DE19739382A1 - Device for determining the disintegration time of compressed medicament shaped bodies, such as tablets or capsules, and method therefor - Google Patents

Abstract

The invention relates to a device for determining the decay time of compressed medicinal shaped bodies (6, 6') such as tablets, in a liquid medium which is located inside a vessel. The inventive device consists of a decay cage (1) with a bottom which is covered with a screen (3, 3') and an upper covering plate (20) which has a plurality of holes, in which test tubes (2) are arranged in an upright manner between the bottom (3, 3') and the covering plate (20) inside said decay cage (1). A perforated disk (4, 4', 4") is introduced in a mobile manner into each of said tubes to weight the individual medicinal shaped bodies. The decay cage (1) is fixed to a head section (21) by means of a central column (15, 15') located in the middle of the covering plate. At least one position sensor (8, 8') is inserted in the wall (7, 7', 7") of the test tube (2), which can interact with the perforated disk (4, 4', 4") inside the test tube (2, 2', 2") in such a way that the sensor signal contains time-related information regarding the height ofthe perforated disk in relation to the bottom of the decay cage and regarding the decay time, wherein the sensor signals are evaluated in an electronic evaluation device (11, 11').

Description

The invention relates to a device for determining the decay time of pressed medicinal tablets, such as tablets or capsules, in one liquid medium, which is located in a vessel, consisting of a decay basket that can be lowered and lifted into the vessel with one of bottom covered with a sieve and an upper cover plate that each has a plurality of holes into which between the bottom and Cover plate standing upright inside the decay basket are arranged, in each of which a perforated disc for weighting the individual NEN drug body is movable, the decay basket with a center column in the middle of the cover plate on one Headboard is held, according to the preamble of claim 1 and a Method for determining the disintegration time of compressed pharmaceutical form bodies according to the preamble of claim 20.

The disintegration time measurement of compressed medicinal tablets, such as tablets and capsules, is carried out in a standardized experimental setup to test the To ensure reproducibility of the measurement results, in particular according to DAB 10, 3rd supplement 1994 or European Pharmacopoeia or USP (USA). The disintegration test determines whether the tablets or Capsules in the prescribed time under precisely executed conditions disintegrate in a liquid medium. The main part of the equipment consists of a rigid decay basket, which is six cylindrical Contains test tubes made of glass. Each tube is cylindrical Disc made of transparent plastic material more precisely prescribed relative density and size, which has five through holes has a bore through the central axis of the disc is. The test tubes are separated by an upper and a lower one visible plate made of plastic material held vertically, each six Have holes. All holes are the same distance from Center point and equal distance from each other. On the bottom of the There is a stainless steel wire strainer on the lower plate. In the middle the plate is attached to a metal column so that the equipment on it Metal column suspended in a hanger and by means of a Motors up and down evenly 28 to 32 times per minute 50 to 60 mm high can be moved. For this, the apparatus is placed in a suitable container  suspended, which contains the prescribed liquid. After this Fill a tablet or capsule into each tube and place the As a weighting, the dissolution time of the tab is determined letten or capsules by observing the measuring device and timing the decay time by the operator.

DE 35 20 034 C1 is a decay device for test specimens, in particular Tablets, become known in which the test specimens in containers of a cer case basket between a Hall generator and one with a magnet provided disc are arranged. The decay basket containers are heated to a constant temperature by means of a heater. If the test specimen disintegrates, the disk moves together with the Magnets to the Hall generator so that it emits a signal which fed to a recording device after exceeding a switching shaft and can be displayed. The transfer of energy for electrical Switching in the decay basket takes place via contacts or through a Radio frequency transmitter and a radio frequency receiver. The transfer the signals to the recording device are made by optoelectric components.

DE 94 19 24 511 U1 is an automatic disintegration time measuring device for pharmaceutical quality and production control of tablets and Dragees are known within a conductive test liquid, which consists of a basket-like decay basket arranged in a beaker with an arranged number of glass tubes, the bottoms of which are circular sieve plates are formed as standing surfaces for the glass tubes be, each sieve plate from two current-carrying electrostatic the wire mesh halves, which forms a slot in Are spaced from each other. A test specimen is placed in each glass tube arranged, which is covered by a float on the DUT lies on. The float has an embedded on the bottom Contact framework made of a metallic material. When moving the Beaker and disintegration of the tablets changes the conductivity of the Test liquid between the wire mesh halves and the contact scaffold of the float can be measured.

