JP2019002735A - Solid formulation and inspection method therefor - Google Patents

Abstract

To provide a solid formulation in which degradation of the visibility of a printed image is suppressed, and the presence or absence of a print failure of a coating layer such as a primer coat layer and an overcoat layer can be confirmed, and an inspection method for the solid formulation.SOLUTION: The solid formulation according to the present invention is a solid formulation in which a coating layer 11 is formed at least at a part of a surface. The solid formulation has at least: a coating region A provided with the coating layer 11 transmitting visible light with a wavelength region of 380 nm to 760 nm, and reflecting ultraviolet light with a wavelength region of smaller than 380 nm; and a non-coating region B absorbing the ultraviolet light with a wavelength of smaller than 380 nm, and not provided with the coating layer 11. A difference of gradation values of the non-coating region B and the coating region A when irradiated with visible light having a wavelength region of 380 nm to 760 nm is smaller than 5, and a difference of gradation values of the non-coating region B and the coating region A when irradiated with the ultraviolet light having the wavelength region of smaller than 380 nm is 5 or more.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a solid preparation and an inspection method thereof, and more specifically, it is difficult to identify when irradiated with visible light, and it is possible to inspect for printing defects when irradiated with ultraviolet light. The present invention relates to a solid preparation having a coating layer on the surface and an inspection method thereof.

  Ink-jet inks used for printing images and the like on solid preparations such as tablets must be composed of raw materials that conform to the standards of pharmaceutical additives, Japanese pharmacopoeia or official food additives specified by the Pharmaceutical Affairs Law. As such an ink-jet ink, a pigment (dye) used for coloring is composed of a dye ink dissolved in the ink-jet ink, and a pigment in which powder (pigment) used for coloring is dispersed in the ink-jet ink. Products made of ink are manufactured and sold.

  Compared with pigment ink, dye ink has a problem of fading easily by light irradiation over time. For this reason, pigment inks having excellent light resistance are increasingly used for printing on solid preparations such as tablets.

  However, solid preparations such as FC (film coating) tablets and sugar-coated tablets have a smooth surface compared to other solid preparations, so that the pigment is not sufficiently fixed and peeled off and transferred. is there. Therefore, at present, the conditions under which pigment ink can be used are limited. In order to solve this problem, it is disclosed that a colorless and transparent overcoat layer as a coating layer is provided on an element imaged with pigment ink or the like to prevent the element from peeling off ( See Patent Document 1 below).

  On the other hand, the overcoat layer is formed by printing a pigment ink on a solid preparation. In order to ensure the visibility of the pigment ink layer composed of a dried film of the pigment ink, the overcoat layer has a visible light transmission property and is colorless. It is preferably transparent. When the overcoat layer is colorless and transparent, in a solid preparation, it is difficult to identify a coating region where the overcoat layer is present using an imaging means such as visual observation or a camera. Therefore, there is a problem that it is difficult to inspect the overcoat layer for printing defects.

JP 2002-207275 A

  The present invention has been made in view of the above problems, and its purpose is to suppress a decrease in the visibility of a printed image and to check whether there is a printing defect in a coating layer such as a primer coat layer or an overcoat layer. An object of the present invention is to provide a solid preparation that can be confirmed and an inspection method thereof.

The above problems are solved by the invention described below.
That is, the solid preparation according to the present invention is a solid preparation in which a coating layer is provided on at least a part of the surface in order to solve the above problems, and transmits visible light having a wavelength range of 380 nm to 760 nm. And at least a coating region provided with the coating layer that reflects ultraviolet rays having a wavelength range of less than 380 nm, and a non-coating region that absorbs ultraviolet rays in the wavelength range and is not provided with the coating layer. When the visible light having a wavelength range of 380 nm to 760 nm is irradiated to the coating region and the non-coating region, a difference in gradation value of the coating region with respect to the non-coating region is less than 5, and the coating region and the non-coating region When the region is irradiated with ultraviolet rays in the wavelength range, The difference between the tone value of the route area is 5 or more.

  The conventional overcoat layer has light transmittance in the visible light region having a wavelength range of 380 nm to 760 nm from the viewpoint of ensuring good visibility of the printed image. For this reason, it has been difficult for conventional overcoat layers to detect ejection failures such as missing nozzles and printing failures due to misalignment of the printing position visually or with an imaging means such as a camera. On the other hand, the solid preparation of the present invention has a gradation value difference of less than 5 with respect to the non-coating region when the coating region and the non-coating region are irradiated with visible light in the wavelength region as described above. It is comprised so that it may become. For this reason, the coating region provided with the coating layer is difficult to visually identify under irradiation of visible light in the wavelength range.

  The coating region is a region provided with a coating layer that reflects ultraviolet rays having a wavelength range of less than 380 nm, and the non-coating region is a region that absorbs ultraviolet rays in the wavelength range. Further, when the coating region and the non-coating region are irradiated with ultraviolet rays in the wavelength region, the coating region and the non-coating region have the light reflectivity that the coating region has and the light absorption property that the non-coating region has. The difference of the gradation value of the coating region is configured to be 5 or more. For this reason, the coating layer can be identified under irradiation of ultraviolet rays in the wavelength range, and the presence or absence of printing defects in the coating layer can be inspected.

  Further, in the above configuration, an ink layer is provided at least partly between the surface of the solid preparation and the coating layer, and the coating layer converts the pigment contained in the ink layer into the solid preparation. It may be an overcoat layer that contains at least a pigment fixing component that is fixed to the surface and has light reflectivity with respect to ultraviolet rays in the wavelength range.

  According to the said structure, by providing an ink layer in at least one part between the surface of a solid formulation, and a coating layer, the said coating layer can be functioned as an overcoat layer, and the said ink layer can be coat | covered and protected. Here, since the coating layer as the overcoat layer transmits visible light having a wavelength range of 380 nm to 760 nm, for example, it is possible to suppress the visibility of a printed image formed by the ink layer from being hindered. Moreover, since the coating layer as an overcoat layer protects an ink layer, when it contacts with another solid formulation etc., transfer of the said ink layer can be suppressed. In addition, since the coating layer includes a pigment fixing component that fixes the pigment contained in the ink layer to the surface of the solid preparation, the peeling of the pigment from the surface of the solid preparation can be prevented. Furthermore, since the pigment fixing component has light reflectivity with respect to the ultraviolet ray in the wavelength range, the function of reflecting the ultraviolet ray in the wavelength range can be imparted to the coating layer.

  In the solid preparation, the pigment fixing component is preferably polyvinylpyrrolidone having a number average molecular weight in the range of 2000 to 200000.

  The solid preparation inspection method according to the present invention is a solid preparation inspection method in which a coating layer is provided on at least a part of the surface in order to solve the above-mentioned problems, and the solid preparation has a wavelength range of 380 nm. A coating region provided with the coating layer that transmits visible light of ˜760 nm and reflects ultraviolet rays having a wavelength range of less than 380 nm, and absorbs ultraviolet rays in the wavelength range, and is provided with the coating layer. A non-coating region that is not coated, and a difference in gradation value of the coating region with respect to the non-coating region when the coating region and the non-coating region are irradiated with visible light in the wavelength region is less than 5, In the non-coating region when the coating region and the non-coating region are irradiated with ultraviolet rays in the wavelength region The coating region has a gradation value difference of 5 or more, an irradiation step of irradiating the coating region and the non-coating region with irradiation light including at least ultraviolet rays in the wavelength region, and the irradiation light is the coating Receiving the reflected light reflected by the area and imaging the coating area and the non-coated area, and receiving the reflected light reflected by the coating area, the coated area and the non-coated area And an imaging step of imaging.

