JP2016053593A - Lubricant flatting analyzer, method, program, and recording medium - Google Patents

Abstract

PROBLEM TO BE SOLVED: To precisely measure a flatting state of a lubricant.SOLUTION: A lubricant flatting analyzer 1 determines a flatting state of a lubricant on a measured object 2 in which particles forming a tablet (excipient: lactose) and the lubricant are mixed. The lubricant flatting analyzer 1 comprises: an electromagnetic wave output device 12 for outputting an electromagnetic wave of a frequency of 20 GHz or more and 500 THz or less; an optical element 14 having a full reflection face 14a for fully reflecting the electromagnetic wave, and an evanescent wave generated from the full reflection face 14a being received by the measured object 2; an electromagnetic wave detector 18 for detecting the electromagnetic wave which is fully reflected by the full reflection face 14a; and a flatting determination device 20. The flatting determination device 20 determines a flatting state of the lubricant, based on a change in reflectance ratio of the full reflection face 14 to passing of a mixing time. An absorption ratio of the electromagnetic wave in a predetermined frequency area of the particles is higher than an absorption ratio of the electromagnetic wave in a frequency area other than the predetermined frequency area of the particles.SELECTED DRAWING: Figure 1

Description

  The present invention relates to an analysis of the spread state of a lubricant in a tablet.

  In the pharmaceutical manufacturing process, it is common to mix a lubricant with pharmaceutical particles in order to prevent tableting troubles such as sticking in the tableting process. A typical lubricant is magnesium stearate, which has the effect of increasing the fluidity of pharmaceutical particles. With proper mixing of the lubricant, the friction between the tablet mortar and the tablet is reduced.

  However, if the lubricant is improperly mixed (ie if the mixing time is too long), the lubricant spreads too much during mixing and the entire drug particle is covered with a thin film of lubricant. It becomes a state. Many of the lubricants have hydrophobicity, which adversely affects tablet hardness, disintegration and dissolution. Therefore, the lubricant mixing time is an important process parameter related to pharmaceutical quality.

In addition, the guidelines of the International Conference on Harmonization of Pharmaceutical Regulations (ICH) in Japan and the United States propose Quality by Design (QbD), which fully designs and builds pharmaceutical quality at the research and development stage. A guarantee is required. As a technology that adapts to this, PAT (Process, a technology that controls the in-process process by monitoring the critical quality attributes (CQA) of pharmaceuticals in real time.
Analytical Technology) is important.

  The spread of lubricant, which is one of CQA, is evaluated by observation with an electron microscope and analysis of contact angle and discharge force. However, these analysis methods are destructive tests and lack real-time properties, so it is difficult to use them as PAT tools.

  Therefore, in Patent Document 1 (see abstract), the spread state of the lubricant can be evaluated by measuring the total absorbance in a wavelength region including the absorption wavelength characteristic of the lubricant component. Proposed.

JP 2010-8404 A JP 2008-298460 A JP 2008-77799 A JP 2006-3285 A International Publication No. 2006/083001

  However, the total value of the absorbance measured by the technique described in Patent Document 1 is not information that directly captures the spread of the lubricant attached to the pharmaceutical particles. For this reason, it is difficult to accurately measure the spread of the lubricant.

  Therefore, an object of the present invention is to accurately measure the spread state of the lubricant.

  The spread analysis apparatus for a lubricant according to the present invention is an apparatus for analyzing the spread state of the lubricant in a measurement object in which particles constituting the tablet and the lubricant are mixed, and is 20 GHz or more An electromagnetic wave output device that outputs an electromagnetic wave having a frequency of 500 THz or less; an optical element that has a total reflection surface that totally reflects the electromagnetic wave; and the object to be measured receives an evanescent wave generated from the total reflection surface; and the total reflection surface Based on the detection result of the electromagnetic wave detector, the electromagnetic wave detector that detects the electromagnetic wave totally reflected by the electromagnetic wave, the reflectance of the electromagnetic wave by the total reflection surface or the value based on the reflectance, the frequency of the electromagnetic wave, A spectrum deriving unit derived in association with the manufacturing conditions of the particles or the object to be measured, and a feature extracting unit extracting a feature based on the manufacturing conditions from the derived result of the spectrum deriving unit. Sea urchin made.

  According to the spread analysis apparatus for a lubricant configured as described above, there is provided an apparatus for analyzing the spread state of the lubricant in a measured object in which particles constituting the tablet and the lubricant are mixed. Provided. The electromagnetic wave output device outputs electromagnetic waves with a frequency of 20 GHz to 500 THz. The optical element has a total reflection surface that totally reflects the electromagnetic wave, and the object to be measured receives an evanescent wave generated from the total reflection surface. An electromagnetic wave detector detects the electromagnetic wave totally reflected by the total reflection surface. Based on the detection result of the electromagnetic wave detector, the spectrum deriving unit determines the reflectance of the electromagnetic wave by the total reflection surface or the value based on the reflectance, the frequency of the electromagnetic wave, and the manufacturing conditions of the particle or the object to be measured. Derived in association with. The feature extraction unit extracts a feature based on the manufacturing condition from the derivation result of the spectrum deriving unit.

  In the lubricant spread analysis apparatus according to the present invention, the manufacturing condition may include a mixing time in which the particles and the lubricant are mixed.

  In the lubricant spread analysis apparatus according to the present invention, the manufacturing condition may include the number of rotations of a mixing apparatus that performs the mixing.

  In the lubricant spreading analysis apparatus according to the present invention, the characteristic based on the manufacturing conditions is a part of a predetermined frequency region, and the absorption rate of the electromagnetic wave in the predetermined frequency region of the particles is You may make it change compared with the absorption factor of the said electromagnetic wave in frequency domains other than the said predetermined frequency domain of particle | grains.

  In the lubricant spread analysis apparatus according to the present invention, the feature based on the manufacturing condition may be a principal component obtained by principal component analysis of a derivation result of the spectrum deriving unit.

  In the lubricant spread analyzer according to the present invention, the manufacturing condition is a mixing time in which the particles and the lubricant are mixed, and the feature based on the manufacturing condition is a predetermined frequency region. The absorption rate of the electromagnetic wave in the predetermined frequency region of the particle is changed compared to the absorption rate of the electromagnetic wave in a frequency region other than the predetermined frequency region of the particle, and the feature extraction unit A spread determining unit that determines the spread state of the lubricant based on the change of the extraction result with respect to the lapse of the mixing time may be provided.

