CN101549177B - Medicament coating applied to fixation screw in rachis, preparation method thereof and application thereof - Google Patents
Medicament coating applied to fixation screw in rachis, preparation method thereof and application thereof Download PDFInfo
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- CN101549177B CN101549177B CN200910051827A CN200910051827A CN101549177B CN 101549177 B CN101549177 B CN 101549177B CN 200910051827 A CN200910051827 A CN 200910051827A CN 200910051827 A CN200910051827 A CN 200910051827A CN 101549177 B CN101549177 B CN 101549177B
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Abstract
The invention relates to a medicament coating applied to fixation screw in rachis, a preparation method thereof and application thereof. Thickness of the medicament coating is 30-300 microns and the coating is uniform inside and outside. After being treated by ultrasonic wave, the screw is sequentially soaked in hydrofluoric acid and hydrogen peroxide solution, and then soaked in protein having concentration of 1mg/ml; after surface of the screw is rinsed with PBS, the screw is soaked in PBS dissolved with 0.2mol/L of diimine and 0.05mol/L of N-hydroxysuccinimide for 30min; the screw is then soaked in solution of distilled water dissolved with bisphosphonates and other medicaments for 24 hours, thus the medicament coating is obtained. The medicament coating screw can be applied to fixationin rachis so as to improve bone quality, reduce danger of fracture, and reduce diameter of screw on condition of same withdrawal resistance, thus risk because of screw with big diameter is reduced; t he medicament coating has simple technique, low cost, good economic benefit and good application prospect.
Description
Technical field
The invention belongs to medication coat and the preparation and the application of clinical internal fixation screw, particularly relate to a kind of medication coat and preparation and application that is used for internal fixation of spine art screw.
Background technology
A lot of internal fixation of spine product lines are arranged in the market, no matter that product, screw is the basic module of each product.The biomechanics characteristic of bone and screw contact surface: as resisting fatigue, resistance to plucking exert oneself, that decision such as antitorque commentaries on classics internal fixation of spine is stable is good and bad.Influence having of bone and screw contact surface biomechanics characteristic: the screw thread of the diameter of the material of screw, the length of screw, screw, the pitch of screw, screw, the profile of screw handle, patient's bone density.
Becoming flexible or deviating from of internal fixation of spine is common complication, particularly in the poor patient of bone mass.Though corpse or in zoopery axially resistance to plucking exert oneself to be widely used and assess internal fixation of spine and whether stablize.The resistance to plucking that increases bone and screw contact surface is exerted oneself can be through following several method: 1) change the design of screw, have the fixed withdrawal resistance of experiment proof V-type column type, the tapered spiral shell of V-type best; 2) increase the length and/or the diameter of screw, but but increased corresponding risk like nerve and blood vessel around the nerve of fracture of vertebral pedicle, damage vertebral body front and blood vessel, the damage screw; 3) change bone mass; As in the nail road, injecting polymethyl methacrylate (PMMA), can improve the constant intensity of screw like this, but also bring risk such as PMMA to leak in the canalis spinalis accordingly; Use simultaneously and produce 40～100 ℃ of high temperature in the process of PMMA and damage surrounding tissue; Give to overhaul simultaneously and cause difficulty, increase operation risk and prolong operating time, in the nail road, inject calcium sulfate bone cement etc. in addition.
Improve at present the bone mass medicine and have three types: one type is to act on several types of medicines such as osteoclast such as A, B, C, D, and they mainly reduce losing of bone through the effect osteoclast; Second type is to act as osteocyte, and like several types of medicines such as E, F, G, H, this type of medicine is through acting on osteoblast, bone density improving and bone amount; The 3rd type is bone mineralising medicine, is used to prevent osteoporotic basic medication, and several types of I, J etc. are arranged.
