CN106552293A - A kind of preparation method of the gluconic acid modified hydroxyapatite bone cement of high intensity - Google Patents
A kind of preparation method of the gluconic acid modified hydroxyapatite bone cement of high intensity Download PDFInfo
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- CN106552293A CN106552293A CN201611052573.4A CN201611052573A CN106552293A CN 106552293 A CN106552293 A CN 106552293A CN 201611052573 A CN201611052573 A CN 201611052573A CN 106552293 A CN106552293 A CN 106552293A
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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
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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
- A61L27/02—Inorganic materials
- A61L27/12—Phosphorus-containing materials, e.g. apatite
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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
- A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
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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
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
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Abstract
The present invention relates to a kind of preparation method of the gluconic acid modified hydroxyapatite bone cement of high intensity, it is with the modified hydroxyapatite in Jing gluconic acids surface as solid phase powder, as solidify liquid, both obtain the gluconic acid modified hydroxyapatite bone cement of high intensity after reconciling to gluconic acid solution with distilled water or low concentration.Bone cement preparation method of the present invention is simple to operate, and with good biocompatibility and osteoconductive, compression strength is high, reaches as high as 78MPa, higher than at present with single-phase hydroxyapatite as the bone cement of solid phase pulvis.First generation PMMA bone cement solidification process thermal discharge height is overcome simultaneously and second generation CPC bone cement solidification process can change pH value, cause the shortcoming of tissue inflammation, solidification process of the present invention is as which is not against acid-base reaction, pH value around is made to be in neutrality, and heat release is extremely low, its excellent combination property meets clinical requirement.The present invention widens the range of application of gluconic acid to improve hydroxyapatite bone cement performance developing new way.
Description
Technical field
The present invention relates to biology medical material technical field, and in particular to a kind of gluconic acid modified hydroxy-apatite of high intensity
The preparation method of stone bone cement.
Background technology
Bone cement has wide as bone tissue reparation and alternative materials, in Orthopeadic Surgery, dentistry and orthopedic clinical
Prospect, for the filling up of Cranial defect, fixed and serve as slow releasing carrier of medication.
The bone cement material for being applied to clinic at present mainly has two big class：First generation polymethyl methacrylate (PMMA) is
The acrylic compounds bone cement and second generation calcium phosphate bone cement (CPC) of representative.PMMA bone cement good mechanical properties, intensity are high, this
It is its outstanding feature, but as amount of heat and part residual monomer are released during curing reaction, then patient can be made to produce one be
The complication of row, is limited in clinical practice；And CPC overcomes the shortcoming of the first generation, curing exotherm is few, and its chemical composition with
The inorganic constituents of skeleton is similar, but mechanicalness after hardening is still deposited in clinical practice so as to biocompatibility very well
Can be not enough, solidification process can change ambient body fluid pH value based on acid-base reaction, the shortcomings of so as to cause inflammation.
Change for second generation bone cement solidification process pH value, it is considered to made with the hydroxyapatite of its final cured product
Bone cement is prepared for raw material, hydroxyapatite as the main inorganic composition in bone tissue, with extraordinary biocompatibility
And osteoconductive.In second generation bone cement, hydroxyapatite is more to add solid phase pulvis as crystal seed, for promoting bone cement solid
Change.Only used as solid phase pulvis, the aqueous citric acid solution of high concentration is solidify liquid to the high river pure ha of Sichuan University,
But its compression strength only has 13MPa, and high concentrated acid can cause histogenic immunity to react.
Japanese scholars Mamoru Aizawa propose that in the patent of Publication No. JP2005-95346A a kind of Jing phytic acid is molten
The modified hydroxyapatite bone cement in liquid surface, the hydroxy apatite powder that its powder is modified for Jing plant acid solutions surface, liquid phase
For deionized water, solidification process will not change pH value substantially, but its compression strength is not high, only 6.8MPA.He is in public affairs afterwards
The number of opening be JP2008-200476A, JP2009-178225A, US2010/0132593A1, JP2012-130672 in by optimization
Powder granularity, preparation technology, the series exploration for adding polysaccharide or phytic acid in solidify liquid, reach bone cement compression strength
36MPa, between cancellous bone and cortex bone, but is clinically simply possible to use in non-weight bearing area.
The Qi Yan of Nanjing Aero-Space University proposes a kind of the new of high intensity in Publication No. CN201410809660.4
Hydroxyapatite bone cement, is with the single-phase hydroxy apatite powder being modified through plant acid solution surface as solid phase pulvis, with low
Strength aqueous citric acid solution be solidify liquid, made by bone cement compression strength be up to 66MPa.
Therefore the present invention can be proposed high-strength as the solid phase of novel high-strength bone cement for the hydroxyapatite that surface is modified
Gluconic acid modified hydroxyapatite bone cement is spent, its compression strength reaches as high as 78MPa.
