CN109248338A - Absorbable membrane and its preparation method and application, dental implant - Google Patents
Absorbable membrane and its preparation method and application, dental implant Download PDFInfo
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- CN109248338A CN109248338A CN201811368011.XA CN201811368011A CN109248338A CN 109248338 A CN109248338 A CN 109248338A CN 201811368011 A CN201811368011 A CN 201811368011A CN 109248338 A CN109248338 A CN 109248338A
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- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
- A61L27/34—Macromolecular materials
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- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/54—Biologically active materials, e.g. therapeutic substances
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
-
- 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
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
-
- 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
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/216—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
-
- 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
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
-
- 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
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/602—Type of release, e.g. controlled, sustained, slow
- A61L2300/604—Biodegradation
-
- 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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/12—Materials or treatment for tissue regeneration for dental implants or prostheses
Abstract
The present invention relates to field of medicaments, in particular to a kind of Absorbable membrane and its preparation method and application, dental implant.The preparation method of Absorbable membrane, comprising: polylactic-co-glycolic acid and Lovastatin are dissolved in solvent, mixed liquor is made；Mixed liquor is made alternatively, polylactic-co-glycolic acid and Fluvastatin are dissolved in solvent；Mixed liquor is sprawled to obtain liquid film, the solvent in the liquid film that volatilizees obtains Absorbable membrane.Method provided in an embodiment of the present invention can obtain homogeneous film, which can have preferably inducing tissue regeneration effect, and can be used for the treatment in extensive tis-sue damage.The high mechanical strength of Absorbable membrane provided in an embodiment of the present invention, is greater than 15MPa, and support is new enough organizes the formation of.Dental implant provided in this embodiment, it is properer with alveolar bone to be conducive to the dental implant later period, shortens treatment cycle.
Description
Technical field
The present invention relates to field of medicaments, in particular to a kind of Absorbable membrane and its preparation method and application, Dental implantion
Body.
Background technique
Crucial step is the application of shielding film in regeneration induction technology.Traditional film is divided into Absorbable membrane and can not inhale
Winder (pure titanium film).Nonabsorable film is clinical generally to induce bone again using Absorbable membrane due to needing second operation to take out
In raw operation.Our Absorbable membrane of past is mainly collagem membrane, but the regeneration effect of collagem membrane regeneration induction is bad.
Summary of the invention
The purpose of the present invention is to provide a kind of Absorbable membrane and its preparation method and application, dental implant, it is intended to change
It is apt to the bad problem of regeneration effect existing for existing shielding film regeneration induction.
First aspect present invention provides a kind of preparation method of Absorbable membrane, comprising:
Polylactic-co-glycolic acid and Lovastatin are dissolved in solvent, mixed liquor is made；Mixed liquor is sprawled to obtain liquid film,
Solvent in volatilization liquid film obtains Absorbable membrane；Alternatively,
Polylactic-co-glycolic acid and Fluvastatin are dissolved in solvent, mixed liquor is made；Mixed liquor is sprawled to obtain liquid film,
Solvent in volatilization liquid film obtains Absorbable membrane.
Lovastatin and Fluvastatin itself are the drug for dropping hyperlipidemia, and Lovastatin and Fluvastatin can induce
The generation of albumen, further, Lovastatin and Fluvastatin can lure the generation of Bone Morphogenetic Protein to induce osteocyte
So that the generation of skeletonization.
In some embodiments of first aspect present invention, the matter of polylactic-co-glycolic acid and Fluvastatin or Lovastatin
Amount is than being 10:0.8-1.2；The ratio of polylactic-co-glycolic acid and solvent is 0.78-0.82g/ml.
Each raw material is under said ratio, and the viscosity of mixed liquor is preferable, and film forming procedure is very fast, be not in film split or
Non-uniform situation, solvent to the solubility of polylactic-co-glycolic acid and Fluvastatin or Lovastatin preferably and solute concentration compared with
Height, being conducive to the later period quickly evaporates solvent.Preferably, the mass ratio of polylactic-co-glycolic acid and Fluvastatin or Lovastatin
For 10:1, the ratio of polylactic-co-glycolic acid and solvent is 0.8g/ml.
