JP2011136974A - Gum drug for chewing and method for producing the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a gum drug for chewing having primarily an anti-inflammatory action to the throat, in which the drug efficacy component dwells in the mouth for a long time by chewing so that the component is in prolonged contact with affected areas in the throat, and the drug has excellent stabilized drug efficacy in preserving, storing, etc., without deterioration or the like of the drug efficacy component even when preserved and left to stand for long time at ordinary houses; and to provide a method for producing the gum drug by which the drug invariably stable in quality can be produced, without causing deterioration of the drug efficacy component in the course of production, nor causing alteration of components due to mutual reaction between used components. <P>SOLUTION: This gum drug for chewing includes a gum base and the drug efficacy component, where the gum base has a chewable elastic rubbery form, and the drug efficacy component is uniformly included in the gum base, the drug efficacy component contains an antiphlogistic having an anti-inflammatory action primarily on the inflammation of throat, and the antiphlogistic exerts the anti-inflammatory action by direct contact with the affected area in the mouth together with saliva by virtue of chewing. Specifically, the drug efficacy component can be uniformly dispersed in the gum base by a method where a mixed powder of the drug efficacy component and a vehicle is prepared, and then the mixed powder is kneaded with the gum base. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to pharmaceutical products. More specifically, the present invention mainly relates to a chewing gum pharmaceutical applied to the oral cavity having the effect of reducing and healing inflammation of the throat.

  Conventionally, as pharmaceuticals related to the throat of the human body, two types of pharmaceuticals are known from the viewpoint of efficacy. One is a medicine having an effect such as anti-inflammation for reducing and healing throat inflammation, and the other is a medicine having a throat bactericidal action for the prevention of cold syndrome.

In the case of pharmaceuticals having efficacy such as anti-inflammation for reducing and healing inflammation of the throat, two types of pharmaceuticals are known from the viewpoint of how to use the pharmaceuticals. One is a drug that depends on the blood concentration for blood vessel absorption by oral administration or injection, and the other is a direct contact drug that is used by directly contacting a medicinal component with the diseased part of the mouth. is there.
Direct contact drugs include liquid ointment type drugs such as adhesive liquids or creams, liquid drugs such as gargles that contain liquids such as mouthwashes in contact with the affected area and then exhale, and throat sprays. Spray type pharmaceuticals that are sprayed or sprayed into the mouth and contacted with the affected area, and troche type pharmaceuticals that contact the affected area while dissolving a solid solid containing a medicinal component such as a troche in the mouth are known.

  As a gargle-type medicine and spray-type medicine having an effect such as antipharyngeal inflammation, various kinds of medicines corresponding to the purpose are known. For example, Japanese Patent Laid-Open No. 2001-39844 discloses a gargle containing proanthocyanidins that is highly safe and has an excellent effect in eliminating throat inflammation. JP-A-8-3074 also contains a medicinal component such as an anti-inflammatory agent, a blood flow promoter and a bactericidal agent, and an oral fluid containing gellan gum having an effect of improving the retention of the medicinal component in the oral cavity. A composition is disclosed. Japanese Patent Application Laid-Open No. 2002-258552 discloses a spray for stomatitis containing an anti-inflammatory analgesic, a local anesthetic, and a thickener. Japanese Patent Application Laid-Open No. 2009-62285 contains sodium azulenesulfonate that mainly exhibits anti-inflammatory effects and cetylpyridinium chloride that acts as a bactericidal agent. The concentration of the medicinal component, the pH of the solution, and the surfactant to be added Liquids for oral and throat diseases in which various component elements such as the type and the type of solvent are limited have been proposed.

A certain medicinal component acts mainly as an anti-inflammatory agent, mainly as an analgesic agent, or mainly as a bactericidal effect, depending on the content, content ratio, or combination use with other medicinal components in pharmaceutical products. In this way, pharmaceuticals that are used with different main efficacy of their medicinal ingredients are common. For example, sodium azulene sulfonate is an anti-inflammatory agent (JP-A-8-3074, JP-A-2009-62285, JP-A-11-302196), bactericidal agent (JP-A-2005-278428), mucosal repair agent (JP-A-2002-255852). ). Further, it is disclosed that cetylpyridinium chloride acts as a disinfectant (Japanese Patent Laid-Open Nos. 8-3074 and 2005-278428).
Here, the definition of an anti-inflammatory agent and an anti-inflammatory agent is demonstrated. Strictly speaking, anti-inflammatory agents are used for the purpose of curing and healing inflammation, and anti-inflammatory agents are used for the purpose of suppressing the occurrence of inflammation. In particular, the phrase anti-inflammatory agent is originally used for the purpose of suppressing the occurrence of inflammation; however, it may also be used for the purpose of curing and healing inflammation, and its description. It should be judged by the overall context being made. Thus, it should be noted that an anti-inflammatory agent and an anti-inflammatory agent may be used as the same meaning or different meanings.

  On the other hand, gargle-type medicines and troche-type medicines are known as pharmaceuticals having a throat bactericidal action for the prevention of cold syndrome. For example, many types of gargle-type pharmaceuticals and troche-type pharmaceuticals containing a disinfectant or disinfectant such as cetylpyridinium chloride are known.

In recent years, chewing gum type drugs have been proposed in addition to oral type drugs, injection type drugs, gargle type drugs, spray type drugs, and troche type drugs as described above in terms of the method of using the drugs.
Chewing gum type pharmaceuticals are those in which a medicinal component is contained in a gum base, and by repeatedly chewing the chewing gum type medicinal product, the medicinal component is contained in saliva, and the medicinal component is administered in the mouth. Incorporated into the body through the mucous membranes of the medicine, or some of the medicinal components flow into the gastrointestinal tract and are absorbed from the gastrointestinal tract and taken into the body, and also act on nerves such as perception, smell, and smell in the oral cavity By exerting the effect, the effect is demonstrated.

As such chewing gum type pharmaceuticals, chewing gum containing a nicotine component is known. A nicotine-containing chewing gum has the effect of relieving withdrawal symptoms such as irritability, reduced concentration, depression, and weight gain that occur when a person with nicotine addiction due to tobacco smoking suddenly quits smoking. The chewing gum containing the nicotine component is, for example, a method of chewing for 30 minutes to 60 minutes by repeating the state of chewing one piece at a time and pasting it in the mouth. By chewing the nicotine component-containing chewing gum in the mouth, the nicotine component is taken into the body through the mucous membrane of the mouth, that is, through percutaneous absorption, and has the effect of alleviating the above-mentioned withdrawal symptoms.
For example, as a chewing gum containing nicotine, JP 2002-539236 discloses a medicinal chewing gum composition comprising a nicotine component and a method for producing the tablet. A medicinal chewing gum composition having an active factor such as a nicotine component dispersed in a gum base and coated with a mixture of a water-soluble component and a water-insoluble component, and further a flavoring agent, sweetener, dehydrating agent, A medicated chewing gum composition containing additives such as a PH stabilizer and an encapsulating agent is disclosed. In addition, as a production method for producing the above-mentioned medicinal chewing gum composition, an insoluble component (such as curable castor oil) is heated until a complete solution is obtained, and a soluble component (such as carbohydrate or other alcohol) and an active factor (nicotine) The active ingredient), pour the mixture containing the active agent into the solution of the insoluble ingredients, cool the resulting mixture, mix the gum base and additives, and exceed room temperature A process for producing a medicated chewing gum composition by compression at no temperature is disclosed. It is also disclosed that such chewing gum tablets are used in treatment for smoking cessation.

  Moreover, as chewing gum containing a medicinal component, for example, Japanese Patent Application Laid-Open No. 2005-278428 proposes a chewing gum containing a medicinal component having an action of disinfecting and sterilizing the mouth and throat. As a medicinal ingredient having an action of disinfecting and sterilizing the throat in the mouth, popidone iodine, sodium azulenesulfonate, decalinium chloride, domifane bromide, chlorhexidine gluconate, methyl salicylate, cetylpyridinium chloride and the like are selectively contained. Is disclosed.

  On the other hand, various chewing gums which are a kind of confectionery and methods for producing the same are known as conventional techniques and well-known techniques. For example, Japanese Patent Laid-Open No. 5-199842 discloses a chewing gum manufacturing method in which at least one or more kinds of herbs are added to and mixed with a chewing gum manufacturing raw material, and this mixture is formed. In other words, gum base, powdered sugar, glucose, starch syrup, etc. are put into a mixer and mixed, and then the mixture is filled with medicinal herbs of a predetermined size such as rose pink flowers, lavender flowers, and peppermint leaves. After that, after the obtained mixture is extruded through an extrusion nozzle and rolled with a rolling roll, a plate-shaped chewing gum having a predetermined shape is produced.

  JP 2001-39844 A   JP-A-8-3074   Japanese Patent Laid-Open No. 2002-255852   JP-A-5-199842   JP 2002-539236 A   JP-A-2005-278428   JP 2009-62285 A   JP-A-11-302196

  In a pharmaceutical product that is effective when the medicinal product stays in the mouth and the medicinal component comes into contact with the affected part of the throat, the usage of the gargle type medicinal product contains the medicinal component, for example, 4 to 5 times a day It is a method in which a mouthwash is diluted to a predetermined concentration with water and is contained in the mouth, and then is contacted with the affected part of the throat for several seconds before being discharged. Moreover, the usage of the spray-type pharmaceutical is, for example, a method in which a spray liquid containing a medicinal ingredient is sprayed directly into the mouth 4 to 5 times a day and brought into contact with the affected part of the throat. In such a gargle-type drug or spray-type drug, the active ingredient is in contact with the affected part of the throat for about 1 to 3 minutes, and thereafter, the active ingredient flows into the gastrointestinal tract together with saliva and the like. This means that the residence time in the mouth is short. There is a demand for a pharmaceutical product in which a medicinal component stays in the mouth for a longer time and contacts the affected part of the throat for a longer time.

  The usage of the troche type pharmaceutical is, for example, a method in which the medicinal component is brought into contact with the affected part of the throat by slowly dissolving in the mouth 4 to 5 times a day without chewing one by one. In this case, the time required for one troche to dissolve in the mouth is about 3 minutes to about 7 minutes, that is, the time that the medicinal component is in contact with the affected part of the throat is about 10 minutes at the longest. After that, the medicinal component flows away into the gastrointestinal tract together with saliva and the like. That is, the time during which the medicinal component is in contact with the affected part of the throat is short, so that there are cases where sufficient efficacy cannot be exhibited. Also, in order to lengthen the time that the medicinal ingredients are in contact with the affected part of the throat, if the medicinal ingredient concentration is the same and the amount of one lozenge is increased, the total amount of medicinal ingredients to be taken increases, which adversely affects the body. May cause side effects that are undesirable. In addition, in order to make the total amount of medicinal components to be taken the same, if the medicinal component concentration is decreased and the amount of one troche is increased, the medicinal component concentration in contact with the affected area is decreased, resulting in poor efficacy. Tend to be undesirable.

  Liquid drugs such as gargle type drugs and spray type drugs that contain multiple types of medicinal ingredients dissolved in a solvent may cause turbidity and precipitates due to the effects of temperature and humidity. There is a tendency that the content of the component changes or the medicinal component deteriorates or deteriorates due to temperature, humidity, light, etc. after standing for a long time, and the medicinal efficacy tends to decrease. For example, dissolving multiple types of medicinal ingredients in a solvent such as mouthwashes and sprays containing multiple types of medicinal ingredients, sodium azulene sulfonate acting as an anti-inflammatory agent and cetylpyridinium chloride acting as a bactericidal agent In the liquid pharmaceuticals contained in the product, the expiration date is limited because storage tends to cause deterioration over time due to temperature, humidity and light during storage.

  The chewing gum pharmaceutical containing the nicotine component, as described above, has the effect of chewing the chewing gum in the mouth so that the nicotine component is absorbed into the body through the mucous membrane of the mouth, thereby exerting the effect. . That is, this nicotine-containing chewing gum does not exhibit efficacy / effect when the medicinal component comes into direct contact with the affected area unlike the troche type pharmaceutical.

  Further, as described in Japanese Patent Application Laid-Open No. 2005-278428, a chewing gum having a throat disinfection / sterilization action for the prevention of cold syndrome has been proposed. However, the chewing gum proposed in Japanese Patent Application Laid-Open No. 2005-278428 is proposed. Is a chewing gum that aims to disinfect and disinfect the throat, and is effective for disinfecting and disinfecting it. There is no mention or suggestion about the effect of disinfecting the throat due to inflammation of the throat. It is thought that it does not demonstrate the efficacy of extinguishing.

  On the other hand, in pharmaceutical manufacturing methods, generally, medicinal ingredients tend to deteriorate under the influence of heat, humidity, and oxygen, reducing the efficacy and effects of medicinal ingredients, and tend to change to ingredients that cause side effects. Therefore, a production method that does not degrade the medicinal component is desired. In particular, as disclosed in JP-A-11-302196, sodium azulenesulfonate used as a flame retardant is an unstable substance that is easily decomposed by oxygen, moisture, light, heat, etc. Long-term storage is difficult for preparations, and countermeasures are required. In addition, during the manufacturing process, multiple types of components such as medicinal components, rubber bases, and other components that have been mixed tend to react with each other and easily change into components that cause side effects. A manufacturing method that does not change is desired.

