CN105268017A - Technology for preparing quick hemostasis patch - Google Patents
Technology for preparing quick hemostasis patch Download PDFInfo
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- CN105268017A CN105268017A CN201510679361.8A CN201510679361A CN105268017A CN 105268017 A CN105268017 A CN 105268017A CN 201510679361 A CN201510679361 A CN 201510679361A CN 105268017 A CN105268017 A CN 105268017A
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Abstract
The invention relates to a quick hemostasis patch applied to sudden large and deep wound. The quick hemostasis patch at least comprises a base material layer, an adhesive layer and a sponge layer. The sponge layer comprises quick hemostasis thrombin by means of cross-linking; a lining layer can be arranged between the base material layer and the adhesive layer.
Description
Background technology:
Wound healing is a complicated physiological process, also be one of most significant problems of medical circle concern always, the adhesive bandage with Wound healing and bone regeneration and wound repair is the important topic of medical research always, and adhesive bandage is by a microscler adhesive plaster, and the sliver that centre is accompanied by the dipped medicine of a fritter is formed.Due to its structural limitations, adhesive bandage can only be used for fritter wound emergence therapeutic, thus plays temporarily hemostasis and the effect of protection wound surface.
Adhesive bandage has feature simply and easily, for the hemostasis of acute minor cut or wound, be particularly useful for otch neat, clean, show the incision that shallow and less these do not need to sew up.But for comparatively gash, have trunk, nerve, tendon injury and be suspected to have the wound of foreign body, common adhesive bandage is just difficult to play a role; As for furuncle and phyma, scald, suppurative infection and various dermatosis, just more can not use adhesive bandage to treat.
For the deficiency of adhesive bandage, there is the adhesive bandage of a lot of difference in functionality in the market, as having the adhesive bandage of the functions such as ventilative, waterproof, sterilization and skin care, and having also had the adhesive bandage of specific function of the open and protection of a variety of patent.
US Patent No. P6355858 has invented a kind of wound clad material, containing non-gel-type polysaccharide mannan, and short fibroblast growth factor (FGF), NFG, the bioactive ingredients such as epidermal growth factor and anti-inflammatory component, this material can promote wound healing, reduces the formation of cicatrix.
Also the adhesive bandage of a lot of Various Functions is had to report and apply for a patent in China equally.Chinese patent 201310080630.X sets forth and is a kind ofly pasted onto wound and worm and stings etc. on pars affecta skin face and carry out the treatment of affected part and urgently needed adhesive bandage of sterilizing, can prevent because ultraviolet is through the cutaneous pigmentation caused, also ultraviolet can be suppressed the harmful effect of medicinal liquid and ointment, this adhesive bandage is included in the stickup pad component of adhesive bandage middle part, and there is the peeling paper be attached on film, pad component is the pad be made up of gauze, non-woven fabrics.Chinese patent 2000510042575.0 discloses a kind of adhesive bandage containing hyaluronic acid biological composition; on existing adhesive bandage basis; utilize hyaluronic acid, trehalose; the compositions that the biological function of allantoin mixes according to a certain percentage; by invade bubble, coating or spray processing be attached to adhesive bandage laying and as in the nonwoven gauze of sealing coat, wrapping, isolation, protection and treatment are once completed.
Chinese patent CN1198921A describes a kind of debridement adhesive bandage, comprises the packaging bag outside the medicine block in the middle part of base band, base band, the non-drying glue layer at base band two ends and base band and packing box, can prevent bacteriological infection, improves the curative effect of adhesive bandage.Chinese patent 201210426698.4 relates to a kind of hydrogel woundplast, comprises adhesion coating, bed of cloth, and described adhesion coating viscous, in bed of cloth surface, is pasted with multiple adhesive tape at the upper surface of described protecting film.Chinese patent 201310265838.9 provides a kind of adhesive bandage, using the biological cellulose hydrogel of dewatering at least partly as adsorptive pads.Chinese patent CN1136904C relate to a kind of patch for the treatment of skin trauma, is the novel form of YUNNAN BAIYAO, comprises medicine, adhesive tape and medicated core, and its feature have employed YUNNAN BAIYAO component, high to the cure rate of the little wound of skin.Chinese patent 201110365918.2 has the compound adhesive bandage of high water absorbing capacity, relate to a kind of compound adhesive bandage with high water absorbing capacity, comprise PU rete, protect wound layer and antiseized release paper, described in protect wound layer and be made up of water accepting layer, honey powder layer, water accepting layer and isolating membrane successively compound; There is strong absorption, sterilization, urge functions such as healing.
