Multi-dosage-form dissolving and dissolving-out device

Abstract

The invention provides a multi-dosage-form dissolving and dissolving-out device, a medium storage device is arranged on a device base, the medium storage device is configured to be used for storing a dissolving-out medium or a dissolving medium, a constant-temperature detection chamber is arranged on the device base, a flow cell is arranged in the constant-temperature detection chamber, and the flow cell can be detached and replaced relative to the constant-temperature detection chamber. The flow cell is internally provided with a cell chamber, the cell chamber is configured to be used for accommodating a dissolution sample to be detected, the fluid driver is arranged on the device base, the input end of the fluid driver is connected with the medium storage device, and the output end of the fluid driver is connected with the flow cell. The sample collecting chamber is arranged on the device base and is used for collecting and temporarily storing a dissolved sample to be detected; the flow cell can be detached and replaced relative to the constant-temperature detection chamber, and flow cells for different dosage forms can be replaced, so that the multi-dosage form dissolving and dissolving-out device can be used for dissolving time digital testing of preparations such as oral dissolving films or / and oral disintegrating tablets or / and buccal tablets and can also be used for dissolving-out testing of multiple dosage forms.

Description

Technical Field

[0001] The present application relates to the technical field of pharmaceutical detection, and particularly to a multi-form dissolution and disintegration device. Background Art

[0002] In the quality control of pharmaceutical preparations, dissolution rate and dissolution time are core indicators for evaluating the drug release characteristics. For example, the dissolution time and dissolution rate of film agents, the quality and disintegration time of orally disintegrating tablets, etc. all need to be evaluated through scientific detection means. For dosage forms such as oral osmotic pump tablets, sustained-release tablets, enteric-coated capsules, sustained-release capsules, transdermal patches, long-acting injection microspheres, and in vivo implants, their dissolution time may far exceed 1 day. If relying solely on manual visual observation, sampling, and off-line detection, it is not only time-consuming and laborious, but also difficult to ensure accuracy, and it is impossible to obtain detection results anytime and anywhere. Therefore, there is an urgent need in this field to provide a digital dissolution and disintegration measurement device, as well as a dissolution measurement device for various dosage forms, to solve the technical problems of low current detection efficiency and difficult accuracy guarantee. Summary of the Invention

[0003] Based on this, it is necessary to provide a multi-form dissolution and disintegration device for the above-mentioned technical problems.

[0004] The present application provides a multi-form dissolution and disintegration device, and the multi-form dissolution and disintegration device includes:

[0005] A device base;

[0006] A medium reservoir, the medium reservoir is arranged on the device base, and the medium reservoir is configured to store the dissolution samples to be detected;

[0007] A constant temperature detection chamber, the constant temperature detection chamber is arranged on the device base, a flow cell is arranged inside the constant temperature detection chamber, and the flow cell is detachably connected to the constant temperature detection chamber. A cell chamber is arranged inside the flow cell, and the cell chamber is configured to accommodate the dissolution samples to be detected;

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

[0009] A sample collection chamber, the sample collection chamber is arranged on the device base, and the sample collection chamber is used to collect and temporarily store the dissolution samples to be detected.

[0010] In one embodiment, a light source emitter and a photoelectric sensor are disposed inside the constant temperature detection chamber. The light source emitter faces the photoelectric sensor. The light source emitter is configured to emit a light source toward 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 penetration window, and the light penetration window is configured to transmit the light source emitted by the light source emitter.

[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 as 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-dose form dissolution device includes:

[0015] A filter, an input end of the filter is communicated with a chamber of the flow cell, and an output end of the filter is connected to an inner transfer pipe of the sample collection chamber through an ultraviolet detector.

[0016] In one embodiment, the flow cell is configured as a film agent flow cell, a patch flow cell, an orally disintegrating tablet flow cell, an implant flow cell or a sustained-release and controlled-release tablet flow cell; and / or,

[0017] The number of the flow cells is configured as several, and several of the flow cells are connected in parallel with each other.

[0018] In one embodiment, a collection test tube and a transfer device are disposed inside the sample collection chamber in a matching manner. The transfer device includes a transfer pipe and a diversion pipe which are communicated with each other. The transfer pipe is configured to be communicated with the chamber of the flow cell, and the diversion pipe is configured to divert the dissolution sample to be detected to the collection test tube.

