Multi-dosage form dissolution dissolution apparatus

Abstract

The application provides a multi-dosage form melting and dissolution device. A medium container is arranged on a device base. The medium container is configured to store a dissolution medium or a melting medium. A constant temperature detection chamber is arranged on the device base. A flow cell is arranged in the constant temperature detection chamber. The flow cell is detachably replaced relative to the constant temperature detection chamber. The flow cell has a cell chamber in the inside. The cell chamber is configured to accommodate a dissolution sample to be detected. A fluid driver is arranged on the device base. An input end of the fluid driver is connected with the medium container. An output end of the fluid driver is connected with the flow cell. A sample collection chamber is arranged on the device base. The sample collection chamber is used to collect and temporarily store the dissolution sample to be detected. The flow cell is detachably replaced relative to the constant temperature detection chamber. Different dosage forms of the flow cell can be replaced. The multi-dosage form melting and dissolution device can be used for digital melting time test of oral dissolving film, oral disintegrating tablet, buccal tablet and other preparations, and can also be used for dissolution test of multiple dosage forms.

Description

Technical Field

[0001] This application relates to the field of pharmaceutical testing technology, and in particular to multi-dosage form dissolution apparatus. Background Technology

[0002] In the quality control of pharmaceutical formulations, dissolution rate and dissolution time are core indicators for evaluating drug release characteristics. For example, the dissolution time and rate of film-forming agents, and the quality and disintegration time of orally disintegrating tablets, all require evaluation through scientific testing methods. For dosage forms such as oral osmotic pump tablets, sustained-release tablets, enteric-coated capsules, transdermal patches, long-acting injectable microspheres, and implantable drugs, the dissolution time may far exceed one day. Relying solely on manual visual observation, sampling, and offline testing is not only time-consuming and labor-intensive, but also lacks accuracy and the ability to obtain test results anytime, anywhere. Therefore, there is an urgent need in this field to provide a digital dissolution and disintegration assay device, as well as dissolution assay devices for various dosage forms, to solve the current technical problems of low detection efficiency and difficulty in guaranteeing accuracy. Summary of the Invention

[0003] Therefore, it is necessary to provide a multi-dosage form dissolving and leaching device to address the aforementioned technical problems.

[0004] This application provides a multi-dosage form dissolution apparatus, the multi-dosage form dissolution apparatus comprising:

[0005] Device base;

[0006] A medium reservoir disposed on the base of the device, the medium reservoir being configured to store a leaching sample to be tested;

[0007] A constant temperature detection chamber is disposed on the base of the device. A flow cell is disposed inside the constant temperature detection chamber and is detachably connected to the constant temperature detection chamber. The flow cell has a chamber inside, which is configured to contain the leaching sample to be tested.

[0008] A fluid actuator is disposed on the device base, the input end of the fluid actuator is connected to the medium reservoir, and the output end of the fluid actuator is connected to the flow cell;

[0009] A sample collection chamber is disposed on the base of the device, and the sample collection chamber is used to collect and temporarily store the leaching samples to be tested.

[0010] In one embodiment, the constant temperature detection chamber is provided with a light source emitter and a photoelectric sensor, the light source emitter facing the photoelectric sensor, the light source emitter being configured to emit a light source to the photoelectric sensor, a flow cell being located between the light source emitter and the photoelectric sensor, the flow cell being provided with a light transmission window, the light transmission window being configured to allow the light source emitted by the light source emitter to pass through.

[0011] In one embodiment, the light source emitter is configured as a visible light emitter or an ultraviolet light emitter; and / or,

[0012] The light source emitted by the light source emitter is configured to emit visible light or ultraviolet light; and / or,

[0013] The photoelectric sensor is configured as a visible light sensor, an infrared light sensor, or an ultraviolet light sensor.

[0014] In one embodiment, the multi-dosage form dissolution apparatus includes:

[0015] The filter has its input end connected to the chamber of the flow cell, and its output end connected to the inner tube of the sample collection chamber via an ultraviolet light detector.

[0016] In one embodiment, the flow cell is configured as a membrane flow cell, a patch flow cell, an orally disintegrating tablet flow cell, an implantable drug flow cell, or a sustained-release tablet flow cell; and / or,

[0017] The number of flow pools is configured to be several, and the several flow pools are connected in parallel.