In some embodiments of first aspect present invention, solvent is methylene chloride.
Methylene chloride is preferable to the dissolubility of polylactic-co-glycolic acid, and the volatility of methylene chloride is preferable, evaporates solvent
Afterwards, available pure Absorbable membrane.
In some embodiment of first aspect present invention, mixed liquor is sprawled into the step of obtaining liquid film and is specifically included:
Mixed liquor is placed on film carrier body, mixed liquor is equably spread in film carrier body using rotation film instrument.
It is found in inventor's experimentation, mixed liquor is sprawled using rotation film instrument, the uniform liquid film of quality can be obtained.
In some embodiments of first aspect present invention, film carrier body is glass slide.
Liquid film is spread on glass slide, after solvent flashing, Absorbable membrane can be evaporated preferably with glass slide.
Second aspect of the present invention provides a kind of Absorbable membrane, and Absorbable membrane is provided a kind of absorbable by first aspect present invention
The preparation method of film is made.
Third aspect present invention provides a kind of application, the specially application of the Absorbable membrane of second aspect of the present invention offer,
Application of the Absorbable membrane in the regeneration of induction biological tissue, biological tissue includes bone, body surface, gastral mucous membrane or breathing
The mucous membrane in road.
In some embodiments of third aspect present invention, Absorbable membrane is used for bone induction and regeneration.
Absorbable membrane is applied to bore regenerating, induces the generation of Bone Morphogenetic Protein, carries out regeneration induction, Absorbable membrane to bone
To be membranaceous, compared to other granular renewable inducing substances, at least having can be with large area induced osteanagenesis, application range
It is bigger.
In some embodiments of third aspect present invention, Absorbable membrane is for inducing Regeneration of Alveolar Bone.
Osteanagenesis of the Absorbable membrane for tooth socket induces, and can solve because Alveolar bone insufficiency leads to not support
Stable problem of the implant in bone tissue, Absorbable membrane first can induce dentale to regenerate, then be planted.
Fourth aspect present invention provides a kind of dental implant, and the surface of dental implant is coated with second aspect of the present invention offer
Absorbable membrane.
The surface of dental implant coats Absorbable membrane, and it is properer with alveolar bone to be conducive to the dental implant later period, gives birth to faster
It is long.
Absorbable membrane provided in an embodiment of the present invention and its preparation method and application, dental implant beneficial effect be:
The preparation method of Absorbable membrane provided in an embodiment of the present invention can obtain homogeneous film, the embodiment of the present invention
The high mechanical strength of the Absorbable membrane of offer, is greater than 15MPa, and support is new enough organizes the formation of, can preferably inducing action,
And it can be used for extensive tis-sue damage.Absorbable membrane has medicament slow release effect, and is easily absorbed by above-mentioned biological tissue, can be with
It is used in the regeneration of induction biological tissue.
Dental implant provided in this embodiment, it is properer with alveolar bone to be conducive to the dental implant later period, grows faster, contracting
Short treatment cycle, it is more attractive.
Detailed description of the invention
In order to illustrate the technical solution of the embodiments of the present invention more clearly, below will be to needed in the embodiment attached
Figure is briefly described, it should be understood that the following drawings illustrates only certain embodiments of the present invention, therefore is not construed as pair
The restriction of range for those of ordinary skill in the art without creative efforts, can also be according to this
A little attached drawings obtain other relevant attached drawings.
Fig. 1 shows the stress-strain diagram in test example 1；
Fig. 2 shows the tensile strength of two experimental groups during test example 1；
Fig. 3 shows the numerical procedure of bone defect and bone regeneration in test example 3；
The bone that Fig. 4 shows each experimental group skull lacks the MIcrosope image of 4 weeks slices of model；
The bone that Fig. 5 shows each experimental group skull lacks the MIcrosope image of 8 weeks slices of model；
The bone that Fig. 6 shows 6 groups of skulls of embodiment lacks the high power lens image of 8 weeks slices of model；
The bone that Fig. 7 shows the right shin bone of each experimental group lacks the MIcrosope image of 4 weeks slices of model；
The bone that Fig. 8 shows the right shin bone of each experimental group lacks the MIcrosope image of 8 weeks slices of model.
