An apparatus and processing technology for amlodipine besylate tablets.

Abstract

This invention relates to the field of tablet testing technology, specifically disclosing a processing device and process for amlodipine besylate tablets. The device includes: a base, an intermittent rotation mechanism, an operating plate, V-grooves, guide grooves, and nozzles. The intermittent rotation mechanism is located at the top center of the base, and the operating plate is located at the top of the intermittent rotation mechanism. Several V-grooves are equidistantly arranged circumferentially at the top of the operating plate. A guide groove penetrating the bottom of the operating plate is formed at the center of the bottom of the inner cavity of each V-groove. Several nozzles are disposed on the inner walls of the V-grooves. This device achieves 100% online, non-destructive, and automated detection of tablet cohesion. By converting microstructural defects into quantifiable signal differences, it achieves high detection accuracy and reliability, significantly improving the process control level and drug safety assurance capabilities in the production of amlodipine besylate tablets.

Description

Technical Field

[0001] This invention relates to the field of tablet testing technology, specifically to a processing apparatus and process for amlodipine besylate tablets. Background Technology

[0002] Amlodipine besylate tablets are an important drug widely used to treat hypertension and coronary heart disease. As a calcium channel blocker, its production quality is directly related to the safety and efficacy of the drug. The production of this tablet mainly includes core processes such as material pretreatment, mixing, granulation, drying, tableting and coating. Among them, tableting is a key step in which uniform granular materials are formed into tablets under extremely high pressure in a tableting machine through a die. Stable control of the process parameters is the basis for ensuring that the tablet weight, hardness and content uniformity meet the pharmacopoeia standards.

[0003] However, in existing large-scale automated production, there are still significant technical blind spots in the quality monitoring of tablets after compression. Currently, production lines mainly rely on online monitoring of tablet press operating parameters (such as main pressure and filling depth) and sampling destructive testing of finished products (such as hardness testing and friability testing) to indirectly assess overall quality. Although these methods can effectively control the average quality level of batches, they cannot achieve 100% online, non-destructive testing of the internal structural compactness, i.e., cohesion, of each tablet. Therefore, there is a risk on the production line that is not effectively covered by the existing technology system: even among tablets compressed under the same batch and identical macroscopic process parameters, there may still be individual or a small number of tablets with insufficient cohesion and loose structure.

[0004] This problem arises from the inherent microscopic complexity and randomness of the pharmaceutical tableting process. First, despite highly optimized mixing processes, the distribution of powder particles at the microscale (such as the local ratio of active ingredients to excipients), the physical properties of the particles themselves (such as particle size, morphology, and porosity), and the distribution of trace lubricants all exhibit unavoidable statistical fluctuations. Second, during high-speed tableting, the instantaneous uniformity of powder filling in the die cavity, the efficiency of air removal between particles, and the microscopic state of the punch surface (such as extremely slight adhesion) may all undergo minute changes that are difficult to completely control. The random coupling of these factors may result in a very small number of tablets not achieving optimal bonding force between internal particles during forming, thus forming a loose microscopic structure or weak areas inside even when the macroscopic hardness meets the standard.

[0005] If such defective tablets with insufficient cohesion are not detected and enter the market, they may cause a series of adverse consequences. First, the loose structure will affect the mechanical strength of the tablet, making it more prone to wear, fragmentation or microcracks during subsequent coating, packaging and transportation, affecting the product appearance and possibly causing dosage loss. Second, and more importantly, insufficient cohesion will directly change the drug's dissolution behavior. The loose structure may cause the tablet to disintegrate prematurely in the body or release the active ingredient abnormally quickly, failing to maintain the designed sustained-release or controlled-release curve, thereby affecting the stability and safety of the efficacy, and may even cause risks caused by fluctuations in blood drug concentration. Summary of the Invention

[0006] The purpose of this invention is to provide a processing apparatus and process for amlodipine besylate tablets, in order to solve the problem in the prior art that it is difficult to detect and identify insufficient cohesion or loose internal structure defects of tablets after compression in an online, non-destructive, and tablet-by-tablet manner.

[0007] To achieve the above objectives, the present invention provides the following technical solution: a processing device and processing technology for amlodipine besylate tablets, comprising: a base, an intermittent rotation mechanism, an operating plate, V-grooves, guide grooves, nozzles, a first high-precision industrial pressure sensor, an impact mechanism, a first guide rod, a pressure plate, and a bracket. The intermittent rotation mechanism is disposed at the top center of the base, the operating plate is disposed at the top of the intermittent rotation mechanism, and there are several V-grooves, which are equidistantly arranged circumferentially at the top of the operating plate. A guide groove penetrating the bottom of the operating plate is formed at the center of the bottom of the inner cavity of each V-groove. There are several nozzles. A plurality of nozzles are respectively disposed on the inner wall of a plurality of V-shaped grooves. The number of first high-precision industrial pressure sensors is a plurality of each, and the plurality of first high-precision industrial pressure sensors are respectively disposed at the middle of the bottom end of the inner cavity of the plurality of V-shaped grooves. The first guide rod is slidably adapted to be inserted into the inner cavity of the guide groove, and the top end of the first guide rod is slidably extended into the inner cavity of the V-shaped groove. The pressure plate is slidably embedded in the inner cavity of the V-shaped groove. The top end of the first guide rod is disposed at the bottom end of the pressure plate, and the bottom end of the pressure plate is in contact with the top end of the first high-precision industrial pressure sensor. The bracket is disposed at the top end of the base, and the impact mechanism is disposed on the outer wall of the bracket.

[0008] Preferably, the impact mechanism includes: an outer cylinder, an impact actuation component, a drive component, and an impact power component; the outer cylinder is disposed at the rear top of the support, the impact actuation component is disposed in the inner cavity of the outer cylinder, the drive component is disposed at the bottom of the inner cavity of the outer cylinder, and the impact power component is disposed at the top of the inner cavity of the outer cylinder.

