A concentration and purification device based on polypeptide drug production and its preparation method

Abstract

The present invention proposes a concentration and purification device based on polypeptide drug production and a preparation method thereof, which relates to the technical field of polypeptide drug production. A stirring inclined plate is provided, which pushes the mixed solution downward, and the solution reaching the bottom then moves outward, and the solution reaching the outside returns to the upper layer to form a circular circulation trajectory. A scraper body with a scraper circulation groove is provided. The scraper body scrapes off polypeptide macromolecules adsorbed on the surface of the semipermeable membrane. The polypeptide macromolecules return to the upper solution under the action of the solution circulation trajectory and are fully mixed with the original solution. The solution moving outward assists the polypeptide macromolecules to move outward in the scraper circulation groove. The fan blade body cuts the polypeptide macromolecules on the one hand and provides auxiliary thrust for the movement of the solution on the other hand. When the scraped polypeptide macromolecules return to the upper solution, they are fully mixed with the original solution under the action of the stirring plate corrugated groove, the swing plate body and the swing plate corrugated groove, effectively preventing the membrane pores from being blocked and ensuring the quality of the product.

Description

Technical Field

[0001] The present invention relates to the technical field of polypeptide drug production, and in particular to a concentration and purification device based on polypeptide drug production and a preparation method thereof. Background Art

[0002] The concentration and purification device for peptide drug production is a device used to remove impurities, solvents, etc. from the mixed liquid in the peptide drug production process through physical or chemical methods to increase the concentration of the peptide drug and achieve a higher purity.

[0003] In Chinese patent publication number CN218025894U, the utility model discloses a concentration and purification device for the production of recombinant polypeptide drugs, which includes: a box body, a feed port is respectively provided at the top and bottom of the box body, and a plug cover is connected to the feed port; a filter membrane assembly, the filter membrane assembly is sealed and connected to the inner side wall of the box body on all sides; an anti-blocking rotating scraping and sweeping assembly, the anti-blocking rotating scraping and sweeping assembly is rotatably connected to the box body, and the scraping portion in the anti-blocking rotating scraping and sweeping assembly contacts the filter membrane assembly; a first air compressor, the first air compressor is fixedly connected to the outer side wall of the box body, and the first air outlet pipe of the first air compressor is connected to the inner cavity of the box body; a second air compressor, the second air compressor is fixedly connected to the outer side wall of the box body, and the second air outlet pipe of the second air compressor is connected to the inner cavity of the box body, and the first air outlet pipe and the second air outlet pipe are respectively located on both sides of the filtration direction of the filter membrane assembly; an exhaust valve, the exhaust valve is connected to the box body. The novel structure is simple, prevents blockage, and has high purification efficiency.

[0004] When using existing concentration and purification equipment for the production of polypeptide drugs, the mixed solution is purified through a semipermeable membrane, the solvent is separated from the solution, and the polypeptide is retained on the surface of the semipermeable membrane. The polypeptide adsorbed on the surface of the semipermeable membrane will clog the membrane pores, resulting in a significant decrease in membrane flux, affecting the efficiency of concentration and purification. At the same time, membrane clogging will extend the residence time of the polypeptide on the membrane surface, which can easily cause the polypeptide to denature, degrade or aggregate, thereby affecting the quality and activity of the product. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to overcome the defects of the existing technology. The present invention proposes a concentration and purification device based on the production of polypeptide drugs and a preparation method thereof, which solves the problem of polypeptide adsorption on the surface of the semipermeable membrane causing membrane pore blockage.

