JP2017158809A - Inhalant testing apparatus - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an inhalant testing apparatus capable of easily reproducing behavior of an inhalant in the respiratory tract of a person by a test operation using a simulated respiratory tract modeling the respiratory tract of the person.SOLUTION: An inhalant testing apparatus 10 includes: a transparent resin respiratory tract model 1 having a respiratory tract passage 1a; pharmaceutical feeding means (a powder feeder 2); a lung chamber 3; suction means (a suction fan 4); and an observation light source (a lamp 5). In a state where light is applied from the lamp 5 to the respiratory tract model 1, a flowing state of the pharmaceutical in the respiratory tract passage 1a can be observed from one side of the respiratory tract model 1, by reflection of the light applied. Further, the flowing state of the pharmaceutical can be observed from the other side of the respiratory tract model 1, by transmission of the light applied from the lamp 5.SELECTED DRAWING: Figure 1

Description

  The present invention relates to an inhalation drug testing apparatus that can visually confirm the behavior of a drug in a simulated airway that looks like a human airway.

  In order to alleviate or treat symptoms of respiratory diseases, transpulmonary inhalants such as powder or mist (including oral and nasal inhalants here. Or "drug" or "drug"). There are many unclear parts, such as how far this inhaled drug reached during use, or in which part of the respiratory tract or lung the inhaled drug cannot be seen directly. .

  In other words, if the target organ that delivers the inhaled drug is, for example, the lung, the powder or mist-like drug reaches the lungs from the oral cavity through the pharynx, larynx, trachea, bronchi, etc. To do. At this time, it is inevitable that a part of the medicine put into the oral cavity will adhere to the inner wall of the oral cavity or pharynx before reaching the lungs, and the remaining part of the drug that has not adhered is intended. To reach the lungs.

  Therefore, in an actual drug prescription, considering that only a part of the injected (inhaled) drug reaches the lungs, an amount of drug larger than the amount of drug to be administered is injected into the oral cavity. However, since the drug that does not reach the lung and adheres to the inner wall of the oral cavity or pharynx is also absorbed by the body, more (excess) of the drug than the expected amount (expected amount to reach the lung) is absorbed by the body. Therefore, there are concerns about side effects such as adverse drug reactions caused by this excessive drug.

  Accordingly, various proposals have been made to investigate the behavior of inhaled drugs during inhalation (the movement and adhesion state of inhaled drug particles) and to estimate the amount of the inhaled drug that reaches the lungs. For example, many attempts have been made to analyze the behavior of particles such as drugs by computer simulation using a lung numerical model (virtual lung on data) as disclosed in Patent Document 1. Yes.

  Indirect measurement of the actual lungs, airways, pharynx, etc. to estimate the accumulation of inhaled drugs in the lung (Cited document 2) and estimate the patient's suction power (inhalation performance) A method (Cited document 3) is proposed.

  There is also a proposal to reproduce the behavior of drug adhesion (deposition) and absorption in the lung (alveoli) by making a device (membrane) that mimics the function of the lungs and actually flowing the drug through this device. (See Patent Documents 4 and 5).

Special table 2012-527921 gazette JP-T-2007-515237 Special table 2013-514818 gazette Special table 2010-529478 JP 2014-73125 A

  By the way, it is difficult to understand whether any of the test methods such as the above proposals accurately reproduce the behavior of the inhaled drug in the body. Moreover, the amount of inhaled drug adhering to the pharynx, respiratory tract, etc. and the amount reaching the lungs are thought to vary greatly depending on the physique, age, physical condition, posture, pharyngeal / tracheal shape, etc.

  For this reason, researchers in pursuit of efficient DDS (drug delivery system) via the mouth or nose and companies that manufacture, sell, and develop inhaled drugs are inhaled between the pharynx, airways, and lungs. There is a strong demand for direct visual confirmation of the actual behavior of drugs.

  In this way, if the behavior of the inhaled drug in the body can be observed visually or in a simulated form close to it, the efficiency of DDS can be increased, adverse drug reactions can be reduced, or the performance of the inhaled drug , It is thought that it can contribute to the improvement of quality and safety and the progress of research.

