CN100415304C - Biological degradable hemostatic sponge material and its preparing method - Google Patents
Biological degradable hemostatic sponge material and its preparing method Download PDFInfo
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- CN100415304C CN100415304C CNB2006100419133A CN200610041913A CN100415304C CN 100415304 C CN100415304 C CN 100415304C CN B2006100419133 A CNB2006100419133 A CN B2006100419133A CN 200610041913 A CN200610041913 A CN 200610041913A CN 100415304 C CN100415304 C CN 100415304C
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Abstract
The present invention discloses a biological degradable hemostatic sponge material and a preparation method thereof. The preparation method has the steps: (1) dissolving collagen which is like human collagen into 0.5% to 3% of solution by distilled water; (2) dissolving chitosan into 0.5% to 2% of solution by dilute acid, and neutralizing the solution by alkali; (3)uniformly mixing the two kinds of solution, forming sponge after the processes of vacuum defoaming, freezing and drying, and irradiating the sponge by cobalt-60 for disinfection so as to obtain the biological degradable hemostatic sponge material. The biological degradable hemostatic sponge has favorable adhesiveness with tissue, low immune rejection reaction and strong toughness. The biological degradable hemostatic sponge material has favorable properties of alleviating pain and resisting bacteria, has high restorability of promoting injured tissue, prevents the possibility of re-bleeding, thoroughly prevents the unavoidable virus hidden danger of gelatin and animal collagen protein, and greatly enhances the safety.
Description
Technical field
The present invention relates to a kind of biological degradable hemostatic sponge material and preparation method thereof, belong to biomedical materials field.
Background technology
Extensively hemorrhage and oozing of blood is to need the difficult problem that solves in surgical operation and the wound.
Collagen protein is that the animal body intensive amount is maximum, the widest protein distributes, be the primary structure albumen of body, be the key component of supporting tissue and connective tissue, it has excellent biological compatibility, anthemorrhagic performance, short new cell formation function and cell adhesion.Studies show that in recent years, collagen protein can stop blooding rapidly in 10 seconds, and can promote granulation growth and wound healing, prevents once more hemorrhage generation.
Human-like Collagen is after one section mRNA reverse transcription with human body known array collagen protein generates cDNA, repeat and modification through particular sequence, transform in escherichia coli, and get through high density fermentation, separation and Extraction and purification, invent and produce without competition by Xi'an giant's biological gene technical concern company limited.It has fundamentally solved the water-insoluble and the viral hidden danger problems such as (bovine spongiform encephalopathy, swine fever epidemic disease, bird flus) of animal extraction collagen protein, and have good biological characteristics and function, short new cell forms and urgees epithelial cell, fibroblastic growth function, it is good to compare animal body extraction collagen protein, and immune rejection is low.
Chitin is the natural macromolecular material that extracts from the cell wall of the shell of Crustaceans such as shrimp, Eriocheir sinensis and bacterium, algae rudimentary plant, and chitosan is the deacetylated product of chitin, is the unique alkaline polysaccharide of occurring in nature.Studies show that in recent years, chitosan have excellent performances such as pain relieving, hemostasis, antibacterial, excellent biological compatibility and biodegradability, are very suitable for the raw material as hemostatic material.
The toughness of simple gelfoam or collagen haemostatic sponge is relatively poor, and does not have pain relieving and antibacterial effect, as Chinese patent CN200410022462.X and CN01133795.8; The promoting growth of cell of simple chitosan sponge and short organized renewing ability a little less than, have hemorrhage once more possibility.Can effectively overcome above shortcoming to the compound sthptic sponge of collagen protein-chitosan that both combine at present, as patent application CN02109638.4, but there is viral hidden danger simultaneously in it and promotes that wound recovers shortcoming slowly.Research for sthptic sponge also mainly concentrates on collagen protein and modification aspect thereof in the world, as patent US6649162, AU726163B and RU2122867, what but they used all is that traditional animal is extracted collagen protein, also inevitably exist viral hidden danger, limited the application of this sthptic sponge greatly.
Summary of the invention
One of purpose of the present invention provides a kind of biodegradable hemostatic sponge material that Human-like Collagen and chitosan are combined, and to overcome gelatin and the inevitable viral hidden danger of animal collagen sponge, improves the safety of hemostatic sponge material.
