JP2001031898A - Ink for printing oral administration product - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain a printing ink which uses a water-soluble resin as a binder component, maintains good peeling resistance, simultaneously extends an interval for cleaning up the parts of a printing machine to improve the efficiency of printing, and improves the visibility of the obtained printed letters. SOLUTION: This printing ink for oral administration products is obtained by adding a colorant component to an aqueous vehicle containing a water-soluble resin as a binder component. Therein, a wetting agent for extending an interval for cleaning up the parts of a printing machine is added to the printing ink. In order to further extend the cleaning-up interval and improve the visibility of printed letters, an additive such as a plasticizer or sodium alginate is added.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

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

[0002]

2. Description of the Related Art In solid preparations such as tablets, hard capsules, and soft capsules, symbols, letters, numbers, 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:
It is carried out using a printing ink obtained by mixing or dispersing pigments such as iron sesquioxide, titanium oxide, and edible dye aluminum lake in a vehicle in which shellac is dissolved in an alcohol-based organic solvent such as butanol.

[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.

In order to solve such a problem, the present applicant has previously proposed a water-based printing ink in which a colorant component is blended in a water-based vehicle containing a water-soluble resin as a binder component (Japanese Patent Application No. H10-163873). Hei 10-210841).

According to this water-based ink, when used for printing tablets and capsules, for example, a sugar coating layer or a coating layer or a capsule film made of a water-soluble resin, which forms the printing surface of these printing materials, and a printing ink. The printing ink is integrated with the printing surface by being compatible with the water-soluble resin which is a binder component of the above, and printing excellent in peel resistance can be surely obtained.

[0007] However, this water-based ink has a drawback that the clean-up interval of printing equipment is shorter than that of an organic solvent-based printing ink using shellac as a binder, although printing with excellent peel strength can be obtained. I was

[0008] In other words, printing on tablets and capsules is performed, 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 printing ink. The ink is adhered to the portion, and once transferred to a rotating transfer rubber roll while contacting the die roll surface, the rubber roll surface is pressed against a printed material such as a tablet, so that the ink is applied to a printed material in a stamp manner. This is performed by transferring.

In this case, a small amount of ink remaining on the surface of the rubber roll without being transferred to the substrate is gradually dried and solidified and adheres to the surface of the rubber roll as dirt, which causes the substrate to be soiled or causes printing defects. It may be. Therefore, the rubber roll is washed with a solvent every predetermined time so that good printing is always performed.In this case, the water-based ink using a water-soluble resin as a binder is an organic solvent-based ink. The ink tends to dry and solidify on the rubber roll as compared with the printing ink, so that the rubber roll must be washed frequently, which is disadvantageous in processing efficiency.

[0010] The sharpness of the obtained print is an extremely important performance in judging the superiority of the printing ink, and clearer and sharper printing is always required. From this point of view, the printing obtained by the above conventional water-soluble ink has practically sufficient sharpness, but leaves room for further improvement.

The present invention has been made in view of the above circumstances, and for a printing ink using a water-soluble resin as a binder component, it is intended to extend a cleanup interval at the time of printing while maintaining good peel resistance. It is an object of the present invention to eliminate disadvantages in printing efficiency and to improve the clarity of obtained printing to further improve printing performance.

[0012]

Means for Solving the Problems and Embodiments of the Invention The present inventors have conducted intensive studies to achieve the above object, and as a result, have found that a colorant component is added to an aqueous vehicle containing a water-soluble resin as a binder component. By adding an appropriate amount of a moisturizing agent such as polyhydric alcohols such as glycerin and polyethylene glycol and sodium lauryl sulfate and dioctyl sodium sulfosuccinate to the printing ink of the orally administered product thus formulated, The present invention has been found to be able to effectively prevent excessive drying and solidification, and to extend the cleanup interval during printing while maintaining good peel resistance, thereby completing the present invention.

Accordingly, the present invention provides a printing ink for an orally administered product comprising a water-based vehicle containing a water-soluble resin as a binder component and a coloring agent component, wherein a wetting agent is added to the printing ink. Is provided.

Further, the present inventors have further studied to improve the sharpness of the printed image. As a result, they can be obtained by adding an appropriate amount of a plasticizer such as triethyl citrate or triacetin together with the above wetting agent. It has been found that printing can be made sharper and sharper at the edges, and that the cleanup interval can be further extended. Furthermore, the present inventors have further searched for an additive capable of obtaining the same effect, and found that the same effect can be obtained by adding sodium alginate, dextrin, polyvinylpyrrolidone and the like.

