Drug dissolution testing device
By introducing a stirring and liquid extraction mechanism into the dissolution test device, the gastrointestinal peristalsis is simulated and the solution is quantitatively extracted, the detection deviation problem of existing devices during high-frequency sampling is solved, and the accuracy and reliability of dissolution test are improved. .
Patent Information
- Application Number
- CN202411558294.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-11-04
- Publication Date
- 2025-01-10
AI Technical Summary
It is difficult for the existing dissolution test device to quantitatively extract the drug solution inside the dissolution cup during high frequency sampling, resulting in a deviation in the detection result.
A drug dissolution test device is designed, including a stirring mechanism and a liquid extraction mechanism. The agitator drives the worm and spline shaft through a motor to drive the stirring paddle to rotate in a fixed axis to simulate gastrointestinal peristalsis; the liquid extraction mechanism passes through negative pressure The positive pressure and air pressure drive the inlet pipe to quantitatively extract the solution, and use the optical fiber UV probe to detect the drug concentration in real time.
Quantitative extraction and real-time detection of drug solutions inside the dissolution cup are realized, which improves the accuracy and physiological correlation of dissolution tests, reduces drug precipitation and evaporation, and enhances data reliability.
Smart Images

Figure CN119290764A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the technical field of drug dissolution testing, in particular to a drug dissolution testing device. Background Art
[0002] Drug dissolution refers to the rate and extent of dissolution of active drug ingredients from solid preparations such as tablets, capsules or granules under specified conditions. It is one of the important indicators for evaluating the quality of oral solid preparations of drugs, and is also an indispensable link in drug research and development, production and quality control. The dissolution test provides a simple and effective in vitro evaluation method by simulating the disintegration and dissolution process of drugs in the human gastrointestinal tract. The dissolution behavior of drugs directly affects their bioavailability. Therefore, the determination of dissolution is of great significance to ensure the efficacy and safety of drugs.
[0003] At present, the commonly used dissolution determination method is to place a specified amount of preparation into the dissolution cup of the dissolution instrument, control a specific rotation speed in a constant temperature environment of 37℃±0.5℃, and operate in a specified dissolution medium. Within a predetermined time, samples are taken according to the standard process and the amount of drug dissolved is determined. This process effectively simulates the dissolution behavior of oral solid preparations in the gastrointestinal tract and provides reference data for drug quality evaluation.
[0004] The existing Chinese patent with publication number CN106442904B includes a base, four adjusting bolts are arranged on the edge of the base, a reference block is arranged on the base, a level bubble is arranged on the reference block, a cylindrical boss and a heating box are arranged on the top of the base, an annular water bath is arranged on the cylindrical boss, an annular cover is arranged on the top of the annular water bath, a lifting mechanism is arranged on the cylindrical boss, a cylindrical shell is arranged on the top of the lifting mechanism, a driving motor is arranged on the top of the cylindrical shell, a plurality of rotating shafts are arranged in an annular array on the cylindrical shell, a stirring paddle is arranged at the bottom of the rotating shaft, and a dissolution cup is arranged in the annular water bath.
[0005] When the above device is in use, the driving motor can drive multiple shafts to rotate through the bevel gear transmission, which can ensure the consistency of the stirring speed in multiple dissolution cups in the annular water bath, and can avoid the interference caused by the different rotation speeds of the shafts in different dissolution cups. The positioning block cooperates with the positioning hole to avoid the displacement of the dissolution cup during the inspection. However, in actual use, personnel are usually required to take samples of the dissolution of the drug. When sampling at a high frequency, it is easy to cause deviations in the sampling time and sample amount, which affects the test results of the drug dissolution. Therefore, it is difficult to quantitatively extract and test the drug solution inside the dissolution cup.
[0006] For this purpose, we proposed a drug dissolution test device. Summary of the invention
[0007] The object of the present invention is to provide a drug dissolution test device, which has the advantages of quantitatively extracting and detecting the drug solution inside the dissolution cup, and solves the problems in the background technology.
