Soluble microneedle production process and injection molding device with controllable dosage thereof

Abstract

The invention discloses a soluble microneedle production process and an injection molding device with controllable dosage thereof, and relates to the technical field of microneedle patch production, the injection molding device comprises an injection molding machine, the injection molding machine realizes uniform distribution and accurate control of drugs in microneedles through a precise injection molding process, the injection molding machine is provided with an adjusting assembly, and the adjusting assembly is connected with the injection molding machine. The adjusting assembly flexibly adjusts the injection mode according to the characteristics and requirements of the medicine; and injector main bodies are embedded in the upper and lower groups of storage plates. By arranging the multiple sets of injector bodies and injecting different medicine matrix materials through the injector bodies at different positions, the injection molding flexibility is improved, the injection speed and flow can be adjusted according to different medicine characteristics and requirements, and therefore the injection molding quality is improved; and the injected matrix material can be uniformly distributed in the lower mold, so that the defects such as cavities or bubbles can be avoided to a certain extent.

Description

Technical Field

[0001] The invention relates to the technical field of microneedle patch production, in particular to a soluble microneedle production process and an injection molding device with controllable drug delivery amount. Background Art

[0002] When producing soluble microneedle patches, the matrix material is mostly injected into the mold through injection molding equipment, and then the matrix material is evenly distributed in the mold through centrifuge oscillation. After one oscillation, the matrix material is filled into the mold again and the centrifugal oscillation is repeated. The operation process is cumbersome and the dosage of the drug in each injection molding process cannot be accurately controlled, which has certain defects.

[0003] The defects of existing microneedle production injection molding equipment are:

[0004] 1. In the application document CN113797435A, the main consideration is how to quickly complete the uniform casting of the large-plane microneedle casting mold, and the problem that the existing microneedle production injection molding equipment cannot adjust the dosage of each injection molding process according to the different characteristics of the drug during use is not considered;

[0005] 2. In the patent document CN216139310U, the main consideration is how to speed up the demoulding speed and improve the yield rate, but it does not take into account that the existing microneedle injection molding equipment does not have a plugging device for the injection device, and the finished product is prone to defects such as holes and bubbles. Summary of the invention

[0006] The object of the present invention is to provide a soluble microneedle production process, the steps of the production process are as follows:

[0007] (1) Preparation of semi-finished products: Mix the raw materials for preparing soluble microneedles and store them at a low temperature of -10°C to 0°C for later use;

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

[0009] (3) Take out the mold and put it into a low-temperature constant temperature box for drying and curing, and then cut it.

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

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

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

[0013] As an embodiment of the present invention, in the step (3), the drying temperature is 10 to 40°C.

[0014] As an embodiment of the present invention, in the step (3), the drying temperature is 15 to 30°C.

[0015] A controllable injection molding device for producing soluble microneedles, comprising an injection molding machine, wherein the injection molding machine realizes uniform distribution and precise control of the drug in the microneedles through a precise injection molding process, and an adjustment component is installed on the injection molding machine, and the adjustment component flexibly adjusts the injection mode according to the characteristics and needs of the drug;

[0016] The two sides of the injection molding machine are slidably connected with columns, and the surfaces of the two groups of columns close to each other are provided with cross bars, and the front of the cross bars is provided with a mounting plate, and the mounting plate is in an inverted L shape, and the inner surface of the mounting plate is provided with a magnetic attraction type baffle, and the adjustment component includes a storage rack fixed on the top of the mounting plate, and the longitudinal section of the storage rack is a U-shaped structure, and a servo motor is installed on the bottom wall of the storage rack, and a storage tray 1 is installed at the output end of the servo motor, and a support column is installed at the bottom center of the storage tray 1, and a storage tray 2 is installed at the bottom of the support column, and the outer surfaces of the storage tray 1 and the storage tray 2 are both installed with evenly arranged magnetic attraction components, and the outer surfaces of the magnetic attraction components are installed with storage plates;

[0017] The upper and lower sets of storage plates are embedded with the syringe body, and a second iron block is installed on the top of the upper storage plate, and the second iron block is located on the outside of the syringe body. Evenly arranged electric push rods are installed on the top of the mounting plate, and the electric push rods are located on the outside of the storage rack. A connecting plate is installed at the output end of the electric push rod, and a second electromagnet is embedded in the bottom of the connecting plate.