The category-A medicine is not by zymolytic chemical compound, and biodegradation does not take place, and mainly through acting on osteoclast, its mechanism of action has 3 aspects: 1. directly influence the morphology of osteoclast, disturb osteoblastic function; 2. form a Concentraton gradient at bone surface, disturb of the activation of other cell osteoclast; 3. change the activity of bone matrix, thereby influence the final activation of substrate osteoclast.It was 3 generations that the category-A medicine is divided into, and what use now was the 3rd generation, the 3rd generation medicine bone mass is increased; Bone turnover rate descends; Keep the new quality that forms skeleton when increasing the bone amount, thereby reduce fracture risk, treatment only three months lumbar vertebra BMD has promptly that to raise be 4.9%.J class medicine promotes bone formation through promoting small intestinal and renal tubules to the absorption of calcium, can stimulate bone resorption again simultaneously.Current research Table A class medicine and the medication combined application of J class can obviously improve bone mass.
For improve research focus that pedicle screw or steel plate screw resistance to plucking exert oneself present in the design that changes screw, increase the diameter of screw; In the nail road, inject bone cement; All these researchs all have corresponding shortcoming; Up to the present, in the research and development of whole internal fixation of spine product, also there is not a company to pay close attention to the research and development of medicine screw.
Summary of the invention
Technical problem to be solved by this invention provides a kind of medication coat and preparation and application that is used for internal fixation of spine art screw; Medication coat screw of the present invention can not increase patient's operating difficulty; Under the situation of identical withdrawal resistance, can reduce the diameter of screw, can reduce the risk of the big screw belt of diameter like this, like fracture of vertebral pedicle; The perineural damage of screw can increase patient's bone mass and treat patient's osteoarthritis in the treatment rachiopathy; This medication coat technology is simple, and cost is low, and economic benefit is friendly, has a good application prospect.
A kind of medication coat that is used for internal fixation of spine art screw of the present invention is characterized in that: medication coat thickness is 30～300 microns, and is inside and outside even.
Described medicine is selected from two or more the mixture in estrogens, selective estrogen receptor modulators class, bis phosphoric acid salt, calcitonin class, the vitamins, and the mass ratio of two kinds of medicines is 20～80: 20～80;
Described medicine is the mixture of bis phosphoric acid salt and other drug; Other drug is selected from one or more the mixture in estrogens, selective estrogen receptor modulators class, calcitonin class, the vitamins, and the mass ratio of bis phosphoric acid salt and other drug is 20～80: 20～80;
Described bis phosphoric acid salt is ibandronate or alendronate; The selective estrogen receptor modulators class is a raloxifene; The calcitonin class is Mi Gai breath or elcatonin; Vitamins is a vitamin D, the B12 that supports one's family, the K or the E that supports one's family support one's family;
Described medication coat can discharge medicine and continue and discharge more than 15-21 days with constant speed.
A kind of preparation that is used for the medication coat of internal fixation of spine art screw of the present invention comprises step:
(1) screw surface treatment
With ultrasonic Treatment screw 5～8 minutes, be soaked among 100% the Fluohydric acid. HF 20 minutes, be immersed in 75～80 ℃ the mixed solution of hydrogen peroxide and deionized water 5～10 minutes then, use distilled water flushing at last;
(2) preparation of screw surface fiber proteinogen coating
Screw is soaked in the protein that concentration is 1mg/ml; And to be dissolved in pH be among 7.4 the phosphate buffered saline (PBS) PBS 30 minutes; The screw surface is washed with PBS; Be soaked among the PBS of N-hydroxy-succinamide of the carbodiimides that is dissolved with 0.2mol/L and 0.05mol/L 30 minutes, pH value is 5.4～5.6 again;
(3) preparation of medication coat screw
With the medicine that needs coating by mass ratio 20～80: 20～80 are dissolved in the distilled water, and screw is immersed in this solution 24 hours, make the medication coat screw.
The volume ratio of Fluohydric acid. HF, hydrogen peroxide and deionized water is 1: 2: 500 described in the step (1).
Being applied to of a kind of medication coat that is used for internal fixation of spine art screw of the present invention improved bone mass in the internal fixation of spine art, reduces fracture risk, and the resistance to plucking that in the internal fixation of spine art, improves screw exerts oneself 20～40%, can keep 1-2.
