CN106535946A - Polymer foam composition, method for preparing polymer foam composition using same, and polymer foam for packing - Google Patents
Polymer foam composition, method for preparing polymer foam composition using same, and polymer foam for packing Download PDFInfo
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- CN106535946A CN106535946A CN201580038810.9A CN201580038810A CN106535946A CN 106535946 A CN106535946 A CN 106535946A CN 201580038810 A CN201580038810 A CN 201580038810A CN 106535946 A CN106535946 A CN 106535946A
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- foam
- polymers
- polymer foam
- weight
- ossein
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive plasters or dressings
- A61F13/0203—Adhesive plasters or dressings having a fluid handling member
- A61F13/0223—Adhesive plasters or dressings having a fluid handling member characterized by parametric properties of the fluid handling layer, e.g. absorbency, wicking capacity, liquid distribution
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive plasters or dressings
-
- 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
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/28—Polysaccharides or their derivatives
-
- 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
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/32—Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
-
- 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
Abstract
The present invention relates to a polymer foam composition, a method for preparing a polymer foam using the same, and a polymer foam for packing obtained from the same. More specifically, by providing a polymer foam composition capable of giving a high moisture absorption rate on the basis of three components of collagen, a hyaluronic acid derivative, and carboxymethylcellulose, and a polymer foam using the same, the present invention can offer an anti-adhesive effect to a wound while offering a dual haemostatic effect of a first haemostatic effect of collagen itself when applied to a wound face in the paranasal sinuses or the nasal cavity and a second haemostatic effect by the pressure due to absorption and expansion of body fluid and blood.
Description
Technical field
The present invention relates to polymer foam composition, the foam of polymers manufacture method using said composition and be derived from
Wrapping foam of polymers, more specifically, the polymer foam composition be based on ossein, hyaluronic acid derivant and carboxymethyl
3 kinds of compositions of cellulose and high water absorbing capacity can be provided；The foam of polymers manufacture method provides polymerization by using said composition
Thing foam, when the foam of polymers is applied to paranasal sinusess or nasal cavity wound face, in 1 haemostatic effect of ossein itself
On the basis of, additionally it is possible to 2 haemostatic effects are obtained by due to absorbing the compressing for expanding and causing after body fluid and blood, so as to
Double-hemostasis function effect is provided, while the preventing adhesiving effect to wound can be provided.
Background technology
Generally after paranasal sinusess or operation in nasal cavity, in order to stop blooding using kpetrolatum gauze or wound covering material.It is known
Although this thin grid can control bleeding, frequently adhesion of nasal cavity can be caused, be drawn when exchanging in gauze or wound covering material
Play the severe pain of patient.In order to overcome this problem, it is developed recently the special wrapping product of paranasal sinusess to sell.
The conventional method of apoplexy due to endogenous wind of planting of nasal cavity wrapping is the use of gauze or kpetrolatum gauze, is developed except snuffing recently
The property received PVA (polyvinylacetate sponge (polyvinyl acetate sponge),), as biological decomposition close
Into material polyurethane (copolyether ester polyurethane (co-polyether-ester urethane),) and conduct
The hyaluronic acid of biological decomposition natural materialBased on product and sell.
The feature of preferable wrapper material is excellent haemostatic effect, prevents the generation of excessive sludged blood, will also maintain
The space of nasothurbinal, epithelium regeneration promote and put that adhesion effect is excellent, and most important of which is that makes the sense of discomfort of patient most
Littleization.
Especially, the most necessary condition of wrapper material is anthemorrhagic performance.When postoperative hemorrhage is uncontrollable, patient has danger
Danger, the blood of outflow form sludged blood, and sludged blood causes wound adhesion and tissue closing.The space of nasothurbinal maintains to pass through
Till physical method lasts till mucosa regeneration, if realizing that tissue can occur if space maintains closes, so as to will be again
Performed the operation.Wrapping will be removed after epithelium regeneration, now if wrapper material and tissue adhesion, induce epithelium damage again and
Bleeding, so that postpone regeneration, induction pain.
Up to the present the wrapping product major part developed is the hemostatic article oppressed by physics.Actually sometimes
Using hemorrhage as wrapper material, although common hemorrhage anthemorrhagic performance is excellent, there is induction wound adhesion, form granulation
Swollen problem.For Nondegradable PVA products, it is known that need to remove, pain and bleeding is induced during removal, is induced when remaining
Chronic inflammatory disease.For biological degradability synthetic material, with catabolite is toxic, the too fast degraded before wound regeneration
Problem.In order to overcome these shortcomings, be developed and utilize using the product of natural material hyaluronic acid derivant, but exist due to
Physical property it is bad and cannot hemostasis by compression, overall performance difference the problems such as.
By the way, hyaluronic acid (Hyaluronic acid) 1934 by Meyer and Palmer in vitreous body of eye
Found in liquid (vitreous humor) first, which is long-chain linear polysaccharide class, the biopolymerization being widespread in nature
Thing.Hyaluronic acid is dissolved in water and forms the very high liquid of viscosity, has 10 according to its source3～107The molecule of dalton (dalton)
The high molecular weight polysaccharide class of amount.Hyaluronic acid is due to its excellent biocompatibility and the spy of biological degradability and preventing tissue adhesion
Property and be mainly utilized as anti-blocking agent.Hyaluronic acid product is soluble in the moisture such as blood, body fluid, so as to have developed itself and diethyl
Thiazolinyl sulfone, diepoxidess or formaldehyde are crosslinked and are improved insoluble method.
