Impurity removal device and impurity removal method for crude heparin sodium

Abstract

The impurity removal device comprises an impurity removal box body and a cooling box body, the lower portion of the impurity removal box body is provided with a bottom plate, the upper portion of the bottom plate is fixedly connected with a first vertical plate and a second vertical plate, the first vertical plate and the second vertical plate are each provided with a sliding groove, and the first vertical plate and the second vertical plate are each provided with a sliding groove; the left side and the right side of the impurity removal box are fixedly connected with sliding blocks used for being connected with the sliding grooves correspondingly. By arranging the impurity removal box body and the cooling box body which can shake, full mixing and cooling of a heparin sodium solution in the impurity removal process are achieved. Specifically, the box body is driven by a cam device on the cooling box body to obliquely move front and back to drive a first gear to rotate, and then a steel cable is controlled through gear transmission and a winder to pull the impurity removal box body to move up and down. The dynamic impurity removal mode increases the opportunity of contact between the solution and the filter material, so that the heparin sodium can be uniformly mixed with the resin, and the adsorbent in the resin can more effectively adsorb impurities.

Description

Technical Field

[0001] The invention belongs to the technical field of heparin sodium impurity removal, and in particular relates to a crude heparin sodium impurity removal device and an impurity removal method thereof. Background Art

[0002] As an important anticoagulant drug, heparin sodium is widely used in clinical practice. However, during the production process, crude heparin sodium often contains a variety of impurities, such as proteins, lipids and other polysaccharides, the presence of which will seriously affect the quality and efficacy of heparin sodium. Therefore, the development of efficient impurity removal processes and technologies has become one of the key links in the production of heparin sodium. In recent years, with the advancement of biopharmaceutical technology, the impurity removal process of heparin sodium has also developed rapidly, and various physical, chemical and biological methods have been successively applied to actual production. For example, the use of ion exchange, ultrafiltration, gel filtration and other technologies has achieved good results. However, these traditional methods still have some limitations in practical applications, especially when dealing with large-scale industrial production, efficiency and cost issues are particularly prominent.

[0003] Traditional impurity removal methods usually rely on static adsorption or filtration processes. Although this method can remove a certain amount of impurities, it is prone to adsorbent saturation or filter medium clogging when processing a large amount of raw materials, resulting in reduced processing efficiency. In addition, traditional impurity removal equipment often lacks an effective cooling system, or the cooling contact area is small, resulting in unstable temperature control during the treatment process as long as the bottom layer of sodium heparin contacts the cooling device, affecting product quality. Temperature control is particularly important for high-concentration crude sodium heparin solutions, because under high temperature conditions, sodium heparin may degrade, affecting the purity and activity of the final product. Therefore, how to achieve precise temperature control while maintaining efficient impurity removal has become a problem that needs to be solved in the current sodium heparin impurity removal technology. Therefore, we propose a crude sodium heparin impurity removal device and impurity removal method. Summary of the invention

[0004] In view of the problems existing in the prior art, the purpose of the present invention is to provide a device for removing impurities from crude sodium heparin and a method for removing impurities therefrom. By providing a shaking impurity removal box and a cooling box, the cooling area is increased and the sodium heparin solution is turned over, so that the cooling efficiency is higher. In addition, shaking the impurity removal box up and down can reduce blockage, quickly filter, and improve production efficiency.

[0005] The present invention is achieved in this way: a device for removing impurities from crude sodium heparin comprises an impurity removal box and a cooling box, wherein the lower part of the impurity removal box is provided with a bottom plate, the upper part of the bottom plate is fixedly connected with a first vertical plate and a second vertical plate, the first vertical plate and the second vertical plate are respectively provided with slide grooves, the left side and the right side of the impurity removal box are respectively fixedly connected with sliders for connecting with the slide grooves; the two sides of the cooling box are respectively fixedly connected with a first rotating shaft, the first rotating shaft is fixedly connected with a first gear, the first gear is transmission-connected with a second gear, the second gear is fixedly connected with a winder, the winder is fixedly connected with a steel cable, one end of the steel cable is fixedly connected with the lower part of the impurity removal box; the upper part of the impurity removal box is fixedly connected with a spring, and a cam device for pushing the cooling box to tilt forward and backward is installed on the cooling box, the impurity removal box and the cooling box are connected by a hose, and a refrigeration plate is installed on the side wall of the cooling box; when the cooling box tilts forward and backward, the first gear can drive the second gear and the winder to rotate, and pull the impurity removal box up and down through the steel cable.

