YY/T 1805.2-2021Tissue engineering medical device products—Collagen protein - Part 2: Determination of molecular weight of type I collagen—Sodium dodecyl sulfate polyacrylamide gel electrophoresis (English PDF)

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.

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.

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.

4 Abbreviations

The following abbreviations apply to this document.

Gly Glycine (Glycine);

HCl hydrochloric acid (Hydrochloricacid);

NaOH sodium hydroxide (Sodiumhydroxide);