JP6755165B2 - Pigment fixing composition and solid preparation - Google Patents

Description

The present invention relates to a pigment fixing composition and a solid preparation, and more specifically, it is possible to impart excellent scratch resistance and peel resistance to a printed image formed on a tablet surface of a pharmaceutical product, a food product, or the like. The present invention relates to a pigment fixing composition and a solid preparation having good flightability from an inkjet head.

The inkjet ink for printing on tablets and the like needs to be composed of raw materials conforming to the standards stipulated in the Pharmaceutical Affairs Law and the like. As such inkjet inks, for example, those made of dye inks using water-soluble edible tar pigments and the like as coloring materials and those consisting of pigment inks using edible iron oxide pigments and the like as coloring materials are manufactured and sold. ing.

Among these inkjet inks, the former dye ink has a problem that it fades with the passage of time due to light irradiation and is inferior in light resistance as compared with the latter pigment ink. Therefore, there are an increasing number of cases where pigment inks having excellent light resistance are used for printing on tablets and the like.

However, for example, when printing on a film-coated tablet or a sugar-coated tablet using a pigment ink, these surfaces are smoother than other tablets, so that the pigment of the printing coating film does not sufficiently fix on the tablet surface. There is a problem that the peeled pigment is transferred to other tablets or the like due to peeling. As a result, the cases where the pigment ink can be used for printing the tablet surface are currently limited.

As a method for solving these problems, for example, a method of adding a polymer emulsion composed of a water-insoluble edible polymer compound to a pigment ink as a binder to improve the fixability of the pigment on the tablet surface can be mentioned ( See Patent Document 1 below). However, in the inkjet recording method, it is necessary to secure sufficient flying property of the ink droplets, and from the viewpoint of ensuring the flying property, the amount of the polymer emulsion added to the pigment ink is limited. Therefore, even in the method of adding the polymer emulsion, it becomes difficult as a result to sufficiently fix the pigment in the printed coating film on the tablet surface.

Further, when the pigment ink containing a water-insoluble edible polymer compound dries on the end face of the inkjet head, the pigment ink may solidify at the nozzle of the inkjet head and cause clogging. However, there is also a problem that it is extremely difficult to remove the adhered substances of the pigment ink containing the water-insoluble edible polymer compound even with a cleaning liquid or the like.

JP-A-2016-176016

The present invention has been made in view of the above problems, and an object of the present invention is to improve the fixability of a pigment in a printed image on the surface of a solid preparation such as a pharmaceutical product or food, and to coat and protect the pigment. It is an object of the present invention to provide a pigment fixing composition and a solid preparation capable of improving the scratch resistance and peeling resistance of a printed image.

The inventors of the present application have studied pigment fixing compositions and solid preparations in order to solve the above problems. As a result, they have found that the above-mentioned problems can be solved by adopting the following configuration, and have completed the present invention.

That is, the pigment fixing composition according to the present invention is a pigment fixing composition used for printing a solid preparation by an inkjet method in order to solve the above-mentioned problems, and the pigment fixing composition is said. A pigment fixing component that is permeable to solid preparations, has water-soluble and edible properties, contains at least water, and does not substantially contain a water-insoluble component. Is characterized in that an edible pigment is fixed on the surface of the solid preparation.

The pigment fixing composition having the above constitution is used for a pigment fixing treatment for improving the scratch resistance and peeling resistance of a printed image by fixing an edible pigment on the surface of a solid preparation. The pigment fixing composition having the above composition has a composition containing at least a pigment fixing component and water, and substantially free of a water-insoluble component. On the other hand, the solid preparation is composed of tablets or capsules of pharmaceuticals and foods, and is soluble in water. Therefore, when the pigment fixing composition is brought into contact with the surface of the solid preparation, the pigment fixing composition can be permeated into the solid preparation.

