| 柯林楠,黄元礼,方玉,段晓杰,刘丽,蒋丽霞,王春仁.胶原蛋白基再生医疗产品质量控制[J].中国药事,2019,33(4):475-480 |
| 胶原蛋白基再生医疗产品质量控制 |
| Quality Control of Collagen-Based Regenerative Medical Products |
| 投稿时间：2019-01-07 |
| DOI：10.16153/j.1002-7777.2019.04.020 |
| 中文关键词: 胶原蛋白 再生医疗 生物材料 动物源 质量控制 |
| 英文关键词: collagen regenerative medicine biomaterials animal origin quality control |
| 基金项目:国家重点研发计划（编号2016YFC1101202）；中国食品药品检定研究院中青年发展研究基金课题（编号2018C6） |
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| 中文摘要: |
| 由于胶原蛋白具有良好的生物相容性、可降解性、生物活性及可加工性等，作为再生医疗产品中重要的生物材料，被广泛应用于神经、骨、软骨、肌腱、韧带、血管植入物和皮肤修复中。为了保证胶原蛋白基再生医疗产品的安全和有效，有必要建立适当的质量控制体系。本文重点从原材料、产品性能、病毒去除/灭活、包装和灭菌等方面来探讨胶原蛋白基再生医疗产品质量控制的考虑要点，为该类产品的研发、生产及监管提供技术参考。 |
| 英文摘要: |
| Because collagen has good biocompatibility, biodegradability, bioactivity and processability, it is widely used as an important biological material in regenerative medical products. It is also widely used in nerve, bone, cartilage, tendon, ligament and blood vessel implantation as well as skin substitute. In order to ensure the safety and efficiency of collagen-based regenerative medical products, it is necessary to establish an appropriate quality control system. This paper focuses on the consideration of quality control of collagen-based regenerative medical products from the aspects of raw materials, product performance, virus removal/inactivation, packaging and sterilization in order to provide technical references for the research and development, production and supervision of such products. |
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