The present invention solves the above-mentioned problems, has a medicinal component concentration that can exhibit sufficient efficacy and effects and has no side effects, the medicinal product stays in the mouth for a long time, and the medicinal component is present in the affected part of the throat. In addition, it can be contacted for a long time, and even when stored in a normal atmosphere such as room temperature, humidity, and brightness in a general household, it can be stored for a long time without causing deterioration of medicinal ingredients. An object of the present invention is to provide a chewing gum medicine having a medicinal stability and mainly having an anti-inflammatory effect on the throat. Another object of the present invention is to provide a chewing gum medicine having both an anti-inflammatory effect and a bactericidal effect mainly in the throat.
In addition, in the manufacturing process, pharmaceutical products with consistently stable quality can be manufactured without causing deterioration of medicinal components due to the influence of heat, etc., and further, without causing component changes due to mutual reaction of used components. An object of the present invention is to provide a method for producing a chewing gum medicine having an antiphlogistic effect on the throat. It is another object of the present invention to provide a method for producing a chewing gum medicine having both an antiphlogistic effect on the throat due to inflammation of the throat and a bactericidal effect.

  The chewing gum medicine of the present invention is a chewing gum medicine comprising at least a gum base and a medicinal component, wherein the gum base comprises a plurality of gum ingredients and has a chewable elastic rubber form. The medicinal component is contained in the gum base, and the medicinal component contains at least an anti-inflammatory agent having an anti-inflammatory effect mainly to extinguish inflammation of the throat, and the anti-inflammatory agent is saliva by chewing. At the same time, it has a function of directly contacting the affected part in the mouth and exerting the anti-inflammatory effect.

  Desirably, the medicinal component contains at least a medicinal component of an anti-inflammatory agent having an anti-inflammatory effect mainly for extinguishing inflammation of the throat and a disinfectant having an action for mainly sterilizing the mouth, and the anti-inflammatory agent comprises chewing agents. The function of directly contacting the affected area in the mouth together with saliva and exerting the anti-inflammatory effect, and the function of the bactericidal agent directly contacting the affected area in the mouth together with saliva by chewing and exerting the bactericidal action Have

  Desirably, in addition to the gum base and the medicinal component, it further comprises an excipient, the excipient has an effect of adjusting the convenience of administration while maintaining the medicinal efficacy of the medicinal component, The medicinal component and the excipient are contained in the gum base.

  Desirably, the medicinal component is uniformly dispersed in the gum base.

  Desirably, the medicinal component has a powdery particle shape, the particle size of the medicinal component is 50 μm or less, and the medicinal component is uniformly dispersed in the gum base.

  Desirably, the anti-inflammatory agent as the medicinal component is at least one selected from the group consisting of sodium azulene sulfonate, methyl salicylate, lysozyme chloride, dipotassium glycyrrhizinate, and chlorpheniramine maleate that mainly exhibit anti-inflammatory effects.

  Desirably, the bactericidal agent as the medicinal component is at least one selected from the group consisting of cetylpyridinium chloride, decalinium chloride, benzothorium chloride, chlorhexine hydrochloride, chlorhexidine gluconate, and an iodo compound that mainly exert a bactericidal action.

  Preferably, the excipient is at least one selected from erythritol, L-menthol, xylitol, reduced starch syrup, sorbitol, mannitol, maltitol, palatinose, and aster palm.

  Desirably, the gum component contained in the gum base is at least vinyl acetate resin, polyisobutylene, butadiene-styrene copolymer, polyethylene, gelton, chicle gum, solver gum, ester gum, crown gum, microcrystalline wax, It is at least one selected from the group consisting of glycerin fatty acid ester, stearic acid, magnesium stearate, calcium stearate, natural wax, petroleum wax, and inorganic powder.

  Desirably, the medicinal component contains at least a flame retardant of sodium azulene sulfonate that mainly exhibits an anti-inflammatory effect.

  Desirably, the medicinal component contains at least an anti-inflammatory agent of both sodium azulene sulfonate and dipotassium glycyrrhizinate which mainly exhibit anti-inflammatory effects.

  Desirably, the medicinal component contains at least an anti-inflammatory agent of both sodium azulene sulfonate and dipotassium glycyrrhizinate that mainly exhibits anti-inflammatory effects, and a cetylpyridinium chloride bactericidal agent that mainly exhibits bactericidal action.

  The method for producing a chewing gum medicine of the present invention is a method for producing a chewing gum medicine having the effect of at least mainly exerting an anti-inflammatory effect by directly contacting the affected area in the mouth together with saliva by chewing, ) Kneading a plurality of types of gum components to prepare a gum base in which the plurality of types of gum components are uniformly mixed; and (b) kneading the gum base, medicinal components and excipients. A step of preparing a gum medical raw material in which the gum component, the medicinal component and the excipient are uniformly mixed, and (c) mastication by molding the gum medical raw material into a predetermined shape. And a step of obtaining a gum drug, wherein the medicinal component contains at least an anti-inflammatory agent that mainly exhibits an anti-inflammatory effect, and in the step (b), the medicinal component is uniformly dispersed in the gum base. Knead to contain The features.

  Desirably, in the manufacturing method of the chewing gum pharmaceutical, the medicinal component further contains a bactericidal agent having a bactericidal action in addition to the anti-inflammatory agent.

  Desirably, in the step (b), the medicinal ingredient and the excipient are uniformly mixed to prepare a medicinal ingredient / excipient mixture, and then the obtained medicinal ingredient / excipient mixture is obtained. And the gum base are mixed uniformly to prepare the gum medical raw material, whereby the medicinal component is uniformly dispersed in the gum base. Features.

  Desirably, in the step (b), the medicinal component having a powdery particle shape with a particle size of 50 μm or less is used.

  Preferably, in the step (b), a medicinal component having a powdery particle shape is used as the medicinal component, and in the step (b), the medicinal efficacy is mixed with the medicinal component and the excipient. The ingredients are pulverized to a particle size of 50 μm or less to prepare a uniformly mixed medicinal ingredient / excipient mixture, and then the obtained medicinal ingredient / excipient mixture and the gum base Are uniformly kneaded to prepare the gum medical raw material, whereby the medicinal component having a particle size of 50 μm or less is uniformly dispersed in the gum base. The powdery particles of the medicinal component are contained so that the gum base covers the surface of the powdery particles.

  Preferably, in the method for producing a chewing gum medicine, the medicinal component is at least one selected from the group consisting of sodium azulenesulfonate, methyl salicylate, lysozyme chloride, dipotassium glycyrrhizinate, and chlorpheniramine maleate. It is an anti-inflammatory agent that mainly exhibits anti-inflammatory effects.

  Desirably, in the method for producing a chewing gum pharmaceutical, the medicinal component contains at least an anti-inflammatory agent of sodium azulenesulfonate that exhibits anti-inflammatory effect, and the excipient includes xylitol, erythritol, and L-menthol. At least one selected from the group consisting of: In the step (b), the sodium azulenesulfonate and the excipient are uniformly mixed and pulverized to obtain a medicinal component / potentiator having a predetermined particle size. Preparing a dosage mixture, and then uniformly mixing the obtained medicinal ingredient / excipient mixture and the gum base to prepare the gum medical raw material, The sodium azulene sulfonate as the medicinal component is uniformly dispersed in the gum base.

  Desirably, in the above method for producing a chewing gum pharmaceutical, the medicinal ingredients are at least an anti-inflammatory agent of both sodium azulene sulfonate and dipotassium glycyrrhizinate exhibiting anti-inflammatory effects, and cetylpyridinium chloride exhibiting a bactericidal action. A fungicide, and the excipient contains at least one selected from the group consisting of xylitol, erythritol, and L-menthol, and in the step (b), the sodium azulenesulfonate and the dipotassium glycyrrhizinate And the cetylpyridinium chloride medicinal ingredient and the excipient are uniformly mixed and pulverized to prepare a medicinal ingredient / excipient mixture having a predetermined particle diameter, and then the obtained medicinal ingredient / Mix the excipient mixture and the gum base uniformly to prepare the gum medical raw material. And thereby containing the respective medicinal components of the sodium azulenesulfonate, the dipotassium glycyrrhizinate and the cetylpyridinium chloride in a uniform dispersion in the gum base. .

  Preferably, in the step (b), the medicinal component is pulverized to a particle size of 50 μm or less, and the excipient is also pulverized to a particle size of 50 μm or less. The particle diameter of is 50 μm or less.

The chewing gum medicine of the present invention is a chewing gum medicine containing at least a gum base and a medicinal component, wherein the gum base comprises a plurality of gum ingredients and has a chewable viscoelastic rubber form. And the medicinal component is contained in the gum base, the medicinal component contains at least an anti-inflammatory agent having an anti-inflammatory effect for extinguishing inflammation of the throat, and the anti-inflammatory agent is obtained by chewing. It has the function of directly contacting the affected area in the mouth together with saliva and exerting the anti-inflammatory effect.
With this configuration, the anti-inflammatory effect can be fully exerted and the medicinal component concentration has no side effects, and the medicinal product stays in the mouth for a long time, so that the medicinal component can contact the affected part of the throat for a longer time. In addition, since the medicinal component can be directly brought into contact with the inflamed area during this period, the content of the limited medicinal component can be utilized to the maximum, and the utilization efficiency of medicinal efficacy can be increased. In addition, it has excellent medicinal stability in storage and storage that can prevent deterioration without causing deterioration of medicinal ingredients even if stored in a normal atmosphere such as room temperature, humidity, and brightness in a general household for a long time. A chewing gum medicine having an anti-inflammatory effect mainly against throat inflammation is obtained.

In the chewing gum pharmaceutical product, the medicinal component contains at least the medicinal component of an anti-inflammatory agent having an anti-inflammatory effect mainly for extinguishing inflammation of the throat and a bactericide having an action of mainly sterilizing the mouth, The agent has a function of directly contacting the affected area in the mouth with saliva by chewing and exerting the anti-inflammatory effect, and the fungicide has a function of directly contacting the affected area in mouth with saliva and exerting the bactericidal action by chewing Have
With this configuration, sufficient anti-inflammatory effect and bactericidal action can be exhibited, and the medicinal component concentration has no side effects, the medicinal product stays in the mouth for a long time, and the medicinal component contacts the affected part of the throat for a longer time It is possible to prevent deterioration without causing deterioration of medicinal ingredients even if stored in a normal atmosphere such as room temperature, humidity, brightness, etc. in a general household for a long period of time. It has stability and mainly exhibits anti-inflammatory effects against throat inflammation, and also exhibits a bactericidal action to sterilize the mouth, and the synergistic effect of this anti-inflammatory action and bactericidal action has the effect of healing the inflammation of the affected area Remarkably improved.

The chewing gum medicine further comprises an excipient in addition to the gum base and the medicinal ingredient, and the excipient acts to adjust the convenience of administration while maintaining the medicinal efficacy of the medicinal ingredient. And the medicinal component and the excipient are contained in the gum base.
With this configuration, the above-mentioned anti-inflammatory effect and the effect of healing the inflammation of the affected area, the effect that the medicinal component is in contact with the affected area of the throat for a long time, the effect of having medicinal stability that can prevent quality deterioration during long-term storage and storage, etc. The effect is further improved.

In the chewing gum medicine, the medicinal component is uniformly dispersed in the gum base.
In addition to the above-mentioned anti-inflammatory effect and the effect of healing the inflammation of the affected area, the effect that the medicinal ingredients are in contact with the affected area of the throat for a longer time, and the effect of medicinal stability that can prevent deterioration of quality during long-term storage and storage. Since the medicinal component is covered with a gum base, the medicinal component is prevented from being exposed to the outside air such as air, so that the medicinal component is deteriorated due to oxygen and humidity in the air. Therefore, the effect of further improving the medicinal stability in the storage and storage described above can be obtained.

In the chewing gum medicine, the medicinal component has a powdery particle shape, the particle size of the medicinal component is 50 μm or less, and the medicinal component is uniformly dispersed in the gum base. ing.
In addition to the above-mentioned anti-inflammatory effect and the effect of healing the inflammation of the affected area, the effect that the medicinal ingredients are in contact with the affected area of the throat for a longer time, and the effect of medicinal stability that can prevent deterioration of quality during long-term storage and storage. In addition, the medicinal stability during storage and storage can be further improved, and when chewing gum medicine is chewed and chewed, the unpleasant feeling of chewing a hard solid is prevented and smooth. A chewing gum medicine having a soft chewing feeling can be obtained.

In the chewing gum medicine, the anti-inflammatory agent as the medicinal component is selected from the group consisting of sodium azulenesulfonate, methyl salicylate, lysozyme chloride, dipotassium glycyrrhizinate, and chlorpheniramine maleate, which mainly exhibit anti-inflammatory effects. At least one.
With this configuration, the above-mentioned anti-inflammatory effect and the effect of healing the inflammation of the affected area, the effect that the medicinal component is in contact with the affected area of the throat for a long time, the effect of having medicinal stability that can prevent quality deterioration during long-term storage and storage, etc. Thus, a chewing gum drug with significantly improved effects can be obtained.

