A tablet ejection device of a tablet press applied to a preparation process of diclofenac sodium enteric-coated tablets

Abstract

The application relates to a tablet ejection device applied to a preparation process of diclofenac sodium enteric-coated tablets, which comprises a tablet ejection groove, the tablet ejection groove is arranged to be inclined downward along the direction of tablet ejection, at least five groups of powder suction holes are arranged at the bottom of the tablet ejection groove, the diameters of the powder suction holes are smaller than the diameter of the tablets; at least five elastic sheets are vertically arranged on the upper surface of the tablet ejection groove behind the at least five groups of powder suction holes, the elastic sheets are pivotally connected to the bottom of the tablet ejection groove and can rotate relative to the groove wall between the first position and the second position; at least five powder collecting boxes are arranged below the at least five groups of powder suction holes; at least five dust collectors are connected with the at least five powder collecting boxes through pipelines; when the elastic sheets are in the first position, the elastic sheets intercept the tablets entering the tablet ejection groove; when the elastic sheets are rotated to the second position, the tablets slide to the elastic sheets behind. The tablet ejection device can timely and effectively remove the drug powder, so that the coating effect of the tablets is uniform.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical equipment, and more specifically to a tablet extrusion device for a tablet press used in the preparation process of diclofenac sodium enteric-coated tablets. Background Technology

[0002] Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) derived from phenylacetic acid. It works by inhibiting cyclooxygenase activity, thereby blocking the conversion of arachidonic acid into prostaglandins. It also promotes the binding of arachidonic acid to triglycerides (triacylglycerols), reducing the concentration of free arachidonic acid in cells, thus indirectly inhibiting the production of leukotrienes, bradykinin, and other products, thereby exerting its antipyretic, analgesic, and anti-inflammatory effects. However, diclofenac sodium easily irritates the gastrointestinal tract, causing adverse gastrointestinal reactions in patients. Therefore, diclofenac sodium needs to be coated into an enteric-coated formulation to avoid its irritation to the gastric mucosa.

[0003] The preparation process of diclofenac sodium enteric-coated tablets is as follows: premixing, granulation, wet granulation, drying, dry granulation, total mixing, tableting, and coating. The tableting step involves using a tablet press to compress the diclofenac sodium mixed powder into tablet cores through a mold. These tablet cores are then coated to form diclofenac sodium enteric-coated tablets. The quality of the tablet cores affects the coating effect. Currently, fully automatic high-speed rotary tablet presses are mainly used to compress diclofenac sodium mixed powders. This method has advantages such as high production efficiency and stable tablet weight. However, in actual production, it has been found that during the tablet core compression process, the mixed powder scatters around the turntable and enters the tablet discharge trough along with the tablet cores, sliding into the receiving bin. This results in powder waste and powder adhering to the tablet cores. Furthermore, this powder residue remains in the tablet discharge trough, causing secondary contamination of subsequent tablet cores. Mixing the powder with the diclofenac sodium tablet core will affect the coating effect of the diclofenac sodium tablet core and the effective dosage of diclofenac sodium enteric-coated tablets. At best, it will result in poor appearance of the diclofenac sodium enteric-coated tablets; at worst, it will lead to uneven or incomplete coating, affecting the dissolution site or rate of the active ingredient diclofenac sodium in vivo. Ultimately, this can cause local irritation to the stomach and damage to the drug by gastric juices, resulting in poor efficacy. Therefore, how to remove the powder adhering to the tablet core before coating is a problem that the pharmaceutical industry urgently needs to address.

[0004] In existing technologies, the separation of tablets and powder is often achieved by setting baffles and powder suction holes in the tablet discharge slot, or by connecting a vibrating screen after the tablet discharge slot. Since tablets in tablet presses, especially rotary tablet presses, enter the tablet discharge slot one tablet at a time, the method of setting baffles and powder suction holes in the tablet discharge slot results in tablets colliding with the baffle individually, generating very small impact forces, leading to poor separation of tablets and powder. Furthermore, powder residue can easily remain on the screen and baffle, causing secondary contamination of the tablets. The method of connecting a vibrating screen also suffers from powder residue remaining on the screen and tablet discharge slot, causing secondary contamination of the tablets. Additionally, the device is complex, power-intensive, and prone to malfunction. Moreover, when the tablet press stops working and only a small number of tablets remain in the vibrating screen, the device must continue to operate until the last tablet slides out of the vibrating screen outlet, a process that is power-intensive and inefficient. Summary of the Invention

[0005] Based on this, the present invention overcomes the shortcomings and deficiencies of the prior art and provides a tablet extrusion device for a tablet press, used to remove the powder adhering to the diclofenac sodium tablet core, so as to improve the coating effect of the diclofenac sodium tablet core and make the diclofenac sodium enteric-coated tablets have good, uniform and consistent efficacy.

