Determination equipment for dissolution rate of traditional Chinese medicine sustained-release tablets

Abstract

The utility model discloses a traditional Chinese medicine sustained release tablet dissolution rate measuring device which comprises a machine base, a machine head connected to the machine base, a testing assembly arranged on the machine base, and a dissolution tester body formed by a stirring assembly arranged on the machine head, and the testing assembly comprises a cup base and a dissolution cup arranged on the cup base in a sliding mode. The stirring assembly comprises a fixing frame arranged in the machine head and a stirring paddle arranged on the fixing frame in a sliding mode in the dissolution cup, a connecting shaft acting on the periphery of the stirring paddle is rotationally arranged on the fixing frame located at the sliding position of the stirring paddle, and the connecting shaft is driven to rotate through a driving component installed on the fixing frame. A connecting base is further rotationally arranged on the machine base, the connecting base is arranged on the periphery of the stirring paddle in a sleeving mode, an adjusting piece is rotationally arranged on the connecting base, a cup cover matched with the cup base is further arranged on the stirring paddle in a sliding mode, and a locking piece used for the cup cover is arranged on the top of the cup base.

Description

Technical Field

[0001] This utility model relates to the field of pharmaceutical technology, specifically to a device for determining the dissolution rate of traditional Chinese medicine sustained-release tablets. Background Technology

[0002] As a novel form of pharmaceutical preparation, sustained-release tablets of traditional Chinese medicine offer advantages such as prolonged drug action time and reduced frequency of administration. Sustained-release tablets should meet the relevant requirements for sustained-release preparations and should undergo dissolution (also known as release rate) testing.

[0003] Currently, most methods for determining the dissolution rate of sustained-release tablets of traditional Chinese medicine employ either the basket method or the paddle method. The basket method is suitable for tablets or capsules, where the sample is placed in a rotating basket to simulate the gastrointestinal fluid environment. The paddle method involves placing the sample directly at the bottom of the dissolution vessel and stirring with a paddle, suitable for viscous media or easily floating formulations. However, most commercially available dissolution analyzers use a multi-dissolution vessel structure. While this offers some testing efficiency and comparative effects for the same type of drug, it is often inconvenient to adapt specific measurement parameters on the corresponding dissolution vessels for different types of drugs, resulting in operational complexity. Furthermore, the multi-dissolution vessel structure of dissolution analyzers is also inconvenient for adjusting to different measurement environments, leading to inconvenience. Additionally, existing single-cup dissolution analyzers using the paddle method often make it difficult to adjust the stirring paddle and remove the solution from the dissolution vessel. Large stirring amplitudes or axial deviations can also affect the stability of the dissolution results. Utility Model Content

[0004] The purpose of this invention is to provide a dissolution testing device for sustained-release tablets of traditional Chinese medicine. This dissolution testing device adopts a single-cup dissolution apparatus structure, which not only has certain ease of use compared with multi-cup dissolution apparatus, but also facilitates operations such as removing the stirring paddle and the solution in the dissolution cup, while further improving the stability of the relative position between the stirring paddle and the dissolution cup. It also has high testing effect and applicability for specific drugs in the same category, such as sustained-release tablets of traditional Chinese medicine.

[0005] The technical solution adopted by this utility model to solve the above problems is:

[0006] A dissolution testing device for sustained-release tablets of traditional Chinese medicine includes a base and a head connected to it, and a dissolution apparatus body formed by a test component and a stirring component respectively placed on the base and the head. The test component includes a cup holder and a dissolution cup slidably disposed on it. The stirring component includes a fixed frame disposed inside the head and a stirring paddle slidably disposed on it inside the dissolution cup. A connecting shaft acting on the periphery of the stirring paddle is rotatably disposed on the fixed frame located at the sliding position of the stirring paddle. The connecting shaft is driven to rotate by a driving component installed on the fixed frame. A connecting seat is also rotatably disposed on the base. The connecting seat is sleeved around the stirring paddle and has an adjusting component rotatably disposed on it. A cup cover adapted to the cup holder is slidably disposed on the stirring paddle. A locking component for the cup cover is disposed on the top of the cup holder.

[0007] Preferably, the stirring paddle includes a connecting rod that slides on the fixed frame inside the machine head and a stirring head that can be detachably installed at its bottom. The stirring head is provided with multiple sets of stirring blades arranged in a circular and uniform manner.

[0008] Preferably, the cup lid is provided with a medicine inlet and the medicine inlet is covered with a suitable sealing cap.

[0009] Preferably, the testing assembly further includes a pH test probe disposed inside the cup holder and a heating seat disposed on the base at the bottom of the cup holder.