In the chewing gum medicine, in addition to the anti-inflammatory agent, at least one mainly sterilizing selected from the group consisting of cetylpyridinium chloride, decalinium chloride, benzothorium chloride, chlorhexine hydrochloride, chlorhexidine gluconate, and iodine compounds as the medicinal component. Contains a bactericidal agent that exerts its action.
With this configuration, the above-mentioned anti-inflammatory effect and the effect of healing the inflammation of the affected area, the effect that the medicinal component is in contact with the affected area of the throat for a long time, the effect of having medicinal stability that can prevent quality deterioration during long-term storage and storage, etc. In addition to significantly improving the effect of the anti-inflammatory effect on the throat, the anti-inflammatory effect is mainly exerted and the bactericidal action of sterilizing the mouth is exhibited. The synergistic effect of the anti-inflammatory action and the bactericidal action cures the inflammation of the affected area. This effect is further significantly improved.

In the chewing gum medicine, the excipient is at least one selected from erythritol, L-menthol, xylitol, reduced starch syrup, sorbitol, mannitol, maltitol, palatinose, and aster palm.
With this configuration, the above-mentioned anti-inflammatory effect, the effect of healing the inflammation of the affected area, the effect that the medicinal component is in contact with the affected area of the throat for a longer time, and the effect of having medicinal stability that can prevent the deterioration of quality during long-term storage and storage are obtained. In addition, the adhesion persistence of the medicinal component to the affected area is increased, and sweetness or refreshing feeling when chewed is exhibited, and the dispersibility of the medicinal component is improved.

In the chewing gum medicine, the gum component contained in the gum base is at least vinyl acetate resin, polyisobutylene, butadiene-styrene copolymer, polyethylene, gelton, chicle gum, solver gum, ester gum, crown gum, It is at least one selected from the group consisting of microcrystalline wax, glycerin fatty acid ester, stearic acid, calcium stearate, magnesium stearate, natural wax, petroleum wax, and inorganic powder.
With this configuration, the above-mentioned anti-inflammatory effect, the effect of healing the inflammation of the affected area, the effect that the medicinal component is in contact with the affected area of the throat for a longer time, and the effect of having medicinal stability that can prevent the deterioration of quality during long-term storage and storage are obtained. In addition, a chewing gum medicine having a chewy taste that does not feel uncomfortable when chewing the chewing gum medicine and chewing the chewing gum for confectionery is obtained.

  In the chewing gum pharmaceutical product, the medicinal component contains at least an anti-inflammatory agent of sodium azulenesulfonate that mainly exhibits anti-inflammatory effect. With this configuration, especially in the configuration using sodium azulene sulfonate, which is easily deteriorated by light, humidity, oxygen, etc., the above-mentioned anti-inflammatory effect and the effect of healing the inflammation of the affected area, the medicinal component is further applied to the affected area of the throat for a longer time The effect of contact, the effect of medicinal stability that can prevent deterioration in quality during long-term storage and storage, and the like are obtained. Further, in the configuration in which the sodium azulene sulfonate has a powdery particle shape, the particle diameter is 50 μm or less, and the medicinal component is uniformly dispersed in the gum base, While such effects are further improved, the chewing gum medicine has a smooth, soft chewing feeling that prevents the unpleasant feeling of chewing a hard solid when chewing and chewing the chewing gum medicine. Is obtained. Furthermore, in the constitution containing the excipient, the adhesion persistence of the medicinal ingredient to the affected part is increased, the sweetness or refreshing feeling when chewing is exhibited, the dispersibility of the medicinal ingredient is improved, When the chewing gum medicine is chewed and chewed, the effect of having a chewy taste without feeling uncomfortable as if chewing chewing gum for confectionery is obtained. A chewing gum medicine that exhibits all these effects is obtained.

    In the chewing gum medicine, the medicinal component contains at least an anti-inflammatory agent of both sodium azulene sulfonate and dipotassium glycyrrhizinate which mainly exert anti-inflammatory effect. In this configuration, sodium azulene sulfonate mainly has an effect of exerting an effect of healing inflammation of the affected part by directly contacting the diseased part of the throat. On the other hand, dipotassium glycyrrhizinate has the effect of healing inflammation in the affected area by direct contact with the diseased part of the throat, and when the dipotassium glycyrrhizinate flows into the gastrointestinal tract, it is absorbed into blood vessels in the gastrointestinal tract and blood. It has the effect of entering the flow and thereby also exerting the effect of healing the inflammation of the affected area of the throat. By using both of these medicinal ingredients in combination, a strong anti-inflammatory effect can be obtained by the effects of both direct contact with the affected area and inclusion in the bloodstream. Furthermore, like the above-mentioned effects, these medicinal ingredients have the shape of powder particles, the particle diameter is 50 μm or less, and the medicinal ingredients are uniformly dispersed in the gum base. In such a configuration, such an effect is remarkably improved, and when the chewing gum medicine is chewed and chewed, an unpleasant feeling like chewing a hard solid is prevented, and a smooth soft chewing is prevented. A chewing gum medicine with comfort is obtained. Furthermore, in the constitution containing the excipient, the adhesion persistence of the medicinal ingredient to the affected part is increased, the sweetness or refreshing feeling when chewing is exhibited, the dispersibility of the medicinal ingredient is improved, When the chewing gum medicine is chewed and chewed, the effect of having a chewy taste without feeling uncomfortable as if chewing chewing gum for confectionery is obtained. A chewing gum medicine that exhibits all these effects is obtained.

  In the chewing gum medicine, the medicinal component contains at least an anti-inflammatory agent of both sodium azulene sulfonate and dipotassium glycyrrhizinate which mainly exerts anti-inflammatory effect, and a cetylpyridinium chloride disinfectant which mainly exerts a bactericidal action. . In this configuration, a sufficient anti-inflammatory effect and bactericidal action can be exhibited, the medicinal product stays in the mouth for a long time, and the medicinal component can be in contact with the affected part of the throat for a longer time. It has excellent medicinal stability in storage and storage that prevents deterioration of medicinal components without causing deterioration of medicinal components even when stored in a normal atmosphere such as room temperature, humidity, and brightness for a long time, and inflammation of the throat On the other hand, the anti-inflammatory effect is mainly exhibited, the bactericidal action for sterilizing the mouth is exhibited, and the synergistic effect of the anti-inflammatory effect and the bactericidal action further enhances the effect of inducing throat inflammation. Furthermore, like the above-mentioned effects, these medicinal ingredients have the shape of powder particles, the particle diameter is 50 μm or less, and the medicinal ingredients are uniformly dispersed in the gum base. In such a configuration, such an effect is remarkably improved, and when the chewing gum medicine is chewed and chewed, an unpleasant feeling like chewing a hard solid is prevented, and a smooth soft chewing is prevented. A chewing gum medicine with comfort is obtained. Furthermore, in the constitution containing the excipient, the adhesion persistence of the medicinal ingredient to the affected part is increased, the sweetness or refreshing feeling when chewing is exhibited, the dispersibility of the medicinal ingredient is improved, When the chewing gum medicine is chewed and chewed, the effect of having a chewy taste without feeling uncomfortable as if chewing chewing gum for confectionery is obtained. A chewing gum medicine that exhibits all these effects is obtained.

The method for producing a chewing gum medicine of the present invention is a method for producing a chewing gum medicine having the effect of at least mainly exerting an anti-inflammatory effect by directly contacting the affected area in the mouth together with saliva by chewing, ) Kneading a plurality of types of gum components to prepare a gum base in which the plurality of types of gum components are uniformly mixed; and (b) kneading the gum base, medicinal components and excipients. A step of preparing a gum medical raw material in which the gum component, the medicinal component and the excipient are uniformly mixed, and (c) mastication by molding the gum medical raw material into a predetermined shape. And a step of obtaining a gum drug, wherein the medicinal component contains at least an anti-inflammatory agent that mainly exhibits an anti-inflammatory effect, and in the step (b), the medicinal component is uniformly dispersed in the gum base. Mixed to contain The features.
Due to this manufacturing method, pharmaceutical products with consistently stable quality in manufacturing, without causing deterioration of medicinal ingredients due to the influence of heat, etc., and without causing component changes due to mutual reaction of components used in the manufacturing process. Can be manufactured.
Furthermore, it is possible to exert a sufficient anti-inflammatory effect and has a medicinal component concentration with no side effects, the medicinal product stays in the mouth for a long time, and the medicinal component can contact the affected part of the throat for a long time, Has excellent medicinal stability in storage and storage that prevents deterioration of medicinal components without causing deterioration of medicinal components even when stored in a normal atmosphere such as room temperature, humidity, and brightness in a general household. Thus, a chewing gum drug mainly having an anti-inflammatory effect against throat inflammation can be obtained.

In the above method for producing a chewing gum pharmaceutical, the medicinal component further contains a bactericidal agent having a bactericidal action in addition to the anti-inflammatory agent.
Due to this manufacturing method, pharmaceutical products with consistently stable quality in manufacturing, without causing deterioration of medicinal ingredients due to the influence of heat, etc., and without causing component changes due to mutual reaction of components used in the manufacturing process. Can be manufactured.
In addition, it has sufficient anti-inflammatory effect and bactericidal action, and has a medicinal component concentration with no side effects, and the medicinal product stays in the mouth for a long time, and the medicinal component may contact the affected part of the throat for a long time. Excellent medicinal stability in storage and storage that can prevent deterioration without causing deterioration of medicinal components even if stored in a normal atmosphere such as room temperature, humidity, and brightness in a general household for a long time. It has anti-inflammatory effect mainly on throat inflammation and sterilizes the mouth, and the synergistic effect of anti-inflammatory effect and bactericidal action significantly improves the healing effect on the affected area. A chewing gum medicine is obtained.

In the above method for producing a chewing gum medicine, the step (b) was obtained by uniformly mixing the medicinal ingredient and the excipient to prepare a medicinal ingredient / excipient mixture, and then obtained It has a step of uniformly mixing the medicinal ingredient / excipient mixture and the gum base to prepare the gum medical raw material, whereby the medicinal ingredient is uniformly contained in the gum base. It is characterized by being dispersed and contained.
By this production method, in particular, the medicinal ingredient and the excipient are uniformly mixed to prepare a medicinal ingredient / excipient mixture, and then the obtained medicinal ingredient / excipient mixture and the gum base are obtained. Can be mixed to produce a chewing gum medicine in which the medicinal components are uniformly dispersed and contained in the gum base without aggregation of the medicinal components. When a medicinal ingredient and an excipient are mixed, the excipient acts as a lubricant and prevents aggregation of the medicinal ingredient, so that the medicinal ingredient can be uniformly dispersed in the gum base. . The excipient can also be uniformly dispersed in the gum base.
In addition, the above-mentioned anti-inflammatory effect and the effect of healing the inflammation of the affected area, the effect of the medicinal component being in contact with the affected area of the throat for a long time, the effect of having medicinal stability that can prevent quality deterioration in long-term storage and storage, Thus, a chewing gum drug having the effect of improving the stability of medicinal effects during storage and storage, and the like, can be obtained.

In the method for producing a chewing gum medicine, the medicinal component having a powdery particle shape with a particle size of 50 μm or less is used in the step (b).
With this manufacturing method, the above-mentioned anti-inflammatory effect and the effect of healing the inflammation of the affected area, the effect that the medicinal ingredients are in contact with the affected area of the throat for a long time, and the effect of medicinal stability that can prevent the deterioration of quality in long-term storage and storage In addition, the effect of further improving the medicinal stability during storage and storage can be obtained.
In particular, by using a medicinal ingredient having a powdery particle shape with a particle size of 50 μm or less, an unpleasant feeling like chewing a hard solid when chewing and chewing the chewing gum medicine is prevented, A chewing gum medicine having a smooth soft chewing feeling is obtained.
Furthermore, by using a medicinal component having a powdery particle shape with a particle size of 50 μm or less, the effect of containing the medicinal component uniformly dispersed in the gum base is improved.

In the above method for producing a chewing gum medicine, in the step (b), a medicinal component having a powdery particle shape is used as the medicinal component, and the step (b) comprises the medicinal component and the excipient. The medicinal component is pulverized to a size of 50 μm or less to prepare a homogeneously blended medicinal component / excipient mixture, and then the obtained medicinal component / enhancement is obtained. A step of uniformly mixing the mixture of the form and the gum base to prepare the gum medical raw material, whereby the medicinal component having a particle size of 50 μm or less is added to the gum base. It is characterized in that it is uniformly dispersed in.
With this manufacturing method, the above-mentioned anti-inflammatory effect and the effect of healing the inflammation of the affected area, the effect of the medicinal component being in contact with the affected area of the throat for a longer time, and the medicinal stability that can prevent quality deterioration during long-term storage and storage A chewing gum medicine having the action and effect such as the action and the effect is further improved and the action and effect of further improving the medicinal stability during storage and storage is obtained. Also, since the particle size of the medicinal component is 50 μm or less, when chewing gum medicine is chewed and chewed, the unpleasant feeling of chewing a hard solid is prevented, and smooth soft chewing comfort A chewing gum medicine having the following is obtained.
Furthermore, in particular, the medicinal component can be efficiently pulverized to a particle size of 50 μm or less by preparing a medicinal component / excipient mixture by uniformly mixing the medicinal component and the excipient. . When a medicinal ingredient and an excipient are mixed, the excipient acts as a lubricant and prevents aggregation of the medicinal ingredient, so that the medicinal ingredient is efficiently reduced to a particle size of 50 μm or less. Can be crushed. In addition, by mixing the obtained medicinal ingredient / excipient mixture and the gum base uniformly, the medicinal ingredients and excipients are not agglomerated, so that A chewing gum medicine in which both are uniformly dispersed in the gum base can be produced.

