A dissolution apparatus retrofit device

Abstract

The utility model relates to the technical field of medicine detection, provide a kind of dissolution instrument retrofit device, including the receiving seat that can be installed in the bottom of dissolution cup or integrated with dissolution cup, receiving seat is centrally protruding and is arranged, receiving seat is connected receiving seat cap or support rod, support rod top and perpendicular to support rod setting connecting shaft, connecting shaft rotation installs receiving table, a pair of sample basket is fixedly installed in receiving table both ends, magnet block is arranged in the top of sample basket, the top of dissolution cup is provided with rotating shaft, the bottom of rotating shaft is provided with magnetic paddle, the sample basket includes basket body, basket cover is arranged in the top of basket body, magnet block is installed in the top of basket cover. The occurrence of accumulation can be avoided or alleviated, and the dissolution behavior in vivo is better simulated.

Description

Technical Field

[0001] This utility model relates to the field of pharmaceutical testing equipment technology, specifically to a dissolution apparatus modification device. Background Technology

[0002] A drug dissolution apparatus is an instrument used for drug dissolution testing. It is a mechatronic testing device controlled by a microcomputer, with a precision control system centrally controlling each component. Drug dissolution testing is a method for detecting the dissolution rate and degree of solid drug formulations such as tablets, capsules, and granules under certain conditions. It can also be described as a method of simulating disintegration and dissolution in the gastrointestinal tract using an instrument. It is used to evaluate the bioequivalence and bioavailability of drugs. The commonly used dissolution modes of dissolution apparatus mainly include the basket method and the paddle method.

[0003] The basket method involves placing the solid dosage form to be tested into a perforated support basket, immersing the basket in the test medium, and then rotating the basket to promote the dissolution process. By removing the sample at different time points and measuring the sample concentration, the quality of the dosage form can be evaluated.

[0004] The paddle method involves placing the solid dosage form to be tested into a dissolution vessel containing a quantitative dissolution medium, stirring it to promote the dissolution process, and then taking samples at different time points to measure the sample concentration, thereby evaluating the quality of the dosage form.

[0005] In existing paddle and basket dissolution testing techniques, after solid dosage forms disintegrate or dissolve, active substances (especially poorly soluble drugs) and poorly soluble excipients tend to deposit in the center of the dissolution vessel, forming an accumulation. However, drugs do not accumulate in the human body, and this accumulation will prevent the dissolution data from accurately reflecting the release characteristics. In addition, the paddle and basket methods cannot simulate the release behavior of solid dosage forms under the continuous relaxation and contraction movement pattern of the gastrointestinal tract, and cannot accurately reflect the dissolution process in vivo. Utility Model Content

[0006] To achieve the above objectives, this utility model proposes a modification device for a dissolution apparatus, including a receiving seat that can be installed at the bottom of the dissolution cup or is integrated with the dissolution cup, the receiving seat being centrally convex.

[0007] Further configured, the receiving seat is connected to a receiving seat cap or a support rod, a connecting shaft is provided at the top of the support rod and perpendicular to the support rod, the connecting shaft rotatably mounts the receiving platform, a pair of sample baskets are fixedly mounted at both ends of the receiving platform, a magnet is provided at the top of the sample basket, a rotating shaft is provided at the top of the dissolution cup, and a magnetic paddle is provided at the bottom of the rotating shaft; the sample basket includes a basket body, a basket cover is provided at the top of the basket body, and a magnet is installed on the top of the basket cover. Further configuration involves the magnetic poles of the two baskets' magnets facing the same direction, meaning the upward-facing magnetic poles are either both N poles or both S poles.

[0008] Further configured, the distance between the sample baskets is equal to the blade width.

[0009] A further configuration is that the top sidewall of the shaft is threaded.

[0010] A further configuration is provided where a distance is provided between the sample basket and the blade.

[0011] A further configuration is provided, wherein a bearing is fixedly mounted on the coupling, and a bearing seat is provided outside the bearing.

