CN105056280A - Hemostatic material - Google Patents
Hemostatic material Download PDFInfo
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- CN105056280A CN105056280A CN201510501972.3A CN201510501972A CN105056280A CN 105056280 A CN105056280 A CN 105056280A CN 201510501972 A CN201510501972 A CN 201510501972A CN 105056280 A CN105056280 A CN 105056280A
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- China
- Prior art keywords
- hemostatic material
- hemostatic
- polyglutamic acid
- acid calcium
- absorbable hemostatic
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Abstract
The invention aims to provide a hemostatic material. The hemostatic material is made of poly glutamic acid calcium, has an excellent hemostatic property, does not rely on a body blood coagulation mechanism, is high in biocompatibility, and can be completely degraded in a body for absorption; besides, the processing, sterilization and quality control are easy during production; a base material of polyglutamic acid is a polyamino acid material obtained through microbial fermentation synthesis, the structure is controllable, the biodegradability is realized, the biocompatibility is favorable, a product forming process is simple, and the quality is easy to control; in addition, the hemostatic process of the hemostatic material is free of influence of a normal blood coagulation mechanism, and the hemostatic effect of the hemostatic material on patients who take an anticoagulant and low in platelets and complete blood cells can also be realized; moreover, the polyglutamic acid is relatively high in bioadhesion to facilitate the control of persistent bleeding of organizations, so that the hemostatic capability is relatively high.
Description
Technical field
The invention belongs to biology medical material technical field, be specifically related to a kind of hemostatic material.
Background technology
The statistical result showed of clinical practice injured or postoperative uncontrollable hemorrhage be murderous main cause, and Absorbable hemostatic material is in various surgical operation, directly can reduce body lose blood thus effectively maintain blood volume, avoid whole body blood-clotting agent to use the untoward reaction brought, thus reduce blood transfusion and operating time; Reduce and postoperatively to ooze out, reduce complication, therefore application and the research and development of Absorbable hemostatic material are just subject to the great attention of various countries' medical circle and industrial circle.The Absorbable hemostatic material gone on the market both at home and abroad at present has Fibrin Glue, gelfoam, oxidized cellulose, modified starch, microfibrillar collagen, chitosan and Sorbsan etc.Although above-mentioned hemostatic material can play certain anastalsis, still there are some problems in clinical practice.Such as, Fibrin Glue is applied comparatively extensive in clinical operation hemostasis, but fibrin glue component belongs to blood products, there is the danger of antigenicity and viral disease transmission, and its application security is subject to certain query, and cost is higher; The wound tissue adhesive force of gelfoam is poor, easily breaks and comes off, not good enough for larger its haemostatic effect hemorrhage; And microfibrillar collagen, collagen sponge etc. also with Fibrin Glue, the same heterogenous animal protein product that belongs to of gelatin, there is the danger of immunogenicity and virus disseminating; Oxidized cellulose is more loose, is absorbed fast, but may cause hemorrhage again by body, and its peracidity environment produced can cause nerve injury by a kind of diffusivity chemism; Chitosan, carboxymethyl chitosan, alginic acid, modified starch etc. belong to natural polysaccharide, and production exists the problems such as lot stability difference, Quality Control are difficult.Therefore, exploitation safety is better, and the better hemostatic material of haemostatic effect is imperative.
Summary of the invention
Object of the present invention provides a kind of hemostatic material, and namely a kind of hemostatic material using polyglutamic acid calcium to prepare, has good anthemorrhagic performance, do not rely on body clotting mechanism, and have excellent biocompatibility, in vivo degradable absorption; In addition, production is easy to processing, sterilizing and quality control.
First the present invention provides polyglutamic acid calcium preparing the application in hemostatic material,
A kind of Absorbable hemostatic material, this Absorbable hemostatic material contains polyglutamic acid calcium,
Also be added with medical accessory in above-mentioned hemostatic material, described adjuvant is preferably one or more mixing of propylene glycol, glycerol, sorbitol, mannitol, xylitol, Polyethylene Glycol;
Another aspect of the present invention provides the preparation method of this Absorbable hemostatic material, comprises the steps:
1) polyglutamic acid calcium and adjuvant are dispersed in water;
2) by step 1) the solution lyophilization that obtains, then make membrane material;
3) by step 2) namely obtain hemostatic material after the membrane material sterilizing that obtains.
In above-mentioned steps (1), described polyglutamic acid calcium and the mass ratio of water are preferably 1% ~ 12%;
Above-mentioned steps 3) in, described sterilization method optimization ethylene oxide or irradiation sterilization.
The application of Absorbable hemostatic material of the present invention in preoperative, the art of operation, in postoperative hemostasis and wound healing.