  In the lubricant spread analysis apparatus according to the present invention, the value based on the reflectance may be an absorptance of the electromagnetic wave on the total reflection surface.

  In the spread analysis device for a lubricant according to the present invention, the value based on the reflectivity is a value obtained by n-order differentiation of the reflectivity with a value based on the frequency of the electromagnetic wave, or the total reflection surface of the electromagnetic wave. It is a value obtained by n-order differentiation of the absorptance at a value based on the frequency of the electromagnetic wave, and the n may be an integer of 1 or more.

  The lubricant spreading analysis apparatus according to the present invention is configured such that a plurality of objects to be measured are acquired from a mixture in which the particles and the lubricant are mixed, and a plurality of values based on the reflectance are plural. The standard deviation of the reflectance of the object to be measured, the standard deviation of the absorptance of the electromagnetic wave for the plurality of objects to be measured on the total reflection surface, and the reflectance is a value based on the frequency of the electromagnetic wave. The standard deviation of the differentiated value, or the standard deviation of the value obtained by performing n-order differentiation of the absorption rate on the basis of the frequency of the electromagnetic wave, may be an integer of 1 or more.

  In the lubricant spread analyzer according to the present invention, the particles may be excipients.

  In the lubricant spreading analysis device according to the present invention, the electromagnetic wave absorption rate of the particles in the predetermined frequency region is the absorption rate of the electromagnetic waves in a frequency region other than the predetermined frequency region of the particles. You may make it higher.

  In the lubricant spread analysis apparatus according to the present invention, the optical element includes an incident surface that receives the electromagnetic wave from the electromagnetic wave output device, and the electromagnetic wave that is totally reflected by the total reflection surface is emitted to the air. And the refractive index of the optical element is higher than the refractive index of the air, total reflection occurs inside the optical element, and the object to be measured is disposed outside the optical element. And you may make it touch the said total reflection surface.

  In the lubricant spread analyzer according to the present invention, the object to be measured may be pressed against the total reflection surface.

  The lubricant spread analyzer according to the present invention includes a measured object acquisition unit that acquires the measured object from a mixture in which the particles and the lubricant are mixed, and the measured object. You may make it provide the to-be-measured object arrangement | positioning part arrange | positioned on the said total reflection surface, and the to-be-measured object discharge part which discharges | emits the said to-be-measured object which finished the detection of the said electromagnetic wave from the said total reflection surface.

  Note that the lubricant spread analyzer according to the present invention may stop mixing of the particles and the lubricant based on the result of the spread state determination by the spread determination unit.

  The present invention is an apparatus for determining the spread state of a lubricant in a measurement object in which particles constituting a tablet and a lubricant are mixed, and outputs an electromagnetic wave having a frequency of 20 GHz to 500 THz. An output device, a total reflection surface that totally reflects the electromagnetic wave, an optical element that receives the evanescent wave generated from the total reflection surface, and the electromagnetic wave that is totally reflected by the total reflection surface is detected. A method for determining a spread state of a lubricant using a spread analysis device for a lubricant having an electromagnetic wave detector, based on a detection result of the electromagnetic wave detector, by the total reflection surface of the electromagnetic wave From the derivation result of the spectrum deriving step, the spectrum deriving step of deriving the reflectance or the value based on the reflectance in association with the frequency of the electromagnetic wave and the manufacturing conditions of the particles or the object to be measured, A feature extraction step of extracting a feature based on concrete conditions, a spread determination method of lubricants having a.

  The present invention is an apparatus for determining the spread state of a lubricant in a measurement object in which particles constituting a tablet and a lubricant are mixed, and outputs an electromagnetic wave having a frequency of 20 GHz to 500 THz. An output device, a total reflection surface that totally reflects the electromagnetic wave, an optical element that receives the evanescent wave generated from the total reflection surface, and the electromagnetic wave that is totally reflected by the total reflection surface is detected. A program for causing a computer to execute a process for determining a spread state of a lubricant using a spread analysis device for a lubricant having an electromagnetic wave detector, and determining the spread state of the lubricant The processing is based on the detection result of the electromagnetic wave detector, the reflectance of the electromagnetic wave by the total reflection surface or the value based on the reflectance, the frequency of the electromagnetic wave, and the manufacturing conditions of the particles or the object to be measured. Vs. Spectrum deriving step of deriving by correlating, the derivation result of the spectrum deriving step, a program and a feature extraction step of extracting a feature based on the production conditions.

  The present invention is an apparatus for determining the spread state of a lubricant in a measurement object in which particles constituting a tablet and a lubricant are mixed, and outputs an electromagnetic wave having a frequency of 20 GHz to 500 THz. An output device, a total reflection surface that totally reflects the electromagnetic wave, an optical element that receives the evanescent wave generated from the total reflection surface, and the electromagnetic wave that is totally reflected by the total reflection surface is detected. A computer-readable recording medium storing a program for causing a computer to execute a process for determining a spread state of a lubricant using a lubricant spread analyzer having an electromagnetic wave detector, The process of determining the spread state of the lubricant is based on the detection result of the electromagnetic wave detector, and the reflectance of the electromagnetic wave by the total reflection surface or the value based on the reflectance is calculated based on the detection result of the electromagnetic wave. A spectrum deriving step derived in association with a wave number and a manufacturing condition of the particle or the object to be measured, and a feature extracting step of extracting a feature based on the manufacturing condition from a deriving result of the spectrum deriving step. Recording medium.

It is a figure which shows the structure of the spreading analysis apparatus 1 of the lubricant concerning embodiment of this invention. It is a functional block diagram which shows the structure of the spread determination apparatus 20 concerning embodiment of this invention. The ATR spectrum of lactose (excipient) and magnesium stearate (lubricant) is shown. It is a conceptual diagram of the reflectance by the total reflection surface 14a of the terahertz wave for every mixing time. It is a conceptual diagram of the extraction result of the characteristic spectrum extraction part 20g concerning 1st embodiment. It is a figure which shows the value which carried out the secondary differentiation of the reflectance by the total reflection surface 14a of the terahertz wave for every mixing time according to 2nd embodiment with the frequency of the terahertz wave. It is a conceptual diagram of the extraction result of the characteristic spectrum extraction part 20g concerning 2nd embodiment. A range of values obtained by secondarily differentiating the reflectivity of the total reflection surface 14a of the terahertz wave for each DUT 2 in the predetermined frequency region by the frequency of the terahertz wave according to the third embodiment is shown for each mixing time. FIG.

