JP4812626B2 - Solid preparation for oral dissolution - Google Patents

Description

  The present invention relates to a solid preparation for oral dissolution that can be easily treated with a single preparation simultaneously with treatment for pain such as throat and continuous sterilization in the oral cavity.

  The number of patients complaining of sore throats and swelling is increasing due to the progress of air conditioning OA, pollution such as air pollution, and environmental pollution of climate climate. In general, for the treatment of sore throat and swelling, there are a method of directly sterilizing the affected part from the outside and a method of transferring a drug to the circulating blood to suppress inflammation that causes the sore throat and swelling from the inside. For example, as a method of directly sterilizing the affected part from the outside, the wrinkle is performed with a gargle having a bactericide such as povidone iodine or cetylpyridinium chloride. Or the method of sterilizing by dissolving the lozenge containing a disinfectant in the mouth is taken. On the other hand, as a method of suppressing inflammation from the inside, taking tablets containing an anti-inflammatory agent such as tranexamic acid can be considered. In general, treatment of sore throat and swelling is performed by combining these different usages. Therefore, it is inconvenient to perform treatment at work or school due to location restrictions due to use of water. Therefore, there has been a demand for development of a formulation with improved convenience, that is, a formulation with improved compliance.

In order to solve such a problem, a preparation (Patent Document 1) in which a main drug speed disintegration part is compression-coated on a delayed-release tablet is known. However, a fast-acting drug and a long-acting drug are not contained in the body after swallowing. Released. In addition, it is easy to swallow and easy to swallow for oral administration, characterized by comprising an inner core of an easily swallowable size containing a pharmaceutically active ingredient, and a rapidly disintegrating compression coating layer formed around the inner core Although a tablet (patent document 2) is known, it is necessary to swallow after the rapidly disintegrating compression coating layer is dissolved. Therefore, in all cases, even if a drug having a direct bactericidal effect is applied to the throat, the effect cannot be sustained.
JP 62-246512 A JP-A-8-143473

  Accordingly, an object of the present invention is to provide a solid preparation which can be easily treated with a single preparation simultaneously with treatment for pain such as throat and continuous sterilization in the oral cavity.

  Therefore, as a result of various studies to find a solid preparation that can be easily treated with a single preparation at the same time as treatment for pain such as throat and continuous sterilization in the oral cavity, a disintegration test according to the disintegration test method of the Japanese Pharmacopoeia For oral dissolution by combining a part containing an oral bactericidal component that disintegrates or dissolves over 3 minutes and a part containing an oral anti-inflammatory component that disintegrates or dissolves in 45 seconds to 2 minutes. When it was made into a preparation, it was found that when it was dissolved in the oral cavity, a solid preparation capable of simultaneously treating the sore throat and sterilizing in the oral cavity at the same time was easily obtained, and the present invention was completed.

  That is, when the present invention is subjected to a disintegration test according to the Japanese Pharmacopoeia disintegration test method, a part containing an oral anti-inflammatory component that disintegrates or dissolves in 45 seconds to 2 minutes and an oral disinfection that disintegrates or dissolves over 3 minutes. The present invention provides a solid preparation for dissolution in the oral cavity comprising a part containing an ingredient.

  When the solid preparation of the present invention is dissolved in the oral cavity and taken, treatment for pain such as throat and continuous sterilization in the oral cavity can be easily performed simultaneously and in a single preparation. Furthermore, since the present preparation can be taken without water, it has an excellent practical advantage that it can be taken anytime and anywhere.

It is a figure which shows the external view and sectional drawing of this invention solid formulation which consists of an outer layer and an inner core. It is a figure which shows the external view and sectional drawing of this invention solid formulation which is a two-layer laminated preparation. It is a figure which shows the external view and sectional drawing of this invention solid formulation which is a plate-shaped formulation.

  Oral pain in the present invention includes sore throat, laryngitis, tonsillitis, stomatitis, throat, discomfort / screaming in the throat, and excessive cigarette inhalation.

