A process for manufacturing soluble microneedles and an injection molding device for controllable dosage.

Abstract

This invention discloses a soluble microneedle manufacturing process and a molding device for controllable drug dosage, relating to the field of microneedle patch production technology. The molding device includes an injection molding machine, which achieves uniform distribution and precise control of the drug within the microneedles through a precise injection molding process. The injection molding machine is equipped with an adjustment component that flexibly adjusts the injection mode according to the characteristics and requirements of the drug. Two sets of upper and lower mounting plates embed syringe bodies. This invention improves the flexibility of molding by setting multiple syringe bodies and injecting different drug matrix materials through syringe bodies at different positions. It also allows adjustment of the injection speed and flow rate according to different drug characteristics and requirements, thereby improving the quality of molding. Combined with negative pressure filtration, the injected matrix material can be evenly distributed within the lower mold, thus avoiding defects such as voids or bubbles to a certain extent.

Description

Technical Field

[0001] This invention relates to the field of microneedle patch production technology, specifically to a soluble microneedle production process and a molding device for controllable dosage. Background Technology

[0002] Soluble microneedle patches are mostly produced by injecting matrix material into a mold using injection molding equipment, and then using a centrifuge to vibrate the matrix material so that it can be evenly distributed in the mold. After one vibration, the matrix material is filled into the mold again, and the centrifugation and vibration are repeated. The operation process is cumbersome and cannot accurately control the dosage of the drug in each injection molding process, which has certain defects.

[0003] The existing injection molding equipment for microneedle production has the following drawbacks:

[0004] 1. In the application document CN113797435A, the main consideration is how to quickly and uniformly complete the casting of large-area microneedle casting molds, without taking into account the problem that the existing microneedle production casting equipment cannot adjust the dosage of the drug in each casting process according to the different characteristics of the drug.

[0005] 2. In the patent document CN216139310U, the main consideration is how to speed up the demolding speed and improve the yield, but it does not take into account that the existing microneedle injection molding equipment does not block the injection tool, and the finished product is prone to defects such as holes and bubbles. Summary of the Invention

[0006] The purpose of this invention is to provide a manufacturing process for soluble microneedles, the steps of which are as follows:

[0007] (1) Preparation of semi-finished products: Mix the raw materials for the preparation of soluble microneedles and store them at -10℃~0℃ for later use;

[0008] (2) Injection molding: The semi-finished product obtained in step (1) is injected into the mold through an injection molding device;

[0009] (3) Remove the mold and put it into a low temperature constant temperature oven to dry and solidify it, then cut it.

[0010] In one embodiment of the present invention, the viscosity of the semi-finished product is 5000-10000 cps.

[0011] In one embodiment of the present invention, the raw material for preparing the soluble microneedles includes sodium hyaluronate.

[0012] In one embodiment of the present invention, in step (1), the raw materials for preparing soluble microneedles are mixed and stored at a low temperature of -6℃ to 2℃ for later use.

[0013] In one embodiment of the present invention, the drying temperature in step (3) is 10-40°C.

[0014] In one embodiment of the present invention, the drying temperature in step (3) is 15-30°C.

[0015] A dosage-controllable injection molding device for the production of soluble microneedles includes an injection molding machine, which achieves uniform distribution and precise control of the drug in the microneedles through a precise injection molding process. The injection molding machine is equipped with an adjustment component, which flexibly adjusts the injection mode according to the characteristics and requirements of the drug.

[0016] The injection molding machine has columns slidably connected to both sides. A crossbar is provided on the surface of the two columns that are close to each other. A mounting plate is provided on the front of the crossbar. The mounting plate is inverted L-shape. A magnetic baffle is provided on the inner surface of the mounting plate. The adjustment assembly includes a shelf fixed to the top of the mounting plate. The shelf has a U-shaped longitudinal section. A servo motor is installed on the bottom wall of the shelf. A storage tray one is installed at the output end of the servo motor. A support column is installed at the bottom center of storage tray one. A storage tray two is installed at the bottom of the support column. Magnetic components are evenly arranged on the outer surfaces of both storage tray one and storage tray two. A storage plate is installed on the outer surface of the magnetic components.

