CN101485904A - Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle and application - Google Patents
Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle and application Download PDFInfo
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- CN101485904A CN101485904A CNA2009100678555A CN200910067855A CN101485904A CN 101485904 A CN101485904 A CN 101485904A CN A2009100678555 A CNA2009100678555 A CN A2009100678555A CN 200910067855 A CN200910067855 A CN 200910067855A CN 101485904 A CN101485904 A CN 101485904A
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Abstract
The invention relates to a medicine-carried injectable calcium sulfate based slow-release implant composition and application thereof. The slow-release implant composition adopts a component A and a component B, wherein the component A comprises 100 portions of semi-hydrated sulfuric acid, 0.1 to 10 portions of nucleater, 0.1 to 5 portions of plasticizer, 0 to 5 portions of surfactant and 2 to 5 portions of medicine-carrying particles, and the medicine-containing mass concentration is between 4 and 20 percent; and the component B is a diluent, and the weight of the diluent is 30 to 60 portions as calculated by 100 portions of the semi-hydrated sulfuric acid. The medicine-carried particle injectable calcium sulfate based slow-release implant system has the advantages that: the slow-release implant system can inject local medicine-release implant into focuses and make the implant formed without operation, overcome the defect that general preformed implant materials do not closely contact circumferential bone tissues, and prevent encapsulation of fiber tissues; due to the osteoacusis function of calcium sulfate, the slow-release implant system is more suitable for growth and repair of the bone tissues; and due to unique medicine-carried particles, the slow-release implant system can realize local medicine release, is stable to release medicines, has long medicine effect time and high medicine utilization rate, and is suitable for treating bone defect and the like caused by osteomyelitis, osteocarcinoma and the like.
Description
Technical field
The invention belongs to the biological medicine technology field, particularly a kind of Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle and application.
Background technology
The repair and reconstruction that bone is damaged are one of important directions of surgery and related discipline research always.For the damaged reparation of bone, the normal employing filled from body bone and biomaterial clinically, but all needs to implant through operation, even also needs second operation to remove packing material, brings huge misery to the patient.Along with the development of minimally invasive surgery, research and application injectable bone material are just becoming emerging research focus in recent years.There is the injectable bone repair materials of bibliographical information mainly to comprise materials such as autologous bone marrow and complex thereof, bone cement, syringeability calcium phosphate at present.
Chronic osteomyelitis is difficult to treatment owing to dead space, sequestrum form, and thoroughly focal cleaning is aided with the topical application antibiotic and is considered to efficient ways.After succeeding in developing gentamycin-PMMA pelletron (Septopal) in 1978 and being applied to treat osteomyelitis, this plantation people formula slow release body has been promoted in Europe to be used.Septopal has characteristics such as toxicity is little, drug effect is long, often is applied to plastic surgery and osteomyelitis etc.
But Septopal has only 25% gentamycin to be released out usually; In addition, the chain pearl is easy to tightly be held by fibrous connective tissue, has limited antibiotic release more, thereby makes the part can't reach the antibiotic concentration of expection.Because PMMA chain pearl can not degrade, second operation cuts gets pearl, but this operation meeting brings huge misery to the patient, pull out chain after residual bone damaged, thereby also form sinus tract easily and dead space causes repeated infection.Because above-mentioned deficiency has limited its application clinically.
Summary of the invention
In order to solve the deficiencies in the prior art, the present invention proposes a kind of new Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle and application.
Concrete technology is as follows:
Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle of the present invention adopts two component A and B; It is characterized in that mass fraction is as follows:
Component A:
100 parts of half-H 2 O calcium sulphates,
0.1～10 part of nucleator,
0.1～5 part of plasticiser,
0～5 part in surfactant,
2～5 parts of medicine carrying microgranules, pastille mass concentration are 4%～20%;
B component is a diluent, and consumption is in 100 parts of half-H 2 O calcium sulphates, and diluent is 30～60 parts.