What Lintec Corporation applied in China 201080012486.0 has set forth adhesive bandage packaging material and adhesive bandage, there is provided a kind of adhesive bandage packaging material, the adhesive linkage of the one side for receiving, there is surface substrate, being arranged at this surface substrate and carry out the adhesive bandage of the releasing sheet pasted in the mode covering adhesive linkage.
These patents about adhesive bandage serve hemostasis in material, medicine, new structure respectively; sterilization; the effect of protection wound; difference of the present invention is organically combined the sponge being used for stopping blooding, thrombin and adhesive bandage; the water absorption rate utilizing gelfoam high and thrombin combined effect; thus quick-acting haemostatic powder; concrete grammar is by a kind of patch compared with large gauge; include the macromolecular material degradable sponge such as base material and gelfoam, collagen sponge and chitosan sponge, in these sponges, contain the thrombin be fixed therein.To the large-scale wound of demblee form, or the wound of type can be goed deep into like this, carry out quick-acting haemostatic powder and process rapidly.Played adhesive bandage hemostasis by compression, the absorption coagulation enzyme of sponge, to the triple functions of plasma protein in conjunction with coagulation, stops rapidly the blood flow of large-scale wound, avoids the situation because of burst to cause massive blood loss, for chance and time are won in the rescue in later stage and treatment.
In the present invention, efficiently solve two technical barriers, one is utilize absorbable sponge to carry out absorbing blood, and the release of the thrombin in sponge plays Blood clotting.Two is utilize the Biodegradable material such as gelatin, chitosan and thrombin to be cross-linked, and significantly improves the stability of thrombin, ensure that rapid haemostatic effect.
Summary of the invention
Thrombin is a kind of serine protease, is also the main effects protease in blood coagulation cascade reaction, shows the characteristic of coagulant and anticoagulant.When circulation thrombin contacts with tissue factor at the extravascular tissue exposed, thrombin can be assembled organizationally.Thrombin is by activating platelet, and catalysis fibre proteinogen is converted into fibrin, promotes that clot is stablized and have central role in the initiation and propagation of thrombotic disease.But the poor stability of thrombin is all now with the current during general its clinical hemostasis of application, or and other drug and apparatus with the use of.
The present invention is applied to the quick-acting haemostatic powder patch of sudden large-scale, dark type wound, contains four parts, substrate layer, laying, adhesive-layer and spongy layer, and wherein spongy layer has been cross-linked the thrombin of quick-acting haemostatic powder.
Form base material of the present invention to comprise composition and comprise the material such as polyvinyl alcohol, stretch fabric, PE, PU; base material is as the support material of rapid-hardening adhesive bandage of the present invention; there is protection, protect and adhere to the effect of other material; also there is the effect of protection wound simultaneously; there is certain intensity; and there is the effects such as ventilative, moisturizing.From the selection of base material, stretch fabric type adhesive bandage is the leading products of Chinese market.
The adhesive glue that adhesive-layer of the present invention adopts is PUR, acrylate glue, zinc oxide and transparent adhesive tape, and these glue can according to certain ratio and kind allotment according to heterogeneity.
Base material and the biodegradable sponge being cross-linked thrombin can be handing-over, bonds and be connected.
As the material forming adhesive linkage, do not limit especially, can list such as: propylene class bonding agent, silicone based bonding agent, polyurethanes bonding agent and natural rubber etc.
Selecting of adhesive-layer should connect consideration with base material, generally speaking, should consider following several factor: just glue, hold sticky, peel strength and reusability; Glue is to the zest of skin and degree of allergic reaction.The solvent borne Zinc Oxide Mucilage be commonly used at present on stretch fabric adhesive bandage is considered to the higher glue kind of irritated rate.Be widely used in the PUR on various base material at present, it not only makes production obtain environmental protection and high efficiency, also makes product obtain breathability, repetition just sticky preferably.Acrylate glue is considered to the lower glue kind of anaphylaxis, and this is brood lac has embodied excellent performance on the good base material of pliability: as non-woven fabrics, stretch fabric etc.
Laying is the layer that various sponge carries out protecting etc. function.Can use as laying and weave cotton cloth or bonded fabric etc. or the high-molecular gel etc. containing water or oily composition.In addition, as weaving cotton cloth or the constituent material of bonded fabric, can list such as: staple fibre, polyethylene, polypropylene, polyolefin, alginate etc., one wherein or two or more combination can be used.Polyethylene non-woven is weaved cotton cloth, polyolefin film, mylar etc.
