CN1736928A - Preparation method of calcium orthophosphate bone cement degradable to pore in human body - Google Patents
Preparation method of calcium orthophosphate bone cement degradable to pore in human body Download PDFInfo
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Abstract
The invention relates to a preparation method for calcium phosphate aggregate cement that can degradate in human body, which comprises: preparing said cement powder by alpha-type tricalcium phosphate, calcium biphosphate and calcium carbonate powder; adding chitose microsphere in prepared analog body fluid, clearing and drying to mix with said solid powder to prepare composite powder; using buffle solution to add baking soda and sodium alginate to prepare solidification liquid; finally, mixing the powder and liquid to prepare composite slurry.
Description
Technical field
The invention belongs to medical bone cement technical field of material, particularly calcium phosphate porous bone-cement composite material preparation method.
Background technology
Solidify calcium phosphate bone cement have under normal temperature or Human Physiology envrionment temperature in-situ solidifying, cured body structure and composition similar to natural bone mineral facies structure with composition, perform the operation in arbitrarily plastotype, can fill characteristics such as the bone of different shape is damaged, can be widely used in fracture fixation, bone defect repair, tooth section and clinical scopes such as decorative sursery reparation and pharmaceutical carrier, be the focus of bone reparation and hard tissue substituting material area research.
Though common calcium phosphate bone cement material also has certain porosity, but because the hole yardstick is nano level or submicron order, lack the macropore that impels the osseous tissue growth, not only osteocyte can not be grown into, tissue juice also is difficult to infiltrate, and material degraded and absorbed process is in vivo successively carried out, thereby specific absorption is low, degraded has slowly hindered the generation and the reconstruction of new bone tissue.Tang Peifu adds sodium bicarbonate in the solid solution of carbonating hydroxyapatite bone cement, preparation porous bone cement material, big porosity in the cured body more than 70 microns can reach 40%, the aperture mainly is distributed in 160～390 micrometer ranges, ultimate compression strength is about 6 MPas, after bone was implanted into for 16 weeks, the new bone growth area accounted for 35% of the damaged area of green bone.(see " experimental study of Porous Carbonated Hydroxyapatite Bone Cement " [doctorate paper] Beijing: Chinese People's Liberation Army General Hospital, 2002).In above-mentioned research, though bone cement material porosity increases, improved the vivo degradation speed and the osteogenic ability of material, failing resolving aperture and porosity increases the problem that the strength of materials brought reduces.Its ultimate compression strength only is about 1/10th of common micropore calcium phosphate bone cement, can only be used for not carrying or the reparation of the bone defect that bearing capacity is very low, has seriously limited the range of application of this material.
Summary of the invention
The objective of the invention is in order to overcome above-mentioned porous calcium phosphate bone cement preparation method's deficiency, but a kind of preparation method of calcium phosphate bone cement of degradation in vivo pore-forming is provided.The characteristics that the present invention is faster than calcium phosphate bone cement material according to chitosan material degradation in vivo speed, chitosan microball and calcium phosphate bone cement is compound, but have vivo degradation pore-forming, early strength height, the fireballing characteristics of later stage degradation.
But the preparation method of the calcium phosphate bone cement of degradation in vivo pore-forming of the present invention may further comprise the steps:
(1) in molar ratio with α type tricalcium phosphate, monocalcium phosphate and calcium carbonate powders:
α type tricalcium phosphate: monocalcium phosphate: lime carbonate=(8～12): (1～2): (3～5) ball milling in anhydrous ethanol medium mixes, 80～100 ℃ of oven dry, preparation calcium phosphate bone cement bone photo powder;
(2) in 1000 ml deionized water or distilled water, add sodium-chlor 8.00～24.00 grams, sodium bicarbonate 0.35～1.01 gram, Repone K 0.23～0.69 gram, dipotassium hydrogen phosphate 0.23～0.69 gram, magnesium chloride 0.31～0.93 gram, calcium chloride 0.28g～0.84 gram, sodium sulfate 0.07～0.21 gram, Tutofusin tris 6.06～18.18 grams are prepared simulated body fluid, and with hydrochloric acid soln the pH value of simulated body fluid are transferred to 7.2～7.4;
(3) with behind the chitosan microball usefulness deionized water cleaning, drying, place Glass Containers, the simulated body fluid that adds step (2) preparation, and chitosan microball is immersed in the simulated body fluid fully, 36～38 ℃ of temperature, under the condition of humidity 60～90%, immersion treatment 2～20 days, every 24～48 hours, remove old liquid during this time, change the fresh simulated body fluid of same concentrations;
(4) with the chitosan microball after step (3) immersion treatment, after deionized water or distilled water cleaning, 80～100 ℃ of oven dry;
(5) with the solid phase powder of the chitosan microball after step (4) oven dry and step (1) preparation (5～50) by volume: mix (95～50), prepares chitosan microball and calcium phosphate bone cement composite powder.
