Preparation process for soluble drug-loaded microneedle patch

Abstract

The invention discloses a preparation process for a soluble drug-loading microneedle patch, which comprises the following steps: S1, injecting a soluble microneedle solution into a microneedle groove of a microneedle female die to form a microneedle, and enabling the soluble microneedle solution to form convex liquid drops on the surface of the microneedle groove corresponding to the microneedle female die; s2, sequentially performing semi-curing drying treatment and semi-curing humidifying treatment on the micro-needle female die containing the bulge liquid drops to obtain pretreated bulges; and S3, pressing the gasket onto the pre-treated bulge, drying, and demolding to obtain the product. According to the preparation method, the gasket is used for replacing a viscous layer, the adhesion performance between the gasket and the soluble microneedle solution is improved by performing semi-curing drying treatment and semi-curing humidifying treatment on the microneedle female die containing the protruding liquid drops, the microneedles formed in the microneedle female die can be separated from the microneedle grooves, and preparation of the soluble microneedle patch is achieved; and the influence of the permeation of the adhesive material on the safety and the drug effect stability of the microneedle is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical and cosmetic microneedles, and particularly relates to a preparation process for a soluble drug-loaded microneedle patch. Background Art

[0002] Currently, the preparation process of soluble microneedle patches is mainly as follows: injecting a microneedle solution into a microneedle female mold (the microneedle female mold is generally made of silica gel, and microneedle grooves in the shape of microneedles are formed on the silica gel for filling the microneedle solution to solidify into microneedles. The microneedle grooves include a tip part groove and a root part groove, and the root part groove is close to one end of the surface of the microneedle mold female mold), and then covering a sticky layer on the microneedle female mold filled with the microneedle solution. The sticky layer is used to bond the microneedles formed in the microneedle female mold, so that the microneedles are fixedly bonded to the sticky layer, which is convenient for demolding and separating the solidified microneedles from the microneedle female mold to become a soluble microneedle patch.

[0003] The main component of the adhesive material of the existing sticky layer generally uses a rubber-type or resin-type colloid. This adhesive material is easy to penetrate into the microneedles, so that the inside of the microneedles contains the components of the adhesive material. During use, when the microneedles pierce into the human body, the adhesive material that penetrates into the microneedles enters the human body through the channels formed by the microneedles piercing the skin, which is likely to cause adverse effects on the human body. At the same time, because the components of the adhesive material penetrate into the microneedles, it will affect the use effect of the microneedle components, and the influence effects of different components of the adhesive material on different microneedle components are all different.

[0004] For the soluble microneedle patch obtained by the existing preparation process, since the adhesive material is easy to penetrate into the microneedles, there are certain potential safety and efficacy stability hazards in the use of the microneedles. Therefore, how to avoid the influence of the penetration of the adhesive material on the microneedles and improve the safety and efficacy stability of the soluble microneedle patch is a technical problem that the industry urgently needs to solve. Summary of the Invention

[0005] In order to solve the above technical problems, the present invention provides a preparation process for a soluble drug-loaded microneedle patch. By using a gasket instead of a sticky layer and performing semi-curing drying treatment and semi-curing humidification treatment on the microneedle female mold containing raised droplets, the adhesion performance between the gasket and the soluble microneedle solution is improved, and the microneedles formed in the microneedle female mold can be detached from the microneedle grooves, realizing the preparation of the soluble microneedle patch and avoiding the influence of the penetration of the adhesive material on the safety and efficacy stability of the microneedles in the existing microneedle patch preparation process.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions:

[0007] A preparation process for a soluble drug-loaded microneedle patch includes the following steps:

[0008] S1. Inject a soluble microneedle solution into the microneedle grooves of the microneedle female mold, so that the soluble microneedle solution fills the microneedle grooves to form microneedles, and the soluble microneedle solution forms raised droplets on the surface of the corresponding microneedle grooves of the microneedle female mold;

[0009] S2. Sequentially perform semi-curing drying treatment and semi-curing humidifying treatment on the microneedle female mold containing raised droplets in step S1, so that the raised droplets form pre-treated protrusions;

[0010] S3. Press a gasket onto the pre-treated protrusions in step S2, dry and demold to obtain the soluble drug-loaded microneedle patch.

