JPS6234104B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to an automatic disintegration test device that can automatically perform disintegration tests on pharmaceutical samples such as solid preparations for internal use.

In recent years, regarding pharmaceutical manufacturing and quality control,
GMP (Good Pharmaceutical Manufacturing Standards)
Standards called "Manufacturing Practice" have been established internationally. Considering the importance of pharmaceuticals being directly related to human life, GMP requires not only quality control such as chemical analysis tests but also maintenance of equipment, environment, and other conditions that are most suitable for manufacturing. This is a standard that states that the necessary care should be taken in all manufacturing operations, including manufacturing, packaging, labeling, and storage.

The Japanese Pharmacopoeia stipulates the disintegration test method as one test to make this GMP effective. This disintegration test method is used for solid preparations such as tablets, pills, capsules, granules, lozenges, and preparations coated with sucrose or other suitable substances for internal use or for application to the oral cavity or bulge mucosa.
This is a test for disintegration or resistance to water or artificial digestive fluids, and disintegration refers to the phenomenon in which a shaped solid preparation disappears in the test fluid, or at least disperses into particles smaller than a certain standard. It is. Furthermore, the Japanese Pharmacopoeia stipulates certain standards not only for the disintegration test method but also for the equipment used in the test.

However, in the conventional disintegration test equipment, it was necessary for the tester to monitor the equipment until the end of the specified or arbitrary test time. For example, when performing a disintegration test on an enteric-coated preparation, the first liquid (artificial gastric juice) is used for 3 hours, and the second liquid (artificial intestinal juice) is used for 1 hour.
We had to continue monitoring for a long time, a total of four hours. For this reason, the tester had the disadvantage that not only was the tester inflicted great pain due to being restrained for a long time, but the personnel costs required for the test were also considerably high.

Therefore, the present applicant proposed an automatic disintegration test device that can overcome the above-mentioned drawbacks, as shown in Japanese Utility Model Publication No. 48-25162. Although this device was extremely useful in allowing disintegration tests to be performed automatically at low cost, it also had the following unresolved issues. In other words, this conventional device:
In order to automatically raise the test device containing the formulation sample above the test liquid level at the end of the set test time, the suspension mechanism of the test device is constantly biased upward by a compression spring. At the same time as the test was completed, the compression spring was released from the stopper, and the compression spring biased the hanging mechanism upward to raise the tester above the test liquid level. As a result, in this conventional device, due to the characteristics of the compression spring, when the compression spring comes off the stopper, a sudden upward force is applied to the hanging mechanism, which prevents the formulation sample in the tester from flying up. There were drawbacks such as the test liquid spilling out of the test container. Also,
This conventional device has the inconvenience of having to manually perform the setting operation of compressing the spring and engaging it with the stopper.

Further, as this type of automatic disintegration testing device, a device as shown in Japanese Patent Publication No. 54-29918 has also been proposed.

This automatic disintegration test device has a structure in which the means for vertically swinging the tester during the disintegration test and for raising the tester above the liquid level at the end of the disintegration test are performed by an air cylinder that reciprocates up and down. It is said that

However, such a structure using an air cylinder requires a compressor, a filter, a control valve, etc. for operating the air cylinder, and the device inevitably becomes complicated and large in size. Moreover, the cost becomes high.

On the one hand, this type of testing equipment must be able to easily and reliably perform the collapse test, but on the other hand, since this type of equipment is the one that performs the test, it must be complicated and large. In this respect, the above-mentioned automatic collapse test device using an air cylinder had a serious drawback.

Moreover, in this automatic collapse testing device, the tester moves up and down along with the up and down movement of the piston rod of the air cylinder.
It had the same drawback as the automatic disintegration test device of No. 25162, namely, that the test liquid would scatter outside the test container when the test device was moved up and down.

Also, the above-mentioned Utility Model Publication No. 48-25162 and Special Publication No. 54
In addition to Publication No. 29918, several conventional devices have been proposed, but these conventional devices are complicated to handle and have a complicated structure, or require extra equipment to be added to the tester. It had serious shortcomings such as not being able to comply with the regulations of the pharmacopoeia.