  Embodiments of the present invention will be described below with reference to the drawings.

  FIG. 1 is a diagram showing a configuration of a lubricant spread analyzer 1 according to an embodiment of the present invention. The lubricant spread analyzer 1 includes an electromagnetic wave detection device 10, a spread determination device 20, and a powder mixing device 30.

  The powder mixing device 30 is a device for mixing particles and a lubricant. The particles constitute a tablet, for example, an excipient (such as lactose). Lactose is often used as a pharmaceutical excipient. The lubricant is, for example, magnesium stearate. The powder mixed by the powder mixing device 30 is compressed into tablets. The powder mixing device 30 contains a mixture in which particles (excipients) and a lubricant are mixed. Mixing takes place over a period of time (eg, 30 or 60 minutes). The time during which the particles (excipient) and the lubricant are mixed is referred to as the mixing time. In addition, a mixture shall contain an excipient | filler very much rather than a lubricant in weight ratio. For example, the mixture should contain 98% lactose and 2% lubricant by weight. However, the mixture may contain an active ingredient and additives.

  The electromagnetic wave detection device 10 includes an object acquisition unit 11, an object arrangement unit 13, an object discharge unit 15, an electromagnetic wave output device 12, an optical element 14, a pressurizer 16, and an electromagnetic wave detector 18.

  The device under test acquisition unit 11 acquires the device under test 2 from a mixture in which particles (excipients) and a lubricant contained in the powder mixing device 30 are mixed. The DUT 2 is also a part of the mixture, in which particles and a lubricant are mixed. The lubricant spread analysis device 1 is a device that determines the spread state of the lubricant in the object to be measured 2.

  The measurement object 2 may be acquired manually without using the measurement object acquisition unit 11. A plurality (for example, 10) of the DUT 2 may be obtained from the mixture. The DUT 2 is acquired every predetermined mixing time (for example, 0 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes,...).

  A tablet obtained by tableting the mixture may be used as the DUT 2, but it is desirable to use the mixture as the DUT 2 in a powder state.

  The DUT placement unit 13 places the DUT 2 acquired by the DUT acquisition unit 11 on the total reflection surface 14a. The placement of the DUT 2 on the total reflection surface 14a may be performed manually.

  The measured object discharge unit 15 discharges the measured object 2 that has been detected by the electromagnetic wave detector 18 from the total reflection surface 14a. In addition, discharge | emission of the to-be-measured object 2 may be performed manually.

  The electromagnetic wave output device 12 outputs an electromagnetic wave having a frequency of 20 GHz to 500 THz. The frequency of the electromagnetic wave output from the electromagnetic wave output device 12 is a terahertz region of 0.02 THz to 12 THz suitable for measuring the change in the surface state of the DUT 2 as the change in absorption of the DUT 2. Is desirable. Therefore, in the present embodiment, description will be made assuming that the electromagnetic wave output from the electromagnetic wave output device 12 is a terahertz wave.

The optical element 14 is, for example, an ATR prism. However, ATR is attenuated by total reflection (Attenuated
Means Total Reflection). The optical element 14 has a total reflection surface 14a, an incident surface 14b, and an output surface 14c.

  The incident surface 14 b receives the terahertz wave from the electromagnetic wave output device 12. The refractive index of the optical element 14 is higher than the refractive index of air around the optical element 14, and the terahertz wave is refracted toward the total reflection surface 14a.

  The total reflection surface 14a totally reflects the terahertz wave that has passed through the incident surface 14b. That is, total reflection occurs inside the optical element 14. Note that an electromagnetic wave (terahertz wave) propagating in the optical element 14 is totally reflected inside the optical element 14 when incident on the total reflection surface 14a at a critical angle or more.

  The DUT 2 is arranged outside the optical element 14 and is in contact with the total reflection surface 14a. As a result, the DUT 2 receives the evanescent wave generated from the total reflection surface 14a. The refractive index of the optical element 14 is preferably larger than the refractive index of the DUT 2.

In the region of the total reflection surface 14a where the electromagnetic wave (terahertz wave) is totally reflected in the optical element 14, an evanescent wave oozes out on the back surface (outside of the optical element 14). The penetration length Dp of the evanescent wave is determined by using the wavelength λ of the electromagnetic wave, the refractive index n ₁ of the optical element 14, the refractive index n 2 of the DUT ₂ , and the incident angle θ to the total reflection surface 14 a in the optical element 14. It can be represented by the following formula.

このエバネッセント波がしみ出した領域に被測定物２を配置すると、被測定物２の特徴的な吸収に関する分光情報が得られる。

When the device under test 2 is arranged in a region where the evanescent wave has oozed out, spectral information regarding characteristic absorption of the device under test 2 can be obtained.

  In ATR spectroscopy, information on the object to be measured 2 in the wavelength order corresponding to or longer than the length of the evanescent wave seepage can be obtained, so that a slight change in the surface of the object to be measured 2 can be sensed with high sensitivity.

  The emission surface 14c is a surface from which the terahertz wave totally reflected by the total reflection surface 14a is emitted to the air.

  The pressurizer 16 presses the DUT 2 against the total reflection surface 14. As a result, the DUT 2 comes into close contact with the total reflection surface 14.

  The electromagnetic wave detector 18 detects the intensity of the terahertz wave totally reflected by the total reflection surface 14a.

  FIG. 2 is a functional block diagram showing the configuration of the spread determination device 20 according to the embodiment of the present invention.

  The spread determination device 20 includes an AD converter 20a, a reference spectrum recording unit 20b, a mixing time input unit 20c, a spectrum deriving unit 20d, a spectrum recording unit 20e, a characteristic frequency recording unit 20f, a characteristic spectrum extracting unit 20g, and a characteristic spectrum recording unit. 20h, a spread determination unit 20i, a spread recording unit 20j, and a display 20k.

  The AD converter 20a converts the intensity (which is an analog signal) of the terahertz wave detected by the electromagnetic wave detector 18 into a digital signal and outputs the digital signal.

  The reference spectrum recording unit 20b is a total reflection attenuation spectrum measured in a state in which the DUT 2 is not disposed on the optical element 14 (the reflection of the total reflection surface 14a associated with the frequency of the electromagnetic wave output from the electromagnetic wave output device 12). Rate) is recorded as a reference spectrum.

