Method for evaluating medication sensation, device for evaluating medication sensation, and program

Abstract

To provide a dose sensation evaluation method for a pharmaceutical preparation that can be quantitatively evaluated.SOLUTION: A dose sensation evaluation method of a pharmaceutical preparation includes attaching a part of an electromyograph to a human body and acquiring measurement data measured when dosing a pharmaceutical preparation using the attached electromyograph, and generating dose sensation evaluation information when dosing the pharmaceutical preparation on the basis of the measurement data. In the dose sensation evaluation method, the electromyograph may be attached to either the suprahyoid muscles or the infrahyoid muscles of the human body.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a new method for evaluating pharmaceutical preparations, and more particularly to a new measurement method, measurement device, and program for evaluating the intake sensation based on the amount of muscle activity when taking a pharmaceutical preparation. [Background technology]

[0002] In recent years, in addition to subjective evaluation by subjects (Non-Patent Documents 1 to 4), methods have been known to objectively evaluate swallowing ability and the feeling of taking a pharmaceutical preparation using equipment, etc. (Non-Patent Documents 5 to 7). [Prior art documents] [Non-patent literature]

[0003] [Non-Patent Document 1] Yasuyuki Oshima and seven others, "Effect of Size and Shape of Oral Solid Preparations on Ease of Taking and Picking Up (Part 1): Comparison between Elderly People and Students," Japanese Journal of Pharmaceutical Health Care and Sciences, 2006, Vol. 34, No. 12, pp. 842-848 [Non-patent document 2] Yasuo Nakajima, "Comparison of the ease of taking capsules and tablets," Yakuji Shinpo, 1991, No. 1636, pp. 91-94 [Non-patent document 3] Naomi Kurata and three others, "Research into medicines that are easy for the elderly to take - Evaluation of the size of orally disintegrating tablets that can be taken," Japanese Journal of Pharmaceutical Health Care and Sciences, 2010, Vol. 36, No. 6, pp. 397-405 [Non-patent document 4] Hiroko Miura and 1 other person, "The effect of tablet size on medication adherence in frail elderly people - A study based on a simulated medication survey -", Journal of the Japan Geriatrics Society, 2007, 44, pp. 627-633 [Non-patent document 5] Toshio Matsumoto and three others, "Basic research on the ease of taking medicines," Ergonomics, 2007, Vol. 43, pp. 444-445 [Non-patent document 6] Takahiro Ono and five others, "Method of measuring tongue pressure during chewing and swallowing and its clinical application," Journal of the Japanese Society of Dysphagia Rehabilitation, 2006, Vol. 10, No. 3, pp. 207-219 [Non-Patent Document 7] Takahiro Ono and five others, "Quantitative Evaluation of Swallowing Function in Parkinson's Disease Patients Using Tongue Pressure Sensor Sheet," Journal of the Society of Biomechanisms, 2010, Vol. 34, No. 2, pp. 105-110 Summary of the Invention [Problem to be solved by the invention]

[0004] The currently widely used subjective evaluation method by subjects is difficult to maintain objectivity and reproducibility. Therefore, an objective method using equipment is desirable, but an established method is not yet known.

[0005] Therefore, one of the objects of the present invention is to provide a method for quantitatively evaluating the intake sensation of a pharmaceutical preparation. [Means for solving the problem]

[0006] According to one embodiment of the present invention, there is provided a method for evaluating the intake sensation of a pharmaceutical preparation, which comprises attaching a portion of an electromyogram to a human body, obtaining measurement data measured when taking the pharmaceutical preparation using the attached electromyogram, and generating information for evaluating the intake sensation when taking the pharmaceutical preparation based on the measurement data.

[0007] In the method for evaluating palatability, when the measurement data is measured, the electromyograph may be attached to either the suprahyoid muscles or the infrahyoid muscles of the human body.

[0008] In the above-mentioned method for evaluating the taking sensation, after the measurement data is obtained, second data may be generated by performing root mean square processing on first data contained in the measurement data, third data may be generated from the second data by selecting a point that corresponds to the second data and exceeds a value obtained by adding twice the standard deviation to the average value of the baseline when the pharmaceutical preparation is not taken, and the taking sensation evaluation information may be generated based on the third data.

