CN107875450A - A kind of method of 3D printing artificial bone manufacture drying type preparation - Google Patents
A kind of method of 3D printing artificial bone manufacture drying type preparation Download PDFInfo
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- CN107875450A CN107875450A CN201711145670.2A CN201711145670A CN107875450A CN 107875450 A CN107875450 A CN 107875450A CN 201711145670 A CN201711145670 A CN 201711145670A CN 107875450 A CN107875450 A CN 107875450A
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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
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L27/46—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with phosphorus-containing inorganic fillers
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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
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L27/446—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
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- A—HUMAN NECESSITIES
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- 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
- A61L27/54—Biologically active materials, e.g. therapeutic substances
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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
- A61L27/58—Materials at least partially resorbable by the body
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y70/00—Materials specially adapted for additive manufacturing
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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
- A61L2300/604—Biodegradation
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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
A kind of method for 3D printing artificial bone manufacture drying type preparation that the embodiment of the present application provides, is related to field of medical technology, by the way that percentage by weight is dissolved into solvent with Isosorbide-5-Nitrae dioxane for 0.1% 20% copolymer containing lactic acid acetic acid；The first sensitive drug is dissolved in the solvent, and the first suspension is made；It is configured to the first decorating film；Then the second sensitive drug is dissolved, and the second suspension is made；After adding first decorating film, the first creamy material is configured to；Product among the preparation of graininess first will be formed after first creamy material freezing, drying；Among first preparation drying type preparation will be formed after product packing, sealing, the slow releasing pharmaceutical for solving current clinical practice in the prior art is single kind, being used in combination for multi-medicament can not be carried out, and the problem of should not depositing, reached can carry a variety of different pharmaceuticals simultaneously, on-demand, dosage is controllable, Portable sanitary, easily stored technique effect.
Description
Technical field
The present invention relates to field of medical technology, more particularly to a kind of method of 3D printing artificial bone manufacture drying type preparation.
Background technology
Osteomyelitis is the infection and destruction of a kind of bone, and it is by aerobic or anaerobic bacteria, mycobacteria and fungus-caused.In bone
After generally requiring penetrability bone injury site in the scorching treatment of marrow, it is filled by materials such as bone cements.
But present inventor has found above-mentioned technology extremely during inventive technique scheme in realizing the embodiment of the present application
Following technical problem less be present：
In the prior art, in the clinical treatment of osteomyelitis, it is that carrier or holder are sustained to use to use bone cement
Medicine, but such scheme can not carry out the connection of multi-medicament because the slow releasing pharmaceutical of current clinical practice is single kind
The problem of closing and use, and should not depositing.
The content of the invention
A kind of method that the embodiment of the present application manufactures drying type preparation by providing 3D printing artificial bone, solves existing skill
The slow releasing pharmaceutical of current clinical practice is single kind in art, can not carry out being used in combination for multi-medicament, and should not deposit
The problem of putting, reach on-demand, dosage is controllable, Portable sanitary, easily stored technique effect.
In view of the above problems, it is proposed that the embodiment of the present application manufactures drying type preparation to provide a kind of 3D printing artificial bone
Method.
The embodiment of the present application provides a kind of method of 3D printing artificial bone manufacture drying type preparation, and methods described includes：
The copolymer containing lactic acid acetic acid that percentage by weight is 0.1%-20% is dissolved into solvent with 1,4- dioxane；Described
The first sensitive drug is dissolved in solvent, and the first suspension is made；It will be included in first suspension into percentage by weight
The first decorating film is configured to for 5%-50% calcium containing compound；The second sensitive drug is dissolved in the solvent, and is made
Second suspension；After first decorating film is added in second suspension, addition percentage by weight is 0.5%-30%
Calcium containing compound be configured to the first creamy material for raw material；Graininess will be formed after first creamy material freezing, drying
Product among first preparation；Among first preparation drying type preparation will be formed after product packing, sealing.
Preferably, methods described also includes：First creamy material is added in biological 3D printer and printed, shape
Into internal layer；The 3rd sensitive drug is dissolved in the solvent, and the 3rd suspension is made；It will be included in 3rd suspension
Enter the calcium containing compound that percentage by weight is 5%-50% and be configured to the second decorating film；The 4th sensitiveness is dissolved in the solvent
Medicine, and the 4th suspension is made；After adding second decorating film in the 4th suspension, adding percentage by weight is
0.5%-30% calcium containing compound is that raw material is configured to the second creamy material；Second creamy material is added into biological 3D to beat
In print machine, and printed based on the internal layer, form the 3rd creamy material；After the 3rd creamy material freezing, drying
Form product among the preparation of graininess second；Among second preparation drying type preparation will be formed after product packing, sealing.
