Tablet press tablet discharging device and preparation process for diclofenac sodium enteric-coated tablet
Patent Information
- Application Number
- PCT/CN2024/097026
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-02-22
- Filing Date
- 2024-06-03
- Publication Date
- 2025-08-28
Smart Images

Figure CN2024097026_28082025_PF_FP_ABST
Abstract
Description
Tablet discharging device and preparation process of diclofenac sodium enteric-coated tablets Technical field
[0001] The present invention relates to the field of pharmaceutical equipment, and particularly relates to a tablet discharging device and a preparation process of diclofenac sodium enteric-coated tablets. Background technique
[0002] Diclofenac sodium is a non-steroidal anti-inflammatory and analgesic drug derived from phenylacetic acid. It can block the conversion of arachidonic acid to prostaglandin by inhibiting the activity of cyclooxygenase; it can also promote the combination of arachidonic acid with triglyceride (triacylglycerol), reduce the concentration of free arachidonic acid in cells, and indirectly inhibit the generation of products such as leukotrienes and bradykinin, thereby exerting antipyretic, analgesic and anti-inflammatory effects. However, diclofenac sodium is likely to stimulate the gastrointestinal tract and cause adverse gastrointestinal reactions in patients. Therefore, diclofenac sodium needs to be coated to form an enteric 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 screening, drying, dry screening, total mixing, tableting, coating; among them, the tableting step is to use a tableting machine 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. The quality of the tablet core affects the coating effect of the tablet core. At present, a fully automatic high-speed rotary tableting machine is mainly used to tablet the diclofenac sodium mixed powder. This method has the advantages of high production efficiency and stable tablet weight. However, it is found in actual production that during the forming process of the diclofenac sodium tablet core, the mixed powder will scatter around the turntable and enter the tablet discharging groove together with the diclofenac sodium tablet core, and slide into the receiving bucket, resulting in waste of the powder and the powder adhering to the tablet core. In addition, these powders will remain on the tablet discharging groove when passing through the tablet discharging groove, causing secondary pollution to the subsequent tablet cores. Among them, the mixing of the powder 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 tablet. In severe cases, it will lead to uneven or incomplete coating of the diclofenac sodium enteric-coated tablet, affecting the dissolution position or dissolution rate of the active ingredient diclofenac sodium in the organism, and ultimately causing local irritation of the drug to the stomach and damage of the gastric juice to the drug, resulting in poor drug efficacy. Therefore, how to remove the powder adhering to the tablet core before coating is an issue that the pharmaceutical industry needs to pay attention to urgently.
[0004] In the prior art, methods such as setting baffles and sieve holes in the tablet discharging groove or connecting a vibrating sieve to the tablet discharging groove are mostly used for separating tablets and powders. Since the tablets of a tablet press, especially a rotary tablet press, enter the tablet discharging groove one by one in sequence, the method of setting baffles and sieve holes in the tablet discharging groove causes the tablets to collide with the baffles individually, resulting in a very small impact force and poor separation effect between the tablets and the powders. Moreover, the powders are likely to remain on the sieve mesh and the baffles, causing secondary contamination to the tablets. The method of connecting a vibrating sieve later has problems such as powders remaining on the sieve mesh and the tablet discharging groove causing secondary contamination to the tablets, complex device, high power consumption, and easy failure. In addition, when the tablet press stops working and there are only a small number of tablets left in the vibrating sieve, the device still needs to be continuously turned on until the last tablet slides out of the discharging port of the vibrating sieve, and this process has the problems of high power consumption and low production efficiency.
[0005] Summary of the Invention [[ID=⑤]]
[0006] 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 the powders attached to the core of diclofenac sodium tablets, so as to improve the coating effect of the core of diclofenac sodium tablets and make the enteric-coated diclofenac sodium tablets have good and uniform efficacy. <s
[0007] The present invention is realized through the following technical solutions: A tablet discharging device for an enteric-coated diclofenac sodium tablet press, comprising:
[0008] A tablet discharging groove, the tablet discharging groove is provided with a feeding port and a discharging port, and the bottom of the groove slopes downward along the discharging direction;
[0009] At least three elastic pieces, the elastic pieces pivot on the groove wall of the tablet discharging groove and can rotate relative to the groove wall between a first position and a second position. The elastic pieces are arranged in an interlaced manner and divide the tablet discharging groove into a primary separation cavity and at least two secondary separation cavities along the discharging direction. A set of sieve holes are opened at the bottom of the primary separation cavity and the secondary separation cavities, the diameter of the sieve holes is smaller than the diameter of the tablets, and the elastic pieces are all arranged on one side of each set of sieve holes close to the discharging port;
[0010] A dust suction mechanism, the dust suction mechanism corresponds to the sieve holes and comprises 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;
[0011] Wherein, when the elastic piece is in the first position, the tablet is intercepted by the elastic piece; when the elastic piece is in the second position, the tablet is released and slides towards the discharging port.
[0012] Compared with the prior art, in the present invention, a shrapnel is provided on the tablet outlet groove to intercept the tablets. The tablets collide with the shrapnel or the tablets on the shrapnel, resulting in the shedding of drug powder. At the same time, a vacuum cleaner is used to remove the drug powder that enters the tablet outlet groove together with the tablets and the drug powder removed by collision, avoiding the accumulation of drug powder and causing secondary pollution to the subsequent tablets. When a certain number of intercepted tablets are reached, the shrapnel rotates downward to the second position, causing a large number of tablets to slide down to the rear shrapnel together, applying a large impact force to the shrapnel, thereby enhancing the effect of removing powder by impact on the tablets. The tablets collide with the shrapnel in the tablet outlet device at least three times, effectively removing the drug powder adhered to the surface of the tablets. During the process of repeated sliding and collision, the tablets automatically turn over, making the powder removal more thorough and facilitating the grinding and polishing of the tablets. In addition, during this process, the defective tablets that do not meet the quality standards are broken due to collision and thus fall into the powder collection box through the sieve holes, playing a role in screening qualified tablets and making the quality of the tablets to be coated subsequently uniform.