Through the US 3,618,395 a tablet disintegration time measuring device with moving Tubes in a bath liquid are known with a variety of themselves opposite spaced electrodes on the bottom of the tablet  containing tubes. The presence of a tablet bothers you Electrodes applied electromagnetic field, the interference a Influenced timer whose signals can be evaluated.

WO 97/140 35 is a device for determining the decay time of compressed pharmaceutical tablets, in which on the Bottom of the decay basket around each hole an electrical coil as an inlet gene or multi-layer coil is arranged, which is part of an electrical oscillation is a circle, with a conductor loop on the disc for path-dependent Damping of the electrical resonant circuit is arranged in common to an electrical evaluation device for generating vibrations and Evaluation of the measurement results are connected.

A disadvantage of the known devices is in particular that the used measuring methods such modifications of the test equipment that these ent the required by the pharmaceutical industry partly fail to comply with the relevant standards according to DAB 10 or USP.

Sensors in the bottom area of the decay basket change that, for example Flow conditions within the test tube. Continue to join Devices in which parts of the electronic components, e.g. B. Hall sensors or coils, located inside the medium, often off notice these components. Another disadvantage with known devices is that the decay time through the entry of certain parameters, e.g. B. Falling below a certain thickness of the dissolving test specimen, is determined by a switching process, the measurement of Decay time cannot be checked with regard to their quality.

A non-contact displacement sensor with one with alternating current loaded measuring coil is known from PCT / DE 93/00703, wherein the measuring coil has at least two voltage taps, with an electrically and / or magnetically conductive test object and with a Evaluation circuit for determining the position of the measurement object in relation output voltage corresponding to the voltage taps coil, which is encapsulated in a housing. The measurement object is a ring that encompasses the housing at a distance and along the housing wall is movable. On successive sections of the measuring coil tensions that can be tapped are added up, with each subtotal men can be formed, reflected in the increasing number of  distinguished voltage values. Those subtotals who which again adds up to an output voltage, which then clearly related to the position of the ring.

DE-196 50 657.4 has proposed a touch working measuring sensor according to PCT / DE 93/00703 the measuring object to be arranged displaceably in the interior of the measuring coil, the total impedance of the measuring coil is independent of the position of the test object.

The invention has for its object a device of the beginning to create the type mentioned, which practically without changes to the pre written parameters for the equipment according to DAB 10 or USP the movement of the hole disc within the test tube without contact detect and determine the disintegration time of the pressed medicinal tablet. Furthermore, the device should be as repair and maintenance as possible be due. A possibility should also be made available that To evaluate the quality of the measurement of the decay time.

The object is achieved by a device of the type mentioned, at least according to the invention in the wall of the test tube a spatially resolving sensor is introduced, which is within the hole disk of the test tube is able to interact in such a way that the Sensor signal Information about the height of the hole disc above the floor of the decay basket as a function of time and thus over the decay time ent stops, the sensor signals being evaluated in an electronic evaluation system will. The sensor signals are preferably evaluated according to Method according to claim 21. This method allows in addition to Determination of the decay time also the evaluation of the quality of the respective Measurement as it provides information about the time course of the The state of dissolution of the drug tablet is independent of the movement of the decay basket there.

Further advantageous embodiments of the invention are in the Subclaims marked.

To determine the thickness of the disintegrating tablet as a function of time To be able to monitor the widest possible range extends the spatially resolving sensor preferably from the bottom of the decay basket  facing side up to a height H above the floor or above the sieve. The current position of the hole disc can thus be in the area of the sensor and thus the thickness of the dissolving tablet as a function of time be determined. The height H should be greater than the thickness possible investigating drug.

