JPH09316009A - Production of disintegrative composition and production of disintegrative formed product using the same composition - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a method for producing a disintegrative composition capable of imparting excellent disintegrating property to the resultant molding without impairing moldability by adding a food raw material or a medicinal active ingredient in tableting or granulating and provide a method for producing a disintegrative formed product by using the composition. SOLUTION: Agar powder is mixed with an insoluble vegetable fiber and/or yeasts in an amount of 1-5 times by weight based on the agar powder, water or water-containing ethyl alcohol having <50vol.% alcohol concentration and as necessary the resultant mixture is dried to afford the objective disintegrative composition. The disintegrative composition is mixed with a food raw material or a medicinal organic active ingredient and the mixture is tableted or granulated to produce the objective formed product. Cellulose, wheat fiber, corn fiber, beat fiber or alginic acid, particularly crystalline cellulose is preferably used as the insoluble vegetable fiber.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention is capable of forming a tablet, a granule or the like by mixing a food material or a pharmaceutically active ingredient.
It also relates to a method for producing a disintegrating composition that disintegrates in a short time when water is added, and a method for producing a disintegrating molded article using the composition.

[0002]

2. Description of the Related Art Conventionally, a bulking agent is mixed with a food material having physiological activity such as chlorella or royal jelly, or an excipient is mixed with a medicinal active ingredient, followed by tableting or granulation to obtain tablets or granules. It is being molded into.

Conventionally, lactose, cellulose, starch, rice flour and the like have been used as such fillers or excipients. Bulking agents or excipients are required to be able to be tableted or granulated in the state of mixing food materials or pharmaceutically active ingredients, and also to be rapidly disintegrated in the body when orally ingested. Sometimes.

However, the conventionally used extenders or excipients have moldability but insufficient disintegration property, or have excellent disintegration property but have difficulty in moldability. Many of them had a small amount of those having both moldability and disintegration. In addition, in many cases, the disintegration property was poor especially when wet granulation.

On the other hand, a so-called effervescent tablet has been proposed in which an effervescent agent and a neutralizing agent are mixed so that the tablet disintegrates due to the generation of carbon dioxide due to neutralization when charged in water. Was not suitable for use in foods and pharmaceuticals that were orally ingested to be disintegrated in the body.

Further, Japanese Patent Publication No. 5-75373 discloses (1) 10 to 50 parts by weight of aspartame and (2) one or more kinds selected from carboxymethyl starch, carboxymethyl cellulose and derivatives thereof. 2 parts by weight or 5 agar
Disclosed is a method for producing a disintegrating tablet containing aspartame, characterized by comprising: ~ 15 parts by weight and (3) 30-85 parts by weight of lactose, and compressing to a tablet hardness of 0.5-2 kg. There is.

[0007]

[Patent Document 1] Japanese Patent Publication No. 5-75373 discloses that, as a disintegrant, carboxymethyl starch,
It is disclosed that one or more selected from carboxymethyl cellulose, derivatives thereof, guar gum, powdered agar, crystalline cellulose and starch are added, but in the method described in the publication, the main material is used. The above disintegrant is added in the form of powder to a certain aspartame and lactose as a bulking agent, and the mixture is tableted by a dry method.

However, according to the experiments conducted by the present inventors, even if agar powder, cellulose or the like was used as a disintegrant, if they were mixed as they were in the powder state and tablet-molded by the dry method, it would be Disintegration in water is not sufficiently obtained,
Therefore, it was found that disintegration in the body when ingested orally cannot be fully expected.

Therefore, an object of the present invention is to add moldability to tablets or granules by adding it to a food material or a pharmaceutically active ingredient, and to impart excellent disintegrability to the obtained molded product. It is an object of the present invention to provide a method for producing a disintegrating composition that can be used, and a method for producing a disintegrating molded article using the composition.

[0010]

Means for Solving the Problems The first object of the present invention, which was made to achieve the above object, is agar powder, and 1 to 5 times by weight of the agar powder, insoluble dietary fiber and / or yeasts. , Water or an aqueous solution of ethyl alcohol having an alcohol concentration of less than 50% by volume is mixed, which is a method for producing a disintegrating composition.

The second aspect of the present invention is a method for producing a disintegrating composition in which the mixture is further dried.

A third aspect of the present invention is that the insoluble dietary fiber comprises
It is a method for producing a disintegrating composition which is at least one selected from cellulose, wheat fiber, corn fiber, beet fiber and alginic acid.