[0013] Further, the sieve holes include first sieve holes and second sieve holes. The first sieve holes are covered and opened on the bottom of the primary separation chamber, and the second sieve holes are opened on the bottom of the secondary separation chamber. The width of the area where the second sieve holes are located is smaller than the distance between the shrapnels. This structure allows sufficient time for the powder on the tablets to be sucked away, and at the same time enables the tablets to rub against each other, improving the separation rate of the powder. At the same time, this structure provides a sufficient smooth surface between the second sieve holes and the front shrapnel mechanism, enabling the tablets to accelerate during the sliding process before reaching the second sieve holes, increasing the impact speed, and making the powder shake off during impact.
[0014] Further, a silica gel pad is laid on the bottom of the primary separation chamber, and powder passing holes corresponding to the first sieve holes are opened on the silica gel pad. The silica gel material can enhance the friction between the bottom of the chamber and the tablets, so that the powder on the tablets is further separated under the action of friction, realizing the primary screening of the powder and tablets.
[0015] Further, several through holes are opened on the shrapnel, and a second vibrator is provided on the shrapnel. When the shrapnel is in its first position, the second vibrator on the shrapnel vibrates. This structure enables the tablets to collide with the shrapnel or the tablets above the shrapnel multiple times, which is beneficial to the removal of drug powder. It allows the drug powder to slide through the through holes of the shrapnel or the shrapnel, avoiding remaining on the shrapnel and causing secondary pollution to the subsequent tablets. Moreover, the through holes of the shrapnel can increase the contact sites between the tablets and the shrapnel, dispersing the overall stress on the tablets and reducing unnecessary damage to the tablets. At the same time, this structure enables the tablets to continuously collide and rub against each other during the stacking process, realizing the grinding and polishing of the tablets.
[0016] Further, it further includes at least three torsion springs. One end of each torsion spring is fixedly connected to the elastic piece respectively, and the other end is fixedly connected to the groove wall. The structure of the sheet discharging device is more compact.
[0017] Further, it further includes at least three rotating rods and a counterweight box. The rotating rods pivot on the groove wall of the sheet discharging groove. One end of each rotating rod is fixedly connected to the elastic piece, and the other end extends to the outside of the sheet discharging groove and is connected to the counterweight box. The counterweight box pulls the elastic piece to reset to the first position by gravity. This makes the sheet discharging device more energy-saving and convenient for adjusting the interception amount of tablets.
[0018] Further, it further includes proximity switches. The proximity switches correspond to the counterweight boxes one by one and are electrically connected to the vacuum cleaners corresponding to the chambers where the counterweight boxes are located. When the elastic piece is in the first position, the proximity switch contacts the counterweight box and sends a signal to make the vacuum cleaner work. This structure avoids the situation that when the elastic piece is in the second position and releases tablets, some tablets are adsorbed by the vacuum cleaner at the sieve holes and cannot slide down. At the same time, it makes the sheet discharging device more power-saving and energy-efficient.
[0019] Further, it further includes a controller and at least three rotating motors. The rotating motors respectively control the rotation of the elastic pieces. The controller is electrically connected to the vacuum cleaner, the rotating motors, the first vibrator and the second vibrator, so as to control their start and stop. This structure can realize the automatic control of the sheet discharging device, meeting the requirements of the current technological development.
[0020] Further, the controller corresponds to the elastic pieces one by one, so as to respectively control the time for each elastic piece to intercept tablets each time or the number of tablets. This structure makes the rotation of the elastic pieces have better flexibility, so as to adjust the tablet interception amount and interception time of different elastic pieces according to actual applications, meeting the requirements of the production site.
[0021] Further, there are two controllers. One is arranged on the left side of the sheet discharging groove and is electrically connected to the rotating motor that drives the elastic piece pivoting on this side and the vacuum cleaner corresponding to the elastic piece pivoting on this side. The other is arranged on the right side of the sheet discharging groove and is electrically connected to the rotating motor that drives the elastic piece pivoting on this side and the vacuum cleaner corresponding to the elastic piece pivoting on this side. The two controllers control the elastic pieces on the left side and the right side to be in different positions or opposite motion states. This structure can reduce the control cost and complexity and realize the lightweight of the device.
[0022] Further, there is one controller. The rotating motors are all electrically connected to the controller. The controller controls the elastic pieces to be in the same position or motion state. This structure can further reduce the control cost and complexity, realize the lightweight of the device, and save power and energy. <Further, when the elastic piece is in its first position, the included angle between it and the groove wall is 70-90°; when the elastic piece is in the second position, the included angle between it and the groove wall is 30-60°. This structure enables the tablet to automatically slide to its free end when intercepted by the elastic piece, avoiding the accumulation of tablets at the rotating rod, resulting in too short a distance between the tablet and the rotating rod (i.e., the fulcrum), and requiring a large amount of power (i.e., the weight of the tablet) to make the rotating rod drive the elastic piece to rotate, thus affecting the number of tablets intercepted by the elastic piece and the effect of removing drug powder.
[0024] The present invention also provides a preparation process for enteric-coated diclofenac sodium tablets, which comprises the following steps:
[0025] S1. Weigh the prescription amounts of microcrystalline cellulose 101, corn starch, diclofenac sodium, lactose, polyvinylpyrrolidone K30, cross-linked polyvinylpyrrolidone, and sodium carboxymethyl starch in sequence and add them to a wet granulator. After dry mixing by high-shear stirring, collect them in a transfer container and inject them into a dry granulator by suction for dry granulation; add external excipients for total mixing; add the diclofenac sodium dispersion to a high-speed tablet press for tabletting. The prepared diclofenac sodium tablet cores are separated from the dispersion by the tablet discharging device of any one of claims 1-9, and the diclofenac sodium tablet cores are collected.
