新脑灵颗粒的质量标准研究
投稿时间:2015-09-28  修订日期:2015-12-01  点此下载全文
引用本文:任新新,王先友,陆文铨,朴淑娟,高守红.新脑灵颗粒的质量标准研究[J].药学实践杂志,2016,34(4):338~342
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任新新 第二军医大学附属长征医院药学部, 上海 200003
河南大学药学院, 河南 开封 475000 
 
王先友 河南大学药学院, 河南 开封 475000  
陆文铨 第二军医大学附属长征医院药学部, 上海 200003  
朴淑娟 第二军医大学附属长征医院药学部, 上海 200003  
高守红 第二军医大学附属长征医院药学部, 上海 200003 gaoshouhong@126.com 
中文摘要:目的 建立新脑灵颗粒的质量标准。方法 采用薄层色谱(TLC)法对该处方中的延胡索、白芷、厚朴、甘草、当归、川芎、五味子和菊花进行鉴别;采用高效液相色谱(HPLC)法测定丹酚酸B的含量,色谱柱:Agilent Eclipse XDB-C18(4.6 mm×250 mm,5μm);流动相:0.5%甲酸水溶液(A)-乙腈(B),梯度洗脱(0~5 min,24%B;5~6 min,24%~19%B;6~25 min,19%~20% B);流速:1.0 ml/min;柱温:25℃;检测波长:286 nm;进样量:10μl。结果 TLC图中特征斑点清晰,专属性强。丹酚酸B在20~1280μg/ml范围内线性关系良好,其回归方程为Y=13.304X-117.50(r=0.9999,n=7),平均回收率96.17%(RSD=1.10%)。结论 该方法简便可行、准确可靠、重复性好,可用于新脑灵颗粒的质量控制。
中文关键词:新脑灵颗粒  丹酚酸B  高效液相色谱  薄层色谱
 
Study on quality control of Xinnaoling granules
Abstract:Objective To establish quality control of Xinnaoling granules. Methods Thin layer chromatography (TLC) methods were used to identify Rhizoma Corydalis, Radix Angelicae dahuricae, Cortex Magnoliae officinalis, Radix Glycyrrhizae, Rhizoma Ligusticum, Ligusticum wallichii, Schisandra Chinensis, Dendranthema morifolium. The concentration of salvianolic acid B was determined by high performance liquid chromatography (HPLC). The method employed a column of Agilent Eclipse XDB-C18 (4.6 mm×250 mm,5 μm) with a mobile phase of 0.5% formic acid (A)-acetonitrile (B) at a temperature 25℃. The gradient elution program was as follow:0~5 min 24% B, 5~6 min 24%~19% B, 6~25 min 19~20% B. The flow rate was 1.0 ml/min, and the injection volume was 10 μl and the detection wavelength was 286 nm. Results The spots in TLC plates were clear and specific. As for salvianolic acid B, the linear range was 20-1280 μg/ml and the equation of linear regression of salvianolic acid B was Y=13.304 X-117.50 (r=0.9999, n=7). The average recovery rate was 96.17% (RSD=1.10%). Conclusion The method was proved to be simple, reliable, reproducible, and could be used in the quality control of Xinnaoling granules.
keywords:Xinnaoling granules  salvianolic acid B  HPLC  TLC
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