  The content of the oral anti-inflammatory component used in the present invention is preferably 1 to 60% by mass in the solid preparation, more preferably 5 to 50% by mass, and particularly preferably 10 to 40% by mass. .

  The oral anti-inflammatory component used in the present invention may be any component that suppresses oral pain, such as tranexamic acid as an antiplasmin agent, dipotassium glycyrrhizinate and potassium glycyrrhizinate as non-steroidal anti-inflammatory agents. , Ammonium glycyrrhizinate, monoammonium glycyrrhizinate, anti-inflammatory enzyme lysozyme chloride, bromelain, serabeptase, semi-alkaline protease and seaprose, and tranexamic acid is particularly preferred. These intraoral anti-inflammatory components are preferably components that are absorbed mainly in the gastrointestinal tract below the stomach and exert an anti-inflammatory effect.

  The part containing the oral anti-inflammatory component used in the present invention is usually 45 seconds to 2 minutes, preferably 45 seconds to 1 minute 45 seconds, particularly preferably 45 when a disintegration test is performed according to the disintegration test method of the Japanese Pharmacopoeia. Disintegrates from 1 second to 30 minutes. Additives that promote disintegration of solid preparations, such as excipients that dissolve, disintegrants or excipients that swell, excipients that easily provide voids in solid preparations, excipients or disintegrants that facilitate the introduction of saliva It is possible to promote rapid disintegration or dissolution for 45 seconds to 2 minutes. Needless to say, the disintegration or dissolution time described above is linked to the disintegration or dissolution time in the oral cavity. By such rapid disintegration or dissolution in the oral cavity, it is rapidly absorbed and exhibits an anti-inflammatory effect.

  The mass of the part containing the oral anti-inflammatory component used in the present invention is usually 100 mg or more, preferably 200 mg or more, more preferably 300 mg to 2500 mg, and particularly preferably 500 mg to 1500 mg. Although there is no restriction | limiting in the magnitude | size of the part containing the intraoral anti-inflammatory component used by this invention, Usually, it is 8 mmφ or more, Preferably it is 9 mmφ or more, More preferably, it is 10 mmφ-18 mmφ, Most preferably, it is 11 mmφ-15 mmφ.

  In addition to the oral anti-inflammatory component, vitamins such as vitamin B2, vitamin B6, vitamin C, orotic acid and pantothenic acid can be blended in the part containing the oral anti-inflammatory component used in the present invention. These drugs can be used alone or in combination of two or more.

  A pharmaceutically acceptable carrier such as an excipient, a binder, a disintegrant, a sweetener, a lubricant, and a fragrance may be used for the part containing the oral anti-inflammatory component used in the present invention. .

  Excipients include lactose, starches, crystalline cellulose, sucrose (purified sucrose, sucrose), fructose, glucose, mannitol, sorbitol, erythritol, xylitol, maltitol, hydrogenated oil, calcium hydrogen phosphate, hydrous silicon dioxide, Examples include light anhydrous silicic acid, calcium silicate, magnesium aluminate silicate, and magnesium aluminate metasilicate.

  Examples of the binder include hydroxypropylmethylcellulose, hydroxypropylcellulose, gelatin, pregelatinized starch, polyvinylpyrrolidone, polyvinyl alcohol, pullulan, gum arabic, and macrogol.

  Disintegrants include carboxymethylcellulose (carmellose), carboxymethylcellulose calcium (carmellose calcium), sodium carboxymethylcellulose (carmellose sodium), sodium carboxymethyl starch, corn starch (corn starch), potato starch, wheat starch, rice starch, hydroxy Examples thereof include propyl starch, partially pregelatinized starch, low-substituted hydroxypropylcellulose, crosslinked polyvinylpyrrolidone (crospopidone), croscarmellose sodium, and crystalline cellulose.

