CN109010908A - A kind of drug controlled-releasing function activity artificial bone and preparation method thereof - Google Patents
A kind of drug controlled-releasing function activity artificial bone and preparation method thereof Download PDFInfo
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- CN109010908A CN109010908A CN201811211465.6A CN201811211465A CN109010908A CN 109010908 A CN109010908 A CN 109010908A CN 201811211465 A CN201811211465 A CN 201811211465A CN 109010908 A CN109010908 A CN 109010908A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/025—Other specific inorganic materials not covered by A61L27/04 - A61L27/12
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
- A61L27/34—Macromolecular materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/52—Hydrogels or hydrocolloids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/602—Type of release, e.g. controlled, sustained, slow
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
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Abstract
The present invention relates to the technical fields of medical artificial bone, and in particular to a kind of drug controlled-releasing function activity artificial bone and preparation method thereof.Artificial bone of the present invention using calcium sulfate/polyaminoacid composite material as carrier attachment, insert in artificial bone by anti-tubercular drug hydrogel, and forms encapsulated layer in outer layer by biodegradable material.Artificial bone of the present invention ensures the slow steady release of drug, realizes the slow controlled-release effect of drug-loaded artificial bone, enables artificial bone long-acting slow-release antituberculotic.
Description
[technical field]
The present invention relates to the technical fields of medical artificial bone, and in particular to a kind of drug controlled-releasing function activity artificial bone
And preparation method thereof.
[background technique]
In field of orthopaedics, the bone defect caused by many reasons such as severe trauma, bone tumour, osteomyelitis is very common.Mesh
Preceding common bone renovating material includes autologous bone and allograph bone.Autologous bone limited source, postoperative complications are more, increase patient
Wound and pain;There is the problems such as loosening, fracture since the exogenous body that will lead to generates rejection in allograph bone,
It is low to transplant success rate.Traumatic bone damage repair process in, easily cause infection, substitution bone collection success or not with whether infect it is close
Cut phase is closed, and patient is bone grafting under Infection Status or under high infection risk mostly in many real works, so period
A large amount of Antibiotic prophylaxis are needed, it is many at present to study the compatibility for all focusing on bone bracket, induced activity and Biological Strength
Characteristic etc. is learned, in anti-infective and treatment infection the characteristic of bone holder material used by but seldom noticing.It considers
Anti-infective characteristic needed for bone bracket, since calcium phosphate bone cement is with the presence of a large amount of microcellular structure, for the knot with a variety of drugs
Conjunction creates excellent condition, and engaging process does not change the activity of drug, it is possible to using calcium phosphate bone cement as carrier,
Preparation carries medicine bone bracket;Carrier of the artificial bone as osteoblast plays and provides sufficient nutriment for Oesteoblast growth
With the important function of living space, the drug-loaded artificial bone with anti-infective characteristic can reduce patient's infection risk.
Drug-loaded artificial bone can at implantation sustained release drugs, obtain higher local organization drug concentration, tie up simultaneously
Blood concentration is held in reduced levels, avoids the toxic side effect of whole body system medication and the drawbacks of shortage blood supply focal zone difficult to get access,
And remaining bone defect after reparation focal cleaning can be filled, therefore be considered as orthopaedics caused by treatment tubercle bacillus, bacterium etc.
One of effective ways of infectious diseases.Existing drug-loaded artificial bone preparation process (such as vacuum suction desivac, pressing mold forming process
Deng) method is simple, the drug-loaded artificial bone of preparation can reach certain medicament slow release purpose, but usually only by drug and carrier material
It is simply mixed to form, there is a problem of that structure is simple, drug release mode is single in varying degrees.And the contained drug kind of material itself
Class is single or the release of drug is too fast;Medicine carrying material can not degrade or degrade very slowly, cause drug release excessively slow etc..
Increasing and bacterial drug resistance the day of bone tissue infectious diseases caused by being mixed with tuberculosis with bacterium or more bacteriums
It is beneficial serious, there is scholar to begin one's study drug-loaded artificial bone that is more efficiently, being capable of long-acting slow-releasing medicine, to reach continued treatment
Purpose.
CN102580161B discloses a kind of artificial bone filling slow-release material with anti-tubercle bacillus effect, with calcium phosphate bone
Cement is carrier attachment, contacts to form gel medicine embedding with calcium chloride solution by sodium alginate/antituberculotic solution
Layer, and encapsulated by biodegradable polyesters class compound in outermost layer, being formed, there is the resistive connection bone of long-term sustained release effect to fill
Material, realizes the reparation of bone defect tissue, while local TB focus being inhibited to recur.Poly- cream is covered with paint, lacquer, colour wash, etc. in the researchs such as Yan Junfa
Acid-co-glycolic acid (abbreviation PLGA) carries three anti-tuberculosis artificial bones, can stablize slow release drug, make lesion office
The drug concentration in portion maintains higher level.