[0006] Optionally, a mounting frame is sleeved on the outer side of the impurity removal box, a column is fixedly connected to the upper part of the mounting frame, and a top plate is welded to the upper part of the column.

[0007] Optionally, a feed pipe is fixedly connected to the upper part of the impurity removal box, an opening for the feed pipe to pass through is opened on the top plate, a cover is installed on the upper part of the feed pipe, and the mounting frame is welded to the first vertical plate and the second vertical plate respectively.

[0008] Optionally, a plurality of switches are provided on the second vertical plate, and the second gear is connected to the first vertical plate and the second vertical plate respectively through a first connecting shaft.

[0009] Optionally, a discharge pipe is installed on the front side of the cooling box, and a valve is provided on the discharge pipe.

[0010] Optionally, a filter frame is installed inside the impurity removal box, and a stainless steel filter screen is fixedly connected to the lower part of the filter frame.

[0011] Optionally, the cam device includes a second rotating shaft and a third rotating shaft, the second rotating shaft is fixedly connected to a first cam, the third rotating shaft is fixedly connected to a second cam, and the first cam and the second cam are arranged in opposite directions.

[0012] Optionally, the cam device also includes a double-headed motor, both ends of the double-headed motor are respectively connected to a second connecting shaft, the end of the second connecting shaft is fixedly connected to a worm, and the third rotating shaft and the second rotating shaft are respectively fixedly connected to a worm gear.

[0013] Optionally, the double-headed motor is connected to the first vertical plate via a first bracket, and the second rotating shaft and the third rotating shaft are respectively connected to the bottom plate via a second bracket.

[0014] The present invention also discloses a method for removing impurities from crude heparin sodium, comprising the device for removing impurities from crude heparin sodium, and further comprising the following steps: S1. Put crude heparin sodium into the impurity removal box, and add saline and resin; S2. Turn on the power of the double-headed motor and the refrigeration plate. The double-headed motor can drive the second connecting shaft to rotate, and drive the second rotating shaft and the third rotating shaft to rotate through the worm gear and the worm. At this time, the first cam and the second cam rotate and push the cooling box to tilt forward and backward; S3, when the cooling box tilts forward and backward, it can drive the first gear to rotate, and then drive the first gear and the winder to rotate. The winder can pull the impurity removal box up and down through the steel cable, so that the heparin sodium can be mixed with the resin, and the resin can absorb impurities; S4. By shaking the impurity removal box up and down, the heparin sodium can pass through the stainless steel filter to remove impurities, and the pure heparin sodium enters the cooling box through the hose and is cooled by the refrigeration plate; S5. Open the valve and the cooled pure heparin sodium is discharged through the discharge pipe.

[0015] Compared with the prior art, the present invention has the following beneficial effects: 1. By providing a shaking impurity removal box and a cooling box, the sodium heparin solution is fully mixed and cooled during the impurity removal process. Specifically, the cam device on the cooling box drives the box to tilt forward and backward, driving the first gear to rotate, and then the steel cable is controlled by the gear transmission and the winder to pull the impurity removal box up and down. This dynamic impurity removal method increases the chance of contact between the solution and the filter material, so that the sodium heparin can be evenly mixed with the resin, and the adsorbent in the resin can more effectively adsorb impurities. In this way, the impurity removal efficiency is improved, the risk of clogging of the filter material is reduced, and the cooling surface area is increased, which improves the cooling efficiency.

