Science and Technology of Food Industry

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Volume 43 Issue 19
Sep.  2022
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ZHAO Lin, JIANG Yu, LAN Tao, et al. Review on Quality Safety Standards and Critical Control Points of Chondroitin Sulfate Sodium[J]. Science and Technology of Food Industry, 2022, 43(19): 7−13. (in Chinese with English abstract). doi: 10.13386/j.issn1002-0306.2022030218.
Citation: ZHAO Lin, JIANG Yu, LAN Tao, et al. Review on Quality Safety Standards and Critical Control Points of Chondroitin Sulfate Sodium[J]. Science and Technology of Food Industry, 2022, 43(19): 7−13. (in Chinese with English abstract). doi: 10.13386/j.issn1002-0306.2022030218.
shu

Review on Quality Safety Standards and Critical Control Points of Chondroitin Sulfate Sodium

  • 1.

    Sub-institute of Agriculture and Food Standardization, China National Institute of Standardization, Beijing 100191, China

  • 2.

    Center for Food Evaluation, State Administration for Market Regulation, Beijing 100160, China

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  • Received Date: March 17, 2022
  • Available Online: August 02, 2022
    Graphical Abstract
    • Abstract
  • Chondroitin sulfate sodium is an acidic mucopolysaccharide extracted from animal cartilage, and has been widely used in the world as anti-osteoarthritis and health food. It is difficult to control the quality and safety of chondroitin sulfate sodium, due to the structure, physical and chemical characteristics, physiological activities of chondroitin sulfate sodium vary with the different animal species, tissues and extraction processes. There are corresponding standards for chondroitin sulfate sodium at home and abroad. Based on the raw material standards of chondroitin sulfate sodium collected in the pharmacopoeia of China, the United States, Japan and Europe, this paper analyzes and summarizes the development status and trend of quality and safety standardization of chondroitin sulfate sodium. Combined with the latest research results, the critical control points affecting the quality and safety of chondroitin sulfate sodium are further extracted, and the sources, potential exogenous pollutants and adulteration are deeply analyzed and discussed, which is conducive to accurately grasp the risk sources affecting the quality and safety of chondroitin sulfate sodium for the supervision department and production enterprises. This paper clarifies the future requirements of quality and safety standardization of chondroitin sulfate sodium, providing reference for the continuous improvement of quality and safety standard system of chondroitin sulfate sodium.
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  • [1]
    VOLPI N. Chondroitin sulfate safety and quality[J]. Molecules,2019,24:1447. doi: 10.3390/molecules24081447
    [2]
    VOLPI N. Analytical aspects of pharmaceutical grade chondroitin sulfates[J]. Journal of Pharmaceutical Ences,2007,96(12):3168−3180.
    [3]
    VOLPI N. Quality of different chondroitin sulfate preparations in relation to their therapeutic activity[J]. Journal of Pharmacy and Pharmacology,2009,61(10):1271−1280. doi: 10.1211/jpp.61.10.0002
    [4]
    侯美曼, 任丽萍, 范慧红. 硫酸软骨素质量控制研究进展[J]. 中国药学杂志,2016,51(12):962−966. [HOU Meiman, REN Liping, FAN Huihong. Overview of the quality control of chondroitin sulfate[J]. Chinese Pharmaceutical Journal,2016,51(12):962−966.

