CN114211699A - Preparation mold and preparation method of high-molecular microneedle - Google Patents
Preparation mold and preparation method of high-molecular microneedle Download PDFInfo
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- CN114211699A CN114211699A CN202111325285.2A CN202111325285A CN114211699A CN 114211699 A CN114211699 A CN 114211699A CN 202111325285 A CN202111325285 A CN 202111325285A CN 114211699 A CN114211699 A CN 114211699A
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Images
Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/17—Component parts, details or accessories; Auxiliary operations
- B29C45/26—Moulds
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/17—Component parts, details or accessories; Auxiliary operations
- B29C45/26—Moulds
- B29C45/34—Moulds having venting means
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- Engineering & Computer Science (AREA)
- Manufacturing & Machinery (AREA)
- Mechanical Engineering (AREA)
- Moulds For Moulding Plastics Or The Like (AREA)
Abstract
本发明公开了一种高分子微针制备模具及制备方法，属于高分子材料成型领域。在微针成型过程中，熔融的高分子材料通过注射孔压到微针成型孔里，空气会随着熔融料的注入通过联通微针成型孔的排气孔，将空气排出，获得高质量的微针。由于不需要提前对模具抽真空，工艺简单，适合工业化批量生产。通过将基底提前置于注料模和所述微针成型模之间，在熔融的微针材料通过基底压入微针成型孔的过程中，可以利用熔融料的温度对基底的部分区域进行软化，使得微针材料和基底材料进行融合，进而使微针主体牢固的成型在基底上。
The invention discloses a polymer microneedle preparation mold and a preparation method, which belong to the field of polymer material molding. During the microneedle forming process, the molten polymer material is pressed into the microneedle forming hole through the injection hole, and the air will pass through the vent hole connected to the microneedle forming hole with the injection of the molten material, and the air will be discharged to obtain high-quality Microneedles. Since it is not necessary to vacuum the mold in advance, the process is simple and suitable for industrial mass production. By placing the substrate between the injection mold and the microneedle forming mold in advance, during the process of pressing the molten microneedle material into the microneedle forming hole through the substrate, the temperature of the molten material can be used to soften a part of the substrate, The microneedle material and the base material are fused, so that the main body of the microneedle is firmly formed on the base.
Description
Technical Field
The invention relates to the field of high polymer material forming, in particular to a preparation mold and a preparation method of a high polymer microneedle.
Background
The micro-needle array is a micro-array with the size of micron grade, when the micro-needle has enough length and mechanical strength, the micro-needle can pierce the stratum corneum of the skin to form a drug delivery channel on the surface of the skin, so that the drug reaches the designated depth of the skin and enters the subcutaneous capillary network to be absorbed, and finally the treatment purpose is realized. The microneedle array can quickly penetrate the skin, has the advantages of trace amount, safety and high efficiency, controls the length of the microneedle, reduces the pain of a patient in treatment and achieves no pain. Meanwhile, the microneedle relates to various fields in our schedule life, including the medical apparatus industry, the pet medical industry, the medical financial industry, the physical examination and health consultation industry, the medical e-commerce industry, the drug research and manufacture industry, the special department industry and the comprehensive hospital industry, and directly related carriers comprise drug carriers such as diabetes, heart disease and the like, vaccine carriers, beauty drug carriers, emergency medical drug carriers and the like.
Due to the long research and development and marketing period of the medicines and vaccines, many enterprises begin to look at some markets with short research and development period, such as the field of consumer medicine, and the common micro-needle hair transplantation and micro-needle beauty treatment are available. To a certain extent, the human skin barrier can resist external stimulation and simultaneously can directly block a plurality of effective components outside the door, so that the effective components can not enter the corium layer to play a role, most of the effective components can only absorb water and preserve moisture attached to the epidermis, and all the effective components directly and completely reach the end point when the effective components are directly punctured by the micro-needles, so that the efficiency is obviously improved.
At present, the main preparation method of the micro-needle is to melt the high molecular micro-needle, then pour the melted micro-needle into a mould to be heated, vacuumize and cool the micro-needle. However, in the prior market, the micro-needle holes on the micro-needle mould are closed, and the air in the micro-needle holes can be exhausted only by vacuumizing, and if the air in the micro-needle forming holes is not exhausted, the quality of the obtained micro-needles is poor. However, air in the microneedle molding hole is exhausted, and the microneedle is difficult to demould due to negative pressure in the molding hole after cooling.