A fourth aspect of the present invention is that the insoluble dietary fiber is
A method for producing a disintegrating composition which is crystalline cellulose.

The fifth aspect of the present invention is (A) agar powder, 1 to 5 times by weight of the agar powder, insoluble dietary fiber and / or yeasts, and water or ethyl alcohol having an alcohol concentration of less than 50% by volume. A disintegrating composition obtained by mixing with an aqueous solution, or a disintegrating composition obtained by further drying the composition, and (B) a food material or a pharmaceutically active ingredient are mixed and tableted or granulated. It is a method for producing a disintegrating molded article characterized by the above.

According to the first method for producing a disintegrating composition of the present invention, agar powder, insoluble dietary fiber and / or yeast, and water or an aqueous ethyl alcohol solution having an alcohol concentration of less than 50% by volume are mixed. As a result, the agar powder is swollen with water or an aqueous solution of ethyl alcohol, and a composition in which insoluble dietary fiber and / or yeasts are incorporated can be obtained. This composition can impart good moldability when added to a food material or a pharmaceutically active ingredient, and can impart excellent disintegrability to the obtained molded product.

According to the second method for producing a disintegrating composition of the present invention, after mixing with agar powder, water or an aqueous solution of ethyl alcohol having an alcohol concentration of less than 50% by volume, insoluble dietary fiber and / or yeasts. By drying, insoluble dietary fiber and / or yeasts are included in the agar, and a dried composition can be obtained. This composition imparts good moldability even when it is added to a food material or a pharmaceutically active ingredient and tableted or granulated by any of wet method or dry method, and the obtained molded article is obtained. It is possible to impart excellent disintegration property to.

As shown in Examples described later, even when agar powder and crystalline cellulose are used together as a disintegrant, both are added to the food material or the pharmaceutically active ingredient in the powder state without swelling the agar powder. Then, when molded by the dry method, sufficient disintegration cannot be obtained.

According to the third method for producing a disintegrating composition of the present invention, by using at least one selected from cellulose, wheat fiber, corn fiber, beet fiber and alginic acid as the insoluble dietary fiber, The effect of the invention can be enhanced.

According to the fourth method for producing a disintegrating composition of the present invention, the effect of the present invention can be maximized by using crystalline cellulose as the insoluble dietary fiber.

According to the fifth method for producing a disintegrable molded article of the present invention, agar powder, water or an ethyl alcohol aqueous solution having an alcohol concentration of less than 50% by volume, and insoluble dietary fiber and / or yeast are mixed. After that, the disintegrating composition of the present invention obtained by further drying if necessary, a food material or a pharmaceutically active ingredient is mixed, and by tableting or granulation molding, excellent disintegration in water, Therefore, it is possible to obtain a tablet or granular food or drug, which is expected to have excellent digestive and absorbability in the body.

[0021]

BEST MODE FOR CARRYING OUT THE INVENTION The disintegrating composition of the present invention comprises agar powder, 1 to 5 times by weight of the agar powder, insoluble dietary fiber and / or yeast, and a water or alcohol concentration of less than 50% by volume. It can be obtained by mixing the above-mentioned aqueous solution of ethyl alcohol and then further drying this mixture if necessary.

The powder agar has a particle size of 50 to 200 μm.
It is preferable that the jelly strength is 500 to 800 g / cm ² . As powder agar that satisfies such conditions, for example, "KT
"Type" (trade name, manufactured by Ina Agar Co., Ltd.) and the like can be used.

As the insoluble dietary fiber, cellulose, wheat fiber, corn fiber, beet fiber,
It is preferable to use at least one selected from alginic acid and the like, and among these, crystalline cellulose is most preferable. The particle size of the insoluble dietary fiber is preferably 10 to 200 μm, and if necessary, the fiber can be crushed before use. As the crystalline cellulose, for example, "Avicel" (trade name, manufactured by Asahi Kasei Corporation) can be used.

In the present invention, yeasts such as live yeast, dried yeast and crushed products thereof may be used in place of or together with the insoluble dietary fiber. The type of yeast is not particularly limited as long as it is generally used for foods, and may be brewer's yeast, alcohol yeast, baker's yeast, sake yeast, wine yeast, or the like.

In the present invention, the mixing ratio of the insoluble dietary fiber and / or yeasts is 1 to 5 times the weight of the powder agar. When the compounding ratio is less than 1 part by weight with respect to the powder agar, there is a problem that moldability and fluidity are difficult, and when it exceeds 5 parts by weight, disintegration and dispersibility tend to be delayed. It is not preferable.

