CN100569299C - Degradable compound biomaterial membrane for medical purpose - Google Patents
Degradable compound biomaterial membrane for medical purpose Download PDFInfo
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- CN100569299C CN100569299C CNB2006101117925A CN200610111792A CN100569299C CN 100569299 C CN100569299 C CN 100569299C CN B2006101117925 A CNB2006101117925 A CN B2006101117925A CN 200610111792 A CN200610111792 A CN 200610111792A CN 100569299 C CN100569299 C CN 100569299C
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- MEYZYGMYMLNUHJ-UHFFFAOYSA-N tunicamycin Natural products CC(C)CCCCCCCCCC=CC(=O)NC1C(O)C(O)C(CC(O)C2OC(C(O)C2O)N3C=CC(=O)NC3=O)OC1OC4OC(CO)C(O)C(O)C4NC(=O)C MEYZYGMYMLNUHJ-UHFFFAOYSA-N 0.000 claims abstract description 14
- 230000015556 catabolic process Effects 0.000 claims abstract description 13
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- 239000002202 Polyethylene glycol Substances 0.000 claims description 17
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- Materials For Medical Uses (AREA)
Abstract
The present invention is as a kind of composite biological medical materials and preparation method, be applicable to and prevent the tissue adhesion in the medical surgery, body tissue sticking patch etc., characteristics are that this film is made of two-layer, as one deck of diaphragm basic material by the degradable synthesized polymer polylactic acid, a kind of or both copolymers of polyglycolic acid are spun into by electrostatic spinning technique, make into membrane fiber and reach Nano grade, the good characteristic that possesses nano meter biomaterial, on basic tunic, apply again or spraying one deck degradable natural polymer chitosan or chitosan derivatives, through post processing, obtain degradable compound biomaterial membrane for medical purpose; Simultaneously, can also in two membranes, add the degradation rate that not commensurability medical plasticizer is regulated film, to adapt to different medical requirements.This product preventing adhesiving effect is remarkable, also can avoid causing local acid inflammation, and have hemostasis, antibacterial, enhancing human body immunity power simultaneously, accelerate effect such as wound healing, be a kind of ideal bio-medical material.
Description
One, technical field
The present invention a kind ofly prevents medical film of degradable compound bio of tissue adhesion, human body soft tissue sticking patch and preparation method thereof after being used to perform the operation, and belongs to the surgery field of medical materials.
Two, background technology
Tissue adhesion is that not one of important difficult problem of fine solution has been arranged since the history of operation both at home and abroad as yet.Along with the development of Medical Technology, can cure fully after the multiple disease underwent operative, and adhesion easily between operation back wound surface and the body tissue.The formation of adhesion is to be absorbed as feature with returning of the fibroblast of neutrophilic granulocyte, macrophage and secondary, and accompanies the generation of local various cytokine and somatomedin.Adhesion not only can cause severe complication, and is the main reason that complication obviously increases when performing the operation once more.In order to prevent the tissue adhesion, people have carried out a large amount of explorations.Inconvenience is used in " sticking rather stopping " agent etc. of the anti-sticking poly lactic acid gel of some fluid or the auspicious promise biomedical material of viscid adherence preventing material such as Shijiazhuang company limited production and Yantai ten thousand sharp medical products company limiteies productions clinically at present, to part operation antiblocking weak effect; Prevent that at some solid diaphragms the degradation time that has as " hundred luxuriant and rich with fragrance rice " chitosan isolating membrane of the biochemical company limited production of Beijing Bai Likang, the polylactic acid membrane that Chengdu Dikang Zhongke Biomedical Materials Co., Ltd produces etc. in the adhering material is too fast, the acid accumulation that easily causes that has causes inflammation, and all lack adhesiveness with body, be difficult for fixedly being difficult to operation, product all exists certain defective and one-sidedness technically, and effect is not really desirable.Therefore, wait in expectation for a long time clinically a kind of safe, convenient, effectively the anti new material comes out.
Three, summary of the invention
(1) goal of the invention
The purpose of this invention is to provide the good degradable compound biomaterial membrane for medical purpose of biological degradability, biocompatibility, biocidal property and adhesiveness, compound by corresponding macromolecular material, overcome the defective of some anti products that exist in the market, reach the purpose of safety, convenient and effective anti, and can regulate the degradation rate of film by adding not commensurability medical plasticizer, adapt to different clinical medical requirements.