[0010] Preferably, the cup holder adopts a split structure, including a cup body connected to the heating base by a plug-in structure and a top cover plugged into it for sliding of the dissolution cup, and the locking member and pH test probe act on the top cover.

[0011] Preferably, the locking component includes multiple sets of connecting rods arranged around the top cover, a locking head sleeved on the top cover, and a locking ring rotatably arranged on the connecting rods above the locking head.

[0012] Preferably, a partition is also attached to the corresponding position of the top cover for sliding the dissolution cup, and the top of the dissolution cup is provided with an outer edge and the diameter of the outer edge is larger than the diameter of the partition.

[0013] Preferably, the machine head and the machine base are each covered with a machine cover of an appropriate size.

[0014] Preferably, the bottom of the base is also provided with multiple sets of support legs, and each support leg has an anti-slip pad attached to its bottom.

[0015] Compared with the prior art, this utility model has the following advantages and effects:

[0016] This invention relates to a dissolution testing device for sustained-release tablets of traditional Chinese medicine. Compared to traditional single-cup dissolution apparatuses, the main structure of this dissolution apparatus features a unique design. The structure of the stirring assembly and the connection method between the stirring paddle and the connecting shaft and seat within the head ensure stability of the stirring paddle connection. Combined with the adjustable components on the connecting seat, this allows for convenient height adjustment of the stirring paddle according to different testing requirements and the specific position of the tablets during dissolution testing. Furthermore, the locking mechanism on the cup lid and cup seat, along with the corresponding structural design of the dissolution cup within the cup seat, facilitates easy removal of the dissolution cup and adjustment of the internal solution and tablets. It also ensures the stability of the dissolution cup within the cup seat during testing, further improving the relative positional stability between the stirring paddle and the dissolution cup. The synchronous belt drive for rotating the stirring paddle further enhances the stirring effect of the assembly and the dissolution stability of the tablets within the dissolution cup, effectively improving the testing results and the accuracy of the dissolution outcome. In addition, compared with traditional multi-dissolution cup detectors, this dissolution apparatus offers greater ease of operation and flexibility. It demonstrates higher testing effectiveness and applicability for specific drugs within the same category, such as traditional Chinese medicine sustained-release tablets. Combined with the corresponding structural design of its drive and testing components, it ensures high efficiency during operation when adjustments are made for different types of drugs. Furthermore, it allows for easy movement and adjustment under different testing environments to meet varying testing requirements, effectively reducing the adverse effects of external environments on the testing process. This satisfies diverse testing needs and environments, enhancing its applicability and practicality. Attached Figure Description

[0017] Figure 1-2 This is a schematic diagram of the overall structure of a device for determining the dissolution rate of sustained-release tablets of traditional Chinese medicine according to an embodiment of this utility model.

[0018] Figure 3 This is an enlarged view of the structure of the stirring assembly on the machine head in an embodiment of this utility model.

[0019] Figure 4 This is a structural disassembly diagram of the test assembly on the base and the stirring paddle on the head in an embodiment of this utility model.

[0020] Figure Numbers: Base 100, Machine Head 101, Display Screen 1011, Control Buttons 1012, Machine Cover 102, Support Legs 103, Anti-slip Pad 1031, Test Component 1, Cup Holder 11, Groove 110, Partition 1101, Top Cover 111, Cup Body 112, Dissolution Cup 12, Outer Edge 121, pH Test Probe 13, Heating Seat 14, Stirring Component 2, Fixing Frame 21, Stirring Paddle 22, Connecting Rod 221, Slide 2211, Stirring Head 222, Stirring Blade 2221, Connecting Shaft 23, Spline Structure 231, Drive Component 24, Synchronous Belt 241, Connecting Seat 25, Adjusting Component 251, Cup Cover 3, Dosing Port 31, Sealing Cap 311, Locking Component 4, Connecting Rod 41, Locking Head 42, Locking Ring 43. Detailed Implementation

[0021] The present invention will now be described in detail with reference to the accompanying drawings and through embodiments. The following embodiments are explanations of the present invention, but the present invention is not limited to the following embodiments.