[0006] This invention is achieved through the following technical solution: a tableting device for a tablet press used in the preparation process of diclofenac sodium enteric-coated tablets, comprising:

[0007] The tablet dispensing trough is inclined downward along the direction of tablet dispensing, and the bottom of the tablet dispensing trough is provided with at least five sets of powder suction holes, the diameter of which is smaller than the diameter of the tablet.

[0008] At least five springs are respectively disposed on the upper surface of the film outlet slot behind at least five sets of powder suction holes. The springs are pivotally connected to the bottom of the film outlet slot and can rotate relative to the slot wall between a first position and a second position.

[0009] At least five powder collection boxes are respectively located below at least five sets of powder suction holes;

[0010] At least five vacuum cleaners, each connected to at least five dust collection boxes via pipes;

[0011] When the spring is in the first position, it intercepts the tablet entering the tablet dispensing slot; when the spring rotates to its second position, the tablet slides down to the spring behind it.

[0012] Compared with existing technologies, this invention uses a spring-loaded device on the tablet dispensing slot to intercept the tablets. The tablets collide with the spring-loaded device or the tablets on the spring-loaded device, causing the drug powder to fall off. At the same time, a vacuum cleaner removes the drug powder that enters the dispensing slot with the tablets and the drug powder that is removed by the collision, avoiding the accumulation of drug powder and causing secondary contamination to subsequent tablets. When a certain number of tablets are intercepted, the spring-loaded device rotates downward to a second position, causing a large number of tablets to slide down to the spring-loaded device behind, applying a greater impact force to the spring-loaded device, thereby enhancing the effect of removing powder from the tablets by impact. The tablets collide with the spring-loaded device at least three times in the tablet dispensing device, effectively removing the drug powder adhering to the surface of the tablets. During the repeated sliding and collision process, the tablets automatically flip over, making the powder removal more thorough and facilitating the grinding and polishing of the tablets. In addition, during this process, substandard tablets are broken by the collision and fall into the powder collection box through the powder suction hole, which has the function of screening qualified tablets, so that the quality of the tablets to be coated is uniform.

[0013] Furthermore, when the spring is in its second position, the angle α between it and the bottom of the tablet dispensing slot satisfies: 0 < α < β, where β is the angle at which the tablet dispensing slot is tilted downwards relative to the horizontal surface. This limitation ensures that when the spring is in its second position, the tablet can slide off the spring.

[0014] Furthermore, when the spring is in its second position, the rear spring adjacent to the spring is in its first position.

[0015] Furthermore, the tablet extrusion device of the tablet press also includes at least five controllers, each electrically connected to at least five vacuum cleaners and controlling the operating frequency of the vacuum cleaners. This limitation ensures that the vacuum cleaners only remove dust when intercepting tablets, saving energy and preventing tablets from sticking to the suction holes and failing to slide down due to the vacuum cleaner's action.

[0016] Furthermore, the tablet extrusion device of the tablet press also includes at least five rotary motors, each controlling at least five springs to rotate between their first and second positions, and each being electrically connected to at least five controllers. With this limitation, the controllers control the rotation frequency of the springs via the rotary motors.

[0017] Furthermore, the tablet extrusion device of the tablet press also includes: at least five permanent magnets, which are respectively fixedly disposed at the bottom of at least five spring sheets; at least five electromagnets, which are respectively fixed on the inner side of the extrusion groove wall below at least five spring sheets, and are respectively electrically connected to the at least five controllers; when the electromagnet is energized, its corresponding permanent magnet drives the spring sheet to rotate to its second position.

[0018] Furthermore, the tablet extrusion device of the tablet press further includes: the tablet extrusion device includes two controllers, wherein the vacuum cleaner, rotating motor, or electromagnet corresponding to the i-th spring (i is an odd number) is electrically connected to one controller; the vacuum cleaner, rotating motor, or electromagnet corresponding to the (i+1)-th spring is electrically connected to the other controller. This limitation ensures that the tablet can be intercepted by all the springs and collide multiple times with the springs or the tablets above the springs, thereby facilitating the removal of drug powder; and reducing the number of controllers makes control more convenient.

[0019] Furthermore, the tablet extrusion device of the tablet press also includes at least five torsion springs, one end of which is fixedly connected to the bottom of at least five springs, and the other end is fixedly connected to the bottom of the tablet extrusion slot.

[0020] Furthermore, the tablet ejection device of the tablet press further includes: at least three of the at least five springs located at the front have a plurality of through holes, the diameter of which is smaller than the diameter of the tablet. This limitation allows drug powder to slide off the springs or through holes, preventing residue on the springs from causing secondary contamination of subsequent tablets. The through holes also increase the contact points between the tablet and the springs, dispersing the overall stress on the tablet and reducing unnecessary damage.