  An object of the present invention is to provide an inhalation drug testing apparatus that can easily reproduce and see the behavior of an inhalation drug in a human airway by a test operation using a simulated airway that looks like the human airway. .

  The present invention provides a transparent resin airway having an airway channel imitating a human airway, in which an air inlet is provided at one end of the channel and a plurality of air outlets are provided at the other end of the channel. A model, a drug supply means connected to the air inlet and supplying a powder or mist-like drug for inhalation to the airway channel, and connected to the plurality of air outlets, and internally imitating a human lung A lung chamber provided with an exhaust port communicating with the lung space, a suction means connected to the exhaust port and sucking air in the lung chamber, and opposed to the airway model A light source for observation that is disposed on one side and irradiates light toward the airway model, and reflects light emitted in a state where light is emitted from the observation light source toward the airway model. From the one side or through the transmission of the irradiated light From the other side opposite to the observation light source across the airway model is inhalants test and wherein the observation of the fluidized state of the drug in the airway passage is possible.

  In addition, the present invention further includes an imaging unit disposed on one side or the other side facing the airway model, and a recording unit that records an image captured by the imaging unit. It is possible to record the flow state of the medicine.

  Further, in the present invention, the observation light source is a laser oscillation light source, the imaging means includes a high sensitivity camera, and the laser oscillation light source is disposed on a side of the airway model as viewed from the high sensitivity camera, The behavior of each drug particle in the airway channel can be recorded from the other side by scattering of the laser light emitted from the laser oscillation light source.

  The inhalation drug testing device of the present invention is characterized by comprising airway model weighing means for measuring the mass of the entire airway model before and after the medicine flows through the airway flow path.

  According to the present invention, the state of a medicine (powder or mist-like inhalation medicine) flowing in an airway channel imitating a human airway provided in a transparent resinous airway model is set as an observation light source. From the same side (one side), it can be visually observed using the reflected light of the medicine. Further, the flow state of the drug in the airway channel can be visually confirmed by using light transmitted through the airway model from the opposite side (the other side) sandwiching the airway model.

  Therefore, the inhaled drug test device of the present invention can directly observe the flow state of the drug in the airway channel in a state closer to the airway in the human body than the conventional method / device. Thereby, it becomes possible to set the optimal dosage (inhalation) amount of the drug in consideration of the amount of adhesion to the airway and the like, which differs depending on the patient and the drug to be used.

  In addition, the inhalation drug test apparatus of the present invention can obtain results closer to the test results using the human body with good reproducibility by using it for research of inhalation drugs and the like. Therefore, the present invention can contribute to researches such as improving the quality and safety of these drugs and improving the efficiency of DDS for the lung.

  Further, in the present invention, the inhalant test apparatus further comprising: an imaging unit disposed on one side or the other side facing the airway model; and a recording unit that records an image captured by the imaging unit. The flow state of the medicine in the flow channel can be recorded as an image from either one side (reflected light) or the other side (transmitted light), which is preferable. This video may be a moving image or a still image, and can be played back and confirmed at any time after the test.

  Also, in the present invention, the observation light source is a laser oscillation light source, the imaging means includes a high sensitivity camera, and the laser oscillation light source is disposed on a side of the airway model as viewed from the high sensitivity camera. The inhaled drug testing apparatus can record the behavior of each drug particle in the airway channel using laser light scattering by the drug particle. Also, by performing calculations such as image analysis using this recording, it is possible to quantitatively capture the movement of each drug particle and the flow of the entire drug in a non-contact manner.

  In the present invention, the inhalation drug testing device comprising an airway model weighing means for measuring the mass of the entire airway model before and after the drug flows in the airway flow path is a weight change before and after the test of the airway model. (Difference) can be accurately measured to accurately determine the amount of drug attached to the airway model after the test. If the result is reflected (feedback) on the result of the image analysis, the accuracy of the analysis can be improved.

