CN105617448A - Fibrous protein compound hemostatic material and preparation method thereof - Google Patents
Fibrous protein compound hemostatic material and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
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- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
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- A—HUMAN NECESSITIES
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- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/02—Surgical adhesives or cements; Adhesives for colostomy devices containing inorganic materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
- A61L24/10—Polypeptides; Proteins
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- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
- A61L24/10—Polypeptides; Proteins
- A61L24/108—Specific proteins or polypeptides not covered by groups A61L24/102 - A61L24/106
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- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J3/00—Processes of treating or compounding macromolecular substances
- C08J3/24—Crosslinking, e.g. vulcanising, of macromolecules
- C08J3/246—Intercrosslinking of at least two polymers
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- C08J5/18—Manufacture of films or sheets
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising agents
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/04—Materials for stopping bleeding
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J2389/00—Characterised by the use of proteins; Derivatives thereof
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J2401/00—Characterised by the use of cellulose, modified cellulose or cellulose derivatives
- C08J2401/08—Cellulose derivatives
- C08J2401/26—Cellulose ethers
- C08J2401/28—Alkyl ethers
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Abstract
The invention discloses a fibrous protein compound hemostatic material and a preparation method thereof. The fibrous protein compound hemostatic material is prepared from, by mass, 5-10 parts of carboxymethylcellulose, 2-4 parts of carboxyethyl cellulose, 1-5 parts of chitosan, 3-8 parts of starch, 1-3 parts of sodium trimetaphosphate, 1-4 parts of sodium alga acid, 3-8 parts of gelatin, 8-12 parts of soy isolate protein, 2-5 parts of amino acid and 20-40 parts of water. The amino acid is basic amino acid. The fibrous protein compound hemostatic material can stop bleeding rapidly and effectively, the amount of bleeding is reduced, and the fibrous protein compound hemostatic material is safe to use; the preparation method is simple, and the prepared membrane-shaped compound hemostatic material is convenient to use and store.
Description
Technical field
The invention belongs to field of medical materials, be specifically related to a kind of fibrin compound hemostatic material and preparation method thereof.
Background technology
Traditional hemostatic fashion mainly ties, press and dressing etc., main hemostasia products has first-aid kit, four-tailed bandage, hemostatic gauze, tourniquet and binder etc., these hemostatic materials can stop blooding in very short time and give treatment to patient, it is control hemorrhage main method, but in use or use after can there is great defect, be therefore extremely limited when clinical practice. Such as; sewing hemostasis is very effective for the wound hemorrhage of soft tissue and big blood vessel; but the haemostatic effect for the parenchymal viscera that fragility is relatively big and blood flow is abundant is very undesirable; and very easily cause pinprick or the hemorrhagic tissue injury of breach, thus having influence on the normal function of the parenchymal viscera such as kidney, brain; Blood capillary is pressed by pressing haemostatic with needing lasting several tens minutes, promotes platelet to assemble, and is control the small-sized the most direct hemorrhage hemostatic fashion of body surface, but but very undesirable for slightly substantial amounts of hemorrhage haemostatic effect. Tourniquet there is also a lot of defect in the process used: if tourniquet is improper to treatment of wounds or does not have correct taking the time and pressure, it is possible to can cause pain near wound, nerve injury, even cause tissue necrosis etc. time serious; Tourniquet is for some special and relatively common wounds, and the wound hemostasis effect such as such as in irregular shape, deep, narrow, arteriorrhexis is bad; Tourniquet is easier to come off, and causes secondary hemorrhage; The reaction that the use of tourniquet can bring out surgical wound surface surrounding soft tissue is congested, and oxygen content is decreased obviously. Visible, traditional hemostatic material can not meet modem surgical safe haemostasis and urgent trauma hemostasis clinical demand, and the weak point of these hemostatic fashion needs other novel hemostatic materials to make up.