[0008] To achieve the above-mentioned purpose, the present invention provides the following technical solutions: a drug dissolution test device, comprising a base placed on the ground, a heating box fixedly connected to the base, a plurality of evenly distributed holes and grooves are provided on the heating box, a dissolution cup for testing the drug dissolution is movably connected to the inner wall of each hole and groove, a limiting ring for supporting the dissolution cup and placing it on the inner wall of the hole and groove is fixedly connected to the outer contour of each dissolution cup near the end, a positioning block is fixedly connected to the symmetrical positions on both sides of the bottom of each limiting ring, and positioning holes matching the outer contour of the positioning block are provided at positions corresponding to the positioning blocks on the heating box, a rectangular shell is fixedly connected to one side of the base through an external bracket, and a stirring mechanism for stirring the solution inside the dissolution cup and a liquid extraction mechanism for detecting the dissolution of the drug inside the dissolution cup are provided on the rectangular shell.
[0009] Preferably, the stirring mechanism includes a spline sleeve that penetrates and is rotatably connected to a position corresponding to the dissolution cup on a rectangular shell, the inner wall of each spline sleeve is movably connected to a spline shaft rod that can perform lifting and reciprocating movements, and the outer contour of the bottom end of each spline shaft rod is fixedly connected to a stirring paddle that stirs the solution inside the dissolution cup.
[0010] Preferably, both ends of the rectangular shell are penetrated and fixedly rotatably connected with a worm driven by a power mechanism, and a worm wheel meshing with the worm is fixedly connected to the outer contour of each spline sleeve, and the above-mentioned power mechanism is an electric motor after power is supplied.
[0011] Preferably, the rectangular shell is provided with an auxiliary mechanism for pulling the spline shaft for lifting and reciprocating adjustment, the auxiliary mechanism includes T-shaped blocks fixedly connected to the corresponding positions of the spline shaft sleeves on the rectangular shell through external brackets, the T-shaped blocks are penetrated and rotatably connected with threaded sleeves, the inner wall of each threaded sleeve is screwed with a threaded rod for lifting and reciprocating movement, and the bottom ends of the threaded rods are coaxially fixed to the spline shafts at the corresponding positions.
[0012] Preferably, each of the T-shaped blocks is provided with a cavity on one side close to the threaded sleeve, the inner wall of the cavity is movably connected with a locking block for locking the threaded sleeve, and the outer contour of the threaded sleeve is provided with a locking groove adapted to the locking block, and each of the locking blocks is fixedly connected to the opposite surface of the cavity with a first spring for guiding the locking block to reset.
[0013] Preferably, the T-shaped block is provided with an unlocking mechanism for pulling the locking block to unlock the threaded sleeve, and the unlocking mechanism includes a movable plate that is penetrated and movably connected to one side of each of the T-shaped blocks close to the locking block for lifting and reciprocating movement, each of the movable plates is provided with an inclined groove that drives the locking block to move horizontally reciprocatingly, and the inner wall of the inclined groove is movably connected with a slider that supports the locking block, and each of the sliders is fixedly connected to the locking block at the corresponding position, and each end of the threaded rod is fixedly connected to a circular plate that enables the movable plate to pull the locking block to unlock the threaded sleeve.
[0014] Preferably, a cover plate for sealing the dissolution cup is rotatably connected to the outer contour of each spline shaft near one end of the stirring paddle, and a second spring for supporting the cover plate is fixedly connected to the corresponding part of each cover plate and the rectangular shell.
[0015] Preferably, the liquid extraction mechanism includes a rectangular shell on one side of which the side close to the movable plate is penetrated and fixedly connected with a cylindrical shell, the inner wall of each of the cylindrical shells is movably connected with a piston plate for axial reciprocating movement, each of the piston plates is penetrated and movably connected with a liquid inlet tube for extracting the solution inside the dissolution cup, and the piston plates are fixedly connected with optical fiber UV probes for detecting the dissolution rate of the drug.
[0016] Preferably, a cylindrical block is fixedly connected to the outer contour of each spline sleeve near the bottom end, a cam groove is opened on the outer contour of each cylindrical block for pulling the liquid inlet pipe to move up and down and reciprocate, and a moving block is fixedly connected to the outer contour of each liquid inlet pipe near the cylindrical block, and one end of each moving block away from the liquid inlet pipe is respectively penetrated to the inner wall of the cam groove on the adjacent side and is movably connected.