Preferably, methods described also includes：The 5th sensitive drug is dissolved in the solvent, and it is suspended to be made the 5th
Liquid；After adding first decorating film in the 5th suspension, it is included in and contains calcification into percentage by weight for 5%-50%
Compound is configured to the 3rd decorating film.
Preferably, methods described also includes：Molten 6th sensitive drug in the solvent, and the 6th suspension is made；
After adding the 3rd decorating film in the 6th suspension, it is included in into the calcium containing compound that percentage by weight is 5%-50%
It is configured to the 4th decorating film.
Preferably, methods described also includes：After the 4th decorating film is added in second suspension, weight is added
The calcium containing compound that percentage is 0.5%-30% is that raw material is configured to the 4th creamy material；4th creamy material is freezed
Product among the preparation of graininess the 3rd are formed after drying；Among 3rd preparation drying type will be formed after product packing, sealing
Preparation.
Preferably, methods described also includes：The drying type preparation is subjected to the radiation sterilization of cobalt -60.
The one or more technical schemes provided in the embodiment of the present application, have at least the following technical effects or advantages：
1st, the method for a kind of 3D printing artificial bone manufacture drying type preparation that the embodiment of the present application provides, by by weight hundred
Divide than being dissolved into solvent with 1,4- dioxane for the 0.1%-20% copolymer containing lactic acid acetic acid；It is molten in the solvent
The first sensitive drug is solved, and the first suspension is made；To be included in first suspension into percentage by weight is 5%-
50% calcium containing compound is configured to the first decorating film；The second sensitive drug is dissolved in the solvent, and it is outstanding to be made second
Turbid；After first decorating film is added in second suspension, the calcic that percentage by weight is 0.5%-30% is added
Compound is that raw material is configured to the first creamy material；Made graininess first is formed after first creamy material freezing, drying
Product among agent；The drying type preparation will be formed after product packing, sealing among first preparation, solve mesh in the prior art
The slow releasing pharmaceutical of preceding clinical practice is single kind, can not carry out being used in combination for multi-medicament, and what should not be deposited ask
Topic, reached can carry simultaneously a variety of different pharmaceuticals, on-demand, dosage is controllable, Portable sanitary, easily stored technology effect
Fruit.
2. the embodiment of the present application is printed by the way that first creamy material is added in biological 3D printer, in formation
Layer；The 3rd sensitive drug is dissolved in the solvent, and the 3rd suspension is made；It will be included in 3rd suspension into weight
The calcium containing compound that amount percentage is 5%-50% is configured to the second decorating film；The 4th sensitiveness medicine is dissolved in the solvent
Thing, and the 4th suspension is made；After adding second decorating film in the 4th suspension, adding percentage by weight is
0.5%-30% calcium containing compound is that raw material is configured to the second creamy material；Second creamy material is added into biological 3D to beat
In print machine, and printed based on the internal layer, form the 3rd creamy material；After the 3rd creamy material freezing, drying
Form product among the preparation of graininess second；Among second preparation drying type preparation will be formed after product packing, sealing.Solution
The slow releasing pharmaceutical of current clinical practice in the prior art of having determined is single kind, can not carry out being used in combination for multi-medicament,
And the problem of should not depositing, further reached can carry a variety of different pharmaceuticals simultaneously, on-demand, dosage is controllable, just
Prompt hygienic, easily stored technique effect.
3. the 5th suspension is made by dissolving the 5th sensitive drug in the solvent in the embodiment of the present application；
After adding first decorating film in 5th suspension, it is included in and matches somebody with somebody into the calcium containing compound that percentage by weight is 5%-50%
It is set to the 3rd decorating film；The 6th sensitive drug is dissolved in the solvent, and the 6th suspension is made；It is suspended the described 6th
After the 3rd decorating film is added in liquid, it is included in and is configured to the 4th solid fraction into the calcium containing compound that percentage by weight is 5%-50%
Thing；After the 4th decorating film is added in second suspension, add percentage by weight and contain calcification for 0.5%-30%
Compound is that raw material is configured to be formed in the preparation of graininess the 3rd after the 4th creamy material is freeze-dried by the 4th creamy material
Between product；Among 3rd preparation drying type preparation will be formed after product packing, sealing.Solve and face at present in the prior art
The slow releasing pharmaceutical of bed application is single kind, the problem of can not carrying out being used in combination for multi-medicament, and should not deposit, is entered
One step, which has reached, can carry a variety of different pharmaceuticals simultaneously, on-demand, dosage is controllable, Portable sanitary, easily stored technology
Effect.
4. the embodiment of the present application has reached effective sterilization and disappeared by the way that the drying type preparation is carried out into the radiation sterilization of cobalt -60
The technique effect of poison.