Specific embodiment
Tooth-planting technology has become the primary selection that more and more absence of tooth patients repair, planting technology also with
The research application of Most scholars and doctor, is able to improved day by day.But clinically there is also many patients, they expect that plantation is repaired
Recovering technology restores beautiful, pronunciation and masticatory function, but there is Alveolar bone insufficiencies by these patients itself, can not support implant
Stabilization in bone tissue, then there is the technology of bone induction and regeneration in the later period.Crucial step exists in bone induction and regeneration technology
In the application of shielding film.Traditional film is divided into Absorbable membrane and nonabsorable film (pure titanium film).Nonabsorable film is due to needing two
Secondary operation is taken out, clinical generally to apply Absorbable membrane in the operation of bone induction and regeneration.Absorbable membrane master in the prior art
It to be collagem membrane, but there are certain defectives for the toughness of collagem membrane.
Initial PLGA (poly (lactic-co-glycolic acid)) is applied to absorbable surgical thread, gradually scientist
It was found that the balling-up of PLGA, the degradability with its own, are made into microballoon and nanosphere, it is slow applied to drug to carry key medicine
In release system, but microballoon and nanosphere can be used for the osteanagenesis induction of tooth socket, and the osteanagenesis inducing action to large area is not
It is very beneficial, therefore, Absorbable membrane is made in PLGA in the present invention.
It in order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below will be in the embodiment of the present invention
Technical solution be clearly and completely described.The person that is not specified actual conditions in embodiment, according to normal conditions or manufacturer builds
The condition of view carries out.Reagents or instruments used without specified manufacturer is the conventional production that can be obtained by commercially available purchase
Product.
Absorbable membrane of the embodiment of the present invention and its preparation method and application, dental implant are specifically described below.
Polylactic-co-glycolic acid and Lovastatin are dissolved in solvent, mixed liquor is made；Mixed liquor is sprawled to obtain liquid film,
Solvent in volatilization liquid film obtains Absorbable membrane；Alternatively,
Polylactic-co-glycolic acid and Fluvastatin are dissolved in solvent, mixed liquor is made；Mixed liquor is sprawled to obtain liquid film,
Solvent in volatilization liquid film obtains Absorbable membrane.
Polylactic-co-glycolic acid (poly (lactic-co-glycolic acid), PLGA) is by two kinds of monomer lactic acids and hydroxyl
Guanidine-acetic acid is polymerized at random, is a kind of degradable functional polymer organic compound, has good biocompatibility, nothing
The performance of malicious, good encystation and film forming,
The carrier for carrying polylactic-co-glycolic acid is Lovastatin (Lovastatin) or Fluvastatin
(fluvastatin)。
Lovastatin and Fluvastatin itself are the drug for dropping hyperlipidemia, and Lovastatin and Fluvastatin can induce
The generation of albumen, further, Lovastatin and Fluvastatin can lure the generation of Bone Morphogenetic Protein to induce osteocyte
So that the generation of skeletonization.
In detail, polylactic-co-glycolic acid and Lovastatin or Lovastatin are dissolved in solvent, obtain mixed solution,
Mixed solution is sprawled to obtain liquid film, the solvent in the liquid film that volatilizees obtains Absorbable membrane.
Preferably, the carrier for carrying polylactic-co-glycolic acid is Fluvastatin (fluvastatin).Fluvastatin preparation
Obtained Absorbable membrane hydrolysis property better than Absorbable membrane made from Lovastatin.
It is found after inventor's experiment, particle is made for mixed solution or the regeneration effect of the substance of other forms is bad, institute
Membranaceous mixed liquor to be made in the present embodiment, the shape of film can be regular geometry such as triangle, quadrangle
Deng, or other irregular shapes.
Absorbable membrane is in the case where inducing bone tissue regeneration:
Absorbable membrane with a thickness of 0.4mm, it is best when with a thickness of 0.4mm, in other some embodiments, Absorbable membrane
Thickness may be between 0.4mm-0.8mm, the too thick regeneration to tissue of the thickness of Absorbable membrane has reaction, in wound
It heals unhelpful.The thickness of Absorbable membrane is too thin, and the dynamics of Absorbable membrane is inadequate, and Absorbable membrane needs to bear the pressure of mucous membrane.
