JP2019135296A - Manufacturing method of solid chemical, and inkjet ink set - Google Patents

Abstract

To provide a manufacturing method of a solid chemical having a colored part in which bleeding in a solid chemical surface is suppressed.SOLUTION: A manufacturing method of a solid chemical having a colored part in at least part of the surface includes a process for attaching an ink composition for inkjet containing an edible color material, an edible material that can be gelatinized or ion-associated by the interaction with a material contained in the solid chemical surface or its neighborhood, and a solvent containing one or more selected from a group consisting of water and an aqueous solvent to a solid chemical surface by an inkjet method.SELECTED DRAWING: None

Description

  The present invention relates to a method for producing a solid drug having a colored portion on the surface, an ink-jet ink composition for forming the colored portion, an ink jet ink set, and a solid drug having a colored portion on the surface.

  Many solid drugs are designed in consideration of absorption and stability of active ingredients, and their shapes are similar. Therefore, it may be difficult to determine the type of the solid medicine taken out from the packaging container. Conventionally, a method of marking the name or abbreviation of a solid drug has been used. However, since the stamped part has the same color as the original solid drug, there are cases where the discrimination power is insufficient. In addition to the name of the solid drug, printing using ink on the surface of the solid drug has been studied in response to a request to write a lot of information such as the manufacturing date and lot number.

  In Patent Document 1, as a tablet having a dry film of ink on which information for enhancing discrimination is printed on the surface of a specific tablet, the hardness of the dry film of the ink at the time of drying is specified on the surface of the specific tablet. A tablet formed by printing with an ink having a pencil hardness of 2B to 4H is disclosed.

  In Patent Document 2, even when printing on an orally disintegrating tablet, color transfer of the printed part does not occur, and the disintegration property in the oral cavity is not impaired, and the printed orally disintegrating tablet is stored at high humidity. As a edible inkjet ink composition with excellent weather resistance, the printed portion does not blur, an edible pigment that is a synthetic pigment aluminum lake, a specific food binder, a water-soluble solvent, water, An ink-jet ink composition for orally disintegrating tablets is disclosed.

International Publication No. 2014/014010 Pamphlet JP 2012-111824 A

  When an ink composition is deposited on a solid drug by an ink jet ink method, the ink composition has a problem that it easily flows or diffuses on the surface of the solid drug. On the other hand, from the viewpoint of preventing bleeding, when the viscosity of the ink is increased, there is a problem that the ink jet nozzle is easily clogged. For example, in Patent Document 1, an ink jet printer having an ink jet nozzle having a relatively large nozzle diameter of 40 μm is used.

  The present invention has been made in view of the above circumstances, a method for producing a solid drug having a colored portion in which bleeding on the surface of the solid drug is suppressed, an ink-jet ink composition in which bleeding on the surface of the solid drug is suppressed, and It is an object of the present invention to provide an inkjet ink set and a solid medicine having a colored portion in which bleeding is suppressed.

The method for producing a first solid drug according to the present invention includes:
A method for producing a solid drug having a colored portion on at least a part of a surface,
It includes at least one selected from the group consisting of an edible colorant and an edible substance that can be gelled or ionically associated with a substance contained on or near the surface of the solid drug, and water and an aqueous solvent. It has the process of attaching the ink composition for inkjet containing a solvent to the solid chemical | medical agent surface by the inkjet method.

  In the first method for producing a solid drug according to the present invention, the viscosity of the ink-jet ink composition is 20 cP or less, so that clogging of the ink-jet nozzle is suppressed and a high-definition colored portion is obtained. To preferred.

  In the first method for producing a solid drug according to the present invention, one of the substance contained on or near the solid drug surface and the edible substance is selected from the group consisting of gelatin and a protein degradation product. It is preferable from the point which suppresses the bleeding in the surface of a solid chemical | medical agent that it is 1 or more types of compounds and the other is a polysaccharide which has an acidic group.

  In the first method for producing a solid drug according to the present invention, one of the substance contained on or near the solid drug surface and the edible substance is sodium alginate and the other is a calcium salt. It is preferable from the viewpoint of suppressing bleeding on the surface of the solid drug.

The second method for producing a solid drug according to the present invention comprises:
A method for producing a solid drug having a colored portion on at least a part of a surface,
A first ink composition containing a first edible colorant, a first edible substance, and a solvent containing at least one selected from the group consisting of water and an aqueous solvent is provided on the surface of the solid drug. A step of attaching by an inkjet method;
One or more selected from the group consisting of a second edible colorant and a second edible substance that can be gelled or ion associated by interaction with the first edible substance, water and an aqueous solvent And a step of adhering a second ink composition containing a solvent containing a solvent to the surface of the solid drug to which the first ink composition is adhered by an inkjet method.

  In the second method for producing a solid medicine according to the present invention, the viscosity of the first ink composition and the viscosity of the second ink composition are each 20 cP or less, and the clogging of the ink jet nozzle is caused. Is preferable, and a high-definition colored portion can be obtained.

  In the second method for producing a solid drug according to the present invention, one of the first edible substance and the second edible substance is selected from the group consisting of gelatin and a protein degradation product. It is preferable from the point which suppresses the bleeding in the surface of a solid chemical | medical agent that it is the above compound and the other is a polysaccharide which has an acidic group.

