CN104888343A - Macromolecule solid micro needle and batched preparing method thereof - Google Patents
Macromolecule solid micro needle and batched preparing method thereof Download PDFInfo
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- CN104888343A CN104888343A CN201510228054.8A CN201510228054A CN104888343A CN 104888343 A CN104888343 A CN 104888343A CN 201510228054 A CN201510228054 A CN 201510228054A CN 104888343 A CN104888343 A CN 104888343A
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Abstract
The invention belongs to the technical field of administration equipment, and relates to a macromolecule solid micro needle and a batched preparing method thereof. The macromolecule solid micro needle is composed of a base and needle body arrays distributed on the base. The height of each needle body in each needle body array is 200-900 microns, the distance between needle points is 200-600 microns, and the diameter of the bottom of each needle body is 30-800 microns. The size of each needle body array is 5 mm*5 mm to 10 cm*10 cm. Compared with the prior art, the macromolecule solid micro needle solves the key problems that in the current beautifying nutrient substance and medicine transdermal releasing technology, due to the shielding function of the cuticle in the skin cuticular layer, the substance transdermal absorption is difficult, and a human body can feel painful and discomfortable. Thus, the macromolecule solid micro needle is good in durability and low in cost, the manufacturing technology of the macromolecule solid micro needle is simple, and the macromolecule solid micro needle is suitable for batched production.
Description
Technical field
The invention belongs to administration device technical field, specifically, relate to a kind of macromolecule solid microneedles and batch preparation thereof.
Background technology
Current most drug can make several formulations, and carries out administration by different route of administration and method.Route of administration and method affect drug metabolism, and then affect the treatment.Compared with the non-invasive manner such as oral administration or topical administration, drug administration by injection has its irreplaceable advantage.Drug administration by injection comprises subcutaneous injection and vein input, for intravenous injection, drug conveying directly can be entered blood by it, and medicine also arrives at focus with blood circulation, utilize compared with digestive tract absorbs the drug with oral administration, have the utilization ratio of drug of speed and Geng Gao faster.Moreover, the drug administration by injection burden to digestive system that can also effectively avoid oral drugs to bring and unnecessary harm.Although, this method of drug administration by injection is effective, but injection brings extra pain to patient usually, and easily cause local skin to damage at injection point, hemorrhage, increase the risk of disease propagation, because wound is an infection point, when therefore the mode of drug administration by injection using for old man and the more weak colony of this kind of immunity of child, potential certain infection risk and difficulty.Meanwhile, injection technique is confined to trained people operation, and being therefore also not suitable for needs patient that is long-term and control successive administration to use.
In order to avoid above-mentioned shortcoming, the medicines such as some macromolecular polypeptide, protein and DNA are transmitted in human body by skin, just need a kind of can overcome keratodermatitis obstruction and the administering mode of the sense of discomfort of patient can be alleviated, this novel administering mode is exactly transdermal administration.Transdermal administration refers in skin surface administration, make medicine with close to constant speed by skin layers, enter through capillary absorbance the dosage form that body circulation produces whole body and local therapeutic effects, such preparation is commonly referred to transdermal patch.In principle, transdermal administration and subcutaneous injection or vein input administration is same medication.Transdermal administration is applied to treatment local skin or general disease, has safer, stable and that patient compliance is good advantage than other dosage forms.Wherein passive transdermal administration technology produces drug effect with simple Concentraton gradient for driving force makes drug diffusion enter blood flow through skin.Diffusion rate depends on size and the hydrophilic of drug molecule and passes cuticular Concentraton gradient.The topmost barrier of drugs through skin is the horny layer of skin, because the permeability of skin to most drug is low, effectively can reach the medicine of drug effect through skin little by Passive diffusion.Therefore find and promote that the approach of Drug Percutaneous Absorption is one of key issue of exploitation transdermal administration technology.
