CN1251655C - Quick biological closing hemostatic device and its production process - Google Patents
Quick biological closing hemostatic device and its production process Download PDFInfo
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- CN1251655C CN1251655C CN 03126852 CN03126852A CN1251655C CN 1251655 C CN1251655 C CN 1251655C CN 03126852 CN03126852 CN 03126852 CN 03126852 A CN03126852 A CN 03126852A CN 1251655 C CN1251655 C CN 1251655C
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
The present invention relates to a rapid biologic closing hemostatic device and a manufacturing technology thereof. The hemostatic device is formed by compounding multiple layers of substances. The present invention is characterized in that the shape of the hemostatic device is flaky or cylindrical or conical; the flaky shape is formed by compounding two to four layers of different substances, and is respectively formed by compounding collagen protein, an absorbable woven net, fibrinogen, XIII blood coagulation factors, thrombin and auxiliary substances. The cylindrical shape and the conical shape are formed by compounding two layers of different substances, wherein the inner layer is composed of collagen protein; the outer layer is composed of fibrinogen, XIII blood coagulation factors, thrombin and auxiliary substances. The hemostatic device forms a lamellar structure by the freeze-drying technology, and has the functions of rapidly stopping blood and closing defect tissues. The hemostatic device has the advantages of no toxic and side effect on human bodies, safe and reliable use and low production cost, and is totally absorbed by human bodies. Hemostatic devices of different sizes and shapes can be manufactured by the manufacturing technology of the present invention, and can be used in various operations.
Description
Technical field
The present invention relates to the medical hemostatic device, especially a kind of quick bio sealing hemostasis device and manufacturing process thereof.
Background technology
At present, be used for the raw material of surgical hemostasis in the prior art: be that to adopt Fibrinogen and thrombin be the fibrin sealant of primary raw material, both at home and abroad after deliberation decades, and produce in batches on a large scale.But use deficiencies such as loaded down with trivial details, that time long, make mistakes easily in the preparation because this product has, therefore be not suitable for using in the occasion of first aid.And in surgical operation, hemorrhage is common phenomena very; Injured afield soldier; Have near all being because can not fast and effeciently stop blooding and seal damaged wound and cause death more than 70%; The various accidents that take place in the middle of daily life as traffic accident etc., have also proposed new requirement to the quick-acting haemostatic powder problem.
Summary of the invention
The object of the present invention is to provide a kind of simple in structure, easy to operate, need not loaded down with trivial details preparation, safe and reliable, the quick bio sealing hemostasis device and the manufacturing process thereof that can play quick-acting haemostatic powder and sealing defective tissue.
The objective of the invention is to be achieved by the following scheme; Quick bio sealing hemostasis device, constitute by the multilamellar material is compound, it is characterized in that: the protein that extracts in the mammalian body is primary raw material, it is shaped as laminated structure, different material is compound constitutes by two to four layers, and they are respectively by collagen layer, absorbable woven mesh layer, Fibrinogen and XIII thrombin layer, thrombin with the adminicle layer is compound constitutes.
Above-mentioned quick bio sealing hemostasis device, said adminicle is made up of calcium ion, aprotinin, vitamin B2, heparin antagonist.
Above-mentioned quick bio sealing hemostasis device, said calcium ion content is 2nmol-2 μ mol/cm
2Aprotinin content is 1-1000KIU/cm
2The content of vitamin B2 is 5-30 μ g/cm
2The heparin antagonist, as protamine, content is 0.01-5mg/cm
2
A kind of quick bio sealing hemostasis device, it is characterized in that: the protein that extracts in the mammalian body is primary raw material, it is shaped as cylinder or cone, constitute by two layers of different material is compound, wherein constitute internal layer by collagen protein, Fibrinogen and XIII thrombin and thrombin and adminicle constitute outer, and are wrapped in the outer surface of collagen protein.
The technology that a kind of manufacturing is installed as mentioned above, said collagen protein 1 derive from pig heel string or Corii Sus domestica or cattle heel string, and after peracid and enzyme processing, making its density is 0.004-0.008g/cm
3, thickness is the composite bed of 5mm.
The technology that a kind of manufacturing is installed as mentioned above, said Fibrinogen and thrombin, by extracting through processed in the mammalian, wherein fibrinogenic content is 0.05-20mg/cm
3, in addition, the content that contains the XIII thrombin is 0.5-20U/cm
2The content of thrombin is 1 μ g-5mg/cm
2
The technology that a kind of manufacturing is installed according to claim 1, the hemostasis device of said laminated structure, getting density is 0.004-0.008g/cm
2, thickness is the collagen protein of 5mm; Content is 0.05-20mg/cm
2Fibrinogen; The aperture is the absorbable woven mesh layer of 4mm; Amount is 0.5-20U/cm
2The XIII thrombin; Content is 2nmol-2 μ mol/cm
2Calcium ion; Reserves are 1-1000KIU/cm
2Aprotinin; Content is 5-30 μ g/cm
2Vitamin B2; Protamine content is 0.01-5mg/cm
2The heparin antagonist; Has good volatile organic solvent, wherein Fibrinogen and and thrombin, through after the pulverization process, particle diameter is 100 orders, with above-mentioned each component low temperature 0-4 ℃ with the organic solvent mix homogeneously after, reuse coating or spray or be dipped on the collagen protein composite bed is perhaps with the method for laminated freezing and the integral body of absorbable woven mesh layer and the former layer of formation product that combines of glue protein.