[0006] To solve the above technical problems, the technical solution adopted by the present invention is: a concentration and purification device based on polypeptide drug production, comprising: a polypeptide drug concentration and purification box, the top of the polypeptide drug concentration and purification box is fixedly connected to a device motor, the output end of the device motor is fixedly connected to a rotating rod, the side of the rotating rod is fixedly connected to a mixing and stirring plate, the interior of the mixing and stirring plate is fixedly connected to a connecting block, the side of the connecting block is movably connected to a swing plate rotating shaft, the outer wall of the swing plate rotating shaft is fixedly connected to a swing plate body, the side of the swing plate body is fixedly connected to a swing plate spring, the swing plate spring and the mixing and stirring plate are fixedly connected, the outer wall of the rotating rod is fixedly connected to a stirring inclined plate, the bottom of the stirring inclined plate is provided with a scraper body, the scraper body and the rotating rod are fixedly connected, a scraper circulation groove is opened inside the scraper body, the inner wall of the scraper circulation groove is fixedly connected to a connecting rod limiting plate, the bottom of the connecting rod limiting plate is penetrated by a fan blade connecting rod, the outer wall of the fan blade connecting rod is fixedly connected to the fan blade body, and the bottom of the scraper body is tightly fitted with a semipermeable membrane body.

[0007] Preferably, a semipermeable membrane mounting frame is provided on the side of the semipermeable membrane body, and the semipermeable membrane mounting frame is fixedly connected to the polypeptide drug concentration and purification box. The bottom of the scraper body is tightly fitted with a porous support plate, and the porous support plate is fixedly connected to the polypeptide drug concentration and purification box.

[0008] Preferably, a pair of swing plate springs are symmetrically arranged about the horizontal center axis of the swing plate body, and the swing plate springs play a buffering role.

[0009] Preferably, a peristaltic pump is fixedly connected to the side of the polypeptide drug concentration and purification box, and the peristaltic pump plays a role of pressurization.

[0010] Preferably, the inner wall of the mixing and stirring plate is provided with a stirring plate corrugated groove, and the side of the stirring plate corrugated groove is provided with a stirring plate inner hole, and the stirring plate inner hole runs through the interior of the mixing and stirring plate.

[0011] Preferably, the outer wall of the swing plate body is provided with swing plate corrugated grooves, and seven pairs of the swing plate corrugated grooves are symmetrically arranged about the horizontal center axis of the swing plate body.

[0012] Preferably, an inclined scraper is fixedly connected to the side of the scraper circulation groove, and a plurality of scraper guide grooves are opened at equal intervals on the outer wall of the inclined scraper.

[0013] Preferably, one end of the fan blade connecting rod is fixedly connected to a rotating gear, the bottom of the rotating gear is engaged with a vertical gear body, and the bottom of the vertical gear body is fixedly connected to a vertical gear fixing rod.

[0014] Preferably, the rotating gear, the vertical gear body and the vertical gear fixing rod are all located inside the rotating rod, the rotating rod is hollow, and the vertical gear fixing rod is fixedly connected to the polypeptide drug concentration and purification box.

[0015] A method for preparing a concentration and purification device for producing polypeptide drugs, comprising the following steps:

[0016] S1. Pour the polypeptide drug solution into the polypeptide drug concentration and purification box, start the device motor and peristaltic pump, and the peristaltic pump pressurizes the polypeptide drug concentration and purification box, applying sufficient pressure. The polypeptide drug solution passes through the semipermeable membrane body to separate the solvent from the solution, while the polypeptide is retained, thereby achieving the purpose of concentration and purification. The device motor drives the rotating rod to rotate. Under the action of the rotating rod, the mixing stirring plate, the stirring inclined plate, and the scraper body begin to rotate. When the stirring inclined plate stirs the polypeptide drug solution, the stirring simultaneously generates a downward thrust, causing the polypeptide drug solution to move downward, and the polypeptide drug solution is fully in contact with the semipermeable membrane body, thereby increasing the concentration speed. After reaching the bottom, the polypeptide drug solution moves toward the edge under the action of the thrust, moves upward after reaching the edge, and finally returns to the upper layer, forming a circular flow trajectory;

[0017] S2. During the rotation of the scraper body, the polypeptide macromolecules adsorbed on the surface of the semipermeable membrane body are scraped off. The polypeptide macromolecules enter the interior of the scraper flow groove under the action of the inclined scraper and the scraper guide groove. At this time, the solution flowing toward the edge enters the scraper flow groove, driving the polypeptide macromolecules to move to the outermost side of the scraper flow groove. At the same time, during the rotation of the scraper body, the rotating gear is driven to move. The rotating gear rotates around the vertical central axis of the vertical gear body. The rotating gear drives the fan blade connecting rod and the fan blade body to rotate. The rotating fan blade body cuts the polypeptide macromolecules and generates an outward thrust to assist the trajectory of the solution flow and transfer the polypeptide macromolecules to the outermost side of the scraper flow groove.

