CN1321702C - Wound dressing for first aid - Google Patents
Wound dressing for first aid Download PDFInfo
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- CN1321702C CN1321702C CNB2005100962394A CN200510096239A CN1321702C CN 1321702 C CN1321702 C CN 1321702C CN B2005100962394 A CNB2005100962394 A CN B2005100962394A CN 200510096239 A CN200510096239 A CN 200510096239A CN 1321702 C CN1321702 C CN 1321702C
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- thrombin
- aid
- wound dressing
- animal
- aminocaproic acid
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Abstract
The present invention relates to a first-aid wound dressing tablet for mainly rescuing trauma casualties outside hospitals. Additives with calcium ions, animal thrombase, amino caproic acid, antibiotics for resisting secondary infection, anodyne, fibroblast growth factors or epithelial cell growth factors are sprayed on a supporter of a synthetic material with biocompatibility. The present invention controls hemorrhage by activating blood coagulation mechanism of human bodies and restraining fibrin dissolution, so the present invention can effectively restrain massive haemorrhage of the artery and vein in short time. The present invention has no any foreign human body protein, and thus, the present invention avoids the pollution of haematogenous virus and has favorable safety.
Description
Technical field
The invention belongs to field of medicaments, particularly a kind of Wound dressing for first aid that outside hospital, the wound wounded is rescued that is mainly used in.
Background technology
Although present a lot of technological progresses have improved in the hospital management to injured personnel, but the treatment to injured personnel before being in hospital also rests on the level of traditional approach, as the processing to the wound hemorrhage only limit to wrap up, fixing and adopt the mechanicalness hemostasis method of high position, also mainly be the mechanicalness hemostasia products for the anti-hemorrhagic compound of traumatic hemorrhage.At present, owing in the casualty that war or traffic accident cause, have 20% to die from a large amount of losing blood approximately; For haemophiliachemophiliac patient, or with the patient of anticoagulant medicine, as the patient of heart disease postoperative, the problem of bleeding profusely rapidly may be more serious.
The battle casualty personnel of external Wound healing and bone regeneration product handle to(for) good being used to should have following requirement: control hemostasis apace, the infection of pain relieving and control secondary.Management severely injured personnel's the first step is exactly to stop blooding as much as possible.If hemorrhage is external, rapidly, and the probability of control is arranged, so to the requirement of hemorrhage control even have precedence over control to respiratory tract.To the wounded of severe haemorrhage, each drips endovascular blood that carries oxygen all may be to give birth to and dead different.
BioGlue operation binding be a kind of by U.S. food drug surveilance office (FDA) approval be used for controlling the hemorrhage product of operation, it contains two kinds of major ingredients: the bovine albumin of purification and glutaraldehyde.Bio Glue operation binding has adopted unique transfer system, use cartridge case disposable usefulness, that be full of in advance and put the apparatus of medicine, be able to the wound of operation is controlled completely for the operation teacher, Bio Glue can create the sealing of a machinery in tens seconds, but did not utilize the clotting mechanism of human body self.Bio Glue operation binding can be used for the control to the massive hemorrhage that opens wide the property wound as the householder method of adult patient's standard hemostasis method (as sewing up), as large artery trunks, and femoral artery and coronarius hemorrhage.But be to use the step complexity of this product, use product before personnel must carry out necessary training, so the emergent management of massive hemorrhage when being not suitable for wound, especially to the field fight wounded's processing, this product only limits to operating room surgery doctor's use at present.
Chinese patent CN2643866 discloses a kind of quick bio sealing hemostasis and has pasted, and it mainly is made of collagen layer, absorbable woven mesh layer, fibrinogen layer and thrombin layer; Chinese patent CN1552465 discloses a kind of fibrin hemostasis and has pasted; it is to be the collagen sponge of raw material production with pig, cattle or horse leg tendon, make at its surface applied Fibrinogen and thrombin again the absorbable medical dressing that can be used for internal organs and body surface wound hemostasis---the fibrin hemostasis is pasted.But fibrin sponge or the collagen sponge that uses bio-absorbable pasted in this class hemostasis, cost an arm and a leg, its water absorption, pliability are poor, be not suitable for the different human body position extensive wound and hemorrhage rapidly, (as tremulous pulse or vein blood vessel breakage) occasion that amount of bleeding is big.In addition, the Fibrinogen of animal origin whether with the original identical activity of people's fibrin, still do not have final conclusion now, and no matter be from animal or all unstable from the Fibrinogen in people source, in solution, can be degraded very soon.
