YY/T 1806.2-2021 English PDF

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YY/T 1806.2-2021: (Evaluation method of in vitro degradation performance of biomedical materials - Part 2: Mussel mucin)
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Basic data

Standard ID: YY/T 1806.2-2021 (YY/T1806.2-2021)
Description (Translated English): (Evaluation method of in vitro degradation performance of biomedical materials - Part 2: Mussel mucin)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Word Count Estimation: 9,958
Issuing agency(ies): State Drug Administration

YY/T 1806.2-2021: (Evaluation method of in vitro degradation performance of biomedical materials - Part 2: Mussel mucin)

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Evaluation method of in vitro degradation performance of biomedical materials Part 2.Mussel mucin) ICS 11.040.01 CCSC30 People's Republic of China Pharmaceutical Industry Standard Evaluation method for in vitro degradation performance of biomedical materials Part 2.Mussel Mucin Published on 2021-09-06 2022-09-01 Implementation Released by the State Drug Administration

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 1806 "Methods for Evaluation of In Vitro Degradation Properties of Biomedical Materials". YY/T 1806 has been released the following parts. --- Part 1.Degradable polyesters; --- Part 2.Mussel mucin. 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 under the jurisdiction of the National Standardization Technical Committee for Biological Evaluation of Medical Devices (SAC/TC248). This document is drafted by. Jiangyin Beresen Biochemical Technology Co., Ltd., Shandong Medical Device Product Quality Inspection Center, China Food and Drug Administration Quality Testing Institute. The main drafters of this document. Gu Chenhao, Chen Fang, Du Xiaodan, Song Maoqian, Meng Xiaoyi, Xu Hong.

Introduction

Mussel mucin is a high-purity single protein obtained by purification from the byssal glands of marine mussels. Mussel mucin has a It has the characteristics of self-oxidative cross-linking to form polymers, has broad-spectrum adhesion, can form a water-resistant protective film and has good biocompatibility. The application in the field of medicine is becoming more and more extensive. Different parts of the human body have different physiological environments, the same biological material in different application environments, its own enzymatic hydrolysis and induced The human immune system responds differently. Studies have shown that the degradation of mussel mucin is mainly enzymatic hydrolysis, and the suitable degradation of mussel mucin is The performance evaluation standard method can promote the performance research and product development of mussel mucin, and can also provide methods for the quality control of related products. Due to the diversity of dosage forms and indications of mussel mucin products, this document does not give specific test methods applicable to all products. in progress When determining the in vitro degradation test of the product, the method given in this document may be referred to but not limited to the actual situation. YY/T 1806 aims to establish a method for evaluating the in vitro degradation performance of biomedical materials, and is intended to consist of two parts. --- Part 1.Degradable polyesters. The purpose is to evaluate the in vitro degradation performance of degradable polyester biomedical materials/devices. price method. --- Part 2.Mussel mucin. The purpose is to evaluate the in vitro degradation performance of mussel mucin biomedical materials/devices method. Evaluation method for in vitro degradation performance of biomedical materials Part 2.Mussel Mucin

1 Scope

This document specifies a method for evaluating the in vitro degradation performance of mussel mucin materials/devices. This document is applicable to the evaluation of in vitro degradation performance of mussel mucin materials/devices.

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 16886.12 Biological Evaluation of Medical Devices Part 12.Sample Preparation and Reference Materials GB/T 16886.13 Biological Evaluation of Medical Devices Part 13.Qualitative and Quantitative Degradation Products of Polymer Medical Devices

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 immobilizedenzyme Enzymes that can catalyze within a certain spatial range and can be used repeatedly and continuously. 3.2 In vitro degradation invitrodegradation Degradation that occurs in a simulated physiological environment.

4 In vitro degradation test design

4.1 Overview Put an appropriate amount of treated sample into a container, add a corresponding amount of degradation medium, vortex evenly, seal the container, and keep a suitable temperature. Spend. Samples were taken at different periods of the experiment to evaluate the degradation performance of mussel mucin. 4.2 Instruments High performance liquid chromatography (HPLC) or amino acid analyzer, electronic balance, pH meter, centrifuge, oven, etc. 4.3 Containers According to the requirements of GB/T 16886.12, the degradation test should be carried out in a clean, sealable, chemically inert container. 4.4 Solution Preparation 50mmol/LTris-HCl buffer. take 1.25mL of 2mol/LTris solution, add saturated NaCl solution and dilute to 50mL, take ......

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