  In the second method for producing a solid drug according to the present invention, one of the first edible substance and the second edible substance is sodium alginate and the other is a calcium salt. It is preferable from the viewpoint of suppressing bleeding on the surface of the solid drug.

The ink-jet ink composition according to the present invention comprises:
An ink composition for solid drug surface printing,
It is selected from the group consisting of edible coloring materials, edible substances containing at least one selected from gelatin, protein degradation products, polysaccharides having acidic groups, sodium alginate, and calcium salts, and water and aqueous solvents. It contains the solvent containing 1 or more types, It is characterized by the above-mentioned.

  The ink composition for inkjet according to the present invention preferably has a viscosity of 20 cP or less from the viewpoint of suppressing clogging of the inkjet nozzle and obtaining a high-definition colored portion.

The inkjet ink set according to the present invention is:
An ink set for printing a solid drug surface,
A first ink composition comprising a first edible colorant, a first edible substance, and a solvent containing one or more selected from the group consisting of water and an aqueous solvent;
One or more selected from the group consisting of a second edible colorant and a second edible substance that can be gelled or ion associated by interaction with the first edible substance, water and an aqueous solvent And an ink set for inkjet, comprising a second ink composition containing a solvent containing

  In the inkjet ink set according to the present invention, the viscosity of the first ink composition and the viscosity of the second ink composition are 20 cP or less, respectively, to suppress clogging of the inkjet nozzle, Moreover, it is preferable from the point from which a high-definition colored part is obtained.

  In the ink set for inkjet according to the present invention, one of the first edible substance and the second edible substance is one or more compounds selected from the group consisting of gelatin and protein degradation products. It is preferable that the other is a polysaccharide having an acidic group from the viewpoint of suppressing bleeding on the surface of the solid drug.

  In the inkjet ink set according to the present invention, one of the first edible substance and the second edible substance is sodium alginate and the other is a calcium salt. It is preferable from the viewpoint of suppressing bleeding on the surface.

The solid drug according to the present invention is formed on at least a part of the surface,
An association product of a gelled product of sodium alginate, or one or more compounds selected from the group consisting of gelatin and a protein degradation product and a polysaccharide having an acidic group;
It has a coloring part containing an edible coloring material.

  ADVANTAGE OF THE INVENTION According to this invention, the manufacturing method of the solid chemical | medical agent which has the coloring part by which the bleeding on the solid chemical | medical agent surface was suppressed, the inkjet ink composition by which the bleeding on the surface of a solid chemical | medical agent is suppressed, an inkjet ink set, and a bleeding It is possible to provide a solid drug having a colored portion in which the suppression is suppressed.

  Hereinafter, with respect to the method for producing a solid drug, the ink composition for inkjet, the inkjet ink set, and the solid drug according to the present invention, the method for producing the first solid drug, the ink composition for inkjet, and the second solid drug The manufacturing method, inkjet ink set, and solid drug will be described in this order.

A. Manufacturing method of the 1st solid medicine The manufacturing method of the 1st solid medicine concerning the present invention,
A method for producing a solid drug having a colored portion on at least a part of a surface,
It includes at least one selected from the group consisting of an edible colorant and an edible substance that can be gelled or ionically associated with a substance contained on or near the surface of the solid drug, and water and an aqueous solvent. It has the process of attaching the ink composition for inkjet containing a solvent to the solid chemical | medical agent surface by the inkjet method.

  According to the first method for producing a solid drug of the present invention, a solid drug having a colored portion in which bleeding on the surface of the solid drug is suppressed can be obtained.

The ink-jet ink composition used in the first method for producing a solid drug of the present invention has an edible substance (hereinafter referred to as “an edible substance that can be gelled or ion associated by interaction with a substance contained on or near the solid drug surface” It may be called "specific edible substance"). When such an ink-jet ink composition adheres to the surface of a solid drug, the specific edible substance gels or associates with the substance contained in or near the surface of the solid drug, and the edible The fluidity of the substance is reduced. It is presumed that the edible colorant in the ink composition is also fixed on the surface of the solid drug as the fluidity of the edible substance decreases. In the present invention, the above interaction is presumed to occur in a short time before the solvent in the ink composition evaporates. Therefore, according to the production method of the present invention, it is a case where water as a solvent has relatively high fluidity and takes a long time to dry, and even when the solvent diffuses on the surface of the solid drug, Since only the solvent diffuses and the edible color material hardly diffuses, it is presumed that bleeding of the colored portion is difficult to occur.
From the above, according to the first method for producing a solid drug of the present invention, a solid drug having a colored portion in which bleeding on the surface of the solid drug is suppressed can be obtained. In addition, according to the production method of the present invention, since the penetration of the edible colorant into the solid drug is suppressed, the color density in the colored part can be increased and a colored part excellent in visibility can be obtained.
Furthermore, according to the production method of the present invention, it is possible to use an ink composition having a low viscosity, so that high-definition printing of, for example, 300 dpi or more, further 600 dpi or more can be performed, and clogging of inkjet nozzles is suppressed. The

[Solid drug]
In the present invention, “solid drug” refers to a solid drug having a printable surface. Although it does not specifically limit with the solid chemical | medical agent which has a printable surface, For example, it can be set as the solid chemical | medical agent which has a surface area of 10 mm < ² > or more. In addition, the surface of the solid drug may be flat or curved, and is not limited to a flat surface, may have irregularities, and may have voids near the surface. Good.
Further, in the present invention, the “solid drug surface or its vicinity” includes not only the outermost surface of the solid drug but also a depth that is visible when the edible color material is fixed. Although the depth which can be visually recognized is not specifically limited, For example, it can be set as the range from the surface of a solid chemical | medical agent to the depth of 100 nm.