  By using the reference spectrum, it is possible to obtain a total reflection attenuation spectrum in which the measurement fluctuation of the system including the fluctuation of the electromagnetic wave emitted from the electromagnetic wave output device 12 is suppressed.

  The mixing time input unit 20c inputs the mixing time (for example, 0 minutes, 5 minutes, 10 minutes,...) At which the DUT 2 is acquired to the spectrum deriving unit 20d. For example, it may be input manually.

  The spectrum deriving unit 20d of the spread determination device 20 is different in each of the following embodiments.

First Embodiment The spectrum deriving unit 20d receives the detection result of the electromagnetic wave detector 18 via the AD converter 20a. Based on the detection result of the electromagnetic wave detector 18, the spectrum deriving unit 20d associates the reflectivity (or the value based on the reflectivity) of the terahertz wave with the total reflection surface 14a with the frequency of the terahertz wave and the mixing time. To derive. When a plurality of devices to be measured 2 are acquired, the average of the reflectance measured for each device to be measured 2 is used as a derived result by the spectrum deriving unit 20d.

  Further, in principle, the reflectance by the total reflection surface 14a is (the intensity of the terahertz wave detected by the electromagnetic wave detector 18) / (the intensity of the terahertz wave output by the electromagnetic wave output device 12). However, the reflectance is calibrated based on the recorded contents of the reference spectrum recording unit 20b, thereby obtaining a total reflection attenuation spectrum that suppresses measurement fluctuations of the system including fluctuations of electromagnetic waves emitted from the electromagnetic wave output device 12. be able to.

The value based on the reflectance is, for example, the absorption rate (“100% -reflectance” or “−log ₁₀ (reflectance)”) of the terahertz wave total reflection surface 14a.

  The spectrum recording unit 20e records the derivation result (spectrum) of the spectrum deriving unit 20d. Refer to FIG. 4 for an example of the recorded contents of the spectrum recording unit 20e.

  FIG. 3 shows ATR spectra of lactose (excipient) and magnesium stearate (lubricant). Referring to FIG. 3, as a result of measuring the reflectance (ATR (%)) of the terahertz wave of about 0.3 THz to 2 THz by the total reflection surface 14a, a characteristic absorption appears in the measured frequency domain (0.53). It can be seen that approximately 93% at THz and 1.37 THz), magnesium stearate has no characteristic absorption.

  It is known that the intensity of the evanescent wave that oozes on the total reflection surface 14a is the strongest on the total reflection surface 14a and attenuates exponentially as the distance from the total reflection surface 14a increases. In addition, it is also known that the protrusion length becomes longer when the refractive index of the DUT 2 on the total reflection surface 14a is high.

  Therefore, in the DUT 2 obtained from the mixture mixed for a sufficient mixing time, the air in the shallow part (the part where the evanescent wave is applied) of the DUT 2 due to the spreading of the lubricant. The distribution of layers is reduced and lactose is distributed more. Therefore, evanescent waves are easily absorbed by lactose in the vicinity of 0.53 THz and 1.37 THz. Therefore, the reflectance of the terahertz wave by the total reflection surface 14a is low.

  That is, due to the spreading of the lubricant, the individual lactose particles are coated, and the fluidity of the particles is increased, so that the lactose particles are smoothly adhered immediately above the total reflection surface 14a, and the distribution of the air layer is It is less. In addition, since the lactose particles in which the lubricant is spread adhere smoothly, the ratio of lactose applied to a region where the evanescent wave is strong increases, and the average value of the absorption rate increases. In addition, the air layer has been replaced by a thin lubricant coating and a lactose layer, so that the evanescent wave seepage length is increased and the absorption is further enhanced.

  On the other hand, in the object to be measured 2 obtained from the mixture mixed over an insufficient mixing time, the lubricant does not spread sufficiently, and the shallow part of the surface of the object to be measured 2 (evanescent waves are not generated). The distribution of the air layer in this part) increases. Therefore, terahertz waves are easily reflected even in the vicinity of 0.53 THz and 1.37 THz. Therefore, the reflectivity of the terahertz wave by the total reflection surface 14a is high.

  FIG. 4 is a conceptual diagram of the reflectance of the terahertz wave total reflection surface 14a for each mixing time. Since FIG. 4 is a conceptual diagram, the illustrated reflectivity is a rough value and shows only an approximate tendency.

  If the mixing time is 0 minute, many air layers are distributed in the shallow portion of the surface of the DUT 2, and the terahertz wave is totally reflected (reflectance 100%).

  If the mixing time is 10 minutes, a little more lactose is distributed in the shallow part of the surface of the DUT 2, and the evanescent wave is easily absorbed by lactose in the vicinity of 0.53 THz and 1.37 THz. Therefore, the reflectivity of the terahertz wave is low in the vicinity of 0.53 THz and 1.37 THz. Since the air layer is also distributed in the shallow part of the surface of the DUT 2, it is not lowered to 93%.

  When the mixing time is 30 minutes, a large amount of lactose is distributed in the shallow portion of the surface of the DUT 2, and the evanescent wave is easily absorbed by the lactose in the vicinity of 0.53 THz and 1.37 THz. Therefore, the reflectivity of the terahertz wave is low in the vicinity of 0.53 THz and 1.37 THz. Since the air layer is hardly distributed in the shallow part of the surface of the object to be measured 2, it becomes as low as 93%.

  The characteristic frequency recording unit 20f records a predetermined frequency region. However, the absorption rate of the terahertz wave in a predetermined frequency region of the particle (excipient: lactose) is changed compared to the absorption rate of the terahertz wave in a frequency region other than the predetermined frequency region of the particle (for example, high )

  When lactose is used as the particles, the predetermined frequency region is in the vicinity of one or both of 0.53 THz and 1.37 THz with reference to FIG. Here, the vicinity of 0.53 THz is set as a predetermined frequency region.

  The feature spectrum extraction unit 20g extracts a predetermined frequency domain portion from the derivation result of the spectrum derivation unit 20d. The feature spectrum extraction unit 20g reads a predetermined frequency region from the feature frequency recording unit 20f. The feature spectrum recording unit 20h records the extraction result of the feature spectrum extraction unit 20g.

  FIG. 5 is a conceptual diagram of the extraction result of the feature spectrum extraction unit 20g according to the first embodiment. Since FIG. 5 is a conceptual diagram, the illustrated reflectivity is a rough value and shows only an approximate tendency.