Another object of the present invention provides the preparation method of above-mentioned biodegradable hemostatic sponge material, and this method technology is simple.
Biological degradable hemostatic sponge material of the present invention is to be made by Human-like Collagen and chitosan, the weight ratio of Human-like Collagen and chitosan can be (1～40): 1, optimal proportion is (3～40): 1, and a kind of people source collagen type of used Human-like Collagen for using the gene recombined escherichia coli high density fermentation to produce; The deacetylation of used chitosan is 50%～90%.
Biological degradable hemostatic sponge material preparation methods is as follows: (1) becomes Human-like Collagen 0.5%～3% solution with dissolved in distilled water; (2) chitosan is dissolved into 0.5%～2% solution with diluted acid, and uses the alkali neutralization; (3) with above-mentioned two kinds of solution mix homogeneously,, form sponge after the lyophilization, cobalt through vacuum defoamation
60Get final product behind the illumination-based disinfection.
In the above-mentioned preparation method, the weight ratio of Human-like Collagen and chitosan is (1～40): 1.A kind of people source collagen type of used Human-like Collagen for using the gene recombined escherichia coli high density fermentation to produce; The degree of deacetylation of used chitosan is 50%～90%.
In the above-mentioned preparation method, used diluted acid is any one in dilute hydrochloric acid, spirit of vinegar, dilute formic acid or the rare propanoic acid, and concentration can be 0.2～0.8moL/L; Used alkali is any one in diluted sodium hydroxide solution, rare potassium hydroxide solution or the sodium bicarbonate solution, and concentration can be 0.05～0.5moL/L.
In the above-mentioned preparation method, also added percentage by weight and be 0.10%～0.5% plasticizer in Human-like Collagen and chitosan mixed solution, described plasticizer is one or both in glycerol or the 1.3-butanediol.
In the above-mentioned preparation method, in Human-like Collagen and chitosan mixed solution, also added percentage by weight and be 0.1%～0.5% thrombin.
Biological degradable hemostatic sponge provided by the present invention compared with prior art, have tangible technological merit and advantage: this sthptic sponge and tissue adherence are good, the immunity rejection is low, toughness is strong, have good pain relieving and anti-microbial property, promote that the wounded tissue recovery capability is strong, can prevent once more hemorrhage possibility, thoroughly stopped gelatin and the inevitable viral hidden danger of animal collagen, safety in utilization increases substantially.
The specific embodiment
The invention will be further described below by concrete embodiment.
Embodiment 1:
Human-like Collagen become 1.0% solution with dissolved in distilled water; With deacetylation be 90%, to be 10000 daltonian chitosans become 0.5% solution with the acetate dissolution of 0.2moL/L to molecular weight, and uses the sodium bicarbonate solution neutralization of 0.1moL/L; Then with the two 20: 1 by volume mix homogeneously, and add 0.2% glycerol, be sub-packed in the container; Become the thick sponge of 2mm through the vacuum defoamation postlyophilization; Cobalt
60Get final product behind the illumination-based disinfection.
Embodiment 2:
Human-like Collagen become 1.0% solution with dissolved in distilled water; With deacetylation be 90%, to be 10000 daltonian chitosans become 0.5% solution with the acetate dissolution of 0.2moL/L to molecular weight, and uses the sodium bicarbonate solution neutralization of 0.1moL/L; Then with the two 10: 1 by volume mix homogeneously, and add 0.2% glycerol and 0.3% thrombin, be sub-packed in the container; Become the thick sponge of 2mm through the vacuum defoamation postlyophilization; Cobalt
60Get final product behind the illumination-based disinfection.
Embodiment 3:
Human-like Collagen become 2.0% solution with dissolved in distilled water; With deacetylation be 90%, to be 10000 daltonian chitosans become 1.0% solution with the acetate dissolution of 0.2moL/L to molecular weight, and uses the sodium bicarbonate solution neutralization of 0.1moL/L; Then with the two 15: 1 by volume mix homogeneously, and add 0.2% glycerol, be sub-packed in the container; Become the thick sponge of 1.5mm through the vacuum defoamation postlyophilization; Cobalt
60Get final product behind the illumination-based disinfection.