[0026] S2. Perform isolation coating on the diclofenac sodium tablet cores to obtain isolated tablets;
[0027] S3. Perform enteric coating on the isolated tablets to obtain the enteric-coated diclofenac sodium tablets.
[0028] Further, step S2 includes: preparing a gastric-soluble film coating suspension and performing isolation layer coating on the diclofenac sodium tablet cores obtained in step S13 by using a high-efficiency coating machine; step S3 includes: preparing an enteric-soluble film coating suspension and performing enteric layer coating on the isolated tablets obtained in step S2 by using a high-efficiency coating machine.
[0029] The preparation process for enteric-coated diclofenac sodium tablets of the present invention uses an improved tablet discharging device of the tablet press in cooperation with the tablet press for tablet pressing and discharging. This preparation process can simply, save electricity, and effectively remove the drug powder adhering to the surface of the diclofenac sodium tablet cores, trim the burrs of the diclofenac sodium tablet cores, and screen out the diclofenac sodium tablet cores that do not meet the quality requirements and are broken due to collision, so that the diclofenac sodium tablet cores with the characteristics of smoothness, uniformity, and good quality are subjected to the coating treatments in step S2 and step S3, and finally uniform enteric-coated diclofenac sodium tablets are obtained. The enteric-coated diclofenac sodium tablets have a good appearance and have a uniform dissolution rate and dissolution position in the organism, solving the problems of poor coating effect of enteric-coated diclofenac sodium tablets caused by adhesion of drug powder, poor shape or quality uniformity of tablets, resulting in poor efficacy of enteric-coated diclofenac sodium tablets and side effects on the stomach. Brief Description of the Drawings
[0030] FIG. 1 is a schematic structural view of the tablet discharging device of Embodiment 1 of the present invention;
[0031] FIG. 2 is a cross-sectional view of the bottom structure of the tablet discharging groove corresponding to the initial separation cavity when the silica gel pad is provided with patterns;
[0032] FIG. 3 is a top view of the tablet discharging device of the tablet press, wherein the elastic piece shown by the solid line of the first screening mechanism is in the first position, and the elastic piece shown by the dotted line is in the second position;
[0033] FIG. 4 is a front view of the tablet discharging device of the tablet press shown in FIG. 1;
[0034] FIG. 5 is a schematic structural view of the elastic piece;
[0035] FIG. 6 is a schematic structural view of the torsion spring in Embodiment 2;
[0036] FIG. 7 is a schematic structural view of the tablet discharging device of the tablet press of Embodiment 3 of the present invention;
[0037] FIG. 8 is a top view of the tablet discharging device of the tablet press of Embodiment 3 of the present invention;
[0038] FIG. 9 is a top view of the tablet discharging device of another embodiment;
[0039] FIG. 10 is a top view of the tablet discharging device of another embodiment;
[0040] FIG. 11 is a series connection diagram from premixing to granulation in the preparation process of diclofenac sodium enteric-coated tablets. Detailed Embodiments
[0041] The present invention will be further described in detail below with reference to the drawings and embodiments. It can be understood that the specific embodiments described herein are only used to explain the present invention, rather than limiting the present invention. For the convenience of description, only the parts related to the present invention are shown in the drawings, rather than all the structures.
[0042] Embodiment 1
[0043] Referring to FIGS. 1-5, the tablet discharging device of this embodiment includes a tablet discharging groove 1 and at least three screening mechanisms. The tablet discharging groove 1 is provided with a feeding port and a discharging port 19, and the bottom of the groove is inclined downward along the discharging direction, so that the tablets can slide into the discharging device along the tablet discharging groove 1 under the action of their own gravity, and then slide out from the discharging port 19. The screening mechanisms are arranged alternately in the tablet discharging groove 1 and divide the tablet discharging groove 1 into an initial separation cavity 1a and at least two sub-separation cavities 1b, 1c along the discharging direction. Each screening mechanism includes an elastic piece mechanism and a dust suction mechanism. The elastic piece mechanism is vertically arranged on the upper surface of the bottom of the tablet discharging groove 1, and the dust suction mechanism 4 is arranged on the lower surface of the tablet discharging groove 1.
[0044] The tablet discharging groove 1 includes a discharging plate 12, and a first groove wall 14 and a second groove wall 16 arranged on both sides of the discharging plate 12. At least three groups of sieve holes 13 are provided on the discharging plate 12, including a group of first sieve holes 13a covering the bottom of the primary separation cavity 1a groove, and at least two groups of second sieve holes 13b, 13c opened at the bottoms of the fine separation cavities 1b, 1c. The first sieve holes 13a and the second sieve holes 13b, 13c are arranged at intervals in sequence along the tablet discharging direction. The diameter of the sieve holes 13 is smaller than the diameter of the tablets, and their sizes and shapes can be changed according to the actual situation. While preventing the tablets from passing through the sieve holes 13, it is necessary to ensure that the powder can pass through the sieve holes 13 and leave the tablet discharging groove 1, so as to achieve the separation of powder and tablets. The dust suction mechanism 4 corresponds to the sieve holes 13, so as to suck away all the powder passing through the sieve holes 13, and avoid waste and pollution caused by powder leakage. In some embodiments, the tablet discharging groove 1 further includes a top baffle 15, and the top baffle 15 covers the first groove wall 14 and the second groove wall 16, so that the tablet discharging groove 1 is only communicated with the outside at the feeding ports and the discharging port 19 at both ends, which is used to prevent the tablets from popping out and avoid the intrusion of dust and dirt.
[0045] The first sieve holes 13a cover the bottom of the primary separation cavity 1a, so that after the tablets pass through the feeding port, the dust suction mechanism can suck away the powder adhered to the tablets. A silica gel pad 17 is further laid on the bottom of the primary separation cavity 1a, and powder passing holes 171 corresponding to the first sieve holes are opened on the silica gel pad 17. The silica gel 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. At the same time, the tablets can also rub against each other to improve the powder separation rate. Meanwhile, the silica gel material can improve 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 force.
