CN107648664A - A kind of gel rubber material for backbone reparation of injectable and preparation method thereof - Google Patents
A kind of gel rubber material for backbone reparation of injectable and preparation method thereof Download PDFInfo
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- CN107648664A CN107648664A CN201711044975.4A CN201711044975A CN107648664A CN 107648664 A CN107648664 A CN 107648664A CN 201711044975 A CN201711044975 A CN 201711044975A CN 107648664 A CN107648664 A CN 107648664A
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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
- A61L27/14—Macromolecular materials
- A61L27/20—Polysaccharides
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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
- A61L27/52—Hydrogels or hydrocolloids
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J3/00—Processes of treating or compounding macromolecular substances
- C08J3/02—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques
- C08J3/03—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques in aqueous media
- C08J3/075—Macromolecular gels
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J3/00—Processes of treating or compounding macromolecular substances
- C08J3/24—Crosslinking, e.g. vulcanising, of macromolecules
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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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/06—Flowable or injectable implant compositions
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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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J2305/00—Characterised by the use of polysaccharides or of their derivatives not provided for in groups C08J2301/00 or C08J2303/00
- C08J2305/04—Alginic acid; Derivatives thereof
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- Oral & Maxillofacial Surgery (AREA)
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Abstract
The present invention relates to gel rubber material for backbone reparation of a kind of injectable and preparation method thereof, certain density mixed solution is configured to using alginic acid and phosphate buffer (PBS7.4), the mixed liquor of calcium chloride, calcium carbonate and guluronic acid is slowly added to using filtration system afterwards, crosslinking certain time obtains gel rubber material.The present invention can efficiently control the mechanical property of crosslinking mechanisms and gel using marine alga acid gel injectable use, solving injection at present and instantaneous crosslink reaction can make it that calcium alginate gel mechanical property is uneven, it is defective in gel, it is narrow plus injection site, the narrow bad operation in space, can amplify such inhomogeneities.
Description
Technical field
The present invention relates to gel rubber material for backbone reparation of a kind of injectable and preparation method thereof, more specifically, it is
It is a kind of that the alginic acid hydrogel material prepared is reacted using Controllable cross-linking
Background technology
Degenerative lumbar refer to articular cartilage occur regression, it is secondary with joint margins and subchondral bone matter with the new shape of proliferative
Into a kind of arthropathy.Work, motion or bad life habits result in the need for repairing lumber ertebral disc transformation position in backbone
Sufferer is growing day by day, and crowd more than 85% can have an experience of slight backache again for conservative estimation, and 40% sufferer among these
There is degenerative lumbar in display.In the U.S., it is only used for treating the expense of interverbebral disc reparation or reconstruction every year more than 200,000,000,000 U.S. dollars,
Including steroid medicine to physical treatment, or even to invasive foraminotomy or spinal fusion art.Operations in treating
Degenerative lumbar is not the method effected a permanent cure, and is only capable of alleviating the Neurological signs as caused by lumbar vertebrae atrophy, such as radiculopathy or ischium
Neuralgia etc..Instantly, recover the height of regression lumbar vertebrae and feature using injection system is considered as treating degenerative lumbar
It is the mode of more feasible and less invasive injury.Therefore, can just be provided using the cellularised support of organizational project enough
Mechanical stability is so as to strengthening treatment repairing effect.Researcher has designed and developed a series of macromolecule hydrogel and has been used for vertebra
Disk injection treatment, including natural polymer, such as Sodium Hyaluronate, collagen, gelling carbohydrate gum, the polypeptide of self assembly and more
The high molecular combination of kind, fibroin albumen and elastin laminin etc.；The pNIPAM of artificial synthesized macromolecule, such as crosslinking, photocuring
PHEMA, and PLGA etc.；Natural polymer and the high molecular mixture of synthesis, such as PEG and hyaluronic acid.
Calcium alginate is a kind of mucopolysaccharide macromolecule of bio-compatible, because its special structure can be as transhipment cell
Medium.The copolymer for forming calcium alginate mainly has G (α-guluronic acid) and M (β-mannuronic acid), because source is different
Both segments also have diversified combination, thus also cause the mechanical property and degradation behavior of otherness.External application
Marine alga acid gel be typically all to be crosslinked with very segregative calcium chloride, yet with cross-linking reaction usually in solution
Middle generation, and the reaction time is short, and cross-link intensity is high, therefore the macroscopic form of calcium alginate gel is difficult control, is often drawn
It is uneven to play mechanical property, uncontrollable problem such as gelation time, form, diffusivity.
