CN103656744A - Bone cement solidification liquid, and preparation method and application thereof - Google Patents
Bone cement solidification liquid, and preparation method and application thereof Download PDFInfo
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- CN103656744A CN103656744A CN201310642408.4A CN201310642408A CN103656744A CN 103656744 A CN103656744 A CN 103656744A CN 201310642408 A CN201310642408 A CN 201310642408A CN 103656744 A CN103656744 A CN 103656744A
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Abstract
The invention relates to a Bone cement solidification liquid, and a preparation method and an application thereof. The solidification liquid comprises, by mass, 3-55% of citric acid, 0.05-10% of phosphorylated chitosan, 15% or less of a water-soluble polymer, 20% or less of an inorganic salt, 45% or less of an organic micromolecule, and the balance water or an acid solution. The preparation method of the solidification liquid enriches a bone cement modification mode by using chitosan, has the advantages of simplicity, feasibility, and good effect, is suitable for the wide use in different inorganic calcium-based bone cement systems, and can be extensively used.
Description
Technical field
The present invention relates to a kind of method of bio-medical material technical field, specifically a kind of bone cement consolidation liquid of phosphonized chitosan modification formula and preparation method thereof.
Background technology
When injectable calcium phosphate bone cement is repaired for bone, its combination property is required harsh, as good biocompatibility, bone conductibility, degradability, certain mechanical strength, anti-collapsibility, injectable etc.And calcium phosphate itself often can not meet above requirement simultaneously, generally must in series of calcium phosphate bone cement powder or consolidation liquid, add modifier, reinforcing agent, cross-linking agent etc.
In numerous materials, chitosan and derivant thereof are due to its good biocompatibility, degradable, have obvious potentiation to be subject to extensive concern to bone cement.Phosphonized chitosan is a kind of common derivant in chitosan, and Chang Zuowei skeleton is replaced and drug controlled release material, is applicable to shaping and organizational project.In addition the dissolubility of phosphonized chitosan and the complexing power of metal ion is had significantly and to be improved compared with chitosan itself.Consider that series of calcium phosphate bone cement can relate to dissolving and the calcium phosphate recrystallize of calcium ion when solidifying.The introducing of phosphoric acid primitive can promote quickly bone cement molding and strengthen.If can be by the advantages separately of chitosan and phosphate radical when developing the Bone Colonizable Cements In Rabbits that combination property is more excellent.
The present invention is directed to above background and the deficiencies in the prior art, a kind of Bone Colonizable Cements In Rabbits consolidation liquid and preparation method thereof is provided.
Summary of the invention
The object of the present invention is to provide a kind of Bone Colonizable Cements In Rabbits consolidation liquid formula and its preparation method and application.In conjunction with the advantage of traditional chitin modified bone cement and phosphate modification bone cement, by synthetic route and formula preparation rightly, develop a kind of Bone Colonizable Cements In Rabbits consolidation liquid formula.
A bone cement consolidation liquid, is characterized in that, wherein each constituent mass percentage composition is as follows:
Citric acid: 3-55%;
Phosphonized chitosan: 0.05-10%;
Water soluble polymer class total amount is not more than 15%, wherein, sodium carboxymethyl cellulose: 0-5%, hyaluronic acid: 0-1%, hydroxypropyl emthylcellulose: 0-2%, polyvinyl alcohol: 0-1.5%, Polyethylene Glycol: 0-10%, starch: 0-5%, gelatin: 0-2%, collagen protein: 0-2%;
Inorganic salts total amount is not more than 20%, wherein, and sodium sulfate: 0-15%, potassium sulfate: 0-15%, ammonium sulfate: 0-15%, magnesium sulfate: 0-10%, sodium chloride: 0-10%, potassium chloride: 0-10%, calcium chloride: 0-15%;
Organic molecule class is not more than 45%, wherein, and sodium glycerophosphate: 0-15%, glucose: 0-15%, mannose: 0-15%, cyclodextrin: 0-5%, glycerol: 0-40%;
Surplus is water, or acid solution.
A preparation method for bone cement consolidation liquid, is characterized in that, comprises the following steps:
(1) preparation is containing the solution of 3-55% citric acid and 0.05-10% phosphonized chitosan;
(2) a kind of or its combination of adding on the basis of citric acid-chitosan solution in water soluble polymer, inorganic salt or organic molecule modifier obtains final consolidation liquid;
(3) if consolidation liquid for a long time need not, be stored in 4 ℃ of environment, molten in advance before use;
(4) bone cement powder and consolidation liquid are in harmonious proportion by liquid-solid ratio, can obtain the bone cement of phosphonized chitosan modification.