[0018] S3. The polypeptide macromolecules moved to the outside are mixed with the solution and return to the top according to the flow trajectory. At this time, when the mixing stirring plate rotates, the mixed solution contacts the stirring plate corrugated groove and the inner hole of the stirring plate. Part of the solution flows out from the inner hole of the stirring plate, and part of the solution fluctuates under the action of the stirring plate corrugated groove. The fluctuating solution contacts the swing plate body, and the solution collides with the swing plate corrugated groove, causing the swing plate body to swing up and down around the swing plate rotation axis to generate turbulence, so that the upper solution and the polypeptide macromolecules are fully mixed, and the swing plate spring plays a buffering role.

[0019] Compared with the prior art, the beneficial effects of the present invention include: a stirring inclined plate is provided, which pushes the mixed solution downward, and the solution reaching the bottom then moves outward, and the solution reaching the outside returns to the upper layer to form a circulating circulation trajectory, and a scraper body with a scraper circulation groove is provided. The scraper body scrapes off the polypeptide macromolecules adsorbed on the surface of the semipermeable membrane, and the polypeptide macromolecules return to the upper solution under the action of the solution circulation trajectory and are fully mixed with the original solution. The solution moving outward assists the polypeptide macromolecules to move outward in the scraper circulation groove. The fan blade body cuts the polypeptide macromolecules on the one hand and provides auxiliary thrust for the movement of the solution on the other hand. When the scraped polypeptide macromolecules return to the upper solution, they are fully mixed with the original solution under the action of the stirring plate corrugated groove, the swinging plate body, and the swinging plate corrugated groove, so that the polypeptide macromolecules and the original solution can be fully and evenly mixed, avoiding the situation of local uneven concentration, effectively preventing membrane pore blockage, and ensuring product quality. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The disclosure of the present invention is illustrated with reference to the accompanying drawings. It should be understood that the drawings are for illustrative purposes only and are not intended to limit the scope of protection of the present invention. In the accompanying drawings, the same reference numerals are used to refer to the same components. Among them:

[0021] Figure 1 This is a schematic front view of the structure of a concentration and purification device for producing polypeptide drugs according to one embodiment of the present invention;

[0022] Figure 2 This is a schematic cross-sectional view of a polypeptide drug concentration and purification box according to one embodiment of the present invention;

[0023] Figure 3 is an enlarged structural schematic diagram of a mixing and stirring plate portion according to one embodiment of the present invention;

[0024] Figure 4 is a schematic cross-sectional structural diagram of a mixing and stirring plate portion according to one embodiment of the present invention;

[0025] Figure 5 is an enlarged structural schematic diagram of a swing plate body according to one embodiment of the present invention;

[0026] Figure 6 is an enlarged structural schematic diagram of a semipermeable membrane body according to one embodiment of the present invention;

[0027] Figure 7 is an enlarged structural schematic diagram of a scraper body portion proposed according to one embodiment of the present invention;

[0028] Figure 8 is an enlarged structural schematic diagram of a rotating gear part according to one embodiment of the present invention;

[0029] Figure 9 is an enlarged structural diagram of a fan blade body according to one embodiment of the present invention;

[0030] Figure 10 Schematic diagram of the explosion structure of the semipermeable membrane body according to one embodiment of the present invention.