  According to the above configuration, the surface of the solid preparation to be imaged is provided with a coating region having a gradation value difference of less than 5 with respect to the non-coating region under irradiation of visible light in the wavelength region. Therefore, it is difficult to visually recognize the coating region by visual observation or imaging means such as a camera under irradiation of visible light in the wavelength range. Moreover, since the coating layer transmits visible light in the above-mentioned wavelength range, for example, when the coating layer is used as an overcoat layer, it is possible to suppress a reduction in the visibility of the printed image.

  The coating region is a region that reflects ultraviolet rays having a wavelength range of less than 380 nm, and the non-coating region is a region that absorbs ultraviolet rays in the wavelength range. When the coating region and the non-coating region are irradiated with light containing ultraviolet rays in the wavelength region, the gradation value difference with respect to the non-coating region is 5 or more. Therefore, in the irradiation step, the coating region and the non-coating region are irradiated with irradiation light including at least ultraviolet rays in the wavelength region, so that at least a part of the irradiation light is reflected by the coating layer in the coating region, and In the non-coating region, at least a part of the irradiation light is absorbed so that the coating layer can be identified (visually recognized). In addition, in the above configuration, the reflected light reflected by the coating region is received, and the coating region and the non-coating region are imaged (imaging process). Thereby, the quality of the printing state of the coating layer can be easily discriminated and inspected, and the yield of the solid preparation can be improved as compared with the prior art.

  In the above configuration, the irradiation step is preferably a step using only ultraviolet rays having a wavelength range of less than 380 nm as the irradiation light. The coating region is a region showing light reflectivity with respect to ultraviolet rays having a wavelength range of less than 380 nm, and the non-coating region is a region showing light absorption with respect to ultraviolet rays in the wavelength range. Therefore, the difference in the gradation value of the coating region with respect to the non-coating region can be maximized by using only the ultraviolet light having a wavelength region of less than 380 nm as the irradiation light used in the irradiation step. As a result, the identification of the coating layer in the solid preparation can be further facilitated, and the inspection accuracy for the presence or absence of printing failure of the coating layer can be further improved.

  In the above configuration, it is preferable that the imaging step is a step of receiving and imaging only the ultraviolet light having a wavelength range of less than 380 nm as the reflected light. As described above, the coating region is a region that exhibits light reflectivity with respect to ultraviolet rays having a wavelength range of less than 380 nm, and the non-coating region is a region that exhibits light absorption with respect to ultraviolet rays in the wavelength range. By receiving only ultraviolet rays having a wavelength range of less than 380 nm, the difference in gradation value of the coating region with respect to the non-coating region can be maximized. As a result, the identification of the coating layer in the solid preparation can be further facilitated, and the inspection accuracy for the presence or absence of printing failure of the coating layer can be further improved.

  In the above-described configuration, an ink layer is provided at least partly between the surface of the solid preparation and the coating layer, and the coating layer applies a pigment contained in the ink layer to the surface of the solid preparation. It may be an overcoat layer containing at least a pigment fixing component which is fixed to the light and has light reflectivity with respect to ultraviolet rays in the wavelength range.

  According to the above configuration, by providing an ink layer at least partly between the surface of the solid preparation and the coating layer, the coating layer can function as an overcoat layer, and the ink layer can be covered and protected. . Here, since the coating layer as the overcoat layer transmits visible light having a wavelength range of 380 nm to 760 nm, for example, it is possible to suppress the visibility of a printed image formed by the ink layer from being hindered. Moreover, since the coating layer as an overcoat layer protects an ink layer, when it contacts with another solid formulation etc., transfer of the said ink layer can be suppressed. Further, since the coating layer has a pigment fixing component that fixes the pigment contained in the ink layer on the surface of the solid preparation, it is possible to prevent peeling of the pigment from the surface of the solid preparation. Furthermore, since the pigment fixing component has light reflectivity with respect to the ultraviolet ray in the wavelength range, the function of reflecting the ultraviolet ray in the wavelength range can be imparted to the coating layer.

  Furthermore, in the said structure, it is preferable that the said pigment fixing component is polyvinyl pyrrolidone in the range of the number average molecular weight 2000-200000.

The present invention has the following effects by the means described above.
That is, according to the solid preparation of the present invention, the coating region where the coating layer is provided and the non-coating region where the coating layer is not provided are irradiated with visible light (380 nm to 760 nm) in the coating region and the non-coating region. When irradiated, the difference of the gradation value of the coating region with respect to the non-coating region is configured to be less than 5. Therefore, in the solid preparation of the present invention, it is difficult to visually recognize (identify) the coating layer by visual observation or imaging means such as a camera under visible light irradiation. The coating region is a region provided with a coating layer that absorbs ultraviolet rays having a wavelength region of less than 380 nm, and the non-coating region is a region that absorbs ultraviolet rays in the wavelength region. The coating area is configured such that when the coating area and the non-coating area are irradiated with ultraviolet rays, the gradation value difference with respect to the non-coating area is 5 or more. Therefore, according to the present invention, it is possible to identify a coating region by irradiation with ultraviolet rays in the wavelength range, and it is possible to provide a solid preparation capable of inspecting whether there is a printing defect in the coating layer.

  Further, according to the method for inspecting a solid preparation according to the present invention, under the visible light, the coating region and the non-coating region of the solid preparation are irradiated with irradiation light containing at least ultraviolet light in the wavelength range. A coating layer that is difficult to identify (visually) by visual observation or imaging means such as a camera is made identifiable, and then the reflected light reflected by the coating region is received to image the coating region and the non-coating region. is there. As a result, it is possible to easily determine and inspect whether the coating layer is properly printed on the solid preparation, and it is possible to provide a solid preparation that suppresses a decrease in yield due to printing failure of the coating layer. .

It is explanatory drawing which represents typically the solid formulation which concerns on one Embodiment of this invention. It is a schematic diagram showing the outline of the imaging device used for the inspection method of a solid formulation.

(Solid preparation)
The solid preparation according to the present embodiment will be described below with reference to FIG. FIG. 1 is an explanatory view schematically showing a solid preparation according to the present embodiment.

  As shown in FIG. 1, the solid preparation 10 of the present embodiment is provided with a coating layer 11 on at least a part of its surface. And the solid formulation 10 of this Embodiment has at least the coating area | region A in which the coating layer 11 is provided, and the non-coating area | region B in which the coating layer 11 is not provided.

  In the present specification, “solid preparation” means food preparations and pharmaceutical preparations. Examples of solid preparations include OD (orally disintegrating) tablets, plain tablets, FC tablets, sugar-coated tablets and the like. A tablet or a capsule is mentioned. The solid preparation may be used for pharmaceuticals or food. Examples of tablets for food use include health foods such as tablet confectionery and supplements. Among solid preparations, the tablet is solid at room temperature, and for example, a tablet prepared by compressing and / or molding a tablet material containing an active ingredient into a certain shape is preferable. The shape of the tablet is not particularly limited, and any shape can be adopted.

<Coating area>
The coating region A is a region where the coating layer 11 showing light reflectivity is provided for ultraviolet rays having a wavelength range of less than 380 nm. Therefore, when the coating region A is irradiated with light containing ultraviolet rays in the wavelength range, at least ultraviolet rays in the wavelength range are reflected. The wavelength range is more preferably in the range of 260 nm to less than 380 nm, and particularly preferably in the range of 280 nm to 360 nm. Moreover, the coating layer 11 has a light transmittance with respect to visible light within a wavelength range of 380 nm to 760 nm. Therefore, when visible light in the wavelength region is irradiated to the coating region A, at least a part of the irradiated visible light in the wavelength region is transmitted due to the light transmittance of the coating layer 11.