Here, it is considered that the pigment fixing composition of the present invention makes it possible to improve the fixing performance of the pigment on the surface of the solid preparation for the reasons described below. That is, first, the mechanical strength of the surface layer portion of the solid preparation (the portion where the pigment fixing composition has permeated into the solid preparation) can be improved by drying the pigment fixing composition that has permeated the solid preparation. You can do it. As a result, even if the solid preparation receives an external force such as an impact, it is possible to prevent the pigment from being scraped off together with the surface layer portion of the solid preparation, and to reduce the transfer of the pigment to another solid preparation or the like. For example, in the case of a solid preparation that is fragile to an external force and whose surface is easily scraped, even if the pigment itself is firmly fixed to the surface of the solid preparation, the transfer of the pigment is caused by the peeling of the surface layer portion of the solid preparation itself. Can occur. The pigment fixing composition of the present invention can prevent the transfer of the pigment even in such a solid preparation by improving the mechanical strength of the surface layer portion.

Second, when the pigment fixing composition that has permeated the solid preparation is dried, the pigment fixing component contained in the pigment fixing composition functions as an adhesive that firmly fixes the pigment on the surface of the solid preparation. It is a thing. This makes it possible to prevent the pigment from peeling off from the surface of the solid preparation.

Third, when the pigment fixing composition is dried in a state where the pigment on the solid preparation is coated, the dried film functions as an overcoat layer. As a result, even if another solid preparation or the like comes into contact with the pigment fixed on the surface of the solid preparation, the transfer of the pigment can be suppressed.

Therefore, the pigment fixing composition having the above-mentioned structure can improve the mechanical strength of the surface layer portion of the solid preparation, adhere the pigment to the surface of the solid preparation, and further coat and protect the pigment as an overcoat layer. Therefore, it is possible to improve the scratch resistance and the peel resistance of the printed image.

Further, the pigment fixing composition having the above constitution utilizes printing by an inkjet method when fixing the pigment on the surface of the solid preparation, but it is inherently water-soluble and substantially contains a water-insoluble component. Since it is not contained in the above, even if the pigment fixing 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.

In the above configuration, the pigment fixing component is polyvinylpyrrolidone having a number average molecular weight in the range of 2000 to 200,000, and the polyvinylpyrrolidone is 1 to 20% by mass based on the total mass of the pigment fixing composition. It is preferably included in the range.

Since polyvinylpyrrolidone is soluble in water and permeable to solid preparations, after the polyvinylpyrrolidone that has permeated the solid preparation has dried, the surface layer portion of the solid preparation (the portion that has been permeated with polyvinylpyrrolidone) is mechanical. The strength can be improved. In addition, since polyvinylpyrrolidone also has an adhesive function, the pigment can be firmly fixed on the surface of the solid preparation. Further, polyvinylpyrrolidone can function as an overcoat layer when a dry coating film is formed with the pigment on the surface of the solid preparation coated.

Here, in the above configuration, polyvinylpyrrolidone having a number average molecular weight in the range of 2000 to 200,000 is used, and 1% by mass or more is contained in the total mass of the pigment fixing composition. As a result, it is possible to prevent the fixability of the pigment to the solid preparation from being excessively lowered. Further, since polyvinylpyrrolidone having a number average molecular weight in the above numerical range is contained in an amount of 20% by mass or less based on the total mass of the pigment fixing composition, the viscosity of the pigment fixing composition becomes too large and the viscosity is Newtonian. It is possible to prevent a large deviation from the state. As a result, when the pigment fixing composition is discharged by the inkjet method, it can be stably discharged from the inkjet head, and it is possible to suppress the deterioration of the flying property of the droplets of the pigment fixing composition. ..

Further, the solid preparation according to the present invention is a solid preparation in which at least an ink layer and an overcoat layer are sequentially laminated on the surface in order to solve the above-mentioned problems, and the ink layer is a pigment having edible properties. The overcoat layer is composed of a dry film of a pigment fixing liquid composed of the pigment fixing composition, and the pigment in the ink layer is a surface layer portion of the solid preparation. It is characterized in that it is fixed on the surface of the solid preparation by the pigment fixing component in the pigment fixing composition that has penetrated into the ink.

