TWI786637B - Drug-containing microneedle patch with exposed needle tip and its preparation method - Google Patents

Abstract

The present invention relates to a drug-containing microneedle patch with exposed needle tips and its preparation method. The drug-containing microneedle patch at least includes a substrate, at least one microneedle and a drug for transdermal delivery, wherein the microneedle is composed of the substrate The bottom surface is extended downwards, and one of the microneedle tips is conical, and the drug for transdermal delivery is only coated on the outer peripheral edge of one of the microneedle needle bodies, so as to expose the needle tip. Also, the drug-containing microneedle patch can be made by performing a filling operation and an insertion operation, and the needle body is located in the chamber to be covered by the transdermally delivered drug, thereby forming a Medicated microneedle patch. In this way, the present invention not only provides a drug-containing microneedle patch that increases the puncture success rate, but also provides a method for preparing the drug-containing microneedle patch to improve the quality of the product.

Description

Drug-containing microneedle patch with exposed needle tip and its preparation method

The present invention relates to a microneedle patch, especially a drug-containing microneedle patch whose needle body is provided with transdermal drug delivery, but the needle tip does not have a drug-containing microneedle patch structure for transdermal drug delivery, and is used to form the aforementioned A method for making a drug-containing microneedle patch.

According to research, the transdermal drug delivery system (TDDS) is a new drug delivery route. In 1998, Mark Prausnitz used silicon to make microneedle patches (microneedle patches, MNP), and activated cells with calcein. Staining with light dye (Calcein AM) confirmed that the microneedle patch can be used for drug delivery. Microneedle patch can be used as a drug carrier, and it can be used in a wide range of applications, including daily drug administration and beauty care. Among them, microneedle patch can be divided into solid microneedles, coated microneedles, hollow Type microneedles and dissolvable microneedles and other types, solid microneedles are made of microchannels in the stratum corneum and then coated with drugs, so that the drugs can enter the skin through the microchannels; coated microneedles are coated on the surface of microneedles Drugs, after the microneedles puncture the stratum corneum, the drugs can diffuse in the skin; the hollow microneedles are similar to traditional injections, the drugs can be contained in the microneedles, and the drugs can be pushed into the skin by injection to diffuse; Dissolving microneedles are made of water-soluble or biodegradable materials, and the drug is placed in the microneedle. The microneedle structure dissolves after puncturing the skin, allowing the drug to be released and diffused. In addition to the above microneedle types, chitosan microneedles are highly biocompatible.

Continuing from the above, microneedle patches can also be used for vaccine administration. Common clinical vaccination methods include oral, subcutaneous, and intramuscular injections. Among them, oral vaccines include rotavirus vaccines, and subcutaneous injections include Japanese encephalitis vaccines. And chickenpox vaccine, intramuscular vaccine types such as influenza vaccine and hepatitis B vaccine. The ideal vaccine refers to the type of vaccine that is easy to inoculate (such as: oral vaccine). The microneedle patch has the advantages of reducing pain and discomfort, small inoculation wounds, and reducing the risk of injection infection. It is expected to become an ideal vaccine after oral vaccines Types of.

Press, the appearance of microneedle (microneedle) can be bullet-shaped, pyramid-shaped, cone-shaped and spike-shaped, and its structure is a structure of micron (μm) level, with a length of about 200 to 2000 μm and a diameter of up to 1 μm. , each microneedle can pierce the stratum corneum with a minimum mechanical strength of 0.058 Newton, and deliver the drug to the epidermis and dermis (that is, transdermal drug delivery), because the microneedle structure is short enough to stimulate the nerve terminal, Therefore, pain can be avoided.