Embodiment 4:
Human-like Collagen become 2.0% solution with dissolved in distilled water; With deacetylation be 90%, to be 10000 daltonian chitosans become 1.0% solution with the acetate dissolution of 0.2moL/L to molecular weight, and uses the sodium bicarbonate solution neutralization of 0.1moL/L; Then with the two 8: 1 by volume mix homogeneously, and add 0.2% glycerol and 0.2% thrombin, be sub-packed in the container; Become the thick sponge of 1.5mm through the vacuum defoamation postlyophilization; Cobalt
60Get final product behind the illumination-based disinfection.
Embodiment 5:
Human-like Collagen become 1.0% solution with dissolved in distilled water; With deacetylation be 75%, to be 100000 daltonian chitosans become 0.5% solution with the acetate dissolution of 0.3moL/L to molecular weight, and uses the sodium bicarbonate solution neutralization of 0.2moL/L; Then with the two 10: 1 by volume mix homogeneously, and add 0.4% 1.3-butanediol, be sub-packed in the container; Become the thick sponge of 2mm through the vacuum defoamation postlyophilization; Cobalt
60Get final product behind the illumination-based disinfection.
Embodiment 6:
Human-like Collagen become 1.0% solution with dissolved in distilled water; With deacetylation be 75%, to be 100000 daltonian chitosans become 0.5% solution with the acetate dissolution of 0.3moL/L to molecular weight, and uses the sodium bicarbonate solution neutralization of 0.2moL/L; Then with the two 6: 1 by volume mix homogeneously, and add 0.4% 1.3-butanediol and 0.3% thrombin, be sub-packed in the container; Become the thick sponge of 2mm through the vacuum defoamation postlyophilization; Cobalt
60Get final product behind the illumination-based disinfection.
Embodiment 7:
Human-like Collagen become 2.0% solution with dissolved in distilled water; With deacetylation be 75%, to be 100000 daltonian chitosans become 1.0% solution with the acetate dissolution of 0.3moL/L to molecular weight, and uses the sodium bicarbonate solution neutralization of 0.2moL/L; Then with the two 6: 1 by volume mix homogeneously, and add 0.4% 1.3-butanediol, be sub-packed in the container; Become the thick sponge of 1.5mm through the vacuum defoamation postlyophilization; Cobalt
60Get final product behind the illumination-based disinfection.
Embodiment 8:
Human-like Collagen become 2.0% solution with dissolved in distilled water; With deacetylation be 75%, to be 100000 daltonian chitosans become 1.0% solution with the acetate dissolution of 0.3moL/L to molecular weight, and uses the sodium bicarbonate solution neutralization of 0.2moL/L; Then with the two 4: 1 by volume mix homogeneously, and add 0.2% glycerol, 0.2% 1.3-butanediol and 0.2% thrombin are sub-packed in the container; Become the thick sponge of 1.5mm through the vacuum defoamation postlyophilization; Cobalt
60Get final product behind the illumination-based disinfection.
Embodiment 9:
Human-like Collagen become 1.0% solution with dissolved in distilled water; With deacetylation be 55%, to be 400000 daltonian chitosans become 0.5% solution with the dissolving with hydrochloric acid of 0.5moL/L to molecular weight, and uses the sodium hydroxide sodium solution neutralization of 0.1moL/L; Then with the two 5: 1 by volume mix homogeneously, and add 0.3% glycerol, be sub-packed in the container; Become the thick sponge of 2mm through the vacuum defoamation postlyophilization; Cobalt
60Get final product behind the illumination-based disinfection.
Embodiment 10:
Human-like Collagen become 1.0% solution with dissolved in distilled water; With deacetylation be 55%, to be 400000 daltonian chitosans become 0.5% solution with the dissolving with hydrochloric acid of 0.5moL/L to molecular weight, and uses the sodium hydroxide sodium solution neutralization of 0.1moL/L; Then with the two 2: 1 by volume mix homogeneously, and add 0.3% glycerol and 0.3% thrombin, be sub-packed in the container; Become the thick sponge of 2mm through the vacuum defoamation postlyophilization; Cobalt
60Get final product behind the illumination-based disinfection.
Embodiment 11:
Human-like Collagen become 2.0% solution with dissolved in distilled water; With deacetylation be 55%, to be 400000 daltonian chitosans become 1.0% solution with the dissolving with hydrochloric acid of 0.5moL/L to molecular weight, and uses the sodium hydroxide sodium solution neutralization of 0.1moL/L; Then with the two 3: 1 by volume mix homogeneously, and add 0.3% glycerol, be sub-packed in the container; Become the thick sponge of 1.5mm through the vacuum defoamation postlyophilization; Cobalt
60Get final product behind the illumination-based disinfection.