In the experimentation of inventor, the Absorbable membrane of different-thickness is made, discovery thickness increase will not in experiment
Increase toughness, it is best with a thickness of toughness when 0.4mm.
It, can according to the application of Absorbable membrane it should be noted that in some other embodiments of the invention
Other thickness are made in absorbing film.
In the present embodiment, the mass ratio of polylactic-co-glycolic acid and Fluvastatin or Lovastatin is 10:0.8-1.2；
The ratio of polylactic-co-glycolic acid and solvent is 0.78-0.82g/ml.
Mixed liquor is sticky when polylactic-co-glycolic acid and the mass ratio of Fluvastatin or Lovastatin are 10:0.8-1.2
Preferably, film forming procedure is very fast for degree, is not in that film splits or non-uniform situation, it is preferable that polylactic-co-glycolic acid and fluorine
The mass ratio for cutting down statin or Lovastatin is 10:1.It is molten when the ratio of polylactic-co-glycolic acid and solvent is 0.78-0.82g/ml
Agent is preferable with the solubility of Fluvastatin or Lovastatin to polylactic-co-glycolic acid and solute concentration is higher, and it is fast to be conducive to the later period
Speed evaporates solvent.Preferably, the ratio of polylactic-co-glycolic acid and solvent is 0.8g/ml.
In some embodiments of the invention, solvent is methylene chloride.Dissolution of the methylene chloride to polylactic-co-glycolic acid
Property it is preferable, and the volatility of methylene chloride is preferable, after evaporating solvent, available pure Absorbable membrane.
It should be noted that in other embodiments of the invention, other solvents can also be used, it is only necessary to which meeting can be same
When dissolve methylene chloride, polylactic-co-glycolic acid, and have preferable volatile performance.
In some embodiments of the invention, mixed liquor is sprawled to obtain liquid film；It specifically includes:
Mixed liquor is placed on film carrier body, mixed liquor is equably spread in film carrier body using rotation film instrument.
It is found in inventor's experimentation, mixed liquor is sprawled using rotation film instrument, the uniform liquid film of quality can be obtained.
Further, above-mentioned film carrier body is glass slide, and inventor's discovery spreads in liquid film on glass slide, solvent flashing
Afterwards, Absorbable membrane can be evaporated preferably with glass slide.
It is understood that in other embodiments of the invention, can also use other instruments or other modes will
Mixed liquor equably drawout, for example, mixed liquor to be placed in the mixed liquor drawout on film carrier body using air-flow.In addition, above-mentioned
Film carrier body be also not necessarily limited to glass slide, such as can be to have other film carrier bodies of same material with glass slide.
The present invention also provides a kind of Absorbable membrane, Absorbable membrane provides a kind of system of Absorbable membrane by first aspect present invention
Preparation Method is made.
The preparation method of Absorbable membrane provided in an embodiment of the present invention can obtain homogeneous film, which can apply
In inducing some biological tissue's regeneration, for example, bone induction and regeneration；Can preferably inducing action, and can be used for large area group
Knit damage.
The present invention also provides a kind of application of above-mentioned Absorbable membrane, Absorbable membrane answering in the regeneration of induction biological tissue
With biological tissue includes the mucous membrane of bone, body surface, gastral mucous membrane or respiratory tract.
Absorbable membrane has medicament slow release effect, and is easily absorbed by above-mentioned biological tissue, so, it can use and given birth in induction
Object regeneration.
Above-mentioned biological tissue can be bone, body surface (such as skin), gastrointestinal mucosal (such as oral mucosa) or exhale
Inhale the mucous membrane (such as schneiderian membrane) in road.
Further, in application process, the weight of experimental subjects (mouse) and the weight of Absorbable membrane are greater than 10:1.?
It is found in inventor's experimentation, Absorbable membrane provided in an embodiment of the present invention can speed up the healing after oral mucosa breakage.