  When the mixing time is 0 minutes, the reflectivity of the terahertz wave near 0.53 THz is 100%, but as the mixing time elapses 5 minutes, 10 minutes, and 15 minutes, the reflectivity decreases, and the mixing After 30 minutes, the reflectance is constant at 93%.

  The spread determination unit 20i determines the spread state of the lubricant based on the change of the extraction result of the feature spectrum extraction unit 20g with respect to the mixing time.

  In the first embodiment, the lubricant is sufficient when the extraction result of the feature spectrum extraction unit 20g shows a constant value or fluctuation within a predetermined range with respect to the lapse of the mixing time. Judged to have been extended. In the example of FIG. 5, it is determined that the lubricant has spread sufficiently at the time of mixing time = 30 minutes. When the mixing time is less than 30 minutes, it is determined that the lubricant is not sufficiently spread.

  When the determination result of the spread state by the spread determination unit 20i indicates that the lubricant is sufficiently spread, the spread determination unit 20i controls the powder mixing device 30 to stop the mixing of the particles and the lubricant. .

  The spread recording unit 20j records the determination result of the spread determination unit 20i. The recorded content of the spread recording unit 20j is “mixing stop” if it is determined that the lubricant is sufficiently spread, and “mixed” if it is determined that the lubricant is not sufficiently spread. Continuation of ".

  The display 20k displays the recorded contents of the spectrum recording unit 20e, the characteristic spectrum recording unit 20h, and the spread recording unit 20j.

  Next, the operation of the lubricant spread analyzer 1 according to the first embodiment will be described.

  First, by the measured object acquisition unit 11, a plurality of predetermined time intervals (for example, 0 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes,...) One piece of device under test 2 is acquired.

  The acquired measured objects 2 are arranged one by one on the total reflection surface 14 a by the measured object arrangement unit 13. The DUT 2 arranged on the total reflection surface 14 a is pressed against the total reflection surface 14 a by the pressurizer 16.

  The terahertz wave output from the electromagnetic wave output device 12 is incident on the optical element (ATR prism) 14 from the incident surface 14b, propagates in the optical element 14, and travels toward the total reflection surface 14a. The terahertz wave is totally reflected by the total reflection surface 14a. At this time, the evanescent wave oozes from the total reflection surface 14a. The shallow part of the surface of the DUT 2 receives the evanescent wave.

  The lactose (excipient) in the shallow part of the surface of the DUT 2 absorbs components with frequencies of 0.53 THz and 1.37 THz, while air reflects terahertz waves.

  The terahertz wave totally reflected by the total reflection surface 14 a is emitted from the emission surface 14 c to the air, and the intensity is detected by the electromagnetic wave detector 18.

  The detected intensity is converted into a digital signal by the AD converter 20a and given to the spectrum deriving unit 20d. When the detection of the intensity of the terahertz wave is completed, the device under test 2 is discharged from the total reflection surface 14 a by the device under test discharge unit 15. And the process of arrange | positioning the following to-be-measured object 2 on the total reflection surface 14a, pressing on the total reflection surface 14a, and discharging | emitting from the total reflection surface 14a is repeated about all the to-be-measured objects 2. FIG.

  The spectrum deriving unit 20d derives the reflectance of the total reflection surface 14a associated with the frequency of the terahertz wave based on the intensity detected by the electromagnetic wave detector 18 (see FIG. 4).

  Further, the spectrum deriving unit 20d acquires the mixing time from the mixing time input unit 20c. Thereby, the reflectance of the total reflection surface 14a can be associated with the mixing time (see FIG. 4).

  Further, the spectrum deriving unit 20d acquires the reflectance of the total reflection surface 14a when the DUT 2 is not disposed on the optical element 14 from the reference spectrum recording unit 20b. Thereby, the reflectance of the total reflection surface 14a can be calibrated.

  The spectrum deriving unit 20d outputs the average reflectance of the total reflection surface 14a measured for each device under test 2 as a result derived by the spectrum deriving unit 20d.

  The derivation result (see FIG. 4) of the spectrum deriving unit 20d is recorded in the spectrum recording unit 20e and given to the feature spectrum extracting unit 20g. The characteristic spectrum extraction unit 20g extracts a part of a predetermined frequency region (for example, near 0.53 THz) from the derivation result (see FIG. 4) of the spectrum derivation unit 20d (see FIG. 5). The feature spectrum extraction unit 20g reads a predetermined frequency region from the feature frequency recording unit 20f. The feature spectrum recording unit 20h records the extraction result of the feature spectrum extraction unit 20g.

  The spread determination unit 20i determines the spread state of the lubricant based on the change of the extraction result of the feature spectrum extraction unit 20g with respect to the mixing time. For example, referring to FIG. 5, it is determined that the lubricant is sufficiently spread in a mixing time of 30 minutes where the reflectance is 93% and constant. The spread recording unit 20j records the determination result of the spread determination unit 20i.

  The display 20k displays the recorded contents of the spectrum recording unit 20e, the characteristic spectrum recording unit 20h, and the spread recording unit 20j.

  In addition, when the result of the spread determination by the spread determination unit 20i indicates that the lubricant has sufficiently spread, the spread determination unit 20i controls the powder mixing device 30 to mix the particles and the lubricant. Stop.

  Moreover, you may calibrate the determination of the spread determination part 20i by the data which measured the to-be-measured object 2 by the destructive inspection method (Tablet hardness test | inspection, bulk density test | inspection, discharge | emission power test | inspection, contact angle test | inspection etc.).

  According to the spread analysis apparatus 1 of the lubricant according to the first embodiment, a predetermined frequency region (a region with a high lactose absorption rate) that changes according to the spread state of the lubricant in the measurement object 2. Since the reflectance (ATR spectrum) of the total reflection surface 14a in (for example, in the vicinity of 0.53 THz) is extracted by the feature spectrum extraction unit 20g, the spread state of the lubricant can be accurately measured.

Second Embodiment In the lubricant spread analysis apparatus 1 according to the second embodiment, the spectrum deriving unit 20d determines the second-order derivative of the reflectance (or absorption rate) of the total reflection surface 14a at the frequency of the terahertz wave. The point from which the obtained value is derived is different from the first embodiment.

  The electromagnetic wave detection device 10 and the powder mixing device 30 in the lubricant spread analyzer 1 according to the second embodiment are the same as described above, and a description thereof is omitted.