The invention has the advantages that: the mechanism of action of this hemostasis device is the final stage that simulate blood is solidified, Fibrinogen is under the effect of thrombin and calcium ion, form the fibrin net, again under the XIII thrombin, become stable fibrin net, stick to effects such as playing hemostasis, sealing defective tissue on the wound.In addition,, thereby not only greatly reduce production cost because Fibrinogen of the present invention and thrombin derive from mammalian, simultaneously in process of production through degerming, depyrogenation, remove technology such as virus, the safety of protecting it on human body, to use.In addition, the present invention sticks in hemostasis and has also adopted the network structure that is woven into by absorbable stitching thread, has strengthened tension force and toughness that hemostasis is pasted.
Description of drawings
Below in conjunction with accompanying drawing the present invention is illustrated.
Fig. 1 is a laminated structure sketch map of the present invention;
Fig. 2 is another embodiment sketch map of Fig. 1;
Fig. 3 is another embodiment sketch map of Fig. 1;
Fig. 4 is the cylindrical structure sketch map;
Fig. 5 is the conical structure sketch map.
The specific embodiment
Do lamellar of the present invention in structure as Fig. 1-Fig. 4, on the basis of its basic structure, can extract four kinds of products respectively out, the lamellar hemostasis device that promptly has four layers, three layers and two-layer structure mainly constitutes by collagen layer 1, absorbable woven mesh layer 2, Fibrinogen and XIII thrombin 3, thrombin and adminicle layer 4 are compound.
Fig. 4-Fig. 5 is the hemostasis device of cylinder of the present invention, conical structure, it constitutes by collagen layer 1, Fibrinogen and XIII thrombin 2 and thrombin and auxiliary layer 4 are compound, wherein constitute internal layer by collagen protein 1, the skin of Fibrinogen and XIII thrombin 2 and thrombin and adminicle 4 constituent apparatus, and be wrapped in the outer surface of collagen protein 1.
Making component of the present invention is: density is 0.004-0.008g/cm
2, thickness is the collagen protein of 5mm; Content is 0.05-20mg/cm
2Fibrinogen; The aperture is the absorbable woven mesh layer of 4mm; Content is 2nmol-2 μ mol/cm
2Calcium ion; Content is 1-1000KIU/cm
2Aprotinin; Content is 5-30 μ g/cm
2Vitamin B2; Protamine content is 0.01-5mg/cm
2The heparin antagonist; Have good volatile organic solvent, wherein Fibrinogen and thrombin are through after the pulverization process, and particle diameter is 100 orders.
Embodiment one:
Manufacturing process of the present invention is: adopt pig heel string or Corii Sus domestica or cattle heel string, through the processing of peracid or enzyme, make insoluble natural collagen protein, be suspended in 0.5% (weight ratio) acetum, the amount of collagen is 3% of a solution weight, pH value about 3.5.Solution is poured in the pallet, and making liquid height is 5mm, to its vacuum lyophilization, promptly obtains the collagen protein lyophilized products with freeze dryer.Absorbable mesh grid is tiled in 500cm
2On the collagen protein lyophilized products, then 1000mg Fibrinogen, 30mg thrombin, 1000U XIII thrombin, 1 * 10
5KIU aprotinin, 5mgCaCl
22H
2O, 12.5mg vitamin B2 grind, and the cold ethanol mix homogeneously with q.s evenly is applied in the mesh grid again, vapors away ethanol under the vacuum state.
Embodiment two:
The 0-4 ℃ of solution that 30ml is included 1000mg Fibrinogen and 1000IU XIII thrombin is poured a 500cm into
2In the pallet, it is evenly distributed, under-60 ℃ that its fast cooling is extremely freezing fully, again 30ml0-4 ℃ of solution that includes the 30mg thrombin is poured on the fibrinogenic coagulum, make its distribution equal rapidly, at-60 ℃ that its fast cooling is extremely freezing fully, on the coagulum of Fibrinogen and thrombin, entirely spread the absorbed mesh grid of suitable size then, then with pig heel string or Corii Sus domestica or cattle heel string collagen protein raw material by acid and enzyme processing, be suspended in 0.6% (weight ratio) acetum, the amount of collagen is 3% of a solution weight, and pH value is about 3.5, rapidly with this liquid, be poured in the aforesaid mesh grid, and it is evenly distributed, and send into and under-60 ℃, make it freezing fully in the freeze dryer, carry out vacuum lyophilization then and make sheet products.
Embodiment three:
With the 500mg Fibrinogen, the 25mg thrombin, 10mg ties up plain B2, after the 10mg protamine grinds, at-40 ℃ of following mix homogeneously, the collagen protein lyophilized products is cut into the cylinder or the cone of suitable size with the cold ethanol of q.s, drops in the liquid of front, make on cylinder or the cone surface adhesion behind the liquid, take out and make the ethanol formation product main body of volatilizing naturally.
