三藤口服液的质量标准研究
投稿时间:2017-02-28  修订日期:2017-04-24  点此下载全文
引用本文:陈小玲,陈顺,高守红,束畅,庞涛,陆文铨.三藤口服液的质量标准研究[J].药学实践杂志,2017,35(4):350~352,384
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陈小玲 第二军医大学附属长征医院药学部, 上海 200003  
陈顺 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 
束畅 第二军医大学附属长征医院药学部, 上海 200003  
庞涛 第二军医大学附属长征医院药学部, 上海 200003  
陆文铨 第二军医大学附属长征医院药学部, 上海 200003  
基金项目:军队医疗机构制剂标准提高科研专项基金(14ZJZ02-4,14ZJZ04-1);上海市科委科研专项基金(15401972200)
中文摘要:目的 建立三藤口服液的质量标准。方法 采用薄层色谱法鉴别处方中的大血藤和鸡血藤,采用HPLC法测定绿原酸的含量,色谱柱为Agilent Zorbax SB-C18柱(4.6 mm×250 mm,5 μm);流动相为乙腈-水(0.1%甲酸)(9∶91,v/v)等度洗脱;流速:1.0 ml/min;柱温:30 ℃;检测波长:330 nm;进样量:20 μl。结果 薄层鉴别色谱中特征斑点明显,专属性强。绿原酸在2.70~202.50 μg/ml浓度范围内线性关系良好,其回归方程为Y = 60.14X-6.37(r>0.999 9)。结论 该法简便、稳定可靠、重复性好,能够较好地控制三藤口服液的质量。
中文关键词:三藤口服液  质量标准  薄层色谱法  高效液相色谱法  绿原酸
 
Research on quality standard of Santeng oral solution
Abstract:Objective To establish the quality standard of Santeng oral solution. Method Sargentodoxa Caulis and Spatholobi Caulis were identified by thin layer chromatography. Chlorogenic acid was assayed by high performance liquid chromatography. The chromatographic column is Agilent Zorbax SB C18 (4.6 mm×250 mm, 5 μm) with a stable temperature of 35 ℃. The mobile phase in isocratic elution consists of acetonitrile and 0.1% folic acid aqueous solution with a preliminary volume ratio of 9∶91. The flow rate is 1.0 ml/min with an injection volume of 20 μl. Results Thin layer chromatography showed distinct spots of Sargentodoxa Caulis and Spatholobi Caulis with a great specificity. A regression formula Y=60.14X-6.37(r>0.999 9) was obtained with a good linearity in concentration range of 2.70~202.50 μg/ml. Conclusion A simple, stable and repeatable method was established for the quality control of Santeng oral solution.
keywords:Santeng oral solution  quality standard  TLC  HPLC  chlorogenic acid
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