Mould for manufacturing micro-needle medicine film

Abstract

The utility model provides a mould for manufacturing a microneedle medicine film, which comprises a mould body, the mould body is provided with at least one microneedle filling area, the mould body corresponding to the microneedle filling area is provided with a top surface and a bottom surface, the top surface is provided with a plurality of microneedle holes, the microneedle holes extend towards the bottom surface, and the microneedle holes extend towards the bottom surface. Each micro needle hole comprises a needle seat and a needle tip, the needle seats and the needle tips are sequentially connected in the extending direction of the micro needle holes, and every two adjacent needle seats form a boundary line on the top face. According to the micro-needle medicine film, residues of medicine on the micro-needle medicine film due to the fact that a bearing plane exists on the top face can be reduced to the maximum extent, and therefore the medicine waste degree in the manufacturing process of the micro-needle medicine film is effectively reduced, it can be guaranteed that the medicine with the preset perfusion amount can enter the micro-needle holes to the maximum extent, and the medicine loading capacity and the utilization rate of the medicine are improved.

Description

Technical Field

[0001] The utility model belongs to the technical field of microneedle medicine film manufacturing, and specifically relates to a mold for manufacturing microneedle medicine film. Background Art

[0002] In recent years, microneedles have gained popularity due to their ability to penetrate the skin and deliver active ingredients, and have been widely used in areas including drug delivery, wound healing and beauty. Currently, the production of microneedles requires the use of a silicone negative mold (i.e. a mold made of silicone), which is filled into the needle tip, solidified and demolded to form a microneedle patch (i.e. a microneedle drug film).

[0003] The existing silicone molds are mostly constructed with multiple microneedle holes on their plane, and then the corresponding liquid is filled into each microneedle hole and dried to form the final microneedle drug film. The aforementioned liquid can be a medicine, a beauty medicine, or of course other medicines that can be applied by microneedle release.

[0004] There are two main ways to use the silicone mold in the existing technology for liquid filling:

[0005] One method is to scrape the surface after filling to remove excess liquid on the plane and only keep the liquid at the needle tip. The problems with this method are: the liquid removed from the surface will be wasted, and the actual effective utilization rate is less than 30%; the loading capacity of the needle tip is limited, and this method results in a very low loading capacity of the last microneedle patch. When a patch with a large loading capacity is required, either the mold size is enlarged or multiple patches are used at a time;

[0006] The other method is overfilling, where the needle tip is integrated with the bottom platform, as shown in the figure below. This method will waste a lot of medicine and is not suitable for products such as precious medicines. Utility Model Content

[0007] Therefore, the utility model provides a mold for manufacturing microneedle drug film, which can solve the technical problem in the prior art that the mold with multiple microneedle holes has a planar structure at the microneedle hole opening, resulting in drug residue on it, thereby causing inaccurate (even insufficient) actual drug filling amount or large drug waste.

[0008] In order to solve the above problems, the utility model provides a mold for manufacturing a microneedle medicine film, comprising:

[0009] A mold body, wherein the mold body has at least one microneedle perfusion area, and the mold body corresponding to the microneedle perfusion area has a top surface and a bottom surface, wherein a plurality of microneedle holes are constructed on the top surface, and the microneedle holes extend toward the bottom surface, and each of the microneedle holes comprises a needle seat and a needle tip, wherein the needle seat and the needle tip are sequentially connected and arranged along the extension direction of the microneedle hole, and two adjacent needle seats form a boundary line on the top surface.

[0010] In some embodiments,

[0011] The boundary line is concave toward one side of the bottom surface to form a drainage gap between two adjacent needle seats.

[0012] In some embodiments,

[0013] The boundary line is a concave arc line.

[0014] In some embodiments,

[0015] The mold body has a first side surface and a second side surface that are arranged opposite to each other, wherein the second side surface is coplanar with the bottom surface, and the first side surface is higher than the top surface, so as to form a membrane molding groove at a position corresponding to the first side surface and the top surface, and there are multiple microneedle perfusion areas, and the multiple microneedle perfusion areas are all constructed on the first side surface.

[0016] In some embodiments,

[0017] The height difference between the first side surface and the top surface is d, and d is not greater than the film thickness of the microneedle drug film to be manufactured.

[0018] In some embodiments,

[0019] The needle seat is in the shape of a truncated cone, and the included angle between the generatrix of the truncated cone and the axis is a, 20°≤a≤30°.

[0020] In some embodiments,

[0021] The needle tip is conical, and the angle between the generatrix of the cone and the axis is b, 2.5°≤b≤15°; and / or the height of the cone is h, 0.3mm≤h≤1mm.