  The shape of the solid drug in the first method for producing a solid drug according to the present invention is only required to have a printable surface, and the solid drug taken orally can absorb the active ingredient in the drug and stabilize the quality. It is designed in consideration of the properties and the like, and is not particularly limited in relation to the present invention, and can be a conventionally known shape. Specific examples of the shape of the solid drug include capsules, tablets, pills, troches, and the like, and tablets, pills, troches, and the like may be coating agents having a coating layer. An uncoated tablet without a coating layer may be used.

According to the production method of the present invention, the specific edible substance in the ink composition for ink jet described later gelates or ion-associates on the surface of the solid drug. Bleeding is suppressed. In particular, the production method of the present invention hardly causes bleeding of the colored portion even when an uncoated tablet having voids is used as the solid drug. It is presumed that bleeding of the edible colorant is suppressed by the gelled product or ion aggregate of the edible substance closing the void. When the solid drug has voids, the porosity represented by the following formula (1) is preferably 30% or less, more preferably 1 to 25%, from the viewpoint of suppression of bleeding. Even more preferably, it is 5 to 20%.
Formula (1): Porosity = {V− (W / ρ)} / V × 100 (%)
(In formula (1), V represents the volume of the solid drug, W represents the mass of the solid drug, and ρ represents the specific gravity of the powder constituting the solid drug.)

  The solid drug usually contains at least a pharmacologically active substance (active ingredient) and, if necessary, further contains various edible additives that are approved for use in pharmaceuticals. The physical active ingredient is not particularly limited, and is appropriately selected according to the use of the solid drug. Examples of additives used as necessary include excipients, binders, disintegrants, lubricants, stabilizers, preservatives, buffering agents (pH adjusters), corrigents, flavoring agents, and coloring agents. Agents and the like. In the present invention, the solid drug may be a coating agent having a coating layer or a capsule.

In the present invention, when the solid drug is the above-mentioned base, the substance contained on the surface of the solid drug or in the vicinity thereof is a pharmacologically active ingredient and an additive used as necessary.
In the present invention, when the solid drug is the coating agent, the substance contained on or near the surface of the solid drug is a substance constituting the coating layer. In the present invention, when the solid drug is the capsule, the substance contained on or near the surface of the solid drug is a substance constituting the capsule.

  The substance contained on the surface of the solid drug or in the vicinity thereof includes a substance that can interact with a specific edible substance in the ink-jet ink composition described later to cause the specific edible substance to gel or ion associate. The substance that can interact with the edible substance may be selected as appropriate in relation to a specific edible substance in the inkjet ink composition described below. Usually, a substance on the surface of a solid drug is selected in advance in consideration of absorption of an active ingredient in the drug, stability of quality, etc., and a specific edible substance in an ink-jet ink composition to be described later is selected accordingly. Is preferably selected.

  The solid drug excipient can be appropriately selected from known ones, such as sucrose, tactitol, trehalose, maltose, saccharose, glucose, palatinit, palatinose, isomaltoligosaccharide, fructose, maltose, sucrose. Sugars such as lactose; sugar alcohols such as sorbitol, maltitol, xylitol; polysaccharides such as starches such as corn starch, magnesium aluminate silicate, calcium hydrogen phosphate, aluminum silicate, calcium phosphate, calcium carbonate, Examples thereof include inorganic acid compounds such as calcium silicate, magnesium silicate, magnesium oxide, and magnesium hydroxide, polyvinyl alcohols, and the like, which can be used alone or in combination of two or more. In the present invention, it is preferable to contain a polysaccharide having an acidic group or an inorganic acid compound containing calcium from the viewpoint of gelling or ion-associating with an edible substance in the inkjet ink composition described below. .

  The excipient in the solid drug is appropriately prepared according to the purpose of the drug, but is usually 0.1 to 70% by mass and preferably 1 to 60% by mass in the solid drug. 5 to 50% by mass is more preferable.

The solid drug binder can be appropriately selected from known ones, and examples thereof include polysaccharides such as agarose and gum arabic, gelatin, and the like.
The content of the binder in the solid drug is appropriately adjusted according to the purpose of the drug, but is usually 0.1 to 50% by mass and 1 to 40% by mass in the solid drug. Is preferable, and it is more preferable to contain 5-30 mass%.

When the solid drug is coated, examples of the coating include polysaccharides such as sucrose, cellulose, and starch.
When the solid drug is a capsule, the composition containing the pharmacologically active ingredient is filled into the capsule in the form of liquid, suspension, semi-solid, powder, granule, etc., or covered with a capsule base material. The capsule is manufactured by encapsulating, and the capsule generally contains gelatin.

In the present invention, the solid drug is one or more compounds selected from the group consisting of gelatin and a protein degradation product, a substance having an acidic group, sodium alginate, or a substance contained on or near the surface of the solid drug. It is preferable to have a calcium salt.
The calcium salt may be an active ingredient itself, such as a calcium preparation, in addition to the above-described excipient component.

