高效液相色谱法测定鹿胎丹参白芍颗粒中葛根素、芍药苷及丹酚酸B含量
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国家重点研发计划“中医药现代化研究”重点专项(2018YFC17068000)


Determination of Puerarin,Paeoniflorin,and Salvianolic Acid B in Lutai Danshen Baishao Granules by HPLC
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    摘要:

    目的:完善鹿胎丹参白芍颗粒质量标准,提高其质量控制水平。方法:建立高效液相色谱法(HPLC)同时测定鹿胎丹参白芍颗粒中葛根素、芍药苷及丹酚酸B含量,并进行方法学考察。结果:鹿胎丹参白芍颗粒工艺验证得出其出膏率为33.39%;HPLC确定了葛根素、芍药苷及丹酚酸B的液相色谱条件,其含量分别为18.94、10.15、9.25 mg/g;并对该方法的稳定性、重复性、精密度、线性及加样回收等方法学考察,其中葛根素、芍药苷及丹酚酸B的平均加样回收率相对标准偏差(RSD)值分别为1.63%、1.01%、1.38%。结论:本研究在现行质量标准的基础上,增加葛根素、芍药苷及丹酚酸B作为质量标准提升控制成分,运用HPLC测定其含量并进行方法学考察,提高了产品的可控性,建立的方法准确可靠,可为完善和提高鹿胎丹参白芍颗粒的质量标准提供科学依据。

    Abstract:

    This study aims to improve the quality standard of Lutai Danshen Baishao Granules and its quality control.Methods:A high-performance liquid chromatography(HPLC) method was developed for simultaneous determination of puerarin,paeoniflorin,and salvianolic acid B in Lutai Danshen Baishao Granules,and methodological investigation was carried out.Results:The process verification of Lutai Danshen Baishao Granules showed that the extract yield was 33.39%.The HPLC conditions for puerarin,paeoniflorin,and salvianolic acid B were determined and their content was 18.94,10.15,and 9.25 mg/g,respectively.The stability,reproducibility,precision,linearity,and spiked recovery of the method were tested.The mean RSD values of the spiked recoveries of puerarin,paeoniflorin,and salvianolic acid B were 1.63%,1.01%,and 1.38%,separately.Conclusion:On the basis of the currently available quality standard,puerarin,paeoniflorin,and salvianolic acid B were added for quality standard improvement,and their content was determined by HPLC.Methodological investigation was performed,and the method proved to be accurate and reliable.This study lays a basis for the improvement of the quality standard of Lutai Danshen Baishao Granules.

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朱映黎,刘磊,张建军,吕美豫,张文雅,侯新娟,王卫茜,王金凤,谷洪顺,王林元.高效液相色谱法测定鹿胎丹参白芍颗粒中葛根素、芍药苷及丹酚酸B含量[J].世界中医药,2022,(22).

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  • 收稿日期:2022-07-07
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  • 在线发布日期: 2022-12-12
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