[0022] The utility model provides a mold for manufacturing a microneedle medicine film, which has the following beneficial effects:

[0023] The needle seats of any two adjacent microneedle holes respectively form a boundary line on the top surface, which can minimize the top surface bearing area in the microneedle perfusion area, so that when the medicine is perfused into the microneedle perfusion area, the residue of the medicine on it due to the existence of the bearing plane on the top surface can be minimized, thereby effectively reducing the degree of medicine waste in the manufacturing process of the microneedle drug film, and thus ensuring that the preset perfusion amount of medicine can enter the microneedle hole in the maximum amount, thereby improving the drug loading and utilization rate of the medicine. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the implementation of the utility model or the technical solution in the prior art, the following is a brief introduction to the drawings required for the implementation or the prior art description. Obviously, the drawings in the following description are only exemplary, and for ordinary technicians in this field, other implementation drawings can be derived from the provided drawings without creative work.

[0025] The structures, proportions, sizes, etc. illustrated in this specification are only used to match the contents disclosed in the specification so as to facilitate understanding and reading by persons familiar with the technology. They are not used to limit the conditions under which the present invention can be implemented, and therefore have no substantial technical significance. Any structural modification, change in proportion or adjustment of size shall still fall within the scope of the technical contents disclosed in the present invention without affecting the effects and purposes that can be achieved by the present invention.

[0026] Figure 1 This is a schematic structural diagram (top view) of a mold for manufacturing a microneedle drug film according to an embodiment of the present utility model;

[0027] Figure 2 for Figure 1 Schematic diagram of the cross section of AA;

[0028] Figure 3 for Figure 2 A partial enlarged view of the

[0029] Figure 4 This is a state diagram of the microneedle perfusion area of ​​the mold of the embodiment of the utility model after the first agent (indicated by black solid in the figure) is perfused and before drying. It can be seen from the figure that the first agent only covers the area where the microneedle holes are distributed;

[0030] Figure 5 for Figure 4 The state diagram of the first agent in the mold after drying shows that the first agent is only at the needle tip position after drying;

[0031] Figure 6 It is a three-dimensional schematic diagram (partial) of a mold according to an embodiment of the utility model.

[0032] The reference numerals are as follows:

[0033] 1. Mold body; 11. Micro-needle hole; 12. Boundary line; 2. Drainage notch; 3. Diaphragm molding groove. DETAILED DESCRIPTION

[0034] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are only part of the embodiments of the utility model, not all of the embodiments. The following description of at least one exemplary embodiment is actually only illustrative and is by no means a limitation on the utility model and its application or use. Based on the embodiments in the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0035] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0036] It should be understood that the term "and / or" used in this article is only a description of the association relationship of associated objects, indicating that there can be three relationships. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. In addition, the character " / " in this article generally indicates that the associated objects before and after are in an "or" relationship.

[0037] Unless otherwise specifically stated, the relative arrangement, numerical expressions and numerical values ​​of the parts and steps described in these embodiments do not limit the scope of the utility model. At the same time, it should be understood that, for ease of description, the sizes of the various parts shown in the accompanying drawings are not drawn according to the actual proportional relationship. The technology, methods and equipment known to ordinary technicians in the relevant field may not be discussed in detail, but in appropriate cases, the technology, methods and equipment should be regarded as a part of the authorization specification. In all examples shown and discussed here, any specific value should be interpreted as merely exemplary, rather than as a limitation. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters represent similar items in the following drawings, so once a certain item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0038] In the description of the present utility model, it needs to be understood that the directions or positional relationships indicated by directional words such as "front, back, up, down, left, right", "lateral, vertical, perpendicular, horizontal" and "top, bottom" are usually based on the directions or positional relationships shown in the drawings, and are only for the convenience of describing the present utility model and simplifying the description. Unless otherwise specified, these directional words do not indicate or imply that the device or element referred to must have a specific direction or be constructed and operated in a specific direction, and therefore cannot be understood as limiting the scope of protection of the present utility model; the directional words "inside and outside" refer to the inside and outside relative to the contours of each component itself.

[0039] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used here to describe the spatial positional relationship between a device or feature and other devices or features as shown in the figure. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figure. For example, if the device in the accompanying drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below other devices or structures". Thus, the exemplary term "above" may include both "above" and "below". The device may also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used here are interpreted accordingly.

[0040] In addition, it should be noted that the use of terms such as "first" and "second" to limit components is only for the convenience of distinguishing the corresponding components. If not otherwise stated, the above terms have no special meaning and therefore cannot be understood as limiting the scope of protection of the utility model.

