CN109908400A - A kind of material and production method of antibiotic-loaded bone cement Invasive lumbar fusion device - Google Patents
A kind of material and production method of antibiotic-loaded bone cement Invasive lumbar fusion device Download PDFInfo
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- CN109908400A CN109908400A CN201910349295.6A CN201910349295A CN109908400A CN 109908400 A CN109908400 A CN 109908400A CN 201910349295 A CN201910349295 A CN 201910349295A CN 109908400 A CN109908400 A CN 109908400A
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Abstract
The invention discloses the materials and production method of a kind of antibiotic-loaded bone cement type Invasive lumbar fusion device.Material as Invasive lumbar fusion device will have many excellent features: high temperature resistant, mechanical performance are excellent, self-lubrication is good, fire-retardant, corrosion resistance, peel resistance, wearability etc..The material of traditional Invasive lumbar fusion device is polyether-ether-ketone (PEEK) resin material, it is the Linear aromatic macromolecular compound in molecular backbone containing chain link, its processing technology is complicated, and the problem that postoperative prosthetic is poor, poor biocompatibility, mechanical strength are excessive is worth our deep thinkings.The present invention, it is characterized in that, the Invasive lumbar fusion device is made by antibiotic-loaded bone cement, and the material of antibiotic-loaded bone cement is made of powder component and liquid component, simple for the preparation process of Invasive lumbar fusion device, with good easy plasticity, it can solidify at room temperature, there is stable solidification process, be made into Invasive lumbar fusion device with suitable mechanical strength, good biocompatibility, because it contains antibiotic, moreover it is possible to play the role of prevention and treatment postoperative infection.
Description
Technical field
The present invention relates to material science and medical domains, more particularly, to a kind of antibiotic-loaded bone cement Invasive lumbar fusion device
Material and production method.
Background technique
Currently, interbody fusion is the effective ways for treating backbone degenerative diseases.Invasive lumbar fusion device can play anti-off effect,
Realize the fusion of lesion centrum.Material requirements high temperature resistant, the mechanical performance of fusion device be excellent, corrosion-resistant, wearability, anti-radiation
Polyether-ether-ketone resin (PEEK) material is used Deng, traditional fusion device, is a kind of special engineering plastics haveing excellent performance, has
Essential characteristic needed for fusion device, still, PEEK material is during heat treatment, internal indefinite form knot easy to form
Crystalline substance causes internal stress to be gathered, stress raisers and influence integral strength.Due to its injection, molding and section bar extrusion technique item
Part is harsh, and environment is increasingly important when using PEEK material.The present invention uses material of the antibiotic-loaded bone cement as Invasive lumbar fusion device
Material, it is intended to which optimization fusion device subtracts the complicated technology of its traditional material, so that Invasive lumbar fusion device is simply made.
The present invention uses making material of the antibiotic-loaded bone cement as Invasive lumbar fusion device, and main component is that polyacrylic acid is poly-
Close object powder and monomer.This material has been widely applied after joint replacement urethroptasty, centrum in convex urethroptasty, in order to reduce
Postoperative bacterium infection can add antibiotic within this material, make it have antibacterial functions.The preparation letter of such product
The advantages that single, easy plasticity, injectable implant procedure is strong, good mechanical properties after implantation, curing time is controllable, clinically
Application development is rapid.
Summary of the invention
For the defects in the prior art, the object of the present invention is to provide a kind of antibiotic-loaded bone cement type Invasive lumbar fusion devices
Material and production method.
Technical scheme is as follows:
A kind of material of antibiotic-loaded bone cement type Invasive lumbar fusion device, is made of powder component and liquid component.
The powder component: polymethyl methacrylate, benzoyl peroxide, zirconium dioxide, antibiotic.
The liquid component: methyl methacrylate, N, N- dimethyl-p-toluidine, hydroquinone.
Preferably, the polymethyl methacrylate in the powder component accounts for 80-90 part of bone cement powder weight.
Preferably, the powder component initiator is benzoyl peroxide, accounts for 0.5-2 part of bone cement powder weight.
Preferably, antibiotic is gentamicin in the powder component, accounts for 1-5 part of bone cement powder weight.
Preferably, the powder component zirconium dioxide, accounts for 8-15 part of bone cement powder weight by 1-50 μm of particle diameter distribution.
Preferably, the methyl methacrylate in the liquid component accounts for 85-99 part of bone cement liquid quality.
