CN114272510B - Soluble microneedle capable of carrying medicine in layered and segmented manner and preparation method thereof - Google Patents
Soluble microneedle capable of carrying medicine in layered and segmented manner and preparation method thereof Download PDFInfo
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- CN114272510B CN114272510B CN202111619302.3A CN202111619302A CN114272510B CN 114272510 B CN114272510 B CN 114272510B CN 202111619302 A CN202111619302 A CN 202111619302A CN 114272510 B CN114272510 B CN 114272510B
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- 239000003814 drug Substances 0.000 title claims abstract description 63
- 238000002360 preparation method Methods 0.000 title claims description 6
- 229940079593 drug Drugs 0.000 claims abstract description 30
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims abstract description 11
- 229920002674 hyaluronan Polymers 0.000 claims abstract description 11
- 229960003160 hyaluronic acid Drugs 0.000 claims abstract description 11
- 238000000034 method Methods 0.000 claims abstract description 10
- 230000000694 effects Effects 0.000 claims abstract description 8
- 238000004519 manufacturing process Methods 0.000 claims abstract description 8
- 238000012377 drug delivery Methods 0.000 claims abstract description 3
- 239000010410 layer Substances 0.000 claims description 134
- 238000003475 lamination Methods 0.000 claims description 29
- 239000012792 core layer Substances 0.000 claims description 24
- 239000002184 metal Substances 0.000 claims description 14
- 230000011218 segmentation Effects 0.000 claims description 7
- 238000004364 calculation method Methods 0.000 claims description 5
- 238000006073 displacement reaction Methods 0.000 claims description 5
- 238000003908 quality control method Methods 0.000 claims description 4
- 238000003491 array Methods 0.000 claims description 3
- 230000009977 dual effect Effects 0.000 claims description 3
- 238000005070 sampling Methods 0.000 claims description 3
- 239000007787 solid Substances 0.000 claims description 3
- 238000005429 filling process Methods 0.000 claims description 2
- 238000001514 detection method Methods 0.000 claims 1
- 230000007547 defect Effects 0.000 abstract description 3
- 238000002156 mixing Methods 0.000 abstract description 3
- 239000004615 ingredient Substances 0.000 abstract description 2
- 230000003285 pharmacodynamic effect Effects 0.000 abstract 2
- 238000010521 absorption reaction Methods 0.000 abstract 1
- 210000003491 skin Anatomy 0.000 description 8
- 238000005516 engineering process Methods 0.000 description 5
- 238000003754 machining Methods 0.000 description 4
- 239000004480 active ingredient Substances 0.000 description 2
- 230000000903 blocking effect Effects 0.000 description 2
- 239000002131 composite material Substances 0.000 description 2
- 239000000758 substrate Substances 0.000 description 2
- 230000003796 beauty Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000004207 dermis Anatomy 0.000 description 1
- 230000003779 hair growth Effects 0.000 description 1
- 230000007721 medicinal effect Effects 0.000 description 1
- 230000004936 stimulating effect Effects 0.000 description 1
- 230000002087 whitening effect Effects 0.000 description 1
- 230000037303 wrinkles Effects 0.000 description 1
Images
Classifications
-
- 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 a soluble microneedle for carrying medicine in a layered and sectional manner, which comprises a shell and an inner layer, wherein the inner layer of the soluble microneedle is divided into different laminated layers from inside to outside, and each laminated layer can be further divided into a plurality of sections; a shell hard layer covers the inner layer; the hard shell layer is made of hyaluronic acid (hyaluronic acid); the soluble microneedle for layered and segmented drug loading overcomes the technical defect that all drug components are added in the conventional soluble microneedle by one-time blending, and realizes accurate position-controlled filling and micro-drug delivery in the process of manufacturing the drug-loaded soluble microneedle; make skin use medicine dissolve the absorption in-process, various drug composition can be according to predetermineeing step order, have sufficient time interval's sequential release in proper order and be absorbed the effect for skin can be according to scientific and reasonable precedence, and the pharmacodynamic ingredient that carries is absorbed in proper order, furthest performance pharmacodynamic achievement.
Description
Technical Field
The invention relates to the technical field of beauty treatment and medical appliances, in particular to a soluble microneedle with layered and segmented medicine carrying and a preparation method thereof.
