CN102961785A - Tumor cavity filler for treating giant cell tumor of bone and preparation method thereof - Google Patents
Tumor cavity filler for treating giant cell tumor of bone and preparation method thereof Download PDFInfo
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- CN102961785A CN102961785A CN2012104523038A CN201210452303A CN102961785A CN 102961785 A CN102961785 A CN 102961785A CN 2012104523038 A CN2012104523038 A CN 2012104523038A CN 201210452303 A CN201210452303 A CN 201210452303A CN 102961785 A CN102961785 A CN 102961785A
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Abstract
The invention belongs to the technical field of medical engineering and provides a tumor cavity filler for treating giant cell tumor of bone and a preparation method thereof. The mixture is formed by mixing a diphosphate medicine and bone cement according to a ratio, wherein the bone cement serves as a controlled release carrier of the diphosphate medicine, so that a topical administration system is formed. The principle is that the bone cement serves as the release carrier of the medicine and the diphosphate medicine is released at a focus, so that the aim that the focus is positioned in a long-term high-concentration medicine environment is fulfilled; and therefore, the effects of suppressing bone destruction and preventing bone resorption through the diphosphate medicine are improved, and the function of repairing the bone destruction through the bone cement is not influenced.
Description
Technical field
The invention belongs to the medical engineering technical field, a kind of tumor chamber implant that is used for the treatment of giant cell tumor of bone and preparation method thereof is provided.
Background technology
Giant cell tumor of bone is the optimum invasive tumor that collagen is sent out, account for 20% of former bone tumor, existing Therapeutic Method generally adopts operative treatment, wherein optimum invasive tumor Surgical boundary requires to reach the edge excision, strike off rear filling bone cement, generally near articular surface place bone grafting, can the Saving cortilage cartilage, reduce the generation of osteoarthritis, all the other cavitys are filled bone cement; But be not that all tumors all possess the condition of striking off, have part can only go tumor resection yet and then carry out the artificial prosthesis substitution, but existing tumor chamber implant generally only selected bone cement, the single effect that only can play filling of its performance.
Giant cell tumor of bone has the high characteristics of local relapse, has the bibliographical information can be up to 20 ﹪-30 ﹪.Although simple Cement has solved the filling in tumor chamber, fails to solve the high problem of its relapse rate.The relapse rate that diphosphonic acid salt medicine can reduce giant cell tumor of bone is used in nearest studies show that.But diphosphonic acid salt drug administration approach is mainly oral and intravenously administrable in these researchs, has in use that bioavailability is low, Time of Administration is long, medical expense is expensive, cause easily many deficiencies such as ulcer of upper digestive tract.For avoiding these deficiencies, topical is a kind of ideal selection.But compound diphosphate bone cement research is in the starting stage in the prior art, does not also occur Related product and research thereof on the market.
Summary of the invention
Many deficiencies for existing treatment bones of extremities giant cell tumor of bone method, the invention provides a kind of tumor chamber implant that is used for the treatment of giant cell tumor of bone and preparation method thereof, this mixture proportionally mixes diphosphonic acid salt medicine and bone cement, with the slow-released carrier of bone cement as diphosphonic acid salt medicine, form a kind of local medicine-applying system, its principle is as drug release carrier by bone cement, with diphosphonic acid salt drug release in affected area, be in one for a long time to reach focus, the purpose of the pharmaceutical environment of high concentration, thereby improve diphosphonic acid salt medicine and suppress osteoclasia, prevent the effect of bone resorption, do not affect simultaneously the effect of bone cement repairing bone defect, can treat the damaged reconstruction of bones of extremities giant cell tumor Postoperative Bone, reduce the giant cell tumor of bone relapse rate.
Concrete technical scheme of the invention process is:
A kind of tumor chamber implant that is used for the treatment of giant cell tumor of bone, the weight ratio of diphosphonic acid salt medicine and bone cement is 5-100:100000 in this implant.
The diphosphonic acid salt medicine that wherein adopts is selected from zoledronic acid also can select other diphosphonic acid salt medicines, as: pamidronate disodium, Allan sodium phosphate etc., wherein preferably adopt zoledronic acid.
Described bone cement is selected from the acrylic resin bone cement, such as the 8. domestic bone cement produced of R bone cement, German LI NK bone cement, Tianjin Synthetic Material Industry Research Institute of PALACOS.
