CN101297989B - Batch preparation of hollow micro-needle based on molding - Google Patents
Batch preparation of hollow micro-needle based on molding Download PDFInfo
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- CN101297989B CN101297989B CN 200810039184 CN200810039184A CN101297989B CN 101297989 B CN101297989 B CN 101297989B CN 200810039184 CN200810039184 CN 200810039184 CN 200810039184 A CN200810039184 A CN 200810039184A CN 101297989 B CN101297989 B CN 101297989B
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- micropin
- mold pressing
- thin plate
- hollow
- microneedle array
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0053—Methods for producing microneedles
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Medical Informatics (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The invention discloses a batch preparation method of a hollow microneedle, which is based on stamping and pertains to medical instrument technology. Firstly, a micro machining method is adopted to prepare the hard mould of microneedle arrays, and then micropores are prepared on a biocompatible metal or a polymer sheet; the space between the micropores is equal to the space between the microneedle arrays; finally, the sheet with micropores is pressed into a protuberant hollow microneedle by stamping; the micropores are the openings of the microneedle prepared by stamping. The batch preparation method of the invention can realize preparation of hollow microneedles in batches at low cost. Since adopting the biocompatible sheet in stamping, the prepared microneedle has good biocompatibility.
Description
Technical field
The present invention relates to a kind of manufacture method of the micropin that is used for transdermal administration of technical field of medical instruments, specifically is a kind of hollow micropin batch preparation based on mold pressing.
Background technology
Along with the development of biological medicine technology, many novel medicament medicaments have appearred, and they have proposed many new requirements to administering mode.As newtype drug or some other biosynthesis medicament,, can not fully reach the effect of its treatment disease with traditional approach administrations such as oral or intravenous injections based on protein, polypeptide, DNA.Become a comparison valid approach that substitutes traditional administering mode and see through dermal delivery of drugs.Pass through dermal delivery of drugs, digestive enzyme is to the first pass effect of decomposition, destruction and the liver of medicine in the intestines and stomach that not only can avoid producing because of oral administration, but also can avoid control because of pain, infection and blood drug level that intravenous injection causes, the most important thing is that transdermal administration can be by the speed of control drug delivery, produce and continue constant blood drug level, the toxic and side effects of reduction medicine.
Transdermal drug delivery system (TDDS) claims transdermal therapeutic system (TTS) again, is meant that medicine passes through skin with certain speed, absorbs a class preparation that enters the body circulation and produce drug effect through blood capillary.The micropin method is a kind of new physical method that is used for transdermal administration.Although the micropin technology just proposed in the seventies in 20th century, the fast development up to the nineties along with MEMS (MEMS) technology, this technology is really starting.First piece of writing report was delivered the article that micropin applies to transdermal delivery system so far from 1998, and the micropin technology receives medicament scholar's concern all the more, is a kind of painless administering mode.The micropin height both can see through the biggest obstacle horny layer of percutaneous dosing, can not contact pain nerve again, and the form by paster imports medicine in the skin through micropin then.Utilize the micropin technology not only can easily import small-molecule drug, but also can import polypeptide and protein-based macromolecular drug.Usually adopt silicon to make the solid or empty micropin array of hundreds of micron.
Find that by prior art documents E.V.Mukerjee etc. write articles " Microneedle array for transdermalbiological fluid extraction and in situ analysis) " (" a kind of be used for the transdermal biological humor sampling and at the existing microneedle array of analyzing " " pick off and executor A ") at " Sensors and ActuatorsA " 114 (2004) pp267-275.Deep erosion and isotropism with silicon that this article is mentioned have prepared microneedle array, because the transdermal bodily fluid sampling.But adopt the micropin of silicon etching technology preparation, technology is complicated, is unfavorable for prepared in batches.Because silicon is the fragile material easy fracture, and silicon is not good biocompatible material.
Summary of the invention
The objective of the invention is at the deficiencies in the prior art and defective, propose a kind of hollow micropin batch preparation based on mold pressing.Make its have technology simple, be suitable for prepared in batches and the low advantage of cost.
The present invention is achieved by the following technical solutions, and the present invention is by the method prepared in batches micropin of micropin mould molded sheet.At first adopt fine machining method to prepare the die hard of microneedle array, on biocompatible metals or polymer sheet, prepare micropore then, the spacing of microneedle array is identical on the spacing of micropore and the mould, by mold pressing thin plate with holes is pressed into the hollow micropin of projection again.Micropore is the opening of mold pressing preparation back micropin.
