中国中药杂志

2019, v.44(24) 5446-5450

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丹参多酚酸对照提取物在丹参药材及注射用丹参多酚酸质量控制中的应用研究
Study on application of salvianolic acids reference extract in quality control of Salvia miltiorrhiza and salvianolic acids for injection

李耀磊;刘丽娜;王莹;金红宇;岳洪水;马双成;
LI Yao-lei;LIU Li-na;WANG ying;JIN Hong-yu;YUE Hong-shui;MA Shuang-cheng;National Institutes for Food and Drug Control;Tianjin Tasly Pride Pharmaceutical Co.,Ltd.;

摘要(Abstract):

该研究旨在考察采用丹参多酚酸对照提取物对丹参药材及注射用丹参多酚酸进行质量控制的可行性。首先采用Agilent ZORBAX SB-C18色谱柱(4. 6 mm×250 mm,5μm),以0. 1%甲酸-水为流动相A,0. 1%甲酸-乙腈为流动相B,采用梯度程序洗脱,柱温30℃,流速1 m L·min-1,检测波长288 nm;并以丹参多酚酸对照提取物为对照物质,对丹参药材中迷迭香酸、紫草酸、丹酚酸B及注射用丹参多酚酸中咖啡酸、丹酚酸E、迷迭香酸、紫草酸、丹酚酸B、丹酚酸Y进行含量测定。结果表明各指标成分在各自的检测质量浓度范围内线性关系良好(r>0. 998 9),进样精密度RSD在0. 30%~0. 90%;丹参药材重复性RSD在1. 4%~3. 0%,注射用丹参多酚酸重复性RSD在2. 1%~5. 2%;丹参药材3种成分的加样回收率在96. 80%~99. 20%,注射用丹参多酚酸6种成分的加样回收率在88. 90%~107. 5%;药材及注射用丹参多酚酸样品溶液在48 h内各成分稳定性良好。采用对照提取物测定丹参药材及注射用丹参多酚酸制剂共8批次,测定结果与采用各指标成分单体对照品测得的结果差异较小。该研究初步验证了丹参多酚酸对照提取物可替代单体对照品用于丹参药材及注射用丹参多酚酸制剂的质量控制。
The purpose of this study was to investigate the feasibility of the salvianolic acids reference extract for quality control for Salvia miltiorrhiza and salvianolic acids for injection. An Agilent ZORBAX SB-C18( 4. 6 mm×250 mm,5 μm) column was used with mobile phase consisting of 0. 1% formic acid-water and 0. 1% formic acid-acetonitrile in gradient elution procedure. The column temperature was 30 ℃; the flow rate was 1 m L·min-1; and the detection wavelength was 288 nm. The content of rosmarinic acid,lithospermic acid and salvianolic acid B in S. miltiorrhiza was determined by using the salvianolic acids reference extract as control substance. The content of caffeic acid,salvianolic acid E,rosmarinic acid,lithospermic acid,salvianolic acid B,and salvianolic acid Y in the salvianolic acids for injection was also determined. The linear relationship between chemicals was good( r>0. 998 9),and the injection precision RSD was 0. 30%-0. 90%. The sexual RSD is between 1. 4% and 3. 0%,and the RSD of the reproducibility of the extract is between 2. 1% and 5. 2%. The recovery rate of the three components in S. miltiorrhiza was 96. 80%-99. 20%,and the recovery rate of the six components in salvianolic acids for injection was 88. 90%-107. 5%. The solution of S. miltiorrhiza and salvianolic acids for injection were stable within 48 h. A total of 8 batches of S. miltiorrhiza and injection were determined by the reference extract,and the difference was smaller than that measured by the monomer control. This study preliminarily verified that the salvianolic acids reference extract can be used as a substitute for the monomer control for the quality control of S. miltiorrhiza and salvianolic acids for injection.

关键词(KeyWords): 丹参多酚酸;丹参;对照提取物;含量测定;丹酚酸B;质量控制
salvianolic acids;Salvia miltiorrhiza;reference extract;content determination;salvianolic acid B;quality control

Abstract:

Keywords:

基金项目(Foundation): 国家“重大新药创制”科技重大专项(2014ZX09304307-002)

作者(Author): 李耀磊;刘丽娜;王莹;金红宇;岳洪水;马双成;
LI Yao-lei;LIU Li-na;WANG ying;JIN Hong-yu;YUE Hong-shui;MA Shuang-cheng;National Institutes for Food and Drug Control;Tianjin Tasly Pride Pharmaceutical Co.,Ltd.;

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