Embodiment 12:
Human-like Collagen become 2.0% solution with dissolved in distilled water; With deacetylation be 55%, to be 400000 daltonian chitosans become 1.0% solution with the dissolving with hydrochloric acid of 0.5moL/L to molecular weight, and uses the sodium hydroxide sodium solution neutralization of 0.1moL/L; Then with the two 1: 1 by volume mix homogeneously, and add 0.3% glycerol and 0.3% thrombin, be sub-packed in the container; Become the thick sponge of 1.5mm through the vacuum defoamation postlyophilization; Cobalt
60Get final product behind the illumination-based disinfection.
Claims (8)
1. biological degradable hemostatic sponge material is characterized in that: the weight ratio of Human-like Collagen and chitosan is (16～40): 1.
2. biological degradable hemostatic sponge material according to claim 1 is characterized in that: a kind of people source collagen type of Human-like Collagen for using the gene recombined escherichia coli high density fermentation to produce.
3. biological degradable hemostatic sponge material according to claim 1 is characterized in that: the deacetylation of used chitosan is 50%～90%.
4. the described biological degradable hemostatic sponge material of claim 1 preparation methods is characterized in that:
(1) Human-like Collagen is become 0.5%～3% solution with dissolved in distilled water;
(2) chitosan is dissolved into 0.5%～2% solution with diluted acid, and uses the alkali neutralization;
(3) with above-mentioned two kinds of solution mix homogeneously,, form sponge after the lyophilization, get final product behind cobalt 60 illumination-based disinfections through vacuum defoamation;
The weight ratio of described Human-like Collagen and chitosan is (16～40): 1.
5. biological degradable hemostatic sponge material preparation methods according to claim 4 is characterized in that: used diluted acid is any one in dilute hydrochloric acid, spirit of vinegar, dilute formic acid or the rare propanoic acid; Used alkali is any one in diluted sodium hydroxide solution, rare potassium hydroxide solution or the sodium bicarbonate solution.
6. according to claim 4 or 5 described biological degradable hemostatic sponge material preparation methods, it is characterized in that: in Human-like Collagen and chitosan mixed solution, also added percentage by weight and be 0.1%～0.5% plasticizer.
7. biological degradable hemostatic sponge material preparation methods according to claim 6 is characterized in that: described plasticizer is one or both in glycerol or the 1.3-butanediol.
8. according to claim 4 or 5 described biological degradable hemostatic sponge material preparation methods, it is characterized in that: in Human-like Collagen and chitosan mixed solution, also added percentage by weight and be 0.1%～0.5% thrombin.
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Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1988942B1 (en) | 2006-03-01 | 2011-07-27 | FMC Biopolymer AS | Gelled composite |
| CN101028543B (en) * | 2007-04-03 | 2010-05-26 | 哈尔滨工业大学 | Degradable sebacic acid and propyl tri-alcohol ester styptic sponge and its preparation |
| CN102258802B (en) * | 2010-05-28 | 2016-01-27 | 朱楚洪 | A kind of Novel multifunctional hemostatic dressing |
| CN102600495A (en) * | 2011-01-19 | 2012-07-25 | 北京博恩康生物科技有限公司 | Absorbable hemostatic composition and preparation method thereof |
| CN102526795A (en) * | 2012-02-15 | 2012-07-04 | 中国人民解放军广州军区武汉总医院 | Chitosan-based styptic sponge and preparation method thereof |
| CN105903066A (en) * | 2016-07-02 | 2016-08-31 | 河南驼人贝斯特医疗器械有限公司 | Preparation method of absorbable and degradable in-vivo hemostatic sponge |
| CN106512075A (en) * | 2016-12-02 | 2017-03-22 | 上海其胜生物制剂有限公司 | Preparation method of high-expansion lamella porous chitosan hemostatic sponge |
| CN110368518A (en) * | 2019-03-19 | 2019-10-25 | 易杨华 | Rubidium salt styptic sponge and its application |
| CN113842494B (en) * | 2021-09-10 | 2022-11-11 | 西北大学 | Injectable hemostatic crystal gel for promoting tissue regeneration and preparation method and application thereof |
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