Generally, the drug-containing microneedles (that is, the microneedle patch is already equipped with drugs) are mostly made of water-containing polymers that can carry drugs. The composition of such polymers is made of soft materials, which need to be cast in the form of flexible PDMS molds. Preparation, because this kind of polymer contains water, its mechanical properties are not good, the elastic modulus is usually less than 10 MPa (million Pa), and the yield strength is usually less than 100 MPa. In this way, the mechanical strength of the drug-containing microneedle is not suitable for skin penetration. Due to the limited penetrability, the needle tip is often bent and cannot penetrate the skin during application, so that it cannot be used in subcutaneous injections that require precise dosage. for the requested purpose.

Therefore, how to increase the rigidity of drug-containing microneedles and prevent the needle tip from being easily bent and unable to pierce the epidermis has become the research target of many enterprises. The strength of the needles, but it will introduce biotoxic cross-linking components; the second is to use physical cross-linking methods (for example, several freezing and thawing steps on the microneedles), although the strength of the drug-containing microneedles can be increased by several times, but it is still not enough to achieve the strength required to successfully puncture the skin. In addition, the aforementioned repeated freezing and thawing process is not conducive to mass production of drug-containing microneedles.

The third is to combine the drug-containing microneedle with a hard water-free polymer support base. Generally speaking, in order to avoid deformation of the tip of the conventional drug-containing microneedle, the common ratio between the height of the needle body and the base of the microneedle is 1:1, and at most it will not exceed 3:1. The needle body of the drug microneedle can only penetrate the skin at a depth of less than 300 microns, which does not reach the puncture depth of pain nerves (1000 microns). Although in the third method, the part of the outer periphery of the soft needle tip is added to the structure of the hard support seat to effectively push the drug closer to the vascular plexus, the puncture behavior of the aforementioned structure still relies on the soft needle tip and still There is a possibility that the tip of the needle will be bent and the puncture will not be successful. Therefore, how to effectively solve the aforementioned problems to provide better quality microneedle products is an important subject of the present invention.

In view of the fact that the mechanical strength of the conventional drug-containing microneedle patch still needs to be strengthened, the inventor finally developed a drug-containing microneedle patch with an exposed needle tip of the present invention and its preparation process after repeated research and testing. With the advent of the present invention, the known problems can be effectively solved.

One object of the present invention is to provide a drug-containing microneedle patch with exposed needle tips, the drug-containing microneedle patch includes a substrate, at least one microneedle and a transdermal delivery drug, wherein the microneedle is composed of the The bottom surface of the base body extends downwards, and one tip of the microneedle is tapered, and the drug for transdermal delivery is only coated on the outer peripheral edge of one needle body of the microneedle so as to expose the needle tip.

Optionally, the longitudinal length of the top side of the microneedle to the bottom side forms a microneedle height, the transverse length of the top side of the microneedle forms a microneedle width, and the difference between the microneedle height and the microneedle width The ratio is 1:1 to 12:1.

Optionally, the longitudinal height ratio of the needle tip to the needle body is about 1:4 to 1:10.

Optionally, the elastic modulus of the microneedles ranges from 1 GPa to 7 GPa.

Optionally, the material of the microneedles can be PEEK, PMMA, PC, PLA, ABS, PP, silicone, epoxy resin or other biocompatible thermoplastic or thermosetting polymer materials.

Another object of the present invention is to provide a method for preparing a drug-containing microneedle patch with an exposed needle tip, the method includes performing a filling operation and performing an insertion operation, wherein the filling operation is a transdermal delivery The drug is filled into at least one cavity of a mold, and the cavity is formed by recessing the top surface of the mold downward; the inserting operation is to insert at least one microneedle of a microneedle patch into the corresponding In the cavity, and one tip of the microneedle will pierce the bottom side of the corresponding cavity, and one needle body of the microneedle is located in the cavity to be covered by the transdermal delivery drug, and then A drug-containing microneedle patch can be formed, wherein the microneedle patch includes a base body and the microneedle, the microneedle is formed by extending downward from the bottom surface of the base body, and the needle point is in a cone shape.

Optionally, before performing the inserting operation, a solidification period is waited for so that the transdermally delivered drug is in a semi-hardened state.

