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舒心片的质量标准研究
刘明智,梁 宏,郝 旭
0
(萍乡市食品药品检验所,江西 萍乡,337000;萍乡市中医院,江西 萍乡,337000)
摘要:
目的:建立中药舒心片中丹酚酸B含量的测定方法。方法:采用高效液相色谱法(HPLC)测定舒心片中丹酚酸B的含量,色谱柱为Agilent TC-C18(2)色谱柱(4.6 mm×250 mm,5 μm),以乙腈-0.1%的磷酸溶液(25∶75)为流动相;检测波长为286 nm;柱温为25℃;流速为1.0 ml/min。结果:供试品和对照品溶液中丹酚酸B与他峰分离度良好;在0.050~1.642 μg之间丹酚酸B呈良好线性关系,R=0.9993,丹酚酸B平均加样回收率为97.58%,RSD=0.25%。结论:经方法学验证,本法可用于舒心片的质量控制。
关键词:  HPLC  舒心片  丹酚酸B  含量测定
DOI:
A study of quality standard for Shuxin tablets
LIU Mingzhi,LIANG Hong,HAO Xu
(Pingxiang Institute for Food and Drug Control,Pingxiang 337000,Jiangxi,China;Pingxiang Hospital of Traditional Chinese Medicine,Pingxiang 337000,Jiangxi,China)
Abstract:
Objective:To establish a method for the content determination of salvianolic acid B in the traditional Chinese medicine Shuxin tablets.Methods:To determine the content of salvianolic acid B in Shuxin tablets,high-performance liquid chromatography was performed on an Agilent TC-C1818(2) column (4.6 mm×250 mm,5 μm) with a mobile phase of acetonitrile-0.1% phosphoric acid solution (25∶75),at a detection wavelength of 286 nm,a column temperature of 25℃,and a flow rate of 1.0 ml/min.Results:The peak of salvianolic acid B was well separated from the other peaks in the solutions of the test article and the reference substance.Salvianolic acid B showed a good linear relationship within the range of 0.050~1.642 μg (R=0.9993),and the average recovery rate of salvianolic acid B was 97.58%,with a relative standard deviation of 0.25%.Conclusion:Methodological verification shows that this method can be used for the quality control of Shuxin tablets.
Key words:  high-performance liquid chromatography  Shuxin tablets  salvianolic acid B  content determination

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