Described above is only the general introduction of technical solution of the present invention, in order to better understand the technological means of the present invention,
And can be practiced according to the content of specification, and in order to allow above and other objects of the present invention, feature and advantage can
Become apparent, below especially exemplified by the embodiment of the present invention.
Brief description of the drawings
, below will be to embodiment or description of the prior art in order to illustrate more clearly of the technical scheme in the embodiment of the present application
In the required accompanying drawing used be briefly described, it should be apparent that, drawings in the following description are some realities of the application
Example is applied, for those of ordinary skill in the art, without having to pay creative labor, can also be attached according to these
Figure obtains other accompanying drawings.
Fig. 1 is the flow signal for the method that a kind of 3D printing artificial bone that the embodiment of the present application provides manufactures drying type preparation
Figure；
Fig. 2 is that the flow for the method that another 3D printing artificial bone that the embodiment of the present application provides manufactures drying type preparation is shown
It is intended to；
Fig. 3 is that the flow for the method that another 3D printing artificial bone that the embodiment of the present application provides manufactures drying type preparation is shown
It is intended to.
Embodiment
A kind of method for 3D printing artificial bone manufacture drying type preparation that the embodiment of the present application provides, methods described include：
The copolymer containing lactic acid acetic acid that percentage by weight is 0.1%-20% is dissolved into solvent with 1,4- dioxane；Described
The first sensitive drug is dissolved in solvent, and the first suspension is made；It will be included in first suspension into percentage by weight
The first decorating film is configured to for 5%-50% calcium containing compound；The second sensitive drug is dissolved in the solvent, and is made
Second suspension；After first decorating film is added in second suspension, addition percentage by weight is 0.5%-30%
Calcium containing compound be configured to the first creamy material for raw material；Graininess will be formed after first creamy material freezing, drying
Product among first preparation；The drying type preparation will be formed after product packing, sealing among first preparation, solve existing skill
The slow releasing pharmaceutical of current clinical practice is single kind in art, can not carry out being used in combination for multi-medicament, and should not deposit
The problem of putting, reached can carry a variety of different pharmaceuticals simultaneously, on-demand, dosage is controllable, Portable sanitary, easily stored
Technique effect.
The exemplary embodiment of the disclosure is more fully described below with reference to accompanying drawings.Although the disclosure is shown in accompanying drawing
Exemplary embodiment, it being understood, however, that may be realized in various forms the disclosure without should be by embodiments set forth here
Limited.On the contrary, these embodiments are provided to facilitate a more thoroughly understanding of the present invention, and can be by the scope of the present disclosure
Completely it is communicated to those skilled in the art.
In order to become apparent from a kind of side for 3D printing artificial bone manufacture drying type preparation that open the embodiment of the present application is provided
Method, some terms are described below.
1st, 3D printer, also known as three-dimensional printer (3DP), it is the one of a kind of increases material manufacturing technology, i.e. RP technique
Kind machine, it is a kind of based on mathematical model file, can be glued with special wax material, powdery metal, plastics or ceramics etc.
Condensation material, the object of three-dimensional is manufactured by printing jointing material from level to level.For the application, using biological 3D
Printer, comparatively speaking, it is particular in that its material used is biomaterial, such as described in the embodiment of the present application
The first creamy material etc..
2nd, the copolymer of lactic acid acetic acid includes Poly(D,L-lactide-co-glycolide, PLGA, PLA, PLG etc., and different proportion
Mixture.Poly(D,L-lactide-co-glycolide (poly (lactic-co-glycolic acid), PLGA) is by two kinds of lists
Body --- lactic acid and hydroxyacetic acid are polymerized at random, are a kind of degradable functional polymer organic compounds, have good
Biocompatibility, the performance of nontoxic, good encystation and film forming, be widely used in pharmacy, medical engineering material and modern times
Chemical industry field.In the U.S., PLGA is formally included into American Pharmacopeia by FDA certifications as pharmaceutic adjuvant.