[0009] In the method for evaluating medication sensation, the medication sensation evaluation information may be generated based on a maximum value of the potential in the third data.

[0010] In the method for evaluating medication sensation, the medication sensation evaluation information may be generated based on an area value generated from the third data.

[0011] In the method for evaluating the feeling of taking a medicine, it may be determined that the feeling of taking a medicine is good when the information on the evaluation of the feeling of taking a medicine satisfies a predetermined condition.

[0012] In the method for evaluating the feeling of taking a pharmaceutical preparation, the subject may be notified of the result of the assessment of the feeling of taking a pharmaceutical preparation.

[0013] In the method for evaluating the intake sensation, the pharmaceutical preparation may be any one of a capsule, a tablet, a granule, and a powder.

[0014] According to one embodiment of the present invention, there is provided a program for causing a computer to execute the above-described method for evaluating medication sensation.

[0015] According to one embodiment of the present invention, there is provided a pharmaceutical formulation intake sensation evaluation device including a control unit that acquires measurement data measured when taking a pharmaceutical formulation using an electromyograph attached to a human body, and generates intake sensation evaluation information when taking the pharmaceutical formulation based on the measurement data.

[0016] In the above-mentioned device for evaluating palatability, when the measurement data is measured, the electromyograph may be attached to either the suprahyoid muscles or the infrahyoid muscles of the human body.

[0017] In the above-mentioned device for evaluating the taking sensation, after acquiring the measurement data, the control unit may generate second data by performing root-mean-square processing on first data included in the measurement data, generate third data from the second data by adopting a point that corresponds to the second data and exceeds a value obtained by adding twice the standard deviation to the average value of the baseline when the pharmaceutical preparation is not taken, and generate the taking sensation evaluation information based on the third data.

[0018] In the above-mentioned medication sensation evaluation device, the control unit may generate the medication sensation evaluation information based on a maximum value of the potential in the third data.

[0019] In the above-mentioned device for evaluating medication sensation, the control unit may generate the medication sensation evaluation information based on an area value generated from the third data.

[0020] In the above-described device for evaluating medication sensation, the control unit may determine that the medication sensation is good when the medication sensation evaluation information satisfies a predetermined condition.

[0021] In the device for evaluating palatability, the control unit may notify the subject of the results of the assessment of the palatability when the subject takes the pharmaceutical preparation.

[0022] In the above-mentioned device for evaluating taking sensation, the pharmaceutical preparation may be any one of a capsule, a tablet, a granule, and a powder. [Effects of the Invention]

[0023] According to the present invention, a method for evaluating the intake sensation of a pharmaceutical preparation, which allows quantitative evaluation, can be provided. [Brief explanation of the drawings]

[0024] [Figure 1] 1 is a diagram showing the hardware configuration of a medication sensation evaluation system according to one embodiment of the present invention. [Figure 2] 1 is a diagram illustrating the software configuration of a medication sensation evaluation system according to one embodiment of the present invention. [Figure 3] 1 is a flow chart showing a method for evaluating medication experience in a medication experience evaluation system according to one embodiment of the present invention. [Figure 4] 1 is a flow chart showing a method for evaluating medication experience in a medication experience evaluation system according to one embodiment of the present invention. [Figure 5] 1 is a flow chart showing a method for evaluating medication experience in a medication experience evaluation system according to one embodiment of the present invention. [Figure 6] 1 is an example of measurement data according to an embodiment of the present invention. [Figure 7] 1 is an example of measurement data according to an embodiment of the present invention. [Figure 8] 1 is an example of measurement data according to an embodiment of the present invention. [Figure 9] 1 is an example of measurement data according to an embodiment of the present invention. [Figure 10] 1 is a graph showing an evaluation of the feeling of taking a pharmaceutical preparation based on impressions (questionnaire) before taking the preparation. [Figure 11] 1 is a graph showing an evaluation of the feeling of taking a pharmaceutical preparation based on impressions (questionnaire) after taking the preparation. [Figure 12] This shows the correlation evaluation results between the feeling of taking the medicine before and after taking the medicine. [Figure 13] 1 is a photograph showing the position where an electromyogram is attached. [Figure 14] 1 shows the results of an evaluation of the intake sensation of a pharmaceutical preparation based on electromyography measurements of the suprahyoid muscles. [Figure 15] 1 shows the results of an evaluation of the intake sensation of a pharmaceutical formulation based on electromyography measurements of the infrahyoid muscles. [Figure 16] This shows the correlation evaluation results between a questionnaire after administration and an evaluation of the feeling of taking a pharmaceutical preparation using electromyography. DETAILED DESCRIPTION OF THE INVENTION

[0025] The following embodiments are merely examples of the present invention, and the present invention is not limited to these embodiments. In the drawings referred to in this embodiment, the same or similar reference numerals are used to designate the same parts or parts having similar functions, and repeated explanations thereof may be omitted.