[0009] Preferably, the intermittent rotation mechanism includes: a support column, a driven wheel, a drive groove, a positioning groove, a first motor, a first connecting rod, a drive wheel, and a drive pin. The bottom end of the support column is located at the middle of the top end of the base, and the top end of the support column is located at the middle of the bottom end of the operating plate. The driven wheel is sleeved on the outer wall of the support column and locked. The outer wall of the driven wheel has several drive grooves equidistantly spaced along the circumference, and several positioning grooves equidistantly spaced along the circumference. The number of drive grooves and positioning grooves is the same as the number of V-grooves. The first motor is screwed to the top end of the base. The first connecting rod is locked to the output end of the first motor through a coupling. The bottom center of the drive wheel is located at the top end of the first connecting rod. The drive wheel and the positioning groove are matched. The drive pin is located at the top end of the drive wheel. When the first motor drives the drive wheel to move along the outer wall of the positioning groove, the drive pin can enter the inner cavity of the positioning groove.

[0010] Preferably, the position of the outer cylinder corresponds to the position of the inner cavity of the V-shaped groove, the axis of the outer cylinder is perpendicular to the bottom end of the inner cavity of the V-shaped groove, the bottom ends of the left and right sides of the outer wall of the outer cylinder are provided with a first movable groove communicating with the inner cavity in the vertical direction, and the bottom ends of the front and rear sides of the inner cavity of the outer cylinder are provided with sliding grooves in the vertical direction.

[0011] Preferably, the impact mechanism further includes: a second guide rod, a slider, a sleeve, and a second movable groove. There are two second guide rods, with their upper and lower ends respectively located on the upper and lower sides of the inner cavities of the two grooves. There are two sliders, each slidably fitted into the top of the inner cavity of the two grooves. The sliders are slidably fitted into the outer wall of the second guide rod. The front and rear sides of the outer wall of the sleeve are respectively located on the inner sides of the two sliders. The left and right sides of the sleeve each have a second movable groove communicating with their inner cavities along the vertical direction. The top ends of the left and right sides of the sleeve slidably penetrate the top ends of the inner cavities of the two first movable grooves.

[0012] Preferably, the impact actuator includes: a ejector pin, a second high-precision industrial pressure sensor, a hemispherical protective head, and connecting posts. The outer wall of the ejector pin is slidably fitted into the inner cavity of the sleeve. The second high-precision industrial pressure sensor is disposed at the top of the inner cavity of the ejector pin. The top of the hemispherical protective head is slidably fitted into the inner cavity of the ejector pin. The bottom end of the hemispherical protective head extends slidably out of the bottom end of the ejector pin. There are two connecting posts, which are respectively disposed at the middle of the left and right sides of the outer wall of the ejector pin. The outer walls of the two connecting posts are slidably fitted into the top ends of the inner cavities of the two second moving slots.

[0013] Preferably, the driving assembly includes: a collar, a lifting rod, a support groove, an electromagnet, a permanent magnet, a support rod, and an electric telescopic rod. The collar is sleeved on the outer wall of the connecting column. There are two lifting rods, each located at the top of one of the two collars. The top of each lifting rod slidably extends beyond the top of the sleeve. A support groove extending through the left side of the outer wall of the lifting rod is provided along the vertical direction. There are two electromagnets, each located on the left and right sides of the top of the sleeve. The permanent magnet is slidably sleeved on the top of the outer wall of the lifting rod. There are two support rods, each located at its left and right ends on the left and right sides of the inner cavity of the permanent magnet. The outer wall of each support rod is slidably fitted into the top of the inner cavity of the support groove. There are two electric telescopic rods, each located at its top end in the middle of the left and right sides of the outer cylinder, and at its bottom end in the left and right sides of the top of the sleeve.

[0014] Preferably, the permanent magnet is located directly above the electromagnet, and the electromagnet and the permanent magnet repel each other when the electromagnet is energized.

[0015] Preferably, the impact power assembly includes: an impact hammer, a traction rod, a first positioning pin, a second motor, a second connecting rod, a toothed gear, and a second positioning pin. The impact hammer is slidably fitted into the top of the inner cavity of the outer cylinder. The bottom end of the traction rod is located at the top of the impact hammer, and the top end of the traction rod slidably extends out of the top of the outer cylinder. The first positioning pin is located at the top of the outer wall of the traction rod. The second motor is screwed to the rear side of the top of the bracket. The second connecting rod is locked to the output end of the second motor via a coupling. The toothed gear is sleeved on the outer wall of the second connecting rod and locked by a set screw. The toothed gear meshes with the traction rod. The second positioning pin is located on the right side of the toothed gear.

[0016] Preferably, the bottom end of the inner cavity of the V-groove is inclined toward the center of the operating plate.

[0017] A processing method for amlodipine besylate tablets includes the following steps:

[0018] S1. Tablet delivery and positioning: Several nozzles are connected to the air pump through pipelines. The first motor is started, and the first motor drives the intermittent rotation mechanism to rotate the control plate intermittently. The compressed amlodipine besylate tablets are delivered to the corresponding V-shaped groove cavity through the external feeding device. Under the action of gravity, the tablets slide inward along the inclined bottom of the V-shaped groove until they contact the inner wall of the V-shaped groove to achieve positioning and prevent slippage.

[0019] S2. Pre-compression and impact detection: When the V-groove carrying the tablet rotates to below the ejector pin, the electric telescopic rod is activated to push the sleeve and ejector pin downwards until the hemispherical protective head contacts the top of the tablet. The pressure continues to press down, causing the hemispherical protective head to squeeze the second high-precision industrial pressure sensor. When the second high-precision industrial pressure sensor detects the preset weak pressure, the electric telescopic rod stops moving, completing the tablet pre-compression. The electromagnet is turned off, and the second motor is activated to drive the toothed gear to rotate, causing the toothed gear to disengage from the traction rod. The impact hammer falls under the action of gravity and strikes the top of the ejector pin. The impact force applied to the tablet is detected by the second high-precision industrial pressure sensor. At the same time, the impact force is transmitted through the tablet and the pressure plate to the first high-precision industrial pressure sensor. Combining the pressure values ​​of the first and second high-precision industrial pressure sensors, as well as the weight and falling height of the impact hammer, the cohesion and looseness of the tablet are calculated to determine whether the tablet has insufficient cohesion or structural defects.

