Tablet press device and preparation process of diclofenac sodium enteric-coated tablets

Abstract

The present invention relates to a tablet press discharging device and a preparation process for diclofenac sodium enteric-coated tablets. The tablet press discharging device comprises: a discharging slot is provided with a feed port and a discharging port, the bottom of the slot is inclined downward along the discharging direction, the discharging slot pivots at least three springs that rotate between a first position and a second position, the springs are interlaced and divide the discharging slot into a primary division chamber and at least two subdivision chambers along the discharging direction, the slot bottoms of the primary division chamber and the subdivision chamber are both provided with a group of sieve holes, the diameter of the sieve holes is smaller than the diameter of the tablets, and the springs are arranged on one side of each group of sieve holes close to the discharging port; the dust collecting mechanism corresponds to the sieve holes, including a powder collecting box and a dust collector, the powder collecting box is arranged below the sieve holes, and the dust collector is connected to the powder collecting box through a pipeline; when the spring is in the first position, the tablets are intercepted by the spring; when the spring is in the second position, the tablets are released and slide toward the discharging port. The discharging device of the present invention can timely and effectively remove the drug powder so that the tablet coating effect is highly uniform.

Description

Technical Field

[0001] The invention relates to the field of pharmaceutical equipment, and in particular to a tablet discharging device of a tablet press for diclofenac sodium enteric-coated tablets and a preparation process thereof. Background Art

[0002] Diclofenac sodium is a nonsteroidal anti-inflammatory analgesic derived from phenylacetic acid. It can inhibit the activity of cyclooxygenase, thereby blocking the conversion of arachidonic acid into prostaglandins. It can also promote the combination of arachidonic acid with triglycerides (triacylglycerols), reduce the concentration of free arachidonic acid in cells, and indirectly inhibit the production of leukotrienes, bradykinin and other products, thereby exerting antipyretic, analgesic and anti-inflammatory effects. However, diclofenac sodium is easy to irritate the gastrointestinal tract and cause adverse gastrointestinal reactions in patients. Therefore, diclofenac sodium needs to be coated to make an enteric-coated preparation 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; wherein, the tableting step is to use a tablet press to press the diclofenac sodium mixed powder into a tablet core through a mold, and the tablet core is made into a diclofenac sodium enteric-coated tablet after coating treatment, and the quality of the tablet core affects the coating effect of the tablet core. At present, the diclofenac sodium mixed powder is mainly tableted by a fully automatic high-speed rotary tablet press, which has the advantages of high production efficiency and stable tablet weight. However, it is found in actual production that during the compression molding process of the diclofenac sodium tablet core, the mixed powder will be scattered around the turntable, and enter the tablet outlet slot together with the diclofenac sodium tablet core, and slide into the receiving barrel, resulting in waste of powder and powder attached to the tablet core. In addition, these powders will remain on the tablet outlet slot when passing through the tablet outlet slot, causing secondary pollution to the subsequent tablet core. Among them, the powder mixed with the diclofenac sodium tablet core will affect the coating effect of the diclofenac sodium tablet core and the effective dose of the diclofenac sodium enteric-coated tablets, which may lead to poor appearance of the diclofenac sodium enteric-coated tablets, or even uneven or incomplete coating of the diclofenac sodium enteric-coated tablets, affecting the dissolution position or dissolution rate of the active ingredient diclofenac sodium in the organism, and ultimately causing the drug to cause local irritation to the stomach and gastric juice to damage the drug, resulting in poor efficacy. Therefore, how to remove the powder attached to the tablet core before coating is an issue that the pharmaceutical industry urgently needs to pay attention to.

[0004] In the prior art, tablets and powders are separated by setting baffles and sieve holes on the tablet outlet slot, or by connecting a vibrating screener to the tablet outlet slot. Since the tablets of a tablet press, especially a rotary tablet press, enter the tablet outlet slot one by one, the method of setting baffles and sieve holes on the tablet outlet slot has the problem that the tablets collide with the baffles individually, and the impact force generated is very small, the tablet and powder separation effect is poor, and the powder easily remains on the screen and baffle to cause secondary contamination of the tablets. The method of connecting a vibrating screener to the outlet slot has the problem that the powder remains on the screen and the tablet outlet slot to cause secondary contamination of the tablets, and the device is complex, power-consuming, and prone to failure. In addition, when the tablet press stops working and only a small number of tablets are left in the vibrating screener, the device still needs to be turned on until the last tablet slides off the outlet of the vibrating screener. This process has the problem of power consumption and low production efficiency. Summary of the invention

[0005] Based on this, the present invention overcomes the shortcomings and deficiencies of the prior art and provides a tablet discharging device for a tablet press, which is used to remove powder attached 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 and uniform drug efficacy.

[0006] The present invention is achieved through the following technical scheme: a tablet discharging device of a tablet press for diclofenac sodium enteric-coated tablets, comprising:

[0007] A sheet discharging trough, wherein the sheet discharging trough is provided with a feeding port and a discharging port, and the bottom of the trough is inclined downward along the discharging direction;

[0008] At least three spring pieces, the spring pieces are pivoted on the slot wall of the tablet discharge slot and can rotate between a first position and a second position relative to the slot wall, the spring pieces are arranged alternately, and divide the tablet discharge slot into a primary division chamber and at least two subdivision chambers along the discharge direction, the slot bottoms of the primary division chamber and the subdivision chamber are each provided with a group of sieve holes, the diameter of the sieve holes is smaller than the diameter of the tablets, and the spring pieces are each arranged on a side of each group of sieve holes close to the discharge port;

[0009] A dust collection mechanism, the dust collection mechanism corresponds to the sieve hole, and comprises a powder collection box and a dust collector, the powder collection box is arranged below the sieve hole, and the dust collector is connected to the powder collection box through a pipeline;

[0010] When the spring is in the first position, the tablet is intercepted by the spring; when the spring is in the second position, the tablet is released and slides toward the discharge port.