[0022] See Figure 1-3 This embodiment relates to a dissolution testing device for sustained-release tablets of traditional Chinese medicine, including a base 100 and a head 101 connected thereto, and a dissolution apparatus body formed by a test component 1 and a stirring component 2 respectively disposed on the base 100 and the head 101. The test component 1 includes a cup holder 11 and a dissolution cup 12 slidably disposed thereon. The stirring component 2 includes a fixed frame 21 disposed inside the head 101 and a stirring paddle 22 slidably disposed thereon inside the dissolution cup 12. A connecting shaft 23 acting on the periphery of the stirring paddle 22 is rotatably disposed on the fixed frame 21 located at the sliding position of the stirring paddle 22. The connecting shaft 23 is driven to rotate by a driving component 24 installed on the fixed frame 21. A connecting seat 25 is also rotatably disposed on the base 100. The connecting seat 25 is sleeved around the stirring paddle 22 and an adjusting component 251 is rotatably disposed thereon. A cup cover 3 adapted to the cup holder 11 is also slidably disposed on the stirring paddle 22. A locking component 4 for the cup cover 3 is disposed on the top of the cup holder 11.

[0023] Specifically in this embodiment, such as Figure 1 and Figure 2The overall structure of this type of traditional Chinese medicine sustained-release tablet dissolution testing equipment is shown. The main body of this dissolution apparatus adopts the conventional control structure of a single-cup dissolution apparatus. Specifically, the control panel on the head 101, the control elements inside the base 100, and the control buttons 1012 at corresponding positions on the head 101 and base 100 enable the control of the stirring assembly 2 and the testing assembly 1, and the corresponding adjustment of the testing parameters. In specific use, the dissolution cup 12 can be detached by sliding up and down through the adapter slot 110 on the cup holder 11. The solution and corresponding traditional Chinese medicine sustained-release tablets can be added and dispensed into the dissolution cup 12 according to testing needs. Further details can be found in the diagram. Figure 3 As shown, the stirring paddle 22 can slide downwards along the head 101 and be positioned within the dissolution cup 12 at the stirring position. Simultaneously, an adjusting element 251, using a bolt-on structure, is rotatably mounted on a connecting seat 25, which is fixed to the base 100 and sleeved around the stirring paddle 22. This allows for the adjustment and locking of the stirring paddle 22 at its corresponding position. After the stirring paddle 22 is adjusted, the cup lid 3 mounted on it can slide down to cover the cup seat 11 and be locked by a locking element 4. This locks the dissolution cup 12 on the cup seat 11 at the corresponding position. The locking element 4 on the cup seat 11 can use a conventional snap-fit ​​or bolt connection structure to facilitate the locking process of the cup lid 3. Furthermore, from... Figure 3As can be seen, the connecting shaft 23 and the stirring paddle 22 are connected by a spline connection structure. The stirring paddle 22 slides up and down on the connecting shaft 23 through multiple sets of sliding grooves 2211 around its periphery via spline structures 231 corresponding to the shaft body. In addition, the driving component 24, which is driven by a synchronous belt 241, drives the rotation of the connecting shaft 23 on the fixed frame 21, thereby driving the rotation of the stirring paddle 22 and the corresponding connecting seat 25 on the head 101. This achieves the stirring process of the solution in the dissolution cup 12 during the dissolution test. At the same time, the display screen 1011 and control buttons 1012 on the head 101 can control the monitoring and adjustment of the corresponding test parameters such as the rotation speed of the stirring paddle 22. Compared to traditional single-cup dissolution apparatuses, this type of dissolution apparatus features a unique structure for its stirring assembly 2 and the connection method between the stirring paddle 22 and the connecting shaft 23 and connecting seat 25 within the head 101. This design ensures the stability of the stirring paddle 22 connection while allowing for easy adjustment of the stirring paddle 22's height based on different testing requirements and the specific position of the tablets within the dissolution cup 12 during dissolution testing. Furthermore, this adjustment works in conjunction with the cup lid 3 and its locking mechanism 4 on the cup seat 11, as well as the dissolution mechanism within the cup seat 11. The corresponding structural design of the dissolution cup 12 facilitates the handling of the dissolution cup 12 and the adjustment of the solution and tablets inside. It also ensures the stability of the dissolution cup 12 within the cup holder 11 during the test, further improving the stability of the relative position between the stirring paddle 22 and the dissolution cup 12. Combined with the stirring process driven by the synchronous belt 241 to rotate the stirring paddle 22, it can further improve the stirring effect of the stirring assembly 2 and the dissolution stability of the tablets in the dissolution cup 12, effectively improving the test effect and the accuracy of the dissolution results of the test assembly 1. In addition, compared with the traditional multi-dissolution cup 12-type detector, this dissolution apparatus has a certain degree of ease of operation and flexibility of use. It has a higher testing effect and applicability for specific drugs in the same category, such as traditional Chinese medicine sustained-release tablets. Combined with the corresponding structural settings of its drive component and test component 1, it can ensure high efficiency in the operation process when making corresponding adjustments for different types of drugs. It is also convenient to move and adjust in different testing environments according to different testing requirements, effectively reducing the adverse effects of the external environment on the testing process, meeting different testing needs and testing environments, and improving applicability and practicality.

