JP2021105617A - Solid preparation and method for inspecting the same - Google Patents

Abstract

To provide a solid preparation capable of preventing the visibility of a print image from being reduced and checking the existence of printing failure of a coating layer, such as a primer coat layer and an overcoat layer, and a method for inspecting the same.SOLUTION: A solid preparation having a coating layer 11 provided in at least a part of the surface transmits visible light having a wavelength of 380-760 nm and includes at least a coating region A having the coating layer 11 reflecting ultraviolet having a wavelength of less than 380 nm and a non-coating region B absorbing the ultraviolet without having the coating layer 11. An ink layer is provided in at least a part between the surface of the solid preparation and the coating layer 11; the coating layer 11 fixing pigment included in the ink layer on the surface of the solid preparation includes at least a pigment fixing component having light reflectivity to the ultraviolet; and the pigment fixing component is polyvinyl pyrrolidone having a number average molecular weight of 2000-200,000.SELECTED DRAWING: Figure 1

Description

The present invention relates to a solid preparation and an inspection method thereof. 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 rays. The present invention relates to a solid preparation having a coating layer on its surface and an inspection method thereof.

Ink for inkjet used for printing images, etc. on solid formulations such as tablets must be composed of raw materials that comply with the standards of the Pharmaceutical Affairs Law, the Japanese Pharmacopoeia, or the Official Food Additives. Such inkjet inks consist of a dye ink in which the powder (dye) used for coloring is dissolved in the inkjet ink, and a pigment in which the powder (pigment) used for coloring is dispersed in the inkjet ink. Those made of ink are manufactured and sold.

Compared with pigment ink, dye ink has a problem that it is easily faded by light irradiation with the passage of time. Therefore, pigment inks having excellent light resistance are often used for printing on solid preparations such as tablets.

However, since the surface of solid preparations such as FC (film-coated) tablets and sugar-coated tablets is smoother than that of other solid preparations, there is a problem that the pigment is not sufficiently fixed and is peeled off and transferred. be. 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 image-formed by pigment ink or the like to prevent peeling of the element (the element is prevented from peeling off). See Patent Document 1 below).

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

JP-A-2002-207275

The present invention has been made in view of the above problems, and an object of the present invention is to suppress deterioration of visibility of a printed image and to determine the presence or absence of printing defects in a coating layer such as a primer coat layer or an overcoat layer. The purpose is to provide a solid preparation that can be confirmed and a method for inspecting the solid preparation.

The above-mentioned 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-mentioned problems, and transmits visible light having a wavelength range of 380 nm to 760 nm. At least there is a coating region provided with the coating layer that reflects ultraviolet rays having a wavelength region of less than 380 nm, and a non-coated region that absorbs ultraviolet rays in the wavelength region and does not have the coating layer. However, when the coated region and the non-coated region are irradiated with visible light having a wavelength range of 380 nm to 760 nm, the difference in the gradation value of the coated region from the non-coated region is less than 5, and the coated region and the non-coated region are not coated. When the region is irradiated with ultraviolet rays in the wavelength region, the difference in gradation value of the coated region with respect to the non-coated region is 5 or more.

The conventional overcoat layer has light transmission in the visible light region in the wavelength range of 380 nm to 760 nm from the viewpoint of ensuring good visibility of the printed image. Therefore, with the conventional overcoat layer, it is difficult to detect ejection defects such as missing nozzles and printing defects due to misalignment of the printing position visually or by an imaging means such as a camera. On the other hand, in the solid preparation of the present invention, as described above, when visible light in the wavelength range is irradiated to the coated region and the non-coated region, the difference in the gradation value of the coated region with respect to the non-coated region is less than 5. It is configured to be. Therefore, the coating region provided with the coating layer makes it difficult to visually identify the coating region under visible light irradiation in the wavelength region.

The coated region is a region provided with a coating layer that reflects ultraviolet rays having a wavelength region of less than 380 nm, and the non-coated region is a region that absorbs ultraviolet rays in the wavelength region. Further, when the coated region and the uncoated region are irradiated with ultraviolet rays in the wavelength region, the coated region has the light reflectivity and the non-coated region has the light absorption property, so that the non-coated region has a light absorption property. It is configured so that the difference in the gradation values of the coating region is 5 or more. Therefore, the coating layer can be identified under ultraviolet irradiation 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 a part between the surface of the solid preparation and the coating layer, and the coating layer uses the pigment contained in the ink layer as the solid preparation. The overcoat layer may be an overcoat layer that is fixed to the surface of the ink and contains at least a pigment fixing component having light reflectivity to ultraviolet rays in the wavelength range.

According to the above configuration, by providing the ink layer in at least a part 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 coated and protected. Here, since the coating layer as the overcoat layer transmits visible light having a wavelength range of 380 nm to 760 nm, it is possible to suppress, for example, from impairing the visibility of the printed image formed by the ink layer. Further, since the coating layer as the overcoat layer protects the ink layer, it is possible to suppress the transfer of the ink layer when it comes into contact with another solid preparation or the like. Further, since the coating layer contains 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 the pigment from peeling off from the surface of the solid preparation. Further, since the pigment fixing component has light reflectivity to ultraviolet rays in the wavelength range, it is possible to impart a function of reflecting ultraviolet rays in the wavelength range 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 200,000.

