JP2000042089A - Method for printing oral administration product and printing ink - Google Patents

Abstract

PROBLEM TO BE SOLVED: To make printing which is excellent in peeling resistance and does not give rise to peeling in spite of friction, etc., on an oral administration product, such as a tablet or capsule agent. SOLUTION: The printing is applied to the surface of the oral administration product, such as the tablet or the capsule agent, by using aq. ink contg. a water- soluble resin which is the same as the base material component forming the surface layer of the object to be printed or has compatibility therewith as a binder component in the printing method for printing the surface of the product described above with characters and patterns. The binder component of the aq. ink is a water-soluble cellulose deriv. This water-soluble cellulose deriv. is preferably cellulose ether substituted with an alkyl group and hydroxylalkyl group or cellulose ester substituted with the hydroxylalkyl group.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a printing method for printing on the surface of an orally administered product such as a tablet, a capsule or some foods, and a printing ink.

[0002]

2. Description of the Related Art In the case of solid preparations such as tablets, hard capsules and soft capsules, symbols, characters and / or patterns are usually printed on the surfaces of the solid preparations in order to identify the medicine.

[0003] Conventionally, printing of these solid preparations is generally performed by:
Printing is performed using a printing ink in which pigments such as iron sesquioxide, titanium oxide, and edible dye aluminum lake are mixed or dispersed in a vehicle in which shellac is dissolved in an alcohol-based organic solvent such as ethanol.

[0004]

However, a solid preparation printed using such a printing ink does not always have sufficient adhesion of the ink to the surface of the solid preparation.
Due to friction when the printed solid preparation is transported to a can or the next process, the printing ink easily peels off from the printing surface, which not only reduces the commercial value of the peeled preparation, but also removes the printed printing There is also a problem that the ink stains other solid preparations.

SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances, and provides a method of printing an orally administered product which has excellent peel resistance and can perform stable printing without peeling due to friction or the like. It is intended to provide ink.

[0006]

Means for Solving the Problems and Embodiments of the Invention As a result of intensive studies to achieve the above object, the present inventor has found that conventional printing has poor peeling resistance for the following reasons. Was found. That is, the surface of the tablet or capsule, which is the printing surface, is made of hydroxypropylmethylcellulose (H
It is formed of a coat layer, a film or a sugar coating layer made of a water-soluble cellulose derivative such as PMC) or a water-soluble resin such as gelatin, dextrin, or gum arabic. When printing is performed using a conventional printing ink that uses a binder as the binder, the printing ink is clearly defined between the printing surface and the water-soluble resin or sugar coating layer on the printing surface because the shellac as the binder is incompatible. It was found that it was merely adhered in a state of being placed on the printing surface while having a good interface, and it was found that it was difficult to obtain a sufficient peel strength.

Accordingly, the present inventors have further studied and found that a water-soluble cellulose derivative or a water-soluble resin such as gelatin, dextrin, gum arabic or the like, which forms the printing surface of a printing substrate, or a water-soluble resin which is compatible with a sugar coating layer. Printing with a water-based ink using a water-soluble vehicle, preferably a water-based vehicle containing the same water-soluble resin as the base component of the printing surface as a binder component, and a water-soluble resin or sugar coating that forms the printing surface of the printing substrate The layer and the water-soluble resin that is the binder component of the printing ink are compatible with each other, and the printing ink is integrated with the printing surface, and it is found that printing with excellent peel resistance is obtained.
The present invention has been completed.

Accordingly, the present invention relates to a printing method for printing characters or patterns on the surface of an orally administered product such as a tablet or capsule, wherein the water-soluble material has the same or compatibility as the base component forming the surface layer of the printing material. A method for printing an orally administered product characterized by printing using an aqueous ink containing a resin as a binder component, and an ink for printing characters and patterns on the surface of an orally administered product such as tablets and capsules. The present invention also provides a printing ink for an orally administered product, characterized by mixing a coloring agent component such as a pigment and a pigment with an aqueous vehicle containing a water-soluble resin as a binder component.

Hereinafter, the present invention will be described in more detail.
As described above, the method for printing an orally administered product of the present invention is an aqueous ink using an aqueous vehicle containing, as a binder component, a water-soluble resin having the same or compatibility as a base component forming a surface layer of a print substrate. Is used for printing.