Additionally, ossein as with low antigenicity, haemostatic effect, excellent tissue regeneration effect biomaterial, extensively
It is general for medical treatment.The product of commercialization at present has hemorrhage, wound covering material, bone grafting material, beauty and shaping graft materials
With stitching thread etc..Known ossein is the reticuloprotein matter for promoting platelet aggregation and activity, makes platelet when blood flows out
Rapid attachment, dispersion and activation, so as to promote hematoblastic coagulation, promote the activity of blooc coagulation factor XII.
Furthermore, the carboxymethyl cellulose for the hydroxyl for constituting the glucose of cellulose being substituted by carboxymethyl and being formed
Also in the medical field with uses of many uses such as anti-blocking agent, wound covering, hemorrhages.Carboxymethyl cellulose is also hydrophilic
Property and be dissolved in water, so as to have the problem for being unable to maintain that shape.In order to increase the insoluble of carboxymethyl cellulose and by its with it is poly-
Acrylate copolymer mixes and is crosslinked the method for (PCT/US1995/006860) and was also disclosed.
In order to overcome above-mentioned these shortcomings, in the urgent need to exploitation is a kind of using on the basis of natural material, strengthen physical property
Especially it is capable of the wrapper material of hemostasis by compression.
The content of the invention
Goal of the invention
In order to overcome the problems referred to above, the present inventor during wholwe-hearted research is continued, find based on ossein,
3 kinds of compositions of hyaluronic acid and carboxymethyl cellulose mix the foam of polymers obtained with crosslinking Treatment in the proper ratio and can carry
For excellent compressive strength and DE, and on the basis of 1 haemostatic effect of ossein itself, additionally it is possible to by due to inhaling
Expand after acceptor liquid and blood and the compressing that causes obtaining 2 haemostatic effects, while the anti to wound can be provided imitating
Really, so as to completing the present invention.
I.e. it is an object of the invention to provide one kind is based on ossein, 3 kinds of compositions of hyaluronic acid and carboxymethyl cellulose
And the polymer foam composition of high water absorbing capacity can be provided；The manufacture method of the foam of polymers, which is by using the combination
Thing provides foam of polymers, when the foam of polymers is applied to paranasal sinusess or nasal cavity wound face, the 1 of ossein itself
On the basis of secondary haemostatic effect, additionally it is possible to only obtain 2 times by due to absorbing the compressing for expanding and causing after body fluid and blood
Blood effect, so as to provide double-hemostasis function effect, while the preventing adhesiving effect to wound can be provided；And thus obtained wrapping is used
Foam of polymers.
Technical scheme
A kind of polymer foam composition is provided according to the present invention, which includes ossein, hyaluronic acid and carboxymethyl cellulose
As effective ingredient, and the cross-linking compound comprising the effective ingredient, wherein, moisture content is 90～99%.
Additionally, providing a kind of manufacture method of foam of polymers according to the present invention, the method includes：Steeped with above-mentioned polymer
Foam compositionss are initial substance, Jing after multistage lyophilization, prepare polymer bubble by high temperature heat cross-linking and pressurization operation
Foam.
Additionally, providing a kind of wrapping foam of polymers according to the present invention, which is obtained by said method, and which is to physiology salt
The trap of water is 10g/g, and the compressive strength in 0.5Hz determined with flow graph (rheometer) is more than 0.1N, DE
For more than 1000pa, with non-compressing haemostatic properties.
Additionally, providing a kind of manufacture method of foam of polymers according to the present invention, the method includes：Steeped with above-mentioned polymer
Foam compositionss are initial substance, manufacture foam of polymers by natural drying or heated drying.
Invention effect
Foam of polymers constructed in accordance, has higher trap and compression strong under conditions of moisture is present
Degree expansion rate, during as nasal cavity and ear or other insert type wound coverings, absorbs body fluid and blood, with based on osseocolla
Former hemostasis and the double-hemostasis function effect based on compressing, wound adhesion of getting along well, so that provide preventing adhesiving effect.
Description of the drawings
Fig. 1 is the foam photo of method manufacture constructed in accordance, and left side is that the wrapping of drying regime is steeped with polymer
Foam photo, right side are the wrapping foam of polymers of swelling state after absorption moisture.
Fig. 2 is that the electron scanning micrograph of the wrapping foam of polymers of method manufacture constructed in accordance is (left
Side up and down × 100, right side up and down × 200).
Fig. 3 is wrapping foam of polymers, comparative example 1 to 5 and the additional embodiment of according to embodiments of the present invention 1,2 manufactures
1st, the 2 wrapping respective contrast photo absorbed after moisture of foam of polymers.
Fig. 4 is that the figure of the degraded by collagenase experimental result for illustrating the sample manufactured according to embodiment 1 and comparative example 3 is general.
Fig. 5 is the photo of the propensity for degradation after illustrating the degraded by collagenase experiment according to the sample of the manufacture of embodiment 1.
Fig. 6 is the contrast collection of illustrative plates according to the sample of the manufacture of embodiment 1 and the whole blood coagulation experimental result of comparable group.
Fig. 7 is the hepatectomy hemostasis experimental result contrast collection of illustrative plates of the sample according to the manufacture of embodiment 1 and comparable group.
Fig. 8 is the hepatic portal vein hemostasis experimental result contrast collection of illustrative plates of the sample according to the manufacture of embodiment 1 and comparable group.