The method for inspecting a solid preparation according to the present invention is a method for inspecting a solid preparation 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 about 760 nm and reflects ultraviolet rays having a wavelength range of less than 380 nm, and the coating layer that absorbs ultraviolet rays in the wavelength range and provides the coating layer. It has at least an uncoated region, and when the coated region and the uncoated region are irradiated with visible light in the wavelength region, the difference in gradation value of the coated region from the uncoated region is less than 5. When the coated region and the non-coated region are irradiated with ultraviolet rays in the wavelength region, the difference in the gradation value of the coated region from the non-coated region is 5 or more, and the coated region and the non-coated region are covered with the above. The irradiation including an irradiation step of irradiating irradiation light including at least ultraviolet rays in a wavelength range, and an imaging step of receiving the reflected light reflected by the irradiation light in the coating region and imaging the coated region and the non-coating region. It includes an imaging step in which light receives reflected light reflected in the coated region and images the coated region and the non-coated region.

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

The coated region is a region that reflects ultraviolet rays having a wavelength region of less than 380 nm, and the non-coated region is a region that absorbs ultraviolet rays in the wavelength region. When the coated region and the non-coated region are irradiated with light containing ultraviolet rays in the wavelength region, the difference in gradation value with respect to the non-coated region is 5 or more. Therefore, in the irradiation step, by irradiating the coated region and the non-coated region with irradiation light containing at least ultraviolet rays in the wavelength region, at least a part of the irradiation light is reflected by the coating layer in the coating region, and the irradiation light is reflected. In the non-coated region, at least a part of the irradiation light is absorbed so that the coating layer can be identified (visually recognized). Then, in the above configuration, the irradiation light receives the reflected light reflected in the coating region, and the coated region and the non-coated region are imaged (imaging step). As a result, the quality of the printed state of the coating layer can be easily determined and inspected, and the yield of the solid preparation can be improved as compared with the conventional case.

In the above configuration, the irradiation step is preferably a step of using only ultraviolet rays having a wavelength range of less than 380 nm as the irradiation light. The coated region is a region that exhibits light reflectivity to ultraviolet rays having a wavelength region of less than 380 nm, and the non-coated region is a region that exhibits light absorption to ultraviolet rays in the wavelength region. Therefore, by limiting the irradiation light used in the irradiation step to 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 of the presence or absence of printing defects of the coating layer can be further improved.

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

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

According to the above configuration, by providing the ink layer in at least a part 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 coated and protected. .. Here, since the coating layer as the overcoat layer transmits visible light having a wavelength range of 380 nm to 760 nm, it is possible to suppress, for example, from impairing the visibility of the printed image formed by the ink layer. Further, since the coating layer as the overcoat layer protects the ink layer, it is possible to suppress the transfer of the ink layer when it comes into contact with another solid preparation or the like. Further, since the coating layer has a pigment fixing component for fixing the pigment contained in the ink layer on the surface of the solid preparation, it is possible to prevent the pigment from peeling off from the surface of the solid preparation. Further, since the pigment fixing component has light reflectivity to ultraviolet rays in the wavelength range, it is possible to impart a function of reflecting ultraviolet rays in the wavelength range to the coating layer.

Further, in the above configuration, it is preferable that the pigment fixing component is polyvinylpyrrolidone having a number average molecular weight in the range of 2000 to 200,000.

The present invention exerts the following effects by the means described above.
That is, according to the solid preparation of the present invention, the coated region provided with the coating layer and the non-coated region not provided with the coating layer emit visible light (380 nm to 760 nm) to the coated region and the non-coated region. When irradiated, the difference in gradation value of the coated region with respect to the non-coated 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 visually or by an imaging means such as a camera under visible light irradiation. The coated 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-coated region is a region that absorbs ultraviolet rays in the wavelength region. The coated region is configured such that when the coated region and the non-coated region are irradiated with ultraviolet rays, the difference in gradation value with respect to the non-coated region is 5 or more. Therefore, according to the present invention, it is possible to provide a solid preparation capable of identifying the coating region by irradiation with ultraviolet rays in the wavelength range and inspecting the presence or absence of printing defects in the coating layer.

Further, according to the method for inspecting a solid preparation according to the present invention, the coated region and the non-coated region of the solid preparation are irradiated with irradiation light containing ultraviolet rays in at least the wavelength range, so that the solid preparation is exposed to the visible light. After making the coating layer identifiable, which is difficult to identify (visually) by visual inspection or imaging means such as a camera, the reflected light reflected in the coating region is received to image the coated region and the non-coated region. be. This makes it possible to easily determine and inspect whether the coating layer is properly printed on the solid preparation, and to provide a solid preparation in which the decrease in yield due to poor printing of the coating layer is suppressed. ..

It is explanatory drawing which shows typically the solid preparation which concerns on one Embodiment of this invention. It is a schematic diagram which shows the outline of the image pickup apparatus used for the inspection method of a solid product.

(Solid formulation)
The solid preparation according to the present embodiment will be described below with reference to FIG. FIG. 1 is an explanatory diagram 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 the surface thereof. The solid formulation 10 of the present embodiment has at least a coating region A provided with the coating layer 11 and a non-coated region B not provided with the coating layer 11.