  The content ratio of one or more compounds selected from the group consisting of gelatin and protein degradation products in the solid drug, polysaccharide having an acidic group, sodium alginate, or calcium salt is a solid drug because it suppresses bleeding. It is preferable that it is 1-80 mass% with respect to 100 mass parts of whole quantity, and it is more preferable that it is 5-60 mass%.

[Inkjet ink composition]
In the first method for producing a solid drug of the present invention, the ink composition for inkjet may be gelled or ion associated by interaction between an edible colorant and a substance contained on or near the surface of the solid drug. An edible substance and a solvent containing one or more selected from the group consisting of water and an aqueous solvent are contained. The ink-jet ink composition contains an edible substance that can be gelled or ionically associated with the solid drug surface or a substance contained in the vicinity thereof, so that the edible substance is gelled on the solid drug surface. By forming or ion-associating, fluidity is lowered, and a colored portion in which bleeding is suppressed can be obtained.

  The inkjet ink composition of the present invention contains at least an edible colorant, an edible substance, and a solvent, and further contains other components as necessary within the range not impairing the effects of the present invention. You may contain. Hereinafter, each component of such an inkjet ink composition will be described in order.

(Edible color material)
In the present invention, the edible color material can be appropriately selected and used from conventionally known color materials that can be taken orally according to the desired color. The edible colorant is preferably a substance used as a food or food additive. As specific examples, natural pigments such as Benikouji pigment, gardenia pigment, cochineal pigment, rack pigment, beet red, anthocyanin pigment, safflower pigment, red pepper pigment, anato pigment, marigold pigment, carotene pigment, turmeric pigment, caramel pigment, Examples include, but are not limited to, edible red No. 2, No. 3, No. 40, No. 102, No. 106; Edible blue No. 1, No. 2; Edible yellow No. 4, No. 5; Is not to be done. One edible color material may be used alone, or two or more edible color materials may be used in combination.

  The content ratio of the edible color material in the inkjet ink composition may be appropriately adjusted so as to enable desired color development, and is not particularly limited, but includes the solvent in the ink composition from the viewpoint of color developability. The total amount is preferably 100 to 30 parts by mass, more preferably 0.5 to 30 parts by mass, and more preferably 1 to 20 parts by mass.

(Edible substance)
The ink-jet ink composition used in the present invention contains an edible substance that can be gelled or ion associated by interaction with a substance contained on or near the surface of the solid drug. The edible substance is appropriately selected and used depending on the substance contained on the surface of the solid drug or in the vicinity thereof. Hereinafter, a preferable combination of a substance contained on or near the solid drug surface and the edible substance will be described.

(1) When the solid drug surface or its vicinity contains one or more compounds selected from the group consisting of gelatin and protein degradation products, it is preferable to use a polysaccharide having an acidic group as the edible substance. This is because the fluidity is lowered by ionic association between the amino group of the gelatin or protein degradation product and the acidic group of the polysaccharide.

  In the present invention, the polysaccharide refers to a compound in which at least two monosaccharides form a sugar chain by a glycosidic bond. In the present invention, the polysaccharide having an acidic group refers to a polysaccharide having one or more acidic groups in the sugar chain. Specific examples of the acidic group include a carboxy group, a sulfo group, a phosphoric acid group, and salts thereof.

In the present invention, the polysaccharide having an acidic group may contain a monosaccharide (saccharide acid) having an acidic group in the sugar chain of the polysaccharide, and the hydroxyl group, aldehyde group, or ketone group in the polysaccharide It may be a polysaccharide derivative substituted with an acidic group.
Specific examples of polysaccharides having an acidic group include aldones such as ribbon acid, arabinonic acid, xylonic acid, lyxonic acid, aronic acid, altronic acid, gluconic acid, mannonic acid, gulonic acid, idonic acid, galactonic acid and talonic acid. Acids; uronic acids such as glucuronic acid, iduronic acid, galacturonic acid, mannuronic acid; and the like, but are not limited thereto.

The polysaccharide having an acidic group used in the present invention preferably has a pH of 6 or less when a 2% aqueous solution is used. This is because when the pH is 6 or less, ion association with the amino group of gelatin or the like easily proceeds and bleeding is further suppressed.
The molecular weight of the polysaccharide having an acidic group used in the present invention is not particularly limited, but the number average molecular weight is preferably 10,000 or more, more preferably 50,000 or more, and 100,000 or more. It is preferably 500,000 or less. When the number average molecular weight is 10,000 or more, the fluidity after ion association is more likely to be lowered, and bleeding is more likely to be suppressed. On the other hand, when the number average molecular weight is 500,000 or less, clogging of the ink jet nozzle is suppressed, and a finer colored portion can be formed.

Among the polysaccharides having acidic groups used in the present invention, it is preferable to select and use thickening polysaccharides having acidic groups from among the polysaccharides used as thickening stabilizers in foods. .
Specific examples of the thickening polysaccharide having an acidic group include carrageenan, xanthan gum, gellan gum, gum arabic, alginic acid, hemicellulose and the like. It is particularly preferable to include gum arabic from the viewpoint of suppressing bleeding of the colored portion. The polysaccharide which has an acidic group may be used individually by 1 type, and may be used in combination of 2 or more type.

