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  

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

作　　者：朱映黎[1] 刘磊 张建军[1] 吕美豫 张文雅 侯新娟 王卫茜 王金凤[1] 谷洪顺 王林元[1] ZHU Yingli;LIU Lei;ZHANG Jianjun;LYU Meiyu;ZHANG Wenya;HOU Xinjuan;WANG Weiqian;WANG Jinfeng;GU Hongshun;WANG Linyuan(Beijing University of Chinese Medicine,Beijing 100029,China;Shineway Pharmaceutical Group Limited,Shijiazhuang 051430,China;Beijing Cairui Institute of Pharmaceutical Science and Technology,Beijing 100094,China)

机构地区：[1]北京中医药大学,北京100029 [2]神威药业集团有限公司,石家庄051430 [3]北京采瑞医药科技研究院,北京100094

出　　处：《世界中医药》2022年第22期3139-3142,共4页World Chinese Medicine

基　　金：国家重点研发计划“中医药现代化研究”重点专项(2018YFC17068000)。

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。Objective: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.

关 键 词：鹿胎丹参白芍颗粒 葛根素 芍药苷 丹酚酸B 含量测定 高效液相色谱法 质量标准 

分 类 号：R285.5[医药卫生—中药学]