  In the present specification, “light reflectivity” means a property of reflecting at least a part of the incident ultraviolet ray in the wavelength range. Further, in this specification, “light transmission” means a property of transmitting at least a part of incident visible light in the wavelength range. In addition, the light transmissivity means that the coating layer 11 is colored as well as colored.

  The coating layer 11 is edible and is preferably composed of a dry film of an aqueous inkjet coating liquid (details will be described later). The dry film can be formed by printing directly on the surface of the solid preparation 10 by using, for example, an ink jet method or the like, using the aqueous coating liquid for ink jet. In the present specification, “edible” means a product that complies with the standards of pharmaceutical additives, Japanese pharmacopoeia or official food additives specified by the Pharmaceutical Affairs Law. It means a system in which a coating composition is ejected as droplets from a fine ink jet head, the droplets are fixed on a solid preparation, and an image is formed.

  Moreover, as the coating layer 11, what functions as an overcoat layer (protective layer) is preferable. In this case, the coating layer 11 is provided so as to cover an ink layer (not shown) that forms a printed image. By covering the ink layer as the overcoat layer, it is possible to protect the printed image. As a result, it is possible to prevent the print image from being transferred to the contact object due to the printing surface coming into contact with the contact object and the image quality from being deteriorated. In addition, the coating layer 11 can protect the printed image, for example, can impart thermal stability, light stability, scratch resistance, and wear resistance (or friction resistance).

  Further, when the coating layer 11 is used as an overcoat layer, the coating layer 11 is composed of a dry film of an aqueous coating liquid for inkjet including a water-soluble pigment fixing component (details will be described later). Is preferably fixed to the solid preparation 10. By including the pigment fixing component in the aqueous coating liquid for inkjet, it is possible to improve the fixing performance of the pigment on the surface of the solid preparation. Since the solid preparation is soluble in water, the pigment fixing component can be permeated into the solid preparation by bringing the aqueous coating liquid for inkjet containing the pigment fixing component into contact with the surface of the solid preparation.

  Here, the reason why the pigment fixing component contained in the coating layer 11 improves the fixing performance of the pigment on the surface of the solid preparation 10 is considered to be as follows. That is, first, by drying the pigment fixing component that has penetrated into the solid preparation 10, the mechanical strength of the surface layer portion of the solid preparation 10 (the portion where the pigment fixing component has penetrated into the solid preparation 10) can be improved. That's it. Thereby, even if the solid preparation 10 receives an external force such as an impact, it is possible to suppress the pigment from being scraped off along with the surface layer portion of the solid preparation 10, and to reduce the transfer of the pigment to other solid preparations. For example, when the solid preparation 10 is fragile to an external force and the surface thereof is easily scraped, the transfer of the pigment is caused by the peeling of the surface layer portion of the solid preparation 10 even if the pigment itself is firmly fixed to the surface of the solid preparation 10. Can occur. The pigment fixing component of the present invention can prevent the transfer of the pigment even for such a solid preparation 10 by improving the mechanical strength of the surface layer portion.

  The second is that the pigment fixing component functions as an adhesive that firmly fixes the pigment to the surface of the solid formulation 10 by drying the pigment fixing component that has penetrated into the solid formulation 10. Thereby, it can prevent that a pigment peels from the solid formulation 10 surface.

  Third, when the pigment fixing component is dried in a state where the pigment on the solid preparation 10 is coated, the dried film functions as an overcoat layer. Thereby, even if other solid preparations contact the pigment fixed on the surface of the solid preparation 10, the transfer of the pigment can be suppressed.

  Therefore, the coating layer 11 having the above-described structure includes a pigment fixing component, thereby improving the mechanical strength of the surface layer portion of the solid preparation 10, adhering the pigment to the surface of the solid preparation 10, and further covering the pigment as an overcoat layer Therefore, the scratch resistance and peel resistance of the printed image can be improved.

  Moreover, when the coating layer 11 is an overcoat layer, it is preferable that the coating layer 11 has a colorless light transmittance with respect to the visible light of the said wavelength range. Thereby, it can suppress that visibility when a printed image is observed through the coating layer 11 falls. However, the present invention does not prevent the coating layer 11 from having colored light transmission for color correction or other special purposes as long as the visibility of the printed image is not adversely affected.

  The thickness of the coating layer 11 (after dry coating) as the overcoat layer may be appropriately set in consideration of the composition of the aqueous coating liquid for inkjet, the required protective performance of the printed image, and the like, and is not particularly limited. Usually, the thickness of the coating layer 11 is in the range of 0.03 μm to 5 μm, preferably 0.05 μm to 3 μm, more preferably 0.1 μm to 1 μm. By setting the thickness of the coating layer 11 to 0.03 μm or more, it is possible to impart scratch resistance and abrasion resistance to the printed image. On the other hand, by setting the thickness of the coating layer 11 to 5 μm or less, it is possible to suppress poor drying of the coating layer composed of droplets of the aqueous inkjet coating liquid and a decrease in the visibility of the printed image.

  The coating layer 11 may be used as a primer coat layer (primer layer). In this case, the coating layer 11 is provided on the surface of the solid preparation. Further, an ink layer is provided on the coating layer 11. By providing the primer coat layer, the adhesion and adhesion between the solid preparation 10 and the ink layer can be improved. As a result, it is possible to reduce the separation of the ink layer in the solid preparation 10 and to suppress the deterioration of the image quality of the ink layer. The thickness of the primer coat layer (after dry coating) may be set as appropriate in consideration of the composition of the coating solution and the required adhesion performance, and is not particularly limited. Usually, the thickness of the primer coat layer is in the range of 0.03 μm to 5 μm, preferably 0.05 μm to 3 μm, more preferably 0.1 μm to 1 μm.

  The ink layer is made of a dry film of an aqueous inkjet ink containing an edible pigment. The ink layer can be formed by directly printing an aqueous inkjet ink on the surface of the solid preparation 10 by a conventionally known method such as an inkjet method. The thickness of the ink layer (after dry coating) is not particularly limited and can be set as necessary.

  Examples of edible pigments include carbon black, yellow iron oxide, yellow iron sesquioxide, iron sesquioxide, bengara or black that comply with the standards of pharmaceutical additives stipulated by the Pharmaceutical Affairs Law, the Japanese Pharmacopoeia or the Food Additives Official Regulations. Examples include iron oxides such as iron oxide, edible red No. 2, edible red No. 3, edible red No. 40, edible yellow No. 4, edible yellow No. 5, edible blue No. 1 or edible blue No. 2, etc. .

  The ink-jet water-based ink is not particularly limited as long as it complies with the standards of pharmaceutical additives, Japanese pharmacopoeia, or food additives official regulations specified by the Pharmaceutical Affairs Law and includes an aqueous pigment composition containing the pigment. Not.

<Uncoated area>
The non-coating region B is a region that absorbs ultraviolet rays when irradiated with light containing at least ultraviolet rays having a wavelength region of less than 380 nm. In this embodiment, the coating layer 11 is not provided. It is.

In order for the non-coating region B to have light absorptivity with respect to ultraviolet rays in the wavelength range, for example, it is preferable to use a solid preparation 10 itself containing an ultraviolet absorbing component. Examples of the ultraviolet absorbing component include titanium dioxide (TiO ₂ ) or zinc oxide (ZnO). These ultraviolet absorbing components can be used alone or in combination. As an example of what the ultraviolet-ray absorptive part is contained in the solid formulation 10 itself, the sugar-coated tablet etc. which contain titanium dioxide as an ultraviolet-absorbing component are mentioned, for example. Further, when the solid preparation 10 itself does not contain the ultraviolet absorbing component or the solid preparation 10 itself contains a component that reflects ultraviolet rays, the solid preparation 10 includes an ultraviolet absorbing layer containing the ultraviolet absorbing component. By providing on the surface, the non-coating region B can be formed. Alternatively, the non-coating region B can be formed by making the reflection wavelength of the coating layer 11 with respect to the ultraviolet rays different from the reflection wavelength of the solid preparation 10 with respect to the ultraviolet rays. In the present specification, “light absorption” means a property of absorbing at least a part of incident ultraviolet rays in the wavelength range.