In addition, the application of the calcium phosphate bone cement on the market is also more and more wider, but because diphosphonic acid salt medication medication has the characteristic with the calcium ion chelating, will certainly affect its release performance in case calcium phosphate bone cement mixes with diphosphonic acid salt medication medication, so the inventor abandons adopting calcium phosphate bone cement and only adopts the acrylic resin bone cement.
In order to obtain better effect, the weight ratio that generally can control diphosphonic acid salt medicine and bone cement is 1-5:10000.
Wherein why select particularly zoledronic acid of diphosphonic acid salt medicine, mainly be because it has two greatly effects to osteoclast: the first directly suppresses the bone resorption activity that osteoclast causes, its important channel be medicine with skeleton in combining closely of hydroxyapatite intercepted osteoclast and contacted with the direct of bone mineral, play a kind of barrier action; In addition, because bone resorption is actually the dissolving of bone matrix minerals, cavity sample proton ATP enzyme on osteoclast film wrinkle wall is realized the acidify of bone matrix, and diphosphonic acid salt medicine can clearly suppress the activity of this enzyme, thereby suppress the acidify to bone matrix, avoid the generation of bone resorption.
And just diphosphonic acid salt medicine and bone cement are mixed according to above-mentioned ratio among the present invention, with a kind of local medicine-applying system of bone cement as the slow-released carrier of diphosphonic acid salt medicine, its principle is as drug release carrier by bone cement, with diphosphonic acid salt drug release in affected area, reached the purpose that focus is in the pharmaceutical environment of long-time a, high concentration, thereby improve diphosphonic acid salt medicine and suppress osteoclasia, prevent the effect of bone resorption, do not affect the effect of bone cement repairing bone defect simultaneously.
The art formula commonly used for the treatment of giant cell tumor of bone is that tumor is struck off bone cement filling art, and often Cement is as implant clinically after striking off tumor tissues, and rebuilding the integrity of skeleton, repairing bone defect not yet finds to substitute its material at present.Bone cement is as the material of repairing bone defect clinically in addition, existing clinical use experience for many years.Having safety and reliability, is pharmaceutical carrier so we select bone cement.We find by experiment, zoledronic acid can tolerate the bone cement exothermic heat of reaction, simultaneously stable discharging in the bone cement carrier, and can reach the valid density for the treatment of, and diphosphonic acid salt medicine can not cause adverse influence to the character of bone cement, can patient's post-operative recovery do not brought inconvenience yet.And the diphosphate of other kinds also has similar characteristic, so the inventor adopts the tumor chamber implant of the two mixture preparation treatment giant cell tumor of bone.
The present inventor provides the preparation method of this tumor chamber implant simultaneously, and concrete steps are as follows:
Accurately taking by weighing diphosphonic acid salt drug powder, to put into aseptic rustless steel dish stand-by, according to said ratio the bone cement powder is also added in the above-mentioned rustless steel dish, stir at the uniform velocity clockwise bone cement zoledronic acid powder to naked eyes with the stirring rod of cleaning and watch lower two kinds of powder mix homogeneously.Pour the bone cement liquid monomer into, stirring prepares and gets.
The implant that adopts said ratio and preparation method to obtain, diphosphonic acid salt medicine discharge from the bone cement carrier smoothly, and slow release diphosphonic acid salt medicine pharmacological property does not out change from bone cement, guarantees its drug effect; Do not affect bone cement solidification process and time after adding simultaneously above-mentioned diphosphonic acid salt medicine, can normally use.
The inventor has carried out compressive strength determination and bending strength and modulus measurements to above-mentioned acquisition implant, finds on lixiviate 4 all afterwards comprcssive strength of bone cements appreciable impact being arranged before the lixiviate bone cement composite bending modulus and bending strength to be had no significant effect.Design parameter is as follows:
Each organizes before the elution of (x ± sd, n=5) bone cement and comprcssive strength (MPa) behind the elution 4W
Front comprcssive strength obviously increased after each organized the bone cement lixiviate, and see according to clinical behaviour in service, adopt said ratio mixed diphosphonic acid salt medicine and bone cement in the situation that does not affect the normal operation parameter of bone cement and standard, guaranteed the continuous and effective of medicine.The parameter of its every bone cement parameter during all no less than simple Cement.
