CN101850154A - Porous bio-ceramic percutaneous implantation device used for topical administration - Google Patents
Porous bio-ceramic percutaneous implantation device used for topical administration Download PDFInfo
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- CN101850154A CN101850154A CN 201010168961 CN201010168961A CN101850154A CN 101850154 A CN101850154 A CN 101850154A CN 201010168961 CN201010168961 CN 201010168961 CN 201010168961 A CN201010168961 A CN 201010168961A CN 101850154 A CN101850154 A CN 101850154A
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Abstract
The invention relates to a porous bio-ceramic percutaneous implantation device used for topical administration, which is characterized by consisting of a porous ceramic embedding body and a rubber helmet, wherein the porous embedding body is I-shaped, and the upper end face of the porous ceramic embedding body is provided with a helmet inserting groove; the rubber helmet is T-shaped, and the shape of the lower part of the rubber helmet corresponds to that of the helmet inserting groove; the edge part of the upper end of the rubber helmet is a snap ring; the lower end face of the rubber helmet is provided with a medicament storage groove; the lower part of the rubber helmet is inserted in the helmet inserting groove; and the snap ring of the rubber helmet is buckled with the upper end of the porous ceramic embedding body. The porous bio-ceramic percutaneous implantation device has a simple structure, can be embedded for a long time, is convenient to use, can realize discontinuous puncture injection administration, needs no skin perforation, reduces pains, and can perform continuous medicament transfusion.
Description
Technical field
The present invention relates to a kind of porous bio-ceramic percutaneous implantation device that is used for topical.
Background technology
Domestic and international state of development: at present, have many chronic and malignant diseases to need the patient part is interrupted or is continued medication, need regularly the local chemotherapy of insulin injection, tumor and immunomodulating etc. as the diabetes patient with severe symptoms.The advantage of embedded type drug-supplying system is: do not have epidermis malabsorption, gastrointestinal degradation and liver " first pass effect ", can reach the body circulation very soon; Drug effect can be avoided the side effect to other tissue in the body in target site, can stablize control blood drug level or targeting moiety drug level for a long time, can improve medicine in partial concentration of focus and utilization rate.Therefore, compare advantage with oral or intravenous systemic administration with uniqueness.Topical mainly is by heeling-in drug-supplying system (Implantable Drug Delivery System, IDDS) realize, Lafarge at first proposed the subdermal implantation pill and obtained the imagination of lasting release for a long time in 1867, nineteen thirty-seven Deansley and Parkes carry out research in the animal body for the first time, pill is imbedded at subcutaneous tissue, medicine discharges with certain speed in a long time, keeps effective blood drug concentration, and the range of application of IDDS expands to a plurality of treatments field by originally contraceptive treatments.
Recently, Liu Hongchen has proposed two kinds of new route of administration designs, i.e. artificial growth body whole body drug-supplying systems
[3]With root canal whole body drug-supplying system
[4]These two kinds design Chinese medicines absorb the arrival whole body through tooth implant surrounding bone tissue and natural tooth root periapical tissue respectively, reach the purpose of treatment part and general disease, for new space has been opened up in the application of IDDS system.But this method has been limited to medicine-feeding part, and is not easy to frequent administration operation.
The sorting technique of IDDS has many, but can be divided into passive embedded type pharmaceutical carrier, active embedded type pharmaceutical carrier and injection supplement type pharmaceutical carrier on structure and principle.The medicament slow release phase of passive embedded type pharmaceutical carrier is limited, and diffusion time, concentration are wayward; Active embedded type pharmaceutical carrier can be controlled time of administration and concentration (metering), but needs retention passages to be in communication with the outside usually, wears skin place easy infection, and is limited through the leather hose holdup time; Though service time, same wayward time of administration and concentration (metering) that injection supplement type thing carrier can prolong carrier.Therefore, develop a kind of can be embedding for a long time, easy to use, the heeling-in drug-supplying system of the kind of administration easy to control, time and concentration becomes the important topic of biomedical material research.
Reference material
1. cold refined, the classification of embedded type drug-supplying system and application, Chinese medicine equipment volume the 5th phase: 5-8. May the 4th in 2007
2. old biography is pretty, and Jiang Xinquan implants the progress of the local chemotherapy of mesenchyma stroma of pouring-in drug sustained release system, foreign medical science stomatology fascicle volume the 1st phase: 21-23 January the 29th in 2002.
3. easily red, Yuan Haoyu, the implant application progress in treatment of cancer, contemporary Chinese medical magazine volume the 1st phase: 75-76 February the 7th in 2005.
4. Lu Bin, novel pharmaceutical formulation and new technique [M]. second edition, Beijing: People's Health Publisher, 2005:1-2.
5. Jia Wei, Gao Wenyuan, Qiu Mingfeng. medicine controlled releasing novel form [M]. Beijing: the .2005:1-300 of Chemical Industry Press.