(2) technical scheme
Degradable compound biomaterial membrane for medical purpose is to be made of two-layer, the basis tunic is the fibrous membrane that electrostatic spinning is spun into, this film is made of the fiber under the micro-nano-scale, have high porosity, high-specific surface area is specially adapted to the requirement of biomedical sector to material structure, another layer is that natural macromolecular material is made, the thickness of total film is between 0.02～0.6 millimeter, and the thickness of basic tunic is between 0.01～0.59 millimeter, and the thickness of another tunic is between 0.01～0.59 millimeter.
Basic tunic is the macromolecular material that is spun into electrostatic spinning in the degradable compound biomaterial membrane for medical purpose, has good biodegradability, also have simultaneously good biocompatibility and Bioabsorbable, select a kind of of degradability synthetic high polymer polylactic acid, polyglycolic acid or both copolymers for use, high molecular viscosity-average molecular weight is 5000～1000000, and wherein preferred molecular weight is 20000～500000 poly-DL-lactic acid.
Another layer of degradable compound biomaterial membrane for medical purpose is water-soluble chitosan or chitosan derivatives, and chitosan has functions such as hemostasis, sterilization, promotion wound healing, the growth of adjusting cell, is a kind of good bioactive materials.
Degradable compound biomaterial membrane for medical purpose can contain water-soluble plasticizer, as Polyethylene Glycol, polypropylene glycol, polytetramethylene glycol etc., molecular weight is 200～60000, wherein Polyethylene Glycol is fat-soluble strong, hydrophilic is good, be organized absorption easily, so Polyethylene Glycol is actual preferred version, molecular weight is 200～60000.
Degradable compound biomaterial membrane for medical purpose can be regulated the degradation rate of film by add plasticizer respectively in polylactic acid and chitosan, thus the product film that acquisition has different absorption.The difference that adds plasticising dosage, its degradation speed are also different.Because the plasticizer that molecular weight is little easily dissolves, form hole and help polylactic acid or degradation of chitosan.Plasticising dosage is big, and its infiltration rate is fast, can satisfy clinical in to the different requirements of anti-tissue adhesion film infiltration rate.
The preparation method of degradable compound biomaterial membrane for medical purpose is: can absorb synthesized polymer material and be spun into the basal layer membrane material by electrostatic spinning technique, one side at basic tunic applies or spraying water-soluble natural macromolecular material, or room temperature was dried 4～24 hours, or 20-40 ℃ of freeze-day with constant temperature 2～12 hours, tailor by specification requirement, through the Co-60 radiation sterilization, obtain degradable compound biomaterial membrane for medical purpose.Can add plasticizer respectively in synthesized polymer material and the natural macromolecular material, regulate the degradation time and the physical aspect of film.
(3) technique effect
The present invention compared with prior art has following characteristics:
The Ranvier's membrane material of degradable compound biomaterial membrane for medical purpose provided by the invention adopts a kind of of polylactic acid, polyglycolic acid or both copolymers to be spun into by electrostatic spinning, become membrane fiber to reach Nano grade, diameter range is generally at 3nm～5 μ m, the little several magnitude of fibre diameter that makes than normal method, advantages such as diaphragm has that porosity height, specific surface area are big, fiber fineness and homogeneity height, draw ratio are big, be beneficial to the endotrophic mass exchange, avoid hematocele and hydrops phenomenon, have significant preventing adhesiving effect; Another layer is to be made of water-soluble chitosan or chitosan derivatives, except that having the adhesion of biological barrier effect preventing tissue, also has significant hemostasis, antibacterial, enhancing human body immunity power promotes epithelial cell growth, be suppressed to fibroblast growth, thereby accelerate the multi-efficiency of wound healing.Degradable compound biomaterial membrane for medical purpose is to be composited by two-layer macromolecular material, have good biological degradability, biocompatibility and biological safety, be better than obviously that gel is membranaceous, porous spongy and general casting films material, can effectively prevent the tissue adhesion, and can be used as the body tissue sticking patch and be widely used in clinical.