Optionally, after the needle point pierces the bottom side of the corresponding chamber, there will be a waiting period until the transdermal drug is fixed on the needle to form the drug-containing microneedle patch.

Optionally, at least the inner bottom surface of the cavity of the mold is made of silicone.

Another object of the present invention is to provide a method for preparing a drug-containing microneedle patch with exposed needle tips, which includes performing an inserting operation and a filling operation, wherein the inserting operation is to apply a microneedle patch At least one microneedle of the sheet extends into at least one cavity of a mould, so that each cavity accommodates a single microneedle, wherein the microneedle patch includes a base body and the microneedle, the microneedle It is formed by extending downward from the bottom surface of the base body, and one of the tips of the microneedles is tapered; the chamber is divided into an upper chamber part and a lower chamber part, and both the upper chamber part and the lower chamber part The space is connected, one of the needle body of the microneedle can be located in the upper chamber, and the outer surface of the needle body will not touch the inner surface of the upper chamber; the needle tip can be located in the lower chamber, and the needle tip can The outer surface can contact or substantially contact the inner surface of the lower chamber; the filling operation is to fill a transdermal delivery drug into the cavity to form a drug-containing microneedle patch, wherein the transdermal delivery The medicine can flow into the upper chamber to cover the needle body, and the transdermally delivered medicine cannot flow into the lower chamber because it is blocked by the needle tip.

Optionally, after the transdermal drug is filled into the corresponding chamber, there will be a waiting period until the transdermal drug is fixed on the needle to form the drug-containing microneedle patch.

Optionally, the gap between the outer surface of the needle tip and the inner surface of the lower chamber portion is smaller than the particle size of the drug for transdermal delivery.

In order to facilitate your review committee to further understand and understand the purpose, technical features and effects of the present invention, the embodiments are hereby combined with the drawings, and the details are as follows:

In order to make the purpose, technical content and advantages of the present invention more clear, the following will further describe the disclosed embodiments of the present invention in detail with reference to the specific embodiments and with reference to the accompanying drawings. Those skilled in the art can understand the advantages and effects of the present invention from the content disclosed in this specification, and the present invention can be implemented or applied through other different specific embodiments, and the details in this specification can also be based on different viewpoints and applications , various modifications and changes can be made without departing from the concept of the present invention. In addition, it is stated in advance that the drawings of the present invention are only simple schematic illustrations, and are not drawn according to actual dimensions.

It should be understood that the examples used anywhere in the description of the present invention, including the use of any term, are only illustrative and in no way limit the scope and meaning of the present invention or any term. Likewise, the present invention is not limited to various embodiments disclosed in the specification. Although the terms first, second or third, etc. may be used herein to describe various elements, each element should not be limited by the aforementioned terms, which are mainly used to distinguish one element from another element and should not be used for any purpose. The elements impose no substantive limitations and should not limit the order in which the various elements can be assembled or arranged in a practical application. In addition, the directional terms mentioned in the embodiments, such as "upper", "lower", "left", "right", etc., are only referring to the directions of the drawings. Therefore, the directional terms used are for illustration and not for limiting the protection scope of the present invention.

The present invention is a drug-containing microneedle patch with exposed needle points and its preparation method. In one embodiment, please refer to Figures 1 and 2. The drug-containing microneedle patch 1 includes a base 11, at least one microneedle Needle 13 and a transdermal drug delivery 15, for the convenience of explaining the relative relationship between each element, be the upper (top) position of the element as the top of the 2nd figure, the lower (bottom) position of the element as the lower part of the 2nd figure, the 2nd figure The left side of Figure 2 is the left position of the component, and the right side of Figure 2 is the right position of the component. In addition, the appearance of the drug-containing microneedle patch 1 of the present invention is not limited to the pattern drawn in Figure 1, and the industry can adjust the style of each component according to product requirements. Therefore, as long as the drug-containing microneedle patch 1 It has the relevant basic structure and functions of the subsequent embodiments, that is, the drug-containing microneedle patch 1 to be protected by the present invention, and it is stated first.