[0019] In one embodiment, a moving bracket and a transfer bracket are disposed inside the sample collection chamber. A plurality of test tube mounting grooves are disposed on the moving bracket, and the test tube mounting grooves are configured to mount the collection test tubes. A plurality of transfer mounting holes are disposed on the transfer bracket, and the transfer mounting holes are configured to mount the transfer devices. Among them, the moving bracket is movably disposed relative to the transfer bracket.

[0020] In one embodiment, the fluid driver includes a driving motor, a plunger pump and a transmission assembly. The driving motor is drivingly connected to the plunger pump through the transmission assembly.

[0021] In one embodiment, the transmission assembly includes a device base, a fixing 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 fixing plate, the pump column is connected to the movable plate, and the driving motor is connected to the movable plate to drive the movable plate to move relative to the fixing plate.

[0022] In one embodiment, a clamping mesh member is disposed inside the cell of the flow cell, and the clamping mesh member is configured to clamp the dissolution sample to be detected; and / or,

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

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

[0025] The interior of the constant temperature detection chamber is filled with constant temperature air; and / or,

[0026] The capacity of the cell inside the flow cell is between 0.002 liters and 5 liters; and / or,

[0027] A liquid level sensor is disposed inside the cell of the flow cell.

[0028] In the above multi-dose dissolution device, since the flow cell can be detachably replaced relative to the constant temperature detection chamber, the interior of the constant temperature detection chamber can selectively replace the flow cells for different dosage forms according to different types of dissolution samples to be detected. Furthermore, the above multi-dose dissolution device can realize the dissolution tests of multiple dosage forms during the experiment.

[0029] For existing detection instruments, they can only detect a single dosage form (such as tablets or patches). When detecting different multiple dosage forms, multiple devices need to be equipped to meet the test requirements. The above multi-dose dissolution device can achieve the detection of multiple dosage forms by replacing the flow cell, greatly improving the versatility and flexibility of the device. It is not only applicable to the R & D and production processes of pharmaceutical factories, but also can be widely used in the detection scenarios of universities and testing institutions, providing an efficient and accurate solution for the dissolution and melting research of pharmaceutical preparations. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 is a perspective view of a multi-dose dissolution device provided by an embodiment of the present application.

[0031] Figure 2 As shown in Figure 1 is a perspective view of the constant temperature detection chamber of the multi-dose dissolution device shown.

[0032] Figure 3 As shown in Figure 1Stereogram of the fluid driver of the multi-dose form dissolution device shown

[0033] Figure 4 As shown in Figure 1 Stereogram of the mating state of the collection test tube and the transfer device in the sample collection chamber of the multi-dose form dissolution device shown

[0034] Figure 5 As shown in Figure 1 Plan view of the mating state of the collection test tube and the transfer device in the sample collection chamber of the multi-dose form dissolution device shown

[0035] Figure 6 Schematic structural diagram of the flow cell provided by one embodiment of the present application

[0036] Figure 7 Schematic structural diagram of the flow cell provided by another embodiment of the present application

[0037] Figure 8 Schematic structural diagram of the flow cell provided by yet another embodiment of the present application

[0038] Figure 9 Schematic diagram of the operating state principle of the multi-dose form dissolution device provided by one embodiment of the present application

[0039] Figure 10 Schematic diagram of the operating state principle of the multi-dose form dissolution device provided by another embodiment of the present application

[0040] Figure 11 Schematic diagram of the operating state principle of the multi-dose form dissolution device provided by yet another embodiment of the present application

[0041] Figure 12 As shown in Figure 1 Circuit configuration structure diagram of the multi-dose form dissolution device shown

[0042] Reference numerals in the drawings:

[0043] 100, dissolution sample to be detected;

[0044] 1000, device base; 2000, medium reservoir; 3000, constant temperature detection chamber; 4000, fluid driver; 5000, sample collection chamber; 6000, filter; 7000, ultraviolet detector; 8000, display device;

[0045] 1100, power supply; 1200, data interface;