  Examples of the sweetening agent include sucrose (purified sucrose, sucrose), fructose, glucose, mannitol, sorbitol, erythritol, xylitol, maltitol, honey, aspartame, dipotassium glycyrrhizinate, saccharin sodium and the like.

  Examples of the lubricant include magnesium stearate, calcium stearate, sodium stearyl fumarate, talc, and sucrose fatty acid ester.

  Examples of the fragrances include l-menthol, caramel, and various fruit fragrances.

  The content of the oral bactericidal component used in the present invention is preferably 0.01 to 40% by mass in the solid preparation, more preferably 0.05 to 30% by mass, and particularly preferably 0.05. -10 mass%.

  Examples of the oral bactericidal component used in the present invention include cetylpyridinium chloride, chlorhexidine hydrochloride, decalinium chloride, creosote, benzalkonium chloride, phenol and thymol, and cetylpyridinium chloride is particularly preferable. These oral bactericidal components are preferably components that exert a direct bactericidal action mainly in the oral cavity.

  The part containing the bactericidal component used in the present invention is usually more than 3 minutes, preferably more than 4 minutes, particularly preferably more than 5 minutes when the disintegration test is performed according to the disintegration test method of the Japanese Pharmacopoeia. Collapse. The disintegration time is preferably 3 to 30 minutes, more preferably 4 to 25 minutes, and particularly preferably 5 to 20 minutes. Disintegration or dissolution for 3 to 30 minutes can be obtained by blending an excipient with good moldability, an excipient or binder having binding properties, or by not blending a disintegrant. By such a continuous disintegration, an oral bactericidal effect can be obtained continuously.

  The mass of the portion containing the oral bactericidal component used in the present invention is usually 50 mg to 1500 mg, preferably 100 mg to 1200 mg, particularly preferably 120 mg to 800 mg. The size of the part containing the oral bactericidal component used in the present invention is usually 4 mmφ to 25 mmφ, preferably 6 mmφ to 25 mmφ, more preferably 6 mmφ to 12 mmφ, still more preferably 7 mmφ to 11.5 mmφ, and particularly preferably 8 mmφ to 11 mmφ. It is.

  In addition to the oral bactericidal component, the part containing the oral bactericidal component used in the present invention can be blended with herbal medicines such as senega, licorice, kyoukyo, soyou and shikon, and an anti-inflammatory agent such as sodium azulenesulfonate. . These drugs can be used alone or in combination of two or more.

  The oral bactericidal component used in the present invention may use a pharmaceutically acceptable carrier such as an excipient, a binder, a sweetener, a lubricant, a fragrance and the like.

  Excipients include lactose, starches, crystalline cellulose, sucrose (purified sucrose, sucrose), fructose, glucose, mannitol, sorbitol, erythritol, xylitol, maltitol, hydrogenated oil, calcium hydrogen phosphate, hydrous silicon dioxide, Examples include light anhydrous silicic acid, calcium silicate, magnesium aluminate silicate, and magnesium aluminate metasilicate.

  Examples of the binder include hydroxypropylmethylcellulose, hydroxypropylcellulose, gelatin, pregelatinized starch, polyvinylpyrrolidone, polyvinyl alcohol, pullulan, gum arabic, and macrogol.

  Examples of the sweetening agent include sucrose (purified sucrose, sucrose), fructose, glucose, mannitol, sorbitol, erythritol, xylitol, maltitol, honey, aspartame, dipotassium glycyrrhizinate, saccharin sodium and the like.

Examples of the lubricant include magnesium stearate, calcium stearate, sodium stearyl fumarate, talc, and sucrose fatty acid ester.
Examples of the fragrances include l-menthol, caramel, and various fruit fragrances.

  The mass ratio of the part containing the oral anti-inflammatory component that disintegrates or dissolves in 45 seconds to 2 minutes and the part containing the oral bactericidal component that disintegrates or dissolves over 3 minutes is usually 1: 0.015 to 1: 8, The ratio is preferably 1: 0.04 to 1: 4, particularly preferably 1: 0.08 to 1: 2.