Referring back to Figures 1 and 2, the substrate 11 can be in the shape of a flat plate, and its bottom surface can extend downward to form each of the microneedles 13, wherein the microneedles 13 can be in a solid shape, and the microneedles 13 can be formed from top to bottom. It includes a needle body 131 and a needle point 133, and at least the needle point 133 can be tapered so as to effectively pierce the skin of the human body. In addition, the transdermal drug 15 can include active pharmaceutical ingredients (Active Pharmaceutical Ingredients, referred to as API) and materials such as hyaluronic acid, chitin, collagen or gelatin that are compatible with the active pharmaceutical ingredients, and can only coat The needle tip 133 is exposed on the outer surface of the needle body 131 of the microneedle 13 to form a drug-containing microneedle. That is to say, the appearance of the drug-containing microneedle of the present invention can form two parts, the first is the "soft drug-containing layer" corresponding to the needle body 131 and the outer edge of the transdermal delivery drug 15, and the second is corresponding to the The "hard puncture part" of the needle point 133, in this way, when the user uses the drug-containing microneedle patch 1, the user can first pierce the stratum corneum of the human skin through the needle point 133, and then allow the transdermal delivery drug 15 to follow The needle shaft 131 enters the skin, so that the transdermal drug 15 can be released and diffused in the skin. In addition, in this embodiment, the base body 11 and the microneedle 13 can be integrally formed, but not limited thereto. In other embodiments of the present invention, the base body 11 and the microneedle 13 It can also be made into independent elements respectively, and then combined into one.

Continuing, please refer to Fig. 1 and 2 again, in order to enable the microneedle 13 to effectively pierce the stratum corneum of the skin, and when piercing the stratum corneum of the skin, it will not lose its effect due to bending (that is, it cannot pierce the skin), after research and experiments by the inventor, the microneedle 13 also has the following two structural features:

(1) The vertical height ratio between the needle point 133 and the needle body 131 can be 1:4 to 1:10, so that the exposed length of the needle point 133 (that is, the "hard puncture part") can be ensured to protrude far beyond the percutaneous Delivery of the drug 15 (i.e., the "soft drug-containing layer") sufficient to preferentially contact and penetrate the stratum corneum of the skin, and then allow the transdermal delivery of the drug 15 into the skin;

(2) The ideal elastic modulus value of the microneedle 13 is 1 GPa (gigapascal) ~ 7GPa, and the ratio of the microneedle height H to the microneedle width W can be 1:1 to 12:1. The microneedle height H of title refers to the longitudinal length from the top side of the microneedle 13 to the bottom side, and the aforementioned microneedle width W refers to the transverse length of the top side of the microneedle 13, so that the microneedle can be 13 When piercing the cuticle of the skin, it will not fail due to bending. Furthermore, if it is hoped that the smallest microneedle 13 can carry the maximum amount of drug, it is more suitable to make the microneedle 13 with a material greater than 3GPa, for example, polyether ether ketone (polyetheretherketone, referred to as PEEK) or Polymethyl methacrylate (polymethyl methacrylate, be called for short PMMA), wherein, PEEK is a kind of biocompatible high temperature resistant engineering plastics, PMMA can be used as the raw material of denture, bone cement, but not limited to this, in other aspects of the present invention In the embodiment, the microneedle 13 can also be made of polycarbonate (PC), polylactic acid (PLA), acrylonitrile butadiene styrene (ABS), polypropylene (PP), silicone, epoxy resin or other Thermoplastic or thermosetting polymer materials with certain biocompatibility.