[0041] See also Figures 1 to 6 As shown, according to an embodiment of the utility model, a mold for manufacturing a microneedle drug film is provided, comprising:

[0042] The mold body 1 (made of silicone), the mold body 1 has at least one microneedle perfusion area (not labeled in the figure), the mold body 1 corresponding to the microneedle perfusion area has a top surface and a bottom surface, and a plurality of microneedle holes 11 are constructed on the top surface. It can be understood that the aforementioned microneedle hole 11 is a blind hole structure with a larger top (top) and a smaller bottom (bottom), and the microneedle hole 11 extends to the bottom surface. Each of the microneedle holes 11 includes a needle seat (not labeled in the figure) and a needle tip (not labeled in the figure), and the needle seat and the needle tip are sequentially connected and arranged along the extension direction of the microneedle hole 11. A boundary line 12 is formed between two adjacent needle seats on the top surface. It can be understood that the top of the needle seat is an open structure, and the filling agent enters the microneedle hole 11 through the opening structure. In a specific embodiment, the aforementioned mold is a silicone mold, which has a certain air permeability so that the liquid in the microneedle hole 11 can be defoamed by a corresponding vacuum device.

[0043] In this technical solution, the needle seats of any two adjacent microneedle holes 11 respectively form a boundary line 12 on the top surface, which can minimize the top surface bearing area in the microneedle perfusion area, so that when the drug is perfused into the microneedle perfusion area, the drug residue on the top surface due to the presence of the bearing plane can be minimized, thereby effectively reducing the waste of drugs in the manufacturing process of the microneedle drug film, thereby ensuring that the preset perfusion amount of drugs can enter the microneedle hole 11 in the largest amount, thereby improving the drug loading and utilization rate of the drugs. It is worth noting that there is a bearing platform between the orifices of the microneedle holes in the prior art. The existence of this platform, on the one hand, causes the drug to be retained and cannot enter the microneedle hole more completely, resulting in the drug loading of the drug failing to reach the expected design value, or more drug needs to be perfused to reach the design value, resulting in drug waste; on the other hand, the drug residue on the aforementioned platform is also easy to hinder the downward movement of the drugs covering the orifices of each microneedle hole in the subsequent drying process, further causing drug waste and insufficient drug loading on the needle tip.

[0044] In a preferred embodiment, the boundary line 12 is concave toward one side of the bottom surface to form a drainage gap 2 between two adjacent needle seats. In this technical solution, the drainage gap 2 between two adjacent needle seats is formed by the depression of the boundary line 12, so that each microneedle hole 11 in the drug infusion area is connected below the top surface through the aforementioned drainage gap 2, which enables the infused drug to be more reliably and stably gathered in the microneedle infusion area, and also enables the drug to flow at a position below the top surface, further improving the utilization rate of the drug and the drug loading capacity of each microneedle hole 11.

[0045] As a preferred embodiment, the boundary line 12 is a concave arc, and the smoothly extended arc can reduce the obstruction to the flow of the drug, ensuring the smooth flow of the drug and facilitating the uniformity of the infusion amount in each microneedle hole 11.

[0046] In a preferred embodiment, a flange is arranged at the outer edge of the microneedle perfusion area, that is, the flange is arranged around the microneedle perfusion area and is integrally formed on the top surface. This flange area is mainly used to form a base layer, which serves as the bottom surface of the microneedle patch and the microneedle needle seat is fixed thereon. The base layer can effectively fix the needle seat and the needle tip, and can enhance the strength of the diaphragm of the microneedle film. In order to reduce the adverse effect on the strength of the diaphragm of the microneedle film, the height of the aforementioned flange is theoretically not more than 20% of the thickness of the diaphragm.

[0047] Furthermore, this structure is particularly suitable for the production of multi-layer microneedles. In order to ensure the accuracy of the introduction and dosage of the drug, the liquid containing the drug is only filled in the area with the needle, that is, in the range surrounded by the aforementioned flange, and after drying, it is only in the needle tip part. After the liquid containing the drug is dried, the liquid without the drug is filled, and the filling area is the film forming groove 3 described below, and finally dried to form a microneedle drug film.

[0048] The mold body 1 has a first side surface and a second side surface that are relatively arranged, wherein the second side surface is coplanar with the bottom surface, that is, it can be understood that the bottom surface and the second side surface are the same side surface of the mold body 1, and the first side surface is higher than the top surface, so as to form a diaphragm forming groove 3 at the position corresponding to the first side surface and the top surface. After the drug is completely filled and dried, the diaphragm of the microneedle drug film will be formed in the aforementioned diaphragm forming groove 3, and there are multiple microneedle perfusion areas, and the multiple microneedle perfusion areas are all constructed on the first side surface.

