JP4847263B2 - Disintegration test apparatus and disintegration test method - Google Patents

Description

  The present invention relates to a disintegration test apparatus and a disintegration test method for evaluating the disintegration property of a sample tablet, and particularly to a disintegration test apparatus and a disintegration test method for a so-called orally disintegrating tablet that disintegrates rapidly in the oral cavity.

  Conventionally, a disintegration test apparatus defined by the Japanese Pharmacopoeia has been used for evaluating the disintegration of sample tablets. This disintegration test apparatus assumes the disintegration of the sample tablet in the stomach, and disintegrates the sample tablet by immersing the sample tablet in the test solution. On the other hand, tablet disintegration in the actual oral cavity depends on a small amount of water such as saliva and a slight rubbing force between the tongue and the upper jaw. Therefore, when evaluating a so-called orally disintegrating tablet that rapidly disintegrates in the oral cavity using this disintegration test apparatus, the orally disintegrating tablet is one that has changed over time or stored under high conditions such as temperature and humidity. In some cases, the time taken for the collapse may be faster than it actually is, or it may be very delayed.

Therefore, as a disintegration test device, a holder (mounting plate) for placing the sample tablet near the liquid surface of the test solution filled in the test tank, and a presser for pressing the sample tablet placed on the receiver from above. (For example, refer to Patent Document 1). In such a disintegration test apparatus, the presser is rotated while the sample lock is sandwiched between the receiver and the presser, and a frictional force is applied to the sample lock.
JP 2004-233332 A

  By the way, in recent years, there has been a strong demand for an efficient evaluation test of sample tablets, and development of a disintegration test apparatus capable of evaluating a plurality of sample tablets at once in a space-saving manner is required. In addition, depending on the sample tablet, disintegrated sample tablet particles (disintegrated particles) adhere to the sample tablet or the mounting plate in a slurry state, and frictional force is not sufficiently applied to the sample tablet by the disintegrating particles, or the mounting is performed. The through-holes in the plate may become clogged, which becomes significant when evaluating relatively large orally disintegrating tablets.

  Accordingly, an object of the present invention is to provide a disintegration test apparatus that can sufficiently and efficiently apply a frictional force to a sample tablet and evaluate the disintegration property of the sample tablet.

  In order to achieve the above object, a disintegration test apparatus according to the present invention is a disintegration test apparatus that disintegrates a sample tablet by bringing the sample tablet into contact with a test solution, and a mounting surface on which a plurality of sample tablets are mounted. A plate having a plurality of through-holes for accommodating the sample lock, and a weight for pressing the sample lock against the plate, at least of the plate and the plate. One is characterized in that it can be moved relative to the other in the direction along the mounting surface.

  When disintegrating a sample tablet by the disintegration test apparatus according to the present invention, a plate is disposed on the upper surface side of the mounting plate, and a plurality of sample tablets are accommodated in a plurality of through holes formed in the plate and are mounted on the mounting plate. Place the sample lock against the placement plate with a weight. Here, at least one of the mounting plate and the plate is configured to be movable relative to the other. Therefore, for example, in a state where the mounting plate is positioned near the liquid surface of the test solution and the sample tablet is brought into contact with the test solution, by moving at least one of the mounting plate and the plate relative to the other, A frictional force is generated on the mounting plate side of the plurality of sample tablets, and it can be as if pressure by the tongue or upper jaw is being applied to the sample tablets in the presence of saliva.

  At this time, since a plurality of sample tablets are accommodated by the through holes of the plate as described above, the positional relationship of the sample tablets can be maintained during such movement, and the sample tablets are in contact with each other. Can be suppressed. That is, it is possible to accurately evaluate a plurality of sample tablets at a time in a space-saving in vitro test system simulating the oral cavity. Furthermore, since the contact area between the mounting plate and the sample tablet is always changed by such movement, it is possible to generate a frictional force on the sample tablet in the region where the collapsing particles are not attached on the mounting plate. As a result, compared to, for example, the case where the sample tablet is rotated on the spot and the frictional force is applied, sufficient frictional force due to the collapsing particles cannot be applied to the sample tablet, or the through hole of the mounting plate is clogged. In addition, the mounting plate has an effect (cleaning effect) of cleaning the disintegrated particles attached by the test liquid. Therefore, according to the present invention, it is possible to load the sample tablet with sufficient and efficient frictional force and to evaluate the disintegration property of the sample tablet.