[0021] Furthermore, a vibrator is provided at the bottom of the spring sheet, and the vibrator is electrically connected to the controller; when the spring sheet is in its first position, the vibrator at the bottom of the spring sheet vibrates. With this limitation, when the tablet is intercepted by the spring sheet, multiple vibrations occur on the spring sheet, which helps to remove drug powder adhering to the surface of the tablet. In addition, the vibration, multiple impacts and flipping of the tablet help to polish the tablet.

[0022] Furthermore, the tablet extrusion device of the tablet press also includes a top baffle, which is fixedly connected to the top edges of the two side walls of the tablet extrusion slot.

[0023] Furthermore, the powder suction hole is a slit, the width of which is less than the thickness of the tablet, or the inner wall of the slit is fitted with a baffle mesh, the aperture of which is less than the diameter of the tablet.

[0024] This invention also provides a preparation process for diclofenac sodium enteric-coated tablets, comprising the following steps:

[0025] S1. Weigh out the prescribed amounts of microcrystalline cellulose 101, corn starch, diclofenac sodium, lactose, povidone K30, crospovidone, and sodium carboxymethyl starch, and add them sequentially to a wet granulation mixer. After dry mixing with high shear stirring, collect the mixture in a transfer container and inject it into a dry granulation mixer for dry granulation. Add the excipients and mix them together. Add the diclofenac sodium dispersion to a high-speed tablet press for tableting. Separate the diclofenac sodium tablet cores from the dispersion using the tableting device of the tablet press and collect the diclofenac sodium tablet cores.

[0026] S2. The diclofenac sodium tablet core is coated with a release coating to obtain a release tablet;

[0027] S3. The release liner is coated with an enteric coating to obtain the diclofenac sodium enteric-coated tablet.

[0028] Further, step S2 includes: preparing a gastric-coated film-coated suspension and using a high-efficiency coating machine to coat the diclofenac sodium tablet core obtained in step S13 with an isolation layer; step S3 includes: preparing an enteric-coated film-coated suspension and using a high-efficiency coating machine to coat the isolation tablet obtained in step S2 with an enteric layer.

[0029] The preparation process of diclofenac sodium enteric-coated tablets of the present invention employs an improved tablet press and tablet ejection device in conjunction with a tablet press for tablet compression and ejection. This preparation process can simply, economically, and effectively remove drug powder adhering to the surface of the diclofenac sodium tablet core, trim the rough edges of the diclofenac sodium tablet core, and screen out diclofenac sodium tablet cores that do not meet quality requirements or are broken due to collision. The diclofenac sodium tablet cores with smooth, uniform, and good quality characteristics are then subjected to the coating treatment in steps S2 and S3, ultimately producing uniform diclofenac sodium enteric-coated tablets. These diclofenac sodium enteric-coated tablets have a good appearance and exhibit uniform dissolution rate and dissolution location in vivo. This solves the problems of poor coating effect of diclofenac sodium enteric-coated tablets caused by drug powder adhesion and poor uniformity of tablet shape or quality, which in turn leads to poor efficacy and side effects on the stomach. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the tablet output device of the tablet press according to Embodiment 1 of the present invention.

[0031] Figure 2 for Figure 1 The top view of the tablet output device of the tablet press shown.

[0032] Figure 3 for Figure 1 A top view of the tablet extrusion device of a tablet press according to another embodiment shown.

[0033] Figure 4 for Figure 1The above is a front view of the tablet output device of the tablet press.

[0034] Figure 5 for Figure 1 The diagram shows the positional relationship between the tablet ejection slot 1 and the spring sheet 21 of the tablet ejection device of the tablet press.

[0035] Figure 6 for Figure 1 The diagram shows the structure of structure D of the tablet output device of the tablet press.

[0036] Figure 7 This is a schematic diagram of the tablet output device of the tablet press according to Embodiment 2 of the present invention.

[0037] Figure 8 for Figure 7 The diagram shows the structure of structure E of the tablet output device of the tablet press. Detailed Implementation

[0038] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and not intended to limit it. For ease of description, the accompanying drawings show only the parts relevant to the invention, not all of the structures.

[0039] Example 1

[0040] See Figure 1 The tablet extrusion device of the tablet press of the present invention includes an extrusion trough 1 and at least five screening mechanisms. The extrusion trough 1 is inclined downward along the direction of tablet discharge and is used to separate tablets from drug powder. The at least five screening mechanisms include a first screening mechanism 2, a second screening mechanism 3, a third screening mechanism 4, a fourth screening mechanism 5, and a fifth screening mechanism 6, which have similar structures and are arranged sequentially at the bottom of the extrusion trough 1.