The water-soluble resin used as a binder component of the printing ink used in the present invention is compatible with a base component forming a surface layer of an orally administered product such as a tablet or a capsule as a printing material. Normally, if both the binder component in the ink and the base component on the surface of the printing material are water-soluble, the aqueous solvent in the ink vehicle dissolves the water-soluble resin on the surface of the printing material and mixes it as a binder. Can be compatible with the water-soluble resin in the prepared vehicle, but it is better covered, especially when the surface of the printed material is formed of a coating layer or film based on the water-soluble resin. The binder component is preferably the same water-soluble resin as the substrate component on the surface of the printing material in order to cause the substrate component on the surface of the printing material to be compatible with the binder resin.

In this case, the surface of the tablet to be printed is
Except for sugar-coated tablets, they are usually coated with a coat layer of a water-soluble cellulose derivative or a water-soluble resin such as dextrin or gum arabic, and the capsules constituting the surface of the capsule are also based on gelatin or a water-soluble cellulose derivative. It is formed of a film as a material, and as the binder component, a water-soluble resin having compatibility with these water-soluble resins is used, and preferably the same as the base component forming these printing surfaces is used. Can be That is, as the binder component in the printing ink, a water-soluble cellulose derivative, dextrin, gum arabic, gelatin, or the like is preferably used depending on the surface material of the printing material. In this case, as the water-soluble cellulose derivative, a cellulose ether substituted with an alkyl group and a hydroxyalkyl group, or a cellulose ether substituted with a hydroxyalkyl group is preferably used. Among them, a tablet coating material and a capsule coating material are used. Hydroxypropylcellulose and hydroxypropylmethylcellulose (HPMC), which are widely used, are particularly preferably used.
Further, these water-soluble cellulose derivatives and the above-mentioned water-soluble resins such as dextrin, gum arabic, gelatin and the like have good compatibility with the sugar-coated layer of sugar-coated tablets, and can be suitably used when printing on sugar-coated tablets. In addition, as described above, the same water-soluble resin as the binder component is preferably used as the base resin on the surface of the printing material, but the “same” as used herein means a structural basic skeleton or a repeating unit. Mean the same, and the difference in molecular weight and the like does not matter.

The mixing ratio of the binder component is not particularly limited, but is usually about 0.1 to 50% by weight. More specifically, in the case of a water-soluble cellulose derivative, about 1 to 25% by weight, and gelatin is low molecular weight gelatin (weight average molecular weight of 8,000 to 12,
000), about 1 to 25% by weight for normal gelatin (about 170,000 to 200,000 weight average molecular weight), about 5 to 50% by weight for dextrin, In the case of gum arabic, it is about 5 to 40% by weight.

A water-based vehicle is prepared by dissolving the water-soluble resin of the binder component in water. To increase the drying speed of the ink, an appropriate amount of ethanol may be added to water.
In this case, an antiseptic effect can be obtained at the same time. Also,
In some cases, it may be necessary to slow down the drying speed to prevent the ink from drying and solidifying on the printing die roll or rubber roll.In this case, an appropriate amount of polyhydric alcohol such as propylene glycol or glycerin is used. It can also be added. Further, a surfactant such as sodium lauryl sulfate or polysorbate may be added to the aqueous vehicle as a wetting agent, or carnauba wax may be added for the purpose of improving the lubricity of the printed (character) coated surface. In addition, additives such as a foam inhibitor may be added as needed without departing from the purpose of the present invention.

The printing ink used in the present invention can be obtained by adding a coloring agent to the aqueous vehicle containing a water-soluble resin as a binder component and coloring the aqueous vehicle. Examples of the coloring agent include inorganic pigments such as titanium oxide, iron sesquioxide, and various food coloring aluminum lakes, food blue Nos. 1, 2, food yellows 4, 5, food reds 2, 3, 102 and the like. Examples include tar dyes and various other natural dyes, and one or more of these can be used. In the present invention using an aqueous vehicle, tar dyes are particularly preferably used from the viewpoint of solubility. In this case, the tar dye is generally inferior to the inorganic pigment in light resistance in many cases.However, by combining a plurality of dyes in various ways within a range that does not greatly affect the color tone, it is possible to obtain good light resistance not inferior to the inorganic pigment. Is also possible. For example, when preparing a deep blue ink, blue No. 1 and red No. 2 are mixed at 1: 0.5 to
By mixing and using 1: 3 (weight ratio), particularly 1: 1 to 1: 2, a deep blue ink excellent in light resistance can be obtained.