  Of the spread determination device 20 in the spread analysis device 1 of the lubricant according to the second embodiment, the AD converter 20a, the reference spectrum recording unit 20b, and the mixing time input unit 20c are the same as described above and will be described. Omitted.

  The spectrum deriving unit 20d receives the detection result of the electromagnetic wave detector 18 via the AD converter 20a. Based on the detection result of the electromagnetic wave detector 18, the spectrum deriving unit 20 d derives a value based on the reflectance of the terahertz wave by the total reflection surface 14 a in association with the frequency of the terahertz wave and the mixing time. When a plurality of devices to be measured 2 are acquired, an average of values based on the reflectance measured for each device to be measured 2 is used as a derived result by the spectrum deriving unit 20d.

  The value based on the reflectance is a value obtained by second-order differentiation of the reflectance with the frequency of the terahertz wave, or a value obtained by second-order differentiation of the absorption rate with the frequency of the terahertz wave.

  FIG. 6 is a diagram illustrating values obtained by secondarily differentiating the reflectivity of the terahertz wave total reflection surface 14a with respect to the frequency of the terahertz wave for each mixing time according to the second embodiment. 6A is the extreme value of the secondary differential value (however, the mixing time is 30 minutes or 60 minutes), and FIG. 6B is the extreme value of the secondary differential value (however, where (C) in FIG. 6 is the extreme value of the secondary differential value (however, the mixing time is 2 minutes), and (d) in FIG. 6 is the extreme value of the secondary differential value ( However, the mixing time is 5 minutes). However, there is almost no difference in the secondary differential value in the vicinity of 0.53 THz between the mixing time of 30 minutes and the case of 60 minutes.

  Referring to FIG. 6, in the vicinity of the characteristic absorption frequency (0.53 THz) of lactose (predetermined frequency range), the secondary differential value increases as the mixing time elapses from 5 minutes to 10 minutes. It can be seen that after 30 minutes, it becomes almost constant. The fact that the secondary differential value takes a positive value means that the graph showing the reflectance is convex (valley) with the reflectance on the vertical axis and the frequency on the horizontal axis. The fact that the second derivative takes a positive value and increases means that the convex (valley) part is deeper (the absorption of lactose becomes stronger) below the graph showing the reflectance. To do.

  The spectrum recording unit 20e records the derivation result (spectrum) of the spectrum deriving unit 20d. See FIG. 6 for an example of the recorded contents of the spectrum recording unit 20e.

  The characteristic frequency recording unit 20f is the same as in the first embodiment, and records a predetermined frequency region (for example, in the vicinity of 0.53 THz).

  The feature spectrum extraction unit 20g extracts a predetermined frequency domain portion from the derivation result of the spectrum derivation unit 20d. The feature spectrum extraction unit 20g reads a predetermined frequency region from the feature frequency recording unit 20f. The feature spectrum recording unit 20h records the extraction result of the feature spectrum extraction unit 20g.

  FIG. 7 is a conceptual diagram of the extraction result of the feature spectrum extraction unit 20g according to the second embodiment. Since FIG. 7 is a conceptual diagram, the illustrated secondary differential value is a rough value and shows only an approximate tendency.

  As the mixing time of 5 minutes and 10 minutes elapses, the secondary differential value increases, and after the mixing time of 30 minutes, the secondary differential value becomes constant at about 60.

  The spread determination unit 20i determines the spread state of the lubricant based on the change of the extraction result of the feature spectrum extraction unit 20g with respect to the mixing time.

  In the second embodiment, the lubricant is sufficient when the extraction result of the feature spectrum extraction unit 20g shows a constant value or fluctuation within a predetermined range with respect to the mixing time. Judged to have been extended. In the example of FIG. 7, it is determined that the lubricant has spread sufficiently at the time of mixing time = 30 minutes. When the mixing time is less than 30 minutes, it is determined that the lubricant is not sufficiently spread.

  The spread recording unit 20j and the display device 20k are the same as those in the first embodiment, and a description thereof will be omitted.

  The operation of the lubricant spread analyzer 1 according to the second embodiment is the same as that of the first embodiment, and a description thereof is omitted. However, the derivation result of the spectrum deriving unit 20d is a value obtained by second-order differentiation of the reflectance (or absorption rate) with the frequency of the terahertz wave (see FIG. 6), and the extraction result of the feature spectrum extracting unit 20g is illustrated in FIG. I want to be.

  According to the spread analysis apparatus 1 of the lubricant according to the second embodiment, the same effects as in the first embodiment can be obtained. In the second embodiment, it is described as “secondary differentiation”, but may be a first-order differentiation or an n-order differentiation (n is an integer of 1 or more). In addition, the second-order differentiation or the like is described based on the frequency of the terahertz wave, but the second-order differentiation or the like may be performed based on the wavelength or wave number of the terahertz wave without being limited to the frequency of the terahertz wave. That is, first-order or higher differentiation may be performed using a value based on the frequency of the terahertz wave.

Third Embodiment In the lubricant spreading analysis apparatus 1 according to the third embodiment, the spectrum deriving unit 20d has (1) a reflectance by the total reflection surface 14a, and (2) an absorptance by the total reflection surface 14a. (3) The difference from the first embodiment is that a standard deviation of a value obtained by second-order differentiation of the reflectance or absorption rate by the total reflection surface 14a with the frequency of the terahertz wave is derived. In the third embodiment, it is described as “secondary differentiation”, but may be a first-order differentiation or an n-order differentiation (n is an integer of 1 or more). In addition, the second-order differentiation or the like is described based on the frequency of the terahertz wave. That is, first-order or higher differentiation may be performed using a value based on the frequency of the terahertz wave.

  The electromagnetic wave detection device 10 and the powder mixing device 30 in the lubricant spread analysis device 1 according to the third embodiment are the same as described above, and the description thereof is omitted.

  Among the spread determination device 20 in the spread analysis device 1 of the lubricant according to the third embodiment, the AD converter 20a, the reference spectrum recording unit 20b, and the mixing time input unit 20c are the same as described above, and will be described. Omitted.

  The spectrum deriving unit 20d receives the detection result of the electromagnetic wave detector 18 via the AD converter 20a. Based on the detection result of the electromagnetic wave detector 18, the spectrum deriving unit 20 d derives a value based on the reflectance of the terahertz wave by the total reflection surface 14 a in association with the frequency of the terahertz wave and the mixing time.