Referring back to Figures 1 and 2, in order to effectively manufacture the aforementioned drug-containing microneedle patch 1, in particular, ensure that the needle tip 133 can be exposed, and that the transdermal drug 15 can completely cover the Needle body 131, the present invention develops two kinds of manufacturing methods, which are explained one by one as follows. In the first manufacturing method of the present invention, please refer to Figures 3A to 3B and shown in Figure 4. First, in step (301) , to perform a filling operation to fill the percutaneous delivery drug 15 into at least one cavity 20 of a mold 2, wherein the top surface of the mold 2 can be concavely provided with each of the cavities 20 (as shown in the first 3A), the chamber 20 can be conical (but not limited thereto), and the liquid transdermal drug 15 can be injected into the chamber 20 (as shown in Figure 3B); after that, In step (302), it is possible to wait for a coagulation period so that the transdermal drug 15 is in a semi-hardened state, wherein the operator can adjust the length of the coagulation period according to actual needs and the material properties of the transdermal drug 15 , and even omit this step without waiting for the solidification period.

From above, please refer to Figures 3C to 3F and Figure 4 in step (303), perform an insertion operation, move the bottom surface of the base body 11 towards the top surface of the mold 2, so that each of the microneedles 13 Can extend into the corresponding chamber 20 (as shown in Figure 3C), so that only a single microneedle 13 is accommodated in each chamber 20, until the needle tip 133 of the microneedle 13 pierces the corresponding chamber 20 and the needle body 131 of the microneedle 13 can be located in the chamber 20, but will not touch the inner wall of the chamber 20 (as shown in Figure 3D), so that the drug can be delivered transdermally 15 wrapping; then, in step (304), wait for the setting period until the transdermal drug 15 is hardened and fixed to the needle body 131; finally, in step (305), perform a demoulding operation so that the transdermal drug 15 and the microneedle 13 can be separated from the inner wall of the chamber 20 (as shown in FIG. 3E ), and then the needle tip 133 can be exposed to form the drug-containing Microneedle patch 1 (as shown in Figure 3F). In addition, in some embodiments, the mold 2 can be formed by batch casting, and in order for the needle point 133 to penetrate the inner bottom surface of the cavity 20, at least the material hardness of the inner bottom surface of the cavity 20 will be The hardness of the needle tip 133 is smaller than that of the inner bottom surface of the chamber 20 made of silicon rubber, rubber or other materials, for example.

In the second manufacturing method of the present invention, another structure of the mold 4 is adopted, wherein the top surface of the mold 4 is concavely provided with at least one cavity 40, and the cavity 40 is divided into an upper chamber portion 401 With the lower chamber part 402, the space between the upper chamber part 401 and the lower chamber part 402 is connected. Please refer to the 5A to 5B figures and the 6th figure. First, in step (501), the substrate 11 The bottom surface of the bottom surface moves toward the top surface direction of a mold 4, so that each of the microneedles 13 can extend into the corresponding chamber 40 (as shown in Figure 5A), and each chamber 40 only accommodates a single microneedle 13, Until the tip 133 of the microneedle 13 is accommodated in the lower chamber portion 402, and the outer surface of the needle tip 133 can contact or substantially (substantially) contact the inner surface of the lower chamber portion 402 (as shown in FIG. 5B ), The needle shaft 131 can be positioned at the upper chamber portion 401, and the outer surface of the needle shaft 131 will not touch the inner surface of the upper chamber portion 401; in particular, in an ideal state, the needle point 133 The outer surface will be completely attached to the inner surface of the lower chamber part 402 (that is, the aforementioned "contact"), but due to the tolerance or surface unevenness in the manufacturing process of the mold 4, the outer surface of the needle point 133 Surface one may be close to the inner surface of the lower chamber portion 402 (ie, the aforementioned "substantially in contact").