[0017] The syringe body is embedded in the upper and lower shelves. Iron block 2 is installed on the top of the upper shelf. Iron block 2 is located on the outside of the syringe body. Electric push rods are evenly arranged on the top of the mounting plate. The electric push rods are located on the outside of the shelf. A connecting plate is installed at the output end of the electric push rod. Electromagnet 2 is embedded in the bottom of the connecting plate.

[0018] Preferably, the top of the injection molding machine is equipped with a placement block, which is located below the baffle. A sleeve is inserted into the top of the placement block, and pressure sensors are evenly arranged on the bottom wall of the placement block. A pressure plate is installed on the top of the pressure sensor, and an ejector pin is installed on the top of the pressure plate. The ejector pin is located inside the sleeve.

[0019] Preferably, the injection molding machine is equipped with a lower pressure platform on its top. The lower pressure platform is located in front of the side of the baffle. A sealing gasket and evenly arranged support rods are installed on the top of the lower pressure platform. The support rods are located inside the sealing gasket. A support plate is installed on the top of the support rods. The top of the support plate is used to place the cover film paper.

[0020] Preferably, an elastic sealing gasket is attached to the top of the sealing gasket one, and an upper pressure plate is installed on the top of the elastic sealing gasket. The surfaces of the upper and lower pressure plates that are close to each other are provided with storage grooves. The upper mold and the lower mold are placed inside the two sets of storage grooves respectively. The top of the lower mold is attached to the bottom of the covering film paper, and the bottom of the upper mold is attached to the top of the covering film paper. A pressure sensor two is embedded in the bottom wall of the lower storage groove. The top of the pressure sensor two is attached to the bottom of the lower mold. The pressure sensor two is used to monitor the amount of injection in the lower mold.

[0021] Preferably, the injection molding machine, the columns, and the crossbar are all equipped with moving components. The moving components in the injection molding machine are used to drive the two sets of columns to move back and forth, the moving components in the two sets of columns are used to drive the crossbar to move up and down, and the moving components in the crossbar are used to drive the mounting plate to move left and right. The moving components include variable frequency motors installed on the front wall of the injection molding machine, the bottom wall of the columns, and the inner wall of one side of the crossbar. The output end of the variable frequency motor is equipped with a reciprocating lead screw, and a sliding sleeve is sleeved on the outer surface of the reciprocating lead screw.

[0022] Preferably, the injection molding machine is equipped with an online monitoring system, which includes a data acquisition unit, an analysis unit, and a display unit. The data acquisition unit includes a data acquisition module and an image acquisition module. The data acquisition module uses a data acquisition device to collect data monitored by pressure sensor one and pressure sensor two. The image acquisition module collects the distribution of the drug in the microneedle mold by arranging image acquisition devices inside the lower pressure stage. The analysis unit uses a central processing unit to analyze the data and image information collected by the data acquisition unit. The display unit uses an external display screen to display abnormal situations. The data acquisition device is also used to collect various operating parameters of the injection molding machine.

[0023] Preferably, the top of the upper pressure table is provided with evenly arranged injection tubes, the bottom end of which penetrates the upper mold and punctures the covering film.

[0024] Preferably, the magnetic suction assembly includes an electromagnet one evenly distributed on the outer surfaces of the first and second storage trays, an iron block one disposed on the inner surface of the storage plate, and the iron block one attracts the electromagnet one. A connecting rod is installed at the bottom of the upper storage plate, and the bottom end of the connecting rod is connected to the top of the lower storage plate. The connecting rod is located on both sides of the syringe body.

[0025] Preferably, an air extraction pipe is provided on one outer wall of the lower pressure platform, and the air extraction pipe is connected to a vacuum filter.

[0026] Preferably, the method of using the injection molding equipment is as follows:

[0027] S1. Place the lower mold in a low-temperature constant temperature chamber at 0℃ and negative pressure for 60 minutes.

[0028] S2, negative pressure filtration;

[0029] S3. Adjust the injection mode according to production needs, and inject the matrix material into the lower mold in a quantitative and automatic manner through the syringe body;

[0030] S4. During the injection molding process, the injection process is monitored and fed back in real time through a monitoring system;

[0031] S5. After injection molding is completed, remove the mold and place it in a low-temperature constant temperature oven. Dry and cure at a low temperature of 25-30 degrees Celsius. After the moisture evaporates, since the lower mold is made of resin material, it can be directly demolded after thermal expansion and contraction.