In some embodiments of the invention, Absorbable membrane is applied to bore regenerating, induces the generation of Bone Morphogenetic Protein, right
Bone carries out regeneration induction, Absorbable membrane be it is membranaceous, compared to other granular renewable inducing substances, at least having can be big
Area bone induction and regeneration, application range are bigger.
In some embodiments of the invention, Absorbable membrane is for inducing Regeneration of Alveolar Bone.Absorbable membrane is used for tooth socket
Osteanagenesis induction, can solve because Alveolar bone insufficiency leads to not that stable in bone tissue of implant is supported to ask
Topic, Absorbable membrane first can induce dentale to regenerate, then be planted.
The present invention also provides a kind of dental implant, the surface of dental implant is coated with above-mentioned Absorbable membrane.
The surface of dental implant coats Absorbable membrane, and it is properer with alveolar bone to be conducive to the dental implant later period, gives birth to faster
It is long.
Feature and performance of the invention are described in further detail with reference to embodiments.
Embodiment 1
The present embodiment provides a kind of Absorbable membranes, are mainly made by the following method:
Polylactic-co-glycolic acid and Lovastatin are dissolved in methylene chloride, mixed liquor is made；Mixed liquor is sprawled to obtain liquid
Film, volatilize liquid film in methylene chloride obtain Absorbable membrane；
The mass ratio of polylactic-co-glycolic acid and Lovastatin is 10:0.8, the ratio of polylactic-co-glycolic acid and methylene chloride
Example is 0.78g/ml.
Absorbable membrane provided in this embodiment can be applied to induction biological tissue regeneration, biological tissue include bone, body surface,
The mucous membrane of gastral mucous membrane or respiratory tract.
Further, Absorbable membrane is used for bone induction and regeneration, induces Regeneration of Alveolar Bone.
Embodiment 2
The present embodiment provides a kind of Absorbable membranes, are mainly made by the following method:
Polylactic-co-glycolic acid and Lovastatin are dissolved in methylene chloride, mixed liquor is made；Mixed liquor is sprawled to obtain liquid
Film, volatilize liquid film in methylene chloride obtain Absorbable membrane；
The mass ratio of polylactic-co-glycolic acid and Lovastatin is 10:1.2, the ratio of polylactic-co-glycolic acid and methylene chloride
Example is 0.82g/ml.
Absorbable membrane provided in this embodiment can be applied to induction biological tissue regeneration, biological tissue include bone, body surface,
The mucous membrane of gastral mucous membrane or respiratory tract.
Further, Absorbable membrane is used for bone induction and regeneration, induces Regeneration of Alveolar Bone.
Embodiment 3
The present embodiment provides a kind of Absorbable membranes, are mainly made by the following method:
Polylactic-co-glycolic acid and Lovastatin are dissolved in methylene chloride, mixed liquor is made；Mixed liquor is sprawled to obtain liquid
Film, volatilize liquid film in methylene chloride obtain Absorbable membrane；
The mass ratio of polylactic-co-glycolic acid and Lovastatin is the ratio of 10:1 polylactic-co-glycolic acid and methylene chloride
For 0.8/ml.
Absorbable membrane provided in this embodiment can be applied to induction biological tissue regeneration, biological tissue include bone, body surface,
The mucous membrane of gastral mucous membrane or respiratory tract.
Further, Absorbable membrane is used for bone induction and regeneration, induces Regeneration of Alveolar Bone.
Embodiment 4
The present embodiment provides a kind of dental implant, dental implant is coated with Absorbable membrane, and Absorbable membrane mainly passes through following
Method is made:
Polylactic-co-glycolic acid and Fluvastatin are dissolved in methylene chloride, mixed liquor is made；Mixed liquor is sprawled to obtain liquid
Film, volatilize liquid film in methylene chloride obtain Absorbable membrane；
The mass ratio of polylactic-co-glycolic acid and Fluvastatin is the ratio of 10:1 polylactic-co-glycolic acid and methylene chloride
For 0.8g/ml.