At present, people develop the quick-acting haemostatic powder apparatus that can utilize biology self clotting mechanism again, as comprise and contain the hemostasis cream that promotes human body clotting mechanism composition, one of them clotting mechanism reinforcing agent is exactly that human thrombin is former, is " Fibrin Glue " and contain the former modal blood coagulation product of human thrombin." Fibrin Glue " is made up of people's Fibrinogen and thrombin, and it is sold in the mode of a medicine box, comprises the bottle and the thrombin solution of the fiber proenzyme of packing.These solution mix, and use wound with the whole bag of tricks, comprise plaster, spray, or patch." but Fibrin Glue " is not consistent, the effective method of stopping blooding, and uses Fibrin Glue to need to mix, soak and wraps up patch, and be time-consuming, and the step complexity.Potential mistake all may take place in the step in each set-up procedure, so the quality of haemostatic effect depends on the people's who uses this product experience.Topmost shortcoming is, in the process of prep solution, has more hemorrhage generation, and solution can not be stopped the sufficiently long time that can reach haemostatic effect at wound by a large amount of hemorrhage washing away.Although on the composition of thrombinogen and operational approach, obtained certain progress, these hemostatic drawbacks limit its application aspect hemostasis.Using another major defect of " Fibrin Glue " is that it comprises human fibrinogen, the albumen of this purification from human blood takes place probably by the danger of haematogenous viral pollutions such as the HIV of highly dangerous and hepatitis virus, so U.S. FDA has forbidden that plasminogen is in clinical use.Except safety issue, isolating human fibrinogen is also very expensive from human plasma.
Summary of the invention
Problem to be solved by this invention is: provide a kind of safe and effective, can control hemorrhage due to the wound rapidly, particularly under the occasion of no hospital emergency treatment, Wound dressing for first aid when massive hemorrhage takes place and preparation method thereof.Here said " massive hemorrhage " be due to injury of digital blood vessels or the visceral organ injury rapidly, big hemorrhage of amount.
The problem that the present invention will further solve is: control pain and secondary infection due to the wound rapidly, and promote the healing of wound.
The technical scheme that addresses the above problem is: the Wound dressing for first aid that is provided is the additive that contains calcium ion, animal thrombin and the aminocaproic acid that sprinkling is arranged on the holder of a synthetic material with biocompatibility.
The final concentration of above-mentioned animal thrombin can be 1～100 active unit/cm
2, the final concentration of aminocaproic acid can be 1～50mg/cm
2
In order to make above-mentioned additive, animal thrombin and aminocaproic acid, on holder, can scribble binding, the preferred gelatin of binding better attached on the holder.
Above-mentioned said holder with synthetic material of biocompatibility can be selected nylon, polyethylene, polyester, polypropylene, fluoropolymer for use, or their combination, the first-selected PVA sponge of the present invention, the PVA sponge is polyvinyl alcohol (Polyvinyl Alcohol) synthetic sponge, it has the small structure of 3 D stereo, similar to natural ocean sponge, all apertures are interconnected, and have very high filter efficiency, very strong water absorption, good flexible and antiwear property.The PVA sponge is into the colloid of positive charge in water, can the strong adsorption metal ion, and as calcium ion etc.Select for use the PVA sponge as holder, can play one's part to the full for each component of spraying on the patch provides support.In addition, the price of PVA sponge is also cheaper.
The first-selected calcium chloride of above-mentioned calcium ions additive, calcium sodium alginate or calcareous algae hydrochlorate can substitute mutually between them.
Above-mentioned said thrombin is meant: animal on one's body the thrombin molecule, thrombin molecule synthetic or reorganization that form naturally, what the present invention preferentially selected for use is thrombin of beef.
Above-mentioned said aminocaproic acid is preferentially selected the analog of 6-aminocaprolc acid or 6-aminocaprolc acid for use, as 5-aminocaproic acid, 7-aminocaproic acid or 8-aminocaproic acid, but is not limited only to 5-aminocaproic acid, 7-aminocaproic acid or 8-aminocaproic acid.
Hemostatic mechanism of the present invention is: when blood vessel is destroyed, the clotting mechanism of human body will be activated behind use the present invention, former thrombin in the blood changes thrombin into, and thrombin can cut into the Fibrinogen in the blood fibrin monomer, and the protein stabilized factor of activation fiber---Hageman factor I, insoluble fibrin is agglomerated into net, thereby catches hemocyte and serum, the final sludged blood that forms causes blood coagulation.Thrombin promotes the fiber proenzyme to provide fibrin, the polymerization of the plasminogen in the enough catalysis patients of the thrombin on the patch of the present invention blood plasma as catalyst.