Preferably, the liquid component N, N- dimethyl-p-toluidine account for 1-5 part of bone cement liquid quality.
Preferably, the liquid component hydroquinone accounts for 0.5-2 part of bone cement liquid quality.
Preferably, the mass ratio of the powder and liquid is 2:1-1.5, after mixed at room temperature can random plasticity, 10-20 point
Solidification, can produce the fusion device of antibiotic-loaded bone cement material in clock.
The invention further relates to the materials and production method of antibiotic-loaded bone cement type Invasive lumbar fusion device, and the method includes as follows
Step:
Step 1, the preparation of powder:
(1) polymethyl methacrylate and zirconium dioxide are filled and (2) divide stirring 1-2hr, be uniformly mixed it；
(2) benzoyl peroxide is added, 2-3h is sufficiently stirred, is uniformly mixed it；
(3) antibiotic is added and is stirred 2-3h under vacuum conditions, mixes well；
Step 2, liquid dosage:
(1), by methyl methacrylate and N, N- dimethyl-p-toluidine is uniformly mixed；
(2) hydroquinone is added, mixing is sufficiently stirred；
Step 3, powder are mixed with liquid:
Operation temperature carries out under the conditions of 23 ± 1 DEG C, and powder is mixed with liquid proportional, and incorporation time 30 seconds to 1
Minute, the mixture that powder and liquid are mixed to prepare subsequently enters the haircuts phase about 2-4 minutes；
Step 4 fills mold forming:
(1) by mixture, pour into Invasive lumbar fusion device mold, it is made to be filled up completely entire mold；
(2) 10-20 minutes after powder is mixed with liquid, mixture viscosity, which starts to increase, enters curing time；
(3), by the waiting filled about 30-60 minutes, after confirming curing molding, can dismantle mold.
Compared with prior art, the invention has the following beneficial effects: (1) material preparation process of the present invention is simple and easy,
It is easy to be made, operating environment is not simply harsh.(2) antibiotic is added, the antibacterial action of antibiotic can be played, reduce postoperative sense
The generation of dye.(3) this material is preferred for orthopaedics implantation and filling extensively, and clinical data is more, can trust as intervertebral
Fusion device uses.(4) bone cement material has excellent mechanical performance, good biocompatibility, room temperature curable.(5)
Easy plasticity, Invasive lumbar fusion device size that can be as needed carry out filling molding shape.(6) this bone cement has good developability, can
Significantly to observe situation after fusion device implantation.
Specific embodiment
The present embodiment is related to the material and production method of a kind of antibiotic-loaded bone cement Invasive lumbar fusion device, and the material is by following original
Material forms by weight, the powder component: 80-90 parts of polymethyl methacrylate, 0.5-2 parts of initiator, and antibiotic 1-5
Part, 8-15 parts of developer.The liquid component: 85-99 parts of methyl methacrylate, N, 1-5 parts of N- dimethyl-p-toluidine, right
0.5-2 parts of benzenediol.The present invention is described in detail combined with specific embodiments below, but following embodiments are not to this hair
Bright restriction.
Embodiment 1:
Step 1, powder group assignment system:
(1) by 82 parts and 14.5 parts of zirconium dioxide of polymethyl methacrylate, 1h is sufficiently stirred, is uniformly mixed it；
(2) it is added 0.5 part of benzoyl peroxide, 2h is sufficiently stirred, is uniformly mixed it；
(3) 3 parts of stirring 2h of antibiotic are added, mix well；
Step 2, liquid dosage:
(1) 98 parts of methyl methacrylate and 1 part of N, N- dimethyl-p-toluidine are uniformly mixed；
(2) it is added 1 part of hydroquinone, mixing is sufficiently stirred；
Step 3 is mixed powder and liquid in 2:1.2 ratio；
Step 4, operation temperature carry out under the conditions of 23 ± 1 DEG C, and carefully stirring mixture about 30 seconds, subsequently enter the haircuts phase about
2.5 minutes, moulding can be carried out to bone cement during this period, squeeze into fusion device mold, it is made to be filled up completely entire mold, bone cement
Viscosity, which starts to increase, enters curing time, waits about 15 minutes completion of cures, can dismantle mold.