Disclosure of Invention
The embodiment of the application provides the preparation mold and the preparation method of the polymer microneedle, so that the yield of the microneedle is improved, the process is simplified, and industrial mass production is realized.
The embodiment of the application provides a preparation mould of polymer micropin, preparation mould of polymer micropin includes:
the injection mould comprises an injection mould body and a plurality of injection holes regularly distributed on the injection mould body, and the axial direction of each injection hole is consistent with the mould closing direction of the high-molecular microneedle preparation mould;
the microneedle forming die is at least partially overlapped with the projection of the injection die along the die closing direction of the die and comprises a forming die body and a plurality of microneedle forming holes regularly distributed on the forming die body, the microneedle forming holes correspond to the injection holes one by one, and the corresponding microneedle forming holes are coaxial with the injection holes; and the number of the first and second groups,
the exhaust mould and the microneedle forming mould are at least partially overlapped along the projection of the mould closing direction, the exhaust mould comprises an exhaust mould body and a plurality of exhaust holes regularly distributed on the exhaust mould body, the exhaust holes correspond to the microneedle forming holes one by one, and the corresponding exhaust holes are coaxial with the microneedle forming holes.
Further, the injection hole and the exhaust hole are both cylinders, the microneedle forming hole is an inverted truncated cone, the bottom surface of the injection hole is the same as the top surface of the microneedle forming hole in shape, and the top surface of the exhaust hole is the same as the bottom surface of the microneedle forming hole in shape.
Further, the shape of the bottom surface of the injection hole and the shape of the top surface of the exhaust hole are both circular, and the diameter b of the injection hole and the diameter a of the exhaust hole have the following relationship:
a＝0.03～0.06b；
the diameter b of the injection hole and the height h of the inverted truncated cone have the following relationship:
b＝0.63～0.83h。
further, the injection mold, the microneedle forming mold and the exhaust mold are made of metal materials, and the injection hole, the microneedle forming hole and the exhaust hole are processed by picosecond laser, femtosecond laser and cutting.
The embodiment of the application provides a preparation method of a high-molecular microneedle, which comprises the following steps:
step S1: preheating the injection mold, the microneedle forming mold and the exhaust mold;
step S2: the microneedle forming die and the exhaust die are matched;
step S3: placing a substrate between the injection mold and the microneedle forming mold, and closing the injection mold and the microneedle forming mold;
step S4: and injecting the molten high polymer material into the microneedle forming hole and the exhaust hole of the microneedle forming die through the injection hole of the injection die, and stopping injecting the molten high polymer material after the microneedle forming hole is filled with the molten high polymer material.
Further, the thickness of the substrate is 1um-2000 um.
Further, the substrate is one or a combination of more of general-purpose plastics, engineering plastic films and fiber cloth.
Further, a plurality of through holes are arranged on the substrate and correspond to the microneedle forming holes, and the diameter c of each through hole is 0.75-0.85 b.
Further, the polymer material comprises one or more of polymer materials such as PLA, PC, PA, PMMA, PP, LCP, POM, PEEK, PPS, PHA, PCL, PEAT, PBS, ABS, PVC, PCTA, PCTG, PEI, PES, PPA, PPE, PPO, PPS, hyaluronic acid and the like.
Further, the following relationship exists between the height h of the inverted frustum and the minimum spacing d between the injection holes: d is 1.35-1.45 h.
One or more technical solutions provided in the embodiments of the present application have at least the following technical effects or advantages:
1. in the microneedle forming process, the molten high polymer material is pressed into the microneedle forming hole through the injection hole, and air is discharged through the exhaust hole communicated with the microneedle forming hole along with the injection of the molten material, so that the high-quality microneedle without bubbles is obtained. Because the mould does not need to be vacuumized in advance, the process is simple, and the method is suitable for industrial mass production.
2. The substrate is arranged between the material injection mold and the microneedle forming mold in advance, and in the process that the melted microneedle material is pressed into the microneedle forming hole through the substrate, partial area of the substrate can be softened by using the temperature of the melted material, so that the microneedle material and the substrate material are fused, and the microneedle is firmly formed on the substrate.
Drawings
Fig. 1 is a view showing a structure of a microneedle in which a microneedle and a substrate are integrally formed in the related art;
fig. 2 is a structural diagram of a polymer microneedle preparation mold according to an embodiment of the present invention;
fig. 3 is a schematic diagram illustrating a mold for preparing a polymer microneedle according to an embodiment of the present invention after being closed;
fig. 4 is a schematic diagram of a mold for preparing a polymer microneedle, according to another embodiment of the present invention, after being closed;
fig. 5 is a structural diagram of a polymer microneedle formed in an embodiment of the present invention.