The content of the invention
Present invention aims to the deficiency that existing bone cement is present, there is provided a kind of method is simple, with good raw
Thing compatibility, high compression strength, solidification process heat release are extremely low and as which is not against acid-base reaction, make around pH value in neutrality
Chelating type hydroxyapatite bone cement.
The purpose of the present invention is achieved through the following technical solutions：With the single-phase hydroxyl that Jing gluconic acid solutions surface is modified
Apatite powder is solid phase pulvis, with distilled water or certain density gluconic acid solution as solidify liquid, by solid phase pulvis with it is solid
Change liquid to be reconciled by certain solid-to-liquid ratio, you can obtain the gluconic acid modified hydroxyapatite bone cement of high intensity.
A kind of preparation method of the gluconic acid modified hydroxyapatite bone cement of high intensity, comprises the following steps：
Step one：It is prepared by solid phase powder：
A certain amount of hydroxy apatite powder is weighed, certain density gluconic acid solution is configured, both is placed in into ball milling
In tank, ball milling is carried out to powder in planetary ball mill at room temperature while modified, within Ball-milling Time is four hours, ball milling
Ball and liquid are separated afterwards, obtain modified mixing slurry；
Modified mixing slurry is dried and is collected, the modified hydroxy apatite powder in Jing gluconic acid solutions surface is just obtained；
Step 2：Bone cement reconciles and prepares：
By certain solid-to-liquid ratio, it is solid phase to weigh the modified hydroxy apatite powder in a certain amount of Jing gluconic acid solutions surface
Powder, together with the mediation of solidify liquid Quick uniform, the viscous slurry for obtaining is the gluconic acid modified hydroxy-apatite of high intensity
Stone bone cement.
Gluconic acid described in step one is 0.005～0.05 with the mass ratio of hydroxyapatite.
Gluconic acid solution concentration described in step one is 0.1%～1%.
Ball grinder described in step one is equipped with 50 diameter 10mmZrO2The ZrO of pearl2Tank.
Drying means described in step one is vacuum freeze drying.
Solidify liquid described in step 2 is distilled water or gluconic acid solution that mass concentration is 10%～40%.
Solid phase powder described in step 2 reconciles mass ratio for 1 with solidify liquid:0.25～1:0.55.
The invention has the advantages that：
(1) present invention is applied to gluconic acid in hydroxyapatite bone cement first, significantly improves its mechanical property,
Maximum compression strength reaches the higher level of PMMA bone cements and CPC intensity up to 78MPa；
(4) gluconic acid of the present invention will not change the thing phase of hydroxyapatite, and Portugal to the modifying process of hydroxyapatite
Grape saccharic acid biological safety is high, good biocompatibility, therefore bone cement has good biocompatibility and osteoconductive；
(5) application extension of gluconic acid to bone cement is repaired medical material by the present invention, as improves hydroxyapatite
Bone cement performance opens up new way, has also widened the range of application of gluconic acid.
Description of the drawings
Fig. 1 show 1,2,3,4 bone cement compression strength of embodiment.
Fig. 2 show 1,2,3,4 bone cement soak pH value of embodiment and changes over curve.
During Fig. 3 show 1,2,3,4 bone cement solidification process of embodiment, temperature changes over curve.
Specific embodiment
Following examples are implemented premised on inventive technique scheme, give detailed embodiment and specific behaviour
Make process, but protection scope of the present invention is not limited to following embodiments.
Embodiment 1：
Step one：It is prepared by solid phase powder：
(1) 10g hydroxyapatite powders are weighed；
(2) concentration that the configuration 50ml NaOH solutions of 0.5mol/L adjust its pH value to 7.3 or so is 0.5% glucose
Acid solution；
(3) both are placed in ball grinder, ball milling is carried out to powder with planetary ball mill at room temperature while modified 2h, its
Middle gluconic acid is 0.025 with the mass ratio of hydroxyapatite；
(4) ball and liquid are separated after ball milling, obtains modified mixing slurry；
(5) vacuum freeze drying is carried out to modified mixing slurry, collection obtains 0.5% gluconic acid solutions of Jing after ball milling 2h
The modified hydroxy apatite powder in surface.
Step 2：Bone cement reconciles and prepares：
(1) solidify liquid is prepared：Solidify liquid is the aqueous gluconic acid that mass concentration is 20%, weighs 4g gluconic acids
Grain, is dissolved in 16g distilled water, obtains final product；
(2) by solid-liquid mass ratio 1:0.4, a certain amount of solid phase powder and 20% aqueous gluconic acid are weighed, quickly
Reconcile uniformly, that is, obtain the gluconic acid modified hydroxyapatite bone cement of high intensity.