[0026] A medication sensation evaluation system according to one embodiment of the present invention will be described in detail with reference to the drawings.

[0027] (1-1. Hardware configuration of the medication sensation evaluation system) FIG. 1 shows the hardware configuration of a medication experience evaluation system 1. As shown in FIG. 1, the medication experience evaluation system 1 includes a medication experience evaluation device 10 and an electromyogram 30. The medication experience evaluation device 10 can also function as a database and application server for medication experience evaluation. The electromyogram 30 is a device worn on the human body to measure changes in electrical potential that occur when a pharmaceutical preparation is taken. For the sake of convenience, this embodiment shows the use of one electromyogram 30, but multiple electromyograms 30 may also be used as appropriate.

[0028] According to the medication experience evaluation system 1, the electromyograph 30 transmits measurement data (data showing fluctuations in potential) measured when a pharmaceutical preparation is taken to the medication experience evaluation device 10 via the network NW. The medication experience evaluation device 10 analyzes the measurement data. The medication experience evaluation device 10 then generates medication experience evaluation information from the analysis results and determines the medication experience based on the medication experience evaluation information (results). The configuration of the medication experience evaluation system for realizing such processing will be described below.

[0029] The medication sensation evaluation device 10 includes a control unit 11, a storage unit 12, a communication unit 13, a display unit 14, and an operation unit 15. The medication sensation evaluation device 10 may be used as a server. In this case, the server may be either an on-premise server or a cloud server.

[0030] The control unit 11 is a computer that uses a CPU (Central Processing Unit), ASIC (Application Specific Integrated Circuit), FPGA (Field Programmable Gate Array), or other arithmetic processing circuit to control processing based on instructions defined in software (program) for controlling the administration sensation evaluation, which will be described later. In addition, a user interface for executing the administration sensation evaluation control program may be provided on the display unit 14 in response to an instruction from the control unit 11.

[0031] The storage unit 12 may be a semiconductor memory such as an SSD (Solid State Drive), a magnetic recording medium (such as a magnetic tape or a magnetic disk), an optical recording medium, a magneto-optical recording medium, or a storage medium capable of storing data. The storage unit 12 functions as a database that stores the medication experience evaluation control information used in the medication experience evaluation control program. The storage unit 12 may be provided in a device different from the medication experience evaluation device 10, as appropriate, and may function as a database.

[0032] The communication unit 13 has a transceiver and transmits and receives measurement data via the network NW to and from the electromyogram 30. The communication between the communication unit 13 and the electromyogram 30 is performed by wire or wirelessly.

[0033] The operation unit 15 includes a controller, a button, or a switch. When the operation unit 15 is moved up, down, left, or right, pressed, or rotated, information based on the operation is transmitted to the control unit 11. Note that if the display unit 14 and the operation unit 15 are a display device (touch panel) having a touch sensor, the display unit 14 and the operation unit 15 may be located in the same place.

[0034] Although not shown, the medication sensation evaluation device 10 may also have a sound output unit (buzzer) and an illumination unit (light).

[0035] The electromyogram device 30 has a control unit 31, a memory unit 32, a communication unit 33, an operation unit 34, and a measurement unit 35. The electromyogram device 30 is used by being attached to either the suprahyoid muscles or the infrahyoid muscles of the human body.

[0036] The control unit 31 is a computer and includes a CPU, an ASIC, an FPGA, or other arithmetic processing circuit. The control unit 31 executes a program related to medication experience evaluation stored in a storage unit 32 such as a memory based on an operation of the operation unit 34, and instructs the execution of processing related to a medication experience evaluation control processing program stored in the storage unit 12 of the medication experience evaluation device 10.