In the above method for producing a chewing gum pharmaceutical, the medicinal component is at least one selected from the group consisting of at least sodium azulenesulfonate, methyl salicylate, lysozyme chloride, dipotassium glycyrrhizinate, chlorpheniramine maleate, It is an anti-inflammatory agent that exhibits an anti-inflammatory effect.
With this manufacturing method, a sufficient anti-inflammatory effect can be exerted and the medicinal component concentration has no side effects, and the medicinal product stays in the mouth for a long time, so that the medicinal component can contact the affected part of the throat for a longer time. Excellent medicinal stability in storage and storage that can prevent deterioration without causing deterioration of medicinal components even if stored in a normal atmosphere such as room temperature, humidity, and brightness in a general household for a long time. A chewing gum pharmaceutical mainly having an anti-inflammatory effect against throat inflammation is obtained. In particular, chewing gum medicines excellent in these functions and effects can be obtained.
In addition, in the manufacturing process, it is possible to manufacture a pharmaceutical product with a stable quality in manufacturing without causing deterioration of medicinal components due to the influence of heat and the like, and further, there is no change in components due to mutual reaction of used components. .

In the above method for producing a chewing gum medicine, the medicinal component contains at least an anti-inflammatory agent of sodium azulene sulfonate that exhibits anti-inflammatory effect, and the excipient includes xylitol, erythritol, and L-menthol. In the step (b), the sodium azulene sulfonate and the excipient are uniformly mixed and pulverized to prepare a medicinal component / excipient mixture having a predetermined particle size. And then mixing the obtained medicinal ingredient / excipient mixture and the gum base uniformly to prepare the gum medical raw material, thereby providing the medicinal ingredient as the medicinal ingredient. The azulene sulfonate sodium is uniformly dispersed in the gum base.
With this manufacturing method, a sufficient anti-inflammatory effect can be exerted and the medicinal component concentration has no side effects, and the medicinal product stays in the mouth for a long time, so that the medicinal component can contact the affected part of the throat for a longer time. Excellent medicinal stability in storage and storage that can prevent deterioration without causing deterioration of medicinal components even if stored in a normal atmosphere such as room temperature, humidity, and brightness in a general household for a long time. A chewing gum pharmaceutical mainly having an anti-inflammatory effect against throat inflammation is obtained. In particular, a chewing gum medicine excellent in these effects can be obtained.
In addition, in the manufacturing process, it is possible to manufacture a pharmaceutical product with a stable quality in manufacturing without causing deterioration of medicinal components due to the influence of heat and the like, and further, there is no change in components due to mutual reaction of used components. .

In the above method for producing a chewing gum medicine, the medicinal component is at least an anti-inflammatory agent of both sodium azulenesulfonate and dipotassium glycyrrhizinate exhibiting anti-inflammatory effect, and a cetylpyridinium chloride anti-bacterial agent exhibiting anti-bacterial activity And the excipient contains at least one of xylitol, erythritol, and L-menthol, and in the step (b), the sodium azulenesulfonate, the dipotassium glycyrrhizinate, and the cetylpyridinium chloride The medicinal component and the excipient are uniformly mixed and pulverized to prepare a medicinal component / excipient mixture having a predetermined particle diameter, and then the obtained medicinal component / excipient mixture is obtained. And the gum base are uniformly mixed to prepare the gum medical raw material. More, each medicinal ingredient of the azulene sodium sulfonate as the dipotassium glycyrrhizinate and the cetylpyridinium chloride, characterized in that is contained and uniformly dispersed in said gum base.
With this manufacturing method, sufficient anti-inflammatory effect and bactericidal action can be exhibited, and the medicinal component concentration has no side effects, the medicinal product stays in the mouth for a long time, and the medicinal component contacts the affected part of the throat for a longer time Excellent storage and storage that can prevent deterioration without causing deterioration of medicinal components even if stored in a normal atmosphere such as room temperature, humidity, and brightness in a general household room for a long period of time. It has medicinal stability, mainly exerts anti-inflammatory effect against throat inflammation, and exhibits bactericidal action to sterilize the mouth, and cures inflammation of affected area by synergistic effect of this anti-inflammatory action and bactericidal action A chewing gum pharmaceutical with significantly improved In particular, a chewing gum medicine excellent in these effects can be obtained.
In addition, in the manufacturing process, it is possible to manufacture a pharmaceutical product with a stable quality in manufacturing without causing deterioration of medicinal components due to the influence of heat and the like, and further, there is no change in components due to mutual reaction of used components. .

In the above method for producing a chewing gum pharmaceutical product, in the step (b), the medicinal component is pulverized to a particle size of 50 μm or less, and the excipient is also pulverized to a particle size of 50 μm or less. The predetermined particle size of the form mixture is 50 μm or less. That is, not only the medicinal components but also the particle size of the powder of the excipient is 50 μm or less.
With this manufacturing method, a sufficient anti-inflammatory effect can be exerted and the medicinal component concentration has no side effects, and the medicinal product stays in the mouth for a long time, so that the medicinal component can contact the affected part of the throat for a longer time. Excellent medicinal stability in storage and storage that can prevent deterioration without causing deterioration of medicinal components even if stored in a normal atmosphere such as room temperature, humidity, and brightness in a general household for a long time. A chewing gum pharmaceutical mainly having an anti-inflammatory effect against throat inflammation is obtained. In particular, a chewing gum medicine excellent in these effects can be obtained.
In addition, in the manufacturing process, it is possible to manufacture a pharmaceutical product with a stable quality in manufacturing without causing deterioration of medicinal components due to the influence of heat and the like, and further, there is no change in components due to mutual reaction of used components. .
In addition, since the particle size of the powder of both the medicinal component and the excipient is 50 μm or less, when the chewing gum medicine is chewed and chewed, it feels uncomfortable as if it is chewing a hard solid. A chewing gum medicine having a smooth and soft chewing feel is obtained.
Furthermore, especially by mixing a medicinal ingredient and an excipient to prepare a medicinal ingredient / excipient mixture, the medicinal ingredient can be efficiently pulverized to a particle size of 50 μm or less. In the process of mixing the medicinal ingredient and the excipient, the excipient acts as a lubricant and prevents aggregation of the medicinal ingredient, so that the medicinal ingredient is efficiently reduced to a particle size of 50 μm or less. Can be crushed. After that, by mixing the obtained medicinal ingredient / excipient mixture and the gum base, the medicinal ingredient and excipient are not aggregated in the gum base without agglomerating the medicinal ingredient and excipient. A chewing gum medicine contained uniformly dispersed can be produced.
Such chewing gum medicines having all the effects and a method for producing the same are obtained.

  Hereinafter, the chewing gum drug and the method for producing the chewing gum drug of the present invention will be described in detail.

  The chewing gum drug of the present invention is a drug that exhibits at least an anti-inflammatory effect that at least mainly reduces inflammation of the throat and cures it.

  In the chewing gum pharmaceutical and the method for producing the chewing gum pharmaceutical of the present invention, the chewing gum pharmaceutical contains at least a gum base and a medicinal component. The gum base is composed of a plurality of gum components and has a chewable elastic rubber form. A medicinal component is contained in the gum base, and the medicinal component mainly contains at least an anti-inflammatory agent having an anti-inflammatory effect for extinguishing inflammation of the throat. The anti-inflammatory agent has a function of exerting an anti-inflammatory effect of being released into the mouth together with saliva by chewing, directly contacting the inflamed affected area in the mouth, reducing inflammation and healing.

Here, the chewing gum medicine is repeatedly chewed, that is, by chewing the chewing gum medicine, the medicinal ingredients contained in the chewing gum medicine are released into the mouth together with saliva and released into the mouth. It means a medicinal product in which a medicinal component stays in the mouth and exhibits a predetermined effect. Among them, in particular, the chewing gum medicine of the present invention has an anti-inflammatory effect that reduces and extinguishes inflammation of the throat as a medicinal ingredient by directly contacting the affected part of the inflammatory disease such as the throat in the oral cavity. Contains anti-inflammatory agent.
In addition, among anti-inflammatory agents that exert anti-inflammatory effects by directly contacting the affected part of the inflammatory disease, depending on the type, anti-inflammatory agents that are absorbed from the gastrointestinal tract and enter the blood vessels to further exhibit anti-inflammatory effects can also be used. .
In the present invention, the anti-inflammatory agent mainly has an anti-inflammatory effect to extinguish inflammation of the throat, is not used mainly for the prevention of cold syndrome, and has an antibacterial or antiseptic action on the oral cavity. It is not intended to use efficacy as the primary purpose. As described above, the medicinal component contained in the present invention mainly contains an anti-inflammatory agent having an anti-inflammatory effect for extinguishing inflammation of the throat.
After the chewing gum medicine is chewed for a long time and the medicinal components are fully utilized, the remaining gum base is exhaled without being swallowed.

  In addition, chewing gum medicines containing both the above-described anti-inflammatory agents that mainly exhibit anti-inflammatory effects and anti-microbial agents that mainly exhibit anti-bacterial action are also possible as medicinal components. The anti-inflammatory agent has the function of directly contacting the affected area in the mouth with saliva by mastication and exerting the anti-inflammatory effect, and the bactericidal agent directly contacts the affected area in the mouth with saliva by mastication and It has the function to demonstrate. In particular, by using a bactericide in addition to the anti-inflammatory agent, an effect of further improving the anti-inflammatory effect can be obtained by the synergistic action of these medicinal components. In addition, a bactericidal agent may be used as a medicinal component which has the function which exhibits the effect which disinfects the inside of a mouth.

By chewing a chewing gum medicine containing a medicinal ingredient in a gum base repeatedly for a long time, the medicinal ingredient is released into the mouth together with saliva, and the medicinal ingredient is applied to the inflamed area of the throat. Direct contact, which reduces, reduces and heals the affected area of inflammation.
In particular, in drugs that act directly in contact with the affected area, such as anti-inflammatory agents that reduce and cure inflammation in the oral cavity, the medicinal component should remain in the mouth for as long as possible to contact the affected area. Thus, the anti-inflammatory effect lasts for a long time, and the effect of improving the anti-inflammatory effect is obtained. For example, the chewing gum medicine can be chewed for about 30 to 60 minutes, and during this time, the medicinal component can stay in the mouth and directly contact the inflamed area. Utilization of medicinal properties can be maximized to increase the efficiency of medicinal use.

Furthermore, since the medicinal ingredients are contained in the rubber base, the medicinal ingredients are not exposed to an atmosphere containing air or moisture, so that the room temperature, humidity, brightness, etc. Even when stored in a normal atmosphere for a long period of time, it has excellent medicinal stability in storage and storage that can prevent degradation without causing degradation of medicinal components.
In particular, a shape configuration in which medicinal components are uniformly dispersed in a rubber base is desirable. In such a state, the medicinal component is surrounded by a rubber base so that the medicinal stability during storage and storage can be further improved.

  In the chewing rubber drug containing the above medicinal components in the rubber base, an optional excipient can be further contained in the rubber base. For example, in a rubber base, a sweetening agent that imparts sweetness, a refreshing agent that improves the mouth sensation, a corrigent that relaxes the peculiar taste of medicinal ingredients, a taste modifier for preparing a chewing taste, etc. It can be added and contained, whereby the convenience of taking such as adding a desired biting taste can be improved and adjusted. In addition, the physical properties of the medicinal components can be compensated for, or the physical properties of the excipient can be effectively utilized to improve handling in weighing and molding. In the configuration in which such excipients are dispersed and contained in the rubber base, the proportion of contact between the excipient and the medicinal component contained decreases, so that the medicinal component and the excipient The medicinal stability in storage and storage that can prevent deterioration of each component contained without further deterioration due to mutual chemical reaction with the agent is further improved.

  Also, in chewing rubber drugs containing the above-mentioned medicinal ingredients in a rubber base, in particular, the medicinal ingredients are in the form of powder particles, and the medicinal ingredients in the form of powder particles are those of the rubber base. A chewing rubber drug can be used which is uniformly dispersed therein. In such a configuration, the above-mentioned anti-inflammatory effect, the effect of healing the inflammation of the affected area, the effect that the medicinal ingredients are in contact with the affected area of the throat for a longer time, and the medicinal stability that can prevent the deterioration of quality in long-term storage and storage In addition to the effect, the medicinal component is covered with a gum base, so that the medicinal component is prevented from being exposed to the outside air such as air. Therefore, the medicinal component due to oxygen and humidity in the air Therefore, the effect of further improving the medicinal stability during storage and storage can be obtained.

In a configuration in which an excipient is used in combination with a medicinal ingredient, the excipient is also in the form of powder particles, and the medicinal ingredient in the form of powder particles is uniformly dispersed in the rubber base. The contained chewing rubber medicine can be used. Even in this configuration, the same effect as described above can be obtained.
In addition, when the medicinal component itself is in liquid form, the liquid medicinal component is configured as a powdery particle shape supported by adsorbing or impregnating an inorganic powder having a supporting function such as talc powder or silica powder. An inorganic powder carrying a medicinal component can be uniformly dispersed in a rubber base.
Furthermore, even when the excipient itself is in a liquid form, it is configured as a powdery particle shape in which the liquid excipient is adsorbed or impregnated onto an inorganic powder having a supporting function such as talc powder or silica powder. The inorganic powder carrying the excipient can be uniformly dispersed in the rubber base.

