Determination device for disintegration time of orally disintegrating preparation

Abstract

The utility model discloses an orally disintegrating preparation disintegration time measuring device, which belongs to the technical field of medicine detection and comprises a pressure applying component, a liquid inlet component, a measuring cup, a sample support, a rotating component, a temperature control component and a monitoring system. The pressure applying assembly comprises a testing end for extending to the sample bracket to apply pressure to the to-be-tested sample, and water outlet holes are distributed in the testing end; the liquid inlet assembly is used for transmitting a liquid medium for testing to the testing end water outlet hole; the measuring cup is used for containing a liquid medium for testing, and a sample support is arranged on the inner wall of the measuring cup and is of a screen structure. The rotating assembly is used for stirring the liquid medium in the measuring cup; the temperature control assembly is used for regulating and controlling the temperature of the liquid medium for testing; the monitoring system is a resistance monitoring system or a moving distance monitoring system. The device disclosed by the utility model can be used for more accurately, conveniently and automatically measuring the disintegration time of the orally disintegrating preparation.

Description

Technical Field

[0001] The utility model belongs to the technical field of drug detection, and particularly relates to a device for measuring the disintegration time of orally disintegrating preparations. Background Art

[0002] Orally disintegrating preparations (including orally disintegrating tablets, orally disintegrating films, etc.) refer to preparations that can rapidly disintegrate or dissolve in the oral cavity without the need for water. They have the advantages of rapid disintegration in the oral cavity, convenient administration, no need for water, and rapid onset of action, and are widely welcomed in clinical practice. The disintegration speed of orally disintegrating preparations is one of their core characteristics and an important indicator for evaluating their quality. The speed of disintegration directly affects the absorption rate and bioavailability of drugs. At present, each country's pharmacopoeia examines the disintegration speed through <Disintegration Time Limit Inspection>, but there are usually problems such as a large difference from the actual oral administration environment, being unable to truly reflect the disintegration behavior of orally disintegrating preparations in the oral cavity, and being unable to accurately measure the disintegration time of orally disintegrating preparations.

[0003] The disintegration process of orally disintegrating preparations is closely related to factors such as the temperature, medium, tongue agitation, and oral closing pressure of the disintegration environment. The detection of the disintegration speed or disintegration time usually needs to be carried out under specific conditions. Some researchers have developed test devices that simulate the oral environment for measuring the disintegration process. For example, the Chinese patent document with the publication number CN116008490A discloses an orally disintegrating tablet disintegration measurement device and a measurement method that can simulate the oral environment. The device includes a medium cup, a sample basket for placing the sample to be tested, a pressure control system, and a water circulation control system; this patent uses the test end of the pressure control system to simulate the resistance of the oral palate; the outer peripheral screen of the sample basket simulates the dispersion path of disintegrating particles; the medium cup simulates the saliva volume in the oral cavity; the water circulation control system simulates the wetting of the tablet by the oral maxilla, the agitation of the oral liquid by the tongue, and the flushing effect on the sample to be tested. The Chinese patent document with the publication number CN209894801U discloses a disintegrator, which includes a constant temperature water bath, a disintegration cup, and a lifting mechanism. An elastic bag and a transparent oral palate imitation are arranged in the disintegration cup. The side wall of the oral palate imitation is fixedly connected to the side wall of the disintegration cup. The oral palate imitation is provided with a water inlet hole and a medicine inlet hole. This disintegrator simulates the movement of the orally disintegrating tablet in the oral cavity and improves the accuracy of disintegration time limit detection.

[0004] The above-mentioned existing technologies simulate the disintegration environment of orally disintegrating preparations in multiple dimensions, but there are problems such as a complex structure composition of the water control system, high requirements for water flow control, and high requirements for the accuracy of disintegration end point determination. Summary of the Utility Model

[0005] In order to solve the deficiencies existing in the prior art, the utility model provides a device for measuring the disintegration time of orally disintegrating preparations, which can more accurately, conveniently, and automatically measure the disintegration time of orally disintegrating preparations.

[0006] The specific technical solution adopted is as follows:

[0007] An apparatus for measuring the disintegration time of an orally disintegrating preparation, comprising a pressure application assembly, a liquid inlet assembly, a measuring cup, a sample holder, a rotation assembly, a temperature control assembly, and a monitoring system;

[0008] The pressure application assembly includes a test end for extending towards the sample holder to apply pressure to the sample to be tested, and water outlet holes are distributed on the test end; the liquid inlet assembly is used to transfer the test liquid medium to the water outlet holes of the test end.

[0009] The measuring cup is used to hold the test liquid medium, and a sample holder is provided on the inner wall. The sample holder is a mesh structure.

[0010] The rotation assembly is used to stir the liquid medium in the measuring cup.

[0011] The temperature control assembly is used to regulate the temperature of the test liquid medium.