[0012] Further configured, the support rod includes a telescopic rod consisting of an inner rod, a spring, a ball, and a sleeve rod, with a receiving platform mounted on the top of the telescopic rod.

[0013] A further configuration includes a sleeve rod fitted onto the outer side of the inner rod, and a spring perpendicular to and penetrating the inner rod, with spheres at both ends of the spring. A further configuration is provided where a groove is provided inside the sleeve rod, and a ball is slidably installed in the groove.

[0014] The beneficial effects of one or more of the above technical solutions: This invention features a basket at the bottom of the dissolution cup that can rotate left and right. Magnets are mounted on the upper part of each basket, and magnetic paddles are correspondingly mounted on the basket. The paddles are made of magnets, with one end being the N pole and the other the S pole. As the magnetic paddles rotate, the tablets move up and down with the basket while simultaneously being agitated by the paddles. The presence of a receiving base ensures that the sediment settles off-center from the dissolution cup, receiving a greater agitation force from the paddles. This solves the problem of poorly soluble drugs accumulating in the center in traditional paddle / basket methods, better reflecting the dissolution of drugs in vivo. The movement pattern is closer to the continuous expansion and contraction of the gastrointestinal tract than paddle and basket methods, better simulating dissolution behavior in vivo. Attached Figure Description

[0015] The accompanying drawings, which form part of this application, are used to provide a further understanding of this application. The illustrative embodiments of this application and their descriptions are used to explain this application and do not constitute a limitation thereof.

[0016] Figure 1 This is a schematic diagram of the structure of Embodiment 1 of the present utility model; Figure 2 This is a schematic diagram of the structure of Embodiment 2 of the present invention; Figure 3 This is a schematic diagram of the support rod of this utility model; Figure 4 This is a schematic diagram of the structure of the receiving cap of this utility model.

[0017] In the diagram, 1. Dissolution cup; 2. Support rod; 3. Sample basket; 31. Basket body; 32. Basket lid; 33. Magnet block; 4. Coupling; 5. Receiver seat; 51. Receiver seat cap; 52. Threaded rod; 53. Telescopic rod; 54. Inner rod; 55. Spring; 56. Ball; 57. Sleeve rod; 6. Magnetic blades; 7. Rotary shaft; 8. Receiving platform; Detailed Implementation The specific implementation of this embodiment will now be described with reference to the accompanying drawings.

[0018] Example 1: Reference Figure 1 A modified dissolution apparatus includes a dissolution cup 1, a receiving seat 5 at the bottom of the dissolution cup 1, a support rod 2 connected to the receiving seat 5, a connecting shaft 4 at the top of the support rod 2 and perpendicular to the support rod 2, a receiving platform 8 rotatably mounted on the connecting shaft 4, a pair of sample baskets 3 fixedly mounted at both ends of the receiving platform 8, a magnet 33 at the top of the sample baskets 3, a rotating shaft 7 at the top of the dissolution cup 1, and a magnetic paddle 6 at the bottom of the rotating shaft 7. The magnetic poles at both ends of the magnetic paddle 6 are opposite. The rotation of the magnetic paddle drives the sample baskets 3 to move up and down reciprocally, while the paddles stir the medium, forming a "lifting + stirring" composite motion, which is closer to the physiological dynamics of gastrointestinal relaxation / contraction. At the same time, the presence of the receiving seat causes the sediment to settle off from the center of the dissolution cup, and the force of the paddle stirring is greater, solving the problem of poorly soluble drugs and / or excipients accumulating in the center in the traditional paddle / basket method, and can better reflect the dissolution of drugs in vivo.

[0019] The sample basket 3 includes a basket body 31, and a basket cover 32 is provided on the top of the basket body 31. A magnet block 33 is fixedly installed on the top of the basket cover 32. The magnetic poles of the magnet blocks 33 of the two baskets are aligned, that is, the upward magnetic poles are both N poles or both S poles. The magnetic poles of the two sample baskets 3 are in the same direction (both N poles or S poles facing upwards), ensuring that the magnetic blades periodically apply upward and downward magnetic forces to the two baskets when they rotate.