The present invention adopts double-decker, wherein one deck is a kind of of polylactic acid, polyglycolic acid or its copolymer, it is acid that its catabolite is, another layer is the water-soluble chitosan or derivatives thereof, catabolite is alkalescence, both close in mutually, and having overcome simple is the acid inflammatory reaction that the Antiadhesive film product degradation in vivo of raw material causes with polylactic acid-based.Utilize the biological viscosity of water-soluble chitosan simultaneously, make product be easy to be adhered fixed according to different parts at operation process, part is exempted operation stitching, is beneficial to operation technique and reduces patient's financial burden.
The present invention removes and regulates product at the intravital degradation time of people by the molecular weight difference of macromolecular material, can also be by adding not commensurability plasticizer, regulate the degradation rate and the physical aspect of medical film, with clinical in the healing time of different operations be complementary, play the purpose that effectively prevents various tissue adhesions.
It is the Ranvier's membrane material that the present invention adopts electrostatic spinning to be spun into fiber membrane, and coating or spraying are gone up another water soluble polymer and be prepared into double-deck degradation material, tailor into different size according to clinical needs, and technology is simple, and is easy and simple to handle, and cost is low.
Four, the specific embodiment
In order to understand better and to implement, describe the present invention in detail below in conjunction with embodiment:
Embodiment 1
Preparation concentration expressed in percentage by weight 80% viscosity-average molecular weight is 10 milliliters of dichloromethane solutions of 5000 poly-DL-lactic acid, add 0.2 gram-molecular weight and be 200 Polyethylene Glycol, at normal temperatures through stirring dissolving in 12～20 hours, be spun into the thin film of 0.01 millimeter of thickness then through electrostatic spinning, put into baking oven, dried by the fire 5～8 hours down for 60 ℃ in temperature, after the taking-up, 5% chitosan aqueous solution for preparing in advance is coated on the film, dried 7 hours through room temperature, the gross thickness of film is 0.02 millimeter, through the Co-60 radiation sterilization, obtains degradable compound biomaterial membrane for medical purpose.
Embodiment 2
Preparation concentration expressed in percentage by weight 50% viscosity-average molecular weight is 10 milliliters of dichloromethane solutions of 10000 poly-DL-lactic acid, add 0.2 gram-molecular weight and be 400 Polyethylene Glycol, at normal temperatures through stirring dissolving in 12～20 hours, be spun into the thin film of 0.01 millimeter of thickness then through electrostatic spinning, put into baking oven, dried by the fire 5～8 hours down for 60 ℃ in temperature, after the taking-up, 8% chitosan aqueous solution for preparing in advance is coated on the film, dried 7 hours through room temperature, the gross thickness of film is 0.02 millimeter, through the Co-60 radiation sterilization, obtains degradable compound biomaterial membrane for medical purpose.
Embodiment 3
Preparation concentration expressed in percentage by weight 7% viscosity-average molecular weight is 10 milliliters of dichloromethane solutions of 100000 poly-DL-lactic acid, at normal temperatures through stirring dissolving in 12～20 hours, be spun into the thin film of 0.07 millimeter of thickness then through electrostatic spinning, put into baking oven, temperature was dried by the fire 5～8 hours down for 60 ℃, after the taking-up, 10% chitosan aqueous solution for preparing in advance is coated on the film, through the oven dry in 12 hours of 20 ℃ of freeze-day with constant temperature, the gross thickness of film is 0.1 millimeter, through the Co-60 radiation sterilization, obtain degradable compound biomaterial membrane for medical purpose.
Embodiment 4
Preparation concentration expressed in percentage by weight 3% viscosity-average molecular weight is 10 milliliters of dichloromethane solutions of 200000 poly-DL-lactic acid, at normal temperatures through stirring dissolving in 12～20 hours, be spun into the thin film of 0.07 millimeter of thickness then through electrostatic spinning, put into baking oven, dried by the fire 5～8 hours down for 60 ℃ in temperature, after the taking-up, 10% chitosan aqueous solution for preparing in advance is coated on the film, through the oven dry in 5 hours of 30 ℃ of freeze-day with constant temperature, the gross thickness of film is 0.1 millimeter, through the Co-60 radiation sterilization, obtain degradable compound biomaterial membrane for medical purpose.