[0049] In this technical solution, a plurality of the aforementioned microneedle perfusion areas are provided on the same mold body 1, which is beneficial to the batch production of microneedle drug films and effectively improves the manufacturing efficiency thereof.

[0050] The height difference between the first side surface and the top surface is d, and d is not greater than the thickness of the diaphragm of the microneedle drug film to be manufactured. It can be understood that the aforementioned height difference is also the groove depth of the aforementioned diaphragm forming groove 3, and the aforementioned diaphragm thickness refers to the thickness of the microneedle drug film after it is manufactured. In this technical solution, the height difference d is not greater than the thickness of the diaphragm, that is, after the microneedle drug film is dried and formed, the diaphragm of the microneedle drug film will not be lower than the diaphragm forming groove 3, which can facilitate the subsequent separation of the microneedle drug film from the mold body 1. In a specific embodiment, d is 0.1mm-0.5mm.

[0051] The structure of the aforementioned microneedle hole 11 can be various, for example, it can be an overall pyramidal shape, a cone shape, a pyramid shape, etc. The shape of the needle seat and the needle tip can be the same or different, for example, the needle seat can be a frustum shape, and the needle tip can be a cone shape, a pyramid shape, etc.

[0052] In order to facilitate the manufacture of the mold, in a preferred embodiment, the needle seat is in the shape of a truncated cone, the needle tip is in the shape of a cone, and the angle between the generatrix of the truncated cone and its axis is a, and the angle between the generatrix of the cone and the axis is b, a>b, so that the microneedle hole 11 is an expanded structure, which can ensure that the needle tip can be filled with a sufficient drug load at a single time, and at the same time can ensure that the needle tip can more smoothly penetrate the target position of the human skin.

[0053] In a preferred embodiment, 20°≤a≤30°. Such a design can prevent the angle from being less than 20°, which may cause the needle seat to pierce the skin together with the needle tip, causing the needle tip to enter the wrong position and causing adverse reactions such as stinging and bleeding. When the angle is greater than 30°, it may affect the flow of the medicine and cause residual medicine on the surface of the needle seat.

[0054] For the needle tip, it is preferably 2.5°≤b≤15°, the height of the cone is h, 0.3mm≤h≤1mm. It has been verified through experiments that when the b value is less than 2.5°, the needle tip is prone to breakage, while when it is higher than 15°, the needle tip is too large, making it difficult to pierce the skin, causing pain and causing strong discomfort to the user. The needle tip height is between 0.3-1mm because when the h value is less than 0.3mm, it may not be able to pierce the stratum corneum and fail to meet the requirements of drug introduction. When it is higher than 1mm, the skin will be completely pierced, causing significant pain or bleeding.

[0055] According to an embodiment of the utility model, a method for manufacturing a microneedle drug film is also provided, which is carried out using the above-mentioned mold to manufacture a microneedle drug film having a single-layer drug. The aforementioned single-layer drug refers to a microneedle drug film that contains only one layer of drug component, and the microneedles and the membrane connecting each microneedle have the same drug component. In this case, the method for manufacturing a microneedle drug film includes the following steps:

[0056] Filling a preset amount of medicine into each of the microneedle perfusion areas, and filling the membrane forming groove 3 with the medicine, the preset amount should ensure that a membrane of a microneedle medicine film is formed in the membrane forming groove 3 after the medicine is dried;

[0057] Placing the mold filled with the medicine in a drying device (e.g., a drying box) for drying;

[0058] The microneedle drug film formed after drying is demolded, for example, a hydrogel sheet can be pasted on the top surface of the film to remove the microneedle drug film from the mold.

[0059] In this technical solution, after the medicine is filled so as to fill the membrane forming groove 3, the medicine can flow into each microneedle hole 11 in the aforementioned microneedle perfusion area, and the medicine in the membrane forming groove 3 partially enters each microneedle hole 11, and the remaining part in the membrane forming groove 3 forms a membrane after drying.