The present invention has adopted the medication coat that will improve bone mass to screw, through topical, can improve the bone mass of medication part bone fast, can improve the resistance to plucking of screw at short notice and exert oneself, and has improved the stability of internal fixation of spine like this, improves curative effect.Further research shows; If two types of medicines are processed the medication coat screw of different ratios; Then this screw can be selected different drug coating screw according to patient's bone density for use; Then the biomechanics characteristic of this screw can further improve, and can reduce side effects of pharmaceutical drugs, is fit to Clinical Application more.
Medication coat of the present invention is workable to screw, can improve the screw resistance to plucking effectively and exert oneself, and improves the stability of internal fixation of spine; Can improve patient's bone mass simultaneously again; Prevention patient's osteoporosis prevents the generation of fracturing once more, and does not influence the spinal fusion rate.
Beneficial effect
(1) medication coat screw of the present invention can not increase patient's operating difficulty; Under the situation of identical withdrawal resistance, can reduce the diameter of screw; Can reduce the risk of the big screw belt of diameter like this; Like fracture of vertebral pedicle, the perineural damage of screw can increase patient's bone mass and treat patient's osteoarthritis in the treatment rachiopathy;
(2) this medication coat technology is simple, and cost is low, and economic benefit is friendly, has a good application prospect.
The specific embodiment
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment only to be used to the present invention is described and be not used in the restriction scope of the present invention.Should be understood that in addition those skilled in the art can do various changes or modification to the present invention after the content of having read the present invention's instruction, these equivalent form of values fall within the application's appended claims institute restricted portion equally.
Embodiment 1
(1) screw surface treatment
With ultrasonic Treatment screw 5 minutes, be soaked in 100% Fluohydric acid. 20 minutes, be immersed in 80 ℃ the mixed solution of hydrogen peroxide and deionized water 10 minutes then, use distilled water flushing at last;
(2) preparation of screw surface fiber proteinogen coating
Screw is soaked in the protein that concentration is 1mg/ml; And to be dissolved in pH be among 7.4 the phosphate buffered saline (PBS) PBS 30 minutes; The screw surface is washed with PBS; Be soaked in the PBS solution of N-hydroxy-succinamide N-hydroxysuccinimide of the carbodiimides ethyl-dimethyl-aminopropylcarbodiimide that is dissolved with 0.2mol/L and 0.05mol/L 30 minutes, pH value is 5.4 again;
(3) preparation of medication coat screw
10g ibandronate and 40g raloxifene are dissolved in the distilled water, screw is immersed in this solution 24 hours, make the medication coat screw.
Embodiment 2
(1) screw surface treatment
With ultrasonic Treatment screw 8 minutes, be soaked in 100% Fluohydric acid. 20 minutes, be immersed in 80 ℃ the mixed solution of hydrogen peroxide and deionized water 10 minutes then, use distilled water flushing at last;
(2) preparation of screw surface fiber proteinogen coating
Screw is soaked in the protein that concentration is 1mg/ml, and to be dissolved in pH be among 7.4 the phosphate buffered saline (PBS) PBS 30 minutes that the screw surface is washed with PBS, is soaked in to be dissolved with 0.2mol/L again
In the PBS solution of ethyl-dimethyl-aminopropylcarbodiimide and 0.05mol/L N-hydroxysuccinimide 30 minutes, pH value was 5.5;
(3) preparation of medication coat screw
20g alendronate and 30g Mi Gai breath is dissolved in the distilled water, screw is immersed in this solution 24 hours, make the medication coat screw.
Embodiment 3
(1) screw surface treatment
With ultrasonic Treatment screw 8 minutes, be soaked in 100% Fluohydric acid. 20 minutes, be immersed in 80 ℃ the mixed solution of hydrogen peroxide and deionized water 10 minutes then, use distilled water flushing at last;
(2) preparation of screw surface fiber proteinogen coating
Screw is soaked in the protein that concentration is 1mg/ml, and to be dissolved in pH be among 7.4 the phosphate buffered saline (PBS) PBS 30 minutes that the screw surface is washed with PBS, is soaked in to be dissolved with 0.2mol/L again
In the PBS solution of ethyl-dimethyl-aminopropylcarbodiimide and 0.05mol/L N-hydroxysuccinimide 30 minutes, pH value was 5.5;
(3) preparation of medication coat screw
50g ibandronate and the 50g B12 that supports one's family is dissolved in the distilled water, screw is immersed in this solution 24 hours, make the medication coat screw.