[0018] In one embodiment, the sample collection chamber is provided with a matching collection tube and a transfer device. The transfer device includes a connecting tube and a guide tube. The connecting tube is configured to communicate with the chamber of the flow cell, and the guide tube is configured to guide the leached sample to be tested to the collection tube.

[0019] In one embodiment, the sample collection chamber is provided with a movable support and a transfer support. The movable support is provided with a plurality of test tube mounting slots, which are configured to install the collection test tubes. The transfer support is provided with a plurality of transfer mounting holes, which are configured to install the transfer device. The movable support is movable relative to the transfer support.

[0020] In one embodiment, the fluid actuator includes a drive motor, a plunger pump, and a transmission assembly, wherein the drive motor is driven and connected to the plunger pump via the transmission assembly.

[0021] In one embodiment, the transmission assembly includes a device base, a fixed plate, and a movable plate; the plunger pump includes a pump body and a pump column; the pump column piston is assembled in the inner cavity of the pump body; the pump body is connected to the fixed plate; the pump column is connected to the movable plate; and the drive motor is connected to the movable plate for driving the movable plate to move relative to the fixed plate.

[0022] In one embodiment, the interior of the flow cell is provided with a clamping mesh configured to clamp the leaching sample to be tested; and / or,

[0023] The interior of the constant temperature testing chamber is configured as a light-proof space; and / or,

[0024] The inner wall of the constant temperature testing chamber is configured to be black; and / or,

[0025] The constant temperature testing chamber is filled with constant temperature air; and / or,

[0026] The capacity of the chambers inside the flow-through tank is between 0.002 liters and 5 liters; and / or,

[0027] A liquid level sensor is installed inside the chamber of the flow tank.

[0028] In the above-mentioned multi-dosage form dissolution device, since the flow cell can be detached and replaced relative to the constant temperature detection chamber, the flow cell inside the constant temperature detection chamber can be selectively replaced with a flow cell for a different dosage form according to the different types of dissolution samples to be tested. This enables the above-mentioned multi-dosage form dissolution device to achieve dissolution testing of multiple dosage forms during the experiment.

[0029] Existing testing instruments can only detect single dosage forms (such as tablets or patches), requiring multiple devices to meet testing needs when testing various dosage forms. The aforementioned multi-dosage form dissolution and melting device, by simply changing the flow cell, can detect multiple dosage forms, greatly improving the equipment's versatility and flexibility. It is suitable not only for pharmaceutical R&D and production processes but also for widespread application in universities and testing institutions, providing an efficient and accurate solution for dissolution and melting studies of pharmaceutical formulations. Attached Figure Description

[0030] Figure 1 This is a perspective view of a multi-dosage form dissolution apparatus provided in one embodiment of this application.

[0031] Figure 2 For example Figure 1 A three-dimensional view of the constant temperature detection chamber of the multi-dosage form dissolution device.

[0032] Figure 3 For example Figure 1A perspective view of the fluid actuator of the multi-dosage form dissolution device.

[0033] Figure 4 For example Figure 1 A three-dimensional view showing the assembly of the collection tubes and adapters in the sample collection chamber of the multi-dosage form dissolution device.

[0034] Figure 5 For example Figure 1 A plan view showing the assembly of the collection tubes and adapters in the sample collection chamber of the multi-dosage form dissolution apparatus.

[0035] Figure 6 This is a schematic diagram of the flow cell structure provided in one embodiment of this application.

[0036] Figure 7 This is a schematic diagram of the flow cell structure provided in another embodiment of this application.

[0037] Figure 8 This is a schematic diagram of the flow cell structure provided in yet another embodiment of this application.

[0038] Figure 9 This is a schematic diagram illustrating the operating principle of a multi-dosage form dissolving and leaching device provided in one embodiment of this application.

[0039] Figure 10 A schematic diagram illustrating the operating principle of a multi-dosage form dissolving and leaching device provided in another embodiment of this application.

[0040] Figure 11 This is a schematic diagram illustrating the operating principle of a multi-dosage form dissolving and leaching device provided in another embodiment of this application.

[0041] Figure 12 For example Figure 1 The circuit configuration diagram of the multi-dosage form dissolution device is shown.

