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Method for detecting biocompatibility of collagen sponge

A collagen sponge and biocompatibility technology, which is applied in the field of sponge biocompatibility testing, can solve problems such as the lack of a collagen sponge biocompatibility testing method, and achieve a comprehensive effect of the testing method.

Inactive Publication Date: 2018-12-11
天津市长江医疗器械有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is still no specific biocompatibility testing method for collagen sponges.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] The preparation of embodiment 1 extract

[0050] Soak the collagen sponge in a ratio of 1.25cm / mL with physiological saline for 24 hours to obtain an extraction solution.

Embodiment 2

[0051] Embodiment 2 sterility test

[0052] The container inoculated with the thioglycollate fluid medium of the test product is divided into two equal parts, one is incubated at 30-35°C, and the other is incubated at 20-25°C. During the cultivation period, it should be observed and recorded daily whether there is bacterial growth. If the medium is turbid after adding the test product or during the cultivation process, after 14 days of cultivation, it is impossible to judge whether there is microbial growth from the appearance. Put it into the same fresh medium and culture it for 3 days, and observe whether the inoculated fresh medium is turbid again; or take a smear of the culture solution, stain it, and examine it under a microscope to determine whether there are bacteria.

[0053] Results: The product was sterile after Co-60 radiation sterilization.

Embodiment 3

[0054] Example 3 Bacterial endotoxin detection

[0055] Four 10×75mm test tubes (or original ampoules of 0.1mL / tube) containing 0.1mL LAL solution, 2 of which were added with 0.1mL of the test product as test tubes, and 1 with 2λ endotoxin working standard 0.1mL of the sample was used as a positive control tube, and 1 tube was added with 0.1mL of the Limulus reagent solution as a negative control tube. After gently mixing the test tube, close the mouth of the tube, put it vertically into a water bath at 37±1°C, and keep it warm for 60±2 minutes. Be careful during the heat preservation process and taking the test tube to avoid negative results caused by vibration.

[0056] Judgment of results: Take the test tube out of the water bath gently, and slowly turn it over 180°. If the gel in the tube does not deform and does not slip off the tube wall, it is positive and recorded as (+), and if the gel cannot remain intact and slips off the tube wall If it is negative, it is recor...

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Abstract

The invention discloses a method for detecting the biocompatibility of collagen sponge. The method comprises the following steps of (1) preparing a collagen sponge leaching solution; (2) carrying outa sterility test on the collagen sponge; (3) detecting the bacterial endotoxin of the collagen sponge; (4) detecting the systemic acute toxicity of the collagen sponge; (5) detecting the cytotoxicityof the collagen sponge; (6) carrying out a hemolytic test on the collagen sponge; (7) carrying out a skin sensitization test on the collagen sponge; (8) carrying out an intracutaneous stimulation teston the collagen sponge; (9) carrying out an implantation test on the collagen sponge; (10) carrying out a genetic toxicity test on the collagen sponge; and (11) carrying out degradation detection onthe collagen sponge. The method has the advantages of being comprehensive and effective, an obtained qualified product meets the national regulatory standards and has an excellent wound healing promoting effect and a good product quality.

Description

technical field [0001] The invention relates to a method for detecting the biocompatibility of a sponge, which belongs to the technical field of medicine, in particular to a method for detecting the biocompatibility of a collagen sponge. Background technique [0002] Due to the development of biochemistry, molecular biology and cell biology techniques, people are increasingly interested in the extracellular matrix, especially its main component - collagen, and the understanding of research methods and structures is gradually improving, especially in clinical practice. It has been used more and more widely, especially in the aspects of hemostasis and repair of surgical trauma, radical treatment of fistula, removal of festering tissue and infection, and has received good results. [0003] Many developed countries in the world are currently researching, developing, and utilizing collagen. In particular, it pays attention to the research, development and utilization of its medi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/00G01N21/25G01N21/78G01N21/84C12Q1/04
CPCC12Q1/04G01N21/25G01N21/78G01N21/84G01N33/00
Inventor 艾育胜艾婧吴天禹孟乙强
Owner 天津市长江医疗器械有限公司
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