[0017] Compared with the prior art, the present invention has the following beneficial effects: First, the motor can drive the worm to perform fixed-axis reciprocating rotation on the rectangular housing, and the worm wheel can drive the spline shaft and the stirring paddle to synchronously perform fixed-axis reciprocating rotation under the action of the worm. When the spline shaft rotates clockwise, the spline shaft drives the stirring paddle to move in the vertical direction close to the dissolution cup under the action of the threaded rod and the threaded sleeve. When the threaded rod drives the spline shaft and the stirring paddle to move to the inner wall of the dissolution cup, the circular plate contacts and moves with the moving plate under the action of the threaded rod, so that the moving plate moves in the vertical direction close to the spline shaft sleeve under the push of the circular plate, and the slider is pulled under the action of the inclined groove. The movable locking block moves in a direction away from the threaded sleeve, and the first spring is squeezed and contracted under the action of the locking block, so that the locking block can move and disengage from the locking groove, and the threaded sleeve is in an unlocked state, so that the threaded rod can drive the threaded sleeve to rotate synchronously, so that the spline shaft can drive the stirring paddle to rotate to stir the solution inside the dissolution cup. The liquid flow generated by the stirring can simulate the peristalsis and stirring action in the gastrointestinal tract, making the dissolution process closer to the actual situation in the human body, while ensuring the uniform flow of the solution, reducing the situation where the local drug concentration is too high or too low, avoiding the drug from precipitating at the bottom of the dissolution cup, and improving the reliability of the data.
[0018] Second, in the initial state, the second spring is in a contracted state. When the spline shaft drives the stirring paddle to move to the inner wall of the dissolution cup for stirring, the cover plate can move synchronously with the spline shaft under the elastic force of the second spring to cover the dissolution cup, thereby preventing the solution inside the dissolution cup from overflowing during stirring and preventing the solution inside the dissolution cup from evaporating.
[0019] 3. When the liquid inlet tube and the piston plate move toward the direction approaching the dissolution cup, the end of the liquid inlet tube away from the piston plate moves into the solution inside the dissolution cup. At this time, the air pressure inside the cylindrical shell is in a negative pressure state, so that the liquid inlet tube can quantitatively extract the solution inside the dissolution cup to the inner wall of the cylindrical shell, so that the optical fiber UV probe contacts the solution inside the cylindrical shell, and then the optical fiber UV probe can detect the drug concentration in the solution. When the liquid inlet tube and the piston plate move toward the direction away from the dissolution cup, the air pressure inside the cylindrical shell is positive pressure, which can enable the liquid inlet tube to discharge the solution inside the cylindrical shell into the solution inside the dissolution cup. At the same time, the solution inside the dissolution cup has a rolling flow effect, which further simulates the peristaltic movement of the gastrointestinal tract, improves the physiological relevance of the experiment, and enhances the accuracy of the dissolution test. As the liquid inlet tube moves up and down and back and forth, it can extract and detect the solution inside the dissolution cup at a uniform speed. At the same time, the optical fiber UV probe can remotely transmit the monitoring data to an external display device, realizing real-time detection of the dissolution of the drug inside the dissolution cup at different time points.
[0020] The coordinated use of the above-mentioned structure solves the problem that, in actual use of the existing device, personnel are usually required to take samples for the dissolution of the drug. When sampling at a high frequency, deviations in the sampling time and sample amount are likely to occur, affecting the test results of the drug dissolution, making it difficult to quantitatively extract and test the drug solution inside the dissolution cup. BRIEF DESCRIPTION OF THE DRAWINGS
[0021] Figure 1 It is a schematic diagram of the three-dimensional structure of the present invention; Figure 2 It is a cross-sectional schematic diagram of the three-dimensional structure of the present invention; Figure 3 It is a schematic cross-sectional view of the three-dimensional structure of the dissolution cup of the present invention; Figure 4 For the present invention Figure 2 Schematic diagram of the structure at A in the middle; Figure 5 For the present invention Figure 3 Schematic diagram of the structure at B in the middle; Figure 6 It is a schematic cross-sectional view of the three-dimensional structure of the T-shaped block of the present invention; Figure 7 It is a cross-sectional schematic diagram of the three-dimensional structure of the cylindrical shell of the present invention; Figure 8 This is a schematic diagram of the three-dimensional structure of the slider of the present invention; Fig. 9 It is a schematic diagram of the three-dimensional structure of the heating box of the present invention.