[0041] See Figures 2-4 The tablet dispensing slot 1 has at least five sets of powder suction holes 12 at its bottom, each corresponding to one of the at least five sieving mechanisms and located in front of each mechanism. The diameter of each powder suction hole 12 is smaller than the diameter of the tablet, and its size and shape can be changed according to actual conditions. In some embodiments, the powder suction hole 12 is a slit 14, the width of which is smaller than the thickness of the tablet, or a baffle 15 is attached to the inner wall of the slit 14, the aperture of which is smaller than the diameter of the tablet. Preferably, the tablet dispensing slot 1 further includes a top baffle 16, which is fixed to the top edge of the two side walls of the dispensing slot 1 to prevent tablets from popping out and to prevent the intrusion of dust and dirt.

[0042] The following description, in conjunction with the specific structure of the first screening mechanism 2, further illustrates the tablet output device of the tablet press of the present invention.

[0043] The first screening mechanism 2 includes a first spring 21, a first rotating rod 22, a first powder collection box 23, a first vacuum cleaner 24, and a first controller 25. The first spring 21 is disposed at the bottom of the film outlet slot 1 and located behind the first set of powder suction holes 12. The first rotating rod 22 is rotatably connected to the bottom of the film outlet slot 1 and fixedly connected to one end of the spring 21, so that the first spring 21 can rotate relative to the bottom of the film outlet slot 1 between its first position and a second position. (See reference...) Figure 5 When the first spring 21 is in its first position, it intercepts the tablets entering the tablet dispensing slot 1. When the first spring 21 is in its second position, the angle α between the first spring 21 and the bottom of the tablet dispensing slot 1 satisfies 0 < α < β, allowing the tablets to slide off the first spring 21 to the second screening mechanism 3. Here, β is the angle between the tablet dispensing slot 1 and the horizontal plane, i.e., the downward tilt angle of the tablet dispensing slot 1. Within the range of 0 to β, the smaller the angle α, the more favorable it is for the tablets to slide off the first spring 21. The first powder collection box 23 is located directly below the first set of powder suction holes 12 and is fixedly connected to the bottom of the tablet dispensing slot 1. The first powder collection box 23 is connected to the vacuum cleaner 24 through a pipe. The first controller 25 is electrically connected to the first vacuum cleaner 24 to control the first vacuum cleaner 24 to suck up the drug powder. In addition, the first controller 25 controls the rotation frequency of the first rotating rod 22. Adjusting this rotation frequency can adjust the interception time or the number of tablets intercepted each time.

[0044] See Figure 6 In some embodiments, the first screening mechanism 2 further includes a first rotating motor 26, which is electrically connected to the first controller 25, and its rotating shaft is fixedly connected to the first rotating rod 24. The first controller 25 controls the first spring 21 to rotate between its first position and a second position via the first rotating motor 26. Preferably, when the first spring 21 is in its first position, the first controller 25 controls the first vacuum cleaner 24 to suck up the drug powder and discharge it. When the interception time reaches a predetermined upper limit or the number of intercepted tablets reaches a predetermined upper limit, the first controller 25 controls the first vacuum cleaner 24 to stop working, and at the same time controls the first rotating motor 26 to drive the first spring 21 to rotate to its second position, so that the tablets intercepted by the first spring 21 slide down to the second screening mechanism 3.

[0045] Preferably, the first controller 23 of the first screening mechanism 2 is also electrically connected to the third rotary motor 41 and the third vacuum cleaner 48 of the third screening mechanism 4, and the fifth rotary motor 61 and the fifth vacuum cleaner 68 of the fifth screening mechanism 6, thereby controlling the springs of the first screening mechanism 2, the third screening mechanism 4, and the fifth screening mechanism 6 to rotate synchronously; and the first controller 33 of the second screening mechanism is also electrically connected to the fourth rotary motor 51 and the fourth vacuum cleaner 58 of the fourth screening mechanism 5, thereby controlling the springs of the second screening mechanism 3 and the fourth screening mechanism 5 to rotate synchronously. Figure 3 ).

[0046] In addition, several through holes 212, 312 and 412 are respectively opened on the first spring 21, the second spring 31 and the third spring 41. The diameter of the through holes is smaller than the diameter of the tablet. The drug powder can fall into the adjacent screening mechanism through the through holes on the spring and enter the powder collection box through the corresponding powder suction hole of the screening mechanism to be removed or recycled. At the same time, the drug powder is prevented from contaminating the tablet located on the fifth spring 61.

[0047] In other embodiments, the first screening mechanism 2 further includes a recovery device (not shown), which is connected to the first powder collection box 23 via a pipe to collect the drug powder in the powder collection box 23 and convey it to the tablet press for reuse.