    Hou Meiman, REN Liping, FAN Huihong. Overview of the quality control of chondroitin sulfate[J]. Chinese Pharmaceutical Journal, 2016, 51(12): 962-966.
    [5]
    BUCSI L, POÓR G. Efficacy and tolerability of oral chondroitin sulfate as a symptomatic slow-acting drug for osteoarthritis (Sysadoa) in the treatment of knee osteoarthritis[J]. Osteoarthritis Cartilage,1998,6(Suppl A):31−36.
    [6]
    ROSITA R, VALENTINA V, ANTONIETTA S, et al. Differential secretome profiling of human osteoarthritic synoviocytes treated with biotechnological unsulfated and marine sulfated chondroitins[J]. International Journal of Molecular Sciences,2021,21(11):3746.
    [7]
    SOUICH D P. Absorption, distribution and mechanism of action of sysadoas[J]. Pharmacology & Therapeutics,2014,142(3):362−374.
    [8]
    UEBELHART D, MALAISE M, MARCOLONGO R, et al. Intermittent treatment of knee osteoarthritis with oral chondroitin sulfate: A one-year, randomized, double-blind, multicenter study versus placebo[J]. Osteoarthritis Artilage,2004,12(4):269−276. doi: 10.1016/j.joca.2004.01.004
    [9]
    PELLETIER J P, RAYNAULD J P, BEAULIEU A D, et al. Chondroitin sulfate efficacy versus celecoxib on knee osteoarthritis structural changes using magnetic resonance imaging: A 2-year multicentre exploratory study[J]. Arthritis Research & Therapy,2016,18(1):256.
    [10]
    ZEGELS B, CROZES P, UEBELHART D, et al. Equivalence of a single dose (1200 mg) compared to a three-time a day dose (400 mg) of chondroitin 4 & 6 sulfate in patients with knee osteoarthritis. Results of a randomized double blind placebo controlled study[J]. Osteoarthritis Cartilage,2013,21(1):22−27. doi: 10.1016/j.joca.2012.09.017
    [11]
    KAHAN A, UEBELHART D, DE VATHAIRE F, et al. Long-term effects of chondroitins 4 and 6 sulfate on knee osteoarthritis: The study on osteoarthritis progression prevention, a two-year, randomized, double-blind, placebo-controlled trial[J]. Arthritis Rheum,2009,60(2):524−533. doi: 10.1002/art.24255
    [12]
    宋居易, 桂萌, 章志超, 等. 鲟鱼硫酸软骨素研究进展[J]. 中国水产,2013(8):74−75. [SONG Juyi, GUI Meng, ZHANG Zhichao, et al. Research progress of sturgeon chondroitin sulfate[J]. China Fisheries,2013(8):74−75. doi: 10.3969/j.issn.1002-6681.2013.08.030

    SONG Juyi, GUI Meng, ZHANG Zhichao, et al. Research progress of sturgeon chondroitin sulfate[J]. China Fisheries, 2013(8): 74-75. doi: 10.3969/j.issn.1002-6681.2013.08.030
    [13]
    张天民. 国外硫酸软骨素类膳食补充剂现状及其对我国相应产业可持续发展的启示[J]. 食品与药品,2008,10(1):4−7. [ZHANG Tianmin. Current situation of chondroitin sulfates dietary supplements at abroad and its enlightenment on sustainable development of corresponding industries in China[J]. Food and Drug,2008,10(1):4−7. doi: 10.3969/j.issn.1672-979X.2008.01.002

    ZHANG Tianmin. Current situation of chondroitin sulfates dietary supplements at abroad and its enlightenment on sustainable development of corresponding industries in China[J]. Food and Drug, 2008, 10(1): 4-7. doi: 10.3969/j.issn.1672-979X.2008.01.002
    [14]
    VOLPI N, GALEOTTI F, MACCARI F, et al. Structural definition of terrestrial chondroitin sulfate of various origin and repeatability of the production process[J]. Journal of Pharmaceutical and Biomedical Analysis,2020,195:113826.
    [15]
    ABDALLAH M M, FERNANDEZ N, MATIAS A A, et al. Hyaluronic acid and chondroitin sulfate from marine and terrestrial sources: Extraction and purification methods[J]. Carbohydrate Polymers,2020,243:116441. doi: 10.1016/j.carbpol.2020.116441
    [16]
    European Pharmacopoeia. EP10.0[S]. Drug Quality Administration, 2017: 2203-2205.
    [17]
    United States Pharmacopeial Convention. USP43-NF38[S]. United States Pharmacopoeia, 2020: 1-5.
    [18]
    边玲, 孔德新, 陈磊, 等. 硫酸软骨素日本标准及其说明[J]. 食品与药品,2013,15(2):150−151. [BIAN Ling, KONG Dexin, CHEN Lei, et al. Chondroitin sulfate standards in Japanese pharmaceutical codex and its explanation[J]. Food and Drug,2013,15(2):150−151. doi: 10.3969/j.issn.1672-979X.2013.02.030