The present invention has been made to solve the above-mentioned drawbacks of the prior art, and has a simple and compact structure that allows for reliable disintegration testing that complies with the Japanese Pharmacopoeia regulations without causing the drug sample to fly out of the tester. It is an object of the present invention to provide an automatic disintegration test device that can be carried out automatically and can reduce the cost of the device.

To achieve this objective, the automatic disintegration test device according to the present invention includes a test device that accommodates a sample and immerses it in a test liquid in a test container, a hanging mechanism that suspends the test device, and a hanging mechanism that suspends the test device. a vertical swinging mechanism that swings the tester up and down during the collapse test and swings the tester outside the test liquid and holds it at the end of the predetermined collapse test; and a vertical swing mechanism that drives the vertical swing mechanism. It consists of a reversible motor and an automatic control mechanism that controls forward and reverse rotation of the motor,
The vertical swing mechanism includes a rotating member that is rotated forward and backward by the motor, a first link arm that has one end linked to the rotating member, and one end that is linked to the other end of the first link arm, and a second end, the other end of which is linked to the suspension mechanism of the tester;
The link arm is provided with a link arm and a link arm operating mechanism that operates the link arm in a forward or reverse direction in accordance with the forward or reverse rotation of the rotating member by the motor, and by switching between the forward and reverse rotation of the motor, The test device is characterized in that the test device is oscillated up and down, and the test device is oscillated out of the test liquid at the end of the disintegration test.
The first link arm and the second link arm are in a maximum extension state where they are aligned with each other when a pin of a reverse rotation stop switch that stops the rotation of the rotating drum at a predetermined position is engaged with a notch of the rotating drum, The tester is raised above the level of the test liquid.

Further, a heater for heating the test liquid to a temperature equivalent to that of human gastric fluid or intestinal fluid may be inserted into the test liquid in the test container. The automatic control mechanism may include a timer that sets the test time and reverses the motor at the end of the set time. moreover,
The link arm operating mechanism may include a forward rotation pin and a reverse rotation pin attached to the rotating drum.

Hereinafter, the present invention will be explained in more detail with reference to embodiments shown in the drawings.

FIG. 1 is an overall perspective view showing an embodiment of an automatic disintegration testing device according to the present invention, and FIG. 2 is a partial side view of the main parts thereof.

As is clear from FIG.
The glass tube 14 of the book is attached to the upper and lower plastic plates 12,
Each glass tube 14 has a basket-type structure in which the glass tubes 16 are provided in an upright position, and the lower end of each glass tube 14 is opened with a wire mesh, and a preparation sample is put into each glass tube 14. The tester 10 accommodates the formulation sample,
Test liquid 20 (fifth) in beaker-shaped test container 18
(Figure) is repeatedly rocked up and down. Therefore, the tester 10 is suspended by a suspension mechanism 22.

In this example, a heater 24 for heating the test liquid 20 to a temperature equivalent to human gastric fluid or intestinal fluid, and a heater 24 for heating the test liquid 20 to a temperature equivalent to that of human gastric fluid or intestinal fluid, and as described later,
A temperature sensor 26 is integrally coupled within the plastic sleeve 28 and inserted into the test liquid 20 for sensing the temperature of the test liquid 20 and controlling the temperature of the test liquid 20 to maintain it constant during the test.

In this embodiment, two sets of testers 10 are provided on the left and right sides. As shown in FIGS. 2 and 5, the hanging mechanism 22 for suspending the tester 10 includes a respective vertical arm 32 guided by an anti-rotation and bearing member 30, and a lower end of the vertical arm 32. It is supported by a vertical swing mechanism 36 via a lateral arm bar 34 to which is fixed.

