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YY/T 1805.3-2022: Tissue engineering medical device products - Collagen protein - Part 3: Quantification of collagen based on marker peptide detection - Liquid chromatography-mass spectrometry
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Tissue engineering medical device products - Collagen protein - Part 3: Quantification of collagen based on marker peptide detection - Liquid chromatography-mass spectrometry
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YY/T 1805.3-2022
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Basic data | Standard ID | YY/T 1805.3-2022 (YY/T1805.3-2022) | | Description (Translated English) | Tissue engineering medical device products - Collagen protein - Part 3: Quantification of collagen based on marker peptide detection - Liquid chromatography-mass spectrometry | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Word Count Estimation | 18,161 | | Issuing agency(ies) | State Drug Administration | YY/T 1805.3-2022: Tissue engineering medical device products - Collagen protein - Part 3: Quantification of collagen based on marker peptide detection - Liquid chromatography-mass spectrometry
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Tissue engineering medical device products - Collagen protein - Part 3.Quantification of collagen based on marker peptide detection - Liquid chromatography-mass spectrometry
ICS 11.040.30
CCSC30
People's Republic of China Pharmaceutical Industry Standard
Tissue Engineering Medical Device Products Collagen
Part 3.Collagen based on characteristic peptide assays
Content Detection Liquid Chromatography-Mass Spectrometry
Published on 2022-01-13
2022-08-01 Implementation
Released by the State Drug Administration
directory
Preface I
Introduction II
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Overview 1
5 Reagents and their preparation 2
6 Instruments and equipment 3
7 Detection method 3
8 Result calculation 5
Appendix A (normative) Detection of characteristic polypeptide content of bovine type I collagen 6
Appendix B (normative) Detection of characteristic polypeptide content of bovine type II collagen 9
Appendix C (normative) Detection of characteristic polypeptide content of porcine type I collagen 12
Reference 15
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
This document is part 3 of YY/T 1805 "Collagen for Tissue Engineering Medical Device Products". YY/T 1805 has been released
The following parts.
--- Part 2.Type Ⅰ collagen molecular weight detection by sodium dodecyl sulfate polyacrylamide gel electrophoresis;
--- Part 3.Liquid chromatography-mass spectrometry for the detection of collagen content based on the determination of characteristic peptides.
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is organized by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices Sub-Technical Committee for Engineering Medical Device Products
(SAC/TC110/SC3) centralized management.
This document is drafted by. Institute of Process Engineering, Chinese Academy of Sciences, China National Institute for Food and Drug Control, Shimadzu Enterprise Management (China) Co., Ltd.
Co., Ltd., Guoke Excellence (Beijing) Pharmaceutical Technology Research Co., Ltd.
The main drafters of this document. Zhang Guifeng, Gao Jianping, Zhang Tianhong, Li Xiaodong, Ji Feng, Li Jinglai, Fan Xingliang, Feng Qianqian, Zhang Le, Xu Liming.
Introduction
Collagen-based materials for tissue engineering medical device products include tissue-extracted collagen and genetically recombined collagen.
Collagen is widely used in the research and development and product preparation of various medical device products. Collagen-based materials have different properties, such as.
Molecular weight, purity, species, type differences, triple helix structure, cell adhesion properties, etc. These properties are directly related to the quality and use of collagen
performance. YY/T 1805 "Collagen for Tissue Engineering Medical Device Products" aims to establish the detection and characterization of some special properties of collagen
The method consists of four parts.
--- Part 1.Terms and Definitions. The purpose is to provide various types of collagen including tissue-extracted collagen and genetically recombinant collagen.
Terms and Definitions.
--- Part 2.Type I collagen molecular weight detection by sodium dodecyl sulfate polyacrylamide gel electrophoresis. The purpose is to bring
Provides a method that can be used for the determination of collagen molecular weight.
--- Part 3.Liquid chromatography-mass spectrometry for the detection of collagen content based on the determination of characteristic peptides. The purpose is to give a specific
It is a liquid chromatography-mass spectrometry detection method that indirectly reflects the content of collagen by quantitative determination of characteristic peptides. The method can also be used for species
Identification of source and type.
--- Part 4.Characterization of collagen helical structure. The purpose is to establish collagen structure analysis with different parameters and indicators
And triple-helix structure characterization methods were used to evaluate the presence, relative content and integrity of the triple-helix structure.
The hydroxyproline method is commonly used in the detection of collagen content, and the content of collagen can be reflected by the detection of hydroxyproline content.
In this document, based on the synthesis of specific collagen-characterized peptide reference substances, the use of liquid chromatography-mass spectrometry for collagen characterization
The determination of peptide content indirectly reflects the content of collagen.
Tissue Engineering Medical Device Products Collagen
Part 3.Collagen based on characteristic peptide assays
Content Detection Liquid Chromatography-Mass Spectrometry
1 Scope
This document specifies a method for the determination of the characteristic polypeptide content of different types of collagen by liquid chromatography-mass spectrometry.
This document is applicable to the determination of the content of characteristic polypeptides of different types of collagen in tissue-extracted and purified collagen and its collagen products.
Determination.
Note. The samples of recombinant collagen and acellular matrix after collagen extraction can refer to this method for the determination of the corresponding collagen characteristic polypeptide content.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 6682 Analysis Laboratory Water Specifications and Test Methods
YY/T 1453 Method for Characterization of Type I Collagen in Tissue Engineering Medical Device Products
Pharmacopoeia of the People's Republic of China (2020 Edition)
3 Terms and Definitions
Terms and definitions defined in YY/T 1453 apply to this document.
4 Overview
The collagen samples were dissolved, heated and denatured, and then digested with trypsin to release the characteristic polypeptides, which were then determined by liquid chromatography-mass spectrometry.
Qualitative and confirmed by the retention time of different types of collagen characteristic peptides and the mass-to-charge ratio of secondary product ion fragments, using external standard method or internal standard method.
standard method for quantification.
Using the synthesized different types of collagen characteristic peptides as the standard, the quantitative detection by external standard method was realized;
The isotope-labeled characteristic polypeptides and non-isotopically-labeled characteristic polypeptides in the column are mixed in a certain proportion to realize quantitative detection by the internal standard method. within the isotope
The standard method helps to improve the interference of matrix effects on the accuracy of the assay.
This document takes the isotopic internal standard method as an example to give the standards for the detection of the characteristic polypeptide content of bovine type I, bovine type II and porcine type I collagen respectively.
Operating procedures and requirements. Among them, the content of bovine type Ⅰ collagen characteristic polypeptides is detected according to Appendix A, and the content of bovine type Ⅱ collagen characteristic polypeptides is tested.
The measurement is carried out according to Appendix B, and the content of characteristic polypeptides of porcine type I collagen is measured according to Appendix C. For different animal sources or different types
Collagen can also be screened for suitable characteristic peptides for quantitative detection after verification.
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