[0011] Compared with the prior art, the present invention arranges a spring on the tablet discharging slot to intercept the tablets, and the tablets collide with the spring or the tablets on the spring, thereby causing the drug powder to fall off, and at the same time, a vacuum cleaner is used to remove the drug powder that enters the tablet discharging slot together with the tablets and the drug powder that is removed by collision, so as to avoid the accumulation of drug powder and cause secondary pollution to subsequent tablets; when the number of tablets to be intercepted reaches a certain number, the spring rotates downward to the second position, so that a large number of tablets slide together to the spring at the rear, exerting a greater impact force on the spring, thereby enhancing the effect of the tablet being impacted and the powder being removed; the tablet collides with the spring at least three times in the tablet discharging device, so as to effectively remove the drug powder adhered to the surface of the tablet; in the process of repeated sliding and collision, the tablet automatically turns over, so that the powder is removed more thoroughly, and it is beneficial to the grinding and polishing of the tablet. In addition, in this process, defective tablets that do not meet the quality standards are broken due to collision, and thus fall into the powder collecting box through the sieve hole, which has the function of screening qualified tablets, so that the quality of the tablets to be coated subsequently is uniform.

[0012] Furthermore, the sieve holes include a first sieve hole and a second sieve hole, the first sieve hole covers the bottom of the groove opened in the primary separation chamber, the second sieve hole is opened in the bottom of the groove of the subdividing chamber, and the width of the area where the second sieve hole is located is smaller than the spacing between the springs. This structure allows sufficient time for the powder on the tablet to be sucked away, and also allows the tablets to rub against each other, thereby improving the separation rate of the powder. At the same time, this structure allows a sufficiently smooth surface between the second sieve hole and the spring mechanism in front, so that the tablet can be accelerated during the sliding process before reaching the second sieve hole, thereby increasing the impact speed and allowing the powder to be shaken off during the impact.

[0013] Furthermore, a silica gel pad is laid on the bottom of the primary separation chamber, and a powder passing hole corresponding to the first sieve hole is opened on the silica gel pad. The silica gel material can increase the friction between the bottom of the groove and the tablet, so that the powder on the tablet is further separated under the action of friction, thereby realizing the primary separation of the powder tablet.

[0014] Furthermore, the spring sheet is provided with a plurality of through holes, and a second vibrator is provided on the spring sheet. When the spring sheet is in its first position, the second vibrator on the spring sheet vibrates. This structure enables the tablets to collide with the spring sheet or the tablets above the spring sheet multiple times, which is beneficial to the removal of the drug powder. The drug powder can slide off the spring sheet or the through hole of the spring sheet to avoid secondary contamination of subsequent tablets by remaining on the spring sheet, and the through hole of the spring sheet can increase the contact points between the tablets and the spring sheet, so that the overall stress on the tablets is dispersed, and unnecessary damage to the tablets is reduced. At the same time, this structure causes the tablets to continuously collide and rub against each other during the stacking process, thereby achieving grinding and polishing of the tablets.

[0015] Furthermore, at least three torsion springs are included, one end of each torsion spring is fixedly connected to the spring sheet, and the other end is fixedly connected to the slot wall. The sheet discharging device has a more compact structure.

[0016] Furthermore, at least three rotating rods and a counterweight box are included, wherein the rotating rod is pivoted on the slot wall of the tablet outlet slot, one end of the rotating rod is fixedly connected to the spring sheet, and the other end extends to the outside of the tablet outlet slot and is connected to the counterweight box, and the counterweight box pulls the spring sheet to return to the first position by gravity, so that the tablet outlet device is more energy-saving and power-saving, and is convenient for adjusting the interception amount of tablets.

[0017] Furthermore, it also includes a proximity switch, which corresponds to the counterweight box one by one and is electrically connected to the vacuum cleaner corresponding to the chamber where the counterweight box is located; when the spring is in the first position, the proximity switch contacts the counterweight box and sends a signal to make the vacuum cleaner work. This structure prevents some tablets from being adsorbed by the vacuum cleaner at the sieve hole and unable to slide off when the spring is in the second position and releases the tablets, and at the same time, makes the tablet discharge device more energy-saving.

[0018] Furthermore, it also includes a controller and at least three rotating motors, the rotating motors respectively control the rotation of the spring pieces, and the controller is electrically connected to the vacuum cleaner, the rotating motor, the first vibrator and the second vibrator, so as to control the start and stop thereof. This structure can realize the automatic control of the film discharging device, which meets the requirements of current technological development.

[0019] Furthermore, the controller corresponds to the springs one by one, thereby controlling the time or number of tablets intercepted by each spring respectively. This structure makes the rotation of the springs more flexible, thereby adjusting the tablet interception amount and interception time of different springs according to actual applications, meeting the needs of the production site.

[0020] Furthermore, there are two controllers, one of which is arranged on the left side of the film outlet slot and is electrically connected to the rotating motor driving the spring sheet pivoted on the side and the vacuum cleaner corresponding to the spring sheet pivoted on the side; the other is arranged on the right side of the film outlet slot and is electrically connected to the rotating motor driving the spring sheet pivoted on the side and the vacuum cleaner corresponding to the spring sheet pivoted on the side; the two controllers control the spring sheet on the left side and the spring sheet on the right side to be in different positions or opposite motion states. This structure can reduce the control cost and complexity and achieve lightweight device.

[0021] Furthermore, the controller has one, the rotating motors are all electrically connected to the controller, and the controller controls the springs to be in the same position or motion state. This structure can further reduce the control cost and complexity, achieve lightweight device, and save electricity and energy.

[0022] Furthermore, when the spring is in its first position, the angle between it and the groove wall is 70-90°; when the spring is in the second position, the angle between it and the groove wall is 30-60°. This structure enables the tablets to automatically slide to their free ends when they are intercepted by the spring, thus preventing the tablets from piling up at the rotating rod, which results in the distance between the tablets and the rotating rod (i.e., the fulcrum) being too short, and requiring a large power (i.e., the weight of the tablets) to drive the rotating rod to rotate the spring, thereby affecting the number of tablets intercepted by the spring and the effect of drug powder removal.

[0023] The present invention also provides a preparation process of diclofenac sodium enteric-coated tablets, comprising the following steps:

[0024] S1. Weigh the prescribed amount of microcrystalline cellulose 101, corn starch, diclofenac sodium, lactose, povidone K30, cross-linked povidone, and sodium carboxymethyl starch, and add them to a wet mixing granulator in sequence. After dry mixing by high shear stirring, collect them into a transfer container, and inject them into a dry granulator by suction for dry granulation; add additional excipients and mix them; add the diclofenac sodium dispersion to a high-speed tablet press for tableting, separate the prepared diclofenac sodium tablet cores from the dispersion by the tablet press discharging device according to any one of claims 1 to 9, and collect the diclofenac sodium tablet cores.