6. Liu Hong minister, the design [J] of canine implant whole body drug-supplying system. oral and maxillofacial surgery prosthodontics magazine, 2006,7 (4): 291-292.
7. Liu Hong minister, root canal whole body administration hypothesis [J]. Chinese gerodontics magazine, 2007,5 (1): 2-3.
8.Matschke?C，Isele?U，Fahr?A，et?al.Sustainedrelease?injectables?formed?insitu?and?their?potential?use?for?veterinary?products[J].J?ControlRel，2002，85(1-3)：1-15。
9.Hatefi?A，Amsden?B.Biodegradable?injectable?insitu?forming?drug?deliverysystems[J].J?ControlRel，2002，80：9-28。
Summary of the invention
The object of the present invention is to provide a kind of porous bio-ceramic percutaneous implantation device that is used for topical simple in structure, easy to use.
To achieve these goals, technical scheme that the present invention adopts is: be used for the porous bio-ceramic percutaneous implantation device of topical, it is characterized in that it is made up of embedding body of porous ceramics and rubber safety helmet; The embedding body of porous ceramics becomes " worker " font, and the upper surface of the embedding body of porous ceramics is provided with safety helmet and inserts groove, and the material of the embedding body of porous ceramics is an osmosis type hydroxyapatite porous ceramics; The rubber safety helmet becomes T-shape, the profile of the bottom of rubber safety helmet is corresponding with the profile that safety helmet inserts groove, the upper end-face edge portion of rubber safety helmet is a latch closure, the lower surface of rubber safety helmet is provided with the drug storage groove, the bottom of rubber safety helmet is inserted safety helmet and is inserted in the groove, and the upper end of the latch closure of rubber safety helmet and the embedding body of porous ceramics interlocks.
The rubber safety helmet is provided with tube for transfusion, and rubber safety helmet and tube for transfusion fuse, and tube for transfusion is connected with the drug storage groove.
The preparation of the embedding body of porous ceramics:
1). the preparation of hydroxylapatite powder: 1.. the preparation of pure ha powder: get Ca (OH)
2, make suspension with distilled water, the concentration of suspension is 3.9wt%; Above-mentioned suspension is inserted in the water bath with thermostatic control, and bath temperature is 40.0 ℃, simultaneously suspension is stirred, and obtains Ca (OH)
2Suspension; Get dense H
3PO
4Be mixed with H
3PO
4Weak solution, H
3PO
4The concentration of weak solution is 3.5wt%; With H
3PO
4Weak solution dropwise is added drop-wise to Ca (OH)
2In the suspension, dripping speed is 120 droplets/minute; Simultaneously, keep water bath heating temperature and stirring; After waiting to dropwise, continue to stir 15 minutes, regulate pH value to 9～11, regulated the back restir 1 hour, take out, made the sol solutions of hydroxyapatite with dilute NaOH solution; The sol solutions of gained was left standstill 24 hours, with the clear water sucking-off on top, dry in baking oven behind the gel sucking filtration of bottom then, make unformed hydroxyapatite; The unformed hydroxyapatite of gained is levigate, then 900 ℃ of insulations 1.5 hours, obtain the hydroxyapatite of high-crystallinity; With hydroxyapatite is medium with water, and ball milling 24 hours after the oven dry, obtains the pure ha powder, and it is stand-by to put into exsiccator;
2.. the mass ratio by unformed hydroxyapatite, water, silver nitrate is 1: 0.08: 10, chooses unformed hydroxyapatite, water and silver nitrate; Unformed hydroxyapatite and silver nitrate added be made into suspension in the entry, heat to 50 ℃ continuous stirring 3 hours, filter then, diafiltration to solution does not have nitrate ion, dry, 900 ℃ of calcinings, be medium ball milling 24 hours then with the dehydrated alcohol, the dry argentiferous hydroxylapatite powder that obtains;
2). the preparation of bio-vitric high temperature adhesive:
With quartz sand, calcium carbonate, calcium hydrogen phosphate and natrium carbonicum calcinatum is raw material, according to Na
2O 18～25wt%, CaO 18～25wt%, P
2O
58～10wt%, SiO
240～48% prescription batching, mix homogeneously is put into alumina crucible, in 1450 ℃ of fusings of silicon molybdenum stove 1.5 hours, takes out shrend with crucible tongs then; With the glass frit of shrend Achates grinder porphyrize, put into ball grinder again and added the dehydrated alcohol ball milling 24 hours, take out filtration, drying, obtain the bio-vitric high temperature adhesive;
3). the pretreatment of carbon dust:
At first, carbon dust is carried out intensive drying, add the oleic acid of carbon dust quality 0.2-1.0wt%, carried out the dry bulb mill together 3 hours; Then carbon dust is carried out sieve classification, drying obtains pretreated carbon dust;
4). the pretreatment of hydroxyapatite porcelain:
By the shared mass percent of each raw material be: pure ha powder 75～95wt%, bio-vitric high temperature adhesive 5～25wt% chooses pure ha powder and bio-vitric high temperature adhesive;
