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YY/T 1805.2-2021: (Tissue engineering medical device products Collagen - Part 2: Detection of molecular weight of type I collagen Sodium lauryl sulfate polyacrylamide gel electrophoresis)
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(Tissue engineering medical device products Collagen - Part 2: Detection of molecular weight of type I collagen Sodium lauryl sulfate polyacrylamide gel electrophoresis)
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YY/T 1805.2-2021
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Basic data | Standard ID | YY/T 1805.2-2021 (YY/T1805.2-2021) | | Description (Translated English) | (Tissue engineering medical device products Collagen - Part 2: Detection of molecular weight of type I collagen Sodium lauryl sulfate polyacrylamide gel electrophoresis) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Word Count Estimation | 9,916 | | Issuing agency(ies) | State Drug Administration | YY/T 1805.2-2021: (Tissue engineering medical device products Collagen - Part 2: Detection of molecular weight of type I collagen Sodium lauryl sulfate polyacrylamide gel electrophoresis)
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(Tissue engineering medical device products Collagen Part 2.Detection of molecular weight of type I collagen Sodium lauryl sulfate polyacrylamide gel electrophoresis)
ICS 11.040.30
CCSC30
People's Republic of China Pharmaceutical Industry Standard
Tissue Engineering Medical Device Products Collagen
Part 2.Type Ⅰ Collagen Molecular Weight Detection
sodium dodecyl sulfate polyacrylamide gel electrophoresis
Published on 2021-09-06
2022-09-01 Implementation
Released by the State Drug Administration
directory
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Abbreviations 1
5 Principle 2
6 Reagents and their preparation 2
7 Instruments and equipment 2
8 Operation method 3
9 results 4
10 Acceptance Criteria5
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 2 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.
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, Sichuan Food and Drug Inspection and Testing Institute, China Food and Drug Control Research Institute
Institute.
The main drafters of this document. Zhang Guifeng, Liu Xinglan, Gao Jianping, Zhang Le, Xing Fangyu, Xu Bin, Gao Xiaoyan, Fan Xingliang.
Introduction
Collagen-based materials for regenerative medicine include tissue-derived collagen extracts and genetically recombined collagen peptides. That
Among them, type I collagen is widely used in the research and development of various medical device products. Collagen-like materials have different properties, such as. Molecular
The size, purity, species and type differences, triple helix structure, cell adhesion properties, etc., these properties are directly related to the quality of collagen
and performance. "YY/T 1805 Collagen for tissue engineering medical device products" aims to establish the test of some special properties of collagen.
The measurement and characterization method is proposed to be composed of 4 parts.
--- Part 1.Terms and Definitions. The purpose is to formulate various formulations including tissue-extracted collagen and genetically recombinant collagen peptides.
terms and definitions.
--- Part 2.Type I collagen molecular weight detection by sodium dodecyl sulfate polyacrylamide gel electrophoresis. The purpose is to bring
Provides specific methods that can be used for collagen molecular weight detection.
--- Part 3.Collagen content detection liquid chromatography-mass spectrometry. The purpose is to give a quantification that can be used for collagen content
detection, and methods of species origin and type identification.
--- Part 4.Characterization of collagen triple helix structure. The purpose is to establish a method for characterizing the triple helix structure of collagen, using
To evaluate the existence and integrity of its triple helix structure.
Tissue Engineering Medical Device Products Collagen
Part 2.Type Ⅰ Collagen Molecular Weight Detection
sodium dodecyl sulfate polyacrylamide gel electrophoresis
1 Scope
This document specifies the determination of the molecular weight of type I collagen by sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE).
method.
This document applies to the determination of the molecular weight of type I collagen (raw material) extracted from tissue.
Note. For other types of collagen or recombinant collagen, if there is a reference substance, the molecular weight can be determined by referring to this method.
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.
YY/T 1453-2016 Method for characterization of type I collagen in tissue engineering medical device products
3 Terms and Definitions
The terms and definitions defined in YY/T 1453-2016 and the following apply to this document.
3.1
SDS-PAGE
A denaturing polyacrylamide gel electrophoresis method. According to most proteins can be combined with the anionic surfactant dodecyl sulfate
Sodium (SDS) is combined into a complex by weight, so that the negative charge far exceeds the original charge of the natural protein itself, eliminating the different proteins.
Molecular charge effect, so that proteins are separated according to molecular weight.
4 Abbreviations
The following abbreviations apply to this document.
Gly Glycine (Glycine);
HCl hydrochloric acid (Hydrochloricacid);
NaOH sodium hydroxide (Sodiumhydroxide);
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