Described nucleator is one or more mixing of inorganic salt.Inorganic salt is sodium phosphate, calcium phosphate, sodium sulfate, calcium carbonate, potassium sulfate or calcium sulphate dihydrate.
Described plasticiser is one or more mixing of natural biological degradable polymer.The natural biological degradable polymer is derivant, cellulose or the cellulose derivative of gelatin, chitosan, alginate, collagen, starch, starch.
Described surfactant is dodecyl sodium sulfate, tristerin, Polyethylene Glycol, polyoxyethylene or sorbitan monooleate (span) series of surfactants.
Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle of the present invention, wherein medicine carrying microgranule is that particle diameter is all less than 100 microns hydrophobic polymer polylactic acid/ethanol copolymer (PLGA) microgranule or hydrophilic polymer chitosan-calcium sulfate microgranule.
The preparation method of the medicine carrying microgranule of Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle is as follows:
(a) adopt nebulization or emulsion process to prepare medicine carrying microballoons to hydrophobic polymer PLGA: nebulization is with behind the lysate of PLGA and the drug molecule solution uniform mixing, it is microgranular to adopt nebulization that it is prepared into, and promptly gets the drug-carrying polymer microgranule behind the washing after drying; Emulsion process be with the PLGA material dissolves in the immiscible organic facies medium of water in, medicine is dispersed or dissolved in this solution then, form dispersion or solution, with dispersion or solution after aqueous phase emulsifying, form droplet, heating makes the organic solvent volatilization, and emulsion droplet begins the hardening balling-up, filtration after scouring drying promptly produces medicine carrying microballoons;
(b) adopt the rp-emulsification cross-linking method to prepare to hydrophilic polymer chitosan-calcium sulfate medicine carrying microgranule: earlier chitosan, medicine to be dissolved in the aqueous solution of glacial acetic acid, to add calcium sulfate then, mix homogeneously; Under intense agitation, it is dropwise added in the organic facies medium that has disperseed surfactant, under the room temperature after emulsifying half an hour, dropwise add cross-linking agent solution, continue reaction 1～2 hour, with product repeatedly vacuum filter repeatedly washing, dry in the electrically heated drying cabinet, promptly get polymer drug-carried fine particle.
Described medicine is anti-inflammatory drug or the anticancer class medicine that is used for osteomyelitis or osteocarcinoma postoperative topical or is used as the bone renovating material of bone defect healing.
Described anti-inflammatory drug is albomycin, gentamycin, vancomycin, tobramycin, head bubble furan suffering or PVP-iodine or metronidazole; Anticancer class medicine is cisplatin, melphalan, carmustine, amycin, camptothecine or paclitaxel, analgesic aspirin, ibuprofen or acetaminophen.
Half-H 2 O calcium sulphate is fully mixed with nucleator, plasticiser, medicine carrying microgranule and surfactant, put into medicine bottle, disinfect then, obtain component A; B component is a diluent.Before using component A and B component are put together, and fully mix, get pasty liquid, it can be expelled to lesions position with syringe.
The injectable calcium sulphate based slow release implantation system of medicine carrying microgranule that contains of the present invention, advantage is to need not operation the local delivery of drug implant to be expelled to lesions position and molding, overcome conventional preforming embedded material and contacted untight defective, can prevent the parcel of fibrous tissue with the surrounding bone tissue; The bone conduction effect of calcium sulfate is more suitable for the growth and the reparation of osseous tissue; The medicine carrying microgranule that it is unique can better be realized local delivery of drug, and release is stable, and effective drug duration is longer, and utilization ratio of drug is higher, is applicable to that bone that treatment osteomyelitis, osteocarcinoma etc. cause is damaged etc.
The specific embodiment
Example 1
Get 4gPLGA, add in the 100ml chloroformic solution and stir, treat to add the 0.16g gentamycin again after the uniform dissolution, continue to stir the formation homogeneous dispersion, with aerosol apparatus it is prepared into drop then, dry back microgranular, with ethanol cyclic washing three times, promptly make the PLGA microgranule of load gentamycin behind the vacuum drying.Above-mentioned gentamycin can change other antibiotic such as albomycin, vancomycin, tobramycin, head bubble furan suffering and analgesic aspirin, ibuprofen, acetaminophen etc. into.