Embodiment 4
(1) screw surface treatment
With ultrasonic Treatment screw 8 minutes, be soaked in 100% Fluohydric acid. 20 minutes, be immersed in 80 ℃ the mixed solution of hydrogen peroxide and deionized water 10 minutes then, use distilled water flushing at last;
(2) preparation of screw surface fiber proteinogen coating
Screw is soaked in the protein that concentration is 1mg/ml, and to be dissolved in pH be among 7.4 the phosphate buffered saline (PBS) PBS 30 minutes that the screw surface is washed with PBS, is soaked in to be dissolved with 0.2mol/L again
In the PBS solution of ethyl-dimethyl-aminopropylcarbodiimide and 0.05mol/L N-hydroxysuccinimide 30 minutes, pH value was 5.5;
(3) preparation of medication coat screw
40g elcatonin and the 10g B12 that supports one's family is dissolved in the distilled water, screw is immersed in this solution 24 hours, make the medication coat screw.
Embodiment 5
(1) screw surface treatment
With ultrasonic Treatment screw 8 minutes, be soaked in 100% Fluohydric acid. 20 minutes, be immersed in 80 ℃ the mixed solution of hydrogen peroxide and deionized water 10 minutes then, use distilled water flushing at last;
(2) preparation of screw surface fiber proteinogen coating
Screw is soaked in the protein that concentration is 1mg/ml, and to be dissolved in pH be among 7.4 the phosphate buffered saline (PBS) PBS 30 minutes that the screw surface is washed with PBS, is soaked in to be dissolved with 0.2mol/L again
In the PBS solution of ethyl-dimethyl-aminopropylcarbodiimide and 0.05mol/L N-hydroxysuccinimide 30 minutes, pH value was 5.5;
(3) preparation of medication coat screw
30g raloxifene and the 20g K that supports one's family is dissolved in the distilled water, screw is immersed in this solution 24 hours, make the medication coat screw.
Embodiment 6
The present invention uses minimum dose bis phosphoric acid salt medication coat to the internal fixation of spine screw through topical, and exerting oneself at the resistance to plucking that improves screw does not influence the fusion rate of spinal column together.Test the average weight 738g of mouse (701～790) with mouse.Observe coating screw and non-coating screw to the influence of mouse L45 vertebral fusion rate, put two pieces of coating screw or non-coating screws in the vertebral body side, merge in the outside behind the employing L45 intervertebral.The fusion rate of two groups of mouse L45 vertebral bodys of 8 weeks back discovery does not have tangible different P＞0.05; The L45 intervertebral fusion rate that wherein is not coated with drug group is 87.5% (24 merely hit 21 intervertebral fusion); The L45 intervertebral fusion rate that is coated with drug group is 82.6% (23 merely hit 19 intervertebral fusion); But the resistance to plucking of screw exerts oneself obviously to improve statistical significance P＜0.05 is arranged, it is 56 ± 13 (N) that the resistance to plucking that wherein is not coated with medicine is exerted oneself, and it is 74 ± 13 (N) that the resistance to plucking that is coated with drug group is exerted oneself.Draw thus, use the medication coat screw of this dosage, medicine only acts on the part that screw contacts with bone, and does not influence the bone at other position, can significantly improve the resistance to plucking of screw under these circumstances to exert oneself, and don't influence interpyramidal fusion.
Claims (5)
1. medication coat that is used for internal fixation of spine art screw, it is characterized in that: medication coat thickness is 30～300 microns, inside and outside evenly; Described medicine is selected from two kinds mixture in selective estrogen receptor modulators, Diphosphonate, calcitonin, the vitamin, and the mass ratio of two kinds of medicines is 20～80: 20～80.