In the present specification, the "solid preparation" means to include a food preparation and a pharmaceutical preparation, and the form of the solid preparation includes, for example, OD (orally disintegrating) tablets, uncoated tablets, FC tablets, sugar-coated tablets and the like. Examples include tablets or capsules. The solid preparation may be used for pharmaceuticals or for foods. Examples of tablets for food use include health foods such as tablets and supplements. Among the solid preparations, the tablet is in a solid state at room temperature, and for example, a tablet material containing an active ingredient is preferably produced by compression and / or molding into a certain shape. The shape of the tablet is not particularly limited, and any shape can be adopted.

<Coding area>
The coating region A is a region provided with a coating layer 11 that exhibits light reflectivity to ultraviolet rays having a wavelength region of less than 380 nm. Therefore, when the coating region A is irradiated with light containing ultraviolet rays in the wavelength range, at least the ultraviolet rays in the wavelength range are reflected. The wavelength range is more preferably 260 nm or more and less than 380 nm, and particularly preferably 280 nm or more and 360 nm or less. Further, the coating layer 11 has light transmission to visible light in the wavelength range of 380 nm to 760 nm. Therefore, when the coating region A is irradiated with visible light in the wavelength region, at least a part of the irradiated visible light in the wavelength region is transmitted due to the light transmission indicated by the coating layer 11.

As used herein, the term "light reflectivity" means the property of reflecting at least a part of the incident ultraviolet rays in the wavelength range. Further, as used herein, the term "light transmissive" means a property of transmitting at least a part of the incident visible light in the wavelength range. Further, the light transmission means that the coating layer 11 includes not only a colorless case but also a colored case.

The coating layer 11 is edible and is preferably a dry film of an inkjet water-based coating liquid (details will be described later). The dry film can be formed by directly printing on the surface of the solid preparation 10 by, for example, an inkjet method or the like, using the aqueous coating liquid for inkjet. In the present specification, "edible" means a pharmaceutical additive specified in the Pharmaceutical Affairs Law, which conforms to the standards of the Japanese Pharmacopoeia or the official standard of food additives, and "inkjet method" means water-based. It means a method in which a coating composition is ejected as droplets from a fine inkjet head, and the droplets are fixed on a solid preparation to form an image.

Further, as the coating layer 11, it is preferable that the coating layer 11 functions as an overcoat layer (protective layer). In this case, the coating layer 11 is provided so as to cover the ink layer (not shown) forming the printed image. By coating the ink layer as the overcoat layer, it is possible to protect the printed image. As a result, it is possible to prevent the printed image from being transferred to the contact object due to the contact of the printed surface with the contact object and the image quality from being deteriorated. Further, by protecting the printed image by the coating layer 11, for example, thermal stability, light stability, abrasion resistance, and abrasion resistance (or abrasion resistance) can be imparted.

Further, when the coating layer 11 is used as an overcoat layer, the coating layer 11 is composed of a dry film of a water-based coating liquid for inkjet containing a water-soluble pigment fixing component (details will be described later), and is a pigment of the ink layer. Is preferably fixed in the solid preparation 10. By containing 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 when the aqueous coating liquid for inkjet containing the pigment fixing component is brought into contact with the surface of the solid preparation.

Here, it is considered that 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 for the reason described below. That is, first, the mechanical strength of the surface layer portion (the portion where the pigment fixing component permeates into the solid preparation 10) of the solid preparation 10 can be improved by drying the pigment fixing component that has permeated into the solid preparation 10. That is. As a result, 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 together with the surface layer portion of the solid preparation 10 and reduce the transfer of the pigment to another solid preparation or the like. For example, when the solid product 10 is fragile to an external force and its surface is easily scraped, even if the pigment itself is firmly fixed to the surface of the solid product 10, the pigment is transferred by peeling off the surface layer portion of the solid product 10. Can occur. The pigment fixing component of the present invention can prevent the transfer of the pigment even with respect to 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 on the surface of the solid preparation 10 by drying the pigment fixing component that has penetrated into the solid preparation 10. This makes it possible to prevent the pigment from peeling off from the surface of the solid product 10.

The third is that when the pigment fixing component is dried while covering the pigment on the solid preparation 10, the dried film functions as an overcoat layer. As a result, even if another solid product or the like comes into contact with the pigment fixed on the surface of the solid product 10, the transfer of the pigment can be suppressed.

Therefore, when the coating layer 11 having the above constitution contains the pigment fixing component, the mechanical strength of the surface layer portion of the solid preparation 10 is improved, the pigment is adhered to the surface of the solid preparation 10, and the pigment is further coated as an overcoat layer. Since it can be protected, it is possible to improve the scratch resistance and the peel resistance of the printed image.

When the coating layer 11 is an overcoat layer, it is preferable that the coating layer 11 has colorless light transmission with respect to visible light in the wavelength range. As a result, it is possible to suppress a decrease in visibility when the printed image is observed through the coating layer 11. However, the present invention does not prevent the coating layer 11 from having colored light transmission for color correction, other special purposes, or the like, as long as it does not adversely affect the visibility of the printed image.

The thickness (after dry coating) of the coating layer 11 as the overcoat layer may be appropriately set in consideration of the composition of the water-based coating liquid for inkjet, the required protection performance of the printed image, and the like, and is not particularly limited. Generally, 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, and more preferably 0.1 μm to 1 μm. By setting the thickness of the coating layer 11 to 0.03 μm or more, scratch resistance and abrasion resistance to the printed image can be imparted. 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 coating liquid for inkjet and deterioration of visibility of the printed image.