In the present invention, an aqueous solution of water or ethyl alcohol having an alcohol concentration of less than 50% by volume swells powdered agar and mixes it with insoluble dietary fiber and / or yeasts, so that the insoluble dietary fiber and / or yeasts are agar. Used to be included in. The addition amount of water or an aqueous solution of ethyl alcohol is preferably such that the powder agar can be sufficiently swollen, and is 1 to 2 times the weight of the total of the powder agar and the insoluble dietary fiber and / or yeasts. It is preferable to set the degree.

When an aqueous solution of ethyl alcohol is used, if the alcohol concentration is 50% by volume or more, the fluidity of the resulting disintegrating composition deteriorates. Therefore, it is mixed with a food material or a pharmaceutically active ingredient into tablets or granules. Molding becomes difficult when making the agent.

[0028] Further, if the agar powder and the insoluble dietary fiber and / or yeast are simply mixed in a dry state without swelling the agar powder with water or an aqueous solution of ethyl alcohol, a sufficient disintegration property is imparted to the molded product. You cannot do it.

In the present invention, the method of mixing the agar powder, the insoluble dietary fiber and / or yeasts, and the aqueous alcohol solution having a water or alcohol concentration of less than 50% by volume is the same as the agar powder having a water or alcohol concentration of 50%. After adding an ethyl alcohol aqueous solution of less than volume% to swell the agar, insoluble dietary fiber and / or yeasts may be added and mixed, or alternatively, agar powder and insoluble dietary fiber and / or yeasts 50% by volume of water or alcohol in the mixture
Less than ethyl alcohol aqueous solution may be added and mixed. After mixing these, it is preferable to thoroughly stir them and knead them.

The disintegrating composition of the present invention is prepared as a wet mixture of agar powder, insoluble dietary fiber and / or yeast, and water or an aqueous ethyl alcohol solution having an alcohol concentration of less than 50% by volume. However, this mixture can be further dried to prepare a dry powder. In the case of a mixture in a wet state, it is necessary to simultaneously add and mix a food material and a pharmaceutically active ingredient, and tableting or granulating it.Therefore, it is desirable to prepare them at the manufacturing site of foods or pharmaceuticals, but dry powder In that case, it can be stored in that state, transported to a food factory or a pharmaceutical factory for use, and can be commercialized as a disintegrating composition itself.

The mixture of agar powder, insoluble dietary fiber and / or yeast, and water or an aqueous solution of ethyl alcohol may be dried by, for example, freeze-drying or hot-air drying. It is preferable to uniformly dry using a machine. The disintegratable composition dried in this manner is preferably prepared so that the particle size thereof is smaller than 30 mesh, from the viewpoint of handleability afterwards.

In the method for producing the disintegrating composition of the present invention, other components such as starches may be added within a range that does not impair the effects of the present invention.

The disintegrating molded article of the present invention is prepared by mixing the disintegrating composition produced as described above with a food material or a pharmaceutically active ingredient, and compressing or granulating the mixture to give tablets or granules. It is manufactured by molding.

As described above, the disintegrating composition is a mixture of agar powder, insoluble dietary fiber and / or yeast, and water or an aqueous ethyl alcohol solution having an alcohol concentration of less than 50% by volume. Also, a mixture of these may be dried. When the dried disintegrating composition and the food material or the pharmaceutically active ingredient are mixed, they may be dry-mixed as they are and tableted or granulated by a dry method, or by adding water. It may be tableted or granulated by a wet method.

As already mentioned, when agar powder and crystalline cellulose are mixed with the food material or the pharmaceutically active ingredient as dry powder and the mixture is tableted or granulated by the dry method, sufficient disintegration property is obtained. However, by using the disintegrating composition of the present invention obtained by swelling the agar powder with water or an aqueous solution of ethyl alcohol to incorporate insoluble dietary fiber and / or yeasts, and drying the mixture. A molded product having excellent disintegration can be obtained even by tableting or granulating by a dry method.

In the present invention, the food material is preferably chondroitin, royal jelly, chlorella, gymnema, garcinia, bovine bone, nucleic acid, mushrooms, collagen, propolis or the like which has a physiological activity or is rich in nutrients which tend to be deficient. Used. As the pharmaceutically active ingredient, various kinds which can be made into tablets or granules can be used.