    BIAN Ling, KONG Dexin, CHEN Lei, et al. Chondroitin sulfate standards in Japanese pharmaceutical codex and its explanation[J]. Food and Drug, 2013, 15(2): 150-151. doi: 10.3969/j.issn.1672-979X.2013.02.030
    [19]
    国家药典委员会. 中国药典2020年版 二部[S]. 中国标准出版社, 2020: 1595.

    Chinese Pharmacopoeia Commission. Materials in Chinese Pharmacopoeia 2020 Edition (Volume 2)[S]. China Standards Press, 2020: 1595.
    [20]
    于海洲, 范慧红, 宋玉娟, 等. 硫酸软骨素含量测定方法研究进展[J]. 中国生化药物杂志,2011,32(2):160−162. [YU Haizhou, FAN Huihong, SONG Yujuan, et al. Research advances in the determination of chondroitin sulfate[J]. Chinese Journal of Biochemical Pharmaceutics,2011,32(2):160−162.

    YU Haizhou, FAN Huihong, SONG Yujuan, et al. Research advances in the determination of chondroitin sulfate[J]. Chinese Journal of Biochemical Pharmaceutics, 2011, 32(2): 160-162.
    [21]
    国务院药品监督管理部门. 国家药品标准 化学药品地方标准上升国家标准第九册[S]. 2002.

    Drug Regulatory Department of the State Council. National drug standards-Local standards for chemicals rise national standards (Volume IX)[S]. 2002.
    [22]
    中国国家标准化管理委员会. GB/T 20365-2006硫酸软骨素和盐酸氨基葡萄糖含量的测定 液相色谱法[S]. 中国标准出版社, 2006

    China National Standardization Administration. Determination method for chondroitin sulfate and glucosamine hydrochloride-Liquid chromatography method[S]. China Standards Press, 2006.
    [23]
    农业农村部农产品加工标准化技术委员会. NY/T 3906-2021硫酸软骨素用原料[S]. 中国标准出版社, 2021

    Agricultural Products Processing Standardization Technical Committee of the Ministry of Agriculture and Rural Areas. NY/T 3906-2021 Raw material for chondroitin sulfate[S]. China Standards Press, 2021.
    [24]
    吕艺蓁, 邓欢, 郭紫薇, 等. 硫酸软骨素硫酸化修饰及硫酸软骨素制剂在大骨节病和骨关节炎中的研究进展[J]. 中华地方病学杂志,2021,40(11):942−946. [LÜ Yizhen, DENG Huan, GUO Ziwei, et al. Research progress of sulfation modification of chondroitin sulfate and chondroitin sulfate preparation in Kashin-Beck disease and osteoarthritis[J]. Chinese Journal of Endemiology,2021,40(11):942−946. doi: 10.3760/cma.j.cn231583-20210301-00059

