Telescopic support of mechanical verification device of dissolution tester

Abstract

The utility model discloses a telescopic support of a mechanical verification device of a dissolution tester, which relates to the technical field of dissolution testers and comprises a bottom support head and a support disc, the bottom support head is connected with the support disc through a support connecting rod component, and the support connecting rod component is of a telescopic structure and has a length-adjustable function. Through fixed connection of corresponding hole sites between the external members, the external members can adapt to dissolution cups of different specifications and realize measurement of swing degrees of a paddle shaft, a basket shaft and a basket; through the length-adjustable supporting connecting rod component, adjustment is carried out according to the sizes of different dissolution cups, and the device can adapt to the dissolution cups of different specifications, so that the problem that a measuring instrument cannot be effectively placed due to space limitation in the prior art is solved, and the adaptability of the device is greatly improved; a support horizontal detection part is arranged on the upper end plane of the supporting disc and used for detecting whether the support is in a horizontal state or not. The accuracy of test data is ensured, and the defect that the levelness cannot be effectively represented in the prior art is overcome.

Description

Technical Field

[0001] The utility model relates to the technical field of dissolution instruments, in particular to a telescopic bracket of a mechanical verification device of a dissolution instrument. Background Art

[0002] To ensure the accuracy and reproducibility of in vitro dissolution test data during generic drug quality and efficacy consistency evaluation, the dissolution apparatus used must meet the instrumentation requirements for Methods 1 and 2 of the General Chapter 0931 Dissolution and Release Methods in Part IV of the Chinese Pharmacopoeia. Furthermore, it must meet the technical requirements of the "Guidelines for Mechanical Validation of Drug Dissolution Apparatus." Mechanical validation of the dissolution apparatus should be performed after installation, relocation, and maintenance. This validation is typically performed every six months, but adjustments can be made based on instrument usage.

[0003] However, the mechanical validation kits currently available for dissolution apparatus suffer from several significant drawbacks. Due to the limited internal space within the dissolution vessel (inner diameter approximately 102 mm ± 4 mm), conventional measuring instruments and holders cannot be effectively placed within the vessel, limiting the ability to measure the paddle shaft, basket shaft, and basket oscillation. This necessitates switching between securing the holder to the vessel opening and placing the vessel in a water bath. Neither approach complies with the "Guidelines for Mechanical Validation of Drug Dissolution Apparatus," which mandates that the component under test be placed in its normal testing position, potentially leading to biased test results.

[0004] Existing technology, such as the bottom-supported drug dissolution apparatus disclosed in CN213956226U, uses the relative position change of two contacting inclined surfaces to transmit the swing value of the hanging basket or shaft. The change in the measuring rod and the swing value of the hanging basket or shaft are then calculated using the Pythagorean theorem. The measuring apparatus is fixed by a bottom support, with the bottom support head and the ends of the supporting connecting rod connected to pins on the bottom support head and the supporting disc, respectively, effectively ensuring the stability of the measuring apparatus. While this provides a certain solution, it still has many limitations in practical application. During the swing test, a dial indicator or related displacement sensor is required, with the measuring head directly contacting the relevant position of the dissolution apparatus to measure horizontal displacement. However, the horizontal space within the dissolution vessel is limited (the inner diameter of the dissolution vessel is 102 mm ± 4 mm), and the length of a conventional dial indicator is approximately 90 mm, making lateral measurement difficult and significantly limiting the feasibility of lateral measurement. In addition, since the test positions of the paddle shaft, basket shaft and basket swing are different, the frequent replacement of supporting connecting rods of different lengths increases the complexity and time cost of the test and affects the efficiency of the test.

[0005] Furthermore, most existing mechanical verification devices fail to effectively characterize their own levelness, further impacting the accuracy of test results. Therefore, a new solution is needed that allows the device to be placed inside the dissolution vessel for wobble testing without disrupting the normal operation of the dissolution apparatus. Utility Model Content

[0006] The problem to be solved by the utility model is that the existing mechanical verification device of the dissolution instrument has problems such as space limitation, insufficient levelness detection, and cumbersome operation. A new telescopic bracket of the mechanical verification device of the dissolution instrument is provided to adapt to dissolution cups of different specifications and improve test efficiency and accuracy.