Reference numerals:
the injection mould 1, the microneedle forming mould 2, the exhaust mould 3, the injection hole 10, the microneedle forming hole 20, the exhaust hole 30, the substrate 4, the microneedle body 5, the microneedle part 200 and the substrate part 100
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, embodiments of the present invention will be described in detail with reference to the accompanying drawings.
Fig. 1 is a structure view of a microneedle in which a microneedle and a substrate are integrally formed in the related art, and as shown in fig. 1, the microneedle includes a microneedle portion 200 and a substrate portion 100 which are made of the same material, and ends of the microneedle portion 200 are connected to the substrate portion 100 to facilitate mold release. However, this method is only suitable for the case where the microneedle material and the substrate material are the same, and the choice of the substrate material is greatly limited. If the microneedle material and the base material are different, the materials need to be replaced at the time of injection, and the microneedle molding efficiency and molding quality are affected. If the microneedle portion 200 is formed separately and then the adhesive base material is covered at the end of the microneedle portion 200, the base material and the microneedle portion 200 are not tightly connected because they are independent from each other, so that the microneedle portion 200 is easily detached during use.
Fig. 2 is a structural diagram of a polymer microneedle preparation mold according to an embodiment of the present invention. As shown in fig. 2, the high molecular microneedle preparation mold includes an injection mold 1, a microneedle forming mold 2, and an exhaust mold 3.
The injection mould 1 comprises an injection mould 1 body and a plurality of injection holes 10 regularly distributed on the injection mould 1 body, and the axial direction of the injection holes 10 is consistent with the mould closing direction of the high-molecular microneedle preparation mould; the projection of the microneedle forming die 2 and the injection die 1 along the die closing direction of the die is at least partially overlapped, the microneedle forming die 2 comprises a forming die body and a plurality of microneedle forming holes 20 regularly distributed on the forming die body, the microneedle forming holes 20 correspond to the injection holes 10 one by one, and the corresponding microneedle forming holes 20 are coaxial with the injection holes 10; the projection of the exhaust mould 3 and the microneedle forming mould 2 along the mould closing direction is at least partially overlapped, the exhaust mould 3 comprises an exhaust mould 3 body and a plurality of exhaust holes 30 regularly distributed on the exhaust mould 3 body, the exhaust holes 30 correspond to the microneedle forming holes 20 one by one, and the corresponding exhaust holes 30 are coaxial with the microneedle forming holes 20.
In the microneedle forming process, the melted high molecular material is pressed into the microneedle forming hole 20 through the injection hole 10, and air is discharged through the exhaust hole 30 communicated with the microneedle forming hole 20 along with the injection of the melted material, so that the high-quality microneedle without bubbles is obtained. Because the mould does not need to be vacuumized in advance, the process is simple, and the method is suitable for industrial mass production.
Alternatively, the injection mold 1, the microneedle forming mold 2, and the exhaust mold 3 may be made of metal, and the injection hole 10, the microneedle forming hole 20, and the exhaust hole 30 may be processed by picosecond laser, femtosecond laser, and cutting.
Fig. 3 is a schematic diagram of a high molecular microneedle preparation mold provided in an embodiment of the present invention after mold assembly. As shown in fig. 3, in some embodiments, the injection hole 10 and the exhaust hole 30 are both cylinders, the microneedle molding hole 20 is an inverted truncated cone, the bottom surface of the injection hole 10 has the same shape as the top surface of the microneedle molding hole 20, and the top surface of the exhaust hole 30 has the same shape as the bottom surface of the microneedle molding hole 20.
Optionally, the bottom surface of the injection hole 10 and the top surface of the exhaust hole 30 are both circular, so that the microneedle defect caused by accumulation of air at corners and difficulty in exhausting can be avoided.
Specifically, the following relationship exists between the diameter b of the injection hole 10 and the diameter a of the exhaust hole 30: a is 0.03-0.06 b; the diameter b of the injection orifice 10 and the height h of the inverted truncated cone have the following relationship: b is 0.63-0.83 h.
Satisfying the above conditions, the microneedle molding hole 20 can have a proper taper, so that the melted material can fill the cavity of the microneedle molding hole 20 at a proper speed, thereby facilitating the air discharge.
