JP6502678B2 - Gastrointestinal tract exercise simulator and method for collecting digestive material for examination - Google Patents

Description

  The present invention relates to a digestive tract motility simulator for grasping the digestive tendency in the digestive tract of food such as semi-solidified liquid food, pharmaceuticals and the like, and a method of collecting digestive material for examination.

  Gastrointestinal tract exercise simulator is a device for analyzing the behavior in the digestive tract of food, medicine and the like under the condition similar to human digestive tract environment and digestive tract exercise. Gastrointestinal tract exercise simulator can be used, for example, to analyze the physical property change and digestion process of semi-solidified fluid food in the digestive tract.

There are two types of digestive tract exercise simulator analogues as follows.
(1) Disintegration / dissolution testing device for oral medicine (mainly tablets) in the digestive tract Device described in Japanese Pharmacopoeia "General Test" (2) For analysis of food digestion / absorption process Testing Apparatus And, in the Japanese Pharmacopoeia, a disintegration tester and three types of dissolution testers are approved.
However, since all three types are mechanisms for testing by adding a large amount of artificial digestive fluid to a sample, it is a non-physiological stirring mechanism far from physiological exercise of human gastrointestinal tract. In addition, it is not a device that can reproduce the physiological behavior (storage, stirring, crushing, transport) in the stomach of a high viscosity food mass.

  Also, Japanese Patent Application Laid-Open Nos. 2004-233332 (Patent Document 1), 2000-249696 (Patent Document 2), 9-501238 (Patent Document 3), 8-252455 (Patent Document 4), etc. have been proposed. ing.

[Patent Document 1] Japanese Patent Laid-Open No. 2000-249696 Tohko 9-501238 JP-A-8-252455

Analyzing the bioavailability of nutritional components and active pharmaceutical ingredients when orally ingesting foods and drugs is a very important task in evaluating the effectiveness of foods and drugs. For this reason, the disintegration tester and the dissolution tester defined in the Japan General Test Method are used not only for pharmaceuticals but also for evaluating the nutritional characteristics of food.
However, in recent years, it has been found that gastrointestinal motility responses such as gastric peristalsis are greatly different depending on food properties such as food shape, especially viscosity, and development of a test apparatus capable of reproducing these physiological gastrointestinal motility is required. It is done.

That is, when a sufficient amount of a normal food or a semisolid food having a viscosity of 10,000 mPa · s or more is ingested, the food mass reached in the stomach is extended in the stomach wall by receptive relaxation and stored in the stomach, and at the same time the stomach wall It has become clear that strong gastric peristalsis is triggered by the response of the receptor that senses the extension of the stomach, and the stomach contents are gradually excreted in the duodenum.
In addition, the stored stomach contents are not totally mixed by gastric peristalsis, and a part of the stomach contents stored in the upper part of the stomach is one part from the upper third part of the stomach wall After being cut out with a peristaltic ring that occurs 3 times per minute and being cut out and cut out from the food mass to be transported to the pyloric region, and after being thoroughly mixed with gastric juice and digested with digestive enzymes such as pepsin It is drained to the duodenum through the pylorus.

Therefore, in order to accurately analyze the behavior of food in the digestive tract, there is a need for a test device that can reproduce a series of processes from storage to stirring in the stomach to mixing of digestive juices to transportation, but the JPC test These functions can not be reproduced in the organ and conventional gastrointestinal models.
However, in the above-mentioned, since it is a mechanism to test by adding a large amount of artificial digestive juice to a specimen, it is a non-physiological stirring mechanism far from physiological exercise of human gastrointestinal tract. In addition, it is not a device that can reproduce the physiological behavior (storage, stirring, crushing, transport) in the stomach of a high viscosity food mass.
An object of the present invention is to provide a digestive tract movement simulator and a method for collecting digestive material for examination which can easily reproduce physiological movement and function of the stomach.

The objects to achieve the above object are as follows.
(1) A digestive tract exercise simulator for simulating a digestive trend in a digestive tract of a subject, wherein the digestive tract exercise simulator is a base on which a subject-filled soft container containing the subject is placed or housed. Part and a container pressing part for pressing the soft container placed or stored in the base part, the container pressing part is a one end side pressing part for pressing one end side of the soft container, and the discharging A container main portion pressing portion for pressing the container main portion including the other end side of the soft container having a portion; and a control portion for controlling the respective pressing portions, the container main portion pressing portion includes a plurality of main portions The control unit is configured to press the one end side pressing unit in such a manner that the amount of the subject that can be stored on the one end side of the soft container decreases stepwise or continuously, and the plurality of main unit pressings Create parts at different times Is allowed, gastrointestinal movement simulator is intended to perform the agitation of the subject with the transport of analyte towards the discharge portion than the one end in the soft container.

(2) Each pressing portion includes a pressing plate for pressing the soft container placed or stored in the base portion from above, and a pressing plate drive mechanism for driving the pressing plate up and down. Gastrointestinal tract exercise simulator as described in the above (1).
(3) The container main portion pressing portion includes a first main portion pressing portion and a second main portion pressing portion, and the control portion sets the timing at which the first main portion pressing portion and the second main portion pressing portion are different. The digestive tract motility simulator according to the above (1) or (2), which is operated by
(4) The container main portion pressing portion includes three or more main portion pressing portions, and the control portion operates the three or more main portion pressing portions at different timings. Or digestive tract exercise simulator as described in (2).
(5) The digestive tract movement simulator according to (1) or (2), wherein the container main portion pressing portion performs peristaltic movement or segmental movement toward the other end side of the soft container.
(6) The gastrointestinal tract motion simulator has a temperature control function for adjusting the temperature of the subject in the subject-filled flexible container within a range of 10 to 60 ° C. (1) to (5) ) The digestive tract exercise simulator according to any one of the above.
(7) The above-described (1) to (1), wherein the base portion includes a storage portion capable of storing the flexible container and the temperature control medium, and a temperature control function for adjusting the temperature of the temperature control medium. Gastrointestinal tract exercise simulator according to any one of 5).
(8) The gastrointestinal tract exercise simulator according to any one of (1) to (7), wherein the gastrointestinal tract exercise simulator has an injection function in communication with the inside of the soft container.
(9) The gastrointestinal tract exercise simulator according to any one of the above (1) to (8), wherein the gastrointestinal tract exercise simulator has a collection function of collecting an effluent flowing out from the discharge part of the soft container.

Moreover, what achieves the above object are as follows.
(10) A method for collecting a test digest for checking the digestive trend of a fluid sample, comprising the steps of preparing a fluid sample, and discharging the sample at least at its end. In the step of filling the flexible container, and in the state where the temperature of the flexible container filled with the fluid test object is maintained at a predetermined temperature, one end side facing the end having the discharge part of the flexible container is stepped or The main portion of the container between the proximal end side having the discharge portion of the flexible container and the one end side is pressed from the one end side while pressing so that the amount of the specimen which can be retained to the one end side of the soft container decreases continuously. An inspection is performed by pressing the gentle moving flow flowing toward the discharge part and agitation of the fluid test object in the soft container, and continuously discharging the digest for inspection from the discharge part And the collection process of sequentially collecting digestive digests How to collect 査用 digest.
(11) The method for collecting digested material for examination according to the above (10), wherein the fluid test substance is a mixture of a tube nutrient or a semi-solidified fluid food and a simulated gastric fluid containing an enzyme .

The digestive tract movement simulator for simulating the digestive movement of the digestive tract of the subject according to the present invention comprises a base part for placing or containing a subject-filled soft container containing the subject, and a placement or storage on the base part Container pressing portion for pressing the soft container, the container pressing portion is a container main portion including the one end side pressing portion pressing the one end side of the soft container, and the other end side of the soft container having the discharging portion The container main portion pressing portion includes a plurality of main portion pressing portions, and the control portion controls the one end side pressing portion stepwise or And pressing the plurality of main portion pressing parts at different timings to continuously transfer the subject from the one end toward the discharge part Agitates the subject in the soft container It has become as. For this reason, the physiological movement and function of the stomach can be easily reproduced, and the digestive movement can be evaluated without using human development for the development products such as medicines and foods.