[0018] Preferably, a storage block is installed on the top of the injection molding machine, the storage block is located below the baffle, a sleeve is inserted on the top of the storage block, and evenly arranged pressure sensors 1 are installed on the bottom wall of the storage block. A pressure plate is installed on the top of the pressure sensor 1, and a ejector pin is installed on the top of the pressure plate, and the ejector pin is located on the inner side of the sleeve.

[0019] Preferably, a pressing platform is installed on the top of the injection molding machine, and the pressing platform is located on the side front of the baffle cover. A sealing gasket and evenly arranged support rods are installed on the top of the pressing platform, and the support rods are located on the inner side of the sealing gasket. A support plate is installed on the top of the support rods, and the top of the support plate is used to place covering film paper.

[0020] Preferably, an elastic sealing gasket is attached to the top of the sealing gasket one, an upper pressing platform is installed on the top of the elastic sealing gasket, and storage grooves are provided on the surfaces of the upper pressing platform and the lower pressing platform close to each other, and evenly arranged upper molds and lower molds are respectively placed inside the two groups of storage grooves, the top of the lower mold fits with the bottom of the covering film paper, and the bottom of the upper mold fits with the top of the covering film paper, and the bottom wall of the lower storage groove is embedded with evenly arranged pressure sensors two, and the top of the pressure sensor two fits with the bottom of the lower mold, and the pressure sensor two is used to monitor the injection volume in the lower mold.

[0021] Preferably, movable components are evenly distributed inside the injection molding machine, columns and cross bars. The movable components in the injection molding machine are used to drive the two groups of columns to move forward and backward, the movable components in the two groups of columns are used to drive the cross bars to move up and down, and the movable components in the cross bars are used to drive the mounting plate to move left and right. The movable components include a variable frequency motor 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 cross bar. A reciprocating screw is installed at the output end of the variable frequency motor, and a sliding sleeve is sleeved on the outer surface of the reciprocating screw.

[0022] Preferably, the injection molding machine is equipped with an online monitoring system, which includes an acquisition unit, an analysis unit and a display unit. The 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 1 and pressure sensor 2. The image acquisition module collects the distribution of the drug in the microneedle mold by arranging an image acquisition device inside the lower pressure table. The analysis unit uses a central processing unit to analyze the data information and image information collected by the acquisition unit. The display unit uses an external display screen to display abnormal conditions. The data acquisition device is also used to collect various operating parameters of the injection molding machine.

[0023] Preferably, the top of the upper pressing platform is provided with uniformly arranged injection tubes, and the bottom ends of the injection tubes penetrate the upper mold and puncture the covering film paper.

[0024] Preferably, the magnetic attraction component includes an electromagnet 1 evenly arranged on the outer surfaces of the first and second storage plates, an iron block 1 is arranged on the inner surface of the storage plate, and the iron block 1 is attracted to the electromagnet 1, a connecting rod is installed at the bottom of the upper storage plate, the bottom end of the connecting rod is connected to the top of the lower storage plate, and the connecting rod is located on both sides of the syringe body.

[0025] Preferably, an exhaust pipe is provided on one side outer wall of the lower pressing platform, and the exhaust pipe is connected to the vacuum filter.

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

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

[0028] S2, negative pressure filtration;

[0029] S3, adjusting the injection mode according to production needs, and quantitatively and automatically injecting the matrix material into the lower mold through the syringe body;

[0030] S4. During the injection molding process, the monitoring system monitors and feeds back the injection process in real time;

[0031] S5. After the injection molding is completed, take out the mold and put it into a low-temperature constant temperature box for drying and curing at a low temperature of 25 to 30 degrees. After the moisture evaporates, since the lower mold is made of resin material, it can be demoulded directly after thermal expansion and contraction.

[0032] A soluble microneedle production process, the steps of the production process are as follows:

[0033] (1) Preparation of semi-finished products: Mix the raw materials for preparing soluble microneedles and store them at a low temperature of -10°C to 0°C for later use;

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

[0035] (3) Take out the mold and put it into a low temperature constant temperature box, dry and solidify it at a low temperature of 25-30℃.

[0036] Compared with the prior art, the present invention has the following beneficial effects:

[0037] 1. The present invention improves the flexibility of injection molding by providing multiple groups 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 properties and requirements, thereby improving the quality of injection molding, and cooperates with negative pressure filtration to make the injected matrix material evenly distributed in the lower mold, thereby avoiding defects such as cavities or bubbles to a certain extent.