[0007] In order to solve the above problems, the utility model provides a telescopic bracket of a dissolution instrument mechanical verification device, comprising a bottom support head and a support disc, wherein the bottom support head is connected to the support disc by a support connecting rod component, and the support connecting rod component is a telescopic structure. The support connecting rod component has the function of adjusting the length and is fixedly connected through corresponding holes between the kits to adapt to dissolution cups of different specifications and realize the measurement of the paddle shaft, basket shaft and basket swing degree; a bracket horizontal detection component is provided at the upper end plane of the support disc, and manual operation components are distributed on the side ends of the bracket horizontal detection component, and the bracket as a whole is placed in the dissolution cup or taken out from the dissolution cup through the manual operation component.

[0008] Preferably, both ends of the support link component are connected to the bottom support head and the support disc pin respectively.

[0009] Preferably, the support-link component includes a support kit and a short support rod connected to the support kit. The support kit and the short support rod both have multiple threaded adjustment holes. The threaded locking piece passes through different threaded adjustment holes to switch between the short rod mode and the long rod mode of the support-link component, so that the user can quickly adjust the length of the bracket according to the dissolution cups of different specifications. Compared with the existing technology, the user no longer needs to frequently replace support rods of different lengths. This not only simplifies the operating process, but also improves the adaptability and flexibility of the equipment, ensuring that the measuring instrument can be effectively placed in the dissolution cup.

[0010] Preferably, there are 1-10 threaded adjustment holes on the support kit and the short support rod, which can be adjusted according to different dissolution cup sizes.

[0011] Preferably, the support kit is a hollow sleeve structure, and the short support rod is inserted into the support kit. The support kit with a hollow sleeve structure and the short support rod maximize the use of limited internal space, so that the measuring device can be better placed in the dissolution cup, effectively improving the feasibility and stability of the test. Compared with traditional brackets, it can more effectively solve the problem of space limitation and ensure the effectiveness of the device in practical applications.

[0012] Preferably, the bracket level detection component is a liquid level bubble structure or an electronic sensor. The liquid level bubble structure can be 1-4. The level detection component can monitor the horizontal state of the bracket in real time. This improvement ensures the accuracy of the test data, overcomes the common defect in the prior art that it cannot effectively characterize its own levelness, and reduces the measurement error caused by incorrect level.

[0013] Preferably, the manual operating component is a handheld lifting structure, which can be provided in groups of three or six. The configuration of multiple handheld lifting structures enhances user convenience during operation, making it easier for the user to install and remove the telescopic bracket from the dissolution vessel, further improving the user experience. Compared to the single operation method of the prior art, this provides greater flexibility, particularly in adapting to user needs in different operating environments.

[0014] Preferably, the manual operating component includes a positioning protrusion. The side ends of the support disc are each provided with an inwardly disposed dovetail groove. The positioning protrusion is fixedly mounted within the dovetail groove. A U-shaped handle is fixedly mounted on the upper end of the positioning protrusion. The positioning protrusion is fixed within the dovetail groove, effectively ensuring the stability and safety of the bracket during use and preventing accidental loosening during operation. Compared to existing fixing methods, this improves the overall structural firmness and ensures the reliability and safety of the device under different operating conditions.

[0015] Compared with the prior art, the present invention has the following beneficial technical effects:

[0016] The telescopic bracket of the utility model can be adjusted according to different dissolution cup sizes through the adjustable length support connecting rod component, and can adapt to dissolution cups of different specifications, thereby solving the problem of the existing technology that cannot effectively place measuring instruments due to space limitations, and greatly improving the adaptability of the equipment. Compared with the complex operation of the existing dissolution instrument mechanical verification device that requires frequent replacement of support connecting rods of different lengths, the utility model realizes the switching between short rod mode and long rod mode through the support connecting rod component, which greatly reduces the complexity and time cost of operation, allowing users to perform tests more quickly and conveniently. By reducing the time of bracket replacement and simplifying the operation process, the utility model significantly improves the efficiency of mechanical verification, ensures that the dissolution instrument can perform swing degree testing under normal operating conditions, and avoids the cumbersome steps and potential errors in traditional methods.