FIG. 1 is an explanatory view for explaining a digestive tract exercise simulator according to an embodiment of the present invention. FIG. 2 is a perspective view of a digestive tract movement simulator which is the device shown in FIG. FIG. 3 is a front view of the digestive tract exercise simulator shown in FIG. FIG. 4 is a right side view of the digestive tract exercise simulator shown in FIG. FIG. 5 is a plan view of the digestive tract motion simulator shown in FIG. FIG. 6 is an explanatory view for explaining the operation of the digestive tract motion simulator shown in FIG. FIG. 7 is an explanatory view for explaining a digestive tract exercise simulator according to another embodiment of the present invention. FIG. 8 is an explanatory view for explaining a digestive tract exercise simulator according to another embodiment of the present invention. FIG. 9 is an explanatory view for explaining a digestive tract exercise simulator according to another embodiment of the present invention. FIG. 10 is an explanatory view for explaining the operation of the digestive tract motion simulator shown in FIG.

The digestive tract motility simulator and the method for collecting digestive products for examination according to the present invention will be described with reference to the embodiments shown in the drawings.
Gastrointestinal tract exercise simulators 1, 1a, 1b, 1c, 10 of the present invention are for simulating examination of the digestive behavior in the digestive tract of a subject.

Gastrointestinal tract exercise simulators 1, 1a, 1b and 10 of this embodiment are provided with a base 2 for placing or storing a subject-filled soft container 5 containing a subject, and a soft placed or housed in the base 2. Container pressing parts 3 and 4 for pressing the container 5 are provided, and the container pressing part is one end side pressing part 3 pressing one end side 51 a of the soft container 5 and the other end of the soft container 5 having the discharge part 52 The container main part pressing part 4 which presses the container main part containing the side 51b, and the control part 6 which controls each pressing part 3 and 4 are provided. The container main portion pressing portion 4 includes a plurality of main portion pressing portions 4a and 4b. The control unit 6 operates the one end side pressing unit 3 so as to increase the degree of pressing step by step or continuously (in other words , presses the one end side of the soft container 5 so as to reduce the amount of the subject that can be stored). ) , The plurality of main part pressing parts 4a and 4b are operated at different timings to transfer the subject from the one end side 51a toward the discharge part 52 and to agitate the subject in the soft container 5. ing.

The gastrointestinal tract exercise simulator 1 of FIG. 1 and the gastrointestinal tract exercise simulator 10 of the embodiment shown in FIGS. 2 to 5 embodying the same will be described.
The digestive tract movement simulators 1 and 10 of this embodiment press the soft container 5 placed or stored in the base unit 2 and the flexible container 5 mounted or housed in the subject filled soft container 5 storing the subject. And a control unit 6 that controls the container pressing units 3 and 4.
In the gastrointestinal tract exercise simulators 1 and 10 of this embodiment, as shown in FIGS. 1 to 6, the base portion 2 includes the soft container 5 and the storage portion 21 capable of storing the temperature control medium. Furthermore, in this embodiment, a temperature control function 11 for adjusting the temperature of the temperature control medium is provided.

  The storage unit 21 can be placed on the bottom surface of the soft container 5 filled with the test object in a flat state, and the storage unit 21 can store the whole. Further, in the base portion 2 shown in FIG. 1, the side portion of the storage portion 21 is provided with the insertion portion 22 through which the discharge portion (discharge tube) 52 of the soft container 5 filled with the object is inserted in a liquid tight state. As the temperature control function, it is preferable to use the temperature control means 11 (for example, product name Thermal Robo, manufactured by As One Corporation) used in the digestive tract movement simulator 10 shown in FIGS. 1 to 5. The temperature control means 11 is mounted on the upper outer edge of the base 2.

  The temperature control means 11 preferably has a temperature control function for adjusting the temperature of the subject within the range of 10 to 60 ° C. In particular, one that can be temperature-controlled to 30 ° C. to 40 ° C. is preferable. Specifically, the temperature control unit 11 has a heating unit 11 a stored so as to be in contact with the temperature control medium stored in the storage unit of the base unit 2. When this temperature control means 11 is used, what has a part which can heat the heating part of temperature control means 11 as storage part 21 is used. By using this temperature control means 11, the base part 2 (storage part 21) can be functioned substantially as a constant temperature water tank. By providing such a temperature control function, the soft container and the pressing surface can be maintained at 37 ° C. For this reason, it is closer to reproduction of digestive tract movement and function.

  The temperature control means may be of the type provided in the digestive tract motion simulator 1a of the embodiment shown in FIG. In the digestive tract movement simulator 1a, the storage unit 21 can be placed on the bottom surface of the soft container 5 filled with the test object in a flat state, and the storage unit 21 can store the whole. Furthermore, the base unit 2 shown in FIG. 7 includes the temperature control medium circulation unit 23, and the temperature control medium is provided in the base unit 2 (the storage unit 21) via the temperature control medium circulation unit 23. It is circulating. The temperature control medium circulating unit 23 is connected to a supply unit 14 having a temperature control function of the temperature control medium.

  And the digestive tract motion simulators 1 and 10 of this Example are equipped with the container pressing part for pressing the soft container 5, as shown in FIGS. In particular, in the gastrointestinal tract exercise simulators 1 and 10 of this embodiment, a container main portion including the one end side pressing portion 3 pressing the one end side 51a of the soft container 5 and the other end side 51b of the soft container 5 having the discharge portion 52 The container main part pressing part 4 which presses is provided. Furthermore, the container main portion pressing portion 4 includes a plurality of main portion pressing portions, specifically, a first main portion pressing portion 4a and a second main portion pressing portion 4b. And digestive tract movement simulator 1, 10 is provided with control part 6 which controls individually the motion of one end side pressing part 3, the 1st main part pressing part 4a, and the 2nd main part pressing part 4b.

  The one end side pressing unit 3 includes a pressing plate 31 for pressing the soft container 5 placed or stored in the base unit 2 from the upper surface, and a pressing plate drive mechanism 32 for driving the pressing plate 31 up and down. The first main portion pressing portion 4a includes a pressing plate 41a for pressing the other end side 51b of the soft container 5 from the upper surface, and a pressing plate drive mechanism 42a for driving the pressing plate 41a up and down. The second main portion pressing portion 4b vertically drives the pressing plate 41b for pressing the central portion between the one end side and the other end side 51b of the soft container 5 from the upper surface, and the shaft 43b to which the pressing plate 41b is fixed. The pressure plate drive mechanism 42b is provided.

  In this embodiment, the pressing plates 31, 41a and 41b have flat pressing surfaces on the lower surface, and the areas of the pressing surfaces are substantially equal. However, the areas of the pressing surfaces of the pressing plates 31, 41a and 41b may be different. For example, the area of the pressing surface of the pressing plate 31 of the one-end pressing portion 3 may be larger or smaller than the area of the pressing surface of the pressing plate of the main portion pressing portions 41a and 41b. The pressing plates 41a and 41b may have different pressing surface areas.

  The material of the pressing plate is not particularly limited. Since the pressing plate has sufficient strength as a presser and is operated for a long time in constant temperature water, it is preferable that the pressing plate be a stainless steel material or the like excellent in corrosion resistance. As for the shape of the pressing plate, it is desirable that at least three pressing plates can cover 50% or more, preferably 80% or more, and more preferably 90% or more of the surface area of the flexible container.

  Also, the area ratio of the portion where each pressing plate contacts the soft container is not strictly defined, but for example, when there are three pressing plates, it is the same (1/3 of the total contact area) Or the area of the pressing surface of the pressing plate on one end side (the esophagus equivalent side) of the soft container is slightly larger than that of the other pressing portions, and the main portion pressing portion (other end side, central portion) of the soft container By making the areas of the pressing surfaces of the two pressing plates the same, it is possible to reproduce motion similar to human stomach peristalsis.

  The pressure plate drive mechanisms 32, 42a and 42b are provided with drive shafts 33, 43a and 43b whose tip portions are fixed to the pressure plates 31, 41a and 41b. As the pressing plate drive mechanisms 32, 42a and 42b, mechanical cylinders (for example, slider type, rod type), hydraulic cylinders, pneumatic cylinders, etc. can be used. In particular, ROBO cylinder (registered trademark, manufactured by IAI Co., Ltd.) which is a mechanical cylinder is preferable.