    LÜ Yizhen, DENG Huan, GUO Ziwei, et al. Research progress of sulfation modification of chondroitin sulfate and chondroitin sulfate preparation in Kashin-Beck disease and osteoarthritis[J]. Chinese Journal of Endemiology, 2021, 40(11): 942-946. doi: 10.3760/cma.j.cn231583-20210301-00059
    [25]
    MULLOY B. Progress in the structural biology of chondroitin sulfate[J]. Advances in Pharmacology,2006,53:49−67.
    [26]
    GARNJANAGOONCHORN W, WONGEKALAK L, ENGKAGUL A. Determination of chondroitin sulfate from different sources of cartilage[J]. Chemical Engineering & Processing Process Intensification,2007,46(5):465−471.
    [27]
    JOHANNE M P, AINA F, EULALIA M, et al. Discrepancies in composition and biological effects of different formulations of chondroitin sulfate[J]. Molecules,2015,20(3):4277−4289. doi: 10.3390/molecules20034277
    [28]
    CANTLEY M, RAINSFORD K D, HAYNES D R. Comparison of the ability of chondroitin sulfate derived from bovine, fish and pigs to suppress human osteoclast activity in vitro[J]. Inflammopharmacology,2013,21(6):407−412. doi: 10.1007/s10787-013-0171-y
    [29]
    XIONG S L, LI A L, HUANG N. Recent advances in the bioactivities and structural analysis of chondroitin sulfate[J]. Advanced Materials Research,2011,152-153:399−407.
    [30]
    刘宁, 刘雅南, 刘涛, 等. 硫酸软骨素的制备研究及发展现状[J]. 食品工业科技,2014,35(3):392−395. [LIU Ning, LIU Yanan, LIU Tao, et al. Study on the preparation and current situation of chondroitin sulfate[J]. Science and Technology of Food Industry,2014,35(3):392−395. doi: 10.13386/j.issn1002-0306.2014.03.085

    LIU Ning, LIU Yanan, LIU Tao, et al. Study on the preparation and current situation of chondroitin sulfate[J]. Science and Technology of Food Industry, 2014, 35(3): 392-395. doi: 10.13386/j.issn1002-0306.2014.03.085
    [31]
    MACCARI F, GALEOTTI F, VOLPI N, et al. Isolation and structural characterization of chondroitin sulfate from bony fishes[J]. Carbohydrate Polymers,2015,129:143−147. doi: 10.1016/j.carbpol.2015.04.059
    [32]
    SUNWOO H H, NAKANO T, HUDSON R J, et al. Isolation, characterization and localization of glycosaminoglycans in growing antlers of wapiti (Cervus elaphus)[J]. Comparative Biochemistry & Physiology Part B Biochemistry & Molecular Biology,1998,120(2):273−283.
    [33]
    智琛琛, 孙考祥. 硫酸软骨素的研究和质量发展概况[J]. 医学理论与实践,2016,29(2):168−169. [ZHI Chenchen, SUN Kaoxiang. Research and quality development of chondroitin sulfate[J]. The Journal of Medical Theory and Practice,2016,29(2):168−169. doi: 10.19381/j.issn.1001-7585.2016.02.011

    ZHI Chenchen, SUN Kaoxiang. Research and quality development of chondroitin sulfate[J]. The Journal of Medical Theory and Practice, 2016, 29(2): 168-169. doi: 10.19381/j.issn.1001-7585.2016.02.011
    [34]
    罗小芳, 郭乙颖, 陈海峰, 等. 不同来源和制备工艺硫酸软骨素的二糖分析[J]. 食品工业,2018,39(10):1−5. [LUO Xiaofang, GUO Yiying, CHEN Haifeng, et al. Disaccharide analysis of chondroitin sulfates from different origins and process conditions[J]. The Food Industry,2018,39(10):1−5.

    LUO Xiaofang, GUO Yiying, CHEN Haifeng, et al. Disaccharide analysis of chondroitin sulfates from different origins and process conditions[J]. The Food Industry, 2018, 39(10): 1-5.
    [35]
    高洁, 赵玲, 马丽曼, 等. 鱼源硫酸软骨素的研究进展[J]. 食品安全质量检测学报,2020,11(22):8166−8172. [GAO Jie, ZHAO Ling, MA Liman, et al. Research progress of fish-derived chondroitin sulfate[J]. Journal of Food Safety and Quality,2020,11(22):8166−8172. doi: 10.19812/j.cnki.jfsq11-5956/ts.2020.22.005

