Development of Certified Reference Material of -sitosterol

MA Yu-cui; WU Xiao-yi; WANG Wei; ZHANG Gui-feng; DU Ning; WANG Chun; WU Cui; CHAO Zhi-mao

doi:10.13422/j.cnki.syfjx.2017160090

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Development of Certified Reference Material of -sitosterol

更新时间：2024-01-04

- Development of Certified Reference Material of -sitosterol
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 23, Issue 16, Pages: 90-95(2017)
- 作者机构：
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.2017160090
  CLC： R284.1
- Published：2017
- 稿件说明：
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MA Yu-cui, WU Xiao-yi, WANG Wei, et al. Development of Certified Reference Material of -sitosterol[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(16): 90-95.
DOI：

MA Yu-cui, WU Xiao-yi, WANG Wei, et al. Development of Certified Reference Material of -sitosterol[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(16): 90-95. DOI： 10.13422/j.cnki.syfjx.2017160090.

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β-谷甾醇标准样品。方法：以白芥子为原料，采用硅胶柱色谱和重结晶技术，纯化获得了β-谷甾醇样品，采用元素分析，UV，红外光谱（IR），质谱（MS），核磁共振（NMR）和X-射线衍射（XRD）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蒸发光散射检测分析技术。样品分装成300瓶（10 mg/瓶）后，进行了均匀性检验、稳定性检验和联合定值。结果：该样品在95%的置信区间范围内样品均匀性良好，在0~8℃条件下24个月内稳定性良好，定值测定结果确定其纯度为95.41%，扩展不确定度为0.30%，达到了GB/T 15000.3系列国家标准样品的技术要求，通过了国家标准化管理委员会组织的验收。结论：成功地研制了β-谷甾醇国家标准样品，该标准样品可用于β-谷甾醇含量测定、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 β-sitosterol according to the Directives for CRM General and Statistical Principle for Certification (GB/T 15000.3-2008) based on the CRM project approved by Standardization Administration of the People's Republic of China (SAC). Method: β-Sitosterol was obtained from the dried seeds of Sinapisalba by means of silica gel column chromatography and recrystallization. The structure of β-sitosterol was confirmed by elemental analysis (EA)

NMR and XRD. Thin layer chromatography was carried out for the identification

and after sample of β-sitosterol was divided into 300 bottles with 10 mg per bottle

the homogeneity test

stability test

and cooperative certification were carried out by high performance liquid chromatography with evaporative light-scattering detector (HPLC-ELSD). Result: The homogeneitywas good within 95% confidence interval. The stability was good within 24 months storage period at 0-8℃. The certified purity value was 95.41%with an expanded uncertainty of 0.30% (k=2). The CRM of β-sitosterol complied with the technical requirement of a series of GB/T 15000.3 guides about CRM

and it was checked and accepted by SAC. Conclusion: The national CRM of β-sitosterol was developed for the first time

which can be used in the content determination

method validation

testing and quality control of related products.

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