Fig. 9 is the contrast photo detected by an unaided eye according to the sample of the manufacture of embodiment 1 and the wound healing result of comparable group.
Figure 10 is the tissue staining contrast photo of the wound healing result of the sample and comparable group according to the manufacture of embodiment 1.
Specific embodiment
Describe the present invention below in conjunction with the accompanying drawings in detail.
The polymer foam composition of the present invention, comprising ossein, hyaluronic acid and carboxymethyl cellulose as effective ingredient,
And the cross-linking compound comprising the effective ingredient, wherein moisture content are 90～99%.
Term " wrapping foam of polymers " used in the present invention is referred in order to outer in the case where not having other restrictions
Section performs the operation and after being cut, inserts in the tissue at above-mentioned surgical incision position, and sutures the polymer used during incision site
Foam.
As one of above-mentioned tissue, including skin histology and ear interior tissue etc. need elasticity tissue, also including ear,
The institute with the space for needing compressive strength and elasticity simultaneously such as eye and nose is in a organized way.
The ossein is to extract from the mammals such as cattle, pig (except human body) or therapeutic medical, can be selected from osseocolla
It is former, go atelocollagen albumen, de- cell process tissue (from skin, heart fascia, bone, cartilage, tela submucosa intestini tenuis, amniotic membrane and
Soft tissue) and gelatin in more than a kind.
The weight average molecular weight (Mw) of the hyaluronic acid can be 1000000～8000000g/mol, or 1000000～
3000000g/mol。
The weight average molecular weight (Mw) of the carboxymethyl cellulose can for 1000～100000g/mol or 5000～
50000g/mol。
The polymer foam composition is can further include as needed selected from carboxyethyl cellulose, hydroxylmethyl cellulose
Element, alginic acid, alginate, chitin, shitosan, dextran, glycogen, starch, colloid and such as heparin, heparin sulfate, sulfur
The carboxylated polysaccharide class of more than a kind in the mucopolysaccharides such as aching and limp ossein.As one its can be constituting polymer foam composition
Assembly be divided into 100 weight portions, its content is in the range of 5～100 weight portions.
Used as one, the effective ingredient is in total 100 weight % being made up of ossein, hyaluronic acid and carboxymethyl cellulose
In, comprising 20～99 weight % of ossein, 0.5～50 weight % of 0.5～30 weight % of hyaluronic acid and carboxymethyl cellulose, here
In the range of can adjust the physical property such as swelling capacity, compressive strength and the DE of the foam and degradation time as needed.
Used as a concrete example, the effective ingredient is in total 100 weight being made up of ossein, hyaluronic acid and carboxymethyl cellulose
In amount %, comprising 20～80 weight % of ossein, 20～40 weight % of 1～25 weight % of hyaluronic acid and carboxymethyl cellulose.
Used as another example, the effective ingredient is in total 100 weight being made up of ossein, hyaluronic acid and carboxymethyl cellulose
In amount %, comprising 30～80 weight % of ossein, 20～35 weight % of 2.5～25 weight % of hyaluronic acid and carboxymethyl cellulose.
Used as one, the moisture content (moisture after mixing) of the effective ingredient is 90～99%, or 95～98%,
The physical property such as swelling capacity, compressive strength and the DE of the foam and degradation time are adjusted in the range of this as needed can.
Used as one, the weight average molecular weight (Mw) of the hyaluronic acid is 10000～3000000g/mol, can be according to combination
The molecular weight of species, is manufactured into variable concentrations.
The ossein can be extracted from the mammals such as cattle, pig (in addition to people) or therapeutic medical, used as one
Can be that the de- cells of the tissue Jing for extracting are processed.
As one, the tissue can be selected from skin, heart fascia, bone, cartilage, tela submucosa intestini tenuis, amniotic membrane and
One kind in soft tissue.
In order to the de- cell is processed, it is possible to use de- cell inorganic agent.
As one, the de- cell inorganic agent with alkali and polar solvent as substrate, can to extract tissue in exempt from
Epidemic disease and foreign body reaction evocating substance play a part of once to remove.
Used as one, the alkali can be by sodium hydroxide, calcium hydroxide, ammonium hydroxide, Calcium Carbonate, magnesium hydroxide, hydrogen-oxygen
More than a kind selected in changing calcium and ammonia is used with the concentration range of 0.01～1M.
Used as concrete example, the alkali can be using the sodium hydrate aqueous solution of 0.4～0.6M.
As one, the polar solvent can using in 10～100% concentration ranges selected from carbon number 1～4
More than a kind in alcohol.
Used as concrete example, the polar solvent can be the ethanol water of 50～80 weight %.
The alkali and polar solvent can with 0.1～1M concentration, 1:9～9:1 ratio range is used.
As needed in the de- cell before processing, can be with more than a kind polarity in the alcohol of carbon number 1～4
Solvent carries out pretreatment.
Used as one, the total operation processed comprising the pretreatment and de- cell can be proceeded as follows.
That is, skin corium (first stage) is separated from biological tissue by physical method；Will be detached skin corium molten with polarity
Agent carries out pretreatment (second stage)；The pretreatment thing is processed into (phase III) using above-mentioned de- cell inorganic agent；
After the de- cell processed material washing for obtaining, the pH (fourth stage) needed for being adjusted to using acid.