[0020] S3. Mechanism Reset: After the test is completed, the second motor continues to drive the toothed gear to rotate. Through the cooperation of the second positioning pin and the first positioning pin, the traction rod and the impact hammer are dragged up until the toothed gear and the traction rod re-mesh, driving the impact hammer to reset to the initial position, and the second motor stops. The electromagnet is started, and the like pole repulsion force between the electromagnet and the permanent magnet drives the support rod to move up. Then, through the electric telescopic rod, the sleeve and the ejector pin are driven to rise synchronously and reset to the initial position.

[0021] S4. Sorting and Cleaning: When the V-shaped trough carrying the tested tablets rotates to the external conveyor belt or waste collection point, the air pump is started and air is blown into the inner cavity of the V-shaped trough through the nozzle to blow the tablets to the corresponding collection position. At the same time, residual powder in the V-shaped trough is blown away to achieve workstation cleaning and avoid cross-contamination.

[0022] The present invention provides a processing apparatus and process for amlodipine besylate tablets, the advantages of which are:

[0023] 1. This invention utilizes an intermittent rotation mechanism and a V-groove with an inclined angle to achieve automatic feeding and precise positioning of tablets, ensuring that each tablet to be inspected enters the inspection station in a consistent posture, effectively eliminating inspection errors caused by positional deviations, and laying the foundation for subsequent high-precision measurements.

[0024] 2. This invention uses an electric telescopic rod to drive the ejector pin downwards and utilizes a second high-precision industrial pressure sensor to achieve precise control of the minute pre-pressure, ensuring that the tablet fits tightly against the bottom pressure plate. This step eliminates the detection gap, ensures the consistency of the impact force transmission path, and greatly improves the repeatability and accuracy of the detection.

[0025] 3. The impact hammer release mechanism controlled by the toothed gear in this invention can provide highly standardized transient mechanical impact. The impact energy is much lower than the tablet crushing force, realizing true non-destructive testing. The core of this invention is to simultaneously collect the dynamic force signals from the top second sensor and the bottom first sensor. By comparing the peak value, rise time and waveform characteristics of the input force and output force, the energy dissipation and structural stiffness inside the tablet can be directly quantified, thereby accurately determining whether the cohesion is qualified. This method has high sensitivity and strong anti-interference ability.

[0026] 4. After the detection is completed, the impact hammer lifting and the ejector pin reset mechanism work together to quickly restore the system to its initial state. The nozzle then uses compressed air to blow the tablets into the corresponding channels and clean the V-groove, realizing a fully automatic cycle of detection, sorting and cleaning, which not only improves production efficiency but also avoids cross-contamination.

[0027] 5. This device achieves 100% online, non-destructive, and automated detection of tablet cohesion. By converting microstructural defects into quantifiable signal differences, it achieves high detection accuracy and reliability, significantly improving the process control level and drug safety assurance capabilities in the production of amlodipine besylate tablets. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the structure of the present invention;

[0029] Figure 2 This is an exploded view of the present invention;

[0030] Figure 3 Exploded view of the intermittent rotating mechanism;

[0031] Figure 4 This is a schematic diagram of the impact mechanism;

[0032] Figure 5 This is a front sectional view of the impact mechanism;

[0033] Figure 6 An exploded view of the impact mechanism;

[0034] Figure 7 for Figure 2 Enlarged view of point A;

[0035] Figure 8 for Figure 5 Enlarged view of point B;

[0036] Figure 9 for Figure 5 Enlarged view of point C;

[0037] Figure 10 for Figure 6 Enlarged view of point D;

[0038] Figure 11 for Figure 6 Enlarged view of point E;

[0039] Figure 12 for Figure 6 Enlarged view at point F;

[0040] Figure 13 for Figure 6 Enlarged view of point G.

[0041] In the diagram: 1. Base; 2. Intermittent rotation mechanism; 201. Support column; 202. Driven wheel; 203. Drive slot; 204. Positioning slot; 205. First motor; 206. First connecting rod; 207. Drive wheel; 208. Drive pin; 3. Operation panel; 4. V-groove; 5. Guide groove; 6. Nozzle; 7. First high-precision industrial pressure sensor; 8. Impact mechanism; 81. Outer cylinder; 82. First moving groove; 83. Slide groove; 84. Second guide rod; 85. Slider; 86. Sleeve; 87. Second moving groove; 88. 8. Ejector pin; 89. Second high-precision industrial pressure sensor; 810. Hemispherical protective head; 811. Connecting column; 812. Collar; 813. Lifting rod; 814. Support groove; 815. Electromagnet; 816. Permanent magnet; 817. Support rod; 818. Electric telescopic rod; 819. Impact hammer; 820. Traction rod; 821. First positioning pin; 822. Second motor; 823. Second connecting rod; 824. Gear with missing teeth; 825. Second positioning pin; 9. First guide rod; 10. Pressure plate; 11. Bracket. Detailed Implementation