(6) buffered soln of volumetric molar concentrations such as the SODIUM PHOSPHATE, MONOBASIC of SODIUM PHOSPHATE, MONOBASIC, Sodium phosphate dibasic reagent and the deionized water of usefulness analytical pure higher level or distilled water preparation 0.2～1.0 volumetric molar concentration and Sodium phosphate dibasic;
(7) step (6) preparation etc. in the buffered soln of volumetric molar concentration by the ratio of 0.2～1.0 mole of per 1000 ml soln, the sodium bicarbonate and the sodium alginate reagent of volumetric molar concentration analytical pure higher level such as interpolation are prepared solid solution respectively;
(8) the solid phase composite powder of step (5) preparation and the solid solution of step (7) preparation are pressed solid-to-liquid ratio (0.5～3): 1 preparation composite bone cement slurry.
The bone cement slurry of above-mentioned steps (8) preparation can directly inject the bone defect with syringe to be used.
Also can inject mould,, solidify under the condition of humidity 80～95% 1～6 hour 36～38 ℃ of temperature, place the simulated body fluid of step (2) preparation then, at 36～38 ℃ of following immersion treatment 2-10 of temperature days, take out the back and clean up 80～100 ℃ of dry for standby with deionized water or distilled water.
Characteristics of the present invention:
The vivo degradation pore-forming, bone cement early strength height, later stage degradation speed is fast, helps the new bone tissue growth.
Utilize the chitosan degradation in vivo characteristics faster than calcium phosphate bone cement, chitosan microball and calcium phosphate bone cement is compound, but the calcium phosphate cement composite material of preparation vivo degradation pore-forming.Common porous calcium phosphate bone cement material, owing to there are a large amount of holes, intensity is lower.In chitosan microball and calcium phosphate cement composite material, the initial stage have only micropore in the cured body, and porosity is low after solidifying, and intensity is higher.Along with chitosan microball degraded in vivo, macropore increases in the matrix material, and porosity increases, thereby realizes that the method for employing vivo degradation pore-forming prepares the purpose of calcium phosphate cement composite material.After chitosan microball and calcium phosphate cement composite material implant, because the chitosan microball degraded is very fast, can in the calcium phosphate bone cement matrix, form and the corresponding hole of microballoon size gradually, osteocyte can be grown in the hole, help the vascularization of material, and guarantee that nutrition supplies with to material inside organization, thereby promote the growth of new bone tissue and from the reconstruction of body bone.
The chitosan microball and the calcium phosphate cement composite material of the present invention's preparation are mainly used in bone defect repair and bone tissue engineering stent material, also can be as the tooth dental repair material.During use, can be with the slurry that modulates, directly inject the bone defect with syringe, also slurry can be injected the mould curing molding after, replant defect to the marrow.
