CN110280152A - Anticoagulation hemodialysis membrane and preparation method thereof - Google Patents
Anticoagulation hemodialysis membrane and preparation method thereof Download PDFInfo
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- CN110280152A CN110280152A CN201910554083.1A CN201910554083A CN110280152A CN 110280152 A CN110280152 A CN 110280152A CN 201910554083 A CN201910554083 A CN 201910554083A CN 110280152 A CN110280152 A CN 110280152A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D67/00—Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
- B01D67/0002—Organic membrane manufacture
- B01D67/0009—Organic membrane manufacture by phase separation, sol-gel transition, evaporation or solvent quenching
- B01D67/0018—Thermally induced processes [TIPS]
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
- B01D71/06—Organic material
- B01D71/08—Polysaccharides
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
- B01D71/06—Organic material
- B01D71/08—Polysaccharides
- B01D71/12—Cellulose derivatives
- B01D71/14—Esters of organic acids
- B01D71/16—Cellulose acetate
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
- B01D71/06—Organic material
- B01D71/30—Polyalkenyl halides
- B01D71/32—Polyalkenyl halides containing fluorine atoms
- B01D71/34—Polyvinylidene fluoride
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
- B01D71/06—Organic material
- B01D71/40—Polymers of unsaturated acids or derivatives thereof, e.g. salts, amides, imides, nitriles, anhydrides, esters
- B01D71/42—Polymers of nitriles, e.g. polyacrylonitrile
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
- B01D71/06—Organic material
- B01D71/66—Polymers having sulfur in the main chain, with or without nitrogen, oxygen or carbon only
- B01D71/68—Polysulfones; Polyethersulfones
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- Urology & Nephrology (AREA)
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Abstract
The present invention relates to a kind of anticoagulation hemodialysis membranes and preparation method thereof, select sulfuric acid lipid or carboxylic acid esters chitosan derivatives；Sulfuric acid lipid or carboxylic acid esters chitosan derivatives are blended with film forming polymer；Additive is added and solvent is configured to preparation liquid and prepares hemodialysis membrane.The present invention is blended using the oil soluble chitosan derivative that sulfonic acid group or carboxylic acid group are modified with film forming polymer, hemodialysis membrane is prepared using submergence sedimentation or thermally induced phase separation, chitosan derivatives are present in manufactured hemodialysis membrane, play the role of improving dialysis membrane hydrophily and anticoagulation function, this method has process simple, it is low in cost, it is easy to the advantages of industry is amplified.
Description
Technical field:
The present invention relates to hemodialysis membrane fields more particularly to a kind of anticoagulation hemodialysis membrane and preparation method thereof.
Background technique:
Chronic kidney hypofunction is global challenge, and by the end of the year 2010, the whole world has 262.1 ten thousand chronic renal failure patients to be controlled
It treats, wherein about 202.9 ten thousand people obtain dialysis treatment in 145 countries, separately there are 59.2 ten thousand people to obtain kidney transplant.Receiving thoroughly
In more than 200 ten thousand patients for analysing treatment, receive treatment in the U.S. there are about 20%, 16% in European Union member countries, and 15% in Japan, remaining is about
49% dialysis patient is distributed in other about 120 countries such as China.2011, global dialysis number was 215.8 ten thousand people, it is contemplated that
3,800,000 people or so will be risen to the year two thousand twenty.
There is hundred million population more than 13 in China, and there are about 2,000,000 people for Chronic Renal Failure Patients in 2012, but not due to past medical insurance covering
Sufficiently, Rural medical treatment insurance reimbursement ratio is low, and the high cost of most of unbearable long-term dialysis treatment of Chronic Renal Failure Patients receives
The number of dialysis treatment is only 10~15% or so.Future realizes that all standing, new agriculture close serious disease and submit an expense account ratio with Chinese medical insurance
Increase, the ratio that Chinese patient with end stage renal disease receives treatment will be substantially increased, and haemodialysis market potential is huge, dialyzer
Using will also there is great growth space.