Specifically, by the first stage, the skin corium of 100 μm～2mm thickness is isolated from epidermal area；By described
Second stage, using one or more of the alcohol selected from carbon number 1～4 polar solvent of 10～100% concentration, process 1～
72 hours；In the phase III, the sodium hydroxide of ethanol and 0.4～0.6M of the cell inorganic agent using 50～80 weight % is taken off
Compatibility；In the fourth stage, using more than a kind in hydrochloric acid, sulphuric acid, peracetic acid, acetic acid etc., pH regulator is 2～
10。
Now, the second stage can be carried out at a temperature of 0～37 DEG C under physical agitation to fourth stage.
Additionally, used as one, the cross-linking compound can be using selected from polyacrylic acid, polyvinyl alcohol, polyethylene pyrrole
More than a kind in pyridine, polyacrylamide and polyethylene glycol oxide, with constitute the ossein of polymer foam composition, hyaluronic acid and
The total content of carboxymethyl cellulose is 100 weight portions, can be put in the range of 0.01～10 weight portion, or 0.05～1 weight portion
The cross-linking compound, can adjust swelling capacity, compressive strength and the DE of the foam within this range as needed
Etc. physical property and degradation time.
As one, the manufacture method of the foam of polymers of the present invention, it is characterised in that combined with the foam of polymers
Thing is initial substance, Jing after multistage lyophilization, manufactures foam of polymers by high temperature heat cross-linking and pressurization operation.
Used as one, the multistage lyophilization can be dried by IQF below 0 DEG C or at -40～0 DEG C
First stage be dried and the slow lyophilization in freezer dryer with 10mmHg pressure below at -40～-20 DEG C
Second stage be dried performing.By above-mentioned multistage lyophilization, can adjust as needed the foam swelling capacity,
The physical property such as compressive strength and DE and degradation time.
As one, the high temperature heat cross-linking can be cross-linking compounds are put into after, at 80～200 DEG C, or 100～
The rapidly heat cross-linking of about 1 hour or so at 180 DEG C, is carried out, by said method, the swollen of the foam can be adjusted as needed
The physical property such as humidity, compressive strength and DE and degradation time.
As one, it is possible to use forcing press carries out the pressurization operation under 1000～5000Psi pressure, in this scope
It is interior to adjust the physical property such as swelling capacity, compressive strength and the DE of the foam and degradation time as needed.
In the present invention, foam of polymers is obtained in that by methods described, the foam of polymers is to normal saline
Trap is more than 10g/g, and the compressive strength in 0.5Hz determined with flow graph (rheometer) is more than 0.1N, DE
For more than 1000pa, with non-compressing haemostatic properties.
Term " non-compressing haemostatic properties " used in the present invention, in the case where being not particularly limited, is referred to
Haemostatic properties can be also provided when urgent.
Additionally, also having the property that：There is to moisture stability, and can suitably absorb transudate, thickness swelling
For more than 200%.
Additionally, spongiform foam of polymers of the invention has high-selenium corn power and can quickly absorb oozing for wound
Go out thing and blood etc., haemostatic effect to non-compressing, the Compressive Hemostasis of elasticity and compressive strength, Wound healing and prevent from gluing
Company provides help.And the spongiform foam of polymers is inserted into nasal cavity or in ear portion, elasticity and compressive strength is maintained,
Will not depart from from corresponding site, therefore, it is possible to the adhesion for preventing affected part from occurring.Additionally, forming physical barriers within a certain period of time
(barrier), can just degrade and can remove by body absorption or artificially through certain hour.
Additionally, the wrapping is as it appears from the above, can need elasticity to skin histology and ear interior tissue etc. as one
Tissue simultaneously needed with gill, eye and nose etc. compressive strength and elasticity the tissue with space wrapping, as concrete example
It can be the wrapping to paranasal sinusess or nasal cavity.
In the present invention, in addition to cryodesiccated method of above-mentioned multistage, can be with the foam of polymers group
Compound is initial substance, by natural drying or heated drying, manufactures polymeric foam.
The foam of polymers provided by the method can be film type or block type.
Thus the film type or bulk polymer foam for providing goes for paranasal sinusess operation or surgery of nasal cavity and middle ear
Inflammation is postoperative to stop blooding and for the dressing of Wound protection.
Below, preferred embodiment is shown in order to help to understand the present invention, but these embodiments is only used for illustrating, this area
Technical staff is it is clear that can carry out numerous variations and revision, these change in the range of the scope of the present invention and technological thought
Also naturally belong to the scope of appended claims with revision.
<Embodiment 1>
As initial substance, by ossein (extracting from Corii Sus domestica) 45 weight %, hyaluronic acid (Shiseido Sodium
Hyaluronate, Mw 1300000g/mol, Shiseido company) 45 weight % of 10 weight % and carboxymethyl cellulose (CMC,
Mw 10000g/mol, CP KELCO companies) mixing.
Polyacrylic acid is used now as cross-linking compound, with the ossein, hyaluronic acid and carboxymethyl cellulose
Total content is 100 weight portions, comprising 0.1 weight portion.
With in the raw material of above-mentioned condition mixing purified water is added to cause drying solid composition as 4% (that is, above-mentioned three components
Effective ingredient moisture content for 96%), then with homogenizing stirring instrument mixing.Obtained aqueous solution in -40～0 DEG C of IQF,
Then in freeze drier (FVTFD 50R, ilsinbiobase company, Korea), at a temperature of -40～20 DEG C, with
10mmHg pressure below, slow lyophilization 2 days.