[0017] The utility model is provided with a support level detection component on the upper end plane of the support disc, which is used to detect whether the support is in a horizontal state, thereby ensuring the accuracy of the test data and overcoming the defect of the prior art that the levelness of the support cannot be effectively represented. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 This is a schematic diagram of the structure of the telescopic bracket of the mechanical verification device of the dissolution instrument of the present utility model.

[0019] Figure 2 This is a side view schematic diagram of the telescopic bracket of the mechanical verification device of the dissolution apparatus of the present invention.

[0020] Figure 3 This is a side view of another embodiment of the telescopic bracket of the mechanical verification device of the dissolution apparatus of the present invention.

[0021] Figure 4 This is a top view schematic diagram of the telescopic bracket of the mechanical verification device of the dissolution apparatus of the present invention.

[0022] In the figure: 1- bottom support head, 2- support disc, 201- dovetail groove, 3- support connecting rod component, 301- support kit, 302- short support rod, 303- threaded adjustment hole, 304- threaded locking piece, 4- bracket horizontal detection component, 5- manual operation component, 501- positioning protrusion, 502- U-shaped handheld part. DETAILED DESCRIPTION

[0023] The present invention will be further explained below with reference to the accompanying drawings and embodiments.

[0024] Reference Figure 1-Figure 4 As shown, the utility model provides a telescopic bracket of a dissolution instrument mechanical verification device, including a bottom support head 1 and a support disc 2, and the two ends of the support connecting rod component 3 are pin-connected to the bottom support head 1 and the support disc 2 respectively, and the support connecting rod component 3 is a telescopic structure, and the support connecting rod component 3 has the function of adjusting the length, and is fixedly connected through the corresponding holes between the kits to adapt to dissolution cups of different specifications and realize the measurement of the paddle shaft, basket shaft and basket swing degree; through the adjustable length support connecting rod component 3, it can be adjusted according to different dissolution cup sizes, and can adapt to dissolution cups of different specifications, thereby solving the problem in the existing technology that measuring instruments cannot be effectively placed due to space limitations, and greatly improving the adaptability of the equipment; compared with the complex operation of the existing dissolution instrument mechanical verification device that requires frequent replacement of support connecting rods of different lengths, the utility model realizes the switching between short rod mode and long rod mode through the support connecting rod component, which greatly reduces the complexity and time cost of the operation, allowing users to perform tests more quickly and conveniently. By reducing the time for bracket replacement and simplifying the operation process, the utility model significantly improves the efficiency of mechanical verification, ensures that the dissolution apparatus performs the swing test under normal operating conditions, and avoids the cumbersome steps and potential errors in traditional methods.

[0025] A support level detection component 4 is provided on the upper surface of the support disc 2. This feature ensures the accuracy of test data and overcomes the drawback of prior art systems that lacks effective self-leveling. Manual operating components 5 are located on each side of the support level detection component 4, which are used to place the entire support into or remove it from the dissolution vessel.

[0026] The support link assembly 3 includes a support sleeve 301 and a short support rod 302 connected to the support sleeve 301. Both the support sleeve 301 and the short support rod 302 have multiple threaded adjustment holes 303. A threaded locking member 304 passes through different threaded adjustment holes 303 to switch the support link assembly 3 between short and long rod modes. When the hole in the short support rod 302 is aligned with the top hole in the support sleeve 301 and secured with the threaded locking member 304, the support is in the short rod mode. When the hole in the short support rod 302 is aligned with the bottom hole in the support sleeve 301 and secured with the threaded locking member 304, the support is in the long rod mode. This allows users to quickly adjust the length of the support to suit different dissolution vessels. Compared to existing technologies, users no longer need to frequently change support rods of different lengths. This not only simplifies the operating process, but also improves the adaptability and flexibility of the equipment, ensuring that the measuring instrument can be effectively placed in the dissolution vessel.