    GAO Jie, ZHAO Ling, MA Liman, et al. Research progress of fish-derived chondroitin sulfate[J]. Journal of Food Safety and Quality, 2020, 11(22): 8166-8172. doi: 10.19812/j.cnki.jfsq11-5956/ts.2020.22.005
    [36]
    张舒亚, 吕蓉, 刘月明, 等. 硫酸软骨素中掺假动物成分的检测研究[J]. 食品工业科技,2009(1):309−310. [ZHANG Shuya, LÜ Rong, LIU Yueming, et al. Identification of animal derived material in chondroitin sulfate[J]. Science and Technology of Food Industry,2009(1):309−310. doi: 10.13386/j.issn1002-0306.2009.01.077

    ZHANG Shuya, LÜ Rong, LIU Yueming, et al. Identification of animal derived material in chondroitin sulfate[J]. Science and Technology of Food Industry, 2009, (1): 309-310. doi: 10.13386/j.issn1002-0306.2009.01.077
    [37]
    VOLPI N. Oral bioavailability of chondroitin sulfate (Condrosulf) and its constituents in healthy male volunteers[J]. Osteoarthritis and Cartilage,2002,10(10):768−777. doi: 10.1053/joca.2002.0824
    [38]
    VOLPI N. Oral absorption and bioavailability of ichthyic origin chondroitin sulfate in healthy male volunteers[J]. Osteoarthritis and Cartilage,2003,11(6):433−441. doi: 10.1016/S1063-4584(03)00051-7
    [39]
    VOLPI N. About oral absorption and human pharmacokinetics of chondroitin sulfate[J]. Osteoarthritis and Cartilage,2010,18(8):1104−1105. doi: 10.1016/j.joca.2010.02.018
    [40]
    LAMARI F N. The potential of chondroitin sulfate as a therapeutic agent[J]. Connective Tissue Research,2008,49(3-4):289−292. doi: 10.1080/03008200802148314
    [41]
    姜玮, 王金凤, 张惠, 等. 硫酸软骨素生产工艺现状与解析[J]. 药物生物技术,2015,22(2):185−188. [JIANG Wei, WANG Jinfeng, ZHANG Hui, et al. Present situation and analysis of chondroitin sulfate production process[J]. Pharmaceutical Biotechnology,2015,22(2):185−188. doi: 10.19526/j.cnki.1005-8915.2015.02.020