[0022] In the figure: 1, base; 2, heating box; 201, hole groove; 202, positioning hole; 3, dissolution cup; 4, limit ring; 5, positioning block; 6, rectangular shell; 7, spline shaft sleeve; 8, spline shaft rod; 9, stirring paddle; 10, worm gear; 11, worm; 12, T-block; 121, cavity; 13, threaded sleeve; 131, locking groove; 14, threaded rod; 15, locking block; 16, first spring; 17, moving plate; 171, inclined groove; 18, slider; 19, circular plate; 20, cover plate; 21, second spring; 22, cylindrical shell; 23, piston plate; 24, liquid inlet pipe; 25, cylindrical block; 251, cam groove; 26, moving block; 27, optical fiber UV probe. DETAILED DESCRIPTION
[0023] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Embodiment 1:
[0024] See also Figures 1 to 9 The present invention provides a technical solution: a drug dissolution test device, comprising a base 1 placed on the ground, a heating box 2 is fixedly connected to the base 1, a plurality of evenly distributed holes 201 are provided on the heating box 2, a dissolution cup 3 for testing drug dissolution is movably connected to the inner wall of each hole 201, a limiting ring 4 for supporting the dissolution cup 3 and placing it on the inner wall of the hole 201 is fixedly connected to the outer contour of each dissolution cup 3 near the end, a positioning block 5 is fixedly connected to the symmetrical positions on both sides of the bottom of each limiting ring 4, and positioning holes 202 adapted to the outer contour of the positioning block 5 are provided at positions corresponding to the positioning blocks 5 on the heating box 2, a rectangular shell 6 is fixedly connected to one side of the base 1 through an external bracket, and a stirring mechanism for stirring the solution inside the dissolution cup 3 and a liquid extraction mechanism for detecting the dissolution of the drug inside the dissolution cup 3 are provided on the rectangular shell 6.
[0025] When in use, by setting the base 1, first the base 1 is placed on a flat ground or desktop, which improves the stability of the experimental device. The heating box 2 is fixedly supported on the base 1 through the heating box 2 set on the base 1. At the same time, the base 1 heats the internal temperature to a constant temperature of 37°C to simulate the body temperature of the human body. Through the hole groove 201 opened on the heating box 2 and the dissolution cup 3 set on the hole groove 201, the dissolution cup 3 can be placed on the inner wall of the heating box 2 through the hole groove 201, and the limiting ring 4 is set on the dissolution cup 3, so that the limiting ring 4 can support the position of the dissolution cup 3. Through the positioning hole 202 opened on the heating box 2 and the positioning block 5 set on the limiting ring 4, the positioning block 5 on the limiting ring 4 is moved and placed on the inner wall of the positioning hole 202, which improves the stability of the dissolution cup 3 and avoids the displacement of the drug in the dissolution cup 3 during the dissolution process.
[0026] The rectangular shell 6 is arranged on the base 1, and the rectangular shell 6 is fixedly supported on the base 1 by an external bracket, so that the rectangular shell 6 is located at a corresponding position on the top of the dissolution cup 3. The drug is first put into the solution inside the dissolution cup 3 through the stirring mechanism and the liquid pumping mechanism arranged on the rectangular shell 6, so that the stirring mechanism can ensure that the solution inside the dissolution cup 3 flows evenly to simulate the movement of the gastrointestinal tract. At the same time, the liquid pumping mechanism can uniformly extract the solution inside the dissolution cup 3 for dissolution detection to monitor the dissolution of the drug at different time points.
[0027] By setting up multiple dissolution cups 3, multiple dissolution cups 3 can test multiple drugs or different batches of the same drug at the same time, reducing the test time and being used to evaluate the dissolution of the same drug in different batches or multiple drugs, which is beneficial to comparison and analysis and improves the reliability of the results. Embodiment 2:
[0028] On the basis of the first embodiment, further: The stirring mechanism includes a spline sleeve 7 that penetrates and is rotatably connected to the position corresponding to the dissolution cup 3 on the rectangular shell 6, and the inner wall of each spline sleeve 7 is movably connected to a spline shaft 8 that can move up and down and reciprocate, and the outer contour of the bottom end of each spline shaft 8 is fixedly connected to a stirring paddle 9 that stirs the solution inside the dissolution cup 3.
[0029] The two ends of the rectangular shell 6 are penetrated and fixedly connected to a worm 11 driven by a power mechanism. A worm wheel 10 meshing with the worm 11 is fixedly connected to the outer contour of each spline sleeve 7. The power mechanism is an energized motor.
[0030] When in use, the spline sleeve 7 provided on the rectangular shell 6 passes through the rectangular shell 6 and is rotatably connected. The spline shaft 8 provided on the spline sleeve 7 and the stirring paddle 9 provided on the spline shaft 8 enable the spline shaft 8 to drive the stirring paddle 9 to be lifted and reciprocated on the inner wall of the spline sleeve 7. The worm 11 provided on the rectangular shell 6 is driven to rotate by a motor, so that the motor can drive the worm 11 to perform fixed-axis reciprocating rotation on the rectangular shell 6.