[0048] Example 2

[0049] The difference between this embodiment and Embodiment 1 is that, in this embodiment, the rotation of the spring is controlled by the energization and de-energization of the electromagnet. (See also...) Figure 7 and Figure 8The first screening mechanism 2 includes a first electromagnet 27, a first permanent magnet 28, and a first torsion spring 29. The first permanent magnet 28 is fixedly disposed at the bottom of the first spring piece 21. The first electromagnet 27 is fixed inside the wall of the dispensing slot 1 and located behind the first spring piece 21. One end of the first torsion spring 29 is fixed to the bottom of the first spring piece 21, and the other end is fixed to the bottom of the dispensing slot 1. When the first electromagnet 27 is energized, the first permanent magnet 28 is attracted by the first electromagnet 27, thereby driving the first spring piece 21 to rotate to its second position and compressing the first torsion spring 29. When the first electromagnet 27 is de-energized, the first torsion spring 29 resets, thereby driving the first spring piece 21 to rotate to its first position. Preferably, the first controller 25 is electrically connected to the first electromagnet 27. The first controller 25 controls the rotation of the first spring piece 21 through the first electromagnet 27 and controls the first vacuum cleaner 24 to pick up the drug powder. Preferably, when the first spring 21 is in its first position, the first controller 25 controls the first vacuum cleaner 24 to suck up the drug powder and discharge it. When the interception time reaches a predetermined upper limit or the number of intercepted tablets reaches a predetermined upper limit, the first controller 25 controls the first vacuum cleaner 24 to stop working, and simultaneously controls the first electromagnet 27 to be energized, so that the first spring 21 rotates to its second position under the drive of the first permanent magnet 28, causing the tablets intercepted by the first spring 21 to slide into the second screening mechanism 3. Preferably, a vibrator (not shown) is provided at the bottom of the first spring 21. The vibrator drives the first spring 21 to vibrate, and the vibrator is electrically connected to the first controller 25. When the first spring 21 is in its first position, the first controller 25 controls the vibrator to drive the first spring 21 to vibrate.

[0050] Preferably, the first controller 23 of the first screening mechanism 2 is also electrically connected to the third rotary motor 41 or third electromagnet 43 of the third screening mechanism 4, the third vacuum cleaner 48, the fifth electromagnet 63 of the fifth screening mechanism 6, and the fifth vacuum cleaner 68; while the second controller 33 of the second screening mechanism is also electrically connected to the fourth electromagnet 53 and the fourth vacuum cleaner 58 of the fourth screening mechanism 5. Figure 3 ).

[0051] The working principle of the tablet extrusion device of the tablet press described in this invention is as follows:

[0052] When the tablet dispensing device starts working, the tablets pressed by the tablet press enter the dispensing slot 1 in sequence and slide down to the first screening mechanism 2 for screening. The tablets collide with the first spring 21 located at the first position and are intercepted by the first spring 21. The drug powder adhering to the tablets is detached from the tablets after being impacted and enters the first powder collection box 23 through the powder suction hole 12. At the same time, the first controller 25 controls the first vacuum cleaner 24 and the vibrator to start working. The vibrator causes the first spring 21 to vibrate, thereby causing the tablets to vibrate or collide with each other, promoting the separation of the tablets and drug powder. The first vacuum cleaner 24 collects the drug powder in the first powder collection box 23 and the dispensing slot 1 and discharges it to avoid the accumulation of drug powder on the surface of the dispensing slot 1 and the first spring 21, which would cause secondary contamination to the tablets.

[0053] When the first shrapnel 21 intercepts the tablet for a predetermined time, the first controller 25 controls the first rotating motor 26 to rotate or the first electromagnet 27 to be energized, thereby causing the first shrapnel 21 to rotate downward relative to the tablet dispensing slot 1 to its second position. Simultaneously, the first controller 25 controls the first vacuum cleaner 24 to stop working, and a large number of tablets slide from above the first shrapnel 21 to the second screening mechanism 3, where they are intercepted by the second shrapnel 31 located in its first position and screened in the second screening mechanism 3. At this time, the first controller 25 controls the first rotating motor 26 to rotate or the first electromagnet 27 to be de-energized, thereby causing the first shrapnel 21 to rotate upward relative to the tablet dispensing slot 1, returning to its first position and intercepting subsequent tablets entering the tablet dispensing slot 1. When the second shrapnel 31 intercepts the tablets for a predetermined time, the second shrapnel 31 rotates to its second position. A large number of tablets processed by the second screening mechanism 3 slide to the third screening mechanism 4, where they are intercepted by the third shrapnel 41 located in its first position and screened in the third screening mechanism. Then the second shrapnel 31 rotates to its first position, ready to intercept a large number of tablets processed by the first screening mechanism 2.