[0046] Preferably, the upper surface of the silica gel pad 17 can be a plane parallel to the inclined bottom of the groove, or provided with纹路such as wavy, stepped or serrated structures distributed at intervals along the discharging direction. When the tablets slide down, they will roll between the纹路of the silica gel pad, so that each surface of the tablets can correspond to the powder passing holes 171, so that the powder on each surface of the tablets can be sucked away. A first vibrator 18 is arranged at the bottom of the tablet discharging groove 1, and the first vibrator 18 corresponds to the primary separation cavity 1a, and vibrates to prompt the tablets to shake off the powder and turn over, and at the same time avoid the tablets from blocking the powder passing holes.
[0047] The first screening mechanism 2a includes a first elastic sheet mechanism 3a and a first dust suction mechanism 4a. The first elastic sheet mechanism 3a includes an elastic sheet 32a, a rotating rod 34a, a counterweight box 36a and counterweight blocks. The elastic sheet 32a is vertically arranged on the upper surface of the discharge plate 12 and is located behind the sieve holes 13a (i.e., on the side of the sieve holes 13a close to the discharge port 19), so that the tablets need to pass through the sieve holes 13a first before colliding with the elastic sheet 32a. The elastic sheet 32a itself has a certain elasticity. When a tablet collides with it, it undergoes elastic deformation and ejects the tablet in the reverse direction, thereby shaking off the powder adhering tightly to the tablet. The rotating rod 34a is rotatably connected to the first groove wall 14 and is fixedly connected to one end of the elastic sheet 32a, enabling the elastic sheet 32a to rotate between its first position and second position relative to the first groove wall 14. When the elastic sheet 32a is in its first position, the distance between the elastic sheet 32a and the second groove wall 16 is less than the thickness of the tablet; when the elastic sheet 32a is in its second position, the distance between the elastic sheet 32a and the second groove wall 16 increases, and the tablet slides off the elastic sheet 32a and slides down to the second screening mechanism 2b after passing through the gap. The counterweight box 36a is arranged outside the tablet outlet groove 1 and is fixedly connected to the other end of the rotating rod 34a, so that the elastic sheet 32a, the rotating rod 34a and the counterweight box 36a form a seesaw structure. The counterweight box 36a pulls the elastic sheet 32a back to the first position by gravity.
[0048] The counterweight box 36a is used to place counterweight blocks. The weight at one end of the counterweight box 36a in the seesaw structure can be adjusted by adjusting the weight or quantity of the counterweight blocks. By adjusting the weight at one end of the counterweight box 36a, the total weight of the tablets intercepted when the elastic sheet 32a is held in the first position can be adjusted. Since the movement trajectories of the counterweight blocks and the counterweight box 36a are parallel to the inclined surface of the groove bottom, when the elastic sheet 32a rotates downward, the counterweight blocks and the counterweight box 36a rotate upward, and their gravitational potential energy increases. Therefore, enough tablets are required to provide the power to drive the elastic sheet 32a to rotate. When the total weight of the tablets is overweight, the gravity of the tablets pushes the elastic sheet 32a to overcome the weight of the counterweight box 36a and the counterweight blocks and rotate downward relative to the first groove wall 14, causing the seesaw structure to rotate, and the elastic sheet 32a rotates to the second position, and the tablets slide off the elastic sheet 32a. When the weight of the elastic sheet 32a and the tablets above it is less than the weight at one end of the counterweight box 36a, the gravity of the counterweight box 36a causes the rotating rod 34a to带动 the elastic sheet 32a to rotate upward relative to the groove wall 14 to achieve reset.
[0049] In the natural state, the elastic piece 32a is located at its first position, and the elastic piece 32a is perpendicular to the first groove wall 14 or the free end of the elastic piece 32a is slightly lower than the fixed end of the elastic piece 32a. When the free end of the elastic piece 32a is slightly lower than the fixed end of the elastic piece 32a, the tablet above the elastic piece 32a automatically slides to the free end of the elastic piece 32a. Preferably, when the elastic piece 32a is located at its first position, the included angle a between it and the first groove wall 14 is 70° - 90°, so as to avoid the inconsistent positions of the tablets stacked each time, resulting in inconsistent power arms from the power exerted by the tablets on the elastic piece 32a to the rotating rod 34a each time, and further resulting in inconsistent numbers of tablets intercepted by the elastic piece 32a each time and its powder removal effect; when the elastic piece 32a is in its second position, the included angle b between it and the first groove wall 14 is 20 - 60°.
[0050] Preferably, the first elastic piece mechanism 3a further includes a limiting block 38a. The limiting block 38a is arranged on the upper surface of the discharge plate 12, fixedly connected to the inner side of the second groove wall 16, and the limiting block 38a is located in front of the elastic piece 32a, and its length is greater than the distance between the elastic piece 32a and the second groove wall 16. The limiting block 38a restricts the upward rotation of the elastic piece 32a relative to the first groove wall 14, and avoids the free end of the elastic piece 32a being relatively high in the seesaw structure in the natural state, increasing the distance between the elastic piece 32a and the second groove wall 16, resulting in the tablets slipping from this distance. Preferably, the limiting block 38a is a triangular prism or a trapezoidal prism. When the limiting block 38a is a triangular prism, one side surface is fixedly connected to the inner side of the second groove wall 16, and one side surface is in contact with the elastic piece 32a located at its first position; when the limiting block 38a is a trapezoidal prism, its bottom surface is fixedly connected to the inner side of the second groove wall 16, one side surface is in contact with the elastic piece 32a located at its first position, and the included angle between the other side surface and the second groove wall 16 is less than 90°, so that the tablets cannot accumulate above the limiting block 38a. The limiting block enables the tablets to collide with the elastic piece as much as possible, and avoids the situation where when the number of tablets is small, the elastic piece rotates upward too much under the action of the counterweight box, resulting in an increase in the distance between the elastic piece and the other groove wall, and causing some tablets to slip from the distance between the elastic piece and the other groove wall, thus affecting the powder removal effect of the tablets.