  The mounting plate is preferably a hole plate provided with a through hole. In this case, by supplying the test solution through the through-hole, the above-described cleaning effect is effectively exhibited, and a frictional force can be effectively generated in the sample tablet by the edge of the through-hole.

  Moreover, it is preferable to further comprise an immersion block immersed in the test solution, and the immersion block is configured to have a variable volume immersed in the test solution. In this case, for example, the volume of the immersion block immersed in the test solution while the sample tablet is disintegrated while the mounting plate is positioned near the liquid surface of the test solution and the sample tablet is in contact with the test solution. Can be increased over time, and the height of the liquid level can be changed over time. This makes it possible to reproduce a process in which saliva is gradually secreted in the oral cavity and the amount of saliva staying in the oral cavity increases.

  Moreover, it is preferable that at least one of the mounting plate and the plate is configured to be movable relative to the other at least by a distance corresponding to the size of the sample tablet. In this case, by moving at least one of the mounting plate and the plate by a distance corresponding to at least the size of the sample tablet, friction force is generated in the sample tablet in the region where the collapsing particles are not attached on the mounting plate. It becomes even more possible. Therefore, it is possible to further prevent the sample tablet from being loaded with sufficient frictional force due to the disintegrating particles.

  Moreover, it is preferable that the plurality of through holes formed in the plate accommodate the sample tablet and at least a part of the weight. In this case, when moving at least one of the mounting plate and the plate with respect to the other, the positional relationship between the sample lock and the weight can be maintained, and the sample lock can be reliably pressed against the mounting plate by the weight. it can. Further, in this case, for example, a plurality of weights are provided, and even if each weight presses the sample lock against the mounting plate, the weights maintain the positional relationship and the weights come into contact with each other during such movement. This can also be prevented. That is, it is possible to stably and surely press the placed sample lock against the placing plate, and to reliably generate a frictional force on the sample lock.

  Moreover, it is preferable that the rib is provided in the periphery of the through-hole in the plate. In this case, the periphery of the through hole in the plate exhibits a rib structure that protrudes upward when the plate is disposed on the upper surface side of the mounting plate. Therefore, when moving at least one of the mounting plate and the plate with respect to the other, the positional relationship of the weights is maintained, and the weights are further prevented from coming into contact with each other. The effect that the sample lock is stably and surely pressed against the mounting plate and the friction force is surely generated in the sample lock is suitably exhibited.

  The disintegration test method according to the present invention is a disintegration test method in which a sample tablet is brought into contact with a test solution to disintegrate the sample tablet, and a plurality of penetrations are formed in a plate disposed on the upper surface side of the mounting plate. A plurality of sample locks are respectively accommodated in the holes, a step of placing the plurality of sample tablets on the placement surface of the placement plate, and the placement plate and the sample lock while pressing the sample lock against the placement plate, A step of disintegrating the sample tablet by moving at least one of the plates relative to the other in a direction along the mounting surface, and a step of detecting the completion of the disintegration of the sample tablet. To do.

  In this disintegration test method according to the present invention, for example, in a state where the mounting plate is positioned near the liquid surface of the test liquid and the sample tablet is brought into contact with the test liquid, a plurality of plates are arranged on the upper surface side of the mounting plate. A plurality of sample locks are respectively stored in the formed through holes, and the sample locks are placed on the placement surface of the placement plate. Then, while pressing the plurality of sample tablets against the mounting plate, at least one of the mounting plate and the plate is relatively moved in the direction along the mounting surface with respect to the other to collapse the plurality of sample tablets. Finally, it is detected that the disintegration of the sample tablet is complete. As a result, friction force can be generated on the mounting plate side of these sample tablets in a state where a plurality of sample tablets are in contact with the test solution, and pressure from the tongue or upper jaw is applied to the sample tablets in the presence of saliva. It can be in the state of adding.