Embodiment 5
Preparation concentration expressed in percentage by weight 3% viscosity-average molecular weight is 10 milliliters of dichloromethane solutions that 200000 Acetic acid, hydroxy-, bimol. cyclic ester-third is handed over resin copolymer, add 0.2 gram-molecular weight and be 4000 Polyethylene Glycol, at normal temperatures through stirring dissolving in 12～20 hours, be spun into the thin film of 0.11 millimeter of thickness then through electrostatic spinning, put into baking oven, dried by the fire 5～8 hours down for 60 ℃ in temperature, after the taking-up, 20% chitosan aqueous solution for preparing in advance is coated on the film, dried 6 hours through room temperature, the gross thickness of film is 0.15 millimeter, through the Co-60 radiation sterilization, obtains degradable compound biomaterial membrane for medical purpose.
Embodiment 6
Preparation concentration expressed in percentage by weight 2.5% viscosity-average molecular weight is 10 milliliters of dichloromethane solutions that 400000 Acetic acid, hydroxy-, bimol. cyclic ester-third is handed over resin copolymer, add 0.2 gram-molecular weight and be 4000 Polyethylene Glycol, at normal temperatures through stirring dissolving in 12～20 hours, be spun into the thin film of 0.11 millimeter of thickness then through electrostatic spinning, put into baking oven, dried by the fire 5～8 hours down for 60 ℃ in temperature, after the taking-up, 20% chitosan aqueous solution for preparing in advance is coated on the film, through the oven dry in 2 hours of 40 ℃ of freeze-day with constant temperature, the gross thickness of film is 0.15 millimeter, through the Co-60 radiation sterilization, obtains degradable compound biomaterial membrane for medical purpose.
Embodiment 7
Preparation concentration expressed in percentage by weight 2% viscosity-average molecular weight is 10 milliliters of dichloromethane solutions of 500000 poly-DL-lactic acid, add 0.2 gram-molecular weight and be 10000 Polyethylene Glycol, at normal temperatures through stirring dissolving in 12～20 hours, be spun into the thin film of 0.15 millimeter of thickness then through electrostatic spinning, put into baking oven, dried by the fire 5～8 hours down for 60 ℃ in temperature, after the taking-up, with 5% chitosan aqueous solution for preparing in advance and 5% Polyethylene Glycol aqueous solution mixed with 1: 1, obtain mixed aqueous solution, be coated in then on the film, dried 8 hours through room temperature, the gross thickness of film is 0.22 millimeter, through the Co-60 radiation sterilization, obtains degradable compound biomaterial membrane for medical purpose.
Embodiment 8
Preparation concentration expressed in percentage by weight 1.5% viscosity-average molecular weight is 10 milliliters of dichloromethane solutions of 800000 poly-DL-lactic acid, add 0.1 gram-molecular weight and be 20000 Polyethylene Glycol, at normal temperatures through stirring dissolving in 12～20 hours, be spun into the thin film of 0.15 millimeter of thickness then through electrostatic spinning, put into baking oven, dried by the fire 5～8 hours down for 60 ℃ in temperature, after the taking-up, with 30% chitosan aqueous solution for preparing in advance and 30% Polyethylene Glycol aqueous solution mixed with 1: 1, obtain mixed aqueous solution, be coated in then on the film, dried 8 hours through room temperature, the gross thickness of film is 0.22 millimeter, through the Co-60 radiation sterilization, obtains degradable compound biomaterial membrane for medical purpose.
Embodiment 9
Preparation concentration expressed in percentage by weight 0.5% viscosity-average molecular weight is 10 milliliters of dichloromethane solutions of 1000000 poly-DL-lactic acid, add 0.2 gram-molecular weight and be 60000 Polyethylene Glycol, at normal temperatures through stirring dissolving in 12～20 hours, be spun into the thin film of 0.28 millimeter of thickness then through electrostatic spinning, put into baking oven, dried by the fire 5～8 hours down for 60 ℃ in temperature, after the taking-up, 5% chitosan aqueous solution for preparing in advance is coated on the film, dried 10 hours through room temperature, the gross thickness of film is 0.3 millimeter, through the Co-60 radiation sterilization, obtains degradable compound biomaterial membrane for medical purpose.