Example 2
Get 3g PLGA, add in the 100ml chloroformic solution and stir, treat to add the 0.6g albomycin again after the uniform dissolution, continue to stir the formation homogeneous dispersion, with the emulsifying in aqueous media of this dispersion, form droplet, under 40 ℃, continue to be stirred to emulsion droplet hardening balling-up, after the filtration, repeatedly wash with ethanol, behind the vacuum drying, the PLGA microgranule of load albomycin.Above-mentioned albomycin can change other antibiotic and anticancer class medicine cisplatin, melphalan, carmustine, amycin, camptothecine or paclitaxels etc. such as gentamycin, vancomycin, tobramycin, head bubble furan suffering into.
Example 3
2g chitosan, 1ml glacial acetic acid, 0.8g vancomycin are added in the 100ml water, after being stirred to it and forming homogeneous solution, add 5g calcium sulfate, mix homogeneously is standby; Under intense agitation, it is dropwise added in the 30ml ethyl benzoate solution that has disperseed 0.5mlspan-80, under the room temperature after emulsifying half an hour, dropwise add the 0.2ml glutaraldehyde solution, continue reaction 1～2 hour,, use washing with alcohol three times the product vacuumizing filtration, dry in the electrically heated drying cabinet, promptly get the chitosan-calcium sulfate microgranule of load vancomycin.Above-mentioned vancomycin can change other antibiotic and anticancer class medicine cisplatin, melphalan, carmustine, amycin, camptothecine or paclitaxels etc. such as gentamycin, albomycin, tobramycin, head bubble furan suffering, analgesic aspirin, ibuprofen, acetaminophen etc. into.
Example 4
Get 100 parts of half-H 2 O calcium sulphates, add the chitosan-calcium sulfate microgranule of 5 parts of load amycin, 10 parts calcium phosphate, 0.1 part hydroxypropyl emthylcellulose, 5 parts tristerin, and mix homogeneously, put into medicine bottle with the Co-60 sterilization, obtain component A.The B component is a simulated body fluid.During use 60 parts of B components and component A are fully mixed, arrive desired area with injector to inject.Above-mentioned amycin can change other antibiotic such as vancomycin albomycin, gentamycin, tobramycin or head bubble furan suffering into; Above-mentioned inorganic salt calcium phosphate can be changed to sodium phosphate, sodium sulfate, calcium carbonate, potassium sulfate or calcium sulphate dihydrate; Above-mentioned tristerin can be changed to dodecyl sodium sulfate, Polyethylene Glycol or polyoxyethylene.
With this injectable calcium sulphate based slow release implantation system implantable bone defect that contains the chitosan-calcium sulfate microgranule of load amycin, drug release time can reach about 2 months, and independent calcium sulfate medicine-carried system, drug release time only has more than 20 day.
Example 5
Get 100 parts of half-H 2 O calcium sulphates, add the PLGA microgranule of 2 parts of load vancomycins, 0.1 part calcium sulphate dihydrate, 2 parts of gelatin and 3 parts of starch, 0.2 part dodecyl sodium sulfate, and mix homogeneously, put into medicine bottle with the Co-60 sterilization, obtain component A.The B component is a normal saline.During use 30 parts of B components and component A are fully mixed, arrive desired area with injector to inject.Above-mentioned vancomycin can change cisplatin, melphalan, carmustine, camptothecine or paclitaxel into; Above-mentioned gelatin can be changed to derivant, cellulose or the cellulose derivative of chitosan, collagen, starch; Above-mentioned dodecyl sodium sulfate can be changed to tristerin, poly-second two or sorbitan monooleate (span) series of surfactants.
With this injectable calcium sulphate based slow release implantation system implantable bone defect that contains the PLGA microgranule of load vancomycin, drug release time can reach about 3 months, and independent calcium sulfate medicine-carried system, drug release time only has more than 20 day.