When a food material or a pharmaceutically active ingredient is mixed with the disintegrating composition of the present invention to prepare a molded article, the amount of the disintegrating composition added is 3% by weight or more in terms of solid content in the product. It is preferable that 3% by weight of the disintegrating composition added
If it is less than the above range, sufficient disintegration cannot be imparted to the obtained molded product. The upper limit of the amount of the disintegrating composition to be blended is not particularly limited, but if it exceeds 30% by weight, problems such as disintegration of the molded product being too fast and tablet thickness increasing occur.

In the disintegrating molded article of the present invention, for example, a lubricant, a binder, a dispersant, an emulsifier, a sweetener, a flavoring agent, etc., ordinarily tablets or granules, as long as the effects of the present invention are not impaired. Additives to be added can be added.

[0039]

【Example】

Example 1 "KT type" (trade name, manufactured by Ina Agar Co., Ltd.), which is powder agar having a jelly strength of 730 g / cm ² and an average particle size of 100 μm.
To 300 parts by weight of water, add 300 parts by weight of water, swell the powdered agar by stirring, and then add 200 parts by weight of "Avicel" (trade name, manufactured by Asahi Kasei Co., Ltd.), which is crystalline cellulose having an average particle size of 40 μm. Then, the mixture was stirred and kneaded to obtain a mixture.

Then, this mixture was put into a fluidized bed dryer and dried with hot air to obtain a disintegrating composition which was a powder of 30 mesh pass.

Example 2 Instead of water, an ethyl alcohol aqueous solution having an alcohol concentration of 33% by volume (hereinafter referred to as "33% alcohol") and an ethyl alcohol aqueous solution having an alcohol concentration of 50% by volume (hereinafter referred to as "55
% Alcohol)), anhydrous ethyl alcohol (hereinafter referred to as "anhydrous alcohol"), and the other examples
In the same manner as described above, an aqueous solution of ethyl alcohol having various concentrations or a disintegrating composition using ethyl alcohol as a solvent was obtained.

Test Example 1 With respect to various disintegrating compositions obtained in Examples 1 and 2,
Appearance, fluidity, tabletability (moldability) and disintegration were tested to evaluate the suitability of the solvent. The fluidity was measured by the angle of repose. Further, the tableting property was judged by tableting under a constant pressure and measuring the hardness of the tablet. Furthermore, the disintegration property is
In accordance with the disintegration test method of the general test method of "12th Bureau Amendment, Japanese Pharmacy Law", it was put into water at 37 ° C and the time until disintegration was measured.

The results are shown in Table 1. In Table 1, appearance, fluidity, tableting property (moldability), and disintegration are evaluated based on the above measurement results.
Slightly bad ... △, bad ... X

[0044]

[Table 1]

From the results shown in Table 1, when water or 33% alcohol was used as the solvent, a composition excellent in all of appearance, fluidity, tableting property (moldability) and disintegration property was obtained. It can be seen that when 50% alcohol is used, the fluidity is poor, and when anhydrous alcohol is used, the fluidity is poor and the tableting property and disintegrating property are slightly poor. Therefore, it is understood that water or an aqueous solution of ethyl alcohol having an alcohol concentration of less than 50% by volume is suitable as a solvent for producing the disintegrating composition.

Comparative Example 1 The same agar powder and crystalline cellulose as in Example 1 were dry mixed without using water to obtain a powder mixture.

Example 3 To 100 parts by weight of the same powder agar as in Example 1, was added 300 parts by weight of water, and the powder agar was swollen by stirring to swell the powdered agar. 200 parts by weight of Beer Co., Ltd.) were added, and the mixture was stirred and kneaded to obtain a mixture.

Next, this mixture was put into a fluidized bed dryer and dried with hot air to obtain a disintegrating composition which was a powder of 30 mesh pass.

Comparative Example 2 The same agar powder and brewer's yeast as in Example 3 were dry mixed without using water to obtain a powder mixture.

Test Example 2 Garcinia and sucrose fatty acid ester as a lubricant,
The disintegrating composition obtained in Example 1 or the powder mixture obtained in Comparative Example 1 was mixed at the compounding ratio shown in Table 2, and a wet method in which an appropriate amount of water was added, or a dry method in which water was not added was mixed. With a triangular punch with a diameter of 8.5 mm, the weight is 250 mg / tablet and the hardness is about 5 kg.
Tablets were obtained by tableting so that The tablets obtained by the wet method are Nos. 1 to 5, and the tablets obtained by the dry method are Nos. 6 to 10.