3rd, calcium containing compound includes hydroxyapatite, tricalcium phosphate, the mixture of calcirm-fluoride and different proportion.Hydroxy-apatite
Stone, also known as hydroxyapatite, alkali calcium phosphate, it is apatite calcium (Ca5(PO4)3(OH) mineralizing naturally).But often write
Into (Ca10(PO4)6(OH)2) form with it is prominent it be dimeric：Hydroxyl and apatite.OH-group can be fluorinated thing,
Chloride and carbanion replace, and generate fluorine-based apatite or chloro apatite, calcium ion therein can be by various metals
Ion is replaced by the way that ion-exchange reactions occurs, and forms the M apatite (metal of M representative substitution calcium ions of corresponding metal ion
Ion).Hydroxyapatite (HA) is the host inorganic constituent of vertebrate skeletal and tooth, hydroxyl phosphorus in the enamel of people
The content of lime stone about 96Wt.% (92Vol.%), 69Wt.% is also accounted in bone.Hydroxyapatite has excellent biology
Compatibility and bioactivity, and can have as a kind of bone or the inducible factor of tooth in oral hygiene to tooth
Preferable remineralization, desensitization and whitening function.Experiment proves HA particles and enamel good biocompatibility, and compatibility is high, its
Mineralized liquid can be effectively formed remineralization deposition, prevent calcium ion from being lost in, solve the problems, such as enamel decalcification, fundamentally pre- preventing decayed tooth
Tooth disease.Toothpaste containing HA materials has strong suction-operated to sialoprotein, glucan, can reduce the bacterial plaque in patient oral cavity,
Promote gingivitis healing, have preferable preventive and therapeutic effect to dental caries, periodontosis
4th, chitosan (chi tosan) is also known as chitosan, is by de- by the chitin that nature is widely present
What acetyl effect obtained, chemical name is Chitosan (1-4) -2- amino-B-D glucose.From 1859, Frenchman
After Rouget obtains chitosan first, the biological functionality and compatibility of this natural polymer, blood compatibility, security,
The premium properties such as microbic resolvability are by all trades and professions extensive concern, in medicine, food, chemical industry, cosmetics, water process, metal
The application study of the numerous areas such as extraction and recovery, biochemical and biomedical engineering achieves major progress.For patient, shell gathers
Sugared reducing blood lipid, the existing research report of hypoglycemic effect.Meanwhile chitosan is included in state food as thickener, fruit glaze agent
Additive uses standard GB-2760.
Embodiment one
Fig. 1 is a kind of schematic flow sheet of the manufacture method for 3D printing artificial bone that the embodiment of the present application provides.Such as Fig. 1 institutes
Show, methods described includes：
Step 110：The Poly(D,L-lactide-co-glycolide that percentage by weight is 1% is dissolved into 1,4- dioxane
Solvent；
Step 120：The first sensitive drug is dissolved in the solvent, and the first suspension is made；
Specifically, sensitive drug refers in osteomyelitis therapeutic process, and carrying out long-term sustained release for destination object controls
Medicine needed for treating.Wherein, the first sensitive drug, the second sensitiveness medicine can be divided into according to the height of drug susceptibility
Thing, the 3rd sensitive drug, wherein, it can be defined as according to the sensitiveness high and low level for destination object：First sensitiveness
The sensitiveness of medicine is less than second sensitive drug, and the sensitiveness of the second sensitive drug is less than the 3rd sensitiveness medicine
Thing.
Further, the setting for sensitiveness high and low level can be obtained by the way of proportioning, such as by experimental data
More conventional combination is obtained, for example A classes sensitive drug and B classes sensitive drug proportioning are relatively adapted to first kind destination object, C classes
Sensitive drug and D classes sensitive drug are relatively adapted to the second class destination object, and such as penicillin, gentamicin, streptomysin can
With the demand according to patient to medicine, it is combined, as example, the sensitiveness height that can design different ratio mode is different
The combination of medicine.
Specifically, in step 110 and step 120, the first sensitive drug is placed in above-mentioned percentage by weight as 1%
1% Poly(D,L-lactide-co-glycolide (PLGA) be dissolved into Isosorbide-5-Nitrae-dioxane in solvent, and it is suspended to be configured to first
Liquid.Because PLGA is a kind of degradable functional polymer organic compound, there is good biocompatibility, can be used as medicinal
Auxiliary material.So the embodiment of the present application is used to house the first sensitive drug from above-mentioned PLGA as carrier.Further, on
It can be powdered to state the first sensitive drug, then realize and the first suspension is formed in above-mentioned solvent.
Step 130：Configured being included in first suspension into the calcium containing compound that percentage by weight is 5%-50%
Into the first decorating film；
Specifically, hydroxyapatite, tricalcium phosphate, calcirm-fluoride and calcium containing compound are vertebrate skeletal and tooth
Host inorganic part, it may have excellent biocompatibility and bioactivity, meanwhile, its mineralized liquid can be effectively formed again
Mineralising is deposited, therefore first can be configured to by the first suspension for 5%-50% calcium containing compound into percentage by weight and consolidate by using
Shape thing；Wherein, calcium containing compound can be hydroxyapatite, tricalcium phosphate, the mixture of calcirm-fluoride and different proportion, wherein,
It is preferred that the hydroxyapatite that percentage by weight is 10%-15% is included in first suspension and is configured to the first decorating film
Embodiment.Above-mentioned first decorating film is the microballoon described in those skilled in the art, and the shape of the decorating film does not do specific limit
It system, can be added in the ointment material of printing artificial bone, and then increase slow release effect.