A chewing gum medicine having a composition in which the medicinal component has a powdery particle shape with a particle size of 50 μm or less and is uniformly dispersed in the gum base is desirable. In this case, in addition to the above-mentioned anti-inflammatory effect and the effect of healing the inflammation of the affected area, the effect that the medicinal component is in contact with the affected area of the throat for a longer time, and the effect of medicinal stability that can prevent quality deterioration during long-term storage and storage In addition, the medicinal stability during storage and storage can be further improved, and when chewing gum medicine is chewed and chewed, the unpleasant feeling of chewing a hard solid is prevented and smooth. A chewing gum medicine having a soft chewing taste is obtained.
In this configuration, a powdery particle having a medicinal component particle size of 50 μm or less is used, and the medicinal component having a powdery particle having a particle size of 50 μm or less is kneaded into the gum base to be uniform. Distributed. Normally, during this kneading process, the medicinal component is not dissolved in the gum base, and is uniformly dispersed in the gum base in a state where the size of the powdery particle size of the medicinal component is maintained. Exist. Further, even if the powdery particle size of the medicinal component is pulverized during the kneading step, the particle size is 50 μm or less and does not increase.
In a configuration in which an excipient is used in combination with a medicinal ingredient, the excipient is also in the form of a powdery particle having a particle size of 50 μm or less, and the medicinal ingredient in the form of a powdery particle is contained in a rubber base. It is possible to use a chewing rubber medicine that is uniformly dispersed in the medicine. Even in this configuration, the same effect as described above can be obtained.

When the medicinal component itself is in liquid form, the liquid medicinal component is adsorbed or impregnated on an inorganic powder having a particle size of 50 μm or less having a supporting function such as talc powder or silica powder. And an inorganic powder having a particle diameter of 50 μm or less carrying the medicinal component can be uniformly dispersed in the rubber base.
Furthermore, even when the excipient itself is in a liquid form, the liquid excipient is supported by adsorbing or impregnating an inorganic powder having a particle size of 50 μm or less having a supporting function such as talc powder and silica powder. An inorganic powder that is configured as a particle shape and carries the excipient can be uniformly dispersed in the rubber base.

  As the anti-inflammatory agent as a medicinal component, an anti-inflammatory agent that mainly exhibits anti-inflammatory effects can be used. As the anti-inflammatory agent, at least one of sodium azulene sulfonate, methyl salicylate, lysotium chloride, dipotassium glycyrrhizinate, and chlorpheniramine maleate is used. Dipotassium glycyrate is also referred to as dipotassium glycyrate. Only one type of these anti-inflammatory agents can be used, or two types of anti-inflammatory agents can be used in combination, and three or more types of anti-inflammatory agents can be used in combination. For example, it is possible to use only sodium azulene sulfonate as an anti-inflammatory agent. In this case, sodium azulene sulfonate is mainly effective in healing inflammation of the affected part by directly contacting the diseased part of the throat. Demonstrate. Dipotassium glycyrrhizinate is effective in healing inflammation of the affected area by direct contact with the diseased area of the throat, and when the dipotassium glycyrrhizinate flows into the gastrointestinal tract, it is absorbed by the blood vessels in the gastrointestinal tract It also has the effect of entering and thereby exerting the effect of healing the inflammation of the affected area of the throat. As described above, as the anti-inflammatory agent, an anti-inflammatory agent that exhibits the effect of healing inflammation of the affected part by directly contacting the diseased part of the throat can be used, but without being limited thereto, The effect of healing the inflammation of the affected area by directly contacting the diseased area of the throat, and the inflammation of the affected area of the throat by being absorbed into the blood vessels in the gastrointestinal tract and flowing into the bloodstream when flowing into the gastrointestinal tract An anti-inflammatory agent having the effect of also exerting the healing effect can be used.

  Further, at least sodium azulenesulfonate and dipotassium glycyrrhizinate can be used in combination as an anti-inflammatory agent. In this case, sodium azulene sulfonate exerts the effect of healing inflammation of the affected part mainly by directly contacting the diseased part of the throat, while dipotassium glycyrrhizinate directly contacts the diseased part of the throat. The effect of healing the inflammation of the affected area, and when the dipotassium glycyrrhizinate flows into the gastrointestinal tract, it is absorbed by the blood vessels in the gastrointestinal tract and enters the bloodstream, thereby healing the inflammation of the affected area of the throat It has the effect of also exerting the effect. Due to the effects of both direct contact with the affected area and inclusion in the bloodstream, a strong anti-inflammatory effect is exhibited.

  As a medicinal component, a chewing gum medicine having a composition containing both medicinal components mainly having a bactericidal effect in addition to an anti-inflammatory agent that mainly exerts an anti-inflammatory effect is also applicable. In this configuration, at least one of cetylpyridinium chloride, decalinium chloride, benzothorium chloride, chlorhexine hydrochloride, chlorhexidine gluconate, iodine compounds, and the like can be used as a bactericidal agent that mainly exhibits a bactericidal action. As a result, the above-mentioned anti-inflammatory effect and the effect of healing the inflammation of the affected area, the effect that the medicinal component is in contact with the affected area of the throat for a longer time, the effect of having medicinal stability that can prevent the deterioration of quality in long-term storage and storage, etc. A chewing gum drug with a significantly improved effect is obtained.

  In particular, chewing gum drugs containing at least sodium azulenesulfonate and dipotassium glycyrrhizinate as anti-inflammatory agents and at least cetylpyridinium chloride as antibacterial agents and using these anti-inflammatory agents and antiseptics in combination are also effective. In such a configuration, anti-inflammatory effect by direct contact with the affected part of the throat by sodium azulene sulfonate, and the effect of healing inflammation of the affected part by directly contacting the diseased part of the throat by dipotassium glycyrrhizinate and the gastrointestinal tract The anti-inflammatory effect, which is absorbed into blood vessels and enters the bloodstream to cure inflammation in the affected area of the throat, and the antibacterial effect such as oral bactericidal action by cetylpyridinium chloride, and the antibacterial effect and bactericidal action, it is even more powerful Exhibits anti-inflammatory effect.

In the chewing gum medicine of the present invention, the excipient is not particularly limited, and a corrigent, a sweetener, a refreshing agent, an adhesion improver and the like are used. For example, at least one excipient selected from erythritol, L-menthol, xylitol, reduced starch syrup, sorbitol, mannitol, maltitol, palatinose, and aster palm is used. Here, L-menthol is also referred to as l-menthol.
A corrigent has the effect | action which eases the taste peculiar to a medicinal ingredient, for example, erythritol and L-menthol act as a corrigent. A refreshing agent has the effect | action which makes the sensation in the mouth favorable, for example, L-menthol also exhibits the effect | action as a refreshing agent. The sweetener has an effect of imparting sweetness. For example, xylitol and reduced starch syrup exhibit an action as a sweetener. The adhesion improver has the effect of improving the adhesion performance of the medicinal component to the diseased diseased part in the mouth. For example, the above-described reduced starch syrup exhibits the effect as an adhesion improver.
By adding and containing at least one of these excipients, as described above, the anti-inflammatory effect and the effect of healing the inflammation of the affected part, the effect that the medicinal component is in contact with the affected part of the throat for a long time, the long-term The effect of having medicinal stability that can prevent quality deterioration during storage and storage is obtained, the persistence of the medicinal component to the affected area is increased, the sweetness or refreshing feeling when chewing is demonstrated, and the medicinal component Effects such as improved dispersibility can be obtained. In particular, when chewing gum medicine is chewed, the adhesion improver is released into the mouth together with the medicinal ingredient, and the medicinal ingredient and the adhesion improver released into the mouth become a mixture and adhere to the diseased part and come into contact with it. And the effect which lengthens contact time is exhibited.

  In the chewing gum medicine of the present invention, the gum components contained in the gum base include solid elastomers such as synthetic rubber, natural rubber / elastomer, plasticizer, synthetic resin such as vinyl polymer, binder, viscosity adjustment Agents, pressure-sensitive adhesives, emulsifiers, inorganic powder fillers, reinforcing agents, lubricants, extenders, fillers, colorants, fragrances and the like are used. For example, as the solid elastomer, polyisobutylene, butadiene-styrene copolymer, isobutylene-isoprene copolymer, polybutadiene, or the like is used. As the synthetic resin, vinyl acetate resin, polyethylene or the like is used. Natural rubber / elastomers include chicle, gelton, nispero, rhodedein, gutta perta, pendale, perillo, solva gum, nisperon, niger gutta, masaland dubabelta, chikiburu, arabic gum, ester gum, crown gum, locust bean gum, xanthan gum, guar gum Etc. are used. As the plasticizer, natural wax, microcrystalline wax, polyethylene wax, paraffin wax, microcrystalline wax and the like are used. As the emulsifier, lecithin, fatty acid monoglyceride, diglyceride, glycerol stearate, propylene glycol stearate and the like are used. In addition, glycerin fatty acid ester, stearic acid, calcium stearate, magnesium stearate, glycerin triacetate, glycerin, rosin alcohol ester, rosin cellulose ester, rosin glycerol ester and the like are used. Examples of inorganic powder fillers include talc powder, silica powder, aluminum hydroxide powder, aluminum silicate powder, calcium silicate powder, diatomaceous earth powder, magnesium oxide powder, calcium carbonate powder, magnesium carbonate, dicalcium phosphate powder, and alumina powder. Powders that do not adversely affect the quality are used. Of the above, inorganic powder fillers, reinforcing agents, lubricants, extenders and fillers may be used for the same purpose. By selecting several kinds of these gum ingredients and using them in combination, when chewing in the mouth, release properties of the medicinal ingredients, hardness, flexibility, adhesiveness, viscoelasticity, In addition, chewing gum pharmaceuticals having various chewing tastes such as temporal change of these characteristics when chewed for a long time can be obtained.

  The method for producing a chewing gum medicine of the present invention is a method for producing a chewing gum medicine having an effect of at least mainly exerting an anti-inflammatory effect by directly contacting the affected area in the mouth together with saliva by chewing, comprising: Kneading different types of gum components to prepare a gum base in which the plurality of types of gum components are uniformly mixed; and (b) kneading the gum base, medicinal components and excipients, A step of preparing a gum medical raw material in which the gum component, the medicinal component and the excipient are uniformly mixed; and (c) the gum medical raw material is molded into a predetermined shape, And wherein the medicinal component contains at least an anti-inflammatory agent that mainly exhibits an anti-inflammatory effect, and in the step (b), the medicinal component is uniformly dispersed in the gum base. Mixing as contained And butterflies. In addition, in the said (c) process, after shape | molding it to the shape made for gum medical, it can also add the sugar-based process which coat | covers a coating agent.

  Further, in this method for producing a chewing gum pharmaceutical, the medicinal component may further contain a bactericidal agent having a bactericidal action in addition to the anti-inflammatory agent.

  In general, a medicinal component may be denatured or deteriorated by the influence of heat, humidity, air, or the like. In addition, when a plurality of medicinal components are contained, the medicinal components may undergo a chemical reaction due to the influence of heat, humidity, air, etc., resulting in a component change.

Due to the above manufacturing method, there is no deterioration of medicinal components due to the influence of heat, humidity, air, etc. in the manufacturing process, and further, there is no change in the components due to the mutual reaction of the used components. Stable quality chewing gum medicines can be manufactured.

  Furthermore, it is possible to exert a sufficient anti-inflammatory effect and has a medicinal component concentration with no side effects, the medicinal product stays in the mouth for a long time, and the medicinal component can contact the affected part of the throat for a long time, Has excellent medicinal stability in storage and storage that prevents deterioration of medicinal components without causing deterioration of medicinal components even when stored in a normal atmosphere such as room temperature, humidity, and brightness in a general household. Thus, a chewing gum drug mainly having an anti-inflammatory effect against throat inflammation can be obtained.

  In addition, even in the configuration where the medicinal component contains an anti-inflammatory agent and a bactericidal agent, the anti-inflammatory agent and the bactericidal agent do not react with each other due to the influence of heat, humidity, air, etc. during the manufacturing process. A chewing gum medicine with consistent quality can be produced. Furthermore, in addition to the above-mentioned effects, the anti-inflammatory effect and bactericidal action can be exhibited, the anti-inflammatory effect is mainly exerted against the sore throat, and the bactericidal action to sterilize the mouth is exhibited. Thus, a chewing gum pharmaceutical with a markedly improved effect of healing inflammation in the affected area can be obtained.

  As the step of kneading a plurality of types of gum components in the step (a) to prepare a gum base in which the plurality of types of gum components are uniformly mixed, known production used in the manufacture of confectionery chewing gum A process can be used.

  As the step of preparing a gum medical raw material in which the gum base, the medicinal component and the excipient are uniformly mixed by kneading the gum base, medicinal component and excipient in the step (b), Although not particularly limited, for example, a batch-type screw-type kneader, a batch-type blade-type kneader, a batch-type roll-type kneader, or such a kneader is kneaded with pressure and weight added. Using a kneading machine such as a batch type pressure kneader, in particular, the temperature range in which the medicinal component used does not deteriorate, the gum base used is viscous, and the gum base and medicinal component Are kneaded in a temperature range where they can be kneaded with each other. In order to prevent deterioration of the medicinal component, a desirable temperature range varies depending on the gum base used and the type of medicinal component, but a temperature range of 20 ° C. to 40 ° C. is generally desirable. Further, it is desirable to knead in an atmosphere of an inert gas such as nitrogen. Alternatively, an effect of shortening the kneading time can be obtained by kneading while applying pressure using a pressure kneader. In addition, the pressure kneader can obtain the effect of kneading while blocking air. Thereby, the medical raw material made from gum by which the said medicinal component and the said excipient | filler were mixed uniformly in the said gum component is obtained.