[0042] Icon labels:

[0043] 100. The leaching sample to be tested;

[0044] 1000, Device base; 2000, Media reservoir; 3000, Constant temperature detection chamber; 4000, Fluid actuator; 5000, Sample collection chamber; 6000, Filter; 7000, Ultraviolet light detector; 8000, Display device;

[0045] 1100, Power supply; 1200, Data interface;

[0046] 3100, Flow cell; 3110, Cell chamber; 3120, Light transmission window; 3130, Clamping mesh; 3140, Flow connector; 3150, Flow support; 3160, Sealing cover; 3200, Light source emitter; 3210, Light source board; 3300, Photoelectric sensor;

[0047] 4100 Drive motor; 4110 Moving screw; 4200 Piston pump; 4210 Pump body; 4220 Pump column; 4230 Pump inlet; 4300 Transmission assembly; 4310 Component base; 4320 Fixed plate; 4330 Movable plate;

[0048] 5100, test tube collection; 5200, adapter; 5210, adapter tube; 5220, guide tube; 5300, movable support; 5310, test tube mounting slot; 5400, adapter support; 5410, adapter mounting hole; 5500, waste liquid collection tank. Detailed Implementation

[0049] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0050] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0051] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0052] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0053] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0054] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0055] See Figures 1 to 12 As shown, this application provides a multi-dosage form dissolution device, which is applicable to the digital detection of dissolution time for dosage forms such as orally disintegrating films and orally disintegrating tablets. The multi-dosage form dissolution device includes a device base 1000, a media reservoir 2000, a constant temperature detection chamber 3000, a fluid actuator 4000, and a sample collection chamber 5000. The device base 1000 may be equipped with a power supply 1100 and a data interface 1200, etc. The power supply 1100 is used to start the multi-dosage form dissolution device, and the data interface 1200 can be used to connect external devices such as printers. The media reservoir 2000 is disposed on the device base 1000 and is configured to store the dissolution sample 100 to be tested (containing dissolution media or melting media). The constant temperature detection chamber 3000 is disposed on the device base 1000, and the interior of the constant temperature detection chamber 3000 can be heated by flowing air to achieve constant temperature control.

[0056] See Figure 2 As shown, a flow cell 3100 is provided inside the constant temperature detection chamber 3000, and the flow cell 3100 is detachably connected to the constant temperature detection chamber 3000. The flow cell 3100 has a chamber 3110 inside, which is configured to contain the leaching sample 100 to be tested. The number of flow cells 3100 can be configured to be several, and several flow cells 3100 are connected in parallel. The constant temperature detection chamber 3000 can also be provided with a flow connector 3140, a flow support 3150, and a sealing cover 3160. The flow connector 3140 is used for quick plug-in assembly of the flow cell 3100 with the fluid driver 4000 and the filter 6000. The flow support 3150 is used to fix the flow cell 3100 in place, and the sealing cover 3160 is used to seal the inside of the constant temperature detection chamber 3000.

[0057] A fluid actuator 4000 is mounted on the device base 1000. The input of the fluid actuator 4000 is connected to the medium reservoir 2000, and the output of the fluid actuator 4000 is connected to the flow cell 3100. A sample collection chamber 5000 is mounted on the device base 1000 and connected to the flow cell 3100. The interior of the sample collection chamber 5000 can be maintained in a low-temperature environment, for example, between 4°C and 8°C, enabling thermally unstable samples to remain stable for extended periods. This is suitable for dissolution assays of long-release drug formulations, and also for drugs that cannot be detected online or are thermally unstable, collecting the dissolution sample 100 for offline detection.

[0058] The aforementioned multi-dosage-form dissolution apparatus is applicable to the dissolution time of films, the disintegration time of orally disintegrating tablets, and the dissolution testing of various drug dosage forms, such as the dissolution and leaching of oral films, the dissolution of transdermal patches, the disintegration of orally disintegrating tablets, the dissolution of sustained-release tablets, and the in vitro dissolution of implantable formulations. Therefore, the dissolution sample 100 to be tested can be of various dosage forms, including oral osmotic pump tablets, sustained-release tablets, enteric-coated capsules, sustained-release capsules, transdermal patches, long-acting injectable microspheres, and implantable formulations.