Described employing fine machining method prepares the die hard of microneedle array, is meant: adopt at the wet etching of (100) face silicon chip surface with KOH to go out to bore the hole, afterwards at the etched surface sputtered metal film, adopt the micropin mould of the method formation metal of electroforming.Or fill ceramic material etching on the silicon awl hole, prepare the micropin mould of pottery through sintering.
Described ceramic material is meant: a kind of in carborundum, silicon nitride, carbonitride of silicium and the aluminium oxide ceramics.
Describedly on biocompatible metals or polymer sheet, prepare micropore, can adopt the method for etching also can adopt the method preparation of laser boring.The spacing of microneedle array is identical on the spacing of micropore and the mould.
Described biocompatible metals or polymer sheet are meant: biocompatible titanium plate, corrosion resistant plate.Polymer sheet is meant a kind of in polymethyl methacrylate (PMMA) thin plate, Merlon (PC) thin plate, polyethylene terephthalate (PETG) thin plate and polystyrene (PS) thin plate.
Describedly thin plate with holes is pressed into the hollow micropin of projection, is meant: by the method for mold pressing, the die hard of microneedle array is pressed on the thin plate with holes, realizes the preparation of hollow micropin by mold pressing.Thin plate with holes is placed on the rubber blanket greater than the micropin height, or be placed on the corresponding die of microneedle array die hard on.The ready-formed micropore of thin plate is the opening of micropin.
By mold pressing among the present invention thin plate with holes is pressed into the hollow micropin of projection, can realizes at a low price the preparation of hollow micropin in batches.Owing to adopt biocompatible thin plate mold pressing, thereby the micropin of preparation has excellent biological compatibility.The micropin administration is a kind of new transdermal administration method.The micropin height both can see through the biggest obstacle horny layer of percutaneous dosing, can not contact the pain nerve of corium again, realized painless administration.The micropin administration is accurate, quick, painless, has merged the advantage of transdermal administration and drug administration by injection, and for macromole, the administration of biological product such as nucleic acid class, polypeptide class, protein vaccine especially has advantage.But the silicon micropin of developing at present is that fragile material is frangible because of silicon not only, and the preparation cost of hollow micropin is high and be unfavorable for industrialization.The present invention has adopted the mode of mold pressing, helps preparing micropin cheaply.
Description of drawings
Fig. 1 adopts fine machining method to prepare the die hard sketch map of microneedle array.
Fig. 2 prepares the micropore sketch map on biocompatible metals or polymer sheet.
Fig. 3 is pressed into thin plate with holes by mold pressing the hollow micropin sketch map of projection.
Among the above-mentioned figure: 1 is that micropin mould, 2 is that micropin mold base, 3 is that micropore, 4 is thin plate.
The specific embodiment
Below in conjunction with accompanying drawing embodiments of the invention are elaborated: present embodiment is being to implement under the prerequisite with the technical solution of the present invention, provided detailed embodiment and concrete operating process, but protection scope of the present invention is not limited to following embodiment.
The implementing procedure of present embodiment is as follows:
Embodiment one: electroforming iron-nickel alloy mould is pressed metallic titanium plate
(1) adopt fine machining method to prepare the die hard of microneedle array
The face silicon chip carries out oxidation in (100), obtains oxide thickness and be 2 microns silicon chip.The employing photoresist is a mask, etch the silicon oxide window, be mask afterwards with the silicon oxide, utilizing the wet etching of KOH to go out the degree of depth is 200-400 micron awl hole array, afterwards at awl hole surface sputtering metallic film, adopt the micropin mold array of the method formation metal of electroforming iron-nickel alloy, as shown in Figure 1.
(2) on biocompatible metals or polymer sheet, prepare micropore
Titanium sheet with 50 microns entirely is bonded at silicon chip surface.It is 40 microns photoresist aperture that the method that adopts photoetching is prepared diameter at titanium plate surface.The spacing of array of orifices is identical with the die hard spacing of microneedle array.Adopt BHF etching titanium to form the aperture that penetrates the titanium sheet.As shown in Figure 2.
(3) thin plate with holes is pressed into the hollow micropin of projection by mold pressing.
It is on 2 millimeters the PDMS rubber blanket that the titanium plate that will have a micropore is placed on thickness.Adjust the position of the micropin mold array of metal, make it depart from the position of 50 microns of micropores on the titanium plate.By the method for mold pressing, the die hard of microneedle array is pressed on the thin plate with holes, forming the degree of depth is 200-400 micron hollow microneedle array.As shown in Figure 3.
