JP2014058503A - Method of producing solidified body and compression molding machine for powdered body - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a method of producing a solidified body which displays a mark, such as a character, when it is irradiated with light, which realizes reduction of installation space, reduction of producing process, shortening of manufacturing time, reduction of photolytic substance and maintenance of excellent collapsibility.SOLUTION: In the method of producing solidified body, the compression molding machine for powdered body comprises upper pestles 5, lower pestles 6 and mortar holes 4 arranged on a table 31. The method comprises: an application process of applying photolytic substance onto at least any one of inner surface of the mortar holes, upper end surface of the lower pestles and lower end surface of the upper pestles; a filling process of filling up the mortar holes with powdered body; a compression molding process of subjecting the powdered body held in the mortar hole to compression molding with the upper pestle and the lower pestle; and colouring process of colouring the molding product by irradiating the molding product provided by the compression molding with light.

Description

  The present invention relates to a production method for producing a solid body such as a tablet having a mark or the like on its surface.

  In the medical field, in order to prevent dispensing errors and medication errors in solid preparations such as tablets, tablets with excellent discrimination are required.

  As a typical method for improving the discrimination, there is a method of performing a stamping process on the tablet punching surface and marking characters on the surface of the tablet, but there is a problem that the stamped part of the tablet is easily lost. . Therefore, a method has been developed for printing characters and the like using ink on the tablet surface. However, there is a problem that the uncoated tablets cannot be printed directly. In addition, since ink is used, there are problems such as printing shading, ink bleeding, stains on other tablets due to non-drying, and blurring of characters.

  In Patent Document 1, as a method for solving these problems, the surface of a tablet or the like in which a discoloration-inducing oxide (titanium oxide, yellow iron sesquioxide, iron sesquioxide) is dispersed in a composition for oral administration is irradiated with a certain laser beam. By doing so, a marking method is disclosed in which the color-change-induced oxide particles are aggregated and discolored to represent characters and symbols.

  However, when the discoloration-inducing oxide is mixed with the composition for oral administration, the discoloration-inducing oxide is dispersed throughout the tablet, etc., and the discoloration-inducing oxide unnecessary for the efficacy and effect of the drug is converted into the tablet. Will contain a lot.

  The discoloration-inducing oxide is desirably dispersed on the surface of the composition for oral administration. In general, for example, in the case of a tablet, after the tablet is produced by a powder compression molding machine, the tablet is carried into a spray coater, a pan coater or the like for coating.

  However, a tablet manufacturing company must install a plurality of machines such as a spray coater and a pan coater in a factory, and a process of bringing tablets taken from a powder compression molding machine into a spray coater, a pan coater, etc. Is also required. Therefore, there are problems of securing installation space, increasing processes, and increasing manufacturing time.

  In addition, since orally disintegrating tablets are more likely to be chipped than normal tablets, it is preferable that the number of steps be reduced.

  Furthermore, when the orally disintegrating tablet is subjected to a coating treatment, the disintegration property may be deteriorated. The coating process is not limited to the film coat, and the same applies to sugar coating and the like.

  On the other hand, in patent document 2, about the manufacturing method of the product implemented using a powder compression molding machine, a step of spraying and applying a lubricant to the upper punch, lower punch, and mortar inner surface, and coating An invention of a method for producing a coated product is disclosed which comprises the steps of spraying and applying the agent, filling the powder in the mortar and compressing with an upper punch and a lower punch. With this manufacturing method, the orally disintegrating tablet can be coated without using a new machine such as a spray coater or pan coater, and there is no problem of securing the installation space and increasing the number of processes.

  However, in the process of molding a molded product with a powder compression molding machine, there is no disclosure or suggestion of injecting a photochromic substance such as titanium oxide, and it is also possible to illuminate and color it. There is no disclosure or suggestion.

  International Publication No. 2006/126561   JP 2012-35289 A

  The present invention pays attention to such problems and the like, and is a method for manufacturing a solid body that displays a mark such as letters by irradiating light on the surface of a molded product in a powder compression molding machine, and has an installation space. Reduction, reduction of manufacturing process, reduction of manufacturing time, reduction of photochromic substances, and maintenance of good disintegration.

  In order to solve such problems, the present invention takes the following measures.

  That is, the method for producing a solid body according to the present invention is a method for producing a solid body in a powder compression molding machine having an upper punch, a lower punch, and a mortar hole provided in a table, the inner surface of the mortar hole, An application step of applying a photochromic substance to at least one of the upper end surface of the ridge and the lower end surface of the upper ridge, a filling step of filling the mortar with powder, and filling into the mortar A compression molding step of compressing and molding the powder with the upper and lower eyelids, and a coloration step of coloring the molded product by irradiating light to the molded product molded by the compression molding. Prepare.