According to another statistics, the dialyzer of the consumption of the whole world in 2009 is about 1.5 hundred million, and domestic market annual requirement is 6,500,000
Branch；World market in 2010 is 1.8 hundred million, and domestic market reaches 10,000,000 or so, and domestic market reaches 25,000,000 within 2012
Branch, domestic haemodialysis market are almost big outer by German Fresenius, Japan Nipro, Sweden Gambro and Japan Asahi tetra-
It provides occupied by enterprise, for occupation rate of market up to 80% or more, this is a kind of challenge and a kind of opportunity, as long as performance can be developed
More preferably, therapeutic effect is preferably dialysed product, and Chinese enterprise will have very big development space in this field.
Haemodialysis is the main means for treating vast acute and chronic patients with renal failure, in haemodialysis product thoroughly
It is most important to analyse film.And in dialysis procedure, when the dialysis membrane and contacting blood of poor biocompatibility, it may destroy blood red thin
Born of the same parents make platelet activation, aggregation, and then form thrombus, cause blood coagulation, and blocks film fiber conduit influences the progress and drop of dialysis
The effect of low dialysis treatment.At present in clinicing aspect, there are no a kind of artificial biomaterial for medical purpose energy perfections to apply in human body.
Blood compatibility is the most important performance indicator of biomaterial, and anticoagulation function is even more to determine that can biomaterial be widely used
Deciding factor.Currently, common such as polysulfones (PSF), polymethyl methacrylate (PMMA), polyether sulfone (PES), polyamide
(PA) and the synthesis dialysis membrane aperture such as polyacrylonitrile (PAN) is larger, and the permeability and ultrafiltration rate to water are high, centering macromolecular toxins
Clearance rate it is high, also there is good mechanical property, flexibility and certain biocompatibility, application is more, but they
Anticoagulation function is not ideal enough, can cause some complication in blood dialysis.These complication mainly include following several
A aspect: allergic reaction, hypoxemia, Abnormality of Coagulation Fibrinolysis, immunologic hypofunction, disorders of lipid metabolism, dialytic osteopathy, battalion
Influence bad and to residual renal function is supported, therefore, the good dialysis membrane of exploitation anticoagulation, bio-compatible is with efficiently and safely complete
It is one of the research hotspot of current medicine and technical field of membrane at dialysis procedure.
Chitosan is widely present in the shell of arthropod, in shrimp, crab silkworm chrysalis shell, is had non-toxic, nonirritant, good
Good biocompatibility and it is biodegradable the features such as, have been widely used for medicine, bioengineering, food, agricultural and chemical industry
Field.Chitosan is because having promotion tissue repair, anticoagulation, preventing the bioactivity such as tissue adhesions, antibacterial, antitumor and promotion
The effect of angiogenesis is also widely used for preparing pharmaceutical carrier, slow-release material, tissue engineering bracket, artificial skin, external
The circulatory system, vascular occlusive agent, anticoagulant material, hemostatic material, absorbable suture etc., have a good application prospect with it is huge
Big economic value.
Containing a large amount of active amino and hydroxyl in chitosan molecule, easily carries out being acylated, be etherified, be alkylated, being esterified, sulphur
Change, carboxylated, season by a variety of chemical modifications such as changes, can introduce a variety of functional groups, so that it is each to obtain many performances in strand
Different chitosan derivatives assign its more specific function.But these groups are also easy to form intramolecular and intermolecular hydrogen bonding,
Close crystal structure is made it have, to be insoluble in most of organic solvents, and then is difficult to be introduced with simple blend method
To among hemodialysis membrane.
The chemical structure of chitosan is similar to heparin, studies have shown that carrying out the amino and hydroxyl in strand to chitosan
It is chemically modified, introduces sulfonic acid group and carboxylic acid group, chitosan derivatives are made.It is poly- that shell had both can be improved in these derivatives
The solubility of sugar in organic solvent, and the anticoagulation function of chitosan can be improved.Using with sulfonic acid group or carboxylic acid group
The chitosan derivatives of group are blended with film forming polymer, prepare haemodialysis using phase separation or thermally induced phase separation
Film, the chitosan derivatives in dialysis membrane obtained can play good blood coagulation resisting function.