[0037] The communication unit 33 has a function of transmitting and receiving data to and from the medication sensation evaluation device 10. For example, a LAN transceiver (e.g., a Wi-Fi transceiver) is used for the communication unit 33. Note that the transceiver is not limited to a LAN transceiver, and a transceiver for mobile terminal communication (e.g., LTE communication) or a transceiver for short-range wireless communication may be provided. The electromyogram 30 is connected to the medication sensation evaluation device 10 via a network NW.

[0038] The operation unit 34 includes a controller, a button, or a switch. When the operation unit 34 is moved up, down, left, or right, pressed, or rotated, information based on the operation is transmitted to the control unit 31.

[0039] The measuring unit 35 includes electrodes to be attached to the human body. The electrodes have any form (shape) such as needle electrodes, wire electrodes, or surface electrodes.

[0040] (1-2. Software configuration of the medication sensation evaluation system) 2 is a diagram showing the software configuration of the medication evaluation system 1. The control unit 11 of the medication evaluation device 10 includes an acquisition unit 11a, a generation unit 11b, a determination unit 11c, and a notification unit 11d.

[0041] The acquiring unit 11a has a function of acquiring measurement data from the electromyogram 30. The acquiring unit 11a may acquire measurement data stored in advance in a medication sensation database (DB) 12a of the storage unit 12.

[0042] The generating unit 11b has a function of generating various information based on the measurement data acquired by the acquiring unit 11a. In this example, the generating unit 11b generates medication sensation evaluation information.

[0043] The determination unit 11c has a function of determining whether the acquired information satisfies a predetermined condition. In this example, the determination unit 11c determines whether the generated medication sensation evaluation information exceeds a threshold value.

[0044] The notification unit 11d has a function of notifying the outside of the result of the assessment of the medication sensation. In this example, the assessment result may be displayed on the display unit 14 of the medication sensation evaluation device 10, may be transmitted to an external device, or may be output as sound or light.

[0045] The electromyogram 30 includes a measuring unit 310 and a transmitting unit 320. The measuring unit 310 has a function of measuring fluctuations in the potential at the site where the measuring unit 310 is attached. The transmitting unit 320 has a function of transmitting the measured potential (measurement data) to the medication sensation evaluation device 10.

[0046] (1-3. Method for evaluating the feeling of taking medicine) Next, a description will be given of a method for evaluating medication sensation realized in the medication sensation evaluation system in the first embodiment of the present invention. Figures 3 to 5 are flow charts showing the method for evaluating medication sensation in the medication sensation evaluation system 1 in this embodiment.

[0047] First, the electromyograph 30 is attached to the human body (step S101). The electromyograph 30 is attached to either the suprahyoid muscle group or the infrahyoid muscle group of the human body when in use.

[0048] When evaluating the medication sensation using the electromyogram 30, recording begins in response to a signal. Next, 5 seconds after the start of recording, a medication signal is given and the person (subject) takes the tablet. Measurement continues for another 5 seconds after taking the tablet. This series of data is used as measurement data (step S103). The frequency band used in the measurement is 50 to 450 Hz. The measurement data measured by the electromyogram 30 is transmitted to the medication sensation evaluation device 10 via a wired or wireless connection (step S105).

[0049] Next, the control unit 11 of the medication sensation evaluation device 10 acquires the transmitted measurement data (step S107). The acquired measurement data is stored in the medication sensation evaluation DB 12a.

[0050] Next, the medication sensation evaluation device 10 generates medication sensation evaluation information based on the measurement data (step S109). A method for generating medication sensation evaluation information will be specifically described below.

[0051] (Generation of medication sensation evaluation information) 4 is a flow diagram for generating medication sensation evaluation information. First, the medication sensation evaluation device 10 acquires measurement data (step S1091). At this time, the measurement data includes RAW data (first data) composed of potential values ​​at each time as shown in FIG. 6. The RAW data includes positive and negative potential values.

[0052] Next, the medication sensation evaluation device 10 performs root mean square (RMS) processing on the RAW data (to generate second data) (step S1092). As a result, the second data indicates a positive potential value, as shown in FIG.

