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复视明胶囊的质量标准研究

肖会敏 张俏 何悦 刘洋 张明科 王四旺

中国药房2018,Vol.29Issue(6):749-753,5.
中国药房2018,Vol.29Issue(6):749-753,5.DOI:10.6039/j.issn.1001-0408.2018.06.07

复视明胶囊的质量标准研究

Study on Quality Standard for Fushiming Capsule

肖会敏 1张俏 2何悦 1刘洋 3张明科 4王四旺1

作者信息

  • 1. 第四军医大学药物研究所,西安710032
  • 2. 陕西中药研究所/陕西省创新药物研究中心,陕西咸阳712000
  • 3. 陕西中医药大学药学院,陕西咸阳712000
  • 4. 西安乐健生物科技有限公司,西安710054
  • 折叠

摘要

Abstract

OBJECTIVE:To establish quality standard of Fushiming capsule. METHODS:TLC was used to qualitatively identify the ligustilide,aurantio obtusin,chrysophanol,fruit of Chinese wolfberry and Whitmania pigra,respectively. HPLC method was used to determine the contents of puerarin and ginsenosides Rb1. The determination was performed on Intersil C18 column with mobile phase consisted of acetonitrile-0.3% phosphoric acid(gradient elution)at flow rate of 1.0 mL/min;the detection wavlength was set at 203 nm,and column temperature was 25 ℃;the sample size was 10 μL. RESULTS:TLC spots of ligustilide,aurantio obtusin,chrysophanol,the fruit of C. wolfberry and W. pigra were clear and well separated without negative interference. The linear range of puerarin and ginsenoside Rb1were 10.56-337.92 μg/mL(r=0.999 7)and 17.80-569.70 μg/mL(r=0.999 6). The limits of quantitation were 2.20,1.86 μg/mL,and the limits of detection were 0.12,0.13 μg/mL,respectively. RSDs of precision,stability and reproducibility tests were lower than 2.0%. The recoveries were 95.65%-99.66%(RSD=1.45%,n=6) and 96.95%-98.52%(RSD=0.77%,n=6),respectively. CONCLUSIONS:Established quality standard can be used for the quality control of Fushiming capsule.

关键词

复视明胶囊/质量标准/薄层色谱法/高效液相色谱法/人参皂苷Rb1/葛根素

Key words

Fushiming capsule/Quality standard/TLC/HPLC/Ginsenosides Rb1/Puerarin

分类

医药卫生

引用本文复制引用

肖会敏,张俏,何悦,刘洋,张明科,王四旺..复视明胶囊的质量标准研究[J].中国药房,2018,29(6):749-753,5.

基金项目

陕西省科学技术厅社会发展科技攻关项目(No.2016SF-349) (No.2016SF-349)

中国药房

OA北大核心CSTPCD

1001-0408

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