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

[0047] 4100, Driving motor; 4110, Moving screw; 4200, Plunger pump; 4210, Pump body; 4220, Pump column; 4230, Pump port; 4300, Transmission assembly; 4310, Device base; 4320, Fixed plate; 4330, Movable plate;

[0048] 5100, Collection test tube; 5200, Adapter device; 5210, Adapter tube; 5220, Diversion tube; 5300, Moving support; 5310, Test tube mounting groove; 5400, Adapter support; 5410, Adapter mounting hole; 5500, Waste liquid collection tank. Detailed implementation manners

[0049] To make the above objects, features, and advantages of the present application more apparent and understandable, the following will describe the detailed implementation manners of the present application with reference to the accompanying drawings. Many specific details are set forth in the following description to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present application. Therefore, the present application is not limited by the specific embodiments disclosed below.

[0050] In the description of the present application, it should be understood that if terms such as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or positional relationship indicated by these terms is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation of the present application.

[0051] In addition, if terms such as "first" and "second" appear, these terms are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one such feature. In the description of the present application, if the term "multiple" appears, the meaning of "multiple" is at least two, such as two, three, etc., unless otherwise specifically and clearly defined.

[0052] In this application, unless otherwise clearly specified or limited, if terms such as "installed", "connected", "linked", "fixed", etc. appear, these terms shall be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components or the interaction relationship between two components, unless otherwise clearly limited. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0053] In this application, unless otherwise clearly specified or limited, if there is a description such as the first feature being "on" or "under" the second feature, its meaning can be that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature can be that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is at a higher horizontal level than the second feature. The first feature being "under", "beneath" and "underneath" the second feature can be that the first feature is directly below or obliquely below the second feature, or simply means 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 "fixed to" or "disposed on" another element, it can be directly on the other element or there can also be an intermediate 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 intermediate element at the same time. If so, the terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used in this application are only for the purpose of illustration and do not represent the only implementation.

[0055] Refer to Figures 1 to 12 As shown, this application provides a multi - dosage - form dissolution and melting device, and the multi - dosage - form dissolution and melting device can be applicable to the digital detection of the dissolution time of dosage forms such as oral soluble films and orally disintegrating tablets. The multi - dosage - form dissolution and melting device includes a device base 1000, a medium reservoir 2000, a constant - temperature detection chamber 3000, a fluid driver 4000, and a sample collection chamber 5000. The device base 1000 can be provided with a power supply 1100 and a data interface 1200, etc. The power supply 1100 is used to start the multi - dosage - form dissolution and melting device, and the data interface 1200 can be used to externally connect devices such as a printer. The medium reservoir 2000 is disposed on the device base 1000, and the medium reservoir 2000 is configured to store the dissolution samples 100 to be detected (including dissolution medium or melting medium). The constant - temperature detection chamber 3000 is disposed on the device base 1000, and the inside of the constant - temperature detection chamber 3000 can use flowing air heating to achieve constant - temperature control.

[0056] Refer toFigure 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 inside of the flow cell 3100 has a cell chamber 3110, and the cell chamber 3110 is configured to accommodate the dissolution sample 100 to be detected. The number of the flow cells 3100 can be configured as several, and several flow cells 3100 are connected in parallel with each other. In addition, a flow joint 3140, a flow support 3150, a sealing cover 3160, etc. can also be provided inside the constant temperature detection chamber 3000. The flow joint 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 can be used to fixedly assemble the flow cell 3100, and the sealing cover 3160 can be used to seal the inside of the constant temperature detection chamber 3000.

[0057] The fluid driver 4000 is provided on the device base 1000. The input end of the fluid driver 4000 is connected to the medium reservoir 2000, and the output end of the fluid driver 4000 is connected to the flow cell 3100. The sample collection chamber 5000 is provided on the device base 1000. The sample collection chamber 5000 is connected to the flow cell 3100. The inside of the sample collection chamber 5000 can be maintained in a low-temperature environment, for example, before being maintained at 4°C to 8°C, it can keep thermally unstable samples stable for a long time, which is suitable for the dissolution determination of long-acting sustained-release pharmaceutical preparations, and is also suitable for drugs that cannot be detected online or are thermally unstable. The dissolution sample 100 to be detected is collected for off-line detection.