According to the above configuration, since the ink layer is protected by being coated with an overcoat layer formed of a dry film of the pigment fixer, it is excellent in scratch resistance and peeling resistance. Further, a pigment fixing component in the permeated pigment fixing composition is present on the surface layer portion of the solid preparation, and the pigment fixing component firmly fixes the pigment in the ink layer on the surface of the solid preparation. Therefore, for example, even if the solid preparation is a film-coated tablet, a sugar-coated tablet, or the like, in which the pigment is difficult to penetrate into the inside and is difficult to fix, the solid preparation has a printed image having excellent scratch resistance and peeling resistance. Can be provided. Thereby, for example, even when product information or the like is directly printed on the surface of the solid preparation, it is possible to provide a solid preparation capable of further improving the distinctiveness and further preventing dispensing mistakes and accidental ingestion.

The composition for fixing a pigment of the present invention is a composition that contains at least a pigment fixing component and water, does not substantially contain a water-insoluble component, and can penetrate into a solid preparation. Therefore, when a pigment fixing process is performed on a printed image consisting of an ink layer of a pigment by printing by an inkjet method using a pigment fixing solution made of a pigment fixing composition, the pigment fixing component that has penetrated into the solid preparation is released. The mechanical strength of the permeated portion can be improved. As a result, it is possible to prevent the pigment from being scraped by an external force or the like together with the surface layer portion of the solid preparation. In addition, since the pigment fixing component also exerts an adhesive function to the pigment, the pigment can be firmly fixed to the surface of the solid preparation. Further, as a result of the dry film of the pigment fixing solution made of the pigment fixing composition covering the ink layer, it also functions as an overcoat layer and protects the ink layer. This makes it possible to improve the scratch resistance and peel resistance of the printed image printed on the solid manufacturing surface. As a result, it is possible to prevent deterioration of the distinctiveness and visibility of the printed image due to peeling of the pigment, scratches on the ink layer, and the like, and to prevent the occurrence of dispensing mistakes and accidental ingestion.

That is, according to the present invention, the fixability of the pigment to solid preparations such as pharmaceuticals and foods is improved, and by coating and protecting the ink layer, the scratch resistance and peeling resistance of the printed image can be improved. It is possible to provide a composition for a pigment fixing solution that can be improved, a pigment fixing solution containing the composition for the pigment fixing solution, and a solid preparation obtained by performing a pigment fixing treatment with the pigment fixing solution.

(Pigment fixing composition)
The pigment fixing composition according to the present embodiment will be described below.
The pigment fixing composition of the present embodiment is used for a pigment fixing treatment of a printed image printed on the surface of a solid preparation, and is printed by subjecting the solid preparation on which the image is printed to a pigment fixing treatment. It enables improvement of scratch resistance and peel resistance of images.

In the present specification, "scratch resistance" means that, when printed on the surface of a solid preparation using a pigment ink by an inkjet method, a part or all of the pigment of the pigment ink fixed on the surface of the solid preparation is other. It means that it can be suppressed from being peeled off or damaged by rubbing against a solid preparation. Further, "peeling resistance" means that when printing is performed on the surface of a solid preparation using a pigment ink by an inkjet method, it is possible to prevent a part or all of the pigment of the pigment ink fixed on the surface of the solid preparation from peeling. Means to get.

The pigment fixing composition of the present embodiment has a structure containing at least a water-soluble and edible pigment fixing component and water, and substantially no water-insoluble component. The pigment fixing composition of the present embodiment is edible because it is composed of a pharmaceutical additive specified by the Pharmaceutical Affairs Law, a material conforming to the standards of the Japanese Pharmacopoeia or the official standard of food additives. , Suitable for use in solid preparations consisting of tablets or capsules of pharmaceuticals and foods.

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 means a case in which 1 g or more is dissolved in 100 g of water under normal temperature and pressure. Further, the "water-soluble component" means a component having such water-soluble property. Further, as used herein, the term "edible" refers to a substance approved for oral administration as a drug or a pharmaceutical additive, and / or a substance approved as a food or a food additive.

Further, the "normal 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 atmospheric pressure near 101 kPa in absolute pressure. It means a condition. 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. Specifically, for example, polyvinylpyrrolidone and the like can be mentioned. Polyvinylpyrrolidone is a water-soluble polymer and falls under the category of pharmaceutical additives specified by the Pharmaceutical Affairs Law. Further, polyvinylpyrrolidone has adhesiveness (wetting property) and film forming property to pigments and the like.