[0011] In step S1 of the present invention, the concentration of the soluble microneedle preparation in the soluble microneedle solution only needs to meet the conventional processing requirements in the art. The mass percentage ratio of the soluble microneedle preparation in the soluble microneedle solution is less than 30%, preferably 30%-50%.

[0012] Further preferably, the soluble microneedle preparation is a conventional preparation in the art, including a soluble microneedle matrix material, and the soluble microneedle matrix material is at least one of polyester, polyhydroxyalkanoate, copolymer of 3-hydroxybutyrate and 3-hydroxyvalerate, polyacrylamide, modified polypropylene, polyhydroxyalkanoate-polyethylene glycol, poly-α-hydroxy acid, poly-β-hydroxy acid, polyhydroxybutyrate, polyestersamide, polycaprolactone, polylactide, polyglycolic acid, polydioxanone, polyorthoester, polyether ester, polyanhydride, glycolic acid-trimethylenecarbonate copolymer, polyphosphate, polyphosphate urethane, polyamino acid, polycyanoacrylate, polytrimethylene carbonate, polycarbonate, polyphosphocreatine, chitosan, dextran, heparin, hyaluronic acid, sucrose, trehalose, mannitol, chondroitin sulfate, Tween 80, gelatin, poly(lactic-co-glycolic acid), polyvinylpyrrolidone, polyvinyl alcohol, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, sodium alginate, maltose, hydroxypropyl-β-cyclodextrin, polylactic acid, polyethylene glycol, glycerol, sodium chloride, inulin, starch and glycogen.

[0013] Preferably, the soluble microneedle solution further contains a drug, and the drug is doxorubicin, triamcinolone acetonide, teriparatide, abaloparatide, GLP-1 analog, growth factor, insulin, acetyl hexapeptide, pilocarpine, hyaluronic acid, tranexamic acid, glutathione, nicotinamide, calcipotriol & betamethasone, monoclonal antibody, influenza vaccine and measles-rubella inactivated vaccine, pilocarpine, adenosine, horse oil, doxorubicin, ascorbic acid, ferulic acid, retinyl retinoate, ascorbic acid, zolmitriptan, tilibang, 4-n-butylresorcinol, lidocaine, amethocaine, encephalitis vaccine, mitomycin, semaglutide, inactivated split influenza virus hemagglutinin vaccine, glucagon, parathyroid hormone (1-34), At least one of 15T vaccine, platelet-rich fibrin (I-PRF), C19-A3 GNP (gold nanoparticles), polio vaccine, adalimumab, IVT aflibercept, tuberculin (purified protein derivative), sumatriptan succinate, ipilimumab, nivolumab, indocyanine green, hepatitis B vaccine, S-OIV influenza A (H1N1) intradermal vaccine, levodopa, recombinant fibrinolytic enzyme, platelet-rich plasma (PRP), botulinum toxin type A, staphylococcal enterotoxin B vaccine, scrub typhus vaccine, SARS-CoV-2 vaccine, malaria vaccine, HIV vaccine, rotavirus inactivated virus vaccine, tuberculosis vaccine, porcine circovirus type 2 vaccine, rabies vaccine, HPV vaccine, melanoma vaccine, porcine reproductive and respiratory syndrome virus (PRRSV) vaccine, Ebola virus vaccine, Zika vaccine, respiratory syncytial virus (RSV) vaccine, severe acute respiratory syndrome coronavirus vaccine.

[0014] The injection described in step S1 of the present invention is a conventional method in the art, including but not limited to spraying or filling to achieve the injection of the soluble microneedle solution, and the specific injection method is not limited herein.