Using the calcium cross-linked alginic acid of chlorination it is verified that the nucleus pulposus cell parting of biosynthesis can be protected in vitro
Up to surrounding, and the 2% calcium cross-linked calcium alginate of chlorination has identical viscoelastic sexual behaviour with natural nucleus pulposus tissue.It is in situ
Crosslinking is probably the key for solving these side effects.In addition, alginic acid can reduce injection to cell during use is injected
Influence, and inject after a period of time can automatically form cytoskeleton.But injection and instantaneous crosslink reaction can cause sea
Calcium alginate gel mechanical property is uneven, defective in gel, narrow plus injection site, the narrow bad operation in space, can amplify
Such inhomogeneities.Therefore, it is to reduce cross-linking reaction speed by the core that marine alga acid gel injectable uses, so as to more preferable
Control crosslinking mechanisms and gel mechanical property.Calcium chloride is replaced using calcium carbonate, is there is situation existing for enough hydrogen ions
Under, the calcium ion in calcium carbonate will all be discharged, therefore control the acid-base value and temperature of crosslinker solution, it becomes possible to be controlled
Cross-linking reaction speed.
Every kind of injection has its handling characteristics, and the wherein advantage of alginic acid cross-linked gel is the most obvious, but its is controllable
Cross-linking reaction speed and the viscoelastic sexual behaviour of class nucleus pulposus be not easy to realize various unmatched defects all be present.This
The injectable backbone of invention repairs gel and is namely based on Special controlling to alginic acid cross-linking reaction, is ensureing its porous, thin
Under conditions of born of the same parents' migration, nutriment transporting and discarded object discharge, intensity and viscoelastic sexual behaviour and marrow after its crosslinking are realized
Core tissue matches, and so as to effectively simulate nucleus pulposus, protects the not frayed injury of interverbebral disc, slows down degeneration.
The content of the invention
For the problems of the prior art, the present invention provides a kind of gel rubber material for backbone reparation of injectable, adopted
The mechanical property of crosslinking mechanisms and gel can be efficiently controlled with marine alga acid gel injectable use, solves current injection
It is defective in gel and instantaneous crosslink reaction can make it that calcium alginate gel mechanical property is uneven, it is narrow plus injection site, it is empty
Between narrow bad operation, such inhomogeneities can be amplified.
To realize above technical purpose, the technical scheme is that：A kind of gel for backbone reparation of injectable
Material, it is characterised in that：The gel rubber material is made up of calcium alginate hydrogel, the calcium alginate degree of cross linking ＞ 40%, is contained
A small amount of phosphate.
The preparation method of the gel rubber material is in accordance with the following steps：
Step 1,1X phosphate buffers are taken, adds in alginic acid, room temperature ultrasound 10min, is configured to alginate solution；
Step 2, calcium carbonate, calcium chloride and guluronic acid are configured to the aqueous solution, it is 8%-10% to obtain total concentration
The calcium mixed liquor of (mass-volume concentration)；
Step 3, alginate solution is passed through to the shell of double syringe, calcium mixed liquor is passed through to the stratum nucleare of double syringe,
Two kinds of solution are released into double syringe, uniform fold is fully cured behind protection surface, 10min, obtains gel rubber material.
The viscosity of alginic acid in the step 1 is 300-800KDa, and the M/G of the alginic acid is 1-2.
The concentration of alginate solution in the step 1 is 1.5%-3.5% (mass-volume concentration).
The supersonic frequency of room temperature ultrasound in the step 1 is 25-55kHz, and the ultrasound uses water bath sonicator.
The pH of phosphate buffer in the step 1 is 7.4.
The mass ratio of guluronic acid is 1-9 more than calcium carbonate in the step 2:3, calcium chloride concentration is 6%-8% (matter
Measure volumetric concentration).