Background
At present, most of soluble microneedles in the market are developed by TTS and DDS technologies as cores, and hyaluronic acid, which is a component existing in the skin, is prepared into a nano-scale fine microneedle product; various active ingredients (such as wrinkle removing, whitening and hair growth stimulating ingredients) can be added into the needle. Hyaluronic acid and other effective components are directly injected into the dermis layer of the skin through the soluble micro-needle and are completely absorbed and dissolved by the skin, so that various problems of the skin can be effectively improved; however, most of the various blending components in the microneedle structure are blended and added at one time, and are absorbed and dissolved by the skin after being used, and the various components cannot be sequentially queued, released and absorbed with enough time intervals, so that the skin cannot sequentially absorb the carried medicinal components according to a scientific and reasonable sequence, and the maximum medicinal effect is difficult to be exerted to the maximum extent.
Disclosure of Invention
The invention aims to provide a soluble microneedle for carrying medicines in a layered and sectional manner aiming at the defects and shortcomings of the prior art, and aims to exert the efficacy of a drug to the maximum extent by designing and preparing a microneedle structure with an internal layered and sectional manner carrying various active ingredients.
In order to achieve the purpose, the invention adopts the technical scheme that: a soluble microneedle for layered and segmented drug loading comprises a shell and an inner layer, wherein the inner layer can be divided into a plurality of laminated layers, a first laminated layer of the inner layer is an inner core layer, and the laminated layers outside the inner core layer are sequentially arranged to the outermost layer from a second laminated layer; namely: the inner layer of the soluble microneedle is divided into different laminated layers from inside to outside, and each laminated layer can be further divided into a plurality of sections; the lamination position and the volume of the segment can be accurately designed according to the specific lamination position of the inner layer of the soluble microneedle, the corresponding lamination thickness and the accurate segment size of the segment, so that the dosage and the release sequence of the drug components carried by the segment are accurately controlled, and the dual control on the drug dosage and the drug application time is achieved; a shell hard layer covers the inner layer; the hard coat layer is made of hyaluronic acid (hyaluronic acid).
Preferably, the soluble microneedle is a conical microneedle structure;
preferably, the inner layer can be divided into 1-3 laminated layers; each stack may be divided into 2-3 segments;
preferably, the inner-layer medicine component is filled in a gel form;
preferably, the preparation method of the layered and segmented drug-loaded soluble microneedle mainly comprises the following steps:
(1) Mass production of solid soluble microneedle arrays by using a female die and standing;
(2) Planning and designing the inner layer space of the soluble microneedle to carry out specific structure segmentation layout according to the requirements of layered segmentation design;
(3) Adopting a metal thin rod hollow microneedle to fill the inner space of the soluble microneedle:
31 ) filling method of different inner layer stacks, namely: filling enough medicine components of the outermost laminated layer into the inner layer; continuously filling the medicine components of the adjacent inner lamination layer, filling enough space of the adjacent inner lamination layer in the whole range, and further extruding and lifting the medicine components filled last time to form the lamination height and thickness of the outermost layer lamination layer design; repeating the above operations until the inner core layer is filled with the medicinal components; finally obtaining a plurality of laminated soluble microneedle inner laminated structures according to the design requirements; it should be noted that, in the filling process, the position of the discharge hole of the metal slender hollow microneedle is continuously lifted according to a preset program so as to ensure that the size specification of the laminated layer at different height positions is consistent with the design requirement;
32 Filling method of different segments of the stack: in the above step 31), the case where the filling manufacture inner layer is a 2-layer laminated structure and the second laminated layer is divided into a bottom segment and an upper segment is taken as an example to explain:
firstly, considering the size displacement effect of the subsequently filled inner core laminated layer medicament components in advance, and filling the inner layer space according to the dosage of the medicament components at the bottom section of the second laminated layer according to the calculation design requirement; then, continuously replacing the medicine components filled in the inner core layer, and filling the medicine components to the preset height of the bottom section of the second laminated layer; filling the space in the whole range of the inner core layer lamination package in the height range, thereby forming the lamination thickness and the sectional height and position of the sectional design at the bottom of the second laminated layer; it should be noted that, in the process of filling the inner core layer, the position of the discharge hole of the metal slender hollow microneedle is continuously lifted according to a preset program so as to ensure that the size specifications of the inner core layer at different height positions are consistent with the design requirements; repeating the above operations circularly to obtain the upper partial section of the second laminated layer of the soluble microneedle inner-layer structure and the inner core layer at the corresponding height position; finally obtaining a plurality of soluble microneedle structures with laminated inner layers according to design requirements;
although the above exemplary case is a simple case of a double-layer inner-layer laminated structure and the second laminated layer is divided into two segments, when the inner-layer structure is three or more layers and one laminated layer is divided into three or more segments, it is only necessary to consider the size displacement effect of each laminated layer and each segment in each filling operation in a composite manner, and the calculation method and principle are the same as those of the simple case of the double-layer inner-layer laminated structure and the second laminated layer is divided into two segments.