In research in the past, before this by Medicine small molecule or by some outside energy, as electric current or ultrasound wave etc., reach the object strengthening drug osmotic ability.Although but these technology can improve medicine-feeding rate to some extent, the medicine of form of ownership can not be applicable to.Afterwards, along with the development of microelectric technique, make some pass through mechanically to penetrate or destroy keratodermatitis and produce path and improve the metal of drug administration speed or silicon micropin device is developed.Adopt this kind of micropin device can realize painless administration, by the size Control to micropin, can epidermis be penetrated, cross horny layer, and not touch skin corium, thus avoid and the contacting of nerve fiber and blood, naturally it also avoid and bleed or pain.Although the exploitation of these devices has great use value, but the technology of preparing of the micropin device of this metalloid or silicon materials not mature enough and their micro structure easily make them inevitably break in use to fall in skin, thus damage is caused to human body, this just makes the micropin application risk of these materials greatly improve.Therefore in order to meet the requirement of drug release to device better, namely less wound or otch is produced, larger drug conveying efficiency, makes the management and of medicine easier, and exploitation has the micropin of biodegradability and biocompatibility and the manufacture method of improvement micropin is very necessary.
Summary of the invention
For solving the problems of the technologies described above, the invention provides the good macromolecule solid microneedles of a kind of economy and durability, Transdermal absorption and batch preparation thereof.
A kind of macromolecule solid microneedles of the present invention, described macromolecule solid microneedles is made up of base and the needle body array be distributed on base; The height of each needle body in described needle body array is 200-900 micron, and needle tip spacing is 200-600 micron, and base diameter is 30-800 micron; Described needle body array size is 5mm × 5mm-10cm × 10cm.
A kind of macromolecule solid microneedles of the present invention, described needle body array and base are made up of the insoluble macromolecular material integral forming of biodegradable.
A kind of macromolecule solid microneedles of the present invention, the shape of described needle body is selected from taper shape, pyramid or polygonal taper.
A kind of macromolecule solid microneedles of the present invention, the needle point of described needle body is conical or polygonal taper, and its shank is cylindrical or Polygonal column shape.
A kind of macromolecule solid microneedles of the present invention, the insoluble macromolecular material of described biodegradable is selected from one or more in polylactic acid, Poly-L-lactic acid, poly (glycolide-lactide), polyglycolic acid, poly-epsilon-caprolactone.
The batch preparation of macromolecule solid microneedles of the present invention, the concrete steps of described batch preparation are: 1) be fixed on the base plate of preparation facilities by micropin mould, then insoluble for biodegradable macromolecule material particle is placed on micropin mould, then whole preparation facilities is placed on heating in an airtight heater until granule melts, heating-up temperature is 50 DEG C-240 DEG C; 2) preparation facilities is taken out from airtight heater, and by the melt while hot moulded section of preparation facilities by insoluble for biodegradable macromolecular material; 3) preparation facilities is cooled to room temperature, or is cooled to room temperature under being placed in the quick condition cooled, then by the preparation facilities demoulding, obtaining base is erose macromolecule solid microneedles; 4) be the macromolecule solid microneedles that erose macromolecule solid microneedles cuts into that base is required form by cutter sweep by obtained base.
The preparation method of described micropin mould is: by polymer and firming agent in mass ratio 5:1-20:1 mix, stir and evacuation removal bubble, then be placed in the container of horizontal positioned, 8-9 hour is heated in the baking oven of 60-70 DEG C, polymer cure becomes a monoblock, then it taken out from container, and utilize cut, micro-nano processing technique prepares micropin mould.
Described polymer is polydimethylsiloxane.
Described firming agent is selected from the firming agent or cross-linking agent that match with polydimethylsiloxane curing mechanism.
Described preparation facilities comprises base plate, pressing plate, top board, housing, guide pillar, screw rod, nut, fixed cap; Base plate and housing, top board are fixed together as the shell of preparation facilities; Guide pillar is fixed on base plate by screw thread-screw-hole type, and pressing plate and guide pillar adopt the mode of matched in clearance; Pressing plate centre leaves a blind hole, and screw rod one end and blind hole adopt the mode of matched in clearance, and are fixed on pressing plate by fixed cap and nut; Top board leaves a through hole, and by screw thread-screw-hole type, screw rod is connected on top board with screw rod.