The animal thrombin can human activin self clotting mechanism, and calcium ion is that the thrombin action activity is necessary, both combineds effect can be at short notice the effective clotting mechanism of human activin self;
Aminocaproic acid can suppress the former activity factor of fibrinous dissolving competitively, make the plasminogen can not the activating position brinase, thereby suppressed fibrinous dissolving, prevented breaking of sludged blood, this is crucial to preventing massive hemorrhage.
For pain and the secondary infection due to the rapid control wound, promote the healing of wound, on holder of the present invention, can add the antibiotic (as tetracycline, chlortetracycline etc.), analgesic of anti-secondary infection or other can promote hyperplasia, the albumen of accelerating wound (as fibroblast somatomedin and epithelial cell growth factor etc.).The preferred broad ectrum antibiotic of antibiotic, the preferred morphine of analgesic.
In order further to strengthen the stable and active of animal thrombin, so that adapt at high temperature, use under the mal-conditions such as field, said animal thrombin preferably uses water miscible N-(3-dimethyl aminopropyl)-N '-ethyl carbodiimide (EDC) and N-maloyl imines (NHS) and animal thrombin to carry out the covalently bound thrombin of chemical covalency cross reaction gained, or carries out the covalently bound thrombin of chemical covalency cross reaction gained with water miscible N-(3-dimethyl aminopropyl)-N '-ethyl carbodiimide (EDC) and 5-maloyl imines sodium salt (Sulfo-NHS) and animal thrombin.
The preparation method of Wound dressing for first aid provided by the present invention is:
To contain binding solution, calcium ion additive solution, animal thrombin solution, aminocaproic acid spray solution to holder, dry, sterilization.
Above-mentioned animal thrombin is the covalently bound thrombin that carries out chemical covalency cross reaction gained with water miscible N-(3-dimethyl aminopropyl)-N '-ethyl carbodiimide and N-maloyl imines or 5-maloyl imines sodium salt and animal thrombin, the condition of its covalency cross reaction is: interconnection is reflected in 2-(N-morphine quinoline) ethyl sulfonic acid (MES) buffer to be carried out, the pH value of this buffer is 5.4～6.4, the molecular proportion of N-(3-dimethyl aminopropyl)-N '-ethyl carbodiimide and thrombin is 5～15: 1, and the molecular proportion of N-maloyl imines or 5-maloyl imines sodium salt and thrombin is 5～15: 1.
Compared with prior art, advantage of the present invention is as follows:
1, owing to invention is from human activin self clotting mechanism and suppresses Fibrinolytic two aspect control over bleeding, so can effectively suppress the artery and vein massive hemorrhage at short notice.
2, the present invention as Fibrinogen, can avoid introducing the pollution of unsafe haematogenous virus, so have good safety like this without any the human body protein of outer rim.
4, easy and simple to handle: need not soak in saline in advance during use, directly patch of the present invention is placed on the bleeding wounds, the surperficial a few minutes that gently are pressed in wound by gauze, binder or other aseptic things of doing get final product (comparatively Shi Yi time is 5 minutes).
5, owing to not containing the expensive refinement from human plasma and the human fibrinogen of purification in the patch, so low production cost.
6, also be added with the composition of pain relieving rapidly, control secondary infection among the present invention, and the composition that promotes wound healing, make it be more suitable for being admitted to hospital before the emergent management of wound.
In addition, because thrombin activity of the present invention and stability are improved by the method for covalency cross coupled, so can be under various natural environment, long preservation under hot weather particularly, the wounded that are particularly useful for open-air fight use, and also are suitable for the emergent management of other preceding wounded's wounds of being admitted to hospital.Except stopping blooding, the present invention can also be used to seal bodily tissue, for example, when wound at throat or breast, when causing leaking gas, can cover wound with the present invention, gently press a period of time in the wound, to cause blood coagulation.With the exception of this, the present invention also can be used for topical therapeutic (as burn or tissue transplantation), also can be made into Bandaid formula paster or plaster.
Description of drawings
Fig. 1 is the active contrast test curve of covalently bound thrombin and non-covalent bonded thrombin.
Fig. 2 is the stable contrast test curve of covalently bound thrombin and non-covalent bonded thrombin.