[0051] Preferably, the first elastic piece mechanism 3a further includes a lateral return spring 39a. The lateral return spring 39a 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.
[0052] Referring to FIG. 5, preferably, a plurality of through holes 31a are formed in the elastic piece 32a. A second vibrator 35a is provided at the bottom of the elastic piece 32a. The second vibrator 35a causes the elastic piece 32a to vibrate, so that the tablets intercepted by the elastic piece 32a are separated from the attached powder. The separated powder can flow out along the sieve holes or move through the through holes to the sieve holes downstream. Preferably, the second vibrator 35a causes the elastic piece 32a to vibrate when the elastic piece 32a is in its first position.
[0053] The first dust suction mechanism 4a includes a powder collecting box 42a, a vacuum cleaner 44a and a pipeline 46a. The powder collecting box 42a is arranged directly below the sieve holes 13 and is fixedly connected to the discharge plate 12. The powder collecting box 42a is connected to the vacuum cleaner 44a through the pipeline 46a. Preferably, the first dust suction mechanism 4a further includes a proximity switch 48a. The proximity switch 48a is electrically connected to the vacuum cleaner 44a. When the elastic piece 32a is in its first position, the counterweight box 36a of the elastic piece mechanism 2a contacts the proximity switch 48a, sending a signal to the vacuum cleaner 44a, and the vacuum cleaner 44a starts to work. Specifically, the first dust suction mechanism 4a further includes a controller 47a. The vacuum cleaner 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, it sends a signal to the controller 47a, and the controller 47a controls the vacuum cleaner 44a and the second vibrator 35a to start working. Preferably, the first dust suction mechanism 4a further includes a recovery device (not shown in the figure). The recovery device is connected to the powder collecting box 42a through a pipeline, and recovers the drug powder in the powder collecting box 42a by means of negative pressure and other methods and conveys it to the tablet press for reuse.
[0054] The second screening mechanism 2b includes a second elastic sheet mechanism 3b and a second dust suction mechanism 4b, and the third screening mechanism 2c includes a third elastic sheet mechanism 3c and a third dust suction mechanism 4c. The second screening mechanism 2b and the third screening mechanism 2c are respectively arranged behind the second screening holes 13b and 13c. Among them, 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 elastic sheet mechanism 3b is rotatably connected to the second groove wall 16, and there is a spacing between the elastic sheet 32b and the first groove wall 14, and this spacing is smaller than the thickness of the tablet. The limiting block 38b is arranged on the upper surface of the discharge plate 12, one side is fixedly connected to the inner side of the second groove wall 16, and one side is in contact with the elastic sheet 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, and its structure is the same as that of the first screening mechanism 2a, or the elastic sheet 32c has no through holes, so as to prevent the powder from falling into the discharge port 19.
[0055] The sub-chambers 1b and 1c are not lined with the silica gel pad 17, and the tablets directly contact the bottom of the groove. The difference between the second screening holes 13b and 13c and the first screening hole 13a is that they are opened at the bottom of the sub-chambers 1b and 1c, and the width of the area where the second screening holes 13b and 13c are located (that is, the width arranged along the discharge direction) is smaller than the spacing between the elastic sheets, so that there is a sufficient smooth surface between the elastic sheet mechanisms in the front, so that the tablets can be accelerated during the sliding process before reaching the second screening holes 13b and 13c, and the impact speed is increased, so that the powder can be shaken off during the impact. Preferably, the width of the second screening holes 13b and 13c is one-fourth to one-sixth of the total width of the sub-chamber.
[0056] The working principle of the tablet discharging device of the tablet press in this embodiment is as follows:
[0057] When the tablet discharging device starts to work, the tablets pressed by the tablet presser sequentially enter the tablet discharging groove 1. During the sliding process of the tablets in the initial separation cavity 1a, the first vibrator 18 starts to make the tablets collide and rub against 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 passing holes and the first sieve holes 13a. Then the tablets slide down to the first screening mechanism 2a for screening: they hit the elastic piece 32a at its first position and are intercepted by the elastic 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 holes 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 makes the elastic piece 32a vibrate and deform, thereby driving the tablets to collide with each other or with the elastic piece 32a, promoting the separation of the tablets from the drug powder, and at the same time making the elastic piece 32a shake off the powder adhered to itself. The vacuum cleaner 44a collects the drug powder in the powder collecting box 42a and the tablet discharging groove 1 and discharges it, avoiding the accumulation of drug powder on the surfaces of the tablet discharging groove 1 and the elastic piece mechanism 3a, which may cause secondary pollution to the tablets. When the number of tablets intercepted by the elastic piece 32a exceeds the upper limit, the gravity of the tablets drives the elastic piece 32a to rotate downward relative to the first groove wall 14 to its second position. At the same time, the counterweight box 36a is separated from the proximity switch 48a, the proximity switch 48a is disconnected, and the vacuum cleaner 44a stops working. A large number of tablets slide from the elastic piece 32a into the fine separation cavity 1b. When the tablets slide to the second screening mechanism 2b, the above screening process is repeated. At this time, there are no tablets or only a small number of tablets above the elastic piece 32a. The gravity at one end of the counterweight box 36a makes the rotating rod 34a drive the elastic piece 32a to rotate upward relative to the first groove wall 14, return to its first position and intercept the subsequent tablets entering the tablet discharging groove 1.
[0058] After being screened by all the screening mechanisms 2, the tablets slide out from the discharge port 19 below the tablet discharging device. During the process of a large number of tablets hitting the elastic piece 32, the elastic piece 32 applies a large impact force to the tablets, which helps to improve the effect of removing drug powder from the tablets by impact.
[0059] Embodiment 2
[0060] Referring to FIG. 6, this embodiment is basically the same as Embodiment 1, and the difference is only that: the counterweight box 36a and the counterweight block, etc. can be replaced by other structures. Taking the first elastic piece mechanism 3a as an example, the first elastic piece mechanism 3a further includes a torsion spring 37a. One end of the torsion spring 37a is fixedly connected to the inner side of the first groove wall 14, and the other end is fixedly connected to the elastic piece 32a. The torsion spring 37a makes the elastic piece 32a in the first position.