The sensor signal is transmitted via cables that come out of the test tube lead, or wirelessly, e.g. B. electro-optical, an evaluation electronics averages. The sensor signal is preferred in the evaluation electronics continuously recorded and used to determine the decay time rated. In doing so, disturbance variables, in particular through the opening and closing Movement of the decay basket and thus the swinging movement of the Hole disk inside the test tube, using a suitable one Software algorithm eliminated. The underlying process is further described below. The cables are preferably within a flexible Band melted down.

Preferably, the electronic elements of the device, in particular the sensor and the evaluation electronics, to avoid short conclude and to increase safety during operation and maintenance of the Device isolated from the medium in which the dissolution test by is led and do not come into contact with it. This can for example the sensor in the cylindrical wall of the test tube be melted, one or more cables from the wall of the Test tubes are led out, the cables preferably from one flexible tape are surrounded. In a further embodiment of the Invention is double-walled the wall of the test tube, the Sensor is arranged between the part walls and one or more cables are led out of the wall of the test tube. The cables serve to transmit the sensor signal and, if necessary, for voltage or Power supply to the sensor. The evaluation is also located electronics in a sealed housing, e.g. B. together with the engine control for moving the decay basket inside the vessel.

Any sensors can be used as sensors Sensor signal itself for determining the position of a test specimen, here the Lochdisk, can be evaluated. For example, sensors can be used which according to the capacitive, inductive, magnetic or optical  Working principle. Inductive sensors can be both high and low find low-frequency operated sensors. Furthermore com Hall sensors in question. The construction of one is also conceivable spatially resolving sensor as a sensor array of a plurality of Individual sensors.

The strength of the sensor signal in response to the presence of the test body depends on its physical properties, e.g. B. inductance, Dielectric constant, magnetic field strength, and the type of use sensors. Since most sensors are weak on a Stan dard-Lochdisk react, so the signal-to-noise ratio is too bad for is a reliable analysis of the sensor signal, it is usually necessary dig to equip the standard hole disk with a target that is from Sensor has reliably detectable properties, which are as much as possible from the physical properties of the environment, especially the liquid medium. To the To improve analysis of the current position of the hole disc, it is from Advantage if the target does not extend over the entire hole disc, but is localized in a small space. It is preferably located in the Area of the bottom, d. H. the one facing the bottom of the decay basket Side of the hole disc. The target is a small magnet, for example a spatially resolving sensor based on the magnetic principle or a conductor loop running around the peripheral disk.

In a preferred embodiment of the invention, the sensor is a coil path measuring sensor consisting of a in the wall of the glass tube the tube axis wound coil with a plurality of Coil taps with constant turns ratio, similar to that Coil of DE-196 50 657.4. The coil is preferred with AC voltage applied and has at least two taps, preferably three or four or five taps. By bringing in the hole disc inside the coil changes the impedance of the coil and thus the coil tension depending on the distance of the hole disc from the bottom of the vessel, creating a position-dependent sensor signal won and is available.

In order to increase the spatial resolution, the target is preferably one around Perforated disk peripheral thin aluminum conductor loop. At  the application of a predetermined alternating voltage to the coil, also square wave voltage, the coil has a certain total impedance as well as certain impedances of the coil sections, which are in the The hole disc sinks past with the closed aluminum loop due to the induction of eddies, the conductor loop flows in time to change. These changes in impedances can act as voltage signals are measured, which, with a suitable evaluation, e.g. B. as from DE 196 50 657 .4 known, a position-dependent sensor signal available stands. Likewise, two or three coils wound into one another, namely bi- or trifilar wound, can be used. With appropriate design of the coil and target and the evaluation electronics is with such A spatial resolution of up to 50 µm can be achieved.

When equipping the hole disc with one or more of these Targets must take care that the weight and shape of the hole disc are not changed compared to the standardized hole disc, as this Parameters influence the measurement results. When choosing a magnet as a target, it is therefore preferably a ring magnet, the bore of which aligned with the center hole of the hole disc. When choosing one Conductor loop is special due to its low density aluminum suitable.

The sensor signals of all test tubes arranged in the decay basket, are fed to the evaluation electronics and preferably simultaneously evaluated. To do this, it is advantageous if the sensors are bus-compatible and over an interface can be configured.