[0012] The monitoring system selects a resistance monitoring system or a moving distance monitoring system. The resistance monitoring system includes a power supply, a resistance recorder, and wires. The power supply is connected to the pressure application assembly and the mesh through the wires, and the resistance recorder records the resistance value between the pressure application assembly and the mesh; the moving distance monitoring system includes a distance recorder installed on the pressure application assembly for recording the descending height of the pressure application assembly.

[0013] The pressure application assembly includes a stepping motor and a screw rod shaft, and can apply a controllable pressure to the sample to be tested through the test end, simulating the extrusion force of the upper jaw and tongue in the oral cavity on the sample to be tested.

[0014] Further, the range of the applied pressure is 0.1 - 10 N.

[0015] Optionally, the end face of the test end in contact with the sample to be tested is circular, square, irregular, etc., depending on the shape of the sample to be tested.

[0016] The liquid inlet assembly includes a conveying device and a connecting pipe. The conveying device transfers the test liquid medium to the water outlet holes of the test end through the connecting pipe, and the liquid medium flows out through the water outlet holes to moisten the sample to be tested, simulating the moistening effect of the saliva in the upper jaw.

[0017] The bottom diameter of the measuring cup is 5 - 100 mm, and there are openings on the side wall. The aperture of the openings is 0.1 mm - 10 mm. The openings on the side wall are used to keep the volume of the liquid medium in the measuring cup constant.

[0018] Preferably, the measuring cup is of a cylindrical structure, with a bottom diameter of 16 mm, the height of the openings on the side wall is 10 mm from the bottom of the cup, the diameter of the openings is 2 - 5 mm, and the measuring cup can hold about 2 ml of liquid medium.

[0019] Preferably, the sample holder is a 24-mesh sieve with a pore size of 710 μm, and the sample holder is installed on the plane at the position of the side wall opening or the plane 0.1 - 5 mm below the side wall opening.

[0020] Furthermore, the installation height of the sample holder is lower than the height of the side wall opening, so that the part of the sample to be tested on the sample holder is partially immersed in the liquid medium.

[0021] The rotation assembly includes a magnetic stir bar and a motor that generates a rotating magnetic field. The magnetic stir bar is placed inside the measuring cup and rotates under the action of the rotating magnetic field to drive the liquid medium in the measuring cup to flow, thereby simulating the shear force of saliva and the tongue on the sample to be tested.

[0022] The disintegration time of a tablet is generally observed by the naked eye. The disappearance of the tablet shape indicates the completion of disintegration, and the time used is the disintegration time. However, the measuring cup in this device is small in volume, and the orally disintegrating preparation contains many water-insoluble components, making the liquid turbid, which is not conducive to the naked eye to determine whether the disintegration is completed. The introduction of the monitoring system (resistance monitoring system or moving distance monitoring system) solves this problem well. The disintegration of the sample to be tested is judged by measuring the resistance or the moving distance. When the sample to be tested disintegrates, the resistance value drops sharply, or the descending distance of the pressing assembly is the largest and no longer changes, so as to judge whether the disintegration is completed.

[0023] Compared with the prior art, the beneficial effects of the present utility model are as follows:

[0024] The device provided by the present utility model can simulate the oral environment in multiple dimensions. 1) With the help of the stepper motor and the screw rod shaft, a controllable pressure can be applied to the sample to be tested through the test end, and the pressure can be finely adjusted, which is easy to achieve in industrial manufacturing; 2) The introduction of the rotation assembly can form water flow agitation, generating a large scouring shear force on the sample to be tested, simulating the action of saliva and the tongue on the sample to be tested, which is easy to achieve in industrial manufacturing and has good detection effects; 3) The device determines the disintegration end point by the change of the resistance value or the change of the moving distance, replacing the naked eye observation, which can realize the automation, accuracy and standardization of monitoring, and improve the accuracy of detection. Description of the Drawings

[0025] Figure 1 It is a schematic structural diagram of the device for measuring the disintegration time of the orally disintegrating preparation of the present utility model;

[0026] Figure 2 It is a schematic structural diagram of the measuring cup part;

[0027] Figure 3 It is a schematic structural diagram of the resistance monitoring system part.

[0028] Reference numerals: 1, liquid inlet assembly; 11, conveying device; 12, connecting pipe; 2, pressure applying assembly; 21, test end; 22, water outlet hole; 3, resistance monitoring system; 31, constant voltage power supply; 32, resistance recorder; 33, wire; 34, detection probe; 4, measuring cup; 41, side wall opening; 5, sample holder; 6, rotating assembly; 61, magnetic stirrer; 62, magnetic stirrer; 7, temperature control assembly; 8, support member. Detailed implementation manners

[0029] The present utility model will be further illustrated below in conjunction with embodiments and the accompanying drawings. It should be understood that these embodiments are only used to illustrate the present utility model and not to limit the scope of the present utility model.