  At this time, since a plurality of sample tablets are accommodated by the through holes of the plate as described above, the positional relationship of the sample tablets can be maintained during such movement, and the sample tablets are in contact with each other. Can be suppressed. That is, it is possible to accurately evaluate a plurality of sample tablets at a time in a space-saving in vitro test system simulating the oral cavity. Furthermore, since the contact area between the mounting plate and the sample tablet is always changed by such movement, it is possible to generate a frictional force on the sample tablet in the region where the collapsing particles are not attached on the mounting plate. Thus, for example, compared to the case where the sample tablet is rotated on the spot and a frictional force is applied, it is possible to prevent the sample tablet from being loaded with a sufficient frictional force due to the collapsing particles, and the mounting plate. Has the effect of cleaning the collapsing particles attached by the test solution (cleaning effect), and the through holes of the mounting plate are not clogged with the collapsing particles. Therefore, according to the present invention, it is possible to load the sample tablet with sufficient and efficient frictional force and to evaluate the disintegration property of the sample tablet.

  In the step of disintegrating the sample tablet, the height of the liquid surface of the test liquid is changed by immersing at least a part of the block having a predetermined volume in the test liquid and changing the immersion volume over time. It is preferable. In this way, by changing the height of the liquid level over time in the process of disintegrating the sample tablet, the saliva is gradually secreted in the oral cavity and the process of increasing the amount of saliva staying in the oral cavity is reproduced. It becomes possible.

  According to the present invention, it is possible to load the sample tablet with sufficient and efficient frictional force and evaluate the disintegration of the sample tablet, and saliva is gradually secreted in the oral cavity and stays in the oral cavity. It is possible to reproduce the process of increasing the amount.

  Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the description of the drawings, the same elements are denoted by the same reference numerals, and redundant descriptions are omitted.

[First Embodiment]
First, a disintegration test apparatus according to a first embodiment of the present invention will be described with reference to FIGS. FIG. 1 is a schematic configuration diagram of a disintegration test apparatus according to the present invention, FIG. 2 is a partial cross-sectional enlarged view of the disintegration test apparatus of FIG. 1, and FIG. 3 is a diagram showing a plate of the disintegration test apparatus of FIG. is there. The disintegration test apparatus is for evaluating the disintegration property of sample tablets. Examples of sample tablets include internal tablets, oral tablets, external tablets, chewable tablets, orally disintegrating tablets (OD tablets), half tablets Examples include solid preparations and sustained-release tablets (sustained release tablets). The disintegration test apparatus 10 of the present embodiment is used for an oral disintegration test for evaluating the disintegration property of a so-called orally disintegrating tablet that disintegrates rapidly in the oral cavity.

  As shown in FIGS. 1 to 3, the disintegration test apparatus 10 includes a test tank 3 in which a test solution 2 is stored, a hole plate (mounting plate) 4 on which a sample tablet D which is an orally disintegrating tablet is placed. The plate 13 disposed on the upper surface side of the hole plate 4, a plurality of weights 5 for pressing the sample lock D against the hole plate 4, and a detector 6 for detecting that the disintegration of the sample lock D is completed. And.

  As shown in FIG. 1, for example, a beaker having a capacity of 600 ml is used in the test tank 3, and the test solution 2 that is neutral purified water corresponding to saliva is stored therein. Here, about 430 ml of the test liquid 2 is stored. A heater 7 such as a pipe heater is provided in the test tank 3, and the test solution 2 is maintained at 37 ° C. by PID control.

  In addition, the test tank 3 includes a liquid level adjustment unit (immersion block) 11 and a discharge tube 12 that are movable in the vertical direction. The liquid level adjustment unit 11 includes the main body 11a, and adjusts the height of the liquid level 2a of the test liquid 2 by adjusting the capacity of the main body 11a soaking in the test liquid 2 by moving in the vertical direction. The volume and shape of the main body 11a are appropriate according to the shape and volume of the test tank 3, the test conditions of the disintegration test, and the like. Here, the main body 11a has a rectangular parallelepiped shape. The discharge tube 12 includes a discharge port 12a. By discharging the test solution 2 from the discharge port 12a to the outside, the storage amount is adjusted so that the liquid level 2a of the test solution 2 does not exceed a certain height. Here, the discharge port 12a is located slightly below the height position where the hole plate 4 is disposed in the test tank 3, so that the liquid surface 2a of the test liquid 2 does not contact the hole plate. .