A method according to the invention for determining the disintegration time of compressed medicament shaped articles, such as tablets or capsules, in a liquid medium with the aid of the device according to the invention, the disintegration basket being moved up and down vertically within the vessel with the aid of a motor, is characterized in that only Discrete values of the time-dependent sensor signal S are evaluated, the sensor signal S _i , which corresponds in time to the sensor signal S in the region of the upper reversal point of the movement of the decay basket, ie S _i = S (t _i ), to determine a relative instantaneous resolution state in each movement cycle of the drug body is used and a quasi-continuous time course of the resolution states determined in this way is created, which provides information about the decay time and the quality of the measurement.

The disintegration time of the dosage form can be specified as the time until the sensor signal S _i exceeds or falls below a predetermined threshold, in which case the threshold corresponds to a predetermined resolution state of the dosage form. The sensor signals S ₁ ,. . ., S _n can have height information x ₁ ,. . ., x _n, ie the height of the perforated disk relative to the bottom of the decay basket at a time corresponding to the upper reversal point or almost the upper reversal point of the decay basket, whereby a measurement is automatically rejected if several successive pairs of values S _i , S _{i + 1} such are that for the corresponding x _i , x _{i + 1} : x _i ≦ x _{i + 1} . An accumulation of such pairs of values shows an event such as the sticking of test specimens to the wall of the test tube - thereby inhibiting the resolution: x _i ≈ x _{i + 1} or erecting a tablet inserted flat into the test tube - thereby apparently increasing the thickness: x _i < x _{i + 1} , which falsifies the correct decay time determination. For the decay time determination, preferably only series of measurements are permitted in which the sensor signals S _{i are} such that, except for statistical fluctuations, x _i <x _{i + 1} , ie true resolution, always applies. The measured values are preferably graphically represented as a function of time; Kinks in the representation x (t) indicate anomalies in the dissolution process. With the device according to the invention and the associated method, an exact analysis of the dissolution process is thus possible, which makes more information accessible than simply falling below a predetermined thickness of the test specimen.

Brief description of the drawing, in which:

Fig. 1 is a side view of a device according to the invention, only two of the test tubes are shown

Fig. 2 shows a longitudinal section of a test tube according to the invention and

Fig. 3 is a plan view of the cover plate with the grooves in which the flexible bands that enclose the electrical cables extend to the center pillar.

Fig. 4 is a side view of another device, being shown by the test tube only two

Fig. 5 shows a detail of the apparatus illustrating the electrical contact between the sensor and the transmitter.

Fig. 1 shows a device according to DAB 10, 3. Addendum 1994 as used in the present invention. The device consists of a decay basket 1 with a circular cover plate 20 and a base 3 , each of which has a plurality of holes 23 , 23 ', usually six, in which cylindrical test tubes 2 , 2 ', 2 '' made of glass are arranged are. The bottom 3 is covered on the underside with a sieve 14 made of stainless steel wire. Cover plate 20 and bottom 3 are rigidly held by one another by vertical spacer bars, not shown, on the outside of the decay basket 1 , which is arranged above a vessel 5 in which there is a liquid medium in which the disintegration time of the medicament shaped body 6 is to be determined. The decay basket 1 is fastened to a holding arm, consisting of a head part 16 and a vertical column 19 , which enables the decay basket 1 to be periodically lowered and raised into the vessel 5 by means of a motor (not shown). Data evaluation and control of the movement of the decay basket 1 is carried out by the evaluation electronics 11 , which together with the motor for moving the decay basket is located entirely within the head part 16 . With interfaces 17 , 18 , the evaluation electronics 11 is capable of using external control units, e.g. B. other such devices or a central computer to communicate.

For the disintegration test, a tablet 6 or capsule is placed in each test tube 2 , 2 'and a precisely defined perforated disc 4 , 4 ' is placed on the tablet as a weight. The perforated disk 4 preferably has a central bore which runs along the central axis of the perforated disk 4 , 4 '.