[0015] The raised droplet described in step S1 of the present invention can increase the mass on the basis of the mass of the soluble microneedle solution required for injecting the microneedles according to the density and viscosity of the soluble microneedle solution used, so as to form a suitable raised droplet on the surface of the microneedle female mold. In the present invention, when the raised droplet is too large, the microneedle solution is likely to overflow the space between the gasket and the surface of the female mold when it fits with the gasket, resulting in the adhesion or partial adhesion of different microneedle patches into a sheet. During subsequent drying treatment, due to different drying degrees, the needle body is prone to breakage during demolding. At the same time, when the microneedle solution that overflows the space between the gasket and the surface of the female mold spreads and adheres into a sheet or partially adheres into a sheet, the solution aggregates due to the action of solution tension, causing the microneedle solution filled in the root groove to escape from the root groove and flow to the connection area outside the gasket, resulting in the inability of the root solution to completely fill the microneedle groove. New problems such as bubbles in the microneedles, incomplete needle shape, and missing needles exist in the prepared microneedle patch, resulting in the detachment of the microneedle body from the gasket after demolding, reducing the yield of the microneedle patch product and increasing the cost. Those skilled in the art can also obtain the raised droplet by the following experience. Taking the microneedle female mold with a volume of 5 - 95 nl as an example, the mass of the raised droplet is 0.01 - 0.40 mg.

[0016] The pre-treated protrusion described in step S2 of the present invention is a soft rubber-like protrusion with adhesiveness on the surface, which is obtained by semi-curing drying treatment and semi-curing humidification treatment of the raised droplet.

[0017] Specifically, through the semi-curing and drying treatment of the raised droplets, the present invention can reduce the fluidity of the solution, fix the shape of the droplets, and avoid the generation of bubbles due to extrusion during lamination. At the same time, by performing a semi-curing and humidifying treatment on the semi-cured and dried raised droplets, the viscosity of the solution surface can be increased, which is beneficial to the lamination of the gasket. There is no need to use an additional adhesive, thus avoiding the impact of chemical substances on the safety and efficacy stability of the soluble microneedles. Preferably, the conditions for the semi-curing and drying treatment in step S2 are: humidity of 30%-70%, temperature greater than 10°C, and placed for 3-60 minutes. More preferably, the temperature is 10-40°C.

[0018] There is no adhesion between the raised object after the semi-curing and drying treatment of the present invention and the gasket, and the raised object does not deform. Further, by performing a semi-curing and humidifying treatment, a raised object in a soft rubber state is obtained. There is adhesion between the raised object in the soft rubber state and the gasket, and the raised object in the soft rubber state deforms.

[0019] Those skilled in the art can select the corresponding humidity and temperature to perform a humidifying treatment on the protrusion after the semi-curing treatment according to the semi-curing humidity and temperature conditions. At the same temperature, the humidifying humidity needs to be higher than the drying humidity. When at different temperatures, when the humidifying temperature is higher than the drying temperature, the humidifying humidity can be slightly lower than the drying humidity, but preferably the humidifying humidity needs to be higher than the drying humidity. Preferably, the conditions for the semi-curing and humidifying treatment are: humidity of 40%-90%, temperature of 20-45°C, and placed for 2-5 minutes.

[0020] The material of the gasket described in step S3 of the present invention is any one of thermoplastic polyurethane, polypropylene (PP), polycarbonate (PC), and acrylonitrile-butadiene-styrene copolymer (ABS). Preferably, the gasket is a thermoplastic polyurethane elastomer rubber (TPU) gasket.

[0021] After the pre-treated raised protrusions are pressed in step S3 of the present invention, a microneedle soft rubber layer is formed between the surface of the microneedle female mold and the gasket, and there is no adhesion between the microneedle soft rubber layers formed corresponding to each pre-treated raised protrusion, which can better achieve uniform drying and further improve the peeling integrity.

[0022] Preferably, the area of the microneedle soft rubber layer is larger than the bottom area of the microneedle roots in the microneedle female mold, which can achieve pressing support and at the same time realize the adhesion area of the gasket, improving the demolding stability of the gasket.

[0023] More preferably, the pressure of the pressing is 1-5 N per square centimeter.

[0024] The drying described in step S3 of the present invention is: humidity of 10%-90%, drying at room temperature (20-25°C) for 15-72 hours.

[0025] In step S1 of the present invention, the microneedles are formed by injecting a soluble microneedle solution at least once. Therefore, the formed microneedles can be integral, two-segment or multi-segment.