The solvent of citric acid-phosphonized chitosan solution that step (1) is described is aqueous solution, or acid solution.
Described acid solution is a kind of or its combination in 0.01-0.3 M hydrochloric acid solution, 0.01-0.3 M sulfuric acid solution, 0.01-0.5 M phosphoric acid solution, 0.01-0.6 M acetic acid solution, 0.01-0.2 M salpeter solution, 0.01-0.5 M ascorbic acid solution, 0.01-0.5 M lactic acid solution.
The manner of formulation of the solution that step (2) is described is that room temperature is dissolved, or 60 ℃ of following heating hydrotropies, can also be aided with mechanical agitation or magnetic agitation.
The described pre-molten mode of step (3) is to make consolidation liquid become flowable liquid 37 ℃ of following heating.
The described bone cement powder of step (5) is that bata-tricalcium phosphate is the bone cement powder that main component, hydroxyapatite are auxiliary element, and the content of hydroxyapatite is 0.5-49%.
The described liquid-solid ratio of step (5) is in every 1 gram of bone cement powder, to add the consolidation liquid of 0.30-0.70 milliliter.
A kind of bone cement consolidation liquid is as the application of bone cement consolidation liquid.
Apparent density method of testing is: first adopt the cylindrical mold of diameter 6 mm height 10 mm to prepare bone cement sample, then measure actual diameter, height and the quality of solidifying the bone cement sample after 24 hours, calculate its density and be apparent density.
The method of testing of defeated and dispersed coefficient is: after solidifying, bone cement soaks after 10 days quality and reduces percentage ratio as defeated and dispersed coefficient in water.
PH value method of testing containing bone cement aqueous solution is: the bone cement that 1.0 g were solidified after 24 hours is placed in 20 mL ultra-pure waters, then with pH meter, measures it at the pH value of different soak times.
Intensity test method is: first adopt the cylindrical mold of diameter 6 mm height 10 mm to prepare bone cement sample, 37
oc, solidifies under 100% damp condition.Then utilize omnipotent mechanical test machine to measure the comprcssive strength of solidifying the bone cement sample after 24 hours.
Bone cement is without solid-liquid separation phenomenon when extruding injection, and injectability coefficient is not less than 80%, and the presetting period is no more than 40 min.It is added to the water pH value within the scope of 5-9 after solidifying, and apparent density is not less than 1.30 g/cm
3, defeated and dispersed coefficient is not more than 3%, and comprcssive strength is not less than 2.5 MPa.
The specific embodiment
Following examples be take invention technical scheme and are implemented as prerequisite, provided detailed embodiment and concrete operating process, but protection scope of the present invention are not limited to following embodiment.
Embodiment 1:
Take 86 g calcium phosphate dibasic dihydrates and 25 g calcium carbonate, joined ball milling mix homogeneously in 165 mL water.Then by water distilling under reduced pressure, 80
othe dry mixed powder that obtains in C vacuum drying oven.By powder body 900
oc stove stage casing adopts wet ball grinding to obtain bone cement dispersion liquid after burning 15 h.After dispersion liquid is centrifugal, dry, obtain bone cement powder main body composition, be mainly bata-tricalcium phosphate.96 g bata-tricalcium phosphates and 4 g hydroxyapatite mix homogeneously are obtained to bone cement powder.
Embodiment 2:
Take 0.2 g phosphonized chitosan and join in 10 mL 40 wt% aqueous citric acid solutions, adding water is 19.8 grams to gross mass.Then add 0.2 gram of sodium carboxymethyl cellulose, obtain the consolidation liquid of phosphonized chitosan and sodium carboxymethyl cellulose modification.The bone cement powder being comprised of bata-tricalcium phosphate and hydroxyapatite in consolidation liquid and embodiment 1 is in harmonious proportion by the liquid-solid ratio of 0.5 mL/g, and it is 31 min that reference standard ASTM C191 measures the presetting period.Injectability coefficient is 94%.Solidifying bone cement apparent density after 24 hours is 1.47 g/cm
3, in water, defeated and dispersed coefficient is 1.5%, comprcssive strength 6.7 MPa.Be added to the water, it is neutral that solution is.