[0061] When the number of tablets intercepted by the elastic piece 32a exceeds the upper limit, the gravity of the tablets drives the elastic piece 32a to rotate towards the second position, overcoming the resistance of the torsion spring 37a, thereby releasing the tablets and causing the torsion spring 37a to deform. When there are no tablets or only a small number of tablets above the elastic piece 32a, the torsion spring 37a resets, thereby driving the elastic piece 32a to return to the first position to intercept the tablets. The elastic pieces in the second screening mechanism 2b and the third screening mechanism 2c can also be connected to the tablet outlet groove 1 through torsion springs, and the principle is the same as above, so it will not be elaborated here. This structure can change the number of tablets that the elastic piece can intercept by changing the hardness of the torsion spring, and automatically release the tablets when the intercepted tablets reach the upper limit. Its structure is simple, which can reduce the energy consumption and cost of the equipment.
[0062] Embodiment 3
[0063] Please refer to FIGS. 7-10. This embodiment is basically the same as Embodiment 1, and the only difference is that: the elastic piece is driven to rotate in an electrically controlled manner by a rotating motor. There are at least three rotating motors, which correspond to the elastic pieces one by one, and their output ends respectively drive the elastic 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.
[0064] The way the controller controls the rotation of the elastic piece can be adjusted according to the actual situation. Please refer to FIG. 8. In one embodiment, there are at least three controllers. Taking three controllers with the same number as the rotating motors as an example, they are 47a, 47b, and 47c respectively. The rotating motors 47a, 47b, and 47c correspond to the elastic pieces one by one, so as to control the time or the number of tablets intercepted by each elastic piece each time.
[0065] Taking the first screening mechanism 2a as an example, it includes a first elastic piece mechanism 3a and a first dust suction mechanism 4a. The first elastic piece mechanism 3a includes an elastic piece 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 elastic piece 32a to rotate between its first position and the second position, thereby releasing or intercepting the tablets above the elastic piece 32a.
[0066] Preferably, the second vibrator 35a is electrically connected to the controller 47a. When the elastic piece 32a is in its first position, the controller 47a controls the second vibrator 35a to drive the elastic piece 32a to vibrate. The controller 47a is electrically connected to the rotating motor 5a and the vacuum cleaner 44a, controls the elastic piece 32a to rotate between its first position and the second position through the rotating motor 5a, and can control the vacuum cleaner 44a to start or stop working. Specifically, the controller 47a can adjust the time or weight of the tablets intercepted by the elastic piece 32a each time.
[0067] The second screening mechanism 2b includes a second elastic sheet mechanism 3b and a second dust suction mechanism 4b, and the third screening mechanism 2c includes a third elastic sheet mechanism 3c and a third dust suction mechanism 4c. The driving modes of the second screening mechanism 2b and the third screening mechanism 2c are the same as that of the first screening mechanism 2a. They respectively drive the rotation of the elastic sheets through independent rotating motors 37b and 37c, and respectively control the second dust suction mechanism 4b and the third dust suction mechanism 4c through controllers 47b and 47c, which will not be elaborated here. In this embodiment, by inputting control signals to the controllers respectively, 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 can be controlled respectively, so that all the elastic sheets can rotate independently according to the situation of the tablets.
[0068] In another embodiment, please refer to FIG. 9. There are two controllers, namely 47a and 47b. One of them is arranged on the left side of the sheet outlet groove and is electrically connected to all the rotating motors 5a and 5c that drive the elastic sheets pivoting on the left side, and is also electrically connected to the dust collector corresponding to the elastic sheets on this side; the other is arranged on the right side of the sheet outlet groove and is electrically connected to all the rotating motors 5b that drive the elastic sheets pivoting on the right side, and is also electrically connected to the dust collector corresponding to the elastic sheets on this side. In this embodiment, the elastic sheets are divided into two groups according to their pivoting positions and are respectively controlled by the two controllers, so that the elastic sheets on the left side and the elastic sheets on the right side are in different positions or opposite motion states. That is, for adjacent elastic sheets, when the upstream elastic sheet releases the tablets, the downstream elastic sheet is in the state of intercepting the tablets.
[0069] In another embodiment, please refer to FIG. 10. There is one controller 47. The dust collector and the rotating motors 5a, 5b and 5c are all electrically connected to the controller. The controller controls the elastic sheets to be in the same position or motion state. In this embodiment, the distance between the elastic sheets needs to be designed according to the sliding speed of the tablets. For adjacent elastic sheets, when the controller controls the elastic sheets to open simultaneously, the first pile of tablets slides down to the discharge port 19 through the downstream elastic sheet. At the same time, the second pile of tablets slides through the upstream elastic sheet and then slides down to the downstream elastic sheet. Since there is a certain distance between the elastic sheets, it takes a certain amount of time for the second pile of tablets to reach the downstream elastic sheet. Before the second pile of tablets reaches the downstream elastic sheet, the controller controls the elastic sheets to close simultaneously, so that the downstream elastic sheet intercepts the second pile of tablets, thereby separating the powder tablets. This embodiment can greatly reduce the control difficulty and equipment cost, and at the same time enable the elastic sheets to rotate greatly when the mutual distance is small, avoiding interference between the elastic sheets.
[0070] Compared with the prior art, the tablet discharging device of the press machine described in Embodiments 1-3 of the present invention has the following advantages:
[0071] (1) When the elastic piece of the present invention is in its first position, it intercepts the tablets entering the tablet discharging device. When a certain number of tablets are reached, the elastic piece rotates to its second position, causing a large number of tablets to slide down together to the lower elastic piece, applying a large impact force to the elastic piece, thereby enhancing the effect of removing powder from the tablets by impact. In addition, the tablets collide with the elastic pieces of at least three screening mechanisms at least three times. During this process, the tablets are automatically turned over, which is beneficial to the removal of the drug powder adhering to the tablet surface.