1 is a schematic configuration diagram of an inhalation drug test device according to a first embodiment of the present invention. It is a schematic block diagram of the inhalation drug test apparatus of 2nd Embodiment of this invention. It is a schematic block diagram of the inhalation drug test apparatus of 3rd Embodiment of this invention. It is (a) front view and (b) side view of the airway model used by embodiment of this invention. (A)-(c) is a photograph which shows a mode that the chemical | medical agent for inhalation flows in an airway model in order, (a) is immediately after injection | pouring of a chemical | medical agent, (b) is a chemical | medical agent (white part) in an airway flow path. (C) is a photograph showing the drug after passing through the airway channel. (A), (b) is a partially enlarged photograph showing a state in which the drug adheres to the airway channel after the drug has flowed through the airway model, (a) shows the oral cavity part, (b) shows The bronchial part is enlarged.

  FIG. 1 is a schematic diagram showing the configuration of the inhalation drug test device according to the first embodiment of the present invention.

  This inhalation drug test apparatus 10 is a basic configuration of the test apparatus of the present invention, and is a transparent resin airway model 1, a drug supply means (powder supply device 2) for supplying a drug, and a human inside. A lung chamber 3 having a pulmonary space imitating the lung, a suction means (suction fan 4) for sucking air, and an observation light source (lamp 5) for irradiating the airway model 1 with light.

  The airway model 1 is formed using a transparent resin (in this example, an acrylic resin) that does not contain a filler. As shown in FIG. This is a model body (model) including a simulated airway channel (simulated airway) 1a. In the present invention, the term “transparent” means that the transmittance of light in the visible light region is 80% or more. The airway model 1 is molded from a resin material in a state of being divided into two in the thickness direction (the front and back direction in FIG. 4A, the left-right direction in FIG. 4B), and is a concave portion that becomes the airway channel 1a. Is formed by bonding together as shown in the side view of FIG. Note that the airway model 1 can be easily cleaned and removed of the inhaled drug and the like adhering to the airway channel 1a after the test by releasing the bonding and dividing the airway model 1.

  In the upper part (left side surface) of the airway model 1, an opening (air inlet 1b) communicating with the internal airway channel 1a is formed. During the test, the air inlet 1b enters the airway channel 1a. The test body (inhalation drug) is introduced. In the lower part of the airway model 1, a plurality (four) of air outlets 1c serving as discharge ports for the test body (medicine for inhalation) are provided on the bottom surface (two places) and on both side faces (one place each). It has been.

  In the actual human body, the channel portion below the airway branch (first two branches) at the lower part of the airway channel 1a shown in the front view of FIG. 4A is a straight (one) channel above the airway channel. The airway model 1 is in a state of being twisted about 90 ° with respect to the portion, but for the convenience of space (volume of the model body), the twist is eliminated, that is, the upper straight line (one) The flow path part and the lower branch flow path part are reproduced in the same phase in the circumferential direction. Separately confirm that there is no difference in the state of air flow in the flow path after the 4th branch, whether the twist is eliminated (this embodiment) or the twist is reproduced (90 ° phase is different). ing.

  Further, the airway channel 1a may be added with a nasal cavity structure, a esophageal channel, or the like, or may have a function of managing the temperature and humidity in the airway channel 1a, depending on the target test. . Furthermore, it is possible to reproduce an environment closer to the human body by applying an appropriate adhesive material to the inner wall of the airway channel 1a.

  As a material for forming the airway model 1, polycarbonate resin, acrylonitrile / butadiene / styrene (ABS) resin, epoxy resin and the like can be used in addition to the acrylic resin, and these may be blended. For any resin type, the formulation uses a transparent formulation that contains little or no filler. In addition, it can replace with each said resin and can also produce the airway model 1 by using glass as a material. In addition, when the airway model 1 is charged and affects the adhesion of inhaled drug particles, an antistatic means (static electricity removing means) may be provided. As the antistatic means, an antistatic spray, a static elimination (discharge) pad, a ground wire (earth), or the like can be used.

  Further, when there is a large gap between the refractive index of light of the observation fluid (for example, air) and the refractive index of light of the transparent resin constituting the airway model 1, the transparent resin is disposed in the airway flow path 1a. It may be filled with a liquid having a refractive index equivalent to the refraction of light. Thereby, the generation of the lens effect can be suppressed and observation without distortion can be performed.

