今日药学

2021, v.31(01) 32-34+42

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HPLC法同时测定中风回春丸中丹参素和丹酚酸B的含量
Content Determination of Tanshinol and Salvianolic Acid B in Zhongfenghuichun Pilule by HPLC

任晋;江涛;李纯;顾利红;栗建明;
REN Jin;JIANG Tao;LI Chun;GU Lihong;LI Jianming;Guangzhou Insitute for Drug Contol,NMPA Key Laboratory of Quality Control of Chinese Patent Medicine;Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co.,Ltd.;

摘要(Abstract):

目的建立同时测定中风回春丸中丹参素和丹酚酸B含量的高效液相色谱法。方法采用ACE Excel 5 Super C18色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液,梯度洗脱;柱温为25℃,进样量为10μL,流速为1.0 m L·min-1;检测波长为280 nm。结果丹参素的线性范围为46.03~1 380.9 ng(r=1.000),平均回收率为101.3%(RSD=1.7%,n=6),丹酚酸B的线性范围为56.55~1 696.5 ng(r=1.000),平均回收率为96.6%(RSD=2.6%,n=6)。结论本方法简便,准确,重现性好,适用于中风回春丸的质量控制。
OBJECTIVE To establish a method for determintation of tanshinol and salvianolic acid B in Zhongfenghuichun pilule by HPLC meanwhile. METHODS ACE Excel 5 Super C18 column( 250 mm×4.6 mm,5 μm) was used with acetonitrile-0.1% phosphoric acid as the mobile phase. The column temperature was 30 ℃ . The injection volume was 10 μL. The flow rate was 1. 0 m L·min-1. The detection wavelength was 280 nm. RESULTS The linearity range of tanshinol and salvianolic acid B were 46. 03-1 380. 9 ng( r =1.000) and 56.55-1 696.5 ng( r = 1.000),respectively. The average recoveries were 101.3%( RSD = 1.7%,n = 6) and 96.6%( RSD = 2.6%,n = 6),respectively. CONCLUSION The method is simple,accurate,reliable and available for the quality control of tanshinol and salvianolic acid B in Zhongfenghuichun pilule.

关键词(KeyWords): 中风回春丸;丹参素;丹酚酸B;含量测定;高效液相色谱法
Zhongfenghuichun pilule;tanshinol;salvianolic acid B;content determination;HPLC

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基金项目(Foundation): 国家药典委员会2019年药品标准提高项目(2019Z100)

作者(Author): 任晋;江涛;李纯;顾利红;栗建明;
REN Jin;JIANG Tao;LI Chun;GU Lihong;LI Jianming;Guangzhou Insitute for Drug Contol,NMPA Key Laboratory of Quality Control of Chinese Patent Medicine;Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co.,Ltd.;

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