[0032] A process for manufacturing soluble microneedles, comprising the following steps:

[0033] (1) Preparation of semi-finished products: Mix the raw materials for the preparation of soluble microneedles and store them at -10℃~0℃ for later use;

[0034] (2) Injection molding: The semi-finished product obtained in step (1) is injected into the mold through an injection molding device;

[0035] (3) Remove the mold and place it in a low-temperature constant temperature oven. Dry and solidify at a low temperature of 25-30℃.

[0036] Compared with the prior art, the beneficial effects of the present invention are:

[0037] 1. This invention improves the flexibility of injection molding by setting up multiple sets of syringe bodies and injecting different drug matrix materials through syringe bodies at different positions. It can also adjust the injection speed and flow rate according to different drug characteristics and needs, thereby improving the quality of injection molding. In addition, with the help of negative pressure filtration, the injected matrix material can be evenly distributed in the lower mold, thus avoiding defects such as voids or bubbles to a certain extent.

[0038] 2. This invention uses an ejector pin and a pressure sensor to detect blockages in the syringe body at different locations before injection molding, thereby avoiding blockages that could affect the injection molding effect. This, in turn, can improve the injection molding quality and the quality and effect of soluble microneedles to a certain extent.

[0039] 3. Before injection molding, the prepared lower mold is placed in the storage slot on the lower pressure platform, and a cover film is laid on its surface. Then, the upper pressure platform containing the upper mold is covered, so that the elastic sealing gasket can contact the sealing gasket. At this time, the injection tube will puncture the cover film. Then, the moving component drives the syringe body to move above the injection tube, and the bottom end of the syringe body is inserted into the injection tube to perform the injection molding operation. During this process, a vacuum filter is used to perform negative pressure filtration between the lower pressure platform and the upper pressure platform, so that the matrix material injected into the lower mold by the syringe body can be evenly distributed in the micro-needle cavity of the lower mold, avoiding voids or air bubbles. Moreover, the cover film can prevent the injected matrix material from overflowing, improving the injection molding effect.

[0040] 4. This invention monitors the distribution of matrix material in the lower mold during the injection molding process using a pressure sensor and captures and records images of the matrix material at the moment of injection into the lower mold and its distribution in the lower mold after injection using an image acquisition device. This allows the system to determine whether there are uneven drug distributions or abnormal pressures during the injection molding process, and to issue timely alarms or adjust production parameters. This enables comprehensive monitoring and intelligent management of the injection molding process. Attached Figure Description

[0041] Figure 1 This is a schematic diagram of the overall structure of the present invention;

[0042] Figure 2 This is a schematic diagram of the planar assembly structure of the adjustment component of the present invention;

[0043] Figure 3 This is a top view of the storage tray of the present invention;

[0044] Figure 4 This is a schematic diagram of the planar assembly structure of the storage plate and the syringe body of the present invention;

[0045] Figure 5 This is a schematic diagram of the planar assembly structure of the storage block and the ejector pin of the present invention;

[0046] Figure 6 This is a schematic diagram of the planar assembly structure of the lower pressure table and the upper pressure table of the present invention;

[0047] Figure 7 This is a schematic diagram of the planar assembly structure of the movable component of the present invention;

[0048] Figure 8 This is a schematic diagram of the assembly structure of the injection molding machine and the lower pressure table of the present invention;

[0049] Figure 9 This is a schematic diagram of the planar assembly structure of the moving component inside the injection molding machine of the present invention.

[0050] In the diagram: 1. Injection molding machine; 2. Column; 3. Crossbar; 4. Baffle; 5. Shelf; 6. Servo motor; 7. Shelf tray 1; 8. Electromagnet 1; 9. Iron block 1; 10. Shelf plate; 11. Connecting rod; 12. Injector body; 13. Electric push rod; 14. Electromagnet 2; 15. Iron block 2; 16. Shelf block; 17. Sleeve; 18. Pressure sensor 1; 19. Pressure plate; 20. Ejector pin; 21. Lower pressure table; 22. Sealing gasket 1; 23. Elastic sealing gasket; 24. Upper pressure table; 25. Lower mold; 26. Support rod; 27. Support plate; 28. Covering film paper; 29. ​​Upper mold; 30. Injection tube; 31. Pressure sensor 2; 32. Variable frequency motor; 33. Reciprocating lead screw; 34. Sliding sleeve. Detailed Implementation