[0020] The distance between sample baskets 3 is similar to the width of the blade, and the spacing between sample baskets 3 matches the width of the blade, so that the magnetic field of the blade completely covers the two baskets, avoiding magnetic force attenuation that could lead to motion failure.

[0021] In one case, the length of the rotating shaft 7 can be the same as that of the stirring paddle that comes with an existing ordinary dissolution apparatus. In this case, the rotating shaft 7 can be directly installed on the dissolution apparatus in the same way as an ordinary paddle rod.

[0022] In another scenario, the paddle of a conventional dissolution apparatus uses a threaded connection at both ends. In this case, the top of the rotating shaft 7 is threaded, and the upper half of the paddle or basket rod of the dissolution apparatus can be connected through the threaded interface. Combined with the existing multi-segment coupling 4 structure, the upper and lower segments are connected to each other through threads, realizing modular disassembly and assembly, and improving equipment maintenance efficiency.

[0023] A distance is provided between the sample basket 3 and the blade to prevent the sample basket 3 from contacting the rotating blade during operation, thus preventing sample breakage or equipment damage caused by mechanical interference.

[0024] A bearing is fixedly installed on the connecting shaft 4, using the existing bearing structure. A receiving platform 8 is set outside the bearing. The bearing supports the connecting shaft 4, minimizing the lifting resistance of the sample basket 3, ensuring smooth movement and reducing energy consumption. The receiving platform 8 fixes the outer ring of the bearing to prevent radial displacement of the connecting shaft 4 and ensure the verticality of the lifting trajectory.

[0025] The support rod 2 includes a telescopic rod 53 composed of an inner rod 54, a spring 55, a ball 56, and a sleeve rod 57. A receiving platform 8 is mounted on the top of the telescopic rod 53. Pulling the telescopic rod 53 to its highest position allows the sample basket 3 containing the medicine to be installed. After installation, the bottom of the sample basket 3 is higher than the liquid level in the dissolution cup. Pushing the telescopic rod 53 lowers it to a preset height and then automatically locks in place, completing the sample placement.

[0026] The inner rod 54 is sleeved on the outer side of the sleeve rod 57. A spring 55 is set perpendicular to and through the inner rod 54. A ball 56 is set at both ends of the spring 55. A groove is set inside the sleeve rod 57. The ball 56 is slidably installed in the groove. The spring 55 pushes the ball 56 into the groove of the sleeve rod 57, so as to realize the segmented fixation of the telescopic rod 53 and prevent accidental slippage during drug addition. The rolling friction of the ball 56 replaces the sliding friction, reducing mechanical wear and extending the service life of the telescopic rod 53.

[0027] A threaded rod 52 is provided at the end of the inner rod 54 and at the lowest end of the support rod 2. A threaded rod 52 is also provided at the bottom end of the receiving cap 51. Both the end of the inner rod 54 and the receiving cap 51 can be connected to the receiving seat via threads, supporting rapid connection. Figure 1 and Figure 2 The two working states are shown in the diagram.

[0028] The receiving seat 5 has an internal thread corresponding to the threaded rod 52 at the bottom of the receiving seat cap 51. The internal thread of the receiving seat 5 is locked with the support rod 2 to prevent the support rod 2 from shaking during the experiment and to ensure the stability of the movement.

[0029] The internal thread of the receiver 5 can also be locked with the receiver cap to prevent liquid from entering the gap between the internal thread and the receiver cap, which could cause drug residue or contamination.

