Quality Control

Characterization and uncertainty evaluation of schizandrin A purity reference material

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  • 1. Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;
    2. Shanghai Standard Technology Co., Ltd., Shanghai 201314, China;
    3. TCM Standard Branch, Shanghai 201314, China

Revised date: 2022-06-30

  Online published: 2024-06-24

Abstract

Objective: According to the JJF 1343 general and statistical principles for characterization of reference material,to establish methods for the characterization of schizandrin A and evaluate the uncertainty. Methods: The purity of organic substance was determined by high performance liquid chromatography, and the contents of water, residual solvents and inorganic impurities were determined at the same time.Then the content of schisandrin A was calculated by mass balance (MB) method and quantitative nuclear magnetic resonance(qNMR) method. The average content obtained from MB and qNMR methods was used to be the characterization result of schisandrin A after statistical analysis, andthe uncertainty was evaluated. Results: The characterization result of schizandrin A was 99.3%, with the uncertainty of 0.4%(k=2). Conclusion: The established method can be used for the determination of schizandrin A and similar purity reference materials. The schizandrin A is approved as a national CRM(GBW (E) 091113). The CRM can be used for the content determination, quality control, analytical instrument calibration and analytical method confirmation, etc.

Cite this article

XU Ji-feng, WANG Zheng-tao, PAN Xue-ge, WANG Feng-qi, ZHANG Tian-yong, XIE Tian-pei, QIAN Yong . Characterization and uncertainty evaluation of schizandrin A purity reference material[J]. Chinese Journal of Pharmaceutical Analysis, 2022 , 42(7) : 1278 -1285 . DOI: 10.16155/j.0254-1793.2022.07.22

References

[1] 杨放, 袁军, 付平.五味子的研究概况[J].华西药学杂志, 2003, 18(6):438
YANG F, YUAN J, FU P. The research situation of Schisandra chinensis[J].West China J Pharm Sci, 2003,18(6): 438
[2] 马永明, 耿亚. 浅谈南五味子[J].中国中医药现代远程教育, 2013, 11(9): 103
MA YM, GENG Y. A brief discussion on Schisandra chinensis[J].Chin Med Mod Dis Educ China, 2013, 11(9): 103
[3] 中华人民共和国药典2020年版. 一部[S].2020:68,255
ChP 2020. VolⅠ[S].2020:68,255
[4] 于新. 药食同源物品使用手册(可用于保健食品的物品)[M].北京: 中国轻工业出版社,2012
YU X. Use Manual of Medicinal and Edible Homologous Articles(Articles that Can Be Used in Health Food)[M].Beijing: China Light Industry Press, 2012
[5] CUI LK, ZHU WZ, YANG ZJ, et al. Evidence of anti-infla-mmatory activity of schizandrin A in animal models of acute infla-mmation[J].Naunyn Schmiedebergs Arch Pharmacol, 2020, 393(11): 2221
[6] 曾智锐, 雷珊, 张金娟, 等.五味子甲素对人胰腺癌细胞株As Pc-1增殖、凋亡的影响及其机制[J].山东医药, 2019, 59(12): 1
ZENG ZR, LEI S, ZHANG JJ, et al. Effects and mechanism of deoxyschizandrin on proliferation and apoptosis of human pancreatic cancer cells AsPc-1[J].Shandong Med J, 2019,59(12): 1
[7] LEE K, AHN JH, LEE KT, et al. Schizandrin A, isolated from schisandra berries, induces cell cycle arrest in ovarian cancer cells and inhibits the protumoural activation of tumour-associated macrophages[J].Nutrients, 2018, 10(1):91
[8] 刘聪, 李贺, 王春梅,等.1996-2016年五味子在国产保健食品中的应用与分析[J].北华大学学报(自然科学版), 2018, 19(2): 191
LIU C, LI H, WANG CM, et al. Application and analysis of Schisandra chinensis in domestic health foods from 1996 to 2016[J].J Beihua Univ(Nat Sci), 2018, 19(2):191
[9] 张林疆, 刘唯芬, 毕开顺,等. 五味子质量标准的研究[J].辽宁中医药大学学报, 2004, 6(3):219
ZHANG LJ, LIU WF, BI KS, et al. Research on Frutus Schisandrae quality standard[J].J Liaoning Univ Tradit Chin Med, 2004, 6(3):219
[10] 全国标准物质管理委员会. 中华人民共和国标准物质目录(2016年)[S].2016
National Administrative Committee for CRM's. Catalogue of Reference Substances(2016)[S].2016
[11] JJG 705-2014 液相色谱仪[S].2008
JJG 705-2014 Liquid Chromatograph[S].2008
[12] HUANG BM, XIAO SY, CHEN TB, et al. Purity assessment of ginsenoside Rg1 usin g quantitative 1H nuclear magnetic resonance[J].J Pharm Biomed Anal, 2017, 139:193
[13] 马康, 杨冉, 王海峰, 等. 质量平衡法分析1,2,3,4-四氯苯的纯度分析与不确定度评定[J].岩矿测试, 2013, 32(2): 334
MA K, YANG R, WANG HF, et al. Analysis of purity and uncertainty for 1,2,3,4-tetrachlorobenzene with the mass balance method[J].Rock Miner Anal, 2013, 32(2): 334
[14] GONG H, HUANG T, YANG Y, et al. Purity determination and uncertainty evaluation of folic acidby mass balance method[J].Talanta, 2012, 101(22): 96
[15] PAULI GF, SHAO-NONG C, CHARLOTTE S, et al. Importan ce of purity evaluation and the potential of quantitative 1H NMR as a purity assay[J].J Med Chem, 2014, 57(22): 9220
[16] LIU SY, HU CQ. A comparative uncertainty study of the calibration of macrolide antibiotic reference standards using quantitative nuclear magnetic resonance and mass balance methods[J].Anal Chim Acta, 2007, 602(1):114
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