  And, as shown in FIG. 1 to FIG. 6, the digestive tract movement simulator 1, 10 of this embodiment is provided with a control unit 6 that controls the container pressing unit 3, 4 a, 4 b. And the control part 6 controls container pressing part 3, 4a, 4b separately. For this reason, the container pressing parts 3, 4 a, 4 b move individually by the control part 6. Specifically, the control unit 6 operates the one end side pressing unit 3 so as to increase the degree of pressing step by step or continuously.

  More specifically, the control unit 6 lowers the pressing plate 31 of the one-side pressing unit 3 stepwise or continuously, and the pressing degree of the one end side 51 a of the soft container 5 gradually or continuously (in other words, Control) to become stronger gradually. In other words, the distance between the upper surface of the base portion 2 and the pressing plate 31 is controlled to be gradually or continuously shortened. As a result, the volume at one end 51 a of the flexible container 5 gradually or continuously decreases, and the amount of the subject that can be retained at this one end decreases. In the control unit 6, the pressing surface of the pressing plate 31 substantially contacts the upper surface of the one end side 51 a of the soft container 5 at the start of simulating the digestive tract movement simulators 1 and 10, and substantially soft container Control is performed so as to be at a position where the one end side 51a of 5 is not pressed (a set maximum position). This position of the pressure plate 31 (pressure surface) is an initial value, and the position is lowered stepwise or continuously from this position.

  Then, the pressing plate 31 (pressing surface) is lowered until the pressing surface of the pressing plate 31 contacts the inner surfaces of the facing sheets on the one end side 51 a of the soft container 5 and the internal storage space disappears substantially. Specifically, the process is performed until the pressing plate 31 reaches the set minimum position stored by the control unit 6. The lowering of the pressing plate 31 may be either stepwise or continuous. In addition, it is desirable that the time for reaching the set minimum position from the set maximum position after the operation of the pressing plate 31 is variable. It is preferable to be able to arbitrarily select 30 to 180 minutes which is the gastric emptying time of a healthy person as the time to reach the setting minimum position from the setting maximum position, and it is preferable to be able to arbitrarily select at least 30 to 90 minutes. And by the selected time, most of the contents filled in the soft container will be discharged.

  Further, when the pressing plate 31 descends stepwise (stepwise), the number of descents and the timing of each descent to reach the set minimum position from the set maximum position are appropriately set according to the purpose. According to the discharge pattern of human stomach contents, at least twice or more corresponding to the stomach contents half life (20 to 40 minutes) and the end of discharge (40 to 180 minutes), preferably in the middle of 0 minutes to the half life and It is preferable to lower the frequency several times or more on the way from the half life to the end. Moreover, it is preferable that each descent | fall timing is substantially the same time.

In addition, the control unit 6 operates the plurality of main portion pressing portions 4a and 4b at different timings to transfer the subject from the one end 51a toward the discharge portion 52 and stir the subject in the soft container 5 Let Specifically, the control unit 6 operates the first main portion pressing portion 4a and the second main portion pressing portion 4b at different timings.
Specifically, at the start of simulating the digestive tract motion simulators 1 and 10, the control unit 6 positions the pressing surface of the pressing plate 41a at the set maximum position (or the set minimum position), and the pressing plate 42a It may be controlled to be located at the set minimum position (or the set maximum position). Then, in the control unit 6, the lowering of each pressing plate 41a, 42a from the highest setting position to the lowest setting position and the rising from the lowest setting position to the highest setting position are repeated in the reverse phase state Thus, the pressing portions 4a and 4b may be controlled.

  Further, at the start of simulating the digestive tract movement simulators 1 and 10, the control unit 6 substantially contacts the upper surface of the other end 51b of the soft container 5 with the pressing surface of the pressing plate 41a and is substantially soft. Control is performed so that the other end 51b of the container 5 is not pressed. Similarly, at the start of simulation of the digestive tract motion simulators 1 and 10, the control surface of the pressing plate 41b is a soft container. The position is controlled so as to be substantially in contact with the upper surface of the central portion 51 c of 5 and not to substantially press the central portion 51 c of the flexible container 5. This position of the pressing plates 41a and 41b (pressing surface) is the set position (highest position). The control unit 6 controls the pressing portions 4a and 4b such that the lowering from the set highest position to the set lower position and the rise from the set lower position to the set highest position are repeated. It is also good.

  Then, in the type of this embodiment, the control unit 6 operates the first main portion pressing portion 4a and the second main portion pressing portion 4b at different timings. Thereby, the transfer of the subject from the one end side 51 a to the discharge unit 52 and the stirring of the subject in the soft container 5 are performed. The control unit 6 controls the movement of the first main portion pressing portion 4a and the second main portion pressing portion 4b, specifically, the vertical movement of the pressing plate 41a and the pressing plate 41b to be substantially in reverse phase. It is preferable to do.

  Also in the type of this embodiment, when one of the pressing plates 41a and 41b (the other) is located at the above-described setting position (highest position), the control unit 6 is the other (one) of the pressing plates 41a and 41b. It is preferable to control so as to be located at the lowermost setting position. In addition, it is preferable that the setting maximum position and the setting minimum position which were mentioned above of the press surface in press part 4a, 4b are the same. However, both set maximum position and set minimum position may be different. Also in this case, it is preferable that the control unit 6 control the vertical movement of the first main portion pressing portion 4a and the second main portion pressing portion 4b in opposite phases.

Further, in the control section 6 of all the above-described embodiments, control may be performed such that the above-described set maximum positions of the pressing plates 41a and 41b are lowered with time. In the gastrointestinal tract movement simulators 1 and 10 of this embodiment, the test items in the soft container 5 are gradually discharged along with the execution of the simulation, so the amount of test items in the soft container 5 decreases. The set maximum position may be controlled to be lowered stepwise or continuously in consideration of this amount of decrease.
In addition, it is preferable that the control unit 6 control the vertical movement of the first main portion pressing portion 4a and the second main portion pressing portion 4b to have a cycle equivalent to gastric peristalsis of about 20 seconds. Further, in the case of using a mechanical type and parameter controllable one such as the above-mentioned ROBO Cylinder (registered trademark) as the pressing portion driving portion, it is preferable that the control portion 6 can set control parameters.

  The simulator 10 according to the embodiment shown in FIGS. 2 to 5 includes a base 35 and a frame 36 erected on the base 35. The frame portion 36 is provided with a standing plate portion 37. The standing plate portion 37 extends vertically upward with respect to the base portion 35. Then, the one end side pressing portion 3, the first main portion pressing portion 4 a and the second main portion pressing portion 4 b are attached to the standing plate portion 37. In addition, the control unit 6 is disposed on the base portion 35 at a portion on the back side of the standing plate portion 37. The control unit 6 is electrically connected to the one end side pressing portion 3, the first main portion pressing portion 4a and the second main portion pressing portion 4b (specifically, the pressing plate drive mechanisms 32, 42a, 42b). , Control them. In addition, four legs 65 are provided on the bottom of the base 35.

  The pressing plate drive mechanism 32, 42a, 42b includes a drive motor and slide portions 34, 44a, 44b that move up and down by the drive of the drive motor. And the fixed plate provided in the upper end side of drive shaft 33, 43a, 43b is being fixed to this slide part 34, 44a, 44b. The pressing plates 31, 41a and 41b are attached to the lower ends of the drive shafts 33, 43a and 43b. As a result, the pressing plates 31, 41a, 41b move up and down by driving the pressing plate drive mechanisms 32, 42a, 42b (driving the drive motor). Thereby, as shown in FIG. 5, the soft container 50 accommodated in the base part 2 is pressed by the pressing plates 31, 41a and 41b from directly above.

Further, in the simulator 10 of the embodiment shown in FIG. 2 to FIG. 5, a placement plate 60 for placing the base portion 2 is provided below the pressing plates 31, 41a and 41b. The base portion 2 is mounted on the mounting plate 60 and fixed. Further, the mounting plate 60 is mounted on the two rails 61 and 62. For this reason, the mounting plate 60 holding the base portion 2 can slide on the rail. By adjusting the position of the base 2 on the rails 61 and 62, it is possible to adjust the position pressed by the pressing plates 31, 41a and 41b of the flexible container 5 in FIG. Further, the mounting plate 60 is provided with a grip portion 63. Thereby, the movement of the mounting plate 60 is easy.
Further, in the simulator 10 of the embodiment shown in FIG. 2 to FIG. 5, the temperature control means 11 is mounted and fixed on the upper side portion of the base portion 2. The temperature control unit 11 may also be electrically connected to the control unit 6 and temperature control may be performed by the control unit.