But in the carried medicine sustained-release artificial bone that the prior art has disclosed, show that it is generally small in 24-72 by experiment in vitro
When it is interior there is the problem of burst drug release, the burst size of drug is larger during this period and fast speed, it is difficult to realize it is expected slowly
The technical effect steadily discharged.
[summary of the invention]
In order to solve the problems in the existing technology, the present invention provides a kind of drug controlled-releasing function activity artificial bone,
It is by changing embedding and encapsulation system, it is ensured that drug can continue slowly and steadily to discharge with a higher concentration, real
The slow controlled-release effect for having showed drug-loaded artificial bone, enables artificial bone long-acting slow-release antituberculotic.
The present invention provides a kind of drug controlled-releasing function activity artificial bones, are to carry with calcium sulfate/polyaminoacid composite material
Body attachment, anti-tubercular drug hydrogel are inserted in artificial bone, and form encapsulated layer in outer layer by biodegradable material, are obtained
A kind for the treatment of tuberculosis artificial bone with long-term sustained release effect.
The present invention provides a kind of drug controlled-releasing function activity artificial bones, are made using calcium sulfate/polyaminoacid as raw material non-
The artificial bone carrier of medicine is carried, and artificial bone obtained is dipped in anti-tubercular drug hydrogel, makes drug loading in artificial bone carrier
In, and in top finishing biodegradable material, obtain the artificial bone.
Wherein, the non-drug-loaded artificial bone obtains powder by grinding calcium sulfate/polyaminoacid, and it is mixed that high purity water is added
Mold is injected in even oscillation, and drying of being formed obtains corresponding non-drug-loaded artificial bone.
Wherein, the anti-tubercular drug hydrogel is with methacrylic acid, ethylene glycol dimethacrylate and methyl-prop
Olefin(e) acid hydroxyl ethyl ester is gel-type vehicle, is mixed to get with anti-tubercular drug.Wherein, methacrylic acid, ethylene glycol dimethacrylate
Volume ratio with hydroxyethyl methacrylate is 1:(3-5): (100-150);Anti-tubercular drug is streptomysin, isoniazid and rifampin
One or more of.
Wherein, the biodegradable material is poly lactide-glycolide acid (PLGA).
The present invention has selected a kind of new aquogel system, by methacrylic acid, ethylene glycol dimethacrylate and first
Base hydroxy-ethyl acrylate presses 1:(3-5): (100-150) volume ratio composition, wherein the addition of methacrylic acid can improve drug
Permeability in system enables drug with a higher concentration release, and in combination with new encapsulation system, the two is made
With realizing so that it is after contacting dissolution medium, drug be able to can continue slowly and steadily to release with a higher concentration
It puts.
Meanwhile the present invention also provides a kind of preparation methods of drug controlled-releasing function activity artificial bone, mainly include as follows
Step:
(1) calcium sulfate/polyaminoacid grind into powder is taken, pure water is added, is mixed, mold, compacting sizing 2- are injected in oscillation
3min takes out dry 12h or more, obtains non-drug-loaded artificial bone;
(2) methacrylic acid is measured, ethylene glycol dimethacrylate is dissolved in hydroxyethyl methacrylate, ultrasound vibration
Mixing is swung, antituberculotic is added, the sonic oscillation in warm water obtains antituberculotic hydrogel;
(3) non-drug-loaded artificial bone is immersed in antituberculotic hydrogel, is encapsulated in anti-tubercular drug in artificial bone;
(4) artificial bone obtained in step (3) is immersed in the solution of biodegradable material, it is dry, obtain drug
Control-release function activity artificial bone.
Wherein, in step (2) methacrylic acid, ethylene glycol dimethacrylate and hydroxyethyl methacrylate volume
Than for 1:(3-5): (100-150).
Wherein, the Immersion time of artificial bone is 1-24h in step (3);The concentration of antituberculotic is 0.1-5mg/ml.
Wherein, biodegradable material solution is that PLGA is dissolved in chloroform in step (4), and the concentration of PLGA is 0.2g/
ml;The time of submergence is 30min, is dried in the shade after taking-up, is dried in vacuo;It is repeated immersion step 2 times after drying, dry, sterilizing obtains
Drug controlled-releasing function activity artificial bone.
The technical advantages of the present invention are that: in drug controlled-releasing function activity artificial bone of the present invention, drug release is slow
It is slow steady, the phenomenon of burst release of drug is avoided, the slow controlled-release effect of drug-loaded artificial bone is realized, it being capable of long-acting slow-release anti-tubercular drug
Object;And the selection of reasonable encapsulating material improves the burst size of drug, ensure that the realization of antibacterial action.