[0016] 2. The up and down shaking of the impurity removal box achieves the goal of preventing the filter material from being blocked. The shaking action is transmitted to the impurity removal box by the tilting movement of the cooling box through the mechanical transmission mechanism. This design can make the sodium heparin solution in the filter frame constantly turn over, avoiding the blockage of the filter screen caused by standing still, and ensuring the smooth progress of the filtering process. It not only improves the filtering speed, but also extends the service life of the filter material and reduces the maintenance cost.

[0017] 3. Constant temperature cooling of the sodium heparin solution is achieved by the refrigeration sheet installed in the cooling box. The operation of the refrigeration sheet is controlled by the cam device through the worm gear mechanism on the second and third rotating shafts. The operation of the refrigeration sheet ensures that the temperature of the sodium heparin solution is kept within a suitable range after the impurity removal process, preventing the sodium heparin from being denatured or degraded due to excessive temperature. In this way, the quality and activity of the sodium heparin are guaranteed, and the purity and efficacy of the final product are improved.

[0018] Further features and advantages of the present invention will become apparent from the following detailed description of exemplary embodiments of the present invention with reference to the attached drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a structural schematic diagram provided by the present invention; Figure 2 It is a plan schematic diagram provided by the present invention; Figure 3 It is an explosion schematic diagram provided by the present invention; Figure 4 It is a schematic diagram of a cooling box provided by the present invention; Figure 5 is a schematic diagram of a first gear and a second gear provided by the present invention; Figure 6 is a schematic diagram of a cam device provided by the present invention; Figure 7 is a schematic diagram of the cam device provided by the present invention after the first bracket is removed; Figure 8 It is a schematic diagram of the filtering frame provided by the present invention; Fig. 9 It is a schematic diagram of the refrigeration plate provided by the present invention.

[0020] In the figure: 1. impurity removal box; 2. mounting frame; 3. top plate; 4. cooling box; 5. bottom plate; 6. second vertical plate; 7. column; 8. filter frame; 9. spring; 10. steel cable; 11. winder; 12. first gear; 13. feed pipe; 14. first vertical plate; 15. slider; 16. second gear; 17. hose; 18. discharge pipe; 19. first bracket; 20. double-headed motor; 21. second rotating shaft; 22. first cam; 23. second bracket; 24. third rotating shaft; 25. second cam; 26. stainless steel filter; 27. refrigeration plate; 28. worm; 29. ​​second connecting shaft; 30. worm wheel. DETAILED DESCRIPTION

[0021] In order to further understand the content, features and effects of the present invention, the following embodiments are given as examples and described in detail with reference to the accompanying drawings.

[0022] like Figures 1 to 9As shown, an impurity removal device for crude heparin sodium is provided in an embodiment of the present invention.

[0023] It includes a cleaning box 1 and a cooling box 4. The lower part of the cleaning box 1 is provided with a bottom plate 5. The upper part of the bottom plate 5 is fixedly connected with a first vertical plate 14 and a second vertical plate 6. The first vertical plate 14 and the second vertical plate 6 are respectively provided with a slide groove. The left side and the right side of the cleaning box 1 are respectively connected to the slide groove through a slider 15. A filter frame 8 is installed inside the impurity removal box 1, and a stainless steel filter screen 26 is fixedly connected to the lower part of the filter frame 8.

[0024] The first gear 12 is fixedly connected to both sides of the cooling box 4 through the first rotating shaft, the first gear 12 is drivingly connected to the second gear 16, the second gear 16 is fixedly connected to the winder 11, the end of the steel cable 10 is fixedly connected to the winder 11, the steel cable 10 is wound on the winder 11, and the other end of the steel cable 10 is fixedly connected to the lower part of the impurity removal box 1; A spring 9 is fixedly connected to the upper part of the impurity removal box 1, and a mounting frame 2 is sleeved on the outer side of the impurity removal box 1. A column 7 is fixedly connected to the upper part of the mounting frame 2. A top plate 3 is welded to the upper part of the column 7. The upper part of the spring 9 contacts the top plate 3, and the mounting frame 2 is welded to the first vertical plate 14 and the second vertical plate 6 respectively.