[0059] Since the flow cell 3100 can be detachably connected to the constant temperature detection chamber 3000, the flow cell 3100 for different dosage forms can be selectively replaced inside the constant temperature detection chamber 3000 according to the different types of dissolution samples 100 to be tested, thereby enabling the above-mentioned multi-dosage form dissolution device to realize multi-dosage form dissolution testing during the experiment.

[0060] See Figure 3As shown, in one embodiment, the fluid actuator 4000 includes a drive motor 4100, a plunger pump 4200, and a transmission assembly 4300. The drive motor 4100 is connected to the plunger pump 4200 via the transmission assembly 4300. By using the plunger pump 4200 to supply the liquid, the flow rate of the aforementioned multi-dosage form dissolving and leaching device can be adjusted from a few microliters / minute to a few milliliters / minute, enabling precise control of the injection rate of the dissolving medium. Therefore, by injecting the dissolving medium into the constant-temperature flow cell 3100 based on the plunger pump 4200, the flow rate of body fluids in different parts of the human body, such as subcutaneous tissue, oral cavity, gastrointestinal tract, and muscles, can be simulated.

[0061] In one embodiment, the transmission assembly 4300 includes a device base 4310, a fixed plate 4320, and a movable plate 4330. The plunger pump 4200 includes a pump body 4210 and a pump column 4220. The piston of the pump column 4220 is assembled in the inner cavity of the pump body 4210. The pump body 4210 is connected to the fixed plate 4320, and the pump column 4220 is connected to the movable plate 4330. The drive motor 4100 is connected to the movable plate 4330 and is used to drive the movable plate 4330 to move relative to the fixed plate 4320. For example, the output end of the drive motor 4100 can be connected to a movable screw 4110. The movable screw 4110 is fitted into a threaded hole in one of the fixed plate 4320 or the movable plate 4330. When the drive motor 4100 drives the movable screw 4110 to rotate on a fixed axis, the movable screw 4110 can be screwed into the threaded hole in one of the fixed plate 4320 or the movable plate 4330, so that one of the fixed plate 4320 or the movable plate 4330 moves relative to the other, thereby controlling the relative distance or relative proximity between the fixed plate 4320 and the movable plate 4330.

[0062] Therefore, as Figure 3 As shown, the aforementioned multi-dosage form dissolving and leaching device can drive the moving screw 4110 to rotate via the drive motor 4100. The moving screw 4110 controls the relative up-and-down movement between the cooperating fixed plate 4320 and the movable plate 4330, thereby pushing the pump column 4220 of the plunger pump 4200 to move up and down. The pump port 4230 of the plunger pump 4200 can be equipped with a water inlet valve for drawing water into the inner cavity of the pump body 4210 of the plunger pump 4200. The water outlet valve on the plunger pump 4200 can be used to inject water into the flow tank 3100. The drive motor 4100 controlling the movement of the plunger pump 4200 can operate according to set parameters. Using the drive motor 4100 to achieve drive, the time and accuracy can reach the second level, and the volume control of the dissolving medium can be accurate to the microliter level.

[0063] See Figure 4 and Figure 5As shown, in one embodiment, the sample collection chamber 5000 is internally provided with a matching collection tube 5100 and an adapter 5200. The adapter 5200 includes a connected adapter tube 5210 and a guide tube 5220. The adapter tube 5210 is configured to communicate with the chamber 3110 of the flow cell 3100, and the guide tube 5220 is configured to communicate with the collection tube 5100. The sample collection chamber 5000 may also be internally provided with a waste liquid collection tank 5500 for collecting waste liquid. The sample collection chamber 5000 may be equipped with a movable support 5300 and an adapter support 5400. The movable support 5300 is provided with several test tube mounting slots 5310, which are configured to mount collection test tubes 5100. The adapter support 5400 is provided with several adapter mounting holes 5410, which are configured to mount adapter devices 5200. The movable support 5300 is movable relative to the adapter support 5400. Therefore, by moving the movable support 5300 relative to the adapter support 5400, different collection test tubes 5100 can be moved relative to the adapter device 5200, so that the different collection test tubes 5100 can move under the expected control to collect liquid below the adapter device 5200.

[0064] See Figures 6 to 8 As shown, in one embodiment, the flow cell 3100 is configured as a film-type flow cell 3100, a patch-type flow cell 3100, an orally disintegrating tablet flow cell 3100, an implant-type flow cell 3100, or a sustained-release tablet flow cell 3100, etc. It is suitable for various dosage forms. Different flow rates and dissolution requirements can be selected according to the characteristics of the dosage form for testing. The test results are displayed on the monitor as melting, disintegration curves and dissolution curves, and recorded and printed.