  The form of the solid preparation of the present invention is not particularly limited as long as it has the above-mentioned two parts, but the part containing the oral anti-inflammatory component is the same as the part containing the oral bactericidal component or more than this part. A form in which disintegration or dissolution starts quickly is preferable. As such a form, (1) the solid preparation is a preparation comprising an outer layer and an inner core, the outer layer is a part containing an oral anti-inflammatory component, and the inner core is a part containing an oral bactericidal component (FIG. 1). (2) A form in which the solid preparation is a laminated preparation of two or more layers, and each layer is separated into a layer containing an oral anti-inflammatory component and a layer containing an oral bactericidal component (FIG. 2 (two-layer example) ); (3) A preparation in which the solid preparation is a plate-like preparation, the portion containing the oral bactericidal component is a perforated disc-like form, and the portion containing the oral anti-inflammatory component is embedded in the hole space (FIG. 3). Here, the disc-shaped preparation may be a disc or a rectangular disc. In the form of (1), the size of the portion containing the bactericidal component and the portion containing the buccal anti-inflammatory component of the present invention is larger than the portion 1 containing the bactericidal component. The ratio (diameter ratio of the preparation) is usually 1.1 to 3 times, preferably 1.2 to 2.6 times, particularly preferably 1.3 to 2 times.

  The solid preparation used in the present invention is obtained, for example, by the following production method. First, both the part containing the oral bactericidal component and the part containing the oral anti-inflammatory component are produced by compression molding granules obtained by a wet granule compression method or a direct powder compression method. For example, the part containing an oral bactericidal component is mixed with a bactericidal component and other pharmaceutically active ingredients and appropriate additives such as excipients and sweeteners. Thereafter, in the wet granule compression method, a core solution is prepared by adding a lubricant solution, a fragrance, and the like to the granulated, dried, and sized granules by adding a binder solution, and mixing and mixing. In the direct powder compression method, an inner core uncoated tablet is produced by adding a lubricant, a fragrance, and the like and mixing and compression molding without granulation. On the other hand, for the part containing the oral anti-inflammatory component, the anti-inflammatory component and other pharmaceutically active ingredients are mixed with appropriate additives such as excipients, disintegrants and sweeteners. Thereafter, in the wet granule compression method, a mixed powder of the outer layer is produced by adding a lubricant, a fragrance, and the like to the granulated, dried, and sized granules after adding a binder solution. In the direct powder compression method, a lubricant, a fragrance and the like are added and mixed without granulation to produce a mixed powder of the outer layer. Using the mixed powder of the inner core uncoated tablet and the outer layer thus obtained, the inner core uncoated tablet is used as a core for compression molding to produce a solid preparation in the form of FIG.

  The part containing the oral bactericidal component in the solid preparation of the present invention is a lozenge. In the present invention, by combining the lozenge and a part containing an anti-oral component that is absorbed in the gastrointestinal tract and exhibits an anti-inflammatory action, the whole is dissolved in the oral cavity to obtain a preparation for use. It is possible to easily perform treatment for pain such as throat and continuous sterilization in the oral cavity at the same time.

  EXAMPLES The present invention will be specifically described below with reference to examples, but the present invention is not limited to these examples.

Example 1
1 g of cetylpyridinium chloride (manufactured by Wako Pure Chemical Industries, Ltd .: trade name: cetylpyridinium chloride), 183.8 g of sorbitol and 3 g of sodium saccharin were mixed, and a kneaded liquid obtained by dissolving 8 g of hydroxypropylcellulose in 40 g of ethanol was used. Wet granulation was performed and the granulated product was dried and sized to obtain 195.8 g of sized powder of the inner core. Magnesium stearate 2 g, menthol powder 2 g and citrus flavor 0.2 g were mixed with the obtained sized powder, and an inner core tablet having a diameter of 8 mm and a mass of 200 mg was produced by a rotary tableting machine. To the obtained inner core tablet, tranexamic acid (trade name: tranexamic acid: 250 g), aspartame 30 g, dipotassium glycyrrhizinate 13 g, mannitol 442.2 g, crospovidone 40 g, magnesium stearate 8 g, menthol powder 16 g The mixed powder mixed with 0.8 g of grapefruit flavor was compression coated with a dry tableting machine at 800 mg per tablet to obtain a solid preparation having a diameter of 13 mm and a mass of 1000 mg.