[0026] In some preferred embodiments, the microneedles in the present invention can be formed into two-segment microneedles by injecting a soluble microneedle solution twice. Specifically, the method for forming the two-segment microneedles specifically includes the following steps:

[0027] S11. Inject a soluble microneedle solution into the tip groove of the microneedle groove of the microneedle female mold, let it stand and dry to form a microneedle tip;

[0028] S12. Inject a soluble microneedle solution into the root groove of the microneedle groove in step S11 until the soluble microneedle solution forms a raised droplet on the surface of the microneedle female mold, let it stand and dry to form a microneedle root.

[0029] The beneficial effects of the present invention are as follows:

[0030] (1) The preparation process of the present invention uses a gasket instead of an adhesive layer. By performing semi-curing drying treatment and semi-curing humidification treatment on the microneedle female mold containing raised droplets, the adhesion performance between the gasket and the raised droplets of the soluble microneedle solution is improved. The microneedles formed in the microneedle female mold can be peeled off from the microneedle groove, realizing the preparation of the soluble microneedle patch, and avoiding the influence of the penetration of the adhesive material on the safety and efficacy stability of the microneedles.

[0031] (2) The semi-curing drying treatment and semi-curing humidification treatment of the present invention enable the soluble microneedle solution to cure more uniformly inside and outside during drying, avoiding uneven curing or excessive drying, and effectively preventing the breakage of the needle body during demolding.

[0032] (3) By optimizing the relationship between the volume of the microneedle female mold and the mass of the soluble microneedle solution, the present invention can effectively control the size of the raised droplets, so that the pre-treated protrusions after semi-curing drying treatment and semi-curing humidification treatment can meet the contact adhesion when pressed with the gasket, while preventing the adjacent pre-treated protrusions on the microneedle patch from sticking during gasket pressing, avoiding the problem that the dried degree of the external and internal solutions is different due to the inability of the adhered area to ventilate during subsequent drying treatment, resulting in the breakage of the needle body during demolding; at the same time, it can also effectively prevent the aggregation of the solution due to the action of surface tension, so that the microneedle solution filled in the root groove escapes from the root groove and flows to the adjacent microneedle groove of the gasket or the connection area outside the gasket, resulting in the problem that the root solution cannot completely fill the microneedle groove, and improving the yield of the microneedle patch product. Description of the Drawings

[0033] Figure 1 It is a soluble drug-loaded microneedle patch prepared according to the embodiment of the present invention.

[0034] Figure 2 This is the soluble drug-loaded microneedle patch prepared in Comparative Example 1 of the present invention.

[0035] Figure 3 This is the soluble drug-loaded microneedle patch prepared in Comparative Examples 2, 5, and 6 of the present invention.

[0036] Figure 4 This is the soluble drug-loaded microneedle patch prepared in Comparative Example 3 of the present invention.

[0037] Figure 5 This is the soluble drug-loaded microneedle patch prepared in Comparative Examples 8, 9, and 10 of the present invention. Specific Embodiments

[0038] The following specific examples illustrate the embodiments of the present invention. Those skilled in the art can easily understand the other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0039] Before further describing the specific embodiments of the present invention, it should be understood that the protection scope of the present invention is not limited to the specific embodiments described below; it should also be understood that the terms used in the embodiments of the present invention are for describing specific embodiments, rather than for limiting the protection scope of the present invention.

[0040] When the embodiments give a numerical range, it should be understood that unless otherwise specified in the present invention, any value at both ends of each numerical range and any value between the two ends can be selected. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which the present invention belongs.

[0041] The present invention does not limit the source of the raw materials used. Unless otherwise specified, the raw materials used in the present invention are all common commercially available products in this technical field.

[0042] Basic Embodiment

[0043] A preparation process for a soluble drug-loaded microneedle patch includes the following steps:

[0044] S1. Inject a soluble microneedle solution into the microneedle grooves of the microneedle female mold, so that the soluble microneedle solution fills the microneedle grooves to form microneedles, and the soluble microneedle solution forms raised droplets on the surface of the microneedle female mold.