Application No. is 201811316273.1 in the prior art to disclose a kind of modified poly- ammonia of sulfonation dihydroxypropylchitosan
Ester hemodialysis membrane and preparation method thereof will chemically react between modification of chitosan and polyurethane, using covalent bond by two
Person connects, and is filmed using the dissolubility of polyurethane, and this method is complex, and chemical reaction step is more, the system of raw material
Standby and purification can consume a large amount of chemical reagent；Application No. is 201710792954.4 to disclose a kind of polyacrylonitrile-carboxymethyl shell
Compound hemodialysis membrane of glycan and preparation method thereof, it is mentioned that carboxymethyl chitosan be a kind of water soluble chitosan, when altogether
After mixed, which can be dissolved in water, can not exist inside seperation film, will not play and increase seperation film hydrophily and resist
The effect of coagulant property, anticoagulation function are mainly obtained by heparin, and the heparin mentioned in the patent is also dissolved in water.
Summary of the invention:
The purpose of the present invention is in view of the drawbacks of the prior art, provide a kind of anticoagulation hemodialysis membrane and its preparation side
Method is blended using the oil soluble chitosan derivative that sulfonic acid group or carboxylic acid group are modified with film forming polymer, heavy using submergence
Drop method or thermally induced phase separation prepare hemodialysis membrane, and chitosan derivatives are present in manufactured hemodialysis membrane, play and mention
The effect of high dialysis membrane hydrophily and anticoagulation function, this method has process simple, low in cost, is easy to the excellent of industry amplification
Point.
In order to achieve the above object, the present invention utilizes the good biocompatibility of chitosan itself, selects and has sulfonic group
The chitosan derivatives of group or carboxylic acid group, the existing good anticoagulation function of the derivative, and organic solvent can be dissolved in
In, anticoagulation hemodialysis membrane is prepared by blending method.
The present invention is achieved through the following technical solutions: a kind of preparation method of anticoagulation hemodialysis membrane,
1) sulfuric acid ester or carboxylic acid esters chitosan derivatives, are chosen；
2) sulfuric acid ester chitosan derivatives are blended with film forming polymer, additive and solvent, preparation liquid is made；
3) anticoagulation hemodialysis membrane, is prepared by submergence sedimentation and thermally induced phase separation.
Test method is as follows, selects pig blood as test sample, and test condition is 200mL/min flow velocity, dialyses 4 hours.
Test haemocyte residual, leucocyte residual and blood platelet residual.While the water penetration of hemodialysis membrane is tested, urea clearance,
Phosphate clearance rate, vitamin B12 clearance rate.Test the blood plasma recalcification time and activated partial thromboplastin time of seperation film
(APTT)。
Wherein, preferably, the molecular weight of the chitosan derivatives is between 5000-200000, chitosan derivatives
Deacetylation between 35%-95%, the degree of substitution of sulfuric acid lipid or carboxylic acid esters group is described between 0.02-0.5
Sulfuric acid ester or carboxylic acid esters chitosan derivatives are modified by amido modified and hydroxyl；The film forming polymer is using poly-
One of high-molecular organic materials such as sulfone, polyether sulfone, Kynoar, polyacrylonitrile, cellulose acetate or a variety of combinations；
The solvent using one of high-molecular organic materials such as dimethylformamide, N-Methyl pyrrolidone, triethyl phosphate or
A variety of combinations；The additive uses polyethylene glycol, polyvinylpyrrolidone, ethylene glycol, anhydrous lithium chloride, polysorbas20, spits
One of temperature 80, ethylene glycol etc. or a variety of combinations.
In a preferred embodiment of the present invention, the hemodialysis membrane film build method is using submergence sedimentation or thermotropic phase point
From method.
The present invention also provides a kind of anticoagulation hemodialysis membranes, are made using above-mentioned preparation method, by following quality
At being grouped as: sulfuric acid ester or carboxylic acid esters chitosan derivatives 0.01%-15%, film forming polymer 10%-22%, addition
Agent 0.1%-15%, solvent 70%-85%.