[0038] 2. The present invention uses a ejector pin and a pressure sensor to detect the blockage of the syringe body at different positions before injection molding, thereby avoiding the situation where the injection molding effect is affected by the blockage of the syringe body, and thus improving the injection molding quality and the quality and effect of the soluble microneedles to a certain extent.

[0039] 3. Before injection molding, the present invention places the processed lower mold into the storage groove on the lower pressing table, and lays covering film paper on its surface, and then covers the upper pressing table equipped with the upper mold so that the elastic sealing gasket can contact the sealing gasket. At this time, the injection tube will pierce the covering film paper, and then the syringe body is driven to move above the syringe through the moving component, and the bottom end of the syringe body is inserted into the syringe for injection molding. During this process, a negative pressure filtration operation is performed between the lower pressing table and the upper pressing table through a vacuum filter, so that the matrix material injected into the lower mold by the syringe body can be evenly distributed in the microneedle cavity in the lower mold, avoiding the occurrence of voids or bubble defects, and through the setting of the covering film paper, the injected matrix material can be prevented from overflowing, thereby improving the effect of injection molding.

[0040] 4. The present invention monitors the distribution of the matrix material in the lower mold during the injection molding process through the second pressure sensor, and captures and records the image of the matrix material injected into the lower mold and the distribution in the lower mold after injection according to the arranged image acquisition device, so as to determine whether there is uneven drug distribution and abnormal pressure during the injection molding process, so as to issue an alarm or adjust the production parameters in time, thereby realizing comprehensive monitoring and intelligent management of the injection molding process. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

[0043] Figure 3 A top view of a storage tray 1 of the present invention;

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

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

[0046] Figure 6 It is a schematic diagram of the planar assembly structure of the lower pressing platform and the upper pressing platform of the present invention;

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

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

[0049] Fig. 9 It is a schematic diagram of the planar assembly structure of the movable components in the injection molding machine of the present invention.

[0050] In the figure: 1. injection molding machine; 2. column; 3. cross bar; 4. baffle; 5. storage rack; 6. servo motor; 7. storage tray 1; 8. electromagnet 1; 9. iron block 1; 10. storage plate; 11. connecting rod; 12. syringe body; 13. electric push rod; 14. electromagnet 2; 15. iron block 2; 16. storage block; 17. sleeve; 18. pressure sensor 1; 19. pressure plate; 20. ejector pin; 21. lower press table; 22. sealing gasket 1; 23. elastic sealing gasket; 24. upper press 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. frequency conversion motor; 33. reciprocating screw; 34. sliding sleeve. DETAILED DESCRIPTION

[0051] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0052] In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", "front end", "rear end", "two ends", "one end", "the other end" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0053] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "provided with", "connected", etc. should be understood in a broad sense. For example, "connected" 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 it can be an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0054] See also Figure 1 , Figure 2 , Figure 3 and Figure 4, an embodiment of the present invention: a controllable injection molding device for producing soluble microneedles, comprising an injection molding machine 1, and the injection molding machine 1 realizes 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, and the adjustment component flexibly adjusts the injection mode according to the characteristics and needs of the drug, columns 2 are slidably connected on both sides of the injection molding machine 1, and a cross bar 3 is arranged on the surfaces of the two groups of columns 2 close to each other, and a mounting plate is arranged on the front of the cross bar 3, the mounting plate is in an inverted L shape, and a magnetic baffle 4 is arranged on the inner surface of the mounting plate, the adjustment component comprises a storage rack 5 fixed on the top of the mounting plate, the longitudinal section of the storage rack 5 is a U-shaped structure, a servo motor 6 is installed on the bottom wall of the storage rack 5, a storage tray 7 is installed on the output end of the servo motor 6, a support column is installed at the bottom center of the storage tray 7, and a storage tray 2 is installed at the bottom of the support column. The outer surfaces of the disk 1 7 and the storage disk 2 are both installed with uniformly arranged magnetic suction components, and the outer surface of the magnetic suction component is installed with a storage plate 10, and the upper and lower groups of storage plates 10 are embedded with a syringe body 12, and the top of the upper storage plate 10 is installed with an iron block 2 15, and the iron block 2 15 is located on the outside of the syringe body 12, and the top of the mounting plate is installed with uniformly arranged electric push rods 13, and the electric push rods 13 are located on the outside of the storage rack 5, and the output end of the electric push rod 13 is installed with a connecting plate, and the bottom of the connecting plate is embedded with an electromagnet 2 14, and the magnetic suction component includes an electromagnet 8 uniformly arranged on the outer surfaces of the storage disk 1 7 and the storage disk 2, and the inner surface of the storage plate 10 is provided with an iron block 9, and the iron block 9 is attracted to the electromagnet 8, and the bottom of the upper storage plate 10 is installed with a connecting rod 11, and the bottom end of the connecting rod 11 is connected to the top of the lower storage plate 10, and the connecting rod 11 is located on both sides of the syringe body 12.