Example 2
1 g of cetylpyridinium chloride (trade name: cetylpyridinium chloride, manufactured by Wako Pure Chemical Industries, Ltd.), 292.7 g of mannitol, 3 g of magnesium stearate, 3 g of menthol powder, and 0.3 g of citrus fragrance are mixed to form a rotary by direct powder compression. An inner core uncoated tablet having a diameter of 9 mm and a mass of 300 mg was produced using a tablet press. To the obtained inner core tablet, tranexamic acid (Daiichi Pharmaceutical Co., Ltd .: trade name tranexamic acid) 400 g, aspartame 30 g, dipotassium glycyrrhizinate 13 g, sorbitol 292.2 g, crospovidone 40 g, sodium stearyl fumarate 8 g, menthol powder A mixed powder in which 16 g and grapefruit flavor 0.8 g were mixed was compression-coated with a dry tableting machine by 800 mg per tablet to obtain a solid preparation having a diameter of 13.5 mm and a mass of 1100 mg.

Example 3
Cetylpyridinium chloride (manufactured by Wako Pure Chemical Industries, Ltd .: trade name: cetylpyridinium chloride) 2g, xylitol 184.3g, erythritol 184.3g and saccharin sodium 5g were mixed and 16g of hydroxypropylcellulose was dissolved in 80g of ethanol to obtain a kneaded Wet granulation was performed using the mixed solution, and the granulated product was dried and sized to obtain 391.6 g of a sized powder of the inner core. 4 g of magnesium stearate, 4 g of menthol powder, and 0.4 g of citrus flavor were mixed with the obtained sized powder, and an inner core uncoated tablet having a diameter of 10 mm and a mass of 400 mg was produced by a rotary tableting machine. To the obtained inner core tablet, 250 g of tranexamic acid (Daiichi Pharmaceutical Co., Ltd .: trade name tranexamic acid), 30 g of aspartame, 13 g of dipotassium glycyrrhizinate, 576 g of sorbitol, 100 g of microcrystalline cellulose, 5 g of magnesium stearate, 25 g of menthol powder, A mixed powder mixed with 1 g of grapefruit flavor was compression coated with a dry tableting machine at 1000 mg per tablet to obtain a solid preparation having a diameter of 14 mm and a mass of 1400 mg.

Experimental example 1
About the solid formulation obtained in Examples 1-3, the disintegration test was implemented using the disintegration tester (Toyama Sangyo Co., Ltd. * NT-4HS type | mold) according to the 14th revision Japanese Pharmacopoeia disintegration test method. Put a total of 6 solid preparations into the glass tube of the basket, immerse them in the test solution in a beaker adjusted to a temperature of 37 ° C and purified water of 1000 mL, 30 reciprocations per minute, and smoothly move up and down with an amplitude of 55 mm Went. The result was measured for the time when the part containing the oral anti-inflammatory component and the part containing the oral bactericidal component were disintegrated or dissolved by visual observation, and an average value of six was calculated. The formulation and results are shown in Table 1.

  As for the disintegration time of the solid preparations of Examples 1 to 3, all of the portions containing an oral bactericidal component such as cetylpyridinium chloride were dissolved in excess of 3 minutes. Moreover, all the parts containing oral anti-inflammatory components such as tranexamic acid collapsed within 120 seconds. From this, the part containing the oral anti-inflammatory component rapidly disintegrates (or dissolves), and the effect of the drug is quickly produced by swallowing it, and the part containing the oral bactericidal component remains and gradually disintegrates ( (Or dissolution), the sterilizing effect such as throat can be maintained. That is, the solid preparation of the present invention is a novel solid preparation that enables rapid analgesic action and continuous sterilization of the affected area. In addition, the usability in the oral cavity was also good.