[0025] A cam device is installed on the cooling box 4 to push the cooling box 4 to tilt forward and backward. The cam device includes a second rotating shaft 21 and a third rotating shaft 24. The second rotating shaft 21 is fixedly connected to the first cam 22, and the third rotating shaft 24 is fixedly connected to the second cam 25. The first cam 22 and the second cam 25 are arranged in opposite directions.

[0026] The cam device also includes a double-headed motor 20 , with second connecting shafts 29 connected to both ends of the double-headed motor 20 , a worm 28 fixedly connected to the end of the second connecting shaft 29 , and a worm wheel 30 fixedly connected to the third rotating shaft 24 and the second rotating shaft 21 .

[0027] The double-headed motor 20 is connected to the first vertical plate 14 via the first bracket 19 , and the second rotating shaft 21 and the third rotating shaft 24 are connected to the bottom plate 5 via the second bracket 23 , respectively.

[0028] The impurity removal box 1 and the cooling box 4 are connected by a hose 17, and a refrigeration plate 27 is installed on the side wall of the cooling box 4; when the cooling box 4 tilts forward and backward, the first gear 12 can drive the second gear 16 and the winder 11 to rotate, and pull the impurity removal box 1 up and down through the steel cable 10.

[0029] A feed pipe 13 is fixedly connected to the upper portion of the impurity removal box body 1 , an opening for the feed pipe 13 to pass through is provided on the top plate 3 , and a cover is installed on the upper portion of the feed pipe 13 .

[0030] The second vertical plate 6 is provided with a plurality of switches, and the second gear 16 is connected to the first vertical plate 14 and the second vertical plate 6 respectively through the first connecting shaft.

[0031] A discharge pipe 18 is installed on the front side of the cooling box 4, and a valve is provided on the discharge pipe 18.

[0032] The present invention also discloses a method for removing impurities from crude heparin sodium, including a crude heparin sodium impurity removal device, and further comprising the following steps: S1, placing crude heparin sodium into the impurity removal box 1, and adding saline and resin; S2. Turn on the power of the double-headed motor 20 and the cooling plate 27. The double-headed motor 20 can drive the second connecting shaft 29 to rotate, and drive the second rotating shaft 21 and the third rotating shaft 24 to rotate through the worm gear 30 and the worm 28. At this time, the first cam 22 and the second cam 25 rotate and push the cooling box 4 to tilt forward and backward; S3, when the cooling box 4 tilts forward and backward, it can drive the first gear 12 to rotate, and then drive the first gear 12 and the winder 11 to rotate. The winder 11 can pull the impurity removal box 1 up and down through the steel cable 10, so that the heparin sodium can be mixed with the resin, and the resin can absorb impurities; S4, by shaking the impurity removal box 1 up and down, the heparin sodium can pass through the stainless steel filter 26 to remove impurities, and the pure heparin sodium enters the interior of the cooling box 4 through the hose 17 and is cooled under the action of the refrigeration plate 27; S5. Open the valve, and the cooled pure heparin sodium is discharged through the discharge pipe 18.

[0033] The design of the cam device is an important innovation of the present invention. Through the combination of the double-headed motor 20, the worm gear 30 and the worm 28 mechanism, the first cam 22 and the second cam 25, the forward and backward tilting movement of the cooling box 4 is realized. This design utilizes the mature principle of the cam mechanism in mechanical engineering and applies it to the motion control of the cooling box 4 during the heparin sodium impurity removal process, so that the cooling box 4 can reciprocate in a predetermined direction.

[0034] The traditional static impurity removal method is easy to cause clogging of the filter material when processing high-concentration heparin sodium solution, affecting the impurity removal efficiency. By introducing the cam device, the dynamic movement of the impurity removal box 1 can be achieved, the contact opportunity between the solution and the filter material can be enhanced, the clogging phenomenon can be reduced, and the impurity removal efficiency can be improved. In addition, the cam device can also optimize the impurity removal process by adjusting the angle and movement frequency of the cam to ensure the best impurity removal effect under different working conditions.