Moreover, as a digestive tract exercise simulator, you may be a type like the digestive tract exercise simulator 1b shown in FIG.
The difference between the digestive tract movement simulator 1b of this embodiment and the above-described digestive tract movement simulator 1 is only the main part pressing portion.
In the digestive tract movement simulator 1b shown in FIG. 8, the main portion pressing portion 40 is provided with three or more (specifically, four) main portion pressing portions 4a, 4b, 4c, 4d. Also in this digestive tract movement simulator 1b, the control unit 6 operates the three or more main portion pressing portions 4a, 4b, 4c, 4d at different timings. When three or more main part pressing parts are provided, the number of pressing parts is preferably about 3 to 10. Furthermore, when such three or more main part pressing parts are provided, the control part 6 preferably controls each main part pressing part to perform a peristaltic motion toward the other end side 51 b of the soft container 5 . Preferably, the control unit 6 has a function of controlling the container pressing units 3 and 40 (4a, 4b, 4c, 4d) so as to perform segmented movements.

  The main portion pressing portion 40 in the simulator 1b of this embodiment includes first to fourth main portion pressing portions 4a, 4b, 4c and 4d. Moreover, the simulator 1b of the Example is equipped with the one end side press part 3 similarly to the simulator 1 mentioned above. And each 1st-4th main part press part 4a, 4b, 4c, 4d is provided with each press board 41a, 41b, 41c, 41d, drive shaft 43a, 43b, 43c, 43d. The area of the pressing surface of each of the pressing plates 41 a, 41 b, 41 c, 41 d is smaller than the area of the pressing surface of the one-end side pressing portion 3. Moreover, it is preferable that the area of the pressing surface of each pressing plate 41a, 41b, 41c, 41d is substantially the same. The areas of the pressing surfaces of the pressing plates 41a, 41b, 41c and 41d may be different from each other.

  And, in the simulator 1b of this embodiment, the control unit 6 controls the one end side pressing portion 3 and the first to fourth main portion pressing portions 4a, 4b, 4c, 4d individually, and each at different timings. It is supposed to be activated. In particular, the control unit 6 is preferably controlled so that the first to fourth main portion pressing portions 4 a, 4 b, 4 c, 4 d perform a peristaltic motion toward the other end side 51 b of the flexible container 5.

  The gastrointestinal tract exercise simulator 1 of this embodiment is provided with a liquid injection function 13 for injecting a liquid into the soft container 5. The liquid injection function 13 is preferably one that can inject a liquid (for example, a digestive enzyme-containing liquid) into the central part of the soft container 5. In the illustrated embodiment, the liquid injection function 13 includes a tube connected to the side hole 16 of the flexible container 5, and an injection mechanism (pump) and a liquid reservoir for injecting the liquid through the tube. Furthermore, the liquid injection function 13 may include a tubular portion which enters from the side hole 16 of the flexible container 5 and extends to the central portion of the central portion of the flexible container 5.

  Furthermore, in the gastrointestinal tract exercise simulator 1 of this embodiment, the collecting function 12 for collecting the effluent flowing out from the discharge part 52 of the flexible container 5 is provided. A soft bag is used as a collecting function. Moreover, the collection function 12 may be equipped with a liquid feeding means. In addition, although a pump etc. are used as a liquid feeding means, it is preferable that it is a thing which does not suck | suck the soft container 5 substantially.

  The gastrointestinal tract exercise simulator of the present invention is effective for simulation of gastric peristalsis. The main digestive tract movements and functions in the stomach are the retention of the stomach contents in about one third of the upper stomach (cardia), the agitation of the contents by the gastric peristalsis at the center to the lower part of the stomach and the digestive juices. Admixture, drainage of the bolus at the lower part of the stomach (the antrum). These are associated with motor function at three sites in the upper part of the stomach (esophageal side: cardiac side), middle part (central stomach), lower part (small intestine side: pyloric side). The gastrointestinal tract exercise simulator of the present invention is capable of reproducing the main functions of the stomach by performing exercises corresponding to the above three sites by at least three pressing parts 3, 4a and 4b. .

  The gastrointestinal tract exercise simulator of the present invention can also be used to simulate small intestine exercise. The main gastrointestinal motility and function in the small intestine are segmental movements in which the middle and both ends of the bolus moving through the small intestine are alternately compressed in a cycle of about 8 seconds, and the resulting digestive fluid (pancreatic and bile fluids) and intestinal fluid. Mixture of

  The material of the soft container is not particularly limited as long as the soft container is easily deformed when the container is pressed by the pressing plate and can withstand an increase in the internal pressure of the container. The internal volume of the container is not particularly limited, but it is desirable to design in accordance with the device size of the pusher and the like. In addition, it is desirable that the container be a container with good transparency so as to facilitate visual confirmation of the mixed state of the contents when examining gastrointestinal motility.

In addition, the digestive tract movement simulator may be of a type such as the digestive tract movement simulator 1 c shown in FIGS. 9 and 10.
The difference between the digestive tract movement simulator 1c of this embodiment and the above-described digestive tract movement simulator 1 is the pressing mechanism of the pressing part, the heating air mechanism, the base part, and the like. The digestive tract motion simulator 1c includes a base portion 2a for storing a subject-filled soft container 5 containing a subject, an end-side container pressing portion 8 for pressing the soft container 5 stored in the base portion 2a, and The control unit 6 includes a control unit 6 that controls the pressing unit 9 and the pressing units 8 and 9.

  In the gastrointestinal tract exercise simulator 1c of this embodiment, as shown in FIGS. 9 and 10, the base portion 2a is a storage portion 21 capable of storing the soft container 5 and the pressing members 81, 91a, 91b of the pressing portions 8, 9. And a lid member 24. The lid member 24 is fixed to the upper surface of the storage unit 21 by a fixing member 25. Further, the lid member 24 includes insertion holes for the ducts 83, 93a, 93b connected to the pressing members 81, 91a, 91b.

Then, the one end side pressing portion 8 communicates the pressing member 81 which expands and contracts by the outflow and inflow of the fluid, the fluid supplying portion 82 which supplies the fluid to the pressing member 81, and the fluid supplying portion 82 and the pressing member 81. The duct 83 is provided.
Similarly, the main-portion pressing portions 9a and 9b expand and contract by pressing in and out of fluid, pressing members 91a and 91b, fluid supplying portions 92a and 92b for supplying fluid to the pressing members 91a and 91b, and fluid supply Ducts 93a and 93b are provided to communicate the portions 92a and 92b with the pressing members 91a and 91b.

  The pressing members 81, 91a, 91b of this embodiment are on a crushed ring having a predetermined width. In the inside, the pressing target portion of the soft container 5 can be stored. The pressing members 81, 91a, 91b of this embodiment are not ring-shaped, but are folded in two (in other words, U-shaped in cross section) and capable of encapsulating the pressing target portion of the soft container 5 It may be.

  Further, in the pressing members 81, 91a, 91b of this embodiment, the lower surface is in contact with the upper surface of the base portion 2a, the upper surface is in contact with the lower surface of the lid member 24, and the outward expansion is substantially restricted. . For this reason, as shown in FIG. 10, the pressing members 81, 91a, 91b expand by the injected fluid and press the soft container 5. Further, the pressure on the soft container 5 is released by discharging the fluid.

  The fluid supply parts 82, 92a, 92b have a pump function for inflow and discharge of the fluid to the pressing members 81, 91a, 91b. Furthermore, the fluid supply parts 82, 92a, 92b preferably have a temperature control function (heating function) of the supply fluid. The temperature of the test object in the soft container 5 can be adjusted by adjusting the temperature of the fluid supplied to the pressing members 81, 91a, 91b.