Double syringe in the step 3 is linked together by mixing flexible pipe, the shell of the alginate solution connection
Inner diameter is 5mm, is 0.5-3mL/min to liquid speed rate.
The internal diameter of the stratum nucleare flexible pipe of calcium mixed liquor connection in the step 3 is 2mm, is 1-5mL/min to liquid speed rate.
The overlay capacity of uniform fold in the step 3 is 1-10mL/cm2。
The present invention is configured to certain density mixed solution, Zhi Houli using alginic acid with phosphate buffer (PBS7.4)
The mixed liquor of calcium chloride, calcium carbonate and guluronic acid is slowly added to filtration system, gel material is obtained by way of crosslinking
Material.
From the above, it can be seen that the present invention possesses advantages below：
1. the present invention can efficiently control the mechanics of crosslinking mechanisms and gel using marine alga acid gel injectable use
Performance, solving injection at present and instantaneous crosslink reaction can make it that calcium alginate gel mechanical property is uneven, defective in gel,
It is narrow plus injection site, the narrow bad operation in space, such inhomogeneities can be amplified.
2. the present invention replaces calcium chloride, in the presence of having enough hydrogen ions, the calcium in calcium carbonate using calcium carbonate
Ion will all be discharged, and reach the acid-base value and temperature of control crosslinker solution, so as to control cross-linking reaction speed.
3. the present invention, which realizes the intensity of gel rubber material and viscoplasticity after cross-linking reaction, to match with nucleus pulposus, from
And nucleus pulposus is effectively simulated, the not frayed injury of interverbebral disc is protected, slows down degeneration.
4. gel rubber material modulus of compressibility about 800-1000kPa, modulus of shearing 15-20kPa prepared by the present invention, diffusion speed
20 μm of rate2/ s, intensity tenability time about 1 year in vivo.
Embodiment
Describe the present invention in detail in conjunction with the embodiments, but any restriction is not done to the claim of the present invention.
Embodiment 1
A kind of gel rubber material for backbone reparation of injectable, it is characterised in that：The gel rubber material is by calcium alginate
Hydrogel is formed, the calcium alginate degree of cross linking ＞ 40%, containing a small amount of phosphate.
The preparation method of the gel rubber material is in accordance with the following steps：
Step 1,1X phosphate buffers are taken, adds in alginic acid, room temperature ultrasound 10min, is configured to alginate solution；
Step 2, calcium carbonate, calcium chloride and guluronic acid are configured to the aqueous solution, it is 8% (mass body to obtain total concentration
Product concentration) calcium mixed liquor；
Step 3, alginate solution is passed through to the shell of double syringe, calcium mixed liquor is passed through to the stratum nucleare of double syringe,
Two kinds of solution are released into double syringe, uniform fold is fully cured behind protection surface, 10min, obtains gel rubber material.
The viscosity of alginic acid in the step 1 is 300KDa, and the M/G of the alginic acid is 1.
The concentration of alginate solution in the step 1 is 1.5% (mass-volume concentration).
The supersonic frequency of room temperature ultrasound in the step 1 is 25kHz, and the ultrasound uses water bath sonicator.
The pH of phosphate buffer in the step 1 is 7.4.
The mass ratio of guluronic acid is 1 more than calcium carbonate in the step 2:3, calcium chloride concentration is that 6% (quality volume is dense
Degree).
Double syringe in the step 3 is linked together by mixing flexible pipe, the shell of the alginate solution connection
Inner diameter is 5mm, is 0.5mL/min to liquid speed rate.
The internal diameter of the stratum nucleare flexible pipe of calcium mixed liquor connection in the step 3 is 2mm, is 1mL/min to liquid speed rate.
The overlay capacity of uniform fold in the step 3 is 1mL/cm2。
Gel rubber material modulus of compressibility manufactured in the present embodiment is 800kPa, and modulus of shearing 15kPa, diffusion rate is 20 μ
m2/s
Embodiment 2
A kind of gel rubber material for backbone reparation of injectable, it is characterised in that：The gel rubber material is by calcium alginate
Hydrogel is formed, the calcium alginate degree of cross linking ＞ 40%, containing a small amount of phosphate.