Embodiment 5
The present embodiment provides a kind of Absorbable membranes, are mainly made by the following method:
Polylactic-co-glycolic acid and Lovastatin are dissolved in methylene chloride, mixed liquor is made；Mixed liquor is placed in film carrier body
On, mixed liquor is equably spread in into glass slide using rotation film instrument and obtains liquid film, the methylene chloride in the liquid film that volatilizees obtains to inhale
Winder；
The mass ratio of polylactic-co-glycolic acid and Lovastatin is the ratio of 10:1 polylactic-co-glycolic acid and methylene chloride
For 0.8g/ml.
Absorbable membrane provided in this embodiment can be applied to induction biological tissue regeneration, biological tissue include bone, body surface,
The mucous membrane of gastral mucous membrane or respiratory tract.
Further, Absorbable membrane is used for bone induction and regeneration, induces Regeneration of Alveolar Bone.
Embodiment 6
The present embodiment provides a kind of Absorbable membranes, are mainly made by the following method:
24g polylactic-co-glycolic acid and 24mg Fluvastatin are dissolved in methylene chloride, mixed liquor is made；Mixed liquor is set
In on the round glass slide of 35mm (diameter), mixed liquor is equably spread in into glass slide using rotation film instrument and obtains liquid film, liquid film
So that methylene chloride is sufficiently volatilized 3 days in drying at room temperature and obtains Absorbable membrane.
Absorbable membrane provided in this embodiment can be applied to induction biological tissue regeneration, biological tissue include bone, body surface,
The mucous membrane of gastral mucous membrane or respiratory tract.
Further, Absorbable membrane is used for bone induction and regeneration, induces Regeneration of Alveolar Bone.
Embodiment 7
The present embodiment provides a kind of dental implant, the surface of dental implant is coated with the absorbable of any one of embodiment 1-6
Film.
Comparative example
24g polylactic-co-glycolic acid is taken, is sufficiently mixed with the methylene chloride of 3ml, it is (straight that mixed solution is placed in 35mm
Diameter) round glass slide on, mixed liquor equably spread in into glass slide using rotation film instrument.Film makes methylene chloride in drying at room temperature
Sufficiently volatilization 3 days, obtains pure PLGA film.
Test example 1
The PLGA film that the Absorbable membrane and comparative example obtain to embodiment 6 obtains carries out tension test.
The Absorbable membrane that embodiment 6 obtains and the PLGA film that comparative example obtains are cut into the rectangle of 20mm × 25mm,
It is that 10mm/min is stretched that mechanical stretch instrument, which is utilized respectively, with the dynamics of 50kgf, speed, and intensity when measuring fracture is made even
Mean value is for statistical analysis.
Test result: the Absorbable membrane average thickness that embodiment 6 is obtained is 0.9mm.PLGA film average thickness is
0.80mm, Fig. 1 show the stress-strain diagram in test example 1；Fig. 2 shows during test example 1 two experimental groups it is anti-
Zhang Qiangdu.
It can be seen that go to resist with certain mechanical strength from Fig. 1 and Fig. 2 and averagely be dried from the pressure of mucous membrane
The mechanical strength of film can reach > 15MPa.PLGA film thickness is thinner than the Absorbable membrane for obtaining embodiment 6 after it is stretched.
Test example 2
Sustained release experiment is carried out to the Absorbable membrane that embodiment 6 obtains.
The Absorbable membrane (one piece) that embodiment 6 obtains is shredded in the PBS buffer solution for being placed in 4ml, in 37 degree of cleansing bath tubs
And it constantly rocks.It is daily to extract 70 microlitres, under 405 wavelength of spectrophotometer, test 30 days.
Test result: the Absorbable membrane that embodiment 6 obtains discharges when second day reaches a peak value, daily later
Averagely discharge 0.0015mg.0.031mg is released altogether within 30 days.
Test example 3
The PLGA film that the Absorbable membrane and comparative example obtain to embodiment 6 obtains carries out osteanagenesis experiment, this experiment has obtained
To the approval of Institutional Review Board.
36 8 weeks big mouse (Wistar white mouse, male) altogether, mouse is fed in animal feeding, dedicated mouse grain with
Clean drinking water.
Fig. 3 shows the numerical procedure of bone defect and bone regeneration in test example 3.