  In such a case, the photochromic substance is compression molded by applying the photochromic substance to at least one of the inner surface of the mortar hole, the upper end surface of the lower punch, and the lower end surface of the upper punch. Since it already adheres to the surface of the molded product after passing through the process, another process such as coating to apply a photochromic substance after compression molding is also possible without using a spray coater or pan coater. Get a body. Moreover, a solid body in which marks such as letters are colored with a small amount of a photochromic substance can be produced. Moreover, since the photochromic substance to apply | coat is a small amount, it has little influence regarding the disintegration property of a molded article. Examples of the photochromic material include oxides.

  Moreover, it is preferable to further include an injection step of injecting an external lubricant onto the inner surface of the mortar, the upper end surface of the lower punch, and the lower end surface of the upper punch.

  The spraying step of spraying the external lubricant may be after or before the coating step of coating the photochromic substance, but in order to improve the releasability, the step before the coating step may be performed. Better. Moreover, the said manufacturing method can be used for manufacture of an orally disintegrating tablet etc. by further providing the injection process which injects an external lubricant.

  In order to more efficiently apply the photochromic material, a method for producing a solid body in a powder compression molding machine having a mortar hole provided in an upper punch, a lower punch, and a table, the inner surface of the mortar A second spraying step of spraying a photochromic substance and an external lubricant to the upper end surface of the lower punch and the lower end surface of the upper punch, and the powder filled in the mortar hole to the upper Examples include a compression molding step in which compression molding is performed with a ridge and the lower heel, and a coloration step in which the molded product is colored by irradiating light to the molded product molded by the compression molding.

  Titanium oxide, iron sesquioxide, yellow iron sesquioxide, and the like, which are photochromic substances, tend to aggregate and become clogged up to the injection process. Therefore, by spraying a mixture of an external lubricant and a photochromic material, clogging of the photochromic material is prevented, and an external lubricant is also sprayed at the same time. You do n’t have to. By setting the ratio of the external lubricant and the photochromic substance to an appropriate ratio, there is an effect that the molded article has both good disintegration property and photochromic property.

  In addition, the photochromic material according to the present invention is not limited to the mode in which the photochromic material itself is colored when irradiated with light, but also when the light is irradiated to the photochromic material. It is a concept that includes a mode in which powders or other substances adjacent to the colored substance are colored. In order to realize coloration with higher discrimination, it is desirable that the photochromic substance is colored in the coloration step.

  In order to color the photochromic substance, the light is preferably ultraviolet laser light.

  Moreover, as an example of the photochromic material that can obtain a highly distinguishable color, the photochromic material includes at least one of titanium oxide, iron sesquioxide, and yellow iron sesquioxide. Titanium oxide, iron sesquioxide or yellow iron sesquioxide is colored by applying ultraviolet laser light to titanium oxide, iron sesquioxide or yellow iron sesquioxide. Thereby, a character etc. can be displayed on a solid body. Titanium oxide includes titanium dioxide.

  And it is preferable that the said solid body is a solid formulation, especially an orally disintegrating tablet. With conventional coatings (film coat, sugar coating, etc.), there is a risk that disintegration delay or the like in the orally disintegrating tablet may occur. However, the amount of photochromic material such as titanium oxide in the present invention is very small, and such influence does not occur. In addition, when a mixture of a photochromic substance such as titanium oxide and an external lubricant is sprayed, such a influence is not caused because a double coating is not formed.

  The powder compression molding machine according to the present invention has a table provided with a mortar hole penetrating vertically and a lower part of the mortar hole, and the upper end portion is inserted into the mortar hole so that it can slide in the mortar hole. A lower arm, an upper arm disposed above the mortar so as to oppose the lower arm, a lower end inserted into the mortar and slidable in the mortar, an inner surface of the mortar, An injection means for injecting a photochromic substance and an external lubricant to the upper end surface of the lower eyelid and the lower end surface of the upper eyelid, and after the injection by the injection means, the upper eyelid and the lower eyelid Filling means for filling the powder to be compressed into the mortar hole, and coloring means for coloring the molded product by irradiating light to the molded product molded by the compression molding.

  Here, the powder refers to an aggregate of fine solids, and is a concept including so-called granules and powder having a shape smaller than the granules.

  According to the present invention, it is possible to reduce the installation space, the manufacturing process, the manufacturing time, the photochromic substance, and the good disintegration.

1 is a side sectional view showing a powder compression molding machine according to an embodiment of the present invention. The principal part top view of the powder compression molding machine of the embodiment. The cylindrical view which shows the relationship between the ridge and the roll in the powder compression molding machine of the embodiment. The principal part enlarged plan view which shows the injection apparatus in the powder compression molding machine of the embodiment. The principal part sectional side view which shows the injection apparatus in the powder compression molding machine of the embodiment. The figure which shows the tableting process of the molded article by the powder compression molding machine of the embodiment. The external view which showed typically the laser marking apparatus used for one Embodiment of this invention. Explanatory drawing which showed the principal part of the laser marking apparatus typically. The principal part top view of the powder compression molding machine of one Embodiment of this invention. The drawing substitute photograph which irradiated the ultraviolet laser to the orally disintegrating tablet obtained in Examples 1-8, and displayed the character.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings.