(4) Quality control: sampling and detecting the soluble microneedles produced and prepared in the steps in batches, and strictly controlling the quality according to the design requirements;
it is noted that, limited to the current state of the art of ultra-precision machining, the number of inner laminate layers of the dissolvable microneedles, as well as the number of segments of different laminates, is relatively limited; with the continuous improvement of the precision of the subsequent ultra-precision machining technology level, the number of the laminated layers of the inner layer and the number of the sections of each laminated layer can be increased; moreover, each stack can be segmented in the circumferential direction, in addition to being vertically segmented in the height direction, i.e.: when the manufacturing technology is feasible, the inner layer structure of the soluble microneedle can realize the ultra-precise interval division of lamination, segmentation and even blocking so as to realize the drug loading design and use requirements with more delicate requirements.
Preferably, the soluble microneedle for carrying the medicine in the layered and segmented mode is characterized in that the same components are filled in all segments of each laminated layer of the inner layer of the soluble microneedle synchronously with the shell, then the metal slender rod hollow microneedle is adopted, different laminated layers and segment positions for preset positioning of the inner layer space of the soluble microneedle are adopted, the metal slender rod hollow microneedle and the medicine carrying components are replaced one by one, accurate position control filling is carried out, and micro-dose is carried out.
Preferably, the diameter of the needle rod top platform of the metal thin rod hollow microneedle is less than 100 micrometers; the diameter of the bottom is less than 200 microns; the height of the rod length is 300-1000 microns.
Has the beneficial effects that: the soluble microneedle for layered and segmented drug loading overcomes the technical defect that all drug components are added in the conventional soluble microneedle by one-time blending, and realizes accurate position-controlled filling and micro-drug delivery in the process of manufacturing the drug-loaded soluble microneedle; in the process of dissolving and absorbing the skin by using the medicine, various medicine components can be sequentially released and absorbed in sequence according to preset steps with enough time intervals, so that the skin can sequentially absorb carried medicine effect components according to a scientific and reasonable sequence, and the medicine effect achievement is exerted to the maximum extent.
Drawings
Fig. 1 is a schematic structural view of a soluble microneedle;
fig. 2 is a schematic cross-sectional view of an inner layer structure of soluble microneedles;
fig. 3 is a schematic sectional view of an upper portion of a second laminate of a dissolvable microneedle inner layer;
fig. 4 is a schematic cross-sectional view of a soluble microneedle inner layer second laminate bottom segment;
wherein: 1. a substrate; 2. soluble microneedles; 3. an inner core layer; 41. a bottom section; 42. an upper segment;
Detailed Description
The present invention will be described in further detail with reference to the accompanying drawings.
Referring to the drawings, as shown in fig. 1-4, a conical layered segmented drug-loaded dissolvable microneedle structure comprises a substrate 1 and dissolvable microneedles 2; the soluble microneedle 2 comprises a shell and an inner layer, the inner layer can be divided into two laminated layers, the first laminated layer of the inner layer is an inner core layer 3, the laminated layer outside the inner core layer is a second laminated layer, and the second laminated layer is divided into two sections, namely a bottom section 41 and an upper section 42; the two segments define specific lamination position, lamination thickness and segment size, so that the lamination position and volume of the segments are precisely designed, the dosage of the drug components carried by each segment and the sequence of release are precisely controlled, and dual control on the drug dosage and the drug application time is achieved;
in specific implementation, the outer shell hard layer covers the outer layer of the inner layer; the hard coat layer is made of hyaluronic acid (hyaluronic acid).