Further, the coating layer 11 may be used as a primer coating 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, it is possible to improve the adhesion and adhesiveness between the solid preparation 10 and the ink layer. As a result, it is possible to reduce the peeling of the ink layer in the solid preparation 10 and suppress the deterioration of the image quality of the ink layer. The thickness of the primer coat layer (after dry coating) may be appropriately set in consideration of the composition of the coating liquid, the required adhesive performance, and the like, and is not particularly limited. Generally, 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, and more preferably 0.1 μm to 1 μm.

The ink layer is composed of a dry film of an inkjet water-based ink containing an edible pigment. The ink layer can be formed by directly printing the water-based ink for inkjet 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 appropriately set as needed.

As edible pigments, carbon black conforming to the standards of pharmaceutical additives, Japanese Pharmacy Law or Food Additives Official Standards stipulated by the Pharmaceutical Affairs Law, yellow iron oxide, yellow iron sesquioxide, iron sesquioxide, red iron oxide or black Examples include iron oxide 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 and the like. ..

The water-based ink for inkjet is particularly limited as long as it conforms to the standards of the Pharmaceutical Affairs Law, the Japanese Pharmacopoeia, or the official standard for food additives, and contains the water-based pigment composition containing the pigment. Not done.

<Uncoated area>
The non-coated region B is a region that absorbs the ultraviolet rays when irradiated with light containing at least ultraviolet rays in a wavelength region of less than 380 nm, and is a region in which the coating layer 11 is not provided in the present embodiment. Is.

In order for the uncoated region B to have light absorption 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 ) and zinc oxide (ZnO). These ultraviolet absorbing components can be used alone or in combination. Examples of the solid preparation 10 itself containing an ultraviolet absorbing component include sugar-coated tablets containing titanium dioxide as an ultraviolet absorbing component. Further, when the solid preparation 10 itself does not contain the ultraviolet absorbing component, or when the solid preparation 10 itself contains a component that reflects ultraviolet rays, the ultraviolet absorbing layer containing the ultraviolet absorbing component is made into the solid preparation 10. By providing it on the surface, it is possible to form the uncoated region B. Alternatively, the non-coated region B can be formed by making the reflection wavelength of the coating layer 11 against ultraviolet rays different from the reflection wavelength of the solid preparation 10 against ultraviolet rays. In addition, in this specification, "light absorption" means the property of absorbing at least a part of the incident ultraviolet rays in the wavelength region.

<Difference in gradation value between coated area and non-coated area>
When the coated region A and the non-coated region B are simultaneously irradiated with visible light in the wavelength region, the difference in the gradation value of the coated region A with respect to the non-coated 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 reduce the coating layer 11 to be visually identified by an imaging means such as a camera or the like under visible light irradiation.

Further, when the coated region A and the non-coated region B are simultaneously irradiated with ultraviolet rays in the wavelength region, the difference in the gradation value of the coated region A with respect to the non-coated region B is 5 or more. By setting the difference in gradation values 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 the present specification, the "gradation value" is a value representing the shading of the captured image, and is an 8-bit gradation value (from 0 to 255) obtained by converting the image data into grayscale. It means the value of 256 steps). Further, in the present specification, the "difference in gradation value" means a value obtained by subtracting the average value of the gradation value of the non-coating region B from the average value of the gradation value of the coating region A. Further, the average value of the gradation values means the average value of the gradation values of a plurality of pixels in the image data of the coated region A or the non-coated region B.

The average value of the gradation values in the coated region A and the non-coated region B when the irradiation light is irradiated can be controlled by, for example, adjusting the light intensity of the irradiation light. Specifically, by appropriately controlling the light intensity of the irradiation light, the difference between the gradation values of the coated region A and the non-coated region B is maximized, and clearer imaging is possible. For example, if the light intensity of the light source of the irradiation light is too weak and the average value of the gradation values of the coated area A and the non-coated 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. If the light intensity of the light source is too high, the imaging is overexposed, the average value of the gradation values of the coated area A and the non-coated area B is both large, and the difference is large, the light intensity of the light source is large. By reducing the value of, the difference in gradation values can be increased. 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 optimum combination with 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 with respect to the non-coating region B is increased. You may control it.

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

The aqueous coating composition of the present embodiment is edible by using a material conforming to the standards of the pharmaceutical additive, the Japanese Pharmacopoeia or the official standard of food additives specified by the Pharmaceutical Affairs Law, and thereby the pharmaceutical product. It can be suitable for use in a solid preparation consisting of tablets or capsules such as foods and foods.

Further, the aqueous coating composition of the present embodiment has light transmission in the visible light region (380 nm to 760 nm). Thereby, when the coating layer is formed by using the aqueous coating liquid containing the aqueous coating composition, the light transmission of the coating layer to visible light can be imparted. The light transmittance of the aqueous coating composition may be colorless as well as colored.

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

Here, the term "water-soluble" as used herein refers to a case where 1 g or more is dissolved in 100 g of water under normal temperature and pressure.

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

The pigment fixing component is not particularly limited as long as it is water-soluble and edible, but imparts light reflectivity to the coating layer 11 by reflecting at least a part of ultraviolet rays having a wavelength range of less than 380 nm. Is preferable. Examples of such pigment fixing components include polyvinylpyrrolidone and the like. Polyvinylpyrrolidone is a water-soluble polymer and falls under the category of pharmaceutical additives specified by the Pharmaceutical Affairs Law. Further, polyvinylpyrrolidone imparts adhesiveness (wetting property) to pigments and the like and film forming property to the coating layer 11. Then, polyvinylpyrrolidone also functions as a light-reflecting component that exhibits light reflectivity to ultraviolet rays in the wavelength range.