[0031] Numbers in the figure: 1. Peptide drug concentration and purification box; 2. Device motor; 3. Rotating rod; 4. Mixing stirring plate; 5. Connecting block; 6. Swinging plate shaft; 7. Swinging plate body; 8. Swinging plate spring; 9. Stirring inclined plate; 10. Scraper body; 11. Scraper circulation groove; 12. Connecting rod limit plate; 13. Fan blade connecting rod; 14. Fan blade body; 15. Semipermeable membrane body; 16. Semipermeable membrane mounting bracket; 17. Porous support plate; 18. Peristaltic pump; 19. Stirring plate corrugated groove; 20. Stirring plate inner hole; 21. Swinging plate corrugated groove; 22. Inclined scraper; 23. Scraper guide groove; 24. Rotating gear; 25. Vertical gear body; 26. Vertical gear fixing rod. DETAILED DESCRIPTION

[0032] It is easy to understand that according to the technical solution of the present invention, without changing the essential spirit of the present invention, a person skilled in the art can propose a variety of interchangeable structural modes and implementation modes. Therefore, the following specific embodiments and drawings are only exemplary descriptions of the technical solution of the present invention and should not be regarded as the entire invention or as a limitation or restriction of the technical solution of the present invention.

[0033] According to the embodiment of the present invention, Figures 1 to 10 Shown.

[0034] The concentration and purification device for peptide drug production is a device used to remove impurities, solvents, etc. from the mixed solution in the peptide drug production process by physical or chemical methods, thereby increasing the concentration of the peptide drug and achieving a higher purity. By utilizing the selective permeability of the semipermeable membrane, under the pressure provided by the peristaltic pump 18, the solvent in the peptide drug solution is separated through the semipermeable membrane, while the peptide molecules are retained due to their large size, thereby achieving the concentration of the solution. In the concentration and purification process of peptide drug production, the peristaltic pump 18 is used to generate a certain pressure. At this time, the peptide drug mixed solution is filtered through the semipermeable membrane body 15 to achieve the purpose of purification. The peptide drug concentration and purification device is used The semipermeable membrane is a thin film with a specific pore size and selective permeability. The pore size is between that of polypeptide molecules and solvent molecules. Under the action of the semipermeable membrane body 15, the solvent is separated from the solution, while the polypeptide is retained on the surface of the semipermeable membrane body 15. The polypeptide adsorbed on the surface of the semipermeable membrane body 15 will block the membrane pores. After the membrane pores are blocked, the resistance of the solution through the membrane increases. Under the same operating pressure, the membrane flux decreases significantly, affecting the efficiency of concentration and purification. At the same time, membrane blockage causes the residence time of the polypeptide on the membrane surface to be prolonged, which can easily cause the polypeptide to denature, degrade or aggregate, thereby affecting the quality and activity of the product. In order to solve this problem, the present invention has made the following design:

