CN110478612A - The method that tip dissolution method prepares the hollow administration micropin of bubble type - Google Patents
The method that tip dissolution method prepares the hollow administration micropin of bubble type Download PDFInfo
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- CN110478612A CN110478612A CN201910633309.7A CN201910633309A CN110478612A CN 110478612 A CN110478612 A CN 110478612A CN 201910633309 A CN201910633309 A CN 201910633309A CN 110478612 A CN110478612 A CN 110478612A
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- micropin
- bubble
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- tip
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
-
- 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
-
- 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
- A61M2037/0046—Solid 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
Abstract
The invention discloses the methods of the hollow administration micropin of tip dissolution method preparation bubble type, prepare metal micro-needle mold using MEMS technology processing；In metal micro-needle die surface one layer of 1mm solubility micropin solution of casting；Soluble solution is poured into micropin mould cavity by vacuumizing, and removes the extra soluble solution of die surface；Soluble solution is dried, soluble tip layer is prepared；PLA sheet material is placed on metal micro-needle die surface, and is heated to molten condition；The PLA of melting is poured into micropin mould cavity by being not thorough to vacuumize, forms bubble type structure in PLA layers；Cooling and demolding obtains having bubble micropin layered；Grinding process is carried out to micropin back sheet, the bubble of back sheet is exposed；The soluble layer of micropin tip layer can dissolve in skin, and remaining PLA bubble layer just forms empty micropin administration channel, realize the effect that empty micropin is administered continuously.Process of preparing of the present invention is simple, is suitable for commercial be widely used.
Description
Technical field
The present invention relates to a kind of processes using the hollow administration micropin of two step castings preparation tip dissolution type bubble.
Background technique
Common administration mode includes oral administration, subcutaneous administrations and cutaneous penetration.Oral administration has and can shift to an earlier date
Determine dosage, be convenient for carrying, patient can self-administration the advantages that, but the effect of the fast degradation of pipe intestinal digesting enzyme and liver are first
The reasons such as effect are crossed, the availability of most of therapeutical peptides and pharmaceutical grade protein is substantially reduced, cause directly to be administered orally
Effect have a greatly reduced quality.Another common administration mode is subcutaneous administrations mode, and disadvantage is also evident from,
Such as can output feeling of pain make one body do not feel good, infection risk.Microneedle cutaneous technology is a kind of by medicament administration to skin
Skin locally conveys or through a kind of medicine-feeding technology that integumentary system conveys, compared with oral administration and subcutaneous administrations mode
Compared with good controlled release drug administration or sustained-release administration effect, and most importantly administration process is painless safely.
Micropin common at present is mostly solid administration micropin, and micro needlepoint terminal spine enters skin, generates the channel of micron-scale,
Drug is directly entered skin layer by micropin channel, to increase infiltration, then application carries medicine plaster on a passage, by passive
Diffusion transmitting drug.But the dosage of solid administration micropin is smaller, and the effective limitation of Medicated Permeation effect.And empty micropin
Compared with solid microneedles, in addition to the size due to needle is small, tissue damage is limited and feeling of pain can be reduced even
Except avoiding completely, biggest advantage is: empty micropin can be pierced into skin as syringe, and micro control may be implemented
Under continued administration, substantially increase the dosage of micropin.But requirement of the manufacture of empty micropin to precision is higher, and more holds
Frangibility, therefore its processing and manufacturing cost is more sufficiently expensive.
Traditional empty micropin preparation process is usually to pass through directly in the substrate of silicon wafer through chemical reaction etching system
Although the micropin of standby hollow structure out, the micropin obtained in this way are not in removing and demoulding damage, but since silicon material compares
It is crisp, it is easy to happen fractures in use, and remain in human skin and can do harm to huamn body.And polylactic acid
It (PLA) is a kind of good degradation material of biocompatibility mainly with corn, cassava etc. for raw material.PLA is hydrolyzed most in body
Final product is water and carbon dioxide, and transpulmonary, kidney, skin excretion have good biocompatibility, obvious inflammatory will not be caused anti-
It answers, be immunoreacted and cell-cytotoxic reaction.