The test tube 2 , 2 'has a spatially resolving sensor 8 , 8 ' which extends within the cylindrical wall 7 over a large area from the opening of the test tube 2 facing the bottom 3 to a height H. This sensor is any sensor which is able to emit sensor signals which are dependent on the height of the perforated disk 4 , 4 'within the test tube 2 , 2 ' and thus on the state of dissolution of the medicinal product body 6 to be tested. Since the movement of the perforated disk 4 , 4 'in the lower region of the test tube 2 , 2 ' is decisive for determining the decay time, it is sufficient if the sensor 8 , 8 'is located in this region, instead of the entire length of the test tube 2 , 2 ', which reduces the costs for a test tube equipped accordingly.

From arranged inside the wall 7 of the sensor 8, 8 'lead wires 9, 9' inside the wall 7 up and out of the test tubes 2, 2 'and also to the transmitter. 11 These cables 9 , 9 'serve to supply current or voltage to the sensor 8 , 8 ' and to transmit the sensor signal to the evaluation electronics 11 . The Prüfröhr on all surfaces 2, 2 'within the decomposition basket 1 belonging cable 9, 9' are guided within a tubular central column 15, which supports the disintegration basket 1 to the head part sixteenth The cable routing within the entire device is such that all cables 9 , 9 'and other electronic components are isolated from the medium and protected against splashes. The cables 9 , 9 'for power supply and / or signal transmission are led out at the upper edge of the test tube 2 , 2 ' from its wall 7 within the top surface, the exit point of the cables 9 , 9 'from the wall 7 being sealed. A computing processor can also be located within the head part 16 or the evaluation electronics 11 , so that an external processor is no longer necessary.

The perforated disk 4 , 4 'preferably has at least one target 10 , 10 ' to which the spatially resolving sensor 8 , 8 'responds reliably, the weight, volume and shape of the perforated disk 4 , 4 ' being unchanged in accordance with the standards. The target 10 , 10 'is arranged in the region of the side of the perforated disk 4 , 4 ' facing the base 3 ; preferably the target 10 , 10 'can be a ring magnet.

Fig. 2 shows in an enlarged view a detector tube 2 '', is integrated in the wall 7 of the sensor 8, referred to herein as a coil 12, preferably in the wall encircling annular long coil having a plurality of selectable electrical Teilabgriffen 21, 21 ', 21 '', 21 ''', namely four taps, which represent the cables 9 of the coil 12 . The partial taps 21 , 21 ', 21 '', 21 ''' are encased by a flexible band 22 which, according to FIG. 3, runs in a groove 24 , 24 'after exiting the test tube 2 '', which runs into the Surface of the cover plate 20 is milled. All of the grooves 24 , 24 ′ within the cover plate 20 are directed radially to the center of the cover plate 20 and extend up to the attachment point of the tubular center column 15 or into the base area thereof, the flexible bands 22 inside the center column 15 upward into the head part 16 run and there are guided into the evaluation electronics 11 '. Peripherally arranged fastening holes 25 within the cover plate 20 serve to screw them onto the vertical spacer bars on the outside of the decay basket. A perforated disc 4 ″ has a target 10 ″, which is a peripheral aluminum band.

When a voltage is applied to the coil 12 , which can also be a square-wave voltage, and when the perforated disk 4 '' falls along the coil 12 , the voltages which can be tapped at successive sections of the coil 12 are added up, subtotals being formed in each case differ in the increasing number of voltage values considered. These subtotals can again be added to an output voltage, which can then be clearly related to the position of the perforated disk 4 ″ with respect to the height of the coil 12 . Only discrete values of the time-dependent sensor signal S are evaluated, the sensor signal S _i , which corresponds in time to the sensor signal S in the region of the upper reversal point of the movement of the decay basket 1 , ie S _i = S (t _i ), being determined in each movement cycle a relative instantaneous Auflösungszu state of the drug body 6 is used, so that a quasi-continuous time course of the thus determined resolution states is created, which provides information about the disintegration time of the drug body and the quality of the measurement.

The number of partial taps of the coil gives the spatial resolution, although with four partial taps, a measuring accuracy of less than 50 micrometers can be reached; the measurement is preferably carried out shortly before Reversal point of the decay basket in the direction of movement upwards.