This printing ink can be prepared by mixing the above components according to a conventional method according to the kind of the water-soluble resin of the above binder component. To use
In particular, when ethanol is not added, it is preferable to take measures against rot due to heating or the like during the preparation of the ink. For example, when using hydroxypropylmethylcellulose (HPMC) as a binder component, a colorant component such as a tar dye is dissolved in purified water, heated to 80 ° C. or higher to disperse the HPMC, and then heated to 80 ° C. or higher for a predetermined time. After holding and sterilizing, cool to room temperature and stir to
By dissolving C to prepare the ink, a sterilization treatment can be performed during the preparation of the ink. When gelatin is used as a binder component, the temperature after sterilization is kept at about 50 ° C. without lowering to room temperature, gelatin is dissolved, and the other components may be prepared in the same manner as in the case of using HPMC. . This water-based ink does not require long-term aging, unlike the conventional ink using shellac as a binder component, and can be efficiently prepared.

In the printing method of the present invention, printing is performed using the above-mentioned aqueous ink using a water-soluble resin as a binder component. Particularly, a method for printing on tablets and capsules using this aqueous ink is particularly preferred. There is no limitation, and printing can be performed according to a conventionally known method using a printing machine such as “Tablet Printing Machine IS-500” manufactured by Shionogi Qualicaps. For example, by rotating a die roll having printed characters or marks etched on the surface while a part of the surface is immersed in the aqueous ink, ink is adhered to the etched portion of the die roll surface, and this is brought into contact with the die roll surface. The printing can be performed by a method in which the ink is transferred to a printing material in a stamp manner by temporarily transferring the ink to a rotating transfer rubber roll and then pressing the surface of the rubber roll against a printing material such as a tablet.

In this case, according to the printing method of the present invention, as a printing ink, a water-soluble resin having compatibility with a base resin or a sugar coating layer which forms a surface layer of tablets or capsules of a substrate to be printed is used as a binder. By using water-based ink,
The base resin or sugar coating layer that forms the surface of tablets and capsules and the water-soluble resin that is the binder component of the printing ink are compatible with each other, and the printing ink is integrated with the printing surface, resulting in printing with excellent peel resistance. It is something that can be done.

Further, the printing ink used in the present invention is:
Since a water-based vehicle in which a water-soluble resin is dissolved in a water-based solvent is used, an increase in viscosity due to evaporation of the solvent hardly occurs, and printing can be stably performed. That is, in the conventional ink using a vehicle in which shellac is dissolved in an organic solvent, the shellac concentration of the binder resin is liable to increase due to the volatilization of the organic solvent, and the ink is easily wound up on the die roll due to the increase in viscosity accompanying the concentration increase. Therefore, it is necessary to frequently dilute the ink. However, since the printing ink used in the present invention uses the aqueous vehicle, such a problem hardly occurs and the number of dilutions can be reduced. . In addition, the working environment is not affected by the volatilization of the organic solvent.

Further, the conventional ink using shellac as a binder requires an alkaline solution when cleaning parts of a printing machine such as a die roll and a transfer roll, but the printing ink used in the present invention is water-based. Since it can be washed off, an alkaline solution is not required at the time of washing, which is excellent in safety.

The printing method and the printing ink of the present invention are suitably used for a drug for oral administration such as a tablet having a water-soluble resin coating layer or a sugar coating layer on its surface, and a capsule made of a water-soluble resin film. However, its use is not limited to medicine, and it can be suitably applied to tablet-shaped so-called health foods and other foods.

[0021]

As described above, according to the method for printing an orally administered product and the printing ink of the present invention, it is possible to perform printing which is excellent in peeling resistance and does not peel even by friction. Moreover, compared to a conventional ink using a vehicle in which shellac is dissolved in an organic solvent, printing can be performed more stably, and workability and safety during printing operation are excellent.

[0022]

EXAMPLES Hereinafter, the present invention will be described in more detail with reference to Examples and Comparative Examples, but the present invention is not limited to the following Examples.

[Examples 1 to 3] A coloring agent component was dissolved or dispersed in purified water and heated to 80 ° C. or higher.
After dissolving or dispersing MC or gelatin and sterilizing while maintaining a heating state of 80 ° C. or higher for 30 minutes, in the case of Example 1 using HPMC, the solution is cooled to room temperature and stirred to obtain H.
Examples 2 and 3 in which PMC was dissolved while using gelatin
In the case of the above, the temperature was lowered to about 50 ° C. and maintained, and this was filtered to prepare three types of aqueous inks having the compositions shown in Table 1. In Table 1, the low-molecular weight gelatin of * 1 has a weight average molecular weight of 8,000 to 12,000, and the normal gelatin of * 2 has a weight average molecular weight of 170,000 to 200,000, * 3.
Is sodium lauryl sulfate.