[0042] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0043] Please see Figures 1-13This invention provides a processing device and processing technology for amlodipine besylate tablets, comprising: a base 1, an intermittent rotation mechanism 2, an operating plate 3, a V-groove 4, a guide groove 5, a nozzle 6, a first high-precision industrial pressure sensor 7, an impact mechanism 8, a first guide rod 9, a pressure plate 10, and a bracket 11. The base 1 serves as the supporting platform for the entire device, providing a stable installation reference for all mechanisms and ensuring the overall rigidity and stability of the equipment during operation. The intermittent rotation mechanism 2 is located at the top center of the base 1, and can drive the operating plate 3 to perform precise, periodic indexing rotation, realizing automatic transfer and accurate positioning of tablets between different workstations. The operating plate 3 is located at the top of the intermittent rotation mechanism 2. 3 is the core support plate, and there are several V-shaped grooves 4. These V-shaped grooves 4 are equidistantly arranged circumferentially at the top of the operating plate 3. A guide groove 5 is formed in the middle of the bottom of the inner cavity of each V-shaped groove 4, penetrating the bottom of the operating plate 3. The bottom of the inner cavity of each V-shaped groove 4 is inclined towards the center of the operating plate 3. The V-shaped groove 4 is used to receive and accommodate individual tablets. Its unique V-shaped cross-section and inclined bottom design allow the tablet to automatically slide and stabilize in a specific position inside the groove by gravity, achieving rapid self-centering and precise positioning, ensuring consistent tablet posture during each test. There are several nozzles 6, each located on the inner wall of one of the V-shaped grooves 4. The nozzles 6 are existing technology and will not be described in detail here. The nozzles 6 are connected to an external air source. After the test is completed... A directional airflow is then injected into the V-shaped groove 4 to blow the tablets away from the groove body to complete the sorting. Simultaneously, residual powder is blown away, achieving automatic cleaning of the workstation and preventing cross-contamination. Several high-precision industrial pressure sensors 7 are used, each positioned at the bottom center of the inner cavity of one of the V-shaped grooves 4. These high-precision industrial pressure sensors 7 are existing technology and will not be described in detail here. They are used to detect and record in real time the dynamic force signal transmitted through the tablets and pressure plate 10 during the impact test. They are key sensing elements for quantifying the force on the bottom of the tablets and assessing structural integrity. A first guide rod 9 is slidably and adaptively inserted into the inner cavity of the guide groove 5. The top end of the first guide rod 9 can slide... The first guide rod 9 extends into the inner cavity of the V-groove 4, ensuring that the pressure plate 10 moves in a unique and unbiased direction when under force, so that the force can be transmitted vertically to the bottom sensor without loss. The pressure plate 10 is slidably embedded in the inner cavity of the V-groove 4. The top end of the first guide rod 9 is set at the bottom end of the pressure plate 10, and the bottom end of the pressure plate 10 is in contact with the top end of the first high-precision industrial pressure sensor 7. The pressure plate 10 is the interface for bearing and transmitting force on the tablet. The bracket 11 is set at the top of the base 1. The bracket 11 is used to support and fix the impact mechanism 8. The impact mechanism 8 is set on the outer wall of the bracket 11. The impact mechanism 8 is the core detection module of the device, responsible for generating a standardized and controllable transient mechanical impact and applying it to the tablet to stimulate its internal mechanical response.

[0044] As a preferred embodiment, the intermittent rotation mechanism 2 further includes: a support column 201, a driven wheel 202, a drive groove 203, a positioning groove 204, a first motor 205, a first connecting rod 206, a drive wheel 207, and a drive pin 208. The bottom end of the support column 201 is located at the center of the top end of the base 1, and the top end of the support column 201 is located at the center of the bottom end of the operating plate 3. The driven wheel 202 is sleeved on the outer wall of the support column 201 and locked. The outer wall of the driven wheel 202 is provided with several drive grooves 203 equidistantly spaced along the circumference. The outer wall of 02 is provided with several positioning grooves 204 evenly spaced along the circumference. The number of drive grooves 203 and positioning grooves 204 is the same as the number of V-grooves 4. The driven wheel 202 is a passive actuator with intermittent motion. The drive grooves 203 and positioning grooves 204 on it are key structures for the mechanism to achieve precise indexing and positioning. Their number corresponds to the V-grooves 4 and determines the number of workstations where the device stops each rotation. The first motor 205 is screwed to the top of the base 1. The first motor 205 is existing technology and will not be described in detail here. The first motor 205 is an intermittent... The power source of the intermittent rotary mechanism provides continuous and stable rotational power. Its start, stop, and speed are precisely controlled by the control system to match the production rhythm of the entire detection cycle. The first connecting rod 206 is locked to the output end of the first motor 205 via a coupling. The bottom center of the drive wheel 207 is set at the top of the first connecting rod 206. The drive wheel 207 matches the positioning groove 204. The drive wheel 207 is the active element of intermittent motion, and its circumferential contour is designed to match the positioning groove 204, serving both as engagement and disengagement functions during the driving process and during stopping. The positioning and locking function of the stage is achieved by setting the drive pin 208 at the top of the drive wheel 207. The position of the drive pin 208 corresponds to and matches the position of the drive groove 203. When the first motor 205 drives the drive wheel 207 to move along the outer wall of the positioning groove 204, the drive pin 208 can enter the inner cavity of the positioning groove 204. The drive pin 208 is a direct drive claw that periodically inserts into the drive groove 203 of the driven wheel 202 during rotation, causing the driven wheel 202 to rotate at a fixed angle. It is the direct execution component for realizing intermittent indexing drive.

[0045] As a preferred embodiment, the impact mechanism 8 further includes: an outer cylinder 81, a first moving groove 82, a sliding groove 83, a second guide rod 84, a slider 85, a sleeve 86, a second moving groove 87, an impact execution assembly, a drive assembly, and an impact power assembly. The outer cylinder 81 is located at the rear top of the support 11, and its position corresponds to the position of the inner cavity of the V-groove 4. The axis of the outer cylinder 81 is perpendicular to the bottom end of the inner cavity of the V-groove 4. The bottom ends of the left and right sides of the outer wall of the outer cylinder 81 are provided with first moving grooves 82 that communicate with its inner cavity in the vertical direction. Both the front and rear bottom ends are provided with grooves 83 along the vertical direction. The outer cylinder 81 is the overall shell and main frame of the impact mechanism 8, providing an installation reference and precise guiding constraint for all internal moving components, ensuring that the impact axis is precisely perpendicularly aligned with the tablet in the lower V-groove 4. There are two second guide rods 84, with their upper and lower ends respectively located on the upper and lower sides of the inner cavity of the two grooves 83. There are two sliders 85, which are slidably and compatiblely inserted into the top of the inner cavity of the two grooves 83. On the outer wall of the second guide rod 84, the front and rear sides of the outer wall of the sleeve 86 are respectively located inside the two sliders 85. The left and right sides of the sleeve 86 are each provided with a second moving groove 87 communicating with its inner cavity along the vertical direction. The top ends of the left and right sides of the sleeve 86 slidably pass through the top ends of the inner cavities of the two first moving grooves 82. The sleeve 86 serves as the carrier and lifting platform for the impact actuator, responsible for sending the impact actuator to the detection position and resetting it. The impact actuator is located in the inner cavity of the outer cylinder 81. When impacted, the impact actuator acts as a rigid force transmission rod to transmit the standard impact. Force is transmitted to the tablet, and the magnitude of the input impact force is synchronously measured using internal sensors. The drive assembly is located at the bottom of the inner cavity of the outer cylinder 81. The drive assembly can precisely control the lifting and lowering movement of the sleeve 86 and the impact execution assembly, and perform a series of actions such as pre-compression and post-detection reset. The impact power assembly is located at the top of the inner cavity of the outer cylinder 81. The impact power assembly can generate a free-fall impact with standardized energy. By precisely controlling the lifting, releasing and resetting of the impact hammer, it is ensured that the impact energy applied to the tablet is consistent each time. This is the basis for achieving repeatability and comparability of the test.