Described step 2) in moulded section process be while hot rotation along with screw rod, and by the guide effect of guide pillar, band dynamic pressure plate moves downward, and the pressure size adopted is 20-500N.
Described step 3) in knockout course be rotation along with screw rod, and by the guide effect of guide pillar, band dynamic pressure plate moves upward, and pressing plate is separated with micropin mould.
The keratodermatitis of barrier action is risen to drug diffusion because macromolecule solid microneedles of the present invention has only penetrated in use and does not penetrate skin corium, syringe needle does not touch the skin corium of abundant nerve and blood capillary, thus pain and sense of discomfort are not caused to human body, more can accept for consumers in general, be particularly suitable for old man and the use of this types of populations of child.Macromolecule solid microneedles of the present invention can be avoided as the easily broken danger dropped in skin of micro structure due to self of metal or silicon micropin, it not only can make low-molecular-weight nutrient substance effectively transmit, and the more important thing is and macro-nutrients and the strong material be difficult to through skin diffusion of hydrophilic can be made also effectively to transmit.
Compared with prior art, macromolecule solid microneedles of the present invention solves the material Transdermal absorption caused due to the barrier action of epiderm skin mesocuticle in current beautifying nourishing material and drug transdermal release tech and is difficult to and causes the key issue such as pain and sense of discomfort to human body.Therefore, macromolecule solid microneedles ruggedness of the present invention is good, cheap, and its preparation technology is simple, is suitable for batch production.
Accompanying drawing explanation
Fig. 1: the preparation flow schematic diagram of macromolecule solid microneedles;
Fig. 2: the preparation facilities figure of macromolecule solid microneedles;
Fig. 3: preparation facilities cuts open to schematic diagram;
Fig. 4: the transverse cross-sectional profile figure that preparation facilities intercepts from A-A line;
Fig. 5: the transverse cross-sectional profile figure that preparation facilities intercepts from B-B line;
Fig. 6: the transverse cross-sectional profile figure that preparation facilities intercepts from C-C line;
Fig. 7: preparation facilities upward view;
Fig. 8: macromolecule solid microneedles schematic diagram;
Fig. 9: macromolecule solid microneedles stereogram;
Figure 10: the Corii Sus domestica figure of macromolecule solid microneedles Corii Sus domestica test;
Figure 11: pricked the stereogram after 20 times in the test of macromolecule solid microneedles Corii Sus domestica;
1-base plate, 2-guide pillar, 3-housing, 4-top board, 5 screw rods, 6-nut, 7-fixed cap, 8-pressing plate.
Detailed description of the invention
Below in conjunction with specific embodiment, macromolecule solid microneedles of the present invention and batch preparation thereof are described further, but protection scope of the present invention is not limited to this.
Embodiment 1
1) by polydimethylsiloxane and aminoethyl piperazine firming agent in mass ratio 10:1 mix, stir and evacuation removal bubble, then be placed in the container of horizontal positioned, heat 8 hours in the baking oven of 60 DEG C, namely solid-state polydimethylsiloxane is obtained, then it taken out from container, and utilize cut, micro-nano processing technique prepares micropin mould;
2) be fixed on the base plate of preparation facilities by micropin mould, be then placed on by particles of polylactic acid on micropin mould, then whole preparation facilities is placed on heating in an airtight heater until granule melts, heating-up temperature is 180 DEG C;
3) preparation facilities is taken out from airtight heater, and by preparation facilities by the moulded section while hot of the melt of polylactic acid;
4) preparation facilities is cooled to room temperature, then by the preparation facilities demoulding, obtaining base is erose macromolecule solid microneedles;
5) be that to cut into base be laminar macromolecule solid microneedles to erose macromolecule solid microneedles by obtained base by cutter sweep.
Described preparation facilities comprises base plate, pressing plate, top board, housing, guide pillar, screw rod, nut, fixed cap; Base plate and housing, top board are fixed together as the shell of preparation facilities; Guide pillar is fixed on base plate by screw thread-screw-hole type, and pressing plate and guide pillar adopt the mode of matched in clearance; Pressing plate centre leaves a blind hole, and screw rod one end and blind hole adopt the mode of matched in clearance, and are fixed on pressing plate by fixed cap and nut; Top board leaves a through hole, and by screw thread-screw-hole type, screw rod is connected on top board with screw rod.