[0045] S2. Sequentially perform semi-curing drying treatment and semi-curing humidification treatment on the microneedle female mold containing raised droplets in step S1 to obtain a pre-treated raised in a soft gel state.

[0046] S3. Press the TPU gasket onto the pre-treated protrusions described in step S2 with a force of 2 N per square centimeter. After pressing, a micro-needle soft glue layer is formed between the surface of the micro-needle female mold and the gasket. The area of the micro-needle soft glue layer is larger than the bottom area of the micro-needle roots in the micro-needle female mold, and the micro-needle soft glue layers formed corresponding to each pre-treated protrusion do not adhere to each other. At 50% humidity, dry at room temperature (20 °C) for 44 h and then demold to obtain the soluble drug-loaded micro-needle patch.

[0047] Examples 1-9 and Comparative Examples 1-3

[0048] The specific parameters of the semi-curing drying treatment and semi-curing humidifying treatment in the preparation processes of Examples 1-9 and Comparative Examples 1-3 are shown in Table 1.

[0049] Table 1

[0050]

[0051]

[0052] The qualified rates of the soluble micro-needle patches prepared in Examples 1-9 and Comparative Examples 1-3 are shown in Table 2.

[0053] Table 2

[0054] Group Yield Rate % Example 1 80.4％ Example 2 87.5％ Example 3 85.3％ Example 4 79.8％ Example 5 86.2％ Example 6 86.3％ Example 7 78.9％ Example 8 76.5％ Example 9 82.9％ Comparative Example 1 29.2％ Comparative Example 2 / Comparative Example 3 30.8％

[0055] As can be seen from Examples 1-9, by adopting the specific semi-curing drying treatment and semi-curing humidifying treatment processes of the present invention, the adhesion performance between the TPU gasket and the soluble micro-needle solution can be improved, and the micro-needles formed in the female mold can be successfully peeled off from the micro-needle grooves, realizing the preparation of the soluble micro-needle patch. Moreover, the prepared soluble micro-needle patch has no bubbles, the needle shape is complete, and there is no problem of missing needles, avoiding the detachment of the micro-needle body from the TPU gasket after demolding, and improving the qualified rate of the micro-needle patch product, as Figure 1 shown in Table 2.

[0056] The differences between Comparative Examples 1 and 2 and Example 1 are only that: the humidity conditions of the semi-curing drying are different. Among them, the semi-curing drying humidity in Comparative Example 1 is 20%. Due to the too low semi-curing drying humidity, the raised droplets are rapidly dried, and the air inside cannot be discharged in time, resulting in the generation of bubbles in the micro-needle cavities and the substrates, as Figure 2 shown; the semi-curing drying humidity in Comparative Example 2 is 80%. Due to the high humidity, the water in the polymer solution of the substrate cannot evaporate, resulting in the phenomenon of inability to dry, as Figure 3 shown.

[0057] The difference between Comparative Example 3 and Example 1 is only that: the temperature conditions for semi-curing drying are different. Among them, the temperature for semi-curing drying in Comparative Example 3 is 8 °C. Since the temperature is too low, the viscosity of the soluble microneedle solution increases at low temperature, accelerating the curing of the raised droplets, and the air inside is not discharged in time, resulting in the generation of bubbles in the microneedle cavities and the substrate, as Figure 4 shown.

[0058] Examples 10 - 18 and Comparative Examples 4 - 11

[0059] The specific parameters of the semi-curing drying treatment and semi-curing humidifying treatment in the preparation processes of Examples 10 - 18 and Comparative Examples 4 - 11 are shown in Table 3.

[0060] Table 3

[0061]

[0062] The yield rates of the soluble microneedle patches prepared in Examples 10 - 18 and Comparative Examples 4 - 11 are shown in Table 4.