[0051] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0052] In the description of this invention, it should be noted that the terms "upper," "lower," "inner," "outer," "front end," "rear end," "both ends," "one end," and "the other end," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0053] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installed," "equipped with," "connected," etc., should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0054] Please see Figure 1 , Figure 2 , Figure 3 and Figure 4This invention provides an embodiment of a drug delivery controllable injection molding device for the production of soluble microneedles, comprising an injection molding machine 1. The injection molding machine 1 achieves uniform distribution and precise control of the drug in the microneedles through a precise injection molding process. An adjustment component is installed on the injection molding machine 1, which flexibly adjusts the injection mode according to the characteristics and requirements of the drug. Columns 2 are slidably connected to both sides of the injection molding machine 1. A crossbar 3 is provided on the surfaces of the two sets of columns 2 that are close to each other. A mounting plate is provided on the front of the crossbar 3. The mounting plate is inverted L-shape, and a magnetic baffle 4 is provided on the inner surface of the mounting plate. The adjustment component includes a shelf 5 fixed to the top of the mounting plate. The shelf 5 has a U-shaped longitudinal section. A servo motor 6 is installed on the bottom wall of the shelf 5. A first storage tray 7 is installed at the output end of the servo motor 6. A support column is installed at the bottom center of the first storage tray 7. A second storage tray is installed at the bottom of the support column. Both tray 7 and tray 2 have evenly arranged magnetic components installed on their outer surfaces. A shelf 10 is installed on the outer surface of the magnetic components. The syringe body 12 is embedded in the upper and lower shelf 10. An iron block 2 15 is installed on the top of the upper shelf 10. The iron block 2 15 is located outside the syringe body 12. An electric push rod 13 is evenly arranged on the top of the mounting plate. The electric push rod 13 is located outside the shelf 5. A connecting plate is installed at the output end of the electric push rod 13. An electromagnet 2 14 is embedded in the bottom of the connecting plate. The magnetic components include an electromagnet 1 8 evenly arranged on the outer surfaces of tray 7 and tray 2. An iron block 1 9 is provided on the inner surface of the shelf 10. The iron block 1 9 is attracted to the electromagnet 1 8. A connecting rod 11 is installed at the bottom of the upper shelf 10. The bottom end of the connecting rod 11 is connected to the top of the lower shelf 10. The connecting rod 11 is located on both sides of the syringe body 12.

[0055] Furthermore, when using this injection molding equipment, firstly, the drug to be injected is selected, then the servo motor 6 in the shelf 5 is started, driving the shelf plate 7 to rotate, thereby adjusting the position of different syringe bodies 12. Then, one set of electromagnets 14 is energized, and the electric push rod 13 is started, driving the connecting plate downward, so that the electromagnets 14 can attract the iron block 15. Then, the electromagnet 8 at that position is de-energized, so that the electric push rod 13 can push the shelf plate 10 downward, which can then drive the syringe body 12 on the shelf plate 10 to move out of the cover 4, and perform a blockage detection on the removed syringe cone sleeve 12. After the monitoring is completed, it is moved to the position to be injected by the moving component, and the injection speed and flow rate are adjusted according to the characteristics and requirements of the drug in the syringe body 12, thereby improving the injection molding quality. With the help of negative pressure filtration, the injected matrix material can be evenly distributed in the lower mold 25, which can avoid defects such as voids or bubbles to a certain extent.

[0056] Please see Figure 1 and Figure 5An embodiment of the present invention provides a dosage-controllable injection molding device for the production of soluble microneedles. The injection molding machine 1 has a placement block 16 installed on its top, which is located below the baffle 4. A sleeve 17 is inserted into the top of the placement block 16. Pressure sensors 18 are evenly arranged on the bottom wall of the placement block 16. A pressure plate 19 is installed on the top of the pressure sensor 18. An ejector pin 20 is installed on the top of the pressure plate 19 and is located inside the sleeve 17.