  The powder supplier 2 (medicine supply means) includes an attachment (mouthpiece 2a) connected to the air inlet 1b of the airway model 1, a cartridge 2b containing a test drug, an air flow path, and the cartridge 2b. A switching device (switching cock 2c) that switches between a route passing through and a route not passing through.

  The powder feeder 2 has the switching cock 2c in a state (test start state) in which the suction means (suction fan 4) is activated and the air for suction flows in the airway model 1 (airway channel 1a). By switching the above, the suction air flows in the cartridge 2b, and the stored test medicine is supplied to the airway channel 1a in the air flow. Instead of the powder feeder 2, a commercially available inhaler (powder, mist) may be installed via a mouthpiece dedicated to the inhaler.

As shown in FIG. 1, the lung chamber 3 is a housing-like housing that surrounds the lower part of the airway model 1, and a space inside the housing is a lung-like space S imitating a human lung. At the center of the pulmonary space S, a partition wall 3c that divides the volume in the pulmonary space S in accordance with the volume ratio of the left and right lungs of the model person is provided. It is configured to be movable. Further, in each lung shaped space of the left and right (Hidarihaishitsu S _L and Migihaishitsu S _R), may be additionally installed movable partition that can be slid in the vertical direction. This makes it possible to deal with lung volumes from infants to adults.

  Holes 3a corresponding to the four air outlets 1c are provided on the surface of the lung chamber 3 that is in contact with the airway model 1, and flows through the airway channel 1 through these holes 3a. Air (exhaust gas) is introduced into the pulmonary space S.

Two suction means (suction fans 4) to be described later are attached to the lower portion (bottom surface) of the lung chamber 3 via an exhaust port 3b provided on the bottom surface of the housing, and this lung-like space S communicates. The inside air can be exhausted independently in the left and right rooms (left lung chamber S _L , right lung chamber S _R ). Then, due to the negative pressure generated by the exhaust, the air in the airway channel 1a is sucked downward through the holes 3a, and human breathing (inhalation action for breathing in) is reproduced.

  The suction fan 4 (suction means) has a motor and rotating blades, and the rotation of the motor is controlled by a separately provided controller (not shown). The suction force is a specification that can be controlled independently by the left and right fans. If the suction force differs between the left and right lungs due to birth, disease, or injury, or if one lung is not functioning. Can also respond. Instead of the suction fan 4, other air suction means such as a suction pump may be used. Further, if an air flow meter is installed in the middle of the path, the suction amount can be set to an amount corresponding to the inhalation flow rate (up to 100 L / min) of the human body with reference to the instruction of the flow meter.

  Further, instead of disposing the suction fan 4, the lung chamber 3 is formed of a soft material having elasticity such as rubber, and this is made of a transparent resin casing with a rubber film (simulated diaphragm) stretched on the bottom surface. It is good also as a structure stored in (simulated body cavity). If the rubber film (simulated diaphragm) is manually moved up and down and the soft material lung chamber 3 is expanded and contracted, it is possible to reproduce an inhalation operation closer to human natural breathing.

  The rotation control of the motor of the suction fan 4 is performed in consideration of the cycle (rhythm) and strength of human breathing (exhalation-exhaust), and switching of the switching cock 2c of the powder feeder 2 (injection of test drug) (Start) is performed by a signal or signal issued from the controller. Thereby, the drug suction behavior of a person is reproduced, and the start timing of drug administration can be synchronized with the breathing pattern.

  The lamp 5 (light source for observation) is arranged on one side (in FIG. 1, in the direction of the back side of the drawing and in the direction of the back side of the airway model 1) facing the airway model 1, and directed toward the airway model 1 (airway model 1). Irradiate light) The irradiated light is incident on the airway model 1 from the surface (wide surface), passes through the transparent airway model 1, and is on the opposite side (the other side of the airway model 1, FIG. 1). Then, the light is emitted from the front side of the paper.