<First embodiment>
The powder compression molding machine of the first embodiment is a rotary type that produces a molded product in which an inner core formed by compressing powder is coated with a coating agent. When the molded product is a tablet, the powder is a powder containing an active ingredient or a powder containing an active ingredient and an excipient.

  As shown in FIG. 1, in a frame 1 of a rotary powder compression molding machine, a vertical shaft 2 serving as a rotating shaft is established, and a rotating disk 3 is attached to the upper portion of the vertical shaft 2 via a connecting portion 21. ing.

  The turntable 3 rotates horizontally, that is, rotates around the vertical shaft 2. The turntable 3 includes a table (mortar disk) 31, an upper punch holder 32, and a lower punch holder 33. As shown in FIG. 2, the table 31 has a substantially disk shape, and a plurality of mortar holes 4 are provided at predetermined intervals along the rotation direction on the outer periphery thereof. The mortar hole 4 penetrates the table 31 in the vertical direction. The table 31 may be divided into a plurality of plates. Further, the mortar hole 4 is not directly formed in the table 31 itself, but a plurality of mortar members which are separate from the table 31 and can be attached to and detached from the table 31 are attached to the table 31, A configuration in which a mortar hole penetrating in the vertical direction is also provided.

  Above and below each mortar 4, an upper heel holding portion 32 and a lower heel holding portion 33 are provided so that the upper heel 5 and the lower heel 6 can be individually slid in the vertical direction with respect to the mortar 4. And hold it. The tip 53 of the upper arm 5 enters and exits the mortar hole 4. The tip 63 of the lower punch 6 is always inserted into the mortar hole 4. The upper rod 5 and the lower rod 6 rotate together with the rotating disk 3 around the vertical shaft 2, that is, revolve.

  A worm wheel 7 is attached to the lower end side of the vertical shaft 2. A worm gear 10 meshes with the worm wheel 7. The worm gear 10 is fixed to a gear shaft 9 that is driven by a motor 8. The driving force output from the motor 8 is transmitted to the gear shaft 9 by the belt 11, and rotationally drives the vertical shaft 2, and thus the rotating disk 3 and the eaves 5 and 6 via the worm gear 10 and the worm wheel 7.

  As shown in FIGS. 2 and 3, on the revolving track around the vertical shaft 2 of the eaves 5 and 6, a preload upper roll 12 and a preload lowerer that are paired up and down with the eaves 5 and 6 interposed therebetween. There are a roll 13, a main roll 14 and a main roll 15. The pre-loading roll 12 and the pre-loading roll 13, and the main-pressing roll 14 and the main-pressing roll 15 are arranged so as to compress the powder filled in the mortar hole 4 from above and below with the tip surfaces of the tips 53 and 63. The two cages 5 and 6 are urged in a direction in which they approach each other.

  The upper rod 5 and the lower rod 6 have head portions 51 and 61 pressed by the rolls 12, 13, 14, and 15, and shaft portions 52 and 62 having a smaller diameter than the head portions 51 and 61, respectively. The tip portions of the shaft portions 52 and 62 are thinner than other portions so as to be inserted into the mortar hole 4 and have a diameter substantially equal to the inner diameter of the mortar hole 4. The rolls 12, 13, 14, and 15 approach the heads 51 and 61 of the saddles 5 and 6 due to the revolution of the saddles 5 and 6, and come into contact with the heads 51 and 61. Furthermore, the rolls 12, 13, 14, and 15 are displaced horizontally while rolling on the heads 51 and 61, and at that time, the upper collar 5 is pushed downward or the lower collar 6 is pushed upward. During the period when the rolls 12, 13, 14, 15 are in contact with the flat surfaces on the ridges 5, 6, the ridges 5, 6 continue to apply a certain pressure to the powder in the mortar 4.

  A molded product discharge unit 16 is configured at a position advanced from the pressurization position by the main roll 14 and the main roll 15 along the rotation direction of the rotary disk 3 and the eaves 5 and 6. In the molded product discharge unit 16, the lower punch 6 is raised until the upper end surface of the tip 63 of the lower punch 6 is substantially the same height as the upper end of the die hole 4, that is, the upper surface of the table 31, and the molded product in the die hole 4 Is pushed out from the mortar 4. In the molded product discharge portion 16, a guide member 17 for guiding the molded product pushed out from the mortar hole 4 is installed. The molded product that has exited the mortar hole 4 comes into contact with the guide member 17 by the rotation of the turntable 3, and moves along the guide member 17 toward the molded product collection position 18.