Embodiment two: electroforming iron-nickel alloy mould compression polymer plate
(1) adopt fine machining method to prepare the die hard of microneedle array
The face silicon chip carries out oxidation in (100), obtains oxide thickness and be 2 microns silicon chip.The employing photoresist is a mask, etch the silicon oxide window, be mask afterwards with the silicon oxide, utilizing the wet etching of KOH to go out the degree of depth is 200-400 micron awl hole array, afterwards at awl hole surface sputtering metallic film, adopt the micropin mold array of the method formation metal of electroforming iron-nickel alloy, as shown in Figure 1.
(2) on biocompatible metals or polymer sheet, prepare micropore
With 50 microns polymethyl methacrylates (PMMA) thin plate, entirely be bonded at silicon chip surface.It is 100 microns aperture that the method that adopts laser boring goes out diameter in PMMA polymer sheet surface preparation.The spacing of array of orifices is identical with the die hard spacing of microneedle array.As shown in Figure 2.
(3) thin plate with holes is pressed into the hollow micropin of projection by mold pressing.
It is on 2 millimeters the PDMS rubber blanket that the polymer sheet that will have a micropore is placed on thickness.Adjust the position of the micropin mold array of metal, make it depart from the position of 50 microns of micropores on the titanium plate.By the method for mold pressing, the die hard of microneedle array is pressed on the thin plate with holes, forming the degree of depth is 200-400 micron hollow microneedle array.As shown in Figure 3.
Embodiment three: the carbonitride of silicium mould is pressed metallic titanium plate
(1) adopt fine machining method to prepare the die hard of microneedle array
The face silicon chip carries out oxidation in (100), obtains oxide thickness and be 2 microns silicon chip.The employing photoresist is a mask, etches the silicon oxide window, is mask with the silicon oxide afterwards, and utilizing the wet etching of KOH to go out the degree of depth is 200-400 micron awl hole array.Filling carbon nitrogen silica flour body in cavity forms carbonitride of silicium mould micropin mold array through high temperature sintering, as shown in Figure 1 afterwards.
(2) on biocompatible metals or polymer sheet, prepare micropore
Titanium sheet with 50 microns entirely is bonded at silicon chip surface.It is 40 microns photoresist aperture that the method that adopts photoetching is prepared diameter at titanium plate surface.The spacing of array of orifices is identical with the die hard spacing of microneedle array.Adopt BHF etching titanium to form the aperture that penetrates the titanium sheet.As shown in Figure 2.
(3) thin plate with holes is pressed into the hollow micropin of projection by mold pressing.
It is on 2 millimeters the PDMS rubber blanket that the titanium plate that will have a micropore is placed on thickness.Adjust the position of carbonitride of silicium micropin mold array, make it depart from the position of 50 microns of micropores on the titanium plate.By the method for mold pressing, the die hard of microneedle array is pressed on the thin plate with holes, forming the degree of depth is 200-400 micron hollow microneedle array.As shown in Figure 3.
Owing to adopt press moulding mode to prepare micropin, can realize the preparation of hollow micropin in batches.The skin that the titanium microneedle array of preparation and polymer micro needle can sting the SD rat, the transdermal administration of realization insulin.
Claims (6)
1. hollow micropin batch preparation based on mold pressing is characterized in that:
At first adopt fine machining method to prepare the die hard of microneedle array,
Prepare micropore then on biocompatible metals or polymer sheet, the spacing of microneedle array is identical on the spacing of micropore and the mould;
By mold pressing thin plate with holes is pressed into the hollow micropin of projection again, micropore is the opening of mold pressing preparation back micropin.
2. the hollow micropin batch preparation based on mold pressing according to claim 1, it is characterized in that, described employing fine machining method prepares the die hard of microneedle array, be meant: adopt to go out awl at (100) face silicon chip surface with the wet etching of KOH and cheat, afterwards at the etched surface sputtered metal film, adopt the method for electroforming to form the micropin mould of metal, or fill ceramic material etching on the silicon awl hole, prepare the micropin mould of pottery through sintering.
3. the hollow micropin batch preparation based on mold pressing according to claim 2 is characterized in that described ceramic material is meant: a kind of in carborundum, silicon nitride, carbonitride of silicium and the aluminium oxide ceramics.
4. the hollow micropin batch preparation based on mold pressing according to claim 1 is characterized in that, describedly prepares micropore on biocompatible metals or polymer sheet, adopts the method for etching or adopts the method preparation of laser boring.
5. according to claim 1 or 4 described hollow micropin batch preparations based on mold pressing, it is characterized in that, described biocompatible metals or polymer sheet, wherein biocompatible metals is a kind of in biocompatible titanium plate, the corrosion resistant plate, and biocompatible polymer sheet is meant a kind of in polymethyl methacrylate thin plate, Merlon thin plate, polyethylene terephthalate thin plate and the polystyrene thin plate.