[0053] Next, the medication sensation evaluation device 10 sets a baseline (0 to 3000 seconds in this case) for the root-mean-square-processed data (second data) as shown in Fig. 8, and determines points (having high potential values) that exceed the average value (also called the "base value") of the baseline plus twice the standard deviation (SD) (average value + 2S.D.) from the second data as muscle activity evaluation points (corresponding to the muscle activity evaluation period of 3000 to 9000 seconds), and defines these values ​​as third data (step S1093). As a result, as shown in Fig. 9, the values ​​at times other than when the medication is taken are set to "0."

[0054] Next, the third data is used to generate a maximum value and a total area value. These maximum value and total area value are divided by the data (maximum value, total area value) when water is drunk to calculate a ratio (step S1094). These are used as the medication sensation evaluation information.

[0055] Returning to FIG. 3, the description will be made. Next, the medication impression evaluation device 10 judges the medication impression using the medication impression evaluation information (step S111). FIG. 5 is a flow diagram of the judgment process. First, the medication impression evaluation device 10 judges the medication impression based on whether the medication impression evaluation information satisfies a predetermined condition (step S1111). The predetermined condition is that the maximum value ratio (or total area ratio) of the medication impression evaluation information is below a preset threshold. If the maximum value ratio (or total area ratio) of the medication impression evaluation information satisfies the predetermined condition (step S1112; Yes), the medication impression is judged to be good (step S1113). If the maximum value ratio (or total area ratio) of the medication impression evaluation information does not satisfy the predetermined condition (step S1112; No), the medication impression is judged to be bad (step S1114).

[0056] The result of the assessment of the palatability may be notified to an external device. In this example, the result of the assessment may be displayed on the display unit 14 of the palatability assessment device 10, transmitted to an external device, or output as sound or light. This completes the method for assessing palatability. In the above-described method for assessing palatability, quantitative data, namely, electric potential values, are used. Therefore, the palatability of a pharmaceutical preparation can be evaluated quantitatively, rather than sensorily.

[0057] <Modification> The present disclosure is not limited to the above-described embodiments and includes various other modifications. For example, the above-described embodiments have been described in detail to clearly explain the present disclosure, and are not necessarily limited to those including all of the described configurations. Furthermore, part of the configuration of one embodiment may be replaced with the configuration of another embodiment, or the configuration of another embodiment may be added to the configuration of one embodiment. Furthermore, part of the configuration of each embodiment may be added to, deleted from, or replaced with other configurations.

[0058] In one embodiment of the present invention, an example has been shown in which the medication sensation evaluation device 10 and the electromyogram 30 are provided separately, but the present invention is not limited to this. The medication sensation evaluation device 10 and the electromyogram 30 may also be provided as an integrated device.

[0059] Although one embodiment of the present invention has been described using capsules as pharmaceutical preparations, the present invention is not limited thereto. For example, similar effects can be obtained by using any of tablets, granules, and powders as pharmaceutical preparations in addition to capsules. [Example]

[0060] Next, the present invention will be described in more detail based on examples. Note that the following explanation is provided to facilitate understanding of the present invention and is not intended to limit the scope of the present invention. In other words, modifications, embodiments, and other examples based on the technical concept of the present invention are all included in the present invention.

[0061] (1. Evaluation of the feeling of taking pharmaceutical preparations based on impressions before taking them (questionnaire)) First, we conducted an evaluation of the ease of taking the pharmaceutical preparation based on the impression before taking it. In this evaluation, the ease of taking the capsule was judged by looking at and touching it before taking it, and the "ease of taking the capsule" was evaluated using a questionnaire on a 10-point scale. The evaluation conditions are as follows: Subjects: Healthy Japanese adults Age: 20-39 BMI (male): 19~24.9 BMI (female): 18.5~24.9 Male: Female (1:1) Number of subjects: 40 Formulation used: Placebo formulation (lactose) 0-5 capsules HPMC Test content: Based on visual and tactile feedback, participants were asked to rate the product on a 10-point scale based on their impression of "ease of taking." (Specifically, a score of 0 indicates that the product is very difficult or difficult to take, and a score of 10 indicates that the product is easy to take or easy to take.)

[0062] Figure 10 is a graph showing the evaluation of the ease of taking a pharmaceutical preparation based on the impression (questionnaire) before taking it. As shown in Figure 10, the impression of taking a pharmaceutical preparation based on the impression showed a tendency that the impression of ease of taking a pharmaceutical preparation was better (the numerical value was higher) as the capsule became smaller.

