心神宁片特征图谱的初步研究  

Preliminary study on the characteristic atlas of Xinshenning Tablets

作　　者：宋佳 侯超 段树卿 李云霞 SONG Jia;HOU Chao;DUAN Shu-qing;LI Yun-xia(Jingfukang Pharmaceutical Group Co.,Ltd.,Hebei Province,Chengde 067000,China;Hebei New Engineering Technology Research Center of Traditional Chinese Medicine,Hebei Province,Chengde 067000,China)

机构地区：[1]颈复康药业集团有限公司,河北承德067000 [2]河北省中药新辅料工程技术研究中心,河北承德067000

出　　处：《中国当代医药》2019年第33期34-36,F0004,共4页China Modern Medicine

摘　　要：目的建立心神宁片的高效液相色谱法(HPLC)特征图谱。方法采用HPLC法建立心神宁片的特征图谱,采用Perkin Elmer C18色谱柱(4.6 mm×250 mm,5μm)色谱柱,流动相:以乙腈(A)~0.2%冰乙酸(B)为流动相进行梯度洗脱;检测波长260 nm;柱温25℃;流速1.0 ml/min;进样体积10μl。结果采用《中药色谱指纹图谱相似度评价系统》进行分析,共确定了8个共有峰,精密度、重复性和稳定性实验中共有峰相对保留时间RSD值均<0.62%,相对峰面积RSD值均<2.86%。初步建立了心神宁片的HPLC特征图谱,并进行了相似度分析。结论所建立的方法简便、有效、重现性良好,建立的对照特征图谱对心神宁片的整体质量提出了更高的要求,为从整体上控制心神宁片的质量提供了科学依据。Objective To analyze the specific chromatograms of Xinshenning Tablets by high performance liquid chromatography(HPLC).Methods Perkin Elmer C18(4.6 mm×250 mm,5μm)column was used for high performance liquid HPLC with a gradient elution of acetonitrile-0.2%glacial acetic acid in mobile phase at a flow rate of 1.0 ml/min.The wavelength was 260 nm,the column temperature was 25°C,and the injection volume was 10μl.Results All results of the experiment were analyzed with Chromatographic Fingerprint Evaluation System,8 common peaks were identified;the RSD of the relative retention time in precision,stability and repea-tability experiments were all less than 0.62%,and the RSD of relative peak area was less than 2.86%.The standard specific chromatogram was established,and similarity analysis was carried out.Conclusion The established HPLC method of Xinshenning Tablets is simple,effective and reproducible,the establishment of the control characteristic map will put forward higher requirements for product quality and provides a basis for the overall control of the quality of compound Xinshenning Tablets.

关 键 词：心神宁片 特征图谱 高效液相 初步研究 

分 类 号：R286[医药卫生—中药学]