[0055] Further, when using the injection molding device, first select the medicine to be injected, then start the servo motor 6 in the storage rack 5, drive the storage plate 7 to rotate, so as to adjust the position of different syringe bodies 12, then energize one group of electromagnets 14, and start the electric push rod 13 to drive the connecting plate to move downward, so that the electromagnet 14 can be attracted with the iron block 15, then the electromagnet 8 at this position is de-energized, so that the electric push rod 13 can push the storage plate 10 to move downward, and then the syringe body 12 on the storage plate 10 can be driven to move out of the baffle 4, and the removed syringe cone sleeve 12 is detected for blockage. After the monitoring is completed, it is moved to the position where injection is required through the moving component, and the injection speed and flow rate are adjusted according to the characteristics and requirements of the medicine in the syringe body 12, so as to improve the quality of the injection molding, and cooperate with the negative pressure filtration, so that the injected matrix material can be evenly distributed in the lower mold 25, and defects such as cavities or bubbles can be avoided to a certain extent.

[0056] See also Figure 1 and Figure 5An embodiment of the present invention is: an injection molding device with controllable dosage for producing soluble microneedles, a placement block 16 is installed on the top of the injection molding machine 1, the placement block 16 is located below the baffle 4, a sleeve 17 is inserted on the top of the placement block 16, and a uniformly arranged pressure sensor 18 is installed on the bottom wall of the placement block 16, a pressure plate 19 is installed on the top of the pressure sensor 18, and a ejector pin 20 is installed on the top of the pressure plate 19, and the ejector pin 20 is located on the inner side of the sleeve 17.

[0057] Furthermore, before injection molding, the electric push rod 13 is used to drive the syringe body 12 to move downward, and the position of the syringe body 12 is adjusted by the moving assembly so that the syringe body 12 can be aligned with the sleeve 17, and then the electric push rod 13 is started again to drive the syringe body 12 to be inserted into the sleeve 17, so that the ejector pin 20 can be inserted into the injection port of the syringe body 12. At this time, if the syringe body 12 is blocked, a downward force will be applied to push the ejector pin 20 to press the pressure plate 19 downward, thereby increasing the force applied to the pressure sensor 18. At this time, the pressure sensor 18 detects an obvious pressure change and displays the change result on the display screen, thereby facilitating the user to judge the blockage condition of the syringe body 12 and avoiding the situation where the syringe body 12 is blocked and affects the injection molding.

[0058] See also Figure 6 and Figure 8 An embodiment of the present invention is: an injection molding device with controllable dosage for producing soluble microneedles, wherein a lower pressing platform 21 is installed on the top of the injection molding machine 1, and the lower pressing platform 21 is located on the side and front of the baffle 4, and a sealing gasket 22 and evenly arranged support rods 26 are installed on the top of the lower pressing platform 21, and the support rods 26 are located on the inner side of the sealing gasket 22, and a support plate 27 is installed on the top of the support rod 26, and the top of the support plate 27 is used to place a covering film paper 28, and an elastic sealing gasket 23 is attached to the top of the sealing gasket 22, and an upper pressing platform 24 is installed on the top of the elastic sealing gasket 23, and the surfaces of the upper pressing platform 24 and the lower pressing platform 21 close to each other are provided with storage grooves, and the inner surfaces of the two groups of storage grooves are provided with storage grooves. The upper mold 29 and the lower mold 25 are respectively placed thereon in an evenly arranged manner. The top of the lower mold 25 fits with the bottom of the covering film paper 28, and the bottom of the upper mold 29 fits with the top of the covering film paper 28. The bottom wall of the lower storage groove is embedded with evenly arranged pressure sensors 31. The top of the pressure sensor 31 fits with the bottom of the lower mold 25. The pressure sensor 31 is used to monitor the injection volume in the lower mold 25. The top of the upper pressing platform 24 is provided with evenly arranged injection tubes 30. The bottom end of the injection tube 30 penetrates the upper mold 29 and then punctures the covering film paper 28. An exhaust pipe is provided on the outer wall of one side of the lower pressing platform 21, and the exhaust pipe is connected to the vacuum filter.