Cryodesiccated spongy foam in high temperature roaster, at 120 DEG C heat cross-linking 1 hour afterwards, in a press
Pressurizeed with 2000Psi, so as to be prepared for wrapping foam of polymers.
The wrapping obtained with the method manufacture of embodiment 1 is shown in Figure 1 with foam of polymers.As with reference to left side in Fig. 1
For the wrapping polymeric foam photo of drying regime, right side be absorb moisture after the wrapping of swelling state shone with foam of polymers
Piece.
Additionally, the scanning electron microscope of the foam of polymers of embodiment 1 (each multiplying power is × 100, × the table that 200) determines
Face and cross-section photograph figure 2 illustrates respectively.As shown in Fig. 2 can confirm that the porous form of open architecture.
<Embodiment 2>
Except as initial substance, by ossein (extracting from Corii Sus domestica) 50 weight %, 25 weight % of hyaluronic acid and carboxylic first
Outside the mixing of 25 weight % of base cellulose, repetition has manufactured wrapping foam of polymers with 1 identical operation of above-described embodiment.
<Comparative example 1>
Cross-linking compound polyacrylic acid is not put into, the heat cross-linking to cryodesiccated spongy foam is eliminated in addition
Operation, and pressurizeed with 2000psi in a press, in addition repeatedly 1 identical operation of above-described embodiment has manufactured wrapping use
Foam of polymers.
<Comparative example 2>
In addition to 0 weight % of ossein, 75 weight % of hyaluronic acid and 25 weight % of carboxymethyl cellulose are mixed, repeat
Wrapping foam of polymers has been manufactured with 1 identical operation of above-described embodiment.
<Comparative example 3>
Except being 2% (that is, the effective ingredient moisture content of described 3 kinds of compositions by the drying solid constituent adjustment of mixed material
Outside 98%), repetition has manufactured wrapping foam of polymers with 1 identical operation of above-described embodiment.
<Comparative example 4>
(carry out heat cross-linking without lyophilization operation) in addition to not carrying out lyophilization operation, repeat with it is above-mentioned
1 identical operation of embodiment has manufactured wrapping foam of polymers.
<Comparative example 5>
Cryodesiccated spongy foam not heat cross-linking 1 hour at 120 DEG C, is directly added with 2000psi in a press
Pressure, in addition repeats to have manufactured wrapping foam of polymers with 1 identical operation of above-described embodiment.
<Additional experimental example 1>
Except Corii Sus domestica is carried out after de- cell is processed in addition to use by ossein as initial substance as follows, weight
Multiple and 1 identical operation of above-described embodiment has manufactured wrapping foam of polymers.
That is, from pig bio-tissue, the skin corium that epidermal area physical separation thickness is 100 μm～2mm, concentration is 10
～100% more than a kind polar solvent in the alcohol of carbon number 1～4, to carrying out pre- place under detached skin corium room temperature
Reason 1～72 hour.
Using compatibility, the de- cell inorganic agent of 50～80% ethanol and 0.4～06.M sodium hydroxide is processed at normal temperatures
State pretreatment thing, wash after the de- cell processed material for being obtained using a kind in hydrochloric acid, sulphuric acid, peracetic acid, acetic acid etc. with
On, it is 2～10 to adjust pH at normal temperatures.
<Additional experimental example 2>
By cryodesiccated spongy foam, at 120 DEG C, the heat cross-linking of 1 hour is replaced with and is dried 24 with 60 DEG C of drying bakers
Hour, then pressurizeed with 2000psi in a press, in addition repeat bag have been manufactured with 1 identical operation of above-described embodiment
Bundle foam of polymers.
Above-described embodiment 1～2, comparative example 1～5 and supplementary test example 1～2 are tested respectively as follows, and is compared
As a result.
<Test example 1：Trap is analyzed>
The absorbance of the foam of polymers of acquisition is determined as follows, and is illustrated in table 1 and Fig. 2.
Absorbance is determined by the following method：Weighed after the dry weight of each corpse or other object for laboratory examination and chemical testing respectively, be put into 100ml beakers, added
The normal saline of 50ml, places 5 minutes.A corpse or other object for laboratory examination and chemical testing is taken out after 5 minutes and is weighed.Trap is calculated according to the following formula.
[formula 1]
Corpse or other object for laboratory examination and chemical testing trap=(corpse or other object for laboratory examination and chemical testing weight of absorption-be dried corpse or other object for laboratory examination and chemical testing weight)/be dried corpse or other object for laboratory examination and chemical testing weight
[table 1]
As shown in upper table 1 and Fig. 2, trap analysis result confirms that the trap of embodiment 1 is average more than 23g/g, real
The trap for applying example 2 is average 7g/g or so.
Confirm the trap of 6.31g/g in contrary non-crosslinked sample comparative example 1, but be unable to maintain that form after absorption,
Although mixed proportion improperly shows equal with embodiment 2 or similar trap in comparative example 2, as shown in figure 3, but
Form is unable to maintain that after absorbing moisture.
Additionally, comparative example 3 is that the content of solid constituent is reduced to 2% only on the basis of embodiment 1, its trap is
40g/g, is not reaching to bad, but shows such as in experimental example afterwards, and the measured value of other physical property is bad, comparative example 4, compares
Example 5, additional experimental example 2 show low absorption degree, although adding the superior absorbent degree that experimental example 1 shows 18g/g, are unable to maintain that
Form.