[0046] More specifically, the impact actuator includes: a ejector pin 88, a second high-precision industrial pressure sensor 89, a hemispherical protective head 810, and a connecting post 811. The outer wall of the ejector pin 88 is slidably fitted into the inner cavity of the sleeve 86. The ejector pin 88 is the core force transmission rod of the impact actuator, enabling precise transmission of impact energy. The second high-precision industrial pressure sensor 89 is located at the top of the inner cavity of the ejector pin 88. The second high-precision industrial pressure sensor 89 is existing technology and will not be described in detail here. The second high-precision industrial pressure sensor 89 is used to directly and in real-time measure the dynamic force applied to the ejector pin axially during the impact process, i.e., the input force. To deliver the impact force of the tablet, the top of the hemispherical protective head 810 is slidably fitted into the inner cavity of the ejector pin 88, and the bottom of the hemispherical protective head 810 extends slidably out of the bottom of the ejector pin 88. The hemispherical protective head 810 is the terminal execution component that directly contacts the tablet, and its material requires high rigidity and no damage to the tablet. While protecting the integrity of the tablet's appearance, it ensures that the impact force is transmitted without loss. There are two connecting posts 811, which are respectively set in the middle of the left and right sides of the outer wall of the ejector pin 88. The outer walls of the two connecting posts 811 are slidably fitted into the top of the inner cavity of the two second moving grooves 87.

[0047] More specifically, the drive assembly includes: a collar 812, a lifting rod 813, a support groove 814, an electromagnet 815, a permanent magnet 816, a support rod 817, and an electric telescopic rod 818. The collar 812 is sleeved on the outer wall of the connecting column 811. There are two lifting rods 813, each located at the top of one of the two collars 812. The top of the lifting rod 813 slidably extends beyond the top of the sleeve 86. A support groove 814, extending horizontally through the left side of the outer wall of the lifting rod 813, is provided along the vertical direction. The lifting rod 813 is the core force-bearing member of the support and locking mechanism, and its vertical movement also... The lifting ring 812 and the ejector pin 88 are directly driven to rise and fall. Two electromagnets 815 are used, positioned on the left and right sides of the top of the sleeve 86. Electromagnets 815 are existing technology and will not be described in detail here. Each electromagnet 815 is a controllable magnetic source; when energized, it generates a controllable magnetic field, forming a repulsive magnetic force with the permanent magnet 816. This magnetic force drives the permanent magnet 816 and the fixed support rod 817 to rise, providing the main power for the support to return to its original position. The permanent magnet 816 is slidably sleeved on the top of the outer wall of the lifting rod 813, located directly above the electromagnet 815. When energized, electromagnet 815 and permanent magnet 816 repel each other due to their similar polarity. Permanent magnet 816 is the moving part of the magnetic actuator, and its function is to respond to the magnetic force change of electromagnet 815. When the electromagnet is energized and generates a repulsive force, it drives the permanent magnet and support rod 817 to move upward and lock. There are two support rods 817, with their left and right ends respectively located on the left and right sides of the inner cavity of permanent magnet 816. The outer wall of the support rod 817 is slidably fitted into the top of the inner cavity of the support groove 814. The support rod 817 is a mechanical pin that directly performs the locking function. There are two electric telescopic rods 818. The top ends of two electric telescopic rods 818 are respectively located at the middle of the left and right sides of the outer cylinder 81, and the bottom ends of the two electric telescopic rods 818 are respectively located at the top left and right sides of the sleeve 86. The electric telescopic rods 818 are existing technology and will not be described in detail here. The electric telescopic rods 818 are power actuators that drive the sleeve 86 and the entire impact actuator assembly to perform large-stroke lifting and lowering. Their function is to precisely control the lowering and rising motion of the sleeve 86. The accuracy and stability of their action directly determine the pre-compression state of the contact between the ejector pin 88 and the tablet and the switching speed of the work station. It is the core driving component for realizing automated detection cycle.