Described moulded section process is while hot the rotation along with screw rod, and by the guide effect of guide pillar, band dynamic pressure plate moves downward, and the pressure size adopted is 200N.
Described knockout course is the rotation along with screw rod, and by the guide effect of guide pillar, band dynamic pressure plate moves upward, and pressing plate is separated with micropin mould.
Compliance test result
1, with the Corii Sus domestica percutaneous penetration that Sulforhodamine B is model drug.
Remove live pig skin one, be placed in the middle of fume hood, (on 25 square millimeters of areas, 100 pins are had by macromolecule solid microneedles prepared by embodiment 1, spacing between pin is 200 microns) put thereon, make it on skin, prick out micropore with have gentle hands by macromolecule solid microneedles, but not transdermal.Then the position of the micropore that micropin is pricked out is dropped in the Sulforhodamine B that liquid-transfering gun pipettes appropriate 1mg/ml, and micropore is covered by this model drug completely, after about 1-2min, remove the remaining model drug of skin surface, and examine under a microscope the percentage ratio that macromolecule solid microneedles successfully pricks transdermal.
2, the access times of macromolecule solid microneedles are on the impact of medicine in subcutaneous absorption efficiency.
Adopt the above-mentioned Corii Sus domestica percutaneous penetration being model drug with Sulforhodamine B, study the situation of change of its medicine under the different access times of micropin in subcutaneous absorption efficiency.This experiment repeats 5 times, the experimental result obtained is shown as: micropin access times are 1-4 time time, medicine is 100% in the meansigma methods of subcutaneous absorption efficiency, when micropin access times are at 5-16 time, medicine is about 98% in the meansigma methods of subcutaneous absorption efficiency, when micropin access times are at 17-18 time, medicine sharply drops to about 20% in the meansigma methods of subcutaneous absorption efficiency, after more than 18 times, find the increase along with access times, medicine constantly declines in the meansigma methods of subcutaneous absorption efficiency.
3, the access times of the macromolecule solid microneedles of differing heights are compared.
Adopt the preparation process of the macromolecule solid microneedles in embodiment 1 to prepare to be highly the micropin of 300 μm, 400 μm, 500 μm, 600 μm, 700 μm, the Corii Sus domestica percutaneous penetration being model drug with Sulforhodamine B, the differing heights of research macromolecule solid microneedles and the relation of its access times.And when specifying to be less than 50% with the percentage ratio of micropin bundle transdermal, micropin is unavailable.The micropin access times that the experimental result obtained is shown as 300 μm are 16-18 time, the micropin access times of 400 μm are 16-17 time, the micropin access times of 500 μm are 16-17 time, and the micropin access times of 600 μm are 15-17 time, and the micropin access times of 700 μm are 10-14 time.In a word, the height of micropin is higher, and the access times of micropin are fewer.
4, equal height, the macromolecule solid microneedles of different bottom surfaces radius is on the impact of medicine in subcutaneous absorption efficiency.
Adopting the preparation process of the macromolecule solid microneedles in embodiment 1 to prepare is highly 600 μm, and bottom surface radius is the micropin of 100 μm, 200 μm, 300 μm, 400 μm, the Corii Sus domestica percutaneous penetration being model drug with Sulforhodamine B, when research macromolecule solid microneedles height is identical, different bottom surface radiuses is on the impact of medicine in subcutaneous absorption efficiency.Obtaining experimental result, to be shown as bottom surface radius larger, and medicine is higher in subcutaneous absorption efficiency.
5, the macromolecule solid microneedles of different macromolecular material is on the impact of medicine in subcutaneous absorption efficiency.