Intensity test：
(1) bone cement of mix homogenously is inserted in the mould that size is φ 6mm × 12mm immediately, treats that 30min is tentatively solid
Change, with sand papering sample two ends, the demoulding obtains bone cement compression sample；
(2) after bone cement compression sample solidifies 24h in 37 DEG C of baking ovens, compression strength survey is carried out with universal testing machine
Examination, load 5KN, pressing speed are 0.5mm/min, at least horizontal survey 4 times of every group of sample.
The mean compressive strength for finally measuring bone cement sample is 70.3MPa, reaches as high as 78MPa.
PH value is tested：
(1) bone cement of mix homogenously is inserted in the mould that size is φ 6mm × 12mm immediately, the demoulding after 30min；
(2) 37 DEG C are put it into, in the distilled water of 100ml, the pH value of test sample soak.
Bone cement soak pH value maintains near neutral until stable.
Solidification process heat release is tested：
(1) solid phase pulvis, solidify liquid, intelligent temperature recorder and temperature test mould are incubated into 2h at 37 DEG C；
(2) under keeping warm mode, solid phase pulvis is pressed into solid-liquid mass ratio 1 with solidify liquid:Inserted after 0.4 mix homogenously immediately
During size is for the mould of φ 60mm × 6mm, with its temperature of intelligent temperature recorder METHOD FOR CONTINUOUS DETERMINATION, until temperature starts continuous decrease
Till a period of time is stable.
In solidification process, the maximum temperature of bone cement is 38.2 DEG C, and temperature rise is only 1.2 DEG C, and heat release is extremely low.
Embodiment 2：
Step one：It is prepared by solid phase powder：
(1) 10g hydroxyapatite powders are weighed；
(2) the 50ml concentration that the configuration NaOH solution of 0.5mol/L adjusts its pH value to 7.3 or so is 0.1% glucose
Acid solution；
(3) both are placed in ball grinder, ball milling is carried out to powder with planetary ball mill at room temperature while modified 4h, its
Middle gluconic acid is 0.005 with the mass ratio of hydroxyapatite；
(4) ball and liquid are separated after ball milling, obtains ball milling slurry；
(5) vacuum freeze drying is carried out to modified mixing slurry, collection obtains 0.1% gluconic acid solutions of Jing after ball milling 4h
The modified hydroxy apatite powder in surface.
Step 2：Bone cement reconciles and prepares：
(1) solidify liquid is prepared：Solidify liquid is the aqueous gluconic acid that mass concentration is 20%, weighs 4g gluconic acids
Grain, is dissolved in 16g distilled water, obtains final product；
(2) by solid-liquid mass ratio 1:0.4, a certain amount of solid phase powder and 20% aqueous gluconic acid are weighed, quickly
Reconcile uniformly, that is, obtain the gluconic acid modified hydroxyapatite bone cement of high intensity.
Intensity test：
With embodiment 1, the mean compressive strength of bone cement compression sample is 51.3MPa to operating procedure.
PH value is tested：
With embodiment 1, bone cement soak pH value maintains near neutral until stable to operating procedure.
Solidification process heat release is tested：
With embodiment 1, in solidification process, the maximum temperature of bone cement is 38 DEG C to operating procedure, and temperature rise is only 1 DEG C, heat release pole
It is low.
Embodiment 3：
Step one：Solid phase powder is prepared with embodiment 1, is obtained 0.5% gluconic acid solution surfaces of the Jing after ball milling 2h and is changed
The hydroxy apatite powder of property.
Step 2：Bone cement reconciles and prepares：
(1) solidify liquid is prepared：Solidify liquid is the aqueous gluconic acid that mass concentration is 10%, weighs 2g gluconic acids
Grain, is dissolved in 18g distilled water, obtains final product；
(2) by solid-liquid mass ratio 1:0.35, a certain amount of solid phase powder and 10% aqueous gluconic acid are weighed, quickly
Reconcile uniformly, that is, obtain the gluconic acid modified hydroxyapatite bone cement of high intensity.
Intensity test：
With embodiment 1, the mean compressive strength of bone cement compression sample is 60.5MPa to operating procedure.
PH value is tested：
With embodiment 1, bone cement soak pH value maintains near neutral until stable to operating procedure.
Solidification process heat release is tested：
(1) solid phase pulvis, solidify liquid, intelligent temperature recorder and bone cement heat release testing mould are incubated at 37 DEG C
2h；
(2) under keeping warm mode, solid phase pulvis is pressed into solid-liquid mass ratio 1 with solidify liquid:Filled out after 0.35 mix homogenously immediately
Enter in the mould that size is φ 60mm × 6mm, with its temperature of intelligent temperature recorder METHOD FOR CONTINUOUS DETERMINATION, until under temperature starts to continue
Till drop a period of time is stable.