[0031] By means of the worm wheel 10 arranged on the spline shaft sleeve 7, and the meshing transmission between the worm wheel 10 and the worm 11, along with the fixed-axis reciprocating rotation of the worm 11, the worm wheel 10 can drive the spline shaft 8 and the stirring paddle 9 to synchronously reciprocate on a fixed axis under the action of the worm 11, so as to facilitate the subsequent stirring of the solution inside the dissolution cup 3. Embodiment three:
[0032] On the basis of the second embodiment, further: The rectangular shell 6 is provided with an auxiliary mechanism for pulling the spline shaft 8 for lifting and reciprocating adjustment. The auxiliary mechanism includes T-blocks 12 fixedly connected to the corresponding positions of the spline shaft sleeve 7 on the rectangular shell 6 through external brackets, and threaded sleeves 13 are penetrated and rotatably connected to the T-blocks 12. The inner wall of each threaded sleeve 13 is screwed with a threaded rod 14 for lifting and reciprocating movement, and the bottom ends of the threaded rods 14 are coaxially fixed to the spline shaft 8 at the corresponding positions.
[0033] A cavity 121 is provided on one side of each T-shaped block 12 close to the threaded sleeve 13, and a locking block 15 for locking the threaded sleeve 13 is movably connected to the inner wall of the cavity 121, and a locking groove 131 adapted to the locking block 15 is provided on the outer contour of the threaded sleeve 13, and a first spring 16 for guiding the locking block 15 to reset is fixedly connected to the opposite surface of each locking block 15 and the cavity 121.
[0034] When in use, the T-shaped block 12 provided on the rectangular shell 6 is fixedly supported on the rectangular shell 6 through an external bracket, and the threaded sleeve 13 provided on the T-shaped block 12 is rotatably connected to the inner wall of the T-shaped block 12. Through the cavity 121 opened on the T-shaped block 12 and the locking block 15 provided on the cavity 121, the cavity 121 supports the moving direction of the locking block 15. Through the first spring 16 provided on the T-shaped block 12 and the locking groove 131 provided on the threaded sleeve 13, the locking block 15 can be moved to the inner wall of the locking groove 131 under the elastic force of the first spring 16, so that the locking block 15 locks the threaded sleeve 13.
[0035] By means of the threaded rod 14 provided on the threaded sleeve 13, and the threaded rod 14 being coaxially fixedly connected with the spline shaft 8, the spline shaft 8 performs fixed-axis reciprocating rotation, and then the threaded rod 14 drives the spline shaft 8 to perform lifting and reciprocating movement under the action of the threaded sleeve 13. When the spline shaft 8 rotates clockwise, the spline shaft 8 drives the stirring paddle 9 to move in the vertical direction close to the dissolution cup 3 under the action of the threaded rod 14 and the threaded sleeve 13, so as to facilitate the subsequent movement of the stirring paddle 9 to the inner wall of the dissolution cup 3 to stir the solution. When the spline shaft 8 rotates counterclockwise, the spline shaft 8 can drive the stirring paddle 9 to reset in the vertical direction away from the dissolution cup 3, and can move the stirring paddle 9 away from the inner wall of the dissolution cup 3, so as to facilitate personnel to take and place the dissolution cup 3 inside the hole groove 201. Embodiment 4:
[0036] On the basis of the third embodiment, further: The T-shaped block 12 is provided with an unlocking mechanism for pulling the locking block 15 to unlock the threaded sleeve 13. The unlocking mechanism includes a movable plate 17 that is penetrated and movably connected to one side of each T-shaped block 12 close to the locking block 15 and performs lifting and reciprocating movement. Each movable plate 17 is provided with an inclined groove 171 that drives the locking block 15 to perform horizontal reciprocating movement. The inner wall of the inclined groove 171 is movably connected with a slider 18 that supports the locking block 15. Each slider 18 is fixedly connected to the locking block 15 at the corresponding position. The end of each threaded rod 14 is fixedly connected to a circular plate 19 that enables the movable plate 17 to pull the locking block 15 to unlock the threaded sleeve 13.