[0065] In one embodiment, a clamping mesh 3130 is provided inside the chamber 3110 of the flow cell 3100, configured to clamp the dissolution sample 100 to be tested. The interior of the constant temperature detection chamber 3000 can be configured as a light-proof space, such as by making the inner wall of the constant temperature detection chamber 3000 black, to ensure the stability of the experimental environment. Opening the chamber cover of the constant temperature detection chamber 3000 allows the flow cell 3100 inside to be replaced according to different dosage forms, adapting to the testing needs of various drug formulations. Constant temperature air is injected into the constant temperature detection chamber 3000. The capacity of the chamber 3110 inside the flow cell 3100 ranges from 0.002 liters to 5 liters, and a liquid level sensor is installed inside the chamber 3110 of the flow cell 3100. Therefore, based on the liquid level sensor, the detection and alarm functions of the dissolution medium capacity can be realized. The liquid level sensor can be connected to a waterless alarm light, etc., to prevent equipment damage or experimental interruption due to water shortage.

[0066] A display device 8000 can be installed on the device base 1000. The display device 8000 can be, for example, a display screen, a touch screen, etc., enabling the aforementioned multi-dosage form dissolution apparatus to have a display screen function. The display screen can set and display various parameters, including total flow rate, flow rate, flow rate / time (seconds, minutes, hours), flow time (seconds, minutes, hours), and pause time (seconds, minutes, hours). Furthermore, the display screen can also display the dissolution experimental results in real time (presented in graphical and numerical form). The aforementioned multi-dosage form dissolution apparatus can also be equipped with wireless transmission functionality, allowing experimental data and graphics to be sent to the tester's terminal, such as a mobile phone or computer. The tester can also remotely change parameters and start or stop the equipment operation through the terminal.

[0067] See Figure 9 As shown, in one example of the test, the dissolution medium can be delivered by the fluid actuator 4000 and enter the chamber 3110 from the inlet below the flow cell 3100. The dissolution sample 100 to be tested (e.g., oral dissolution membrane, patch, etc.) can be placed in the chamber 3110 of the flow cell 3100, for example, by clamping and fixing it with a suitable clamping mesh 3130 such as two layers of stainless steel mesh clamping plates or double-layer mesh. Depending on the characteristics of different dosage forms of the dissolution sample 100 to be tested, other dosage forms that are not suitable for clamping and fixing with the clamping mesh 3130 can be directly placed in the corresponding flow cell 3100.

[0068] When measuring dissolution time or disintegration time, the dissolution medium flows in from the inlet and gradually covers the entire dissolution sample 100 to be tested. Finally, it is collected by the sample collector. For example, it can flow into the collection tube 5100 through the adapter 5200 inside the sample collection chamber 5000.

[0069] The aforementioned multi-dosage form dissolution and leaching device can employ various measurement techniques, such as visible light measurement and ultraviolet light measurement, to monitor the dissolution and leaching process in real time. It can also simulate the dissolution, leaching, and absorption of the formulation in different parts of the human body as much as possible, thereby providing a more scientific and accurate detection method for the dissolution and leaching research of drug formulations.

[0070] In one embodiment, a light source emitter 3200 and a photoelectric sensor 3300 are disposed inside the constant temperature detection chamber 3000. The light source emitter 3200 can be disposed on the device base 1000 or the light source plate 3210 of the constant temperature detection chamber 3000, while the corresponding photoelectric sensor 3300 is installed on the back of the flow cell 3100 for real-time monitoring of the experimental process. For example, the light source emitter 3200 can be positioned facing the photoelectric sensor 3300, and the light source emitter 3200 is configured to emit light to the photoelectric sensor 3300. The flow cell 3100 is located between the light source emitter 3200 and the photoelectric sensor 3300, and the flow cell 3100 is provided with a light transmission window 3120, which is configured to allow the light emitted by the light source emitter 3200 to pass through. The light source emitter 3200 is configured as a visible light emitter, an infrared light emitter, or an ultraviolet light emitter, and the light source emitted by the light source emitter 3200 is configured as visible light, infrared light, or ultraviolet light. The photoelectric sensor 3300 is configured as a visible light sensor, an infrared light sensor, or an ultraviolet light sensor.