In sum, the invention provides a kind of tumor chamber implant of giant cell tumor of bone, it forms a kind of local medicine-applying system, by bone cement as drug release carrier, with diphosphonic acid salt drug release in affected area, be in the purpose of the pharmaceutical environment of long-time a, high concentration to reach focus, thereby improve diphosphonic acid salt medicine and suppress osteoclasia, prevent the effect of bone resorption, do not affect simultaneously the effect of bone cement repairing bone defect, can treat the damaged reconstruction of bones of extremities giant cell tumor Postoperative Bone, reduce the giant cell tumor of bone relapse rate.
The specific embodiment
The specific embodiment of form is described in further detail foregoing of the present invention by the following examples, but this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
Embodiment 1
A kind of tumor chamber implant that is used for the treatment of giant cell tumor of bone, the weight ratio of diphosphonic acid salt medicine and bone cement is 5:100000 in this implant;
The diphosphonic acid salt medicine that wherein adopts is selected from zoledronic acid; Described bone cement is selected from the acrylic resin bone cement;
The preparation method of above-mentioned tumor chamber implant, concrete steps are as follows:
Accurately taking by weighing the zoledronic acid powder, to put into aseptic rustless steel dish stand-by, according to said ratio the bone cement powder is also added in the above-mentioned rustless steel dish, stir at the uniform velocity clockwise bone cement zoledronic acid powder to naked eyes with the stirring rod of cleaning and watch lower two kinds of powder mix homogeneously, pour the bone cement liquid monomer into, stirring prepares and gets.
The inventor has carried out compressive strength determination and bending strength and modulus measurements to above-mentioned acquisition implant, discovery to lixiviate before and after lixiviate 4 week the comprcssive strength of bone cements remarkable increase is arranged, bone cement composite bending modulus and bending strength are had no significant effect, and its parameters is all no less than common bone cement.
Embodiment 2
A kind of tumor chamber implant that is used for the treatment of giant cell tumor of bone, the weight ratio of diphosphonic acid salt medicine and bone cement is 100:100000 in this implant.
The diphosphonic acid salt medicine that wherein adopts is selected from pamidronate disodium; Described bone cement is selected from the acrylic resin bone cement;
The preparation method of above-mentioned tumor chamber implant, concrete steps are as follows:
Accurately taking by weighing the zoledronic acid powder, to put into aseptic rustless steel dish stand-by, according to said ratio the bone cement powder is also added in the above-mentioned rustless steel dish, stir at the uniform velocity clockwise bone cement zoledronic acid powder to naked eyes with the stirring rod of cleaning and watch lower two kinds of powder mix homogeneously, pour the bone cement liquid monomer into, stirring prepares and gets.
The inventor has carried out compressive strength determination and bending strength and modulus measurements to above-mentioned acquisition implant, discovery to lixiviate before and after lixiviate 4 week the comprcssive strength of bone cements remarkable increase is arranged, bone cement composite bending modulus and bending strength are had no significant effect, and its parameters is all no less than common bone cement.
Embodiment 3
A kind of tumor chamber implant that is used for the treatment of giant cell tumor of bone, the weight ratio of diphosphonic acid salt medicine and bone cement is 1:10000 in this implant.
The diphosphonic acid salt medicine that wherein adopts is selected from zoledronic acid; Described bone cement is selected from the acrylic resin bone cement;
The preparation method of above-mentioned tumor chamber implant, concrete steps are as follows:
Accurately taking by weighing the zoledronic acid powder, to put into aseptic rustless steel dish stand-by, according to said ratio the bone cement powder is also added in the above-mentioned rustless steel dish, stir at the uniform velocity clockwise bone cement zoledronic acid powder to naked eyes with the stirring rod of cleaning and watch lower two kinds of powder mix homogeneously, pour the bone cement liquid monomer into, stirring prepares and gets.
The inventor has carried out compressive strength determination and bending strength and modulus measurements to above-mentioned acquisition implant, discovery to lixiviate before and after lixiviate 4 week the comprcssive strength of bone cements remarkable increase is arranged, bone cement composite bending modulus and bending strength are had no significant effect, and its parameters is all no less than common bone cement.
Embodiment 4
A kind of tumor chamber implant that is used for the treatment of giant cell tumor of bone, the weight ratio of diphosphonic acid salt medicine and bone cement is 5:10000 in this implant.