<Difference in gradation value between coated area and non-coated area>
The difference in the gradation value of the coating region A with respect to the non-coating region B when the visible light in the wavelength region is simultaneously irradiated to the coating region A and the non-coating region B is less than 5. By making the difference between the gradation values less than 5, it is possible to make it difficult or reduced to identify the coating layer 11 by visual observation or imaging means such as a camera under visible light irradiation.

  Further, when the coating region A and the non-coating region B are simultaneously irradiated with the ultraviolet rays in the wavelength region, the difference in gradation value of the coating region A with respect to the non-coating region B is 5 or more. By setting the gradation value difference to 5 or more, the coating layer 11 can be identified under ultraviolet irradiation, and the presence or absence of printing defects in the coating layer 11 can be inspected.

  In this specification, the “gradation value” is a value representing the density of a captured image, and is an 8-bit gradation value (from 0 to 255) obtained by converting image data into a gray scale. Of 256 levels). Further, in this specification, the “gradation value difference” means a value obtained by subtracting the average value of the gradation values of the non-coating region B from the average value of the gradation values of the coating region A. Further, the average value of gradation values means the average value of gradation values of a plurality of pixels in the image data of the coating area A or the non-coating area B.

  The average value of the gradation values in the coating area A and the non-coating area B when the irradiation light is irradiated can be controlled by adjusting the light intensity of the irradiation light, for example. Specifically, by appropriately controlling the light intensity of the irradiation light, the difference between the gradation values of the coating area A and the non-coating area B is maximized, thereby enabling clearer imaging. For example, since the light intensity of the light source of the irradiated light is too weak, the average value of the gradation values of the coating area A and the non-coating area B is both small and the difference is small, the light intensity of the light source is increased. This makes it possible to increase the difference in gradation values. Also, if the light intensity of the light source is too high, the image is overexposed and the average value of the gradation values of the coating area A and the non-coating area B is both large and the difference is large, the light intensity of the light source By reducing the value, it becomes possible to increase the difference in gradation values. Further, the difference in the gradation value of the coating region A with respect to the non-coating region B can be controlled by an optimal combination of at least the wavelength of ultraviolet rays contained in the irradiation light in addition to the light intensity of the irradiation light. Alternatively, by adjusting the concentration of the light-reflecting component contained in the coating layer 11, the ultraviolet reflectivity in the coating region A is improved or decreased, and the difference in the gradation value of the coating region A relative to the non-coating region B is increased. You may control.

<Water-based coating liquid for inkjet>
Next, as a constituent material of the coating layer 11 that forms the coating region A, an aqueous coating liquid for ink jet (hereinafter referred to as “aqueous coating liquid”) according to the present embodiment will be described below. The aqueous coating liquid of the present embodiment contains an aqueous inkjet coating composition (hereinafter referred to as “aqueous coating composition”). In the following, the aqueous coating composition includes at least a pigment fixing component and water,
An aqueous coating composition having a function of fixing the pigment contained in the ink layer to the solid preparation by overcoating the ink layer will be described as an example.

  The aqueous coating composition of the present embodiment is edible by using a material that complies with the standards of pharmaceutical additives, Japanese Pharmacopoeia or Food Additives specified by the Pharmaceutical Affairs Law. And can be made suitable for use in solid preparations comprising tablets or capsules of foods and the like.

  Moreover, the aqueous coating composition of this Embodiment has the light transmittance in visible region (380 nm-760 nm). Thereby, when a coating layer is formed using the aqueous coating liquid containing the said aqueous coating composition, the light transmittance with respect to the visible light of the said coating layer can be provided. In addition, the light transmittance which an aqueous | water-based coating composition has may be colored other than the case where it is colorless.

  The pigment fixing component contributes to fixing of the pigment in the printed image printed on the surface of the solid preparation, and has water solubility and edibility.

  As used herein, “water-soluble” refers to a case where 1 g or more dissolves in 100 g of water at room temperature and normal pressure.

  Further, the “normal temperature” means that the temperature is in the range of 5 ° C. to 35 ° C. Further, the “normal pressure” means a pressure (standard atmospheric pressure) in the vicinity of the standard state of the atmosphere. The standard state of the atmosphere is a temperature of about 25 ° C. and an absolute pressure of about 101 kPa. It means atmospheric pressure conditions. Further, the “normal pressure” may include a slightly positive pressure or a negative pressure with respect to the standard atmospheric pressure.

  The pigment fixing component is not particularly limited as long as it has water-solubility and edible properties, but imparts light reflectivity to the coating layer 11 by reflecting at least part of ultraviolet rays having a wavelength range of less than 380 nm. It is preferable that Examples of such a pigment fixing component include polyvinyl pyrrolidone. Polyvinylpyrrolidone is a water-soluble polymer and corresponds to a pharmaceutical additive defined by the Pharmaceutical Affairs Law. Polyvinylpyrrolidone imparts adhesion (wetability) and film-forming properties to pigments and the like to the coating layer 11. Polyvinyl pyrrolidone also functions as a light reflective component that exhibits light reflectivity with respect to ultraviolet rays in the wavelength range.

  The number average molecular weight of polyvinylpyrrolidone is preferably in the range of 2,000 to 200,000, more preferably 10,000 to 16,000, and still more preferably 20,000 to 50,000. By setting the number average molecular weight of polyvinylpyrrolidone to 2000 or more, it becomes possible to exist in a solid form alone at normal temperature and pressure. Moreover, even when it is in a solid form alone at normal temperature and pressure, it is possible to prevent the hardness of the dried film after printing from becoming insufficient due to drying conditions and the like. On the other hand, by setting the number average molecular weight of polyvinylpyrrolidone to 200,000 or less, the viscosity of the aqueous coating composition is excessively increased and the viscosity greatly deviates from the state of Newtonian, and the flying property of the droplets of the aqueous coating composition is increased. Can be prevented from decreasing.

  The number average molecular weight can be determined by polystyrene conversion by gel permeation chromatography (GPC). For example, in the measurement using LC-6A manufactured by Shimadzu Corporation, the separation column Polymer Laboratories PL gel 5 μm MIXED-C: solvent, dimethylformamide (0.01 mol LiBr added): column flow rate 1.0 ml / min: column temperature 50 ° C. : It can be measured using a RI detector under the condition of a sample concentration of 0.2% (W / V).

  The content of the pigment fixing component can be appropriately set according to the type of the pigment fixing component. For example, when the polyvinyl pyrrolidone is used as a pigment fixing component, the lower limit of the content is preferably 1% by mass or more, more preferably 2% by mass or more, particularly preferably the total mass of the aqueous coating composition. Preferably it is 5 mass% or more. Moreover, it is preferable that the upper limit of content of polyvinylpyrrolidone is 20 mass% or less with respect to the total mass of an aqueous coating composition, More preferably, it is 15 mass% or less, Most preferably, it is 10 mass% or less. By setting the lower limit of the content of polyvinylpyrrolidone to 1% by mass or more, it is possible to maintain the fixability of the pigment, and it is possible to suppress a decrease in scratch resistance and peel resistance of the printed image. On the other hand, by setting the upper limit of the content of polyvinylpyrrolidone to 20% by mass or less, the viscosity of the aqueous coating composition increases excessively, and the viscosity greatly deviates from the Newtonian state. It is possible to prevent the drop flying performance from being lowered.