The sensor signals S ₁ ,. . ., S _n are in height information x ₁ ,. . ., x _n , ie the height of the perforated disc 4 '' relative to the bottom of the decay basket 1 at a time corresponding to the upper reversal point of the decay basket 1 , whereby a measurement is automatically rejected if several successive pairs of values S _i , S _{i + 1} such are that for the corresponding x _i , X _{i + 1} applies x _i ≦ x _{i + 1} . In this way it can be recognized whether a tablet has been placed transversely or erected, so that such a value is rejected. Likewise, "sticking" of the tablet to the wall can be recognized. In this way a complete chronological decay diagram of the tablet can be created.

For evaluation purposes are preferably every two seconds while the decay basket is at the top reversal point, the respective thicknesses of the Tablet queried and the values saved. This process will happen again picks up until the tablet disintegrates or until a predetermined residual thickness is reached is. In this way, the time course of the disintegration of the tablet received, whereby the process can be displayed on a monitor. The Stored values of a measurement process can be statistical or by means of Graphs or tables can be evaluated locally in the device, whereby the values to a higher-level, integrating tablet test system Processing can be forwarded via data lines.

If a light-sensitive sensor is used as the sensor, this can be a high-speed opto-electronic, spatially resolving PSD construction be an element whose edge currents are evaluated, their Ratio then provides a statement about the tablet's disintegration time.

FIG. 4 shows a side view of a further device, the representation essentially corresponding to that of FIG. 1. In contrast to the device from FIG. 1, in the embodiment shown here, the connecting cables 9 , 9 'from the sensor elements 8 , 8 ' to the electronics 11 are completely enclosed in the material or in the center rod 15 and in the head part 16 and thus against spray liquid protected. The connecting cables 9 , 9 'are melted into the wall 7 of the test tube 2 , 2 ', emerge from the upper edge of the test tube and are guided inside the upper cover plate 20 . The guidance is implemented, for example, by grooves 24 , 24 ', as shown in FIG. 3. The connecting cables are guided radially in the direction of the center of the cover plate 20 via these grooves. The cables 9 , 9 'emerge from the cover plate within the center column, which is hollow.

The evaluation electronics 11 arranged in the head part 16 further comprises a processor 26 for evaluating the measurement data at the location of the measurement. Such a measuring head is therefore self-sufficient and independent of an external evaluation system, but can also be used in conjunction with an external evaluation system. The evaluated data, but depending on the operating mode, also raw data are transferred via interfaces 17 , 18 for later evaluation.

FIG. 5 shows an alternative for realizing the electrical contact between the sensor 8 inserted into the wall 7 of the test tube 2 and the evaluation electronics in the head part of the measuring device. Cable elements 9 are melted or otherwise introduced into the plate material in the cover plate and end on the underside of the cover plate in a plug element 27 with sockets or pins. The upper edge of the test tube 2 is complementary to it, so it also has a plug element 27 'into which the cable 9 coming from the sensor 8 or the connecting strands of the partial taps open. By placing the cover plate on the decay basket 1 equipped with test tubes, the electrical contact between the evaluation electronics 11 and the sensor elements within the test tubes is established via the cables within the cover plate. The wall 7 of the test tube 2 is not shown to scale in FIG. 5.

Industrial applicability

The object of the invention is in particular for the production of a Device according to DAB 10, 3rd supplement 1994, suitable to automatically to determine the disintegration time of pharmaceutical tablets and a disintegration time chart.  

Reference list

1

Decay basket

2nd

,

2nd

',

2nd

'' Test tubes

3rd

ground

4th

,

4th

',

4th

'' Hole disc

5

vessel

6

Medicinal tablets

7

Cylinder wall

8th

,

8th

'' spatially resolving sensor

9

,

9

' Electric wire

10th

,

10th

',

10th

'' Target

11

,

11

'Evaluation electronics

12th

Kitchen sink

13

poetry

14

Sieve

15

Center column

16

Headboard

17th

,

18th

interface

19th

pillar

20th

Cover plate

21

,

21

',

21

'',

21

'''Partial taps

22

flexible tape

23

,

23

'Holes

24th

,

24th

'Nut

25th

Mounting hole

26

processor

27

,

27

'Connector

Claims (23)