<Experimental example 2：Compressive strength, spring rate analysis>
Embodiment 1～2, comparative example 1～5 is determined as follows, is added experimental example 1～2 and is produced as other companies
The pressure of trade name Nasopore (biodegradable polycarbonate is substrate) of product and Merocel (biodegradation hyaluronic acid is substrate)
Contracting intensity and spring rate, and show the result in table 2 below and Fig. 3.
Specifically, compressive strength and spring rate use flow graph (HAAKE MARSII, Thermo Scientific.Inc
Company) determine.Test portion cuts off standby with 2 × 2cm sizes, in normal saline after swelling 5 minutes, is positioned on test piece platform, uses
Rotor pressurization corpse or other object for laboratory examination and chemical testing 5mm, then in 0.5Hz frequency measurements.A corpse or other object for laboratory examination and chemical testing is pressurizeed after 5mm the reasons why 0.5Hz frequency analyses be with
Material insertion nasal cavity is similar with the environment of ear etc..
[table 2]
As shown in Table 2 above, in DE and compressive strength experimental result, the DE of embodiment 1 is 710pa, compression
Intensity is 1.3N, and it is 0.25N that the DE of embodiment 2 is 50pa, compressive strength.
It is 0.17N that the DE of contrary comparative example 1 is 40pa, compressive strength, and physical strength is very weak, and comparative example 2 is being inhaled
After receiving moisture, form disappears and cannot determine.
Additionally, confirm the DE of comparative example 3 be 396pa, compressive strength be 0.37N, the DE of comparative example 4 is
556pa, compressive strength are 0.33N, and it is 0.20N that the DE of comparative example 5 is 421pa, compressive strength, adds the bullet of experimental example 1
Property degree be 512pa, compressive strength be 0.12N, add experimental example 2 DE be 262pa, compressive strength be 0.23N, can be true
Recognize that to compare embodiment 1 low.
In addition, the DE of commercially available biodegradable polycarbonate product Nasopore is 336pa, compressive strength is
The DE of 0.77N, commercially available biodegradation hyaluronic acid product Merocel is 2577pa, compressive strength is 0.77N, is thereby confirmed that
A corpse or other object for laboratory examination and chemical testing for embodiment 1 compares Nasopore with more excellent DE and compressive strength.
<Test example 3：Expansion rate is analyzed>
Embodiment 1～2, comparative example 1～5, additional experimental example 1～2 and other companies markets are determined as follows
The thickness swelling of polycarbonate products Nasopore, and show the result in table 3.
Specifically, thickness is determined in the dry state, the immersion in normal saline is allowed to abundant aquation for 10 minutes, takes out and surveys
Determine thickness, seek 3 meansigma methodss.
[table 3]
| Distinguish | Drying regime (thickness) | Absorbing state (thickness) | Remarks |
| Embodiment 1 | 1.83±0.12 | 13.98±0.2 | |
| Embodiment 2 | 5.17±0.28 | 13.1±0.2 | |
| Comparative example 1 | 2.6±0.14 | 6.57±1.0 | |
| Comparative example 2 | 2.7±0.77 | - | After swelling, form disappears |
| Comparative example 3 | 5.0±0.2 | 15.8±1.85 | |
| Comparative example 4 | 6.25±0.98 | 11±3.06 | |
| Comparative example 5 | 17.25±0.19 | 16.5±1 | |
| Additional experimental example 1 | 10.9±0.65 | 6.79±1.53 | |
| Additional experimental example 2 | 15.27±0.20 | 10±1.63 | |
| Nasopore | 12.62±0.19 | 13.29±0.19 |
As shown in upper table 3, embodiment 1 is 1.83 in drying regime average thickness, is 13.98, increases to after absorbing moisture
About 7.6 times；Embodiment 2 is 5.17 in drying regime average thickness, is 13.1, increases to about 2.5 times after absorbing moisture.
Additionally, comparative example 1 is 2.6 in drying regime average thickness, it is 6.57 after absorbing moisture, increases to about 2.5 times；Than
Compared with example 2 drying regime average thickness be 2.7, absorb moisture after dissolving be unable to maintain that form.
Additionally, the average thickness of comparative example 3 increases to 15.8 from 5, the average thickness of comparative example 4 increases to 11 from 6.25,
The average thickness of comparative example 5 is reduced to 16 from 17, and the average thickness for adding experimental example 1 is reduced to 6 from 10, adds experimental example 2
Average thickness is reduced to 10 from 15.The group that thickness is reduced belongs to and cannot compress, and dissolving after absorbing moisture can not maintain form or nothing
The situation of method expansion.Especially in comparative example 3, it is thus identified that although dry thickness is bigger than embodiment 1, after final absorption moisture
Thickness is similar degree.
Used as reference, the Merlon Nasopore of other companies markets does not have substantially in drying regime and after absorbing moisture
Thickness change.
<Embodiment 4：Degradation characteristic is analyzed>
In order to confirm the degradation characteristic of the sample of embodiment 1 and the manufacture of comparative example 3, using the collagenase of simulation human body environment
Degrading experiment, analyzes degradation time.Prepare the PBS solution of the 1u/ml of type i collagen enzyme, in 37 DEG C, 50rpm after addition sample
Under the conditions of, stir 14 days in blender.Sample was taken out at the 3rd day, the 7th day, the 10th day and the 14th day, according to the side of experimental example 1
Method uses flow graph, determines compressive strength.N numbers are 4～5, and compression strength values are changed on the basis of sample before Degrading experiment (the 0th day)
Calculate as 100% unit, derivation result.Experimental result confirms that embodiment 1 is reduced through test passage physics value, at the 14th day completely
Decompose.Show during the situation of comparative example 3 than 1 faster propensity for degradation of embodiment, decomposed after the 10th day completely.Fig. 6 is real
The degraded photo of the sample of example 1 is applied, was changed into gel after the 14th day, so as to burst section is easily removed.
