丹绿补肾胶囊HPLC特征图谱  

HPLC specific chromatograms of Danlv Bushen capsules

作　　者：王文鹏 周永妍 郝鹏彬 张岩岩 刘建伟 孙胜斌 姜国志 李军山 WANG Wenpeng;ZHOU Yongyan;HAO Pengbin;ZHANG Yanyan;LIU Jianwei;SUN Shengbin;JIANG Guozhi;LI Junshan(Shineway Pharmaceutical Group Company Limited,Shijiazhuang,Hebei 051430,China)

机构地区：[1]神威药业集团有限公司,河北石家庄051430

出　　处：《河北工业科技》2018年第6期465-468,共4页Hebei Journal of Industrial Science and Technology

基　　金：河北省科技计划项目(16272510);河北省重点研发计划项目(17272505D)

摘　　要：为了提高丹绿补肾胶囊的质量控制标准,采用高效液相色谱法,对其特征图谱进行了方法学考察。选用phenomenex Luna C18(2)(4.6mm×250mm,5μm)色谱柱,流动相为乙腈-0.2%磷酸,梯度洗脱,流速为1.0mL/min,柱温为30℃,检测波长为220nm,建立了丹绿补肾胶囊特征图谱。结果表明:在优化的色谱条件下,丹绿补肾胶囊中的各成分得到了较好分离,以胡椒碱为参照峰,确定了7个共有峰,计算得出了各特征峰与S峰的相对保留时间。10批共有峰相对保留时间的RSD值均小于1.0%,相对峰面积的RSD值均小于2.0%。所建立的特征图谱能较好地评价丹绿补肾胶囊的产品质量,为提高该制剂的质量标准提供了数据基础。In order to improve the quality control standard of Danlv Bushen capsule, the HPLC characteristic chromatogram of Danlv Bushen capsul is investigated by HPLC. Chromatographic conditions： The phenomenex Luna C 18 （2）（4.6 mm×250 mm,5 μm）chromatographic column and the mobile phase of acetonitrile-0.2% aqueous phosphoric acid are used for gradient elution with the flow rate at 1.0 mL/min and the detection wavelength at 220 nm. The column oven temperature is kept at 30 ℃,the characteristic map of Danlu Bushen capsule ias established. In the chromatographic conditions, the constituents of Danlv Bushen capsules show a good separation, seven common peaks are identified, and the relative retention time of the characteristic peaks and the S peaks is calculated. The RSD values of the 10 groups of common peak relative retention time are all less than 1%, and the relative peak area RSD values are less than 2%.The established characteristic atlas could evaluate the quality of Danlv Bushen capsule, and lay a foundation for improving the quality standard.

关 键 词：中药药剂学 丹绿补肾胶囊 特征图谱 胡椒碱 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]