Pure ha powder and bio-vitric high temperature adhesive are mixed, carry out intensive drying, add the oleic acid of pure ha powder and bio-vitric high temperature adhesive gross mass 0.2-1.0wt% then, carried out the dry bulb mill together 3 hours, drying obtains pretreated hydroxyapatite porcelain;
5). the preparation of hot pressing casting cake:
Exsiccant pretreated hydroxyapatite porcelain 40～60vol% is mixed with the pretreated carbon dust of 60～40vol%,, obtain mixed powder through 2 hours mixings of dry bulb mill, stand-by; Press the paraffin molten 60～40vol% of mixed powder 40～60vol%, fusing, choose the paraffin molten of mixed powder and fusing; By oleic addition is mixed powder quality 0.2～1.0wt%, chooses oleic acid; With above-mentioned mixed powder under agitation, add in the paraffin molten of fusing, splash into oleic acid, obtain slip; Slurry is poured on and solidifies formation gatch in back on the cold steel plate, and gatch is displayed more than 72 hours standby;
6). hot-injection molding:
The gatch of depositing is put into Hot-pressed injector hot pressing form " worker " font, 85～110 ℃ of control temperature, after treating fully to melt, evacuation stirs the degassing, and briquetting pressure is controlled at 0.25-0.30MPa, obtains the base substrate of hot-injection molding;
7). dewaxing, plastic removal and biscuiting:
The base substrate of hot-injection molding is imbedded in the fire-resistant saggar of containing hydroxylapatite powder, put into silicon carbide rod furnace and dewax, arrange carbon and biscuiting, programming rate＜2 ℃/min, in 700 ℃～850 ℃ insulation 1.5～2.5h, furnace cooling obtains unglazed base substrate;
8). surface-sealing is handled:
Unglazed base substrate is taken out, fall the hydroxy apatite powder of billet surface clearly, spray deashing with high pressure air then with hairbrush, stand-by; Mass ratio by argentiferous hydroxylapatite powder and water is 1: 1, choose argentiferous hydroxylapatite powder and water, argentiferous hydroxylapatite powder adding distil water is mixed with argentiferous hydroxylapatite powder slurry, be stained with argentiferous hydroxylapatite powder slurry with spread pen, billet surface and contact skin are carried out sealing of hole with the part of stretching out skin, obtain the biscuiting base substrate of sealing of hole after the drying;
9). burn till:
The biscuiting base substrate that drying is good is put into silicon carbide rod furnace and is burnt till, and 5～10 ℃/min of programming rate is warming up to 1220 ℃ of insulations 2 hours, and the furnace cooling that cuts off the power supply then obtains osmosis type hydroxyapatite porous ceramics, i.e. the embedding body of porous ceramics.
Principle of the present invention is to utilize the diffusion of osmosis type hydroxyapatite porous ceramics as route of administration, aperture by control osmosis type hydroxyapatite porous ceramics in preparation process, realize that liquid drug can diffuse in the body, and antibacterial and virus can not enter intravital purpose; Utilize osmosis type hydroxyapatite porous ceramics and the epithelial tissue can good combination, form the bonding state of similar gingiva and tooth, can guarantee that implantation body for a long time, stably implants, skin and implant (being the embedding body of porous ceramics) interface can be because of inflammation lose efficacy, thereby can be by external interruption or the lasting topical that carries out.This device adopts osmosis type hydroxyapatite porous ceramics (or to claim the porous hydroxyapatite bioceramic, or title hydroxyapatite porous ceramics) preparation, its hole mostly is intercommunicating pore, has suitable permeability, can implant subcutaneously for a long time, play the effect of inside and outside liquid (medicine) diffusion admittance of connector.By the aperture of control osmosis type hydroxyapatite porous ceramics, reach external local demand of carrying different pharmaceutical; Control the communication aperture of osmosis type hydroxyapatite porous ceramics and wear the rubber safety helmet by strictness, reach the purpose that prevents that antibacterial and virus from invading.
The invention has the beneficial effects as follows:
1. simple in structure, can be embedding for a long time (described is 2-8 for a long time), easy to use.
2. can realize the puncture injection administration that is interrupted,, reduce painful without wearing skin; Also can implement the seriality loading.
3. the embedding body of porous ceramics stretches out near the surface of skin by silver-containing antibacterial hydroxylapatite ceramic slurry sealing of hole, makes embedding body of porous ceramics and contact skin and the part of stretching out skin have antibacterial functions.
Description of drawings
Fig. 1 is the cross sectional representation that is used for the porous bio-ceramic percutaneous implantation device of topical.
Fig. 2 is the structural representation of the rubber safety helmet of band tube for transfusion.