[0058] In the above multi-formulation dissolution device, the multi-formulation dissolution device can be applicable to the dissolution time of film agents, the disintegration time of orally disintegrating tablets, and the dissolution tests of various pharmaceutical formulations, such as the dissolution of oral film agents, the dissolution of transdermal patches, the disintegration of orally disintegrating tablets, the dissolution of sustained-release and controlled-release tablets, and the in vitro dissolution of in vivo implantable preparations, etc. Therefore, the dissolution sample 100 to be detected can be various different types of formulations such as oral osmotic pump tablets, sustained-release tablets, enteric-coated capsules, sustained-release capsules, transdermal patches, long-acting injection microspheres, and in vivo implants.

[0059] Since the flow cell 3100 can be detachably connected to the constant temperature detection chamber 3000, therefore, different types of flow cells 3100 for different formulations can be selectively replaced inside the constant temperature detection chamber 3000 according to the different types of the dissolution sample 100 to be detected, so that the above multi-formulation dissolution device can realize the dissolution tests of multiple formulations during the experiment.

[0060] Refer to Figure 3As shown, in one embodiment, the fluid driver 4000 includes a driving motor 4100, a plunger pump 4200, and a transmission assembly 4300. The driving motor 4100 is drivingly connected to the plunger pump 4200 through the transmission assembly 4300. By using the liquid supply method of the plunger pump 4200, the flow rate adjustment range of the above multi-dose dissolution device can be from several microliters per minute to several milliliters per minute, and the injection speed of the dissolution medium can be accurately controlled. Therefore, based on the liquid supply method of the plunger pump 4200, injecting the dissolution medium into the thermostatic flow cell 3100 can simulate the body fluid flow rates in different parts of the human body such as under the skin, in the oral cavity, gastrointestinal tract, and muscles.

[0061] In one embodiment, the transmission assembly 4300 includes a device base 4310, a fixing plate 4320, and a movable plate 4330. The plunger pump 4200 includes a pump body 4210 and a pump plunger 4220. The pump plunger 4220 is piston-assembled in the inner cavity of the pump body 4210. The pump body 4210 is connected to the fixing plate 4320, the pump plunger 4220 is connected to the movable plate 4330, and the driving motor 4100 is connected to the movable plate 4330 for driving the movable plate 4330 to move relative to the fixing plate 4320. For example, the output end of the driving motor 4100 can be connected to a moving screw 4110, and the moving screw 4110 is assembled in a threaded hole in one of the fixing plate 4320 or the movable plate 4330. When the driving motor 4100 drives the moving screw 4110 to rotate axially, the moving screw 4110 can be threadedly engaged based on the threaded hole in one of the fixing plate 4320 or the movable plate 4330, causing one of the fixing plate 4320 or the movable plate 4330 to move relative to the other, thereby controlling the relative separation or relative approach between the fixing plate 4320 and the movable plate 4330.

[0062] Therefore, as Figure 3 shown, the above multi-dose dissolution device can drive the moving screw 4110 to rotate through the driving motor 4100, use the moving screw 4110 to control the relative vertical movement between the cooperating fixing plate 4320 and movable plate 4330, and then push the pump plunger 4220 of the plunger pump 4200 to move up and down. A water inlet valve can be provided at the pump port 4230 of the plunger pump 4200 for sucking water into the inner cavity of the pump body 4210 of the plunger pump 4200. The water outlet valve provided on the plunger pump 4200 can be used to inject water into the flow cell 3100. The driving motor 4100 that controls the movement of the plunger pump 4200 can operate according to set parameters. By using the driving of the driving motor 4100, the time and accuracy can reach the second level, and the volume control of the dissolution medium can be accurate to microliters.