[0025] S2, isolating and coating the diclofenac sodium tablet core to obtain an isolating tablet;

[0026] S3, coating the isolation tablet with an enteric layer to obtain the diclofenac sodium enteric-coated tablets.

[0027] Further, step S2 includes: preparing a gastric-soluble 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-soluble film-coated suspension, and using a high-efficiency coating machine to coat the isolation tablet obtained in step S2 with an enteric layer.

[0028] The preparation process of the diclofenac sodium enteric-coated tablets of the present invention adopts an improved tablet press discharging device in cooperation with a tablet press to compress and discharge tablets. The preparation process can simply, cost-effectively and effectively remove drug powder attached to the surface of the diclofenac sodium tablet core, trim the burrs of the diclofenac sodium tablet core, and screen out the diclofenac sodium tablet core that does not meet the quality requirements and is broken due to collision, so that the diclofenac sodium tablet core with the characteristics of being smooth, uniform and of good quality is subjected to coating treatment in steps S2 and S3, and finally uniform diclofenac sodium enteric-coated tablets are prepared. The diclofenac sodium enteric-coated tablets have good appearance, and have uniform dissolution speed and dissolution position in a living body, and solve the problems of poor coating effect of the diclofenac sodium enteric-coated tablets caused by drug powder adhesion, poor tablet shape or poor quality uniformity, and poor efficacy of the diclofenac sodium enteric-coated tablets and side effects on the stomach. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 It is a schematic structural diagram of a tablet discharging device of a tablet press according to embodiment 1 of the present invention.

[0030] Figure 2 A cross-sectional view of the bottom structure of the sheet outlet groove corresponding to the primary dividing cavity when the silicone pad is provided with patterns;

[0031] Figure 3 It is a top view of the tablet discharging device of the tablet press, wherein the spring piece shown by the solid line of the first screening mechanism is in the first position, and the spring piece shown by the dotted line is in the second position;

[0032] Figure 4 for Figure 1 A front view of a tablet discharging device of the tablet press shown;

[0033] Figure 5 is a schematic diagram of the structure of the shrapnel;

[0034] Figure 6 Schematic diagram of the structure of the torsion spring in Example 2;

[0035] Figure 7 It is a schematic structural diagram of a tablet discharging device of a tablet press according to embodiment 3 of the present invention.

[0036] Figure 8 A top view of a tablet discharging device of a tablet press according to Embodiment 3 of the present invention;

[0037] Fig. 9 A top view of a tablet discharging device of a tablet press according to another embodiment;

[0038] Fig.10 A top view of a tablet discharging device of a tablet press according to another embodiment;

[0039] Fig.11 Tandem diagram from premixing to granulation in the preparation process of diclofenac sodium enteric-coated tablets. DETAILED DESCRIPTION

[0040] The present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It is understood that the specific embodiments described herein are only used to explain the present invention, rather than to limit the present invention, and for ease of description, only the parts related to the present invention rather than all structures are shown in the accompanying drawings.

[0041] Example 1

[0042] See also Figure 1-5The tablet discharging device of the tablet press of this embodiment includes a tablet discharging slot 1 and at least three screening mechanisms. The tablet discharging slot 1 is provided with a feed port and a discharge port 19, and the bottom of the slot is inclined downward along the discharging direction, so that the tablets can slide into the tablet discharging device from the feed port along the tablet discharging slot 1 under the action of their own gravity, and then slide out from the discharge port 19. The screening mechanisms are arranged in an interlaced manner in the tablet discharging slot 1, and divide the tablet discharging slot 1 into a primary division chamber 1a and at least two subdivision chambers 1b, 1c along the discharging direction. Each screening mechanism includes a spring mechanism and a dust suction mechanism, respectively. The spring mechanism is vertically arranged on the upper surface of the bottom of the tablet discharging slot 1, and the dust suction mechanism 4 is arranged on the lower surface of the tablet discharging slot 1.

[0043] The tablet discharging slot 1 includes a discharging plate 12 and a first slot wall 14 and a second slot wall 16 arranged on both sides of the discharging plate 12. The discharging plate 12 is provided with at least three groups of sieve holes 13, including a group of first sieve holes 13a covering the bottom of the primary separation chamber 1a, and at least two groups of second sieve holes 13b, 13c opened at the bottom of the subdividing chambers 1b, 1c. The first sieve holes 13a and the second sieve holes 13b, 13c are arranged in sequence along the tablet discharging direction. The diameter of the sieve holes 13 is smaller than the diameter of the tablets, and its size and shape can be changed according to actual conditions. It is necessary to prevent the tablets from passing through the sieve holes 13 while ensuring that the powder can pass through the sieve holes 13 and leave the tablet discharging slot 1 to achieve powder-tablet separation. The dust suction mechanism 4 corresponds to the sieve holes 13, so that all the powder passing through the sieve holes 13 is sucked away to avoid waste and pollution caused by leakage of powder. In some embodiments, the tablet outlet slot 1 further includes a top baffle 15, which covers the first slot wall 14 and the second slot wall 16, so that the tablet outlet slot 1 is connected to the outside only at the feed port and the discharge port 19 at both ends, so as to prevent tablets from popping out and avoid the intrusion of dust and dirt.

[0044] The first sieve holes 13a cover the bottom of the primary separation chamber 1a, so that after the tablets pass through the feed port, the dust suction mechanism can suck away the powder adhering to the tablets. The bottom of the primary separation chamber 1a is also paved with a silicone pad 17, and the silicone pad 17 is provided with a powder passing hole 171 corresponding to the first sieve holes. The silicone pad 17 can reduce the sliding speed of the tablets, so that there is enough time for the powder on the tablets to be sucked away, and at the same time, the tablets can rub against each other to improve the separation rate of the powder. At the same time, the silicone material can increase the friction between the bottom of the groove and the tablets, so that the powder on the tablets is further separated under the action of friction.