  The filling device X is for filling powder into the mortar hole 4, and includes a powder supply mechanism X1, a feed shoe X2, and a grinding plate X3. The powder supply mechanism X1 guides the powder onto the rotation path of the mortar hole 4. The feed shoe X2 drops and fills the powder supplied by the powder supply mechanism X1 into the mortar hole 4 as the lower punch 6 descends to a predetermined height position. After the powder filling by the feed shoe X2, the grinding plate X3 grinds the powder that overflows from the mortar hole 4 by the ascending of the lower punch 6, and removes it from the mortar hole 4.

  The injection device Y (Ya, Yb) is a powder propellant other than powder on the inner peripheral surface of the mortar hole 4, the upper end surface of the tip 63 of the lower punch 6, and the lower end surface of the tip 53 of the upper punch 5. Is to blow. As shown in FIG. 4, the injection device Y guides the propellant supplied from an external propellant supply device (not shown) and injects it toward the upper end surface of the pestle 63 and the tip 63 of the lower punch 6. Downward injection nozzle Y1, upward injection nozzle Y2 that guides the propellant supplied from the propellant supply device and injects it toward the lower end surface of the tip 53 of the upper punch 5, the tip of the mortar 4 and the tips 5 and 6 The surplus propellant that has not adhered to 53, 63 is sucked and discharged to the outside (may be returned to the propellant supply device), as well as the suction duct Y3 for purging, and these downward jet nozzles Y1, upper The case Y4 that holds the direction injection nozzle Y2 and the suction duct Y3 is used as an element.

  As shown in FIG. 5, the downward injection nozzle Y1 has a flow pipe Y11 extending substantially horizontally in a block made of a fluororesin (particularly polytetrafluoroethylene), and the end of the flow pipe Y11 is bent downward. In this way, an injection port Y12 opened on the lower surface of the block is formed. The inner surfaces of the flow pipe Y11 and the injection port Y12 become a smooth surface of a fluororesin, and smoothes the flow and ejection of the propellant. A static electricity generating electrode Y13 is embedded in the downward spray nozzle Y1. The tip of the static electricity generation electrode Y13 has a needle shape or a taper shape, and protrudes to a location in the vicinity of the injection port Y12. For example, a high direct current voltage of about −20 kV is applied to the static electricity generating electrode Y13, and the propellant immediately before jetting is forcibly electrostatically charged by the electric field concentrated on the tip.

  The upward injection nozzle Y2 has a structure just like the downward injection nozzle Y1 shown in FIG. That is, the upward injection nozzle Y2 is formed by piercing a flow pipe extending substantially horizontally in a block made of a fluororesin, and forming an injection port Y22 opened at the upper surface of the block by curving the end of the flow pipe upward. It is. An electrostatic generation electrode is also embedded in the upward injection nozzle Y2. The tip of the static electricity generating electrode has a needle shape or a taper shape, and protrudes to a location near the injection port Y22.

  The suction duct Y3 is at a height position facing the side of the tip 53 of the upper collar 5. The opening of the suction duct Y3 is fixed to the case Y4 and communicates with the internal space of the case Y4.

  The case Y4 is a fluororesin box that substantially covers the downward injection nozzle Y1 and the upward injection nozzle Y2 in order to prevent disordered release of the propellant. The case Y4 is electrically insulated from the turntable 3 and the injection nozzles Y1 and Y2. The case Y4 is provided with an air curtain Y41 for blowing compressed air substantially horizontally toward the opening of the suction duct Y3. The air curtain Y41 creates an air flow in the vicinity of the tip 53 of the upper rod 5, and prevents upward spraying of the propellant injected from the upward injection nozzle Y2 toward the tip 53 of the upper rod 5.

  The external propellant supply device is a μR feeder (Nisshin Engineering Co., Ltd.) that takes out the propellant accurately and stably little by little through a narrow groove filling type roll and feeds it on pressurized air. Name).

  The propellant supplied from the propellant supply device is divided into the downward injection nozzle Y1 and the upward injection nozzle Y2, flows through the flow pipes in the nozzles Y1 and Y2, and is injected from the injection ports Y12 and Y22. During the injection, the propellant is forcibly electrostatically charged. On the other hand, the mortar hole 4 and the ridges 5 and 6 are grounded through the grounding of the rotating disk 3, and the electrostatically charged propellant is an inner peripheral surface of the mortar hole 4, which is a metal surface, and the tip of the lower ridge 6. It strongly adsorbs to the upper end surface of 63 and the lower end surface of the tip 53 of the upper collar 5. The adsorbed propellant does not peel off due to the vibration of the vertical movement of the eaves 5 and 6 or the wind pressure due to the high-speed rotation of the rotating disc 3, but is strongly pressed against the powder simultaneously with the compression molding of the powder by the eaves 5 and 6. Dislocation adheres from the tips 4 of the holes 4 and the ridges 5 and 6 to the tablets.