The specific embodiment
Embodiment 1
With the substrate of lamellar PVA sponge as patch;
Use the macropore atomizers spray on substrate the gelatin solution of 10mg/ml earlier, at room temperature air-dry; The amount of gelatin can be decided according to the use occasion of patch.Usually, gelatin is runny, is dispersed in the phosphate solution, and final concentration is 2mg/cm at least
2, 1mg/cm normally
2To 50mg/cm
2, that the most frequently used is 2mg/cm
2To about 10mg/cm
2
The calcium alginate spray solution to substrate, and is used the aeration drying drying;
With the aerosol apparatus of aperture is concentration that the covalently bound thrombin of beef solution of 10 active units/ml is sprayed onto on the substrate, is put in the vacuum drying oven dry 2 hours, and final concentration is 2 active units/cm
2
With meticulous aperture aerosol apparatus spray concentration on substrate is the 6-aminocaprolc acid solution of 10mg/ml, and final concentration is 1mg/cm
2Promptly get Wound dressing for first aid;
Above-mentioned Wound dressing for first aid is used vacuum drying oven dry 15 minutes, be put into the freeze drying box bone dry again; Patch is packed, and carry out γShe Xianmiejun.
The cross reaction condition of covalently bound thrombin of beef is in this example:
Interconnection is reflected in the MES buffer of 0.05M to be carried out, and the pH value of buffer is 6, and the molecular proportion of EDC and thrombin is 7: 1; The molecular proportion of NHS or Sulfo-NHS and thrombin is 2.8: 1.
The active contrast test of the thrombin of beef of this covalency cross coupled and non-covalent bonded thrombin of beef: with the tripeptides TFA-phe-pro-arg-AFC of the fluorescein AFC labelling substrate as thrombin, the substrates of 17 grams are dissolved among 200 milliliters the DMSO.The dissolved concentration of thrombin is 10 units per ml.During experiment, the substrate solution of 200 microlitres and the thrombin solution of 200 microlitres are mixed.Experimental result shows: the thrombin activity after the covalent bond is than non-covalent bonded thrombin height, and as shown in Figure 1, curve A is covalently bound thrombin of beef among the figure, and curve B is non-covalent bonded thrombin.
The stable contrast test of this covalently bound thrombin of beef and non-covalent bonded thrombin of beef:
Elder generation placed 10 hours down at 42 ℃ respectively freeze dried non-covalent bonded thrombin and covalently bound thrombin, use the method for above-mentioned activity test then, be that substrate is identified promptly with fluorescently-labeled tripeptides, the result shows: the high temperature resistant property of covalently bound thrombin is more much better than non-covalent bonded thrombin, as shown in Figure 2.Curve C is the covalently bound thrombin of beef that high temperature is deposited among the figure, and curve D is the non-covalent bonded thrombin that room temperature is deposited, the non-covalent bonded thrombin that curve is deposited for E high temperature.
Use this example that the pig of anesthesia is tested: cut the femoral artery of pig one side, Wound dressing for first aid of the present invention was pushed on hemorrhage wound 5 minutes, arterial hemorrhage is controlled, hemorrhage no longer recurrence after 20 minutes, the blood pressure stabilization of pig, after 24 hours, hemorrhage still not recurrence.
Embodiment 2
With the substrate of lamellar PVA sponge as patch, the additive of calcium ion is a calcium chloride, and the animal thrombin is covalently bound thrombin of beef, and aminocaproic acid is the 8-aminocaproic acid.Spray the gelatin solution of 15mg/ml earlier on substrate, spray calcium chloride solution then successively, concentration is the thrombin solution of 10 active units/ml and the 8-aminocaproic acid solution that concentration is 20mg/ml.
Animal hemostasis trial and effect are identical with embodiment 1.
Embodiment 3
With the substrate of lamellar PVA sponge as patch, the additive of calcium ion is a calcium alginate, and the animal thrombin is covalently bound thrombin of beef, and aminocaproic acid is a 6-aminocaprolc acid.The spray solution of above-mentioned material after on the substrate, is sprayed broad ectrum antibiotic, morphine and fibroblast somatomedin again.Animal hemostasis trial and effect are identical with embodiment 1.
The size of Wound dressing for first aid of the present invention and shape can decide according to concrete purposes, can be spheric, tapers, and be cuboidal or tubular, and for use in the special part of health, commonly used is square shape sheet.The present invention also can be attached on above-mentioned calcium ion additive, animal thrombin and aminocaproic acid on synthesized polymer or the natural fiber binder.
Claims (9)
1, a kind of Wound dressing for first aid, holder with synthetic material of a biocompatibility, additive, animal thrombin and aminocaproic acid that calcium ion is arranged on this holder is characterized in that said holder with synthetic material of biocompatibility is the polyvinyl alcohol synthetic sponge.
2, Wound dressing for first aid as claimed in claim 1, it is characterized in that said calcium ions additive is any one in calcium chloride, calcium sodium alginate or the calcareous algae hydrochlorate, said aminocaproic acid is any one in 5-aminocaproic acid, 6-aminocaprolc acid, 7-aminocaproic acid or the 8-aminocaproic acid.