  It is preferable that the content rate of the polysaccharide which has an acidic group in the ink composition for inkjets is 0.5-10 mass parts with respect to 100 mass parts of whole quantity containing the solvent in an ink composition, and 1-8. More preferably, it is part by mass. If the content rate of the polysaccharide which has an acidic group is more than the said lower limit, the bleeding of a colored part will be suppressed more. Moreover, by making the content rate of the polysaccharide which has an acidic group below the said upper limit, the viscosity of an ink can be reduced, the clogging in an inkjet nozzle can be suppressed, and higher-definition printing can be performed. .

(2) When the solid drug surface or its vicinity contains a polysaccharide having an acidic group, the edible substance is preferably one or more compounds selected from the group consisting of gelatin and protein degradation products. This is because the fluidity is lowered by ion association between gelatin or a protein degradation product and a polysaccharide having an acidic group.

  In the present invention, gelatin refers to a modified protein that is made water-soluble by boiling collagen with water. In the present invention, the average molecular weight of gelatin is not particularly limited, but is usually 100,000 or more. As gelatin, naturally derived gelatin is preferably used. Naturally-derived gelatin is alkali-hydrolyzed from collagen that can be collected from all parts of the body such as skin, bone, and tendon of various animal species such as cattle, pigs, and fish, or substances used as collagen. It can be obtained by modification by various treatments such as acid hydrolysis and enzymatic degradation.

  In the present invention, the protein degradation product refers to a mixture of an amino acid and a protein obtained by degrading the protein. The protein decomposition method is not particularly limited and may be any of hydrochloric acid decomposition method, enzyme decomposition method, and hot water extraction method. From the viewpoint of suppressing the generation of chloropropanols, the enzyme decomposition method or hot water extraction method The protein degradation product obtained by the above is preferable.

  The total content of one or more compounds selected from the group consisting of gelatin and protein degradation products in the ink composition for inkjet is 0.5 parts by mass with respect to 100 parts by mass as a whole including the solvent in the ink composition. It is preferable that it is -10 mass parts, and it is more preferable that it is 1-8 mass parts. If the total content of one or more compounds selected from the group consisting of gelatin and protein degradation products is not less than the above lower limit, bleeding of the colored portion is further suppressed. In addition, by setting the total content of one or more compounds selected from the group consisting of gelatin and protein degradation products to the upper limit or less, the viscosity of the ink can be reduced, and clogging in the inkjet nozzle can be prevented. Suppressing and higher-definition printing can be performed.

(3) When the solid drug surface or its vicinity contains sodium alginate, the edible substance preferably contains a calcium salt. This is because sodium alginate present on the surface of the solid drug or in the vicinity thereof gels with calcium ions, so that the fluidity of the ink composition is lowered and bleeding of the colored portion is suppressed.

  The calcium salt in the inkjet ink composition is not particularly limited, but is preferably a calcium salt used in food or as a calcium preparation. Specific examples of such calcium salts include, but are not limited to, calcium chloride, calcium carbonate, calcium citrate, calcium lactate, calcium gluconate, calcium L-aspartate, and the like. A calcium salt may be used individually by 1 type, and may be used in combination of 2 or more type.

  The content ratio of the calcium salt in the inkjet ink composition is preferably 0.5 to 10 parts by mass, and preferably 1 to 8 parts by mass with respect to 100 parts by mass as a whole including the solvent in the ink composition. It is more preferable. If the content rate of a calcium salt is more than the said lower limit, the bleeding of a colored part will be suppressed more. Moreover, by making the content rate of a calcium salt below the said upper limit, the viscosity of an ink can be reduced, clogging in an inkjet nozzle can be suppressed, and higher-definition printing can be performed.

(4) When the solid drug surface or its vicinity contains a calcium salt, the edible substance preferably contains sodium alginate. This is because sodium alginate present on the surface of the solid drug or in the vicinity thereof gels with calcium ions, so that the fluidity of the ink composition is lowered and bleeding of the colored portion is suppressed.

  The content ratio of sodium alginate in the inkjet ink composition is preferably 0.5 to 10 parts by mass, and preferably 1 to 8 parts by mass with respect to 100 parts by mass as a whole including the solvent in the ink composition. It is more preferable. If the content rate of a sodium alginate is more than the said lower limit, the bleeding of a colored part will be suppressed more. Moreover, by making the content rate of sodium alginate below the said upper limit, the viscosity of an ink can be reduced, clogging in an inkjet nozzle can be suppressed, and higher-definition printing can be performed.

(Solvent containing at least one selected from the group consisting of water and aqueous solvents)
In the present invention, the ink composition for ink-jet recording is made from the group consisting of water and an aqueous solvent in order to uniformly dissolve or disperse the edible colorant and the edible substance and to obtain an ink having a viscosity suitable for ink-jet ink. Contains a solvent containing one or more selected.
In the present invention, the solvent usually does not remain after the production of the solid drug, but is preferably at least one selected from water and ethanol from the viewpoint of oral intake of the solid drug.

  In the present invention, the content of the solvent is 10 to 80 parts by mass with respect to 100 parts by mass of the total amount of the ink composition for inkjet, from the viewpoint of suppressing bleeding on the solid drug and suppressing clogging in the inkjet nozzle. It is preferably 20 to 70 parts by mass.

(Other ingredients)
The inkjet ink composition used in the present invention may further contain other components as long as the effects of the present invention are not impaired. Examples of the other components include various compounds designated as food additives, and examples include antioxidants such as ascorbic acid, preservatives, and fragrances.