6. the hollow micropin batch preparation based on mold pressing according to claim 1, it is characterized in that, it is characterized in that, the described hollow micropin that thin plate with holes is pressed into projection by mold pressing, be meant: by the method for mold pressing, the die hard of microneedle array is pressed on the thin plate with holes, realizes the preparation of hollow micropin, thin plate wherein with holes is placed on the rubber blanket greater than the micropin height, or be placed on the corresponding die of microneedle array die hard on.
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| CN 200810039184 CN101297989B (en) | 2008-06-19 | 2008-06-19 | Batch preparation of hollow micro-needle based on molding |
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| CN 200810039184 CN101297989B (en) | 2008-06-19 | 2008-06-19 | Batch preparation of hollow micro-needle based on molding |
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| CN101297989B true CN101297989B (en) | 2010-06-23 |
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| GB0402131D0 (en) | 2004-01-30 | 2004-03-03 | Isis Innovation | Delivery method |
| CA2745339C (en) | 2007-12-24 | 2016-06-28 | The University Of Queensland | Coating method |
| EP2247527A4 (en) | 2008-02-07 | 2014-10-29 | Univ Queensland | Patch production |
| WO2009140735A1 (en) | 2008-05-23 | 2009-11-26 | The University Of Queensland | Analyte detection by microneedle patch with analyte selective reagents. |
| US8734697B2 (en) * | 2008-12-22 | 2014-05-27 | The University Of Queensland | Patch production |
| SG175135A1 (en) * | 2009-04-10 | 2011-12-29 | 3M Innovative Properties Co | Methods of making hollow microneedle arrays and articles and uses therefrom |
| WO2012006677A1 (en) | 2010-07-14 | 2012-01-19 | The University Of Queensland | Patch applying apparatus |
| CN102000020B (en) * | 2010-11-17 | 2012-10-10 | 河南羚锐制药股份有限公司北京药物研究院 | Novel micro-needle patch containing degradable polymer and preparation method thereof |
| US11179553B2 (en) | 2011-10-12 | 2021-11-23 | Vaxxas Pty Limited | Delivery device |
| CN102836936B (en) * | 2012-08-30 | 2014-12-24 | 上海交通大学 | Preparation method of solid titanium microneedle for cutaneous penetration |
| EP4218892A1 (en) | 2015-02-02 | 2023-08-02 | Vaxxas Pty Limited | Microprojection array applicator |
| CN104844814A (en) * | 2015-05-29 | 2015-08-19 | 北京化工大学 | Microneedle template and preparation method thereof |
| CN105031744B (en) * | 2015-06-29 | 2018-01-02 | 苏州大学 | A kind of hyperplastic scar micropin and preparation method thereof |
| WO2017045031A1 (en) | 2015-09-18 | 2017-03-23 | Vaxxas Pty Limited | Microprojection arrays with microprojections having large surface area profiles |
| WO2017054040A1 (en) | 2015-09-28 | 2017-04-06 | Vaxxas Pty Limited | Microprojection arrays with enhanced skin penetrating properties and methods thereof |
| DK3606760T3 (en) | 2017-03-31 | 2023-11-06 | Vaxxas Pty Ltd | ARRANGEMENT AND PROCEDURE FOR COATING SURFACES |
| WO2018227246A1 (en) | 2017-06-13 | 2018-12-20 | Vaxxas Pty Limited | Quality control of substrate coatings |
| CA3071680A1 (en) | 2017-08-04 | 2019-02-07 | Vaxxas Pty Limited | Compact high mechanical energy storage and low trigger force actuator for the delivery of microprojection array patches (map) |
| JP6965068B2 (en) | 2017-09-13 | 2021-11-10 | 花王株式会社 | Hollow protrusion manufacturing method, hollow protrusion manufacturing equipment, and hollow protrusion |
| CN111433001B (en) * | 2017-12-05 | 2022-03-18 | 古河电气工业株式会社 | Functional member and method for manufacturing same |
| CN109529186B (en) * | 2018-12-17 | 2021-05-11 | 广东工业大学 | Drug-coated amorphous alloy microneedle and manufacturing method thereof |
| CN113509638A (en) * | 2021-05-18 | 2021-10-19 | 华东师范大学 | Micro-needle array with micropores and preparation method thereof |
| CN115400341B (en) * | 2022-08-30 | 2024-02-02 | 华中科技大学 | Soluble polymer microneedle and preparation method thereof |
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