  However, a plurality of objects to be measured 2 are acquired. The values based on the reflectance are measured for each object 2 to be measured: (1) reflectance by the total reflection surface 14a, (2) absorption by the total reflection surface 14a, and (3) reflection by the total reflection surface 14a. The standard deviation of the value obtained by second-order differentiation of the rate or the absorption rate with the frequency of the terahertz wave.

  The spectrum recording unit 20e records the derivation result (spectrum) of the spectrum deriving unit 20d.

  The characteristic frequency recording unit 20f is the same as in the first embodiment, and records a predetermined frequency region (for example, in the vicinity of 0.53 THz).

  The feature spectrum extraction unit 20g extracts a predetermined frequency domain portion from the derivation result of the spectrum derivation unit 20d. The feature spectrum extraction unit 20g reads a predetermined frequency region from the feature frequency recording unit 20f. The feature spectrum recording unit 20h records the extraction result of the feature spectrum extraction unit 20g.

  FIG. 8 shows a range of values obtained by secondarily differentiating the reflectivity of the total reflection surface 14a of the terahertz wave for each object 2 to be measured in the predetermined frequency region according to the third embodiment by the frequency of the terahertz wave. It is a figure shown for every time. In FIG. 8, a circle mark is given at the center of the range of the secondary differential value. Further, the predetermined frequency region is in the vicinity of 0.53 THz.

  As the mixing time of 0 minutes, 2 minutes, 5 minutes, and 10 minutes elapses, the range of the secondary differential value becomes narrower, and after the mixing time of 30 minutes, the range of the secondary differential value is almost constant. Become. This is because (1) as long as the mixing time is short, the dispersion state of the lubricant on the surface of the lactose particles is large, so the range of the secondary differential value is widened. (2) When the mixing time is long, It means that the range of the second derivative value becomes narrow because the swelling agent spreads sufficiently and the variation in the state of adhesion of the lubricant to the surface of the lactose particles becomes small. The magnitude of the variation is acquired as the magnitude of the standard deviation of the secondary differential value. After the mixing time of 30 minutes, the standard deviation of the secondary differential value is small and almost constant.

  The spread determination unit 20i determines the spread state of the lubricant based on the change of the extraction result of the feature spectrum extraction unit 20g with respect to the mixing time.

  In the third embodiment, the lubricant is sufficient when the extraction result of the feature spectrum extraction unit 20g shows a constant value or fluctuation within a predetermined range with respect to the mixing time. Judged to have been extended. In the example of FIG. 8, it is determined that the lubricant has spread sufficiently at the time of mixing time = 30 minutes. When the mixing time is less than 30 minutes, it is determined that the lubricant is not sufficiently spread.

  The spread recording unit 20j and the display device 20k are the same as those in the first embodiment, and a description thereof will be omitted.

  The operation of the lubricant spread analyzer 1 according to the third embodiment is the same as that of the first embodiment, and a description thereof is omitted. However, the derivation result of the spectrum deriving unit 20d is a standard deviation of reflectance (or absorptance) or a standard deviation of values obtained by second-order differentiation of the reflectance (or absorptance) with the frequency of the terahertz wave.

  According to the spread analysis apparatus 1 of the lubricant according to the third embodiment, the same effects as in the first embodiment can be obtained.

  In the above description, the mixing time is input by the mixing time input unit 20c. However, the rotation time of the powder mixing device 30 (the number of times the container for mixing particles and lubricant is rotated per unit time) may be input by the mixing time input unit 20c. You may make it input mixing time and the rotation speed of the powder mixing apparatus 30 by the mixing time input part 20c. That is, the manufacturing conditions for the particles or the object to be measured may be input.

  Alternatively, the principal component may be obtained by performing principal component analysis on the derived result of the spectrum deriving unit 20d instead of the feature spectrum extracting unit 20g.

  Moreover, said embodiment is realizable as follows. A computer having a CPU, a hard disk, and a medium (floppy (registered trademark) disk, CD-ROM, etc.) reader reads the above-mentioned parts, for example, a medium on which a program for realizing the spread determination device 20 is recorded. Install on the hard disk. Such a method can also realize the above functions.

DESCRIPTION OF SYMBOLS 1 Lubricant spreading analysis apparatus 2 Measured object 10 Electromagnetic wave detection apparatus 11 Measured object acquisition part 13 Measured object arrangement part 15 Measured object discharge part 12 Electromagnetic wave output device 14 Optical element 14a Total reflection surface 14b Incident surface 14c Outgoing surface 16 Pressurizer 18 Electromagnetic wave detector 20 Spread determination device 20a AD converter 20b Reference spectrum recording unit 20c Mixing time input unit 20d Spectrum derivation unit 20e Spectrum recording unit 20f Feature frequency recording unit 20g Feature spectrum extraction unit 20h Feature spectrum recording Section 20i Spreading determination section 20j Spreading recording section 20k Display 30 Powder mixing device

Claims (16)