[0071] See Figure 10 As shown, in one embodiment, regarding the method for determining the melting time of the film and the disintegration time of orally disintegrating tablets, the drug film (or film agent) can be placed in the chamber 3110 of the flow cell 3100, for example, by clamping and fixing it with a suitable clamping mesh 3130 such as two layers of stainless steel mesh clamping plates or double-layer mesh. The melting medium is injected into the flow cell 3100 at timed and quantitative intervals. The drug film in the clamping mesh 3130 can block the visible light emitted by the visible light emitter from illuminating the visible light sensor. As the melting medium gradually injected into the chamber 3110 melts the drug film in the clamping mesh 3130, the photocurrent of the visible light sensor gradually increases. When the melting is completed, the photocurrent of the visible light sensor is at its maximum, which is the endpoint of the drug film melting. The visible light sensor can be used to record the entire melting process and display the melting curve, avoiding subjective errors caused by manual observation.

[0072] When measuring the disintegration time of orally disintegrating tablets, a dedicated orally disintegrating tablet flow cell 3100 must be used. Typically, a lower flow rate is required for disintegration time measurement. When the tablet is placed inside the chamber 3110, it blocks the visible light emitted by the visible light emitter from reaching the visible light sensor, causing a decrease or even no reading on the visible light sensor's ammeter. At this time, the dissolving medium is injected into the chamber 3110 through the inlet of the flow cell 3100. As the orally disintegrating tablet gradually disintegrates, the visible light path is gradually restored, and the intensity of the visible light detected by the visible light sensor gradually increases until a steady state is reached. This steady state represents the disintegration time of the orally disintegrating tablet.

[0073] See Figure 11As shown, regarding the dissolution determination of films, transdermal patches, sustained-release tablets, osmotic pump tablets, or implantable formulations, in one embodiment, the multi-dosage form dissolution device includes a filter 6000. The input end of the filter 6000 is connected to the chamber 3110 of the flow cell 3100, and the output end of the filter 6000 is connected to the inner connecting tube of the sample collection chamber 5000 via an ultraviolet light detector 7000. The ultraviolet light detector 7000 enables digital online real-time detection of the dissolved sample. This determination method is similar to... Figure 10 The dissolution assays shown are similar to those for membranes, transdermal patches, sustained-release tablets, osmotic pump tablets, or implantable drugs. The only difference in the dissolution assays for different types of dissolution flow cells 3100, light source emitters 3200, and photoelectric sensors 3300 is that the online detection can be performed using ultraviolet detection methods. A filter 6000 can be added. The filter 6000 can perform real-time online detection of the filtered dissolution solution or collect the dissolution solution quantitatively over time into a collection tube 5100, and then perform further detection using different methods such as liquid chromatography and fluorescence. Different methods can be selected by those skilled in the art, and no limitation is made here.

[0074] In summary, while there are many types of testing instruments for pharmaceutical preparations, the detection of some novel preparations (such as the melting of films and the disintegration time of orally disintegrating tablets) still largely relies on manual visual inspection. Currently, there is no digital melting and disintegration measurement device, which makes the existing testing methods not only inefficient but also difficult to guarantee in terms of accuracy.

[0075] Therefore, this application provides the above-mentioned multi-dosage form dissolution device, which can be equipped with and replaced with a film dissolution flow cell 3100, an orally disintegrating tablet disintegration assay flow cell 3100, and a flow cell 3100 suitable for dissolution assay of different dosage forms according to the detachable structural design features. A plunger pump 4200 is used to realize quantitative and timed liquid supply. It is not only suitable for measuring the dissolution time of film and the disintegration time of orally disintegrating tablets, but also particularly suitable for detecting the dissolution process of sustained-release preparations (such as tablets, implants and transdermal patches), especially suitable for detecting long-term dissolution, which can reduce labor costs and improve the accuracy of testing.

[0076] Existing testing instruments can only detect single dosage forms (such as tablets or patches), requiring multiple devices to meet testing needs for multiple dosage forms. The aforementioned multi-dosage form dissolution and leaching device can detect multiple dosage forms simply by changing the flow cell 3100, greatly improving the device's versatility and flexibility. It is suitable not only for pharmaceutical R&D and production processes but also for widespread application in universities and testing institutions, providing an efficient and accurate solution for dissolution and leaching studies of pharmaceutical formulations.