[0035] A concentration and purification device for peptide drug production includes: a peptide drug concentration and purification box 1, which provides a relatively closed environment for the concentration and purification process of peptide drugs, prevents the entry of external impurities, ensures the purity of the purification process, and also prevents the internal peptide solution from being contaminated and interfered with by external factors. The top of the peptide drug concentration and purification box 1 is fixedly connected to a device motor 2. The working principle of the device motor 2 is based on the law of electromagnetic induction. When three-phase alternating current is passed through the stator winding of the motor, a rotating magnetic field is generated. This rotating magnetic field cuts the rotor winding, generating an induced electromotive force and an induced current in the rotor winding. The rotor current is affected by the electromagnetic force under the action of the rotating magnetic field, thereby causing the rotor to rotate. The rotor is connected to the stirring shaft through a coupling or other transmission device, driving the stirring blades to rotate, thereby achieving stirring and mixing of liquids, powders and other materials. The device motor 2 is used to drive the synchronous operation of the stirring device and the scraping device. The output end of the device motor 2 is fixedly connected to the rotating rod 3, and the side of the rotating rod 3 is fixedly connected to the mixing stirring plate 4. The inside of the mixing stirring plate 4 is fixedly connected to the connecting block 5, and the connecting block 5 is set in a triangle. When the solution contacts the movable connecting block 5, the sharp corner part of the connecting block 5 disturbs and divides the solution flow. The solution is diverted at the sharp corner, which has a cutting effect. The side of the connecting block 5 is movably connected to the swing plate shaft 6, and the outer wall of the swing plate shaft 6 is fixedly connected to the swing plate body 7. The swing plate body 7 is in the solution. The swing plate 7 swings up and down under the impact, breaking the original flow state of the solution and making the solution produce a more complex flow field. In the process of concentration and purification, the polypeptide molecules can diffuse faster from the high concentration area to the low concentration area, so that the polypeptide macromolecules are mixed more evenly with the original solution, avoiding the situation where the local concentration is too high or too low. The side of the swing plate body 7 is fixedly connected with a swing plate spring 8, which plays the role of buffering and elastic support. The elastic restoring force of the swing plate spring 8 will prompt the swing plate body 7 to quickly return to a certain position after the impact, and in the subsequent solution impact process, its elastic support characteristics are used to help the swing plate body 7 to swing up and down more smoothly. The swing plate spring 8 is fixedly connected to the mixing stirring plate 4, and the outer wall of the rotating rod 3 is fixed. It is connected to a stirring inclined plate 9, which is tilted. The stirring inclined plate 9 generates a downward thrust when rotating, pushing the mixed solution to contact the semipermeable membrane. A scraper body 10 is provided at the bottom of the stirring inclined plate 9. The scraper body 10 is used to scrape off the polypeptide macromolecules covering the surface of the semipermeable membrane. The scraper body 10 is fixedly connected to the rotating rod 3. A scraper circulation groove 11 is provided inside the scraper body 10. The scraper circulation groove 11 is used to transfer and transport the scraped polypeptide macromolecules. The inner wall of the scraper circulation groove 11 is fixedly connected to a connecting rod limiting plate 12. The bottom of the connecting rod limiting plate 12 is penetrated by a fan blade connecting rod 13. The outer wall of the fan blade connecting rod 13 is fixedly connected to a fan blade body 14. The fan blade body 14 is used to cut and transfer the polypeptide macromolecules.The bottom of the scraper body 10 is tightly fitted with a semipermeable membrane body 15. A semipermeable membrane mounting frame 16 is provided on the side of the semipermeable membrane body 15. The semipermeable membrane mounting frame 16 is fixedly connected to the polypeptide drug concentration and purification box 1. The bottom of the scraper body 10 is tightly fitted with a porous support plate 17. The porous support plate 17 is fixedly connected to the polypeptide drug concentration and purification box 1. The combination of the semipermeable membrane mounting frame 16 and the porous support plate 17 can ensure the stability of the semipermeable membrane body 15 and prevent it from collapsing.

[0036] The present invention is provided with a stirring inclined plate 9, which is inclined. The stirring inclined plate 9 applies a downward thrust to the mixed solution during rotation, guiding the solution to flow downward. The solution reaching the bottom then moves outward, and the solution reaching the outside returns to the upper layer, and so on and so forth, forming a three-dimensional flow trajectory. A scraper body 10 with a scraper flow groove 11 is provided. The scraper body 10 scrapes off the polypeptide macromolecules adsorbed on the surface of the semipermeable membrane. The polypeptide macromolecules return to the upper solution under the action of the solution flow trajectory and are fully mixed with the original solution. The solution moving outward assists the polypeptide macromolecules to move outward in the scraper flow groove 11. The fan body 14 cuts the polypeptide macromolecules on the one hand and provides auxiliary thrust for the movement of the solution on the other hand. When the scraped polypeptide macromolecules return to the upper solution, under the action of the stirring plate corrugated groove 19, the swinging plate body 7 and the swinging plate corrugated groove 21 After being fully mixed with the original solution, the scraper body 10 can timely scrape off the polypeptide macromolecules adsorbed on the surface of the semipermeable membrane to prevent them from accumulating on the membrane surface, reducing the possibility of membrane pores being blocked, thereby maintaining the permeability of the semipermeable membrane and ensuring the stable operation of the device, avoiding the polypeptide from staying on the membrane surface, causing polypeptide denaturation, degradation or aggregation, thereby affecting the quality and activity of the product, which is beneficial to ensuring the quality of the product. The stirring inclined plate 9 pushes the solution to form a circulating flow trajectory, so that the polypeptide macromolecules in the solution can continuously flow between different areas and fully contact with other components, accelerating the material exchange process, and helping to improve the efficiency of concentration and purification. Under the synergistic action of the stirring plate corrugated groove 19, the swinging plate body 7 and the swinging plate corrugated groove 21, the polypeptide macromolecules returned after scraping can be fully and evenly mixed with the original solution, avoiding the situation of local uneven concentration, which is beneficial to subsequent purification operations.