[0054] After being sieved by at least five sieving mechanisms, the tablets slide out from the tablet outlet 18 below the tablet ejector. During the process of a large number of tablets impacting the shrapnel, the shrapnel applies a large impact force to the tablets, which helps to improve the effect of removing drug powder from the tablets through impact.

[0055] Preferably, the first screening mechanism 2, the third screening mechanism 4 and the fifth screening mechanism 6 are controlled by the first controller 25, so that the first spring 21, the third spring 41 and the fifth spring 61 are linked together; the second screening mechanism 3 and the fourth screening mechanism 5 are controlled by the second controller 35, so that the second spring 31 and the fourth spring 51 are linked together. When the tablet dispensing device starts working, the first spring 21, the third spring 41, and the fifth spring 61 are in their first positions to intercept tablets entering the tablet dispensing slot 1. When the tablet interception time reaches a predetermined upper limit, the first controller 25 controls the first spring 21, the third spring 41, and the fifth spring 61 to rotate to their second positions. At the same time, the second controller 35 controls the second spring 31 and the fourth spring 51 to be in their first positions, so that the tablets intercepted by the first spring 21, the third spring 41, and the fifth spring 61 slide down to the second spring 31, the fourth spring 51, and the tablet dispensing port 18 of the tablet dispensing slot 1, respectively. The tablets are sieved by the second spring 31 and the fourth spring 51. At the same time, the first controller 25 controls the first spring 21, the third spring 41, and the fifth spring 61 to rotate to their first positions to intercept subsequent tablets entering the tablet dispensing slot 1, as well as tablets sieved by the second spring 31 and the fourth spring 51, so as to realize automated continuous production. In addition, the output port 18 can be the free end below the output slot 1 or the free end of the fifth spring 61.

[0056] Compared with the prior art, the tablet extrusion device of the tablet press of the present invention has the following advantages:

[0057] (1) When the spring of the present invention is in its first position, it intercepts the tablets entering the tablet dispensing device. When the number of tablets reaches a certain amount or the interception time reaches the upper limit, the spring rotates to its second position, causing a large number of tablets to slide down to the spring behind, applying a greater impact force to the spring behind, thereby enhancing the effect of removing powder from the tablets by impact. In addition, the tablets collide with the springs of at least five screening mechanisms multiple times. During this process, the tablets automatically flip over, which is beneficial for removing the drug powder adhering to the surface of the tablets.

[0058] (2) In this invention, the vacuum cleaner removes the drug powder that enters the tablet dispensing slot along with the tablet and the drug powder that adheres to the surface of the tablet, thus avoiding secondary contamination of the tablet by drug powder residue in the tablet dispensing device; in addition, this invention uses a controller to make the vacuum cleaner remove dust only when the spring intercepts the tablet, which can save power and prevent the tablet from being adsorbed at the powder suction hole and unable to slide down.

[0059] (3) When the tablets first enter the dispensing slot and collide with the spring, a large amount of powder falls off. At this time, the springs of at least three of the five screening mechanisms at the front are equipped with through holes. When the tablets are intercepted by the springs at the front, the drug powder can enter the powder collection box through the powder suction hole or enter the powder collection box of the rear screening mechanism through the through hole, which improves the removal effect of drug powder and avoids drug powder residue on the springs, which will cause secondary contamination of the tablets. The last two springs are not equipped with through holes, so that the tablets are not contaminated by drug powder after the powder is removed by the screening mechanism at the front, and drug powder is prevented from sliding out of the dispensing port with the tablets as much as possible. In addition, the through holes of the springs can increase the contact points between the tablets and the springs, so that the overall stress on the tablets is dispersed, reducing unnecessary damage to the tablets. Defective tablets will be broken due to impact and fall into the powder collection box through the powder suction hole or into the powder collection box of the next screening mechanism through the through hole, so that the tablets entering the coating machine are all intact and meet the quality requirements.

[0060] (4) A vibrator is set at the bottom of the spring to make the tablet vibrate on the spring, which is beneficial to remove the drug powder adhering to the surface of the tablet. In addition, the vibration, repeated impact and flipping of the tablet help to polish the tablet.

[0061] (5) The controller accurately controls the rotation of the shrapnel by rotating the motor or electromagnet, so that the motion state of each two adjacent shrapnels is different. That is, when the upper shrapnel rotates to its second position, the lower shrapnel is in its first position, so that the tablet can be intercepted by all the shrapnels, and fully collide and vibrate, thereby improving the powder removal effect.