[0037] When in use, the movable plate 17 provided on the T-shaped block 12 is lifted and moved on the T-shaped block 12, and at the same time, the movable plate 17 is communicated with the inner wall of the cavity 121, through the inclined groove 171 opened on the movable plate 17, and the slider 18 provided on the inclined groove 171, along with the slider 18 being fixedly connected with the locking block 15, the slider 18 supports the position of the locking block 15 under the action of the inclined groove 171.
[0038] By means of the circular plate 19 arranged on the threaded rod 14, as the spline shaft 8 rotates clockwise, the spline shaft 8 drives the stirring paddle 9 to move in the vertical direction close to the dissolution cup 3 under the action of the threaded rod 14 and the threaded sleeve 13. When the threaded rod 14 drives the spline shaft 8 and the stirring paddle 9 to move to the inner wall of the dissolution cup 3, the circular plate 19 contacts and moves with the moving plate 17 under the action of the threaded rod 14, so that the moving plate 17 moves in the vertical direction close to the spline shaft sleeve 7 under the push of the circular plate 19, and the slider 18 pulls the locking block 15 in the direction away from the threaded sleeve 13 under the action of the inclined groove 171. The first spring 16 is squeezed and contracted under the action of the locking block 15, so that the locking block 15 can move and disengage from the locking groove 131, and the threaded sleeve 13 is in an unlocked state, so that the threaded rod 14 can drive the threaded sleeve 13 to rotate synchronously, so that the spline shaft 8 can drive the stirring paddle 9 to rotate to stir the solution inside the dissolution cup 3. The liquid flow generated by the stirring can simulate the peristalsis and stirring action in the gastrointestinal tract, so that the dissolution process is closer to the actual situation in the human body, and at the same time ensures the uniform flow of the solution, reduces the situation where the local drug concentration is too high or too low, avoids the drug from precipitating at the bottom of the dissolution cup 3, and improves the reliability of the data.
[0039] like Figure 2 , Figure 3 , Figure 6 As shown, when the test is completed, along with the counterclockwise rotation of the spline shaft 8, the locking block 15 is reset and moved toward the direction close to the threaded sleeve 13 under the elastic force of the first spring 16, and the slider 18 can drive the movable plate 17 to reset and move in the direction away from the rectangular shell 6 under the action of the inclined groove 171, and when the locking block 15 moves to the inner wall of the locking groove 131 for locking, the threaded rod 14 can drive the spline shaft 8 and the stirring paddle 9 to reset and move in the vertical direction away from the dissolution cup 3 under the action of the threaded sleeve 13, and the stirring paddle 9 can be moved out of the inner wall of the dissolution cup 3, so that personnel can take and place the dissolution cup 3 on the inner wall of the hole groove 201.
[0040] A cover plate 20 for sealing the dissolution cup 3 is rotatably connected to the outer contour of each spline shaft 8 near the stirring paddle 9 , and a second spring 21 for supporting the cover plate 20 is fixedly connected to the corresponding part of each cover plate 20 and the rectangular shell 6 .
[0041] When in use, the cover plate 20 arranged on the spline shaft 8 is sleeved on the outer contour of the spline shaft 8 and rotatably connected, and a second spring 21 is arranged on the cover plate 20, and the second spring 21 can support the cover plate 20. In the initial state, the second spring 21 is in a contracted state. When the spline shaft 8 drives the stirring paddle 9 to move to the inner wall of the dissolution cup 3 for stirring, the cover plate 20 can move synchronously with the spline shaft 8 under the elastic force of the second spring 21 to cover the dissolution cup 3, which can prevent the solution inside the dissolution cup 3 from overflowing during the stirring process and prevent the solution inside the dissolution cup 3 from evaporating. Embodiment five:
[0042] On the basis of the fourth embodiment, further: The liquid extraction mechanism includes a rectangular shell 6, one side of which is close to the movable plate 17 and is penetrated by and fixedly connected with a cylindrical shell 22, the inner wall of each of the cylindrical shells 22 is movably connected with a piston plate 23 for axial reciprocating movement, each of the piston plates 23 is penetrated by and movably connected with a liquid inlet pipe 24 for extracting the solution inside the dissolution cup 3, and the piston plates 23 are fixedly connected with a fiber optic UV probe 27 for detecting the dissolution rate of the drug.