[0072] (2) In the present invention, the vacuum cleaner removes the drug powder that enters the tablet discharging groove together with the tablets and the drug powder adhering to the tablet surface, avoiding the secondary contamination of the tablets by the drug powder remaining in the tablet discharging device. In addition, in the present invention, the vacuum cleaner only dusts when the elastic piece intercepts the tablets through the proximity switch and / or the controller, which can save electricity and avoid the tablets being adsorbed at the sieve holes and unable to slide down.
[0073] (3) The rotating rod, the counterweight box and the elastic piece form a seesaw structure. When the number of tablets intercepted by the elastic piece reaches the upper limit, the elastic piece end of the seesaw structure rotates downward, causing the tablets to slide down to the elastic piece. After the tablets slide down, the gravity at the counterweight box end causes the elastic piece to automatically rotate upward to intercept the tablets. This seesaw structure makes the tablet discharging device more energy-saving and power-saving.
[0074] (4) By setting the inclination angle of the elastic piece in its first position, the tablets automatically slide to the elastic piece on one side of the second groove wall, avoiding the accumulation of tablets at the rotating rod, resulting in too short distance between the tablets and the rotating rod (i.e., the fulcrum), and requiring a large amount of power (i.e., the weight of the tablets) to make the rotating rod drive the elastic piece to rotate, thus affecting the number of tablets intercepted by the elastic piece and the effect of removing drug powder.
[0075] (5) The limiting block can prevent the inconsistent positions of the upward rotation and停留 of the elastic piece, and can prevent the tablets from sliding down from the gap between the elastic piece and the other groove wall, thus affecting the powder removal effect of the tablets. In addition, with the cooperation of the counterweight block, the number of tablets intercepted by the elastic piece can be adjusted.
[0076] (6) Setting through holes on the elastic piece can prevent the drug powder from remaining on the elastic piece and causing secondary contamination to the tablets. In addition, the through holes of the elastic piece can increase the contact sites between the tablets and the elastic piece, disperse the overall stress received by the tablets, reduce the unnecessary breakage of the tablets, and the defective tablets will be broken by impact and fall into the powder collecting box through the sieve holes or fall into the powder collecting box of the next screening mechanism through the through holes, so that the tablets entering the coating machine are all complete and meet the quality requirements.
[0077] (7) A vibrator is arranged at the bottom of the elastic piece to make the tablets vibrate on the elastic piece, which is beneficial to the removal of the drug powder adhering to the tablet surface. In addition, the vibration, multiple impacts and turning over of the tablets contribute to the polishing of the tablets.
[0078] (8) The controller accurately controls the rotation of the elastic pieces through the rotating motor, enabling the motion states of every two adjacent elastic pieces to be different. That is, when the upper elastic piece rotates to its second position, the lower elastic piece is at its first position, so that the tablets can be intercepted by all the elastic pieces, and sufficient collision and vibration can occur, improving the powder removal effect.
[0079] Example 4
[0080] A preparation process for enteric-coated diclofenac sodium tablets comprises the following steps:
[0081] S1. Prepare the diclofenac sodium tablet core;
[0082] S2. Conduct isolation coating on the diclofenac sodium tablet core to obtain an isolation tablet;
[0083] S3. Conduct enteric coating on the isolation tablet to obtain the enteric-coated diclofenac sodium tablets.
[0084] Specifically, in step 1, the preparation method of the diclofenac sodium tablet core comprises the following steps:
[0085] S11. Referring to FIG. 11, use a continuous granulation method with a wet granulator - transfer container - dry granulator - total mixing hopper in series to prepare the powder. That is, weigh the prescription amounts of microcrystalline cellulose 101, corn starch, diclofenac sodium (API), lactose, polyvinylpyrrolidone K30, cross-linked polyvinylpyrrolidone, and sodium carboxymethyl starch in sequence and add them to the HLSG220F wet granulator (China Academy of Aeronautical Manufacturing Technology). After dry mixing by high-shear stirring, collect them in the transfer container and inject them into the dry granulator by suction for dry granulation. This method has the advantages of high production efficiency and uniform and stable particle quality.
[0086] S12. Add external excipients for total mixing: Add the prescription amounts of dry granules and external sodium carboxymethyl starch in sequence for mixing, and then add silicon dioxide and magnesium stearate for mixing to obtain the diclofenac sodium dispersion.
[0087] S13. Tabletting: Add the diclofenac sodium dispersion to the GZPL-620 series high-speed tabletting machine (Beijing Guoyao Longli Technology Co., Ltd.) for tabletting. The tablets obtained are separated from the dispersion by the tablet discharging device described in Example 1 or Example 2 or Example 3 of the present invention, and the tablets at the discharge port are collected to obtain the diclofenac sodium tablet core.
[0088] Specifically, step S2 includes the following steps: Add gastric-soluble coating powder to purified water and continuously stir for 1 h to prepare a gastric-soluble film coating suspension (isolation layer coating solution). Use a BG150F high-efficiency coating machine (China Academy of Aeronautical Manufacturing Technology) to conduct isolation layer coating on the diclofenac sodium tablet core obtained in step S13 to obtain an isolation tablet.
[0089] Specifically, step S3 includes the following steps: adding enteric-coated powder into purified water and continuously stirring for 1 h to prepare an enteric-coated film coating suspension, and using a BG150F high-efficiency coating machine to perform enteric-layer coating on the separating tablets obtained in step S2 to obtain enteric-coated diclofenac sodium tablets.