  The hole plate 4 is made of a conductive material such as stainless steel and has a rectangular plate shape when viewed from above. The hole plate 4 is supported by a support member 4 a and is fixed in the test chamber 3. As shown in FIG. 2, the hole plate 4 has the sample lock D placed on the surface (mounting surface) 8 thereof. A plurality of through holes 9 penetrating from the front surface 8 to the back surface are formed in the hole plate 4 by, for example, photoetching. In addition, the diameter of this through-hole 9 can select various diameters according to the magnitude | size and kind of sample lock, and should just be a magnitude | size which a sample lock does not fall from the said through-hole 9. FIG.

  As shown in FIG. 3A, the plate 13 is formed of, for example, an acrylic resin, and has an outer shape of a rectangle when viewed from the surface 13a. Six through holes 16 are formed in the plate 13 from one end in the longitudinal direction toward the other end. The through-hole 16 has a circular shape when viewed from the surface 13a. The through hole 16 is formed in an appropriate size so as to correspond to the sample tablet D. Here, the diameter of the through hole 16 is slightly larger than that of the sample tablet D. The through-hole 16 may have a rectangular shape or a polygonal shape as viewed from the surface 13a according to the shape of the sample tablet or the like, or from the viewpoint of manufacturing simplification.

  As shown in FIG. 2, the through-hole 16 penetrates from the front surface 13a of the plate 13 to the back surface, and accommodates the sample tablets D therein. Further, the plate 13 is formed to be thicker than the sample tablet D, whereby at least a part of the weight 5, that is, the lower end portion of the weight 5 is also accommodated in the through-hole 16 (details will be described later).

  Alternatively, the through holes 16 may be formed in a plurality of rows without being formed in a row from one end to the other end in the longitudinal direction of the plate. For example, in the plate 17 as shown in FIG. 3B, the through holes 16 are alternately formed in two rows so as not to overlap in the lateral direction from one end to the other end in the longitudinal direction of the plate. Moreover, as shown in FIG.3 (c), the plate 18 may exhibit circular shape seeing from the surface. A through hole 16 is formed along the circumferential direction of the plate 13. Even in these cases, the sample tablets D are accommodated in the respective through holes 16.

  Returning to FIG. 1, the plate 13 is slidably disposed on the surface 8 of the hole plate 4, and a driving device 19 is coupled to the plate 13. As shown in FIGS. 1 and 2A, the driving device 19 reciprocates the plate 13 relative to the hole plate 4 in the direction A along the surface 8 of the hole plate 4. That is, the plate 13 is configured to be movable relative to the hole plate 4 in the direction along the surface 8. The driving device 19 drives the plate 13 in the direction A by a distance equal to or larger than the size of the sample tablet D. As the drive device 19, for example, a motor having a crank mechanism is used. The width in the direction A of the hole plate 4 corresponds to the driving distance of the driving device 19 so that the placed sample lock D does not fall out of the hole plate 4 when the plate 13 moves. On the other hand, the plate 13 is arranged at a position where the sample lock D placed when the plate 13 moves on the surface 8 of the hole plate 4 does not fall out of the hole plate 4.

  The weight 5 applies a load to the sample lock D by its own weight and presses the sample lock D against the hole plate 4. Specifically, the lower end of each weight 5 is accommodated in the through hole 16 of the plate 13, and its one end surface 5 a is brought into contact with the sample lock D placed on the surface 8 of the hole plate 4 to thereby reduce the weight. A self-weight of 5 is loaded on each sample tablet D. The weight 5 has a cylindrical shape, and its outer dimension is slightly smaller than the through hole 16 of the plate 13 described above. In other words, the through hole 16 is formed in an appropriate size so as to correspond to the weight 5, that is, the diameter of the through hole 16 is slightly larger than that of the weight 5. Thereby, the weight 5 is suitably accommodated in the through hole 16. The mass of the weight 5 is 10 g, for example. Various weights may be used depending on the sample tablet and test conditions, and the weight may be 15 g or 20 g.