The tablets Nos. 1 to 10 thus obtained were subjected to a disintegration test in the same manner as in Test Example 1. The results are shown in Table 2.

[0052]

[Table 2] (In the table,% of the composition represents% by weight.)

From the results shown in Table 2, No. 2 containing the disintegrating composition or the powder mixture when tableted by the wet method,
It can be seen that the tablets of Nos. 3, 4, and 5 have a significantly shorter disintegration time than the tablets of No. 1 containing neither the disintegrating composition nor the powder mixture.

In the case of tableting by the dry method, as compared with the tablet No. 6 containing neither the disintegrating composition nor the powder mixture,
The tablets of Nos. 7 and 9 containing the disintegrating composition have a significantly reduced disintegration time, but the tablets of No. 8 containing the powder mixture are
It can be seen that the tablets of 10 do not show much effect of shortening the disintegration time. Further, in both the wet method and the dry method, it can be seen that the effect of reducing the disintegration time is greater as the blending ratio of the disintegrating composition or the powder mixture is higher.

Garcinia, a lubricant, and Comparative Example 1
In a powder mixture of agar powder and crystalline cellulose obtained in,
The tablets of Nos. 3 and 5, which were tabletted by the wet method with the addition of water, were swelled by the agar powder during the wet molding so that the crystalline cellulose was included therein. It corresponds to a molded product. That is, No. 2, 3, 4, 5,
The tablets Nos. 7 and 9 are examples of the present invention, and the tablets Nos. 8 and 10 are comparative examples corresponding to Japanese Patent Publication No.
Tablets 1 and 6 are controls.

That is, as compared with the control No. 1 and 6 tablets, the tablet Nos. 2, 3, 4, 5, 7, and 9 of Example 3 had a significantly shortened disintegration time. No. 3 of Comparative Example 3
It can be seen that the tablets of Nos. 8 and 10 are not so effective in shortening the disintegration time.

Test Example 3 Chlorella, a sucrose fatty acid ester as a lubricant, and the disintegrating composition obtained in Example 3 or the powder mixture obtained in Comparative Example 2 were blended as shown in Table 3. Mixed by the ratio, by dry direct pressing method, round punch with a diameter of 8.0 mm, weight 200 mg /
One tablet was tableted to give a hardness of about 4 kg. These tablets are referred to as Nos. 11 to 15. The tablets of Nos. 12 and 14 are the examples of the present invention, the tablets of Nos. 13 and 15 are the comparative examples, and the tablets of No. 11 are the controls.

The tablets of Nos. 11 to 15 were subjected to a disintegration test in the same manner as in Test Example 1. Table 3 shows the results.

[0059]

[Table 3]

From the results shown in Table 3, when tableting was carried out by the dry method,
Compared to the control No. 11 tablet containing neither the disintegrating composition nor the powder mixture, the tablets of Nos. 12 and 14, which are the examples of the present invention containing the disintegrating composition, had a significantly longer disintegration time. However, it can be seen that the tablets of Comparative Examples Nos. 13 and 15 in which the powder mixture is blended do not show much effect of shortening the disintegration time. Further, it can be seen that the larger the blending ratio of the disintegrating composition or the powder mixture, the greater the effect of shortening the disintegration time.

Test Example 4 A lyophilized product of royal jelly, a sucrose fatty acid ester as a lubricant, and the disintegrating composition obtained in Example 1 or the powder mixture obtained in Comparative Example 1 are shown in a table. The mixture was mixed at the blending ratio shown in Table 4 and tableted by a dry method using a triangular punch having a diameter of 8.5 mm so that the weight was 250 mg / tablet and the hardness was about 5 kg. These tablets are designated as Nos. 16-20. No.
Tablets 17 and 19 are examples of the present invention, tablets No. 18 and 20 are comparative examples, and tablet No. 16 is a control.

The tablets of Nos. 16 to 20 were subjected to a disintegration test in the same manner as in Test Example 1. These results are shown in Table 4.
Shown in

[0063]

[Table 4]

From the results of Table 4, when tableting was carried out by the dry method,
Compared to the control No. 16 tablets containing neither the disintegrating composition nor the powder mixture, the tablets of Nos. 17 and 19 which are the examples of the present invention containing the disintegrating composition had a significantly longer disintegration time. However, it can be seen that the tablets of Comparative Examples Nos. 18 and 20 in which the powder mixture is blended do not show much effect of shortening the disintegration time. Further, it can be seen that the larger the blending ratio of the disintegrating composition or the powder mixture, the greater the effect of shortening the disintegration time.