The number average molecular weight of polyvinylpyrrolidone is preferably in the range of 2000 to 20000, more preferably 1000 to 160000, and even more preferably 20000 to 50000. By setting the number average molecular weight of polyvinylpyrrolidone to 2000 or more, it is possible to exist as a solid substance by itself at normal temperature and pressure. Further, even when it takes the form of a solid by itself 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, the viscosity greatly deviates from the Newtonian state, and the droplet flying property 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 (with 0.01 molLiBr added): column flow rate 1.0 ml / min: column temperature 50 ° C. : Measurement can be performed using an 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 and the like. For example, when the polyvinylpyrrolidone is used as a pigment fixing component, the lower limit of the content thereof is preferably 1% by mass or more, more preferably 2% by mass or more, particularly more than 2% by mass, based on the total mass of the aqueous coating composition. It is preferably 5% by mass or more. The upper limit of the content of polyvinylpyrrolidone is preferably 20% by mass or less, more preferably 15% by mass or less, and particularly preferably 10% by mass or less, based on the total mass of the aqueous coating composition. By setting the lower limit of the content of polyvinylpyrrolidone to 1% by mass or more, the fixability of the pigment can be maintained, and the deterioration of the scratch resistance and the peel resistance of the printed image can be suppressed. 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 is excessively increased, and the viscosity greatly deviates from the Newtonian state, so that the liquid of the aqueous coating composition is liquid. It is possible to prevent the flying property of the drop from being lowered.

The water contained in the aqueous coating composition of the present embodiment is pure water such as ion-exchanged water, ultra-filtered water, reverse osmosis water, distilled water, or water obtained by removing ionic impurities such as ultrapure water. It is preferable to use it. In particular, water that has been sterilized by irradiation with ultraviolet rays or the like is suitable because it can prevent the growth of mold and bacteria for a long period of time. The water content is not particularly limited and can be set 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 the solid preparation when the aqueous coating composition is in a liquid state before drying.

Here, "water-insoluble" in the present specification means that it is substantially insoluble in water, and more specifically, the solubility under normal temperature and pressure is less than 1 g with respect to 100 g of water. Say something. Further, the "water-insoluble component" means a component having such water-insoluble property, and specific examples thereof include a polymer emulsion. Further, examples of the polymer emulsion include polymers such as methacrylic acid, methyl methacrylate, butyl methacrylate, dimethylaminomethyl methacrylate, ethyl acrylate, and trimethylammonium ethyl methacrylate chloride, 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), and Eudragit L30D-55 (methacrylic acid copolymer LD). , Eudragit L100-55 (dry methacrylate 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 (Ammonioalkyl 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 methacrylate, methacrylic acid copolymer) and the like can be exemplified. All of these commercially available products are manufactured by Evonik Industries, and Eudragit is a registered trademark. Further, the "room temperature" means that the temperature is in the temperature range of 5 ° C to 35 ° C.

Further, the aqueous coating composition of the present embodiment may contain a surface tension adjusting agent, if necessary. The surface tension adjusting agent is not particularly limited as long as it conforms to the standards of pharmaceutical additives, Japanese Pharmacy Law or Food Additives Official Standards stipulated by the Pharmaceutical Affairs Law, and for example, caprylic acid decaglyceryl and lauric acid hexaglycerin ester. , Oleic acid hexaglycerin ester, condensed linolenic acid tetraglycerin ester, fatty acid ester coconut palm, decaglyceryl laurate having an HLB of 15 or less, decaglyceryl oleate having an HLB of less than 13. These may be used alone or in combination of two or more.

As the decaglyceryl caprylate, a commercially available product can be used, and as such a commercially available product, for example, 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 Yakuhin Kogyo Co., Ltd., HLB value 16) and the like.
The HLB value is an HLB value obtained by the Griffin method, and means a value obtained by the following formula.
HLB value = 20 × (sum of formulas of hydrophilic groups / molecular weight)
The HLB value is in the range of 0 to 20, and the larger the HLB value, the stronger the hydrophilicity, and the smaller the HLB value, the stronger the hydrophobicity.

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

As the decaglyceryl oleate, one having an HLB of less than 13 can be used. When the HLB is 13 or more, the ejection stability is lowered, such as fading due to clogging of the nozzle of the inkjet head. The lower limit of HLB is preferably 10 or more from the viewpoint of solubility in an aqueous solvent. Further, as the decaglyceryl oleate having an HLB of less than 13, a commercially available product can be used, and as such a commercially available product, for example, NIKKOL (registered trademark) DECAGLYN 1-OV (trade name, Nikko Chemicals Co., Ltd.) HLB value 12) manufactured by SY Glister MO-7S (trade name, manufactured by Sakamoto Yakuhin Kogyo 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 Glyster ML-500 (trade name, manufactured by Sakamoto Yakuhin Kogyo Co., Ltd., HLB value 13.5) and the like.

As the oleic acid hexaglycerin ester, a commercially available product can be used, and as such a commercially available product, for example, SY Glyster MO-5S (trade name, manufactured by Sakamoto Yakuhin Kogyo Co., Ltd., HLB value 11. 6) and the like.