  The weight 5 has a conductive portion 14 made of stainless steel or the like as a conductive material, and an insulating portion 15 made of resin or the like as an insulating material. The conducting portion 14 is configured by sandwiching the insulating portion 15 in the direction along the one end face 5a. In other words, the weight 5 is divided by the insulating portion 15 at the center in the direction along the one end face 5a. Thereby, the conduction parts 14 and 14 are insulated from each other by the insulating part 15. The detectors 6 are electrically connected to the conduction portions 14 respectively. The detector 6 detects that the disintegration of the sample tablet D has been completed by energization between the conduction parts 14 and 14. Here, an electric resistance meter that measures the resistance between the conduction parts 14 and 14 is used. Yes.

  For example, a sponge, rubber, or the like is provided in a region in contact with the sample lock D on the one end surface 15 a of the insulating portion 15. Thereby, when pressing the sample lock D with the weight 5, the weight 5 and the sample lock D are closely_contact | adhered, and the shift | offset | difference of the horizontal direction of the sample lock D is controlled. Note that the contact region may be a region having a rough surface roughness or a region having high adhesiveness.

  When measuring the disintegration time of the sample tablet D using the disintegration test apparatus 10, first, the test liquid 2 is prepared, and the liquid surface 2 a of the test liquid 2 comes into contact with the discharge port 12 a in the discharge tube 12 or is discharged. An amount higher than the outlet 12 a is stored in the test tank 3. At this time, the hole plate 4, the plate 13, and the weight 5 are removed so as not to get wet with the test solution 3.

  Subsequently, by sucking out the test liquid 2 with the discharge tube 12, the liquid surface 2 a of the test liquid 2 is positioned below the vicinity of the hole plate 4 when the hole plate 4 is attached. That is, until the position of the liquid surface 2a of the test liquid 2a is such that when the hole plate 4 is attached, the hole plate 4 and the test liquid 2 are not in contact with each other, the test liquid 2 is used using the discharge tube 12. Discharge from test chamber 3.

  Subsequently, the hole plate 4 and the plate 13 are attached, and each of the six sample tablets D is put into the plurality of through holes 16 formed in the plate 13 so that the sample tablets D are accommodated in the plate 13 and on the surface 8 of the hole plate 4 The sample lock D is placed, and the weight 5 is placed from above the sample lock D (FIG. 2A).

  Subsequently, the surface 8 of the hole plate 4 is infiltrated with the test liquid 2 by immersing at least a part of the main body 11 a of the liquid level adjusting unit 11 in the test liquid 2. At the same time, the drive device 19 moves the plate 13 relative to the hole plate 4 in the direction A, and starts the measurement of the collapse time with the detector 6 (FIG. 2B).

  When the collapse is completed, the weight 5 and the hole plate 4 come into contact with each other, and the conductive portions 14 and 14 are electrically connected (energized) through the hole plate 4 (FIG. 2C). Thereby, the signal which alert | reports completion | finish of decay | disintegration by the detector 6 is detected automatically, As a result, decay | disintegration time is measured. As described above, friction force can be generated on the side of the hole plate 4 of the sample tablets D in a state where the sample tablets D are in slight contact with the liquid surface 2a of the test solution, as if the tongue and upper jaw are in the presence of saliva. It becomes possible to apply the pressure by the above to the sample tablet D so that the sample tablet D is disintegrated.

  At this time, the disintegration test apparatus 10 has the liquid level adjustment part 11 which can move to an up-down direction as mentioned above. Therefore, while measuring the disintegration time of the sample tablet D, the height of the liquid level 2a of the test liquid 2 is changed by changing the volume of the liquid level adjustment unit 11 immersed in the test liquid 2 over time. Is changed over time. In other words, the height of the liquid level 2a during the collapse of the sample tablet D can be adjusted by the liquid level adjustment unit 11.

  Here, in the oral cavity, saliva has a characteristic that it is gradually supplied instead of being generated at a predetermined amount at a time. In addition, when the sample tablet is difficult to disintegrate in the oral cavity, the amount of saliva secreted increases. Therefore, for example, by sinking the main body 11a with time during the disintegration of the sample tablet D, the sample tablet D can be gradually immersed in the test liquid 2, and the test liquid 2 closer to the above-described saliva supply characteristics in the oral cavity. It becomes possible to improve the reproducibility and correlation in the oral cavity. In addition, the immersion speed of the liquid level adjustment unit 11 may be fast or slow depending on the phenomenon in the oral cavity, so that reproducibility and correlation in the oral cavity are pursued more. Will be.