2. a kind of medication coat that is used for internal fixation of spine art screw according to claim 1; It is characterized in that: described medicine is the mixture of Diphosphonate and other drug; Other drug is selected from a kind of in selective estrogen receptor modulators, calcitonin, the vitamin, and the mass ratio of Diphosphonate and other drug is 20～80: 20～80.
3. a kind of medication coat that is used for internal fixation of spine art screw according to claim 1 is characterized in that: described Diphosphonate is ibandronate or alendronate; Selective estrogen receptor modulators is a raloxifene; Calcitonin is Mi Gai breath or elcatonin; Vitamin is a vitamin D, the B12 that supports one's family, the K or the E that supports one's family support one's family.
4. preparation that is used for the medication coat of internal fixation of spine art screw comprises step:
(1) screw surface treatment
With ultrasonic Treatment screw 5～8 minutes, be soaked among 100% the Fluohydric acid. HF 20 minutes, be immersed in 75～80 ℃ the mixed solution of hydrogen peroxide and deionized water 5～10 minutes then, use distilled water flushing at last;
(2) preparation of screw surface fiber proteinogen coating
Screw is soaked in the protein that concentration is 1mg/mL; And to be dissolved in pH be among 7.4 the phosphate buffered saline (PBS) PBS 30 minutes; The screw surface is washed with PBS; Be soaked among the PBS of N-hydroxy-succinamide of the carbodiimides that is dissolved with 0.2mol/L and 0.05mol/L 30 minutes, pH value is 5.4～5.6 again;
(3) preparation of medication coat screw
The medicine dissolution that needs coating in distilled water, is immersed in this solution 24 hours with screw, makes the medication coat screw; The described medicine of coating that needs is selected from two kinds mixture in selective estrogen receptor modulators, Diphosphonate, calcitonin, the vitamin, and the mass ratio of two kinds of medicines is 20～80: 20～80.
5. a kind of preparation that is used for the medication coat of internal fixation of spine art screw according to claim 4, it is characterized in that: the volume ratio of Fluohydric acid. HF, hydrogen peroxide and deionized water is 1: 2: 500 described in the step (1).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910051827A CN101549177B (en) | 2009-05-22 | 2009-05-22 | Medicament coating applied to fixation screw in rachis, preparation method thereof and application thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910051827A CN101549177B (en) | 2009-05-22 | 2009-05-22 | Medicament coating applied to fixation screw in rachis, preparation method thereof and application thereof |
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| Publication Number | Publication Date |
|---|---|
| CN101549177A CN101549177A (en) | 2009-10-07 |
| CN101549177B true CN101549177B (en) | 2012-10-10 |
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| CN200910051827A Expired - Fee Related CN101549177B (en) | 2009-05-22 | 2009-05-22 | Medicament coating applied to fixation screw in rachis, preparation method thereof and application thereof |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102266595A (en) * | 2011-07-14 | 2011-12-07 | 王学凡 | Medicament coating titanium nail using chitosan gelatin as carrier |
| CN102266596A (en) * | 2011-07-26 | 2011-12-07 | 王学凡 | Medicine coating titanium nail using calcium alginate fibers as carrier |
| EP3413934B1 (en) * | 2016-02-12 | 2021-10-13 | Nano Bridging Molecules SA | Improved treatment of implants with phosphonic acid compounds |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2002098307A1 (en) * | 2001-06-07 | 2002-12-12 | The Royal Alexandra Hospital For Children | A device for the delivery of a drug to a fractured bone |
| CN1859881A (en) * | 2003-09-30 | 2006-11-08 | 库尔斯恩蒂斯股份公司 | Antimicrobial hyaluronic acid coatings for orthopedic implants |
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2009
- 2009-05-22 CN CN200910051827A patent/CN101549177B/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2002098307A1 (en) * | 2001-06-07 | 2002-12-12 | The Royal Alexandra Hospital For Children | A device for the delivery of a drug to a fractured bone |
| CN1859881A (en) * | 2003-09-30 | 2006-11-08 | 库尔斯恩蒂斯股份公司 | Antimicrobial hyaluronic acid coatings for orthopedic implants |
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| CN101549177A (en) | 2009-10-07 |
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