[0037] The swing plate spring 8 is symmetrically arranged with respect to the horizontal center axis of the swing plate body 7, forming a double buffer structure. The swing plate spring 8 plays a buffering role. The swing plate spring 8 absorbs the impact force through elastic deformation, which not only effectively protects the swing plate body 7 from rigid impact damage, but also assists the swing plate body 7 to complete the periodic reciprocating motion by virtue of its elastic restoring force. During operation, the swing plate spring 8 utilizes the cycle of energy storage and energy release of the swing plate spring 8 to enhance the operation mechanism of the device, thereby enhancing the mixing effect. The side of the polypeptide drug concentration and purification box 1 is fixedly connected to the peristaltic pump 18, which plays the role of boosting. The inner wall of the mixing stirring plate 4 is provided with a stirring plate corrugated groove 19, which can generate a stronger fluid turbulence effect during the stirring process. The side of the stirring plate corrugated groove 19 is provided with a stirring plate inner hole 20, which runs through the interior of the mixing stirring plate 4, and the outer wall of the swing plate body 7 is provided with a swing plate corrugated groove 21. The swing plate corrugated groove 21 is about the horizontal center of the swing plate body 7. Seven pairs of axes are symmetrically arranged. When the swing plate body 7 swings back and forth under the impact of the solution, the swing plate corrugated groove 21 continuously cuts and disturbs the fluid, forming a multi-dimensional complex flow field, which promotes the full mixing of the polypeptide macromolecules with the solution. The side of the scraper circulation groove 11 is fixedly connected with an inclined scraper 22, and the outer wall of the inclined scraper 22 is evenly spaced with a plurality of scraper guide grooves 23. The design of the scraper guide groove 23 can, on the one hand, guide the scraped polypeptide macromolecules to quickly enter the scraper circulation groove 11, and on the other hand, the micro flow channel formed by the scraper guide groove 23 can reduce the fluid resistance. One end of the fan connecting rod 13 is fixedly connected to a rotating gear 24, and the bottom of the rotating gear 24 is meshed with a vertical gear body 25. The bottom of the vertical gear body 25 is fixedly connected to a vertical gear fixing rod 26. The rotating gear 24, the vertical gear body 25, and the vertical gear fixing rod 26 are all located inside the rotating rod 3. The rotating rod 3 is hollow, and the vertical gear fixing rod 26 is fixedly connected to the polypeptide drug concentration and purification box 1.

[0038] A method for preparing a concentration and purification device for producing polypeptide drugs, comprising the following steps:

[0039] S1, the polypeptide drug solution to be purified is poured into the polypeptide drug concentration and purification box 1, at this time the polypeptide drug solution is located on the top of the semipermeable membrane body 15, the device motor 2 and the peristaltic pump 18 are started, the peristaltic pump 18 pressurizes the polypeptide drug concentration and purification box 1, and applies sufficient pressure. The polypeptide drug solution passes through the semipermeable membrane body 15 to separate the solvent from the solution, and the polypeptide is retained, thereby achieving the purpose of concentration and purification. The device motor 2 drives the rotating rod 3 to rotate. Under the action of the rotating rod 3, the mixing stirring plate 4, the stirring inclined plate 9, and the scraper body 10 start to rotate synchronously. When the stirring inclined plate 9 stirs the polypeptide drug solution, the stirring inclined plate 9 adopts an inclined setting. The stirring inclined plate 9 generates a downward thrust while stirring, so that the polypeptide drug solution moves downward, and the polypeptide drug solution is fully in contact with the semipermeable membrane body 15, thereby increasing the concentration speed. After reaching the bottom, the polypeptide drug solution moves toward the edge under the action of the thrust, moves upward after reaching the edge, and finally returns to the upper layer, forming a circular flow trajectory;