Summary of the invention
In view of the above-mentioned problems, preparing tip dissolution type bubble using two step castings the purpose of the present invention is to provide a kind of
The process of hollow administration micropin.The preparation method operating process is relatively simple, and cost is relatively low needed for preparation, is conducive to efficiently
Rate prepares empty micropin array；And the hollow administration micropin basis material of this method preparation is PLA, is a kind of bio-compatible
Property degradation material, degradation time is or so some months, is sufficiently used for being administered continuously in vivo.
The technical solution adopted by the present invention is the method that tip dissolution method prepares the hollow administration micropin of bubble type, and this method is
A kind of process using the hollow administration micropin of two step castings preparation tip dissolution type bubble, the i.e. first step are poured to obtain micro-
The soluble tip layer of needle, second step are poured to obtain the empty micropin body layer with center bubble.
Specifically includes the following steps:
1) metal micro-needle mold, the micropin microcavity shapes and size of metal micro-needle mold are prepared using MEMS technology processing
Are as follows: 50 μm of bottom diameter pushes up 250 μm of diameter of conical structure；The microcavity interval 2mm of micropin, metal micro-needle mold is by 7 × 7 microcavity arrays
Composition, entire metal micro-needle mold with a thickness of 2mm；
2) in the soluble micropin solution of metal micro-needle die surface one layer of 1mm thickness of casting, soluble micropin solution is matched
Set process are as follows: using deionized water as solvent, being configured to total concentration according to the mass ratio of PVA:PVP=3:1 is 20% (w/w)
Solution；
3) 20min is vacuumized under conditions of -0.1MPa, and soluble micropin solution is poured into metal micro-needle mould cavity
In, and remove the extra soluble micropin solution of metal micro-needle die surface；
4) at 50 DEG C, 1h is thermally dried to soluble micropin solution, molds soluble micropin tip layer；
5) the PLA sheet material of 8mm thickness is placed on metal micro-needle die surface, is heated to 195 DEG C, melt PLA sheet material completely；
6) in a vacuum drying oven, the melting PLA of metal micro-needle die surface is vacuumized, in the item of -0.1MPa
Strict control pumpdown time 10min under part, is vacuumized with achieving the effect that be not thorough.This makes the PLA sheet material of molten condition
It is not completely filled in die cavity, center bubble structure is formd while reserved materials at side wall；
7) cooling and demolding obtains having bubble micropin layered, and bubble structure is spheroid, and one end is solubility
Micropin tip layer, the other end are PLA main body drug delivery layer；
8) plane grinding process is carried out to micropin back sheet using plastic polishing polishing instrument, polishes with a thickness of 2mm, makes micropin
The bubble of back sheet is exposed:
9) in use, micropin tip soluble layer dissolves in skin, remaining PLA bubble layer just forms empty micropin administration
Main structure.
The present invention compares existing empty micropin preparation method, using two step pouring technologies, the relatively simple side of preparation process
Just, low to Preparation equipment and technology of preparing requirement, processing preparation cost is greatly reduced；Micropin tip materials are PVA and PVP etc. raw
The main body drug delivery layer of the soluble material of object compatibility, bubble hollow structure uses PLA degradation material, and PLA itself has good
Good biocompatibility can also be degraded within a certain period of time in skin even if fracture；It is removed by dissolving tip
Later, intermediate bubble hollow passageway is opened, and becomes continued administration channel, reduces the processing and manufacturing difficulty of empty micropin.
Detailed description of the invention
Fig. 1 is the structure chart of the hollow administration micropin of tip dissolution type bubble.
Fig. 2 is the process flow chart using the hollow administration micropin of two step castings preparation tip dissolution type bubble.
Fig. 3 is metal micro-needle die drawing.
Fig. 4 is the administration schematic diagram of the hollow administration micropin of bubble.
Fig. 5 is the structure tag figure of the hollow administration micropin of tip dissolution type bubble.
Specific embodiment
Several preferred embodiments of the invention are described in detail below in conjunction with attached drawing, but the present invention is not restricted to
Specific equipment as described below and technical process.The present invention covers any substitution done in the contents of the present invention and range, repairs
Change, equivalent method and scheme.
In order to make the public have thorough understanding to the present invention, it is described in detail in the following preferred embodiment of the present invention specific
Details, and the present invention can also be understood completely in description without these details for a person skilled in the art.
