江苏省科技期刊可视化阅读平台

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江苏科技信息 ›› 2016, Vol. 33 ›› Issue (20): 73-76.doi: 10.3969/j.issn.1004-7530.2016.20.015

• 论文 • 上一篇    下一篇

痰热清胶囊HPLC指纹图谱研究

钟苹苹, 刘绍勇, 张小利, 徐英   

  1. 上海中医药大学，上海 201203; 上海凯宝药业股份有限公司，上海 201401;上海凯宝药业股份有限公司,上海,201401;上海中药标准化研究中心，上海 201203; 上海凯宝药业股份有限公司，上海 201401
  • 出版日期:2016-07-15 发布日期:2016-07-15
  • 基金资助:
    国家自然科学基金资助项目%项目编号81403089。

Research on HPLC Fingerprint of Tanreqing Capsule

Zhong Pingping, Liu Shaoyong, Zhang Xiaoli, Xu Ying   

  • Online:2016-07-15 Published:2016-07-15

摘要： 文章的研究目的：初步建立痰热清胶囊的HPLC（高效液相色谱）指纹图谱方法，为其品质评价研究提供依据。方法：采用Ultimate XB-C18柱（250mm×4.6mm，5μm）；以乙腈（A）-0.2%甲酸（B）为流动相，进行梯度洗脱；流速为0.8~1.0mL·min-1；检测波长280nm；柱温30℃；进样量10μL。测定3批痰热清胶囊的色谱图，应用相似度分析软件建立痰热清胶囊共有模式，并对指纹共有峰进行指认。结果：首次建立了痰热清胶囊HPLC指纹图谱方法并建立了其共有模式，3批痰热清胶囊的相似度可达1.000；确定共有峰16个，并对其进行药材归属和指认。结论：文章建立的HPLC指纹图谱方法操作简便，可靠、稳定、准确，重复性好，为痰热清胶囊的质量控制提供科学依据。

关键词: 痰热清胶囊, 指纹图谱, HPLC, 质量控制

Abstract: This paper aims to establish the fingerprint of Tanreqing Capsule by HPLC and provide a reliable method for its quality control. The samples were analyzed on Ultimate XB-C18(250mm×4.6mm, 5μm) column with acetonitrile (A)-0.2%formic acid (B) at the mobile phase at 0.8~1.0mL·min-1. The detective wave length was 280 nm and the column temperature was 30℃. The injection was 10μL. The common mode of HPLC fingerprint for 3 batches of Tanreqing Capsule was established with similarity analyses and the common fingerprint peaks were identified. HPLC fingerprint of Tanreqing Capsule was developed firstly. The similarities of 3 batches of samples were 1.000. Sixteen common fingerprint peaks were indicated and attributed to raw materials, and all of them were identified by comparison with reference standards. In conclusion, the method can be used as the evidence for quality control of Tanreqing Capsule with simplicity, reliability, stability, accuracy, and good reproducibility.