Fig. 3 is the micro-structure diagram of the osmosis type hydroxyapatite porous ceramics of the compound preparation method preparation of employing hot pressing notes-pore creating material.
Among the figure: 1-subcutaneous tissue, the embedding body of 2-porous ceramics, 3-puncture injection administration district, 4-drug storage district, 5-rubber safety helmet, 6-tube for transfusion.
The specific embodiment
As shown in Figure 1 and Figure 2, be used for the porous bio-ceramic percutaneous implantation device of topical, it is made up of embedding body 2 of porous ceramics and rubber safety helmet 5; 2 one-tenth " worker " fonts of the embedding body of porous ceramics, the upper surface of the embedding body 2 of porous ceramics (being arranged in the end outside the subcutaneous tissue 1) is provided with safety helmet and inserts groove (Fig. 1 of present embodiment, the cross section that safety helmet inserts groove is trapezoidal), the material of the embedding body 2 of porous ceramics is an osmosis type hydroxyapatite porous ceramics; 5 one-tenth T-shapes of rubber safety helmet, the profile of the bottom of rubber safety helmet 5 is corresponding with the profile that safety helmet inserts groove (or to be claimed to match, the bottom of rubber safety helmet 5 can tightly be inserted safety helmet and be inserted in the groove), the upper end-face edge portion of rubber safety helmet 5 is latch closure (being annular the button), the lower surface of rubber safety helmet 5 is provided with the drug storage groove, and (the drug storage groove is drug storage district 4, the top of drug storage groove is puncture injection administration district 3), the bottom of rubber safety helmet 5 is inserted safety helmet and is inserted in the groove, and the upper end of the embedding body 2 of the latch closure of rubber safety helmet 5 and porous ceramics interlocks.During use, the bottom of the embedding body 2 of porous ceramics is imbedded in the subcutaneous tissue 1, and the upper surface of the embedding body 2 of porous ceramics is positioned at outside the subcutaneous tissue 1.Medicine is injected in the drug storage groove by syringe puncture injection administration district 3, and perhaps the rubber safety helmet is provided with tube for transfusion 6, and rubber safety helmet and tube for transfusion 6 fuse, and tube for transfusion 6 is connected with the drug storage groove, and medicine is injected in the drug storage groove by tube for transfusion 6.Rubber safety helmet 5 is made by elastic silicone rubber.
The external diameter of the embedding body of porous ceramics 2 bottoms is greater than the external diameter of the embedding body of porous ceramics 2 upper ends.The bottom of the embedding body 2 of porous ceramics is a revolving body, and the top of the embedding body 2 of porous ceramics is revolving body.The upper surface of the embedding body 2 of porous ceramics and the above surface compact of cervical region prevent that medicine from spreading to the epidermis direction; The embedding body 2 inner porous of porous ceramics are convenient to medicine and are spread downwards.
One, the preparation of the embedding body of porous ceramics:
(1), the primary feature of osmosis type hydroxyapatite porous ceramics is the characteristic that its porous and hole are interconnected, and further is to control its aperture, pore structure, pore size distribution and permeability, to satisfy the demand that different pharmaceutical discharges.In addition, for the batch process that realizes the embedding body of porous ceramics (or claim drug controlled-release body, or claim the porous sustained-release carrier) and the accurate control of size, also must searching can satisfy the preparation method of above-mentioned requirements simultaneously.The present invention adopts following two kinds of preparation methoies that satisfy above-mentioned requirements.
1. the compound preparation method of hot pressing notes-pore creating material:
Hot-injection molding is the very strong technology of a kind of practicality, is the effective ways of preparation high reliability, complicated shape ceramic component.It has following distinguishing feature: the ceramic part of (1) plastic various complicated shapes and size; (2) even the peculiar blank of shape can guarantee that all densification, even is formed at each position in the blank, the molding blank defective is few; (3) no dust, the harm of noise has improved working environment greatly and has reduced labor intensity; (4) operating pressure is 490～588kPa, only reaches 1/10～1/20 of same size powder die pressing product, and the hot-injection molding machine is simple in structure, and is easy to maintenance, and cost is low, invest little, output is high, the characteristics of constant product quality; (5) can carry out machined (car, mill, dig, mill, boring, saw etc.) to base substrate, thus cancellation or reduce sintering after processing.
The base substrate of hot-injection molding finally obtains product by de-waxing and sintering, by control paraffin content and sintering temperature, the porous ceramics in ceramic of compact or the different porosity and aperture can be obtained,, fine and close relatively pottery can be obtained if improve sintering temperature or prolong temperature retention time.This method is that hot-injection molding method and pore creating material forming method are combined, the carbon dust of employing different-grain diameter or starch are as pore creating material, add in the hot pressing material feeding slurry, by the paraffin content of control slip, the content and the distribution of particles of pore creating material, in conjunction with the control of firing temperature, control pore structure, aperture, pore size distribution and the porosity of the embedding body of porous ceramics.