[0059] Furthermore, before injection molding, the processed lower mold 25 is placed in the storage groove on the lower press table 21, and a covering film paper 28 is laid on its surface, and then the upper press table 24 equipped with the upper mold 29 is covered, so that the elastic sealing gasket 23 can contact the sealing gasket 22. At this time, the injection tube 30 will pierce the covering film paper 28, and then the syringe body 12 is driven by the moving component to move above the injection tube 30, and the bottom end of the syringe body 12 is inserted into the injection tube 30 for injection molding. During this process, a negative pressure filtration operation is performed between the lower press table 21 and the upper press table 24 through a vacuum filter, so that the matrix material injected into the lower mold 25 by the syringe body can be evenly distributed in the microneedle cavity in the lower mold 25, avoiding the occurrence of voids or bubble defects, and through the setting of the covering film paper 28, the injected matrix material can be prevented from overflowing, thereby improving the injection molding effect.

[0060] See also Figure 7 and Fig. 9 An embodiment of the present invention provides: an injection molding device with controllable dosage for producing soluble microneedles, wherein movable components are evenly distributed inside the injection molding machine 1, the columns 2 and the cross bar 3, the movable components in the injection molding machine 1 are used to drive the two groups of columns 2 to move forward and backward, the movable components in the two groups of columns 2 are used to drive the cross bar 3 to move up and down, and the movable components in the cross bar 3 are used to drive the mounting plate to move left and right, and the movable 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 on one side of the cross bar 3, and a reciprocating screw 33 is installed at the output end of the variable frequency motor 32, and a sliding sleeve 34 is sleeved on the outer surface of the reciprocating screw 33.

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

[0062] See also Figure 1 and Figure 6 An embodiment of the present invention is: an injection molding device with controllable dosage for producing soluble microneedles, the injection molding machine 1 is equipped with an online monitoring system, the online monitoring system includes a collection unit, an analysis unit and a display unit, the collection unit includes a data collection module and an image collection module, the data collection module uses a data collector to collect data monitored by pressure sensor 18 and pressure sensor 2 31, the image collection module collects the distribution of drugs in the microneedle mold by arranging an image collection device inside the lower pressure table 21, the analysis unit uses a central processing unit to analyze the data information and image information collected by the collection unit, the display unit uses an external display screen to display abnormal conditions, and the data collector is also used to collect various operating parameters of the injection molding machine 1.

[0063] Furthermore, the pressure sensor 18 is used to monitor whether the syringe body 12 is blocked, and the pressure sensor 2 31 is used to monitor the distribution of the matrix material in the lower mold 25 during the injection molding process, and capture and record the image of the matrix material injected into the lower mold 25 at the moment and the distribution in the lower mold 25 after injection according to the arranged image acquisition device, and then receive the data information and image information from the acquisition unit through the central processor, and conduct in-depth analysis and processing to determine whether there are abnormal conditions in the injection molding process, such as abnormal pressure and uneven drug distribution, so as to issue an alarm or adjust the production parameters in time, and display relevant alarm information through the display screen, including the abnormal type, location and possible solutions, etc., to help the operator respond quickly, and to a certain extent, it can realize comprehensive monitoring and intelligent management of the injection molding process.

[0064] Working principle: before injection molding, first put the lower mold 25 into a low temperature constant temperature box, at a low temperature of -5 to -8℃ and negative pressure for 60 minutes. During this process, energize the electromagnet 14, and then enable it to attract the iron block 15. Then, de-energize the electromagnet 18, and then start the electric push rod 13 to drive the placement plate 10 to move downward. Then, adjust the position of the syringe body 12 on the placement plate 10 through the moving component, and drive the syringe body 12 to insert into the sleeve 17 through the electric push rod 13 for blockage detection. If the ejector pin 20 is inserted into the syringe body 12 for a distance and the pressure change detected by the pressure sensor 18 is still within the threshold range, it is not blocked. Otherwise, the syringe body 12 is blocked. Then, the syringe bodies 12 on other placement plates 10 are tested for blockage in turn.

[0065] After the lower mold 25 is processed, it is placed in the storage tank in the lower pressing platform 21, and then a covering film 28 is laid on the placed lower mold 25, and the upper pressing platform 24 is covered on the lower pressing platform 21, and negative pressure filtration is performed;

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

[0067] A soluble microneedle production process, the steps of the production process are as follows:

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

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

[0070] (3) Take out the mold and put it into a low temperature constant temperature box, dry and solidify it at 26℃.