Embodiment 2:
Step 1, powder group assignment system:
(1) by 82 parts and 13 parts of zirconium dioxide of polymethyl methacrylate, 2h is sufficiently stirred, is uniformly mixed it；
(2) 2 parts of benzoyl peroxide are added, 3h is sufficiently stirred, is uniformly mixed it；
(3) 3 parts of stirring 3h of antibiotic are added, mix well
Step 2, liquid dosage:
(1) 93 parts of methyl methacrylate and 5 parts of N, N- dimethyl-p-toluidine are uniformly mixed；
(2) 2 parts of hydroquinone are added, mixing is sufficiently stirred；
Step 3, with embodiment 1；
Step 4, with embodiment 1.
Embodiment 3:
Step 1, powder group assignment system:
(1) by 86 parts and 10 parts of zirconium dioxide of polymethyl methacrylate, 1h is sufficiently stirred, is uniformly mixed it；
(2) it is added 1 part of benzoyl peroxide, 2h is sufficiently stirred, is uniformly mixed it；
(3) 3 parts of stirring 2h of antibiotic are added, mix well；
Step 2, liquid dosage:
(1) 97 parts of methyl methacrylate and 1.5 parts of N, N- dimethyl-p-toluidine are uniformly mixed；
(2) 1.5 parts of hydroquinone are added, mixing is sufficiently stirred；
Step 3, with embodiment 1；
Step 4, with embodiment 1.
Embodiment 4:
Step 1, powder group assignment system:
(1) by 90 parts and 8 parts of zirconium dioxide of polymethyl methacrylate, 1h is sufficiently stirred, is uniformly mixed it；
(2) it is added 1 part of benzoyl peroxide, 2h is sufficiently stirred, is uniformly mixed it；
(3) 1 part of stirring 2h of antibiotic is added, mixes well；
Step 2, liquid dosage:
(1) 98 parts of methyl methacrylate and 1 part of N, N- dimethyl-p-toluidine are uniformly mixed；
(2) it is added 1 part of hydroquinone, mixing is sufficiently stirred；
Step 3, with embodiment 1；
Step 4, with embodiment 1.
Embodiment 5:
Step 1, powder group assignment system:
(1) by 80 parts and 15 parts of zirconium dioxide of polymethyl methacrylate, 1h is sufficiently stirred, is uniformly mixed it；
(2) 2 parts of benzoyl peroxide are added, 2h is sufficiently stirred, is uniformly mixed it；
(3) 3 parts of stirring 2h of antibiotic are added, mix well；
Step 2, liquid dosage:
(1) 93 parts of methyl methacrylate and 5 parts of N, N- dimethyl-p-toluidine are uniformly mixed；
(2) 2 parts of hydroquinone are added, mixing is sufficiently stirred；
Step 3, with embodiment 1；
Step 4, with embodiment 1.
Comparative example 1
This comparative example difference from Example 1 is, 94 parts of liquid methyl methyl acrylate, N, N- dimethyl-p-toluidine 5
Part, other content is with embodiment 1, and details are not described herein.
Comparative example 2
This comparative example difference from Example 2 is, 97 parts of liquid methyl methyl acrylate and N, N- dimethyl-p-toluidine 1
Part other content is with embodiment 2, and details are not described herein.
Comparative example 3
This comparative example difference from Example 3 is, 85.5 parts of powder polymethyl methacrylate, 1.5 parts of initiator, other
Content is with embodiment 3, and details are not described herein.
Comparative example 4
This comparative example difference from Example 4 is, 94 parts of liquid methyl methyl acrylate, N, N- dimethyl-p-toluidine 5
Part, other content is with embodiment 4, and details are not described herein.
Comparative example 5
This comparative example difference from Example 5 is, 97 parts of liquid methyl methyl acrylate, N, N- dimethyl-p-toluidine 1
Part, other content is with embodiment 5, and details are not described herein.
Test: through the foregoing embodiment and comparative example preparation formula and the obtained antibiotic-loaded bone cement material 10 of method
Block style measures its 4- point bending strength, compression strength.
