Standards and quality control points of alginate-based medical devices_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

REN Ying ¹ ,  ZHANG Demeng ²

1. Center for Medical Device Evaluation, National Medical Products Administration, Beijing, 100081, P.R.China;
2. State Key Laboratory of Seaweed Bioactive Substances, Qingdao Shandong, 266400, P.R.China;

Corresponding author：

ZHANG Demeng, Email: zdm@bmsg.com

Keywords：

Alginate; medical device; product standard; quality control

DOI：

10.7507/1002-1892.201812002

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To analyze standards of alginate-based medical devices at home and abroad, and to emphasize key issues of quality control that should be concerned about.Methods Based on investigation of alginate application in medical devices and alginate-related medical standards, alginate-related technical indicators and quality control points were comprehensively analyzed.Results With the rapid development of alginate-based medical materials and medical devices, the relevant standards at home and abroad have been elaborated on the basic technical indicators and detection methods. In addition to Chinese Pharmacopoeia, China has issued one alginate standard for tissue engineering and three alginate related product standards.Conclusion Considering the special physical and chemical properties of alginate, researchers also need to focus on the sterilization method, expiry date, molecular weight, and ratio of α-L-guluronic acid to β-D-mannuronic acid of alginate, and impurity content.

Citation： REN Ying, ZHANG Demeng. Standards and quality control points of alginate-based medical devices. Chinese Journal of Reparative and Reconstructive Surgery, 2019, 33(8): 1041-1044. doi: 10.7507/1002-1892.201812002 Copy

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1. 位晓娟, 奚廷斐, 顾其胜, 等. 医用海藻酸基生物材料的研究进展. 中国修复重建外科杂志, 2013, 27(8): 1015-1020.
2. Augst AD, Kong HJ, Mooney DJ. Alginate hydrogels as biomaterials. Macromol Biosci, 2006, 6(8): 623-633.
3. Lee KY, Mooney DJ. Alginate: properties and biomedical applications. Prog Polym Sci, 2012, 37(1): 106-126.
4. Sun JY, Zhao X, Illeperuma WR, et al. Highly stretchable and tough hydrogels. Nature, 2012, 489(7414): 133-136.
5. Lin ZF, Wu MM, He HM, et al. 3D Printing of Mechanically stable calcium-free alginate based scaffolds with tunable surface charge to enable cell adhesion and facile biofunctionalization. Advanced Functional Materials, 2019, 29(9): 1808439.
6. Wei Z, Yang JH, Liu ZQ, et al. Novel biocompatible polysaccharide-based self-healing hydrogel. Advanced Functional Materials, 2015, 25(9): 1352-1359.
7. Aderibigbe BA, Buyana B. Alginate in wound dressings. Pharmaceutics, 2018, 10(42): 1-19.
8. The United States Pharmacopeial Convention. United States Pharmacopeia 39/ National Formulary 34. Maryland: United States Pharmacopeial Convention, 2016: 7514-7515.
9. European Directorate for the Quality of Medicines & HealthCare. European Pharmacopoeia. 8th ed. Strasbourg: EDQM, 2013: 3226.
10. 国家药典委员会. 中华人民共和国药典 (2015 年版) 四部. 北京: 中国医药科技出版社, 2015: 554-555.
11. 顾其胜, 周则红, 关心. 医用海藻酸盐产品标准与质量控制. 中国修复重建外科杂志, 2013, 27(6): 760-764.
12. American Society for Testing and Materials. ASTM F2064-17 standard guide for characterization and testing of alginates as starting materials intended for use in biomedical and tissue-engineered medical products application. Pennsylvania: ASTM International, 2017: 1-9.
13. 国家食品药品监督管理局. 中华人民共和国医药行业标准组织工程医疗产品第8部分: 海藻酸钠 YY/T 0606.8-2008. 北京: 中国标准出版社, 2008: 1-14.
14. 国家药品监督管理局. 中华人民共和国医药行业标准齿科藻酸盐印模材料 YY 1027-2001. 北京: 中国标准出版社, 2001: 1-11.
15. 国家食品药品监督管理总局. 中华人民共和国医药行业标准接触性创面敷料 YY/T 1293.5-2017. 北京: 中国标准出版社, 2017: 1-6.
16. 顾其胜, 王帅帅, 王庆生, 等. 海藻酸盐敷料应用现状与研究进展. 中国修复重建外科杂志, 2014, 28(2): 255-258.
17. 国家食品药品监督管理总局. 中华人民共和国医药行业标准组织工程医疗器械产品海藻酸盐凝胶固定或微囊化指南 YY/T 1574-2017. 北京: 中国标准出版社, 2017: 1-15.
18. 国家质量监督检验检疫总局. 中华人民共和国国家标准医疗器械生物学评价第7部分: 环氧乙烷灭菌残留量GB/T 16886.7-2015. 北京: 中国标准出版社, 2016: 105-132.
19. 国家药品监督管理局. 除菌过滤技术及应用指南[EB/OL]. (2018-09-11) [2019-06-13] http://www.nmpa.gov.cn/WS04/CL2183/330190.html.
20. 顾其胜, 王庆生, 位晓娟, 等. 海藻酸盐基生物医用材料与临床医学. 上海: 上海科学技术出版社, 2015: 8-35.
21. 国家食品药品监督管理总局. 无源植入性医疗器械货架有效期注册申报资料指导原则(2017年修订版)[EB/OL]. (2017-05-12) [2019-06-13] http://samr.cfda.gov.cn/WS01/CL0087/173182.html.

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Chinese Journal of Reparative and Reconstructive Surgery

Standards and quality control points of alginate-based medical devices

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