[0057] Furthermore, before injection molding, the electric push rod 13 drives the syringe body 12 downward, and the position of the syringe body 12 is adjusted by the moving component so that the syringe body 12 is aligned with the sleeve 17. Then, the electric push rod 13 is activated again to drive the syringe body 12 into the sleeve 17, so that the ejector pin 20 can be inserted into the injection port of the syringe body 12. If the syringe body 12 is blocked at this time, a downward force will be applied, thereby pushing the ejector pin 20 downward to press the pressure plate 19, thereby increasing the force applied to the pressure sensor 18. At this time, the pressure sensor 18 detects a significant pressure change and displays this change result on the display screen, so that the user can easily judge the blockage of the syringe body 12 and avoid the situation where the syringe body 12 is blocked and affects the injection molding.

[0058] Please see Figure 6 and Figure 8 One embodiment of the present invention provides a dosage-controllable injection molding device for the production of soluble microneedles. The injection molding machine 1 has a lower pressure platform 21 mounted on its top, located in front of the baffle 4. A sealing gasket 22 and evenly distributed support rods 26 are mounted on the top of the lower pressure platform 21, with the support rods 26 located inside the sealing gasket 22. A support plate 27 is mounted on the top of the support rods 26, and the top of the support plate 27 is used to place a covering film 28. An elastic sealing gasket 23 is attached to the top of the sealing gasket 22, and an upper pressure platform 24 is mounted on the top of the elastic sealing gasket 23. Both the upper pressure platform 24 and the lower pressure platform 21 have storage slots on their adjacent surfaces. The inner surfaces of the two sets of storage slots... The upper mold 29 and lower mold 25 are placed evenly. The top of the lower mold 25 is attached to the bottom of the covering film 28, and the bottom of the upper mold 29 is attached to the top of the covering film 28. The bottom wall of the lower storage groove is embedded with an evenly arranged pressure sensor 31. The top of the pressure sensor 31 is attached to the bottom of the lower mold 25. The pressure sensor 31 is used to monitor the amount of injection in the lower mold 25. The top of the upper pressure table 24 is provided with an evenly arranged injection tube 30. The bottom end of the injection tube 30 penetrates the upper mold 29 and punctures the covering film 28. An air extraction pipe is provided on one side of the outer wall of the lower pressure table 21. The air extraction pipe is connected to a vacuum filter.

[0059] Furthermore, before injection molding, the prepared lower mold 25 is placed in the storage slot on the lower pressure table 21, and a cover film 28 is laid on its surface. Then, the upper pressure table 24, which contains the upper mold 29, is placed on top, so that the elastic sealing gasket 23 can contact the sealing gasket 22. At this time, the injection tube 30 will puncture the cover film 28, and then the syringe body 12 will be moved above the injection tube 30 by the moving component. The bottom end of the syringe body 12 is inserted into the injection tube 30 to perform the injection molding operation. During this process, a vacuum filter is used to perform negative pressure filtration between the lower pressure table 21 and the upper pressure table 24, so that the matrix material injected into the lower mold 25 by the syringe body can be evenly distributed in the micro-needle cavity of the lower mold 25, avoiding voids or air bubbles. Moreover, the cover film 28 can prevent the injected matrix material from overflowing, thus improving the injection molding effect.

[0060] Please see Figure 7 and Figure 9 One embodiment of the present invention provides a dosage-controllable injection molding device for the production of soluble microneedles. The injection molding machine 1, the column 2, and the crossbar 3 are all equipped with moving components. The moving components in the injection molding machine 1 are used to drive the two sets of columns 2 to move back and forth. The moving components in the two sets of columns 2 are used to drive the crossbar 3 to move up and down. The moving components in the crossbar 3 are used to drive the mounting plate to move left and right. The moving components include a variable frequency motor 32 installed on the front wall of the injection molding machine 1, the bottom wall of the column 2, and the inner wall of one side of the crossbar 3. The output end of the variable frequency motor 32 is equipped with a reciprocating lead screw 33, and the outer surface of the reciprocating lead screw 33 is sleeved with a sliding sleeve 34.

[0061] Furthermore, during use, the variable frequency motor 32 at the corresponding position is started as needed, which then drives the reciprocating lead screw 33 to rotate, so that the sliding sleeve 34 can move back and forth along the surface of the reciprocating lead screw 33, thereby achieving the purpose of adjusting the position of the syringe body 12.