Embodiment 3:
Take 0.2 g phosphonized chitosan and join in 10 mL 40 wt% aqueous citric acid solutions, adding water is 17.8 g to gross mass.Then add 0.2 g sodium carboxymethyl cellulose and 2 g glycerol, obtain the consolidation liquid of phosphonized chitosan and sodium carboxymethyl cellulose modification.The bone cement powder being comprised of bata-tricalcium phosphate and hydroxyapatite in consolidation liquid and embodiment 1 is in harmonious proportion by the liquid-solid ratio of 0.5 mL/g, and it is 23 min that reference standard ASTM C191 measures the presetting period.Injectability coefficient is 93%.Solidifying bone cement apparent density after 24 hours is 1.44 g/cm
3, in water, defeated and dispersed coefficient is 1.0%, comprcssive strength 7.0 MPa.Be added to the water, it is neutral that solution is.
Embodiment 4:
Take 0.2 g phosphonized chitosan and join in 10 mL 40 wt% aqueous citric acid solutions, adding water is 19.8 g to gross mass.Then add 0.2 g gelatin, obtain phosphonized chitosan and gelatin modified consolidation liquid.The bone cement powder being comprised of bata-tricalcium phosphate and hydroxyapatite in consolidation liquid and embodiment 1 is in harmonious proportion by the liquid-solid ratio of 0.5 mL/g, and it is 6 min that reference standard ASTM C191 measures the presetting period.Injectability coefficient is 97%.Solidifying bone cement apparent density after 24 hours is 1.45 g/cm
3, in water, defeated and dispersed coefficient is 0.9%, comprcssive strength 5.3 MPa.Be added to the water, it is neutral that solution is.
Embodiment 5:
Take 0.2 g phosphonized chitosan and join in 10 mL 40 wt% aqueous citric acid solutions, adding water is 17.8 g to gross mass.Then add 0.2 g gelatin and 2 g glycerol, obtain phosphonized chitosan and gelatin modified consolidation liquid.The bone cement powder being comprised of bata-tricalcium phosphate and hydroxyapatite in consolidation liquid and embodiment 1 is in harmonious proportion by the liquid-solid ratio of 0.5 mL/g, and it is 31 min that reference standard ASTM C191 measures the presetting period.Injectability coefficient is 94%.Solidifying bone cement apparent density after 24 hours is 1.46 g/cm
3, in water, defeated and dispersed coefficient is 1.3%, comprcssive strength 2.7 MPa.Be added to the water, it is neutral that solution is.
Embodiment 6:
Take 0.2 g phosphonized chitosan and join in 10 mL 40 wt% aqueous citric acid solutions, adding water is 19.8 g to gross mass.Then add 0.2 g hydroxypropyl emthylcellulose, obtain the consolidation liquid of phosphonized chitosan and hydroxypropyl emthylcellulose modification.The bone cement powder being comprised of bata-tricalcium phosphate and hydroxyapatite in consolidation liquid and embodiment 1 is in harmonious proportion by the liquid-solid ratio of 0.5 mL/g, and it is 19 min that reference standard ASTM C191 measures the presetting period.Injectability coefficient is 92%.Solidifying bone cement apparent density after 24 hours is 1.51 g/cm
3, in water, defeated and dispersed coefficient is 1.4%, comprcssive strength 4.6 MPa.Be added to the water, it is neutral that solution is.
Embodiment 7:
Take 0.2 g phosphonized chitosan and join in 10 mL 40 wt% aqueous citric acid solutions, adding water is 17.8 g to gross mass.Then add 0.2 g hydroxypropyl emthylcellulose and 2 g glycerol, obtain the consolidation liquid of phosphonized chitosan and hydroxypropyl emthylcellulose modification.The bone cement powder being comprised of bata-tricalcium phosphate and hydroxyapatite in consolidation liquid and embodiment 1 is in harmonious proportion by the liquid-solid ratio of 0.5 mL/g, and it is 26 min that reference standard ASTM C191 measures the presetting period.Injectability coefficient is 90%.Solidifying bone cement apparent density after 24 hours is 1.48 g/cm
3, in water, defeated and dispersed coefficient is 1.7%, comprcssive strength 3.5 MPa.Be added to the water, it is neutral that solution is.
Embodiment 8:
Take 0.2 g phosphonized chitosan and join in 10 mL 40 wt% aqueous citric acid solutions, adding water is 19.6 g to gross mass.Then add 0.2 g hydroxypropyl emthylcellulose and 0.2 g gelatin, obtain phosphonized chitosan, hydroxypropyl emthylcellulose and gelatin modified consolidation liquid.The bone cement powder being comprised of bata-tricalcium phosphate and hydroxyapatite in consolidation liquid and embodiment 1 is in harmonious proportion by the liquid-solid ratio of 0.5 mL/g, and it is 15 min that reference standard ASTM C191 measures the presetting period.Injectability coefficient is 98%.Solidifying bone cement apparent density after 24 hours is 1.51 g/cm
3, in water, defeated and dispersed coefficient is 0.7%, comprcssive strength 11.25 MPa.Be added to the water, it is neutral that solution is.