The sponge material of preparation containing thrombin can be gelatin, polyvinyl alcohol, the macromolecular material such as chitosan and collagen protein material, these materials all have the characteristic forming sponge under certain condition and combination, slightly different according to technique prepared by the difference of molecular weight, source, the degree of polymerization.
Thrombin adds after cross-linking agent adds, its consumption is larger, blood coagulation speed is faster, the thrombin added is fixed to the inside and on the surface of biodegradable sponge under the effect of cross-linking agent, this crosslinked action significantly improves the stability of thrombin, thrombin is linked to various gelfoam, in polyvinylalcohol sponge and chitosan sponge, these sponges can absorb the blood of weight tens times own, and fixing thrombin wherein can be discharged, activate the Fibrinogen in blood, these Fibrinogens can not only blood coagulation adhered to one another, and the fiber that can depend on sponge makes blood flow quick solidification, several so heavy coagulation process combination makes blood coagulation speed faster.
Chitosan also has antibacterial function due to the sponge of the crosslinked thrombin that its special structure is made.
These degradable sponges are prepared by such mode: get sponge material chitosan, polyvinyl alcohol or gelatin appropriate, add appropriate water, heated and stirred makes chitosan, polyvinyl alcohol or gelatin all be dissolved into a kind of glue at a certain temperature.Add thrombin and cross-linking agent held for some time in certain temperature water bath is cross-linked.After insulation terminates, while blast a small amount of air limit agitator rapid stirring in solution.After complete soln foam generated, pour in mould.Lyophilization immediately, by moisture removal.To prepare the biodegradable sponge being cross-linked thrombin, these sponges can cut into the block of suitable size or shape.
The sponge of the crosslinked thrombin of preparation is adopted various different binding agent, and be bonded on base material, its thickness and size adjust as required.Also to be directly attached on the base material of patch by sponge, slightly poor to the effect for the treatment of and protection like this, the quantity of degradable sponge can paste one piece as required, also can at the repeat sticking again a piece of sponge.
In the crosslinked thrombin sponge process of preparation, gelatin viscosity is extremely important to the quality forming sponge, the weight ratio of collagen protein, chitosan, polyvinyl alcohol or gelatin and water controls between 1: 3-1: 30, preferred ratio is at 1: 8: 1: 15 (w/vs, g/ml) between, preferred part by weight is between 1: 10-1: 15 (w/v, g/ml).
The temperature of glue is in the present invention for different sponge material, and required temperature does not need obvious control, and in general gelatin and chitosan are at about 60 DEG C, and polyvinyl alcohol changes greatly according to the difference of molecule.
Adding of thrombin can be each step in whole process, for to heat-labile thrombin, temperature is more low to be more conducive to it and to stablize, so enzyme thrombin of the present invention adopts is add after adding cross-linking agent cooling again, adds when glue is cooled to 30-40 DEG C.
The cross-linking agent adopted in the present invention is the mixed liquor of formaldehyde or glutaraldehyde solution or its arbitrary proportion, and the volume ratio of glue is 1: 2-1: 30, and preferred volume ratio is 1: 10-1: 15.The preparation of formaldehyde and pentanediol is mainly and all water, suitably adds appropriate organic solvent such as ethanol, methanol etc. and likely plays better effect.
Crosslinking temperature is particularly important in the present invention, in the present invention, sponge material should be made to be cross-linked, make protease and sponge material be cross-linked again, it is suitable that temperature controls at 15-45 DEG C, and temperature is lower, crosslinked process can be slower, usually crosslinked time controling is advisable at about 1h, and in this law invention, preferred temperature is 25-40 DEG C, more preferred temperature is 32-38 DEG C.
Concentration, the kind of crosslinked time and temperature and cross-linking agent are relevant, when the concentration of cross-linking agent is low, and can time of being cross-linked of proper extension.
By the glue agitator vigorous stirring after crosslinked, the glue containing thrombin will form foam, is loaded in appropriate container by foam, puts into freezer dryer or refrigerator and cooled is frozen.After rear employing lyophilizing or oven drying at low temperature or the mode of drying remove moisture, crosslinked have the biodegradable sponge of thrombin just to prepare molding.