That is, the vertical swing mechanism 36 is a mechanism for vertically moving the tester 10 within the test liquid 20 and for lifting and holding the tester 10 above the liquid level of the test liquid 20 at the end of the test. This vertical swing mechanism 36
A rotary drum 42 is fixed to a drive shaft 40 of a reversible electric motor 38 having a speed reducer and a brake, and a rotary drum 42 whose one end is linked to one side of the rotary drum 42 by a link pin 44. 1 link arm 46 and a second link arm 50 whose one end is linked to the other end of the first link arm 46 by a link pin 48 and whose other end is linked to a link bar 52 fixed to the arm bar 34. It has a link mechanism. Also,
The vertical swing mechanism 36 has a link arm operating mechanism for operating the first link arm 46 and the second link arm 50 in the forward direction or in the reverse direction, and this link arm operating mechanism is As shown in Figure 3, the first link arm 46 is
A forward rotation pin 54 is provided on the rotating drum 42 to operate in the forward rotation direction (driving direction) as shown in FIG.
and a reversing pin 56 provided on the rotating drum 42 so as to operate the first link arm 46 in the reverse direction as the motor 38 reverses, as shown by arrow B in FIG.

With the above-mentioned link mechanism and link arm operating mechanism, the vertical swing mechanism 36 operates as a hanging mechanism by driving the first link arm 46 in the normal rotation direction with the normal rotation pin 54 during normal rotation as shown in FIG. 22, the test device 10 is repeatedly swung up and down in the test liquid 20 to carry out the collapse test. After a predetermined test time, the first link arm 46 is reversed as shown in FIG. It is driven in the reverse direction by the pin 56. At this time, the moment when the first link arm 46 and the second link arm 50 are in a straight line with each other is the maximum extension state of the link mechanism, and if the length of the first link arm 46 is L, then as shown in FIG. The first link arm 46 at the maximum extension position shown by the solid line has been raised by 2L-L=L compared to the lowest position shown by the two-dot chain line. Therefore, in the state shown in FIG. 4, the tester 10 has a test liquid 20 as shown in FIG.
It will come to a position above the liquid level.

As described above, a reverse rotation stop switch 58 is provided to limit the amount of rotation of the rotary drum 42 to a predetermined amount so as to maintain the link mechanism in the maximum extension state, and a pin 60 for a telescoping stopper of the reverse rotation stop switch 58 is provided. can enter into a notch 62 formed in a part of the outer periphery of the rotating drum 42.

Furthermore, in order to prevent the tester 10 from rapidly descending due to the action of gravity when the tester 10 is swung up and down by the link mechanism, an air-action type shock absorber 66 is vertically provided on the base 64. The upper end of the piston 68 of the shock absorber 66 is fixed to the arm bar 34. Note that the shock absorber 66 is omitted from FIG. 5 for simplicity and clarity.

Further, in this embodiment, as shown in FIG. 5, an automatic control mechanism 70 is provided for automatically controlling the operations of various constituent members. This automatic control mechanism 70 includes a control device 72, a timer 76 connected to the control device 72 by a wire 74 and setting a collapse test time, and a timer 76 connected to the timer 76 by a wire 78 and ending the test time set by the timer 76. It has a buzzer 80 that gives a signal from time to time. Buzzer 80 is connected to control device 72 via wiring 82 .

The control device 72 is connected to the heater 24 and the temperature sensor 26 via wires 84 and 86, respectively, and appropriately controls the temperature of the test liquid 20 heated by the heater 24. Further, the control device 72 controls the motor 3
Since the motor 3 is connected to the motor 3 through the wiring 88 and is connected to the timer 76 through the wiring 74, the motor 3 is
8 can be driven. Further, the control device 72 has wiring 90
connected to the reversal prevention switch 58 via
The operation of the reverse rotation prevention switch 58 can be controlled by a timer 76.

Next, the operation of this embodiment will be systematically and sequentially explained.

First, in order to heat the test liquid 20 in the test container 18 to a temperature equivalent to the temperature of human gastric fluid or intestinal fluid prior to the disintegration test, the test liquid 20 is heated with the heater 24, and the heating temperature is The temperature is sensed by the sensor 26 and the sensing signal is sent to the control device 72.
By providing feedback to the test liquid 20, the temperature of the test liquid 20 is always maintained at an optimum state. Moreover, in this embodiment, since the heater 24 is inserted directly into the test liquid 20, there is an advantage that rapid heating can be performed without heat loss. However,
The heater 24 is placed below the test container 18,
Alternatively, it is also possible to provide a jacket shape around the test container 18.