  As described above, in the disintegration test apparatus 10 of the present embodiment, the sample tablet D is accommodated in the through hole 16 of the plate 13 as described above. Therefore, the positional relationship between the sample tablets D can be maintained during such movement, and the sample tablets D can be prevented from coming into contact with each other. That is, it is possible to accurately evaluate a plurality of sample tablets at a time in a space-saving in vitro test system simulating the oral cavity. Furthermore, since the sample tablet D is accommodated in the through-hole 16 of the plate 13 and the plate 13 is moved, the contact area between the hole plate 4 and the sample tablet D is always changed. It becomes possible to generate a frictional force on the sample tablet D in a region where it does not adhere. Accordingly, for example, compared to the case where the sample tablet D is rotated on the spot and a frictional force is applied, it is possible to prevent the sample tablet D from being loaded with a sufficient frictional force due to the collapsed particles, and the hole The plate 4 has an effect (cleaning effect) that the disintegrated particles attached by the test liquid 2 are washed.

  Therefore, according to the present embodiment, when trying to measure a plurality of sample tablets at the same time, it is necessary to prepare a plurality of devices themselves, and it is difficult to reduce cost and increase efficiency, and a mounting plate The problem that the sample tablet slips due to the disintegrating particles adhering to the sample and sufficient frictional force, that is, sufficient shear stress cannot be applied can be solved, and the sample tablet is sufficiently and efficiently loaded with frictional force. It becomes possible to evaluate the disintegration of the tablet. As a result, by using the disintegration test apparatus 10, it is possible to objectively evaluate the disintegration property of the orally disintegrating tablet without carrying out a sensory evaluation test by a human, and proper quality control of the orally disintegrating tablet is achieved. It can be realized easily. That is, in the present embodiment, the completeness of the disintegration test apparatus is enhanced as an evaluator that is more accepted in the market, and the physiology largely depends on a small amount of water such as saliva and a slight rubbing force between the tongue and the upper jaw. The oral disintegration test, which is an event, can be easily performed with good reproducibility without individual differences.

  As described above, since the through hole 16 is provided in the hole plate 4, the test solution 2 is supplied through the through hole 16, and the cleaning effect is effectively exhibited. The edge can effectively generate a frictional force on the sample tablet D.

  Further, as described above, the hole plate 4 and the plate 13 are configured so that six (plural) sample locks can be placed thereon, so that the test results of the six (multiple) sample locks can be used simultaneously as a reference. Can be evaluated.

  Further, as described above, since the plate 13 moves relative to the hole plate 4 by a distance equal to or larger than the size of the sample tablet D, the sample tablet is formed in the region where the collapsing particles are not attached to the hole plate 4. It becomes possible to generate a frictional force on D. Therefore, it is possible to further prevent the sample tablet from being loaded with sufficient frictional force due to the disintegrating particles.

  Further, as described above, the through-hole 16 formed in the plate 13 accommodates the sample tablet D and the weight 5, so that when the plate 13 is moved, the positions of the sample lock D and the weight 5 are accommodated. The relationship can be maintained, and the sample lock D can be reliably pressed against the hole plate 4 by the weight 5. Furthermore, it is possible to maintain the positional relationship between the weights 5 and prevent the weights 5 from contacting each other during such movement. That is, it is possible to stably and surely press the placed sample tablet D against the hole plate 4, and to reliably generate a frictional force on the sample tablet D.

  Furthermore, as described above, the detector 6 is played on the hole plate 4 in order to detect the contact by the conduction between the conductive portion 14 and the hole plate 4 in the weight 5 and confirm that the collapse is completed. Due to the cleaning effect, it is possible to suppress the collapsed particles from inhibiting the contact between the conductive portion 14 and the hole plate 4 (so-called sensing delay), and it is possible to measure the collapse time with high accuracy.

  By the way, some conventional disintegration test apparatuses place a sample tablet near the liquid surface of the test solution and apply a frictional force by rotating the sample tablet on the spot. In this case, air may accumulate between the hole plate and the test solution or between the sample tablet and the test solution due to the surface tension of the test solution, and the supply of the test solution to the sample tablet is hindered by the air. There is a fear.