[0030] The device achieves dynamic magnetic field coupling between the magnet at the top of the sample basket and the magnet on the paddle. When the device is turned on, the rotating paddle drives the sample basket to tumble left and right around the pivot point. The tablets simultaneously undergo up-and-down tumbling motion (simulating gastrointestinal expansion and contraction) and fluid shear force from the paddle (simulating digestive fluid agitation) within the sample basket. This prevents drug deposition at the bottom of the container, significantly improving the correlation between dissolution data and actual release behavior in the human body. The device can be directly used with existing conventional dissolution apparatuses, eliminating the need to purchase new dissolution equipment and resulting in lower costs.

[0031] Example 2: The receiving cap can be directly screwed onto the receiving seat. In this embodiment, refer to... Figure 2 It includes a dissolution cup 1, a receiving seat 5 at the bottom of the dissolution cup 1, and a receiving seat cap 51 connected to the receiving seat 5; the receiving seat 5 can be integrated with the dissolution cup, or it can be placed directly at the bottom of the dissolution cup configured in a common dissolution apparatus.

[0032] A rotating shaft 7 is installed at the top of the dissolution vessel 1, and a paddle 6 is installed at the bottom of the rotating shaft 7. The upper end of the rotating shaft 7 is mounted on the dissolution apparatus. The motor of the dissolution apparatus drives the paddle to rotate. The stirring paddle composed of the rotating shaft 7 and the paddle 6 can be directly used with existing ordinary dissolution apparatuses. Because the receiving base is positioned high, undissolved powder and excipients will not accumulate at the center of the bottom of the dissolution vessel. Areas further away from the center are subject to greater stirring force from the paddle, making accumulation less likely. This design allows for direct use with existing ordinary dissolution apparatuses, eliminating the need to purchase new dissolution equipment and reducing costs.

[0033] Although the specific embodiments of the present utility model have been described above in conjunction with the accompanying drawings, this is not intended to limit the scope of protection of the present utility model. Those skilled in the art should understand that various modifications or variations that can be made by those skilled in the art without creative effort based on the technical solution of the present utility model are still within the scope of protection of the present utility model.

Claims

1. A device for modifying a dissolution apparatus, characterized in that, Includes a receiving base that can be installed at the bottom of the dissolution cup, or integrated with the dissolution cup, wherein the receiving base is provided with a central protrusion; The receiving seat is connected to the receiving seat cap or the support rod. A connecting shaft is set at the top of the support rod and perpendicular to the support rod. The connecting shaft is used to rotatably install the receiving platform. A pair of sample baskets are fixedly installed at both ends of the receiving platform. A magnet is set at the top of the sample basket. A rotating shaft is set at the top of the dissolution cup. A magnetic paddle is set at the bottom of the rotating shaft. The sample basket includes a basket body, a basket cover is provided on the top of the basket body, and a magnet is installed on the top of the basket cover.

2. The dissolution apparatus modification device according to claim 1, characterized in that, The magnetic poles of the magnets in the two sample baskets are aligned, meaning that the upward-facing magnetic poles are either both N poles or both S poles.

3. The dissolution apparatus modification device according to claim 1, characterized in that, The distance between the sample baskets is equal to the width of the blade.

4. The dissolution apparatus modification device according to claim 1, characterized in that, The top sidewall of the shaft is threaded.

5. The dissolution apparatus modification device according to claim 1, characterized in that, A distance is provided between the sample basket and the blade.

6. The dissolution apparatus modification device according to claim 1, characterized in that, The bearing is fixedly installed on the coupling, and a bearing seat is provided outside the bearing.

7. The dissolution apparatus modification device according to claim 1, characterized in that, The support rod includes a telescopic rod consisting of an inner rod, a spring, a ball, and a sleeve rod, with a receiving platform installed on the top of the telescopic rod.

8. The dissolution apparatus modification device according to claim 7, characterized in that, The inner rod is sleeved on the outer side, and a spring is installed perpendicular to and through the inner rod, with spheres at both ends of the spring.

9. The dissolution apparatus modification device according to claim 8, characterized in that, The sleeve has a groove inside, and the ball is slidably installed in the groove.

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