Embodiment
Embodiment 1
(1) in molar ratio with α type tricalcium phosphate, monocalcium phosphate and calcium carbonate powders:
α type tricalcium phosphate: monocalcium phosphate: lime carbonate=ball milling mixing in anhydrous ethanol medium in 8: 1: 3,80 ℃ of oven dry, preparation orthophosphate skeleton cement solid powder;
(2) in 1000 ml deionized water or distilled water, add sodium-chlor 8 grams, sodium bicarbonate 0.35 gram, Repone K 0.23 gram, dipotassium hydrogen phosphate 0.23 gram, magnesium chloride 0.31 gram, calcium chloride 0.28 gram, sodium sulfate 0.07 gram, Tutofusin tris 6.06 grams are prepared simulated body fluid, and with the hydrochloric acid soln of 0.5 volumetric molar concentration the pH value of simulated body fluid are transferred to 7.2;
(3) with behind the chitosan microball usefulness deionized water cleaning, drying, place Glass Containers, the simulated body fluid that adds step (2) preparation, and chitosan microball is fully immersed in the simulated body fluid, 36 ℃ of temperature, under the condition of humidity 60%, immersion treatment 2 days, every 24 hours, remove old liquid during this time, change the fresh simulated body fluid of same concentrations;
(4) with the chitosan microball after step (3) immersion treatment, after cleaning repeatedly with deionized water or distilled water, 80～100 ℃ of oven dry;
(5) solid phase powder of the chitosan microball after step (4) oven dry with step (1) preparation mixed preparation chitosan microball and calcium phosphate bone cement composite powder in 5: 95 by volume;
(6) prepare the buffered soln of volumetric molar concentrations such as the SODIUM PHOSPHATE, MONOBASIC of 0.3 volumetric molar concentration and Sodium phosphate dibasic with analytical pure SODIUM PHOSPHATE, MONOBASIC, Sodium phosphate dibasic reagent and deionized water or distilled water;
(7) (6) preparation etc. in the buffered soln of volumetric molar concentration by the ratio of 0.2 mole of per 1000 ml soln, add analytical pure sodium bicarbonate and sodium alginate reagent respectively, prepare solid solution;
(8) the solid phase composite powder of step (5) preparation and the solid solution of step (7) preparation are prepared the composite bone cement slurry by solid-to-liquid ratio at 0.5: 1.
The bone cement slurry of step (8) preparation is directly injected the bone defect with syringe.
Embodiment 2
(1) in molar ratio with α type tricalcium phosphate, monocalcium phosphate and calcium carbonate powders:
α type tricalcium phosphate: monocalcium phosphate: lime carbonate=ball milling mixing in anhydrous ethanol medium in 12: 2: 5,100 ℃ of oven dry, preparation calcium phosphate bone cement bone photo powder;
(2) in 1000 ml deionized water or distilled water, add sodium-chlor 24 grams, sodium bicarbonate 1.01 grams, Repone K 0.69 gram, dipotassium hydrogen phosphate 0.69 gram, magnesium chloride 0.93 gram, calcium chloride 0.84 gram, sodium sulfate 0.21 gram, Tutofusin tris 18.18 grams are prepared simulated body fluid, and with the hydrochloric acid soln of 1 volumetric molar concentration the pH value of simulated body fluid are transferred to 7.4;
(3) with behind the chitosan microball usefulness deionized water cleaning, drying, place Glass Containers, the simulated body fluid that adds step (2) preparation, and chitosan microball is fully immersed in the simulated body fluid, 38 ℃ of temperature, under the condition of humidity 90%, immersion treatment 20 days, every 48 hours, remove old liquid during this time, change the fresh simulated body fluid of same concentrations;
(4) with the chitosan microball after step (3) immersion treatment, after cleaning repeatedly with deionized water or distilled water, 80～100 ℃ of oven dry;
(5) solid phase powder of the chitosan microball after step (4) oven dry with step (1) preparation mixed preparation chitosan microball and calcium phosphate bone cement composite powder in 50: 50 by volume.
(6) prepare the buffered soln of volumetric molar concentrations such as the SODIUM PHOSPHATE, MONOBASIC of 1 volumetric molar concentration and Sodium phosphate dibasic with analytical pure SODIUM PHOSPHATE, MONOBASIC, Sodium phosphate dibasic reagent and deionized water or distilled water;
(7) (6) preparation etc. in the buffered soln of volumetric molar concentration by the ratio of 1 mole of per 1000 ml soln, add analytical pure sodium bicarbonate and sodium alginate reagent respectively, prepare solid solution;
(8) the solid phase composite powder of step (5) preparation and the solid solution of step (7) preparation are prepared the composite bone cement slurry by solid-to-liquid ratio at 3: 1.