The topical hemostatic agent the most extensively utilized at present generally all derives from the derivant of oxidized cellulose, and this type of hemostatic material generally coordinates gauze to use, and their haemostatic properties is based on Local activation coagulation process. Although it does not comprise any intrinsic coagulation factor, but it can stimulate the formation of blood clot, and can provide a good three dimensional structure for blood clot tissue, is more beneficial for the stability of blood clot. But the premise of this type of materials serve Blood clotting is to have complete Activated Coagulation process. Krizova et al. studies proof: when lacking some plasma fraction, especially coagulation factor VIII and the blood coagulation XII factor, the local coagulant material including oxidized cellulose shows relatively low activity for activating raw platelet aspect. Before using cellulose base hemostatic material, it is necessary to consider that its potential some use restricted problem and defect. In the environment that humidity is bigger, its haemostatic effect can be substantially reduced. Because in high humidity environment, the withered attached power of material and tissue can be substantially reduced. Additionally, whether use cellulose base to stop gold copper-base alloy and it is also contemplated that whether it can produce complication in local: as local desiccation when using can caused secondary injury to neural, ureter or other special constructions, ischemia phenomenon whether can be caused owing to oppressing, and some inflammation correlated response etc.
Summary of the invention
In order to overcome the defect of current cellulose base hemostatic material, it is an object of the invention to provide a kind of fibrin compound hemostatic material and preparation method thereof, it is possible to quickly effectively hemostasis, reduce amount of bleeding, and use safety.
To achieve these goals, the technological means that the present invention adopts is:
A kind of fibrin compound hemostatic material, it is prepared from by the raw material of following mass parts: carboxymethyl cellulose 5 ~ 10 parts, carboxyethyl cellulose 2 ~ 4 parts, chitosan 1 ~ 5 part, starch 3 ~ 8 parts, sodium trimetaphosphate 1 ~ 3 part, sodium alginate 1 ~ 4 part, 3 ~ 8 parts of gelatin, soybean protein isolate 8 ~ 12 parts, 2 ~ 5 parts of aminoacid, 20 ~ 40 parts of water.
Described aminoacid is basic amino acid.
Described aminoacid is arginine or lysine.
Described fibrin compound hemostatic material, preferably it is prepared from by the raw material of following mass parts: carboxymethyl cellulose 6 ~ 8 parts, carboxyethyl cellulose 3.2 ~ 3.6 parts, chitosan 2 ~ 4 parts, starch 5 ~ 7 parts, sodium trimetaphosphate 1.8 ~ 2.4 parts, sodium alginate 2 ~ 3 parts, 5 ~ 7 parts of gelatin, soybean protein isolate 10 ~ 12 parts, 3 ~ 4 parts of aminoacid, 25 ~ 35 parts of water.
Described fibrin compound hemostatic material, preferably it is prepared from by the raw material of following mass parts: carboxymethyl cellulose 7 parts, carboxyethyl cellulose 3.5 parts, chitosan 3 parts, starch 6 parts, sodium trimetaphosphate 2.2 parts, sodium alginate 2.5 parts, 6 parts of gelatin, soybean protein isolate 11 parts, 3.5 parts of aminoacid, 30 parts of water.
The preparation method of described fibrin compound hemostatic material, comprises the steps:
1) starch and chitosan are added to the water, water bath with thermostatic control, add sodium trimetaphosphate stirring;
2) adding sodium alginate, gelatin, soybean protein isolate and aminoacid in the solution of step 1), 30 ~ 37 DEG C, stirring carries out cross-linking reaction, reacts 10 ~ 16h;
3) in step 2) solution in add carboxymethyl cellulose and carboxyethyl cellulose, pour mask on glass plate, lyophilization, take off film, obtain fibrin compound hemostatic material.
In step 1), the temperature of water bath with thermostatic control is 60 ~ 70 DEG C, water-bath 30 ~ 50min.
Step 2) in temperature be 35 DEG C, react 12h.
Beneficial effect:
A kind of fibrin compound hemostatic material provided by the invention, it is possible to quickly effectively hemostasis, reduces amount of bleeding, and uses safety; Its preparation method is simple, prepares membranaceous composite, easy to use, it is simple to preserve.