The diphosphonic acid salt medicine that wherein adopts is selected from the Allan sodium phosphate; Described bone cement is selected from the acrylic resin bone cement;
The preparation method of above-mentioned tumor chamber implant, concrete steps are as follows:
Accurately taking by weighing the zoledronic acid powder, to put into aseptic rustless steel dish stand-by, according to said ratio the bone cement powder is also added in the above-mentioned rustless steel dish, stir at the uniform velocity clockwise bone cement zoledronic acid powder to naked eyes with the stirring rod of cleaning and watch lower two kinds of powder mix homogeneously, pour the bone cement liquid monomer into, stirring prepares and gets.
The inventor has carried out compressive strength determination and bending strength and modulus measurements to above-mentioned acquisition implant, discovery to lixiviate before and after lixiviate 4 week the comprcssive strength of bone cements remarkable increase is arranged, bone cement composite bending modulus and bending strength are had no significant effect, and its parameters is all no less than common bone cement.
Test example:
The bone cement that the inventor obtains embodiment 1-4 is applied to giant cell tumor of bone postoperative tumor chamber implant, find that the above-mentioned bone cement that has added diphosphonic acid salt medicine can make that affected area is long-time in one, the pharmaceutical environment of high concentration, adopt all in position recurrences of giant cell tumor of bone in more than 30 cases of above-mentioned implant, greatly improved the effect of curing.
Claims (4)
1. tumor chamber implant that is used for the treatment of giant cell tumor of bone, it is characterized in that: the weight ratio of diphosphonic acid salt medicine and bone cement is 5-100:100000 in this implant, and the diphosphonic acid salt medicine that wherein adopts is selected from zoledronic acid or pamidronate disodium or Allan sodium phosphate; Described bone cement is selected from the acrylic resin bone cement.
2. tumor according to claim 1 chamber implant, it is characterized in that: the weight ratio of described diphosphonic acid salt medicine and bone cement is 1-5:10000.
3. tumor according to claim 1 and 2 chamber implant, it is characterized in that: the diphosphonic acid salt medicine that adopts is selected from zoledronic acid.
4. prepare the method for the described tumor of claim 1 chamber implant, it is characterized in that: concrete steps are as follows:
Accurately taking by weighing diphosphonic acid salt drug powder, to put into aseptic rustless steel dish stand-by, according to said ratio the bone cement powder is also added in the above-mentioned rustless steel dish, stir at the uniform velocity clockwise bone cement zoledronic acid powder to naked eyes with the stirring rod of cleaning and watch lower two kinds of powder mix homogeneously, pour the bone cement liquid monomer into, stirring prepares and get final product.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103623465A (en) * | 2013-11-21 | 2014-03-12 | 彭江 | Tissue-engineering bone scaffold capable of locally regulating osteoclasts activity and preparation method thereof |
| CN106659728A (en) * | 2014-07-04 | 2017-05-10 | 奥斯特优制药有限公司 | Compositions and products for use in the treatment of bone fractures and defects |
| CN108114321A (en) * | 2017-12-29 | 2018-06-05 | 广州军区广州总医院 | A kind of anti-giant cell tumor of bone chitosan-nanometer hydroxyapatite stent, its preparation method and application |
| CN108126238A (en) * | 2017-12-29 | 2018-06-08 | 广州军区广州总医院 | Bone defect position filler and preparation method thereof after a kind of giant cell tumor of bone evidement |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103623465A (en) * | 2013-11-21 | 2014-03-12 | 彭江 | Tissue-engineering bone scaffold capable of locally regulating osteoclasts activity and preparation method thereof |
| CN103623465B (en) * | 2013-11-21 | 2015-12-30 | 彭江 | A kind ofly local modulation can become tissue engineered bone support and the preparation method of broken bone active |
| CN106659728A (en) * | 2014-07-04 | 2017-05-10 | 奥斯特优制药有限公司 | Compositions and products for use in the treatment of bone fractures and defects |
| CN108114321A (en) * | 2017-12-29 | 2018-06-05 | 广州军区广州总医院 | A kind of anti-giant cell tumor of bone chitosan-nanometer hydroxyapatite stent, its preparation method and application |
| CN108126238A (en) * | 2017-12-29 | 2018-06-08 | 广州军区广州总医院 | Bone defect position filler and preparation method thereof after a kind of giant cell tumor of bone evidement |
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Application publication date: 20130313 |