    JIANG Wei, WANG Jinfeng, ZHANG Hui, et al. Present situation and analysis of chondroitin sulfate production process[J]. Pharmaceutical Biotechnology, 2015, 22(2): 185-188. doi: 10.19526/j.cnki.1005-8915.2015.02.020
    [42]
    BRUYÈRE O, COOPER C, AL-DAGHRI N M, et al. Inappropriate claims from non-equivalent medications in osteoarthritis: A position paper endorsed by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)[J]. Aging Clinical and Experimental Research,2018,30(2):111−117. doi: 10.1007/s40520-017-0861-1
    [43]
    MALAVAKI C J, ASIMAKOPOULOU A P, LAMARI F N, et al. Capillary electrophoresis for the quality control of chondroitin sulfates in raw materials and formulations[J]. Analytical Biochemistry,2008,374(1):213−220. doi: 10.1016/j.ab.2007.11.006
    [44]
    SUGAHARA K, MIKAMI T, UYAMA T, et al. Recent advances in the structural biology of chondroitin sulfate and dermatan sulfate[J]. Current Opinion in Structural Biology,2003,13(5):612−620. doi: 10.1016/j.sbi.2003.09.011
    [45]
    STYLIANOU M, TRIANTAPHYLLIDOU I E, VYNIOS D H. Advances in the analysis of chondroitin/dermatan sulfate[J]. Advances in Pharmacology,2006,53:141−166.
    [46]
    POMIN V H, PIQUET A A, PEREIRA M S, et al. Residual keratan sulfate in chondroitin sulfate formulations for oral administration[J]. Carbohydr Polym,2012,90(2):839−846. doi: 10.1016/j.carbpol.2012.06.009
    [47]
    GALEOTTI F, MACCARI F, VOLPI N. Selective removal of keratan sulfate in chondroitin sulfate samples by sequential precipitation with ethanol[J]. Analytical Biochemistry,2014,448:113−115. doi: 10.1016/j.ab.2013.11.028
    [48]
    BRUCE C, JAMES M. Keratan sulphate, a complex glycosaminoglycan with unique functional capability[J]. Glycobiology,2018,28:182−206. doi: 10.1093/glycob/cwy003
    [49]
    NAKANO T, OZIMEK L. Detection of keratan sulfate by immunological methods in commercial chondroitin sulfate preparations[J]. Carbohydrate Polymers,2014,99:547−552. doi: 10.1016/j.carbpol.2013.08.052
    [50]
    MØLLER H J, MØLLER-PEDERSEN T, DAMSGAARD T E, et al. Demonstration of immunogenic keratan sulphate in commercial chondroitin 6-sulphate from shark cartilage. Implications for ELISA assays[J]. Clinica Chimica Acta,1995,236(2):195−204. doi: 10.1016/0009-8981(95)06053-G
    [51]
    HOBAN C, BYARD R, MUSGRAVE I. Hypersensitive adverse drug reactions to glucosamine and chondroitin preparations in Australia between 2000 and 2011[J]. Postgraduate Medical Journal,2020,96:190−3. doi: 10.1136/postgradmedj-2019-136957
    [52]
    DEANGELIS P L. Glycosaminoglycan polysaccharide biosynthesis and production: Today and tomorrow[J]. Applied Microbiology & Biotechnology,2012,94(2):295−305.
    [53]
    SCHONBERGER L B. New variant Creuzfeldt-Jakob disease and bovine spongiform encephalopathy[J]. Infectious Disease Clinics of North America,1998,12(1):111−121. doi: 10.1016/S0891-5520(05)70412-8
    [54]
    COSTE J. An overview of the diagnostic tools[J]. Transfusion Clinique et Biologique,2013,20(4):412−415. doi: 10.1016/j.tracli.2013.04.110
    [55]
    ZHANG W, GIANCASPRO G, ADAMS K M, et al. Electrophoretic separation of alginic sodium diester and sodium hexametaphosphate in chondroitin sulfate that interfere with the cetylpyridinium chloride titration assay[J]. Journal of Aoac International,2014,97(6):1503−1513. doi: 10.5740/jaoacint.14-167
    [56]
    VOLPI N, MACCARI F. Quantitative and qualitative evaluation of chondroitin sulfate in dietary supplements[J]. Food Analytical Methods,2008,1(3):195−204. doi: 10.1007/s12161-008-9020-9
    [57]
    DA CUNHA A L, DE OLIVEIRA L G, MAIA L F, et al. Pharmaceutical grade chondroitin sulfate: Structural analysis and identification of contaminants in different commercial preparations[J]. Carbohydrate Polymers,2015,134:300−308. doi: 10.1016/j.carbpol.2015.08.006
    [58]
    李莹莹, 刘钟栋, 杨忠波, 等. 硫酸软骨素掺假鉴定的太赫兹和红外光谱对比[J]. 红外与毫米波学报,2017,36(1):75−80. [LI Yingying, LIU Zhongdong, YANG Zhongbo, et al. Detection of chondroitin sulfate adulteration using terahertz and infrared spectroscopy techniques[J]. Journal of Infrared and Millimeter Waves,2017,36(1):75−80. doi: 10.11972/j.issn.1001-9014.2017.01.015

    LI Yingying, LIU Zhongdong, YANG Zhongbo, et al. Detection of chondroitin sulfate adulteration using terahertz and infrared spectroscopy techniques[J]. Journal of Infrared and Millimeter Waves, 2017, 36(1): 75-80. doi: 10.11972/j.issn.1001-9014.2017.01.015
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