3, Wound dressing for first aid as claimed in claim 1 or 2, it is characterized in that said animal thrombin is the covalently bound thrombin that carries out chemical covalency cross reaction gained with water miscible N-(3-dimethyl aminopropyl)-N '-ethyl carbodiimide and N-maloyl imines and animal thrombin, or carry out the covalently bound thrombin of chemical covalency cross reaction gained with water miscible N-(3-dimethyl aminopropyl)-N '-ethyl carbodiimide and 5-maloyl imines sodium salt and animal thrombin.
4, Wound dressing for first aid as claimed in claim 3 is characterized in that said animal thrombin is a thrombin of beef, and the final concentration of thrombin of beef is 1～100 active unit/cm
2, the final concentration of aminocaproic acid is 1～50mg/cm
2
5, Wound dressing for first aid as claimed in claim 4 is characterized in that being added with antibiotic, analgesic, fibroblast somatomedin or the epithelial cell growth factor of anti-secondary infection on described holder.
6, Wound dressing for first aid as claimed in claim 5 is characterized in that said antibiotic is a broad ectrum antibiotic, and said analgesic is a morphine.
7, Wound dressing for first aid as claimed in claim 6 is characterized in that the gelatin binding is arranged on said holder.
8, according to the preparation method of the described Wound dressing for first aid of claim 1, it is characterized in that: will contain binding solution, calcium ion additive solution, animal thrombin solution, aminocaproic acid spray solution to holder, dry, sterilization, said holder is the polyvinyl alcohol synthetic sponge.
9 preparation methoies as claimed in claim 9, it is characterized in that said animal thrombin is the covalently bound thrombin that carries out chemical covalency cross reaction gained with water miscible N-(3-dimethyl aminopropyl)-N '-ethyl carbodiimide and N-maloyl imines or 5-maloyl imines sodium salt and animal thrombin, the condition of its covalency cross reaction is: interconnection is reflected in 2-(N-morphine quinoline) the ethyl sulfonic acid buffer to be carried out, the pH value of this buffer is 5.4～6.4, the molecular proportion of N-(3-dimethyl aminopropyl)-N '-ethyl carbodiimide and thrombin is 5～15: 1, and the molecular proportion of N-maloyl imines or 5-maloyl imines sodium salt and thrombin is 5～15: 1.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100962394A CN1321702C (en) | 2005-10-26 | 2005-10-26 | Wound dressing for first aid |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100962394A CN1321702C (en) | 2005-10-26 | 2005-10-26 | Wound dressing for first aid |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1772312A CN1772312A (en) | 2006-05-17 |
| CN1321702C true CN1321702C (en) | 2007-06-20 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005100962394A Active CN1321702C (en) | 2005-10-26 | 2005-10-26 | Wound dressing for first aid |
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|---|---|
| CN (1) | CN1321702C (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108939144A (en) * | 2018-07-27 | 2018-12-07 | 广州默拓医药科技有限公司 | A kind of liquid dressing |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5290552A (en) * | 1988-05-02 | 1994-03-01 | Matrix Pharmaceutical, Inc./Project Hear | Surgical adhesive material |
| US5643596A (en) * | 1993-11-03 | 1997-07-01 | Clarion Pharmaceuticals, Inc. | Hemostatic patch |
-
2005
- 2005-10-26 CN CNB2005100962394A patent/CN1321702C/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5290552A (en) * | 1988-05-02 | 1994-03-01 | Matrix Pharmaceutical, Inc./Project Hear | Surgical adhesive material |
| US5643596A (en) * | 1993-11-03 | 1997-07-01 | Clarion Pharmaceuticals, Inc. | Hemostatic patch |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1772312A (en) | 2006-05-17 |
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Application publication date: 20060517 Assignee: Yangling Dai Ying biological medicine group Limited by Share Ltd Assignor: Yangling Daiying Inst. of Biotechnology, Shaanxi Prov. Contract record no.: 2010610000005 Denomination of invention: Wound dressing for first aid Granted publication date: 20070620 License type: Common License Record date: 20100406 |
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Owner name: YANGLING ANDIYUAN BIOTECHNOLOGY CO., LTD. Effective date: 20110826 |
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Effective date of registration: 20110826 Address after: 712100, 10 South Road, Yangling demonstration area, Shaanxi Patentee after: Yangling An Di Yuan Biotech Co., Ltd. Address before: 712100 Shaanxi province Yangling demonstration area Venture Service Center Room 510 Patentee before: Yangling Daiying Inst. of Biotechnology, Shaanxi Prov. |