[Detailed description of the invention]
Fig. 1: drug controlled-releasing function activity artificial bone 0-72 hours external slow releasing pharmaceutical concentration variations.
[specific embodiment]
Now in conjunction with embodiment and attached drawing, invention is further explained.
The preparation method of " calcium sulfate/polyaminoacid " composite material described herein refers to [novel degradable bioactivity
The experimental study of composite material polyaminoacid/calcium sulfate repairing bone defect, Zhao Zenghui, Medical University Of Chongqing].
The preparation of embodiment 1, drug controlled-releasing function activity artificial bone
(1) calcium sulfate/polyaminoacid 0.5g grind into powder is taken, high purity water 0.25ml is added, is mixed, oscillation, injection is directly
Diameter 9mm, height 6mm cylindrical mold in, compacting sizing 2-3min takes out dry 12h, obtains non-drug-loaded artificial bone;
(2) methacrylic acid 0.34ml is measured, ethylene glycol dimethacrylate 1.15ml is dissolved in hydroxyethyl methacrylate
In ethyl ester 40ml, sonic oscillation is mixed, and rifampin 50mg is added, and the sonic oscillation in warm water obtains antituberculotic hydrogel;
(3) non-drug-loaded artificial bone is immersed in the antituberculotic hydrogel that step (2) obtains, encapsulates anti-tubercular drug
In artificial bone;
(4) PLGA 2g is weighed, dissolves in 10ml chloroform, obtains PLGA solution, artificial bone obtained in step (3) is soaked
It not in PLGA solution, takes out, dries in the shade afterwards for 24 hours, be dried in vacuo;It is repeated immersion step 2 times after drying, dry, ethylene oxide goes out
Bacterium obtains drug controlled-releasing function activity artificial bone.
The preparation of embodiment 2, drug controlled-releasing function activity artificial bone
(1) calcium sulfate/polyaminoacid 0.5g grind into powder is taken, high purity water 0.25ml is added, is mixed, oscillation, injection is directly
Diameter 9mm, height 6mm cylindrical mold in, compacting sizing 2-3min takes out dry 12h, obtains non-drug-loaded artificial bone;
(2) methacrylic acid 0.34ml is measured, ethylene glycol dimethacrylate 1.7ml is dissolved in hydroxyethyl methacrylate second
In ester 51ml, sonic oscillation is mixed, and rifampin 50mg is added, and the sonic oscillation in warm water obtains antituberculotic hydrogel;
(3) non-drug-loaded artificial bone is immersed in the antituberculotic hydrogel that step (2) obtains, encapsulates anti-tubercular drug
In artificial bone;
(4) PLGA1g is weighed, dissolves in 10ml chloroform, obtains PLGA solution, artificial bone obtained in step (3) is submerged
It in PLGA solution, takes out, dries in the shade afterwards for 24 hours, be dried in vacuo;It is repeated immersion step 2 times after drying, dry, ethylene oxide sterilizing,
Obtain drug controlled-releasing function activity artificial bone.
The preparation of embodiment 3, drug controlled-releasing function activity artificial bone
(1) calcium sulfate/polyaminoacid 0.5g grind into powder is taken, high purity water 0.25ml is added, is mixed, oscillation, injection is directly
Diameter 9mm, height 6mm cylindrical mold in, compacting sizing 2-3min takes out dry 12h, obtains non-drug-loaded artificial bone;
(2) methacrylic acid 0.34ml is measured, ethylene glycol dimethacrylate 1.02 is dissolved in hydroxyethyl methacrylate second
In ester 34ml, sonic oscillation is mixed, and rifampin 50mg is added, and the sonic oscillation in warm water obtains antituberculotic hydrogel;
(3) non-drug-loaded artificial bone is immersed in the antituberculotic hydrogel that step (2) obtains, encapsulates anti-tubercular drug
In artificial bone;
(4) PLGA 3g is weighed, dissolves in 10ml chloroform, obtains PLGA solution, artificial bone obtained in step (3) is soaked
It not in PLGA solution, takes out, dries in the shade afterwards for 24 hours, be dried in vacuo;It is repeated immersion step 2 times after drying, dry, ethylene oxide goes out
Bacterium obtains drug controlled-releasing function activity artificial bone.
Comparative example 1
According to the preparation method of embodiment 1, artificial bone is prepared, difference is to use PLA as degradation material, cover with paint, lacquer, colour wash, etc.
Encapsulated layer is used as outside artificial bone.
Comparative example 2
If the difference of embodiment 1 is, step is added without methacrylic acid in (2), remaining is same as Example 1.