2. isostatic cool pressing-pore creating material-turning preparation method
Isostatic cool pressing-turning forming method is a kind of method for preparing precision, high-strength revolving body pottery parts, is suitable for the production of precise ceramic component in batches.The carbon dust of employing different-grain diameter or starch add in the isostatic cool pressing powder body as pore creating material, through the cold isostatic compaction bar, are processed into required revolving body base substrate through turning then, obtain porous ceramic bodies through super-dry, row's carbon and sintering.By bonding agent, carbon dust or contents of starch and the distribution of particles in the control ceramic powder, in conjunction with the control of firing temperature, pore structure, aperture, pore size distribution and the porosity of may command porous ceramic bodies (the embedding body of porous ceramics).
(2), the hole sealing technology of the embedding surface of porous ceramics
Because the embedding body of porous ceramics stretches out part (promptly being positioned at the part outside the subcutaneous tissue 1) the surface requirements densification of body surface, and the implant part of the embedding body of porous ceramics (promptly being positioned at the part of subcutaneous tissue 1) also needs internal lesions is implemented directed diffusion administration.Therefore, must carry out surface-sealing as required to the part surface that the embedding body of porous ceramics stretches out body surface, its method is: the bad body to molding carries out biscuiting, row's carbon, after carbon to be arranged is finished, be mixed with slurry with argentiferous hydroxylapatite powder and water, with spread pen its porous surface is made the shallow-layer sealing of hole, dry back high temperature burns till.In addition, the embedding body of porous ceramics is stretched out near the skin surface, with argentiferous hydroxyapatite slurry sealing of hole, the part that makes the embedding body of porous ceramics and contact skin and stretch out skin has antibacterial functions.
(3), the shaped design of the embedding body subdermal implantation part of porous ceramics
In order to satisfy the administration requirements of patient's different parts, different depth, can the porous body shape of subcutaneous part be designed, but be generally the complete body of revolution shape, do not contain other accessory.
Two, the preparation embodiment of the embedding body 2 of porous ceramics:
Adopt the compound preparation method of hot pressing notes-pore creating material to prepare the embedding body of porous ceramics.
1. the preparation of hydroxylapatite powder: comprise the preparation of pure ha powder and argentiferous hydroxylapatite powder.Adopt sol-gel process.
1). the preparation of pure ha powder: the raw material of sol-gel process synthesizing hydroxylapatite is calcium hydroxide (analytical pure, 〉=95%) and strong phosphoric acid (analytical pure, 〉=85%), gets Ca (OH)
2(analytical pure) makes suspension with distilled water, and the concentration of suspension is 3.9wt%; Above-mentioned suspension is inserted in the water bath with thermostatic control, and bath temperature is 40.0 ℃, simultaneously suspension is stirred, and obtains Ca (OH)
2Suspension; Get dense H
3PO
4(analytical pure) is mixed with H
3PO
4Weak solution, H
3PO
4The concentration of weak solution is 3.5wt%; With H
3PO
4Weak solution dropwise is added drop-wise to Ca (OH)
2In the suspension, dripping speed is 120 droplets/minute; Simultaneously, keep water bath heating temperature and stirring; After waiting to dropwise, continue to stir 15 minutes, allow material in the solution fully react after, regulate pH value to 9～11 with dilute NaOH solution, regulated the back restir 1 hour, take out, made the sol solutions of hydroxyapatite; The sol solutions of gained was left standstill 24 hours, with the clear water sucking-off on top, dry in baking oven behind the gel sucking filtration of bottom then, make unformed hydroxyapatite; The unformed hydroxyapatite of gained is levigate, then 900 ℃ of insulations 1.5 hours, obtain the hydroxyapatite of high-crystallinity; The hydroxyapatite that will make with sol-gel process is medium with water, and ball milling 24 hours after the oven dry, obtains the pure ha powder, and it is stand-by to put into exsiccator.
2). the preparation of argentiferous hydroxylapatite powder is slightly different, is 1: 0.08: 10 by the mass ratio of unformed hydroxyapatite, water, silver nitrate, chooses unformed hydroxyapatite, water and silver nitrate; The unformed hydroxyapatite hydroxyapatite of high-temperature calcination (promptly without) and silver nitrate added be made into suspension (silver adds in the suspension with certain density silver nitrate form) in the entry, heat to 50 ℃, continuous stirring 3 hours, filter then, diafiltration to solution does not have nitrate ion, dry, 900 ℃ of calcinings are medium ball milling 24 hours then with the dehydrated alcohol, the dry argentiferous hydroxylapatite powder that obtains.