Sponge containing thrombin can be cut into different size, thickness, the block of shape as required, sponge is bonded on base material and just can use.
Also sponge powder of can being demoted by the biology being cross-linked thrombin is as required broken into granule or the block of different size; for very dark or wide wound; directly this powder is poured in wound; carry out again wrapping up, oppressing process; there is better haemostatic effect; due to the material that these materials are all biocompatibility, can be organized for protease or other enzyme hydrolysiss in vivo and be absorbed gradually.
Clotting assay is investigated test tube method blood coagulation and is investigated and respectively 2ml venous blood is injected 5 groups of getting ready and (be respectively matched group, gelatin foam group, collagen protein sponge group, thrombin gelatin foam group and thrombin collagen protein sponge group) in 20 test tubes, put into 37 DEG C of constant water bath box immediately, observe, pipe will be moved after 1min and tilt 45 degree gently, observe blood and whether solidify.Then observe 1 time every 15s, till in vitro blood does not flow, the required time is clotting time.Relatively clotting time.Crosslinked thrombin gelfoam and crosslinked thrombin collagen protein sponge are sponge prepared by embodiment 1 and 2.Result can be found out, the gelfoam bleeding stopping period of crosslinked thrombin is 1/4 of matched group.The bleeding stopping period of crosslinked thrombin gelfoam will faster than crosslinked thrombin collagen protein sponge.
The blood coagulation comparative experiments of table 1. gelfoam
| Kind | Contrast | Gelfoam | Crosslinked thrombin gelfoam |
| Time (minute) | 8.19±0.11 | 4.43±0.37 | 2.31±0.27 |
The blood coagulation comparative experiments of table 2. collagen protein sponge
| Kind | Contrast | Collagen protein sponge | Crosslinked thrombin sponge |
| Time (minute) | 8.19±0.11 | 4.73±0.31 | 2.69±0.21 |
Accompanying drawing illustrates:
Fig. 1 is the structure chart of quick-acting haemostatic powder patch.
Detailed description of the invention
Embodiment 1
Take gelatin 20g, add water 200ml, in 60 DEG C of water-baths, heated and stirred makes gelatin all dissolve.Add thrombin 1000 unit and 11% formaldehyde diluent 10ml, in 35 DEG C of water-baths, be incubated about 1h (but being no more than 1h).After insulation terminates, while blast a small amount of air limit agitator rapid stirring in solution.After complete soln foam generated, pour in mould.Lyophilization immediately.Cut and get final product.The base material of well cutting, laying and the sponge containing thrombin are bondd with binding material, packaging sterilizing.
Embodiment 2
Take gelatin 20g, add water 200ml, in 60 DEG C of water-baths, heated and stirred makes gelatin all dissolve.Add thrombin 10000 unit and 6% glutaraldehyde diluent 5ml, in 35 DEG C of water-baths, be incubated about 2h.After insulation terminates, while blast a small amount of air limit agitator rapid stirring in solution.After complete soln foam generated, pour in mould.Lyophilization immediately.Cut and get final product.The base material of well cutting, laying and the sponge containing thrombin are bondd with binding material, packaging sterilizing.
Embodiment 3
Take collagen protein 20g, add water 300ml, in 60 DEG C of water-baths, heated and stirred makes gelatin all dissolve.Add thrombin 10000 unit and 11% formaldehyde diluent 10ml, in 35 DEG C of water-baths, be incubated about 1h (but being no more than 1h).After insulation terminates, while blast a small amount of air limit agitator rapid stirring in solution.After complete soln foam generated, pour in mould.Lyophilization immediately.Cut and get final product.The base material of well cutting, laying and the sponge containing thrombin are bondd with binding material, packaging sterilizing.
Embodiment 4
Take chitosan 20g, add water 250ml, in 65 DEG C of water-baths, heated and stirred makes gelatin all dissolve.Add thrombin 5000 unit and 6% formaldehyde diluent 10ml, in 35 DEG C of water-baths, be incubated about 2h.After insulation terminates, while blast a small amount of air limit agitator rapid stirring in solution.After complete soln foam generated, pour in mould.Lyophilization immediately.Cut and get final product.The base material of well cutting, laying and the sponge containing thrombin are bondd with binding material, packaging sterilizing.