[0035] The cooling box 4 is driven to tilt forward and backward by the cam device, so that the impurity removal box 1 can move up and down, which not only increases the contact area between the solution and the filter material, but also improves the filtration efficiency. Experiments show that compared with static impurity removal, the impurity removal efficiency of the present invention is improved by about 30%, and the service life of the filter material is extended by nearly one-fold. This is because dynamic impurity removal reduces the probability of clogging of the filter material and increases the filtration speed.

[0036] The up and down movement of the impurity removal box 1 is achieved by the tilting movement of the cooling box 4 driving the first gear 12 to rotate, and then controlling the steel cable 10 through the gear transmission and the winder 11. This design utilizes the principle of gear transmission and steel cable traction, so that the impurity removal box 1 can reciprocate in the vertical direction.

[0037] During the static impurity removal process, impurities in the solution are easily deposited on the surface of the filter material, resulting in a decrease in filtration efficiency. The design of the dynamic impurity removal box 1 can effectively avoid this situation. Through up and down movement, impurities in the solution are more easily captured by the filter material, while reducing the risk of clogging of the filter material.

[0038] The up and down movement of the dynamic impurity removal box 1 not only improves the impurity removal efficiency, but also reduces the frequency of changing the filter material and reduces the production cost. In addition, the up and down movement also helps to improve the mixing uniformity of the solution and ensure the consistency of the impurity removal effect. Studies have shown that when the impurity removal device of the present invention processes the same amount of crude heparin sodium, the time required is shortened by 20% compared with the traditional method, and the purity of the final product is increased by about 5%.

[0039] The design of the cooling plate 27 is to keep the solution at a constant low temperature during the impurity removal process. The continuous operation of the cooling plate 27 ensures that the solution will not be degraded due to temperature increase during the impurity removal and filtration process, thereby protecting the activity of the heparin sodium.

[0040] In the process of removing impurities, temperature control is crucial to the activity of sodium heparin. Traditional cooling methods often make it difficult to achieve precise temperature control, which can easily lead to temperature fluctuations in the solution and affect product quality. The design of the refrigeration plate enables the cooling box 4 to maintain a constant low temperature environment, thereby protecting the activity of sodium heparin from damage.

[0041] The constant temperature cooling condition provided by the refrigeration plate 27 can ensure that the heparin sodium maintains a high activity during the impurity removal process and avoids degradation caused by excessive temperature. Experimental data show that after adopting the cooling device of the present invention, the activity loss rate of heparin sodium is reduced from the original 10% to 2%, which greatly improves the quality of the product. In addition, constant temperature cooling also helps to improve the impurity removal efficiency, because at a lower temperature, the solubility of heparin sodium increases, which is conducive to the separation of impurities.

[0042] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A device for removing impurities from crude sodium heparin, comprising a removal box (1) and a cooling box (4), Features: The lower part of the impurity removal box (1) is provided with a bottom plate (5), the upper part of the bottom plate (5) is fixedly connected with a first vertical plate (14) and a second vertical plate (6), the first vertical plate (14) and the second vertical plate (6) are respectively provided with a slide groove, and the left side and the right side of the impurity removal box (1) are respectively fixedly connected with a slide block (15) for connecting with the slide groove; The two sides of the cooling box (4) are respectively fixedly connected to a first rotating shaft, the first rotating shaft is fixedly connected to a first gear (12), the first gear (12) is drivingly connected to a second gear (16), the second gear (16) is fixedly connected to a winder (11), the winder (11) is fixedly connected to a steel cable (10), and one end of the steel cable (10) is fixedly connected to the lower part of the impurity removal box (1); A spring (9) is fixedly connected to the upper portion of the impurity removal box (1), a cam device for pushing the cooling box (4) to tilt forward and backward is installed on the cooling box (4), the impurity removal box (1) and the cooling box (4) are connected via a hose (17), and a refrigeration fin (27) is installed on the side wall of the cooling box (4); When the cooling box (4) tilts forward and backward, the first gear (12) can drive the second gear (16) and the wire winder (11) to rotate, and pull the impurity removal box (1) up and down through the steel cable (10).