The bar coater No. 3 using a gelatin film and an HPMC film (both 50 × 100 m
m) Each ink obtained above was applied to a thickness of about 7 μm and dried at room temperature for 24 hours to prepare a test piece, and the following test was performed. Table 1 shows the results. As a comparative example, the same test was performed using a commercially available ink having the composition shown in Table 1. The results are also shown in Table 1.

Peeling test Using a pencil scratch tester specified in JIS K5400, the pencil holder was removed, and a 8 mmφ × 9
mm cylindrical adapter and attach it to the adapter.
A test paper (mirror coated paper) of 10 mm × 10 mm is attached. The test piece was fixed to the test piece mounting table of this testing machine with tape, a 500 g weight was placed on the weight base, and the test piece mounting table was moved at a speed of 0.5 mm / sec. The test paper was rubbed while being pressed with a pressure of 500 g, and the same surface was
After repeated rubbing, the ink stain on the test paper surface was evaluated on a scale from 0 (no stain) to 10 (very dirty). Adhesion test Using a pencil scratch tester specified in JIS K5400, the pencil holder was removed, a tungsten needle was attached to the frustum, a weight was placed on the frustum, and the specimen was fixed to the specimen mounting stand. The needle was brought into contact with the specimen, and the specimen mounting table was moved 70 mm at a speed of 0.5 mm per second to scratch the painted surface of the specimen with the above-mentioned needle. Weight) was taken as the adhesive force. Slip angle test (static friction) A 30 mm x 30 mm square sample was cut out from the above test piece, fixed to an inclined table with tape, and a 50 g weight (2
(0 mmφ), the tilt table was gradually tilted, the tilt angle at which the weight started to move was recorded, and the same operation was repeated three times, and the average value was defined as the slip angle.

[0026]

[Table 1]

As shown in Table 1, it was confirmed that the printing ink of the present invention was excellent in peel resistance, adhesion and slipperiness.

[Formulation Examples] Table 2 shows other formulation examples of the printing ink according to the present invention. In addition, the preparation method is the same as that of the said Example.

[0029]

[Table 2]

 ──────────────────────────────────────────────────続 き Continued on the front page F term (reference) 4B018 LB10 LE01 LE02 MA08 MB03 MC04 4C076 AA46 AA59 BB01 DD57Y EE32Y EE38Y EE42Y EE58Y FF36 FF53 4J039 AB02 AB07 AF07 BA13 BA32 BA35 BA37 BE01 BE02 CA03 EA15 EA34 EA16

Claims (10)

[Claims] 1. A printing method for printing characters or patterns on the surface of an orally administered product such as a tablet or a capsule, wherein a water-soluble resin having the same or compatibility as a base component forming a surface layer of a printed material is used as a binder component. A method for printing an orally administered product, wherein printing is performed using an aqueous ink contained as an ink. 2. The method according to claim 1, wherein the binder component of the aqueous ink is a water-soluble cellulose derivative. 3. The method for printing an orally administered product according to claim 2, wherein the water-soluble cellulose derivative is a cellulose ether substituted with an alkyl group and a hydroxyalkyl group, or a cellulose ether substituted with a hydroxyalkyl group. 4. The method according to claim 3, wherein the water-soluble cellulose derivative is hydroxypropylmethylcellulose. 5. The method for printing an orally administered product according to claim 1, wherein the binder component of the aqueous ink is selected from gelatin, dextrin and gum arabic. 6. An ink for printing characters or patterns on the surface of an orally administered product such as a tablet or capsule, wherein a colorant component such as a pigment or a pigment is added to an aqueous vehicle containing a water-soluble resin as a binder component. A printing ink for an orally administered product, characterized by being formulated. 7. The printing ink for an orally administered product according to claim 6, wherein the water-soluble resin of the binder component is selected from a water-soluble cellulose derivative, gelatin, dextrin, and gum arabic. 8. The printing ink according to claim 7, wherein the binder component is a cellulose ether substituted with an alkyl group and a hydroxyalkyl group, or a cellulose ether substituted with a hydroxyalkyl group. 9. The printing ink for an orally administered product according to claim 8, wherein the binder component is hydroxypropyl methylcellulose. 10. The printing ink for an orally administered product according to any one of claims 6 to 9, further comprising a tar dye as the colorant component.