The base material polyglutamic acid that the present invention adopts is a kind of polyamino acid material obtained by fermentable synthesis, and structure-controllable, biodegradable, biocompatibility are good, and product forming technique is simple, and quality is easy to control; Secondly, the hemostasis of product does not affect by normal coagulation mechanism, still can play anastalsis to using the low patient of the patient of anticoagulant, platelet and complete blood cell; And polyglutamic acid has good bioadhesive, be conducive to the persistence oozing of blood controlling tissue, hemostatic capability is stronger.
Accompanying drawing explanation
Fig. 1: scanning electron microscope (SEM) photo of polyglutamic acid calcium hemostatic material prepared by the present invention.
Detailed description of the invention
Material prepared by the present invention has strongly hydrophilic and is mandruka structure, therefore after contacting with hemorrhage wound surface, absorbing fluid is swelling fast for energy, form high viscosity hydrocolloid, rapid and wound surface closely attaches, form effective physics shutoff, mechanicalness sealing blood vessels cut and organize wound surface, reach the object of quick-acting haemostatic powder; Meanwhile, visible component (as platelet, erythrocyte, thrombin and the fibrin etc.) enrichment of wound surface blood, and Ca in material
2+the release of ion all can accelerate the activation of the intrinsic coagulation factor, reaches auxiliary anastalsis; Material self degradation in vivo becomes aminoacid to be absorbed by the body.
Polyglutamic acid calcium used in the present invention, its molecular chemical formula is (C
10h
12o
6n
2ca)
m(C
5h
7o
3n)
n, wherein n:m=0 ~ 18; As n:m=0, Ca
2+with the mol ratio 0.5 of carboxyl; During n:m=18, Ca
2+with the mol ratio 0.05 of carboxyl.
Below in conjunction with embodiment and accompanying drawing, the present invention is described in further detail.
Embodiment 1
Take 5 grams of polyglutamic acid calcium (n:m=8, namely the mol ratio of calcium ion and polyglutamic acid carboxyl is 0.1) and 1.5 grams of glycerol, be fully dissolved in 100mL deionized water, obtain polyglutamic acid calcium/glycerol mixed solution; Polyglutamic acid calcium/glycerol mixed solution is poured in Teflon mould ,-18 DEG C of precooling 24h, then lyophilization 24h, obtain the mandruka stock of thickness 3mm; Adopt mold pressing to be depressed into the thick perforated membrane of 1mm, cut out to 3cm × 5cm specification, pack, γ ray sterilization, the mass area ratio obtaining white is 20mg/cm
2porous hemostasis material film, its stereoscan photograph is as shown in Figure 1.
Embodiment 2
Take 10 grams of polyglutamic acid calcium (n:m=3, the i.e. mol ratio 0.2 of calcium ion and polyglutamic acid carboxyl), 2 grams of glycerol and 3 grams of mannitol, be fully dissolved in 100mL deionized water, obtains polyglutamic acid calcium/glycerol/mannitol mixed solution; Polyglutamic acid calcium/glycerol/mannitol mixed solution is poured in Teflon mould ,-80 DEG C of precooling 24h, then lyophilization 24h, obtain the mandruka stock of thickness 2mm; Adopt mold pressing to be depressed into the thick perforated membrane of 0.8mm, cut out to 3cm × 5cm specification, pack, γ ray sterilization, the mass area ratio obtaining white is 15mg/cm
2porous hemostasis material film.
Embodiment 3
Take 10 grams of polyglutamic acid calcium (n:m=18, the i.e. mol ratio 0.05 of calcium ion and polyglutamic acid carboxyl), 2 grams of glycerol and 3 grams of propylene glycol, be fully dissolved in 100mL deionized water, obtains polyglutamic acid calcium/glycerol/mixed with propylene glycol solution; Polyglutamic acid calcium/glycerol/mixed with propylene glycol solution is poured in Teflon mould ,-80 DEG C of precooling 24h, then lyophilization 24h, obtain the mandruka stock of thickness 2.5mm; Adopt mold pressing to be depressed into the thick perforated membrane of 1mm, cut out to 3cm × 5cm specification, pack, γ ray sterilization, the mass area ratio obtaining white is 24mg/cm
2porous hemostasis material film.