When the test liquid 20 is heated to a predetermined temperature, the formulation samples housed one by one in the glass tubes 14 of the tester 10 are heated to the test liquid 20 together with the tester 10 as shown by the two-dot chain line in FIG. immerse in. Therefore,
The motor 38 is rotated in the forward direction, and the forward rotation of the motor 38 causes the rotary drum 42 to rotate as shown in the direction of arrow A in FIG. As a result, the forward rotation pin 54 comes into contact with one side of the first link arm 46 near the link pin 48, thereby operating the first link arm 46 in the direction of arrow A. As a result, the second link arm 50 performs a link movement using the link pin 48, and as the rotating drum 42 rotates, the link bar 52 swings in the vertical direction. In that case,
Each time the rotating drum 42 rotates once, the link bar 52 reciprocates up and down once.

The vertical swinging motion of the vertical swinging mechanism 36 is performed by the hanging mechanism 2 via the arm bar 34 and the vertical arm 32.
2, the suspension mechanism 22 repeatedly swings the tester 10 up and down within the test liquid 20 to perform a disintegration test on the formulation sample within the glass tube 14. In that case, an air action type shock absorber 66
By providing this, when the tester 10 is lowered, it is reliably prevented from performing a sudden downward movement due to its own weight and the weight of the hanging mechanism 22 and the vertical swinging mechanism 36, so that a smooth collapse test can be performed. I can do it.

When the test time reaches the time preset by the timer 76, the motor 38 automatically stops and automatically starts reverse rotation under the control of the controller 72. As a result, the rotating drum 42 rotates in the reverse direction shown by arrow B in FIG. , drives the first link arm 46 in the reverse direction.

As a result, the first link arm 46 and the second link arm 50 are in the maximum extended state where they are in a straight line with respect to each other, as shown by solid lines in FIGS. 4 and 5, and the first link arm 46 at this time has its length In the case of L, compared to when it is at the lowest position, 2L−L=
This means that it is at a position that has risen upward by L.
Therefore, the vertical swing mechanism 36 rises by the length L, and the tester 10 also moves the arm bar 34, arm 32,
It is lifted by a length L via the hanging mechanism 22, and is located above the liquid level of the test liquid 20, as shown by the solid line in FIG. At that time, the tester 10 is smoothly raised by the link mechanism by decelerating the motor 38 to an appropriate speed, so that the formulation sample in the tester 10 does not fly out, and the test liquid 20 does not scatter outside the test container 18. This will be prevented.

In this manner, when the rotating drum 42 is reversed until the first link arm 46 and the second link arm 50 are in the maximum extended position in which they are aligned with each other, the reverse rotation stop switch 58 is actuated by the controller 72 via the wiring 90. , the pin 60 enters the notch 62 of the rotating drum 42, so that the rotating drum 42
is prevented from reversing further, and at the same time
The reverse rotation of the motor 38 is also stopped. Therefore, the tester 10 is maintained above the level of the test liquid 20. When the disintegration test is completed in this way and the tester 10 is lifted above the level of the test liquid 20, the timer 76 causes the buzzer 80 to sound, notifying the tester that the test has ended.

As described above, according to this embodiment, the disintegration test can be performed completely automatically at low cost without the need for constant monitoring by a tester, and the test can be smoothly performed in accordance with the regulations of the pharmacopoeia. Moreover, the preparation sample does not fly out of the tester 10, and the test liquid 20 does not scatter outside the test container 18, and this apparatus can be manufactured at a very low cost.

Incidentally, by preparing a plurality of automatic disintegration test devices of the present invention and setting the timers of each device to different times, it is possible to know the actual disintegration time almost accurately.