<Test example 5：Anthemorrhagic performance is analyzed>
In order to confirm the hemostasis effectiveness of the sample of the manufacture of embodiment 1, by using the hepatectomy model and hepatic portal of mouse
Vein model and whole blood (whole blood) solidification experiments are being evaluated.Experimental group uses 1 sample of embodiment, matched group
Using the Hemostatic products Surgicel fibrillar being licensed (health, the U.S. are treasured by Johson ＆ Johnson).
5-1 whole blood coagulations are tested
Whole blood (Whole blood) solidification experiments are carried out by the following method.10mm is added in teat glass2The sample of size
After product, gather the blood 1ml of Mus and inject.Negative control group is using the group for being only suitable for blood, and is compared with experimental group, surveys
Determine the time of blood coagulation.Bleeding stopping period test by using animal's whole blood is effective to evaluate the hemostasis of the sample of embodiment 1
Property.Experimental result is as shown in figure 4, blood solidifies completely when confirming 2 minutes in negative control group (Control)；As for the positive
Matched group (Surgicel, Johson ＆ Johnson), at more than 50 seconds, blood solidified completely；As for experimental group, in 45 seconds or so blood
Solidify completely.Compare with negative control group, positive controls and experimental group show shorter bleeding stopping period.
5-2 hepatectomy models
In accordance with ISO 10993-2, " animal welfare organizations (Animal welfare requirements) " is real for zoopery
Apply.Operation consent, Mus are carried out after anesthesia shaving using inhalation anesthesia (isoflurane 2%) machine, after being sterilized with ketopyrrolidine, in aseptic handss
Operated on art platform.Hepatectomy model is obtained as follows.After the animal abdominal part central authorities of anesthesia are cut, the liver middle period is made
(Middle lobe) completely it is exposed out, cut off diameter 8mm using biopsy punch (Biopy punch).Going out after hepatectomy
Blood position coated prod and apply certain force (hammer of 50g) maintain stopped blooding within 5 minutes.The blood flow volume of outflow is weighed after 5 minutes.
Experimental result as shown in figure 5, using hepatectomy model anthemorrhagic performance confirm experiment in, the blank not stopped blooding
(Conrol) group shows the amount of bleeding of average 3.53g；Matched group (Surgicel, Johson ＆ Johnson) shows 1.57g；Embodiment 1
Sample shows the amount of bleeding of 1.83g.Confirm that comparing blank control group for 2 groups shows significant difference, matched group and experiment
Not there is between group the difference of statistical significance.
5-3 hepatic portal vein damage models
Hepatic portal vein model is obtained by the following method.After the abdominal part central authorities of the animal of anesthesia are cut, hepatic portal vein is made
It is completely exposed, punctured for blood vessel using 21G.After coated prod is to stop blooding 5 minutes on the bleeding part, weighs and flow out
Blood.Experimental result is not as shown in figure 8, in the anthemorrhagic performance using hepatic portal vein damage model confirms experiment, carry out
The blank control group of hemostasis shows the amount of bleeding of average 2.72g；Matched group Surgicel groups show 0.89g；As experimental group
Embodiment 1 shows the amount of bleeding of 0.39g.Confirm that comparing blank control group for 3 groups shows significant difference, matched group and reality
Test the difference not between group with statistical significance.
<Experimental example 6：Wound healing performance evaluation>
In order to confirm the spongy elastic wound covering material of embodiment 1 and the spongy elastic wound cladding material of matched group
Curative effect and safety of the material to wound, burn and scar, using animal model SD rats (Sprague Dawley Rat)
Tested.
After the holostrome trauma model that white mouse back forms 2cm × 2cm, using experimental group (embodiment 1) and positive control
GroupProtection wound site, was confirmed using digital camera at the 2nd day, the 4th day, the 7th day, the 10th day and the 14th day
The size of wound and inflammatory reaction (Fig. 9).Additionally, have rated by Histopathology assessment method in the 14th day collection graft
Safety and effectiveness (Figure 10).
Experimental result, during testing in laboratory animal there are not specific symptoms or the phenomena of mortality, analysis result is from Fig. 9
With in Figure 10 it has been confirmed that experimental group and positive controlsRegeneration to the cambium of wound site has
Effect, with equal healing ability.Further, confirm two groups and specific inflammatory and immunoreation do not occur.
Claims (15)
1. a kind of polymer foam composition, comprising ossein, hyaluronic acid and carboxymethyl cellulose as effective ingredient, and includes
The cross-linking compound of the effective ingredient.
2. polymer foam composition according to claim 1, wherein, by ossein, hyaluronic acid and carboxymethyl cellulose
In total 100 weight % of element composition, the effective ingredient includes 20～99 weight % of ossein, 0.5～30 weight % of hyaluronic acid
And 0.5～50 weight % of carboxymethyl cellulose.
3. polymer foam composition according to claim 1, wherein, the ossein is (except people from mammal
Outside) extract and the de- cells of Jing process.
4. polymer foam composition according to claim 1, wherein, the weight average molecular weight (Mw) of the hyaluronic acid is
1000000～1900000g/mol.