Embodiment 4
The anthemorrhagic performance evaluation test of polyglutamic acidic group hemostatic material film.According to document [O.Murakamia, M.Yokoyamab, , H.Nishidac, Y.Tomizawac, H.Kurosawa.Asimplehemostasismodelforthequantitativeevalu ationofhydrogel-basedlocalhemostaticbiomaterialsontissue surface.ColloidsandSurfacesB:Biointerfaces, 2008] hemostasis wound animal model is set up: rat liver Hemorrhage Model, evaluation comparison polyglutamic acidic group hemostatic material film 1 (prepared by embodiment 1) respectively, the haemostatic effect of polyglutamic acidic group hemostatic material film 2 (prepared by embodiment 2) and commercial absorbable haemostatic membrane (matched group).Select SD rat (body weight is 200 scholar 20g) 36, male female half and half, be divided into 3 groups at random, often organize 12, male and female half and half.3 groups are respectively: polyglutamic acidic group hemostatic material film 1 (prepared by embodiment 1), polyglutamic acidic group hemostatic material film 2 (prepared by embodiment 2) and commercial absorbable haemostatic membrane (matched group).All animals all adopts pentobarbital sodium intraperitoneal injection of anesthesia, and dosage is 30mg/Kg.Open abdomen, blot the serum around liver and body fluid, Parafilm and load weighted gauze are placed on below lobus sinister liver, the blood that gauze flows out for absorbing liver of being wounded by stabbing, Parafilm is for preventing the body fluid beyond filter paper absorption liver outflow blood; Wound is manufactured at the right lobule liver back side with No. 12 syringe needles (i.e. 18G syringe needle), the degree of depth is about 5mm (parallel bundle two pin), hemostatic material is placed on bleeding part, starts timing simultaneously, lift the upper body of rat with hands a little, the blood oozed out is flowed rapidly on gauze.When not having blood to ooze out, and recording bleeding stopping period and amount of bleeding, the results are shown in table 1.
Table 1: Liver Damage in Rats anthemorrhagic performance evaluation test result
| Sequence number | Embodiment 1 | Embodiment 2 | Control sample |
| Bleeding stopping period (s) | 113±15 | 96±19 | 121±4 |
| Amount of bleeding (g) | 0.8747±0.1397 | 0.509±0.1991 | 1.1844±0.1748 |
Result shows: bleeding stopping period and the amount of bleeding of polyglutamic acidic group hemostatic material film are all significantly less than matched group, have better haemostatic effect.
Embodiment 5
The anti hemorrhagic healing traumatic evaluation of effect test of polyglutamic acidic group hemostatic material film.Select SD rat (body weight is 200 scholar 20g) 54, male female half and half, be divided into 3 groups at random, often organize 18, male and female half and half.3 groups are respectively: polyglutamic acidic group hemostatic material film 1 (prepared by embodiment 1), polyglutamic acidic group hemostatic material film 2 (prepared by embodiment 2) and commercial absorbable haemostatic membrane (matched group).All animals all adopts pentobarbital sodium intraperitoneal injection of anesthesia, and dosage is 30mg/Kg.Open abdomen, with operating scissors by rat lobus sinister liver liver edge Partial Resection, form the wound surface of long 1.5cm, dark 0.2cm, set up rat liver defect model.Apply material hemostasis immediately, after 3 minutes, the edge of a knife is sewed up and is closed abdomen, iodophor disinfection, and grouping is raised, and respectively puts to death 6 rats respectively at 1,2,3 week, observes animal liver damage wound healing situation.Embodiment 1 group: test 7 days, wound healing 50-60%, a small amount of tissue adhesion, has a small amount of gel-like material; Test 14 days, wound healing 70-80%, a small amount of tissue adhesion, material is degradable; Test 21 days, wound surface heals completely, a small amount of adhesion of wound surface, and material is degradable, does not observe the vestige of material.Embodiment 2 groups: test 7 days, wound healing 50-60%, a small amount of tissue adhesion, has a small amount of gel-like material; Test 14 days, wound healing 70-80%, a small amount of tissue adhesion, material is degradable; Test 21 days, wound surface heals completely, a small amount of tissue adhesion, and material is degradable, does not observe the vestige of material.Matched group: test 7 days, wound healing 30-40%, has obvious tissue adhesion, can be observed gel-like material, not degradable; Test 14 days, wound healing 50-60%, has obvious tissue adhesion, can be observed gel-like material, not degradable; Test 21 days, wound healing 80-90%, has obvious adhesions between tissues, and material is degradable, does not observe the vestige of material.
Above-described embodiment is the present invention's preferably embodiment; but embodiments of the present invention are not restricted to the described embodiments; change, the modification done under other any does not deviate from spirit of the present invention and principle, substitute, combine, simplify; all should be the substitute mode of equivalence, be included within protection scope of the present invention.
Claims (8)
1. polyglutamic acid calcium is preparing the application in hemostatic material.
2. an Absorbable hemostatic material, is characterized in that, described Absorbable hemostatic material employs polyglutamic acid calcium in preparation process.