Production Example 1
Cetylpyridinium chloride (manufactured by Wako Pure Chemical Industries, Ltd .: trade name cetylpyridinium chloride) (1.0 g), sodium azulene sulfonate (trade name, sodium azulene sulfonate manufactured by Alps Chemical Industries, Ltd.) (0.8 g), sorbitol (183 0.0 g) and saccharin sodium (3.0 g) are mixed, and wet granulation is performed using a kneaded liquid obtained by dissolving hydroxypropyl cellulose (8.0 g) in ethanol (40.0 g). The product was dried and sized to obtain 195.8 g of an inner core sized powder. Magnesium stearate (2.0 g), menthol powder (2.0 g), and citrus fragrance (0.2 g) are mixed with the obtained sized powder, and an inner core uncoated tablet having a diameter of 8 mm and a mass of 200 mg by a rotary tableting machine. Manufactured. To the obtained inner core tablet, tranexamic acid (Daiichi Pharmaceutical Co., Ltd .: trade name tranexamic acid) (250.0 g), riboflavin (Roche Vitamin Japan Co., Ltd .: trade name Japanese Pharmacopoeia Riboflavin) (12.0 g), hydrochloric acid Pyridoxine (manufactured by Takeda Pharmaceutical Company Limited: trade name: pyridoxine hydrochloride) (50.0 g), aspartame (30.0 g), dipotassium glycyrrhizinate (13.0 g), mannitol (380.2 g), crospovidone (40.0 g) , Magnesium stearate (8.0 g), menthol powder (16.0 g), mixed powder mixed with grapefruit flavor (0.8 g), 800 mg per tablet, compression coated with a dry tableting machine, diameter 13 mm, mass 1000 mg of solid formulation was obtained.

Production Example 2
Cetylpyridinium chloride (manufactured by Wako Pure Chemical Industries, Ltd .: trade name cetylpyridinium chloride) (1.0 g), sodium azulene sulfonate (trade name, sodium azulene sulfonate manufactured by Alps Chemical Industries, Ltd.) (0.8 g), sorbitol (183 0.0 g) and saccharin sodium (3.0 g) are mixed, and wet granulation is performed using a kneaded liquid obtained by dissolving hydroxypropyl cellulose (8.0 g) in ethanol (40.0 g). The product was sized after drying. Magnesium stearate (2.0 g), menthol powder (2.0 g), and citrus flavor (0.2 g) were mixed with the obtained powder to obtain 200 g of a tableting powder having an antibacterial effect on the throat. On the other hand, tranexamic acid (Daiichi Pharmaceutical Co., Ltd .: trade name tranexamic acid) (250.0 g), riboflavin (Roche Vitamin Japan Co., Ltd .: trade name Japanese Pharmacopoeia Riboflavin) (12.0 g), pyridoxine hydrochloride (Takeda Pharmaceutical) Product name: Pyridoxine hydrochloride (50.0 g), aspartame (30.0 g), dipotassium glycyrrhizinate (13.0 g), mannitol (380.2 g), crospovidone (40.0 g), magnesium stearate ( 8.0 g), 800 g of a tableting powder of a component containing an anti-inflammatory component of throat mixed with menthol powder (16.0 g) and grapefruit flavor (0.8 g) was obtained. Therefore, a tableting powder of a component containing an anti-inflammatory component and a component having a bactericidal effect on the throat was compression-molded by a multilayer tableting machine to obtain a solid preparation having a diameter of 13 mm and a mass of 1000 mg.