[0063] Table 4

[0064]

[0065]

[0066] As can be seen from Examples 10 - 18, by adopting the specific processes of semi-curing drying treatment and semi-curing humidifying treatment of the present invention, the adhesion performance between the TPU gasket and the soluble microneedle solution can be improved, and the microneedles formed in the female mold can be successfully peeled off from the microneedle grooves, realizing the preparation of the soluble microneedle patch. Moreover, the prepared soluble microneedle patch has no bubbles, complete needle shapes, and no missing needle problems, avoiding the detachment of the microneedle bodies from the TPU gasket after demolding, and improving the yield rate of the microneedle patch products, as Figure 1 and Table 4 show.

[0067] The differences between Comparative Examples 4 and 5 and Example 10 are only that: the humidity conditions for semi-curing humidifying are different. Among them, the humidity for semi-curing humidifying in Comparative Example 4 is relatively low at 35%, and the raised parts in a solid state on the surface cannot be humidified, thus unable to achieve the fixed adhesion between the raised parts and the TPU gasket; the humidity for semi-curing humidifying in Comparative Example 5 is 95%, resulting in too fast a melting speed of the raised parts in a solid state on the surface, and the TPU gasket cannot be applied in time during the experimental operation, as Figure 3 shown.

[0068] The difference between Comparative Example 6 and Example 10 is only that: the temperature conditions for semi-curing humidifying are different. Due to the relatively high humidifying temperature in Comparative Example 6, the melting speed of the raised droplets is too fast, and the TPU gasket cannot be applied in time during the experimental operation, as Figure 3 shown.

[0069] The differences between Comparative Example 7 and Comparative Example 8 and Example 10 are only as follows: the time conditions for semi-curing humidification are different. Among them, the time of Comparative Example 7 is shorter, and the protrusions in a solid state on the surface are not moderately melted and cannot adhere to the TPU gasket. The protrusions in Comparative Example 8 are completely melted, and the microneedle bases are connected into one piece after being covered with TPU. After the microneedles are demolded, the outer microneedles are over-dried, resulting in the phenomenon of broken needles, as Figure 5 shown.

[0070] The difference between Comparative Example 9 and Example 10 is that there are no semi-curing drying and semi-curing humidification steps. In Comparative Example 9, there are phenomena such as the base spreading and sticking together, the outer microneedles being over-dried after the microneedles are demolded, resulting in broken needles, at the same time, the solution in the needle cavity is missing, bubbles are formed, and the needle body falls off after demolding, as Figure 5 shown.

[0071] The difference between Comparative Example 10 and Example 10 is that the semi-curing humidification step is cancelled. In Comparative Example 10, the microneedles are over-dried, the adhesion strength between the microneedles and the TPU gasket is not high, and some microneedles fall off, as Figure 5 shown.

[0072] The above is a further description of the present invention in combination with specific embodiments, but these embodiments are merely exemplary and do not constitute any limitation to the scope of the present invention. Those skilled in the art should understand that the details and forms of the technical solutions of the present invention can be modified or replaced without departing from the spirit and scope of the present invention, but these modifications and replacements all fall within the protection scope of the present invention.

Claims

1. A preparation process for a soluble drug-loaded microneedle patch, characterized in that, It includes the following steps: S1. Inject a soluble microneedle solution into the microneedle grooves of the microneedle female mold, so that the soluble microneedle solution fills the microneedle grooves to form microneedles, and the soluble microneedle solution forms raised droplets on the surface of the corresponding microneedle grooves of the microneedle female mold; S2. Sequentially perform semi-curing drying treatment and semi-curing humidifying treatment on the microneedle female mold containing raised droplets in step S1, so that the raised droplets form pre-treated protrusions; S3. Press a gasket onto the pre-treated protrusions in step S2, dry and demold to obtain the soluble drug-loaded microneedle patch.

2. The preparation process according to claim 1, wherein The pre-treated protrusions in step S2 are soft glue state protrusions with sticky surfaces.

3. The preparation process according to claim 1, wherein The conditions for the semi-curing drying treatment in step S2 are: The humidity is 30%-70%, the temperature is not lower than 10°C, and it is placed for 3-60 min; The conditions for the semi-curing humidifying treatment are: the humidity is 40%-90%, the temperature is 20-45°C, and it is placed for 2-5 min.