Statistical analysis:
Stretching experiment we used Welch ' s test.Tectology measurement analyzes us and has used Bonferroni
Post-test analysis.All numerical value is all that p < 0.05 has statistical significance.
The bone of skull lacks experiment:
All animals are all the production that bone defect model is carried out under general anesthesia.The bone defect size of skull is 7mm (diameter)
Circle, blank assay be simple bone defect model do not cover any film.All experiments are all divided into three groups: blank group,
PLGA film group, 6 groups of embodiment.All mouse are 4 weeks all after epiphragma, the fixed microsection manufacture of slaughter in 8 weeks and dyeing.
The bone that Fig. 4 shows each experimental group skull lacks the MIcrosope image of 4 weeks slices of model；
In Fig. 4: a-1 represents blank group, and b-1 represents PLGA film group, and c-1 represents 6 groups of embodiment, right side a-2, b-2, c-2
For each group of corresponding high power lens observation area.Dotted line is that arrow is the bone defect broken ends of fractured bone, and arrow is area of new bone range.
The bone that Fig. 5 shows each experimental group skull lacks the MIcrosope image of 8 weeks slices of model；
In Fig. 5: A-1 represents blank group, and B-1 represents PLGA film group, and C-1 represents 6 groups of embodiment, right side A-2, B-2, C-2
For each group of corresponding high power lens observation area.Dotted line is that arrow is the bone defect broken ends of fractured bone, and arrow is area of new bone range.
The bone that Fig. 6 shows 6 groups of skulls of embodiment lacks the high power lens image of 8 weeks slices of model.
The bone that can be seen that skull from Fig. 1-Fig. 6 lacks in experimentation, and the 4th week, blank control group was observed in defect
Some bon e formations.PLGA film group is with the presence of bon e formation, but film still has remaining.Some bon e formations are also observed in 6 groups of embodiment, are lacked
Area is damaged to be covered by connective tissue and residual film.
8th week, some bon e formations were observed at all groups of defect center.However, being observed in defect perimeter few
Measure new bone formation.6 groups of embodiment of defect viewed edge is to new bon e formation and bone remoulding.
In discovery in the 4th week, p < 0.01,6 groups of new embodiment variant with blank group ostosis.8th week, in p < 0.05
When, 6 groups of embodiment have notable difference with other two groups of new bones.
The bone of right shin bone lacks experiment:
All animals are all the production that bone defect model is carried out under general anesthesia.Thigh bone bone defect size is the square of 2mm × 3mm
Shape.Blank assay is that simple bone defect model does not cover any film.All experiments are all divided into three groups: blank group, PLGA film
Group, 6 groups of embodiment.All mouse are 4 weeks all after epiphragma, the fixed microsection manufacture of slaughter in 8 weeks and dyeing.
The bone that Fig. 7 shows the right shin bone of each experimental group lacks the MIcrosope image of 4 weeks slices of model；
In Fig. 7: a-1 represents blank group, and b-1 represents PLGA film group, and c-1 represents 6 groups of embodiment, right side a-2, b-2, c-2
For each group of corresponding high power lens observation area.Arrow is bone defect region；NB (new bone) represents new bone；OB
(original bone) represents raw bone.
The bone that Fig. 8 shows the right shin bone of each experimental group lacks the MIcrosope image of 8 weeks slices of model；
In Fig. 8: A-1 represents blank group, and B-1 represents PLGA film group, and C-1 represents 6 groups of embodiment, right side A-2, B-2, C-2
For each group of corresponding high power lens observation area.Arrow is bone defect region；NB (new bone) represents new bone；OB
(original bone) represents raw bone.
It can be seen that from Fig. 7 and Fig. 8 in all groups without discovery immune response.Blank group discovery in 4th week has new bone
It is formed, remaining two groups have a large amount of new bone formations.8th week, it is found that all groups have in bone defect and are full of by new bone.
4th week, some bon e formations are observed in blank control group.In PLGA film and 6 groups of embodiment, quilt at bone defect
New bone is filled.8th week, defect was filled with the bone newly formed in all groups.The Regenerated Bone that 6 groups of embodiment is more compared with other groups
It is thick, finer and close.