  Therefore, when the airway model 1 is viewed from the other side (the front side of the paper), the object (medicine particles) flowing in the airway channel 1a or the wall surface of the airway channel 1a is transmitted by the transmitted light (transmitted light). The attached object is recognized as a shadow. Thereby, the state of the medicine flowing through the airway channel 1a can be observed.

  In this state, the airway model 1 can also be observed from one side (in FIG. 1, the rear side direction in the drawing, the back side of the airway model 1 where the lamp 5 is disposed). When the airway model 1 is viewed from one side (the back side of the paper), the reflected light of the irradiation light from an object (medicine particles) flowing in the airway channel 1a or an object attached to the wall surface of the airway channel 1a is light. It is recognized as a point, and using this, the state of the drug flowing in the airway channel 1a can be observed.

  As the lamp 5, a halogen lamp, a xenon lamp, an LED lamp, or the like can be used.

Next, a second embodiment of the present invention including an imaging unit, a recording unit, a tracer, and an airway model weighing unit will be described.
FIG. 2 is a block diagram showing a schematic configuration of the inhalation drug testing device according to the second embodiment of the present invention. In addition, the same code | symbol as FIG. 1 is attached | subjected to the structural member which has the function similar to 1st Embodiment, and the detailed description is abbreviate | omitted.

  The inhalant test apparatus 20 of the second embodiment of the present invention is different from the inhalant test apparatus 10 of the first embodiment in that a CCD (Charge Coupled Device) camera 6 is disposed as an imaging means of the present invention. It is a point provided with recording means (personal computer 7) for recording an image (image data) picked up by the CCD camera 6. In addition, a tracer generator 8 is provided on the test drug supply side (upper part) of the airway model 1 to make the air flow in the airway flow path 1a easier to see, and the test drug discharge side (lower side) of the airway model 1 is arranged. ) Is provided with an airway model weighing means (electronic balance 9) for measuring mass change of the airway model 1 before and after the test.

  When the CCD camera 6 (imaging means) is disposed on one side facing the airway model 1 (the same direction as the lamp 5 on the back side of the airway model 1 in FIG. 2), the airway model 1 As seen from the one side (the back side of the paper), reflection of light irradiated from the back side direction of the airway model 1 caused by an object (medicine particles) flowing through or attached to the airway channel 1a It is imaged and recorded as the upper light spot.

  On the contrary, as shown in FIG. 2, when the CCD camera 6 is disposed on the other side facing the airway model 1 (the front surface side in FIG. 2, the side opposite to the lamp 5), the airway model 1. As seen from the other side (the front side of the paper), the shadow (shadow) caused by the light irradiated from the back side direction of the airway model 1 caused by an object (medicine particle) flowing or adhering in the airway channel 1a. Are captured and recorded as black spots on the image.

  The personal computer 7 (recording means) includes a recording medium such as a hard disk drive that records image data captured by the CCD camera 6, and a panel display that displays the image data as a video (moving image or still image). The recorded image including the display unit can be reproduced and confirmed (observed) at any time.

  Further, the personal computer 7 is provided with a calculation means, and can perform processing such as enlargement, reduction, trimming, and clipping of the recorded image while looking at the display section. Depending on the image, light spots or black spots made of drug particles may be difficult to see. In this case, contrast adjustment of the image, redrawing with a changed threshold value (threshold value), or the like can be performed. .

  The tracer generator 8 is arranged in an auxiliary manner with respect to the main powder supply device 2, and by using this, the airway flow path at the time of the test can be obtained without supplying the test chemical. The airflow in 1a can be reproduced and confirmed.

  The configuration of the tracer generator 8 includes a tracer storage tank (not shown) inside, and as this tracer, powder (solid powder), mist (liquid), etc. that have excellent followability to the fluid used are used. Is done. In addition, in order to push out the tracer (particles) in the tracer storage tank, auxiliary pressurizing means (a compressor or a pump dedicated to the tracer generator 8) may be provided.

  Further, a switching cock 8a similar to the switching unit of the powder supply unit 2 is interposed in the flow path between the tracer generator 8 and the air inlet 1b of the airway model 1 to supply the tracer particles. Can be switched on and off.