Further, as the fluid supplied to the pressing members 81, 91a, 91b, air, water, a liquid having a heat retaining property (for example, polyethylene glycol) or the like can be used.
In this embodiment, the widths of the pressing members 81, 91a, 91b are substantially the same. However, the widths of the pressing members 81, 91a, 91b may be different. For example, the width of the pressing member 81 of the one-end pressing portion 8 may be larger or smaller than the width of the main portion pressing members 91a and 91b. Further, the main portion pressing member 91a and the main portion pressing member 91b may have different widths.

  The material of the pressing members 81, 91a, 91b is not particularly limited. A bag-like material formed of a soft material and having a certain degree of pressure resistance is preferable. If the pressing members 81, 91a, 91b are ring-shaped, the front surface of the pressing portion of the soft container 5 can be pressed. When the pressing members 81, 91a, 91b are folded in half, it is preferable that 70% or more, preferably 90% or more of the pressing portion of the soft container 5 is covered.

And also in the digestive tract motion simulator 1c of this embodiment, the control unit 6 that controls the container pressing unit 8, 9a, 9b is provided. And the control part 6 controls container pressing part 8, 9a, 9b separately. For this reason, the container pressing parts 8, 9a, 9b individually move differently by the control part 6.
Specifically, the control unit 6 operates the one end side pressing unit 8 so as to increase the degree of pressing step by step or continuously. More specifically, the control unit 6 injects the fluid stepwise or continuously to the pressing member 81 of the one-side pressing unit 8, and the pressing degree of the one end side 51 a of the soft container 5 is stepwise or continuously. (In other words, gradually) control to become stronger. In other words, the pressing member 81 gradually increases, the one end side 51a of the soft container 5 is gradually crushed, and the amount of the subject that can be retained at the one end side 51a decreases.

  Further, at the start of simulation of the digestive tract movement simulator 1 c, the control unit 6 substantially contacts the inner surface of the pressing member 81 with the outer surface of the one end side 51 a of the soft container 5 and substantially one end of the soft container 5. Fluid injection is performed so as not to press the side 51a. This state of the pressing member 81 is an initial state, and from this state, the one end side 51a of the soft container 5 is squeezed stepwise or continuously.

  Then, expansion of the pressing member 81 (in other words, injection of fluid to the pressing member 81) is performed until the inner surfaces of the facing sheets are in contact at the one end side 51a of the soft container 5 and the internal storage space disappears substantially. . Specifically, it is performed until the injection amount of the fluid reaches the set injection amount stored by the control unit 6. And, the injection of fluid may be stepwise, but is preferably continuous.

  In addition, the control unit 6 operates the plurality of main portion pressing portions 9a and 9b at different timings to transfer the subject from the one end side 51a toward the discharge portion 52 and stir the subject in the soft container 5 Let Specifically, the control unit 6 operates the first main portion pressing portion 9a and the second main portion pressing portion 9b at different timings. In the control unit 6, the inner surface of the pressing member 91a substantially contacts the outer surface of the other end 51b of the soft container 5 at the start of simulation of the digestive tract movement simulator 1c, and the inner surface of the pressing member 91b is The fluid injection is performed so as to substantially contact the outer surface of the central side 51 c and not substantially press the flexible container 5. This state of the pressing members 9a and 9b is an initial state, and from this state, the one end side 51a of the soft container 5 is crushed gradually or continuously.

  Specifically, when one of the pressing members 91a and 91b (the other) is in the above-described initial state, the control unit 6 is in a state where the fluid of the set injection amount is injected to the other (one) of the pressing members 91a and 91b. It is preferable to control so that In addition, it is preferable that the setting injection quantity to the press members 91a and 91b in the press parts 9a and 9b is the same. However, both set injection amounts may be different. Also in this case, the control unit 6 preferably controls the expansion / contraction of the first main portion pressing portion 9a and the second main portion pressing portion 9b so as to be in opposite phase.

  In addition, the control unit 6 may control so that the above-described set maximum positions of the pressing members 91a and 91b decrease with time. In the gastrointestinal tract movement simulators 1 and 10 of this embodiment, the test items in the soft container 5 are gradually discharged along with the execution of the simulation, so the amount of test items in the soft container 5 decreases. In consideration of this amount of decrease, the initial injection amount may be changed stepwise or continuously. Further, it is preferable that the control unit 6 controls the expansion / contraction of the first main portion pressing portion 9a and the second main portion pressing portion 9b to have a cycle equivalent to gastric peristalsis of about 20 seconds.

Next, the method of collecting a digestive product for examination for confirming the digestive tendency of a fluid sample according to the present invention will be described.
The method for collecting a digestive product for examination of the present invention is carried out to confirm the digestive trend of a fluid sample. Then, the method for collecting a digestive product for examination of the present invention comprises the steps of preparing a fluid test object, filling the test object in the flexible container 5 having the discharge part 52 at least at an end, and In a state where the temperature of the flexible container 5 filled with the inspection object is maintained at a predetermined temperature, the pressure on one end side facing the end portion having the discharge portion 52 of the flexible container 5 is increased stepwise or continuously. Slow moving flow flowing from the one end toward the discharge part 52 and the fluid test object in the soft container 5 while pressing the container main part between the base end side and the one end side having the discharge part 52 of the soft container 5 The stirring operation is performed so as to continuously carry out the test digest from the discharge unit 52, thereby performing a sampling step of sequentially sampling the test digest.

Each process will be described. In the embodiment described below, the gastrointestinal tract exercise simulators 1 and 10 described above are used.
The step of preparing a fluid sample is performed, for example, by mixing a gavage nutrient or a semi-solidified fluid diet with a simulated gastric fluid containing an enzyme. The artificial gastric juice containing pepsin is preferably mixed in advance with the contents of the stomach and filled in a soft container. However, it may be continuously injected into the soft container by a syringe, a pump or the like through a tube connected to the soft container.

  As a gavage nutrient, one which is prepared to have a viscosity in the form of a viscous, thickened, etc. before being administered outside the human body, that is, in the digestive tract of a human being, is used. The tube nutrition is basically composed of a main ingredient containing a nutritional component and a thickener for imparting viscosity to the main ingredient. The tube nutrient may not contain a thickener as long as it can be adjusted to a desired viscosity with only the main agent. In addition, the enteral nutrition may be one in which the main agent and the thickener are mixed in advance and made into a single agent and marketed, and the main agent and the thickener are used as a commercial mixture immediately before use. It may be.

The main agent may be, for example, an enteral nutrient approved as a medicine, a commercially available liquid food not approved as a medicine, a liquid food material, or a food material of a healthy person, which can be flowed by grinding or mixing it with a mixer Although various flowable foodstuffs can be used, there is no particular limitation.
The thickener is, for example, one or a combination of two or more of guar gum, carrageenan, carboxymethylcellulose, xanthan gum, fenugreek gum, chitin, chitosan, povidone, hydroxypropyl cellulose and the like, but is not particularly limited.

  In addition, semi-solidified liquid food may be used in the step of preparing the flowable specimen. Some of the above-mentioned tube feeding agents correspond to semi-solidified liquid foods. "Semi-solidification" is different from liquid type liquid food or nutrient, and in the standing state it is semi-solid or gel-like, but it changes into a paste-like state by applying deformation or force, or packaging container It does not spread flatly when it is put out on a flat plate, and it refers to a state where it can be held with its height.

  The semi-solidified liquid food comprises one or more pastes selected from the group consisting of xanthan gum, carrageenan, galactomannan (eg guar gum, cod gum, locust bean gum etc.), agar, gellan gum, pectin, glucomannan and alginates It can be prepared by containing a starch degradation product. The content of the above-mentioned paste in the semi-solidified liquid food is not particularly limited. Usually, it is 0.05 to 10% by mass, preferably 0.1 to 5% by mass.

Next, the step of filling the flexible container 5 having the discharge portion 52 at least at the end portion of the test object is performed.
First, the soft container 5 is prepared. As the soft container 5, a bag-like one made of a soft synthetic resin sheet is used. Specifically, as the flexible container 5, polyolefin (for example, polyethylene, polypropylene, polybutadiene, ethylene-propylene copolymer, mixture of polypropylene and polyethylene or polybutene, etc., mixture containing polyolefin), partially cross-linked product of these, ethylene -Vinyl acetate copolymer (EVA), polyester (polyethylene terephthalate, polybutylene terephthalate etc.), soft vinyl chloride resin, polyvinyl acetate, polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyester elastomer, styrene, ethylene, butylene, etc. Various thermoplastic elastomers such as styrene-based elastomers such as styrene copolymerization or any combination thereof (blend resin, polymer alloy Those formed in a bag shape by the laminate or the like) can be used.