[0045] Preferably, the upper surface of the silicone pad 17 can be a plane parallel to the inclined groove bottom, or provided with wave-shaped, step-shaped or sawtooth-shaped patterns distributed at intervals along the discharge direction, so that the tablets will roll between the patterns of the silicone pad during the sliding process, so that each side of the tablet can correspond to the powder hole 171, so that the powder on each side of the tablet can be sucked away. A first vibrator 18 is provided at the bottom of the tablet discharge groove 1, and the first vibrator 18 corresponds to the primary separation chamber 1a, and the tablets are prompted to shake off the powder and turn over through vibration, while preventing the tablets from blocking the powder hole.

[0046] The first screening mechanism 2a includes a first spring mechanism 3a and a first dust suction mechanism 4a, wherein the first spring mechanism 3a includes a spring 32a, a rotating rod 34a, a counterweight box 36a and a counterweight block. The spring 32a is vertically arranged on the upper surface of the discharge plate 12 and is located behind the sieve hole 13a (i.e., the side of the sieve hole 13a close to the discharge port 19), so that the tablets need to pass through the sieve hole 13a before colliding with the spring 32a. The spring 32a itself has a certain elasticity. When the tablet collides with it, it is elastically deformed and the tablet is ejected in the opposite direction, thereby shaking off the powder that is tightly adhered to the tablet. The rotating rod 34a is rotatably connected to the first slot wall 14 and is fixedly connected to one end of the spring 32a, so that the spring 32a can rotate between its first position and its second position relative to the first slot wall 14. When the spring sheet 32a is in its first position, the distance between the spring sheet 32a and the second slot wall 16 is smaller than the thickness of the tablet; when the spring sheet 32a is in its second position, the distance between the spring sheet 32a and the second slot wall 16 increases, and the tablet slides off the spring sheet 32a, passes through the distance and slides toward the second screening mechanism 2b. The counterweight box 36a is arranged outside the tablet outlet slot 1 and is fixedly connected to the other end of the rotating rod 34a, so that the spring sheet 32a, the rotating rod 34a and the counterweight box 36a form a seesaw structure, and the counterweight box 36a pulls the spring sheet 32a to return to the first position by gravity.

[0047] The counterweight box 36a is used to place the counterweight block. The weight of one end of the counterweight box 36a in the seesaw structure can be adjusted by adjusting the weight or number of the counterweight blocks. By adjusting the weight of one end of the counterweight box 36a, the total weight of the tablets intercepted by the spring sheet 32a when it is kept in the first position can be adjusted. Since the movement trajectory of the counterweight block and the counterweight box 36a is parallel to the inclined surface of the bottom of the groove, when the spring sheet 32a rotates downward, the counterweight block and the counterweight box 36a rotate upward, and their gravitational potential energy increases. Therefore, sufficient tablets are required to provide the power to drive the spring sheet 32a to rotate. When the total weight of the tablets is overweight, the gravity of the tablets pushes the spring sheet 32a to overcome the weight of the counterweight box 36a and the counterweight block, and rotate downward relative to the first groove wall 14, so that the seesaw structure rotates, and the spring sheet 32a rotates to the second position, and the tablets slide off the spring sheet 32a. When the weight of the spring piece 32a and the tablets above it is less than the weight of one end of the counterweight box 36a, the gravity of the counterweight box 36a causes the rotating rod 34a to drive the spring piece 32a to rotate upward relative to the groove wall 14 to achieve reset.

[0048] In the natural state, the spring sheet 32a is located in its first position, and the spring sheet 32a and the first slot wall 14 are perpendicular to each other or the free end of the spring sheet 32a is slightly lower than the fixed end of the spring sheet 32a. When the free end of the spring sheet 32a is slightly lower than the fixed end of the spring sheet 32a, the tablets above the spring sheet 32a automatically slide to the free end of the spring sheet 32a. Preferably, when the spring sheet 32a is located in its first position, the angle a between it and the first slot wall 14 is 70° to 90°, so as to avoid the different positions of the tablets stacked each time, resulting in the inconsistent power applied to the spring sheet 32a by the tablets to the power arm of the rotating rod 34a each time, thereby resulting in the inconsistent number of tablets intercepted by the spring sheet 32a each time and its powder removal effect; when the spring sheet 32a is in its second position, the angle b between it and the first slot wall 14 is 20° to 60°.

[0049] Preferably, the first spring sheet mechanism 3a further includes a limit block 38a, which is arranged on the upper surface of the discharge plate 12 and fixedly connected to the inner side of the second slot wall 16, and is located in front of the spring sheet 32a, and its length is greater than the distance between the spring sheet 32a and the second slot wall 16. The limit block 38a limits the upward rotation of the spring sheet 32a relative to the first slot wall 14, so as to avoid that in a natural state, the free end of the spring sheet 32a in the seesaw structure is higher, so that the distance between the spring sheet 32a and the second slot wall 16 is increased, causing the tablet to slide from the distance. Preferably, the stop block 38a is a triangular prism or a trapezoidal prism. When the stop block 38a is a triangular prism, one side thereof is fixedly connected to the inner side of the second slot wall 16, and the other side thereof is in contact with the spring piece 32a located at the first position thereof; when the stop block 38a is a trapezoidal prism, the bottom surface thereof is fixedly connected to the inner side of the second slot wall 16, one side thereof is in contact with the spring piece 32a located at the first position thereof, and the angle between the other side thereof and the second slot wall 16 is less than 90°, so that the tablets cannot be accumulated above the stop block 38a. The stop block makes the tablets collide with the spring piece as completely as possible, and prevents the spring piece from rotating upward at too large an angle under the action of the counterweight box when there are fewer tablets, thereby increasing the distance between the spring piece and the other slot wall, causing some tablets to slide off from the distance between the spring piece and the other slot wall, thereby affecting the powder removal effect of the tablets.

[0050] Preferably, the first spring mechanism 3a further includes a transverse return spring 39a, which is arranged between the counterweight box 36a and the first groove wall 14, with one end fixedly connected to the outer side of the first groove wall 14 and the other end fixedly connected to the counterweight box 36a.

[0051] See also Figure 5 Preferably, a plurality of through holes 31a are provided on the spring sheet 32a. A second vibrator 35a is provided at the bottom of the spring sheet 32a. The second vibrator 35a causes the spring sheet 32a to vibrate, so that the tablet intercepted by the spring sheet 32a is separated from the powder attached thereto. The separated powder can flow out along the sieve hole or move to the sieve hole downstream through the through hole. Preferably, the second vibrator 35a causes the spring sheet 32a to vibrate when the spring sheet 32a is in its first position.