An apparatus for analyzing the spread state of the lubricant in a measurement object in which particles constituting the tablet and the lubricant are mixed,
An electromagnetic wave output device that outputs electromagnetic waves with a frequency of 20 GHz to 500 THz,
An optical element that has a total reflection surface that totally reflects the electromagnetic wave, and the object to be measured receives an evanescent wave generated from the total reflection surface;
An electromagnetic wave detector for detecting the electromagnetic wave totally reflected by the total reflection surface;
Based on the detection result of the electromagnetic wave detector, the reflectance of the electromagnetic wave by the total reflection surface or the value based on the reflectance is associated with the frequency of the electromagnetic wave and the manufacturing condition of the particle or the object to be measured. A spectrum deriving unit for deriving,
A feature extraction unit that extracts features based on the manufacturing conditions from the derivation result of the spectrum deriving unit;
With
The manufacturing conditions include the number of times that the mixing device for performing the mixing is rotated per unit time.
Lubricant spreading analyzer. A lubricant spreading analysis device according to claim 1,
The feature based on the manufacturing condition is a portion of a predetermined frequency region,
The absorption rate of the electromagnetic wave in the predetermined frequency region of the particle is changed compared to the absorption rate of the electromagnetic wave in a frequency region other than the predetermined frequency region of the particle,
Lubricant spreading analyzer. A lubricant spreading analysis device according to claim 1,
The feature based on the manufacturing condition is a principal component obtained by principal component analysis of the derivation result of the spectrum derivation unit.
Lubricant spreading analyzer. A lubricant spreading analysis device according to claim 1,
The production condition is a mixing time in which the particles and the lubricant are mixed,
The feature based on the manufacturing condition is a portion of a predetermined frequency region,
The absorption rate of the electromagnetic wave in the predetermined frequency region of the particle is changed compared to the absorption rate of the electromagnetic wave in a frequency region other than the predetermined frequency region of the particle,
A lubricant spreading analysis apparatus comprising: a spread determining unit that determines a spread state of the lubricant based on a change of the extraction result of the feature extracting unit with respect to the mixing time. A lubricant spreading analysis device according to claim 1,
The value based on the reflectance is the absorption rate of the electromagnetic wave in the total reflection surface.
Lubricant spreading analyzer. A lubricant spreading analysis device according to claim 1,
The value based on the reflectance is a value obtained by n-order differentiation of the reflectance with a value based on the frequency of the electromagnetic wave, or an absorptivity of the electromagnetic wave at the total reflection surface by n-order differentiation with a value based on the frequency of the electromagnetic wave. And n is an integer of 1 or more.
Lubricant spreading analyzer. A lubricant spreading analysis device according to claim 1,
From the mixture in which the particles and the lubricant are mixed, a plurality of the objects to be measured are obtained,
The values based on the reflectivity are the standard deviation of the reflectivity for the plurality of objects to be measured, the standard deviation of the absorptance on the total reflection surface of the electromagnetic waves for the plurality of objects to be measured, and the reflectivity. A standard deviation of a value obtained by n-order differentiation with a value based on the frequency of the electromagnetic wave, or a standard deviation of a value obtained by performing n-order differentiation of the absorption rate with a value based on the frequency of the electromagnetic wave, wherein n is an integer of 1 or more. is there,
Lubricant spreading analyzer. A lubricant spreading analysis device according to claim 1,
The particles are excipients;
Lubricant spreading analyzer. A spread analysis apparatus for a lubricant according to claim 2,
The absorption rate of the electromagnetic wave in the predetermined frequency region of the particle is higher than the absorption rate of the electromagnetic wave in a frequency region other than the predetermined frequency region of the particle,
Lubricant spreading analyzer. A lubricant spreading analysis device according to claim 1,
The optical element is
An incident surface that receives the electromagnetic wave from the electromagnetic wave output device;
An emission surface from which the electromagnetic wave totally reflected by the total reflection surface is emitted to the air;
Have
The refractive index of the optical element is higher than the refractive index of the air,
Total reflection occurs inside the optical element,
The object to be measured is disposed outside the optical element, and is in contact with the total reflection surface;
Lubricant spreading analyzer. A spread analysis device for a lubricant according to claim 10,
The object to be measured is pressed against the total reflection surface;
Lubricant spreading analyzer. A lubricant spreading analysis device according to claim 1,
A measured object acquisition unit that acquires the measured object from a mixture in which the particles and the lubricant are mixed;
A measured object arrangement part for arranging the measured object on the total reflection surface;
A measured object discharge section for discharging the measured object from the total reflection surface after the detection of the electromagnetic wave;
Lubricant spread analysis device with A spread analysis device for a lubricant according to claim 4,
Based on the result of determination of the spread state by the spread determination unit, the mixing of the particles and the lubricant is stopped.
Lubricant spreading analyzer. An apparatus for determining the spread state of the lubricant in a measurement object in which particles constituting the tablet and the lubricant are mixed, and an electromagnetic wave output device that outputs an electromagnetic wave having a frequency of 20 GHz or more and 500 THz or less, An optical element having a total reflection surface that totally reflects the electromagnetic wave, the object to be measured receiving an evanescent wave generated from the total reflection surface, and an electromagnetic wave detector that detects the electromagnetic wave totally reflected by the total reflection surface; A method for determining the spread state of a lubricant using a lubricant spread analyzer having
Based on the detection result of the electromagnetic wave detector, the reflectance of the electromagnetic wave by the total reflection surface or the value based on the reflectance is associated with the frequency of the electromagnetic wave and the manufacturing condition of the particle or the object to be measured. A spectrum deriving step to derive,
A feature extraction step of extracting features based on the manufacturing conditions from the derivation result of the spectrum derivation step;
With
The manufacturing conditions include the number of times that the mixing device for performing the mixing is rotated per unit time.
Method for determining spread of lubricant. An apparatus for determining the spread state of the lubricant in a measurement object in which particles constituting the tablet and the lubricant are mixed, and an electromagnetic wave output device that outputs an electromagnetic wave having a frequency of 20 GHz or more and 500 THz or less, An optical element having a total reflection surface that totally reflects the electromagnetic wave, the object to be measured receiving an evanescent wave generated from the total reflection surface, and an electromagnetic wave detector that detects the electromagnetic wave totally reflected by the total reflection surface; A program for causing a computer to execute processing for determining a spread state of a lubricant using a lubricant spread analyzer having
Processing to determine the spread state of the lubricant,
Based on the detection result of the electromagnetic wave detector, the reflectance of the electromagnetic wave by the total reflection surface or the value based on the reflectance is associated with the frequency of the electromagnetic wave and the manufacturing condition of the particle or the object to be measured. A spectrum deriving step to derive,
A feature extraction step of extracting features based on the manufacturing conditions from the derivation result of the spectrum derivation step;
With
The manufacturing conditions include the number of times that the mixing device for performing the mixing is rotated per unit time.
program. An apparatus for determining the spread state of the lubricant in a measurement object in which particles constituting the tablet and the lubricant are mixed, and an electromagnetic wave output device that outputs an electromagnetic wave having a frequency of 20 GHz or more and 500 THz or less, An optical element having a total reflection surface that totally reflects the electromagnetic wave, the object to be measured receiving an evanescent wave generated from the total reflection surface, and an electromagnetic wave detector that detects the electromagnetic wave totally reflected by the total reflection surface; A computer-readable recording medium storing a program for causing a computer to execute a process of determining a spread state of the lubricant using a lubricant spread analysis device having
Processing to determine the spread state of the lubricant,
Based on the detection result of the electromagnetic wave detector, the reflectance of the electromagnetic wave by the total reflection surface or the value based on the reflectance is associated with the frequency of the electromagnetic wave and the manufacturing condition of the particle or the object to be measured. A spectrum deriving step to derive,
A feature extraction step of extracting features based on the manufacturing conditions from the derivation result of the spectrum derivation step;
With
The manufacturing conditions include the number of times that the mixing device for performing the mixing is rotated per unit time.
recoding media.

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