世界中医药

作者	单位
朱映黎1，刘磊2，张建军1，吕美豫1，张文雅1，侯新娟1，王卫茜3，王金凤1，谷洪顺3，王林元1	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

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中文摘要:

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。

English Summary:

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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