  Therefore, in this embodiment, as shown in FIG. 2, a plurality of injection devices Y are provided, and the first injection device Ya, the second injection device Yb, the filling device X, the preload roll 12, 13, the main pressure rolls 14 and 15, and the molded product discharge portion 16 are arranged in this order along the rotation direction of the rotating disk 3. And the external lubricant K is injected as a propellant from the 1st injection apparatus Ya, and the photochromic substance T is injected as a propellant from the 2nd injection apparatus Yb.

  The external lubricant K sprayed by the first spraying device Ya includes a binding in which the powder M is fixed to the inner periphery of the mortar hole 4 and sticking in which the powder M is fixed to the tips 53 and 63 of the punches 5 and 6. This is for preventing any damage (scratching, roughening, or chipping of the molded product). Examples of the lubricant K include stearic acid metal salts (particularly magnesium stearate), talc and the like. On the other hand, examples of the photochromic substance T ejected by the second ejection device Yb include magnesium oxide, zinc oxide, aluminum oxide, anatase type or rutile type titanium oxide, ferric oxide, yellow ferric oxide, and the like. In particular, anatase-type or rutile-type titanium oxide, iron sesquioxide, yellow sesquioxide, and the like can be colored.

  The manufacturing process of a molded product using the rotary powder compression molding machine of this embodiment is as follows. First, as shown in FIG. 6 (I), the first injection device Ya has the inner peripheral surface of the mortar hole 4 passing through the vicinity, the upper end surface of the tip 63 of the lower punch 6, and the tip of the upper punch 5. An external lubricant K is sprayed onto the lower end surface of 53 and applied. Next, as shown in FIG. 6 (II), the second injection device Yb has the inner peripheral surface of the mortar hole 4 passing through the vicinity, the upper end surface of the tip 63 of the lower punch 6, and the tip of the upper punch 5. On the lower end surface of 53, the photochromic substance T is sprayed and applied on the external lubricant K. Then, as shown in FIG. 6 (III), the filling device X fills the mortar hole 4 passing through the vicinity with the powder M. Thereafter, as shown in FIG. 6 (IV), the upper punch 5 and the lower punch 6 are pressed against the pre-loading rolls 12 and 13 to pre-compress the powder M in the mortar hole 4, and then the main-pressing rolls 14 and 15. To compress the powder M in the mortar hole 4. Characters and the like can be displayed on the surface of the molded product by a coloration process in which light is applied to the molded product by compression using an ultraviolet laser or the like.

  Specific examples of the coloration process of the present invention will be described below. FIG. 7 is a side view showing a schematic configuration of the laser marking device Z according to the coloration process of the present invention. The laser marking device Z performs marking on the surface of a molded product such as a tablet.

  As shown in FIG. 7, the laser marking device Z is conveyed by a conveyance drum Z10 that holds a molded product on the outer peripheral surface and conveys the molded product by rotation, a supply device Z20 that supplies the molded product to the conveyance drum Z10, and a conveyance drum Z10. A laser beam scanning device Z30 that performs marking by irradiating a molded product with a laser beam, a marking inspection device Z40 that inspects the marking state of the molded product, and a discharge device Z50 that discharges the solid body after the inspection. . In the present embodiment, the configuration of the laser beam scanning device Z30 will be mainly described.

  As shown in FIG. 8, the laser beam scanning device Z30 is arranged in the vicinity of the conveyance drum Z10 and more downstream in the conveyance direction of the molded product than the supply device Z20, and as schematically shown in FIG. And a pair of galvanometer mirrors Z32 and Z33, a focusing lens Z34, and a controller Z35.

  The laser light source Z31 is a device that emits a laser beam that forms a marking pattern on a molded product, and a laser having an output of 0.1 to 10 W and a wavelength of 200 to 1100 nm is used as the laser of this embodiment. For example, when marking is performed by burning the components present on the surface of the molded article, 1060 to 1064 nm is preferable, but when using the photochromic substance T as in the present embodiment, 351 to 355 nm or A laser with a wavelength of 263 to 266 nm is preferred.

  The reflection angle of the pair of galvanometer mirrors Z32 and Z33 can be changed by drive devices Z32a and Z33a such as servo motors, respectively, one galvanometer mirror Z32 has a reflection angle in the X direction, and the other galvanometer mirror Z33 has a reflection angle in the Y direction. Can be changed. Thereby, the laser beam emitted from the laser light source Z31 can be applied to the circumferential direction and the axial direction of the transport drum Z10 in the marking area on the transport drum Z10.

  The converging lens Z34 is composed of, for example, an f-θ lens, and converges the laser light reflected by the pair of galvanometer mirrors Z32 and Z33 onto the surface of the molded product. The converging lens Z34 is supported so as to be movable in the vertical direction, and the focal position of the laser beam can be adjusted as appropriate.