3. an Absorbable hemostatic material, is characterized in that, described Absorbable hemostatic material includes polyglutamic acid calcium.
4. Absorbable hemostatic material as claimed in claim 3, it is characterized in that, described Absorbable hemostatic material is added with medical accessory.
5. Absorbable hemostatic material as claimed in claim 4, is characterized in that, described adjuvant be propylene glycol, glycerol, sorbitol, mannitol, xylitol, Polyethylene Glycol one or more.
6. the preparation method of Absorbable hemostatic material according to claim 4, comprises the steps:
1) polyglutamic acid calcium and adjuvant are dispersed in water;
2) by step 1) the solution lyophilization that obtains, then make membrane material;
3) by step 2) namely obtain hemostatic material after the membrane material sterilizing that obtains.
7. method as claimed in claim 6, is characterized in that, described step 1) in the mass ratio of polyglutamic acid calcium and water be 1% ~ 12%.
8. method as claimed in claim 6, is characterized in that, described step 3) in sterilization method be ethylene oxide sterilizing or irradiation sterilization.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510501972.3A CN105056280A (en) | 2015-08-17 | 2015-08-17 | Hemostatic material |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510501972.3A CN105056280A (en) | 2015-08-17 | 2015-08-17 | Hemostatic material |
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Family
ID=54485939
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106139236A (en) * | 2016-08-17 | 2016-11-23 | 林春梅 | A kind of absorbable medical hemostatic material and preparation technology thereof |
| CN107243086A (en) * | 2017-06-06 | 2017-10-13 | 广西达庆生物科技股份有限公司 | A kind of absorbable compound hemostatic powder and preparation method thereof |
| CN109045345A (en) * | 2018-08-29 | 2018-12-21 | 佛山市森昂生物科技有限公司 | A kind of biological hemostatic powder and preparation method thereof |
| EP3446719A4 (en) * | 2016-04-20 | 2019-12-18 | Nipro Corporation | Sheet-like hemostatic material employing poly- -glutamic acid, and method of manufacturing same |
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| CN103083711A (en) * | 2013-01-11 | 2013-05-08 | 浙江三创生物科技有限公司 | Chitosan-iodine composite biological medical film and preparation method thereof |
| CN202982400U (en) * | 2012-11-20 | 2013-06-12 | 浙江三创生物科技有限公司 | Three-layer self-adhesion-type composite biological dressing |
| CN103467772A (en) * | 2013-09-12 | 2013-12-25 | 中国人民武装警察部队后勤学院 | Chitosan/gamma-polyglutamic acid polyelectrolyte sponge as well as preparation method and application thereof |
| US8932560B2 (en) * | 2007-09-04 | 2015-01-13 | University of Maryland, College Parke | Advanced functional biocompatible polymeric matrix used as a hemostatic agent and system for damaged tissues and cells |
-
2015
- 2015-08-17 CN CN201510501972.3A patent/CN105056280A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8932560B2 (en) * | 2007-09-04 | 2015-01-13 | University of Maryland, College Parke | Advanced functional biocompatible polymeric matrix used as a hemostatic agent and system for damaged tissues and cells |
| CN202982400U (en) * | 2012-11-20 | 2013-06-12 | 浙江三创生物科技有限公司 | Three-layer self-adhesion-type composite biological dressing |
| CN103083711A (en) * | 2013-01-11 | 2013-05-08 | 浙江三创生物科技有限公司 | Chitosan-iodine composite biological medical film and preparation method thereof |
| CN103467772A (en) * | 2013-09-12 | 2013-12-25 | 中国人民武装警察部队后勤学院 | Chitosan/gamma-polyglutamic acid polyelectrolyte sponge as well as preparation method and application thereof |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3446719A4 (en) * | 2016-04-20 | 2019-12-18 | Nipro Corporation | Sheet-like hemostatic material employing poly- -glutamic acid, and method of manufacturing same |
| EP3733218A1 (en) | 2016-04-20 | 2020-11-04 | Nipro Corporation | Sheet-like hemostatic material employing poly-y-glutamic acid, and method of manufacturing same |
| CN106139236A (en) * | 2016-08-17 | 2016-11-23 | 林春梅 | A kind of absorbable medical hemostatic material and preparation technology thereof |
| CN107243086A (en) * | 2017-06-06 | 2017-10-13 | 广西达庆生物科技股份有限公司 | A kind of absorbable compound hemostatic powder and preparation method thereof |
| CN109045345A (en) * | 2018-08-29 | 2018-12-21 | 佛山市森昂生物科技有限公司 | A kind of biological hemostatic powder and preparation method thereof |
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Application publication date: 20151118 |