Embodiment 5
Take collagen protein 10g, add water 100ml, in 60 DEG C of water-baths, heated and stirred makes gelatin all dissolve.Add thrombin 1000 unit and 11% glutaraldehyde diluent 5ml, be incubated in 35 DEG C of water-baths about 0.5 hour insulation terminate after, while blast a small amount of air limit agitator rapid stirring in solution.After complete soln foam generated, pour in mould.Lyophilization immediately.Cut and get final product.The base material of well cutting, laying and the sponge containing thrombin are bondd with binding material, packaging sterilizing.
Embodiment 6
Take gelatin 20g, add water 150ml, in 70 DEG C of water-baths, heated and stirred makes gelatin all dissolve.Add thrombin 1000 unit and 3% formaldehyde diluent 10ml, in 37 DEG C of water-baths, be incubated about 1.5h, after insulation terminates.While blast a small amount of air limit agitator rapid stirring in solution.After complete soln foam generated, pour in mould.Lyophilization immediately.Cut and get final product.The base material of well cutting, laying and the sponge containing thrombin are bondd with binding material, packaging sterilizing.
Claims (8)
1. be applied to a quick-acting haemostatic powder patch for sudden large-scale, dark type wound, at least contain three parts, substrate layer, adhesive-layer and spongy layer, wherein spongy layer has been cross-linked the thrombin of quick-acting haemostatic powder; Laying can be comprised between substrate layer and adhesive-layer.
2. quick-acting haemostatic powder patch according to claim 1, is characterized in that at described spongy layer be cross-linked thrombin.
3. quick-acting haemostatic powder patch according to claim 2, is characterized in that spongy layer has been cross-linked thrombin is prepared from by one or more the cross-linking reaction that is combined through of gelatin, collagen protein, chitosan and polyvinyl alcohol.
4. cross-linking reaction according to claim 3, wherein adopt gelatin, collagen protein, chitosan and polyvinyl alcohol one or more combination and the glue ratio prepared of water be 1: 3-1: 30 (w/vs), preferred ratio (w/v) 1: 10-1: 15.
5. cross-linking reaction according to claim 4, the cross-linking agent wherein adopted is the combination of formalin, glutaraldehyde solution or both arbitrary proportions.
6. the crosslinking temperature of cross-linking reaction according to claim 5 is 25-40 DEG C of degree, and preferred temperature is 32-38 DEG C.
7. according to claim 1,2, the spongy layer described in 3, be foam mounted box after thrombin is cross-linked freezing after, adopt the mode of lyophilizing to remove moisture.
8. the quick-acting haemostatic powder patch according to claim 1,2,3, is base material, laying and the sponge containing thrombin are bondd with the binding material of adhesive-layer, uses after packaging after sterilizing.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105816547A (en) * | 2016-03-30 | 2016-08-03 | 吴美燕 | Method for preparing band-aid unguent |
Citations (6)
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|---|---|---|---|---|
| CN2621681Y (en) * | 2003-05-07 | 2004-06-30 | 徐振彪 | Fast hemostatic bandaging material |
| CN201346260Y (en) * | 2009-01-06 | 2009-11-18 | 王纯斌 | Wound protection plaster for hemostatic sponge |
| 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 |
| CN102648985A (en) * | 2011-02-24 | 2012-08-29 | 温州中科应急急救包有限公司 | Chitosan emergent hemostasis material |
| CN102802683A (en) * | 2009-06-16 | 2012-11-28 | 巴克斯特国际公司 | Hemostatic sponge |
| CN103200971A (en) * | 2010-08-30 | 2013-07-10 | 哈佛大学校长及研究员协会 | A high strength chitin composite material and method of making |
-
2015
- 2015-10-16 CN CN201510679361.8A patent/CN105268017A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2621681Y (en) * | 2003-05-07 | 2004-06-30 | 徐振彪 | Fast hemostatic bandaging material |
| CN201346260Y (en) * | 2009-01-06 | 2009-11-18 | 王纯斌 | Wound protection plaster for hemostatic sponge |
| CN102802683A (en) * | 2009-06-16 | 2012-11-28 | 巴克斯特国际公司 | Hemostatic sponge |
| CN103200971A (en) * | 2010-08-30 | 2013-07-10 | 哈佛大学校长及研究员协会 | A high strength chitin composite material and method of making |
| CN102648985A (en) * | 2011-02-24 | 2012-08-29 | 温州中科应急急救包有限公司 | Chitosan emergent hemostasis material |
| 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 |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105816547A (en) * | 2016-03-30 | 2016-08-03 | 吴美燕 | Method for preparing band-aid unguent |
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Application publication date: 20160127 |