PRODUCT STANDARD AND QUALITY CONTROL OF MEDICAL ALGINATES_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

GU Qisheng ^1,2 , ZHOU Zehong ¹ , KUAN Hsin ¹

1Shanghai Biomedical Enterprise LLC, Shanghai, 200336, P.R.China;;
2Shanghai Qisheng Institution of Biomaterials and Technology. Corresponding author: GU Qisheng, E-mail: qishenggu@163.com;

Corresponding author：

Keywords：

Sodium alginate; Calcium alginate; Product standard; Quality control

DOI：

10.7507/1002-1892.20130168

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Objective To compare product standards of drug and medical device made from sodium alginate and calcium alginate between domestic and abroad, and to emphases on the process parameters monitoring based on different standards. Methods Sodium alginate and calcium alginate standards of both domestic and foreign were analyzed and summarized, and the differences and commonalities of various product standards among each standard were compared. Results Differences exist in product standards of sodium alginate and calcium alginate between domestic and abroad, whether drug or medical device, but the fundamental control points are concordant. Conclusion Companies should focus on product quality control requirements combined with its own unique manufacturing process characteristics to develop reasonable and controllable quality standards, which can ensure safe and effective clinical use.

Citation： GU Qisheng,ZHOU Zehong,KUAN Hsin. PRODUCT STANDARD AND QUALITY CONTROL OF MEDICAL ALGINATES. Chinese Journal of Reparative and Reconstructive Surgery, 2013, 27(6): 760-764. doi: 10.7507/1002-1892.20130168 Copy

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4.	Lee RJ, Hinson A, Helgerson S, et al. Polymer-based restoration of left ventricular mechanics. Cell Transplant, 2013, 22(3): 529-533.
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14.	孙雪, 奚廷斐, 卢大伟. 用于组织工程医疗产品海藻酸钠主要性能指标的测定. 中国组织工程研究, 2012, 16(38): 7140-7144.
15.	顾其胜, 朱彬. 海藻酸盐基生物医用材料. 中国组织工程研究与临床康复, 2007, 11(26): 5194-5198.
16.	De Vos P, De Haan B, Van Schilfgaarde R. Effect of the alginate composition on the biocompatibility of alginate-polylysine microcapsules. Biomaterials, 1997, 18(3): 273-278.
17.	De Vos P, van Hoogmoed CG, van Zanten J, et al. Long-term biocompatibility, chemistry, and function of microencapsulated pancreatic islets. Biomaterials, 2003, 24(2): 305-312.
18.	国家药品监督管理局. 关于发布医疗器械注册产品标准编写规范的通知. 2002-11-07.
19.	中华人民共和国医药行业标准医疗器械生物学评价第1部分: 风险管理过程中的评价与试验. GB/T 16886.1-2011. 北京: 中国标准出版社, 2011: 1-16.
20.	中华人民共和国卫生部药品标准新药转正标准第十册: 海藻酸钙. 1996: 65.
21.	Committee on Food Chemicals Codes. Food Chemicals Codex V Calcium Alginate. Washington DC: Nation Academies Press, 2003: 61.
22.	龚泰芳, 方彩云, 陈文, 等. 海藻酸盐的理化特性及其在组织工程研究和临床中的应用. 中国组织工程研究与临床康复, 2007, 11(18): 3613-3615.
23.	Bernd HA Rehm. Alginates: Biology and Applications. Heidelberg: Springer, 2009: 1-266.
24.	Kong HJ, Smih MK, Mooney DJ. Designing alginate hydrogels to maintain viability of immobilized cells. Biomaterials, 2003, 24(22): 4023-4029.

1. 顾其胜, 奚廷斐. 海藻酸与临床医学. 上海: 第二军医大学出版社, 2006: 1-200.
2. 秦益民. 海藻酸. 北京: 中国轻工业出版社, 2008: 1-217.
3. Andersen T, Strand BL, Formo K, et al. Alginates as biomaterials in tissue engineering. Carbohydr Chem, 2012, 37: 227-258.
4. Lee RJ, Hinson A, Helgerson S, et al. Polymer-based restoration of left ventricular mechanics. Cell Transplant, 2013, 22(3): 529-533.
5. European Directorate for the Quality of Medicines & HealthCare. European Pharmacopoeia. 7th ed. Strasbourg: EDQM, 2010: 2909-2910.
6. British Pharmacopoeia Commission. British Pharmacopoeia 2012. London: TSO, 2012: 1951.
7. The United States Pharmacopeial Convention. United States Pharmacopeia 35/ National Formulary 30. Maryland: United States Pharmacopeial Convention, 2012: 1950.
8. 国家药典委员会. 中华人民共和国药典. 二部2010年版. 北京: 中国医药科技出版社, 2010: 1218.
9. 国家药典委员会. 国家药品标准工作手册. 3版. 1998: 110-142.
10. American Society for Testing and Materials. ASTM F2064-00(2006)e1 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, 2006: 1-8.
11. 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.
12. American Society for Testing and Materials. ASTM F2259-2010(2012)e1 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy. Pennsylvania: ASTM International, 2012: 1-4.
13. 孙雪. 用于生物材料和组织工程的海藻酸钠质量控制研究. 北京: 中国药品生物制品检定所, 2006.
14. 孙雪, 奚廷斐, 卢大伟. 用于组织工程医疗产品海藻酸钠主要性能指标的测定. 中国组织工程研究, 2012, 16(38): 7140-7144.
15. 顾其胜, 朱彬. 海藻酸盐基生物医用材料. 中国组织工程研究与临床康复, 2007, 11(26): 5194-5198.
16. De Vos P, De Haan B, Van Schilfgaarde R. Effect of the alginate composition on the biocompatibility of alginate-polylysine microcapsules. Biomaterials, 1997, 18(3): 273-278.
17. De Vos P, van Hoogmoed CG, van Zanten J, et al. Long-term biocompatibility, chemistry, and function of microencapsulated pancreatic islets. Biomaterials, 2003, 24(2): 305-312.
18. 国家药品监督管理局. 关于发布医疗器械注册产品标准编写规范的通知. 2002-11-07.
19. 中华人民共和国医药行业标准医疗器械生物学评价第1部分: 风险管理过程中的评价与试验. GB/T 16886.1-2011. 北京: 中国标准出版社, 2011: 1-16.
20. 中华人民共和国卫生部药品标准新药转正标准第十册: 海藻酸钙. 1996: 65.
21. Committee on Food Chemicals Codes. Food Chemicals Codex V Calcium Alginate. Washington DC: Nation Academies Press, 2003: 61.
22. 龚泰芳, 方彩云, 陈文, 等. 海藻酸盐的理化特性及其在组织工程研究和临床中的应用. 中国组织工程研究与临床康复, 2007, 11(18): 3613-3615.
23. Bernd HA Rehm. Alginates: Biology and Applications. Heidelberg: Springer, 2009: 1-266.
24. Kong HJ, Smih MK, Mooney DJ. Designing alginate hydrogels to maintain viability of immobilized cells. Biomaterials, 2003, 24(22): 4023-4029.

Chinese Journal of Reparative and Reconstructive Surgery

PRODUCT STANDARD AND QUALITY CONTROL OF MEDICAL ALGINATES

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