  The controller Z35 stores a marking pattern to be applied to a molded product such as a character, symbol or figure designed by CAD or the like as marking information in a memory unit (not shown). While grasping the rotational position, the marking of each molded product is performed by controlling the emission of the laser light source Z31 and the driving of the driving devices Z32a and Z33a based on the marking information.

  Misfilling or dropping off of a molded product with respect to the transport drum Z10 can be determined by an appearance inspection device Z60 that detects the state of filling of the transport drum Z10 between the supply device Z20 and the laser beam scanning device Z30. When the appearance inspection apparatus Z60 does not detect the molded product, the controller Z35 controls the emission of the laser light source Z31 so as not to perform marking.

  The laser beam scanning device Z30 is covered with a cylindrical protective cover Z36, and a suction device (not shown) for sucking dust generated during marking processing is connected to the side surface of the protective cover Z36. A neutralization device (not shown) for neutralizing the solid matter is provided.

  As described above, the solid body manufacturing method according to the present embodiment is a coloration process in which light is applied to the surface of a molded product obtained by compression molding a powder such as a medicine with the above-described powder compression molding machine. It can be easily implemented by going through.

  Although the embodiment of the present invention has been described above, the specific configuration of each part is not limited to the above-described embodiment, and various modifications can be made without departing from the spirit of the present invention.

  For example, in the above-described embodiment, an aspect of obtaining a molded product in which the photochromic substance is applied to the entire surface of the compression-molded powder is disclosed, but the photochromic substance is applied only to either the upper eyelid or the lower eyelid. By doing so, a molded product in which the photochromic substance is applied only to either the upper or lower surface may be obtained. Moreover, although the solid body which printed only on the single side | surface of the molded article was disclosed in the said embodiment, the solid body which printed on the up-and-down both sides and side surface of the molded article can also be manufactured. Further, specific modes of the laser marking device and the powder to be compression-molded are not limited to those of the above-described embodiment, and various modes including existing ones can be applied.

<Second embodiment>
The powder compression molding machine of the second embodiment injects a mixture TK of an external lubricant K and a photochromic substance T. Hereinafter, the difference from the first embodiment will be described with emphasis. The description of the configuration common to the first embodiment is omitted.

  The manufacturing process of a molded product using the rotary powder compression molding machine of this embodiment is as follows. As shown in FIG. 9, the first injection device Ya is applied to the inner peripheral surface of the mortar hole 4 passing through the vicinity, the upper end surface of the tip 63 of the lower punch 6, and the lower end surface of the tip 53 of the upper punch 5. The mixture of the external lubricant K and the photochromic substance T is applied by spraying. Then, the filling device X fills the mortar hole 4 passing through the vicinity with the powder M. Thereafter, the upper punch 5 and the lower punch 6 are pressed against the preloading rolls 12 and 13 to precompress the powder M in the mortar hole 4 and further pressed against the main pressure rolls 14 and 15 to be powdered in the mortar hole 4. The body M is fully compressed. Characters and the like can be displayed on the surface of the molded product by a coloration process in which light is applied to the molded product by compression using an ultraviolet laser or the like.

  In order to spray the photochromic substance T having strong cohesiveness without being clogged up to the spraying step, it is effective to use a mixture with the external lubricant K. This also eliminates the need for separately spraying the external lubricant K. In addition, since it is not necessary to separately spray the external lubricant K, the surface of the molded product has the photochromic substance T, and the color developability is improved.

  The specific configuration of each part is not limited to the above embodiment, and various modifications can be made without departing from the spirit of the present invention.

  Specific examples of this embodiment are as follows.

  Hereinafter, although a reference example and an example are given and a 2nd embodiment is described, the present invention is not limited at all by the reference example and an example.

<Reference Example 1>
Production of powder 792.5 g of partially pregelatinized starch (PCS / Asahi Kasei Chemicals) was put into a fluidized bed granulation drying coating machine (MP-01SPC type / Paurek), and 250 g of donepezil hydrochloride (manufactured by TEVA) was previously added. ) And 7.5 g of polyvinyl alcohol / acrylic acid / methyl methacrylate copolymer (POVACOAT / manufactured by Daido Kasei Kogyo Co., Ltd.) were dissolved and dispersed in 750 g of purified water, and layered and granulated.

  Next, 20 g of polyvinyl alcohol copolymer and talc (Crown Talc / manufactured by Matsumura Sangyo) were dissolved and dispersed in 1,300 g of purified water, sprayed, coated, and dried. To this dried granulated product, methacrylic acid copolymer LD (Eudragid L30D55 / Evonik Tegusa Japan) 1,500 g, D-mannitol (Mannit P / Mitsubishi Foodtech) 125 g, talc 125 g and triethyl citrate (Citro) Flex 2SC-60 / manufactured by Morimura Corporation) was coated with a solution dissolved and dispersed in 1,875 g of purified water and dried to obtain coated granules.