[0063] Refer to Figure 4 and Figure 5As shown, in one embodiment, a collection test tube 5100 and a transfer device 5200 that cooperate with each other are provided inside the sample collection chamber 5000. The transfer device 5200 includes a transfer pipe 5210 and a diversion pipe 5220 that are connected and communicate with each other. The transfer pipe 5210 is configured to communicate with the chamber 3110 of the flow cell 3100, and the diversion pipe 5220 is configured to connect to the collection test tube 5100. A waste liquid collection tank 5500 may also be provided inside the sample collection chamber 5000 for collecting waste liquid. A moving bracket 5300 and a transfer bracket 5400 may be provided inside the sample collection chamber 5000. A number of test tube mounting grooves 5310 are provided on the moving bracket 5300, and the test tube mounting grooves 5310 are configured to mount the collection test tube 5100. A number of transfer mounting holes 5410 are provided on the transfer bracket 5400, and the transfer mounting holes 5410 are configured to mount the transfer device 5200. Among them, the moving bracket 5300 is movably arranged relative to the transfer bracket 5400. Therefore, by moving the moving bracket 5300 relative to the transfer bracket 5400, different collection test tubes 5100 can be driven to move relative to the transfer device 5200, so that different collection test tubes 5100 can move to the lower part of the transfer device 5200 under expected control to receive liquid.

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

[0065] In one embodiment, a clamping mesh member 3130 is provided inside the chamber 3110 of the flow cell 3100, and the clamping mesh member 3130 is configured to clamp the dissolution sample 100 to be detected. The inside of the constant temperature detection chamber 3000 can be configured as a light-shielded space. For example, the inner wall of the constant temperature detection chamber 3000 is configured to be black to ensure the stability of the experimental environment. Opening the chamber cover of the constant temperature detection chamber 3000, the flow cell 3100 in the constant temperature detection chamber 3000 can be replaced according to different dosage forms to meet the test requirements of various pharmaceutical preparations. Constant temperature air is injected into the constant temperature detection chamber 3000. The capacity of the chamber 3110 inside the flow cell 3100 is between 0.002 liters and 5 liters, and a liquid level sensor is provided 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 an anhydrous alarm lamp, etc., to prevent problems such as equipment damage or experiment interruption caused by water shortage.

[0066] A display device 8000 may be provided on the device base 1000, and the display device 8000 may be, for example, a display screen, a touch screen, etc. This enables the above-mentioned multi-dose dissolution device to have a display screen function. The display screen can set and display a variety of parameters, including total flow, flow rate, flow / time (seconds, minutes, hours), circulation time (seconds, minutes, hours) and pause time (seconds, minutes, hours). In addition, the display screen can also display the experimental results of dissolution in real time (presented in graphical and digital form). The above-mentioned multi-dose dissolution device can also be provided with a wireless transmission function, and the experimental data and graphics can be sent to the tester's terminal, such as a mobile phone or a computer, and the tester can also remotely change parameters, start or stop the equipment operation through the terminal.

[0067] See also Figure 9 As shown, in one of the test examples, the dissolution medium can be sent out by the fluid driver 4000 and enter the cell chamber 3110 from the inlet below the circulation cell 3100. The dissolution sample 100 to be tested (such as an orodispersible film, a patch, etc.) can be set in the cell chamber 3110 of the circulation cell 3100, for example, by clamping and fixing it with a clamping mesh 3130 such as a two-layer stainless steel mesh clamp plate, a double-layer grid, etc. According to 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 using the clamping mesh 3130 can be directly placed in the corresponding circulation cell 3100.

[0068] When measuring the dissolution time or disintegration time, the dissolution medium flows in from the inlet and gradually covers the entire dissolution sample 100 to be tested, and is finally 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 above-mentioned multi-dose dissolution device can adopt different measurement technologies such as visible light measurement technology and ultraviolet light measurement technology for detection, monitor the dissolution and dissolution process in real time, and simulate the dissolution, dissolution and absorption of the preparation in various parts of the human body as much as possible, thereby providing a more scientific and accurate detection method for the dissolution and dissolution research of drug preparations.

[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 board 3210 of the constant temperature detection chamber 3000, and 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 arranged facing the photoelectric sensor 3300. The light source emitter 3200 is configured to emit a light source to the photoelectric sensor 3300. The flow cell 3100 is located between the light source emitter 3200 and the photoelectric sensor 3300. The flow cell 3100 is provided with a light penetration window 3120, and the light penetration window 3120 is configured to transmit the light source emitted by the light source emitter 3200. Among them, the light source emitter 3200 is configured as a visible light emitter, an infrared light emitter or a ultraviolet light emitter, the light source emitted by the light source emitter 3200 is configured as visible light, infrared light or ultraviolet light, and the photoelectric sensor 3300 is configured as a visible light sensor, an infrared light sensor or a ultraviolet light sensor.