Detailed description of the invention
Embodiment 1
A kind of fibrin compound hemostatic material, is prepared from by the raw material of following mass parts: carboxymethyl cellulose 5 parts, carboxyethyl cellulose 2 parts, chitosan 1 part, starch 3 parts, sodium trimetaphosphate 1 part, sodium alginate 1 part, 3 parts of gelatin, soybean protein isolate 8 parts, lysine 2 parts, 20 parts of water.
Preparation method, comprises the steps:
1) starch and chitosan being added to the water, water bath with thermostatic control, add sodium trimetaphosphate stirring, the temperature of water bath with thermostatic control is 65 DEG C, water-bath 40min;
2) adding sodium alginate, gelatin, soybean protein isolate and aminoacid in the solution of step 1), 35 DEG C, stirring carries out cross-linking reaction, reacts 12h;
3) in step 2) solution in add carboxymethyl cellulose and carboxyethyl cellulose, pour mask on glass plate, lyophilization, take off film, obtain fibrin compound hemostatic material.
Embodiment 2
A kind of fibrin compound hemostatic material, is prepared from by the raw material of following mass parts: carboxymethyl cellulose 10 parts, carboxyethyl cellulose 4 parts, chitosan 5 parts, starch 8 parts, sodium trimetaphosphate 3 parts, sodium alginate 4 parts, 8 parts of gelatin, soybean protein isolate 12 parts, lysine 5 parts, 40 parts of water.
Preparation method, comprises the steps:
1) starch and chitosan are added to the water, water bath with thermostatic control, add sodium trimetaphosphate stirring; The temperature of water bath with thermostatic control is 65 DEG C, water-bath 40min;
2) adding sodium alginate, gelatin, soybean protein isolate and aminoacid in the solution of step 1), 35 DEG C, stirring carries out cross-linking reaction, reacts 12h;
3) in step 2) solution in add carboxymethyl cellulose and carboxyethyl cellulose, pour mask on glass plate, lyophilization, take off film, obtain fibrin compound hemostatic material.
Embodiment 3
A kind of fibrin compound hemostatic material, is prepared from by the raw material of following mass parts: carboxymethyl cellulose 6 parts, carboxyethyl cellulose 3.2 parts, chitosan 2 parts, starch 5 parts, sodium trimetaphosphate 1.8 parts, sodium alginate 2 parts, 5 parts of gelatin, soybean protein isolate 10 parts, arginine 3 parts, 25 parts of water.
Preparation method, comprises the steps:
1) starch and chitosan being added to the water, water bath with thermostatic control, add sodium trimetaphosphate stirring, the temperature of water bath with thermostatic control is 65 DEG C, water-bath 40min;
2) adding sodium alginate, gelatin, soybean protein isolate and aminoacid in the solution of step 1), 35 DEG C, stirring carries out cross-linking reaction, reacts 12h;
3) in step 2) solution in add carboxymethyl cellulose and carboxyethyl cellulose, pour mask on glass plate, lyophilization, take off film, obtain fibrin compound hemostatic material.
Embodiment 4
A kind of fibrin compound hemostatic material, is prepared from by the raw material of following mass parts: carboxymethyl cellulose 8 parts, carboxyethyl cellulose 3.6 parts, chitosan 4 parts, starch 7 parts, sodium trimetaphosphate 2.4 parts, sodium alginate 3 parts, 7 parts of gelatin, soybean protein isolate 12 parts, arginine 4 parts, 35 parts of water.
Preparation method, comprises the steps:
1) starch and chitosan being added to the water, water bath with thermostatic control, add sodium trimetaphosphate stirring, bath temperature is 65 DEG C, and water bath time is 40min;
2) adding sodium alginate, gelatin, soybean protein isolate and aminoacid in the solution of step 1), 35 DEG C, stirring carries out cross-linking reaction, reacts 12h;
3) in step 2) solution in add carboxymethyl cellulose and carboxyethyl cellulose, pour mask on glass plate, lyophilization, take off film, obtain fibrin compound hemostatic material.