[0071] It will be apparent to those skilled in the art that the 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 the spirit or essential features of the invention. Therefore, the embodiments should be considered exemplary and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description, and it is intended that all variations falling within the meaning and scope of the equivalent elements of the claims be included in the invention. Any reference numeral in a claim should not be considered as limiting the claim to which it relates.

Claims

1. A soluble microneedle production process, characterized in that: The steps of the production process are as follows: (1) Preparation of semi-finished products: Mix the raw materials for preparing soluble microneedles and store them at a low temperature of -10°C to 0°C for later use; (2) Injection molding: injecting the semi-finished product obtained in step (1) into a mold through an injection molding device; (3) Take out the mold and put it into a low-temperature constant temperature box for drying and curing, and then cut it.

2. A soluble microneedle production process according to claim 1, characterized in that: The viscosity of the semi-finished product is 5000-10000 cps.

3. A soluble microneedle production process according to claim 1, characterized in that: The raw materials for preparing the soluble microneedles include sodium hyaluronate.

4. A soluble microneedle production process according to claim 1, characterized in that: In the step (1), the raw materials for preparing the soluble microneedles are mixed and stored at a low temperature of -6°C to 2°C for later use.

5. A soluble microneedle production process according to claim 1, characterized in that: In the step (3), the drying temperature is 10 to 40°C.

6. A soluble microneedle production process according to claim 1, characterized in that: In the step (3), the drying temperature is 15 to 30°C.

7. An injection molding device with controllable dosage for the soluble microneedle production process according to any one of claims 1 to 6, characterized in that: The invention comprises an injection molding machine (1), wherein the injection molding machine (1) realizes uniform distribution and precise control of the drug in the microneedle through a precise injection molding process, and an adjustment component is installed on the injection molding machine (1), and the adjustment component flexibly adjusts the injection mode according to the characteristics and needs of the drug; The two sides of the injection molding machine (1) are slidably connected with columns (2), and the surfaces of the two groups of columns (2) close to each other are provided with cross bars (3), and the front of the cross bars (3) is provided with a mounting plate, and the mounting plate is in an inverted L shape, and the inner surface of the mounting plate is provided with a magnetic attraction type baffle (4), and the adjustment component includes a storage rack (5) fixed on the top of the mounting plate, and the longitudinal section of the storage rack (5) is in a U-shaped structure, and the bottom wall of the storage rack (5) is installed with a servo motor (6), and the output end of the servo motor (6) is installed with a storage tray (7), and a support column is installed at the bottom center of the storage tray (7), and the bottom of the support column is installed with a storage tray (2), and the outer surfaces of the storage tray (7) and the storage tray (2) are both installed with evenly arranged magnetic attraction components, and the outer surfaces of the magnetic attraction components are installed with a storage plate (10); The upper and lower sets of storage plates (10) are embedded with a syringe body (12); a second iron block (15) is installed on the top of the upper storage plate (10); the second iron block (15) is located outside the syringe body (12); evenly arranged electric push rods (13) are installed on the top of the installation plate; the electric push rods (13) are located outside the storage rack (5); a connecting plate is installed at the output end of the electric push rod (13); and a second electromagnet (14) is embedded at the bottom of the connecting plate.

8. A method for using an injection molding device with controllable dosage for producing soluble microneedles, applicable to the injection molding device with controllable dosage for producing soluble microneedles according to claim 7, characterized in that: The use of injection molding equipment is as follows: S1, placing the lower mold (25) into a low temperature constant temperature box, at 0°C and negative pressure for 60 minutes; S2, negative pressure filtration; S3, adjusting the injection mode according to production needs, and quantitatively and automatically injecting the matrix material into the lower mold (25) through the syringe body (12); S4. During the injection molding process, the monitoring system monitors and feeds back the injection process in real time; S5. After the injection molding is completed, the mold is taken out and placed in a low temperature constant temperature box, and dried and solidified at a low temperature of 25-30 degrees. After the water evaporates, since the lower mold (25) is made of resin material, it can be directly demoulded after thermal expansion and contraction.

9. A soluble microneedle, characterized in that: Prepared according to the process according to any one of claims 1 to 6.

10. The soluble microneedle according to claim 9, characterized in that: Used in traditional Chinese medicine and skin care fields.

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