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知百安神口服液的质量标准改进研究Δ

夏天一 张凤 李志文 庞涛 李静娴 朴淑娟 陈万生 邬蓉

中国医院用药评价与分析2016,Vol.16Issue(7):880-882,883,4.
中国医院用药评价与分析2016,Vol.16Issue(7):880-882,883,4.DOI:10.14009/j.issn.1672-2124.2016.07.006

知百安神口服液的质量标准改进研究Δ

Study on Quality Improvement of Zhibaianshen Oral LiquidΔ

夏天一 1张凤 1李志文 1庞涛 1李静娴 1朴淑娟 1陈万生 1邬蓉1

作者信息

  • 1. 第二军医大学附属长征医院药材科,上海200003
  • 折叠

摘要

Abstract

OBJECTIVE:To improve the quality standard of Zhibaianshen oral lquid .METHODS: Anemarrhenae rhizoma and lilii bulbus were identified by TLC method , and the concentration of neomangiferin and mangiferin were determined by HPLC method.Separation was carried out on a Agilent Eclipse XDB-C18 (4.6 mm ×250 mm, 5μm) column with the mobile phase of acetonitrile and 0.2%formic acid in gradient elution at a flow rate of 1 ml/min.The detection wavelength was set at 246 nm, the column temperature was 30 ℃, and the injection volume was 20 μl.RESULTS:The characteristics of spots in TLC were quite clear with strong specificity .As for neomangiferin and mangiferin , the linear range of the calibration curve was 10.5-210.0 and 10.4-208.0 μg/ml, respectively (r2≥0.999 9), and the results of precision , accuracy and stability were satisfactory with RSD less than 2.00%.The average recovery rate turned out to be 103.49%( RSD=0.86%) and 98.81%( RSD=1.26%) ( n=6 ) .CONCLUSIONS: The established method is simple and reliable , which can be used for the quality control of Zhibaianshen oral liquid .

关键词

薄层色谱法/高效液相色谱法/知百安神口服液/质量标准

Key words

TLC/HPLC/Zhibaianshen oral liquid/Quality standard

分类

药学

引用本文复制引用

夏天一,张凤,李志文,庞涛,李静娴,朴淑娟,陈万生,邬蓉..知百安神口服液的质量标准改进研究Δ[J].中国医院用药评价与分析,2016,16(7):880-882,883,4.

基金项目

“重大新药创制”科技重大专项 ()

中国医院用药评价与分析

1672-2124

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