Step 140：The second sensitive drug is dissolved in the solvent, and the second suspension is made；
Step 150：After first decorating film is added in second suspension, addition percentage by weight is 0.5%-
30% calcium containing compound is that raw material is configured to the first creamy material；
Specifically, in step 140 and step 150, second sensitive drug is dissolved in the solvent, and make
Into the second suspension, second sensitive drug can be powdered, then realize and described second is formed in above-mentioned solvent
Suspension, then first decorating film is dispersed randomly in second suspension, adding percentage by weight is
0.5%-30% calcium containing compound is that raw material is configured to the first creamy material.
Further, due to hydroxyapatite, tricalcium phosphate, calcirm-fluoride and calcium containing compound are vertebrate skeletal and tooth
The host inorganic part of tooth, it may have excellent biocompatibility and bioactivity, meanwhile, its mineralized liquid being capable of effective shape
Deposited into remineralization, that is to say, that the material hardness that the ratio of above-mentioned hydroxyapatite is bigger, obtains is added in the volume
Bigger, easy degree of decomposition is lower.So the hydroxyapatite content of the first creamy material by making preparation is less than described first
The hydroxyapatite content of decorating film, after reaching and first decomposing first creamy material, then first decorating film is decomposed,
And then realize that the material of hypersensitivity first discharges, discharged after the material of hyposensitivity, be finally reached secondary sustained release, and then increased slow
Release effect.
Step 160：Product among the preparation of graininess first will be formed after first creamy material freezing, drying；
Step 170；Among first preparation drying type preparation will be formed after product packing, sealing.
Specifically, first creamy material is freezed, after drying process processing, forms graininess or powdered thing
Matter, i.e., described first preparation centre product, wherein containing first decorating film, first decorating film is that micron-sized drug containing is micro-
Ball, it is scattered among first preparation in product, the substep for medicine is sustained.Then product among first preparation are carried out
It is standby using the radiation sterilization of cobalt -60 after packing, sealing.
For further, in drying type preparation prepared by the embodiment of the present application, the physical behavior of the drying type preparation is
Graininess is powdered, and the drug material of the 3D printing artificial bone is prepared into the granular formulations of drying type, can basis
Different situations need, and reach on-demand, dosage is controllable, Portable sanitary, easily stored technique effect.
Embodiment two
In order to realize the use of more middle sensitive drugs, reach further lifting slow release effect, the embodiment of the present application is also
A kind of method of 3D printing artificial bone manufacture drying type preparation is provided, as shown in Fig. 2 methods described includes：
Step 210：First creamy material is added in biological 3D printer and printed, forms internal layer；
Specifically, the first creamy material for meeting biological 3D printer input requirements is added in biological 3D printer
Row 3D printing, because 3D printing technique already belongs to basic technology, therefore the embodiment of the present application is no longer specifically described 3D printer
Print procedure and method.It should be noted that the structure of above-mentioned 3D printer printing should be with the bone phase shortage needed for destination object
Match somebody with somebody, that is to say, that by the personalization features of 3D printing technique, can be lacked as destination object with the bone of destination object, be beaten with 3D
Print technology is means, prints the 3D printing artificial bone matched with bone phase shortage.Above-mentioned 3D printing technique solves clinical at present answer
The slow releasing pharmaceutical used in, shape is single, simple in construction, can not meet the deficiency of various types of bone surgery requirements.Than
As said, bone window is too narrow, and plug is not entered；Or bone window is too big, it is difficult to closes, after suturing on the contrary so that the medicine outflow used
Problem.After 3D printing, drug composite system can be made to be matched with bone window structure, beneficial to filling, and can in closure
By bone window or removal bone, the i.e. scarce size of bone, to rationally design closure 3D printing artificial bone, play the envelope for being advantageous to medicine
Close, the effect that will not flow out medicine.
Further, in step 210, the 3D printing technique applied in the embodiment of the present application is to print one using it
Medicine-containing particle of the kind with sandwich construction, prints to internal layer, that is, enter as the medicine being finally sustained by the first creamy material
Row release.
Step 220：The 3rd sensitive drug is dissolved in the solvent, and the 3rd suspension is made；
Step 230：Configured being included in the 3rd suspension into the calcium containing compound that percentage by weight is 5%-50%
Into the second decorating film；
Specifically, it is included in into the calcium containing compound that percentage by weight is 5%-50%, matches somebody with somebody in the 3rd suspension
Second decorating film, second decorating film and the medicine-containing microsphere that first decorating film is in creamy material is made, no
What same point was the second decorating film carrying is the second sensitive drug, and what first decorating film carried is the first sensitiveness
Medicine.The two is scattered in the creamy material of different layers respectively, reaches the effect of two level sustained release.
