A national reference standard for fructosazine and deoxyfructosazine

doi:10.19803/j.1672-8629.20220223

Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (3): 282-285.
DOI: 10.19803/j.1672-8629.20220223

Previous Articles Next Articles

A national reference standard for fructosazine and deoxyfructosazine

LIU Bo^1,2, GUO Yunxiao³, ZHANG Tong^1,2, HUANG Lu^1,2, HE Lanying^1,2, FAN Huihong^1,2,*

¹Institute for Chemical Drug Control, National Institutes for Food and Drug Control, Beijing 102629, China;
²NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing 102629, China;
³School of Pharmacy, China Pharmaceutical University, Nanjing Jiangsu 210009, China

Received:2022-05-07 Online:2023-03-15 Published:2023-03-17

Abstract

Abstract: Objective To establish new national reference standards for fructosazine and deoxyfructosazine used for impurity determination of raw materials or preparations of glucosamine in order to ensure the quality of products of glucosamine. Methods UV, HRMS, ¹HNMR, ¹³CNMR, 2D NMR and CD were used to confirm the structure while the content of the product was calculated using the mass balance method before being verified by the QNMR method. Results The structure of this product was identified and the contents of fructosazine and deoxyfructosazine were assigned as 98.0% and 95.1% respectively. Conclusion Fructosazine and deoxyfructosazine have been established as national reference standards for the first time, which can be applied to quality control of glucosamine and related products.

Key words: fructosazine, deoxyfructosazine, glucosamine, establishing national reference standards

CLC Number:

R927

LIU Bo, GUO Yunxiao, ZHANG Tong, HUANG Lu, HE Lanying, FAN Huihong. A national reference standard for fructosazine and deoxyfructosazine[J]. Chinese Journal of Pharmacovigilance, 2023, 20(3): 282-285.

References

[1] TARUC RL, LYNCH SA.Diagnosis and treatment of osteoarthritis[J]. Primary Care, 2013, 40(4): 821-836.
[2] SACITHARAN PK.Ageing and osteoarthritis[J]. Subcell Biochem, 2019, 91:123-159.
[3] TANG X, WANG S, ZHAN S, et al.The prevalence of symptomatic knee osteoarthritis in China: results from the china health and retirement longitudinal study[J]. Arthritis Rheumatol, 2016, 68(3): 648-653.
[4] LESPASIO MJ, PIUZZI NS, HUSNI ME, et al.Knee osteoarthritis: a primer[J]. Permanente Journal, 2017, 21: 16-183.
[5] HERMANN W, LAMBOVA S, MULLER-LADNER U.Current treatment options for osteoarthritis[J]. Current Rheumatology Reviews, 2018, 14(2): 108-116.
[6] EBELL MH.Osteoarthritis: rapid evidence review[J]. American Family Physician, 2018, 97(8): 523-526.
[7] LOO S, JYET Q, WONG N.Advantages and challenges of stem cell therapy for osteoarthritis (Review)[J]. Biomedical Reports, 2021, 15(2): 67-78.
[8] JI LW, FU DX.Pharmacological effects and safety of amino glucose[J]. China Pharmaceutical Journal(中国药学杂志), 2007, 42(19): 1513-1516.
[9] XIAO YL, LI LP, CHENG YN, et al.Progress in the study of pharmacology and application of chondroitin sulfate[J]. China Pharmaceutical Journal(中国药学杂志), 2014, 49(13): 1093-1098.
[10] CHEN SY, HU N, JIA YB, et al.Expert consensus on clinical drug treatment of osteoarthritis[J]. Chinese Journal of the Frontiers of Medical Science(中国医学前沿杂志), 2021, 13(7): 32-43.
[11] LI CH, HUANG H, WU HL, et al.Efficacy of diclofenac sodium patch combined with glucosamine sulfate in the treatment of primary osteoarthritis[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2013, 10(11): 641-646.
[12] ZHANG WB.Expert consensus on glucosamine in the treatment of osteoarthritis[J]. Chinese Journal of Surgery(中华外科杂志), 2008, 46(18): 1437-1438.
[13] WAND D, LIU JP, TANG FX.Effect of glucosamine sulfate combined with ultra-short wave on knee osteoarthritis[J]. Chinese Journal of Practical Medicine(中国实用医刊), 2021, 48(20): 69-72.
[14] The United States Pharmacopeial Convention. U.S. Pharmacopeia National Formulary (USP43-NF38) Volume 2[M]. Baltimore: United Book Press, 2021: 7698-7698.
[15] Convention On the Elaboration of a European Pharmacopoeia. European Pharmacopoeia(EP 10.0)[M]. 2019. 2757-2758.
[16] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People’s Republic of China (中华人民共和国药典)[M]. Beijing: China Medical Science Press, 2020.
[17] HAN YZ.Certification of certified reference materials[J]. Chemical Analysis and Meterage(化学分析计量), 2001, 10(5): 38-40.

A national reference standard for fructosazine and deoxyfructosazine

PDF (PC)

Knowledge

Abstract

Cite this article

share this article

References

Related Articles 2

Recommended Articles

Metrics

[1]	LI Chun-hui, HUANG Hao, WU Hong-li, ZHAO Xiang, BIAN Wu . Efficacy of Diclofenac Sodium Patch Combined with Glucosamine Sulfate in the Treatment of Primary Osteoarthritis [J]. Chinese Journal of Pharmacovigilance, 2013, 10(11): 641-642.
[2]	HUANG Peng, ZHANG Xiu-Zhen, TIAN De-xiang, FENG Chuan-Ping. Ion Chromatography Determination of Glucosamine Calcium Citrate Dispersible Tablets [J]. Chinese Journal of Pharmacovigilance, 2010, 7(8): 449-450.