  An electronic balance 9 (airway model weighing means) for measuring a change in mass of the airway model 1 is provided below the airway model 1 of the inhalation drug test apparatus 20 and between the airway model 1 and the lung chamber 3. It is arranged.

  The electronic balance 9 compares the mass of the pre-test airway model 1 measured in advance with the mass of the post-test airway model 1 to which a test drug or the like adheres, thereby allowing the inside of the airway channel 1a of the airway model 1 ( The weight of the test drug attached to the wall surface can be identified. Thereby, the inhalation drug testing device 20 can not only observe the flow state of the drug in the airway channel 1a (simulated airway) visually or by a recorded image, but also information obtained from the image (suggestion, touch, etc.). Can be confirmed by the weight (actual value) of the adhered test drug.

Next, a third embodiment of the present invention will be described in which the observation light source is a laser oscillation light source and the imaging means is a high sensitivity camera.
FIG. 3 is a block diagram showing a schematic configuration of the inhalation drug testing device according to the second embodiment of the present invention. In addition, the same code | symbol as FIG. 1, FIG. 2 is attached | subjected to the structural member which has the function similar to 1st, 2nd embodiment, and the detailed description is abbreviate | omitted.

  The inhalant test apparatus 30 of the third embodiment of the present invention differs from the inhalant test apparatus 10 of the first embodiment in that a high-sensitivity camera 11 is provided as an imaging means of the present invention, and the high-sensitivity camera is provided. 11 is provided with a recording means (personal computer 7) for recording the image (image data) captured in step 11. Another difference is that a laser oscillation light source 12 is used as an observation light source for irradiating the airway model 1 with light, and this laser oscillation light source 12 is in the imaging (observation) direction of the high sensitivity camera 11. It is a point arrange | positioned in the direction orthogonal to (in this example, the side of the said airway model 1).

  The inhalant test apparatus 30 includes the tracer generator 8 described in the second embodiment and auxiliary pressurizing means dedicated to the tracer generator 8. Further, the electronic balance 9 (airway model weighing means) may be provided.

  The laser oscillation light source 12 is a laser sheet light source used in the PIV (Particle Image Velocity) method, and enters the airway model 1 from the side of the airway model 1 (perpendicular to the camera 11). A sheet-like laser beam spreading in a planar shape around the airway channel 1a when viewed from the front of the model 1 (on the one side or the other side) is irradiated. As the laser oscillation light source 12, an Nd-YAG laser, an argon laser, a He-Ne laser, a semiconductor laser, or the like can be used.

  The high-sensitivity camera 11 is arranged on the front side (the one side or the other side) of the airway model 1, and the individual test specimen (inhalation drug) particles in the airway channel 1a due to the irradiation of the laser light. Is recorded in the recording means such as the personal computer 7.

  In the PIV method, the high-sensitivity camera 11 is used to capture an image at a high speed (acquisition / recording speed: several milliseconds to several microseconds). Then, the fluid image can be analyzed using the calculation means such as the personal computer 7 to obtain the flow velocity of the object (particle). As an analysis method, a particle tracking method, an auto-cross correlation tracking method, or the like is used.

  In an actual test operation, if a test drug is supplied from the powder supplier 2, the behavior of the particles in the airway channel 1a can be confirmed and verified. In addition, when only the tracer generator 8 is used, the airflow (flow method, staying point, etc.) in the airway channel 1a can be verified. These powder feeder 2 and tracer generator 8 may be used in combination.

  With the above configuration, the inhalation drug testing device 30 of the present embodiment can quantitatively capture the movement of each drug particle and the flow of the entire drug in the airway channel 1a without contact. Furthermore, if the size and number of the particles are counted, the flow rate of the test body (inhalation drug) in the airway channel 1a and the total amount (mass) of the flowed particles can be indirectly measured from the image analysis. it can.

  Further, when the inhalation drug testing device 30 includes the electronic balance 9, the weight change (difference) before and after the test of the airway model 1 is accurately measured, and the amount of the drug adhered in the airway channel 1a after the test is determined. It is also possible to accurately determine and reflect (feedback) the result on the result of the image analysis. In that case, the behavior of the particles can be analyzed with higher accuracy.