[0090] Compared with the prior art, the diclofenac sodium tablet cores obtained in step S1 are screened by the tablet discharging device of the tablet press in Example 1, Example 2 or Example 3 of the present invention, removing the drug powder adhering to the surface of the diclofenac sodium tablet cores, trimming the burrs of the diclofenac sodium tablet cores, and screening out the diclofenac sodium tablet cores that do not meet the quality requirements and are broken due to collision, 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 obtain uniform enteric-coated diclofenac sodium tablets. The enteric-coated diclofenac sodium tablets have a good appearance, and have a uniform dissolution rate and dissolution position in the organism, solving the problems of poor coating effect of enteric-coated diclofenac sodium tablets caused by adhesion of drug powder, poor tablet shape or poor quality uniformity, resulting in poor efficacy of enteric-coated diclofenac sodium tablets and side effects on the stomach. The preparation process using the improved tablet discharging device of the tablet press has the advantages of simple device used, power saving, high production efficiency, avoiding pollution and waste.
[0091] It should be understood that in the description of the present application, the orientation or positional relationship indicated by the terms "center", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is 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 should not be construed as a limitation to the present application. The terms "first" and "second" are only used for descriptive purposes, and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features, that is, the features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In addition, unless otherwise specified, the meaning of "plurality" is two or more.
[0092] It should be noted that in the description of the present application, unless otherwise clearly specified and limited, the terms "set", "connected", "connected", "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 directly connected, or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific situations.
[0093] The present invention is not limited to the above embodiments. If various modifications or variations of the present invention do not depart from the spirit and scope of the present invention, and if these modifications and variations are within the scope of the claims of the present invention and equivalent technical scope, then the present invention also intends to include these modifications and variations.
Claims
1. A tablet discharging device for a tablet press of diclofenac sodium enteric-coated tablets, characterized in that: include: A sheet discharging trough, which is provided with a feed port and a discharge port, and whose bottom is inclined downward along the discharge direction; At least three spring plates, each of which is pivoted on a slot wall of the tablet discharge slot and rotatable relative to the slot wall between a first position and a second position, the spring plates being staggered and dividing the tablet discharge slot into a primary separation chamber and at least two subdivision chambers along the discharge direction, the slot bottoms of the primary separation chamber and the subdivision chamber each being provided with a group of sieve holes, the diameter of the sieve holes being smaller than the diameter of the tablets, and the spring plates being provided on a side of each group of sieve holes close to the discharge port; A dust collection mechanism, the dust collection mechanism corresponding to the sieve holes, comprising a powder collection box and a dust collector, the powder collection box being arranged below the sieve holes, and the dust collector being connected to the powder collection box through a pipe; 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.
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 dividing cavity, and the second sieve hole is opened in the bottom of the groove of the subdividing cavity. The width of the area where the second sieve hole is located is smaller than the distance 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 provided at the bottom of the sheet discharge slot, and the first vibrator corresponds to the primary separation cavity.
5. The tablet discharging device of the tablet press according to claim 4, characterized in that: The spring piece is provided with a plurality of through holes, and a second vibrator is provided on the spring piece. When the spring piece is in its first position, the second vibrator on the spring piece vibrates.
6. The tablet discharging device of the tablet press according to claim 4, characterized in that: It also includes at least three torsion springs, one end of each torsion spring is fixedly connected to the elastic sheet, and the other end is fixedly connected to the slot wall.
7. The tablet discharging device of the tablet press according to claim 4, characterized in that: It also includes at least three rotating rods and a counterweight box. The rotating rod is pivoted on the slot wall of the film 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 film outlet slot and is connected to the counterweight box. The counterweight box pulls the spring sheet back to the first position through gravity.
8. The tablet discharging device of the tablet press according to claim 7, 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.
9. The tablet discharging device of the tablet press according to claim 4, characterized in that: It also includes a controller and at least three rotating motors, which respectively control the rotation of the elastic pieces. The controller is electrically connected to the vacuum cleaner, the rotating motors, the first vibrator and the second vibrator to control the start and stop thereof.
10. The tablet discharging device of the tablet press according to claim 9, characterized in that: The controller corresponds to the springs one by one, thereby respectively controlling the time or the number of tablets intercepted by each spring.
11. The tablet discharging device of the tablet press according to claim 9, characterized in that: There are two controllers, one of which is arranged on the left side of the sheet 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 sheet 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 and the spring sheet on the right to be in different positions or opposite motion states.
12. The tablet discharging device of the tablet press according to claim 9, 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.
13. The tablet discharging device of the tablet press according to claim 1, characterized in that: When the spring piece is in its first position, the angle between it and the groove wall is 70-90 degrees; when the spring piece is in its second position, the angle between it and the groove wall is 30-60 degrees.
14. 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 polyvinylpyrrolidone, and sodium carboxymethyl starch, add them to a wet mixing granulator in sequence, dry mix them under high shear stirring, collect them in a transfer container, and inject them into a dry granulator by suction for dry granulation; add the additional excipients and mix them; add the diclofenac sodium dispersion to a high-speed tablet press for tableting, and the prepared diclofenac sodium tablet cores are subjected to The tablet discharge device of the tablet press according to any one of claims 1 to 13 separates the tablet cores from the dispersion and collects the diclofenac sodium tablet cores. S2. performing isolation coating on the diclofenac sodium tablet core to prepare an isolation tablet; S3. Enteric-coated the isolation tablet to obtain the diclofenac sodium enteric-coated tablets.
15. The process for preparing diclofenac sodium enteric-coated tablets according to claim 14, wherein: Step S2 includes: preparing a gastric-soluble film-coating suspension, and using a high-efficiency coating machine to coat the diclofenac sodium core tablets obtained in step S13 with an isolation layer; step S3 includes: preparing an enteric-soluble film-coating suspension, and using a high-efficiency coating machine to coat the isolation tablets obtained in step S2 with an enteric layer.
Citation Information
Patent Citations
Tablet discharging device of tablet press for diclofenac sodium enteric-coated tablets and preparation process of diclofenac sodium enteric-coated tablets
CN117984608A
Tablet discharging device of tablet press applied to diclofenac sodium enteric-coated tablet preparation process
CN118024660A
Can get rid of rotary tablet machine of useless piece, recovery dust in step
CN205970091U
Gumming device of tablet press
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Powder sieving and tablet discharging groove of tablet press
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