[0043] A cylindrical block 25 is fixedly connected to the outer contour of each spline sleeve 7 near the bottom end, and a cam groove 251 is opened on the outer contour of each cylindrical block 25 for pulling the liquid inlet pipe 24 to move up and down and reciprocate. A moving block 26 is fixedly connected to the outer contour of each liquid inlet pipe 24 near the cylindrical block 25, and one end of each moving block 26 away from the liquid inlet pipe 24 passes through the inner wall of the cam groove 251 on the adjacent side and is movably connected.
[0044] When in use, the cylindrical shell 22 is fixed on the rectangular shell 6 through the cylindrical shell 22 set on the rectangular shell 6, and the piston plate 23 and the liquid inlet pipe 24 are set on the movable plate 17, so that the piston plate 23 and the liquid inlet pipe 24 are axially movable and connected on the inner wall of the cylindrical shell 22, and at the same time, the liquid inlet pipe 24 passes through the cover plate 20 and is movably connected, and the cylindrical block 25 set by the spline sleeve 7, then the cylindrical block 25 can rotate synchronously with the spline sleeve 7, through the cam groove 251 opened on the cylindrical block 25, and the movable block 26 set on the liquid inlet pipe 24, along with the spline sleeve 7 drives the cylindrical block 25 to rotate, so that 06 can drive the liquid inlet pipe 24 and the piston plate 23 to axially reciprocate on the inner wall of the cylindrical shell 22 under the action of the cam groove 251.
[0045] Through the fiber optic UV probe 27 arranged on the piston plate 23, when the liquid inlet tube 24 and the piston plate 23 move toward the direction close to the dissolution cup 3, the end of the liquid inlet tube 24 away from the piston plate 23 moves into the solution inside the dissolution cup 3. At this time, the air pressure inside the cylindrical shell 22 is in a negative pressure state, so that the liquid inlet tube 24 can quantitatively extract the solution inside the dissolution cup 3 to the inner wall of the cylindrical shell 22, so that the fiber optic UV probe 27 contacts the solution inside the cylindrical shell 22, and then the fiber optic UV probe 27 can detect the drug concentration in the solution. The above-mentioned fiber optic UV probe 27 is an existing device, so it will not be described in detail here.
[0046] When the liquid inlet tube 24 and the piston plate 23 move in a direction away from the dissolution cup 3, the air pressure inside the cylindrical shell 22 is positive, which enables the liquid inlet tube 24 to discharge the solution inside the cylindrical shell 22 into the solution inside the dissolution cup 3. At the same time, the solution inside the dissolution cup 3 has a rolling flow effect, further simulating the peristaltic movement of the gastrointestinal tract, improving the physiological relevance of the experiment, and enhancing the accuracy of the dissolution test.
[0047] As the liquid inlet tube 24 moves up and down and back and forth, the liquid inlet tube 24 can uniformly extract and detect the solution inside the dissolution cup 3. At the same time, the optical fiber UV probe 27 can remotely transmit the monitoring data to an external display device, thereby realizing real-time detection of the dissolution of the drug inside the dissolution cup 3 at different time points.
[0048] Furthermore, the existing device can quantitatively extract and detect the drug solution inside the dissolution cup during actual use, which is easy to use and better than traditional products.
[0049] The standard parts used in this embodiment can be purchased directly from the market, and the non-standard structural components recorded in the specification and the drawings can also be directly processed according to the existing technical common sense. At the same time, the connection method of each component adopts the mature conventional means in the prior art, and the machinery, parts and equipment all adopt the conventional models in the prior art, so no specific description will be given here.
[0050] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.
Claims
1. A drug dissolution test device, characterized in that: The invention comprises a base (1) placed on the ground, wherein a heating box (2) is fixedly connected to the base (1), wherein the heating box (2) is provided with a plurality of evenly distributed holes (201), wherein the inner wall of each hole (201) is movably connected with a dissolution cup (3) for testing the dissolution rate of a drug, wherein a limiting ring (4) is fixedly connected to the outer contour near the end of each dissolution cup (3) for supporting and placing the dissolution cup (3) on the inner wall of the hole (201), wherein a positioning block (5) is fixedly connected to symmetrical positions on both sides of the bottom of each limiting ring (4), and a positioning hole (202) matching the outer contour of the positioning block (5) is provided at a position corresponding to the positioning block (5) on the heating box (2), wherein a rectangular shell (6) is fixedly connected to one side of the base (1) via an external bracket, wherein the rectangular shell (6) is provided with a stirring mechanism for stirring the solution inside the dissolution cup (3) and a liquid extraction mechanism for testing the dissolution rate of the drug inside the dissolution cup (3).