The preparation method of the gel rubber material is in accordance with the following steps：
Step 1,1X phosphate buffers are taken, adds in alginic acid, room temperature ultrasound 10min, is configured to alginate solution；
Step 2, calcium carbonate, calcium chloride and guluronic acid are configured to the aqueous solution, it is 10% (quality to obtain total concentration
Volumetric concentration) calcium mixed liquor；
Step 3, alginate solution is passed through to the shell of double syringe, calcium mixed liquor is passed through to the stratum nucleare of double syringe,
Two kinds of solution are released into double syringe, uniform fold is fully cured behind protection surface, 10min, obtains gel rubber material.
The viscosity of alginic acid in the step 1 is 800KDa, and the M/G of the alginic acid is 2.
The concentration of alginate solution in the step 1 is 3.5% (mass-volume concentration).
The supersonic frequency of room temperature ultrasound in the step 1 is 55kHz, and the ultrasound uses water bath sonicator.
The pH of phosphate buffer in the step 1 is 7.4.
The mass ratio of guluronic acid is 9 more than calcium carbonate in the step 2:3, calcium chloride concentration is that 8% (quality volume is dense
Degree).
Double syringe in the step 3 is linked together by mixing flexible pipe, the shell of the alginate solution connection
Inner diameter is 5mm, is 3mL/min to liquid speed rate.
The internal diameter of the stratum nucleare flexible pipe of calcium mixed liquor connection in the step 3 is 2mm, is 5mL/min to liquid speed rate.
The overlay capacity of uniform fold in the step 3 is 10mL/cm2。
Gel rubber material modulus of compressibility manufactured in the present embodiment is 900kPa, and modulus of shearing 18kPa, diffusion rate is 20 μ
m2/s
Embodiment 3
A kind of gel rubber material for backbone reparation of injectable, it is characterised in that：The gel rubber material is by calcium alginate
Hydrogel is formed, the calcium alginate degree of cross linking ＞ 40%, containing a small amount of phosphate.
The preparation method of the gel rubber material is in accordance with the following steps：
Step 1,1X phosphate buffers are taken, adds in alginic acid, room temperature ultrasound 10min, is configured to alginate solution；
Step 2, calcium carbonate, calcium chloride and guluronic acid are configured to the aqueous solution, it is 9% (mass body to obtain total concentration
Product concentration) calcium mixed liquor；
Step 3, alginate solution is passed through to the shell of double syringe, calcium mixed liquor is passed through to the stratum nucleare of double syringe,
Two kinds of solution are released into double syringe, uniform fold is fully cured behind protection surface, 10min, obtains gel rubber material.
The viscosity of alginic acid in the step 1 is 500KDa, and the M/G of the alginic acid is 1.5.
The concentration of alginate solution in the step 1 is 2.5% (mass-volume concentration).
The supersonic frequency of room temperature ultrasound in the step 1 is 40kHz, and the ultrasound uses water bath sonicator.
The pH of phosphate buffer in the step 1 is 7.4.
The mass ratio of guluronic acid is 4 more than calcium carbonate in the step 2:3, calcium chloride concentration is that 7% (quality volume is dense
Degree).
Double syringe in the step 3 is linked together by mixing flexible pipe, the shell of the alginate solution connection
Inner diameter is 5mm, is 1.5mL/min to liquid speed rate.
The internal diameter of the stratum nucleare flexible pipe of calcium mixed liquor connection in the step 3 is 2mm, is 3mL/min to liquid speed rate.
The overlay capacity of uniform fold in the step 3 is 5mL/cm2。。
Gel rubber material modulus of compressibility prepared by the present invention is 1000kPa, and modulus of shearing 20kPa, diffusion rate is 20 μ
m2/s
In summary, the present invention has advantages below：
1. the present invention can efficiently control the mechanics of crosslinking mechanisms and gel using marine alga acid gel injectable use
Performance, solving injection at present and instantaneous crosslink reaction can make it that calcium alginate gel mechanical property is uneven, defective in gel,
It is narrow plus injection site, the narrow bad operation in space, such inhomogeneities can be amplified.
2. the present invention replaces calcium chloride, in the presence of having enough hydrogen ions, the calcium in calcium carbonate using calcium carbonate
Ion will all be discharged, and reach the acid-base value and temperature of control crosslinker solution, so as to control cross-linking reaction speed.