[0030] The monitoring assembly will take the resistance monitoring system as an example to illustrate the content of the present utility model. As Figure 1 shown, a device for measuring the disintegration time of orally disintegrating preparations includes a liquid inlet assembly 1, a pressure applying assembly 2, a measuring cup 4, a sample holder 5, a rotating assembly 6, a temperature control assembly 7, a resistance monitoring system 3 and a support member 8;

[0031] The liquid inlet assembly 1 includes a conveying device 11 and a connecting pipe 12. The conveying device 11 is a peristaltic pump. The conveying device 11 transmits the externally temperature-controlled test liquid medium to the water outlet hole 22 of the test end through the connecting pipe 12. The connecting pipe 12 can be a 3*5mm silicone tube, and the rotation speed of the peristaltic pump is controlled within the range of 0-100 rpm; the liquid medium flows out through the water outlet hole 22 and wets the sample to be tested from above, simulating the wetting effect of the maxillary saliva.

[0032] The pressure applying assembly 2 includes a test end 21 for extending towards the sample holder to apply pressure to the sample to be tested. The water outlet holes 22 are distributed on the test end 21; the pressure applying assembly 2 further includes a stepping motor and a screw rod shaft. One end of the screw rod shaft is connected to the stepping motor, and the other end is connected to the test end. The stepping motor drives the screw rod shaft to apply a pressure in the range of 0.1-10 N to the sample to be tested through the test end 21, simulating the pressure of the maxilla and tongue in the oral cavity on the sample to be tested. The end face of the test end 21 in contact with the sample to be tested can be set to a circular, square or irregular shape according to the properties of the sample to be tested (circular is suitable for the detection of orally disintegrating tablets).

[0033] The measuring cup 4 is used to hold the test liquid medium. It has a cylindrical structure with a bottom diameter of 16 mm. There are openings on the side wall. The height of the side wall opening 41 is 10 mm from the bottom of the cup, and the opening diameter is 2 - 5 mm. The side wall opening 41 is used to keep the volume of the liquid medium in the measuring cup constant. The measuring cup 4 can hold about 2 ml of liquid medium. Inside the inner wall of the measuring cup 4, there is a sample holder 5 with a sieve structure. The height of the sample holder 5 from the bottom of the measuring cup is 7 - 10 mm, and it is detachable to replace different pore sizes. Specifically, a 24 - mesh sieve is preferably used, with a pore size of 710 μm. The sample holder 5 is installed 0.1 - 5 mm below the side wall opening 41. During the test, the sample to be tested is placed on the sample holder 5. After installing the measuring cup 4, there is a distance of 0 - 3 mm between the sample holder 5 and the top of the liquid medium surface, which can partially wet the sample to be tested and avoid complete immersion.

[0034] The rotating assembly 6 is used to stir the liquid medium in the measuring cup 4. The rotating assembly 6 includes a magnetic stir bar 61 and a magnetic stirrer 62 with a motor. As Figure 2 shown, the measuring cup 4 is placed on the magnetic stirrer 62, and the magnetic stir bar 61 is placed at the bottom inside the measuring cup 4, below the sample to be tested. After the magnetic stirrer 62 is started, a magnetic field is generated. The magnetic stir bar 61 rotates under the action of the rotating magnetic field, driving the agitation of the liquid medium, generating a water flow shear effect, simulating saliva flushing and tongue friction shear.

[0035] The temperature control assembly 7 is used to regulate the temperature of the test liquid medium;

[0036] The disintegration of tablets is usually observed by the naked eye. The disappearance of the tablet shape indicates the completion of disintegration, which is greatly affected by the subjective factors of the observer. The device of the present utility model introduces a resistance monitoring system 3 to objectively judge whether the sample to be tested has completed disintegration. The resistance monitoring system 3 includes a constant - voltage power supply 31; a resistance recorder 32; a wire 33; and two detection probes 34. The first detection probe is connected to the test terminal 21, and the second detection probe is connected to the fixed interface of the sample holder 5. A voltage is applied across the sample to be tested through the constant - voltage power supply, and the resistance value between the test terminal 21 and the sample holder 5 is detected by the detection probe 34. The resistance recorder 32 records the resistance. As the sample to be tested disintegrates, the distance between the test terminal 21 and the sample holder 5 shortens, the water content of the spacer gradually increases, and the resistance changes accordingly, and stops changing after complete disintegration. According to the change of the resistance value, it can be determined whether the disintegration of the sample to be tested is completed, and the corresponding disintegration time is recorded.

