Study on Quality Standard of Sanwei Radix Isatidis Granules

LIANG Guocheng; CHEN Sining; CHEN Shuyin; YANG Hongmei; HUANG Xiao’ou; QIN Zhonggui; QIN Xin; WEI Shimin

doi:10.14009/j.issn.1672-2124.2021.08.010

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Study on Quality Standard of Sanwei Radix Isatidis Granules

更新时间：2022-10-08

- Study on Quality Standard of Sanwei Radix Isatidis Granules
- Vol. 21, Issue 8, Pages: 938-943(2021)
- 作者机构：
  
  1. 广西中医药大学附属瑞康医院药物研发中心
  2. 广西大学化学化工学院
  3. 广西壮瑶药工程技术研究中心
- 作者简介：
- 基金信息：
- DOI：10.14009/j.issn.1672-2124.2021.08.010
  CLC： R286.0
- Published：2021，
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LIANG Guocheng, CHEN Sining, CHEN Shuyin, et al. Study on Quality Standard of Sanwei Radix Isatidis Granules. [J]. 21(8):938-943(2021)
DOI：

LIANG Guocheng, CHEN Sining, CHEN Shuyin, et al. Study on Quality Standard of Sanwei Radix Isatidis Granules. [J]. 21(8):938-943(2021) DOI： 10.14009/j.issn.1672-2124.2021.08.010.

摘要

目的:研究医院制剂三味板蓝根颗粒的质量标准

提升该制剂的质量。方法:采用薄层色谱法(thin layer chromatography

TLC)对三味板蓝根颗粒进行原药材的定性鉴别研究;采用紫外-可见分光光度法(ultraviolet and visible spectrophotometry

UV-Vis)对该制剂的总有效成分之一的多糖进行含量测定研究;采用高效液相色谱法(high performance liquid chromatography

HPLC)对该制剂的活性成分(R

S)-告依春进行含量测定研究。结果:经TLC法进行定性鉴别研究

三味板蓝根颗粒中板蓝根、山芝麻均与相应的对照药材及对照品在同一位置呈相同斑点

且阴性无干扰;经UV-Vis法测定

该制剂的多糖含量为6.31%

RSD为0.67%;经HPLC法测定

该制剂中(R

S)-告依春的含量为0.035 5 mg/g

RSD为5.98%。结论:与三味板蓝根颗粒原有的质量标准相比

本研究增加了TLC、UV-Vis和HPLC法进行研究

研究方法简便快速、稳定可靠

可纳入医院制剂三味板蓝根颗粒的质量标准

为控制该制剂的质量提供依据。

Abstract

OBJECTIVE: To study the quality standard of hospital preparation Sanwei radix isatidis granules

so as to improve the quality of the preparation. METHODS: Thin Layer chromatography（ TLC） was used for the qualitative identification of Sanwei radix isatidis granules. Ultraviolet and visible spectrophotometry（ UV-Vis） was used to determine the content of polysaccharides

which was one of the total active ingredients of the preparation. High performance liquid chromatography（ HPLC） was used to determine the content of the active ingredient（ R

S）-goitrin in this preparation. RESULTS: According to the qualitative identification by TLC method

radix isatidis and screwtree root in Sanwei isatidis radix isatidis granules showed the same spots in the same position with the corresponding control materials and control substances

and the spots were negative without interference. According to UV-Vis

the content of polysaccharide was 6. 31% and RSD was 0. 67%. The content of（ R

S）-goitrin in the preparation was 0. 035 5 mg/g and RSD was 5. 98% by HPLC method. CONCLUSIONS: Compared with the original quality standard of Sanwei radix isatidis granules

TLC

UV-Vis and HPLC methods are enrolled into the study

which are simple

rapid

stable and reliable

and can be incorporated into the quality standard of hospital preparation Sanwei radix isatidis granules to provide basis for controlling the quality of the preparation.

关键词

三味板蓝根颗粒薄层色谱法紫外-可见分光光度法高效液相色谱法质量标准提升

Keywords

Sanwei radix isatidis granulesThin layer chromatographyUltraviolet and visible spectrophotometryHigh performance liquid chromatographyImprovement of quality standard

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