC法对酒续断配方颗粒的 6 个含量指标马钱苷酸、川续断皂苷Ⅵ、绿原酸、异绿原酸A、异绿原酸B、异绿原酸C进行含量测定,并应用一测多评法同时测定 6 个指标的含量,为其质量控制提供依据.方法采用超高效液相UPLC-UV,以ACQUITYHSST3(2.1 mm×100 mm,1.8μm)为色谱柱,以乙腈-0.05%磷酸为流动相进行梯度洗脱,检测波长为 220 nm,流速 0.3 ml/min,进样体积 2μl,柱温 30℃.同时测定酒续断配方颗粒中马钱苷酸、川续断皂苷Ⅵ、绿原酸、异绿原酸A、异绿原酸B、异绿原酸C 6 种成分的含量,采用一测多评法,以绿原酸为内参物,通过相对校正因子测定马钱苷酸、川续断皂苷Ⅵ、异绿原酸A、异绿原酸B、异绿原酸C含量,同时采用外标法测定多批酒续断配方颗粒中这 6 个指标成分的含量,比较计算值与实测值的差异,验证一测多评法的准确性.结果建立相对校正因子重现性良好,采用相对校正因子计算的含量值与实测值之间无明显差异.结论本研究建立的测定方法鉴别快捷、准确、重复性良好,可为酒续断配方颗粒质量控制的评价提供数据依据.

外文摘要：Objective To determine 6 content indexes of Jiuxuduan Formula Granules by UPLC method,and to determine the content of 6 indexes simultaneously by one test and multiple evaluation method,so as to provide the basis for quality control.Methods UPLC-UV chromatography was performed on ACQUITYHSST3(2.1 mm×100 mm,1.8μm)column with acetonitrile-0.05%phosphoric acid as mobile phase for gradient elution.The detection wavelength was set at 220 nm,the flow rate was 0.3 ml/min,the sample volume was 2μl,and the column temperature was 30℃.At the same time,the contents of 6 components in Jiuxuduan Formula Granules were determined by using one test and multiple evaluation method,with chlorogenic acid as the internal reference,the contents of margianin,chlorogenic acid Ⅵ,isochlorogenic acid A,isochlorogenic acid B and isochlorogenic acid C were determined by relative correction factor.At the same time,the external standard method was used to determine the content of these 6 index components in multiple batches of Jiuxuduan Formula Granules,and the difference between the calculated values and the measured values was compared to verify the accuracy of the method.Results The reproducibility of the established relative correction factor was good,and there was no obvious difference between the content value calculated by the relative correction factor and the measured value.Conclusion The method established in this study is fast,accurate and reproducible,and can provide data basis for the quality control evaluation of Jiuxuduan Formula Granules.

外文关键词：

Jiuxuduan Formula GranulesOne test multiple evaluation methodMargannic acidSaposide ⅥChlorogenic acidIsochlorogenic acid AIsochlorogenic acid BIsochlorogenic acid C

作者：

蔡小兵、江斌、李璐、梁素仪、郑晓英、张辉、谭沛

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作者单位：

华润三九医药股份有限公司,广东深圳 518000

华润三九现代中药制药有限公司,广东惠州 516000

关键词：

酒续断配方颗粒一测多评法马钱苷酸川续断皂苷Ⅵ 绿原酸异绿原酸A 异绿原酸B 异绿原酸C

基金：

深圳市科技计划

项目编号：

JSGG20191129093418578

出版年：

2024

中国处方药

南方医药经济研究所

中国处方药

影响因子：0.649

ISSN：1671-945X

年,卷(期)：2024.22(3)

参考文献量14