[0027] There are 1-10 threaded adjustment holes 303 on the support kit and the short support rod 302, which can be adjusted according to different dissolution cup sizes.

[0028] The support kit 301 has a hollow sleeve structure, and the short support rod 302 is inserted into the support kit 301. The hollow sleeve structure of the support kit and the short support rod 302 maximize the use of the limited internal space, allowing the measuring device to be better placed in the dissolution cup, effectively improving the feasibility and stability of the test. Compared with traditional brackets, it can more effectively solve the problem of space limitations and ensure the effectiveness of the device in practical applications.

[0029] The bracket level detection component 4 is a liquid level bubble structure or an electronic sensor. The liquid level bubble structure can be 1-4. The level detection component can monitor the horizontal state of the bracket in real time. This improvement ensures the accuracy of the test data, overcomes the common defect in the existing technology that it cannot effectively characterize its own levelness, and reduces the measurement error caused by incorrect level.

[0030] Manual operating member 5 is a handheld lifting mechanism, which can be configured in groups of three or six. Multiple handheld lifting mechanisms enhance user convenience during operation, making it easier for the user to install and remove the telescopic bracket from the dissolution vessel, further improving the user experience. Compared to the single operation method of the existing technology, this provides greater flexibility, especially in different operating environments, and can more effectively adapt to user needs.

[0031] The manual operating member 5 includes a positioning protrusion 501. The support disc 2 is provided with inwardly-oriented dovetail grooves 201 on each side. The positioning protrusion 501 is fixedly mounted within the dovetail grooves 201. A U-shaped handle 502 is fixedly mounted on the upper end of the positioning protrusion 501. This positioning protrusion's securement within the dovetail groove effectively ensures the stability and safety of the bracket during use, preventing accidental loosening during operation. Compared to existing fixing methods, this improves the overall structural robustness, ensuring the reliability and safety of the device under various operating conditions.

[0032] The connecting threaded locking member 304 connecting the short support rod 302 and the support kit 301 is a set screw or a hand screw to achieve tool-free fixation.

[0033] The number of the support kits 301 and the short support rods 302 can be 3 sets, 6 sets, 9 sets, or 12 sets.

[0034] The support kit 301 enables it to be adapted to different sized dissolution vessels, and the size is adjustable to accommodate a standard 1L dissolution vessel as well as various volume dissolution vessels such as 100mL, 200mL, 250mL, 350mL, 500mL, 2L, and 4L.

[0035] The support kits 301 and the short support rods 302 are combined into 3 sets, 6 sets, 9 sets or 12 sets to meet different testing requirements.

[0036] In order to facilitate understanding of the above technical solutions of the present invention, the above technical solutions of the present invention are described in detail below through specific usage methods.

[0037] In the figure: 1 bottom support head, 2 support disc, 201 dovetail groove, 3 support connecting rod component, 301 support kit, 302 short support rod, 303 threaded adjustment hole, 304 threaded locking piece, 4 bracket level detection component, 5 manual operation component, 501 positioning protrusion, 502 U-shaped handheld part.

[0038] The specific working process is as follows: During use, according to the specifications of the dissolution vessel, the operator selects the appropriate adjustment hole position and determines the length of the support link component 3. The support is secured with the threaded lock 304 to ensure stability. The operator loosens the threaded lock 304, slides the short support rod 302 into the support sleeve 301, selects the appropriate hole position to adjust the support length, and re-tightens the threaded lock 304 after the length is adjusted. The operator then places the entire support into the dissolution vessel and uses the handheld lifting mechanism in the manual operation component 5 to easily lift and adjust the support position to ensure that the support disc 2 is in full contact with the bottom of the dissolution vessel. The operator then observes the support level detection component 4 on the support disc 2. If a liquid level bubble structure is used, the bubble is ensured to be in the middle position; if an electronic sensor is used, the displayed value is ensured to be zero. If necessary, the position of the support disc 2 is adjusted to ensure that the entire support is level. After confirming that the support is secure, the operator can connect the corresponding measuring instrument, such as a dial indicator or displacement sensor, to the support disc 2 to begin testing the paddle shaft, basket shaft, and basket swing. During the test, the operator monitors the measurement results and ensures that the bracket remains stable and level throughout the test. After the test, the operator records the test data and analyzes it to ensure compliance with the "Guidelines for Mechanical Validation of Drug Dissolution Apparatus." If any data anomalies are detected, the operator can readjust the bracket and test again until accurate results are obtained. After the test, the operator easily removes the bracket from the dissolution vessel to avoid damage to the dissolution apparatus and the bracket itself. The bracket is then cleaned to ensure it remains in good condition for the next use.