2. A drug dissolution test device according to claim 1, characterized in that: The stirring mechanism comprises a spline shaft sleeve (7) which penetrates and is rotatably connected to a position corresponding to the dissolution cup (3) on a rectangular shell (6); the inner wall of each of the spline shaft sleeves (7) is movably connected to a spline shaft rod (8) which is capable of lifting and reciprocating; and the outer contour of the bottom end of each of the spline shaft rods (8) is fixedly connected to a stirring paddle (9) for stirring the solution inside the dissolution cup (3).
3. A drug dissolution test device according to claim 2, characterized in that: The two ends of the rectangular housing (6) are penetrated and rotatably connected to a worm (11) driven to rotate by a power mechanism. The outer contour of each spline sleeve (7) is fixedly connected to a worm wheel (10) meshing with the worm (11). The power mechanism is an electric motor after power is supplied.
4. A drug dissolution test device according to claim 3, characterized in that: The rectangular housing (6) is provided with an auxiliary mechanism for pulling the spline shaft (8) to perform lifting and reciprocating adjustment, the auxiliary mechanism comprising a T-shaped block (12) fixedly connected to the corresponding position of the spline shaft sleeve (7) on the rectangular housing (6) through an external bracket, a threaded sleeve (13) passing through and rotatably connected to each of the T-shaped blocks (12), a threaded rod (14) for lifting and reciprocating movement being screwed onto the inner wall of each of the threaded sleeves (13), and the bottom end of the threaded rod (14) is coaxially fixedly connected to the spline shaft (8) at the corresponding position. Each of the T-shaped blocks (12) is provided with a cavity (121) on one side close to the threaded sleeve (13); a locking block (15) for locking the threaded sleeve (13) is movably connected to the inner wall of the cavity (121); a locking groove (131) adapted to the locking block (15) is provided on the outer contour of the threaded sleeve (13); and a first spring (16) for guiding the locking block (15) to reset is fixedly connected to the opposite surface of each locking block (15) and the cavity (121); a pull rod (16) is provided on the T-shaped block (12); An unlocking mechanism for unlocking the threaded sleeve (13) by a movable locking block (15), the unlocking mechanism comprising a movable plate (17) which penetrates and is movably connected to a side of each T-shaped block (12) close to the locking block (15) and is capable of lifting and reciprocating movements, each movable plate (17) is provided with an inclined groove (171) for driving the locking block (15) to move horizontally and reciprocatingly, the inner wall of the inclined groove (171) is movably connected to a slider (18) for supporting the locking block (15), and each slider (18) is separately The threaded rods (14) are fixedly connected to the locking blocks (15) at the corresponding positions, and the end of each of the threaded rods (14) is fixedly connected to a circular plate (19) that enables the movable plate (17) to pull the locking block (15) to unlock the threaded sleeve (13); the outer contour of each of the spline shaft rods (8) close to the stirring paddle (9) is rotatably connected to a cover plate (20) for sealing the dissolution cup (3), and each of the cover plates (20) is fixedly connected to the corresponding part of the rectangular shell (6) with a second spring (21) for supporting the cover plate (20).
5. A drug dissolution test device according to claim 4, characterized in that: The liquid pumping mechanism comprises a rectangular shell (6) on which one side close to the movable plate (17) is penetrated and fixedly connected with a cylindrical shell (22), and the inner wall of each cylindrical shell (22) is movably connected with a piston plate (23) that performs axial reciprocating movement.
6. A drug dissolution test device according to claim 5, characterized in that: Each of the piston plates (23) is penetrated and movably connected with a liquid inlet pipe (24) for extracting the solution inside the dissolution cup (3), and the piston plates (23) are fixedly connected with an optical fiber UV probe (27) for detecting the dissolution rate of the drug.
7. A drug dissolution test device according to claim 6, characterized in that: A columnar block (25) is fixedly connected to the outer contour of each spline shaft sleeve (7) near the bottom end, and a cam groove (251) for pulling the liquid inlet pipe (24) to move up and down and reciprocate is provided on the outer contour of each columnar block (25).
8. A drug dissolution test device according to claim 7, characterized in that: A movable block (26) is fixedly connected to the outer contour of each liquid inlet pipe (24) on the side close to the columnar block (25), and one end of each movable block (26) away from the liquid inlet pipe (24) passes through the inner wall of the cam groove (251) on the adjacent side and is movably connected.
Citation Information
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A drug dissolution tester
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