Bone cement material properties test result prepared by 1 embodiment of table and comparative example
| Number | Bending strength (MPa) | Composite bending modulus (MPa) | Yield strength (MPa) |
| Embodiment 1 | 62.278 | 2971.260 | 76.856 |
| Comparative example 1 | 65.436 | 2863.724 | 78.518 |
| Embodiment 2 | 76.553 | 3013.485 | 83.426 |
| Comparative example 2 | 75.246 | 3005.254 | 80.256 |
| Embodiment 3 | 88.345 | 3205.471 | 84.284 |
| Comparative example 3 | 86.252 | 3406.296 | 86.325 |
| Embodiment 4 | 80.544 | 2700.145 | 84.255 |
| Comparative example 4 | 81.265 | 2721.237 | 87.646 |
| Embodiment 5 | 66.259 | 2842.354 | 82.565 |
| Comparative example 5 | 68.457 | 2875.664 | 84.258 |
By above-mentioned data, it can be concluded that, bone cement material prepared by the present invention has preferable mechanical strength, and ISO 5833 is fixed
The following parameter of justice: 4- point bending strength at least 50MPa, bending modulus at least 1800MPa, compression strength at least 70MPa.It can be seen that examination
It tests result and is all satisfied requirement.
The above is only a preferred embodiment of the present invention, description is more specific in detail, but is not to the present invention
The limitation of patent, protection scope are not limited to above-described embodiment, and all technical solutions belonged under thinking of the present invention belong to this
The protection scope of invention.It should be pointed out that those of ordinary skill in the art, without departing from the principles of the present invention
Several improvements and modifications, these modifications and embellishments should also be considered as the scope of protection of the present invention.
Claims (8)
1. a kind of material and production method of antibiotic-loaded bone cement type Invasive lumbar fusion device, which is characterized in that the intervertebral fusion
Device contains developer and antibiotic using antibiotic-loaded bone cement as making material.
2. antibiotic-loaded bone cement according to claim 1 includes powder and two component of liquid, wherein powder includes polypropylene
Acid polymer powder, antibiotic powder, developer, initiator;Liquor includes acrylate monomer, polymerization inhibitor, activator.
3. acrylic acid polymer powder according to claim 2 is selected from polymethyl methacrylate, styrene-methyl third
One of e pioic acid methyl ester copolymer or methyl acrylate-methylmethacrylate copolymer are a variety of, and the polyacrylic acid is poly-
The particle size range for closing object powder is 20-200 μm.
4. antibiotic powder according to claim 2, predominantly can antibiotic resistant to high temperature, be selected from gentamicin, appropriate step
One of mycin, vancomycin or clindamycin are a variety of.
5. developer according to claim 2 is selected from barium sulfate, zirconium oxide or strontium sulfate, cause as claimed in claim 2
Agent is selected from benzoyl peroxide, benzoyl peroxide or methyl ethyl ketone peroxide.
6. acrylate monomer according to claim 2 includes methyl methacrylate, methyl acrylate or metering system
Acid butyl ester;Polymerization inhibitor is selected from quinhydrones, hydroquinone monomethyl ether or hydroquinone;Activator includes N-N- dimethyl-p-toluidine.
7. antibiotic-loaded bone cement according to claim 2 includes taking for powder and two component of liquid, wherein powder and liquid
It is 2:1-1.5 with ratio.
8. the material and production method of a kind of antibiotic-loaded bone cement Invasive lumbar fusion device according to claim 1, feature exist
In the production method includes the following steps:
Step 1, the preparation of powder:
(1) 1-2hr is sufficiently stirred in polymethyl methacrylate and zirconium dioxide, is uniformly mixed it；
(2) benzoyl peroxide is added, 2-3h is sufficiently stirred, is uniformly mixed it；
(3) antibiotic is added and is stirred 2-3h under vacuum conditions, mixes well；
Step 2, liquid dosage:
(1), by methyl methacrylate and N, N- dimethyl-p-toluidine is uniformly mixed；
(2) hydroquinone is added, mixing is sufficiently stirred；
Step 3, powder are mixed with liquid:
Operation temperature carries out under the conditions of 23 ± 1 DEG C, and powder is mixed with liquid proportional, and incorporation time 30 seconds to 1
Minute, the mixture that powder and liquid are mixed to prepare subsequently enters the haircuts phase about 2-4 minutes；
Step 4 fills mold forming:
(1) by mixture, pour into Invasive lumbar fusion device mold, it is made to be filled up completely entire mold；
(2) 10-20 minutes after powder is mixed with liquid, mixture viscosity, which starts to increase, enters curing time；
(3), by the waiting filled about 30-60 minutes, after confirming curing molding, can dismantle mold.
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| CN114920885A (en) * | 2022-06-08 | 2022-08-19 | 上海尚融生物科技有限公司 | Cement for mechanical system signal transmission, preparation process and application thereof |
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