[0062] Please see Figure 1 and Figure 6 The present invention provides an embodiment of a dosage-controllable injection molding device for the production of soluble microneedles. The injection molding machine 1 is equipped with an online monitoring system, which includes a data acquisition unit, an analysis unit, and a display unit. The data acquisition unit includes a data acquisition module and an image acquisition module. The data acquisition module uses a data acquisition device to collect data monitored by pressure sensor 18 and pressure sensor 31. The image acquisition module collects the distribution of the drug in the microneedle mold by arranging image acquisition devices inside the lower pressure stage 21. The analysis unit uses a central processing unit to analyze the data and image information collected by the acquisition unit. The display unit uses an external display screen to display abnormal situations. The data acquisition device is also used to collect various operating parameters of the injection molding machine 1.

[0063] Furthermore, pressure sensor 18 is used to monitor whether there is any blockage in the syringe body 12, and pressure sensor 31 is used to monitor the distribution of matrix material in the lower mold 25 during the injection molding process. Based on the image acquisition device, it captures and records the image of the matrix material being injected into the lower mold 25 and its distribution in the lower mold 25 after injection. Then, the central processing unit receives the data and image information from the acquisition unit and performs in-depth analysis and processing to determine whether there are any abnormalities in the injection molding process, such as abnormal pressure or uneven drug distribution. This allows for timely alarm issuance or adjustment of production parameters, and the display screen shows the relevant alarm information, including the type of abnormality, location, and possible solutions, helping operators to react quickly. To a certain extent, this enables comprehensive monitoring and intelligent management of the injection molding process.

[0064] Working principle: Before injection molding, the lower mold 25 is first placed in a low temperature constant temperature chamber at -5 to -8℃ and negative pressure for 60 minutes. During this process, electromagnet 2 14 is energized so that it can attract iron block 2 15. Then, electromagnet 1 8 is de-energized and the electric push rod 13 is started to move the placement plate 10 downward. Then, the position of the syringe body 12 on the placement plate 10 is adjusted by the moving component, and the syringe body 12 is inserted into the sleeve 17 by the electric push rod 13 for blockage detection. If the ejector pin 20 is inserted into the syringe body 12 a certain distance and the pressure change detected by the pressure sensor 1 18 is still within the threshold range, there is no blockage. Otherwise, the syringe body 12 is blocked. Then, the blockage detection of the syringe bodies 12 on other placement plates 10 is performed in turn.

[0065] After the lower mold 25 is processed, it is placed in the storage slot in the lower press table 21. Then, a covering film 28 is laid on the placed lower mold 25, and the upper press table 24 is placed on the lower press table 21 for negative pressure filtration.

[0066] Then, the injection pressure and speed are adjusted according to the characteristics of the drug to be injected. The matrix material is quantitatively and automatically injected into the lower mold 25 through the syringe body 12. During the injection process, the injection process is monitored and fed back in real time through the monitoring system. After the injection is completed, the mold is removed and placed in a low temperature constant temperature box, and dried and cured at a low temperature of 25-30 degrees Celsius. After the moisture evaporates, since the lower mold 25 is made of resin material, it can be directly demolded after thermal expansion and contraction, which can improve the demolding efficiency to a certain extent.

[0067] A process for manufacturing soluble microneedles, comprising the following steps:

[0068] (1) Preparation of semi-finished products: Mix the raw materials for the preparation of soluble microneedles and store them at -1℃ for later use;

[0069] (2) Injection molding: The semi-finished product obtained in step (1) is injected into the mold through an injection molding device;

[0070] (3) Remove the mold and place it in a low-temperature constant temperature oven. Dry and solidify at 26°C.