One case study on implementation structural representation of the hollow administration micropin of two step castings preparation tip dissolution type bubble of the invention
As shown in Figure 1,5, which is removed figure by soluble micropin tip layer 1, PLA hollow bubble main structure 2 and PLA backed abrasive
Layer 3 forms, wherein soluble 1 height of micropin tip layer is 200 μm, 2 height of PLA hollow bubble main structure is 350 μm, PLA
Backed abrasive removes layer 3 with a thickness of 2mm.
Metal micro-needle mold includes soluble micropin tip layer, hollow bubble structure, the hollow drug delivery layer of PLA main body and PLA
Substrate polishing removal layer；
The process flow chart of the preparation method is as shown in Figure 2, comprising the following steps:
Step 1: metal micro-needle mold is prepared using MEMS technology processing, metal micro-needle mould structure is as shown in figure 3, mould
Have micropin microcavity size: 50 μm of bottom diameter, pushing up 250 μm of diameter of conical structure；Microcavity interval 2mm, mold is by 7 × 7 microcavity array groups
At, entire metal micro-needle mold with a thickness of 2mm.
Step 2: using deionized water as solvent, being configured to total concentration according to the mass ratio of PVA:PVP=3:1 is
The solution of configuration is cast in metal micro-needle die surface by the solution of 20% (w/w), makes the liquid level 1mm on mold.
Step 3: whole device being horizontally arranged in a vacuum drying oven, 20min is vacuumized under conditions of -0.1MPa,
It is poured into soluble micropin solution in micropin mould cavity, and removes the extra solution of die surface；
Step 4: being 50 DEG C by vacuum oven temperature setting, be thermally dried 1h to soluble micropin solution, dry
Mold soluble micropin tip layer, high 200 μm of obtained tip layer or so.
Step 5: placing a piece of 20mmx20mm size on metal micro-needle die surface, the PLA sheet material of 8mm thickness, entirely
Device placement is heated to 195 DEG C, after 30min in a vacuum drying oven, and PLA sheet material melts completely.
Step 6: vacuumizing the melting PLA on metal die surface, and strict control is taken out under conditions of -0.1MPa
Vacuum time 10min.Vacuumized by being not thorough, make the PLA of molten condition can retain in metal die center bubble and
Side wall structure can be formed.
Step 7: by water-bath cooling after 10min, demoulding obtains having bubble empty micropin layered.
Step 8: using plastic polishing polishing instrument to micropin back sheet carry out plane grinding process, polishing removal with a thickness of
The bubble of back sheet is exposed in 2mm.
Step 9: in use, micropin tip soluble layer dissolves in skin, remaining PLA bubble layer just forms hollow micro-
Main structure is administered in needle.Bubble it is hollow administration micropin administration schematic diagram as shown in figure 4, its main structure by the hollow medicine of bubble type
Object channel 1 and PLA empty micropin body layer 2 form.
In the above-described embodiments, two step pouring technologies of use, the relatively simple convenience of preparation process, two step pouring technologies point
Not Wei the first step be poured to obtain the soluble tip layer of micropin, second step is poured to obtain the empty micropin main body with center bubble
Layer, this method are low to Preparation equipment and technology of preparing requirement, and processing preparation cost is greatly reduced；Micropin tip materials be PVA and
The theme drug delivery layer of the soluble material of the biocompatibilities such as PVP, bubble hollow structure uses PLA degradation material, PLA itself
With good biocompatibility, can also be degraded within a certain period of time in skin even if fracture；By the way that tip is molten
After solution removal, intermediate bubble hollow passageway is opened, and becomes continued administration channel, reduces the processing and manufacturing of empty micropin
Difficulty.
It is as described above according to the embodiment of the present invention, the embodiment described details all there is no detailed descriptionthe,
Not limiting the invention is only the specific embodiment.Obviously, as described above, can make many modifications and variations.This theory
The embodiment that bright book is chosen and specifically described is principle and practical application in order to better explain the present invention, thus belonging to making
Technical field technical staff can be used using modification of the invention and on the basis of the present invention well.The present invention is only by right
The limitation of claim and its full scope and equivalent.