Embodiment 10
Preparation concentration expressed in percentage by weight 1.5% viscosity-average molecular weight is 10 milliliters of dichloromethane solutions of 800000 poly-DL-lactic acid, add 0.1 gram-molecular weight and be 20000 Polyethylene Glycol, at normal temperatures through stirring dissolving in 12～20 hours, be spun into the thin film of 0.01 millimeter of thickness then through electrostatic spinning, put into baking oven, dried by the fire 5～8 hours down for 60 ℃ in temperature, after the taking-up, with 30% chitosan aqueous solution for preparing in advance and 30% Polyethylene Glycol aqueous solution mixed with 1: 1, obtain mixed aqueous solution, be coated in then on the film, dried 24 hours through room temperature, the gross thickness of film is 0.6 millimeter, eliminates bacterium through the Co-60 radiation, obtains degradable compound biomaterial membrane for medical purpose.
Embodiment 11
Preparation concentration expressed in percentage by weight 0.5% viscosity-average molecular weight is 10 milliliters of dichloromethane solutions of 1000000 poly-DL-lactic acid, add 0.2 gram-molecular weight and be 60000 Polyethylene Glycol, at normal temperatures through stirring dissolving in 12～20 hours, be spun into the thin film of 0.59 millimeter of thickness then through electrostatic spinning, put into baking oven, dried by the fire 5～8 hours down for 60 ℃ in temperature, after the taking-up, 5% chitosan aqueous solution for preparing in advance is coated on the film, dried 4 hours through room temperature, the gross thickness of film is 0.6 millimeter, through the Co-60 radiation sterilization, obtains degradable compound biomaterial membrane for medical purpose.
Claims (6)
1 one kinds of degradable compound biomaterial membrane for medical purpose, be used in particular for preventing in the medical surgery tissue adhesion, this medical film is made of two-layer, wherein one deck is by the synthesized polymer material polylactic acid, the degradable basis tunic that a kind of or polylactic acid-polyglycolic acid copolymer of polyglycolic acid is spun into by electrostatic spinning, another that is combined with each other layer is the compound tunic of being made by natural macromolecular material water-soluble chitosan or chitosan derivatives of degradable with it, the gross thickness of film is between 0.02～0.6 millimeter, wherein, the thickness of basis tunic is between 0.01～0.59 millimeter, the thickness of compound tunic is between 0.01～0.59 millimeter, add plasticizer respectively in basis tunic and the compound tunic, regulate the degradation time and the physical aspect of film.
2 degradable compound biomaterial membrane for medical purpose according to claim 1 is characterized in that, the viscosity-average molecular weight of the synthesized polymer material of wherein said basic tunic is 5000～1000000.
3 degradable compound biomaterial membrane for medical purpose according to claim 1 is characterized in that wherein said degradable compound biomaterial membrane for medical purpose contains water-soluble plasticizer, and water-soluble plasticizer comprises Polyethylene Glycol, polypropylene glycol and polytetramethylene glycol.
4 degradable compound biomaterial membrane for medical purpose according to claim 3 is characterized in that, the molecular weight of wherein said water-soluble plasticizer is 200～60000.
5 degradable compound biomaterial membrane for medical purpose according to claim 3 is characterized in that, the molecular weight of wherein said Polyethylene Glycol is 200～60000.
6 degradable compound biomaterial membrane for medical purpose according to claim 1, it is characterized in that, the preparation method of degradable compound biomaterial membrane for medical purpose is: can absorb the synthesized polymer material polylactic acid, a kind of or the polylactic acid-polyglycolic acid copolymer of polyglycolic acid is spun into the basal layer membrane material by electrostatic spinning technique, one side at basic tunic applies or spraying water-soluble natural macromolecular material chitosan or chitosan derivatives, or room temperature was dried 4～24 hours, or 20～40 ℃ of freeze-day with constant temperature 2～12 hours, tailor by specification requirement, through the Co-60 radiation sterilization, obtain degradable compound biomaterial membrane for medical purpose, add plasticizer in synthesized polymer material and the natural macromolecular material respectively, regulate the degradation time and the physical aspect of film.
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| CNB2006101117925A CN100569299C (en) | 2006-08-29 | 2006-08-29 | Degradable compound biomaterial membrane for medical purpose |
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| CNB2006101117925A CN100569299C (en) | 2006-08-29 | 2006-08-29 | Degradable compound biomaterial membrane for medical purpose |
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| CN100569299C true CN100569299C (en) | 2009-12-16 |
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