As the condensed linolenic acid tetraglycerin ester, a commercially available product can be used, and examples of such a commercially available product include SY Glister CR-310 (trade name, manufactured by Sakamoto Yakuhin Kogyo Co., Ltd.). Be done.

As the fatty acid ester coconut palm, a commercially available product can be used, and examples of such a commercially available product include tirabazole W-01 (trade name, manufactured by Taiyo Kagaku Co., Ltd.) and the like.

The content of the surface tension adjusting agent is preferably in the range of 0.5% by mass to 5% by mass and 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 the inkjet method, ejection defects due to poor formation of the meniscus surface in the nozzle of the inkjet head are prevented, and the nozzle is concerned. It is possible to prevent the clogging of the nozzle. 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 adverse effects on discharge due to the insoluble content of the surface tension adjusting agent and poor emulsification.

In addition, other additives may be blended in the aqueous coating composition of the present embodiment. However, other additives shall be within the range that does not hinder the solution of the problem of the present invention, and shall comply with the standards of the Pharmaceutical Additives, Japanese Pharmacopoeia or Food Additives Official Standards stipulated by the Pharmaceutical Affairs Law. It takes. Examples of such other additives include surfactants, viscosity regulators, preservatives, lubricants, foaming agents, viscosity regulators, defoamers and the like. The content of these other additives is not particularly limited and can be set as needed.

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 at the time of ejection from the inkjet nozzle, considering the ejection stability from the inkjet nozzle. By setting the viscosity of the aqueous coating composition within the above numerical range, it is possible to suppress the occurrence of clogging in the inkjet nozzle, maintain good ejection stability, and suppress a decrease in flight performance. The viscosity of the aqueous coating composition can be obtained, for example, by measuring with a viscometer (trade name: VISCOMATE MODEL VM-10A, manufactured by SEKONIC CORPORATION) under the condition of a measurement temperature of 25 ° C.

The aqueous coating composition of the present embodiment can be produced by mixing the above-mentioned components by an appropriate method. The mixing method and the order of addition 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 substances that cause clogging. Thereby, the aqueous coating composition according to the present embodiment can be obtained.

The mixing method of each material is not particularly limited, and for example, the materials are sequentially added to a container equipped with a stirring device such as a mechanical stirrer or a magnetic stirrer to perform stirring and mixing. The filtration method is not particularly limited, and for example, known natural filtration, pressure filtration, vacuum filtration, centrifugal filtration and the like can be adopted.

Further, since the aqueous coating composition of the present embodiment uses a pharmaceutical additive defined by the Pharmaceutical Affairs Law, etc., and an edible pigment fixing component conforming to the standards of the Japanese Pharmacopoeia or the official standard of food additives. , Pharmaceuticals or supplements, etc. It is possible to apply directly on the printed image of a solid agent consisting of tablets or capsules.

In the above-described 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, the aqueous coating composition may contain a light-reflecting component as a third component different from the pigment fixing component.

<Printing method of coating layer>
The method of 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 liquid containing the aqueous coating composition.

The inkjet printing method on the surface of the solid preparation is not particularly limited. Specifically, for example, the aqueous coating liquid is ejected as droplets from a fine nozzle, and the droplets are attached 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 method, thermal method, electrostatic suction method, etc.) can be adopted. ..

The discharge amount of the aqueous coating solution can be appropriately set in consideration of the degree of penetration of the pigment fixing solution 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, and 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 adhering 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. Further, the drying conditions such as the drying time and the drying temperature are not particularly limited, and can be appropriately set according to the discharge amount of the aqueous coating liquid, the type of the aqueous coating composition, and the like. 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 of the inkjet head or the like. It can be easily removed with an aqueous cleaning solution or the like.

When the coating layer 11 is an overcoat layer that covers the ink layer, the coating layer 11 is formed by printing the ink layer using the water-based coating liquid in the same manner as described above. Will be done.

(Inspection method for solid product)
Next, the inspection method of the solid preparation according to the present embodiment will be described below with reference to FIG.
The inspection method of 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 coated region A and the non-coated region B with irradiation light containing at least ultraviolet rays having a wavelength region of less than 380 nm. By irradiating the irradiation light including the ultraviolet rays in the wavelength range, at least a part of the ultraviolet rays in the wavelength range contained in the irradiation light is reflected in the coating region A due to the light reflectivity of the coating layer 11. In the uncoated region B, at least a part of the ultraviolet rays in the wavelength range contained in the irradiation light is absorbed due to the light absorption property of the solid preparation 10. As a result, in the coated region A, the difference in gradation value with respect to the non-coated region B becomes 5 or more, and the coating layer 11 is in an identifiable state.

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 in the wavelength range of less than 380 nm and the non-coated region B absorbs the ultraviolet rays, the irradiation light used in the irradiation step is limited to the ultraviolet rays in the wavelength range. By doing so, it is possible to prevent the image from being imaged in the imaging process by combining the light in other wavelength ranges such as visible light and infrared light. That is, by irradiating only the ultraviolet rays in the wavelength range, 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 better contrast becomes possible.

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 ~ It is 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, there is no difference in brightness, and it is possible to prevent the image from being imaged in a black crushed state. .. On the other hand, by setting the illuminance of the irradiation light to 50,000 μW / m ² or less, it is possible to prevent the image from being imaged in a state of overexposure with no difference in brightness. Further, the irradiation angle of the irradiation light with respect to the solid preparation 10 is not particularly limited and can be appropriately set. The "irradiation angle" means the angle formed by the irradiation direction of the irradiation light applied to the solid pharmaceutical product 10 and the horizontal plane on which the solid product 10 is placed.