The flexible container has a volume of 100 to 2000 ml and a substantially rectangular shape, and the length of the long side (length from one end to the other end) is 130 to 520 mm, the length of the short side (width of the container Of 60 to 240 mm and a sheet thickness of 0.2 to 1.0 mm) are preferred. Moreover, as a discharge tube connected to the other end of the soft container, a soft resin tube is used. As the soft resin, those listed for the soft container 5 are preferable.
Then, the fluid sample prepared as described above is injected into the flexible container 5 from the discharge tube. The injection amount of the test substance is preferably 20 to 100% of the volume of the soft container 5, and particularly preferably 30 to 50%.

  Next, in a state where the temperature of the flexible container 5 filled with the fluid test object is maintained at a predetermined temperature, one end side facing the end portion having the discharge portion 52 of the flexible container 5 is pressed stepwise or continuously The soft moving flow and soft container 5 flow from the one end side toward the discharge part 52 from the main part of the container between the base end side and the one end side having the discharge part 52 of the soft container 5 while pressing so as to increase the degree. The fluid sample is pressed so as to be stirred, and the digesting material for examination is continuously discharged from the discharge part 52, thereby performing a sampling step of sequentially collecting the digest for examination. This process simulates the gastric digestion model.

A specific embodiment will be described with reference to FIG.
In this embodiment, as the soft container 5, one in which a discharge tube is disposed between the sheets at the other end by heat sealing the peripheral portions of two soft vinyl chloride resin sheets is used. This soft container has a volume of 1000 ml, a short side length (width) of 120 mm, a long side length of 260 mm, and a sheet thickness of 0.4 mm, and the discharge part tube is a soft vinyl chloride resin tube and has an inner diameter It was 6 mm, outer diameter 8 mm, and length 500 mm.

The pressing plate 31 of the one-end pressing portion 3, the pressing plate 41a of the first main portion pressing portion 4a, and the pressing plate 41b of the second main portion pressing portion 4b are on the container mounting surface (bottom surface, origin 0) of the base portion 2. On the other hand, the controller 6 performs necessary settings so as to move up and down as follows.
In this process, a plurality of steps whose conditions are changed are sequentially performed. The number of steps is preferably about 3 to 8. The following steps simulate the gastric digestion model.

1) Condition of Step 1-Driving time 2 to 12 minutes (specifically, 4 minutes)
The height of the pressing plate 31 of the one-end pressing portion (the distance between the origin and the bottom surface of the pressing plate) is lowered to 1.0 to 25.0 mm (specifically, 9.0 mm) and stopped.
The initial height of the pressing plate 41a of the first main portion pressing portion (distance between the origin and the bottom surface of the pressing plate) 20 to 30 mm (specifically, 25.0 mm), minimum height 0.0 to 2.0 mm ( Specifically, it is reciprocated in a cycle of 10 to 60 seconds (specifically, 20 seconds) between 1.0 mm.
The initial height of the pressing plate 41b of the second main portion pressing portion (distance between the origin and the bottom surface of the pressing plate) 20 to 30 mm (specifically, 25.0 mm), minimum height 0.0 to 2.0 mm ( Specifically, it is reciprocated in a cycle of 10 to 60 seconds (specifically, 20 seconds) between 1.0 mm.
The vertical movement of the first main portion pressing portion and the vertical movement of the second main portion pressing portion are performed in opposite directions (opposite phases).

2) Condition of step 2-Driving time 3 to 14 minutes (specifically, 7 minutes)
The height of the pressing plate 31 of the one end side pressing portion (distance between the origin and the bottom surface of the pressing plate) is lowered to 1.0 to 25.0 mm (specifically, 7.0 mm) and stopped.
・ The height (the distance between the origin and the bottom surface of the pressing plate) of the pressing plate 41a of the first main portion pressing portion 15.0 to 25.0 mm (specifically, 20.0 mm), the minimum height 0.0 to 2 .0 mm (specifically, 1.0 mm) is reciprocated in a cycle of 10 to 60 seconds (specifically, 20 seconds).
The height of the pressing plate 41b of the second main portion pressing portion (the distance between the origin and the bottom surface of the pressing plate is 15.0 to 25.0 mm (specifically, 20.0 mm), and the minimum height is 0.0 to 2. Reciprocate between 0 mm (specifically, 1.0 mm) in a cycle of 10 to 60 seconds (specifically, 20 seconds).
The vertical movement of the first main portion pressing portion and the vertical movement of the second main portion pressing portion are performed in opposite directions (opposite phases).

3) Condition of Step 3-Driving time 5 to 22 minutes (specifically, 11 minutes)
The height of the pressing plate 31 of the one end side pressing portion (distance between the origin and the bottom surface of the pressing plate) is lowered to 1.0 to 25.0 mm (specifically, 4.5 mm) and stopped.
· Height of the pressing plate 41a of the first main portion pressing portion (distance between the origin and the bottom surface of the pressing plate) 10.0 to 20.0 mm (specifically, 15.0 mm), minimum height 0.0 to 2 .0 mm (specifically, 1.0 mm) is reciprocated in a cycle of 10 to 60 seconds (specifically, 20 seconds).
・ The height (the distance between the origin and the bottom surface of the pressing plate) 10.0-20.0 mm (specifically, 15.0 mm) of the pressing plate 41b of the second main portion pressing portion, and the minimum height 0.0-2 .0 mm (specifically, 1.0 mm) is reciprocated in a cycle of 10 to 60 seconds (specifically, 20 seconds).
The vertical movement of the first main portion pressing portion and the vertical movement of the second main portion pressing portion are performed in opposite directions (opposite phases).

4) Condition of step 4-Driving time 10 to 40 minutes (specifically, 20 minutes)
The height of the pressing plate 31 of the one end side pressing portion (distance between the origin and the bottom surface of the pressing plate) is lowered to 1.0 to 25.0 mm (specifically, 2.0 mm) and stopped.
The height of the pressing plate 41a of the first main portion pressing portion (distance between the origin and the bottom surface of the pressing plate) 5.0 to 15.0 mm (specifically, 10.0 mm), and the height 0.0 to 2. Reciprocate between 0 mm (specifically, 1.0 mm) in a cycle of 10 to 60 seconds (specifically, 20 seconds).
・ The height of the pressing plate 41b of the second main portion pressing portion (distance between the origin and the bottom surface of the pressing plate) 5.0 to 15.0 mm (specifically, 10.0 mm), minimum height 0.0 to 2 .0 mm (specifically, 1.0 mm) is reciprocated in a cycle of 10 to 60 seconds (specifically, 20 seconds).
The vertical movement of the first main portion pressing portion and the vertical movement of the second main portion pressing portion are performed in opposite directions (opposite phases).

5) Condition of Step 5-Driving time 9 to 36 minutes (specifically, 18 minutes)
The height of the pressing plate 31 of the one end side pressing portion (distance between the origin and the bottom surface of the pressing plate) is lowered to 1.0 to 25.0 mm (specifically, 1.0 mm) and stopped.
The height of the pressing plate 41a of the first main portion pressing portion (the distance between the origin and the bottom surface of the pressing plate) 0.0 to 10.0 mm (specifically, 5.0 mm), and the height 0.0 to 2. Reciprocate between 0 mm (specifically, 1.0 mm) in a cycle of 10 to 60 seconds (specifically, 20 seconds).
· Height (distance between the origin and the bottom surface of the pressing plate) of the pressing plate 41b of the second main portion pressing portion 0.0 to 10.0 mm (specifically, 5.0 mm), minimum height 0.0 to 2 .0 mm (specifically, 1.0 mm) is reciprocated in a cycle of 10 to 60 seconds (specifically, 20 seconds).
The vertical movement of the first main portion pressing portion and the vertical movement of the second main portion pressing portion are performed in opposite directions (opposite phases).