  The step of obtaining the chewing gum medicine by molding the gum medical raw material in the step (c) into a predetermined shape is not particularly limited. For example, it is generally known for use in the production of a thin confectionery chewing gum. Using an extrusion molding machine of the above-described extrusion type, it is possible to obtain a gum-made medical molding material having a thin plate shape, a disk shape, or any other shape. However, compared with the manufacturing method of confectionery chewing gum, it is a temperature range in which the medicinal components used are not deteriorated, and the gum base used has a viscosity and can be molded in a temperature range that can be processed into a predetermined shape. desirable. Although a desirable temperature range varies depending on the type of gum base and medicinal component used, a temperature range of, for example, 10 ° C. to 40 ° C. is desirable in order to prevent deterioration of the medicinal component. Further, it is desirable to mold in an atmosphere of an inert gas such as nitrogen.

  The process for obtaining a chewing gum medicine by coating the gum medical molding material in the step (d) is not particularly limited, but is intended to prevent deterioration of medicinal ingredients due to humidity during storage of the gum medicine. A sugar-coating agent having a moisture-proof effect can be used. Coating agents include, for example, powdered maltitol, starch syrup, bees sugar containing gum arabic, coloring agents, wax agents, fruit flavors that are similar to the taste of sweetness and fruits, etc. The coating agent containing the component which exhibits the refreshing taste for producing a feeling can be used.

In the step (b), the medicinal ingredient and the excipient are uniformly mixed to prepare a medicinal ingredient / excipient mixture, and then the obtained medicinal ingredient / excipient mixture and the gum base It is desirable to have a step of uniformly kneading and preparing a gum medical raw material. Thus, by mixing the medicinal component and the excipient uniformly in advance, aggregation of the medicinal component is prevented, and a medicinal component / excipient mixture in which the medicinal component is uniformly dispersed together with the excipient is obtained. can get. In this process, it is considered that the medicinal component is uniformly dispersed together with the excipient in order for the excipient to function as a lubricant. After that, by kneading the gum base with the medicinal ingredient / excipient mixture in which the medicinal ingredient is uniformly dispersed together with the excipient, the medicinal ingredient is uniformly dispersed in the gum base and is added. A gum drug is obtained in which the form is uniformly dispersed in the gum base.
As a method for preparing a medicinal ingredient / excipient mixture by uniformly mixing medicinal ingredients and excipients, for example, using a mixer equipped with rotating blades for fruits and vegetables used in general households. Using a method of mixing the ingredients of the above, or an industrial rotary vane mixer having a mechanism similar to such a household rotary vane mixer, to uniformly mix the medicinal ingredients and excipients it can. In addition, a method in which a medicinal ingredient and an excipient are introduced into a rotating cylindrical container and the medicinal ingredient and the excipient are uniformly mixed can be used. There is also a method of putting medicinal ingredients and excipients into a mortar and grinding with a stick. Alternatively, a method in which a medicinal ingredient and an excipient are put into a closed container, an inert gas such as air or nitrogen is allowed to flow, and the medicinal ingredient and the excipient are uniformly mixed by an air flow can be used.

  In particular, in the step (b), it is desirable to use a medicinal component having a powdery particle shape with a particle size of 50 μm or less. As a result, the medicinal component having powdery particles having a particle diameter of 50 μm or less is kneaded into the gum base and uniformly dispersed. Normally, during this kneading process, the medicinal component is not dissolved in the gum base, and is uniformly dispersed in the gum base in a state where the size of the powdery particle size of the medicinal component is maintained. Exist. Further, even if the powdery particle size of the medicinal component is pulverized during the kneading step, the particle size is 50 μm or less and does not increase.

  In a configuration in which an excipient is used in combination with a medicinal ingredient, the excipient is also in the form of a powdery particle having a particle size of 50 μm or less, and the medicinal ingredient in the form of a powdery particle is contained in a rubber base. It is possible to use a chewing rubber medicine that is uniformly dispersed in the medicine.

  When the medicinal component itself is in liquid form, the liquid medicinal component is adsorbed or impregnated on an inorganic powder having a particle size of 50 μm or less having a supporting function such as talc powder or silica powder. And an inorganic powder having a particle diameter of 50 μm or less carrying the medicinal component can be uniformly dispersed in the rubber base.

  Furthermore, even when the excipient itself is in a liquid form, the liquid excipient is supported by adsorbing or impregnating an inorganic powder having a particle size of 50 μm or less having a supporting function such as talc powder and silica powder. An inorganic powder that is configured as a particle shape and carries the excipient can be uniformly dispersed in the rubber base.

  In the step (b), a medicinal ingredient having a powdery particle shape is used as the medicinal ingredient, and the medicinal ingredient is pulverized to a particle size of 50 μm or less while mixing the medicinal ingredient and the excipient, A step of preparing a uniformly mixed medicinal ingredient / excipient mixture, and then kneading the obtained medicinal ingredient / excipient mixture and the gum base uniformly to prepare a medical raw material made of gum Thus, a medicinal component having a particle diameter of 50 μm or less is uniformly dispersed in the gum base so that the surface of each powdery particle of the medicinal component is covered with the gum base. It can be included.

  A medicinal component having a powdery particle shape is used as the medicinal component, and the medicinal component is pulverized to a size of 50 μm or less while mixing the medicinal component and the excipient, and the medicinal component is uniformly mixed. As a method for preparing the excipient mixture, for example, the above-described mixing apparatus can be used. That is, a method of mixing these components using a mixer equipped with fruit and vegetable rotary blades used in general households, or an industrial type having a mechanism similar to such a household rotary blade mixer Using a rotary blade mixer, the medicinal component and the excipient can be mixed uniformly. In addition, a method in which a medicinal ingredient and an excipient are introduced into a rotating cylindrical container and the medicinal ingredient and the excipient are uniformly mixed can be used. Moreover, the method of mixing a medicinal ingredient and an excipient | filler uniformly with a stick | rod in a mortar can be used. Alternatively, a method in which a medicinal ingredient and an excipient are put into a closed container, an inert gas such as air or nitrogen is allowed to flow, and the medicinal ingredient and the excipient are uniformly mixed by an air flow can be used. By selectively using the mixing operation conditions using these mixing devices, the medicinal component and excipient are pulverized to a particle size of 50 μm or less, and the medicinal component and particle size of 50 μm or less are added. A medicinal ingredient / excipient mixture in which the form is uniformly mixed can be prepared.

  In the above method for producing a chewing gum pharmaceutical, the medicinal component is at least one mainly selected from the group consisting of sodium azulenesulfonate, methyl salicylate, lysozyme chloride, dipotassium glycyrrhizinate, chlorpheniramine maleate, and mainly an anti-inflammatory agent. An anti-inflammatory agent that exhibits efficacy can be used.

  In the above method for producing a chewing gum pharmaceutical, the medicinal component contains at least an anti-inflammatory agent of sodium azulenesulfonate that exhibits anti-inflammatory effect, and the excipient includes xylitol, erythritol, and L-menthol. In the step (b), sodium azulene sulfonate and the excipient are uniformly mixed and pulverized to prepare a medicinal component / excipient mixture having a predetermined particle size, After that, it has a step of uniformly mixing the obtained medicinal ingredient / excipient mixture and the gum base to prepare a gum medical raw material, whereby the sodium azulene sulfonate as medicinal ingredient is gum A production method in which the base is uniformly dispersed in the base can be applied.

  As a medicinal component, it contains at least an anti-inflammatory agent of sodium azulene sulfonate and dipotassium glycyrrhizinate that exhibit anti-inflammatory effect, and a cetylpyridinium chloride anti-microbial agent that exhibits anti-bacterial action, and the excipient is xylitol And at least one of erythritol and L-menthol, and in the step (b), the pharmaceutical ingredients of sodium azulenesulfonate, dipotassium glycyrrhizinate and cetylpyridinium chloride and the excipient are uniformly mixed. Grinding to prepare a medicinal ingredient / excipient mixture having a predetermined particle size, and then uniformly mixing the obtained medicinal ingredient / excipient mixture and the gum base, A process for preparing sodium azulenesulfonate, dipotassium glycyrrhizinate and chloride. Each medicinal properties Chirupirijiniumu can be applied to manufacturing methods of incorporating and homogeneously dispersed in the gum base.

  In the above method for producing a chewing gum medicine, it is particularly desirable that the predetermined particle diameter of the medicinal component / excipient mixture having a predetermined particle diameter is 50 μm or less.

  In the present invention, the content of the ingredients, the combination of ingredients, the concentration of ingredients, etc. are selected and contained within the range allowed by the laws and regulations such as pharmaceutical or food additives. Can be made. Furthermore, it can be manufactured in consideration of the “Pharmaceutical Manufacturing and Sales Guidelines” issued by the Ministry of Health, Labor and Welfare.

  Hereinafter, typical examples of the chewing gum drug and the method for producing the chewing gum drug of the present invention will be described.

(Typical Example 1)
First, the process of adjusting a gum base by kneading a plurality of types of gum components will be described. A predetermined amount of each component of vinyl acetate resin, polyisobutylene, gelton, ester gum, microcrystalline wax, glycerin fatty acid ester is weighed and put into a kneader, at a temperature at which the used gum component can be melted, The mixture was kneaded until uniform, and then a predetermined amount of talc powder was added into the kneader and further kneaded until these components became uniform, thus preparing a gum base. The obtained gum base has a viscoelastic solid similar to a known confectionery chewing gum, which can be easily deformed by pressing at room temperature.

  Next, a process of preparing a medicinal ingredient / excipient mixture by mixing medicinal ingredients and excipients will be described. Separately, sodium azulenesulfonate as a medicinal component (solid form at low temperature of about 90 ° C or lower, decomposed at high temperature, exact melting point / decomposition temperature is unknown), dipotassium glycyrrhizinate (solid form at normal temperature, melting point: 60 ° C) ), Cetylpyridinium chloride (solid form at room temperature, melting point: about 80-84 degrees C), xylitol as excipient (solid form at room temperature, melting point: about 92-96 degrees C), erythritol (solid at room temperature) Shape, melting point: about 121 degrees C), L-menthol (solid form at room temperature, melting point: about 42-45 degrees C), each of a predetermined amount of the powdery component is weighed, a mixer similar to a household mixer The mixture is crushed and crushed, and a uniformly mixed medicinal component / excipient mixture is prepared. Even after mixing, these medicinal components and excipients are all in the form of powder particles, and the particle diameter of each component is 50 μm or less. In this crushing and mixing step, the components used are mixed in an atmosphere in a temperature range that does not melt. In this embodiment, the mixture is crushed and mixed at an ambient temperature of 25 degrees C.

  Next, a process of preparing a gum medical raw material by kneading a gum base and a medicinal component / excipient mixture will be described. A predetermined amount of the gum base obtained as described above is put into a pressure-type kneader, and further, a predetermined amount of starch syrup is added and preliminarily kneaded. Thus, the obtained medicinal ingredient / excipient mixture is added, and these gum base and medicinal ingredient / excipient mixture are kneaded to prepare a uniformly mixed gum medical raw material. In this step, the medicinal ingredients and excipients are easily mixed and kneaded so that they are uniformly dispersed in the gum base. In this kneading step, kneading is performed in a temperature range in which the used medicinal ingredients and excipients do not melt. In the present embodiment, kneading is performed at an ambient temperature of about 35 degrees C. In particular, the medicinal components are present uniformly dispersed in the gum base without aggregation.

  Next, a process for preparing a gum medical molding material by molding the gum medical raw material into a predetermined shape will be described. The gum-made medical raw material obtained as described above is prepared by using an extrusion molding machine and a compression molding machine to form a disc-shaped gum medical molding material in which bubbles do not stay. Also in this molding process, molding is performed at a temperature range in which the used medicinal ingredients and excipients do not melt.

  The components of the obtained gum medical raw material and disc-shaped gum medical molding material were sodium azulenesulfonate (0.08% by weight), dipotassium glycyrrhizinate (0.25% by weight), cetylpyridinium chloride (0. 1% by weight), xylitol (38.0% by weight), erythritol (19.0% by weight), L-menthol (1.0% by weight), starch syrup (2.0% by weight), gum as excipients Base (39.57 wt%).

  Next, the sugar coating process will be described. Place the disc-shaped gum-made medical molding material obtained as described above into a sugar coating machine, mix molasses (a mixture of maltitol, chickenpox, gum arabic, and water) and blow dry. The first molasses layer is formed, then the molasses in which the colorant is dissolved is put into a sugar coating machine to form a colored coating layer, and then the molasses is further charged and blown dry to form the second molasses layer, Subsequently, a wax-containing polishing liquid is added, mixed and blown and dried to form a polishing layer, and then a moisture-proof coating liquid containing a special wax is added and blown and dried to form a sugar coating comprising a plurality of sugar coating layers. A chewing gum medicine coated with is produced. In this sugar coating process, treatment is performed in a temperature range in which the used medicinal ingredients and excipients do not melt. In this embodiment, the treatment is performed at an ambient temperature of about 35 degrees C. In this way, a sugar-coated chewing gum medicine is produced. The sugar-coated chewing gum medicine has a disk shape having a diameter of about 17 mm and a thickness of about 10 mm. Moreover, it has hardness and viscoelasticity that can be easily viscoelastically deformed by applying mechanical pressure at about 36 degrees C.