2. The impurity removal device for crude heparin sodium according to claim 1, Features: The outer side of the impurity removal box (1) is sleeved with a mounting frame (2), the upper part of the mounting frame (2) is fixedly connected with a column (7), and the upper part of the column (7) is welded with a top plate (3).

3. The impurity removal device for crude heparin sodium according to claim 2, Features: A feed pipe (13) is fixedly connected to the upper portion of the impurity removal box (1), an opening for the feed pipe (13) to pass through is provided on the top plate (3), a cover is installed on the upper portion of the feed pipe (13), and the mounting frame (2) is respectively welded to the first vertical plate (14) and the second vertical plate (6).

4. The impurity removal device for crude heparin sodium according to claim 1, Features: The second vertical plate (6) is provided with a plurality of switches, and the second gear (16) is connected to the first vertical plate (14) and the second vertical plate (6) respectively via a first connecting shaft.

5. The impurity removal device for crude heparin sodium according to claim 1, Features: A discharge pipe (18) is installed on the front side of the cooling box (4), and a valve is provided on the discharge pipe (18).

6. The impurity removal device for crude heparin sodium according to claim 1, Features: A filter frame (8) is installed inside the impurity removal box (1), and a stainless steel filter screen (26) is fixedly connected to the lower part of the filter frame (8).

7. The impurity removal device for crude heparin sodium according to claim 1, Features: The cam device comprises a second rotating shaft (21) and a third rotating shaft (24); the second rotating shaft (21) is fixedly connected to a first cam (22); the third rotating shaft (24) is fixedly connected to a second cam (25); the first cam (22) and the second cam (25) are arranged in opposite directions.

8. The impurity removal device for crude heparin sodium according to claim 7, Features: The cam device further comprises a double-headed motor (20), the two ends of the double-headed motor (20) are respectively connected to a second connecting shaft (29), the end of the second connecting shaft (29) is fixedly connected to a worm (28), and the third rotating shaft (24) and the second rotating shaft (21) are respectively fixedly connected to a worm wheel (30).

9. The impurity removal device for crude heparin sodium according to claim 8, Features: The double-headed motor (20) is connected to the first vertical plate (14) via a first bracket (19), and the second rotating shaft (21) and the third rotating shaft (24) are respectively connected to the bottom plate (5) via a second bracket (23).

10. A method for removing impurities from crude heparin sodium according to claim 1, comprising the device for removing impurities from crude heparin sodium according to any one of claims 1 to 9, Features: It includes the following steps: S1. Place crude heparin sodium into the impurity removal box (1), and add saline and resin; S2, turning on the power of the double-headed motor (20) and the refrigeration plate (27), so that the double-headed motor (20) can drive the second connecting shaft (29) to rotate, and drive the second rotating shaft (21) and the third rotating shaft (24) to rotate through the worm gear (30) and the worm (28), at which time the first cam (22) and the second cam (25) rotate and push the cooling box (4) to tilt forward and backward; S3, when the cooling box (4) tilts forward and backward, it can drive the first gear (12) to rotate, and then drive the first gear (12) and the winder (11) to rotate. The winder (11) can pull the impurity removal box (1) up and down through the steel cable (10), so that the sodium heparin can be mixed with the resin, and the resin can absorb impurities; S4, by shaking the impurity removal box (1) up and down, the heparin sodium can pass through the stainless steel filter (26) to remove impurities, and the pure heparin sodium enters the interior of the cooling box (4) through the hose (17) and is cooled under the action of the cooling plate (27); S5. Open the valve, and the cooled pure heparin sodium is discharged through the discharge pipe (18).

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