[0039] In the description of the present invention, it should be noted that the terms "upper" and "lower" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. Unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be internal communication between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0040] It should be noted that, in the present invention, relational terms such as "first" and "second" are merely used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply the existence of any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device that includes a series of elements includes not only those elements, but also other elements that are not explicitly listed, or also includes elements that are inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "includes a..." does not exclude the presence of other identical elements in the process, method, article or device that includes the element.

[0041] The foregoing description is intended only to provide specific embodiments of the present invention, intended to enable those skilled in the art to understand and implement the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not intended to be limited to the embodiments shown herein, but rather to conform to the broadest scope consistent with the principles and novel features of the present invention described herein.

[0042] This implementation process is only for explaining the technical idea of ​​the utility model and cannot be used to limit the protection scope of the utility model. Any modifications made on the basis of this technical solution in accordance with the technical idea proposed by the utility model shall fall within the protection scope of the utility model.

Claims

1. A telescopic bracket for a dissolution instrument mechanical verification device, comprising a bottom support head (1) and a support disc (2), wherein the bottom support head (1) and the support disc (2) are connected via a support connecting rod component (3), characterized in that: The supporting connecting rod component (3) is a telescopic structure, and the supporting connecting rod component (3) has the function of adjusting the length. It is fixedly connected through the corresponding holes between the sets to adapt to dissolution cups of different specifications and realize the measurement of the paddle shaft, basket shaft and basket swing degree; the upper end plane of the supporting disc (2) is provided with a bracket horizontal detection component (4), and the side ends of the bracket horizontal detection component (4) are all provided with manual operation components (5), and the bracket as a whole is placed in the dissolution cup or taken out from the dissolution cup through the manual operation component (5).

2. The telescopic bracket of the dissolution instrument mechanical verification device according to claim 1, characterized in that: The two ends of the support connecting rod component (3) are respectively connected to the bottom support head (1) and the support disc (2) by pins.

3. The telescopic bracket of the dissolution instrument mechanical verification device according to claim 2, characterized in that: The supporting connecting rod component (3) comprises a supporting kit (301) and a short supporting rod (302) connected to the supporting kit (301); the supporting kit (301) and the short supporting rod (302) both have a plurality of threaded adjustment holes (303); and the threaded locking member (304) passes through different threaded adjustment holes (303) to switch between a short rod mode and a long rod mode of the supporting connecting rod component (3).

4. The telescopic bracket of the dissolution apparatus mechanical verification device according to claim 3, characterized in that: The support kit (301) is a hollow sleeve structure, and the short support rod (302) is inserted into the support kit (301).

5. The telescopic bracket of the mechanical verification device of the dissolution apparatus according to claim 1, characterized in that: The support level detection component (4) is a liquid level bubble structure or an electronic sensor.

6. The telescopic bracket of the dissolution apparatus mechanical verification device according to claim 1, characterized in that: The manual operating component (5) is a handheld lifting structure.

7. The telescopic bracket of the dissolution apparatus mechanical verification device according to claim 4, characterized in that: The manual operating component (5) comprises a positioning convex portion (501), and the side ends of the support disc (2) are uniformly provided with inwardly arranged dovetail grooves (201), the positioning convex portion (501) is fixedly arranged in the dovetail groove (201), and a U-shaped hand-held portion (502) is fixedly provided at the upper end of the positioning convex portion (501).

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