[0062] (6) The i-th screening mechanism and the (i+1)-th screening mechanism (i is an odd number) are controlled by two controllers respectively, which simplifies the device and reduces the control parameters, while enabling the film output device to achieve automated and continuous production.

[0063] Example 3

[0064] A process for preparing diclofenac sodium enteric-coated tablets includes the following steps:

[0065] S1. Preparation of diclofenac sodium tablet cores;

[0066] S2. The diclofenac sodium tablet core is coated with a release coating to obtain a release tablet;

[0067] S3. The release liner is coated with an enteric coating to obtain the diclofenac sodium enteric-coated tablet.

[0068] Specifically, in step 1, the preparation method of diclofenac sodium tablet core includes the following steps:

[0069] S11. A continuous granulation method using a wet granulator-transfer container-dry granulator-main mixing hopper connected in series is used to prepare powder. Specifically, the prescribed amounts of microcrystalline cellulose 101, corn starch, diclofenac sodium (API), lactose, povidone K30, crospovidone, and sodium carboxymethyl starch are weighed and sequentially added to an HLSG220F wet granulator (China Academy of Aeronautical Manufacturing Technology). After dry mixing with high shear stirring, the mixture is collected in a transfer container and then fed into a dry granulator for dry granulation. This method offers advantages such as high production efficiency and uniform and stable particle quality.

[0070] S12. Adding excipients and mixing: Add the prescribed amount of dry granules and sodium carboxymethyl starch in sequence and mix. Then add silicon dioxide and magnesium stearate and mix to obtain diclofenac sodium dispersion.

[0071] S13. Tableting: The diclofenac sodium dispersion is added to a GZPL-620 series high-speed tablet press (Beijing Guoyao Longli Technology Co., Ltd.) for tableting. The resulting tablets are separated from the dispersion by the tablet dispensing device of the tablet press described in Example 1 or Example 2 of this invention. The tablets at the dispensing port 18 are collected to obtain the diclofenac sodium tablet core.

[0072] In addition, step S2 includes adding gastric-soluble coating powder to purified water and stirring continuously for 1 hour to prepare a gastric-soluble film-coated suspension (isolation layer coating solution), and using a BG150F high-efficiency coating machine (China Aviation Manufacturing Technology Research Institute) to coat the diclofenac sodium tablet core obtained in step S13 with an isolation layer to obtain an isolation tablet.

[0073] Step S3 involves adding enteric-coated powder to purified water and stirring continuously for 1 hour to prepare an enteric-coated film-coated suspension. The enteric coating layer of the release tablets obtained in step S2 is then applied using a BG150F high-efficiency coating machine (China Academy of Aviation Manufacturing Technology) to obtain diclofenac sodium enteric-coated tablets.

[0074] Compared with the prior art, the diclofenac sodium tablet cores obtained in step S1 are screened by the tableting device of the tablet press in Example 1 or Example 2 of this invention. This removes the drug powder adhering to the surface of the diclofenac sodium tablet cores, trims the rough edges of the diclofenac sodium tablet cores, and screens out diclofenac sodium tablet cores that do not meet quality requirements or are broken due to collision. The diclofenac sodium tablet cores with smooth, uniform, and good quality are then fed into the coating machine for coating treatment (steps S2 and S3). Finally, uniform diclofenac sodium enteric-coated tablets are obtained. These diclofenac sodium enteric-coated tablets have a good appearance and a uniform dissolution rate and dissolution location in vivo. This solves the problems of poor coating effect of diclofenac sodium enteric-coated tablets caused by drug powder adhesion and poor uniformity of tablet shape or quality, which leads to poor efficacy and side effects on the stomach.

[0075] This invention is not limited to the above-described embodiments. If any modifications or variations to this invention do not depart from the spirit and scope of this invention, and if such modifications and variations fall within the scope of the claims and equivalent technologies of this invention, then this invention also intends to include such modifications and variations.

Claims

1. A tableting device for a tablet press used in the preparation process of diclofenac sodium enteric-coated tablets, characterized in that, include: The tablet dispensing trough is inclined downward along the direction of tablet dispensing, and the bottom of the tablet dispensing trough is provided with at least five sets of powder suction holes, the diameter of which is smaller than the diameter of the tablet. At least five springs are respectively disposed on the upper surface of the film outlet slot behind at least five sets of powder suction holes. The springs are pivotally connected to the bottom of the film outlet slot and can rotate relative to the bottom of the slot between a first position and a second position. At least five powder collection boxes are respectively located below at least five sets of powder suction holes; At least five vacuum cleaners, each connected to at least five dust collection boxes via pipes; When the spring is in the first position, it intercepts the tablet entering the tablet dispensing slot; when the spring rotates to its second position, the tablet slides from above the spring to the adjacent spring behind it.

