摘要
随着胶原类产品在食品化妆品领域的广泛应用和产业化发展的快速增长,近年来,胶原在医疗领域的应用也备受关注,大中小企业纷纷介入医疗产品的研发,产业化进程发展迅猛。胶原的结构、纯度等各种性能直接影响着其预期医疗应用的质量和安全性。然而,目前还没有系统的胶原类产品表征和质量评价体系,相关标准、指南的制定远远滞后于产业发展的步伐。为此,中国食品药品检定研究院(以下简称中检院)在对国内外相关标准和规范进行大量调研的基础上,组织起草了《医用胶原类产品的表征和质量评价技术共识》。在经过第一轮的征求意见后,于2019年6月28日组织召开了专题学术论坛,与参会的专家和代表180人初步达成共识,对有争议的部分进行了进一步修改完善;于2019年7月又经过了第二轮征求意见。经过进一步的修改和完善,形成最终稿。本技术共识给出了背景和意义、适用范围、胶原相关的基本术语和定义、胶原类产品的性能指标和可参考的评价方法以及产品的质量控制和风险管理。旨在为医用胶原类产品研发、生产、质量控制、检测评价以及技术审评提供参考。标准化方法和标准品是进行严格质量控制必不可少的工具和手段。中检院正在组织胶原蛋白表征一系列方法标准的建立和不同类别胶原(如Ⅰ型、Ⅱ型及Ⅲ型等)及其不同种属胶原及胶原特征肽标准品的研制。其中,牛Ⅰ型胶原蛋白标准品将于2019年上市;牛Ⅱ型胶原蛋白标准品预期于2020年上市(可关注中检院标准物质供应网站)。
With the wide application of collagen products in the field of food and cosmetics and the rapid growth of industrialization,the application of collagen in the medical field has also attracted much attention in recent years.Large and medium-sized enterprises have intervened in the research and development of collagen-based medical products,and the industrialization process has developed rapidly.The structure,purity and other properties of collagen directly affect the quality and safety of its intended medical applications.However,there is no systematic characterization and quality evaluation system for collagen products,and the development of relevant standards and guidelines lags far behind the pace of industrial development.For this purpose,National Institutes for Food and Drug Control(hereinafter referred to as NIFDC)has organized and drafted a technical consensus on the characterization and quality evaluation of collagen products used for medical application on the basis of extensive investigations on relevant standards and guidelines at home and abroad.After the first round of comments and suggestions,a special academic forum was organized on June 28,2019.A preliminary consensus was reached among 180 experts and delegates who joined the forum.The controversial parts were further revised and improved.In July,2019,the second round of comments and suggestions was conducted.After further modification and improvement,the final draft was formed.The technical consensus presents the background and significance,scope of application,Basic terms and definitions of collagen,performance indexes,evaluation methods of collagen products for reference as well as quality control and risk management of collagen products.The purpose of the technical consensus is to provide references for research and development,manufacture,quality control,testing and evaluation and technical review of collagenbased medical products.Standardized methods and reference materials are indispensable tools and means for rigorous quality control.NIFDC is establishing a series of methods and standards for the characterization of collagen and developing collagen proteins and collagen characteristic peptide reference materials of different types(such as type Ⅰ,type Ⅱ,type Ⅲ,etc.)and different species(such as bovine,pig,human,etc.).Among them,the bovine type Ⅰ collagen reference materials will be on the market in 2019;the bovine type Ⅰ collagen reference materials are expected to be on the market in 2020(for details,please see the website for reference materials of NIFDC).
出处
《中国药事》
CAS
2019年第11期1222-1234,共13页
Chinese Pharmaceutical Affairs
基金
国家科技重点研发计划“生物源性材料及产品的检测与评价关键技术和标准化研究(2016-2020)”(编号2016YFC1103203)