[0052] The first dust collecting mechanism 4a includes a powder collecting box 42a, a dust collector 44a and a pipe 46a. The powder collecting box 42a is arranged directly below the sieve hole 13 and fixedly connected to the discharge plate 12. The powder collecting box 42a is connected to the dust collector 44a through a pipe 46a. Preferably, the first dust collecting mechanism 4a also includes a proximity switch 48a, which is electrically connected to the dust collector 44a. When the spring 32a is in its first position, the counterweight box 36a of the spring mechanism 2a contacts the proximity switch 48a, sends a signal to the dust collector 44a, and the dust collector 44a starts to work. Specifically, the first dust suction mechanism 4a also includes a controller 47a, the dust collector 44a is electrically connected to the controller 47a, the controller 47a is electrically connected to the proximity switch 48a, the first vibrator 18 and the second vibrator 35a, when the proximity switch 48a contacts the counterweight box 36a, a signal is sent to the controller 47a, and the controller 47a controls the dust collector 44a and the second vibrator 35a to start working. Preferably, the first dust suction mechanism 4a also includes a recovery device (not shown), which is connected to the powder collection box 42a through a pipeline, and the drug powder in the powder collection box 42a is recovered by negative pressure and the like and is transferred to the tablet press for reuse.

[0053] The second screening mechanism 2b includes a second spring mechanism 3b and a second dust suction mechanism 4b, and the third screening mechanism 2c includes a third spring mechanism 3c and a third dust suction mechanism 4c. The second screening mechanism 2b and the third sieve hole mechanism 2c are respectively arranged behind the second sieve holes 13b and 13c. The second screening mechanism 2b is located behind the first screening mechanism 2a, and its structure is similar to that of the first screening mechanism 2a. The difference from the first screening mechanism 2a is that the rotating rod 34b of the second spring mechanism 3b is rotatably connected to the second slot wall 16, and the spring 32b is spaced from the first slot wall 14, which is smaller than the thickness of the tablets. The limit block 38b is arranged on the upper surface of the discharge plate 12, one side of which is fixedly connected to the inner side of the second slot wall 16, and the other side is in contact with the spring 32b. The third screening mechanism 2c is arranged on the same side as the first screening mechanism 2a and is located behind the second screening mechanism 2b. Its structure is the same as that of the first screening mechanism 2a, or the spring piece 32c has no through hole, so as to prevent powder from falling into the discharge port 19.

[0054] The subdivided cavities 1b and 1c are not provided with silicone pads 17, and the tablets are in direct contact with the bottom of the groove. The second sieve holes 13b and 13c are different from the first sieve holes 13a in that they are opened at the bottom of the groove of the subdivided cavities 1b and 1c, and the width of the area where the second sieve holes 13b and 13c are located (i.e., the width of the layout along the discharge direction) is smaller than the spacing between the shrapnel, so that there is a sufficient smooth surface between the shrapnel mechanism in front, so that the tablets can be accelerated in the process of sliding before reaching the second sieve holes 13b and 13c, and the impact speed can be increased, so that the powder can be shaken off when impacting. Preferably, the width of the second sieve holes 13b and 13c is one-fourth to one-sixth of the total width of the subdivided cavity.

[0055] The working principle of the tablet discharging device of the tablet press described in this embodiment is as follows:

[0056] When the tablet discharging device starts working, the tablets pressed by the tablet press enter the tablet discharging slot 1 in sequence. During the process of the tablets sliding down in the primary separation chamber 1a, the first vibrator 18 is started to make the tablets collide and rub with the silica gel pad 17, so that most of the powder is separated from the tablets. The separated powder enters the powder collecting box 42a through the powder hole and the first sieve hole 13a. Then the tablets slide to the first screening mechanism 2a for screening processing: they hit the spring piece 32a located in its first position and are intercepted by the spring piece 32a. The drug powder adhered to the tablets is separated from the tablets after being hit and enters the powder collecting box 42a through the sieve hole 13a. At the same time, the counterweight box 36a contacts the proximity switch 48a, triggering the proximity switch 48a to close and send a signal to the controller 47a to control the vacuum cleaner 44a and the second vibrator to start working. The second vibrator causes the spring piece 32a to vibrate and deform, thereby driving the tablets to hit each other or collide with the spring piece 32a, promoting the separation of the tablets and the drug powder, and at the same time causing the spring piece 32a to shake off the powder attached to itself. The vacuum cleaner 44a collects the drug powder in the powder collecting box 42a and the tablet outlet slot 1 and discharges it, avoiding the accumulation of drug powder on the surface of the tablet outlet slot 1 and the spring piece mechanism 3a, causing secondary contamination of the tablets. When the tablets intercepted by the spring sheet 32a exceed the upper limit, the gravity of the tablets drives the spring sheet 32a to rotate downward to its second position relative to the first slot wall 14. At the same time, the counterweight box 36a is separated from the proximity switch 48a, the proximity switch 48a is disconnected, the vacuum cleaner 44a stops working, and a large number of tablets slide from the spring sheet 32a into the subdividing chamber 1b. When the tablets slide to the second screening mechanism 2b and repeat the above screening process. At this time, there are no tablets or only a small number of tablets above the spring sheet 32a. The gravity of one end of the counterweight box 36a causes the rotating rod 34a to drive the spring sheet 32a to rotate upward relative to the first slot wall 14, return to its first position and intercept the subsequent tablets entering the tablet outlet slot 1.

[0057] After being screened by all the screening mechanisms 2, the tablets slide out from the discharge port 19 below the tablet discharge device. In the process of a large number of tablets hitting the shrapnel 32, the shrapnel 32 applies a large impact force to the tablets, which helps to improve the effect of tablet impact to remove drug powder.

[0058] Example 2

[0059] See also Figure 6 This embodiment is basically the same as the embodiment 1, and the difference is that the counterweight box 36a and the counterweight block can be replaced by other structures. Taking the first spring mechanism 3a as an example, the first spring mechanism 3a also includes a torsion spring 37a, one end of which is fixedly connected to the inner side of the first slot wall 14, and the other end is fixedly connected to the spring 32a. The torsion spring 37a makes the spring 32a in the first position.