The application also discloses a preparation method of the high-molecular microneedle, which is suitable for the high-molecular microneedle preparation mould. The method comprises the following steps:
step S1: preheating the material injection mold 1, the microneedle forming mold 2 and the exhaust mold 3;
step S2: the microneedle forming die 2 and the exhaust die 3 are matched;
step S3: and placing the substrate 4 between the injection mold 1 and the microneedle forming mold 2, and closing the injection mold 1 and the microneedle forming mold 2.
Step S4: injecting the melted high molecular material into the microneedle forming hole 20 and the exhaust hole 30 of the microneedle forming die 2 through the injection hole 10 of the injection die 1, and stopping injecting the melted high molecular material after the microneedle forming hole 20 is filled with the melted high molecular material.
By placing the substrate 4 between the injection mold 1 and the microneedle forming mold 2 in advance, in the process that the melted microneedle material is pressed into the microneedle forming hole 20 through the substrate 4, the temperature of the melted material can be utilized to soften a partial region of the substrate 4, so that the microneedle material and the substrate material are fused, and the microneedle main body is firmly formed on the substrate 4.
Fig. 4 is a structural diagram of a polymer microneedle molded in an embodiment of the present invention, and as shown in fig. 4, the melt and the substrate material are fused, and the microneedle body 5 molded in the present invention is tightly combined with the substrate 4, so that the array is beautiful, and is suitable for the injection molding preparation of the microneedle in an industrial scale.
Optionally, the substrate has a thickness of 1um to 2000 um. The substrate can be one or a combination of more of general plastic, engineering plastic film and fiber cloth, and the selection range of the substrate material is wider due to no limitation of microneedle materials, so that flexible substrate microneedle arrays and hard substrate microneedle arrays can be manufactured.
Alternatively, as shown in fig. 3, in some embodiments, for a substrate material with a lower melting point or a thinner melting point, the substrate 4 may be melted directly by the temperature of the melt, and the melt is pressed into the microneedle forming hole 20 through the substrate 4 for forming, so that the melt and the substrate material are better fused.
In other embodiments, openings may be made in substrate 4 for substrate materials having higher or thicker melting points, as shown in FIG. 4. Specifically, a plurality of through holes are arranged on the substrate 4, the through holes are arranged corresponding to the microneedle forming holes 20, and the diameter c of each through hole is 0.75-0.85 b, so that the edge of each through hole on the substrate 4 is wrapped and softened by the molten material, and the firmness of the microneedles on the substrate is further improved.
Optionally, the microneedle material is a polymer material, and the polymer material includes one or more of PLA, PC, PA, PMMA, PP, LCP, POM, PEEK, PPs, PHA, PCL, PEAT, PBS, ABS, PVC, PCTA, PCTG, PEI, PES, PPA, PPE, PPO, PPs, hyaluronic acid, and the like.
Optionally, the following relationship exists between the height h of the inverted frustum and the minimum spacing d between the injection holes 10: d is 1.35-1.45 h, so that the substrate warping caused by the concentrated melting of all substrates by the temperature of the molten material can be avoided on the premise of ensuring the efficiency.
The following embodiments are specifically described below.
Example 1
And sequentially closing the material injection mold, the silk fiber cloth, the microneedle forming mold and the air hole mold. And (3) baking the POM-K in a beaker at 100 ℃ for 3h in a material baking machine, and vacuumizing to remove air in the molten material. And then melting the POM-K, uniformly injecting the POM-K from the injection mold, stopping injecting the molten POM-K after the microneedle molding holes are filled with the molten POM-K, removing the injection mold and the pore mold, cooling and demolding to obtain the POM-K microneedle array with the flexible substrate.
Example 2
And sequentially closing the injection mold, the PET porous film with the thickness of 0.1mm, the microneedle forming mold and the air hole mold. Putting commercially available PC into a drying machine, drying the material for 4h at 120 ℃, vacuumizing to remove air in the molten material, melting the PC at 320 ℃, then uniformly injecting the molten material into an injection mold, stopping injecting the molten PC after the microneedle molding holes are filled with the molten PC, removing the injection mold and the air hole mold after removing the injected material and cooling, and then demolding to obtain the P0M-K microneedle array with the flexible substrate.
Example 3
And sequentially closing the material injection mold, the nylon cloth with the thickness of 0.01mm, the microneedle forming mold and the air hole mold. Putting commercially available PLA into a material drying machine, drying the material for 2h at the temperature of 100 ℃, then melting the material at the temperature of 160 ℃, uniformly injecting molten material from a material injection mold, stopping injecting the material when the material is injected from air holes, then removing the material injection mold, removing the air hole mold after cooling, and then demolding to obtain the PLA microneedle array with the flexible substrate.