Step 240：The 4th sensitive drug is dissolved in the solvent, and the 4th suspension is made；
Step 250：After adding second decorating film in the 4th suspension, addition percentage by weight is 0.5%-
30% calcium containing compound is that raw material is configured to the second creamy material；
Specifically, second creamy material and first creamy material are for biological 3D printing artificial bone
Raw material, difference is that internal contained drug is different, for printing the different layers of the artificial bone.Contain in second creamy material
There is the 4th powdered sensitive drug, and carry the microballoon of the 3rd sensitive drug, i.e., it is described due to the hydroxyl phosphorus of microballoon
Lime stone content is lower than the hydroxyapatite content of the creamy material, can be formed and first decompose release creamy material, then decomposes microballoon,
And then ladder is realized, there is step, science, controllable medicament slow release therapeutic effect
Step 260：Second creamy material is added in biological 3D printer, and printed based on the internal layer,
Form the 3rd creamy material；
Specifically, second creamy material is printed on the basis of first creamy material, also
It is to say, the second creamy material is covered on the content of the first creamy material formation, can be designed according to different situations
Into 2 layers, 3 layers, the embodiment of the present application is not intended to be limited in any to the number of plies of the creamy material.On specific slow release effect, meeting
Formation is first sustained the second creamy material, then discharges the second decorating film in the second creamy material, then is sustained the first creamy material,
The effect of the first decorating film in the first creamy material is finally discharged, and by institute's drug containing in different creamy materials and decorating film
Thing sensitiveness is different, and outer layer sensitiveness is high, and internal layer sensitiveness is relatively low, and then realizes that the material of hypersensitivity first discharges, muting sensitive sense
Property material after discharge, and then lifted slow release effect technique effect.
Step 270：Product among the preparation of graininess second will be formed after 3rd creamy material freezing, drying；
Step 280：Among second preparation drying type preparation will be formed after product packing, sealing.
Specifically, the 3rd creamy material is freezed, product among first preparation is obtained after drying process,
3rd creamy material is freezed, after drying process processing, formation particulate material, i.e., among described second preparation
Product, the particulate material are specially multilayer drug containing structure, and in the multilayer drug containing material, every layer also has medicine-containing microsphere, are led to
Species difference and the difference of positional structure of contained drug are crossed, reaches multi-medicament substep and is sustained, extend the effect of slow-release time
Fruit.Then it is standby using the radiation sterilization of cobalt -60 after product among second preparation being dispensed, sealed.
For further, in drying type preparation prepared by the embodiment of the present application, by the medicine material of the 3D printing artificial bone
Material is prepared into the granular formulations of drying type, can need progress medication according to different situations, reach on-demand, dosage can
Control, Portable sanitary, easily stored technique effect.
Embodiment three：
In order to realize the use of more middle sensitive drugs, reach further lifting slow release effect, the embodiment of the present application is also
A kind of method of 3D printing artificial bone manufacture drying type preparation is provided, refer to Fig. 3, methods described includes：
Step 310：The 5th sensitive drug is dissolved in the solvent, and the 5th suspension is made；
Step 320：After adding first decorating film in the 5th suspension, it is 5%- to be included in into percentage by weight
50% calcium containing compound is configured to the 3rd decorating film.
Step 330：The 6th sensitive drug is dissolved in the solvent, and the 6th suspension is made；
Step 340：After adding the 3rd decorating film in the 6th suspension, it is 5%- to be included in into percentage by weight
50% calcium containing compound is configured to the 4th decorating film.
Step 350：After the 4th decorating film is added in second suspension, addition percentage by weight is 0.5%-
30% calcium containing compound is that raw material is configured to the 4th creamy material；
Step 360：Product among the preparation of graininess the 3rd are formed after 4th creamy material is freeze-dried；
Step 370：Among 3rd preparation drying type preparation will be formed after product packing, sealing.
For the embodiment of the present application, the 5th sensitive drug and the 6th sensitive drug are obtained, wherein, described the
The sensitiveness of five sensitive drugs is higher than first sensitive drug, and the sensitiveness of the 6th sensitive drug is higher than described
5th sensitive drug.After 5th sensitive drug is made into the 5th suspension, first decorating film is added
In 5th suspension, the calcium containing compound that percentage by weight is 5%-50% is added into, it is become more sticky shape
State, it is put into the sieve of fixed dimension, sifts out the microballoon of identical size, freezing, air-dry, form the 3rd decorating film, then
3rd decorating film is put into the suspension containing the 6th sensitive drug, it is 5%-50%'s to be added into percentage by weight
Calcium containing compound, it is become more sticky state, be put into the sieve of fixed dimension, sift out the microballoon of identical size, it is cold
Freeze, air-dry, finally obtain the 4th decorating film with three-decker.The sieve aperture size can have a variety of different size chis
Very little, specific size selects according to clinical demand, and the embodiment of the present application imposes any restrictions not to this.