[0040] S2. During the rotation of the scraper body 10, the scraper body 10 is in close contact with the semipermeable membrane body 15, and the polypeptide macromolecules adsorbed on the surface of the semipermeable membrane body 15 are scraped off. The polypeptide macromolecules are separated from the semipermeable membrane body 15 under the action of the scraper body 10, and the suspended polypeptide macromolecules enter the scraper flow groove 11 under the action of the inclined scraper 22 and the scraper guide groove 23. As the scraper body 10 rotates, the polypeptide macromolecules move outward from the inside of the scraper flow groove 11 under the action of centrifugal force. At this time, the solution flowing toward the edge enters the scraper flow groove 11, and the running trajectory drives multiple The peptide macromolecules move toward the outermost side of the scraper flow groove 11. At the same time, the scraper body 10 drives the rotating gear 24 to move during the rotation process. The rotating gear 24 rotates around the vertical center axis of the vertical gear body 25. The vertical gear body 25 is always engaged with the rotating gear 24. The rotating gear 24 moves at the top of the vertical gear body 25. The rotating gear 24 drives the fan blade connecting rod 13 and the fan blade body 14 to rotate. The rotating fan blade body 14 cuts the polypeptide macromolecules and generates an outward thrust to assist the solution flow trajectory and transfer the polypeptide macromolecules to the outermost side of the scraper flow groove 11.

[0041] S3. The polypeptide macromolecules moved to the outside are mixed with the solution and returned to the top according to the flow trajectory. At this time, when the mixing stirring plate 4 is rotating, the mixed solution contacts the stirring plate corrugated groove 19 and the stirring plate inner hole 20. Part of the solution flows out from the stirring plate inner hole 20 to achieve diversion, and part of the solution generates fluctuations under the action of the stirring plate corrugated groove 19. The fluctuating solution contacts the swing plate body 7, and the solution collides with the swing plate corrugated groove 21, causing the swing plate body 7 to swing up and down around the swing plate rotation axis 6 to generate turbulence. The elastic supporting force of the swing plate spring 8 can strengthen the swinging of the swing plate body 7, so that local eddies and turbulence are formed in the solution, increasing the shear force inside the solution, allowing the various components in the solution to be more fully mixed and contacted, promoting the full mixing of the upper solution and the polypeptide macromolecules. By observing the concentration of the mixed solution in real time, it is judged whether the purification has achieved the expected goal, so as to adjust the operating parameters in time or decide when to terminate the concentration process to ensure the quality standards of the polypeptide drug product.

[0042] The technical scope of the present invention is not limited to the contents of the above description. Those skilled in the art can make various deformations and modifications to the above embodiments without departing from the technical idea of ​​the present invention, and these deformations and modifications should all fall within the protection scope of the present invention.

Claims

1. A concentration and purification device based on the production of polypeptide drugs, characterized in that: include: The top of the polypeptide drug concentration and purification box is fixedly connected to the device motor, the output end of the device motor is fixedly connected to the rotating rod, the side of the rotating rod is fixedly connected to the mixing stirring plate, the inner side of the mixing stirring plate is fixedly connected to the connecting block, the side of the connecting block is movably connected to the swing plate rotating shaft, the outer wall of the swing plate rotating shaft is fixedly connected to the swing plate body, the side of the swing plate body is fixedly connected to the swing plate spring, the swing plate spring and the mixing stirring plate are fixedly connected. The outer wall of the rotating rod is fixedly connected to the stirring inclined plate, the bottom of the stirring inclined plate is provided with a scraper body, the scraper body is fixedly connected to the rotating rod.

2. The concentration and purification device for polypeptide drug production according to claim 1, characterized in that: A semipermeable membrane mounting frame is provided on the side of the semipermeable membrane body, and the semipermeable membrane mounting frame is fixedly connected to the polypeptide drug concentration and purification box. The bottom of the scraper body is tightly fitted with a porous support plate, and the porous support plate is fixedly connected to the polypeptide drug concentration and purification box.

3. The concentration and purification device for polypeptide drug production according to claim 2, characterized in that: A pair of the swing plate springs are symmetrically arranged about the horizontal center axis of the swing plate body, and the swing plate springs play a buffering role.