[0063] (2. Evaluation of the feeling of taking pharmaceutical preparations based on impressions after taking them (questionnaire)) Next, the results of the evaluation of the feeling of taking the pharmaceutical preparation were carried out based on the impression (questionnaire) after taking the capsule. In this evaluation, the ease of taking the tablet was actually felt by taking the capsule, and the "feel of taking" was evaluated on a 10-point scale by questionnaire. The evaluation conditions are as follows: Subjects: Healthy Japanese adults Age: 20-39 BMI (male): 19~24.9 BMI (female): 18.5~24.9 Male: Female (1:1) Number of subjects: 40 Formulation used: Placebo formulation (lactose) 0-5 capsules HPMC How to take: Take 1 capsule with 20 mL of water (total 6 times) - Take doses at approximately 5 minute intervals Posture when taking the medicine: Sit in a chair with your chin level Test content: After actually taking the medicine, participants were asked to rate their impression (impression) of "how easy it was to take" on a 10-point scale (specifically, if it was very difficult or there was resistance, a score of 0 was given, and if it was easy to take or there was no resistance at all (it was no different from drinking water) a score of 10 was given).

[0064] Figure 11 is a graph showing the evaluation of the feeling of taking a pharmaceutical preparation based on the impression after taking it (questionnaire). As shown in Figure 11, the evaluation of the feeling of taking a pharmaceutical preparation based on the impression after taking it also showed a tendency that the smaller the capsule, the better the feeling of taking it (the higher the numerical value).

[0065] (3. Correlation of the evaluation of the feeling of taking a pharmaceutical preparation with the impressions before and after taking the drug) A correlation evaluation was performed on the results of the evaluation of the feeling of taking a pharmaceutical formulation based on the impressions before and after taking it. Figure 12 shows the results of the correlation evaluation between the impression before taking it and the impression (impression) after taking it. As shown in Figure 12, a high correlation was observed between the results of the evaluation of the feeling of taking it based on the impression before taking it and the results of the evaluation of the feeling of taking it based on the impression (impression) after actually taking it. In other words, it was confirmed that there is a high correlation between the judgment based on visual (tactile) information and the actual feeling of taking it.

[0066] (4. Evaluation of the Intake Sensitivity of Pharmaceutical Preparations Based on Electromyography) Next, the results of the evaluation of the feeling of taking the pharmaceutical preparation based on electromyogram measurement were carried out. In this evaluation, a human electromyogram (manufactured by Trunk Solutions) was attached to the subject. The evaluation conditions were as follows: Subjects: Healthy Japanese adults Age: 20-39 BMI (male): 19~24.9 BMI (female): 18.5~24.9 Male: Female (1:1) Number of subjects: 40 Formulation used: Placebo formulation (lactose) 0-5 capsules HPMC How to take: Take 1 capsule with 20 mL of water (total 6 times) - Take doses at approximately 5 minute intervals Posture when taking the medicine: Sit in a chair with your chin level Test details: The amount of muscle activity related to swallowing was measured using an electromyograph attached to the suprahyoid and infrahyoid muscles (see Figure 13). Analysis method: The results when 20 mL of water was taken alone were set to 1.00, and the ratios (maximum value ratio, total area ratio) of the electromyogram measurements taken with the capsules to those taken with water were calculated. Measurements were taken three times with 20 mL of water, and the average value of the three measurements was used. A t-test (two-tailed, paired) was performed between each formulation, and a significance test was performed with a significance level of 0.05.

[0067] Figure 14 shows the results of an evaluation of the ingestion sensation of a pharmaceutical formulation based on electromyography measurements of the suprahyoid muscles. Figure 15 shows the results of an evaluation of the ingestion sensation of a pharmaceutical formulation based on electromyography measurements of the infrahyoid muscles. As shown in Figure 14, the results of the ingestion sensation evaluation using an electromyography meter attached to the suprahyoid muscles showed an increase in values ​​correlating with capsule size. Also, as shown in Figure 15, the results of the ingestion sensation evaluation using an electromyography meter attached to the infrahyoid muscles showed an increase in values ​​generally corresponding to capsule size, although there was some variability in the values ​​when the capsule size was small.