In solidification process, the maximum temperature of bone cement is 37.9 DEG C, and temperature rise is only 0.9 DEG C, and heat release is extremely low.
Embodiment 4：
Step one：Solid phase powder is prepared with embodiment 1, is obtained 0.5% gluconic acid solution surfaces of the Jing after ball milling 2h and is changed
The powder of the hydroxyapatite of property.
Step 2：Bone cement reconciles and prepares：
(1) solidify liquid is prepared：Solidify liquid is distilled water；
(2) by solid-liquid mass ratio 1:0.25, a certain amount of solid phase powder and distilled water are weighed, it is quick to reconcile uniformly, that is, obtain
The gluconic acid modified hydroxyapatite bone cement of high intensity.
Intensity test：
With embodiment 1, the mean compressive strength of bone cement compression sample is 44.2MPa to operating procedure.
PH value is tested：
With embodiment 1, bone cement soak pH value maintains near neutral until stable to operating procedure.
Solidification process heat release is tested：
(1) solid phase pulvis, solidify liquid, intelligent temperature recorder and bone cement heat release testing mould are incubated at 37 DEG C
2h；
(2) under keeping warm mode, solid phase pulvis is pressed into solid-liquid mass ratio 1 with solidify liquid:Filled out after 0.25 mix homogenously immediately
Enter in the mould that size is φ 60mm × 6mm, with its temperature of intelligent temperature recorder METHOD FOR CONTINUOUS DETERMINATION, until under temperature starts to continue
Till drop a period of time is stable.
In solidification process, the maximum temperature of bone cement is 37.6 DEG C, and temperature rise is only 0.6 DEG C, and heat release is extremely low.
The above, is only presently preferred embodiments of the present invention, not makees any pro forma restriction to the present invention, any ripe
Professional and technical personnel is known, it is in the range of without departing from technical solution of the present invention, according to the technical spirit of the present invention, real to more than
Apply any simple modification, equivalent that example made and improve etc., still fall within technical solution of the present invention protection domain it
It is interior.
Claims (7)
1. the preparation method of the gluconic acid modified hydroxyapatite bone cement of a kind of high intensity, it is characterised in that including following step
Suddenly：
Step one：It is prepared by solid phase powder：
A certain amount of hydroxy apatite powder is weighed, certain density gluconic acid solution is configured, both is placed in ball grinder,
Ball milling is carried out to powder while being modified, within Ball-milling Time is four hours in planetary ball mill at room temperature, is divided after ball milling
From ball and liquid, modified mixing slurry is obtained；
Modified mixing slurry is dried and is collected, the modified hydroxy apatite powder in Jing gluconic acid solutions surface is just obtained；
Step 2：Bone cement reconciles and prepares：
By certain solid-to-liquid ratio, it is solid phase powder to weigh the modified hydroxy apatite powder in a certain amount of Jing gluconic acid solutions surface
Body, together with the mediation of solidify liquid Quick uniform, the viscous slurry for obtaining is the gluconic acid modified hydroxyapatite of high intensity
Bone cement.
2. the preparation method of the gluconic acid modified hydroxyapatite bone cement of high intensity according to claim 1, its feature
It is：In the step one, wherein gluconic acid and the mass ratio of hydroxyapatite are 0.005～0.05.
3. the preparation method of the gluconic acid modified hydroxyapatite bone cement of high intensity according to claim 1, its feature
It is：In the step one, gluconic acid solution concentration is 0.1%-1%.
4. the preparation method of the gluconic acid modified hydroxyapatite bone cement of high intensity according to claim 1, its feature
It is：In the step one, ball grinder is equipped with 50 diameter 10mmZrO2The ZrO of pearl2Tank.
5. the preparation method of the gluconic acid modified hydroxyapatite bone cement of high intensity according to claim 1, its feature
It is：In the step one, drying means is vacuum freeze drying.
6. the preparation method of the gluconic acid modified hydroxyapatite bone cement of high intensity according to claim 1, its feature
It is：In the step 2, solidify liquid is distilled water or gluconic acid solution that mass concentration is 10%～40%.
7. the preparation method of the gluconic acid modified hydroxyapatite bone cement of high intensity according to claim 1, its feature
It is：In the step 2, solid phase powder reconciles mass ratio for 1 with solidify liquid:0.25～1:0.55.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116161955A (en) * | 2022-12-19 | 2023-05-26 | 南京航空航天大学 | Normal-temperature one-step extrusion 3D printing forming preparation method of high-strength hydroxyapatite bone tissue engineering scaffold |
| CN116161955B (en) * | 2022-12-19 | 2024-05-03 | 南京航空航天大学 | Normal-temperature one-step extrusion 3D printing forming preparation method of high-strength hydroxyapatite bone tissue engineering scaffold |
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