[0024] The stirring paddle 22 includes a connecting rod 221 that slides on the fixing frame 21 inside the head 101 and a stirring head 222 that can be detachably installed at its bottom. The stirring head 222 is arranged in multiple groups by several groups of stirring blades 2221 that are arranged around it and evenly distributed thereon. For details, please refer to [link to relevant documentation]. Figure 4As shown, the stirring paddle 22 slides on the connecting shaft 23 and connecting seat 25 inside the machine head 101 via the connecting rod 221. The stirring head 222 at the bottom of the connecting rod 221 adopts a threaded structure for detachable connection during rotation, which facilitates the installation, disassembly and cleaning of the stirring head 222. At the same time, multiple sets of stirring heads 222 can be replaced according to the number of stirring blades 2221 on the stirring head 222 to meet the stirring effect under different testing requirements and improve the structural flexibility of the stirring assembly 2 during use.

[0025] The cup lid 3 is also provided with a medicine inlet 31, and the medicine inlet 31 is covered with a matching cap 311, from which... Figure 3 and Figure 4 As can be seen, the setting of the drug inlet 31 on the cup lid 3 facilitates the drug addition process during the test, further improving the ease of operation. At the same time, the sealing process of the lid 311 can effectively reduce the contamination of the solution in the dissolution cup 12 caused by drug addition and other operations and external environmental factors.

[0026] The test assembly 1 also includes a pH test probe 13 disposed inside the cup holder 11 and a heating seat 14 disposed on the base 100 at the bottom of the cup holder 11. Figure 1 As can be seen, the heating seat 14 acting on the base 100 can heat the bottom of the dissolution cup 12 inside the cup holder 11 at an appropriate temperature during the test. It can heat the solution in the dissolution cup 12 at the corresponding temperature and keep the temperature constant according to different test requirements. In addition, the pH test probe set in the cup holder 11 can also detect the pH value of the corresponding solution during the dissolution of the tablet in the dissolution cup 12 in real time. At the same time, the pH value is displayed in real time through the display screen 1011 set on the head 101, thereby further improving the functional diversity of the test component 1 and improving the test effect and usage flexibility of this dissolution apparatus.

[0027] The cup holder 11 adopts a split structure, including a cup body 112 connected to the heating base 14 via a plug-in structure, and a top cover 111 plugged into it for sliding of the dissolution cup 12. The locking member 4 and the pH test probe 13 act on the top cover 111. Figure 4 As can be seen, the cup holder 11 with this split structure, which connects the cup body 112 and the top cover 111 connected to the heating base 14 via a plug-in structure, can ensure the sealing of the internal structure of the cup holder 11 during installation, while facilitating disassembly and cleaning operations on the base 100. This further improves the detachability and disassembly flexibility of the cup holder 11, meeting different usage needs.

[0028] The locking component 4 includes multiple sets of connecting rods 41 arranged around the top cover 111, a locking head 42 sleeved on the top cover 111, and a locking ring 43 rotatably mounted on the connecting rods 41 and positioned above the locking head 42. Figure 1 The locking mechanism 4 on the top cover 111 shown locks the cup lid 3. For details of the connection structure, please refer to [reference needed]. Figure 4 As shown, the locking head 42 can rotate on the connecting rod 41 on the top cover 111. During the rotation, the matching structure of the locking head 42 enables the separation and blocking of the cup lid 3 from the top cover 111. In conjunction with the locking ring 43 on the connecting rod 41, which is set above the locking head 42 with a bolt structure, the locking head 42 can be locked. The locking component 4 with this structure can not only ensure the locking effect on the cup lid 3, but also improve the convenience of the adjustment process, making it easy to adjust and disassemble.

[0029] A partition 1101 is also attached to the corresponding position of the top cover 111 for sliding the dissolution cup 12. The top of the dissolution cup 12 is provided with an outer edge 121, and the diameter of the outer edge 121 is set to be larger than the diameter of the partition 1101. Figure 4 The dissolution cup 12 shown has an outer edge 121 and a partition 1101 on the top cover 111. Specifically, the dissolution cup 12 inside the cup holder 11 is placed on the partition 1101 via the top cover 111. The placement process can be referred to... Figure 1 As shown, the partition 1101, with its structure of the outer edge 121 at the top of the dissolution cup 12, allows for a certain distance between the dissolution cup 12 and the top end face of the top cover 111. Furthermore, the setting that the diameter of the outer edge 121 is larger than the diameter of the partition 1101 facilitates the removal of the dissolution cup 12 from the cup holder 11. Additionally, the partition 1101 can be made of flexible materials such as rubber pads, which can also provide a certain buffering and shock absorption effect during the removal and fixing of the dissolution cup 12, meeting different usage requirements.