[0068] (5. Correlation between post-dose impressions and evaluation of drug intake sensations using electromyography) A correlation evaluation was performed between the post-dose impression (questionnaire) and the results of the evaluation of the pharmaceutical formulation's intake comfort using electromyogram measurement. The subjects used for the questionnaire evaluation and the electromyogram evaluation were the same. Figure 16 shows the correlation evaluation results between the post-dose impression (questionnaire) and the evaluation of the pharmaceutical formulation's intake comfort using electromyogram measurement. The electromyogram measurement results were obtained by measuring the area-to-total ratio when an electromyogram was attached to the suprahyoid muscles. As shown in Figure 16, a high correlation was observed between the intake comfort questionnaire results and the electromyogram evaluation values ​​(suprahyoid muscles, area-to-total ratio). In other words, it was confirmed that electromyogram measurement correlates with the actual difficulty of taking the pharmaceutical formulation (taking the pharmaceutical formulation), and is useful as a quantitative evaluation method for the intake comfort of pharmaceutical formulations. [Explanation of symbols]

[0069] 1. Medication impression evaluation system, 10. Medication impression evaluation device, 11. Control unit, 11a. Acquisition unit, 11b. Generation unit, 11c. Determination unit, 12. Memory unit, 12a. Medication impression database (DB), 13. Communication unit, 14. Display unit, 15. Operation unit, 30. Electromyogram device, 31. Control unit, 32. Memory unit, 33. Communication unit, 34. Operation unit, 35. Measurement unit

Claims

1. The computer attaching an electromyogram having electrodes integrally formed on a human body, and using the electromyogram, obtaining measurement data measured when a pharmaceutical preparation consisting of a solid preparation is taken; generating information on the evaluation of the feeling of taking the pharmaceutical preparation based on the measurement data; When measuring the measurement data, the electrodes of the electromyogram are attached to either the suprahyoid muscles or the infrahyoid muscles of the human body; After acquiring the measurement data, performing root mean square processing on first data, which is raw data included in the measurement data, to generate second data indicating a positive potential value; Generate third data indicating muscle activity evaluation points from the second data by using points that exceed a value obtained by adding twice the standard deviation to the average value of the baseline corresponding to the second data when the pharmaceutical preparation is not being taken; generating information on the evaluation of the feeling of taking the pharmaceutical preparation by dividing a first area value calculated by time-integrating the third data by a second area value calculated by time-integrating data measured by the electromyogram when drinking water and corresponding to the third data; A method for evaluating the swallowing sensation of pharmaceutical preparations.

2. When the ingestion feeling evaluation information satisfies a predetermined condition, it is determined that the ingestion feeling is good. The method for evaluating the intake sensation of the pharmaceutical preparation according to claim 1.

3. notifying the result of the assessment of the feeling of taking the medicine; The method for evaluating the intake sensation of a pharmaceutical preparation according to claim 2.

4. A program for executing the method for evaluating drug intake sensation according to any one of claims 1 to 3.

5. acquiring measurement data measured when a pharmaceutical preparation consisting of a solid preparation is taken using an electromyogram having electrodes attached to a human body; a control unit that generates information on an evaluation of a feeling of taking a pharmaceutical preparation based on the measurement data; When measuring the measurement data, Attaching the electrodes of the electromyograph to either the suprahyoid muscles or the infrahyoid muscles of the human body; The control unit After obtaining the measurement data, generating second data indicating a positive potential value by performing root mean square processing on first data, which is raw data included in the measurement data; generating third data indicating muscle activity evaluation points from the second data by using points that correspond to the second data and exceed a baseline average value when the pharmaceutical preparation is not being taken plus two standard deviations; generating information on the evaluation of the feeling of taking the pharmaceutical preparation by dividing a first area value calculated by time-integrating the third data by a second area value calculated by time-integrating data measured by the electromyogram when drinking water and corresponding to the third data; A device for evaluating the feeling of taking pharmaceutical preparations.

6. The control unit When the ingestion feeling evaluation information satisfies a predetermined condition, it is determined that the ingestion feeling is good. The device for evaluating the intake sensation of a pharmaceutical preparation according to claim 5.

7. The control unit notifying the result of the assessment of the feeling of taking the medicine; The device for evaluating the intake sensation of a pharmaceutical preparation according to claim 6.

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