  By operating the one end side pressing portion 3, the first main portion pressing portion 4a, and the second main portion pressing portion 4b as described above, the container main between the base end side having the discharge portion 52 of the soft container 5 and the one end side Slow moving flow flowing from the one end toward the discharge unit 52 from one end and agitation of the fluid test object in the soft container 5 are performed, and the collection container (not shown) connected to the discharge unit 52 is for inspection Digests can be collected sequentially.

Example 1
400 g (364 ml) of a commercially available semisolid nutrient (semi-solidified liquid food), PG soft (manufactured by Terumo Corporation, viscosity 20,000 mPa · s) was filled in the above-mentioned soft container having a volume of 1000 ml.
Then, the one-end side pressing portion 3, the first main portion pressing portion 4a, and the second main portion pressing portion 4b are operated as follows, and the discharge amount from the soft container every 10 minutes is measured. The rate (remaining rate) was calculated, and the result is as shown in Table 1. The half life according to this setting condition was about 25 minutes. In addition, the half life of the amount of discharge of the food (storage rate in the stomach) is generally 25 minutes as described in the document (Semi-solid short-time intake method guidebook, Fuminori Aida, Medical and Dental Drug Publishing Co., Ltd.) It is believed to be a degree.
Moreover, it was as Table 2 when the viscosity of the extract | collected material extract | collected every 10 minutes was measured. Therefore, it could be confirmed that the semi-solidified fluid was disintegrated in time. In addition, viscosity measurement was performed on measurement conditions (rotor No. 4, rotation number 6 rpm, time 1 minute) using Brookfield, viscometer DVII + pro.

Table 1
Discharge time (minutes) Discharge rate (remaining rate) (%)
0 100.0
10 73.0
20 56.3
30 35.4
40 34.0
50 18.8
60 18.1

Table 2
Discharge time (minutes) Collected viscosity (mPa · s)
10 15460
20 14257
30 13330
40 12882
50 11758
60 11631

The conditions of the steps were as follows.
1) Condition of step 1 Driving time 4 minutes Height of pressing plate at one end side pressing portion 9.0 mm
Reciprocation movement between initial height 25.0 mm and minimum height 1.0 mm of pressing plate of first main portion pressing portion and second main portion pressing portion in cycle 20 seconds Vertical motion and first movement of first main portion pressing portion 2 Vertical movement of the main part pressing part is opposite (opposite phase)

2) Condition of step 2 Driving time 7 minutes Height of the pressing plate of one end side pressing portion 7.0 mm
Reciprocation movement between initial height 20.0 mm and minimum height 1.0 mm of pressing plates of first main portion pressing portion and second main portion pressing portion in cycle 20 seconds Vertical motion and first movement of first main portion pressing portion 2 Vertical movement of the main part pressing part is opposite (opposite phase)

3) Condition of step 3 Driving time 11 minutes Height of the pressing plate of one end side pressing portion 4.5 mm
Reciprocation movement between the initial height 15.0 mm and the minimum height 1.0 mm of the pressing plate of the first main portion pressing portion and the second main portion pressing portion in a cycle of 20 seconds The vertical motion of the first main portion pressing portion and the first 2 Vertical movement of the main part pressing part is opposite (opposite phase)

4) Condition of step 4 Driving time 20 minutes Height of pressing plate at one end side pressing portion 2.0 mm
Reciprocation movement between the initial height 10.0 mm and the minimum height 1.0 mm of the pressing plate of the first main portion pressing portion and the second main portion pressing portion in a cycle of 20 seconds The up and down motion of the first main portion pressing portion and the first 2 Vertical movement of the main part pressing part is opposite (opposite phase)

5) Condition of step 5 · Driving time 18 minutes · Height 1.0 mm of pressing plate at one end side pressing portion
· Reciprocation movement between initial height 5.0 mm and minimum height 1.0 mm of pressing plates of first main portion pressing portion and second main portion pressing portion in a cycle of 20 seconds with vertical motion of first main portion pressing portion The vertical movement of the second main part pressing part is opposite (opposite phase)

When the segmental movement of the small intestine is simulated by using the above-described digestive tract movement simulators 1 and 10, the control unit controls the one-end pressing portion 3 and the first main portion pressing portion 4a as follows. , And control the second main portion pressing portion 4b.
Setting conditions-Driving time 180 to 600 minutes (specifically, 360 minutes)
The initial height (the distance between the origin and the bottom surface of the pressing plate) 19.0 to 29.0 mm (specifically, 24.0 mm) of the pressing plate 31 at one end side pressing portion, and the minimum height 0.0 to 2. Reciprocate between 0 mm (specifically, 1.0 mm) in a cycle of 4 to 16 seconds (specifically, 8 seconds).

The initial height of the pressing plate 41a of the first main portion pressing portion (distance between the origin and the bottom surface of the pressing plate) 19.0 to 29.0 mm (specifically, 24.0 mm), the minimum height 0.0 to Reciprocate between 2.0 mm (specifically, 1.0 mm) in a cycle of 4 to 16 seconds (specifically, 8 seconds).
The initial height of the pressing plate 41b of the second main portion pressing portion (the distance between the origin and the bottom surface of the pressing plate) 19.0 to 29.0 mm (specifically, 24.0 mm), and the minimum height 0.0 to Reciprocate between 2.0 mm (specifically, 1.0 mm) in a cycle of 4 to 16 seconds (specifically, 8 seconds).
The vertical movement of the one end side pressing part and the vertical movement of the first main part pressing part (the other end side) are the same, and the vertical movement of the second main part pressing part is the opposite (opposite phase) to them. Do.

(Example 2)
A commercially available semi-solid nutritive agent (semi-solidified liquid food), PG soft (manufactured by Terumo Corporation, viscosity 20,000 mPa · s) to which food dye blue of Kyoritsu Foods Co., Ltd. is added, and Kyoritsu Foods Co., Ltd. Food dye red was added, and those not added were prepared.

About 133 g of a blue pigment added semisolid nutrient, about 133 g of a non-pigmented semisolid nutrient, and about 133 g of a red pigmented semisolid nutrient are poured from the one end into a soft container having a volume of 1000 ml. The soft container after the semisolid nutrient injection had a band-like pattern in which one end was red, the center was beige, and the other end was blue.
Then, the one-end side pressing portion 3, the first main portion pressing portion 4a, and the second main portion pressing portion 4b are operated as shown in the first embodiment (steps 1 to 5), and every ten minutes from the soft container The color of the discharge part of was confirmed, and the results are as shown in Table 3. It was confirmed that the semisolid nutrient was discharged sequentially from one end side to the proximal end side of the soft container.

Table 3
Discharge time (minutes) Discharge color 10 Blue 20 Blue 30 Blue to Purple 40 Purple 50 Purple to Red 60 Red

(Example 3)
In the same manner as in Example 1, 400 g (364 ml) of a commercially available semisolid nutrient (semi-solidified liquid food), PG soft (manufactured by Terumo Corporation, viscosity 20,000 mPa · s) in the above-described soft container having a volume of 1000 ml And, 40 ml of artificial gastric juice was filled. As artificial gastric juice, brand name: Disintegration test first liquid (pH 1.2, manufactured by Kanto Chemical Co., Ltd.) was used.
And when the viscosity of the extract | collected thing extract | collected every 10 minutes was measured, it was as Table 4. Therefore, it could be confirmed that the semi-solidified fluid was disintegrated in time. In addition, viscosity measurement was performed on measurement conditions (rotor No. 4, rotation number 6 rpm, time 1 minute) using Brookfield, viscometer DVII + pro.

Table 4
Discharge time (minutes) Collected viscosity (mPa · s)
10 11998
20 8015
30 6099
40 6151
50 6083
60 5966

(Example 4)
In the same manner as in Example 1, in a soft container having a volume of 1000 ml as described above, 0.5% agar (trade name: hand-made pagar agar, Ina Food Industry Co., Ltd.) in the commercially available liquid nutrient Telomer 2.0a (viscosity 40 mPa · s) (Manufactured by Company) was added, and the semi-solidified product was charged with 400 g.
And when the viscosity of the extract | collected thing extract | collected every 10 minutes was measured, it was as Table 5. Therefore, it could be confirmed that the semi-solidified fluid was disintegrated in time. In addition, viscosity measurement was performed on measurement conditions (rotor No. 4, rotation number 6 rpm, time 1 minute) using Brookfield, viscometer DVII + pro.