  Fluidized bed granulation drying coating machine using this coated granule, 3890.5 g of D-mannitol, 1,000 g of crystalline cellulose (Theolas KG-802 / Asahi Kasei Chemicals) and low substituted hydroxypropyl cellulose (NBD-022 / Shin-Etsu Chemical) (FD-GPCG-5SPC / manufactured by POWREC), granulated while spraying a solution obtained by dissolving 90 g of hydroxypropylcellulose (HPC-L / manufactured by Nippon Soda) in 2,910 g of purified water, dried and formed Granules were obtained.

  This granulated granulated powder is 150 g of crystalline cellulose, 12 g of menthol (manufactured by Katsura Kobayashi), 150 g of aspartame (manufactured by Ajinomoto), 7.5 g of fragrance (dried coat strawberry / manufactured by Takada fragrance), and magnesium stearate (manufactured by Taihei Chemical Sangyo). 100 g was added to a tumbler mixer (TM-15S type / manufactured by Showa Giken) and mixed to obtain powder for donepezil hydrochloride orally disintegrating tablets.

  In Examples 1 to 8 below, 200 g of this powder was compression molded using a rotary powder compression molding machine (AQUARIUS3 / manufactured by Kikusui Seisakusho) equipped with an external lubrication device (ELS-P1 / manufactured by Kikusui Seisakusho). Is. A mixture of the photochromic substance T (titanium oxide or iron sesquioxide) and an external lubricant K is injected into a mold using the external lubricant device, and orally disintegrating tablets (diameter 8 mm, thickness 3.3 mm, 1 tablet mass 190 mg) was manufactured, and the adhesion amount of titanium oxide or iron sesquioxide in the orally disintegrating tablet was measured.

  Further, the orally disintegrating tablets produced in Examples 1 to 8 were irradiated with an ultraviolet laser, and the state of letters and the disintegration property were examined (FIG. 10).

A mixture in which 500 g of titanium oxide and 500 g of magnesium stearate are uniformly mixed in advance is sprayed onto the tip surfaces of the upper punch 5 and the lower punch 6 and the inside of the mortar hole 4 at an injection flow rate of 28 g per hour using the external lubricant device. Then, tableting was performed at a rate of 30 revolutions per minute to obtain an orally disintegrating tablet. The amount of titanium oxide deposited on the tablet surface was 0.86 mg / cm ² .

A mixture in which 300 g of titanium oxide and 700 g of magnesium stearate are uniformly mixed in advance is sprayed onto the tip surfaces of the upper punch 5 and the lower punch 6 and 4 in the mortar hole at an injection flow rate of 78 g per hour using the external lubricant device. Then, tableting was performed at a rate of 30 revolutions per minute to obtain an orally disintegrating tablet. The amount of titanium oxide deposited on the tablet surface was 0.46 mg / cm ² .

A mixture in which 200 g of iron sesquioxide and 800 g of magnesium stearate are uniformly mixed in advance is sprayed onto the tip surfaces of the upper punch 5 and the lower punch 6 and 4 in the mortar at a spray flow rate of 76 g per hour using the external lubricant device. Tableting was performed at a rate of 30 revolutions per minute to obtain an orally disintegrating tablet. The adhesion amount of iron sesquioxide on the tablet surface was 0.05 mg / cm ² .

A mixture in which 100 g of yellow ferric oxide and 900 g of magnesium stearate are uniformly mixed in advance is applied to the tip surfaces of the upper punch 5 and the lower punch 6 and to the inside 4 of the mortar at a jet flow rate of 72 g per hour using the external lubricant device. Tableting was performed at a speed of 30 revolutions per minute while spraying to obtain an orally disintegrating tablet. The adhesion amount of yellow ferric oxide on the tablet surface was 0.06 mg / cm ² .

A mixture in which 50 g of titanium oxide and 950 g of magnesium stearate are uniformly mixed in advance is sprayed onto the tip surfaces of the upper and lower punches 5 and 6 and in the die hole 4 at a spraying flow rate of 72 g per hour using the external lubricant device. Then, tableting was performed at a rate of 30 revolutions per minute to obtain an orally disintegrating tablet. The amount of titanium oxide deposited on the tablet surface was 0.16 mg / cm ² .

A mixture obtained by uniformly mixing 200 g of titanium oxide, 700 g of stearic acid and 100 g of magnesium stearate in advance at an injection flow rate of 112 g per hour using the external lubricant device, the tip surfaces of the upper punch 5 and the lower punch 6, and the inside of the mortar Tableting was carried out at a speed of 30 revolutions per minute while spraying on 4, to obtain an orally disintegrating tablet. The amount of titanium oxide deposited on the tablet surface was 0.36 mg / cm ² .