5. polymer foam composition according to claim 1, wherein, the weight average molecular weight of the carboxymethyl cellulose
(Mw) it is 1000～80000g/mol.
6. polymer foam composition according to claim 1, wherein, the polymer foam composition is further included
Selected from carboxyethyl cellulose, hydroxymethyl cellulose, alginic acid, alginate, chitin, shitosan, dextran, glycogen, starch,
The carboxylated polysaccharide class of more than a kind in the mucopolysaccharide such as colloid and heparin, heparin sulfate, chondroitin sulfate.
7. polymer foam composition according to claim 1, wherein, the cross-linking compound selected from polyacrylic acid,
More than a kind in polyvinyl alcohol, polyvinyl pyridine, polyacrylamide and polyethylene glycol oxide, with the total content of the effective ingredient
For 100 weight portions, the content of the cross-linking compound is 0.01～10 weight portion.
8. a kind of manufacture method of foam of polymers, it is characterised in that the method includes：With any one of claim 1 to 7 institute
The polymer foam composition stated be initial substance, Jing after multistage lyophilization, by high temperature heat cross-linking and pressurization operation come
Manufacture foam of polymers.
9. the manufacture method of foam of polymers according to claim 8, wherein, is dried by the IQF below 0 DEG C
First stage be dried and the slow lyophilization in freezer dryer with 10mmHg pressure below at -40～-20 DEG C
Second stage be dried carrying out the multistage lyophilization.
10. the manufacture method of foam of polymers according to claim 8, wherein, in the high temperature heat cross-linking, will be crosslinked
After compound input, at 80～200 DEG C, rapidly heat cross-linking is carried out.
The manufacture method of 11. foam of polymers according to claim 8, wherein, using forcing press in 1000～5000Psi
The pressurization operation is carried out under pressure.
A kind of 12. foam of polymers, comprising ossein, hyaluronic acid and carboxymethyl cellulose as effective ingredient, it is described effectively into
Divide and be crosslinked by cross-linking compound, the foam of polymers is more than 10g/g to the trap of normal saline, uses flow graph
The compressive strength in 0.5Hz for determining is more than 0.1N, and DE is more than 1000pa.
13. foam of polymers according to claim 12, wherein, the foam of polymers is used for wrapping up paranasal sinusess or nose
Chamber.
A kind of 14. manufacture methods of foam of polymers, including：With the foam of polymers group any one of claim 1 to 7
Compound is initial substance, by natural drying or heated drying, manufactures polymeric foam.
The manufacture method of 15. foam of polymers according to claim 14, wherein, the foam of polymers be film type or
Block type.
Applications Claiming Priority (3)
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| KR10-2014-0089507 | 2014-07-16 | ||
| KR1020140089507A KR101649792B1 (en) | 2014-07-16 | 2014-07-16 | Polymer Foam Composition for Noncompression Hemostasis, Method Of Producing Polymer for Noncompression Hemostasis Foam Using The Same, And Polymer Foam for Packing Noncompression Hemostasis Therefrom |
| PCT/KR2015/007280 WO2016010330A1 (en) | 2014-07-16 | 2015-07-14 | Polymer foam composition, method for preparing polymer foam composition using same, and polymer foam for packing |
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| CN106535946A true CN106535946A (en) | 2017-03-22 |
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| CN201580038810.9A Pending CN106535946A (en) | 2014-07-16 | 2015-07-14 | Polymer foam composition, method for preparing polymer foam composition using same, and polymer foam for packing |
Country Status (4)
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| JP (1) | JP2017522162A (en) |
| KR (1) | KR101649792B1 (en) |
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| KR101826664B1 (en) * | 2017-06-16 | 2018-02-08 | 주식회사 제네웰 | Polyurethane foam mask pack and method for the same |
| KR102142720B1 (en) * | 2018-02-06 | 2020-08-07 | (주)현우테크 | A adhesion prevention film with excellent adhesion property |
| KR101980063B1 (en) * | 2019-01-25 | 2019-05-17 | 주식회사 휴메딕스 | Sponge Type Biodegradable Hemostatic Compositions Containing Hyaluronic Acid |
| KR102258962B1 (en) * | 2019-09-30 | 2021-05-31 | 울산대학교 산학협력단 | Nasal packing device |
| KR102297667B1 (en) * | 2019-11-19 | 2021-09-03 | 주식회사 제네웰 | Method for preparing collagen mat and collagen mat prepared therefrom |
| KR102459780B1 (en) * | 2020-06-30 | 2022-10-28 | (주)메디코어 | Sponge-type wound dressing applied to nasal cavity and preparation method thereof |
| KR102271980B1 (en) * | 2020-11-30 | 2021-07-02 | 주식회사 피엘마이크로메드 | Collagen-arginate wound dressing and method of preparing the same |
| KR102603701B1 (en) * | 2020-12-04 | 2023-11-17 | 한국생산기술연구원 | Expandable wound dressing and process for preparing the same |
| WO2022138993A1 (en) * | 2020-12-21 | 2022-06-30 | 주식회사 엘앤씨바이오 | Composition for treating wound comprising dermal tissue-derived extracellular matrix and method for preparing same |
| KR20230066153A (en) * | 2021-11-05 | 2023-05-15 | 주식회사 테라시온 바이오메디칼 | Biocompatible powder type hemostatic agent and method for preparing the same |
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| KR101649792B1 (en) | 2016-08-22 |
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| WO2016010330A1 (en) | 2016-01-21 |
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