The imaging step is a step of receiving the reflected light reflected by the irradiation light in the coated region A and the non-coated region B and imaging the coated region A and the non-coated region B. Since the coated region A reflects more ultraviolet rays in the wavelength region than the uncoated region B, a difference in gradation value occurs between the coated region A and the uncoated region B in the imaging. The presence or absence of printing defects in the coating layer 11 can be inspected by the difference in the gradation value of the coating region A with respect to the non-coating region B.

The light receiving condition is preferably set so as to show the maximum sensitivity with respect to the wavelength range of the irradiation light. Specifically, it is preferable to set the light receiving conditions so that the wavelength range of the light that can be received is at least partially matched with the wavelength range of the irradiation light, and more preferably, the wavelength range of the light that can be received is set to less than 380 nm. It is to set. As a result, the amount of received light is increased, and the coated region A and the non-coated region B can be imaged with good contrast. If the light receiving sensitivity is low or not with respect to the wavelength range such as reflected light, it may be difficult to image the coated region A and the non-coated region B.

Further, the light receiving angle when receiving the reflected light or the like is not particularly limited, and may be appropriately set so that the received light amount of the reflected light or the like is maximized. The "light receiving angle" means the angle formed by the light beam having the maximum amount of light such as reflected light in the coating region A and the normal line with respect to the horizontal plane.

The inspection step is a step of confirming the presence or absence of printing defects in the coating layer 11 imaged in the imaging step. The inspection method is not particularly limited, and a conventionally known method can be adopted. For example, ultraviolet rays in the wavelength range are irradiated to a coating layer of a solid preparation having no printing defects and reflected, and the coating layer is imaged in advance to serve as a reference coating layer. Then, the coating layer of the solid preparation to be inspected (hereinafter referred to as "the coating layer to be inspected") is also 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. After that, 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, a case where the irradiation step, the imaging step, and the inspection step are performed after printing (including the drying step) of the coating layer 11 has been described as an example. However, the present invention is not limited to this aspect, and a series of steps from the irradiation step to the inspection step is performed after the aqueous coating liquid is applied to form a coating layer (coating layer before drying). , It may be performed before the drying step of the coating layer. In this case, since the coating layer before drying contains water or the like, the reflectance of ultraviolet rays in the wavelength range can be further improved. Therefore, in the case where the inspection step is performed before drying, the difference in the gradation value of the coating region A with respect to the non-coating region B can be increased as compared with the case where the inspection step is performed after drying. As a result, the identification of the coating layer 11 in the solid formulation 10 can be further facilitated, and the inspection accuracy of the coating layer 11 for the presence or absence of printing defects can be further improved.

<Imaging device>
Next, the imaging apparatus used for imaging the coated region A and the uncoated region B of the solid preparation 10 will be described below with reference to FIG. FIG. 2 is a schematic view showing an outline of an imaging device used in the imaging step in the inspection method of the solid product 10.

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

The light irradiating means 21 is not particularly limited as long as it can irradiate ultraviolet rays having a wavelength range of less than 380 nm, and for example, known ones such as incandescent lamps, discharge lamps, and light emitting diode lamps, or sunlight may be used. Can be done.

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

The imaging means 22 receives the reflected light reflected by the solid preparation 10 by irradiation with the irradiation light, and captures images of the coated region A and the non-coated region B. More specifically, the imaging means 22 includes a conventionally known ultraviolet camera and the like.

Further, when it is desired to control the wavelength of the light received by the imaging means 22, the imaging means 22 may receive the 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. The second optical filter 24 is not particularly limited, and examples thereof include a conventionally known wavelength filter capable of blocking or attenuating visible light, infrared light, and the like. Further, as the image pickup means 22, one having such a second optical filter 24 built-in may be used.

Hereinafter, preferred embodiments of the present invention will be described in detail exemplarily. However, the materials, contents, etc. described in the following examples are not limited to those of the present invention unless otherwise specified. In addition, all of the solid preparations, pigments and pigment-fixing components conform to the standards of the Pharmaceutical Affairs Law, the Japanese Pharmacopoeia, or the official standard of food additives.

(Preparation of water-based pigment ink composition for inkjet and printing of ink layer)
As shown in Table 1 below, 25% by mass of carbon black was prepared 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 were prepared as pigment dispersants. It was dispersed 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-exchanged 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 adjuster, and propylene glycol was used as the wetting agent.

The values in Table 1 are values of mass% with respect to the total mass of the pigment dispersion solution, and the values in Table 2 are values of mass% with respect to the total mass of the aqueous pigment ink composition unless otherwise specified. be. In addition, each material conforms to the standards of the Pharmaceutical Affairs Law, the Japanese Pharmacopoeia, or the official standard for food additives.

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

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

(Measurement of number average molecular weight)
The number average molecular weight of polyvinylpyrrolidone is a value determined by gel permeation chromatography using polystyrene as a standard product under the following conditions.
Measuring device: LC-6A (manufactured by Shimadzu Corporation)
Separation column: PL gel 5 μm MIXED-C (manufactured by Polymer Laboratories)
Eluent: Dimethylformamide (with 0.01 molLiBr 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

(Printing of overcoat layer)
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 the aqueous coating composition having the composition shown in Table 3. Further, the overcoat layer is printed so that the overcoat layer covers the ink layer, and the coated area provided with the overcoat layer on the surface of the sugar-coated tablet and the non-coated area not provided with the overcoat layer are printed. Formed.