[Example]
FIG. 5 is a photograph of the state in which test drug particles actually flow through the airway model 1 and the subsequent adhesion state using the inhalation drug testing device 30 of the third embodiment. The conditions for the observation test are as follows.
Test drug-formulation powder (particle size 5-10 μm, aerodynamic particle size 2 μm)
-Suction environment-pump suction (suction flow rate 20-30L / min)
・ Drug administration-Extrusion spray by syringe (sample 1mg, extrusion air capacity 0.25mL)
Observation light source—semiconductor LD excitation Nd: YVO ₄ laser light source (wavelength 532 nm)
PIV method—The result is a video recorded with a digital camera (30 fps video).

A video (still image) was cut out from the moving image obtained by the PIV method by image editing.
FIG. 5A is a photograph showing the entire airway model 1 before the test drug is introduced.
FIG. 5B shows a state in which the shape of the airway channel 1a in the airway model 1 is well raised immediately after the test agent is introduced.
FIG. 5C shows a state in which the test drug passes through the airway model 1 and reaches the lung chamber 3, and the drug attached to the wall surface (inner wall of the airway) is seen in the airway channel 1a. I can take it.

  6 (a) and 6 (b) are enlarged photographs of the airway channel 1a portion to which the drug has adhered, FIG. 6 (a) is an oral region, and FIG. 6 (b) is an enlarged bronchial region. Is.

  As described above, the inhaled drug test device of the present invention can directly observe the flow state of the drug in the airway channel in a state closer to the airway in the human body than the conventional method / device. Thereby, it becomes possible to set the optimal dosage (inhalation) amount of the drug in consideration of the amount of adhesion to the airway and the like, which differs depending on the patient and the drug to be used. In addition, by performing calculations such as image analysis using this recording, the movement of each drug particle and the flow of the entire drug can be quantitatively captured without contact.

DESCRIPTION OF SYMBOLS 1 Airway model 1a Airway flow path 1b Air inflow port 1c Air outflow port 2 Powder supply device 2a Mouthpiece 2b Cartridge 2c Switching cock 3 Lung chamber 3a Hole 3b Exhaust port 4 Suction fan 5 Lamp 6 CCD camera 7 Personal computer 8 Tracer generator 8a switching cock 9 electronic balance 10 inhalation drug test apparatus 11 high sensitivity camera 12 laser oscillation light source 20 inhalation drug test apparatus 30 inhalation drug test apparatus S pulmonary space

Claims (4)

A transparent resin airway model having an airway channel imitating a human airway, in which an air inlet is provided at one end of the channel and a plurality of air outlets are provided at the other end of the channel,
A drug supply means connected to the air inlet and supplying a powdered or mist-like drug for inhalation to the airway channel;
A lung chamber connected to the plurality of air outlets, having a lung-like space imitating a human lung therein, and provided with an exhaust port communicating with the lung-like space;
A suction means connected to the exhaust port for sucking air in the lung chamber;
An observation light source disposed on one side facing the airway model and irradiating light toward the airway model,
In a state in which light is irradiated from the observation light source toward the airway model, the observation is performed with the airway model sandwiched from the one side or by transmission of the irradiated light by reflection of the irradiated light. An inhalation drug testing device characterized in that the flow state of the drug in the airway channel can be observed from the other side facing the light source for use.   An imaging means disposed on one side or the other side facing the airway model, and a recording means for recording an image taken by the imaging means, further comprising a flow state of the drug in the airway channel 2. The inhalation drug testing device according to claim 1, wherein recording is possible.   The observation light source is a laser oscillation light source, the imaging means includes a high sensitivity camera, and the laser oscillation light source is disposed on the side of the airway model as viewed from the high sensitivity camera, and the laser oscillation light source The inhalation drug testing device according to claim 2, wherein the behavior of each drug particle in the airway channel can be recorded from the other side by scattering of the irradiated laser beam.   The inhalant drug test according to any one of claims 1 to 3, further comprising an airway model weighing means for measuring a mass of the entire airway model before and after the medicine flows in the airway channel. apparatus.