In specific implementation, the inner-layer medicine component is filled in a gel form;
in specific implementation, the preparation method of the soluble microneedle mainly comprises the following steps:
(1) Mass production of solid soluble microneedle arrays by using a female die and standing;
(2) According to the requirements of layered and segmented design, the inner layer space of the soluble microneedle is planned and designed to carry out specific structure segmentation layout: namely, the inner layer structure is divided into two laminated layers, and the second laminated layer is divided into two sections;
(3) Adopting a metal thin rod hollow microneedle to fill the inner space of the soluble microneedle:
considering the size displacement effect of the subsequently filled inner core laminated layer medicament components in advance, and filling the inner layer space according to the dosage of the medicament components at the bottom section of the second laminated layer according to the calculation design requirement; then, continuously replacing the medicine components filled in the inner core layer, and filling the medicine components to the preset height of the bottom section of the second laminated layer; filling the space in the whole range of the inner core layer lamination package in the height range, thereby forming the lamination thickness and the sectional height and position of the second lamination layer bottom section design; it should be noted that, in the process of filling the inner core layer, the position of the discharge hole of the metal slender hollow microneedle is continuously lifted according to a preset program so as to ensure that the size specifications of the inner core layer at different height positions are consistent with the design requirements; repeating the above operations circularly to obtain the upper partial section of the second laminated layer of the soluble microneedle inner-layer structure and the inner core layer at the corresponding height position; finally obtaining a plurality of soluble microneedle structures with laminated inner layers according to design requirements;
(4) Quality control: sampling and detecting the soluble microneedles produced and prepared in the steps in batches, and strictly controlling the quality according to the design requirements;
although the above embodiment is a simple case of a double-layer inner-layer laminated structure and the second laminated layer is divided into two segments, when the inner-layer structure is three or more layers and one laminated layer is divided into three or more segments, the size displacement effect of each laminated layer and each segment in each filling operation needs to be considered in a composite manner, and the calculation method and principle are the same as those in the embodiment.
It is noted that, limited to the current state of the art of ultra-precision machining, the number of inner laminate layers of the dissolvable microneedles, as well as the number of segments of different laminates, is relatively limited; with the continuous improvement of the precision of the subsequent ultra-precision machining technology level, the number of the laminated layers of the inner layer and the number of the sections of each laminated layer can be increased; moreover, each stack can be segmented in the circumferential direction, in addition to being vertically segmented in the height direction, i.e.: when the manufacturing technology is feasible, the inner layer structure of the soluble microneedle can realize ultra-precise interval division of lamination, segmentation and even blocking so as to meet the use requirement of drug loading design with finer and more delicate requirements.
Claims (7)
1. A soluble microneedle for carrying medicine in a layered and sectional manner is characterized in that: the soluble microneedle comprises a shell and an inner layer, wherein the inner layer can be divided into a plurality of laminated layers, the first laminated layer of the inner layer is an inner core layer, and the plurality of laminated layers outside the inner core layer are sequentially arranged to the outermost layer from the second laminated layer; namely: the inner layer of the soluble microneedle is divided into different laminated layers from inside to outside, and each laminated layer can be further divided into a plurality of sections; the lamination position and the volume of the segment can be accurately designed according to the specific lamination position of the inner layer of the soluble microneedle, the corresponding lamination thickness and the accurate segment size of the segment, so that the dosage and the release sequence of the drug components carried by the segment are accurately controlled, and the dual control on the drug dosage and the drug application time is achieved; a shell hard layer covers the inner layer; the hard shell layer is made of hyaluronic acid;
the preparation method of the layered and segmented drug-loaded soluble microneedle comprises the following steps:
(1) Mass production of solid soluble microneedle arrays by using a female die and standing;
(2) Planning and designing the inner layer space of the soluble microneedle to carry out specific structure segmentation layout according to the requirements of layered segmentation design;
(3) Adopting a metal thin rod hollow microneedle to fill the inner space of the soluble microneedle:
31 ) filling method of different inner layer stacks, namely: filling enough medicine components laminated on the outermost layer into the inner layer; continuously filling the medicine components of the adjacent inner lamination layer, filling enough space of the adjacent inner lamination layer in the whole range, and further extruding and lifting the medicine components filled last time to form the lamination height and thickness of the outermost layer lamination layer design; repeating the above operations until the inner core layer is filled with the medicinal components; finally obtaining a plurality of laminated soluble microneedle inner laminated structures according to design requirements; it should be noted that during the filling process, the position of the discharge hole of the metal slender hollow microneedle should be continuously lifted according to a preset program to ensure that the lamination dimension specifications at different height positions are consistent with the design requirements;
32 Two stacks and the second stack is divided into two segments:
firstly, considering the size displacement effect of the subsequently filled inner core laminated layer medicament components in advance, and filling the inner layer space according to the dosage of the medicament components at the bottom section of the second laminated layer according to the calculation design requirement; then, continuously replacing the medicine components filled in the inner core layer, and filling the medicine components to the preset height of the bottom section of the second laminated layer; filling the space in the whole range of the inner core layer lamination package in the height range, thereby forming the lamination thickness and the sectional height and position of the sectional design at the bottom of the second laminated layer; in the process of filling the inner core layer, the position of a discharge hole of the metal slender hollow microneedle is continuously lifted according to a preset program so as to ensure that the size specifications of the inner core layer at different height positions are consistent with the design requirements; repeating the above operations circularly to obtain the upper partial section of the second laminated layer of the soluble microneedle inner-layer structure and the inner core layer at the corresponding height position; finally obtaining a plurality of soluble microneedle structures with laminated inner layers according to design requirements;
(4) Quality control: and (3) carrying out batch sampling detection on the soluble microneedles produced and prepared in the steps, and strictly carrying out quality control according to design requirements.