Test Example 5 Gymnema, lactose, crystalline cellulose, the disintegrating composition obtained in Example 1 or the powder mixture obtained in Comparative Example 1 were mixed at the mixing ratios shown in Table 5. , Water was added, the mixture was extruded in a basket with a screen of 1 mm, granulated, and dried at 50 ° C. to obtain granules having 18 mesh pass. These granules are referred to as Nos. 21-23.

Since granulation was carried out by adding water, the mixture containing the powder mixture obtained in Comparative Example 1 also corresponds to the example of the present invention. Therefore, the granules of Nos. 22 and 23 were used. For example, No. 21 granular material containing crystalline cellulose is a control.

Regarding the granules of Nos. 21 to 23, the granulation property,
Granule strength was measured, and a disintegration test was conducted in the same manner as in Test Example 1. The granulation property was evaluated by measuring the calorific value and the granulation pressure during granulation, and the granule strength was evaluated by a friability test using a fly aviator, and evaluated by the evaluation criteria shown in Table 5, respectively. The test results are shown in Table 6.

[0068]

[Table 5]

[0069]

[Table 6]

From the results in Table 6, it is an example of the present invention in which agar powder and crystalline cellulose were used in combination, as compared with the control No. 21 granular material in which crystalline cellulose was added without using agar powder. It can be seen that the disintegration time is significantly shortened for the granular materials of .22 and 23. Further, the control No. 21 granules are excellent in granule strength, but have poor granulation properties, whereas the No. 22 and 23 granules in the examples have granulation properties and granules. It can be seen that it has excellent strength.

Test Example 6 Beef bones, lactose, crystalline cellulose, the disintegrating composition obtained in Example 1 or the powder mixture obtained in Comparative Example 1 were used.
After mixing in the mixing ratio shown in Table 6, water was added, and the mixture was extruded and granulated in a basket with a screen of 1 mm and dried at 50 ° C,
A 18 mesh pass granular material was obtained. These granules
No. 24-26.

Since the mixture was granulated by adding water, the mixture of the powder mixture obtained in Comparative Example 1 is also an example of the present invention, and therefore the granules of Nos. 25 and 26 are examples. , No.
24 granules are controls.

Test Example 5 for No. 24-26 granular materials
The granulation property and the granule strength were measured by the same method as described in (1), and the disintegration test was performed by the same method as in Test Example 1. The results are shown in Table 7.

[0074]

[Table 7]

From the results of Table 7, it is an example of the present invention in which the agar powder and the crystalline cellulose were used in combination, as compared with the control No. 24 granular material in which the crystalline cellulose was added without using the agar powder. It can be seen that the disintegration time is significantly shortened for the granular materials of .25 and 26.

[0076]

As described above, according to the present invention,
When tableting or granulating a food material or a pharmaceutically active ingredient, an agar powder swollen with water or an aqueous solution of ethyl alcohol is used to obtain a disintegrating composition obtained by incorporating insoluble dietary fiber and / or yeasts. By adding, a molded product having excellent disintegration can be obtained without impairing the moldability.

Claims (5)

[Claims] 1. An agar powder and 1 to the agar powder.
A process for producing a disintegrating composition, which comprises mixing 5 times by weight of insoluble dietary fiber and / or yeast with water or an aqueous solution of ethyl alcohol having an alcohol concentration of less than 50% by volume. 2. The method for producing a disintegrating composition according to claim 1, wherein the mixture is further dried. 3. The insoluble dietary fiber is cellulose, wheat fiber, corn fiber, beet fiber,
2. At least one selected from alginic acid.
Or the method for producing the disintegrating composition according to item 2. 4. The method for producing a disintegrating composition according to claim 3, wherein the insoluble dietary fiber is crystalline cellulose. 5. A mixture of (A) agar powder, 1 to 5 times by weight of the agar powder, insoluble dietary fiber and / or yeast, and water or an aqueous ethyl alcohol solution having an alcohol concentration of less than 50% by volume. The disintegrating composition obtained as described above, or the disintegrating composition obtained by further drying the composition, and (B) a food material or a pharmaceutically active ingredient are mixed, and the mixture is tableted or granulated. Manufacturing method of disintegrating molded article.