[0048] More specifically, the impact power assembly includes: an impact hammer 819, a traction rod 820, a first positioning pin 821, a second motor 822, a second connecting rod 823, a toothed gear 824, and a second positioning pin 825. The impact hammer 819 is slidably and appropriately inserted into the top of the inner cavity of the outer cylinder 81. The position of the impact hammer 819 corresponds to the position of the top of the ejector pin 88. The impact hammer 819 is the core mass block that generates standard impact energy. Its weight and falling height have been precisely designed and calibrated to ensure that the impact energy generated each time it is released is highly consistent and far lower than the tablet crushing force. Its free fall impacts the top of the ejector pin 88. The end is a standardized input source that stimulates the tablet to generate a dynamic mechanical response. The bottom end of the traction rod 820 is set at the top end of the impact hammer 819. The top end of the traction rod 820 extends slidably out of the top end of the outer cylinder 81. The traction rod 820 is the lifting and guiding rod of the impact hammer 819, responsible for lifting the impact hammer 819 to a preset fixed height, providing potential energy for free fall, and ensuring the vertical motion trajectory of the impact hammer 819 during the fall. The first positioning pin 821 is set at the top of the outer wall of the traction rod 820. The first positioning pin 821 and the second positioning pin 825 cooperate to make the toothed gear 824 engage with the traction rod 825 during the reset process. The guide structure for the re-engagement of the guide rod 820 is connected to the rear top of the bracket 11 by screws to the second motor 822, which is existing technology and will not be described in detail here. The second motor 822 is the power source for the lifting and resetting mechanism of the impact hammer 819. By driving the toothed gear 824 to rotate, it precisely executes the lifting and resetting cycle of the impact hammer. The second connecting rod 823 is locked to the output end of the second motor 822 by a coupling. The toothed gear 824 is sleeved on the outer wall of the second connecting rod 823 and locked by a set screw. The toothed gear 824 meshes with the traction rod 820. 824 is a special transmission component that realizes integrated control of lifting, releasing and resetting. It achieves the cyclic control of impact hammer 819 with a single rotational action. The second positioning pin 825 is located on the right side of the toothed gear 824. The positions of the second positioning pin 825 and the first positioning pin 821 are corresponding and matched. The core function of the second positioning pin 825 is to cooperate with the first positioning pin 821. After the impact hammer falls, the rotation of the toothed gear 824 causes the second positioning pin 825 to push the first positioning pin 821, thereby driving the traction rod 820 to mesh with the toothed gear 824 and completing the automatic resetting of the impact hammer 819.

[0049] The working principle includes the following steps:

[0050] Step 1: In use, connect all nozzles 6 to the air pump via pipes, start the first motor 205, and use the output end of the first motor 205 to drive the drive wheel 207 to rotate through the first connecting rod 206, thereby driving the drive pin 208 to move circumferentially. As the drive pin 208 moves circumferentially, it will gradually move into the inner cavity of the drive groove 203. At this time, the drive wheel 207 separates from the positioning groove 204, releasing the positioning of the driven wheel 202. After the drive pin 208 moves into the inner cavity of the drive groove 203, the drive pin 208 continues to move circumferentially and cooperates with the drive groove 203 to drive the driven wheel 202 to rotate. Thus, the driven wheel 202 can drive the operating plate 3 to rotate through the support column 201. As the drive pin 208 moves circumferentially... The movement will cause it to gradually move out of the inner cavity of the drive groove 203. At this time, the drive wheel 207 rotates into the inner cavity of the positioning groove 204 again, thereby repositioning the driven wheel 202, thus completing the intermittent rotation of the operating plate 3. Since the number of drive grooves 203 and positioning grooves 204 is the same as the number of V-grooves 4, different external feeding devices corresponding to V-grooves 4 can be replaced. After the tableting is completed, the amlodipine besylate tablets are conveyed into the inner cavity of the corresponding V-groove 4 through the external feeding device. Since the bottom of the inner cavity of the V-groove 4 is inclined towards the center of the operating plate 3, the tablets in the inner cavity of the V-groove 4 will slide towards the inner side of the inner cavity of the V-groove 4 under the action of gravity until the tablets contact the inner wall of the V-groove 4, thereby preventing the tablets from slipping out of the inner cavity of the V-groove 4.

[0051] Step 2: As the operating plate 3 drives the V-groove 4 to rotate, after the tablet rotates to below the ejector pin 88, activate the electric telescopic rod 818. The electric telescopic rod 818 pushes the sleeve 86 downwards, thereby using the top of the inner cavity of the second moving groove 87 and the connecting column 811 to move the ejector pin 88 downwards until the hemispherical protective head 810 contacts the top of the tablet. Continuing to push the ejector pin 88 downwards will cause the top of the hemispherical protective head 810 to move upwards along the inner cavity of the ejector pin 88, thereby using the top of the hemispherical protective head 810 to press the second high-precision industrial pressure sensor 89. When the second high-precision... After the industrial pressure sensor 89 detects a slight pressure, the electric telescopic rod 818 stops moving the ejector pin 88 downwards, thus pre-compressing the tablet and ensuring its flatness. At this time, the electromagnet 815 is turned off, losing its magnetism. Under the influence of gravity, the permanent magnet 816 moves the support rod 817 downwards until it contacts the electromagnet 815. This starts the second motor 822, whose output, via the second connecting rod 823, drives the toothed gear 824 to rotate until it disengages from the traction rod 820, thereby releasing the impact hammer 81. Under the influence of gravity, the traction rod 820 moves downward and falls onto the top of the ejector pin 88, thus applying an impact force to the ejector pin 88. This impact force is transmitted through the hemispherical protective head 810 to the second high-precision industrial pressure sensor 89. The second high-precision industrial pressure sensor 89 can detect the impact force applied to the tablet, and this impact force is transmitted through the ejector pin 88, the tablet, and the pressure plate 10 to the first high-precision industrial pressure sensor 7. The pressure values ​​displayed by the second high-precision industrial pressure sensor 89 and the first high-precision industrial pressure sensor 7, combined with the weight of the impact hammer 819, are used to determine the impact force. The cohesion and looseness of the tablet are calculated based on the drop height. For example, normal tablets have high stiffness and high deceleration upon impact, resulting in a high peak force displayed by the first high-precision industrial pressure sensor 7. Loose tablets have low stiffness and a lower peak force when absorbing impact. Normal tablets, as displayed by the first high-precision industrial pressure sensor 7, have a faster force rise, while loose tablets, having undergone structural compaction first, have a slower force rise. Loose tablets deform significantly, resulting in a longer force application time, as displayed by the first high-precision industrial pressure sensor 7. Normal tablets deform less and have a shorter impact time, etc. This allows us to determine whether the tablet has insufficient cohesion or a loose structure.