2. The layered, segmented drug-loaded soluble microneedle according to claim 1, wherein: the soluble microneedle is a conical microneedle structure.
3. The layered, segmented drug-loaded dissolvable microneedle according to claim 1, wherein: the inner layer can be divided into 1-3 laminated layers; each stack may be divided into 2-3 segments.
4. The layered, segmented drug-loaded dissolvable microneedle according to claim 1, wherein: the inner layer medicine component is filled in a gel form.
5. The layered, segmented drug-loaded soluble microneedle according to claim 1, wherein: each section of each lamination of the inner layer is filled with the same components with the shell synchronously, and then the metal slender rod hollow microneedle is adopted to preset different lamination and section positions of the inner layer space of the soluble microneedle, the metal slender rod hollow microneedle and the drug-carrying components are replaced one by one block, so that accurate position control filling and micro drug delivery are carried out.
6. The layered, segmented drug-loaded dissolvable microneedle according to claim 1, wherein: the diameter of a platform at the top end of the needle rod of the metal thin rod hollow microneedle is less than 100 micrometers; the diameter of the bottom is less than 200 microns; the height of the rod length is 300-1000 microns.
7. The layered, segmented drug-loaded dissolvable microneedle according to claim 1, wherein: the hyaluronic acid is hyaluronic acid.
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| DE102007002832A1 (en) * | 2007-01-19 | 2008-07-24 | Robert Bosch Gmbh | Method for manufacturing device with arrangement of micro-needles, involves preparing silicon semiconductor substrate, whose surface is applied and structured with masking layer |
| CN204684441U (en) * | 2015-05-05 | 2015-10-07 | 陈彦彪 | A kind of solvable micropin |
| CN204890943U (en) * | 2015-08-07 | 2015-12-23 | 北京化工大学 | Multistage needle array that declines |
| CN107050635A (en) * | 2016-12-30 | 2017-08-18 | 向卓林 | A kind of soluble micropin of segmented, microneedle array and preparation method thereof |
| CN108392728A (en) * | 2018-02-12 | 2018-08-14 | 南通纺织丝绸产业技术研究院 | A kind of compound micropin of silk fibroin multilayer and preparation method thereof |
| CN110876711B (en) * | 2019-12-11 | 2021-03-26 | 北京化工大学 | Method for preparing multilayer polymer microneedle |
| CN111544759B (en) * | 2020-04-26 | 2022-02-25 | 优微（珠海）生物科技有限公司 | Microneedle patch for removing black eye circles and preparation method thereof |
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|---|---|---|---|---|
| JP2010233674A (en) * | 2009-03-30 | 2010-10-21 | Fujifilm Corp | Microneedle sheet, its use method and method for producing the same |
| EP2338557A1 (en) * | 2009-12-23 | 2011-06-29 | Debiotech S.A. | Soluble microneedle |
| JP2014188329A (en) * | 2013-03-28 | 2014-10-06 | Toppan Printing Co Ltd | Method for manufacturing needle-like body |
| EP3357422A1 (en) * | 2017-02-07 | 2018-08-08 | Koninklijke Philips N.V. | Microneedles and insertable devices with integrated antenna array |
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