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 a solid form by itself under 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 pigment fixing composition is excessively increased, and the viscosity greatly deviates from the Newtonian state, so that the droplets of the pigment fixing composition It is possible to prevent the flight property from being lowered.

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. : Can be measured 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 its content is preferably 1% by mass or more, more preferably 2% by mass or more, based on the total mass of the pigment fixing composition. Particularly preferably, it is 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 pigment fixing 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 pigment fixing composition is excessively increased, and the viscosity greatly deviates from the Newtonian state, and the pigment fixing composition is concerned. It is possible to prevent the flying property of the droplets from being lowered.

The water contained in the pigment fixing composition of the present embodiment is pure water such as ion-exchanged water, ultrafiltration water, reverse osmosis water, distilled water, or ultrapure water from which ionic impurities have been removed. Is preferably used. 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. Further, the water content is not particularly limited and can be appropriately set as needed.

The pigment fixing composition of the present embodiment does not substantially contain a water-insoluble component and is water-soluble. Therefore, the pigment fixing composition of the present embodiment can penetrate into a solid preparation when the pigment fixing 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, it means that the solubility under normal temperature and pressure is less than 1 g with respect to 100 g of water. .. 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 (Methacrylate 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 Acrylic / Methyl Methacrylate Copolymer Dispersion) , Eudragit FS30D (methyl acrylate, methyl methacrylate, copolymer of methacrylate) 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 pigment fixing composition does not substantially contain the water-insoluble component, not only when the water-insoluble component does not exist at all, but also when the content is inevitably present as an impurity or the like. It is a meaning including the case of.

Further, the pigment fixing 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 the Pharmaceutical Affairs Law and the like, and for example, caprylic acid decaglyceryl, lauric acid hexaglycerin ester, oleic acid hexaglycerin ester, condensed linolenic acid tetraglycerin ester, etc. Examples thereof include fatty acid ester coconut palm, decaglyceryl laurate having an HLB of 15 or less, and 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, HLB value 14.8 manufactured by Sakamoto Yakuhin Kogyo Co., Ltd.) 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 Pharmaceutical 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 Glister MO-5S (trade name, manufactured by Sakamoto Pharmaceutical 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 pigment fixing 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 meniscus surface formation at the nozzles of the inkjet head are prevented, and the nozzle eyes are prevented. It is possible to prevent clogging 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 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 pigment fixing 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 Standard specified 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 pigment fixing 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 pigment fixing 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 pigment fixing 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 pigment fixing 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. As a result, the pigment fixing composition according to the present embodiment can be obtained.

In addition, the pigment fixing composition of the present embodiment uses an edible pigment fixing component that conforms to the standards of pharmaceutical additives, the Japanese Pharmacopoeia, or the official standard of food additives specified by the Pharmaceutical Affairs Law and the like. Therefore, it is possible to directly apply it on a printed image of a solid agent consisting of tablets or capsules such as pharmaceuticals or supplements.

(Pigment fixing treatment)
The pigment fixing composition of the present embodiment is used for a pigment fixing treatment in a printed image printed on the surface of a solid preparation. Specifically, the fixing process is performed by applying a pigment fixing solution made of a pigment fixing composition to a printed image. The coating is performed by an inkjet method, and more specifically, the pigment fixing solution is ejected as droplets onto a solid preparation on which an image is printed from a fine nozzle, and the droplets are adhered onto the printed image. 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 amount of the pigment-fixing droplets ejected from the nozzle 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. it can. 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.

After the droplets of the pigment fixer are ejected and adhered to the ink layer of the printed image of the solid preparation, natural drying or heat drying is performed. As a result, the pigment fixing solution that has permeated the surface layer of the solid preparation can be dried, and the pigment fixing component contained in the pigment fixing solution adheres to the surface of the solid preparation to form the solid. Firmly adheres to the surface of the formulation. Further, the coating film layer formed on the ink layer becomes a dry film by drying and functions as an overcoat layer. The drying time and drying temperature are not particularly limited, and can be appropriately set according to the printing speed, the type of solid preparation, and the like.