  According to the first method for producing a solid drug of the present invention, since bleeding of the colored portion is suppressed, the viscosity of the inkjet ink composition can be 20 cP (centipoise) or less, and preferably 1 cP or more and 18 cP or less. . By using an ink-jet ink composition having a viscosity of 20 cP or less, for example, high-definition printing of 600 dpi or more can be performed, and solid drug discrimination can be improved.

  The ink jet method in the present invention can be appropriately selected from conventionally known methods. Specific examples of the ink jet method include a charge control method that ejects ink using electrostatic attraction, a drop-on-demand method (pressure pulse method) that uses vibration pressure of a piezo element, and an ink that changes an electrical signal into an acoustic beam. Either an acoustic ink jet method in which ink is ejected by using radiation pressure by irradiating the ink, or a thermal ink jet (bubble jet (registered trademark)) method in which ink is heated to form bubbles and the generated pressure is used. There may be.

In the present invention, the amount of ink droplets of ink ejected by the ink jet method is not particularly limited, and may be appropriately adjusted according to the application. In view of obtaining a high-definition printed matter, the amount of ink droplets is preferably 0.5 to 30 pl, and more preferably 1.0 to 25 pl.
The colored portion after printing may be heat-dried, but is preferably dried at room temperature from the viewpoint of suppressing deterioration of the pharmacologically active substance of the solid drug. According to the production method of the present invention, it is possible to obtain a solid drug in which bleeding of colored portions is suppressed even when dried at room temperature.

B. Manufacturing method of 2nd solid medicine The manufacturing method of the 2nd solid medicine concerning the present invention,
A method for producing a solid drug having a colored portion on at least a part of a surface,
A first ink composition containing an edible colorant, a first edible substance, and a solvent containing at least one selected from the group consisting of water and an aqueous solvent is applied to a solid drug surface by an inkjet method. The process of adhering;
A solvent containing at least one selected from the group consisting of a edible colorant and a second edible substance that can be gelled or ionically associated with the first edible substance, and water and an aqueous solvent. And a second ink composition containing the step of adhering to the surface of the solid drug to which the first ink composition is adhered by an ink jet method.

  According to the second method for producing a solid medicine according to the present invention, a solid medicine having a colored portion in which bleeding on the surface of the solid medicine is suppressed can be obtained regardless of the components contained in the solid medicine.

In the second method for producing a solid drug of the present invention, a first edible colorant, a first edible substance, and a solvent containing one or more selected from the group consisting of water and an aqueous solvent. 1 ink composition;
A solvent containing at least one selected from the group consisting of a edible colorant and a second edible substance that can be gelled or ionically associated with the first edible substance, and water and an aqueous solvent. And an ink jet ink set in combination with a second ink composition containing
In the second method for producing a solid medicine, the first edible substance contained in the first ink composition and the second edible substance contained in the second ink composition include: Two types of ink compositions that gel or ion associate by interaction are used in combination. Therefore, an interaction between the first edible substance and the second edible substance is performed by sequentially superposing and adhering the first ink composition and the second ink composition to the solid medicine. As a result, the fluidity of the first edible substance and the second edible substance decreases. It is presumed that the edible colorant in the ink composition is also fixed on the surface of the solid drug as the fluidity of the edible substance decreases. In the present invention, the above interaction is presumed to occur in a short time before the solvent in the ink composition evaporates. Therefore, according to the production method of the present invention, it is a case where water as a solvent has relatively high fluidity and takes a long time to dry, and even when the solvent diffuses on the surface of the solid drug, Since only the solvent diffuses and the edible color material hardly diffuses, it is presumed that bleeding of the colored portion is difficult to occur. In addition, the second method for producing a solid drug can be suitably used regardless of the type of the solid drug because it does not require an interaction with a substance contained on or near the surface of the solid drug.

  Hereinafter, although the manufacturing method of a 2nd solid chemical | medical agent is demonstrated, since it can be set as the thing similar to a 1st manufacturing method about a solid chemical | medical agent, description here is abbreviate | omitted.

[Inkjet ink set]
The second solid drug of the present invention contains a first edible color material, a first edible substance, and a solvent containing one or more selected from the group consisting of water and an aqueous solvent. A first ink composition;
One or more selected from the group consisting of a second edible colorant and a second edible substance that can be gelled or ion associated by interaction with the first edible substance, water and an aqueous solvent And an ink set for ink-jet recording comprising a second ink composition containing a solvent containing

In the present invention, when the first edible substance contained in the first ink composition is one or more compounds selected from the group consisting of gelatin and protein degradation products, the second ink composition contains The second edible substance contained is preferably a polysaccharide having one or more groups selected from a carboxyl group and a carboxyalkyl group, or a polysaccharide derivative thereof, and the second edible substance contained in the first ink composition. If one edible substance is a polysaccharide having one or more groups selected from a carboxyl group and a carboxyalkyl group, or a polysaccharide derivative thereof, the second edible property contained in the second ink composition It is preferred that the substance is one or more compounds selected from the group consisting of gelatin and protein degradation products.
Further, when the first edible substance contained in the first ink composition is sodium alginate, it is preferably the second calcium salt contained in the second ink composition, and the first ink composition. When the first edible substance contained in the product is a calcium salt, the second edible substance contained in the second ink composition is preferably sodium alginate.
Each component in the first ink composition and the second ink composition is the same as the ink-jet ink composition in the first method for producing a solid drug. it can.