[0071] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

Claims

1. A process for the production of soluble microneedles, characterized by, The production process comprises the following steps: Step a, semi-finished product preparation: the raw materials for preparing the soluble microneedle are mixed and stored at a low temperature of -10-0°C, and then used; Step b, injection molding: the semi-finished product obtained in step a is injected into a mold through an injection molding device; Step c, the mold is taken out and dried and solidified in a constant temperature oven, and then cut; The viscosity of the semi-finished product is 5000-10000 cps; The raw materials for preparing the soluble microneedle comprise sodium hyaluronate; In step a, the raw materials for preparing the soluble microneedle are mixed and stored at a low temperature of -6-2°C, and then used; The injection molding device comprises an injection molding machine (1), and the injection molding machine (1) realizes uniform distribution and accurate control of the medicine in the microneedle through a precise injection molding process. An adjusting assembly is installed on the injection molding machine (1), and the adjusting assembly flexibly adjusts the injection mode according to the characteristics and requirements of the medicine. Two vertical columns (2) are slidably connected to the two sides of the injection molding machine (1), and the surfaces of the two groups of vertical columns (2) that are close to each other are provided with horizontal rods (3). The front surface of the horizontal rod (3) is provided with a mounting plate, and the mounting plate is in an inverted L shape. A magnetic shielding cover (4) is arranged on the inner surface of the mounting plate. The adjusting assembly comprises a storage rack (5) fixed to the top of the mounting plate. The longitudinal section of the storage rack (5) is in a U-shaped structure. A servo motor (6) is installed on the bottom wall of the storage rack (5). A storage disc one (7) is installed at the output end of the servo motor (6), A support column is installed at the bottom center position of the storage disc one (7), and a storage disc two is installed at the bottom of the support column. Magnetic attraction assemblies are uniformly arranged on the outer surfaces of the storage disc one (7) and the storage disc two. A storage plate (10) is installed on the outer surface of the magnetic attraction assembly; A syringe body (12) is embedded in the upper and lower storage plates (10). An iron block two (15) is installed on the top of the upper storage plate (10) and located outside the syringe body (12). Uniformly arranged electric push rods (13) are installed on the top of the mounting plate and located outside the storage rack (5). A connecting plate is installed at the output end of the electric push rod (13), and an electromagnet two (14) is embedded in the bottom of the connecting plate; A storage block (16) is installed on the top of the injection molding machine (1) and located below the shielding cover (4). A sleeve (17) is inserted into the top of the storage block (16). Uniformly arranged pressure sensors one (18) are installed on the bottom wall of the storage block (16). A pressing plate (19) is installed on the top of the pressure sensor one (18). A thimble (20) is installed on the top of the pressing plate (19) and located inside the sleeve (17). The top of the injection molding machine (1) is provided with a lower pressing table (21), the top of the lower pressing table (21) is provided with a sealing pad I (22) and uniformly arranged supporting rods (26), the top of the supporting rods (26) is provided with a supporting plate (27), the top of the supporting plate (27) is used for placing a covering film paper (28), the top of the sealing pad I (22) is attached with an elastic sealing pad (23), the top of the elastic sealing pad (23) is provided with an upper pressing table (24), the surface of the upper pressing table (24) and the lower pressing table (21) that are close to each other are provided with a storage groove, the inner part of the two groups of storage grooves is respectively placed with uniformly arranged upper molds (29) and lower molds (25), the bottom wall of the lower storage groove is inlaid with uniformly arranged pressure sensors II (31), the top of the pressure sensors II (31) is attached with the bottom of the lower mold (25), the top of the upper pressing table (24) is provided with uniformly arranged injection pipes (30), one side of the outer wall of the lower pressing table (21) is provided with an air exhaust pipe, and the air exhaust pipe is connected with a vacuum filter; The use method of the injection molding equipment is as follows: S1, the lower mold (25) is placed in a low temperature constant temperature box, 0℃ low temperature, negative pressure 60min; S2, negative pressure filtration; S3, according to the needs of production, adjusting the injection mode, quantitatively and automatically injecting the matrix material into the lower mold (25) through the syringe main body (12); S4, in the injection molding process, the injection process is monitored and fed back in real time through the monitoring system; S5, after the injection molding is completed, the mold is taken out and placed in a low temperature constant temperature box, 25-30 degrees low temperature drying and curing, after the moisture volatilizes, since the lower mold (25) is made of resin material, it can be directly demolded after thermal expansion and cold contraction.

2. The process for producing dissolvable microneedles according to claim 1, wherein: In the step c, the drying temperature is 10-40℃.

3. The process for producing dissolvable microneedles according to claim 2, wherein: In the step c, the drying temperature is 15-30℃.

4. A dissolvable microneedle, characterized by, Prepared according to the process of claim 3.

5. The dissolvable microneedle of claim 4, wherein, Used in the field of traditional Chinese medicine and skin care.

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