Further, the 4th decorating film is added in second suspension, obtained the 3rd creamy material
Comprising the 4th decorating film and creamy material, the 4th decorating film is the medicine-containing microsphere with three-decker, is divided per Rotating fields
Not Han You different sensitive drugs, its sensitiveness is successively weakened by outer layer to internal layer, along with above-mentioned material is not easily decomposed, is made micro-
Ball can reach the effect for successively decomposing release medicine in itself, and the 4th decorating film is scattered in containing different sensitive drugs
Creamy material in, further enhance prolonged drug sustained release and substep medication technique effect.
Further, the 4th creamy material is freezed, product among first preparation is obtained after drying process,
4th creamy material is freezed, after drying process processing, form powdered rubber, i.e., product among described 3rd preparation,
Because the main matter in product among the 3rd preparation is the 4th decorating film and the second sensitive drug, and the above-mentioned 4th
Decorating film is micron-sized medicine-containing microsphere, so the physical behavior of product finding of naked eye is powdered among the 3rd preparation.Institute
It is specially multilayer drug containing structure to state the 4th decorating film, can be 2 layers, 3 layers etc., the specific number of plies can depending on different situations,
It can reach multi-medicament substep by the species difference of contained drug and the difference of positional structure and be sustained, when extending sustained release
Between effect.Then it is standby using the radiation sterilization of cobalt -60 after product among second preparation being dispensed, sealed.
For further, in drying type preparation prepared by the embodiment of the present application, by the medicine material of the 3D printing artificial bone
Material is prepared into the granular formulations of drying type, can need progress medication according to different situations, reach on-demand, dosage can
Control, Portable sanitary, easily stored technique effect.
The one or more technical schemes provided in the embodiment of the present application, have at least the following technical effects or advantages：
1st, the method for a kind of 3D printing artificial bone manufacture drying type preparation that the embodiment of the present application provides, by by weight hundred
Divide than being dissolved into solvent with 1,4- dioxane for the 0.1%-20% copolymer containing lactic acid acetic acid；It is molten in the solvent
The first sensitive drug is solved, and the first suspension is made；To be included in first suspension into percentage by weight is 5%-
50% calcium containing compound is configured to the first decorating film；The second sensitive drug is dissolved in the solvent, and it is outstanding to be made second
Turbid；After first decorating film is added in second suspension, the calcic that percentage by weight is 0.5%-30% is added
Compound is that raw material is configured to the first creamy material；Made graininess first is formed after first creamy material freezing, drying
Product among agent；The drying type preparation will be formed after product packing, sealing among first preparation, solve mesh in the prior art
The slow releasing pharmaceutical of preceding clinical practice is single kind, can not carry out being used in combination for multi-medicament, and what should not be deposited ask
Topic, reached can carry simultaneously a variety of different pharmaceuticals, on-demand, dosage is controllable, Portable sanitary, easily stored technology effect
Fruit.
2. the embodiment of the present application is printed by the way that first creamy material is added in biological 3D printer, in formation
Layer；The 3rd sensitive drug is dissolved in the solvent, and the 3rd suspension is made；It will be included in 3rd suspension into weight
The calcium containing compound that amount percentage is 5%-50% is configured to the second decorating film；The 4th sensitiveness medicine is dissolved in the solvent
Thing, and the 4th suspension is made；After adding second decorating film in the 4th suspension, adding percentage by weight is
0.5%-30% calcium containing compound is that raw material is configured to the second creamy material；Second creamy material is added into biological 3D to beat
In print machine, and printed based on the internal layer, form the 3rd creamy material；After the 3rd creamy material freezing, drying
Form product among the preparation of graininess second；Among second preparation drying type preparation will be formed after product packing, sealing.Solution
The slow releasing pharmaceutical of current clinical practice in the prior art of having determined is single kind, can not carry out being used in combination for multi-medicament,
And the problem of should not depositing, further reached can carry a variety of different pharmaceuticals simultaneously, on-demand, dosage is controllable, just
Prompt hygienic, easily stored technique effect.