  According to the second method for producing a solid medicine of the present invention, since bleeding of the colored portion is suppressed, each of the first ink composition and the second ink composition can have a viscosity of 20 cP or less. Preferably, it can be 1 cP or more and 18 cP or less. By using an ink-jet ink composition having a viscosity of 20 cP or less, for example, high-definition printing of 600 dpi or more can be performed, and solid drug discrimination can be improved.

  The ink jet method in the present invention can be appropriately selected from conventionally known methods. Specific examples of the ink jet method include a charge control method that ejects ink using electrostatic attraction, a drop-on-demand method (pressure pulse method) that uses vibration pressure of a piezo element, and an ink that changes an electrical signal into an acoustic beam. Either an acoustic ink jet method in which ink is ejected by using radiation pressure by irradiating the ink, or a thermal ink jet (bubble jet (registered trademark)) method in which ink is heated to form bubbles and the generated pressure is used. There may be.

  In the present invention, the amount of ink droplets of ink ejected by the ink jet method is not particularly limited, and may be appropriately adjusted according to the application. In view of obtaining a high-definition printed matter, the amount of ink droplets is preferably 0.5 to 30 pl, and more preferably 1.0 to 25 pl.

In the second method for producing a solid medicine of the present invention, the first ink composition is attached to the surface of the solid medicine, and then the second ink composition is applied to the part to which the first ink composition is attached. It adheres in layers.
In the present invention, after the first ink composition is attached, it may have a drying step of drying the first ink composition, and the second ink composition is continuously attached without being dried. May be. Moreover, you may have a drying process which dries a colored part after adhesion of a 2nd ink composition.

  According to the first production method and the second production method of the present invention, one or more compounds selected from the group consisting of a gelled sodium alginate or gelatin and a protein degradation product on at least a part of the surface A solid drug comprising a colored portion containing a polysaccharide having one or more groups selected from carboxy group and carboxyalkyl group, or an association thereof with a polysaccharide derivative thereof, and an edible colorant is suitably obtained. be able to. The solid medicine obtained by the production method is a solid medicine excellent in visibility because bleeding of the colored portion is suppressed.

  Hereinafter, it demonstrates more concretely using an Example. In addition, this invention is not limited to an Example.

[Example 1: Production of solid drug having colored portion]
(1) Preparation of Ink Set A 30% by weight aqueous solution of Showa Chemical's gum arabic powder was prepared, and this was added to Newmind's natural edible ink yellow containing gardenia yellow, and 2% by weight of gum arabic. A yellow ink composition 1 (viscosity: 8 to 9 cP) was prepared.
Separately from this, a red ink composition 1 (viscosity: 8 to 9 cP) containing 2% by mass of gelatin is added to New Mind's natural edible ink red containing Benikouji pigment, and RM gelatin made by Zerice. Prepared.
The yellow ink composition 1 and the red ink composition 1 were combined to make an ink set 1.

(2) Manufacture of a solid drug having a colored portion Oral disintegrating tablet for rhinitis manufactured by Rohto Pharmaceutical Co., Ltd. (including corn starch, cellulose, hydroxypropylcellulose, sucralose, etc., porosity obtained by the above formula (1): 23% ) Was fixed on a vacuum stage, and inkjet printing was performed with a NE-54HPR high-speed inkjet printer manufactured by Newmind, while being conveyed by a belt conveyor. For printing, the conveyance speed is adjusted so as to be equivalent to 600 dpi, and a circle having a diameter of 0.5 mm is overprinted in the order of the yellow ink composition 1 and the red ink composition 1 to obtain a solid drug 1 having a colored portion. Obtained.

[Example 2: Production of solid drug having colored portion]
A solid drug having a colored portion in the same manner as in (2) of Example 1 except that the printing order in Example 2 (2) was changed to the order of the red ink composition 1 and the yellow ink composition 1. 2 was obtained.

[Example 3: Production of solid drug having colored portion]
(1) Preparation of ink set Yellow ink composition 2 containing 2% by mass of sodium alginate by adding low-viscosity sodium alginate manufactured by Pure Chemical Co., Ltd. to natural edible ink yellow made by Newmind, containing gardenia yellow Viscosity: 10-12 cP) was prepared.
Separately from this, red ink composition 2 (viscosity: 6 to 7 cP) containing 2% by mass of calcium chloride by adding pure chemical calcium chloride to New Mind's natural edible ink red containing Benikouji pigment. ) Was prepared.
The yellow ink composition 2 and the red ink composition 2 were combined to make an ink set 2.

(2) Production of solid drug having colored portion In (2) of Example 1 above, instead of yellow ink composition 1 and red ink composition 1, yellow ink composition 2 and red ink composition 2 were respectively used. Except having changed, it carried out similarly to (2) of Example 1, and obtained the solid chemical | medical agent 2 which has a coloring part.

[Comparative Example 1]
In Example 1 (2), instead of the yellow ink composition 1 and red ink composition 1 prepared in Example 1 (1), each contains a yellow ink composition not containing gum arabic and gelatin. A comparative solid drug 1 having a colored portion was obtained in the same manner as in (2) of Example 1 except that the red ink composition was not changed.