Continuing, please refer to Figures 5C to 5D and Figure 6, in step (502), a filling operation is performed to fill the chamber 40 with the drug 15 for transdermal delivery (as shown in Figure 5C). shown), wherein the transdermal drug 15 can flow into the upper chamber 401 to cover the needle body 131, but the transdermal drug 15 will be blocked by the needle tip 133 and cannot flow into the lower chamber In other words, although the outer surface of the needle tip 133 substantially contacts the inner surface of the lower chamber part 402, the gap between the outer surface of the needle tip 133 and the inner surface of the lower chamber part 402 will be smaller than the inner surface of the lower chamber part 402. Therefore, the transdermal drug 15 still cannot flow into the lower chamber 402 . Afterwards, in step (503), it will wait for the setting period until the transdermal drug 15 is hardened and fixed on the needle body 131; finally, in step (504), a demoulding operation is performed to make the transdermal drug 15 harden and fixed on the needle body 131; Both the drug 15 and the microneedle 13 for transdermal delivery can be separated from the inner wall of the chamber 40 (as shown in FIG. 5D ), and then the needle tip 133 can be exposed to form the drug-containing microneedle patch 1 . In addition, in some embodiments, the mold 4 can adopt an industrial continuous process, and harden the material at a low temperature for injection molding. The material of the mold 4 can be silicone rubber, but not limited thereto.

In addition, in other embodiments, since the transdermal drug 15 is a kind of soft material and has thick characteristics, when the transdermal drug 15 is injected into the upper chamber 401 in a large amount and at one time, it is located in the lower chamber. The air at 402 cannot be discharged to form a space without the transdermal drug 15, so the transdermal drug 15 can only be coated on the outer periphery of the needle body 131, and the needle tip 133 will be exposed. Medicinal microneedle patch 1. Moreover, since the lower chamber portion 402 can be preformed in the mold 4, when the needle point 133 extends downward into the mold 4, the mold 4 or the needle point 133 will not be damaged, and mass production and quality.

To sum up, please refer to Figures 1 and 2, the mechanical strength and puncture success rate of the microneedle 13 can be increased through the drug-containing microneedle patch 1 of the present invention, and the hard needle tip 133 of the microneedle 13 can be used to puncture a part After the stratum corneum of the skin, the soft drug-containing material coated on the needle body 131 of the microneedle 13 can go deep into the epidermal tissue under the stratum corneum together with the microneedle 13 to achieve the effect of drug reaction under the skin. The drug material softens and is absorbed in the skin after a few minutes. When the microneedle 13 is pulled out, the hard part is pulled away, leaving the active drug ingredient in the skin, and the process of delivering the drug by the microneedle 13 is completed, and the drug-containing drug of the present invention The manufacturing method of the microneedle patch 1 can improve the mass production and quality of the product of the microneedle 13, and further contribute to the application of the microneedle patch in the future. According to, the above description is only a preferred embodiment of the present invention, but the scope of rights claimed by the present invention is not limited thereto. According to those who are familiar with the art, according to the technical content disclosed in the present invention, they can The easily conceivable equivalent changes shall all fall within the scope of protection of the present invention.

[knowledge] none [this invention] 1: Drug-containing microneedle patch 11: Matrix 13: Microneedle 131: needle body 133: needle tip 15: Transdermal drug delivery 2, 4: Mold 20, 40: chamber 301~305, 501~504: steps 401: Upper Room 402: lower room H: microneedle height W: microneedle width