[0071] Refer to Figure 10 As shown, in one embodiment, regarding the determination method of the dissolution time of the film agent and the disintegration time of the orally disintegrating tablet, the medicinal film (or called film agent) can be disposed in the cell chamber 3110 of the flow cell 3100, and is clamped and fixed, for example, by a suitable clamping mesh member 3130 such as two layers of stainless steel mesh splints or double-layer grids. The dissolution medium is injected into the flow cell 3100 at a fixed time and in a fixed amount from the inlet. The medicinal film in the clamping mesh member 3130 can block the visible light irradiated by the visible light emitter to the visible light sensor. When the dissolution medium gradually injected into the interior of the cell chamber 3110 dissolves the medicinal film in the clamping mesh member 3130, the photocurrent of the visible light sensor gradually increases. When it increases to the completion of dissolution, the photocell amount of the visible light sensor is the largest, and this is the dissolution end point of the medicinal film at this time. The visible light sensor can be used to record the entire process of this melting and display the dissolution curve, avoiding the subjective error brought by manual observation.

[0072] When measuring the disintegration time of the orally disintegrating tablet, it is necessary to replace it with a dedicated flow cell 3100 for orally disintegrating tablets. Usually, a lower flow rate is required to measure the disintegration time. When the tablet is placed inside the cell chamber 3110, it will block the visible light irradiated by the visible light emitter to the visible light sensor, resulting in a decrease or even no reading in the ammeter measurement value of the visible light sensor. At this time, the dissolution medium is injected from the inlet of the flow cell 3100 into the cell chamber 3110. As the orally disintegrating tablet gradually disintegrates, the light path of the visible light gradually recovers, and the light intensity of the visible light that the visible light sensor can detect will gradually increase until it reaches a stable state. The appearance of this stable state indicates the disintegration time of the orally disintegrating tablet.

[0073] Refer to Figure 11As shown, for the dissolution determination of film agents, transdermal patches, sustained-release tablets, osmotic pump tablets or in vivo implants, in one embodiment, the multi-formulation dissolution device includes a filter 6000. The input end of the filter 6000 is communicated with the chamber 3110 of the flow-through cell 3100, and the output end of the filter 6000 is connected to the inner transfer pipe of the sample collection chamber 5000 through an ultraviolet detector 7000. The ultraviolet detector 7000 can realize the digital on-line real-time detection of the dissolution samples. This determination method is similar to Figure 10 the film agent dissolution determination shown therein. The dissolution determination of film agents, transdermal patches, sustained-release tablets, osmotic pump tablets or in vivo implants only changes different types of dissolution flow-through cells 3100, light source emitters 3200 and photoelectric sensors 3300. The on-line detection can adopt the ultraviolet detection method, and a filter 6000 can be added. The filter 6000 can perform real-time on-line detection on the filtered dissolution solution or quantitatively collect the dissolution solution into the collection test tube 5100 according to time, and then detect it separately by methods such as liquid chromatography and fluorescence according to different methods. Those skilled in the art can select different methods, which are not limited herein.

[0074] In summary, due to the variety of testing instruments for pharmaceutical preparations, but the detection of some new preparations (such as the dissolution of film agents and the disintegration time of orally disintegrating tablets) still relies on manual visual inspection in most cases. There is currently no digital dissolution and disintegration determination device, making the existing testing methods not only inefficient, but also difficult to guarantee accuracy.

[0075] Therefore, the present application provides the above-mentioned multi-formulation dissolution device, which can be equipped with and replaced with a film agent dissolution flow-through cell 3100, an orally disintegrating tablet disintegration determination flow-through cell 3100, and flow-through cells 3100 suitable for the dissolution determination of different formulations according to the detachable structural design characteristics, and uses a plunger pump 4200 to achieve quantitative and timed liquid supply. It is not only applicable to the dissolution time determination of film agents and the disintegration time determination of orally disintegrating tablets, but also particularly applicable to detecting the dissolution process of sustained-release preparations (such as tablets, implants and transdermal patches), especially applicable to the detection of long-term dissolution, which can reduce the labor cost and improve the accuracy of the test.