When heat-drying is performed, the method is not particularly limited as long as it promotes the evaporation of the solvent (water) in the pigment fixer. For example, a method of blowing hot air onto a recording medium to which droplets of a pigment fixer are attached, a method of treating with warm air such as radiant heating, conduction heating, high frequency drying, and a method of heating with a heater can be mentioned. Since the pigment fixing composition of the present embodiment does not substantially contain a water-insoluble component, it is assumed that the pigment fixing solution composed of the pigment fixing composition is dried and fixed on the end face of the inkjet head or the like. Can be easily removed with an aqueous cleaning solution or the like.

(Solid preparation)
In the present specification, the term "solid preparation" means a food preparation and a pharmaceutical preparation, and examples of the solid preparation include tablets or capsules such as OD tablets, uncoated tablets, FC tablets, and sugar-coated tablets.

In the solid preparation of the present embodiment, at least an ink layer and an overcoat layer are sequentially laminated on the surface.

The ink layer is formed of a dry film of a water-based inkjet ink containing an edible pigment, and forms a printed image.

As edible pigments, carbon black conforming to the standards of pharmaceutical additives, Japanese Pharmacy Law or Food Additives Official Regulations 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 ink layer can be formed by printing by an inkjet method under arbitrary conditions. The thickness of the ink layer is not particularly limited, and can be appropriately set as needed.

The overcoat layer is composed of a dry film of a pigment fixing solution made of a pigment fixing composition, and is provided in a state of being covered with an ink layer. The overcoat layer can physically protect the ink layer, and more specifically, it provides protection against scratches, abrasion, blocking and ferrotyping of the ink layer.

The overcoat layer preferably has light transparency from the viewpoint of ensuring good visibility of the printed image (that is, the ink layer). However, the overcoat layer has an arbitrary color for color correction or other purposes within a range that does not adversely affect the visibility when the printed image is visually recognized through the overcoat layer. May be good. In that case, the pigment fixer forming the overcoat layer may contain a water-soluble dye or the like conforming to a standard specified by the Pharmaceutical Affairs Law or the like. The term "light transparency" means that the printed image formed by the ink layer can be visually visually recognized through the overcoat layer.

Further, a pigment fixing component is present in the surface layer portion of the solid preparation (the portion in which the pigment fixing solution made of the pigment fixing composition has penetrated). This pigment fixing component is derived from the pigment fixing composition, and is a residual component of the pigment fixing solution that has permeated the surface layer portion of the solid preparation after drying. Then, since the pigment fixing component is present in the surface layer portion of the solid preparation, the mechanical strength of the surface layer portion can be improved. As a result, even if the solid preparation receives an external force such as an impact, it is possible to prevent the pigment from being scraped off together with the surface layer portion of the solid preparation, and to reduce the transfer of the pigment to another solid preparation or the like. Further, since this pigment fixing component existing in the surface layer portion exhibits adhesiveness to the pigment in the ink layer, the pigment is firmly fixed (fixed) to the surface of the solid preparation. As a result, the scratch resistance and peeling resistance of the ink layer are further improved.

As described above, in the solid preparation of the present embodiment, the pigment of the ink layer formed on the solid preparation is firmly fixed by the pigment fixing component present on the surface layer portion of the solid preparation, and is over. Since the coat layer covers and protects the ink layer, it has a printed image having excellent scratch resistance and peeling resistance. As a result, even when product information related to solid preparations is displayed as a printed image, deterioration of the distinctiveness and visibility of the printed image due to peeling of pigments and scratches on the ink layer is suppressed, and dispensing mistakes and accidental ingestion occur. Occurrence can be further prevented.

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.

(Preparation of water-based ink composition for inkjet)
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 tensioning 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% by mass. A water-based ink composition for inkjet was prepared so as to be%. 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 value in Table 1 is a value of mass% with respect to the total mass of the pigment dispersion solution, and the numerical value in Table 2 is a value of mass% with respect to the total mass of the aqueous ink composition unless otherwise specified. .. In addition, each material conforms to the standards of pharmaceutical additives, the Japanese Pharmacopoeia, or the official standard of food additives specified by the Pharmaceutical Affairs Law.