3. the present invention, which realizes the intensity of gel rubber material and viscoplasticity after cross-linking reaction, to match with nucleus pulposus, from
And nucleus pulposus is effectively simulated, the not frayed injury of interverbebral disc is protected, slows down degeneration.
4. gel rubber material modulus of compressibility about 800-1000kPa, modulus of shearing 15-20kPa prepared by the present invention, diffusion speed
20 μm of rate2/ s, intensity tenability time about 1 year in vivo.
It is understood that above with respect to the specific descriptions of the present invention, it is merely to illustrate the present invention and is not limited to this
Technical scheme described by inventive embodiments.It will be understood by those within the art that still the present invention can be carried out
Modification or equivalent substitution, to reach identical technique effect；As long as meet use needs, all protection scope of the present invention it
It is interior.
Claims (10)
- A kind of 1. gel rubber material for backbone reparation of injectable, it is characterised in that：The gel rubber material is by calcium alginate water Gel is formed, the calcium alginate degree of cross linking ＞ 40%, containing a small amount of phosphate.
- A kind of 2. gel rubber material for backbone reparation of injectable according to claim 1, it is characterised in that：It is described solidifying The preparation method of glue material is in accordance with the following steps：Step 1,1X phosphate buffers are taken, adds in alginic acid, room temperature ultrasound 10min, is configured to alginate solution；Step 2, calcium carbonate, calcium chloride and guluronic acid are configured to the aqueous solution, it is 8%-10% (mass bodies to obtain total concentration Product concentration) calcium mixed liquor；Step 3, alginate solution is passed through to the shell of double syringe, calcium mixed liquor is passed through to the stratum nucleare of double syringe, by two Kind solution releases double syringe, and uniform fold is fully cured behind protection surface, 10min, obtains gel rubber material.
- A kind of 3. gel rubber material for backbone reparation of injectable according to claim 2, it is characterised in that：The step The viscosity of alginic acid in rapid 1 is 300-800KDa, and the M/G of the alginic acid is 1-2.
- A kind of 4. gel rubber material for backbone reparation of injectable according to claim 2, it is characterised in that：The step The concentration of alginate solution in rapid 1 is 1.5%-3.5% (mass-volume concentration).
- A kind of 5. gel rubber material for backbone reparation of injectable according to claim 2, it is characterised in that：The step The supersonic frequency of room temperature ultrasound in rapid 1 is 25-55kHz, and the ultrasound uses water bath sonicator.
- A kind of 6. gel rubber material for backbone reparation of injectable according to claim 2, it is characterised in that：The step The pH of phosphate buffer in rapid 1 is 7.4.
- A kind of 7. gel rubber material for backbone reparation of injectable according to claim 2, it is characterised in that：The step The mass ratio of guluronic acid is 1-9 more than calcium carbonate in rapid 2:3, calcium chloride concentration is 6%-8% (mass-volume concentration).
- A kind of 8. gel rubber material for backbone reparation of injectable according to claim 2, it is characterised in that：The step Double syringe in rapid 3 is linked together by mixing flexible pipe, and the shell inner diameter of the alginate solution connection is 5mm, It is 0.5-3mL/min to liquid speed rate.
- A kind of 9. gel rubber material for backbone reparation of injectable according to claim 2, it is characterised in that：The step The internal diameter of the stratum nucleare flexible pipe of calcium mixed liquor connection in rapid 3 is 2mm, is 1-5mL/min to liquid speed rate.
- A kind of 10. gel rubber material for backbone reparation of injectable according to claim 2, it is characterised in that：It is described The overlay capacity of uniform fold in step 3 is 1-10mL/cm2。
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114917410A (en) * | 2022-07-19 | 2022-08-19 | 媄典(北京)生物科技有限公司 | Pomegranate type gel ball and preparation method thereof |
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| CN114917410A (en) * | 2022-07-19 | 2022-08-19 | 媄典(北京)生物科技有限公司 | Pomegranate type gel ball and preparation method thereof |
| CN114917410B (en) * | 2022-07-19 | 2022-09-30 | 媄典(北京)生物科技有限公司 | Pomegranate type gel ball and preparation method thereof |
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