Accordingly, the present invention provides, as a preferred embodiment, the printing ink of the present invention wherein a plasticizer is added together with a wetting agent, and one or more selected from sodium alginate, dextrin and polyvinylpyrrolidone together with a wetting agent. An object of the present invention is to provide the printing ink of the present invention to which two or more additives are added.

Hereinafter, the present invention will be described in more detail.
The printing ink of the orally administered product of the present invention, as described above,
It is a printing ink of an orally administered product obtained by blending a colorant component with an aqueous vehicle containing a water-soluble resin as a binder component, and an appropriate amount of a wetting agent is added.

The water-soluble resin used as a binder component of the printing ink of the present invention may be any as long as it can be orally administered and can act as an ink binder. In this case, if both the binder resin in the ink and the base resin on the surface of the printing material are both water-soluble, the water-soluble resin on the surface of the printing material is dissolved by the aqueous solvent in the ink vehicle and is blended as a binder. It is possible to obtain a print excellent in peel resistance by compatibilizing and integrating with the water-soluble resin in the vehicle, but in order to better integrate the base resin and the binder resin on the surface of the printing material, The binder resin is preferably the same water-soluble resin as the base resin on the surface of the printing material.

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. A water-soluble resin having compatibility with these water-soluble resins is preferably used as the binder component, and more preferably the same as the base component forming these printing surfaces. Is used. 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. In addition, these cellulose ethers, especially HPMC, can be adhered and integrated well with a general gelatin film or a sugar-coated layer of a sugar-coated tablet as a capsule film,
It is very suitably used as a binder component of the printing ink of the present invention.

The mixing ratio of the binder component is appropriately selected according to the type of the water-soluble resin, and is not particularly limited, but is usually about 0.1 to 50% by weight, and more specifically, In the case of a water-soluble cellulose derivative, 2 to 15
% By weight, gelatin is about 1 to 25% by weight in the case of low molecular weight gelatin (weight average molecular weight of about 8,000 to 12,000) and usually gelatin (weight average molecular weight of about 170,000 to 200,000) according to the molecular weight. )), About 0.1 to 5% by weight, dextrin for about 5 to 50% by weight, and gum arabic for about 5 to 40% by weight.

An aqueous vehicle is prepared by dissolving the water-soluble resin of the binder component in water. In this case, in the present invention, a wetting agent is added for the purpose of extending the clean-up interval. Any humectant that can be orally administered and can be dissolved or dispersed in an aqueous solvent may be used. Examples thereof include polyhydric alcohols such as glycerin, polyethylene glycol and propylene glycol, sodium lauryl sulfate, and dioctyl sodium sulfosuccinate. And the like. Among these, although not particularly limited, polyhydric alcohols are preferably used, and glycerin is particularly preferably used. As the polyethylene glycol, those having an average molecular weight of 200 to 20,000, particularly 400 to 1,540 are preferably used. Two or more of these wetting agents may be used in combination. For example, a polyhydric alcohol such as glycerin may be used in combination with the above sodium lauryl sulfate, dioctyl sodium sulfosuccinate, or the like.

The above-mentioned wetting agent is used in an appropriate amount according to the kind of the wetting agent so that a good effect of extending the clean-up interval can be obtained. When the amount of addition is out of the range of 0.1 to 20% by weight, a sufficient effect of extending the clean-up interval may not be obtained depending on the type of the wetting agent. When added in excess, the sharpness of the printing edge may be reduced and the sharpness of the printing may be reduced. In addition, when glycerin is used as a wetting agent, a suitable addition amount of glycerin is 1 to 10% by weight, particularly 2 to 5% by weight.

In the present invention, it is preferable to add a plasticizer together with the above-mentioned wetting agent. By adding the plasticizer, it is possible to improve the sharpness of printing and further extend the cleanup interval.

The plasticizer may be any as long as it can be orally administered and can be dissolved or dispersed in an aqueous solvent.
Triethyl citrate, triacetin, propylene glycol, polyethylene glycol, D-sorbitol and the like. Among them, triethyl citrate and triacetin can synergistically extend the clean-up interval when used in combination with the above-mentioned wetting agent. In combination with the above, it is possible to achieve a long cleanup interval far exceeding that of conventional organic solvent-based inks. Propylene glycol and polyethylene glycol are also used as wetting agents as described above, but when glycerin or the like is used as a wetting agent, they can be used as plasticizers.