3. the 5th suspension is made by dissolving the 5th sensitive drug in the solvent in the embodiment of the present application；
After adding first decorating film in 5th suspension, it is included in and matches somebody with somebody into the calcium containing compound that percentage by weight is 5%-50%
It is set to the 3rd decorating film；The 6th sensitive drug is dissolved in the solvent, and the 6th suspension is made；It is suspended the described 6th
After the 3rd decorating film is added in liquid, it is included in and is configured to the 4th solid fraction into the calcium containing compound that percentage by weight is 5%-50%
Thing；After the 4th decorating film is added in second suspension, add percentage by weight and contain calcification for 0.5%-30%
Compound is that raw material is configured to be formed in the preparation of graininess the 3rd after the 4th creamy material is freeze-dried by the 4th creamy material
Between product；Among 3rd preparation drying type preparation will be formed after product packing, sealing.Solve and face at present in the prior art
The slow releasing pharmaceutical of bed application is single kind, the problem of can not carrying out being used in combination for multi-medicament, and should not deposit, is entered
One step, which has reached, can carry a variety of different pharmaceuticals simultaneously, on-demand, dosage is controllable, Portable sanitary, easily stored technology
Effect.
4. the embodiment of the present application has reached effective sterilization and disappeared by the way that the drying type preparation is carried out into the radiation sterilization of cobalt -60
The technique effect of poison.
Although preferred embodiments of the present invention have been described, but those skilled in the art once know basic creation
Property concept, then can make other change and modification to these embodiments.So appended claims be intended to be construed to include it is excellent
Select embodiment and fall into having altered and changing for the scope of the invention.
Obviously, those skilled in the art can carry out the essence of various changes and modification without departing from the present invention to the present invention
God and scope.So, if these modifications and variations of the present invention belong to the scope of the claims in the present invention and its equivalent technologies
Within, then the present invention is also intended to comprising including these changes and modification.
It should be noted last that above embodiment is merely illustrative of the technical solution of the present invention and unrestricted,
Although the present invention is described in detail with reference to example, it will be understood by those within the art that, can be to the present invention
Technical scheme modify or equivalent substitution, without departing from the spirit and scope of technical solution of the present invention, it all should cover
Among scope of the presently claimed invention.
Claims (7)
- A kind of 1. method of 3D printing artificial bone manufacture drying type preparation, it is characterised in that methods described includes：The copolymer containing lactic acid acetic acid that percentage by weight is 0.1%-20% is dissolved into solvent with 1,4- dioxane；The first sensitive drug is dissolved in the solvent, and the first suspension is made；By being included in first suspension the first decorating film is configured into the calcium containing compound that percentage by weight is 5%-50%；The second sensitive drug is dissolved in the solvent, and the second suspension is made；After first decorating film is added in second suspension, add percentage by weight and contain calcification for 0.5%-30% Compound is that raw material is configured to the first creamy material；Product among the preparation of graininess first will be formed after first creamy material freezing, drying；Among first preparation drying type preparation will be formed after product packing, sealing.
- 2. the method as described in claim 1, it is characterised in that the percentage by weight that adds contains calcification for 0.5%-30% Compound is that raw material is configured to after the first creamy material, and methods described also includes：First creamy material is added in biological 3D printer and printed, forms internal layer；The 3rd sensitive drug is dissolved in the solvent, and the 3rd suspension is made；By being included in the 3rd suspension the second decorating film is configured into the calcium containing compound that percentage by weight is 5%-50%；The 4th sensitive drug is dissolved in the solvent, and the 4th suspension is made；After adding second decorating film in the 4th suspension, add percentage by weight and contain calcification for 0.5%-30% Compound is that raw material is configured to the second creamy material；Second creamy material is added in biological 3D printer, and printed based on the internal layer, forms the 3rd paste Material；Product among the preparation of graininess second will be formed after 3rd creamy material freezing, drying；Among second preparation drying type preparation will be formed after product packing, sealing.
- 3. the method as described in claim 1, it is characterised in that described to be included in first suspension into percentage by weight For 5%-50% calcium containing compound be configured to the first decorating film after, methods described also includes：The 5th sensitive drug is dissolved in the solvent, and the 5th suspension is made；After adding first decorating film in the 5th suspension, it is included in and contains calcification into percentage by weight for 5%-50% Compound is configured to the 3rd decorating film.
- 4. method as claimed in claim 3, it is characterised in that methods described also includes：Molten 6th sensitive drug in the solvent, and the 6th suspension is made；After adding the 3rd decorating film in the 6th suspension, it is included in and contains calcification into percentage by weight for 5%-50% Compound is configured to the 4th decorating film.
- 5. method as claimed in claim 4, it is characterised in that methods described also includes：After the 4th decorating film is added in second suspension, add percentage by weight and contain calcification for 0.5%-30% Compound is that raw material is configured to the 4th creamy material；Product among the preparation of graininess the 3rd are formed after 4th creamy material is freeze-dried；Among 3rd preparation drying type preparation will be formed after product packing, sealing.
- 6. the method as described in claim 1, it is characterised in that methods described also includes：By the drying type preparation carry out cobalt- 60 radiation sterilizations.
- 7. a kind of artificial bone drying type preparation, it is characterised in that the preparation is made by above-mentioned 1-6 methods describeds.
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