Embodiment 5
A kind of fibrin compound hemostatic material, it is prepared from by the raw material of following mass parts: carboxymethyl cellulose 7 parts, carboxyethyl cellulose 3.5 parts, chitosan 3 parts, starch 6 parts, sodium trimetaphosphate 2.2 parts, sodium alginate 2.5 parts, 6 parts of gelatin, soybean protein isolate 11 parts, arginine 3.5 parts, 30 parts of water.
Preparation method, comprises the steps:
1) starch and chitosan being added to the water, water bath with thermostatic control, add sodium trimetaphosphate stirring, bath temperature is 65 DEG C, and water bath time is 40min;
2) adding sodium alginate, gelatin, soybean protein isolate and aminoacid in the solution of step 1), 30 ~ 37 DEG C, stirring carries out cross-linking reaction, reacts 10 ~ 16h;
3) in step 2) solution in add carboxymethyl cellulose and carboxyethyl cellulose, pour mask on glass plate, lyophilization, take off film, obtain fibrin compound hemostatic material.
Reference examples 1
The described aminoacid that differs only in of the present embodiment fibrin compound hemostatic material preparation method and material component and embodiment 5 is acidic amino acid glutamic acid.
Reference examples 2
The present embodiment fibrin compound hemostatic material preparation method and material component and differing only in of embodiment 5 do not include soybean protein isolate and arginine in component.
The mensuration of the BCI index of fibrin compound hemostatic material and comparing
First, people's whole blood that 100 �� L contain anticoagulant ACD (2.5% ACD, 10 �� L) adds in a little container; Secondly the CaCl2 solution (0.2mol/L) of 20 �� L is joined and blood carries out preliminary blood coagulation, then the sample that weight is 0.03g is poured in small container and covered into blood, more above-mentioned beaker is put into cultivation 10min in 37 DEG C of incubators; Afterwards 25ml deionized water is poured slowly in beaker along walls of beaker, does not destroy the blood solidified as far as possible, this beaker is inserted 5min in 37 DEG C of constant temperature digital display water bath chaders; Finally take out beaker and stand 5min, take out the liquid in a small amount of beaker afterwards on ultraviolet spectrophotometer, measure its absorbance at 542nm place. The BCI value of sample calculates such as formula: BCI=100* (absorbance at 542nm place of the liquid after sample hemostasis)/(not adding the liquid of the sample absorbance at 542nm place), hemostatic capability and the BCI value of material are inversely proportional to, namely BCI value is more low, and the anthemorrhagic performance of material is more good.
The BCI index of comparing embodiment 1 ~ 5, reference examples 1 ~ 2 and commercially available YUNNAN BAIYAO, result is shown in Table 1.
Table 1:
Claims (8)
1. a fibrin compound hemostatic material, it is characterized in that being prepared from by the raw material of following mass parts: carboxymethyl cellulose 5 ~ 10 parts, carboxyethyl cellulose 2 ~ 4 parts, chitosan 1 ~ 5 part, starch 3 ~ 8 parts, sodium trimetaphosphate 1 ~ 3 part, sodium alginate 1 ~ 4 part, 3 ~ 8 parts of gelatin, soybean protein isolate 8 ~ 12 parts, 2 ~ 5 parts of aminoacid, 20 ~ 40 parts of water.
2. fibrin compound hemostatic material according to claim 1, it is characterised in that: described aminoacid is basic amino acid.
3. fibrin compound hemostatic material according to claim 2, it is characterised in that: described aminoacid is arginine or lysine.
4. fibrin compound hemostatic material according to claim 2, it is characterized in that being prepared from by the raw material of following mass parts: carboxymethyl cellulose 6 ~ 8 parts, carboxyethyl cellulose 3.2 ~ 3.6 parts, chitosan 2 ~ 4 parts, starch 5 ~ 7 parts, sodium trimetaphosphate 1.8 ~ 2.4 parts, sodium alginate 2 ~ 3 parts, 5 ~ 7 parts of gelatin, soybean protein isolate 10 ~ 12 parts, 3 ~ 4 parts of aminoacid, 25 ~ 35 parts of water.