[Comparative Example 2]
(1) Preparation of comparative ink set Shellac manufactured by Koyo Chemical Co., Ltd. was dissolved while neutralizing with sodium hydroxide to obtain a 30% by weight aqueous solution of shellac.
Add 30% aqueous solution of shellac to Newmind natural edible ink yellow containing Gardenia yellow and Newmind natural edible ink red containing Benikouji pigment, respectively. A comparative yellow ink composition (viscosity: 25 to 30 cP) and a comparative red ink composition (viscosity: 25 to 30 cP) each containing mass% were obtained.

(2) Production of solid drug having colored portion In (2) of Example 1 above, instead of yellow ink composition 1 and red ink composition 1, they were changed to a comparative yellow ink composition and a comparative red ink composition, respectively. Except for having done, it carried out similarly to (2) of Example 1, and obtained the comparison solid chemical | medical agent 2 which has a coloring part.

[Example 4: Production of solid drug having colored portion]
Oral disintegrating tablet for oral motion sickness manufactured by Daiichi Sankyo Healthcare Co., Ltd. (cellulose, corn starch, calcium carbonate, calcium silicate) instead of the oral disintegrating tablet for oral rhinitis manufactured by ROHTO PHARMACEUTICAL CO., LTD. In the same manner as in (1) of Example 1, except that the L-phenylalanine compound sugar was contained and the porosity obtained by the above formula (1) was changed to 8%, a solid drug 4 having a colored portion was obtained. Obtained.

[Example 5: Production of solid drug having colored portion]
In Example 3 (2), instead of the oral disintegrating tablet for rhinitis manufactured by Rohto Pharmaceutical Co., Ltd., the oral disintegrating tablet for motion sickness manufactured by Daiichi Sankyo Healthcare Co. was changed to (1 ), A solid drug 5 having a colored portion was obtained.

[Reference Example 6: Production of solid drug having colored portion]
In the same manner as in Example 1 (1), a yellow ink composition 1 (viscosity: 8 to 9 cP) containing 2% by mass of gum arabic was prepared.
Matsuya's edible gelatin capsules were fixed on a vacuum stage, and conveyed by a belt conveyor, and inkjet printing was performed with a NE-54HPR high-speed inkjet printer manufactured by Newmind. In printing, the conveyance speed was adjusted so as to be equivalent to 600 dpi, and the yellow ink composition 1 was printed in a single color on a circle having a diameter of 0.5 mm to obtain a solid drug 6 having a colored portion.

<Bleeding evaluation>
About the solid chemical | medical agent which has the colored part obtained by the said Example and comparative example, respectively, The change of the diameter of the colored part after 2 minutes after printing and after a printing using a 15 time magnifier with a 1 / 10mm scale And observed visually.
(Bleeding evaluation criteria)
A: The bleeding was less than 0.05 mm.
B: The bleeding was 0.05 mm or more and less than 0.1 mm.
C: Bleeding was 0.1 mm or more.

  The solid drugs having colored portions of Examples 1 to 5 and Reference Example 6 all have a bleeding of less than 0.05 mm, and the evaluation is A, and it is clear that high-definition printing without bleeding is possible. It was. In Comparative Example 1, the evaluation was B, and high-definition printing could not be performed. Moreover, in Comparative Example 2, since stable ejection cannot be obtained, and drawing is partially performed as large dots, high-resolution drawing cannot be performed at a portion where ink is not applied and a portion where the ink is applied and blurs greatly. Was C.

Claims (8)

A method for producing a solid drug having a colored portion on at least a part of a surface,
A first ink composition containing a first edible colorant, a first edible substance, and a solvent containing at least one selected from the group consisting of water and an aqueous solvent is provided on the surface of the solid drug. A step of attaching by an inkjet method;
One or more selected from the group consisting of a second edible colorant and a second edible substance that can be gelled or ion associated by interaction with the first edible substance, water and an aqueous solvent And a step of adhering a second ink composition containing a solvent containing a solvent to the surface of the solid agent to which the first ink composition is adhered by an inkjet method.   The method for producing a solid drug according to claim 1, wherein the viscosity of the first ink composition and the viscosity of the second ink composition are each 20 cP or less.   One of the first edible substance and the second edible substance is one or more compounds selected from the group consisting of gelatin and protein degradation products, and the other is a polysaccharide having an acidic group. The manufacturing method of the solid chemical | medical agent of Claim 1 or 2.   The method for producing a solid drug according to claim 1 or 2, wherein one of the first edible substance and the second edible substance is sodium alginate and the other is a calcium salt. An ink set for printing a solid drug surface,
A first ink composition comprising a first edible colorant, a first edible substance, and a solvent containing one or more selected from the group consisting of water and an aqueous solvent;
One or more selected from the group consisting of a second edible colorant and a second edible substance that can be gelled or ion associated by interaction with the first edible substance, water and an aqueous solvent And an ink set for inkjet, comprising a second ink composition containing a solvent containing   The inkjet ink set according to claim 5, wherein the viscosity of the first ink composition and the viscosity of the second ink composition are each 20 cP or less.   One of the first edible substance and the second edible substance is one or more compounds selected from the group consisting of gelatin and protein degradation products, and the other is a polysaccharide having an acidic group. The inkjet ink set according to claim 5 or 6.   The inkjet ink set according to claim 5 or 6, wherein one of the first edible substance and the second edible substance is sodium alginate and the other is a calcium salt.