1. Device for determining the disintegration time of compressed medicament shaped bodies ( 6 ), such as tablets or capsules, in a liquid medium which is located in a vessel ( 5 ), consisting of a disintegration basket which can be lowered and raised in the vessel ( 5 ) ( 1 ) with a bottom ( 3 ) covered from below with a sieve and an upper cover plate ( 20 ), each having a plurality of holes, into which test tubes ( 2 ) between the bottom ( 3 ) and cover plate ( 20 ) within the decay basket ( 1 ) , 2 ', 2 '') are arranged in an upright position, in each of which a perforated disc ( 4 , 4 ', 4 '') can be movably inserted for weighting the individual medicament shaped body ( 6 ), the decay basket ( 1 ) with one in the The center pillar ( 15 ), which attaches to the middle of the cover plate ( 20 ), is held on a head part ( 16 ), characterized in that at least one spatially resolving sensor ( 8 , 8 ) is in the wall ( 7 ) of the test tube ( 2 , 2 ', 2 '')') introduced i st, which is able to interact with the hole disc ( 4 , 4 ', 4 '') within the test tube ( 2 , 2 ', 2 '') in such a way that the sensor signal provides information about the height of the hole disc ( 4 , 4 ', 4 '') above the bottom ( 3 ) of the decay basket ( 1 ) as a function of time and thus over the decay time, the sensor signals being evaluated in an electronic evaluation unit ( 11 , 11 '). 2. Device according to claim 1, characterized in that the spatially resolving sensor ( 8 , 8 ') from the bottom ( 3 ) facing side of the test tube ( 2 , 2 ', 2 '') up to a height H above the floor ( 3 ) extends within the wall ( 7 ). 3. Apparatus according to claim 1, characterized in that the spatially resolving sensor ( 8 , 8 ') within the wall ( 7 ) from the lower edge of the test tube ( 2 , 2 ', 2 '') to a height which is the thickness of the floor ( 3 ) corresponds approximately. 4. Device according to one of claims 1 to 3, characterized in that the sensor ( 8 , 8 ') in the wall ( 7 ) of the test tube ( 2 , 2 ', 2 '') is melted. 5. Device according to one of claims 1 to 3, characterized in that the wall ( 7 ) of the test tube ( 2 , 2 ', 2 '') is double-walled, the sensor ( 8 , 8 ') being arranged between the partial walls and the upper and lower openings between the part walls are sealed so that the sensor ( 8 , 8 ') is isolated from the liquid medium. 6. The device according to claim 4 or 5, characterized in that one or more cables ( 9 , 9 '; 21 , 21 ', 21 '', 21 ''') for power supply and / or signal transmission at the upper edge of the test tube ( 2nd , 2 ', 2 '') are led out of the wall ( 7 ) thereof, the exit point of the cable ( 9 , 9 '; 21 , 21 ', 21 '', 21 ''') from the wall ( 7 ) being sealed . 7. The device according to claim 6, characterized in that the cables ( 9 , 9 '; 21 , 21 ', 21 '', 21 ''') sealed in the interior of the center column ( 15 ) to the evaluation electronics ( 11 , 11 ') are guided so that the cables ( 9 , 9 '; 21 , 21 ', 21 '', 21 ''') are insulated from the medium and protected against spray liquid, for example are guided in a flexible band film ( 22 ). 8. Apparatus according to claim 6 or 7, characterized in that the cables ( 9 , 9 '; 21 , 21 ', 21 '', 21 ''') or the cables ( 9 , 9 '; 21 , 21 ' , 21 '', 21 ''') enveloping band film ( 22 ) in a groove ( 24 , 24 ') of the cover plate ( 20 ) from the upper edge of the test tube ( 2 , 2 ', 2 '') to the attachment point of the center column ( 15 ) are guided, the grooves ( 24 , 24 ') being directed radially to the center of the cover plate ( 20 ). 9. Apparatus according to claim 4 or 5, characterized in that the transmission of the sensor signal to the evaluation electronics ( 11 , 11 ') without contact, for. B. inductive, optical or electro-optical. 10. Device according to one of claims 1 to 9, characterized in that the spatially resolving sensor ( 8 , 8 ') is a capacitive, inductive, magnetic or optical sensor. 