Embodiment four:
With the 1500mg Fibrinogen, 1500U XIII thrombin, the 50mg thrombin, the 15mg vitamin B2 after the 10mg protamine grinds, at-4-0 ℃ following mix homogeneously, is layered on 500cm with the absorbed mesh grid of suitable size with the cold ethanol of q.s
2On the collagen protein lyophilized products, with sprayer unit this liquid evenly is sprayed onto in the mesh grid then, make under the vacuum state ethanol vapor away sheet products.
Claims (7)
1, a kind of quick bio sealing hemostasis device, constitute by the multilamellar material is compound, it is characterized in that: this hemostasis device is to be primary raw material with the protein that extracts in the mammalian body, it is shaped as laminated structure, different material is compound constitutes by two to four layers, and they are respectively by collagen layer (1), absorbable woven mesh layer (2), Fibrinogen and XIII thrombin (3), thrombin and the compound formation of adminicle layer (4).
2, quick bio sealing hemostasis device according to claim 1, it is characterized in that: said adminicle is made up of calcium ion, aprotinin, vitamin B2, heparin antagonist.
3, quick bio sealing hemostasis device according to claim 2, it is characterized in that: calcium ion content is 2nmol-2 μ mol/cm
2Aprotinin content is 1-1000KIU/cm
2The content of vitamin B2 is 5-30 μ g/cm
2The heparin antagonist, as protamine, content is 0.01-5mg/cm
2
4, a kind of quick bio sealing hemostasis device, it is characterized in that: this hemostasis device is to be primary raw material with the protein that extracts in the mammalian body, it is shaped as column type or pyramid type structure, constitute by two-layer material is compound, constitute internal layer by collagen protein (1), fibrous layer albumen and XIII thrombin (3) and thrombin and adminicle (4) constitute outer, and are wrapped in the outer surface of collagen protein (1).
5, a kind of manufacturing technology of installing according to claim 1, it is characterized in that: said collagen protein 1 derives from pig heel string or Corii Sus domestica or cattle heel string, and after peracid and enzyme were handled, making its density was 0.004-0.008g/cm
3, thickness is the composite bed of 5mm.
6, a kind of manufacturing technology of installing according to claim 1 is characterized in that: said Fibrinogen and thrombin, by extracting through processed in the mammalian, wherein fibrinogenic content is 0.05-20mg/cm
3, in addition, the content that contains the XIII thrombin is 0.5-20U/cm
2The content of thrombin is 1 μ g-5mg/cm
2
7, a kind of manufacturing technology of installing according to claim 1, it is characterized in that: the hemostasis device of laminated structure, getting density is 0.004-0.008g/cm
2, thickness is the collagen protein of 5mm; Content is 0.05-20mg/cm
2Fibrinogen; The aperture is the absorbable woven mesh layer of 4mm; Content is 0.5-20U/cm
2The XIII thrombin; Content is 2nmol-2 μ mol/cm
2Calcium ion; Reserves are 1-1000KIU/cm
2Aprotinin; Content is 5-30 μ g/cm
2Vitamin B2; Protamine content is 0.01-5mg/cm
2The heparin antagonist; Has good volatile organic solvent, wherein Fibrinogen and and thrombin, through after the pulverization process, particle diameter is 100 orders, with above-mentioned each component low temperature 0-4 ℃ with the organic solvent mix homogeneously after, reuse coating or spray or be dipped on the collagen protein composite bed is perhaps with the method for laminated freezing and the integral body of absorbable woven mesh layer and the former layer of formation product that combines of glue protein.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03126852 CN1251655C (en) | 2003-06-13 | 2003-06-13 | Quick biological closing hemostatic device and its production process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03126852 CN1251655C (en) | 2003-06-13 | 2003-06-13 | Quick biological closing hemostatic device and its production process |
Publications (2)
| Publication Number | Publication Date |
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| CN1460458A CN1460458A (en) | 2003-12-10 |
| CN1251655C true CN1251655C (en) | 2006-04-19 |
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| CN 03126852 Expired - Fee Related CN1251655C (en) | 2003-06-13 | 2003-06-13 | Quick biological closing hemostatic device and its production process |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102178975B (en) * | 2011-04-25 | 2013-10-23 | 福建南生科技有限公司 | Fibrous protein hemostatic patch and making method thereof |
| MY185054A (en) * | 2011-05-24 | 2021-04-30 | Takeda As | Rolled collagen carrier |
| CN102940551B (en) * | 2012-11-20 | 2014-07-23 | 广州创尔生物技术股份有限公司 | High-concentration collagen sponge wound protection paste and preparation method thereof |
| CN104524603B (en) * | 2014-12-30 | 2018-09-25 | 广州市拜特凇医药科技有限公司 | It can be by the virus removal/ablation method for hemostasis biological products/biomaterial that living organism absorbs |
| CN106427179A (en) * | 2016-09-22 | 2017-02-22 | 河南工业大学 | Preparation method of wheat germ protein hemostatic bandage |
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