The beneficial effects of the present invention are: the present invention, which uses, has sulfuric acid ester or carboxylic acid esters chitosan derivatives, pass through
The modification of sulfuric ester or carboxylate improves the dissolubility of chitosan in organic solvent, and then is blended with film forming polymer, utilizes
It submerges sedimentation and calorific value phase separation method prepares Modified Membrane, chitosan can be introduced into hemodialysis membrane using the method,
Reach and improve the anticoagulant effect of seperation film, the modification of chitosan in the present invention is insoluble in water, can protect in seperation film
It deposits, plays hydrophily and anticoagulation function.
Specific embodiment:
The preferred embodiments of the present invention will be described in detail below, so that advantages and features of the invention can be easier to by this
Field personnel understanding, so as to make a clearer definition of the protection scope of the present invention.
Embodiment 1:
(degree of substitution of molecular weight of chitosan 100000, sulfonic group or carboxylic acid group is 50g Sulfated chitosans
0.24, the deacetylation of chitosan is 65%) 150g polysulfones, and 60g polyethylene glycol 400 and 740g dimethyl acetamide mix,
At 80 DEG C heating stirring for 24 hours, vacuum defoamation.Using spinning head spinning, core liquid is deionized water, anti-by submergence sedimentation preparation
Blood coagulation hemodialysis membrane.
Test performance is as follows:
Effective membrane area of modified haemodialyser is 1.4m2.Haemocyte residual is 0.72 ‰, and leucocyte residual is
2.17 ‰, blood platelet residual is 0.18 ‰.The water penetration of hemodialysis membrane is 22.3mL/m2/ h/mmHg, urea clearance are
199.2mL/m2/ min, phosphate clearance rate are 175.2mL/m2/ min, vitamin B12 clearance rate are 135.2mL/m2/min.Point
Blood plasma recalcification time from film reaches 30min, and the APTT time can reach 40 seconds.
Embodiment 2:
70g Sulfated chitosans (degree of substitution of molecular weight of chitosan 80000, sulfonic group or carboxylic acid group is 0.34,
The deacetylation of chitosan is 75%) 150g polysulfones, 60g polyethylene glycol 400 and the mixing of 720g dimethylformamide, at 80 DEG C
Lower heating stirring for 24 hours, vacuum defoamation.Using spinning head spinning, core liquid is deionized water, prepares anticoagulation by submerging sedimentation
Hemodialysis membrane.
Test performance is as follows:
Effective membrane area of modified haemodialyser is 1.4m2.Haemocyte residual is 0.72 ‰, and leucocyte residual is
2.17 ‰, blood platelet residual is 0.18 ‰.The water penetration of hemodialysis membrane is 20.3mL/m2/ h/mmHg, urea clearance are
175.2mL/m2/ min, phosphate clearance rate are 157.2mL/m2/ min, vitamin B12 clearance rate are 127.2mL/m2/min.Point
Blood plasma recalcification time from film reaches 50min, and the APTT time can reach 45 seconds.
Embodiment 3:
(degree of substitution of molecular weight of chitosan 150,000, sulfonic group or carboxylic acid group is 70g carboxylic esterification chitosan
0.28, the deacetylation of chitosan is 85%) 210g polyacrylonitrile, and 60g polyethylene glycol 400 and 660g dimethylformamide are mixed
Close, at 120 DEG C heating stirring for 24 hours, vacuum defoamation.Using spinning head spinning, core liquid is deionized water, passes through Thermal inactive
Method prepares anticoagulation hemodialysis membrane.
Test performance is as follows:
Effective membrane area of modified haemodialyser is 1.4m2.Haemocyte residual is 0.70 ‰, and leucocyte residual is
2.27 ‰, blood platelet residual is 0.19 ‰.The water penetration of hemodialysis membrane is 19.6mL/m2/ h/mmHg, urea clearance are
173.0mL/m2/ min, phosphate clearance rate are 152.2mL/m2/ min, vitamin B12 clearance rate are 120.2mL/m2/min.Point
Blood plasma recalcification time from film reaches 65min, and the APTT time can reach 55 seconds.
Comparative example 1:
Hemodialysis membrane is taken to be tested, test result is as follows:
Effective membrane area of modified haemodialyser is 1.4m2.Haemocyte residual is 1.02 ‰, and leucocyte residual is
3.21 ‰, blood platelet residual is 0.35 ‰.The water penetration of hemodialysis membrane is 10.2mL/m2/ h/mmHg, urea clearance are
153.8mL/m2/ min, phosphate clearance rate are 149.6mL/m2/ min, vitamin B12Clearance rate is 100.2mL/m2/min.Blood
Slurry recalcification time is 2min, and the APTT time is 10 seconds.