  As water contained in the aqueous coating composition of the present embodiment, water from which ionic impurities such as ion-exchanged water, ultrafiltered water, reverse osmosis water, distilled water, or ultrapure water have been removed. It is preferable to use it. In particular, water sterilized by ultraviolet irradiation or the like is preferable because generation of mold and bacteria can be prevented over a long period of time. Moreover, it does not specifically limit as content of water, It can set suitably as needed.

  The aqueous coating composition of the present embodiment preferably contains no water-insoluble components and is water-soluble. Thereby, the aqueous coating composition of the present embodiment can penetrate into a solid preparation when the aqueous coating composition is in a liquid state before drying.

  Here, in the present specification, “water-insoluble” means substantially insoluble in water, and more specifically, the solubility under normal temperature and normal pressure is less than 1 g with respect to 100 g of water. Say something. Furthermore, the “water-insoluble component” means a component having such water-insolubility, and specifically includes a polymer emulsion and the like. Furthermore, examples of the polymer emulsion include polymers such as methacrylic acid, methyl methacrylate, butyl methacrylate, dimethylaminomethyl methacrylate, ethyl acrylate, and trimethylammonium ethyl methacrylate, and copolymers thereof. Commercially available polymer emulsions include Eudragit E100 (aminoalkyl methacrylate copolymer E), Eudragit EPO (aminoalkyl methacrylate copolymer E), Eudragit L100 (methacrylic acid copolymer L), Eudragit L30D-55 (methacrylic acid copolymer LD). Eudragit L100-55 (dry methacrylic acid copolymer LD), Eudragit S100 (methacrylic acid copolymer S), Eudragit RL100 (ammonioalkyl methacrylate copolymer), Eudragit RLPO (ammonioalkyl methacrylate copolymer), Eudragit RL30D (ammonioalkyl methacrylate copolymer) Dispersion), Eudragit RS100 (A Monioalkyl methacrylate copolymer), Eudragit RSPO (ammonioalkyl methacrylate copolymer), Eudragit RS30D (ammonioalkyl methacrylate copolymer dispersion), Eudragit NE30D (ethyl acrylate / methyl methacrylate copolymer dispersion), Eudragit FS30D (methyl acrylate, methyl acrylate) Examples thereof include methyl methacrylate / methacrylic acid copolymer). All of these commercially available products are manufactured by Evonik, and Eudragit is a registered trademark. Further, the “normal temperature” means that the temperature is in the range of 5 ° C. to 35 ° C.

  Further, the aqueous coating composition of the present embodiment may contain a surface tension adjusting agent as necessary. The surface tension modifier is not particularly limited as long as it conforms to the standards of pharmaceutical additives, Japanese pharmacopoeia or official food additives specified by the Pharmaceutical Affairs Law. For example, decaglyceryl caprylate, hexaglycerin laurate Oleic acid hexaglycerin ester, condensed linolenic acid tetraglycerin ester, fatty acid ester palm palm, HLB of 15 or less lauric acid decaglyceryl, HLB of less than 13 oleic acid decaglyceryl and the like. You may use these individually by 1 type or in mixture of 2 or more types.

A commercially available product can be used as the decaglyceryl caprylate, and examples of such a commercially available product include Ryoto (registered trademark) polyglycerate CE19D (trade name, manufactured by Mitsubishi Chemical Foods Co., Ltd., HLB). Value 15), SY glister MCA750 (trade name, manufactured by Sakamoto Pharmaceutical Co., Ltd., HLB value 16), and the like.
The HLB value is an HLB value according to the Griffin method and means a value obtained by the following equation.
HLB value = 20 × (sum of formula weight of hydrophilic group / molecular weight)
The HLB value is a value in the range of 0 to 20. The larger the HLB value, the stronger the hydrophilicity, and the smaller the HLB value, the stronger the hydrophobicity.

  As said decaglyceryl laurate, that whose HLB is 15 or less can be used. When the decaglyceryl laurate has an HLB of more than 15, the ejection stability is lowered, for example, the occurrence of fading due to clogging of the nozzles of the inkjet head. The lower limit of HLB is preferably 10 or more from the viewpoint of solubility in an aqueous solvent. In addition, as decaglyceryl laurate having an HLB of 15 or less, a commercially available product can be used. As such a commercially available product, for example, NIKKOL (registered trademark) DECAGLYN 1-L (trade name, Nikko Chemicals ( Co., Ltd., HLB value 14.5), SY Glister ML-750 (trade name, manufactured by Sakamoto Pharmaceutical Co., Ltd., HLB value 14.8), and the like.

  As said decaglyceryl oleate, that whose HLB is less than 13 can be used. When the HLB is 13 or more, the ejection stability is deteriorated, such as blurring due to clogging of the nozzles of the inkjet head. In addition, it is preferable that the minimum of HLB is 10 or more from a viewpoint of the solubility with respect to a water solvent. In addition, as decaglyceryl oleate having an HLB of less than 13, a commercially available product can be used. As such a commercially available product, for example, NIKKOL (registered trademark) DECAGLYN 1-OV (trade name, Nikko Chemicals ( Co., Ltd., HLB value 12), SY glister MO-7S (trade name, manufactured by Sakamoto Pharmaceutical Co., Ltd., HLB value 12.9), and the like.

  As the lauric acid hexaglycerin ester, a commercially available product can be used, and as such a commercially available product, for example, NIKKOL (registered trademark) HEXAGLYN 1-L (trade name, manufactured by Nikko Chemicals Co., Ltd., HLB) Value 14.5), SY Glister ML-500 (trade name, manufactured by Sakamoto Pharmaceutical Co., Ltd., HLB value 13.5), and the like.

  Commercially available products can be used as the oleic acid hexaglycerin ester. Examples of such commercially available products include SY Glyster MO-5S (trade name, manufactured by Sakamoto Pharmaceutical Co., Ltd., HLB value 11. 6) and the like.

  Commercially available products can be used as the condensed linolenic acid tetraglycerin ester. Examples of such commercially available products include SY Glyster CR-310 (trade name, manufactured by Sakamoto Pharmaceutical Co., Ltd.). It is done.

  A commercially available product can be used as the fatty acid ester palm palm. Examples of such a commercially available product include Tirabazole W-01 (trade name, manufactured by Taiyo Kagaku Co., Ltd.).

  The content of the surface tension adjusting agent is preferably in the range of 0.5% by mass to 5% by mass, and preferably in the range of 1% by mass to 3% by mass with respect to the total mass of the aqueous coating composition. Is more preferable. When the content of the surface tension adjusting agent is 0.5% by mass or more, when printing is performed by an inkjet method, ejection failure due to poor meniscus surface formation at the nozzle in the inkjet head is prevented, and the nozzle Can be prevented from occurring. As a result, the discharge stability can be improved. On the other hand, when the content of the surface tension adjusting agent is 5% by mass or less, it is possible to prevent an adverse effect on discharge due to insoluble matter or poor emulsification of the surface tension adjusting agent.

  Moreover, the other additive may be mix | blended with the aqueous coating composition of this Embodiment. However, other additives are within the range that does not impede the solution of the problems of the present invention, and are compatible with the standards of pharmaceutical additives, Japanese pharmacopoeia or official food additives specified by the Pharmaceutical Affairs Law. Cost. Examples of such other additives include surfactants, viscosity modifiers, preservatives, lubricants, foaming agents, viscosity modifiers, antifoaming agents, and the like. The content of these other additives is not particularly limited, and can be appropriately set as necessary.