Example 4
And sequentially closing the material injection mold, the 0.05 mm-thick non-porous PC mold, the microneedle forming mold and the air hole mold. Placing the modified PCL in a material baking machine, baking the material for 30min at 100 ℃, then melting, vacuumizing and removing the melt. And then uniformly injecting the molten PCL from the injection mold, stopping injecting the molten PCL after the microneedle molding holes are filled with the molten PCL, then removing the injection mold and the gas hole mold, and cooling and demolding to obtain the PCL microneedle array with the flexible substrate.
And sequentially closing the material injection mold, the nylon cloth with the thickness of 0.01mm, the microneedle forming mold and the air hole mold. Placing the PCL and the mold in a material baking machine for 30min at 50 ℃, placing the PCL and the mold in a vacuum oven for heating for 8min at 100 ℃, pouring the molten PCL into a preheated mold forming part (a mold blocking part is arranged below the mold forming part), then placing the material without the mold in the vacuum oven, vacuumizing and heating for 10min at 100 ℃, replacing the mold blocking part into a mold gas layer part after cooling, then injecting high-pressure air from the mold gas layer part, and demolding to obtain the PCL microneedle array.
Comparison of results
The local parts of the facial mask in the four groups of examples were randomly selected and subjected to rat in-vitro skin puncture experiments (after the rat in-vitro skin puncture, methyl blue was used for penetration, and whether residual methyl blue remained in the punctured micropores was observed), and the experimental results are shown in the following fig. 2-4 and the following table.
Rat in vitro skin puncture experiment
The test results showed that each microneedle array in the four examples had a very good skin-breaking effect, and no broken microneedle residue remained in the rat skin. Meanwhile, in the embodiment, the microneedle array is good, and the microneedle is sharp.
While preferred embodiments of the present invention have been described, additional variations and modifications in those embodiments may occur to those skilled in the art once they learn of the basic inventive concepts. Therefore, it is intended that the appended claims be interpreted as including preferred embodiments and all such alterations and modifications as fall within the scope of the invention.
It will be apparent to those skilled in the art that various changes and modifications may be made in the present invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.
Claims (10)
1. A mold for preparing a polymer microneedle, comprising:
the injection mould comprises an injection mould body and a plurality of injection holes regularly distributed on the injection mould body, and the axial direction of each injection hole is consistent with the mould closing direction of the high-molecular microneedle preparation mould;
the microneedle forming die is at least partially overlapped with the projection of the injection die along the die closing direction of the die and comprises a forming die body and a plurality of microneedle forming holes regularly distributed on the forming die body, the microneedle forming holes correspond to the injection holes one by one, and the corresponding microneedle forming holes are coaxial with the injection holes; and the number of the first and second groups,
the exhaust mould and the microneedle forming mould are at least partially overlapped along the projection of the mould closing direction, the exhaust mould comprises an exhaust mould body and a plurality of exhaust holes regularly distributed on the exhaust mould body, the exhaust holes correspond to the microneedle forming holes one by one, and the corresponding exhaust holes are coaxial with the microneedle forming holes.
2. The mold for preparing a polymer microneedle according to claim 1, wherein the injection hole and the exhaust hole are both cylinders, the microneedle molding hole is an inverted truncated cone, the bottom surface of the injection hole has the same shape as the top surface of the microneedle molding hole, and the top surface of the exhaust hole has the same shape as the bottom surface of the microneedle molding hole.
3. A mold for preparing a polymer microneedle according to claim 2, wherein the bottom surface of the injection hole and the top surface of the air vent are both circular, and the diameter b of the injection hole and the diameter a of the air vent have the following relationship:
a＝0.03～0.06b；
the diameter b of the injection hole and the height h of the inverted truncated cone have the following relationship:
b＝0.63～0.83h。
4. the mold for preparing a polymer microneedle according to any one of claims 1 to 3, wherein the injection mold, the microneedle forming mold and the air vent mold are made of a metal material, and the injection hole, the microneedle forming hole and the air vent hole are formed by picosecond laser, femtosecond laser and cutting.