Claims (3)
1. the method that tip dissolution method prepares the hollow administration micropin of bubble type, it is characterised in that: specifically includes the following steps:
1) metal micro-needle mold, the micropin microcavity shapes and size of metal micro-needle mold are as follows: bottom are prepared using MEMS technology processing
50 μm of diameter, the conical structure for pushing up 250 μm of diameter；The microcavity interval 2mm of micropin, metal micro-needle mold are made of 7 × 7 microcavity arrays,
Entire metal micro-needle mold with a thickness of 2mm；
2) in the soluble micropin solution of metal micro-needle die surface one layer of 1mm thickness of casting, the configuration of soluble micropin solution
Journey are as follows: using deionized water as solvent, being configured to total concentration according to the mass ratio of PVA:PVP=3:1 is the molten of 20% (w/w)
Liquid；
3) 20min is vacuumized under conditions of -0.1MPa, and soluble micropin solution is poured into metal micro-needle mould cavity,
And remove the extra soluble micropin solution of metal micro-needle die surface；
4) at 50 DEG C, 1h is thermally dried to soluble micropin solution, molds soluble micropin tip layer；
5) the PLA sheet material of 8mm thickness is placed on metal micro-needle die surface, is heated to 195 DEG C, melt PLA sheet material completely；
6) in a vacuum drying oven, the melting PLA of metal micro-needle die surface is vacuumized, under conditions of -0.1MPa
Strict control pumpdown time 10min, is vacuumized with achieving the effect that be not thorough；This makes the PLA sheet material of molten condition endless
Full packing forms center bubble structure in die cavity at side wall while reserved materials；
7) cooling and demolding obtains having bubble micropin layered, and bubble structure is spheroid, and one end is soluble micropin
Tip layer, the other end are PLA main body drug delivery layer；
8) plane grinding process is carried out to micropin back sheet using plastic polishing polishing instrument, polishes with a thickness of 2mm, makes micropin backing
The bubble of layer is exposed:
9) in use, micropin tip soluble layer dissolves in skin, remaining PLA bubble layer just forms empty micropin administration main body
Structure.
2. the method for the hollow administration micropin of tip dissolution method preparation bubble type according to claim 1, it is characterised in that: empty
Heart micropin is made of soluble micropin tip layer, PLA hollow bubble main structure and PLA backed abrasive removal layer, wherein solvable
Property micropin tip layer height be 200 μm, PLA hollow bubble main structure height be 350 μm, PLA backed abrasive remove thickness degree
For 2mm.
3. the method for the hollow administration micropin of tip dissolution method preparation bubble type according to claim 1, it is characterised in that: cold
But using after water-bath cooling 10min, demoulding obtains having bubble empty micropin layered for demoulding.
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| CN201910633309.7A CN110478612B (en) | 2019-07-15 | 2019-07-15 | Method for preparing bubble type hollow administration microneedle by tip dissolution method |
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| CN201910633309.7A CN110478612B (en) | 2019-07-15 | 2019-07-15 | Method for preparing bubble type hollow administration microneedle by tip dissolution method |
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| CN110478612B CN110478612B (en) | 2020-10-27 |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112618945A (en) * | 2020-12-14 | 2021-04-09 | 北京航空航天大学 | Hollow closed type microneedle, preparation method thereof and operating device comprising microneedle |
| CN113274344A (en) * | 2021-06-29 | 2021-08-20 | 无锡元旭生物技术有限公司 | Bubble type hollow microneedle and preparation method thereof |
| WO2021197836A3 (en) * | 2020-04-02 | 2022-01-13 | Lts Lohmann Therapie-Systeme Ag | Carrier element for micro-needles, and micro-needle array device |
| CN114699510A (en) * | 2021-12-29 | 2022-07-05 | 浙江湃肽生物有限公司 | Simelide microneedle array and preparation method thereof |
| CN114849054A (en) * | 2022-06-16 | 2022-08-05 | 山东大学 | Soluble needle point hollow injection microneedle patch and method |
| CN115445072A (en) * | 2022-08-22 | 2022-12-09 | 清华大学深圳国际研究生院 | Soluble bubble microneedle array layer, soluble bubble roller microneedle and preparation method thereof |
| FR3130167A1 (en) * | 2021-12-10 | 2023-06-16 | Commissariat A L'energie Atomique Et Aux Energies Alternatives | Device for injecting/withdrawing a fluid through the skin of a living being |
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| CN110478612B (en) | 2020-10-27 |
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