[0052] Step 3: After the test is completed, the second motor 822 continues to drive the toothed gear 824 to rotate until the second positioning pin 825 and the first positioning pin 821 contact. The rotating second positioning pin 825 then drags the first positioning pin 821, causing the traction rod 820 to move upwards. The engagement between the first and second positioning pins 821 and 825 causes the toothed gear 824 to mesh with the traction rod 820 again. The rotating toothed gear 824 then drives the traction rod 820, causing the impact hammer 819 to move upwards until it returns to its initial position. The output of the second motor 822 stops rotating, and the electromagnet 815 is activated. The electromagnet 815 generates magnetism when energized, and the repulsion between the like poles of the electromagnet 815 and the permanent magnet 816 causes the permanent magnet 816 to move upwards. 816 drives the support rod 817 to move upward until the outer wall of the support rod 817 contacts the top of the inner cavity of the support groove 814. The electric telescopic rod 818 is activated, which drives the sleeve 86 to move upward. The sleeve 86 then drives the electromagnet 815 to move upward. The repulsion between the like poles of the electromagnet 815 and the permanent magnet 816 drives the permanent magnet 816 to drive the support rod 817 to move upward synchronously with the electromagnet 815. The cooperation between the support rod 817 and the top of the inner cavity of the support groove 814 drives the lifting rod 813 and the collar 812 to move upward synchronously with the sleeve 86. The cooperation between the collar 812 and the connecting column 811 drives the ejector pin 88 to move upward synchronously with the sleeve 86 until the ejector pin 88 moves to the initial position.

[0053] Step 4: After the test is completed, when the tablets are rotated to the external conveyor belt or waste collection point, start the air pump. The air pump blows air into the inner cavity of the V-groove 4 through the nozzle 6. The air pressure can blow the tablets in the inner cavity of the V-groove 4 towards the external conveyor belt or waste collection point. In addition, the air pressure can blow away the residual tablet powder in the inner cavity of the V-groove 4, ensuring that the inner cavity of the V-groove 4 is clean and tidy.

[0054] In summary, this device achieves 100% online, non-destructive, and automated detection of tablet cohesion. By converting microstructural defects into quantifiable signal differences, it offers high detection accuracy and reliability, significantly improving the process control level and drug safety assurance capabilities in the production of amlodipine besylate tablets.

[0055] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A processing apparatus for amlodipine besylate tablets, characterized in that, include: Base (1); Intermittent rotation mechanism (2), which is located at the top center of the base (1); Operation panel (3), the operation panel (3) is disposed at the top of the intermittent rotation mechanism (2); V-groove (4), the number of V-groove (4) is several, and several V-groove (4) are respectively arranged at equal intervals along the circumference at the top of the operating plate (3). A guide groove (5) penetrating the bottom of the operating plate (3) is provided in the middle of the bottom of the inner cavity of the V-groove (4). The number of nozzles (6) is several, and the several nozzles (6) are respectively disposed on the inner wall of several V-shaped grooves (4); The first high-precision industrial pressure sensor (7) is a plurality of the first high-precision industrial pressure sensors (7), and the plurality of the first high-precision industrial pressure sensors (7) are respectively disposed in the middle of the bottom end of the inner cavity of the plurality of V-shaped grooves (4). The first guide rod (9) is slidably adapted to be inserted into the inner cavity of the guide groove (5), and the top end of the first guide rod (9) is slidably extended into the inner cavity of the V-groove (4). The pressure plate (10) is slidably embedded in the inner cavity of the V-groove (4), the top end of the first guide rod (9) is set at the bottom end of the pressure plate (10), and the bottom end of the pressure plate (10) is in contact with the top end of the first high-precision industrial pressure sensor (7). A bracket (11) is disposed at the top of the base (1); Impact mechanism (8), said impact mechanism (8) is disposed on the outer wall of the bracket (11); The impact mechanism (8) includes: Outer cylinder (81), the outer cylinder (81) is disposed on the rear side of the top of the bracket (11); An impact actuator assembly is disposed within the inner cavity of the outer cylinder (81); A drive assembly is disposed at the bottom of the inner cavity of the outer cylinder (81); An impact power assembly is disposed at the top of the inner cavity of the outer cylinder (81); The position of the outer cylinder (81) corresponds to the position of the inner cavity of the V-groove (4). The axis of the outer cylinder (81) is perpendicular to the bottom end of the inner cavity of the V-groove (4). The bottom ends of the left and right sides of the outer wall of the outer cylinder (81) are provided with a first moving groove (82) that communicates with its inner cavity in the up and down direction. The bottom ends of the front and rear sides of the inner cavity of the outer cylinder (81) are provided with a sliding groove (83) in the up and down direction. The impact mechanism (8) further includes: The second guide rod (84) has two parts, and the upper and lower ends of the two second guide rods (84) are respectively set on the upper and lower sides of the inner cavity of the two slide grooves (83); Slider (85), there are two sliders (85), the two sliders are slidably and compatiblely inserted into the top of the inner cavity of the two slide grooves (83), and the sliders (85) are slidably and compatiblely connected to the outer wall of the second guide rod (84). The sleeve (86) has its outer wall front and rear sides respectively located inside the two sliders (85). The left and right sides of the sleeve (86) are provided with second moving grooves (87) communicating with their inner cavities in the up and down direction. The top ends of the left and right sides of the sleeve (86) can slide through the top ends of the inner cavities of the two first moving grooves (82). The impact actuation component includes: A ejector pin (88) is slidably fitted into the inner cavity of a sleeve (86) at the middle of its outer wall. The second high-precision industrial pressure sensor (89) is disposed at the top of the inner cavity of the ejector pin (88); A hemispherical protective head (810) is provided, the top end of which is slidably fitted into the inner cavity of the ejector pin (88), and the bottom end of which is slidably extended out of the bottom end of the ejector pin (88). Connecting post (811), there are two connecting posts (811), the two connecting posts (811) are respectively set in the middle of the left and right sides of the outer wall of the ejector pin (88), and the outer walls of the two connecting posts (811) are respectively slidably adapted to be inserted into the top of the inner cavity of the two second moving slots (87); The driving component includes: A collar (812) is fitted onto the outer wall of the connecting post (811); The lifting rod (813) has two lifting rods (813), which are respectively set at the top of two collars (812). The top of the lifting rod (813) extends slidably out of the top of the sleeve (86). The left side of the outer wall of the lifting rod (813) is provided with a support groove (814) that runs through the left and right sides in the vertical direction. Electromagnet (815), there are two electromagnets (815), and the two electromagnets (815) are respectively disposed on the left and right sides of the top end of the sleeve (86); A permanent magnet (816) is slidably sleeved on the top of the outer wall of the lifting rod (813); Support rod (817), there are two support rods (817), the left and right ends of the two support rods (817) are respectively set on the left and right sides of the inner cavity of the permanent magnet (816), and the outer wall of the support rod (817) is slidably adapted to be inserted into the top of the inner cavity of the support groove (814); Electric telescopic rod (818), the number of electric telescopic rods (818) is two, the top ends of the two electric telescopic rods (818) are respectively set in the middle of the left and right sides of the outer cylinder (81), and the bottom ends of the two electric telescopic rods (818) are respectively set in the top left and right sides of the sleeve (86). The permanent magnet (816) is located directly above the electromagnet (815), and the electromagnet (815) and the permanent magnet (816) repel each other when the electromagnet is energized. The impact power assembly includes: Impact hammer (819), which is slidably and compatiblely inserted into the top of the inner cavity of the outer cylinder (81), and the position of the impact hammer (819) corresponds to the position of the top of the ejector pin (88); A traction rod (820) is provided at the bottom end of the impact hammer (819), and the top end of the traction rod (820) extends slidably out of the top end of the outer cylinder (81). The first positioning pin (821) is disposed on the top of the outer wall of the traction rod (820); The second motor (822) is screwed to the rear top of the bracket (11); The second connecting rod (823) is locked to the output end of the second motor (822) by a coupling; A toothed gear (824) is sleeved on the outer wall of the second connecting rod (823) and locked by a set screw. The toothed gear (824) meshes with the traction rod (820). The second locating pin (825) is located on the right side of the toothed gear (824).