By comparison as it can be seen that modified by surface, the residual quantity of the haemocyte of haemodialyser, leucocyte and blood platelet
It is substantially reduced, water penetration, urea clearance, phosphate clearance rate and vitamin B12The clearance rate of clearance rate is all significantly increased.
Anticoagulation hemodialysis membrane blood plasma recalcification time obtained and APTT time all significantly extend.The results show that haemodialyser
Anticoagulation function be improved significantly, dialysis performance is significantly improved.
Finally, it should be noted that above embodiments, only a specific embodiment of the invention, to illustrate skill of the invention
Art scheme, rather than its limitations, scope of protection of the present invention is not limited thereto, although with reference to the foregoing embodiments to the present invention into
Go detailed description, those skilled in the art should understand that: anyone skilled in the art is at this
It invents in the technical scope disclosed, can still modify or can be thought easily to technical solution documented by previous embodiment
To variation or equivalent replacement of some of the technical features；And these modifications, variation or replacement, do not make corresponding
The essence of technical solution is detached from the spirit and scope of technical solution of the embodiment of the present invention, should all cover in protection scope of the present invention
Within.Therefore, protection scope of the present invention should be subject to the protection scope in claims.
Claims (7)
1. a kind of preparation method of anticoagulation hemodialysis membrane, it is characterised in that: select sulfuric acid lipid or carboxylic acid esters chitosan
Derivative；Sulfuric acid lipid or carboxylic acid esters chitosan derivatives are blended with film forming polymer；Additive and solvent configuration is added
Hemodialysis membrane is prepared at preparation liquid.
2. the preparation method of anticoagulation hemodialysis membrane according to claim 1, it is characterised in that: the chitosan derivative
The molecular weight of object between 5000-200000, the deacetylation of chitosan derivatives between 35%-95%, sulfuric acid lipid or
The degree of substitution of carboxylic acid esters group is between 0.02-0.5.
3. the preparation method of anticoagulation hemodialysis membrane according to claim 1, it is characterised in that: the film forming polymer
Using one of polysulfones, polyether sulfone, Kynoar, polyacrylonitrile, cellulose acetate or a variety of combinations.
4. the preparation method of anticoagulation hemodialysis membrane according to claim 1, it is characterised in that: the solvent uses two
One of methylformamide, N-Methyl pyrrolidone, triethyl phosphate or a variety of combinations.
5. the preparation method of anticoagulation hemodialysis membrane according to claim 1, it is characterised in that: the additive uses
One of polyethylene glycol, polyvinylpyrrolidone, ethylene glycol, anhydrous lithium chloride, polysorbas20, Tween 80, ethylene glycol are a variety of
Combination.
6. the preparation method of anticoagulation hemodialysis membrane according to claim 1, it is characterised in that: hemodialysis membrane film forming
Method is using submergence sedimentation and thermally induced phase separation.
7. a kind of anticoagulation hemodialysis membrane, which is characterized in that use anticoagulation blood as claimed in any one of claims 1 to 6
The preparation method of dialysis membrane is made, by following quality at being grouped as: sulfuric acid ester or carboxylic acid esters chitosan derivatives
0.01%-15%, film forming polymer 10%-22%, additive 0.1%-15%, solvent 70%-85%.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110756066A (en) * | 2019-11-25 | 2020-02-07 | 中南大学 | Sulfonated citric acid chitosan modified polysulfone hemodialysis membrane and preparation method thereof |
| CN113083031A (en) * | 2021-04-27 | 2021-07-09 | 贵州省材料产业技术研究院 | Electrically neutral polyvinylidene fluoride ultrafiltration membrane and preparation method thereof |
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| CN113083031A (en) * | 2021-04-27 | 2021-07-09 | 贵州省材料产业技术研究院 | Electrically neutral polyvinylidene fluoride ultrafiltration membrane and preparation method thereof |
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