A mixture of 200 g of titanium oxide, 700 g of hydroxypropyl cellulose and 100 g of magnesium stearate uniformly mixed with the outer lubricant device at an injection flow rate of 86 g per hour, the tip surfaces of the upper punch 5 and the lower punch 6, and the mortar Tableting was performed at a rate of 30 revolutions per minute while spraying into the inner 4 to obtain an orally disintegrating tablet. The amount of titanium oxide deposited on the tablet surface was 0.21 mg / cm ² .

A mixture obtained by uniformly mixing 200 g of titanium oxide, 700 g of corn starch and 100 g of magnesium stearate in advance, using the external lubricant device at an injection flow rate of 110 g / h, the tip surfaces of the upper and lower ridges 5 and 6, Tableting was carried out at a speed of 30 revolutions per minute while spraying on 4, to obtain an orally disintegrating tablet. The amount of titanium oxide deposited on the tablet surface was 0.19 mg / cm ² .

  Table 1 summarizes the contents from Example 1 to Example 8.

These orally disintegrating tablets manufactured in Examples 1 to 8 are irradiated with a laser under the conditions of PE = 38%, 30,000 Hz using an ultraviolet laser marking device (LIS-250 type / manufactured by Qualicaps) to display characters. (FIG. 10).

  As shown in FIG. 10, the characters displayed by coloring with an ultraviolet laser on the orally disintegrating tablets produced in Examples 1 to 8 have clear discrimination.

  Table 2 shows the results of examining the tablet hardness and oral disintegration time of the orally disintegrating tablets of Comparative Examples described later and the orally disintegrating tablets of Examples 1 to 8.

  As shown in Table 2, the orally disintegrating tablets of Examples 1 to 8 were inferior to the orally disintegrating tablets of Comparative Examples.

  Therefore, the present invention can display letters and the like with an ultraviolet laser without affecting the disintegration property of the orally disintegrating tablet, and can reduce the installation space, the manufacturing process, the manufacturing time, and the photochromic substance. Can be reduced.

<Comparative example>
Using the rotary powder compression molding machine equipped with the external lubricant device, the powder obtained in Reference Example 1 was mixed with the external lubricant K using the rotary lubricant device. 6 and sprayed into the acetabular surface 4 to obtain an orally disintegrating tablet (diameter 8 mm, thickness 3.3 mm, 1 tablet mass 190 mg).

31 ... Table 4 ... Mortar hole 5 ... Upper punch 6 ... Lower punch K ... Lubricant T ... Photochromic substance M, N ... Powder X ... Filling device Y ... Injection device

Claims (7)

A method for producing a solid body in a powder compression molding machine provided with an upper punch, a lower punch, and a mortar hole provided in a table,
An application step of applying a photochromic substance to at least one of the inner surface of the mortar, the upper end surface of the lower punch, and the lower end surface of the upper punch;
A filling step of filling the mortar with powder;
A compression molding step of compressing and molding the powder filled in the mortar with the upper and lower punches;
A solid body manufacturing method comprising: a color forming step of coloring the molded product by irradiating light to the molded product molded by the compression molding. The manufacturing method of the solid body of Claim 1 further equipped with the injection process which injects an external lubricant to the inner surface of the said mortar hole, the upper end surface of the said lower punch, and the lower end surface of the said upper punch. A method for producing a solid body in a powder compression molding machine provided with an upper punch, a lower punch, and a mortar hole provided in a table,
A second injection step of injecting a photochromic substance and an external lubricant on the inner surface of the mortar, the upper end surface of the lower punch, and the lower end surface of the upper punch,
A compression molding step of compressing and molding the powder filled in the mortar with the upper and lower punches;
A solid body manufacturing method comprising: a color forming step of coloring the molded product by irradiating light to the molded product molded by the compression molding. The method for producing a solid body according to claim 1, wherein the light is ultraviolet laser light. The method for producing a solid body according to claim 1, 2, 3, or 4, wherein the photochromic substance contains at least one of titanium oxide, iron sesquioxide, and yellow iron sesquioxide. The method for producing a solid body according to claim 1, 2, 3, 4, or 5, wherein the solid body is an orally disintegrating tablet. A table provided with a mortar hole penetrating vertically;
A lower arm that is disposed below the acetabulum and has an upper end inserted into the acetabulum and slidable within the acetabulum;
An upper arm that is arranged above the mortar so as to face the lower arm, and whose lower end is inserted into the mortar and is slidable in the mortar,
An injection means for injecting a photochromic substance and an external lubricant to the inner surface of the mortar, the upper end surface of the lower punch, and the lower end surface of the upper punch;
A filling means for filling the mortar hole with the powder compression-molded by the upper punch and the lower punch after injection by the injection means;
A powder compression molding machine comprising: color forming means for coloring the molded product by irradiating light to the molded product molded by the compression molding.