[0076] Aiming at the disadvantage that the existing detection instruments can only detect a single formulation (such as tablets or patches), and multiple devices need to be equipped to meet the test requirements when detecting multiple formulations. The above-mentioned multi-formulation dissolution device can realize the detection of multiple formulations by replacing the flow-through cell 3100, greatly improving the versatility and flexibility of the device. It is not only applicable to the R & D and production processes of pharmaceutical factories, but also can be widely used in the detection scenarios of universities and testing institutions, providing an efficient and accurate solution for the dissolution and dissolution research of pharmaceutical preparations.

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

[0078] The above-described embodiments merely represent several implementation manners of the present application. The description thereof is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. A multi-dose dissolution device, characterized in that: The multi-dose dissolving device comprises: Device base; a medium reservoir, the medium reservoir being disposed on the device base and configured to store a dissolution sample to be tested; A constant temperature detection chamber, the constant temperature detection chamber is arranged on the device base, a circulation pool is arranged inside the constant temperature detection chamber, and the circulation pool is detachably connected to the constant temperature detection chamber, and the circulation pool has a cell chamber inside, and the cell chamber is configured to accommodate a dissolution sample to be detected; A fluid driver, the fluid driver is arranged on the device base, the input end of the fluid driver is connected to the medium reservoir, and the output end of the fluid driver is connected to the circulation pool; A sample collection chamber is arranged on the device base, and is used to collect and temporarily store the dissolution sample to be detected.

2. The multi-dose dissolving and dissolving device according to claim 1, characterized in that: A light source emitter and a photoelectric sensor are arranged inside the constant temperature detection chamber, the light source emitter faces the photoelectric sensor, the light source emitter is configured to emit light to the photoelectric sensor, the circulation pool is located between the light source emitter and the photoelectric sensor, the circulation pool is provided with a light penetration window, and the light penetration window is configured to transmit the light source emitted by the light source emitter.

3. The multi-dose dissolving and dissolving device according to claim 2, 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 as 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.

4. The multi-dose dissolving and dissolving device according to claim 1, characterized in that: The multi-dose dissolving device comprises: The filter has an input end connected to the cell chamber of the circulation cell, and an output end connected to the inner transfer tube of the sample collection chamber through an ultraviolet detector.

5. The multi-dose dissolving and dissolving 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; and / or, The number of the circulation cells is configured to be several, and the several circulation cells are connected in parallel.

6. The multi-dose dissolving and dissolving device according to claim 1, characterized in that: The interior of the sample collection chamber is provided with matching collection tubes and adapter devices, the adapter device includes a connecting adapter tube and a flow guide tube, the adapter tube is configured to be connected to the cell chamber of the circulation cell, and the flow guide tube is configured to guide the dissolution sample to be detected to the collection tube.

7. The multi-dose dissolving and dissolving device according to claim 6, characterized in that: A movable bracket and an adapter bracket are provided inside the sample collection chamber, the movable bracket is provided with a plurality of test tube mounting slots, the test tube mounting slots are configured for mounting the collection test tubes, the adapter bracket is provided with a plurality of adapter mounting holes, the adapter mounting holes are configured for mounting the adapter device, wherein the movable bracket is movably arranged relative to the adapter bracket.

8. The multi-dose dissolving and dissolving device according to claim 1, characterized in that: The fluid driver comprises a driving motor, a plunger pump and a transmission assembly, and the driving motor is drivingly connected to the plunger pump via the transmission assembly.

9. The multi-dose dissolving and dissolving device according to claim 8, characterized in that: 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. The drive motor is connected to the movable plate and is used to drive the movable plate to move relative to the fixed plate.

10. The multi-dose dissolving and dissolving device according to claim 1, characterized in that: A clamping mesh is provided inside the cell chamber of the circulation cell, and the clamping mesh is configured to clamp the dissolution sample to be detected; and / or, The interior of the constant temperature detection chamber is configured as a light-proof space; and / or, The inner wall of the constant temperature detection chamber is configured to be black; and / or, Constant temperature air is injected into the interior of the constant temperature detection chamber; and / or, The capacity of the cell chamber inside the circulation cell is between 0.002 liters and 5 liters; and / or, A liquid level sensor is arranged inside the cell chamber of the circulation cell.

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