This plasticizer is used in an appropriate amount according to the kind of the plasticizer so that a good effect of improving the sharpness of printing can be obtained. The amount of the plasticizer is not limited.
The content is preferably 5 to 40% by weight. In order to further improve the print definition and further extend the cleanup interval due to a synergistic effect with the above-mentioned wetting agent,
The content is preferably 5 to 30% by weight. If the amount of the plasticizer is less than 0.5% by weight, the effect of improving the clarity of printing may not be obtained. On the other hand, if it exceeds 40% by weight, it is difficult to completely dissolve the colorant component. May be.

As in the case of the above-mentioned plasticizer, addition of the above-mentioned wetting agent together with the above-mentioned wetting agent can improve the sharpness of printing and further extend the clean-up interval. One or more of dextrin and polyvinylpyrrolidone can be added. These additives are
It may be added in place of the above plasticizer, or may be used in combination with the above plasticizer.

These additives are also used in an appropriate amount according to the kind of the additive so as to obtain a good effect of improving the sharpness of printing. The amount of the additive is not limited, but is usually 0.5 to 0.5. The content is preferably 40% by weight, and more preferably 5 to 30% by weight in order to further improve the print definition and further extend the cleanup interval due to the synergistic effect with the above-mentioned wetting agent.

The printing ink of the present invention uses the water-soluble resin binder, the wetting agent, and the above-mentioned plasticizer, which is optionally added, and an aqueous vehicle in which the additive is dissolved in water. Other appropriate additives can be added as long as the purpose is not deviated. For example, an appropriate amount of ethanol may be added within the range not departing from the object of the present invention for the purpose of preservative effect, and carnauba wax may be added for the purpose of improving the lubricity of the coated surface of the print. Additives such as agents can be added as needed without departing from the purpose of the present invention.

The printing ink of the present invention can be obtained by adding a coloring agent to the aqueous vehicle 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. Tar dyes and the like can be used, 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, the blue 1
By mixing No. 2 and Red No. 2 at a ratio of 1: 0.5 to 1: 3 (weight ratio), a dark blue ink having good light fastness can be obtained.

This printing ink can be prepared by mixing the above components in accordance with a usual method according to the kind of the water-soluble resin of the above binder component. To use
In particular, when ethanol is not added as a preservative, it is preferable to take measures against rot by heating or the like during the preparation of the ink. For example, when using hydroxypropylmethylcellulose (HPMC) as a binder resin, a colorant component such as a tar dye is dissolved in purified water, and a wetting agent,
Dissolve the plasticizer and additives while sequentially adding them. This solution was heated to 80 ° C. or higher to disperse HPMC,
After holding for a predetermined time and sterilizing as described above, the ink is prepared by dissolving HPMC by cooling to room temperature and stirring, so that a sterilization treatment can be performed during ink preparation. 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.

There is no particular limitation on the method of printing using the printing ink of the present invention. For example, when printing is performed on tablets or capsules, printing may be performed using a tablet printing machine IS-500 manufactured by Shionogi Qualicaps. Printing can be performed using a printer according to a conventionally known method. 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 ink of the present invention,
By the action of the wetting agent, the ink remaining on the surface of the transfer rubber roll is effectively prevented from rapidly drying and solidifying, and is effectively prevented from being fixed. The clean-up interval can be extended, and when the above-mentioned plasticizers and / or additives are added, a long clean-up interval far exceeding conventional organic solvent-based inks can be achieved. In this case, the conventional organic solvent-based ink using shellac as a binder required an alkaline solution when cleaning parts of a printing press such as a die roll and a transfer rubber roll. Since a water-based vehicle is used, it can be washed off with water, so that no alkaline solution is required for washing, and safety is excellent.

Further, since the printing ink of the present invention uses an aqueous vehicle in which a water-soluble resin is dissolved in an aqueous solvent, the viscosity does not easily increase due to the evaporation of the solvent, and the printing operation can be performed stably. it can. 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 of the present invention uses the above-mentioned aqueous vehicle, such a problem does not easily occur 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 printing ink of the present invention is such that the base resin or the sugar coating layer forming the surface layer of the tablet or capsule is compatible with the water-soluble resin which is a binder component of the ink, so that the printing ink becomes compatible with the printing surface. Integrate and print with excellent peel resistance are obtained, and by adding the above-mentioned plasticizers and additives,
By sharpening the edge of printing, extremely clear printing can be reliably obtained.

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

[0035]

As described above, according to the printing ink of the present invention, it is possible to clean up printing equipment parts at the time of printing while maintaining good peeling resistance of a printing ink using a water-soluble resin as a binder component. The printing efficiency can be improved by extending the interval, and the printing performance can be improved, so that clearer printing can be reliably obtained.

[0036]

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.