  The viscosity of the aqueous coating composition is preferably 2 mPa · s to 7 mPa · s, more preferably 3 mPa · s to 5 mPa · s when discharging the ink jet nozzle in consideration of ejection stability from the ink jet nozzle. By setting the viscosity of the aqueous coating composition within the above numerical range, the occurrence of clogging at the ink jet nozzle can be suppressed, good discharge stability can be maintained, and the decrease in flightability can be suppressed. The viscosity of the aqueous coating composition can be obtained, for example, by measuring using a viscometer (trade name: VISCOMATE MODEL VM-10A, manufactured by Seconic Corporation) at a measurement temperature of 25 ° C.

  The aqueous coating composition of the present embodiment can be produced by mixing the aforementioned components by an appropriate method. The mixing method and addition order of each component are not particularly limited. After mixing, the mixture is sufficiently stirred, and if necessary, filtration is performed to remove coarse particles and foreign matters that cause clogging. Thereby, the aqueous coating composition which concerns on this Embodiment can be obtained.

  In addition, it does not specifically limit as a mixing method of each material, For example, it stirs and mixes by adding a material sequentially to the container provided with stirring apparatuses, such as a mechanical stirrer and a magnetic stirrer. Moreover, it does not specifically limit as a filtration method, For example, well-known natural filtration, pressure filtration, reduced pressure filtration, centrifugal filtration etc. are employable.

  In addition, the aqueous coating composition of the present embodiment uses an edible pigment fixing component that complies with the standards of pharmaceutical additives, Japanese Pharmacopoeia or the Food Additives Standards defined by the Pharmaceutical Affairs Law, etc. It can be applied directly on a printed image of a solid agent comprising tablets or capsules such as pharmaceuticals or supplements.

  In the above embodiment, the case where the pigment fixing component functions as a light reflecting component has been described as an example. However, the present invention is not limited to this embodiment. For example, a light reflective component as a third component different from the pigment fixing component may be contained in the aqueous coating composition.

<Printing method of coating layer>
The method for forming the coating layer 11 on the surface of the solid preparation 10 is not particularly limited, and examples thereof include a method of printing by an inkjet method using an aqueous coating solution containing the aqueous coating composition.

  The ink jet printing method for the surface of the solid preparation is not particularly limited. Specifically, for example, the aqueous coating liquid is discharged as droplets from a fine nozzle, and the droplets adhere to the tablet surface. The discharge method is not particularly limited, and for example, a known method such as a continuous injection type (charge control type, spray type, etc.), an on-demand type (piezo type, thermal type, electrostatic suction type, etc.) can be employed. .

  The discharge amount of the aqueous coating liquid can be appropriately set in consideration of the degree of penetration of the pigment fixing liquid into the solid preparation, the layer thickness of the overcoat layer, the printing speed, the drying time, and the like. Usually, it is in the range of 1 pl to 30 pl, preferably 2 pl to 20 pl, more preferably 3 pl to 10 pl.

  Next, the coating layer 11 is formed by drying the coating layer composed of droplets of the aqueous coating liquid attached to the surface of the solid preparation. The drying method is not particularly limited, and natural drying, hot air drying, infrared drying, and the like can be performed. Moreover, it does not specifically limit about drying conditions, such as drying time and drying temperature, According to the discharge amount of the said aqueous coating liquid, the kind of said aqueous coating composition, etc., it can set suitably. In addition, since the water-based coating composition of the present embodiment does not substantially contain a water-insoluble component, even if the water-based coating liquid composed of the water-based coating composition is dried and fixed on the end face or the like of the inkjet head, It can be easily removed with an aqueous cleaning solution or the like.

  Moreover, when the coating layer 11 is an overcoat layer which coat | covers the said ink layer, formation of the coating layer 11 is printed by the method similar to the above using the said aqueous coating liquid after the printing of the said ink layer. Done.

(Inspection method for solid preparations)
Next, a method for inspecting a solid preparation according to the present embodiment will be described below with reference to FIG.
The inspection method for the solid preparation 10 of the present embodiment includes at least an irradiation step, an imaging step, and an inspection step.

  The irradiation step is a step of irradiating the coating region A and the non-coating region B with irradiation light including at least ultraviolet rays having a wavelength range of less than 380 nm. In the coating region A, at least a part of the ultraviolet light in the wavelength region included in the irradiation light is reflected in the coating region A due to the light reflectivity of the coating layer 11 by irradiation with the irradiation light including the ultraviolet light in the wavelength region. In the non-coating region B, at least a part of the ultraviolet rays in the wavelength region included in the irradiation light is absorbed by the light absorption property of the solid preparation 10. Thereby, in the coating area A, the difference of the gradation value with respect to the non-coating area B becomes 5 or more, and the coating layer 11 is made identifiable.

  Here, as the irradiation light, it is preferable to irradiate only ultraviolet rays in the wavelength range. Since the coating layer 11 reflects ultraviolet rays having a wavelength range of less than 380 nm, and the non-coating region B absorbs the ultraviolet rays, the irradiation light used in the irradiation process is only ultraviolet rays in the wavelength range. By doing so, it is possible to prevent light in other wavelength ranges such as visible light and infrared light from being imaged in the imaging process. That is, by irradiating only the ultraviolet rays in the wavelength region, the difference in the gradation value of the coating region A with respect to the non-coating region B can be further increased, and imaging with a better contrast is possible.

In addition, the wavelength range of the ultraviolet rays contained in the irradiation light may be in the range of less than 380 nm, and the wavelength range of the ultraviolet rays can be appropriately set according to the type of the ultraviolet absorbing component contained in the coating layer 11. . Further, the illuminance of the irradiation light is not particularly limited, usually in the range of ^{1000μW / m 2 ~50000μW / m 2} , preferably ^{5000μW / m 2 ~30000μW / m 2} , more preferably 10000μW ^{/ m} 2 ~ 20000 μW / m ² . By setting the illuminance of the irradiation light to 1000 μW / m ² or more, the absolute amount of received light in the imaging process is insufficient, and there is no difference in brightness, so that it is possible to prevent an image from being captured in a black-black state. . On the other hand, by setting the illuminance of the irradiated light to 50000 μW / m ² or less, it is possible to prevent an image from being captured in a single white color with no brightness difference. Furthermore, the irradiation angle with respect to the solid formulation 10 of irradiation light is not specifically limited, It can set suitably. The “irradiation angle” means an angle formed by the irradiation direction of irradiation light irradiated on the solid preparation 10 and a horizontal plane on which the solid preparation 10 is placed.

  The imaging step is a step of receiving the reflected light reflected by the coating light A and the non-coating region B and imaging the coating region A and the non-coating region B. Compared with the non-coating region B, the coating region A reflects a larger amount of ultraviolet light in the wavelength region, so that a difference in gradation value occurs between the coating region A and the non-coating region B in the imaging. Based on the difference in the gradation value of the coating region A with respect to the non-coating region B, it is possible to inspect whether or not the coating layer 11 has a printing defect.

  The light receiving conditions are preferably set so as to show the maximum sensitivity with respect to the wavelength range of the irradiated light. Specifically, it is preferable to set the light receiving conditions so that the wavelength range of light that can be received is at least partially coincident with the wavelength range of irradiation light, and more preferably, the wavelength range of light that can be received is less than 380 nm. Is to set. As a result, the amount of received light is increased, and the coated area A and the non-coated area B can be imaged with good contrast. Note that when the light receiving sensitivity is low or absent with respect to a wavelength region such as reflected light, it may be difficult to image the coating region A and the non-coating region B.

  The light receiving angle when receiving reflected light or the like is not particularly limited, and may be set as appropriate so that the amount of received light such as reflected light is maximized. The “light receiving angle” means an angle formed between a light beam having a maximum light quantity such as reflected light in the coating region A and a normal line to the horizontal plane.