[0030] The machine head 101 and the machine base 100 are respectively covered with machine covers 102 of appropriate size, as detailed in the following figures. Figure 2 As shown, the structure of the cover 102 at the corresponding position of the machine head 101 and the machine base 100 facilitates daily inspection and subsequent maintenance of the internal stirring assembly 2, corresponding control elements and their corresponding connection lines.

[0031] The base 100 is also provided with multiple sets of support legs 103 at its bottom, and each support leg 103 has an anti-slip pad 1031 attached to its bottom. The multiple sets of support legs 103 at the bottom of the base 100 have a certain supporting effect and can prevent the bottom of the base 100 from directly contacting the ground, thus avoiding damage to the surface of the base 100 or moisture or corrosion caused by external solutions. At the same time, the anti-slip pads 1031 attached to the bottom of the support legs 103 have a certain anti-slip and shock absorption effect, thereby further improving the positional stability of this Chinese medicine sustained-release tablet dissolution tester during the dissolution test process, and thus effectively improving the working stability of the stirring component 2 and the testing component 1.

[0032] The above description in this specification is merely illustrative of the present invention. Those skilled in the art to which this invention pertains may make various modifications or additions to the described specific embodiments or use similar methods to replace them, as long as they do not depart from the content of this specification or exceed the scope defined in the claims, all of which shall fall within the protection scope of this invention.

Claims

1. A dissolution testing device for sustained-release tablets of traditional Chinese medicine, comprising a base and a head connected thereto, and a dissolution apparatus body formed by a testing component and a stirring component respectively disposed on the base and the head, characterized in that: The test assembly comprises a cup seat and a dissolution cup slidingly arranged on the cup seat, the stirring assembly comprises a fixed frame arranged in the machine head and a stirring paddle slidingly arranged in the dissolution cup, a connecting shaft rotatingly arranged on the fixed frame at the sliding position of the stirring paddle and acting on the periphery of the stirring paddle, the connecting shaft is driven to rotate by a driving component mounted on the fixed frame, a connecting seat is also rotatingly arranged on the machine base, the connecting seat is sleeved on the periphery of the stirring paddle and a regulating member is rotatingly arranged on the connecting seat, a cup cover adapted to the cup seat is also slidingly arranged on the stirring paddle, and a locking member for the cup cover is arranged on the top of the cup seat.

2. The Chinese medicine sustained-release tablet dissolution determination device according to claim 1, characterized in that: The stirring paddle comprises a connecting rod slidingly arranged on the fixed frame in the machine head and a stirring head detachably mounted on the bottom of the connecting rod, and the stirring head is arranged in multiple groups by a plurality of groups of stirring blades arranged around and uniformly distributed on the stirring head.

3. The dissolution test apparatus for traditional Chinese medicine sustained-release tablets according to claim 1, characterized in that: A medicine feeding port is also formed in the cup cover, and a cover is arranged on the medicine feeding port.

4. The dissolution test apparatus for traditional Chinese medicine sustained-release tablets according to claim 1, characterized in that: The test assembly further comprises a PH test probe arranged in the cup seat and a heating seat arranged on the machine base and acting on the cup seat.

5. The dissolution test apparatus for traditional Chinese medicine sustained-release tablets according to claim 4, characterized in that: The cup seat is arranged in a split structure, comprising a cup body connected to the heating seat by a plug-in structure and a top cover plugged with the cup body and used for sliding of the dissolution cup, and the locking member and the PH test probe act on the top cover.

6. The dissolution test apparatus for traditional Chinese medicine sustained-release tablets according to claim 5, characterized in that: The locking member comprises a plurality of connecting rods arranged around the top cover, a locking head sleeved on the connecting rods, and a locking ring rotatingly arranged on the connecting rods above the locking head.

7. The dissolution test apparatus for traditional Chinese medicine sustained-release tablets according to claim 5, characterized in that: A partition is also pasted on the top cover, and the top of the dissolution cup is provided with an outer edge with a diameter greater than that of the partition.

8. The dissolution test apparatus for traditional Chinese medicine sustained release tablets according to claim 1, characterized in that: Machine covers of appropriate sizes are respectively arranged on the machine head and the machine base.

9. The dissolution test apparatus for traditional Chinese medicine sustained release tablets according to claim 1, characterized in that: A plurality of supporting legs are also arranged on the bottom of the machine base, and anti-skid pads are pasted on the bottom of each supporting leg.

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