2. the preparation of bio-vitric high temperature adhesive (or claiming biological glass powder):
With quartz sand, calcium carbonate, calcium hydrogen phosphate and natrium carbonicum calcinatum is raw material, according to Na
2O 18～25wt%, CaO 18～25wt%, P
2O
58～10wt%, SiO
240～48% prescription batching, mix homogeneously is put into alumina crucible, in 1450 ℃ of fusings of silicon molybdenum stove 1.5 hours, takes out shrend with crucible tongs then; With the glass frit of shrend Achates grinder porphyrize, put into ball grinder again and added the dehydrated alcohol ball milling 24 hours, take out filtration, drying, obtain the bio-vitric high temperature adhesive, stand-by.
3. the pretreatment of carbon dust:
At first, carbon dust is carried out intensive drying, add the oleic acid of carbon dust quality 0.2～1.0wt%, carried out the dry bulb mill together 3 hours; Then carbon dust is carried out sieve classification, drying obtains pretreated carbon dust, stores stand-by.
4. the pretreatment of hydroxyapatite porcelain:
By the shared mass percent of each raw material be: pure ha powder 75～95wt%, bio-vitric high temperature adhesive 5～25wt% chooses pure ha powder and bio-vitric high temperature adhesive;
Pure ha powder and bio-vitric high temperature adhesive (or claiming biological glass powder) are mixed, carry out intensive drying, the oleic acid that adds pure ha powder and bio-vitric high temperature adhesive gross mass 0.2～1.0wt% then, carried out the dry bulb mill together 3 hours, again the porcelain powder is carried out sieve classification, drying obtains pretreated hydroxyapatite porcelain, stores stand-by.
5. the preparation of hot pressing casting cake:
Exsiccant pretreated hydroxyapatite porcelain 40～60vol% is mixed with the pretreated carbon dust of 60～40vol%,, obtain mixed powder through 2 hours mixings of dry bulb mill, stand-by; Press the paraffin molten 60～40vol% of mixed powder 40～60vol%, fusing, choose the paraffin molten of mixed powder and fusing; By oleic addition is mixed powder quality 0.2～1.0wt%, chooses oleic acid; Above-mentioned mixed powder under stirring fast, is slowly added in the paraffin molten of fusing, splash into oleic acid, regulate the flowability of slip, obtain slip; The control slip can form continuous flow line (with Glass rod lixiviate slip when flowing, slip trickles into line along Glass rod) be the maximum adding quantity of mixed powder, in addition, according to of the requirement of the embedding body of porous ceramics to the porosity, can be by regulating carbon dust and slurry paraffin content, regulate the porosity, the pore size distribution that grain warp by regulating carbon dust and paraffin content are regulated the embedding body of porous ceramics; Slurry is poured on and solidifies formation gatch in back on the cold steel plate, and gatch is through displaying more than 72 hours, and it is more even that wax and powder body are merged, and changes hot pressing again over to and annotate operation.
6. hot-injection molding:
The gatch of depositing is put into Hot-pressed injector hot pressing form " worker " font, 85～110 ℃ of control temperature, after treating fully to melt, evacuation stirs the degassing, and briquetting pressure is controlled at 0.25-0.30MPa, obtains the base substrate of hot-injection molding.
7. dewaxing, plastic removal and biscuiting:
The base substrate of hot-injection molding is imbedded in the fire-resistant saggar of containing hydroxylapatite powder, put into silicon carbide rod furnace and dewax, arrange carbon and biscuiting, programming rate＜2 ℃/min, in 700 ℃～850 ℃ insulation 1.5～2.5h, furnace cooling obtains unglazed base substrate.
8. surface-sealing is handled:
Unglazed base substrate is taken out, fall the hydroxy apatite powder of billet surface clearly, spray deashing with high pressure air then with hairbrush, stand-by.Mass ratio by argentiferous hydroxylapatite powder and water is 1: 1, choose argentiferous hydroxylapatite powder and water, the argentiferous hydroxylapatite powder slurry of argentiferous hydroxylapatite powder adding distil water preparation, be stained with argentiferous hydroxylapatite powder slurry with spread pen, the part (promptly with contact skin and the part of stretching out skin) that billet surface need be sealed is carried out sealing of hole, wait after the drying to burn, obtain dry good biscuiting base substrate.
9. burn till:
The biscuiting base substrate that drying is good is put into silicon carbide rod furnace and is burnt till, and 5～10 ℃/min of programming rate is warming up to 1220 ℃ of insulations 2 hours, and the furnace cooling that cuts off the power supply then obtains osmosis type hydroxyapatite porous ceramics, i.e. the embedding body of porous ceramics.
The key technical indexes of the embedding body of porous ceramics:
Biocompatibility: the requirement of the GB/T16886 series standard that is up to state standards;
Pore footpath: 20-500nm;
Under the pressure of 6000Pa to the infiltration rate of 25 ℃ of pure water: 20-500 μ l/cm
2S;
Transmitance to antibacterial: 0%.