11. The device according to claim 10, characterized in that the spatially resolving sensor ( 8 , 8 ') has a coil ( 12 ) with at least two, preferably three or four, partial taps ( 21 , 21 ', 21 '', 21 ''') is. 12. The apparatus according to claim 11, characterized in that the coil ( 12 ) can be acted upon with AC voltage. 13. Device according to one of claims 1 to 10, characterized in that the spatially resolving sensor ( 8 , 8 ') consists of a plurality of individual sensors. 14. Device according to one of claims 1 to 13, characterized in that the perforated disc ( 4 , 4 ', 4 '') has at least one target ( 10 , 10 ', 10 '') on which the spatially resolving sensor ( 8 , 8 ', 12 ) responds reliably, the weight, volume and shape of the perforated disk ( 4 , 4 ', 4 '') being unchanged in accordance with the standards. 15. The apparatus according to claim 14, characterized in that the target ( 10 , 10 ', 10 '') is arranged in the region of the bottom ( 3 ) facing side of the perforated disc ( 4 , 4 ', 4 ''). 16. The apparatus according to claim 11 or 12, characterized in that the target ( 10 , 10 ') is a ring magnet. 17. Device according to one of claims 14 and 15, characterized in that the perforated disk ( 4 , 4 ', 4 '') has a conductor loop as a target ( 10 ''), which is preferably made of aluminum. 18. Device according to one of claims 1 to 17, characterized in that the sensor signals of all sensors ( 8 , 8 ') within the test tube chen ( 2 , 2 ', 2 '') of the decay basket ( 1 ) in an electronic evaluation unit ( 11 , 11 ') can be evaluated to determine the disintegration time of the pharmaceutical tablets ( 6 ), the evaluation electronics ( 11 , 11 ') being located in a sealed manner in the head part ( 16 ) of the device. 19. Device according to one of claims 1 to 18, characterized in that the sensors ( 8 , 8 ') are bus-compatible and can be configured via at least one interface ( 17 , 18 ). 20. Device according to one of claims 1 to 19, characterized in that there is at least one computing processor ( 26 ) within the head part ( 16 ) or the evaluation electronics ( 11 ), the motor and the motor control for raising and lowering as well of the decay basket ( 1 ) is integrated in the head part ( 16 ). 21. A method for determining the disintegration time of compressed medicament shaped bodies ( 6 ), such as tablets or capsules, in a liquid medium within a vessel ( 5 ) with the aid of the device according to one of claims 1 to 20, the disintegration basket ( 1 ) using a motor is moved up and down vertically within the vessel ( 5 ), characterized in that only discrete values of the time-dependent sensor signal S are evaluated, with the sensor signal S _i in each movement cycle, which is temporally the sensor signal S in the region of the upper reversal point of the movement of the decay basket ( 1 ) corresponds to, ie S _i = S (t _i ), is used to determine a relative instantaneous state of dissolution of the drug body ( 6 ) and a quasi-continuous time course of the dissolution states determined in this way is created, which provides information about the decay time of the Medicament shaped body ( 6 ) and the quality of the measurement there. 22. The method according to claim 21, characterized in that the disintegration time of the drug body ( 6 ) is that time until the sensor signal S _i exceeds or falls below a predetermined threshold, the threshold corresponding to a predetermined state of dissolution of the drug body ( 6 ). 23. The method according to claim 21, characterized in that the sensor signals S ₁ ,. . ., S _n in height information x ₁ ,. . ., x _n ie the height of the perforated disc ( 4 , 4 ', 4 '') relative to the bottom of the decay basket ( 1 ) at a time corresponding to the upper reversal point of the decay basket ( 1 ), whereby a measurement is automatically rejected if Several successive pairs of values S _i , S _{i + 1 are} such that the following applies to the corresponding x _i , x _{i + 1} : x _i ≦ x _{i + 1} .