[0077] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0078] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A multi-dosage form dissolving and leaching device, characterized in that, The multi-dosage form dissolution apparatus includes: Device base; A medium reservoir is disposed on the base of the device and configured to store a leaching sample to be tested, the leaching sample including a leaching medium or a melting medium; A constant temperature detection chamber is provided on the base of the device. A flow cell is provided inside the constant temperature detection chamber and is detachably connected to the constant temperature detection chamber. The flow cell has a chamber inside and is configured to contain the leaching sample to be tested. A fluid actuator is disposed on the device base, the input end of the fluid actuator is connected to the medium reservoir, and the output end of the fluid actuator is connected to the flow cell; A sample collection chamber is disposed on the base of the device, and the sample collection chamber is used to collect and temporarily store the leaching sample to be tested; The constant temperature detection chamber is equipped with a light source emitter and a photoelectric sensor. The light source emitter faces the photoelectric sensor and is configured to emit light to the photoelectric sensor. The flow cell is located between the light source emitter and the photoelectric sensor. The flow cell is provided with a light transmission window and is configured to allow the light emitted by the light source emitter to pass through. The fluid actuator includes a drive motor, a plunger pump, and a transmission assembly. The drive motor is connected to the plunger pump via the transmission assembly. The transmission assembly includes a device base, a fixed plate, and a movable plate. The plunger pump includes a pump body and a pump column. The piston of the pump column is assembled in the inner cavity of the pump body. The pump body is connected to the fixed plate, and the pump column is connected to the movable plate. The drive motor is connected to the movable plate and is used to drive the movable plate to move relative to the fixed plate.

2. The multi-dosage form dissolving and leaching device according to claim 1, characterized in that, The light source emitter is configured as a visible light emitter or an ultraviolet light emitter; and / or, The light source emitted by the light source emitter is configured to emit visible light or ultraviolet light; and / or, The photoelectric sensor is configured as a visible light sensor, an infrared light sensor, or an ultraviolet light sensor.

3. The multi-dosage form dissolving and leaching device according to claim 1, characterized in that, The multi-dosage form dissolution apparatus includes: The filter has its input end connected to the chamber of the flow cell, and its output end connected to the inner tube of the sample collection chamber via an ultraviolet light detector.

4. The multi-dosage form dissolving and leaching device according to claim 1, characterized in that, The flow cell is configured as a membrane flow cell, a patch flow cell, an orally disintegrating tablet flow cell, an implant flow cell, or a sustained-release tablet flow cell.

5. The multi-dosage form dissolving and leaching apparatus according to claim 1, characterized in that, The number of flow pools is configured to be several, and the several flow pools are connected in parallel.

6. The multi-dosage form dissolving and leaching apparatus according to claim 1, characterized in that, The sample collection chamber is equipped with a matching collection tube and a transfer device. The transfer device includes a connecting tube and a guide tube. The connecting tube is configured to communicate with the chamber of the flow cell, and the guide tube is configured to guide the leached sample to be tested to the collection tube.

7. The multi-dosage form dissolving and leaching apparatus according to claim 6, characterized in that, The sample collection chamber is equipped with a movable support and an adapter support. The movable support has several test tube mounting slots configured to mount the collection test tubes. The adapter support has several adapter mounting holes configured to mount the adapter device. The movable support is movable relative to the adapter support.

8. The multi-dosage form dissolving and leaching apparatus according to claim 1, characterized in that, The flow cell is equipped with a clamping mesh inside the cell chamber, which is configured to clamp the leaching sample to be tested.

9. The multi-dosage form dissolving and leaching apparatus according to claim 1, characterized in that, The interior of the constant temperature testing chamber is configured as a light-proof space; and / or, The inner wall of the constant temperature testing chamber is configured to be black; and / or, The constant temperature testing chamber is filled with constant temperature air.

10. The multi-dosage form dissolving and leaching apparatus according to claim 1, characterized in that, The capacity of the chambers inside the flow-through tank is between 0.002 liters and 5 liters; and / or, A liquid level sensor is installed inside the chamber of the flow tank.

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