The microstructure of osmosis type hydroxyapatite porous ceramics (the embedding body of porous ceramics):
Fig. 3 is the embedding body of porous ceramics that adopts the compound preparation method preparation of hot pressing notes-pore creating material, by the content and the sintering temperature of control pore creating material, can be in the aperture of regulating osmosis type hydroxyapatite porous ceramics in a big way 20nm-0.1 μ m) and pore-size distribution (aperture:.
Claims (5)
1. the porous bio-ceramic percutaneous implantation device that is used for topical is characterized in that it is made up of embedding body of porous ceramics (2) and rubber safety helmet (5); The embedding body of porous ceramics (2) becomes " worker " font, and the upper surface of the embedding body of porous ceramics (2) is provided with safety helmet and inserts groove, and the material of the embedding body of porous ceramics (2) is an osmosis type hydroxyapatite porous ceramics; Rubber safety helmet (5) becomes T-shape, the profile of the bottom of rubber safety helmet (5) is corresponding with the profile that safety helmet inserts groove, the upper end-face edge portion of rubber safety helmet (5) is a latch closure, the lower surface of rubber safety helmet (5) is provided with the drug storage groove, the bottom of rubber safety helmet (5) is inserted safety helmet and is inserted in the groove, and the upper end of the latch closure of rubber safety helmet (5) and the embedding body of porous ceramics (2) interlocks.
2. the porous bio-ceramic percutaneous implantation device that is used for topical according to claim 1 is characterized in that: the rubber safety helmet is provided with tube for transfusion (6), and rubber safety helmet and tube for transfusion (6) fuse, and tube for transfusion (6) is connected with the drug storage groove.
3. the porous bio-ceramic percutaneous implantation device that is used for topical according to claim 1 is characterized in that: the external diameter of the embedding body of porous ceramics (2) bottom is greater than the external diameter of the embedding body of porous ceramics (2) upper end.
4. the porous bio-ceramic percutaneous implantation device that is used for topical according to claim 1 is characterized in that: the bottom of the embedding body of porous ceramics (2) is a revolving body, and the top of the embedding body of porous ceramics (2) is revolving body.
5. the porous bio-ceramic percutaneous implantation device that is used for topical according to claim 1 is characterized in that: the preparation of the embedding body of porous ceramics:
1). the preparation of hydroxylapatite powder: 1.. the preparation of pure ha powder: get Ca (OH)
2, make suspension with distilled water, the concentration of suspension is 3.9wt%; Above-mentioned suspension is inserted in the water bath with thermostatic control, and bath temperature is 40.0 ℃, simultaneously suspension is stirred, and obtains Ca (OH)
2Suspension; Get dense H
3PO
4Be mixed with H
3PO
4Weak solution, H
3PO
4The concentration of weak solution is 3.5wt%; With H
3PO
4Weak solution dropwise is added drop-wise to Ca (OH)
2In the suspension, dripping speed is 120 droplets/minute; Simultaneously, keep water bath heating temperature and stirring; After waiting to dropwise, continue to stir 15 minutes, regulate pH value to 9～11, regulated the back restir 1 hour, take out, made the sol solutions of hydroxyapatite with dilute NaOH solution; The sol solutions of gained was left standstill 24 hours, with the clear water sucking-off on top, dry in baking oven behind the gel sucking filtration of bottom then, make unformed hydroxyapatite; The unformed hydroxyapatite of gained is levigate, then 900 ℃ of insulations 1.5 hours, obtain the hydroxyapatite of high-crystallinity; With hydroxyapatite is medium with water, and ball milling 24 hours after the oven dry, obtains the pure ha powder, and it is stand-by to put into exsiccator;
2.. the mass ratio by unformed hydroxyapatite, water, silver nitrate is 1: 0.08: 10, chooses unformed hydroxyapatite, water and silver nitrate; Unformed hydroxyapatite and silver nitrate added be made into suspension in the entry, heat to 50 ℃ continuous stirring 3 hours, filter then, diafiltration to solution does not have nitrate ion, dry, 900 ℃ of calcinings, be medium ball milling 24 hours then with the dehydrated alcohol, the dry argentiferous hydroxylapatite powder that obtains;
2). the preparation of bio-vitric high temperature adhesive:
With quartz sand, calcium carbonate, calcium hydrogen phosphate and natrium carbonicum calcinatum is raw material, according to Na
2O 18～25wt%, CaO 18～25wt%, P
2O
58～10wt%, SiO
240～48% prescription batching, mix homogeneously is put into alumina crucible, in 1450 ℃ of fusings of silicon molybdenum stove 1.5 hours, takes out shrend with crucible tongs then; With the glass frit of shrend Achates grinder porphyrize, put into ball grinder again and added the dehydrated alcohol ball milling 24 hours, take out filtration, drying, obtain the bio-vitric high temperature adhesive;