At the 4th week, p < 0.01,6 groups of embodiment had apparent otherness with other two groups.8th week, p < 0.01, embodiment 6
Group has apparent otherness in New born formation with other two groups.
From the experiment and result in test example 1- test example 3 it can be seen that
The drug for the Absorbable membrane 30 days releasable quite dosage that embodiment 6 provides induces bone with extremely low side effect
Shielding film in regeneration because it needs certain mechanical strength to go to resist the pressure from mucous membrane, and ensures there is certain sky
Between supportability, give skeletonization certain space.The mechanical strength of average desciccator diaphragm can reach > 15MPa, and what embodiment 6 provided can
Absorbing film is in animal experiments, it can be seen that its intensity can support new bone formation space.
In addition, also showing Absorbable membrane provided in an embodiment of the present invention is to have its applicability in bone induction and regeneration.
Promote in addition, inventor has found that Absorbable membrane also has in mucous membrane (respiratory mucosa and gastrointestinal mucosal) regeneration
Into inducing action, its regeneration can be induced.
The foregoing is only a preferred embodiment of the present invention, is not intended to restrict the invention, for the skill of this field
For art personnel, the invention may be variously modified and varied.All within the spirits and principles of the present invention, made any to repair
Change, equivalent replacement, improvement etc., should all be included in the protection scope of the present invention.
Claims (10)
1. a kind of preparation method of Absorbable membrane characterized by comprising
Polylactic-co-glycolic acid and Lovastatin are dissolved in solvent, mixed liquor is made；It sprawls the mixed liquor to obtain liquid film,
The solvent to volatilize in the liquid film obtains Absorbable membrane；Alternatively,
Polylactic-co-glycolic acid and Fluvastatin are dissolved in solvent, mixed liquor is made；It sprawls the mixed liquor to obtain liquid film,
The solvent to volatilize in the liquid film obtains Absorbable membrane.
2. the preparation method of Absorbable membrane according to claim 1, which is characterized in that the polylactic-co-glycolic acid and institute
The mass ratio for stating Fluvastatin or the Lovastatin is 10:0.8-1.2；The ratio of the polylactic-co-glycolic acid and the solvent
Example is 0.78-0.82g/ml.
3. the preparation method of Absorbable membrane according to claim 1, which is characterized in that the solvent is methylene chloride.
4. the preparation method of Absorbable membrane according to claim 1-3, which is characterized in that spread the mixed liquor
The step of exhibition obtains the liquid film specifically includes:
The mixed liquor is placed on film carrier body, the mixed liquor is equably spread in into the film carrier body using rotation film instrument.
5. the preparation method of Absorbable membrane according to claim 4, which is characterized in that the film carrier body is glass slide.
6. a kind of Absorbable membrane, which is characterized in that the Absorbable membrane is by the described in any item Absorbable membranes of claim 1-5
Preparation method is made.
7. application of the Absorbable membrane as claimed in claim 6 in the regeneration of induction biological tissue, which is characterized in that the biology group
Knit the mucous membrane including bone, body surface, gastral mucous membrane or respiratory tract.
8. application according to claim 7, which is characterized in that the Absorbable membrane is used for bone induction and regeneration.
9. application according to claim 7, which is characterized in that the Absorbable membrane is for inducing Regeneration of Alveolar Bone.
10. a kind of dental implant, which is characterized in that the surface of the dental implant is coated with as claimed in claim 6 absorbable
Film.
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| CN201811368011.XA CN109248338A (en) | 2018-11-16 | 2018-11-16 | Absorbable membrane and its preparation method and application, dental implant |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201811368011.XA CN109248338A (en) | 2018-11-16 | 2018-11-16 | Absorbable membrane and its preparation method and application, dental implant |
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| CN101219119A (en) * | 2008-01-25 | 2008-07-16 | 吉林大学 | Method of preparing simvastatin sustained-release microsphere carried series |
| CN102271723A (en) * | 2009-01-12 | 2011-12-07 | 哈达斯特医疗研究服务和开发有限公司 | Tissue regeneration membrane |
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