Printing inks having the compositions shown in Examples 1 to 13 and Comparative Examples 1 to 4 in Table 1 were prepared, and were prepared using a tablet printer “IS-500” manufactured by Shionogi Qualicaps Co., Ltd.
Printing tests on tablets coated with HPMC were performed. At this time, gradually increase the clean-up interval of the transfer rubber roll of the printing machine to find out the longest interval at which good printing can be performed without causing printing defects, and to determine the sharpness of the print immediately before the clean-up. Was evaluated according to the following criteria. Table 1 shows the results. Further, the same test was performed using a commercially available ink having the composition shown in Comparative Example 5 in Table 1. The results are also shown in Table 1. For reference, FIG. 1 shows an enlarged photograph of a print taken immediately before cleanup (worst case) printed using the ink of Example 2 and, for comparison, immediately after cleanup printed using the ink of Comparative Example 1 FIG. 2 shows an enlarged photograph of the (best) print. Evaluation criteria of print clarity A : The edges of the print are very sharp and very clear. 〇: The edges of the print are sharp and clear. Δ: Slightly inferior in edge sharpness, but sharp overall. ×: Bleeding occurs at the edge, and the line shape becomes thick and unclear due to the bleeding.

[0038]

[Table 1]

As shown in Table 1, the water-based ink of the present invention (Examples 1 to 13) to which the wetting agent was added had a longer clean-up interval than the conventional water-based inks (Comparative Examples 1 to 4). The inks of Examples 1 to 5 in which the plasticizer or sodium alginate was added together with the wetting agent in an appropriate amount range of 15 to 40% by weight, together with the extension of the cleanup interval, were able to improve the print definition. Can also be effectively improved, and in Examples 1 to 5,
It was confirmed that the ink No. 5 can achieve a long clean-up interval equal to or far exceeding the conventional organic solvent-based ink (Comparative Example 5).

As shown in the enlarged photograph of FIG. 2, in the conventional printing with the ink of Comparative Example 1, even under the best conditions immediately after the cleanup, the edges of the printing blurred and the line characters became thick, and the printing was sharp. On the other hand, as shown in the enlarged photograph of FIG. 1, the printing with the ink of Example 2 according to the present invention was performed 60 times after the previous cleanup.
Good sharpness was maintained even under the worst conditions immediately before the cleanup after a lapse of minutes.

Next, using a bar coater No. 3, a gelatin film and an HPMC film (both of 50 × 1) were used.
00 mm) and the above Examples 1 to 13 and Comparative Examples 1 to 5
Each ink 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 2 shows the results
Shown in 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, and 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 of 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 base 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.

[0042]

[Table 2]

As shown in Table 2, the printing film obtained by using the printing ink of the present invention has the following properties:
In terms of slipperiness, the ink had excellent performance equivalent to that of the conventional water-based ink (Comparative Examples 1 to 4), and surpassed the conventional organic solvent-based ink (Comparative Example 5).

[Brief description of the drawings]

FIG. 1 is a 10-times enlarged photograph showing printing immediately before cleanup obtained by using a printing ink of Example 2.

FIG. 2 is a 10-times enlarged photograph showing printing immediately after cleanup obtained by using the printing ink of Comparative Example 1.

Continued on the front page F term (reference) 4J039 AB01 AB02 AB07 AD23 AE07 BA29 BC07 BC09 BC10 BC19 BC20 BC54 BE01 BE02 BE13 BE22 CA06 EA36 EA42 EA43 EA45 FA07 GA07

Claims (9)

[Claims] 1. A printing ink for an orally administered product comprising a water-based vehicle containing a water-soluble resin as a binder component and a coloring agent component, wherein a wetting agent is added to the printing ink for an orally administered product. 2. The printing ink for an orally administered product according to claim 1, wherein a polyhydric alcohol is added as the wetting agent. 3. The printing ink according to claim 2, wherein the polyhydric alcohol added as the wetting agent is glycerin. 4. A plasticizer is added together with a wetting agent.
A printing ink for an orally administered product according to any one of claims 1 to 3. 5. The printing ink according to claim 4, wherein the plasticizer is one or more selected from triethyl citrate, triacetin, propylene glycol, polyethylene glycol, and D-sorbitol. 6. The oral administration product according to claim 1, wherein one or more additives selected from sodium alginate, dextrin, and polyvinylpyrrolidone are added together with the wetting agent. Printing ink. 7. The method according to claim 1, wherein the water-soluble resin of the binder component is a water-soluble cellulose derivative.
A printing ink for an orally administered product according to the above item. 8. The printing ink according to claim 7, 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. 9. The printing ink for an orally administered product according to claim 8, wherein the water-soluble cellulose derivative is hydroxypropylmethylcellulose.