3). the pretreatment of carbon dust:
At first, carbon dust is carried out intensive drying, add the oleic acid of carbon dust quality 0.2-1.0wt%, carried out the dry bulb mill together 3 hours; Then carbon dust is carried out sieve classification, drying obtains pretreated carbon dust;
4). the pretreatment of hydroxyapatite porcelain:
By the shared mass percent of each raw material be: pure ha powder 75～95wt%, bio-vitric high temperature adhesive 5～25wt% chooses pure ha powder and bio-vitric high temperature adhesive;
Pure ha powder and bio-vitric high temperature adhesive are mixed, carry out intensive drying, add the oleic acid of pure ha powder and bio-vitric high temperature adhesive gross mass 0.2-1.0wt% then, carried out the dry bulb mill together 3 hours, drying obtains pretreated hydroxyapatite porcelain;
5). the preparation of hot pressing casting cake:
Exsiccant pretreated hydroxyapatite porcelain 40～60vol% is mixed with the pretreated carbon dust of 60～40vol%,, obtain mixed powder through 2 hours mixings of dry bulb mill, stand-by; Press the paraffin molten 60～40vol% of mixed powder 40～60vol%, fusing, choose the paraffin molten of mixed powder and fusing; By oleic addition is mixed powder quality 0.2～1.0wt%, chooses oleic acid; With above-mentioned mixed powder under agitation, add in the paraffin molten of fusing, splash into oleic acid, obtain slip; Slurry is poured on and solidifies formation gatch in back on the cold steel plate, and gatch is displayed more than 72 hours standby;
6). hot-injection molding:
The gatch of depositing is put into Hot-pressed injector hot pressing form " worker " font, 85～110 ℃ of control temperature, after treating fully to melt, evacuation stirs the degassing, and briquetting pressure is controlled at 0.25-0.30MPa, obtains the base substrate of hot-injection molding;
7). dewaxing, plastic removal and biscuiting:
The base substrate of hot-injection molding is imbedded in the fire-resistant saggar of containing hydroxylapatite powder, put into silicon carbide rod furnace and dewax, arrange carbon and biscuiting, programming rate＜2 ℃/min, in 700 ℃～850 ℃ insulation 1.5～2.5h, furnace cooling obtains unglazed base substrate;
8). surface-sealing is handled:
Unglazed base substrate is taken out, fall the hydroxy apatite powder of billet surface clearly, spray deashing with high pressure air then with hairbrush, stand-by; Mass ratio by argentiferous hydroxylapatite powder and water is 1: 1, choose argentiferous hydroxylapatite powder and water, argentiferous hydroxylapatite powder adding distil water is mixed with argentiferous hydroxylapatite powder slurry, be stained with argentiferous hydroxylapatite powder slurry with spread pen, billet surface and contact skin are carried out sealing of hole with the part of stretching out skin, obtain the biscuiting base substrate of sealing of hole after the drying;
9). burn till:
The biscuiting base substrate that drying is good is put into silicon carbide rod furnace and is burnt till, and 5～10 ℃/min of programming rate is warming up to 1220 ℃ of insulations 2 hours, and the furnace cooling that cuts off the power supply then obtains osmosis type hydroxyapatite porous ceramics, i.e. the embedding body of porous ceramics.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102872527A (en) * | 2012-10-10 | 2013-01-16 | 广州医学院 | Percutaneously implanted diffusion medicine deliver and method for manufacturing same |
| CN108409317A (en) * | 2018-04-08 | 2018-08-17 | 武汉理工大学 | Mesoporous type hydroxylapatite ceramic is percutaneously implantable pass device and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101001589A (en) * | 2004-06-01 | 2007-07-18 | 贝克顿迪肯森公司 | Ocular implant and methods for making and using same |
| US20080147021A1 (en) * | 2006-12-15 | 2008-06-19 | Jani Dharmendra M | Drug delivery devices |
| JP2009298699A (en) * | 2006-09-19 | 2009-12-24 | Saga Univ | Antibacterial medicine-containing capsule, and artificial joint attached with the same |
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| CN101001589A (en) * | 2004-06-01 | 2007-07-18 | 贝克顿迪肯森公司 | Ocular implant and methods for making and using same |
| JP2009298699A (en) * | 2006-09-19 | 2009-12-24 | Saga Univ | Antibacterial medicine-containing capsule, and artificial joint attached with the same |
| US20080147021A1 (en) * | 2006-12-15 | 2008-06-19 | Jani Dharmendra M | Drug delivery devices |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102872527A (en) * | 2012-10-10 | 2013-01-16 | 广州医学院 | Percutaneously implanted diffusion medicine deliver and method for manufacturing same |
| CN102872527B (en) * | 2012-10-10 | 2014-04-23 | 广州医学院 | Percutaneously implanted diffusion medicine deliver and method for manufacturing same |
| CN108409317A (en) * | 2018-04-08 | 2018-08-17 | 武汉理工大学 | Mesoporous type hydroxylapatite ceramic is percutaneously implantable pass device and preparation method thereof |
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