  The inspection step is a step of confirming whether or not there is a printing defect in the coating layer 11 imaged in the imaging step. It does not specifically limit as an inspection method, A conventionally well-known method is employable. For example, the ultraviolet ray in the wavelength region is irradiated and reflected on a coating layer of a solid preparation having no printing defect, and the coating layer is imaged in advance to serve as a reference coating layer. The coating layer of the solid preparation to be inspected (hereinafter referred to as “the coating layer to be inspected”) is irradiated with ultraviolet rays under the same irradiation conditions as the reference coating layer, and under the same imaging conditions as the reference coating layer. Take an image. Thereafter, the imaging data of the reference coating layer and the imaging data of the coating layer to be inspected are compared to determine whether or not there is a printing defect in the coating layer to be inspected.

  In the above description, the case where the irradiation process, the imaging process, and the inspection process are performed after the printing of the coating layer 11 (including the drying process) has been described as an example. However, the present invention is not limited to this embodiment, and a series of steps from the irradiation step to the inspection step is performed after the aqueous coating liquid is applied and the coating layer (coating layer before drying) is formed. You may perform before the drying process of the said application layer. In this case, since the coating layer before drying contains moisture and the like, the reflectance of ultraviolet rays in the wavelength region can be further improved. Therefore, in the case where the inspection process is performed before drying, the difference in the gradation value of the coating area A with respect to the non-coating area B can be increased as compared with the case where the inspection process is performed after drying. As a result, it is possible to further easily identify the coating layer 11 in the solid preparation 10 and further improve the inspection accuracy of the coating layer 11 for the presence of printing defects.

<Imaging device>
Next, an imaging apparatus used for imaging the coating area A and the non-coating area B of the solid preparation 10 will be described below with reference to FIG. FIG. 2 is a schematic diagram showing an outline of an imaging apparatus used in an imaging process in the solid pharmaceutical 10 inspection method.

  As shown in FIG. 2, the imaging device of the present embodiment includes at least a light irradiation unit 21 for irradiating the solid preparation 10 with irradiation light and an imaging unit 22 for imaging the solid preparation 10.

  The light irradiation means 21 is not particularly limited as long as it can irradiate ultraviolet rays having a wavelength range of less than 380 nm. For example, a known one such as an incandescent bulb, a discharge lamp, a light-emitting diode lamp, or sunlight is used. Can do.

  Moreover, when the light irradiation means 21 irradiates light containing visible light etc., and wants to irradiate only the ultraviolet-ray of the said wavelength range with respect to the solid preparation 10, the light (for example, wavelength range other than the said wavelength range) , Visible light, infrared light, etc.) may be irradiated through the first optical filter 23 that blocks or attenuates. Alternatively, the light irradiating means 21 having such a built-in first optical filter 23 may be used.

  The imaging means 22 receives reflected light reflected by the solid preparation 10 by irradiation of irradiation light, and takes images of the coating area A and the non-coating area B. More specifically, the imaging unit 22 may be a conventionally known ultraviolet camera or the like.

  Further, when it is desired to control the wavelength of light received by the image pickup means 22, the image pickup means 22 may receive light via a second optical filter 24 such as a wavelength filter. Thereby, for example, the wavelength range of the received light can be matched with the wavelength range of the irradiation light. It does not specifically limit as the 2nd optical filter 24, For example, the conventionally well-known wavelength filter etc. which can interrupt | block or attenuate visible light, infrared light, etc. are mentioned. Further, as the image pickup means 22, a device incorporating such a second optical filter 24 may be used.

  Hereinafter, preferred embodiments of the present invention will be described in detail by way of example. However, materials, contents, and the like described in the following examples are not intended to limit the scope of the present invention only to those unless otherwise specified. In addition, solid preparations, pigments, and pigment fixing components all conform to the standards of pharmaceutical additives, Japanese pharmacopoeia or official food additives specified by the Pharmaceutical Affairs Law.

(Preparation of aqueous pigment ink composition for inkjet and printing of ink layer)
As shown in Table 1 below, 25% by mass of carbon black as a pigment, 7.5% by mass of polyoxyethylene alkyl ether (manufactured by Nikko Chemicals Co., Ltd.) and 67.5% by mass of ion-exchanged water are prepared as a pigment dispersant. The dispersion was performed at room temperature for 16 hours (dispersion time). As a result, a pigment dispersion solution having a carbon black pigment concentration of 25% by mass was obtained.

  Further, as shown in Table 2 below, the pigment dispersion solution, the surface tension adjusting agent, the wetting agent and the ion exchange water are mixed, and the pigment concentration is 3% by mass, the surface tension adjusting agent concentration is 2% by mass, and the wetting agent concentration is 40%. An aqueous pigment ink composition was prepared so as to have a mass%. Polyglycerin fatty acid ester (trade name: SY Glister, manufactured by Sakamoto Yakuhin Kogyo Co., Ltd.) was used as the surface tension adjusting agent, and propylene glycol was used as the wetting agent.

  The numerical values in Table 1 are mass% values with respect to the total mass of the pigment dispersion solution, and the numerical values in Table 2 are mass% values with respect to the total mass of the aqueous pigment ink composition unless otherwise specified. is there. Each material complies with the standards of pharmaceutical additives, Japanese pharmacopoeia or official food additives specified by the Pharmaceutical Affairs Law.

  Printing was performed only on one side of a sugar-coated tablet containing titanium dioxide (a sugar-coating layer is sucrose) by an ink-jet recording method using an ink-jet aqueous ink comprising the water-based pigment ink composition. Printing was performed by a single pass (one pass) system using an inkjet printer (printing jig with a KC 600 dpi head). The printing conditions were a mass per droplet of 5 ng and a droplet volume of 5 pl. Further, after printing, the printed image surface was dried by natural drying for 24 hours. Thereby, an ink layer was formed on the surface of the sugar-coated tablet.

(Preparation of aqueous coating composition for inkjet)
As shown in Table 3 below, 5% by mass of polyvinyl pyrrolidone (BASF Japan Ltd.) having a number average molecular weight of about 40,000 as a coating component of the aqueous coating composition and a pigment fixing component exhibiting light reflectivity, and capryl as a surface tension adjusting agent. An aqueous coating composition was prepared by placing 2% by mass of acid decaglyceryl (manufactured by Sakamoto Yakuhin Kogyo Co., Ltd.) and 93% by mass of ion-exchanged water into a container and stirring and mixing.

(Measurement of number average molecular weight)
The number average molecular weight of polyvinylpyrrolidone is a value determined by gel permeation chromatography under the following conditions using polystyrene as a standard product.
Measuring device: LC-6A (manufactured by Shimadzu Corporation)
Separation column: PL gel 5 μm MIXED-C (manufactured by Polymer Laboratories)
Eluent: Dimethylformamide (0.01 mol LiBr added)
Column flow rate: 1.0 ml / min
Detector: RI detector Column temperature: 50 ° C
Sample concentration: 0.2% (W / V)
Molecular weight standard: Standard polystyrene

(Overcoat layer printing)
An overcoat layer as a coating layer was printed on the surface of the sugar-coated tablet on which the ink layer was printed. The overcoat layer was printed by an inkjet recording method using an aqueous coating liquid composed of an aqueous coating composition having the composition shown in Table 3. In addition, the overcoat layer is printed so that the overcoat layer covers the ink layer, and a coated region where the overcoat layer is provided on the sugar-coated tablet surface and a non-coated region where the overcoat layer is not provided. Formed.

  Further, the overcoat layer was printed by a single pass (one pass) method using an inkjet printer (printing jig with KC 600 dpi head). The printing conditions were a mass per droplet of 5 ng and an appropriate amount of liquid of 5 pl. Further, after the overcoat layer was printed, the overcoat layer was dried by natural drying for 24 hours. The overcoat layer had light transmittance with respect to visible light of 380 nm to 760 nm, and ensured good visibility with respect to the ink layer. In addition, under the visible light, the overcoat layer could not be identified visually or with a camera.