  On the other hand, in the present embodiment, as described above, in the state where the sample tablet D is brought into contact with the test liquid 2, the plate 13 is driven relative to the hole plate 4 by the driving device 19, and the sample tablet D is thus obtained. A frictional force is generated on the hole plate 4 side. As a result, the contact position between the sample tablet and the hole plate changes, so that air between the sample tablet and the test solution is more likely to escape than when the sample tablet is rotated on the spot. Therefore, according to this embodiment, the problem that the supply of the test solution to the sample tablet is hindered by the air can be solved, and the test solution 2 is sufficiently supplied to the sample tablet D without being too much or too little. It becomes possible to do.

  Further, in the present embodiment, as described above, the heater 7 is provided in the test tank 3 and the test solution 2 is kept at 37 ° C. As a result, the test liquid 2 is further reproduced as saliva, and thus the reproducibility in the oral cavity can be further enhanced.

  Further, as described above, while measuring the disintegration time of the sample tablet D, the liquid level 2a of the test liquid 2 can be gradually raised by sinking the liquid level adjusting unit 11 with time. As a result, it is possible to reproduce a process in which saliva is gradually secreted in the oral cavity and the amount of saliva remaining in the oral cavity increases.

  Further, as described above, the disintegration time is automatically measured by contacting the weight 5 and the hole plate 4 and electrically conducting the contact between the conduction portion 14 and the hole plate 4. . Therefore, the detection function can be mounted on the weight 5 itself, and the collapse time can be automatically and automatically measured easily and reliably.

[Second Embodiment]
Next, a collapse test apparatus 20 according to the second embodiment of the present invention will be described with reference to FIG. FIG. 4 is a view corresponding to FIG. 2 of the disintegration test apparatus according to the second embodiment of the present invention. The disintegration test apparatus 20 of the second embodiment is different from the disintegration test apparatus 10 of the first embodiment in that a plate 23 shown in FIG. 4 is provided instead of the plate 13 (see FIG. 2). The plate 23 has a rib structure (rib) 24 protruding upward at the periphery of the through-hole 16 when the plate 23 is disposed on the surface 8 of the hole plate 4.

  This embodiment also has the same effect as that of the above embodiment, that is, the sample tablet D is sufficiently and efficiently loaded with frictional force, and the disintegration property of the sample tablet can be evaluated. Furthermore, in the present embodiment, as described above, the peripheral edge of the through hole 16 of the plate 13 is a rib structure 24 that protrudes upward when the plate 13 is disposed on the upper surface of the hole plate 4. Therefore, the above effect, that is, when the plate 13 is moved, the positional relationship between the sample lock D and the weight 5 is maintained and the positional relationship between the weights 5 is also maintained, and the weights 5 are prevented from contacting each other. The effect of performing is suitably demonstrated. Therefore, the sample lock D pressed by the weight 5 can be stably and reliably placed on the hole plate 4 and the sample lock D can be stably and reliably pressed against the hole plate 4.

  The present invention is not limited to the embodiment described above. For example, in the above-described embodiment, the hole plate 4 and the plate 13 are configured so that six sample tablets can be placed, but may be six or more or six or less. Further, the number of sample tablets to be placed may be six or less. Furthermore, about the external shape of the plate 13 and arrangement | positioning of the through-hole 16, it can be set as various shapes and arrangement patterns other than the said embodiment.

  Further, the movement of the plate may be a curved locus, a circular locus, or a wave locus in addition to the straight locus as in the direction A of the above embodiment. Furthermore, in the said embodiment, although the plate 13 was set as the structure which moves relatively with respect to the hole plate 4, it may be set as the structure which a hole plate moves relatively with respect to a plate, and it is good also as a structure containing these both.

  The shape of the main body 11a may be a cone, a triangular pyramid, a rectangular parallelepiped, a cube, or the like, and may not be solid but hollow. For example, in the case of a cone or a triangular pyramid, the moving speed of the liquid level adjustment unit 11 is constant and the rising speed of the liquid level 2a is increased (decreased) by sinking the apex thereof downward (upward) over time. Can do.