[Fig. 1] is a three-dimensional schematic diagram of the drug-containing microneedle patch of the present invention; [Fig. 2] is a partial cross-sectional schematic diagram of the drug-containing microneedle patch of the present invention; [Fig. 3A] is a partial cross-sectional schematic diagram of a mold for a method of preparing a drug-containing microneedle patch of the present invention; [Fig. 3B] is a cross-sectional schematic diagram of adding the drug into the mold for transdermal delivery of the drug-containing microneedle patch of the present invention; [Fig. 3C] is a partial cross-sectional schematic diagram of the microneedle patch extending into the mold in one of the preparation methods of the drug-containing microneedle patch of the present invention; [Picture 3D] is a cross-sectional schematic diagram of the combination of the microneedle patch and the transdermal drug delivery in the mould, which is one of the preparation methods of the drug-containing microneedle patch of the present invention; [Figure 3E] is a cross-sectional schematic diagram of the combination of the microneedle patch and the transdermal drug delivery in one of the preparation methods of the drug-containing microneedle patch of the present invention; [Fig. 3F] is a three-dimensional schematic diagram of forming a drug-containing microneedle patch according to a method for preparing the drug-containing microneedle patch of the present invention; [Fig. 4] is a flow chart of a preparation method of a drug-containing microneedle patch of the present invention; [Fig. 5A] is a partial cross-sectional schematic diagram of the microneedle patch extending into the mold according to another preparation method of the drug-containing microneedle patch of the present invention; [Figure 5B] is a schematic cross-sectional view of the microneedle patch combined with the mold in another preparation method of the drug-containing microneedle patch of the present invention; [Fig. 5C] is another schematic cross-sectional view of adding the drug into the mold for transdermal delivery of the drug-containing microneedle patch of the present invention; [Figure 5D] is a cross-sectional schematic diagram of the combination of the microneedle patch and the transdermal drug delivery in another preparation method of the drug-containing microneedle patch of the present invention; and [Fig. 6] is a flow chart of another preparation method of the drug-containing microneedle patch of the present invention.

11: Matrix 13: Microneedle 131: needle body 133: needle tip 15: Transdermal drug delivery 2: Mold 20: chamber

Claims (7)

A method for manufacturing a drug-containing microneedle patch with exposed needle tips, the method includes the following steps: performing a filling operation, filling a transdermal delivery drug into at least one cavity of a mold, wherein the cavity is formed by the The top surface of the mold is recessed downward; and an inserting operation is performed, at least one microneedle of a microneedle patch is inserted into the corresponding cavity, and one tip of the microneedle will pierce the corresponding On the bottom side of the chamber, a needle body of the microneedle is located in the chamber to be covered by the transdermally delivered drug, thereby forming a drug-containing microneedle patch, wherein the microneedle patch It includes a base body and the microneedle, the microneedle is formed by extending downward from the bottom surface of the base body, and the needle tip is cone-shaped. The preparation method according to claim 1, wherein, before performing the inserting operation, a solidification period is waited for so that the transdermal drug is in a semi-hardened state. The method according to claim 1 or 2, wherein, after the needle point pierces the bottom side of the corresponding chamber, it will wait for a certain period of time until the transdermal drug is fixed on the needle to form the containing Medicine microneedle patch. The manufacturing method according to claim 1, wherein at least the inner bottom surface of the cavity of the mold is made of silica gel. A method for preparing a drug-containing microneedle patch with exposed needle tips, the preparation method comprising the following steps: performing an inserting operation, respectively extending at least one microneedle of a microneedle patch into at least one cavity of a mould, so that each chamber accommodates a single microneedle, wherein the microneedle patch includes a base and the microneedle, the microneedle is formed by extending downward from the bottom of the base, and one tip of the microneedle It is cone-shaped; the chamber is divided into an upper chamber and a lower chamber, the space between the upper chamber and the lower chamber communicates, and one of the needle bodies of the microneedle can be located in the upper chamber, and the outer surface of the needle shaft does not contact the inner surface of the upper chamber; the needle tip can be located on the lower chamber and the outer surface of the needle tip can contact or substantially contact the inner surface of the lower chamber; and performing a filling operation, filling a transdermal drug into the chamber to form a drug-containing microneedle patch, wherein the transdermal drug can flow into the upper chamber to cover the needle body , and the transdermally delivered drug is blocked by the needle tip and cannot flow into the lower chamber. The manufacturing method as described in Claim 5, wherein, after the transdermal delivery drug is filled into the corresponding chamber, it will wait for a certain shaping period until the transdermal delivery drug is fixed on the needle to form the drug-containing microneedle patches. The method of claim 5, wherein the gap between the outer surface of the needle tip and the inner surface of the lower chamber is smaller than the particle size of the drug for transdermal delivery.

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