Preparation of Certified Reference Material of Sakuranetin

MA Yu-cui; WU Cui; WANG Wei; WANG Chun; DU Ning; LIU Hai-ping; WU Xiao-yi; CHAO Zhi-mao

doi:10.13422/j.cnki.syfjx.2017090051

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Preparation of Certified Reference Material of Sakuranetin

更新时间：2024-01-04

- Preparation of Certified Reference Material of Sakuranetin
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 23, Issue 9, Pages: 51-56(2017)
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- DOI：10.13422/j.cnki.syfjx.2017090051
  CLC： R284.1
- Published：2017
- 稿件说明：
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MA Yu-cui, WU Cui, WANG Wei, et al. Preparation of Certified Reference Material of Sakuranetin[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(9): 51-56.
DOI：

MA Yu-cui, WU Cui, WANG Wei, et al. Preparation of Certified Reference Material of Sakuranetin[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(9): 51-56. DOI： 10.13422/j.cnki.syfjx.2017090051.

摘要

目的：依据GB/T 15000.3-2008《标准样品工作导则（3）标准样品：定值的一般原则和统计方法》，在国家标准化管理委员会批准立项的基础上，研制樱花素国家标准样品。方法：以中药毛白杨的干燥茎皮为原料，通过提取、分离，纯化制备了樱花素样品，采用旋光度、元素分析、红外光谱、紫外光谱、高分辨质谱、核磁共振谱和X-单晶衍射进行了结构鉴定。进行了薄层色谱的鉴别。建立了高效液相色谱紫外检测分析技术。样品分装成400瓶（每瓶5 mg）后，进行了均匀性检验、稳定性检验和联合定值。结果：该样品为DL-5，4'-二羟基-7-甲氧基二氢黄酮，95%置信区间范围内的均匀性良好，0~8℃条件下24个月内稳定性良好，定值结果确定其纯度为99.97%，相对扩展不确定度为0.02%，通过了国家标准化管理委员会组织的验收，达到了国家标准样品的技术要求。结论：成功地研制了樱花素国家标准样品，可用于樱花素含量测定、检测方法评定、相关产品的检测与质量控制。

Abstract

Objective: To develop a certified reference material (CRM) of sakuranetin according to the Work Guideline for Reference Materials (3):Reference Material-General Principles and Statistical Method for Certification (GB/T 15000.3-2008) upon the approved by Standardization Administration of China (SAC). Method: Sakuranetin was extracted from dried barks of Populus tomentosa. The structure of sakuranetin was identified by optical rotation

elemental analysis

high-resolution MS

NMR

and X-ray diffraction analysis. Thin layer chromatography was carried out for the identification. Sakuranetin was divided into 400 bottles

with 5 mg per bottle. The homogeneity test

stability test

and quantitative analysis were carried out by high-performance liquid chromatography-ultra violet detector. Result: This CRM is DL-5

4'-dihydroxy-7-methoxyflavanone. The homogeneity of the 95% confidence interval was good. The storage period was 24 months at 0-8℃. The certified purity value was 99.97%

with a relative expanded uncertainty of 0.02%. The CRM of sakuranetin reached the technical requirements of CRM

and was accepted by SAC. Conclusion: The CRM of sakuranetin is successfully developed

and can be used for determining content

evaluating test methods

detecting relevant products and controlling quality.

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Related Institution

Institute of Chinese Materia Medica，China Academy of Chinese Medical Sciences

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