  Moreover, in the said embodiment, although the one liquid level adjustment part 11 is provided, you may provide the some liquid level adjustment part. In the case of providing a plurality of liquid level adjustment units, it is preferable to provide ones having different volumes. For example, a liquid level adjustment unit having a large volume and a liquid level adjustment unit having a small volume are provided. Using the adjustment unit, the surface 8 of the hole plate 4 is infiltrated with the test liquid 2 at the start of the collapse as described above, while the liquid level adjustment unit with a small volume is used to reduce the liquid level during the collapse as described above. The height of 2a may be changed over time.

  Moreover, in the said embodiment, although the conduction | electrical_connection parts 14 and 14 electrically connect via the hole plate 4, the decay | disintegration time is measured, The electrical resistance between a conduction | electrical_connection part and a hole plate is measured. It may be detected, or the position of the weight may be detected using a laser position sensor to measure the disintegration time of the sample tablet. Further, for example, the disintegration time may be measured visually.

  Further, in place of or in addition to the through hole, a concave portion (groove) or a convex portion may be formed on the surface of the mounting plate, or the surface roughness may be roughened. Even in this case, the same effect as described above can be obtained in which the friction force of the sample tablet D can be sufficiently and efficiently applied and the disintegration property of the sample tablet can be evaluated. In this case, in order to secure the supply amount of the test liquid to the sample tablet, it is preferable to use a liquid supply means (for example, a nozzle) that directly supplies the test liquid to the sample tablet.

  Of course, the test solution may be arbitrarily selected according to the assumed test conditions.

1 is a schematic configuration diagram of a disintegration test apparatus according to a first embodiment of the present invention. It is a partial cross-sectional enlarged view of the collapse test apparatus of FIG. It is a figure which shows the plate of the disintegration test apparatus of FIG. It is a figure corresponding to FIG. 2 of the disintegration test apparatus which concerns on 2nd Embodiment of this invention.

Explanation of symbols

  DESCRIPTION OF SYMBOLS 10,20 ... Disintegration test apparatus, 2 ... Test liquid, 2a ... Liquid level, 4 ... Hole plate (mounting plate), 5 ... Weight, 8 ... Surface (mounting surface), 9 ... Through-hole, 11 ... Liquid level Adjustment part (immersion block), 13, 17, 18, 23 ... plate, 16 ... through hole, 24 ... rib structure (rib), D ... sample tablet.

Claims (8)

A disintegration test device for bringing a sample tablet into contact with a test solution to disintegrate the sample tablet,
A mounting plate having a mounting surface for mounting a plurality of the sample tablets;
A plate in which a plurality of through holes for accommodating the sample tablets are formed;
A weight that presses the placed sample lock against the placement plate, and
At least one of the mounting plate and the plate is configured to be movable relative to the other in a direction along the mounting surface.   The collapse test apparatus according to claim 1, wherein the placing plate is a hole plate provided with a through hole.   3. The collapse according to claim 1, wherein at least one of the mounting plate and the plate is configured to be movable relative to the other at least by a distance corresponding to the size of the sample tablet. Test equipment.   The disintegration test apparatus according to any one of claims 1 to 3, wherein a plurality of the through holes formed in the plate accommodate the sample tablet and at least a part of the weight.   The disintegration test apparatus according to claim 4, wherein a rib is provided on a peripheral edge of the through hole in the plate. Further comprising an immersion block immersed in the test solution,
The disintegration test apparatus according to any one of claims 1 to 5, wherein the immersion block has a variable volume immersed in the test solution. A disintegration test method in which a sample tablet is brought into contact with a test solution to disintegrate the sample tablet,
A plurality of the sample locks are respectively accommodated in a plurality of through holes formed in the plate arranged on the upper surface side of the mounting plate, and the plurality of sample tablets are mounted on the mounting surface of the mounting plate. Process,
While pressing the sample lock against the mounting plate, the sample tablet is collapsed by moving at least one of the mounting plate and the plate relative to the other in a direction along the mounting surface. Process,
And a step of detecting that the disintegration of the sample tablet is completed.   In the step of disintegrating the sample tablet, the height of the liquid surface of the test solution is changed by immersing at least a part of a block having a predetermined volume in the test solution and changing the immersion volume over time. The disintegration test method according to claim 7, wherein:

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