Example 6
Get 100 parts of half-H 2 O calcium sulphates, add chitosan-calcium sulfate microgranule, 4 parts potassium sulfate, 1 part alginate and 0.4 part the sorbitan monooleate of 4 parts of load ibuprofen, and mix homogeneously, put into medicine bottle with the Co-60 sterilization, obtain component A.The B component is a deionized water.During use 50 parts of B components and component A are fully mixed, arrive desired area with injector to inject.Above-mentioned ibuprofen can change aspirin, acetaminophen etc. into; Above-mentioned potassium sulfate can be changed to calcium sulphate dihydrate, calcium phosphate or sodium phosphate.
Example 7
Get 100 parts of half-H 2 O calcium sulphates, add the PLGA microgranule of 3 parts of load amycin, 4 parts head bubble furan suffering, 3 parts calcium sulphate dihydrate and 2 parts calcium carbonate, 3 parts amylodextrin, and mix homogeneously, put into medicine bottle with the Co-60 sterilization, obtain component A.The B component is a normal saline.During use 40 parts of B components and component A are fully mixed, arrive desired area with injector to inject.Above-mentioned amycin can be changed to cisplatin, melphalan, carmustine, camptothecine or paclitaxel; Above-mentioned amylodextrin can be changed to chitosan, collagen or cellulose and derivant thereof.
The present invention is not limited to the technology described in the embodiment; its description is illustrative; and it is nonrestrictive; authority of the present invention is limited by claim; based on present technique field personnel according to the present invention can change, technology related to the present invention that method such as reorganization obtains, all within protection scope of the present invention.
Claims (10)
1. an Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle adopts two component A and B; It is characterized in that mass fraction is as follows:
Component A:
100 parts of half-H 2 O calcium sulphates,
0.1～10 part of nucleator,
0.1～5 part of plasticiser,
0～5 part in surfactant,
2～5 parts of medicine carrying microgranules, pastille mass concentration are 4%～20%;
B component is a diluent, and consumption is in 100 parts of half-H 2 O calcium sulphates, and diluent is 30～60 parts.
2. Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle as claimed in claim 1 is characterized in that described nucleator is one or more mixing of inorganic salt.
3. Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle as claimed in claim 2 is characterized in that described inorganic salt is sodium phosphate, calcium phosphate, sodium sulfate, calcium carbonate, potassium sulfate or calcium sulphate dihydrate.
4. Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle as claimed in claim 1 is characterized in that described plasticiser is one or more mixing of natural biological degradable polymer.
5. Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle as claimed in claim 4 is characterized in that described natural biological degradable polymer is the derivant of gelatin, chitosan, alginate, collagen, starch, starch, cellulose or cellulose derivative.
6. Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle as claimed in claim 1 is characterized in that described surfactant is dodecyl sodium sulfate, tristerin, Polyethylene Glycol, polyoxyethylene or sorbitan monooleate series of surfactants.
7. Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle as claimed in claim 1 is characterized in that described medicine carrying microgranule is that particle diameter is all less than 100 microns hydrophobicity polylactic acid/ethanol copolymer microgranule or hydrophilic polymer chitosan-calcium sulfate microgranule.
8. the preparation method of the medicine carrying microgranule of the Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle of claim 7 is characterized in that:
(a) adopt nebulization or emulsion process to prepare medicine carrying microballoons to hydrophobic polymer PLGA: nebulization is with behind the lysate of PLGA and the drug molecule solution uniform mixing, it is microgranular to adopt nebulization that it is prepared into, and promptly gets the drug-carrying polymer microgranule behind the washing after drying; Emulsion process be with the PLGA material dissolves in the immiscible organic facies medium of water in, medicine is dispersed or dissolved in this solution then, form dispersion or solution, with dispersion or solution after aqueous phase emulsifying, form droplet, heating makes the organic solvent volatilization, and emulsion droplet begins the hardening balling-up, filtration after scouring drying promptly produces medicine carrying microballoons;
(b) adopt the rp-emulsification cross-linking method to prepare to hydrophilic polymer chitosan-calcium sulfate medicine carrying microgranule: earlier chitosan, medicine to be dissolved in the aqueous solution of glacial acetic acid, to add calcium sulfate then, mix homogeneously; Under intense agitation, it is dropwise added in the organic facies medium that has disperseed surfactant, under the room temperature after emulsifying half an hour, dropwise add cross-linking agent solution, continue reaction 1～2 hour, with product repeatedly vacuum filter repeatedly washing, dry in the electrically heated drying cabinet, promptly get polymer drug-carried fine particle.