Embodiment 9:
Take 0.2 g phosphonized chitosan and join in 10 mL 40 wt% aqueous citric acid solutions, adding water is 17.6 g to gross mass.Then add 0.2 g hydroxypropyl emthylcellulose, 0.2 g gelatin and 2 g glycerol, obtain final consolidation liquid.The bone cement powder being comprised of bata-tricalcium phosphate and hydroxyapatite in consolidation liquid and embodiment 1 is in harmonious proportion by the liquid-solid ratio of 0.5 mL/g, and it is 15min that reference standard ASTM C191 measures the presetting period.Injectability coefficient is 98%.Solidifying bone cement apparent density after 24 hours is 1.47 g/cm
3, in water, defeated and dispersed coefficient is 0.5%, comprcssive strength 2.7 MPa.Be added to the water, it is neutral that solution is.
Claims (9)
1. a bone cement consolidation liquid, is characterized in that, wherein each constituent mass percentage composition is as follows:
Citric acid: 3-55%;
Phosphonized chitosan: 0.05-10%;
Water soluble polymer class total amount is not more than 15%, wherein, sodium carboxymethyl cellulose: 0-5%, hyaluronic acid: 0-1%, hydroxypropyl emthylcellulose: 0-2%, polyvinyl alcohol: 0-1.5%, Polyethylene Glycol: 0-10%, starch: 0-5%, gelatin: 0-2%, collagen protein: 0-2%;
Inorganic salts total amount is not more than 20%, wherein, and sodium sulfate: 0-15%, potassium sulfate: 0-15%, ammonium sulfate: 0-15%, magnesium sulfate: 0-10%, sodium chloride: 0-10%, potassium chloride: 0-10%, calcium chloride: 0-15%;
Organic molecule class is not more than 45%, wherein, and sodium glycerophosphate: 0-15%, glucose: 0-15%, mannose: 0-15%, cyclodextrin: 0-5%, glycerol: 0-40%;
Surplus is water, or acid solution.
2. the preparation method of bone cement consolidation liquid according to claim 1, is characterized in that, comprises the following steps:
(1) preparation is containing the solution of 3-55% citric acid and 0.05-10% phosphonized chitosan;
(2) a kind of or its combination of adding on the basis of citric acid-chitosan solution in water soluble polymer, inorganic salt or organic molecule modifier obtains final consolidation liquid;
(3) if consolidation liquid for a long time need not, be stored in 4 ℃ of environment, molten in advance before use;
(4) bone cement powder and consolidation liquid are in harmonious proportion by liquid-solid ratio, can obtain the bone cement of phosphonized chitosan modification.
3. the preparation method of bone cement consolidation liquid according to claim 2, is characterized in that, the solvent of citric acid-phosphonized chitosan solution that step (1) is described is aqueous solution, or acid solution.
4. the preparation method of bone cement consolidation liquid according to claim 3, it is characterized in that, described acid solution is a kind of or its combination in 0.01-0.3 M hydrochloric acid solution, 0.01-0.3 M sulfuric acid solution, 0.01-0.5 M phosphoric acid solution, 0.01-0.6 M acetic acid solution, 0.01-0.2 M salpeter solution, 0.01-0.5 M ascorbic acid solution, 0.01-0.5 M lactic acid solution.
5. the preparation method of bone cement consolidation liquid according to claim 2, is characterized in that, the manner of formulation of the solution that step (2) is described is that room temperature is dissolved, or 60 ℃ of following heating hydrotropies, can also be aided with mechanical agitation or magnetic agitation.
6. the preparation method of bone cement consolidation liquid according to claim 2, is characterized in that, the described pre-molten mode of step (3) is for making consolidation liquid become flowable liquid 37 ℃ of following heating.
7. the preparation method of bone cement consolidation liquid according to claim 2, it is characterized in that, the described bone cement powder of step (5) is that bata-tricalcium phosphate is the bone cement powder that main component, hydroxyapatite are auxiliary element, and the content of hydroxyapatite is 0.5-49%.
8. the preparation method of bone cement consolidation liquid according to claim 2, is characterized in that, the described liquid-solid ratio of step (5) is in every 1 gram of bone cement powder, to add the consolidation liquid of 0.30-0.70 milliliter.
According to claim 1 bone cement consolidation liquid as the application of bone cement consolidation liquid.