(9) the bone cement slurry with step (8) preparation injects mould, 36～38 ℃ of temperature, solidified 1-6 hour under the condition of humidity 80～95%, place the simulated body fluid of step (2) preparation then, at 36～38 ℃ of following immersion treatment 2-10 of temperature days, take out the back and clean up 80～100 ℃ of dry for standby with deionized water or distilled water.
Claims (2)
1, but a kind of preparation method of calcium phosphate bone cement of degradation in vivo pore-forming is characterized in that, may further comprise the steps:
(1) in molar ratio with α type tricalcium phosphate, monocalcium phosphate and calcium carbonate powders:
α type tricalcium phosphate: monocalcium phosphate: lime carbonate=(8～12): (1～2): (3～5) ball milling in anhydrous ethanol medium mixes, 80～100 ℃ of oven dry, preparation calcium phosphate bone cement bone photo powder;
(2) in 1000 ml deionized water or distilled water, add sodium-chlor 8.00～24.00 grams, sodium bicarbonate 0.35～1.01 gram, Repone K 0.23～0.69 gram, dipotassium hydrogen phosphate 0.23～0.69 gram, magnesium chloride 0.31～0.93 gram, calcium chloride 0.28g～0.84 gram, sodium sulfate 0.07～0.21 gram, Tutofusin tris 6.06～18.18 grams are prepared simulated body fluid, and with hydrochloric acid soln the pH value of simulated body fluid are transferred to 7.2～7.4;
(3) with behind the chitosan microball usefulness deionized water cleaning, drying, place Glass Containers, the simulated body fluid that adds step (2) preparation, and chitosan microball is immersed in the simulated body fluid, 36～38 ℃ of temperature, under the condition of humidity 60～90%, immersion treatment 2～20 days, every 24～48 hours, remove old liquid during this time, change the fresh simulated body fluid of same concentrations;
(4) with the chitosan microball after step (3) immersion treatment, after deionized water or distilled water cleaning, 80～100 ℃ of oven dry;
(5) with the solid phase powder of the chitosan microball after step (4) oven dry and step (1) preparation (5～50) by volume: mix (95～50), prepares chitosan microball and calcium phosphate bone cement composite powder.
(6) buffered soln of volumetric molar concentrations such as the SODIUM PHOSPHATE, MONOBASIC of SODIUM PHOSPHATE, MONOBASIC, Sodium phosphate dibasic reagent and the deionized water of usefulness analytical pure higher level or distilled water preparation 0.2～1.0 volumetric molar concentration and Sodium phosphate dibasic;
(7) step (6) preparation etc. in the buffered soln of volumetric molar concentration by the ratio of 0.2～1.0 mole of per 1000 ml soln, add respectively the analytical pure higher level etc. the sodium bicarbonate and the sodium alginate reagent of volumetric molar concentration, prepare solid solution;
(8) the solid phase composite powder of step (5) preparation and the solid solution of step (7) preparation are pressed solid-to-liquid ratio (0.5～3): 1 preparation composite bone cement slurry.
2, but the preparation method of the calcium phosphate bone cement of degradation in vivo pore-forming as claimed in claim 1 is characterized in that, also comprises:
(9) the composite bone cement slurry that step (8) is obtained injects mould, 36～38 ℃ of temperature, solidified under the condition of humidity 80～95% 1～6 hour, place the simulated body fluid of step (2) preparation then, at 36～38 ℃ of following immersion treatment 2-10 of temperature days, take out the back and clean up 80～100 ℃ of dry for standby with deionized water or distilled water.
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| US7943597B2 (en) | 2008-04-08 | 2011-05-17 | Cypress Pharmaceutical, Inc. | Phosphate-binding chitosan and uses thereof |
| CN102526798A (en) * | 2012-01-18 | 2012-07-04 | 华东理工大学 | Injectable compound bone cement and preparation method thereof |
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