4. The concentration and purification device for polypeptide drug production according to claim 3, characterized in that: A peristaltic pump is fixedly connected to the side of the polypeptide drug concentration and purification box, and the peristaltic pump plays a role of boosting pressure.

5. The concentration and purification device for polypeptide drug production according to claim 4, characterized in that: The inner wall of the mixing and stirring plate is provided with a stirring plate corrugated groove, and the side of the stirring plate corrugated groove is provided with a stirring plate inner hole, and the stirring plate inner hole runs through the interior of the mixing and stirring plate.

6. The concentration and purification device for polypeptide drug production according to claim 5, characterized in that: The outer wall of the swing plate body is provided with swing plate corrugated grooves, and seven pairs of the swing plate corrugated grooves are symmetrically arranged about the horizontal central axis of the swing plate body.

7. The concentration and purification device for polypeptide drug production according to claim 6, characterized in that: An inclined scraper is fixedly connected to the side of the scraper circulation groove, and a plurality of scraper guide grooves are opened at equal intervals on the outer wall of the inclined scraper.

8. The concentration and purification device for polypeptide drug production according to claim 7, characterized in that: One end of the fan blade connecting rod is fixedly connected to a rotating gear, the bottom of the rotating gear is meshed with a vertical gear body, and the bottom of the vertical gear body is fixedly connected to a vertical gear fixing rod.

9. The concentration and purification device for polypeptide drug production according to claim 8, characterized in that: The rotating gear, the vertical gear body and the vertical gear fixing rod are all located inside the rotating rod. The rotating rod is hollow. The vertical gear fixing rod is fixedly connected to the polypeptide drug concentration and purification box.

10. A preparation method using the concentration and purification device for polypeptide drug production according to claim 9, characterized in that: The following steps are involved: S1. Pour the polypeptide drug solution into the polypeptide drug concentration and purification box, start the device motor and peristaltic pump, and the peristaltic pump pressurizes the polypeptide drug concentration and purification box, applying sufficient pressure. The polypeptide drug solution passes through the semipermeable membrane body to separate the solvent from the solution, while the polypeptide is retained, thereby achieving the purpose of concentration and purification. The device motor drives the rotating rod to rotate. Under the action of the rotating rod, the mixing stirring plate, the stirring inclined plate, and the scraper body begin to rotate. When the stirring inclined plate stirs the polypeptide drug solution, the stirring simultaneously generates a downward thrust, causing the polypeptide drug solution to move downward, and the polypeptide drug solution is fully in contact with the semipermeable membrane body, thereby increasing the concentration speed. After reaching the bottom, the polypeptide drug solution moves toward the edge under the action of the thrust, moves upward after reaching the edge, and finally returns to the upper layer, forming a circular flow trajectory; S2. During the rotation of the scraper body, the polypeptide macromolecules adsorbed on the surface of the semipermeable membrane body are scraped off. The polypeptide macromolecules enter the interior of the scraper flow groove under the action of the inclined scraper and the scraper guide groove. At this time, the solution flowing toward the edge enters the scraper flow groove, driving the polypeptide macromolecules to move to the outermost side of the scraper flow groove. At the same time, during the rotation of the scraper body, the rotating gear is driven to move. The rotating gear rotates around the vertical central axis of the vertical gear body. The rotating gear drives the fan blade connecting rod and the fan blade body to rotate. The rotating fan blade body cuts the polypeptide macromolecules and generates an outward thrust to assist the trajectory of the solution flow and transfer the polypeptide macromolecules to the outermost side of the scraper flow groove. S3. The polypeptide macromolecules moved to the outside are mixed with the solution and return to the top according to the flow trajectory. At this time, when the mixing stirring plate rotates, the mixed solution contacts the stirring plate corrugated groove and the inner hole of the stirring plate. Part of the solution flows out from the inner hole of the stirring plate, and part of the solution fluctuates under the action of the stirring plate corrugated groove. The fluctuating solution contacts the swing plate body, and the solution collides with the swing plate corrugated groove, causing the swing plate body to swing up and down around the swing plate rotation axis to generate turbulence, so that the upper solution and the polypeptide macromolecules are fully mixed, and the swing plate spring plays a buffering role.

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