2. The processing apparatus for amlodipine besylate tablets according to claim 1, characterized in that, The intermittent rotation mechanism (2) includes: Support column (201), the bottom end of the support column (201) is located at the top center of the base (1), and the top end of the support column (201) is located at the bottom center of the operating plate (3); Driven wheel (202), the driven wheel (202) is sleeved on the outer wall of the support column (201) and locked, the outer wall of the driven wheel (202) is provided with a plurality of drive grooves (203) at equal intervals along the circumference, the outer wall of the driven wheel (202) is provided with a plurality of positioning grooves (204) at equal intervals along the circumference, the number of drive grooves (203) and positioning grooves (204) is the same as the number of V-grooves (4); The first motor (205) is screwed to the top of the base (1); The first connecting rod (206) is locked to the output end of the first motor (205) by a coupling; The drive wheel (207) has its bottom center located at the top of the first connecting rod (206), and the drive wheel (207) matches the positioning groove (204). The drive pin (208) is located at the top of the drive wheel (207). When the first motor (205) drives the drive wheel (207) to move along the outer wall of the positioning groove (204), the drive pin (208) can enter the inner cavity of the positioning groove (204).

3. The processing apparatus for amlodipine besylate tablets according to claim 2, characterized in that, The bottom of the inner cavity of the V-groove (4) is inclined toward the center of the operating plate (3).

4. A processing method for amlodipine besylate tablets, wherein the process is applied in the processing apparatus for amlodipine besylate tablets as described in claim 3, characterized in that, Includes the following steps: S1. Tablet delivery and positioning: Connect several nozzles (6) to the air pump through pipelines, start the first motor (205), and use the first motor (205) to drive the intermittent rotation mechanism (2) to drive the operation plate (3) to rotate intermittently; after tableting, the amlodipine besylate tablets are delivered to the inner cavity of the corresponding V-shaped groove (4) through the external feeding device. Under the action of gravity, the tablets slide inward along the inclined bottom end of the V-shaped groove (4) until they contact the inner wall of the V-shaped groove (4) to achieve positioning and prevent slippage; S2. Pre-compression and impact detection: When the V-groove (4) carrying the tablet rotates to below the ejector pin (88), the electric telescopic rod (818) is activated to push the sleeve (86) and ejector pin (88) downwards until the hemispherical protective head (810) contacts the top of the tablet. The pressure continues to press down so that the hemispherical protective head (810) squeezes the second high-precision industrial pressure sensor (89). When the second high-precision industrial pressure sensor (89) detects the preset weak pressure, the electric telescopic rod (818) stops moving, completing the tablet pre-compression; the electromagnet (815) is turned off, and the second motor (822) is activated to drive the toothed gear (824) to rotate. The toothed gear (824) is disengaged from the traction rod (820), and the impact hammer (819) falls under the action of gravity and hits the top of the ejector pin (88). The impact force applied to the tablet is detected by the second high-precision industrial pressure sensor (89). At the same time, the impact force is transmitted to the first high-precision industrial pressure sensor (7) through the tablet and the pressure plate (10). Combining the pressure values ​​of the first high-precision industrial pressure sensor (7) and the second high-precision industrial pressure sensor (89) with the weight and falling height of the impact hammer (819), the cohesion and looseness of the tablet are calculated, and it is determined whether the tablet has insufficient cohesion or structural defects. S3. Mechanism Reset: After the test is completed, the second motor (822) continues to drive the toothed gear (824) to rotate. Through the cooperation of the second positioning pin (825) and the first positioning pin (821), the traction rod (820) and the impact hammer (819) are dragged up until the toothed gear (824) and the traction rod (820) re-mesh, driving the impact hammer (819) to reset to the initial position, and the second motor (822) stops. The electromagnet (815) is started, and the like repulsion force between the electromagnet (815) and the permanent magnet (816) drives the support rod (817) to move up. Then, through the electric telescopic rod (818), the sleeve (86) and the ejector pin (88) are driven to rise synchronously and reset to the initial position. S4. Sorting and cleaning: When the V-shaped groove (4) carrying the tested tablets rotates to the external conveyor belt or waste collection point, the air pump is started and air is blown into the inner cavity of the V-shaped groove (4) through the nozzle (6) to blow the tablets to the corresponding collection position. At the same time, the residual powder in the V-shaped groove (4) is blown away to achieve workstation cleaning and avoid cross-contamination.

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