5. fibrin compound hemostatic material according to claim 4, it is characterized in that being prepared from by the raw material of following mass parts: carboxymethyl cellulose 7 parts, carboxyethyl cellulose 3.5 parts, chitosan 3 parts, starch 6 parts, sodium trimetaphosphate 2.2 parts, sodium alginate 2.5 parts, 6 parts of gelatin, soybean protein isolate 11 parts, 3.5 parts of aminoacid, 30 parts of water.
6. the preparation method of fibrin compound hemostatic material described in any one in claim 1 to 5, it is characterised in that comprise the steps:
1) starch and chitosan are added to the water, water bath with thermostatic control, add sodium trimetaphosphate stirring;
2) adding sodium alginate, gelatin, soybean protein isolate and aminoacid in the solution of step 1), 30 ~ 37 DEG C, stirring carries out cross-linking reaction, reacts 10 ~ 16h;
3) in step 2) solution in add carboxymethyl cellulose and carboxyethyl cellulose, pour mask on glass plate, lyophilization, take off film, obtain fibrin compound hemostatic material.
7. the preparation method of the fibrin compound hemostatic material according to claim 6, it is characterised in that: in step 1), the temperature of water bath with thermostatic control is 60 ~ 70 DEG C, water-bath 30 ~ 50min.
8. the preparation method of the fibrin compound hemostatic material according to claim 6, it is characterised in that: step 2) in temperature be 35 DEG C, react 12h.
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN105963757A (en) * | 2016-06-27 | 2016-09-28 | 苏州蔻美新材料有限公司 | Autolyzed hemostatic composite material and preparation method thereof |
CN105963760A (en) * | 2016-06-27 | 2016-09-28 | 苏州蔻美新材料有限公司 | Absorbable medical anti-microbial dressing and preparation method thereof |
CN107233615A (en) * | 2017-08-03 | 2017-10-10 | 苏州凌科特新材料有限公司 | A kind of hemostatic and antibacterial material and preparation method thereof |
CN108057128A (en) * | 2017-12-12 | 2018-05-22 | 常州美帛纺织品有限公司 | A kind of preparation method of medical sodium alginate composite membrane |
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JP2003062057A (en) * | 2001-08-29 | 2003-03-04 | Next:Kk | Minute particles of biopolymer for homeostasis and adhesion prevention |
CN102772821A (en) * | 2012-08-01 | 2012-11-14 | 苏州博创同康生物工程有限公司 | Absorbable and hemostatic multifunctional particle with tissue induction and preparation and application of multifunctional particle |
CN104874014A (en) * | 2015-05-22 | 2015-09-02 | 苏州市贝克生物科技有限公司 | Preparation method of medical hemostatic occlusion dressing |
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2016
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Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2003062057A (en) * | 2001-08-29 | 2003-03-04 | Next:Kk | Minute particles of biopolymer for homeostasis and adhesion prevention |
CN102772821A (en) * | 2012-08-01 | 2012-11-14 | 苏州博创同康生物工程有限公司 | Absorbable and hemostatic multifunctional particle with tissue induction and preparation and application of multifunctional particle |
CN104874014A (en) * | 2015-05-22 | 2015-09-02 | 苏州市贝克生物科技有限公司 | Preparation method of medical hemostatic occlusion dressing |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105963757A (en) * | 2016-06-27 | 2016-09-28 | 苏州蔻美新材料有限公司 | Autolyzed hemostatic composite material and preparation method thereof |
CN105963760A (en) * | 2016-06-27 | 2016-09-28 | 苏州蔻美新材料有限公司 | Absorbable medical anti-microbial dressing and preparation method thereof |
CN107233615A (en) * | 2017-08-03 | 2017-10-10 | 苏州凌科特新材料有限公司 | A kind of hemostatic and antibacterial material and preparation method thereof |
CN108057128A (en) * | 2017-12-12 | 2018-05-22 | 常州美帛纺织品有限公司 | A kind of preparation method of medical sodium alginate composite membrane |
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Application publication date: 20160601 |