Table 5
Discharge time (minutes) Collected viscosity (mPa · s)
10 20529
20 15586
30 15307
40 15028
50 15041
60 14564

(Example 5)
In the same manner as in Example 1, in a soft container having a volume of 1000 ml as described above, 0.5% agar (trade name: hand-made pagar agar, Ina Food Industry Co., Ltd.) in the commercially available liquid nutrient Telomer 2.0a (viscosity 40 mPa · s) Made into a semi-solidified product (400 g (364 ml)) and 40 ml of artificial gastric juice. As artificial gastric juice, brand name: Disintegration test first liquid (pH 1.2, manufactured by Kanto Chemical Co., Ltd.) was used.
And when the viscosity of the extract collected every 10 minutes was measured, it was as Table 6. Therefore, it could be confirmed that the semi-solidified fluid was disintegrated in time. In addition, viscosity measurement was performed on measurement conditions (rotor No. 4, rotation number 6 rpm, time 1 minute) using Brookfield, viscometer DVII + pro.

Table 6
Discharge time (minutes) Collected viscosity (mPa · s)
10 14130
20 8998
30 6032
40 5327
50 4932
60 4599

(Example 6)
A commercially available liquid nutrient Tellurum 2.0a (viscosity 40 mPa · s) was added with 0.5% agar (trade name: hand-made pagar agar, Ina Food Industry Co., Ltd.) and semi-solidified to give Kyoritsu food The thing which added the food coloring blue of the corporation, the thing which added the food coloring red of Kyoritsu Foods Co., Ltd., and the thing which is not added were prepared.

In the same manner as in Example 2, from the one end side, about 133 g of a blue pigmented semisolid nutrient, about 133g of a pigmentless semisolid nutrient, and about 133 g of a red pigmented semisolid nutrient from the one end side In the order of The soft container after the semisolid nutrient injection had a band-like pattern in which one end was red, the center was beige, and the other end was blue.
Then, the one-end side pressing portion 3, the first main portion pressing portion 4a, and the second main portion pressing portion 4b are operated as shown in the first embodiment (steps 1 to 5), and every ten minutes from the soft container The color of the discharge part of was confirmed, and the results are as shown in Table 7. It was confirmed that the semisolid nutrient was discharged sequentially from one end side to the proximal end side of the soft container.

Table 7
Discharge time (minutes) Discharge color 10 Blue 20 Blue 30 Blue to Purple 40 Purple 50 Purple to Red 60 Red

(Example 7)
In the same manner as in Example 1, 400 g (364 ml) of a commercially available semisolid nutrient (semi-solidified liquid food), PG soft (manufactured by Terumo Corporation, viscosity 20,000 mPa · s) in the above-described soft container having a volume of 1000 ml And, 40 ml of artificial gastric juice was filled. As artificial gastric juice, one containing 0.8% of digestive enzyme (trade name: pepsin 1: 10000, derived from porcine gastric mucosa, manufactured by Wako Pure Chemical Industries, Ltd.) was used. Then, a tube was inserted into the soft container, and the artificial gastric fluid was continuously injected at 1.7 mL / min (as a gastric fluid secretion amount).
And, when the protein digestibility of the collected matter collected every 15 minutes was measured, it was as shown in Table 8. Thus, it was confirmed that the protein in the semi-solidified fluid was digested. Protein mass spectrometry was performed using SUMIGRAPH NC-22F (manufactured by Sumika Chemical Analysis Service, Ltd.).

Table 8
Efflux time (minutes) Protein digestibility (%)
15 9
30 12
45 15
60 17

(Example 8)
In the same manner as in Example 1, in a soft container having a volume of 1000 ml as described above, 0.5% agar (trade name: hand-made pagar agar, Ina Food Industry Co., Ltd.) in the commercially available liquid nutrient Telomer 2.0a (viscosity 40 mPa · s) Made into a semi-solidified product (400 g (364 ml)) and 40 ml of artificial gastric juice. As artificial gastric juice, one containing 0.8% of digestive enzyme (trade name: pepsin 1: 10000, derived from porcine gastric mucosa, manufactured by Wako Pure Chemical Industries, Ltd.) was used. Then, a tube was inserted into the soft container, and the artificial gastric fluid was continuously injected at 1.7 mL / min (as a gastric fluid secretion amount).
And, when the protein digestibility of the collected matter collected every 15 minutes was measured, it was as shown in Table 9. Thus, it was confirmed that the protein in the semi-solidified fluid was digested. Protein mass spectrometry was performed using SUMIGRAPH NC-22F (manufactured by Sumika Chemical Analysis Service, Ltd.).

Table 9
Efflux time (minutes) Protein digestibility (%)
15 3
30 6
45 8
60 10

1, 1a, 1b, 1c, 10 digestive tract movement simulator 2 base 3 one end side pressing part 4 (4a, 4b) main part pressing part 5 subject filled soft container 6 control part

Claims (11)

A digestive tract exercise simulator for simulating a digestive movement in a digestive tract of a subject, comprising:
The digestive tract motion simulator includes a base portion for placing or storing a subject-filled soft container containing the subject, and a container pressing portion for pressing the soft container placed or stored on the base portion. The container pressing unit includes: one end side pressing unit pressing one end side of the soft container; and a container main unit pressing unit pressing the container main unit including the other end side of the soft container having a discharging unit; and a control unit for controlling the respective pressing portions, the container main portion pressing portion is provided with a plurality of main section pressing portion, wherein the control unit, stepwise or continuously said flexible container to said one end pressing portion And pressing the plurality of main portion pressing parts at different timings to transfer the subject toward the discharge part from the one end side and the softness. Stirring of the subject in the container Gastrointestinal motility simulator, characterized in that for. Each of the pressing portions includes a pressing plate for pressing the soft container placed or stored in the base portion from above, and a pressing plate drive mechanism that drives the pressing plate up and down. Gastrointestinal tract exercise simulator described in. The container main portion pressing portion includes a first main portion pressing portion and a second main portion pressing portion, and the control portion operates the first main portion pressing portion and the second main portion pressing portion at different timings. The gastrointestinal tract exercise simulator according to claim 1 or 2, which has been made to The container main portion pressing portion is provided with three or more main portion pressing portions, and the control portion operates the three or more main portion pressing portions at different timings. Digestive tract exercise simulator. The digestive tract movement simulator according to claim 1 or 2, wherein the container main portion pressing portion performs peristaltic movement or segmental movement toward the other end side of the soft container. The digestive tract movement simulator according to any one of claims 1 to 5, further comprising a temperature control function for adjusting the temperature of the subject in the subject-filled flexible container within a range of 10 to 60 ° C. Digestive tract exercise simulator. The said base part is provided with the accommodating part which can accommodate the said soft container and the medium for temperature control, and the temperature control function for adjusting the temperature of the said medium for temperature control in any one of Claim 1 thru | or 5 Gastrointestinal tract exercise simulator described. The digestive tract exercise simulator according to any one of claims 1 to 7, wherein the digestive tract exercise simulator has an injection function in communication with the inside of the soft container. 9. The gastrointestinal tract exercise simulator according to any one of claims 1 to 8, wherein the gastrointestinal tract exercise simulator has a collecting function of collecting an effluent flowing out of the discharge part of the soft container. What is claimed is: 1. A method of collecting a test digest for checking the digestive trend of a fluid sample, comprising the steps of preparing a fluid sample, a soft container having a discharge part at least at an end of the sample. In the filling step, in a state where the temperature of the flexible container filled with the fluid test object is maintained at a predetermined temperature, one end side facing the end portion having the discharge portion of the flexible container is stepwise or continuously The container main portion between the proximal end side having the discharge portion of the soft container and the one end side is pressed from the one end side while pressing the object amount capable of being held at the one end side of the soft container By pressing so as to carry out gentle moving flow and agitation of the fluid sample in the soft container, and continuously draining the test It is important to carry out the process of collecting How to collect inspection digests to be. The method for collecting a digest for examination according to claim 10, wherein the fluid test substance is a mixture of a gavage nutrient or a semi-solidified fluid food and a simulated gastric fluid containing an enzyme.

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