4. The preparation process according to claim 1, characterized in that, The number of the microneedle grooves in step S1 is not less than 1. After the pre-treated protrusions in step S3 are pressed, a microneedle soft glue layer is correspondingly formed between the surface of the microneedle female mold and the gasket, and there is no adhesion between the microneedle soft glue layers formed by each pre-treated protrusion.

5. The preparation process according to claim 4, characterized in that, The area of the microneedle soft glue layer is larger than the bottom area of the microneedle roots in the microneedle female mold.

6. The preparation process according to claim 1, characterized in that, The material of the gasket in step S3 is any one of thermoplastic polyurethane, polypropylene, polycarbonate, and acrylonitrile-butadiene-styrene copolymer.

7. The preparation process according to claim 1, characterized in that, The soluble microneedle solution in step S1 contains a soluble microneedle skeleton material, and the soluble microneedle skeleton material is at least one of polyester, polyhydroxyalkanoate, copolymer of 3-hydroxybutyrate and 3-hydroxyvalerate, polyacrylamide, modified polypropylene, polyhydroxyalkanoate-polyethylene glycol, poly-α-hydroxy acid, poly-β-hydroxy acid, polyhydroxybutyrate, polyestersamide, polycaprolactone, polylactide, polyglycolic acid, polydioxanone, polyorthoester, polyether ester, polyanhydride, glycolic acid-trimethylenecarbonate copolymer, polyphosphate, polyphosphate urethane, polyamino acid, polycyanoacrylate, polytrimethylene carbonate, polycarbonate, creatine phosphate, chitosan, dextran, heparin, hyaluronic acid, sucrose, trehalose, mannitol, chondroitin sulfate, Tween 80, gelatin, poly(lactic-co-glycolic acid), polyvinylpyrrolidone, polyvinyl alcohol, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, sodium alginate, maltose, hydroxypropyl-β-cyclodextrin, polylactic acid, polyethylene glycol, glycerol, sodium chloride, inulin, starch, and glycogen.

8. The preparation process according to claim 7, characterized in that, The soluble microneedle solution described above further contains a drug, and the drug is doxorubicin, triamcinolone acetonide, teriparatide, abaloparatide, GLP-1 analog, growth factor, insulin, acetyl hexapeptide, pilocarpine, hyaluronic acid, tranexamic acid, glutathione, niacinamide, calcipotriol & betamethasone, monoclonal antibody, influenza vaccine and measles-rubella inactivated vaccine, pilocarpine, adenosine, horse oil, doxorubicin, ascorbic acid, ferulic acid, retinyl retinoate, ascorbic acid, zolmitriptan, tilibang, 4-n-butylresorcinol, lidocaine, amethocaine, encephalitis vaccine, mitomycin, semaglutide, inactivated split influenza virus hemagglutinin vaccine, glucagon, parathyroid hormone, at least one of 15T vaccine, platelet-rich fibrin, C19-A3 GNP, polio vaccine, adalimumab, IVT aflibercept, tuberculin, sumatriptan succinate, ipilimumab, nivolumab, indocyanine green, hepatitis B vaccine, S-OIV influenza A (H1N1) intradermal vaccine, levodopa, recombinant fibrinolytic enzyme, platelet-rich plasma, botulinum toxin type A, staphylococcal enterotoxin B vaccine, scrub typhus vaccine, SARS-CoV-2 vaccine, malaria vaccine, HIV vaccine, rotavirus inactivated virus vaccine, tuberculosis vaccine, porcine circovirus type 2 vaccine, rabies vaccine, HPV vaccine, melanoma vaccine, porcine reproductive and respiratory syndrome virus vaccine, Ebola virus vaccine, Zika vaccine, respiratory syncytial virus vaccine, acute respiratory syndrome coronavirus vaccine.

9. The preparation process according to claim 1, characterized in that, The pressure for pressing in step S3 is 1-5 N per square centimeter; The drying is: the humidity is 10%-90%, and it is dried at room temperature for 15-72 h.

10. The preparation process according to any one of claims 1-9, characterized in that, The microneedles in step S1 are formed by injecting the soluble microneedle solution at least once.

Images