(Examples 1-6)
First, on the sugar-coated tablet on which the ink layer and the overcoat layer are printed, the area where the overcoat layer is printed with respect to the area where the overcoat layer is not printed (non-coating area B) under visible light (room light) A difference in gradation value of (coating region A) was obtained. A camera with built-in smartphone (trade name: iPhone6 (registered trademark), manufactured by Apple Inc.) was used for imaging the surface of the sugar-coated tablet on which the overcoat layer was printed.

  The difference between the gradation values was determined as follows. That is, image data captured and acquired by the digital camera was converted into an 8-bit gray scale using commercially available software, and 256 gradation values from 0 to 255 in a plurality of pixels were obtained. Further, the average value of the obtained gradation values was calculated, and the difference between the gradation values was calculated by subtracting the average value of the gradation values of the non-coating region B from the average value of the gradation values of the coating region A.

Next, the sugar-coated tablet on which the overcoat layer was printed was irradiated with ultraviolet rays while changing the wavelength for each example (irradiation process), and the reflected light reflected from the overcoat layer was imaged (imaging process). As the irradiation means, a xenon light source (trade name: MAX-303) manufactured by Asahi Spectroscopic Co., Ltd. shown in Table 4 below was used. The wavelength of the ultraviolet rays to be irradiated was changed by using a mirror module attached to the xenon light source and various UV bandpass filters (first optical filters) in combination. The ultraviolet wavelength was 260 nm, 280 nm, 300 nm, 320 nm, 340 nm, and 360 nm as shown in Table 3 below. The light intensity of the xenon light source was about 5000 μW / cm ² .

  Moreover, as an imaging means used in the imaging process, an ultraviolet camera shown in Table 5 below was used. The irradiation process and the imaging process were performed in a dark room where no external light other than the xenon light source entered.

  Subsequently, the difference in the gradation value of the region where the overcoat layer is printed (coating region A) with respect to the region where the overcoat layer is not printed (non-coating region B) under irradiation with ultraviolet rays of each wavelength. Was calculated. The difference between the gradation values was determined in the same manner as in the case of irradiation with visible light. The results are shown in Table 6 below.

(Comparative Example 1)
In this comparative example 1, UV light having a wavelength of 380 nm was used as irradiation light using a UV bandpass filter (LX0380, manufactured by Asahi Spectroscopy) (first filter). Other than that was carried out similarly to Examples 1-6, the irradiation process and the imaging process were performed, and the difference of the gradation value of the said coating area | region A with respect to the said non-coating area | region B of the imaging was computed.

(Overcoat layer discrimination)
In Examples 1 to 6 and Comparative Example 1, evaluation of the distinguishability of the overcoat layer under ultraviolet irradiation was performed. Moreover, the evaluation criteria which evaluated the discrimination property under visible light also to the sugar-coated tablet before ultraviolet irradiation were as follows. The results are shown in Table 6 below.
○: The difference in the gradation value of the coating region A with respect to the non-coating region B is 5 or more, and the coating layer can be identified. ×: The difference in the gradation value of the coating region A with respect to the non-coating region B is less than 5. Difficult to identify coating layer

(result)
As shown in Table 6, the difference in the gradation value of the coating region A with respect to the non-coating region B under the visible light irradiation of the sugar-coated tablet on which the overcoat layer was printed was 3, and the overcoat layer was confirmed by visual observation. I couldn't.

  Next, as shown in Table 6, when the sugar-coated tablets of Examples 1 to 6 are irradiated with ultraviolet rays having predetermined wavelengths in the range of 260 nm to 360 nm, in the coating region A on which the overcoat layer is printed. As a result of the reflected ultraviolet light, the image was captured white by an ultraviolet camera. On the other hand, in the non-coating region B, since the ultraviolet rays were absorbed, the black image was picked up by the ultraviolet camera. Further, in each of Examples 1 to 6, the difference in gradation value of the coating region A with respect to the non-coating region B can be 8 or more, and the contrast is generated to such an extent that the overcoat layer can be sufficiently identified. I was able to.

  On the other hand, when the ultraviolet ray having a wavelength of 380 nm was irradiated as in Comparative Example 1, the difference in the gradation value of the coating region A with respect to the non-coating region B was 3, and it was difficult to identify the overcoat layer. From these results, when an ultraviolet ray having a wavelength range of less than 380 nm is irradiated, the overcoat layer provided on the surface of the solid preparation can be identified. It was confirmed.

DESCRIPTION OF SYMBOLS 10 Solid preparation 11 Coating layer 21 Light irradiation means 22 Imaging means 23 1st optical filter 24 2nd optical filter A Coating area | region B Non-coating area | region

Claims (8)

A solid preparation provided with a coating layer on at least a part of its surface,
A coating region provided with the coating layer that transmits visible light having a wavelength range of 380 nm to 760 nm and reflects ultraviolet rays having a wavelength range of less than 380 nm;
It has at least an uncoated region that absorbs ultraviolet rays in the wavelength range and is not provided with the coating layer,
The difference in gradation value of the coating region with respect to the non-coating region when the coating region and the non-coating region are irradiated with visible light having a wavelength range of 380 nm to 760 nm is less than 5,
A solid preparation in which a difference in gradation value of the coating region with respect to the non-coating region is 5 or more when the coating region and the non-coating region are irradiated with ultraviolet rays in the wavelength region. An ink layer is provided at least in part between the surface of the solid preparation and the coating layer;
2. The overcoating layer according to claim 1, wherein the coating layer is an overcoat layer that fixes a pigment contained in the ink layer on the surface of the solid preparation and includes at least a pigment fixing component having light reflectivity with respect to ultraviolet rays in the wavelength range. The solid formulation described.   The solid preparation according to claim 2, wherein the pigment fixing component is polyvinylpyrrolidone having a number average molecular weight in the range of 2,000 to 200,000. A method for inspecting a solid preparation in which a coating layer is provided on at least a part of a surface,
The solid preparation is
A coating region provided with the coating layer that transmits visible light having a wavelength range of 380 nm to 760 nm and reflects ultraviolet rays having a wavelength range of less than 380 nm;
It has at least an uncoated region that absorbs ultraviolet rays in the wavelength range and is not provided with the coating layer,
The difference in gradation value of the coating region with respect to the non-coating region when the visible light in the wavelength region is irradiated to the coating region and the non-coating region is less than 5,
The difference in gradation value of the coating region with respect to the non-coating region when the coating region and the non-coating region are irradiated with ultraviolet rays in the wavelength region is 5 or more,
An irradiation step of irradiating the coating region and the non-coating region with irradiation light including at least ultraviolet rays in the wavelength range;
A method for inspecting a solid preparation, comprising: an imaging step in which the irradiation light receives reflected light reflected by the coating region and images the coating region and the non-coating region.   The method for inspecting a solid preparation according to claim 4, wherein the irradiation step is a step of using only ultraviolet rays having a wavelength range of less than 380 nm as the irradiation light.   6. The method for inspecting a solid preparation according to claim 4, wherein the imaging step is a step of receiving and imaging only ultraviolet rays having a wavelength range of less than 380 nm as the reflected light. An ink layer is provided at least in part between the surface of the solid preparation and the coating layer;
The coating layer is an overcoat layer containing at least a pigment fixing component that fixes the pigment contained in the ink layer on the surface of the solid preparation and has light reflectivity with respect to ultraviolet rays in the wavelength range. 7. The method for examining a solid preparation according to any one of 6 above. The method for inspecting a solid preparation according to claim 7, wherein the pigment fixing component is polyvinyl pyrrolidone having a number average molecular weight of 2000 to 200000.