5. A method for preparing a polymer microneedle, which is suitable for the polymer microneedle preparation mold according to claims 1-4, and comprises the following steps:
step S1: preheating the injection mold, the microneedle forming mold and the exhaust mold;
step S2: the microneedle forming die and the exhaust die are matched;
step S3: placing a substrate between the injection mold and the microneedle forming mold, and closing the injection mold and the microneedle forming mold;
step S4: and injecting the molten high polymer material into the microneedle forming hole and the exhaust hole of the microneedle forming die through the injection hole of the injection die, and stopping injecting the molten high polymer material after the microneedle forming hole is filled with the molten high polymer material.
6. The method of claim 5, wherein the substrate has a thickness of 1um to 2000 um.
7. The method of claim 5, wherein the substrate is one or more of general purpose plastic, engineering plastic film, and fiber cloth.
8. The manufacturing method according to any one of claims 5 to 7, wherein a plurality of through holes are arranged on the substrate, the through holes are arranged corresponding to the microneedle molding holes, and the diameter c of each through hole is 0.75-0.85 b.
9. The method according to any one of claims 5 to 7, wherein the polymer material comprises one or more of PLA, PC, PA, PMMA, PP, LCP, POM, PEEK, PPS, PHA, PCL, PEAT, PBS, ABS, PVC, PCTA, PCTG, PEI, PES, PPA, PPE, PPO, PPS, hyaluronic acid, and the like.
10. The preparation method according to any one of claims 5 to 7, wherein the following relationship exists between the height h of the inverted truncated cone and the minimum distance d between the injection holes: d is 1.35-1.45 h.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115137964A (en) * | 2022-05-31 | 2022-10-04 | 优微（珠海）生物科技有限公司 | Microneedle preparation mold, microneedle preparation method and microneedle preparation production line |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103895166A (en) * | 2014-04-11 | 2014-07-02 | 昆山市兴凯胜精密模具有限公司 | Automatic dismantling and separating fixture for products |
| CN104117137A (en) * | 2014-07-08 | 2014-10-29 | 清华大学 | Capsule type hollow medicine loading micro-needle array and producing method thereof |
| CN204095067U (en) * | 2014-10-20 | 2015-01-14 | 广东梅雁吉祥水电股份有限公司 | On a kind of caliper, brake pad prepares mould |
| CN105643839A (en) * | 2015-12-24 | 2016-06-08 | 广州新济药业科技有限公司 | Die used for manufacturing microneedle chip and manufacturing method for microneedle chip |
| CN207412507U (en) * | 2017-03-14 | 2018-05-29 | 汉典生物科技（上海）有限公司 | A kind of ultra-fine transdermal micro needle |
| CN108939283A (en) * | 2018-07-16 | 2018-12-07 | 清华大学深圳研究生院 | A kind of microneedle array that human-body safety is degradable and its manufacturing method and mold |
| CN113427706A (en) * | 2021-07-14 | 2021-09-24 | 森心(上海)科技有限公司 | Microneedle module manufacturing equipment and manufacturing method |
-
2021
- 2021-11-10 CN CN202111325285.2A patent/CN114211699A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103895166A (en) * | 2014-04-11 | 2014-07-02 | 昆山市兴凯胜精密模具有限公司 | Automatic dismantling and separating fixture for products |
| CN104117137A (en) * | 2014-07-08 | 2014-10-29 | 清华大学 | Capsule type hollow medicine loading micro-needle array and producing method thereof |
| CN204095067U (en) * | 2014-10-20 | 2015-01-14 | 广东梅雁吉祥水电股份有限公司 | On a kind of caliper, brake pad prepares mould |
| CN105643839A (en) * | 2015-12-24 | 2016-06-08 | 广州新济药业科技有限公司 | Die used for manufacturing microneedle chip and manufacturing method for microneedle chip |
| CN207412507U (en) * | 2017-03-14 | 2018-05-29 | 汉典生物科技（上海）有限公司 | A kind of ultra-fine transdermal micro needle |
| CN108939283A (en) * | 2018-07-16 | 2018-12-07 | 清华大学深圳研究生院 | A kind of microneedle array that human-body safety is degradable and its manufacturing method and mold |
| CN113427706A (en) * | 2021-07-14 | 2021-09-24 | 森心(上海)科技有限公司 | Microneedle module manufacturing equipment and manufacturing method |
Non-Patent Citations (1)
| Title |
|---|
| 文根保编: "《复杂注塑模现代设计》", 金盾出版社, pages: 447 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115137964A (en) * | 2022-05-31 | 2022-10-04 | 优微（珠海）生物科技有限公司 | Microneedle preparation mold, microneedle preparation method and microneedle preparation production line |
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