9. the application of the Injectable calcium sulphate-based sustained-release implantation component containing medicine-carrying particle of claim 1 is characterized in that the anti-inflammatory drug or the anticancer class medicine of the bone renovating material that is used for osteomyelitis or osteocarcinoma postoperative topical or is used as bone defect healing.
10. application as claimed in claim 9 is characterized in that described anti-inflammatory drug is albomycin, gentamycin, vancomycin, tobramycin, head bubble furan suffering or PVP-iodine or metronidazole; Anticancer class medicine is cisplatin, melphalan, carmustine, amycin, camptothecine or paclitaxel, analgesic aspirin, ibuprofen or acetaminophen.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102085389A (en) * | 2011-01-14 | 2011-06-08 | 北京大清生物技术有限公司 | Preparation method of injectable bone repair material |
| CN107158473A (en) * | 2017-05-08 | 2017-09-15 | 上海纳米技术及应用国家工程研究中心有限公司 | A kind of calcium phosphate bone cement for embedding load medicine silica nodule and its preparation method and application |
| CN108295305A (en) * | 2018-03-21 | 2018-07-20 | 刘小勇 | A kind of filling material of bone and preparation method thereof |
| CN110694107A (en) * | 2019-10-08 | 2020-01-17 | 中山大学附属第八医院（深圳福田） | Strontium-containing alpha-calcium sulfate hemihydrate/nano-silver/ginsenoside-carrying sodium alginate microsphere bone substitute material and preparation method thereof |
| CN113144292A (en) * | 2021-03-11 | 2021-07-23 | 苏州大学 | Stem cell secretion, preparation method thereof, bioactive bone cement, preparation method and application |
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2009
- 2009-02-13 CN CNA2009100678555A patent/CN101485904A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102085389A (en) * | 2011-01-14 | 2011-06-08 | 北京大清生物技术有限公司 | Preparation method of injectable bone repair material |
| CN102085389B (en) * | 2011-01-14 | 2013-10-16 | 北京大清生物技术有限公司 | Preparation method of injectable bone repair material |
| CN107158473A (en) * | 2017-05-08 | 2017-09-15 | 上海纳米技术及应用国家工程研究中心有限公司 | A kind of calcium phosphate bone cement for embedding load medicine silica nodule and its preparation method and application |
| CN107158473B (en) * | 2017-05-08 | 2019-12-27 | 上海纳米技术及应用国家工程研究中心有限公司 | Calcium phosphate bone cement embedded with drug-loaded silica plastid and preparation method and application thereof |
| CN108295305A (en) * | 2018-03-21 | 2018-07-20 | 刘小勇 | A kind of filling material of bone and preparation method thereof |
| CN110694107A (en) * | 2019-10-08 | 2020-01-17 | 中山大学附属第八医院（深圳福田） | Strontium-containing alpha-calcium sulfate hemihydrate/nano-silver/ginsenoside-carrying sodium alginate microsphere bone substitute material and preparation method thereof |
| CN113144292A (en) * | 2021-03-11 | 2021-07-23 | 苏州大学 | Stem cell secretion, preparation method thereof, bioactive bone cement, preparation method and application |
| CN113144292B (en) * | 2021-03-11 | 2021-12-21 | 苏州大学 | Stem cell secretion, preparation method thereof, bioactive bone cement, preparation method and application |
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Application publication date: 20090722 |