(Image printing by inkjet method)
Using the above-mentioned water-based ink composition, printing was performed on only one side of each of the sugar-coated tablet and the film-coated tablet (both having a diameter of about 7 mm) by an inkjet recording method. Printing was performed by a single-pass (one-pass) method using an inkjet printer (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 printed image surface was dried by natural drying for 24 hours.

(Example 1)
The pigment fixing composition according to this example was prepared with the compounding composition shown in Table 3 below. That is, polyvinylpyrrolidone K12 (manufactured by BASF Japan Ltd.) having a number average molecular weight of about 4000 as a pigment fixing component is 20.0% by mass, and decaglyceryl caprylate (manufactured by Sakamoto Yakuhin Kogyo Co., Ltd.) is used as a surface tension adjuster. A composition for fixing a pigment according to this example was prepared by putting 0% by mass and 78.0% by mass of ion-exchanged water in a container and stirring and mixing them.

Unless otherwise specified, the numerical values in Table 3 below are all expressed in% by mass. In addition, each material conforms to the standards of pharmaceutical additives, the Japanese Pharmacopoeia, or the official standard of food additives specified by the Pharmaceutical Affairs Law.

(Example 2)
In this example, polyvinylpyrrolidone K17 (manufactured by BASF Japan Ltd.) having a number average molecular weight of about 10,000 was used as the pigment fixing component. A pigment fixing composition according to this example was prepared in the same manner as in Example 1 except for the above.

(Example 3)
In this example, polyvinylpyrrolidone K30 (manufactured by BASF Japan Ltd.) having a number average molecular weight of about 40,000 is used as the pigment fixing component, and the content of polyvinylpyrrolidone K30 is 5 with respect to the total mass of the pigment fixing composition. The content of 0.0% by mass and ion-exchanged water was changed to 93.0% by mass. Other than these, a pigment fixing composition according to this example was prepared in the same manner as in Example 1.

(Example 4)
In this example, polyvinylpyrrolidone K60 (manufactured by Tokyo Chemical Industry Co., Ltd.) having a number average molecular weight of about 160,000 is used as the pigment fixing component, and the content of polyvinylpyrrolidone K60 is added to the total mass of the pigment fixing composition. The content of 1.0% by mass and ion-exchanged water was changed to 97.0% by mass. Other than these, a pigment fixing composition according to this example was prepared in the same manner as in Example 1.

(Comparative Example 1)
In this comparative example, polyvinylpyrrolidone K90 (manufactured by BASF Japan Ltd.) having a number average molecular weight of about 360000 was used as the pigment fixing component. A pigment fixing composition according to this comparative example was prepared in the same manner as in Example 4 except for these.

(Measurement of number average molecular weight)
The number average molecular weight of polyvinylpyrrolidone is a value obtained under the following conditions by gel permeation chromatography 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 (added 0.01 molLiBr)
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

(Measurement of viscosity)
The viscosities of the pigment fixing compositions of Examples 1 to 4 and Comparative Example 1 were measured, respectively. The viscosity was measured using a viscometer (VISCOMATE MODEL VM-10A, manufactured by SEKONIC CORPORATION) under the condition of a measurement temperature of 25 ° C. The results are shown in Table 3 above.

(Discharge stability (flying property))
Matte paper (trade name: Super Fine Paper, manufactured by Epson Corporation) was prepared as a recording medium, and printing was performed by an inkjet method using the pigment fixing compositions of Examples 1 to 4 and Comparative Example 1, respectively. .. Printing was performed by a single-pass (one-pass) method using an inkjet printer (a printing jig equipped with a KC 600 dpi head).

To evaluate the flight property of the pigment fixing composition, how much nozzle chipping increased in the printed image when the inkjet printer was stopped after ejecting the pigment fixing composition from the head and then reprinted, and It was done depending on whether or not sleepiness was observed. The chipping of the nozzle means that the droplets of the pigment fixing composition are not ejected from the nozzle in which the clogging occurs. The term "sleeping" means that, in the early stage of printing, the droplets of the pigment fixing composition are not ejected, and the exported portion of the printed image is blurred and becomes unclear.