As explained above, according to the present invention, the vertical swinging mechanism is used to swing the tester up and down during the collapse test, and to swing the tester out of the test liquid and hold it at the end of the predetermined collapse test. The vertical swing mechanism includes a rotating member that is rotated forward and backward by a motor, and a first member that is linked at one end to the rotating member.
a link arm, a second link arm whose one end is linked to the other end of the first link arm and whose other end is linked to the suspension mechanism of the tester; and a link arm operating mechanism that operates the link arm in the forward or reverse direction according to the rotation direction, and by switching the motor between forward and reverse rotation, the tester is vertically oscillated during the collapse test and the collapse test is performed. By having a structure that allows the tester to swing out of the test liquid at the end of the test, the tester can be moved up and down extremely smoothly, making it possible to perform tests like the conventional device described above. It is possible to reliably prevent the sample from flying out of the instrument and the test liquid from splashing outside the test container.

Further, according to the present invention, the vertical swinging mechanism has a simple structure as described above, and includes a compressor, a filter, a control valve, etc. for operating an air cylinder such as the automatic collapse test device using an air cylinder described above. Since this is not necessary, it is possible to simplify the device, make it smaller, and further reduce the cost.

As a result, the present invention satisfies the conflicting demands for this type of testing device, namely, the need to facilitate and ensure automatic collapse testing, and the need to simplify and downsize the device. I can comply.

[Brief explanation of the drawing]

FIG. 1 is an overall perspective view of an embodiment of the automatic collapse test device according to the present invention, FIG. 2 is a side view of the main parts of the device according to the present invention, and FIGS. 3 and 4 are respectively the link mechanism according to the present invention. FIG. 5 is an explanatory diagram showing the general configuration of the apparatus of the present invention. 10... Test device, 18... Test container, 20...
Test liquid, 22... Hanging mechanism, 24... Heater,
26...Temperature sensor, 36...Vertical swing mechanism, 3
8... Motor, 42... Rotating drum, 46... First link arm, 50... Second link arm, 5
4...Forward rotation pin, 56...Reverse rotation pin, 58...
... Reverse rotation stop switch, 60 ... Pin, 62 ... Notch, 70 ... Automatic control mechanism, 72 ... Control device, 76 ... Timer, 80 ... Buzzer.

Claims (1)

[Scope of Claims] 1. A test device that accommodates a sample and immerses it in a test liquid in a test container, a hanging mechanism that suspends the test device, and a hanging mechanism that suspends the test device during a collapse test. a vertically swinging mechanism that swings the test device up and down and holds the tester outside the test liquid at the end of a predetermined collapse test; a motor capable of forward and reverse rotation that drives the vertical swinging mechanism; The vertical swinging mechanism includes a rotating member that is rotated in the forward and reverse directions by the motor, a first link arm that is linked at one end to the rotating member, and a first link arm that is linked at one end to the rotating member. A second link arm is linked to the other end of the first link arm, and the other end is linked to the hanging mechanism of the tester; and a link arm operating mechanism that operates in the direction or reverse direction, and by switching the motor between forward and reverse directions, the tester is vertically oscillated during the collapse test, and the test liquid is removed from the tester at the end of the collapse test. An automatic collapse test device in which rocking and shaking are performed. 2. The automatic collapsing test device according to claim 1, wherein the link arm actuation mechanism comprises a forward rotation pin and a reverse rotation pin provided on a rotating member. 3. The rotating member is a rotating drum, and the rotating drum is provided with a notch that engages a pin of a reverse rotation stop switch that stops the rotating drum from reversing at a predetermined position. Automatic disintegration test device according to item 1. 4. A patent characterized in that the first link arm and the second link arm are in a maximum extended state in which they are in a straight line with each other when the pin of the reverse rotation stop switch is engaged in the notch of the rotating drum. An automatic disintegration test device according to claim 3. 5. The automatic disintegration testing apparatus according to claim 1, wherein a heater for heating the test liquid is inserted into the test liquid in the test container. 6. The automatic collapse test device according to claim 1, wherein the automatic control mechanism has a timer that sets a test time and reverses the motor at the end of the set time.