[0060] When the number of tablets intercepted by the shrapnel 32a exceeds the upper limit, the gravity of the tablets drives the shrapnel 32a to overcome the resistance of the torsion spring 37a and rotate to the second position, thereby releasing the tablets and deforming the torsion spring 37a. When there are no tablets or only a small number of tablets above the shrapnel 32a, the torsion spring 37a is reset, thereby driving the shrapnel 32a to return to the first position and intercept the tablets. The shrapnel in the second screening mechanism 2b and the third screening mechanism 2c can also be connected to the tablet outlet slot 1 through the torsion spring. The principle is the same as above and will not be repeated. This structure can change the number of tablets that the shrapnel can intercept by changing the hardness of the torsion spring, and automatically release the tablets when the intercepted tablets reach the upper limit. It has a simple structure and can reduce the energy consumption and cost of the equipment.

[0061] Example 3

[0062] See also Figure 7-10 This embodiment is basically the same as the first embodiment, and the difference is that the spring piece is driven to rotate by a rotating motor in an electrically controlled manner. There are at least three rotating motors, which correspond to the spring pieces one by one, and their output ends respectively drive the spring pieces to rotate. Taking three as an example, the rotating motors are 5a, 5b, and 5c respectively, and the rotating motors 5a, 5b, and 5c are controlled by a controller.

[0063] The controller can be adjusted according to the actual situation. Figure 8 In one embodiment, the controller has at least three, for example, the same number as the rotating motors, which are 47a, 47b and 47c. The rotating motors 47a, 47b and 47c correspond to the springs one by one, thereby controlling the time or number of tablets intercepted by each spring respectively.

[0064] Taking the first screening mechanism 2a as an example, it includes a first spring mechanism 3a and a first dust suction mechanism 4a, wherein the first spring mechanism 3a includes a spring 32a, a rotating rod 34a and a second vibrator 35a. The output end of the rotating motor 5a is connected to the rotating rod 34a to control the spring 32a to rotate between its first position and the second position, thereby releasing or intercepting the tablets above the spring 32a.

[0065] Preferably, the second vibrator 35a is electrically connected to the controller 47a. When the spring piece 32a is in its first position, the controller 47a controls the second vibrator 35a to drive the spring piece 32a to vibrate. The controller 47a is electrically connected to the rotating motor 5a and the vacuum cleaner 44a. The rotating motor 5a controls the spring piece 32a to rotate between its first position and the second position, and can control the vacuum cleaner 44a to start or stop working. Specifically, the controller 47a can adjust the time or weight of each tablet intercepted by the spring piece 32a.

[0066] The second screening mechanism 2b includes a second spring mechanism 3b and a second dust suction mechanism 4b, and the third screening mechanism 2c includes a third spring mechanism 3c and a third dust suction mechanism 4c. The driving mode of the second screening mechanism 2b and the third screening mechanism 2c is the same as that of the first screening mechanism 2a. They are driven by an independent rotating motor 37b, 37c to rotate, and the second dust suction mechanism 4b and the third dust suction mechanism 4c are controlled by controllers 47b and 47c, respectively, which will not be repeated. In this embodiment, the control signals can be input to the controllers respectively, so as to control the start and stop of the rotating motors in the first screening mechanism 2a, the second screening mechanism 2b and the third screening mechanism 2c respectively, so that all the springs can be rotated independently according to the situation of the tablets.

[0067] In another embodiment, see Fig. 9 There are two controllers, 47a and 47b, one of which is arranged on the left side of the sheet outlet slot and is electrically connected to all the rotating motors 5a and 5c driving the spring sheet pivoted on the left side, and is also electrically connected to the vacuum cleaner corresponding to the spring sheet on this side; the other is arranged on the right side of the sheet outlet slot and is electrically connected to all the rotating motors 5b driving the spring sheet pivoted on the right side, and is also electrically connected to the vacuum cleaner corresponding to the spring sheet on this side. In this embodiment, the spring sheets are divided into two groups according to their pivoting positions, and are controlled by the two controllers respectively, so that the spring sheets on the left side and the spring sheets on the right side are in different positions or opposite motion states, that is, for adjacent spring sheets, when the upstream spring sheet releases the tablet, the downstream spring sheet is in a state of intercepting the tablet.

[0068] In another embodiment, see Fig.10, the controller 47 has one, the vacuum cleaner and the rotating motors 5a, 5b, 5c are all electrically connected to the controller, and the controller controls the shrapnel to be in the same position or motion state. In this embodiment, the distance between the shrapnel needs to be designed according to the sliding speed of the tablets. For adjacent shrapnel, when the controller controls the shrapnel to open at the same time, the first pile of tablets slides to the discharge port 19 through the downstream shrapnel. At the same time, the second pile of tablets slides to the downstream shrapnel through the upstream shrapnel. Since there is a certain distance between the shrapnel, it takes a certain amount of time for the second pile of tablets to reach the downstream shrapnel. Before the second pile of tablets reaches the downstream shrapnel, the controller controls the shrapnel to close at the same time, so that the downstream shrapnel intercepts the second pile of tablets, thereby separating the powder and tablets. This embodiment can greatly reduce the control difficulty and equipment cost, and at the same time enable the shrapnel to rotate significantly when the distance between each other is small, avoiding interference between the shrapnel.

[0069] Compared with the prior art, the tablet discharging device of the tablet press described in Examples 1-3 of the present invention has the following advantages:

[0070] (1) When the spring sheet of the present invention is in its first position, it intercepts the tablets entering the tablet discharging device. When the number of tablets reaches a certain level, the spring sheet rotates to its second position, causing a large number of tablets to slide down to the spring sheet below, exerting a greater impact force on the spring sheet, thereby enhancing the effect of removing powder from the tablets by impact. In addition, the tablet collides with the spring sheets of at least three screening mechanisms at least three times. During this process, the tablet automatically turns over, which is beneficial to the removal of drug powder adhered to the surface of the tablet.