2. The tablet output device of the tablet press according to claim 1, characterized in that, The spring is in its second position, and the angle α between it and the bottom of the ejector slot satisfies: 0 < α < β, where β is the angle at which the ejector slot is tilted downward relative to the horizontal surface.

3. The tablet extrusion device of the tablet press according to claim 2, characterized in that, When the spring is in its second position, the adjacent rear spring is in its first position.

4. The tablet extrusion device of the tablet press according to claim 3, characterized in that, Also includes: At least five controllers, each electrically connected to at least five vacuum cleaners, control the operating frequency of the vacuum cleaners.

5. The tablet extrusion device of the tablet press according to claim 4, characterized in that, Also includes: At least five rotating motors, each controlling at least five springs to rotate between their first and second positions, and each electrically connected to at least five controllers.

6. The tablet output device of the tablet press according to claim 4, characterized in that, Also includes: At least five permanent magnets are fixedly disposed at the bottom of at least five spring pieces; at least five electromagnets are fixedly disposed on the inner side of the plate outlet groove wall below at least five spring pieces, and are electrically connected to the at least five controllers respectively; when the electromagnets are energized, their corresponding permanent magnets drive the spring pieces to rotate to their second position.

7. The tablet output device of the tablet press according to claim 6, characterized in that, Also includes: It also includes at least five torsion springs, one end of which is fixedly connected to the bottom of at least five spring pieces, and the other end is fixedly connected to the bottom of the spring piece slot.

8. The tablet extrusion device of the tablet press according to claim 3, characterized in that, The tablet press dispensing device includes two controllers and at least five rotating motors. The at least five rotating motors control at least five springs to rotate between their first and second positions. Among the at least five springs, the vacuum cleaner and rotating motor corresponding to the i-th spring (i is an odd number) are electrically connected to one controller, and the vacuum cleaner and rotating motor corresponding to the (i+1)-th spring are electrically connected to the other controller. Alternatively, the tablet extrusion device of the tablet press includes two controllers, at least five permanent magnets and at least five electromagnets. The at least five permanent magnets are respectively fixedly disposed at the bottom of at least five springs, and the at least five electromagnets are respectively fixedly disposed on the inner side of the extrusion slot wall below the at least five springs. When an electromagnet is energized, its corresponding permanent magnet drives the spring to rotate to its second position. Among the at least five springs, the vacuum cleaner and electromagnet corresponding to the i-th spring (i is an odd number) are electrically connected to one controller, and the vacuum cleaner and electromagnet corresponding to the (i+1)-th spring are electrically connected to another controller.

9. The tablet output device of the tablet press according to claim 8, characterized in that, At least three of the at least five spring clips located at the front have several through holes, the diameter of which is smaller than the diameter of the tablet.

10. The tableting device for a tablet press according to claim 9, characterized in that, A vibrator is provided at the bottom of the spring piece, and the vibrator is electrically connected to the controller; when the spring piece is in its first position, the vibrator at the bottom of the spring piece vibrates.

11. The tablet extrusion device of the tablet press according to claim 10, characterized in that, It also includes a top baffle, which is fixedly connected to the top edges of the two side walls of the film outlet slot.

12. The tablet extrusion device of the tablet press according to claim 11, characterized in that, The powder suction hole is a slit, the width of which is less than the thickness of the tablet, or a baffle mesh is attached to the inner wall of the slit, the aperture of which is smaller than the diameter of the tablet.

13. A preparation process for diclofenac sodium enteric-coated tablets, characterized in that, Includes the following steps: S1. Weigh out the prescribed amounts of microcrystalline cellulose 101, corn starch, diclofenac sodium, lactose, povidone K30, crospovidone, and sodium carboxymethyl starch and add them sequentially to a wet granulation mixer. After dry mixing by high-shear stirring, collect the mixture in a transfer container and inject it into a dry granulation machine for dry granulation by suction. Add the excipients and mix them together. Add the diclofenac sodium dispersion to a high-speed tablet press for tableting. Separate the diclofenac sodium tablet cores from the dispersion using the tableting device of any one of claims 1 to 12 and collect the diclofenac sodium tablet cores. S2. The diclofenac sodium tablet core is coated with a release coating to obtain a release tablet; S3. The release liner is coated with an enteric coating to obtain the diclofenac sodium enteric-coated tablet.

14. The preparation process of diclofenac sodium enteric-coated tablets according to claim 13, characterized in that, Step S2 includes: preparing a gastric-coated film-coated suspension and using a high-efficiency coating machine to coat the diclofenac sodium tablet core obtained in step S1 with an isolation layer; Step S3 includes: preparing an enteric-coated film-coated suspension and using a high-efficiency coating machine to coat the isolation tablet obtained in step S2 with an enteric layer.

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