Adopt the preparation process of the macromolecule solid microneedles in embodiment 1, but change different macromolecular material, prepare the macromolecule solid microneedles that height is identical, bottom surface radius is identical containing polylactic acid, Poly-L-lactic acid, poly (glycolide-lactide), polyglycolic acid, poly-epsilon-caprolactone, the Corii Sus domestica percutaneous penetration being model drug with Sulforhodamine B, studies the different macromolecular material of macromolecule solid microneedles to the impact of medicine in subcutaneous absorption efficiency.Obtaining experimental result, to be shown as polylactic acid mechanical property best, and the skin processed with it is the highest to drug absorption efficiency.
Claims (10)
1. a macromolecule solid microneedles, is characterized in that, described macromolecule solid microneedles is made up of base and the needle body array be distributed on base; The height of each needle body in described needle body array is 200-900 micron, and needle tip spacing is 200-600 micron, and base diameter is 30-800 micron; Described needle body array size is 5mm × 5mm-10cm × 10cm.
2. a kind of macromolecule solid microneedles according to claim 1, is characterized in that, described needle body array and base are made up of the insoluble macromolecular material integral forming of biodegradable.
3. a kind of macromolecule solid microneedles according to claim 1, is characterized in that, the shape of described needle body is selected from taper shape, pyramid or polygonal taper; The needle point of described needle body is conical or polygonal taper, and its shank is cylindrical or Polygonal column shape.
4. a kind of macromolecule solid microneedles according to claim 2, is characterized in that, the insoluble macromolecular material of described biodegradable is selected from one or more in polylactic acid, Poly-L-lactic acid, poly (glycolide-lactide), polyglycolic acid, poly-epsilon-caprolactone.
5. the batch preparation of macromolecule solid microneedles according to claim 1, it is characterized in that, the concrete steps of described batch preparation are: 1) be fixed on the base plate of preparation facilities by micropin mould, then insoluble for biodegradable macromolecule material particle is placed on micropin mould, then whole preparation facilities is placed on heating in an airtight heater until granule melts, heating-up temperature is 50 DEG C-240 DEG C; 2) preparation facilities is taken out from airtight heater, and by the melt while hot moulded section of preparation facilities by insoluble for biodegradable macromolecular material; 3) preparation facilities is cooled to room temperature, or is cooled to room temperature under being placed in the quick condition cooled, then by the preparation facilities demoulding, obtaining base is erose macromolecule solid microneedles; 4) be the macromolecule solid microneedles that erose macromolecule solid microneedles cuts into that base is required form by cutter sweep by obtained base.
6. the batch preparation of macromolecule solid microneedles according to claim 5, it is characterized in that, the preparation method of described micropin mould is: by polymer and firming agent in mass ratio 5:1-20:1 mix, 8-9 hour is heated in the baking oven of 60-70 DEG C, polymer cure becomes a monoblock, then it taken out from container, and utilize cut, micro-nano processing technique prepares micropin mould.
7. the batch preparation of macromolecule solid microneedles according to claim 6, is characterized in that, described polymer is polydimethylsiloxane.
8. the batch preparation of macromolecule solid microneedles according to claim 5, is characterized in that, described preparation facilities comprises base plate, pressing plate, top board, housing, guide pillar, screw rod, nut, fixed cap; Base plate and housing, top board are fixed together as the shell of preparation facilities; Guide pillar is fixed on base plate by screw thread-screw-hole type, and pressing plate and guide pillar adopt the mode of matched in clearance; Pressing plate centre leaves a blind hole, and screw rod one end and blind hole adopt the mode of matched in clearance, and are fixed on pressing plate by fixed cap and nut; Top board leaves a through hole, and by screw thread-screw-hole type, screw rod is connected on top board with screw rod.
9. the batch preparation of macromolecule solid microneedles according to claim 5, it is characterized in that, described step 2) in moulded section process be while hot rotation along with screw rod, and by the guide effect of guide pillar, band dynamic pressure plate moves downward, and the pressure size adopted is 20-500N.
10. the batch preparation of macromolecule solid microneedles according to claim 5, it is characterized in that, described step 3) in knockout course be rotation along with screw rod, and by the guide effect of guide pillar, band dynamic pressure plate moves upward, and pressing plate is separated with micropin mould.
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