[0071] (2) In the present invention, the vacuum cleaner removes the drug powder that enters the tablet discharging slot together with the tablets and the drug powder that adheres to the surface of the tablets, thereby preventing the drug powder from remaining in the tablet discharging device and causing secondary contamination of the tablets. In addition, the present invention uses a proximity switch and / or a controller to enable the vacuum cleaner to remove dust only when the shrapnel intercepts the tablets, thereby saving electricity and preventing the tablets from being adsorbed on the sieve holes and unable to slide down.

[0072] (3) The rotating rod, the counterweight box and the spring sheet form a seesaw structure. When the number of tablets intercepted by the spring sheet reaches an upper limit, one end of the spring sheet of the seesaw structure rotates downward to make the tablets slide down to the spring sheet. After the tablets slide down, the gravity of one end of the counterweight box causes the spring sheet to automatically rotate upward to intercept the tablets. The seesaw structure makes the tablet discharging device more energy-saving and power-saving.

[0073] (4) By setting the inclination angle of the spring sheet in its first position, the tablets automatically slide to the spring sheet on one side of the second groove wall, thereby preventing the tablets from piling up on the rotating rod, which would cause the distance between the tablets and the rotating rod (i.e., the fulcrum) to be too short. A large amount of power (i.e., the weight of the tablets) is required to enable the rotating rod to drive the spring sheet to rotate, thereby affecting the number of tablets intercepted by the spring sheet and the effect of drug powder removal.

[0074] (5) The limit block can prevent the spring from rotating upward and stopping at different positions, and can prevent the tablet from sliding out of the gap between the spring and the other groove wall, thereby affecting the powder removal effect of the tablet; in addition, in combination with the counterweight block, the number of tablets intercepted by the spring can be adjusted;

[0075] (6) Providing through holes on the shrapnel can prevent drug powder from remaining on the shrapnel and causing secondary contamination to the tablets. In addition, the through holes of the shrapnel can increase the contact points between the tablets and the shrapnel, so that the overall stress on the tablets is dispersed, and unnecessary damage to the tablets is reduced. Defective tablets will be broken by impact and fall into the powder collecting box through the sieve holes or into the powder collecting box of the next screening mechanism through the through holes, so that the tablets entering the coating machine are complete and meet the quality requirements.

[0076] (7) A vibrator is arranged at the bottom of the shrapnel to make the tablet vibrate on the shrapnel, which is helpful to remove the drug powder adhering to the surface of the tablet. In addition, the vibration, multiple impacts and turning over of the tablet are helpful to grind and polish the tablet.

[0077] (8) The controller accurately controls the rotation of the springs by rotating the motor, so that the motion states of each two adjacent springs are different, that is, when the upper spring rotates to its second position, the lower spring is in its first position, so that the tablets can be intercepted by all the springs, undergoing sufficient collision and vibration, thereby improving the powder removal effect.

[0078] Example 4

[0079] A preparation process of diclofenac sodium enteric-coated tablets comprises the following steps:

[0080] S1, preparing diclofenac sodium tablet core;

[0081] S2, isolating and coating the diclofenac sodium tablet core to obtain an isolating tablet;

[0082] S3, coating the isolation tablet with an enteric layer to obtain the diclofenac sodium enteric-coated tablets.

[0083] Specifically, in step 1, the preparation method of diclofenac sodium tablet core comprises the following steps:

[0084] S11. Reference Fig.11The powder is prepared by a continuous granulation method of a wet mixing granulator-transfer container-dry granulator-total mixing hopper in series, that is, the prescribed amount of microcrystalline cellulose 101, corn starch, diclofenac sodium (API), lactose, povidone K30, cross-linked povidone, and sodium carboxymethyl starch are weighed and added to the HLSG220F wet mixing granulator (China Aviation Manufacturing Technology Research Institute) in sequence, and then collected in a transfer container after dry mixing by high shear stirring, and injected into the dry granulator by suction for dry granulation. This method has the advantages of high production efficiency and uniform and stable granule quality.

[0085] S12, adding additional excipients and mixing: adding the prescribed amount of dry granules and additional sodium carboxymethyl starch in sequence and mixing, and then adding silicon dioxide and magnesium stearate and mixing to obtain a diclofenac sodium dispersion.

[0086] S13, tableting: adding the diclofenac sodium dispersion to a GZPL-620 series high-speed tablet press (Beijing Guoyao Longli Technology Co., Ltd.) for tableting, and separating the tablets from the dispersion through the tablet discharging device of the tablet press described in Example 1, Example 2, or Example 3 of the present invention, and collecting the tablets at the discharge port to obtain diclofenac sodium tablet cores.

[0087] Specifically, step S2 includes the following steps: adding the gastric soluble coating powder to purified water and continuously stirring for 1 hour to prepare a gastric soluble film coating suspension (isolation layer coating liquid), 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.

[0088] Specifically, step S3 includes the following steps: adding the enteric coating powder to purified water and continuously stirring for 1 hour to prepare an enteric film coating suspension, and using a BG150F high-efficiency coating machine to coat the isolation tablet prepared in step S2 with an enteric layer to prepare diclofenac sodium enteric-coated tablets.

[0089] Compared with the prior art, the diclofenac sodium tablet cores prepared in step S1 are screened by the tablet discharging device of the tablet press of embodiment 1, embodiment 2 or embodiment 3 of the present invention, the drug powder attached to the surface of the diclofenac sodium tablet cores is removed, the burrs of the diclofenac sodium tablet cores are trimmed, and the diclofenac sodium tablet cores that do not meet the quality requirements and are broken due to collision are screened out, so that the diclofenac sodium tablet cores with the characteristics of smoothness, uniformity and good quality enter the coating machine for coating treatment (step S2, step S3), and finally uniform diclofenac sodium enteric-coated tablets are prepared. The diclofenac sodium enteric-coated tablets have a good appearance and a uniform dissolution rate and dissolution position in the organism, which solves the problems of poor coating effect of diclofenac sodium enteric-coated tablets caused by drug powder adhesion, poor tablet shape or poor quality uniformity, and poor efficacy of diclofenac sodium enteric-coated tablets and side effects on the stomach. The preparation process using the improved tablet press discharging device has the advantages of simple device, power saving, high production efficiency, and avoidance of pollution and waste.

[0090] It should be understood that, in the description of the present application, the terms "center", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application. The terms "first" and "second" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated, that is, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In addition, unless otherwise specified, "multiple" means two or more.