Production Example 3
Sorbitol (1384.7 g) and saccharin sodium (22.0 g) are mixed, and cetylpyridinium chloride (manufactured by Wako Pure Chemical Industries, Ltd .: trade name cetylpyridinium chloride) (1.0 g), sodium azulene sulfonate (manufactured by Alps Pharmaceutical Industries, Ltd.) : Brand name Sodium azulenesulfonate) (0.8 g), Hydroxypropylcellulose (60.0 g) dissolved in ethanol (300.0 g), wet granulation was performed using the kneaded liquid, and granulated. The dried product is sized, mixed with magnesium stearate (15.0 g), menthol powder (15.0 g), and citrus fragrance (1.5 g), and then using a ring type 21 mmφ mortar with a rotary tableting machine. A ring-shaped solid preparation having a mass of 1500 mg was produced. On the other hand, tranexamic acid (Daiichi Pharmaceutical Co., Ltd .: trade name tranexamic acid) (80.0 g), riboflavin (Roche Vitamin Japan Co., Ltd .: trade name Japanese Pharmacopoeia Riboflavin) (4.0 g), pyridoxine hydrochloride (Takeda Pharmaceutical) Product name: Pyridoxine hydrochloride (16.0 g), aspartame (8.0 g), dipotassium glycyrrhizinate (3.0 g), mannitol (64.8 g), hydroxypropylcellulose (8.0 g) in ethanol (40 Wet granulation using a kneaded solution obtained by dissolving in 0.0 g), the granulated product is dried and then sized, crospovidone (10.0 g), magnesium stearate (2.0 g), menthol Producing a mixed powder in which powder (4.0 g) and grapefruit flavor (0.2 g) are mixed, and the inside (hole) of the resulting ring-shaped solid preparation The mixed powder was 200mg filled per tablet of the portion compressed by a tablet machine to yield a diameter of 21 mm, the solid preparation of mass 1700 mg.

Claims (8)

  When a disintegration test is performed according to the disintegration test method of the Japanese Pharmacopoeia, from a part containing an oral anti-inflammatory component that disintegrates or dissolves in 45 seconds to 2 minutes and a part containing an oral bactericidal component that disintegrates or dissolves over 3 minutes A solid preparation for oral dissolution.   The intraoral anti-inflammatory component is a component that exhibits an anti-inflammatory effect by being absorbed in the digestive tract below the stomach, and the oral sterilizing component is a component that directly exerts a sterilizing effect in the oral cavity. Solid formulation.   The solid preparation for oral dissolution according to claim 1, wherein the solid preparation is a preparation comprising an outer layer and an inner core, the outer layer is a portion containing an oral anti-inflammatory component, and the inner core is a portion containing an oral bactericidal component.   The solid preparation for oral dissolution according to claim 1, wherein the solid preparation is a laminated preparation of two or more layers, and each layer is separated into a layer containing an oral anti-inflammatory component and a layer containing an oral antiseptic component. .   The solid preparation is a plate-like preparation, the part containing an oral bactericidal component is a perforated disk-like form, and the part containing an oral anti-inflammatory component is a form embedded in a hole space. Solid preparation for oral dissolution.   The oral anti-inflammatory component contains one or more drugs selected from tranexamic acid, dipotassium glycyrrhizinate, potassium glycyrrhizinate, ammonium glycyrrhizinate, monoammonium glycyrrhizinate, lysozyme chloride, bromelain, serabeptase, semi-alkaline protease, and ceprose. The solid preparation for intraoral dissolution of any one of Claims 1-5.   The oral bactericidal effect component contains one or more drugs selected from cetylpyridinium chloride, chlorhexidine hydrochloride, decalinium chloride, creosote, benzalkonium chloride, phenol and thymol. Solid preparation for oral dissolution.   The mass ratio of the part containing the oral anti-inflammatory component that disintegrates or dissolves in 45 seconds to 2 minutes and the part containing the oral bactericidal component that disintegrates or dissolves in excess of 3 minutes is 1: 0.015 to 1: 8. Item 8. A solid preparation for oral dissolution according to any one of Items 1 to 7.

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