The flight property was evaluated using the following criteria. The results are shown in Table 3 above.
◯: The amount of sleep is less than 1 cm and the number of nozzle clogging increases is 0 ×: The amount of sleep is 2 cm or more, or the number of nozzle clogging increases is 10 or more Δ: When the flight property evaluation does not correspond to any of the above ○ and × The flight property was evaluated for printing after an open time of 15 minutes (a time interval between first discharging the pigment fixing composition from the head and then stopping and then printing again). The amount of sleepiness means the length (cm) until the blurring of writing due to the pigment fixing composition not being ejected in the single-pass printed image is eliminated. The number of nozzle clogging increases means the number of nozzles in which the pigment fixing composition cannot be ejected due to drying and fixing of the pigment fixing composition on the end face of the head while the inkjet printer is stopped. ..

(Scratch resistance / peel resistance)
Using the pigment fixing composition of Example 3, 20 tablets each of sugar-coated tablets and film-coated tablets on which images were printed were subjected to pigment fixing treatment. The pigment fixing treatment was performed by a single-pass (one-pass) method using an inkjet printer (printing jig equipped with a KC 600 dpi head). The discharge conditions of the pigment fixing composition were 7 ng for the mass per droplet and 7 pl for the appropriate amount of the liquid. Further, after discharging the pigment fixing composition, it was naturally dried for 24 hours at room temperature (25 ° C.).

After the pigment fixing treatment, a bottle shaking test was performed to confirm the scratch resistance and peeling resistance of the pigment. Specifically, 20 sugar-coated tablets after the pigment fixing treatment were placed in a glass bottle having a volume of 50 cc, and the bottle was manually shaken for 1 minute. As a result, a collision load was applied to the printed surface to evaluate scratch resistance and peel resistance. A similar bottle swing test was also performed on film-coated tablets. After the bottle shaking test, the presence or absence of pigment transfer on the surface opposite to the printed surface was observed using an electronic loupe for each of the sugar-coated tablets and the film-coated tablets. In addition, image-printed sugar-coated tablets and film-coated tablets that had not been subjected to pigment fixing treatment were also subjected to bottle shaking tests. The results are shown in Table 4 below. In Table 4, the pigments having the highest degree of transfer are listed.

(result)
As shown in Table 3, the pigment fixing compositions of Examples 1 to 4 containing polyvinylpyrrolidone having a number average molecular weight in the range of 2000 to 200,000 as a pigment fixing component all have good flight properties and are discharged. It was confirmed that the performance was excellent. On the other hand, in the pigment fixing composition of Comparative Example 1 containing polyvinylpyrrolidone having a number average molecular weight of about 360,000 as a pigment fixing component, the content of the polyvinylpyrrolidone was 1.0% by mass with respect to the total mass. Was confirmed to be inferior in flight performance.

Further, as shown in Table 4, when each of the sugar-coated tablet and the film-coated tablet is subjected to the pigment fixing treatment using the pigment fixing composition according to Example 3, the transfer due to the peeling of the pigment is significantly suppressed. It was confirmed that On the other hand, in sugar-coated tablets and film-coated tablets that have not been subjected to pigment fixing treatment, improvement in transfer due to pigment peeling could not be confirmed.

Claims (2)

A pigment fixing composition used for printing on solid preparations by an inkjet method.
The pigment fixing composition is permeable to the solid preparation and
It contains at least water-soluble and edible pigment fixing components and water, and does not substantially contain water-insoluble components and pigments .
Further, the pigment fixing components all SANYO fixing the edible pigment to said solid formulation surface,
The pigment fixing component is polyvinylpyrrolidone having a number average molecular weight in the range of 2000 to 200,000.
The polyvinylpyrrolidone is a pigment fixing composition contained in a range of 1 to 20% by mass with respect to the total mass of the pigment fixing composition. A solid preparation in which at least an ink layer and an overcoat layer are sequentially laminated on the surface.
The ink layer comprises a dry film of a water-based inkjet ink containing an edible pigment.
The overcoat layer is composed of a dry film of a pigment fixing solution made of the pigment fixing composition according to claim 1 .
Further, the pigment in the ink layer is a solid preparation fixed on the surface of the solid preparation by the pigment fixing component in the pigment fixing composition that has penetrated into the surface layer portion of the solid preparation.