(Comparative Example 1)
In the above-mentioned typical embodiment 1, a medicinal ingredient and an excipient are mixed in advance to prepare a medicinal ingredient / excipient mixture, and the medicinal ingredient / excipient mixture and a gum base are kneaded. In contrast, in this comparative example, first, only the medicinal component and the gum base are kneaded, and during the kneading, an excipient is further added to continue kneading. That is, as in Typical Example 1, sodium azulene sulfonate as a medicinal ingredient was added to a gum base prepared by kneading a plurality of types of gum ingredients, and kneading was continued. In this case, a part of sodium azulene sulfonate aggregated and was not uniformly dispersed in the gum base. In addition, sodium azulene sulfonate and dipotassium glycyrrhizinate were added at the same time and kneading was continued, but even in this case, a part of sodium azulene sulfonate and dipotassium glycyrrhizinate aggregated uniformly in the gum base. Not distributed. In addition, sodium azulene sulfonate, dipotassium glycyrrhizinate and cetylpyridinium chloride were added at the same time and kneading was continued. It was not uniformly dispersed in the gum base. Thereafter, further kneading was continued by adding xylitol, erythritol, L-menthol and chickenpox as excipients to these medicinal ingredients and gum base, which were kneaded. However, sodium azulenesulfonate, dipotassium glycyrrhizinate and a part of cetylpyridinium chloride were present in the gum base in an aggregated state.

  Also, kneading was continued by adding starch syrup as an excipient to a gum base prepared by kneading a plurality of types of gum ingredients, and then adding sodium azulene sulfonate as a medicinal ingredient. . Next, kneading was continued by adding dipotassium glycyrrhizinate, and further kneading was continued by adding cetylpyridinium chloride. Even in this case, sodium azulenesulfonate, dipotassium glycyrrhizinate, and a part of cetylpyridinium chloride were present in the gum base in an aggregated state. In these kneading steps, similarly to the typical example 1, the kneading was carried out at an ambient temperature of about 35 ° C. in a temperature range in which the medicinal ingredients and excipients used did not melt.

  That is, as in Typical Example 1, a medicinal ingredient / excipient mixture is prepared in advance by mixing medicinal ingredients and excipients, and the medicinal ingredient / excipient mixture and gum base are kneaded. In the case of the method, the medicinal ingredients and excipients are present in the gum base uniformly dispersed without agglomeration. In the case of the method in which the medicinal component and the excipient were added separately and kneaded, a part of the medicinal component was aggregated and not uniformly dispersed. Therefore, excipients such as xylitol, erythritol, and L-menthol function as a lubricant that uniformly disperses medicinal ingredients such as sodium azulenesulfonate, dipotassium glycyrrhizinate, and cetylpyridinium chloride in the gum base. It seems that it is because it also has.

(Typical Example 2)
In the step of preparing the medicinal ingredient / excipient mixture by mixing the medicinal ingredient and the excipient described in the above-mentioned exemplary embodiment 1, only sodium azulene sulfonate is used as the medicinal ingredient, and as the excipient Using xylitol and L-menthol, a predetermined amount of each powdery component was weighed, and crushed with a pestle in a mortar and uniformly mixed with a medicinal component / excipient mixture. Even after mixing, these medicinal components and excipients are all in the form of powder particles, and the particle diameter of each component is 50 μm or less. In this crushing and mixing step, crushing and mixing were performed at an ambient temperature of 25 ° C. in an atmosphere in a temperature range in which each of the components used did not melt. Next, using the same gum base as in the above-mentioned typical example 1, a predetermined amount of the gum base is put into a kneader filled with nitrogen gas, and further, a predetermined amount of starch syrup is added and pre-kneaded. In the pre-kneaded kneader, the medicinal component / excipient mixture obtained as described above is added, and these gum base and medicinal component / excipient mixture are kneaded, A uniformly mixed gum medical raw material was prepared. Next, using the extrusion molding machine and the compression molding machine, a disc-shaped gum medical molding material was prepared from the gum medical raw material obtained as described above. Also in this molding process, molding is performed at a temperature range in which the used medicinal ingredients and excipients do not melt. In particular, the medicinal components are present uniformly dispersed in the gum base without aggregation.

  The components of the obtained gum medical raw material and disc-shaped gum medical molding material were sodium azulene sulfonate (0.3% by weight), xylitol (57.0% by weight) as an excipient, L- Menthol (1.13% by weight), chickenpox (2.0% by weight), gum base (39.57% by weight).

  Next, the disc-shaped gum medical molding material obtained as described above was placed in a sugar coating machine, and coated with a sugar coating comprising a plurality of sugar coating layers by the same sugar coating process as in Example 1. A chewing gum drug was produced. The sugar-coated chewing gum medicine has a disk shape with a diameter of about 10 mm and a thickness of about 7 mm. Moreover, it has hardness and viscoelasticity that can be easily viscoelastically deformed by applying mechanical pressure at about 36 degrees C.

(Typical Example 3)
In the step of preparing the medicinal component / excipient mixture by mixing the medicinal component and excipient described in the above-mentioned typical example 1, sodium azulenesulfonate and dipotassium glycyrrhizinate are used as medicinal components, Using xylitol, erythritol, and L-menthol as the dosage form, weighed a predetermined amount of each powdered component, crushed it with a pestle in a mortar and prepared a uniformly mixed medicinal component / excipient mixture . Even after mixing, these medicinal components and excipients are all in the form of powder particles, and the particle diameter of each component is 50 μm or less. In this crushing and mixing step, crushing and mixing were performed at an ambient temperature of 25 ° C. in an atmosphere in a temperature range in which each of the components used did not melt. Next, using the same gum base as in the above-mentioned typical example 1, a predetermined amount of the gum base is put into a kneader filled with nitrogen gas, and further, a predetermined amount of starch syrup is added and pre-kneaded. In the pre-kneaded kneader, the medicinal component / excipient mixture obtained as described above is added, and these gum base and medicinal component / excipient mixture are kneaded, A uniformly mixed gum medical raw material was prepared. Next, the gum medical raw material obtained as described above was prepared by using an extrusion molding machine to prepare a thin gum medical molding material. Also in this molding process, molding is performed at a temperature range in which the used medicinal ingredients and excipients do not melt. In particular, the medicinal components are present uniformly dispersed in the gum base without aggregation.

  The components of the obtained gum medical raw material and disc-shaped gum medical molding material were sodium azulene sulfonate (0.1% by weight), dipotassium glycyrrhizinate (0.30% by weight), and an excipient. Of xylitol (38.2 wt%), erythritol (19.0 wt%), L-menthol (1.1 wt%), starch syrup (2.0 wt%), gum base (39.3 wt%) is there.

  Next, the sheet-like gum-made medical molding material obtained as described above was placed in a sugar coating machine, and coated with a sugar coating comprising a plurality of sugar coating layers by the same sugar coating process as in Example 1. A chewing gum drug was produced. The sugar-coated chewing gum medicine has a thin plate shape of about 15 mm in length, about 7 mm in width, and about 3 mm in thickness. Moreover, it has hardness and viscoelasticity that can be easily viscoelastically deformed by applying mechanical pressure at about 36 degrees C.

(Typical Example 4)
In the step of preparing the medicinal component / excipient mixture by mixing the medicinal component and the excipient described in the above-mentioned typical example 1, as a medicinal component, sodium azulenesulfonate that mainly exhibits anti-inflammatory effect is used. Using an anti-inflammatory agent and cetylpyridinium chloride, which mainly exerts a bactericidal action, using xylitol and erythritol as excipients, weighing a predetermined amount of each powdered component and crushing with a pestle in a mortar A uniformly mixed medicinal component / excipient mixture was prepared. Even after mixing, these medicinal components and excipients are all in the form of powder particles, and the particle diameter of each component is 50 μm or less. In this crushing and mixing step, crushing and mixing were performed at an ambient temperature of 25 ° C. in an atmosphere in a temperature range in which each of the components used did not melt. Next, using the same gum base as in the above-mentioned typical example 1, a predetermined amount of the gum base is put into a kneader, and further, a predetermined amount of starch syrup is added and pre-kneaded, and the pre-kneaded In the kneading machine, the medicinal ingredient / excipient mixture obtained as described above was added, and the gum base and medicinal ingredient / excipient mixture were kneaded and mixed uniformly. Gum medical raw materials were prepared. Next, the gum medical raw material obtained as described above was prepared by using an extrusion molding machine and a compression molding machine to prepare a plate-shaped gum medical molding material. Also in this molding process, molding is performed at a temperature range in which the used medicinal ingredients and excipients do not melt. In particular, the medicinal components are present uniformly dispersed in the gum base without aggregation.

  The components of the obtained gum medical raw material and plate-shaped gum medical molding material were sodium azulenesulfonate (0.3% by weight), cetylpyridinium chloride (0.1% by weight), Xylitol (38.0% by weight), erythritol (19.0% by weight), chickenpox (2.0% by weight), gum base (40.6% by weight).

  Next, the sheet-like gum-made medical molding material obtained as described above was placed in a sugar coating machine, and coated with a sugar coating comprising a plurality of sugar coating layers by the same sugar coating process as in Example 1. A chewing gum drug was produced. The sugar-coated chewing gum medicine has a thin plate shape of about 10 mm in length, about 8 mm in width, and about 4 mm in thickness. Moreover, it has hardness and viscoelasticity that can be easily viscoelastically deformed by applying mechanical pressure at about 36 degrees C.

(Typical Example 5)
Anti-inflammatory of dipotassium glycyrrhizinate that mainly exerts anti-inflammatory effect as a medicinal component in the step of preparing the medicinal component / excipient mixture by mixing the medicinal component and excipient described in the above-mentioned typical example 1 Erythritol and L-menthol as excipients, weigh out a predetermined amount of each powdered ingredient, crush it with a pestle in a mortar and mix evenly A mixture was prepared. Even after mixing, these medicinal components and excipients are all in the form of powder particles, and the particle diameter of each component is 50 μm or less. In this crushing and mixing step, crushing and mixing were performed at an ambient temperature of 25 ° C. in an atmosphere in a temperature range in which each of the components used did not melt. Next, using the same gum base as in the above-mentioned typical example 1, a predetermined amount of the gum base is put into a kneader, and further, a predetermined amount of starch syrup is added and pre-kneaded, and the pre-kneaded In the kneading machine, the medicinal ingredient / excipient mixture obtained as described above was added, and the gum base and medicinal ingredient / excipient mixture were kneaded and mixed uniformly. Gum medical raw materials were prepared. Next, using the extrusion molding machine and the compression molding machine, a disc-shaped gum medical molding material was prepared from the gum medical raw material obtained as described above. Also in this molding process, molding is performed at a temperature range in which the used medicinal ingredients and excipients do not melt. In particular, the medicinal components are present uniformly dispersed in the gum base without aggregation.

  The components of the obtained gum medical raw material and disc-shaped gum medical molding material were dipotassium glycyrrhizinate (0.4% by weight), erythritol (57% by weight) L-menthol as an excipient (1.0%). % By weight), starch syrup (2.0% by weight), and gum base (39.6% by weight).

  Next, the disc-shaped gum medical molding material obtained as described above was placed in a sugar coating machine, and coated with a sugar coating comprising a plurality of sugar coating layers by the same sugar coating process as in Example 1. A chewing gum drug was produced. The sugar-coated chewing gum medicine has a disk shape having a diameter of about 17 mm and a thickness of about 10 mm. Moreover, it has hardness and viscoelasticity that can be easily viscoelastically deformed by applying mechanical pressure at about 36 degrees C.

(Typical Example 6)
Anti-inflammatory of dipotassium glycyrrhizinate that mainly exerts anti-inflammatory effect as a medicinal component in the step of preparing the medicinal component / excipient mixture by mixing the medicinal component and excipient described in the above-mentioned typical example 1 Using cetylpyridinium chloride, which mainly exhibits a bactericidal action, and using xylitol, erythritol, and L-menthol as excipients, weighing a predetermined amount of each powdered component, and pulverizing similar to a home mixer A mixture of medicinal ingredients / excipients that is crushed by a mixer and mixed uniformly is prepared. Even after mixing, these medicinal components and excipients are all in the form of powder particles, and the particle diameter of each component is 50 μm or less. In this crushing and mixing step, crushing and mixing are performed at an ambient temperature of 25 ° C. in an atmosphere in a temperature range in which each used component does not melt. Next, using the same gum base as in the above-mentioned typical example 1, a predetermined amount of the gum base is put into a kneader, and further, a predetermined amount of starch syrup is added and pre-kneaded, and the pre-kneaded In the kneading machine, the medicinal ingredient / excipient mixture obtained as described above was added, and the gum base and medicinal ingredient / excipient mixture were kneaded and mixed uniformly. A gum medical raw material is prepared. Next, the gum medical raw material obtained as described above was prepared by using an extrusion molding machine and a compression molding machine to prepare a thin gum medical molding material. Also in this molding process, molding is performed at a temperature range in which the used medicinal ingredients and excipients do not melt. In particular, the medicinal components are present uniformly dispersed in the gum base without aggregation.