1 extracorporeal releasing test of test example
It takes according to artificial bone made from embodiment 1 and comparative example 1, is added in the simulated body fluid of 10ml, is protected from light at 37 DEG C
In constant temperature oscillator, revolving speed is set as 100r/min;In 3,12,24,36,48,72h, leaching liquor sample 5ml is taken, covers 5ml,
Filtering, and with high performance liquid chromatography detection, calculate the release of each sampling time point.Chromatographic condition: mobile phase uses
0.01mol/L sodium heptanesulfonate (pH 2.2): acetonitrile=45:55,250mm × 4.6mm chromatographic column;Flow velocity 1.0ml/min, detection
Wavelength 270nm, 30 DEG C of column temperature, sample introduction 10ml.
As shown in Figure 1, drug controlled-releasing function activity artificial bone described in the embodiment of the present invention 1 discharges within 0-72 hours
Uniformly, the phenomenon that there is no burst releases, and comparative example 1 has phenomenon of burst release in 0~12h using conventional PLA material encapsulating,
Drug concentration suddenly increases, 12~for 24 hours drug concentration suddenly reduce;And methyl-prop is added without in 2 aquogel system of comparative example
Olefin(e) acid, drug discharge more uniformly in 0~72h, but drug difficulty penetrates aquogel system, the medicine of each time point in body fluid
Object concentration is substantially reduced than embodiment 1, this explanation, and methacrylic acid, which is added, can improve the penetrating of hydrogel embedding system
Property.
The foregoing is only a preferred embodiment of the present invention, but scope of protection of the present invention is not limited thereto,
Anyone skilled in the art in the technical scope disclosed by the present invention, according to the technique and scheme of the present invention and its
Inventive concept is subject to equivalent substitution or change, should be covered by the protection scope of the present invention.
Claims (9)
1. a kind of drug controlled-releasing function activity artificial bone, which is characterized in that with artificial bone made of calcium sulfate/polyaminoacid be carry
Body attachment, anti-tubercular drug hydrogel are inserted in artificial bone, and form encapsulated layer in outer layer by biodegradable material;Its
In, the biodegradable material is poly lactide-glycolide acid, and the hydrogel is with methacrylic acid, second two
Alcohol dimethylacrylate and hydroxyethyl methacrylate are gel-type vehicle.
2. a kind of drug controlled-releasing function activity artificial bone according to claim 1, it is characterised in that: the metering system
The volume ratio of acid, ethylene glycol dimethacrylate and hydroxyethyl methacrylate is 1:(3-5): (100-150).
3. a kind of drug controlled-releasing function activity artificial bone according to claim 1, it is characterised in that: the metering system
The volume ratio of acid, ethylene glycol dimethacrylate and hydroxyethyl methacrylate is 1:(3-4): (100-130).
4. a kind of drug controlled-releasing function activity artificial bone according to claim 1, it is characterised in that: the anti-tubercular drug is
One or more of streptomysin, isoniazid and rifampin.
5. a kind of drug controlled-releasing function activity artificial bone according to claim 4, it is characterised in that: the anti-tubercular drug is
Rifampin.
6. a kind of preparation method of drug controlled-releasing function activity artificial bone as described in claim 1, mainly includes the following steps:
(1) calcium sulfate/polyaminoacid grind into powder is taken, pure water is added, is mixed, mold is injected in oscillation, and compacting sizing is taken out
Dry 12h or more, obtains non-drug-loaded artificial bone;
(2) measurement methacrylic acid, ethylene glycol dimethacrylate are dissolved in hydroxyethyl methacrylate, and sonic oscillation is mixed
It is even, antituberculotic is added, the sonic oscillation in warm water obtains antituberculotic hydrogel;
(3) non-drug-loaded artificial bone is immersed in antituberculotic hydrogel, is encapsulated in anti-tubercular drug in artificial bone;
(4) artificial bone obtained in step (3) is immersed in the solution of biodegradable material, it is dry, obtain medicine controlled releasing
Functional activity artificial bone.
7. preparation method according to claim 6, which is characterized in that the Immersion time of artificial bone is in the step (3)
1-24h;The concentration of antituberculotic is 0.1-5mg/ml.
8. preparation method according to claim 6, which is characterized in that biodegradable material solution in the step (4)
It is dissolved in chloroform for poly lactide-glycolide acid, the concentration of poly lactide-glycolide acid is 0.1-0.3g/ml.
9. preparation method according to claim 6, which is characterized in that the time submerged in the step (4) is 30min,
It dries in the shade, is dried in vacuo after taking-up;It is repeated immersion step 2 times after drying, it is artificial to obtain drug controlled-releasing function activity for dry, sterilizing
Bone.
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Application publication date: 20181218 |