[0091] It should be noted that, in the description of this application, unless otherwise clearly specified and limited, the terms "disposed", "connected", "connected", and "hollow" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0092] The present invention is not limited to the above-mentioned embodiments. If various changes or modifications to the present invention do not depart from the spirit and scope of the present invention, and if these changes and modifications fall within the scope of the claims and equivalent technologies of the present invention, the present invention is also intended to include these changes and modifications.

Claims

1. A tablet discharging device for a tablet press of diclofenac sodium enteric-coated tablets, characterized in that: include: A sheet discharging trough, wherein the sheet discharging trough is provided with a feeding port and a discharging port, and the bottom of the trough is inclined downward along the discharging direction; At least three spring pieces, the spring pieces are pivoted on the slot wall of the tablet discharge slot and can rotate between a first position and a second position relative to the slot wall, the spring pieces are arranged alternately, and divide the tablet discharge slot into a primary division chamber and at least two subdivision chambers along the discharge direction, the slot bottoms of the primary division chamber and the subdivision chamber are each provided with a group of sieve holes, the diameter of the sieve holes is smaller than the diameter of the tablets, and the spring pieces are each arranged on a side of each group of sieve holes close to the discharge port; A dust collection mechanism, the dust collection mechanism corresponds to the sieve hole, and comprises a powder collection box and a dust collector, the powder collection box is arranged below the sieve hole, and the dust collector is connected to the powder collection box through a pipeline; When the spring is in the first position, the tablet is intercepted by the spring; when the spring is in the second position, the tablet is released and slides toward the discharge port; The tablet press discharging device further comprises at least three torsion springs, one end of which is fixedly connected to the spring sheet and the other end of which is fixedly connected to the slot wall. The spring sheet is placed in the first position, and the hardness of the spring sheet changes the number of tablets intercepted when the spring sheet is kept in the first position. Alternatively, the tablet discharge device of the tablet press further comprises at least three rotating rods and a counterweight box, wherein the rotating rod is pivoted on the slot wall of the tablet discharge slot, one end of the rotating rod is fixedly connected to the spring sheet, and the other end extends to the outside of the tablet discharge slot and is connected to the counterweight box, and the counterweight box pulls the spring sheet to return to the first position by gravity, and the weight of the counterweight box changes the total weight of the tablets intercepted when the spring sheet is kept in the first position; Alternatively, the tablet press discharging device also includes a controller and at least three rotating motors, the rotating motors respectively control the rotation of the springs, the controller is electrically connected to the vacuum cleaner and the rotating motors, so as to control the start and stop thereof, and the controller corresponds to the springs one-to-one, so as to respectively control the time or the number of tablets intercepted by each spring each time.

2. The tablet discharging device of the tablet press according to claim 1, characterized in that: The sieve holes include a first sieve hole and a second sieve hole, the first sieve hole covers the bottom of the groove opened in the primary division cavity, the second sieve hole is opened in the bottom of the groove of the subdivision cavity, and the width of the area where the second sieve hole is located is smaller than the spacing between the spring pieces.

3. The tablet discharging device of the tablet press according to claim 2, characterized in that: The bottom of the primary separation chamber is also paved with a silica gel pad, and the silica gel pad is provided with powder passing holes corresponding to the first sieve holes.

4. The tablet discharging device of the tablet press according to claim 2, characterized in that: A first vibrator is disposed at the bottom of the sheet discharging slot, and the first vibrator corresponds to the primary division cavity.

5. The tablet discharging device of the tablet press according to claim 4, characterized in that: The spring sheet is provided with a plurality of through holes, and a second vibrator is arranged on the spring sheet. When the spring sheet is in its first position, the second vibrator on the spring sheet vibrates.

6. The tablet discharging device of the tablet press according to any one of claims 1 to 4, characterized in that: It also includes a proximity switch, which corresponds to the counterweight box one by one and is electrically connected to the vacuum cleaner corresponding to the chamber where the counterweight box is located; when the spring is in the first position, the proximity switch contacts the counterweight box and sends a signal to make the vacuum cleaner work.

7. The tablet discharging device of the tablet press according to claim 5, characterized in that: The controller is electrically connected to the first vibrator and the second vibrator to control the start and stop of the first vibrator and the second vibrator.

8. The tablet discharging device of the tablet press according to any one of claims 1 to 4, characterized in that: There are two controllers, one of which is arranged on the left side of the film outlet slot and is electrically connected to the rotating motor that drives the spring sheet pivoted on this side and the vacuum cleaner corresponding to the spring sheet pivoted on this side; the other is arranged on the right side of the film outlet slot and is electrically connected to the rotating motor that drives the spring sheet pivoted on this side and the vacuum cleaner corresponding to the spring sheet pivoted on this side; the two controllers control the spring sheet on the left side and the spring sheet on the right side to be in different positions or opposite motion states.

9. The tablet discharging device of the tablet press according to any one of claims 1 to 4, characterized in that: There is one controller, and the rotating motors are all electrically connected to the controller. The controller controls the springs to be in the same position or motion state.

10. The tablet discharging device of the tablet press according to claim 1, characterized in that: When the spring sheet is in its first position, the angle between it and the groove wall is 70-90°; when the spring sheet is in the second position, the angle between it and the groove wall is 30-60°.

11. A process for preparing diclofenac sodium enteric-coated tablets, characterized in that: The steps include: S1. Weigh the prescribed amount of microcrystalline cellulose 101, corn starch, diclofenac sodium, lactose, povidone K30, cross-linked povidone, and sodium carboxymethyl starch, and add them to a wet mixing granulator in sequence. After dry mixing by high shear stirring, collect them into a transfer container, and inject them into a dry granulator by suction for dry granulation; add additional excipients and mix them; add the diclofenac sodium dispersion to a high-speed tablet press for tableting, separate the prepared diclofenac sodium tablet core from the dispersion by the tablet press device according to any one of claims 1 to 10, and collect the diclofenac sodium tablet core; S2, isolating and coating the diclofenac sodium tablet core to obtain an isolating tablet; S3, coating the isolation tablet with an enteric layer to obtain the diclofenac sodium enteric-coated tablets.

12. The process for preparing diclofenac sodium enteric-coated tablets according to claim 11, characterized in that: Step S2 includes: preparing a gastric-soluble 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-soluble 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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