  The components of the obtained gum medical raw material and sheet-shaped gum medical molding material were dipotassium glycyrrhizinate (0.3% by weight), cetylpyridinium chloride (0.1% by weight), xylitol as an excipient ( 38.0% by weight), erythritol (19.0% by weight), L-menthol (1.0% by weight), starch syrup (2.0% by weight), and gum base (39.6% by weight).

  Next, the disc-shaped gum medical molding material obtained as described above was placed in a sugar coating machine, and coated with a sugar coating comprising a plurality of sugar coating layers by the same sugar coating process as in Example 1. A chewing gum drug was produced. The sugar-coated chewing gum medicine has a thin plate shape having a vertical width of about 20 mm, a horizontal width of about 7 mm, and a thickness of about 5 mm. Moreover, it has hardness and viscoelasticity that can be easily viscoelastically deformed by applying mechanical pressure at about 36 degrees C.

  A chewing gum pharmaceutical comprising at least a gum base and a medicinal ingredient, wherein the medicinal ingredient is contained in the gum base, and the medicinal ingredient is at least mainly an anti-inflammatory agent having an anti-inflammatory effect to extinguish inflammation of the throat The anti-inflammatory agent is a chewing gum drug having a function of exerting the anti-inflammatory effect by directly contacting the affected part in the mouth together with saliva by chewing. This makes it possible to exert a sufficient anti-inflammatory effect, and has a medicinal component concentration with no side effects, so that the medicinal product stays in the mouth for a long time, and the medicinal component can contact the affected part of the throat for a longer time. In addition, during this time, since the medicinal component can be brought into direct contact with the affected part of the inflammation, the content of the limited medicinal component can be utilized to the maximum, and the utilization efficiency of the medicinal effect can be increased. In addition, it has excellent medicinal stability in storage and storage that can prevent deterioration without causing deterioration of medicinal ingredients even if stored in a normal atmosphere such as room temperature, humidity, and brightness in a general household for a long time. A chewing gum medicine having an anti-inflammatory effect mainly against throat inflammation is obtained.

  In chewing gum medicines, chewing gum medicines containing at least the medicinal ingredients of an anti-inflammatory agent having an anti-inflammatory effect mainly for extinguishing inflammation of the throat and an anti-inflammatory agent mainly for sterilizing the mouth. Can exhibit sufficient anti-inflammatory and bactericidal effects, and has a medicinal concentration with no side effects, the medicinal product stays in the mouth for a long time, and the medicinal component may contact the affected part of the throat for a longer time. Excellent medicinal stability in storage and storage that can prevent deterioration without causing deterioration of medicinal components even if stored in a normal atmosphere such as room temperature, humidity, and brightness in a general household for a long time. It exhibits anti-inflammatory effect mainly against throat inflammation, and also exhibits bactericidal action to sterilize the mouth, and the affected part is affected by the synergistic effect of this anti-inflammatory action and bactericidal action. The effect of healing the inflammation is remarkably improved.

  In the chewing gum medicine, the medicinal component further contains an excipient in addition to the gum base and the medicinal component, and the excipient has an effect of adjusting the medicinal efficacy of the medicinal component, In the chewing gum medicine that is contained in the gum base, the excipient is effective for healing the above-mentioned anti-inflammatory effect and inflammation of the affected area, and the medicinal components are in contact with the affected area of the throat for a longer time. The effects such as the effect and the medicinal stability that can prevent the deterioration of quality during long-term storage / storage are further improved. In addition, a chewing gum medicine to which a desired chewing taste such as sweetness and refreshing feeling is added can be obtained.

  In the method for producing a chewing gum medicine comprising at least a gum base and a medicinal component of the present invention, the medicinal component is mixed so as to be uniformly dispersed in the gum base. As a result, in the manufacturing process, pharmaceutical products with consistently stable quality are manufactured without causing deterioration of medicinal components due to heat and other factors, and without causing component changes due to mutual reaction of components used. it can. Furthermore, it is possible to exert a sufficient anti-inflammatory effect and has a medicinal component concentration with no side effects, the medicinal product stays in the mouth for a long time, and the medicinal component can contact the affected part of the throat for a long time, Has excellent medicinal stability in storage and storage that prevents deterioration of medicinal components without causing deterioration of medicinal components even when stored in a normal atmosphere such as room temperature, humidity, and brightness in a general household. Thus, a chewing gum drug mainly having an anti-inflammatory effect against throat inflammation can be obtained.

  In the above method for producing a chewing gum pharmaceutical, the medicinal component further contains a bactericidal agent having a bactericidal action in addition to the antiphlogistic agent, and the medicinal component of these anti-inflammatory agent and bactericidal agent is contained in the gum base. It mixes so that it may disperse | distribute uniformly and may be contained. As a result, in the manufacturing process, pharmaceutical products with consistently stable quality are manufactured without causing deterioration of medicinal components due to heat and other factors, and without causing component changes due to mutual reaction of components used. it can. In addition, it has sufficient anti-inflammatory effect and bactericidal action, and has a medicinal component concentration with no side effects, and the medicinal product stays in the mouth for a long time, and the medicinal component may contact the affected part of the throat for a long time. Excellent medicinal stability in storage and storage that can prevent deterioration without causing deterioration of medicinal components even if stored in a normal atmosphere such as room temperature, humidity, and brightness in a general household for a long time. It has anti-inflammatory effect mainly on throat inflammation and sterilizes the mouth, and the synergistic effect of anti-inflammatory effect and bactericidal action significantly improves the healing effect on the affected area. A chewing gum medicine is obtained.

Claims (21)

A chewing gum pharmaceutical comprising at least a gum base and a medicinal component,
The gum base is composed of a plurality of gum components and has a chewable elastic rubber form,
The medicinal component is contained in the gum base,
The medicinal component contains at least an anti-inflammatory agent having an anti-inflammatory effect mainly to extinguish throat inflammation,
The chewing gum medicine, wherein the anti-inflammatory agent has a function of exerting the anti-inflammatory effect by directly contacting the affected part in the mouth together with saliva by chewing. The medicinal component contains at least the medicinal component of an anti-inflammatory agent having an anti-inflammatory effect mainly to extinguish inflammation of the throat and a bactericide having an action of mainly sterilizing the mouth,
The anti-inflammatory agent is in direct contact with the affected area in the mouth with saliva by chewing, and has a function of exerting the anti-inflammatory effect,
The chewing gum medicine according to claim 1, wherein the bactericidal agent has a function of exerting the bactericidal action by directly contacting the affected part in the mouth together with saliva by chewing. In addition to the gum base and the medicinal component, further includes an excipient,
The excipient has an effect of adjusting the convenience of administration while maintaining the efficacy of the medicinal component,
The chewing gum medicine according to claim 1 or 2, wherein the medicinal component and the excipient are contained in the gum base.   The chewing gum medicine according to any one of claims 1 to 3, wherein the medicinal component is uniformly dispersed and contained in the gum base. The medicinal component has a powdery particle shape,
The particle size of the medicinal component is 50 μm or less,
The chewing gum medicine according to any one of claims 1 to 3, wherein the medicinal component is uniformly dispersed and contained in the gum base.   The anti-inflammatory agent as the medicinal component is at least one selected from the group consisting of sodium azulenesulfonate, methyl salicylate, lysozyme chloride, dipotassium glycyrrhizinate, and chlorpheniramine maleate, which mainly exhibit anti-inflammatory effects. The chewing gum medicine according to any one of claims 1 to 5.   The bactericidal agent as the medicinal component is at least one selected from the group consisting of cetylpyridinium chloride, decalinium chloride, benzothorium chloride, chlorhexine hydrochloride, chlorhexidine gluconate, and iodo compounds that mainly exert a bactericidal action. The chewing gum medicine according to any one of claims 2 to 5.   The chewing gum medicine according to claim 3, wherein the excipient is at least one selected from erythritol, L-menthol, xylitol, reduced starch syrup, sorbitol, mannitol, maltitol, palatinose, and aster palm. .   The gum component contained in the gum base is at least vinyl acetate resin, polyisobutylene, butadiene-styrene copolymer, polyethylene, gelton, chicle gum, solver gum, ester gum, crown gum, microcrystalline wax, glycerin fatty acid ester The chewing gum medicine according to any one of claims 1 to 8, which is at least one selected from the group consisting of: stearic acid, calcium stearate, magnesium stearate, natural wax, petroleum wax, and inorganic powder. .   The chewing gum medicine according to any one of claims 1 to 9, wherein the medicinal component contains at least an anti-inflammatory agent of sodium azulenesulfonate that mainly exhibits anti-inflammatory effect.   The chewing gum according to any one of claims 1 to 9, wherein the medicinal component contains at least an anti-inflammatory agent of both sodium azulenesulfonate and dipotassium glycyrrhizinate which mainly exhibit anti-inflammatory effect. Pharmaceuticals.   The medicinal component contains at least an anti-inflammatory agent of both sodium azulene sulfonate and dipotassium glycyrrhizinate which mainly exhibit anti-inflammatory effects, and a cetylpyridinium chloride disinfectant which mainly exhibits anti-bacterial action. Item 10. A chewing gum drug according to any one of Items 2 to 9. A method for producing a chewing gum medicine having the effect of directly exerting an anti-inflammatory effect by directly contacting the affected part in the mouth together with saliva by chewing,
(A) kneading a plurality of types of gum components to prepare a gum base in which the plurality of types of gum components are uniformly mixed; and
(B) kneading the gum base, a medicinal component and an excipient to prepare a gum medical raw material in which the gum component, the medicinal component and the excipient are uniformly mixed;
(C) forming the gum medical raw material into a predetermined shape to obtain a chewing gum medicine;
Consists of
The medicinal component contains at least an anti-inflammatory agent that mainly exhibits an anti-inflammatory effect,
In the step (b), the chewing gum medicine is produced by kneading so that the medicinal component is uniformly dispersed and contained in the gum base.   The method for producing a chewing gum medicine according to claim 13, wherein the medicinal component further contains a bactericidal agent having a bactericidal action in addition to the anti-inflammatory agent. The step (b)
The medicinal ingredient and the excipient are uniformly mixed to prepare a medicinal ingredient / excipient mixture,
Uniformly mixing the obtained medicinal ingredient / excipient mixture and the gum base to prepare the gum medical raw material,
Thereby, the said medicinal component is uniformly disperse | distributed and contained in the said gum base, The manufacturing method of the chewing gum pharmaceutical of Claim 13 or 14 characterized by the above-mentioned.   The method for producing a chewing gum medicine according to claim 13, 14 or 15, wherein in the step (b), the medicinal component having a powdery particle shape with a particle size of 50 µm or less is used. In the step (b), a medicinal component having a powdery particle shape is used as the medicinal component,
In the step (b), the medicinal ingredient and the excipient are mixed and the medicinal ingredient is pulverized to a particle size of 50 μm or less and mixed uniformly. Prepare a mixture, then
Uniformly kneading the obtained medicinal ingredient / excipient mixture and the gum base to prepare the gum medical raw material,
As a result, the medicinal component having a particle size of 50 μm or less is uniformly dispersed in the gum base so that the surface of the powdery particles of the medicinal component is covered with the gum base. 16. The method for producing a chewing gum medicine according to claim 13, 14 or 15, wherein the chewing gum medicine is contained.   The medicinal component is at least one selected from the group consisting of at least sodium azulenesulfonate, methyl salicylate, lysotium chloride, dipotassium glycyrrhizinate, chlorpheniramine maleate, and is an anti-inflammatory agent that mainly exhibits an anti-inflammatory effect. A method for producing a chewing gum medicine according to any one of claims 13 to 17. The medicinal component contains at least an anti-inflammatory agent of sodium azulene sulfonate that exhibits anti-inflammatory effect,
The excipient contains at least one selected from the group consisting of xylitol, erythritol, and L-menthol,
In the step (b), the sodium azulenesulfonate and the excipient are uniformly mixed and pulverized to prepare a medicinal ingredient / excipient mixture having a predetermined particle size,
Uniformly mixing the obtained medicinal ingredient / excipient mixture and the gum base to prepare the gum medical raw material,
The chewing gum medicine according to any one of claims 13 to 17, wherein the sodium azulene sulfonate as the medicinal component is thereby uniformly dispersed in the gum base. Method. The medicinal component contains at least an anti-inflammatory agent of sodium azulenesulfonate and dipotassium glycyrrhizinate that exhibit anti-inflammatory effect, and a cetylpyridinium chloride anti-microbial agent that exhibits anti-bacterial action,
The excipient contains at least one selected from the group consisting of xylitol, erythritol, and L-menthol,
In the step (b), a medicinal component having a predetermined particle size is obtained by uniformly mixing and grinding the medicinal component of the sodium azulenesulfonate, the dipotassium glycyrrhizinate and the cetylpyridinium chloride, and the excipient. -Prepare an excipient mixture, then
Uniformly mixing the obtained medicinal ingredient / excipient mixture and the gum base to prepare the gum medical raw material,
Accordingly, the medicinal ingredients of the sodium azulene sulfonate, the dipotassium glycyrrhizinate and the cetylpyridinium chloride are uniformly dispersed in the gum base, and are contained. A method for producing a chewing gum medicine according to any one of the above.   In the step (b), the medicinal component is pulverized to a particle size of 50 μm or less, the excipient is also pulverized to a particle size of 50 μm or less, and a predetermined particle size of the predetermined medicinal component / excipient mixture 21. The method for producing a chewing gum medicine according to claim 19 or 20, characterized in that is not more than 50 μm.