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YY/T 1477.6-2020: Standard test models for primary wound dressing performance evaluation - Part 6: Animal diabetes type 2 refractory wound surface model for wound healing evaluation
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Standard test models for primary wound dressing performance evaluation - Part 6: Animal diabetes type 2 refractory wound surface model for wound healing evaluation
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YY/T 1477.6-2020
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Basic data | Standard ID | YY/T 1477.6-2020 (YY/T1477.6-2020) | | Description (Translated English) | Standard test models for primary wound dressing performance evaluation - Part 6: Animal diabetes type 2 refractory wound surface model for wound healing evaluation | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.120.20 | | Word Count Estimation | 6,645 | | Date of Issue | 2020-09-27 | | Date of Implementation | 2021-09-01 | | Regulation (derived from) | Announcement No. 108 (2020) of the National Medical Products Administration | | Issuing agency(ies) | State Drug Administration | YY/T 1477.6-2020: Standard test models for primary wound dressing performance evaluation - Part 6: Animal diabetes type 2 refractory wound surface model for wound healing evaluation
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(Standard test model for evaluating the performance of contact wound dressings:Part 6: Animal model of difficult-to-heal type 2 diabetes wounds to evaluate the performance of wound healing)
ICS 11:120:20
C48
People's Republic of China Pharmaceutical Industry Standard
Standard test model for performance evaluation of contact wound dressing
Part 6: Evaluation of the properties of promoting wound healing
Animal model of difficult-to-heal wounds with type 2 diabetes
2020-09-27 release
2021-09-01 implementation
Issued by the State Drug Administration
Foreword
YY/T 1477 "Standard Test Model for Performance Evaluation of Contact Wound Dressings", including the following parts:
---Part 1: In vitro wound model for evaluating antibacterial activity;
---Part 2: Evaluation of animal scald models for promoting wound healing performance;
---Part 3: In vitro wound model for evaluating fluid control performance;
---Part 4: In vitro model to evaluate the potential adhesion of wound dressings;
---Part 5: In vitro model for evaluating hemostatic performance;
---Part 6: An animal model of difficult-to-heal wounds with type 2 diabetes to evaluate the performance of wound healing:
This part is part 6 of YY/T 1477:
This section was drafted in accordance with the rules given in GB/T 1:1-2009:
Please note that certain contents of this document may involve patents: The issuing agency of this document is not responsible for identifying these patents:
This part was proposed by the State Drug Administration:
This part is under the jurisdiction of Shandong Medical Device Product Quality Inspection Center:
Drafting organizations of this section: Shandong Medical Device Product Quality Inspection Center, China Food and Drug Control Research Institute, Jiangyin Berison Biochemical
Technology Co:, Ltd:
The main drafters of this section: Sun Likui, Tang Jinglong, Gu Ming, Che Guoxi, Kang Ruijuan, Wang Shuo, Zhan Rongkai:
Introduction
Animal type 2 diabetes model is an ideal animal model for evaluating the performance of contact wound dressings in promoting the healing of difficult-to-heal wounds: obtain
Type 2 diabetic animals usually have two methods: One method is to use chemical drugs (such as alloxan, etc:) to destroy normal animal pancreatic B cells:
Obtain, such as induced diabetic rats: Another method is to select genetically mutated genetic diabetic animals, commonly used db/db
Mice, whose Leptin receptor point mutations lead to signal pathway disorders, have typical symptoms such as obesity, hyperglycemia, poor wound healing, and metabolic disorders:
Symptoms of type 2 diabetes:
Animal wound healing is different from humans: Most of the wound healing is based on contraction, while human wounds are based on crawling coverage of epidermal cells: Headquarters
In the spontaneous type 2 diabetes (db/db) mouse model given by the score, the expression of myofibroblasts in the skin is reduced, and the wound is healed with fine epidermis:
Cell crawling covering is the main animal model for evaluating contact wound dressings to promote the healing of difficult-to-heal wounds:
Standard test model for performance evaluation of contact wound dressing
Part 6: Evaluation of the properties of promoting wound healing
Animal model of difficult-to-heal wounds with type 2 diabetes
1 Scope
This part of YY/T 1477 specifies an animal model of difficult-to-heal wounds with type 2 diabetes:
This section is applicable to the evaluation of the healing properties of hard-to-heal wound dressings:
2 Normative references
The following documents are indispensable for the application of this document: For dated reference documents, only the dated version applies to this article
Pieces: For undated references, the latest version (including all amendments) applies to this document:
GB/T 16886:2 Biological Evaluation of Medical Devices Part 2: Animal Welfare Requirements
3 main equipment
Small animal breathing anesthesia machine (optional), skin trephine 16mm~20mm, sterile surgical instruments, dry heat sterilizer, pathological examination equipment:
4 Experimental animals
4:1 General
All animal experiments should be carried out in laboratories approved by the national accreditation body and in compliance with all applicable regulations on the welfare of laboratory animals, and
It should also meet the requirements of GB/T 16886:2:
4:2 Species and requirements of animals
Commonly used experimental animals are db/db mice (C57BLKS/J) from 6 to 8 weeks, with half males and half males, 6 to 8 mice in each group: If other
Strain animal, its suitability should be explained: The animals were bred adaptively for 5-10 days before the experiment: It is necessary to carry out small
The weight and blood sugar of the mouse are measured, and the blood sugar value is ≥18mmol/L to be used as experimental mice; if the blood sugar level is not up to standard, fasting and water feeding are required
After 8 hours of rearing, measure the blood glucose level again, at this time, the blood glucose level ≥16mmol/L can be used as experimental mice:
5 Test procedure
5:1 Establishing model of difficult-to-heal wounds
5:1:1 Sterilization of surgical instruments and skin trephine
Medical surgical scissors, medical curved tweezers, microscissors, and skin trephine are washed with tap water, soaked in distilled water, rinsed, and wrapped in tin foil:
Put it into a clean instrument box, sterilize by dry heat, and maintain at 160°C for 2 hours or 180°C for 30 minutes:
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