The overcoat layer was printed by a single-pass (one-pass) method using an inkjet printer (a printing jig equipped with a KC 600 dpi head). The printing conditions were a mass of 5 ng per droplet and an appropriate amount of liquid of 5 pl. After printing the overcoat layer, the overcoat layer was naturally dried for 24 hours. The overcoat layer has light transmission to visible light of 380 nm to 760 nm, and good visibility to the ink layer is ensured. Further, under the visible light, the overcoat layer could not be visually identified and identified by a camera.

(Examples 1 to 6)
First, with respect to 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 (indoor light). The difference in the gradation value of (coating region A) was obtained. A camera built into a smartphone (trade name: iPhone6 (registered trademark), manufactured by Apple Inc.) was used to image the surface of the sugar-coated tablet on which the overcoat layer was printed.

The difference in gradation values was obtained as follows. That is, the image data captured and acquired by the digital camera was image-converted to 8-bit grayscale 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 step), and the reflected light reflected from the overcoat layer was imaged (imaging step). As the irradiation means, a xenon light source (trade name: MAX-303) manufactured by Asahi Spectroscopy Co., Ltd. shown in Table 4 below was used. The wavelength of the ultraviolet rays to be irradiated was changed by using the mirror module attached to the xenon light source and various UV bandpass filters (first optical filters) in combination. As shown in Table 3 below, the wavelengths of ultraviolet rays were set to 260 nm, 280 nm, 300 nm, 320 nm, 340 nm, and 360 nm. Further, the light intensity of the xenon light source was set to about 5000 μW / cm ² .

Further, as the imaging means used in the imaging step, an ultraviolet camera shown in Table 5 below was used. The irradiation step and the imaging step were performed in a dark room where outside light other than the xenon light source did not enter.

Subsequently, the difference in 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 ultraviolet irradiation of each wavelength. Was calculated. The difference in the gradation values was obtained 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 Comparative Example 1, a UV bandpass filter (LX0380, manufactured by Asahi Spectroscopy Co., Ltd.) (first filter) was used, and ultraviolet rays having a wavelength of 380 nm were used as irradiation light. Other than that, the irradiation step and the imaging step were performed in the same manner as in Examples 1 to 6, and the difference in the gradation value of the coating region A with respect to the non-coated region B of the imaging was calculated.

(Identity of overcoat layer)
In Examples 1 to 6 and Comparative Example 1, the distinctiveness of the overcoat layer under ultraviolet irradiation was evaluated. In addition, the identification of sugar-coated tablets before UV irradiation was evaluated under visible light, and the evaluation criteria were as follows. The results are shown in Table 6 below.
◯: The difference in gradation value of the coating region A with respect to the non-coated 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-coated region B is less than 5. Difficult to identify coating layer

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

Next, as shown in Table 6, when the sugar-coated tablets of Examples 1 to 6 were irradiated with ultraviolet rays having a predetermined wavelength in the range of 260 nm to 360 nm, in the coating region A on which the overcoat layer was printed. Was imaged white with an ultraviolet camera due to the reflection of the irradiated ultraviolet rays. On the other hand, in the non-coated region B, the ultraviolet rays were absorbed, so that the image was captured in black by the ultraviolet camera. Further, in each of Examples 1 to 6, the difference in the 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 ultraviolet rays having a wavelength of 380 nm were irradiated as in Comparative Example 1, the difference in gradation value of the coating region A with respect to the non-coating region B was 3, making it difficult to identify the overcoat layer. From these results, when the ultraviolet rays having a wavelength range of less than 380 nm are irradiated, the overcoat layer provided on the surface of the solid preparation can be identified, so that the presence or absence of printing defects of the overcoat layer can be inspected. It was confirmed that.

10 Solid formulation 11 Coating layer 21 Light irradiation means 22 Imaging means 23 First optical filter 24 Second optical filter A Coating area B Non-coating area

Claims (4)

A solid product having a coating layer on at least a part of the 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 a non-coated region that absorbs ultraviolet rays in the wavelength range and is not provided with the coating layer.
An ink layer is provided at least partly between the surface of the solid preparation and the coating layer.
The coating layer contains 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 to ultraviolet rays in the wavelength range.
The pigment fixing component is a solid preparation of polyvinylpyrrolidone having a number average molecular weight in the range of 2000 to 200,000. A method for inspecting a solid product having a coating layer on at least a part of the 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 a non-coated region that absorbs ultraviolet rays in the wavelength range and is not provided with the coating layer.
An ink layer is provided at least partly between the surface of the solid preparation and the coating layer.
The coating layer contains 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 to ultraviolet rays in the wavelength range.
The pigment fixing component is polyvinylpyrrolidone having a number average molecular weight in the range of 2000 to 200,000.
An irradiation step of irradiating the coated region and the non-coated region with irradiation light containing at least ultraviolet rays in the wavelength region.
A method for inspecting a solid pharmaceutical product, which comprises an imaging step in which the irradiation light receives the reflected light reflected in the coating region and images the coated region and the non-coated region. The method for inspecting a solid preparation according to claim 2, 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. The method for inspecting a solid preparation according to claim 2 or 3, 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.

Images