[0037] The device of the present utility model accurately, conveniently, and automatically measures the disintegration time of orally disintegrating tablets through a mechanical - physical process, simulates the oral environment from multiple dimensions, measures the disintegration behavior of orally disintegrating tablets under near - real conditions, can establish an in - vitro disintegration determination method for orally disintegrating tablets with a stronger in - vivo and in - vitro correlation, and provides a new technical route for effectively evaluating the quality of orally disintegrating tablets.

[0038] The specific method for using the disintegration time measuring device for orodispersible tablets comprises the following steps: (1) Turn on the temperature control component and adjust the temperature of the test liquid medium to reach 35°C to 38°C; (2) Install the liquid inlet component 1, the pressure application component 2 and the rotating component 6. After the temperature is stable, conduct a trial operation. After the above system runs stably, proceed to the next step; (3) Install the detection probes 34 of the resistance monitoring system 3 on the test end 21 and the sample holder 5 respectively. After the measuring cup 4 is fixed, connect the circuit and conduct a trial operation. Record the resistance value change curve when there is no sample and adjust the output voltage of the constant voltage power supply 31; (4) The test liquid medium is water or buffer salt solution. Add the liquid medium into the measuring cup 4 until the medium flows out from the opening. At this time, the liquid level height is about 2 mm away from the sample holder 5; Place the sample to be tested in the measuring cup 4. The diameter of the sample to be tested should be ≤ 10 mm; (5) After adjusting the height of the screw rod shaft until the test end 21 contacts the sample to be tested, turn on the peristaltic pump of the conveying device 11, the magnetic stirrer 62 and the stepping motor of the pressure application component 2. Adjust the water flow rate, stirring speed and pressure magnitude, observe the change of the resistance value and judge the completion of disintegration, and record the disintegration time.

[0039] The above-described embodiments have elaborated on the technical solutions of the present invention in detail. It should be understood that the above are only specific embodiments of the present invention and are not used to limit the present invention. Any modifications, supplements or substitutions in a similar manner within the principle scope of the present invention shall be included within the protection scope of the present invention.

Claims

1. An apparatus for measuring the disintegration time of an orally disintegrating preparation, characterized in that, It includes a pressure application component, a liquid inlet component, a measuring cup, a sample holder, a rotation component, a temperature control component and a monitoring system; The pressure application component includes a test end for extending towards the sample holder to apply pressure to the sample to be tested, and water outlet holes are distributed on the test end; the liquid inlet component is used to transport the test liquid medium to the water outlet holes of the test end; The measuring cup is used to hold the test liquid medium, and a sample holder is provided on the inner wall. The sample holder is a screen structure; The rotation component is used to stir the liquid medium in the measuring cup; The temperature control component is used to regulate the temperature of the test liquid medium; The monitoring system selects a resistance monitoring system or a moving distance monitoring system. The resistance monitoring system includes a power supply, a resistance recorder and a wire. The power supply is connected to the pressure application component and the screen through the wire, and the resistance recorder records the resistance value between the pressure application component and the screen; the moving distance monitoring system includes a distance recorder, which is installed on the pressure application component and is used to record the descending height of the pressure application component.

2. The disintegration time measuring device for the orally disintegrating preparation according to claim 1, characterized in that, The pressure application component includes a stepping motor and a screw rod shaft, and can apply a pressure in the range of 0.1 - 10 N to the sample to be tested through the test end.

3. The apparatus for measuring the disintegration time of the orally disintegrating preparation according to claim 1, wherein The end face of the test end in contact with the sample to be tested is circular, square or irregular in shape.

4. The disintegration time measuring device for the orally disintegrating preparation according to claim 1, wherein The liquid inlet component includes a conveying device and a connecting pipe. The conveying device transports the test liquid medium to the water outlet holes of the test end through the connecting pipe.

5. The disintegration time measuring device for the orally disintegrating preparation according to claim 1, wherein, The bottom diameter of the measuring cup is 5 - 100 mm, and there are openings on the side wall. The aperture of the openings is 0.1 mm - 10 mm. The openings on the side wall are used to keep the volume of the liquid medium in the measuring cup constant.

6. The disintegration time measuring device for orally disintegrating preparations according to claim 5, characterized in that, The sample holder selects a 24 - mesh screen, and the sample holder is installed on the plane at the position of the opening on the side wall or the plane 0.1 - 5 mm below the opening on the side wall.

7. The apparatus for measuring the disintegration time of the orally disintegrating preparation according to claim 5, wherein The installation height of the sample holder is lower than the height of the opening on the side wall, so that the part of the sample to be tested on the sample holder is immersed in the liquid medium.

8. The disintegration time measuring device for the orally disintegrating preparation according to claim 1, characterized in that, The rotation component includes a magnetic stir bar and a motor that generates a rotating magnetic field. The magnetic stir bar is placed in the measuring cup and rotates under the action of the rotating magnetic field to drive the liquid medium in the measuring cup to flow.

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