[0060] According to an embodiment of the present invention, a method for manufacturing a microneedle drug film is also provided, which is carried out using the above-mentioned mold to manufacture a microneedle drug film having at least two drugs, comprising the following steps:

[0061] A first preset amount of the first medicament is filled into each of the microneedle perfusion areas, and the first medicament is controlled to cover only the area where each of the microneedle holes 11 is distributed. For example, when a circle of flanges is provided at the outer edge of the microneedle perfusion area, the area where the aforementioned microneedle holes 11 are distributed is also the space surrounded by the flanges. When the aforementioned flanges are not provided on the mold body 1, the area where the aforementioned microneedle holes 11 are distributed is also the area surrounded by the outer edge of the needle seat of the microneedle hole 11 at the outermost edge of all the microneedle holes 11 in the microneedle perfusion area. At this time, see Figure 4 In the state shown, it can be understood that the first preset amount at this time should be sufficient to completely enter each microneedle hole 11 after the first agent is dried, that is, there is no residual amount of the first agent on the top surface in theory;

[0062] The mold filled with the first drug is placed in a drying device for drying, and the first drug after drying will all enter each micro-needle hole 11 and be located at the needle tip position of the micro-needle hole 11;

[0063] Afterwards, a second preset amount of the second agent is filled into each of the microneedle injection areas of the mold having the dried first agent, and the second agent is controlled to fill the membrane forming groove 3. At this time, the second preset amount should be sufficient to ensure that part of the second agent is in each microneedle hole 11 and outside the upper area of ​​the first agent after drying, and the remaining second agent is in the membrane forming groove 3 to form a membrane;

[0064] placing the mold filled with the second drug in a drying device again for drying, thereby completing the overall manufacturing of the microneedle drug film;

[0065] The microneedle drug film formed after drying is demoulded.

[0066] This technical solution is especially used when accurate control of drug loading is required or the first drug is relatively expensive. Selecting at least two drugs in an upper and lower layer to manufacture the microneedle drug film can greatly reduce the manufacturing cost. At the same time, a more accurate drug loading can better meet the treatment conditions.

[0067] When the number of drugs to be manufactured for the microneedle drug film is three or more, before filling the second drug and after drying the first drug, the process further includes: filling and drying various drugs in sequence according to the order of filling the microneedle drugs to form a microneedle drug film with multiple different drug layers. The specific drugs used in each layer are selected according to different application conditions, and each layer of drugs undergoes the process steps of filling and drying, which is similar to the formation process of the first drug, and will not be repeated here.

[0068] Under some working conditions, there are different requirements for the drug loading amount of the microneedle holes 11 in different areas. In order to meet this working condition, during the drug filling process, the corresponding filling equipment is controlled to fill the same microneedle perfusion zone with the corresponding drug. For example, the central area of ​​the microneedle perfusion zone is perfused with one filling amount, and the outer edge area is perfused with another different perfusion amount.

[0069] The above is only a preferred embodiment of the utility model, and is not intended to limit the utility model. Any modifications, equivalent replacements and improvements made within the spirit and principles of the utility model should be included in the protection scope of the utility model. The above is only a preferred implementation of the utility model. It should be pointed out that for ordinary technicians in this technical field, several improvements and variations can be made without departing from the technical principles of the utility model, and these improvements and variations should also be regarded as the protection scope of the utility model.

Claims

1. A mold for making a microneedle drug film, It is characterized in that include: A mold body (1), wherein the mold body (1) has at least one microneedle perfusion area, and the mold body (1) corresponding to the microneedle perfusion area has a top surface and a bottom surface, wherein a plurality of microneedle holes (11) are constructed on the top surface, and the microneedle holes (11) extend toward the bottom surface, and each of the microneedle holes (11) comprises a needle seat and a needle tip, wherein the needle seat and the needle tip are sequentially connected and arranged along the extension direction of the microneedle hole (11), and two adjacent needle seats form a boundary line (12) on the top surface.

2. The mold according to claim 1, It is characterized in that The boundary line (12) is concave toward one side of the bottom surface to form a drainage gap (2) between two adjacent needle seats.

3. The mold according to claim 1 or 2, It is characterized in that The boundary line (12) is a concave arc line.

4. The mold according to claim 1, It is characterized in that The mold body (1) has a first side surface and a second side surface that are arranged opposite to each other, wherein the second side surface is coplanar with the bottom surface, and the first side surface is higher than the top surface, so as to form a membrane forming groove (3) at a position corresponding to the first side surface and the top surface, and there are multiple microneedle perfusion areas, and the multiple microneedle perfusion areas are all constructed on the first side surface.

5. The mold according to claim 4, It is characterized in that The height difference between the first side surface and the top surface is d, and d is not greater than the film thickness of the microneedle drug film to be manufactured.

6. The mold according to claim 1, It is characterized in that The needle seat is in the shape of a truncated cone, and the included angle between the generatrix of the truncated cone and the axis is a, 20°≤a≤30°.

7. The mold according to claim 1, It is characterized in that The needle tip is conical, and the included angle between the generatrix of the cone and the axis is b, 2.5°≤b≤15°.

8. The mold according to claim 1, It is characterized in that The needle tip is conical, the height of the cone is h, and 0.3mm≤h≤1mm.

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