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| CN104027838A (en) * | 2014-05-28 | 2014-09-10 | 上海纳米技术及应用国家工程研究中心有限公司 | Fast-curing sodium citrate and carboxylation chitosan reinforced bone cement and preparation method thereof |
| CN104368042A (en) * | 2014-11-19 | 2015-02-25 | 上海纳米技术及应用国家工程研究中心有限公司 | Preparation method of brushite bone cement |
| CN104491924A (en) * | 2015-01-05 | 2015-04-08 | 上海纳米技术及应用国家工程研究中心有限公司 | Preparation method of injectable medicine-carrying brushite bone cement |
| CN105327395A (en) * | 2015-11-19 | 2016-02-17 | 上海纳米技术及应用国家工程研究中心有限公司 | Preparation method of bone cement catalytically cured by acidic HA (hydroxyapatite) |
| CN106075564A (en) * | 2016-08-31 | 2016-11-09 | 上海纳米技术及应用国家工程研究中心有限公司 | A kind of magnetic coupling bone cement and preparation method thereof |
| CN106552293A (en) * | 2016-11-24 | 2017-04-05 | 南京航空航天大学 | A kind of preparation method of the gluconic acid modified hydroxyapatite bone cement of high intensity |
| CN106620856A (en) * | 2016-11-08 | 2017-05-10 | 上海纳米技术及应用国家工程研究中心有限公司 | Chemotherapy-thermotherapy type bone repair material on basis of nano-carriers and preparation and application of chemotherapy-thermotherapy type bone repair material |
| CN111991615A (en) * | 2020-08-11 | 2020-11-27 | 上海纳米技术及应用国家工程研究中心有限公司 | Preparation method of lanthanide-doped injectable calcium phosphate bone cement, product and application thereof |
| CN112043870A (en) * | 2020-08-18 | 2020-12-08 | 上海纳米技术及应用国家工程研究中心有限公司 | Preparation of 3D-printed polyvinyl alcohol/calcium phosphate drug-loaded bone repair scaffold, product and application thereof |
| CN112107732A (en) * | 2020-09-18 | 2020-12-22 | 成都理工大学 | Anti-scouring high-mineralization-activity composite bone cement and preparation method thereof |
| US11597859B2 (en) | 2020-01-24 | 2023-03-07 | Oatey Co. | Solvent cement formulations having extended shelf life |
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| CN104027838A (en) * | 2014-05-28 | 2014-09-10 | 上海纳米技术及应用国家工程研究中心有限公司 | Fast-curing sodium citrate and carboxylation chitosan reinforced bone cement and preparation method thereof |
| CN104368042A (en) * | 2014-11-19 | 2015-02-25 | 上海纳米技术及应用国家工程研究中心有限公司 | Preparation method of brushite bone cement |
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| CN105327395B (en) * | 2015-11-19 | 2018-07-13 | 上海纳米技术及应用国家工程研究中心有限公司 | A kind of preparation method of acid hydroxy group apatite catalytic curing bone cement |
| CN106075564A (en) * | 2016-08-31 | 2016-11-09 | 上海纳米技术及应用国家工程研究中心有限公司 | A kind of magnetic coupling bone cement and preparation method thereof |
| CN106620856A (en) * | 2016-11-08 | 2017-05-10 | 上海纳米技术及应用国家工程研究中心有限公司 | Chemotherapy-thermotherapy type bone repair material on basis of nano-carriers and preparation and application of chemotherapy-thermotherapy type bone repair material |
| CN106552293A (en) * | 2016-11-24 | 2017-04-05 | 南京航空航天大学 | A kind of preparation method of the gluconic acid modified hydroxyapatite bone cement of high intensity |
| CN106552293B (en) * | 2016-11-24 | 2019-11-05 | 南京航空航天大学 | A kind of preparation method of the gluconic acid modified hydroxyapatite bone cement of high intensity |
| US11597859B2 (en) | 2020-01-24 | 2023-03-07 | Oatey Co. | Solvent cement formulations having extended shelf life |
| US11976222B2 (en) | 2020-01-24 | 2024-05-07 | Oatey Co. | Solvent cement formulations having extended shelf life |
| CN111991615A (en) * | 2020-08-11 | 2020-11-27 | 上海纳米技术及应用国家工程研究中心有限公司 | Preparation method of lanthanide-doped injectable calcium phosphate bone cement, product and application thereof |
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| CN112107732A (en) * | 2020-09-18 | 2020-12-22 | 成都理工大学 | Anti-scouring high-mineralization-activity composite bone cement and preparation method thereof |
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